Texas Health and Safety Code

As effective September 1, 2019

Subtitle A

Chapter 430

Sec. 430.001: Definitions

In this subtitle:

(1) "Commissioner" means the commissioner of state health services.

(2) "Department" means the Department of State Health Services.

(3) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0940, eff. April 2, 2015.

Chapter 431

Subchapter A

Sec. 431.001: Short Title

This chapter may be cited as the Texas Food, Drug, and Cosmetic Act.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.002: Definitions

In this chapter:

(1) "Advertising" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.

(2) "Animal feed," as used in Subdivision (23), in Section 512 of the federal Act, and in provisions of this chapter referring to those paragraphs or sections, means an article intended for use as food for animals other than man as a substantial source of nutrients in the diet of the animals. The term is not limited to a mixture intended to be the sole ration of the animals.

(3) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

(4) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

(5) "Butter" means the food product usually known as butter that is made exclusively from milk or cream, or both, with or without common salt or additional coloring matter, and containing not less than 80 percent by weight of milk fat, after allowing for all tolerances.

(6) (A) "Color additive" means a material that:

(i) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; and

(ii) when added or applied to a food, drug, or cosmetic, or to the human body or any part of the human body, is capable, alone or through reaction with other substance, of imparting color. The term does not include any material exempted under the federal Act.

(B) "Color" includes black, white, and intermediate grays.

(C) Paragraph (A) does not apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.

(7) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

(8) "Consumer commodity," except as otherwise provided by this subdivision, means any food, drug, device, or cosmetic, as those terms are defined by this chapter or by the federal Act, and any other article, product, or commodity of any kind or class that is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or for use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and that usually is consumed or expended in the course of the consumption or use. The term does not include:

(A) a meat or meat product, poultry or poultry product, or tobacco or tobacco product;

(B) a commodity subject to packaging or labeling requirements imposed under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136), or The Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.);

(C) a drug subject to the provisions of Section 431.113(c)(1) or Section 503(b)(1) of the federal Act;

(D) a beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C. 205(e)); or

(E) a commodity subject to the provisions of Chapter 61, Agriculture Code, relating to the inspection, labeling, and sale of agricultural and vegetable seed.

(9) "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations.

(10) "Cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleaning, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of those articles. The term does not include soap.

(11) "Counterfeit drug" means a drug, or the container or labeling of a drug, that, without authorization, bears the trademark, trade name or other identifying mark, imprint, or device of a drug manufacturer, processor, packer, or distributor other than the person who in fact manufactured, processed, packed, or distributed the drug, and that falsely purports or is represented to be the product of, or to have been packed or distributed by, the other drug manufacturer, processor, packer, or distributor.

(12) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

(13) "Device," except when used in Sections 431.003, 431.021(l), 431.082(g), 431.112(c) and 431.142(c), means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:

(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or

(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.

(14) "Drug" means articles recognized in the official United States Pharmacopoeia National Formulary, or any supplement to it, articles designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, articles, other than food, intended to affect the structure or any function of the body of man or other animals, and articles intended for use as a component of any article specified in this subdivision. The term does not include devices or their components, parts, or accessories. A food for which a claim is made in accordance with Section 403(r) of the federal Act, and for which the claim is approved by the secretary, is not a drug solely because the label or labeling contains such a claim.

(15) "Federal Act" means the Federal Food, Drug and Cosmetic Act (Title 21 U.S.C. 301 et seq.).

(16) "Food" means:

(A) articles used for food or drink for man;

(B) chewing gum; and

(C) articles used for components of any such article.

(17) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include:

(A) a pesticide chemical in or on a raw agricultural commodity;

(B) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity;

(C) a color additive;

(D) any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, Pub. L. No. 85-929, 52 Stat. 1041 (codified as amended in various sections of 21 U.S.C.), pursuant to the federal Act, the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the Meat Inspection Act of 1906 (21 U.S.C. 601 et seq.); or

(E) a new animal drug.

(18) "Health authority" means a physician designated to administer state and local laws relating to public health.

(19) "Immediate container" does not include package liners.

(20) "Infant formula" means a food that is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

(21) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information that appears on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of the article, or is easily legible through the outside container or wrapper.

(22) "Labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(23) "Manufacture" means:

(A) the process of combining or purifying food or packaging food for sale to a person at wholesale or retail, and includes repackaging, labeling, or relabeling of any food;

(B) the process of preparing, propagating, compounding, processing, packaging, repackaging, labeling, testing, or quality control of a drug or drug product, but does not include compounding that is done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging that is done in accordance with Section 562.154, Occupations Code;

(C) the process of preparing, fabricating, assembling, processing, packing, repacking, labeling, or relabeling a device; or

(D) the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

(24) "New animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed:

(A) the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of the drug (except that such an unrecognized drug is not deemed to be a "new animal drug" if at any time before June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, and if at that time its labeling contained the same representations concerning the conditions of its use);

(B) the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under those conditions, has become recognized but that has not, otherwise than in the investigations, been used to a material extent or for a material time under those conditions; or

(C) is composed wholly or partly of penicillin, streptomycin, chloratetracycline, chloramphenicol, or bacitracin, or any derivative of those substances, unless:

(i) a published order of the secretary is in effect that declares the drug not to be a new animal drug on the grounds that the requirement of certification of batches of the drug, as provided by Section 512(n) of the federal Act, is not necessary to ensure that the objectives specified in Section 512(n)(3) of that Act are achieved; and

(ii) Paragraph (A) or (B) of this subdivision does not apply to the drug.

(25) "New drug" means:

(A) any drug, except a new animal drug, the composition of which is such that such drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof (except that such an unrecognized drug is not a "new drug" if at any time before May 26, 1985, it was subject to the Food and Drug Act of June 30, 1906, and if at that time its labeling contained the same representations concerning the conditions of its use); or

(B) any drug, except a new animal drug, the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(26) "Official compendium" means the official United States Pharmacopoeia National Formulary, or any supplement to it.

(27) "Package" means any container or wrapping in which a consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers. The term includes wrapped meats enclosed in papers or other materials as prepared by the manufacturers thereof for sale. The term does not include:

(A) shipping containers or wrappings used solely for the transportation of a consumer commodity in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors;

(B) shipping containers or outer wrappings used by retailers to ship or deliver a commodity to retail customers if the containers and wrappings do not bear printed matter relating to any particular commodity; or

(C) containers subject to the provisions of the Standard Barrel Act (Apple Barrels) (15 U.S.C. 231, 21 U.S.C. 20) or the Standard Barrel Act (Fruits and Vegetables) (15 U.S.C. 234-236).

(28) "Person" includes individual, partnership, corporation, and association.

(29) "Pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances, is a "pesticide" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136(u)), as now in force or as amended, and that is used in the production, storage, or transportation of raw agricultural commodities.

(30) "Principal display panel" means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.

(31) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

(32) "Saccharin" includes calcium saccharin, sodium saccharin, and ammonium saccharin.

(33) "Safe" refers to the health of humans or animals.

(34) "Secretary" means the secretary of the United States Department of Health and Human Services.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 149, eff. Sept. 1, 1991; Acts 1991, 72nd Leg., ch. 539, Sec. 1, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 459, Sec. 1, eff. Sept. 1, 1993; Acts 1997, 75th Leg., ch. 629, Sec. 1, eff. Sept. 1, 1997; Acts 2003, 78th Leg., ch. 111, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 383, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 982, Sec. 1, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 1099, Sec. 1, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch. 28 (S.B. 492), Sec. 5, eff. September 1, 2005.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0941, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0942, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(75), eff. April 2, 2015.

Sec. 431.003: Article Misbranded Because of Misleading Labeling Or Advertising

If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or any combination of these, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof, or under such conditions of use as are customary or usual.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 150, eff. Sept. 1, 1991.

Sec. 431.004: Representation of Drug As Antiseptic

The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that the drug is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.005: Provisions Regarding Sale of Food, Drugs, Devices, Or Cosmetics

The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics, shall be considered to include the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug, or cosmetic establishment.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.006: Certain Combination Products

If the United States Food and Drug Administration determines, with respect to a product that is a combination of a drug and a device, that:

(1) the primary mode of action of the product is as a drug, a person who engages in wholesale distribution of the product is subject to licensure under Subchapter I; and

(2) the primary mode of action of the product is as a device, a distributor or manufacturer of the product is subject to licensure under Subchapter L.

Comments

Added by Acts 1999, 76th Leg., ch. 132, Sec. 1, eff. May 20, 1999.

Sec. 431.007: Compliance with Other Law; Molluscan Shellfish

A person who is subject to this chapter and who handles molluscan shellfish, as that term is defined by Section 436.002, shall comply with Section 436.105.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 1, eff. June 18, 1999. Renumbered from Sec. 431.006 by Acts 2001, 77th Leg., ch. 1420, Sec. 21.001(78), eff. Sept. 1, 2001.

Sec. 431.008: Applicability of Chapter to Distressed Or Reconditioned Merchandise and Certain Licensed Entities

(a) This chapter applies to a food, drug, device, or cosmetic that is distressed merchandise for purposes of Chapter 432 or that has been subject to reconditioning in accordance with Chapter 432.

(b) Except as provided by Subsection (c), this chapter applies to the conduct of a person licensed under Chapter 432.

(c) A person who holds a license under Chapter 432 and is engaging in conduct within the scope of that license is not required to hold a license as a wholesale drug distributor under Subchapter I, a food wholesaler under Subchapter J, or a device distributor under Subchapter L.

Comments

Added by Acts 2001, 77th Leg., ch. 265, Sec. 1, eff. May 22, 2001.

Sec. 431.009: Applicability of Chapter to Frozen Desserts

(a) This chapter applies to a frozen dessert, an imitation frozen dessert, a product sold in semblance of a frozen dessert, or a mix for one of those products subject to Chapter 440. A frozen dessert, an imitation frozen dessert, a product sold in semblance of a frozen dessert, or a mix for one of those products is food for purposes of this chapter.

(b) Except as provided by Subsection (c), this chapter applies to the conduct of a person licensed under Chapter 440.

(c) A person who holds a license under Chapter 440 related to the manufacturing of a product regulated under that chapter and is engaging in conduct within the scope of that license is not required to hold a license as a food manufacturer or food wholesaler under Subchapter J.

Comments

Added by Acts 2003, 78th Leg., ch. 112, Sec. 1, eff. Sept. 1, 2003.

Sec. 431.010: Applicability of Chapter to Milk and Milk Products

(a) This chapter applies to milk or a milk product subject to Chapter 435. Milk or a milk product is a food for purposes of this chapter.

(b) Except as provided by Subsection (c), this chapter applies to the conduct of a person who holds a permit under Chapter 435.

(c) A person who holds a permit under Chapter 435 related to the processing, producing, bottling, receiving, transferring, or transporting of Grade A milk or milk products and who is engaging in conduct within the scope of that permit is not required to hold a license as a food manufacturer or food wholesaler under Subchapter J.

Comments

Added by Acts 2003, 78th Leg., ch. 757, Sec. 1, eff. Sept. 1, 2003.

Sec. 431.011: Applicability of Chapter to Consumable Hemp Products and Manufacturers

(a) This chapter applies to a consumable hemp product subject to Chapter 443. An article regulated under this chapter may not be deemed to be adulterated solely on the basis that the article is a consumable hemp product.

(b) Except as provided by Subsection (c), this chapter applies to the conduct of a person who holds a license under Chapter 443.

(c) A person who holds a license under Chapter 443 related to the processing of hemp or the manufacturing of a consumable hemp product regulated under that chapter and is engaging in conduct within the scope of that license is not required to hold a license as a food manufacturer or food wholesaler under Subchapter J.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 4, eff. June 10, 2019.

Subchapter B

Sec. 431.021: Prohibited Acts

The following acts and the causing of the following acts within this state are unlawful and prohibited:

(a) the introduction or delivery for introduction into commerce of any food, drug, device, or cosmetic that is adulterated or misbranded;

(b) the adulteration or misbranding of any food, drug, device, or cosmetic in commerce;

(c) the receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

(d) the distribution in commerce of a consumer commodity, if such commodity is contained in a package, or if there is affixed to that commodity a label that does not conform to the provisions of this chapter and of rules adopted under the authority of this chapter; provided, however, that this prohibition shall not apply to persons engaged in business as wholesale or retail distributors of consumer commodities except to the extent that such persons:

(1) are engaged in the packaging or labeling of such commodities; or

(2) prescribe or specify by any means the manner in which such commodities are packaged or labeled;

(e) the introduction or delivery for introduction into commerce of any article in violation of Section 431.084, 431.114, or 431.115;

(f) the dissemination of any false advertisement;

(g) the refusal to permit entry or inspection, or to permit the taking of a sample or to permit access to or copying of any record as authorized by Sections 431.042-431.044; or the failure to establish or maintain any record or make any report required under Section 512(j), (l), or (m) of the federal Act, or the refusal to permit access to or verification or copying of any such required record;

(h) the manufacture within this state of any food, drug, device, or cosmetic that is adulterated or misbranded;

(i) the giving of a guaranty or undertaking referred to in Section 431.059, which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in this state from whom the person received in good faith the food, drug, device, or cosmetic; or the giving of a guaranty or undertaking referred to in Section 431.059, which guaranty or undertaking is false;

(j) the use, removal, or disposal of a detained or embargoed article in violation of Section 431.048;

(k) the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale after shipment in commerce and results in such article being adulterated or misbranded;

(l) (1) forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under this chapter or the regulations promulgated under the provisions of the federal Act;

(2) making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing on any drug or container or labeling thereof so as to render such drug a counterfeit drug;

(3) the doing of any act that causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug;

(m) the using by any person to the person's own advantage, or revealing, other than to the department, to a health authority, or to the courts when relevant in any judicial proceeding under this chapter, of any information acquired under the authority of this chapter concerning any method or process that as a trade secret is entitled to protection;

(n) the using, on the labeling of any drug or device or in any advertising relating to such drug or device, of any representation or suggestion that approval of an application with respect to such drug or device is in effect under Section 431.114 or Section 505, 515, or 520(g) of the federal Act, as the case may be, or that such drug or device complies with the provisions of such sections;

(o) the using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Sections 431.042-431.044 or Section 704 of the federal Act;

(p) in the case of a prescription drug distributed or offered for sale in this state, the failure of the manufacturer, packer, or distributor of the drug to maintain for transmittal, or to transmit, to any practitioner licensed by applicable law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter that is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved under the federal Act. Nothing in this subsection shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this chapter;

(q) (1) placing or causing to be placed on any drug or device or container of any drug or device, with intent to defraud, the trade name or other identifying mark, or imprint of another or any likeness of any of the foregoing;

(2) selling, dispensing, disposing of or causing to be sold, dispensed, or disposed of, or concealing or keeping in possession, control, or custody, with intent to sell, dispense, or dispose of, any drug, device, or any container of any drug or device, with knowledge that the trade name or other identifying mark or imprint of another or any likeness of any of the foregoing has been placed thereon in a manner prohibited by Subdivision (1); or

(3) making, selling, disposing of, causing to be made, sold, or disposed of, keeping in possession, control, or custody, or concealing with intent to defraud any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing on any drug or container or labeling of any drug or container so as to render such drug a counterfeit drug;

(r) dispensing or causing to be dispensed a different drug in place of the drug ordered or prescribed without the express permission in each case of the person ordering or prescribing;

(s) the failure to register in accordance with Section 510 of the federal Act, the failure to provide any information required by Section 510(j) or (k) of the federal Act, or the failure to provide a notice required by Section 510(j)(2) of the federal Act;

(t) (1) the failure or refusal to:

(A) comply with any requirement prescribed under Section 518 or 520(g) of the federal Act; or

(B) furnish any notification or other material or information required by or under Section 519 or 520(g) of the federal Act;

(2) with respect to any device, the submission of any report that is required by or under this chapter that is false or misleading in any material respect;

(u) the movement of a device in violation of an order under Section 304(g) of the federal Act or the removal or alteration of any mark or label required by the order to identify the device as detained;

(v) the failure to provide the notice required by Section 412(b) or 412(c), the failure to make the reports required by Section 412(d)(1)(B), or the failure to meet the requirements prescribed under Section 412(d)(2) of the federal Act;

(w) except as provided under Subchapter M of this chapter and Section 562.1085, Occupations Code, the acceptance by a person of an unused prescription or drug, in whole or in part, for the purpose of resale, after the prescription or drug has been originally dispensed, or sold;

(x) engaging in the wholesale distribution of drugs or operating as a distributor or manufacturer of devices in this state without obtaining a license issued by the department under Subchapter I, L, or N, as applicable;

(y) engaging in the manufacture of food in this state or operating as a warehouse operator in this state without having a license as required by Section 431.222 or operating as a food wholesaler in this state without having a license under Section 431.222 or being registered under Section 431.2211, as appropriate;

(z) unless approved by the United States Food and Drug Administration pursuant to the federal Act, the sale, delivery, holding, or offering for sale of a self-testing kit designed to indicate whether a person has a human immunodeficiency virus infection, acquired immune deficiency syndrome, or a related disorder or condition;

(aa) making a false statement or false representation in an application for a license or in a statement, report, or other instrument to be filed with or requested by the department under this chapter;

(bb) failing to comply with a requirement or request to provide information or failing to submit an application, statement, report, or other instrument required by the department;

(cc) performing, causing the performance of, or aiding and abetting the performance of an act described by Subsection (x);

(dd) purchasing or otherwise receiving a prescription drug from a pharmacy in violation of Section 431.411(a);

(ee) selling, distributing, or transferring a prescription drug to a person who is not authorized under state or federal law to receive the prescription drug in violation of Section 431.411(b);

(ff) failing to deliver prescription drugs to specified premises as required by Section 431.411(c);

(gg) failing to maintain or provide pedigrees as required by Section 431.412 or 431.413;

(hh) failing to obtain, pass, or authenticate a pedigree as required by Section 431.412 or 431.413;

(ii) the introduction or delivery for introduction into commerce of a drug or prescription device at a flea market;

(jj) the receipt of a prescription drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit, and the delivery or proffered delivery of such a drug for payment or otherwise; or

(kk) the alteration, mutilation, destruction, obliteration, or removal of all or any part of the labeling of a prescription drug or the commission of any other act with respect to a prescription drug that results in the prescription drug being misbranded.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 151, eff. Sept. 1, 1991; Acts 1991, 72nd Leg., ch. 539, Sec. 2, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 440, Sec. 1, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 1047, Sec. 6, eff. Sept. 1, 1995; Acts 1997, 75th Leg., ch. 282, Sec. 1, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 262, Sec. 1, eff. Sept. 1, 2001; Acts 2001, 77th Leg., ch. 1138, Sec. 2, eff. Jan. 1, 2002; Acts 2003, 78th Leg., ch. 198, Sec. 2.71, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 321, Sec. 2, eff. June 18, 2003; Acts 2003, 78th Leg., ch. 383, Sec. 2, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 982, Sec. 2, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(i), eff. March 1, 2006.

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 1, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0943, eff. April 2, 2015.

Sec. 431.0211: Exception

Any provision of Section 431.021 that relates to a prescription drug does not apply to a prescription drug manufacturer, or an agent of a prescription drug manufacturer, who is obtaining or attempting to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 2, eff. September 1, 2007.

Sec. 431.022: Offense: Transfer of Product Containing Ephedrine

(a) A person commits an offense if the person knowingly sells, transfers, or otherwise furnishes a product containing ephedrine to a person 17 years of age or younger, unless:

(1) the actor is:

(A) a practitioner or other health care provider licensed by this state who has obtained, as required by law, consent to the treatment of the person to whom the product is furnished; or

(B) the parent, guardian, or managing conservator of the person to whom the product is furnished;

(2) the person to whom the product is furnished has had the disabilities of minority removed for general purposes under Chapter 31, Family Code; or

(3) the product is a drug.

(b) An offense under this section is a Class C misdemeanor unless it is shown on the trial of the offense that the defendant has been previously convicted of an offense under this section, in which event the offense is a Class B misdemeanor.

(c) A product containing ephedrine that is not described in Subsection (a)(3) must be labeled in accordance with department rules to indicate that sale to persons 17 years of age or younger is prohibited.

Comments

Added by Acts 1999, 76th Leg., ch. 151, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0944, eff. April 2, 2015.

Sec. 431.023: Limited Exemption for Distressed Food, Drugs, Devices, Or Cosmetics

In relation to a food, drug, device, or cosmetic that is distressed merchandise for purposes of Chapter 432, Sections 431.021(a), (c), and (d) do not prohibit:

(1) the introduction or delivery for introduction into commerce of the merchandise for the purpose of reconditioning in accordance with Chapter 432 and not for sale to the ultimate consumer;

(2) the receipt in commerce of the merchandise for the purpose of reconditioning in accordance with Chapter 432 and not for sale to the ultimate consumer;

(3) the holding of merchandise for the purpose of reconditioning in accordance with Chapter 432 and not for resale to the ultimate consumer; or

(4) the reconditioning of the merchandise in accordance with Chapter 432.

Comments

Added by Acts 2001, 77th Leg., ch. 265, Sec. 2, eff. May 22, 2001.

Subchapter C

Sec. 431.041: Definition

In this subchapter, "detained or embargoed article" means a food, drug, device, cosmetic, or consumer commodity that has been detained or embargoed under Section 431.048.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.042: Inspection

(a) To enforce this chapter, the department or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge:

(1) enter at reasonable times an establishment, including a factory or warehouse, in which a food, drug, device, or cosmetic is manufactured, processed, packed, or held for introduction into commerce or held after the introduction;

(2) enter a vehicle being used to transport or hold the food, drug, device, or cosmetic in commerce; or

(3) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the establishment or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of this chapter.

(b) The inspection of an establishment, including a factory, warehouse, or consulting laboratory, in which a prescription drug or restricted device is manufactured, processed, packed, or held for introduction into commerce extends to any place or thing, including a record, file, paper, process, control, or facility, in order to determine whether the drug or device:

(1) is adulterated or misbranded;

(2) may not be manufactured, introduced into commerce, sold, or offered for sale under this chapter; or

(3) is otherwise in violation of this chapter.

(c) An inspection under Subsection (b) may not extend to:

(1) financial data;

(2) sales data other than shipment data;

(3) pricing data;

(4) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under this chapter;

(5) research data other than data:

(A) relating to new drugs, antibiotic drugs, and devices; and

(B) subject to reporting and inspection under regulations issued under Section 505(i) or (j), 519, or 520(g) of the federal Act; or

(6) data relating to other drugs or devices that, in the case of a new drug, would be subject to reporting or inspection under regulations issued under Section 505(j) of the federal Act.

(d) An inspection under Subsection (b) shall be started and completed with reasonable promptness.

(e) This section does not apply to:

(1) a pharmacy that:

(A) complies with Subtitle J, Title 3, Occupations Code;

(B) regularly engages in dispensing prescription drugs or devices on prescriptions of practitioners licensed to administer the drugs or devices to their patients in the course of their professional practice; and

(C) does not, through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process a drug or device for sale other than in the regular course of its business of dispensing or selling drugs or devices at retail;

(2) a practitioner licensed to prescribe or administer a drug who manufactures, prepares, propagates, compounds, or processes the drug solely for use in the course of the practitioner's professional practice;

(3) a practitioner licensed to prescribe or use a device who manufactures or processes the device solely for use in the course of the practitioner's professional practice; or

(4) a person who manufactures, prepares, propagates, compounds, or processes a drug or manufactures or processes a device solely for use in research, teaching, or chemical analysis and not for sale.

(f) The executive commissioner may exempt a class of persons from inspection under this section if the executive commissioner finds that inspection as applied to the class is not necessary for the protection of the public health.

(g) The department or a health authority who makes an inspection under this section to enforce the provisions of this chapter applicable to infant formula shall be permitted, at all reasonable times, to have access to and to copy and verify records:

(1) in order to determine whether the infant formula manufactured or held in the inspected facility meets the requirements of this chapter; or

(2) that are required by this chapter.

(h) If the department or a health authority while inspecting an establishment, including a factory or warehouse, obtains a sample, the department or health authority before leaving the establishment shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.793, eff. Sept. 1, 2001; Acts 2003, 78th Leg., ch. 111, Sec. 2, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0945, eff. April 2, 2015.

Sec. 431.043: Access to Records

A person who is required to maintain records under this chapter or Section 519 or 520(g) of the federal Act or a person who is in charge or custody of those records shall, at the request of the department or a health authority, permit the department or health authority at all reasonable times access to and to copy and verify the records, including records that verify that the hemp in a consumable hemp product was produced in accordance with Chapter 122, Agriculture Code, or 7 U.S.C. Chapter 38, Subchapter VII.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0946, eff. April 2, 2015.

Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 5, eff. June 10, 2019.

Sec. 431.044: Access to Records Showing Movement in Commerce

(a) To enforce this chapter, a carrier engaged in commerce or other person receiving a food, drug, device, or cosmetic in commerce or holding a food, drug, device, or cosmetic received in commerce shall, at the request of the department or a health authority, permit the department or health authority at all reasonable times to have access to and to copy all records showing:

(1) the movement in commerce of the food, drug, device, or cosmetic;

(2) the holding of the food, drug, device, or cosmetic after movement in commerce; and

(3) the quantity, shipper, and consignee of the food, drug, device, or cosmetic.

(b) The carrier or other person may not refuse access to and copying of the requested record if the request is accompanied by a written statement that specifies the nature or kind of food, drug, device, or cosmetic to which the request relates.

(c) Evidence obtained under this section or evidence that is directly or indirectly derived from the evidence obtained under this section may not be used in a criminal prosecution of the person from whom the evidence is obtained.

(d) A carrier is not subject to other provisions of this chapter because of the carrier's receipt, carriage, holding, or delivery of a food, drug, device, or cosmetic in the usual course of business as a carrier.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0947, eff. April 2, 2015.

Sec. 431.045: Emergency Order

(a) The commissioner or a person designated by the commissioner may issue an emergency order, either mandatory or prohibitory in nature, in relation to the manufacture or distribution of a food, drug, device, or cosmetic in the department's jurisdiction if the commissioner or the person designated by the commissioner determines that:

(1) the manufacture or distribution of the food, drug, device, or cosmetic creates or poses an immediate and serious threat to human life or health; and

(2) other procedures available to the department to remedy or prevent the occurrence of the situation will result in unreasonable delay.

(b) The commissioner or a person designated by the commissioner may issue the emergency order without notice and hearing if the commissioner or a person designated by the commissioner determines this is practicable under the circumstances.

(c) If an emergency order is issued without a hearing, the department shall propose a time and place for a hearing and refer the matter to the State Office of Administrative Hearings. An administrative law judge of that office shall set the time and place for the hearing at which the emergency order is affirmed, modified, or set aside. The hearing shall be held under the contested case provisions of Chapter 2001, Government Code, and the department's formal hearing rules.

(d) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 629, Sec. 4, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 262, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0948, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(75), eff. April 2, 2015.

Sec. 431.046: Violation of Rules

A violation of a rule adopted under this chapter is a violation of this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.047: Violation; Injunction

(a) The department or a health authority may petition the district court for a temporary restraining order to restrain a continuing violation of Subchapter B or a threat of a continuing violation of Subchapter B if the department or health authority finds that:

(1) a person has violated, is violating, or is threatening to violate Subchapter B; and

(2) the violation or threatened violation creates an immediate threat to the health and safety of the public.

(b) A district court, on petition of the department or a health authority, and on a finding by the court that a person is violating or threatening to violate Subchapter B shall grant any injunctive relief warranted by the facts.

(c) Venue for a suit brought under this section is in the county in which the violation or threat of violation is alleged to have occurred or in Travis County.

(d) The department and the attorney general may each recover reasonable expenses incurred in obtaining injunctive relief under this section, including investigative costs, court costs, reasonable attorney fees, witness fees, and deposition expenses. The expenses recovered by the department may be used by the department for the administration and enforcement of this chapter. The expenses recovered by the attorney general may be used by the attorney general.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 3, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0949, eff. April 2, 2015.

Sec. 431.048: Detained Or Embargoed Article

(a) The department shall affix to an article that is a food, drug, device, cosmetic, or consumer commodity a tag or other appropriate marking that gives notice that the article is, or is suspected of being, adulterated or misbranded and that the article has been detained or embargoed if the department finds or has probable cause to believe that the article:

(1) is adulterated;

(2) is misbranded so that the article is dangerous or fraudulent under this chapter; or

(3) violates Section 431.084, 431.114, or 431.115.

(b) The tag or marking on a detained or embargoed article must warn all persons not to use the article, remove the article from the premises, or dispose of the article by sale or otherwise until permission for use, removal, or disposal is given by the department or a court.

(c) A person may not use a detained or embargoed article, remove a detained or embargoed article from the premises, or dispose of a detained or embargoed article by sale or otherwise without permission of the department or a court. The department may permit perishable goods to be moved to a place suitable for proper storage.

(d) The department shall remove the tag or other marking from an embargoed or detained article if the department finds that the article is not adulterated or misbranded.

(e) The department may not detain or embargo an article, including an article that is distressed merchandise, that is in the possession of a person licensed under Chapter 432 and that is being held for the purpose of reconditioning in accordance with Chapter 432, unless the department finds or has probable cause to believe that the article cannot be adequately reconditioned in accordance with that chapter and applicable rules.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 282, Sec. 2, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 265, Sec. 3, eff. May 22, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0950, eff. April 2, 2015.

Sec. 431.049: Removal Order for Detained Or Embargoed Article

(a) If the claimant of the detained or embargoed articles or the claimant's agent fails or refuses to transfer the articles to a secure place after the tag or other appropriate marking has been affixed as provided by Section 431.048, the department may order the transfer of the articles to one or more secure storage areas to prevent their unauthorized use, removal, or disposal.

(b) The department may provide for the transfer of the article if the claimant of the article or the claimant's agent does not carry out the transfer order in a timely manner. The costs of the transfer shall be assessed against the claimant of the article or the claimant's agent.

(c) The claimant of the article or the claimant's agent shall pay the costs of the transfer.

(d) The department may request the attorney general to bring an action in the district court in Travis County to recover the costs of the transfer. In a judgment in favor of the state, the court may award costs, attorney fees, court costs, and interest from the time the expense was incurred through the date the department is reimbursed.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 152, eff. Sept. 1, 1991; Acts 1997, 75th Leg., ch. 282, Sec. 3, eff. Sept. 1, 1997.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0951, eff. April 2, 2015.

Sec. 431.0495: Recall Orders

(a) In conjunction with the issuance of an emergency order under Section 431.045 or the detention or embargo of an article under Section 431.048, the commissioner may order a food, drug, device, cosmetic, or consumer commodity to be recalled from commerce.

(b) The commissioner's recall order may require the articles to be removed to one or more secure areas approved by the department.

(c) The recall order must be in writing and signed by the commissioner.

(d) The recall order may be issued before or in conjunction with the affixing of the tag or other appropriate marking as provided by Section 431.048(a) or in conjunction with the commissioner's issuance of an emergency order under Section 431.045.

(e) The recall order is effective until the order:

(1) expires on its own terms;

(2) is withdrawn by the commissioner;

(3) is reversed by a court in an order denying condemnation under Section 431.050; or

(4) is set aside at the hearing provided to affirm, modify, or set aside an emergency order under Section 431.045.

(f) The claimant of the articles or the claimant's agent shall pay the costs of the removal and storage of the articles removed.

(g) If the claimant or the claimant's agent fails or refuses to carry out the recall order in a timely manner, the commissioner may provide for the recall of the articles. The costs of the recall shall be assessed against the claimant of the articles or the claimant's agent.

(h) The commissioner may request the attorney general to bring an action in the district court of Travis County to recover the costs of the recall. In a judgment in favor of the state, the court may award costs, attorney fees, court costs, and interest from the time the expense was incurred through the date the department is reimbursed.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 153, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0952, eff. April 2, 2015.

Sec. 431.050: Condemnation

An action for the condemnation of an article may be brought before a court in whose jurisdiction the article is located, detained, or embargoed if the article is adulterated, misbranded, or in violation of Section 431.084, 431.114, or 431.115.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.051: Destruction of Article

(a) A court shall order the destruction of a sampled article or a detained or embargoed article if the court finds that the article is adulterated or misbranded.

(b) After entry of the court's order, an authorized agent shall supervise the destruction of the article.

(c) The claimant of the article shall pay the cost of the destruction of the article.

(d) The court shall tax against the claimant of the article or the claimant's agent all court costs and fees, and storage and other proper expenses.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.052: Correction By Proper Labeling Or Processing

(a) A court may order the delivery of a sampled article or a detained or embargoed article that is adulterated or misbranded to the claimant of the article for labeling or processing under the supervision of the department if:

(1) the decree has been entered in the suit;

(2) the costs, fees, and expenses of the suit have been paid;

(3) the adulteration or misbranding can be corrected by proper labeling or processing; and

(4) a good and sufficient bond, conditioned on the correction of the adulteration or misbranding by proper labeling or processing, has been executed.

(b) The claimant shall pay the costs of the supervision.

(c) The court shall order that the article be returned to the claimant and the bond discharged on the representation to the court by the department that the article no longer violates this chapter and that the expenses of the supervision are paid.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0953, eff. April 2, 2015.

Sec. 431.053: Condemnation of Perishable Articles

(a) The department shall immediately condemn or render by any means unsalable as human food an article that is a nuisance under Subsection (b) and that the department finds in any room, building, or other structure or in a vehicle.

(b) Any meat, seafood, poultry, vegetable, fruit, or other perishable article is a nuisance if it:

(1) is unsound;

(2) contains a filthy, decomposed, or putrid substance; or

(3) may be poisonous or deleterious to health or otherwise unsafe.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0954, eff. April 2, 2015.

Sec. 431.054: Administrative Penalty

(a) The department may assess an administrative penalty against a person who violates Subchapter B or an order adopted or registration issued under this chapter.

(b) In determining the amount of the penalty, the department shall consider:

(1) the person's previous violations;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the person's demonstrated good faith; and

(5) such other matters as justice may require.

(c) The penalty may not exceed $25,000 a day for each violation.

(d) Each day a violation continues may be considered a separate violation.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 4, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0955, eff. April 2, 2015.

Sec. 431.055: Administrative Penalty Assessment Procedure

(a) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.

(b) If a hearing is held, an administrative law judge of the State Office of Administrative Hearings shall make findings of fact and shall issue to the department a written proposal for decision regarding the occurrence of the violation and the amount of the penalty that may be warranted.

(c) If the person charged with the violation does not request a hearing, the department may assess a penalty after determining that a violation has occurred and the amount of the penalty that may be warranted.

(d) After making a determination under this section that a penalty is to be assessed against a person, the department shall issue an order requiring that the person pay the penalty.

(e) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0956, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(75), eff. April 2, 2015.

Sec. 431.056: Payment of Administrative Penalty

(a) Not later than the 30th day after the date an order finding that a violation has occurred is issued, the department shall inform the person against whom the order is issued of the amount of the penalty for the violation.

(b) Not later than the 30th day after the date on which a decision or order charging a person with a penalty is final, the person shall:

(1) pay the penalty in full; or

(2) file a petition for judicial review of the department's order contesting the amount of the penalty, the fact of the violation, or both.

(b-1) If the person seeks judicial review within the period prescribed by Subsection (b), the person may:

(1) stay enforcement of the penalty by:

(A) paying the amount of the penalty to the court for placement in an escrow account; or

(B) posting with the court a supersedeas bond for the amount of the penalty; or

(2) request that the department stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(B) sending a copy of the affidavit to the department.

(b-2) If the department receives a copy of an affidavit under Subsection (b-1)(2), the department may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(c) A bond posted under this section must be in a form approved by the court and be effective until all judicial review of the order or decision is final.

(d) A person who does not send money to, post the bond with, or file the affidavit with the court within the period prescribed by Subsection (b) waives all rights to contest the violation or the amount of the penalty.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0957, eff. April 2, 2015.

Sec. 431.057: Refund of Administrative Penalty

On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order that:

(1) the appropriate amount of any penalty payment plus accrued interest be remitted to the person not later than the 30th day after that date; or

(2) the bond be released, if the person has posted a bond.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0958, eff. April 2, 2015.

Sec. 431.058: Recovery of Administrative Penalty By Attorney General

The attorney general at the request of the department may bring a civil action to recover an administrative penalty under this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0959, eff. April 2, 2015.

Sec. 431.0585: Civil Penalty

(a) At the request of the department, the attorney general or a district, county, or city attorney shall institute an action in district court to collect a civil penalty from a person who has violated Section 431.021.

(b) The civil penalty may not exceed $25,000 a day for each violation. Each day of violation constitutes a separate violation for purposes of the penalty assessment.

(c) The court shall consider the following in determining the amount of the penalty:

(1) the person's history of any previous violations of Section 431.021;

(2) the seriousness of the violation;

(3) any hazard posed to the public health and safety by the violation; and

(4) demonstrations of good faith by the person charged.

(d) Venue for a suit brought under this section is in the city or county in which the violation occurred or in Travis County.

(e) A civil penalty recovered in a suit instituted by a local government under this section shall be paid to that local government.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 154, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0960, eff. April 2, 2015.

Sec. 431.059: Criminal Penalty; Defenses

(a) A person commits an offense if the person violates any of the provisions of Section 431.021 relating to unlawful or prohibited acts. A first offense under this subsection is a Class A misdemeanor unless it is shown on the trial of an offense under this subsection that the defendant was previously convicted of an offense under this subsection, in which event the offense is a state jail felony. In a criminal proceeding under this section, it is not necessary to prove intent, knowledge, recklessness, or criminal negligence of the defendant beyond the degree of culpability, if any, stated in Section 431.021 to establish criminal responsibility for the violation.

(a-1) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(a-2) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(b) A person is not subject to the penalties of Subsection (a):

(1) for having received an article in commerce and having delivered or offered delivery of the article, if the delivery or offer was made in good faith, unless the person refuses to furnish, on request of the department or a health authority, the name and address of the person from whom the article was received and copies of any documents relating to the receipt of the article;

(2) for having violated Section 431.021(a) or (e) if the person establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in this state from whom the person received in good faith the article, to the effect that:

(A) in the case of an alleged violation of Section 431.021(a), the article is not adulterated or misbranded within the meaning of this chapter; and

(B) in the case of an alleged violation of Section 431.021(e), the article is not an article that may not, under the provisions of Section 404 or 405 of the federal Act or Section 431.084 or 431.114, be introduced into commerce;

(3) for having violated Section 431.021, if the violation exists because the article is adulterated by reason of containing a color additive not from a batch certified in accordance with regulations promulgated under the federal Act, if the person establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer of the color additive, to the effect that the color additive was from a batch certified in accordance with the applicable regulations promulgated under the federal Act;

(4) for having violated Section 431.021(b), (c), or (k) by failure to comply with Section 431.112(i) with respect to an article received in commerce to which neither Section 503(a) nor Section 503(b)(1) of the federal Act applies if the delivery or offered delivery was made in good faith and the labeling at the time of the delivery or offer contained the same directions for use and warning statements as were contained in the labeling at the same time of the receipt of the article; or

(5) for having violated Section 431.021(l)(2) if the person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing would result in a drug being a counterfeit drug, or for having violated Section 431.021(l)(3) if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug.

(c) A publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, is not liable under this section for the dissemination of the false advertisement, unless the person has refused, on the request of the department, to furnish the department the name and post-office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in this state who caused the person to disseminate the advertisement.

(d) A person is not subject to the penalties of Subsection (a) for a violation of Section 431.021 involving misbranded food if the violation exists solely because the food is misbranded under Section 431.082 because of its advertising, and a person is not subject to the penalties of Subsection (a) for such a violation unless the violation is committed with the intent to defraud or mislead.

(e) It is an affirmative defense to prosecution under Subsection (a) that the conduct charged is exempt, in accordance with Section 431.023, from the application of Section 431.021.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 155, eff. Sept. 1, 1991; Acts 2001, 77th Leg., ch. 265, Sec. 4, eff. May 22, 2001; Acts 2003, 78th Leg., ch. 111, Sec. 3, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 383, Sec. 3, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 982, Sec. 3, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(h), eff. March 1, 2006.

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 14, eff. September 1, 2007.

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 14 Sec. 14, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0961, eff. April 2, 2015.

Sec. 431.060: Initiation of Proceedings

(a) The attorney general, or a district, county, or municipal attorney to whom the department or a health authority reports a violation of this chapter, shall initiate and prosecute appropriate proceedings without delay.

(b) The department or attorney general may, as authorized by Section 307 of the federal Act, bring in the name of this state a suit for civil penalties or to restrain a violation of Section 401 or Section 403(b) through (i), (k), (q), or (r) of the federal Act if the food that is the subject of the proceedings is located in this state.

(c) The department or attorney general may not bring a proceeding under Subsection (b):

(1) before the 31st day after the date on which the state has given notice to the secretary of its intent to bring a suit;

(2) before the 91st day after the date on which the state has given notice to the secretary of its intent to bring a suit if the secretary has, not later than the 30th day after receiving notice from the state, commenced an informal or formal enforcement action pertaining to the food that would be the subject of the suit brought by the state; or

(3) if the secretary is diligently prosecuting a suit in court pertaining to that food, has settled a suit pertaining to that food, or has settled the informal or formal enforcement action pertaining to that food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 459, Sec. 2, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0962, eff. April 2, 2015.

Sec. 431.061: Minor Violation

This chapter does not require the department or a health authority to report for prosecution or the institution of proceedings under this chapter a minor violation of this chapter if the department or health authority believes that the public interest is adequately served by a suitable written notice or warning.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0963, eff. April 2, 2015.

Subchapter D

Sec. 431.081: Adulterated Food

A food shall be deemed to be adulterated:

(a) if:

(1) it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance the food shall not be considered adulterated under this subdivision if the quantity of the substance in the food does not ordinarily render it injurious to health;

(2) it:

(A) bears or contains any added poisonous or added deleterious substance, other than one that is a pesticide chemical in or on a raw agricultural commodity, a food additive, a color additive, or a new animal drug which is unsafe within the meaning of Section 431.161;

(B) is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of Section 431.161(a);

(C) is, or it bears or contains, any food additive which is unsafe within the meaning of Section 431.161(a); provided, that where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under Section 431.161(a), and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of Section 431.161 and Section 409 of the federal Act, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of such residue in the processed food, when ready to eat, is not greater than the tolerance prescribed for the raw agricultural commodity; or

(D) is, or it bears or contains, a new animal drug, or a conversion product of a new animal drug, that is unsafe under Section 512 of the federal Act;

(3) it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for foods;

(4) it has been produced, prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome, or injurious to health;

(5) it is, in whole or in part, the product of a diseased animal, an animal which has died otherwise than by slaughter, or an animal that has been fed upon the uncooked offal from a slaughterhouse;

(6) its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(7) it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect in accordance with Section 409 of the federal Act;

(b) if:

(1) any valuable constituent has been in whole or in part omitted or abstracted therefrom;

(2) any substance has been substituted wholly or in part therefor;

(3) damage or inferiority has been concealed in any manner;

(4) any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is;

(5) it contains saccharin, dulcin, glucin, or other sugar substitutes except in dietary foods, and when so used shall be declared; or

(6) it be fresh meat and it contains any chemical substance containing sulphites, sulphur dioxide, or any other chemical preservative which is not approved by the United States Department of Agriculture, the Animal and Plant Health Inspection Service (A.P.H.I.S.) or by department rules;

(c) if it is, or it bears or contains, a color additive that is unsafe under Section 431.161(a); or

(d) if it is confectionery and:

(1) has any nonnutritive object partially or completely imbedded in it; provided, that this subdivision does not apply if, in accordance with department rules, the object is of practical, functional value to the confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol, other than alcohol not in excess of five percent by volume. Any confectionery that bears or contains any alcohol in excess of one-half of one percent by volume derived solely from the use of flavoring extracts and less than five percent by volume:

(A) may not be sold to persons under the legal age necessary to consume an alcoholic beverage in this state;

(B) must be labeled with a conspicuous, readily legible statement that reads, "Sale of this product to a person under the legal age necessary to consume an alcoholic beverage is prohibited";

(C) may not be sold in a form containing liquid alcohol such that it is capable of use for beverage purposes as that term is used in the Alcoholic Beverage Code;

(D) may not be sold through a vending machine;

(E) must be labeled with a conspicuous, readily legible statement that the product contains not more than five percent alcohol by volume; and

(F) may not be sold in a business establishment which derives less than 50 percent of its gross sales from the sale of confectioneries; or

(3) bears or contains any nonnutritive substance; provided, that this subdivision does not apply to a nonnutritive substance that is in or on the confectionery by reason of its use for a practical, functional purpose in the manufacture, packaging, or storage of the confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of this chapter; and provided further, that the executive commissioner may, for the purpose of avoiding or resolving uncertainty as to the application of this subdivision, adopt rules allowing or prohibiting the use of particular nonnutritive substances.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 439, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0964, eff. April 2, 2015.

Sec. 431.082: Misbranded Food

A food shall be deemed to be misbranded:

(a) if its labeling is false or misleading in any particular or fails to conform with the requirements of Section 431.181;

(b) if, in the case of a food to which Section 411 of the federal Act applies, its advertising is false or misleading in a material respect or its labeling is in violation of Section 411(b)(2) of the federal Act;

(c) if it is offered for sale under the name of another food;

(d) if it is an imitation of another food, unless its label bears, in prominent type of uniform size, the word "imitation" and immediately thereafter the name of the food imitated;

(e) if its container is so made, formed, or filled as to be misleading;

(f) if in package form unless it bears a label containing:

(1) the name and place of business of the manufacturer, packer, or distributor; and

(2) an accurate statement, in a uniform location on the principal display panel of the label, of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under this subsection reasonable variations shall be permitted, and exemptions as to small packages shall be established, by department rules;

(g) if any word, statement, or other information required by or under the authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(h) if it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by federal regulations or department rules as provided by Section 431.245, unless:

(1) it conforms to such definition and standard; and

(2) its label bears the name of the food specified in the definition and standard, and, in so far as may be required by those regulations or rules, the common names of ingredients, other than spices, flavoring, and coloring, present in such food;

(i) if it purports to be or is represented as:

(1) a food for which a standard of quality has been prescribed by federal regulations or department rules as provided by Section 431.245, and its quality falls below such standard unless its label bears, in such manner and form as those regulations or rules specify, a statement that it falls below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by federal regulations or department rules as provided by Section 431.245, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as those regulations or rules specify, a statement that it falls below such standard;

(j) unless its label bears:

(1) the common or usual name of the food, if any; and

(2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the information panel of the total percentage of the fruit or vegetable juice contained in the food; except that spices, flavorings, and colors not required to be certified under Section 721(c) of the federal Act, other than those sold as such, may be designated as spices, flavorings, and colors, without naming each; provided that, to the extent that compliance with the requirements of this subdivision is impractical or results in deception or unfair competition, exemptions shall be established by department rules;

(k) if it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the executive commissioner determines to be, and by rule prescribed, as necessary in order to fully inform purchasers as to its value for such uses;

(l) if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact; provided that, to the extent that compliance with the requirements of this subsection is impracticable, exemptions shall be established by department rules. The provisions of this subsection and Subsections (h) and (j) with respect to artificial coloring do not apply in the case of butter, cheese, and ice cream;

(m) if it is a raw agricultural commodity that is the produce of the soil and bears or contains a pesticide chemical applied after harvest, unless the shipping container of the commodity bears labeling that declares the presence of the chemical in or on the commodity and the common or usual name and the function of the chemical, except that the declaration is not required while the commodity, after removal from the shipping container, is being held or displayed for sale at retail out of the container in accordance with the custom of the trade;

(n) if it is a product intended as an ingredient of another food and if used according to the directions of the purveyor will result in the final food product being adulterated or misbranded;

(o) if it is a color additive, unless its packaging and labeling are in conformity with the packaging and labeling requirements applicable to the color additive as may be contained in regulations issued under Section 721 of the federal Act;

(p) if its packaging or labeling is in violation of an applicable regulation issued under Section 3 or 4 of the federal Poison Prevention Packaging Act of 1970 (15 U.S.C. 1472 or 1473);

(q) (1) if it is a food intended for human consumption and is offered for sale, unless its label or labeling bears nutrition information that provides:

(A) (i) the serving size that is an amount customarily consumed and that is expressed in a common household measure that is appropriate to the food; or

(ii) if the use of the food is not typically expressed in a serving size, the common household unit of measure that expresses the serving size of the food;

(B) the number of servings or other units of measure per container;

(C) the total number of calories in each serving size or other unit of measure that are:

(i) derived from any source; and

(ii) derived from fat;

(D) the amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugar, dietary fiber, and total protein contained in each serving size or other unit of measure; and

(E) any vitamin, mineral, or other nutrient required to be placed on the label and labeling of food under the federal Act; or

(2) (A) if it is a food distributed at retail in bulk display cases, or a food received in bulk containers, unless it has nutrition labeling prescribed by the secretary; and

(B) if the secretary determines it is necessary, nutrition labeling will be mandatory for raw fruits, vegetables, and fish, including freshwater or marine finfish, crustaceans, mollusks including shellfish, amphibians, and other forms of aquatic animal life, except that:

(3) (A) Subdivisions (1) and (2) do not apply to food:

(i) that is served in restaurants or other establishments in which food is served for immediate human consumption or that is sold for sale or use in those establishments;

(ii) that is processed and prepared primarily in a retail establishment, that is ready for human consumption, that is of the type described in Subparagraph (i), that is offered for sale to consumers but not for immediate human consumption in the establishment, and that is not offered for sale outside the establishment;

(iii) that is an infant formula subject to Section 412 of the federal Act;

(iv) that is a medical food as defined in Section 5(b) of the Orphan Drug Act (21 U.S.C. Section 360ee(b)); or

(v) that is described in Section 405, clause (2), of the federal Act;

(B) Subdivision (1) does not apply to the label of a food if the secretary determines by regulation that compliance with that subdivision is impracticable because the package of the food is too small to comply with the requirements of that subdivision and if the label of that food does not contain any nutrition information;

(C) if the secretary determines that a food contains insignificant amounts of all the nutrients required by Subdivision (1) to be listed in the label or labeling of food, the requirements of Subdivision (1) do not apply to the food if the label, labeling, or advertising of the food does not make any claim with respect to the nutritional value of the food, provided that if the secretary determines that a food contains insignificant amounts of more than half the nutrients required by Subdivision (1) to be in the label or labeling of the food, the amounts of those nutrients shall be stated in a simplified form prescribed by the secretary;

(D) if a person offers food for sale and has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers that is not more than $50,000, the requirements of this subsection do not apply to food sold by that person to consumers unless the label or labeling of food offered by that person provides nutrition information or makes a nutrition claim;

(E) if foods are subject to Section 411 of the federal Act, the foods shall comply with Subdivisions (1) and (2) in a manner prescribed by the rules; and

(F) if food is sold by a food distributor, Subdivisions (1) and (2) do not apply if the food distributor principally sells food to restaurants or other establishments in which food is served for immediate human consumption and the food distributor does not manufacture, process, or repackage the food it sells;

(r) if it is a food intended for human consumption and is offered for sale, and a claim is made on the label, labeling, or retail display relating to the nutrient content or a nutritional quality of the food to a specific disease or condition of the human body, except as permitted by Section 403(r) of the federal Act; or

(s) if it is a food intended for human consumption and its label, labeling, and retail display do not comply with the requirements of Section 403(r) of the federal Act pertaining to nutrient content and health claims.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 156, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 459, Sec. 3, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0965, eff. April 2, 2015.

Sec. 431.083: Food Labeling Exemptions

(a) Except as provided by Subsection (c), the executive commissioner shall adopt rules exempting from any labeling requirement of this chapter:

(1) small open containers of fresh fruits and fresh vegetables; and

(2) food that is in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on conditions that the food is not adulterated or misbranded under the provisions of this chapter when removed from the processing, labeling, or repacking establishment.

(b) Food labeling exemptions adopted under the federal Act apply to food in this state except as modified or rejected by department rules.

(c) The executive commissioner may not adopt rules under Subsection (a) to exempt foods from the labeling requirements of Sections 403(q) and (r) of the federal Act.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 459, Sec. 4, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0966, eff. April 2, 2015.

Sec. 431.084: Emergency Permits for Foods Contaminated with Microorganisms

(a) The department shall provide for the issuance of temporary permits to a manufacturer, processor, or packer of a class of food in any locality that provides conditions for the manufacture, processing, or packing for the class of food as necessary to protect the public health only if the department finds after investigation that:

(1) the distribution in this state of a class of food may, because the food is contaminated with microorganisms during the manufacture, processing, or packing of the food in any locality, be injurious to health; and

(2) the injurious nature of the food cannot be adequately determined after the food has entered commerce.

(b) The executive commissioner by rule shall establish standards and procedures for the enforcement of this section.

(c) During the period for which permits are issued for a class of food determined by the department to be injurious under Subsection (a), a person may not introduce or deliver for introduction into commerce the food unless the person is a manufacturer, processor, or packer who has a permit issued by the department as authorized by rules adopted under this section.

(d) The department may immediately suspend a permit issued under this section if a condition of the permit is violated. An immediate suspension is effective on notice to the permit holder.

(e) A holder of a permit that has been suspended may at any time apply for the reinstatement of the permit. Immediately after a hearing and an inspection of the permit holder's establishment, the department shall reinstate the permit if adequate measures have been taken to comply with and maintain the conditions of the permit as originally issued or as amended.

(f) A permit holder shall provide access to the permit holder's factory or establishment to the department to allow the department to determine whether the permit holder complies with the conditions of the permit. Denial of access is grounds for suspension of the permit until the permit holder freely provides the access.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0967, eff. April 2, 2015.

Subchapter E

Sec. 431.111: Adulterated Drug Or Device

A drug or device shall be deemed to be adulterated:

(a) (1) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or

(2) (A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

(B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or

(3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(4) if it:

(A) bears or contains, for purposes of coloring only, a color additive that is unsafe under Section 431.161(a); or

(B) is a color additive, the intended use of which in or on drugs or devices is for purposes of coloring only, and is unsafe under Section 431.161(a); or

(5) if it is a new animal drug that is unsafe under Section 512 of the federal Act;

(b) if it purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. Such determination as to strength, quality or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under the authority of the federal Act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standards of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standards is plainly stated on its label. Whenever a drug is recognized in The United States Pharmacopeia and The National Formulary (USP-NF), it shall be subject to the requirements of the USP-NF;

(c) if it is not subject to Subsection (b) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

(d) if it is a drug and any substance has been:

(1) mixed or packed therewith so as to reduce its quality or strength; or

(2) substituted wholly or in part therefor;

(e) if it is, or purports to be or is represented as, a device that is subject to a performance standard established under Section 514 of the federal Act, unless the device is in all respects in conformity with the standard;

(f) (1) if it is a class III device:

(A) (i) that is required by a regulation adopted under Section 515(b) of the federal Act to have an approval under that section of an application for premarket approval and that is not exempt from Section 515 as provided by Section 520(g) of the federal Act; and

(ii) (I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the United States Food and Drug Administration by the 90th day after the date of adoption of the regulation; or

(II) for which that application was filed and approval was denied or withdrawn, for which that notice was filed and was declared incomplete, or for which approval of the device under the protocol was withdrawn;

(B) that was classified under Section 513(f) of the federal Act into class III, which under Section 515(a) of the federal Act is required to have in effect an approved application for premarket approval, that is not exempt from Section 515 as provided by Section 520(g) of the federal Act, and that does not have the application in effect; or

(C) that was classified under Section 520(l) of the federal Act into class III, which under that section is required to have in effect an approved application under Section 515 of the federal Act, and that does not have the application in effect, except that:

(2) (A) in the case of a device classified under Section 513(f) of the federal Act into class III and intended solely for investigational use, Subdivision (1)(B) does not apply to the device during the period ending on the 90th day after the date of adoption of the regulations prescribing the procedures and conditions required by Section 520(g)(2) of the federal Act; and

(B) in the case of a device subject to a regulation adopted under Section 515(b) of the federal Act, Subdivision (1) does not apply to the device during the period ending on whichever of the following dates occurs later:

(i) the last day of the 30-day calendar month beginning after the month in which the classification of the device into class III became effective under Section 513 of the federal Act; or

(ii) the 90th day after the date of adoption of the regulation;

(g) if it is a banned device;

(h) if it is a device and the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installations are not in conformity with applicable requirements under Section 520(f)(1) of the federal Act or an applicable condition as prescribed by an order under Section 520(f)(2) of the federal Act; or

(i) if it is a device for which an exemption has been granted under Section 520(g) of the federal Act for investigational use and the person who was granted the exemption or any investigator who uses the device under the exemption fails to comply with a requirement prescribed by or under that section.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 440, Sec. 2, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0968, eff. April 2, 2015.

Sec. 431.112: Misbranded Drug Or Device

A drug or device shall be deemed to be misbranded:

(a) (1) if its labeling is false or misleading in any particular; or

(2) if its labeling or packaging fails to conform with the requirements of Section 431.181.

(b) if in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under Subdivision (2) reasonable variations shall be permitted, and exemptions as to small packages shall be allowed in accordance with regulations prescribed by the secretary under the federal Act;

(c) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(d) (1) if it is a drug, unless:

(A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula):

(i) the established name (as defined in Subdivision (3)) of the drug, if any; and

(ii) in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; provided, that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subparagraph shall apply only to prescription drugs; and

(B) for any prescription drug the established name of the drug or ingredient, as the case may be, on the label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient; and provided, that to the extent that compliance with the requirements of Paragraph (A)(ii) or this paragraph is impracticable, exemptions shall be allowed under regulations promulgated by the secretary under the federal Act;

(2) if it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in Subdivision (4)) prominently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with this subdivision is impracticable, exemptions shall be allowed under regulations promulgated by the secretary under the federal Act;

(3) as used in Subdivision (1), the term "established name," with respect to a drug or ingredient thereof, means:

(A) the applicable official name designated pursuant to Section 508 of the federal Act; or

(B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium; or

(C) if neither Paragraph (A) nor Paragraph (B) applies, then the common or usual name, if any, of such drug or of such ingredient; provided further, that where Paragraph (B) applies to an article recognized in the United States Pharmacopoeia National Formulary, the official title used in the United States Pharmacopoeia National Formulary shall apply;

(4) as used in Subdivision (2), the term "established name" with respect to a device means:

(A) the applicable official name of the device designated pursuant to Section 508 of the federal Act;

(B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compendium; or

(C) if neither Paragraph (A) nor Paragraph (B) applies, then any common or usual name of such device;

(e) unless its labeling bears:

(1) adequate directions for use; and

(2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or durations of administration or application, in such manner and form, as are necessary for the protection of users unless the drug or device has been exempted from those requirements by the regulations adopted by the secretary;

(f) if it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein unless the method of packing has been modified with the consent of the secretary. Whenever a drug is recognized in the United States Pharmacopoeia National Formulary, it shall be subject to the requirements of the United States Pharmacopoeia National Formulary with respect to packaging and labeling. If there is an inconsistency between the requirements of this subsection and those of Subsection (d) as to the name by which the drug or its ingredients shall be designated, the requirements of Subsection (d) prevail;

(g) if it has been found by the secretary to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the secretary shall by regulations require as necessary for the protection of public health;

(h) if:

(1) it is a drug and its container is so made, formed, or filled as to be misleading; or

(2) it is an imitation of another drug; or

(3) it is offered for sale under the name of another drug;

(i) if it is dangerous to health when used in the dosage, or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof;

(j) if it is a color additive, the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be contained in rules issued under Section 431.161(b);

(k) in the case of any prescription drug distributed or offered for sale in this state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of:

(1) the established name as defined in Subsection (d), printed prominently and in type at least half as large as that used for any trade or brand name;

(2) the formula showing quantitatively each ingredient of the drug to the extent required for labels under Subsection (d); and

(3) other information in brief summary relating to side effects, contraindications, and effectiveness as required in regulations issued under Section 701(e) of the federal Act;

(l) if it was manufactured, prepared, propagated, compounded, or processed in an establishment in this state not registered under Section 510 of the federal Act, if it was not included in a list required by Section 510(j) of the federal Act, if a notice or other information respecting it was not provided as required by that section or Section 510(k) of the federal Act, or if it does not bear symbols from the uniform system for identification of devices prescribed under Section 510(e) of the federal Act as required by regulation;

(m) if it is a drug and its packaging or labeling is in violation of an applicable regulation issued under Section 3 or 4 of the federal Poison Prevention Packaging Act of 1970 (15 U.S.C. 1472 or 1473);

(n) if a trademark, trade name, or other identifying mark, imprint or device of another, or any likeness of the foregoing has been placed thereon or on its container with intent to defraud;

(o) in the case of any restricted device distributed or offered for sale in this state, if:

(1) its advertising is false or misleading in any particular; or

(2) it is sold, distributed, or used in violation of regulations prescribed under Section 520(e) of the federal Act;

(p) in the case of any restricted device distributed or offered for sale in this state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued by the manufacturer, packer, or distributor with respect to that device:

(1) a true statement of the device's established name as defined in Section 502(e) of the federal Act, printed prominently and in type at least half as large as that used for any trade or brand name thereof; and

(2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and in the case of specific devices made subject to regulations issued under the federal Act, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations under the federal Act;

(q) if it is a device subject to a performance standard established under Section 514 of the federal Act, unless it bears such labeling as may be prescribed in such performance standard; or

(r) if it is a device and there was a failure or refusal:

(1) to comply with any requirement prescribed under Section 518 of the federal Act respecting the device; or

(2) to furnish material required by or under Section 519 of the federal Act respecting the device.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 282, Sec. 4, eff. Sept. 1, 1997; Acts 2003, 78th Leg., ch. 111, Sec. 4, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 1099, Sec. 2, eff. Sept. 1, 2003.

Sec. 431.113: Exemption for Certain Drugs and Devices

(a) The executive commissioner shall adopt rules exempting from any labeling or packaging requirement of this chapter drugs and devices that are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packaged on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter on removal from such processing, labeling, or repacking establishment.

(b) Drugs and device labeling or packaging exemptions adopted under the federal Act shall apply to drugs and devices in this state except insofar as modified or rejected by department rules.

(c) (1) A drug intended for use by man that:

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(B) is limited by an approved application under Section 505 of the federal Act to use under the professional supervision of a practitioner licensed by law to administer such drug shall be dispensed only:

(i) on a written prescription of a practitioner licensed by law to administer such drug; or

(ii) on an oral prescription of such practitioner that is reduced promptly to writing and filed by the pharmacist; or

(iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order that is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act that results in a drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section 431.112, except Sections 431.112(a)(1), (h)(2), and (h)(3), and the packaging requirements of Sections 431.112(f), (g), and (m), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drugs dispensed in the course of the conduct of business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of Subdivision (1).

(3) A drug that is subject to Subdivision (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear at a minimum, the symbol "RX Only." A drug to which Subdivision (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2003, 78th Leg., ch. 111, Sec. 5, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 1099, Sec. 3, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0969, eff. April 2, 2015.

Sec. 431.114: New Drugs

(a) A person shall not sell, deliver, offer for sale, hold for sale or give away any new drug unless:

(1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and

(2) a copy of the letter of approval or approvability issued by the United States Food and Drug Administration is on file with the department if the product is manufactured in this state.

(b) A person shall not use in or on human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the United States Food and Drug Administration a completed and signed investigational new drug (IND) application in accordance with 21 C.F.R. 312.20-312.38 and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) of the federal Act.

(c) This section shall not apply:

(1) to any drug that is not a new drug as defined in the federal Act;

(2) to any drug that is licensed under the Public Health Service Act (42 U.S.C. 201 et seq.); or

(3) to any drug approved by the department by the authority of any prior law.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 157, eff. Sept. 1, 1991; Acts 2003, 78th Leg., ch. 111, Sec. 6, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0970, eff. April 2, 2015.

Sec. 431.115: New Animal Drugs

(a) A new animal drug shall, with respect to any particular use or intended use of the drug, be deemed unsafe for the purposes of this chapter unless:

(1) there is in effect an approval of an application filed pursuant to Section 512(b) of the federal Act with respect to the use or intended use of the drug; and

(2) the drug, its labeling, and the use conforms to the approved application.

(b) A new animal drug shall not be deemed unsafe for the purposes of this chapter if the article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under Section 512(j) of the federal Act.

(c) This section does not apply to any drug:

(1) licensed under the virus-serum-toxin law of March 4, 1913 (21 U.S.C. 151-159);

(2) approved by the United States Department of Agriculture; or

(3) approved by the department by the authority of any prior law.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 158, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0971, eff. April 2, 2015.

Sec. 431.116: Average Manufacturer Price

(a) In this section, "average manufacturer price" has the meaning assigned by 42 U.S.C. Section 1396r-8(k), as amended.

(b) A person who manufactures a drug, including a person who manufactures a generic drug, that is sold in this state shall file with the department:

(1) the average manufacturer price for the drug; and

(2) the price that each wholesaler in this state pays the manufacturer to purchase the drug.

(c) The information required under Subsection (b) must be filed annually or more frequently as determined by the department.

(d) The department and the attorney general may investigate the manufacturer to determine the accuracy of the information provided under Subsection (b). The attorney general may take action to enforce this section.

(e) Repealed by Acts 2005, 79th Leg., Ch. 349, Sec. 29, eff. September 1, 2007.

(f) Notwithstanding any other state law, pricing information disclosed by manufacturers or labelers under this section may be provided by the department only to the Medicaid vendor drug program for its sole use. The Medicaid vendor drug program may use the information only as necessary to administer its drug programs, including Medicaid drug programs.

(g) Notwithstanding any other state law, pricing information disclosed by manufacturers or labelers under this section is confidential and, except as necessary to permit the attorney general to enforce state and federal laws, may not be disclosed by the Health and Human Services Commission or any other state agency in a form that discloses the identity of a specific manufacturer or labeler or the prices charged by a specific manufacturer or labeler for a specific drug.

(h) The attorney general shall treat information obtained under this section in the same manner as information obtained by the attorney general through a civil investigative demand under Section 36.054, Human Resources Code.

(i) Notwithstanding any other state law, the penalties for unauthorized disclosure of confidential information under Chapter 552, Government Code, apply to unauthorized disclosure of confidential information under this section.

Comments

Added by Acts 2001, 77th Leg., ch. 1003, Sec. 2, eff. Sept. 1, 2001. Amended by Acts 2003, 78th Leg., ch. 198, Sec. 2.199, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch. 349 (S.B. 1188), Sec. 29, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0972, eff. April 2, 2015.

Sec. 431.117: Priority for Health Care Providers in Distribution of Influenza Vaccine

The executive commissioner shall study the wholesale distribution of influenza vaccine in this state to determine the feasibility of implementing a system that requires giving a priority in filling orders for influenza vaccine to physicians and other licensed health care providers authorized to administer influenza vaccine over retail establishments. The executive commissioner may implement such a system if it is determined to be feasible.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 922 (H.B. 3184), Sec. 2, eff. June 15, 2007.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0973, eff. April 2, 2015.

Subchapter F

Sec. 431.141: Adulterated Cosmetic

A cosmetic shall be deemed to be adulterated:

(a) if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual; provided, that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon; "Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness"; and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this subsection and Subsection (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes;

(b) if it consists in whole or in part of any filthy, putrid, or decomposed substance;

(c) if it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(d) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(e) if it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of Section 431.161(a).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 431.142: Misbranded Cosmetic

(1) A cosmetic shall be deemed to be misbranded:

(a) if:

(1) its labeling is false or misleading in any particular; and

(2) its labeling or packaging fails to conform with the requirements of Section 431.181;

(b) if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location on the principal display panel of the label; provided, that under Subdivision (2) reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by department rules;

(c) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(d) if its container is so made, formed, or filled as to be misleading;

(e) if it is a color additive, unless its packaging and labeling are in conformity with the packaging and labeling requirements, applicable to the color additive, prescribed under Section 721 of the federal Act. This subsection shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes, as defined by Section 431.141(a); or

(f) if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 3 or 4 of the federal Poison Prevention Packaging Act of 1970 (15 U.S.C. 1472 or 1473).

(2) The executive commissioner shall adopt rules exempting from any labeling requirement of this chapter cosmetics that are in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at an establishment other than the establishment where it was originally processed or packed, on condition that the cosmetics are not adulterated or misbranded under the provisions of this chapter on removal from the processing, labeling, or repacking establishment. Cosmetic labeling exemptions adopted under the federal Act shall apply to cosmetics in this state except insofar as modified or rejected by department rules.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 159, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0974, eff. April 2, 2015.

Subchapter G

Sec. 431.161: Poisonous Or Deleterious Substances

(a) Any poisonous or deleterious substance, food additive, pesticide chemical in or on a raw agricultural commodity, or color additive shall, with respect to any particular use or intended use, be deemed unsafe for the purpose of Section 431.081(a)(2) with respect to any food, Section 431.111(a) with respect to any drug or device, or Section 431.141 with respect to any cosmetic. However, if a rule adopted under Section 431.181 or Subsection (b) is in effect that limits the quantity of that substance, and if the use or intended use of that substance conforms to the terms prescribed by the rule, a food, drug, or cosmetic shall not, by reason of bearing or containing that substance in accordance with the rules, be considered adulterated within the meaning of Section 431.081(a)(1), 431.111, or 431.141.

(b) The executive commissioner, whenever public health or other considerations in the state so require or on the petition of an interested party, may adopt rules prescribing tolerances for any added, poisonous, or deleterious substances, food additives, pesticide chemicals in or on raw agricultural commodities, or color additives, including zero tolerances and exemptions from tolerances in the case of pesticide chemicals in or on raw agricultural commodities. The rules may prescribe the conditions under which a food additive or a color additive may be safely used and may prescribe exemptions if the food additive or color additive is to be used solely for investigational or experimental purposes. Rules adopted under this section limiting the quantity of poisonous or deleterious substances in food must provide equal or stricter standards than those adopted by the federal Food and Drug Administration or its successor. A person petitioning for the adoption of a rule shall establish by data submitted to the executive commissioner that a necessity exists for the rule and that its effect will not be detrimental to the public health. If the data furnished by the petitioner are not sufficient to allow the executive commissioner to determine whether the rules should be adopted, the executive commissioner may require additional data to be submitted. The petitioner's failure to comply with the request is sufficient grounds to deny the request. In adopting rules relating to those substances, the executive commissioner shall consider, among other relevant factors, the following information furnished by the petitioner, if any:

(1) the name and all pertinent information concerning the substance, including, if available, its chemical identity and composition, a statement of the conditions of the proposed use, directions, recommendations, and suggestions, specimens of proposed labeling, all relevant data bearing on the physical or other technical effect, and the quantity required to produce that effect;

(2) the probable composition of any substance formed in or on a food, drug, or cosmetic resulting from the use of that substance;

(3) the probable consumption of that substance in the diet of man and animals, taking into account any chemically or pharmacologically related substance in the diet;

(4) safety factors that, in the opinion of experts qualified by scientific training and experience to evaluate the safety of those substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;

(5) the availability of any needed practicable methods of analysis for determining the identity and quantity of:

(A) that substance in or on an article;

(B) any substance formed in or on an article because of the use of that substance; and

(C) the pure substance and all intermediates and impurities; and

(6) facts supporting a contention that the proposed use of that substance will serve a useful purpose.

(c) The executive commissioner may adopt emergency rules under Chapter 2001, Government Code, to establish tolerance levels of poisonous or deleterious substances in food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0975, eff. April 2, 2015.

Subchapter G-1

Sec. 431.171: Designation of Consumer Commodity As Abusable Synthetic Substance

(a) The commissioner may designate a consumer commodity as an abusable synthetic substance if the commissioner determines that the consumer commodity is likely an abusable synthetic substance and the importation, manufacture, distribution, or retail sale of the commodity poses a threat to public health.

(b) In determining whether a consumer commodity is an abusable synthetic substance, the commissioner may consider:

(1) whether the commodity is sold at a price higher than similar commodities are ordinarily sold;

(2) any evidence of clandestine importation, manufacture, distribution, or diversion from legitimate channels;

(3) any evidence suggesting the product is intended for human consumption, regardless of any consumption prohibitions or warnings on the packaging of the commodity; or

(4) whether any of the following factors suggest the commodity is an abusable synthetic substance intended for illicit drug use:

(A) the appearance of the packaging of the commodity;

(B) oral or written statements or representations of a person who sells, manufactures, distributes, or imports the commodity;

(C) the methods by which the commodity is distributed; and

(D) the manner in which the commodity is sold to the public.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 712 (H.B. 1212), Sec. 2, eff. September 1, 2015.

Sec. 431.172: Applicability of Chapter to Abusable Synthetic Substance

A commodity classified as an abusable synthetic substance by the commissioner under Section 431.171 is subject to:

(1) the provisions of this chapter that apply to food and cosmetics, including provisions relating to adulteration, packaging, misbranding, and inspection; and

(2) all enforcement actions under Subchapter C.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 712 (H.B. 1212), Sec. 2, eff. September 1, 2015.

Subchapter H

Sec. 431.181: Fair Packaging and Labeling

(a) All labels of consumer commodities, as defined by this chapter, shall conform with the requirements for the declaration of net quantity of contents of Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.) and the regulations promulgated pursuant thereto; provided, that consumer commodities exempted from the requirements of Section 4 of the Fair Packaging and Labeling Act shall also be exempt from this subsection.

(b) The label of any package of a consumer commodity that bears a representation as to the number of servings of the commodity contained in the package shall bear a statement of the net quantity (in terms of weight, measure, or numerical count) of each serving.

(c) No person shall distribute or cause to be distributed in commerce any packaged consumer commodity if any qualifying words or phrases appear in conjunction with the separate statement of the net quantity of contents required by Subsection (a), but nothing in this subsection shall prohibit supplemental statements at other places on the package describing in nondeceptive terms the net quantity of contents; provided, that the supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the commodity contained in the package.

(d) Whenever the executive commissioner determines that rules containing prohibitions or requirements other than those prescribed by Subsection (a) are necessary to prevent the deception of consumers or to facilitate value comparisons as to any consumer commodity, the executive commissioner shall adopt with respect to that commodity rules effective to:

(1) establish and define standards for the characterization of the size of a package enclosing any consumer commodity, which may be used to supplement the label statement of net quantity of contents of packages containing such commodity, but this subdivision shall not be construed as authorizing any limitation on the size, shape, weight, dimensions, or number of packages that may be used to enclose any commodity;

(2) regulate the placement on any package containing any commodity, or on any label affixed to the commodity, of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary and customary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents;

(3) require that the label on each package of a consumer commodity (other than one which is a food within the meaning of Section 431.002) bear:

(A) the common or usual name of the consumer commodity, if any; and

(B) in case the consumer commodity consists of two or more ingredients, the common or usual name of each ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or

(4) prevent the nonfunctional slack-fill of packages containing consumer commodities. For the purpose of this subdivision, a package shall be deemed to be nonfunctionally slack-filled if it is filled of substantially less than its capacity for reasons other than:

(A) protection of the contents of the package; or

(B) the requirements of the machine used for enclosing the contents in the package.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0976, eff. April 2, 2015.

Sec. 431.182: False Advertisement

(a) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.

(b) The advertising of a food that incorporates a health claim not in conformance with or defined by Section 403(r) of the federal Act is deemed to be false or misleading for the purposes of this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 459, Sec. 5, eff. Sept. 1, 1993.

Sec. 431.183: False Advertisement of Drug Or Device

(a) An advertisement of a drug or device is false if the advertisement represents that the drug or device affects:

(1) infectious and parasitic diseases;

(2) neoplasms;

(3) endocrine, nutritional, and metabolic diseases and immunity disorders;

(4) diseases of blood and blood-forming organs;

(5) mental disorders;

(6) diseases of the nervous system and sense organs;

(7) diseases of the circulatory system;

(8) diseases of the respiratory system;

(9) diseases of the digestive system;

(10) diseases of the genitourinary system;

(11) complications of pregnancy, childbirth, and the puerperium;

(12) diseases of the skin and subcutaneous tissue;

(13) diseases of the musculoskeletal system and connective tissue;

(14) congenital anomalies;

(15) certain conditions originating in the perinatal period;

(16) symptoms, signs, and ill-defined conditions; or

(17) injury and poisoning.

(b) Subsection (a) does not apply to an advertisement of a drug or device if the advertisement does not violate Section 431.182 and is disseminated:

(1) to the public for self-medication and is consistent with the labeling claims permitted by the federal Food and Drug Administration;

(2) only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or

(3) only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the drug or device.

(c) The executive commissioner by rule shall authorize the advertisement of a drug having a curative or therapeutic effect for a disease listed under Subsection (a) if the executive commissioner determines that an advance in medical science has made any type of self-medication safe for the disease. The executive commissioner may impose conditions and restrictions on the advertisement of the drug necessary in the interest of public health.

(d) This section does not indicate that self-medication for a disease other than a disease listed under Subsection (a) is safe or effective.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 160, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0977, eff. April 2, 2015.

Subchapter I

Sec. 431.201: Definitions

In this subchapter:

(1) "Nonprescription drug" means any drug that is not a prescription drug as defined by Section 431.401.

(2) "Place of business" means each location at which a drug for wholesale distribution is located.

(3) "Wholesale distribution" means distribution to a person other than a consumer or patient, and includes distribution by a manufacturer, repackager, own label distributor, broker, jobber, warehouse, or wholesaler.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(b), eff. March 1, 2006.

Sec. 431.2011: Applicability of Subchapter

This subchapter applies only to the wholesale distribution of nonprescription drugs.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(c), eff. March 1, 2006.

Sec. 431.202: License Required

(a) A person may not engage in wholesale distribution of nonprescription drugs in this state unless the person holds a wholesale drug distribution license issued by the department under this subchapter or Subchapter N.

(b) An applicant for a license under this subchapter must submit an application to the department on the form prescribed by the department or electronically on the state electronic Internet portal.

(c) A license issued under this subchapter expires on the second anniversary of the date of issuance.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 161, eff. Sept. 1, 1991; Acts 1991, 72nd Leg., ch. 539, Sec. 5, eff. Sept. 1, 1991.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(d), eff. March 1, 2006.

Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 28, eff. June 17, 2011.

Sec. 431.203: Contents of License Statement

The license statement must contain:

(1) the name under which the business is conducted;

(2) the address of each place of business that is licensed;

(3) the name and residence address of:

(A) the proprietor, if the business is a proprietorship;

(B) all partners, if the business is a partnership; or

(C) all principals, if the business is an association;

(4) the date and place of incorporation, if the business is a corporation;

(5) the names and residence addresses of the individuals in an administrative capacity showing:

(A) the managing proprietor, if the business is a proprietorship;

(B) the managing partner, if the business is a partnership;

(C) the officers and directors, if the business is a corporation; or

(D) the persons in a managerial capacity, if the business is an association; and

(6) the residence address of an individual in charge of each place of business.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 7, eff. Sept. 1, 1991.

Sec. 431.2031: Effect of Operation in Other Jurisdictions; Reports

(a) A person who engages in the wholesale distribution of drugs outside this state may engage in the wholesale distribution of drugs in this state if the person holds a license issued by the department.

(b) The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with this chapter and the minimum standards adopted under this chapter.

(c) The department may issue a license to a person who engages in the wholesale distribution of drugs outside this state to engage in the wholesale distribution of drugs in this state, if after an examination of the reports of the person's compliance history and current compliance record, the department determines that the person is in compliance with this subchapter and department rules.

(d) The department shall consider each licensing statement filed by a person who wishes to engage in wholesale distribution of drugs in this state on an individual basis.

Comments

Added by Acts 1991, 72nd Leg., ch. 539, Sec. 8, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0978, eff. April 2, 2015.

Sec. 431.204: Fees

(a) The department shall collect fees for:

(1) a license that is filed or renewed;

(2) a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.206; and

(3) an inspection performed in enforcing this subchapter and rules adopted under this subchapter.

(b) The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:

(1) reviewing and acting on a license;

(2) amending and renewing a license;

(3) inspecting a licensed facility; and

(4) implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.

(c) Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and appropriated to the department to carry out the administration and enforcement of this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(e), eff. March 1, 2006.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0979, eff. April 2, 2015.

Sec. 431.206: Change of Location of Place of Business

(a) Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business.

(b) The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location.

(c) Not more than 10 days after the completion of the change of location, the licensee shall notify the department in writing to confirm the completion of the change of location and provide verification of the information previously provided or correct and confirm any information that has changed since providing the notice of intent.

(d) The notice and confirmation required by this section are deemed adequate if the licensee sends the notices by certified mail, return receipt requested, to the central office of the department or submits them electronically through the state electronic Internet portal.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(f), eff. March 1, 2006.

Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 29, eff. June 17, 2011.

Sec. 431.207: Refusal to License; Suspension Or Revocation of License

(a) The department may refuse an application for a license or may suspend or revoke a license if the applicant or licensee:

(1) has been convicted of a felony or misdemeanor that involves moral turpitude;

(2) is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

(3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(4) is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(5) has not complied with this chapter or the rules implementing this chapter;

(6) has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(7) has violated Chapter 481 or 483;

(8) has violated the rules of the public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain; or

(9) fails to complete a license application or submits an application that contains false, misleading, or incorrect information or contains information that cannot be verified by the department.

(b) The executive commissioner by rule shall establish minimum standards required for the issuance or renewal of a license under this subchapter.

(c) The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 9, eff. Sept. 1, 1991; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(f), eff. March 1, 2006.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0980, eff. April 2, 2015.

Sec. 431.208: Reporting of Purchase Price

(a) On the department's request, a person who engages in the wholesale distribution of drugs in this state shall file with the department information showing the actual price at which the wholesale distributor sells a particular drug to a retail pharmacy.

(b) The executive commissioner shall adopt rules to implement this section.

(c) The department and the attorney general may investigate the distributor to determine the accuracy of the information provided under Subsection (a). The attorney general may take action to enforce this section.

(d) Repealed by Acts 2005, 79th Leg., Ch. 349, Sec. 29, eff. September 1, 2007.

Comments

Added by Acts 2001, 77th Leg., ch. 1003, Sec. 3, eff. Sept. 1, 2001.

Amended by:

Acts 2005, 79th Leg., Ch. 349 (S.B. 1188), Sec. 29, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0981, eff. April 2, 2015.

Subchapter J

Sec. 431.221: Definitions

In this subchapter:

(1) "Place of business" means:

(A) each location where:

(i) a person manufactures food; or

(ii) food for wholesale is distributed; or

(B) a warehouse where food is stored.

(2) "Food manufacturer" means a person who combines, purifies, processes, or packages food for sale through a wholesale outlet. The term also includes a retail outlet that packages or labels food before sale and a person that represents itself as responsible for the purity and proper labeling of an article of food by labeling the food with the person's name and address. The term does not include a restaurant that provides food for immediate human consumption to a political subdivision or to a licensed nonprofit organization if the restaurant would not otherwise be considered a food manufacturer under this subdivision.

(3) "Food wholesaler" means a person who distributes food for resale, either through a retail outlet owned by that person or through sales to another person. The term "food wholesaler" shall not include:

(A) a commissary which distributes food primarily intended for immediate consumption on the premises of a retail outlet under common ownership;

(B) an establishment engaged solely in the distribution of nonalcoholic beverages in sealed containers; or

(C) a restaurant that provides food for immediate human consumption to a political subdivision or to a licensed nonprofit organization if the restaurant would not otherwise be considered a food wholesaler under this subdivision.

(4) Deleted by Acts 1997, 75th Leg., ch. 629, Sec. 2, eff. Sept. 1, 1997

(5) "Direct seller" means an individual:

(A) who is not affiliated with a permanent retail establishment and who engages in the business of:

(i) in-person sales of prepackaged nonperishable foods, including dietary supplements, to a buyer on a buy-sell basis, a deposit-commission basis, or a similar basis for resale in a home; or

(ii) sales of prepackaged nonperishable foods, including dietary supplements, in a home;

(B) who receives substantially all remuneration for a service, whether in cash or other form of payment, which is directly related to sales or other output, including the performance of the service, and not to the number of hours worked; and

(C) who performs services under a written contract between the individual and the person for whom the service is performed, and the contract provides that the individual is not treated as an employee with respect to federal tax purposes.

(6) "Licensed nonprofit organization" means an organization that is licensed under any statutory authority of the State of Texas and is exempt from federal income taxation under Section 501(a), Internal Revenue Code of 1986, and its subsequent amendments, as an organization described in Section 501(c)(3) of that code.

(7) "Warehouse operator" means a person that operates a warehouse where food is stored.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 348, Sec. 1, eff. Aug. 28, 1995; Acts 1995, 74th Leg., ch. 1047, Sec. 1, eff. Sept. 1, 1995; Acts 1997, 75th Leg., ch. 629, Sec. 2, eff. Sept. 1, 1997; Acts 1997, 75th Leg., ch. 1378, Sec. 1, eff. Sept. 1, 1997; Acts 2003, 78th Leg., ch. 334, Sec. 1, eff. June 18, 2003; Acts 2003, 78th Leg., ch. 383, Sec. 5, eff. Sept. 1, 2003.

Amended by:

Acts 2005, 79th Leg., Ch. 728 (H.B. 2018), Sec. 23.001(51), eff. September 1, 2005.

Sec. 431.2211: Application of Subchapter

(a) A person is not required to hold a license under this subchapter if the person is:

(1) a person, firm, or corporation that only harvests, packages, or washes raw fruits or vegetables for shipment at the location of harvest;

(2) an individual who only sells prepackaged nonperishable foods, including dietary supplements, from a private home as a direct seller;

(3) a person who holds a license under Chapter 432 and who only engages in conduct within the scope of that license; or

(4) a restaurant that provides food for immediate human consumption to a political subdivision or to a licensed nonprofit organization if the restaurant would not otherwise be required to hold a license under this subchapter.

(a-1) A person is not required to hold a license under this subchapter if the person holds a license under Chapter 440 and is engaging in conduct within the scope of that license.

(a-2) A person is not required to hold a license under this subchapter if the person holds a permit under Chapter 435 related to the processing, producing, bottling, receiving, transferring, or transporting of Grade A milk or milk products and is engaging in conduct within the scope of that permit.

(a-3) A person is not required to hold a license under this subchapter if the person holds a license under Chapter 443 and is engaging in conduct within the scope of that license.

(b) An exemption from the licensing requirements prescribed by this subchapter does not exempt the person from other provisions prescribed by this subchapter or from rules adopted by the executive commissioner to administer and enforce those provisions.

(c) This subchapter does not apply to the distribution of beverages in sealed containers by holders of licenses or permits issued under Chapter 19, 20, 23, or 64, Alcoholic Beverage Code. The provisions of the Alcoholic Beverage Code prevail to the extent of any conflict with this chapter.

(d) A food wholesaler is not required to obtain a license under this subchapter for a place of business if all of the food distributed from that place of business will be stored in a warehouse licensed under this subchapter.

(e) A food wholesaler that is not required to obtain a license for a place of business under Subsection (d) shall register that place of business with the department. The executive commissioner shall adopt rules for the registration of food wholesalers under this section.

Comments

Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 348, Sec. 2, eff. Aug. 28, 1995; Acts 1997, 75th Leg., ch. 629, Sec. 3, eff. Sept. 1, 1997; Acts 1997, 75th Leg., ch. 1378, Sec. 2, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 262, Sec. 3, eff. Sept. 1, 2001; Acts 2003, 78th Leg., ch. 112, Sec. 2, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 334, Sec. 2, eff. June 18, 2003; Acts 2003, 78th Leg., ch. 383, Sec. 6, eff. Sept. 1, 2003; Acts 2003, 78th Leg., ch. 757, Sec. 2, eff. Sept. 1, 2003.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 1, eff. September 1, 2012.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0982, eff. April 2, 2015.

Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 6, eff. June 10, 2019.

Acts 2019, 86th Leg., R.S., Ch. 1359 (H.B. 1545), Sec. 392, eff. September 1, 2019.

Sec. 431.222: License Required; Licensing Fees

(a) Except as provided by Section 431.2211, a food manufacturer, food wholesaler, or warehouse operator in this state must apply for and obtain from the department every two years a license for each place of business that the food manufacturer, food wholesaler, or warehouse operator operates in this state. The food manufacturer, food wholesaler, or warehouse operator must pay a licensing fee for each establishment.

(b) The department shall require a food manufacturer that distributes only food manufactured by that firm to obtain only a license as a food manufacturer. A person that does not manufacture food and serves only as a food wholesaler must obtain only a food wholesaler's license. A person that distributes both its own manufactured food and food it does not manufacture must obtain only a food manufacturer's license. A warehouse operator who also distributes food is required to obtain only a warehouse operator license.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 162, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993; Acts 2003, 78th Leg., ch. 383, Sec. 7, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0983, eff. April 2, 2015.

Sec. 431.223: Contents of License Application

(a) The person applying for a license under this subchapter must provide, at a minimum, the following information in a license application:

(1) the name under which the food manufacturer, wholesale distributor, or warehouse operator conducts business;

(2) the address of each place of business in this state that is licensed;

(3) if the food manufacturer, wholesale distributor, or warehouse operator is an individual, a partnership, or an association, the name or names of:

(A) the proprietor, if the business is a sole proprietorship;

(B) all partners, if the business is a partnership; or

(C) all principals, if the business is an association;

(4) if the food manufacturer, wholesale distributor, or wholesale operator is a corporation, the date and place of incorporation and the name and address of its registered agent in this state;

(5) the names and residences of the individuals in an administrative capacity, showing:

(A) the managing proprietor, if the business is a sole proprietorship;

(B) the managing partner, if the business is a partnership;

(C) the officers and directors, if the business is a corporation; or

(D) the persons in a managerial capacity, if the business is an association; and

(6) the residence address of a person in charge of each place of business.

(b) The license application must be signed, verified, and filed on a form furnished by the department according to department rules.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993; Acts 2003, 78th Leg., ch. 383, Sec. 8, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0984, eff. April 2, 2015.

Sec. 431.224: Fees

(a) The department shall collect fees for:

(1) a license that is filed or renewed;

(2) a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.2251; and

(3) an inspection performed to enforce this subchapter and rules adopted under this subchapter.

(b) The department may charge fees every two years.

(c) The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:

(1) reviewing and acting on a license;

(2) amending and renewing a license;

(3) inspecting a licensed facility; and

(4) implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.

(d) The department shall use not less than one-half of license fees collected for inspecting a licensed place of business or enforcing this subchapter, and the remainder for the administration of this subchapter.

(e) All license fees received by the department under this subchapter shall be deposited in the state treasury to the credit of the food and drug registration account.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 163, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0985, eff. April 2, 2015.

Sec. 431.2245: Processing of Licensing Fees

(a) The department shall establish a system for processing licensing fees under this chapter, including vended water facility licensing fees.

(b) Under the fee processing system, the maximum time for processing a fee payment made by a negotiable instrument may not exceed 48 hours, beginning at the time that the negotiable instrument is first received by the department and ending at the time that the fee payment is submitted for deposit by the department to the treasury division of the office of the comptroller.

(c) The comptroller shall cooperate with the department in developing the fee processing system.

Comments

Added by Acts 1999, 76th Leg., ch. 697, Sec. 1, eff. Aug. 30, 1999.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0986, eff. April 2, 2015.

Sec. 431.225: Expiration Date

(a) The executive commissioner by rule may provide that licenses expire on different dates.

(b) If the license expiration date is changed, license fees shall be prorated so that each license holder pays only that portion of the license fee allocable to the number of months during which the license is valid. On renewal of the license on the new expiration date, the total license renewal fee is payable.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 164, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0987, eff. April 2, 2015.

Sec. 431.2251: Change in Location of Place of Business

Not later than the 31st day before the date of the change, the license holder shall notify in writing the department of the license holder's intent to change the location of a licensed place of business. The notice shall include the address of the new location and the name and residence address of the individual in charge of the place of business. Not later than the 10th day after the completion of the change of location, the license holder shall forward to the department the name and residence address of the individual in charge of the new place of business. Notice is considered adequate if the license holder provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the central office of the department.

Comments

Added by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0988, eff. April 2, 2015.

Sec. 431.226: Refusal to Grant License; Suspension Or Revocation of License

(a) The department may refuse an application for a license or may suspend or revoke a license.

(b) The executive commissioner by rule shall establish minimum standards for granting and maintaining a license. In adopting rules under this section, the executive commissioner shall:

(1) ensure that the minimum standards prioritize safe handling of fruits and vegetables based on known safety risks, including any history of outbreaks of food-borne communicable diseases; and

(2) consider acceptable produce safety standards developed by a federal agency, state agency, or university.

(c) The refusal or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 713, Sec. 1, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 2, eff. September 1, 2011.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0989, eff. April 2, 2015.

Sec. 431.227: Food Safety Best Practice Education Program

(a) The department shall approve food safety best practice education programs for places of business licensed under this chapter.

(b) A place of business that completes a food safety best practice education program approved by the department shall receive a certificate valid for five years from the date of completion of the program.

(c) When determining which places of business to inspect under Section 431.042, the appropriate inspecting authority shall consider whether the place of business holds a valid certificate from a food safety best practice education program under this section.

(d) The executive commissioner shall adopt rules to implement this section.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 3, eff. September 1, 2011.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0990, eff. April 2, 2015.

Subchapter K

Sec. 431.241: Rulemaking Authority

(a) The executive commissioner may adopt rules for the efficient enforcement of this chapter.

(b) The executive commissioner may conform rules adopted under this chapter, if practicable, with regulations adopted under the federal Act.

(c) The enumeration of specific federal laws and regulations in Sections 431.244 and 431.245 does not limit the general authority granted to the executive commissioner in Subsection (b) to conform rules adopted under this chapter to those adopted under the federal Act.

(d) The executive commissioner may adopt the federal regulations issued by the secretary pursuant to the Prescription Drug Marketing Act of 1987 (21 U.S.C. Sections 331, 333, 353, and 381), as necessary or desirable so that the state wholesale drug distributor licensing program in Subchapter N may achieve compliance with that Act.

(e) The executive commissioner shall not establish a drug formulary that restricts by any prior or retroactive approval process a physician's ability to treat a patient with a prescription drug that has been approved and designated as safe and effective by the United States Food and Drug Administration, in compliance with federal law and subject to review by the executive commissioner.

(f) Nothing in this section shall effect a prior approval program in operation on the effective date of this section nor shall any portion of this chapter prohibit a prior approval process on any federally exempted products.

(g) The department may assess a fee for the issuance of a certificate of free sale and another certification issued under this chapter. The executive commissioner by rule shall set each fee in an amount sufficient to recover the cost to the department of issuing the particular certificate.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 11, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 675, Sec. 7, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0991, eff. April 2, 2015.

Sec. 431.242: Contested Case Hearings and Appeals

A hearing under this chapter or an appeal from a final administrative decision shall be conducted under Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Sec. 431.244: Federal Regulations Adopted As State Rules

(a) A regulation adopted by the secretary under the federal Act concerning pesticide chemicals, food additives, color additives, special dietary use, processed low acid food, acidified food, infant formula, bottled water, or vended bottled water is a rule for the purposes of this chapter, unless the executive commissioner modifies or rejects the rule.

(b) A regulation adopted under the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.) is a rule for the purposes of this chapter, unless the executive commissioner modifies or rejects the rule. The executive commissioner may not adopt a rule that conflicts with the labeling requirements for the net quantity of contents required under Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1453) and the regulations adopted under that Act.

(c) A regulation adopted by the secretary under Sections 403(b) through (i) of the federal Act is a rule for the purposes of this chapter unless the executive commissioner modifies or rejects the rule. The executive commissioner may not adopt a rule that conflicts with the limitations provided by Sections 403(q) and (r) of the federal Act.

(d) A federal regulation that this section provides as a rule for the purposes of this chapter is effective:

(1) on the date that the regulation becomes effective as a federal regulation; and

(2) whether or not the executive commissioner or department has fulfilled the rulemaking provisions of Chapter 2001, Government Code.

(e) If the executive commissioner modifies or rejects a federal regulation, the executive commissioner shall comply with the rulemaking provisions of Chapter 2001, Government Code.

(f) For any federal regulation adopted as a state rule under this chapter, including a regulation considered to be a rule for purposes of this chapter under Subsection (a), (b), or (c), the department shall provide on its Internet website:

(1) a link to the text of the federal regulation;

(2) a clear explanation of the substance of and purpose for the regulation; and

(3) information on providing comments in response to any proposed or pending federal regulation, including an address to which and the manner in which comments may be submitted.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 12, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 459, Sec. 6, eff. Sept. 1, 1993; Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 4, eff. September 1, 2011.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0992, eff. April 2, 2015.

Sec. 431.245: Definition Or Standard of Identity, Quality, Or Fill of Container

(a) A definition or standard of identity, quality, or fill of container of the federal Act is a definition or standard of identity, quality, or fill of container in this chapter, except as modified by department rules.

(b) The executive commissioner by rule may establish definitions and standards of identity, quality, and fill of container for a food if:

(1) a federal regulation does not apply to the food; and

(2) the executive commissioner determines that adopting the rules will promote honest and fair dealing in the interest of consumers.

(c) A temporary permit granted for interstate shipment of an experimental pack of food that varies from the requirements of federal definitions and standards of identity is automatically effective in this state under the conditions of the permit.

(d) The department may issue additional permits if the department determines that:

(1) it is necessary for the completion of an otherwise adequate investigation; and

(2) the interests of consumers are safeguarded.

(e) A permit issued under Subsection (d) is subject to the terms and conditions of department rules.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0993, eff. April 2, 2015.

Sec. 431.246: Removal of Adulterated Item from Stores

The executive commissioner shall adopt rules that provide a system for removing adulterated items from the shelves of a grocery store or other retail establishment selling those items.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0994, eff. April 2, 2015.

Sec. 431.247: Delegation of Powers Or Duties

(a) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(75), eff. April 2, 2015.

(b) A health authority may, unless otherwise restricted by law, delegate a power or duty imposed on the health authority by this chapter to an employee of the local health department, the local health unit, or the public health district in which the health authority serves.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(75), eff. April 2, 2015.

Sec. 431.248: Memorandum of Understanding with Department of Agriculture

(a) The department and the Department of Agriculture shall execute a memorandum of understanding that:

(1) requires each agency to disclose to the other agency any positive results of testing conducted by the agency for pesticides in food; and

(2) specifies how each agency will assist the other in performing its duties regarding pesticides in food.

(b) The executive commissioner and the Department of Agriculture shall adopt the memorandum of understanding as a rule.

(c) The department and the Department of Agriculture shall request the federal Food and Drug Administration to join in execution of the memorandum of understanding.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0995, eff. April 2, 2015.

Sec. 431.249: Dissemination of Information

(a) The department may publish reports summarizing the judgments, decrees, and court orders rendered under this chapter, including the nature and disposition of the charge.

(b) The department may disseminate information regarding a food, drug, device, or cosmetic in a situation that the department determines to involve imminent danger to health or gross deception of consumers.

(c) This section does not prohibit the department from collecting, reporting, and illustrating the results of an investigation by the department.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0996, eff. April 2, 2015.

Sec. 431.250: Public Comments for Federal Grants and Contracts

(a) The department shall annually solicit comments from interested persons regarding the grants and contracts the department has requested from or entered into with the United States Food and Drug Administration for implementing the federal Act and its amendments, including the Food Safety Modernization Act (21 U.S.C. Section 2201 et seq.).

(b) The department shall solicit comments by posting on the department's Internet website a detailed description of and providing notice to interested persons of each grant and contract described by Subsection (a) requested or entered into during the previous year. The description and notice must include the benefits to this state, the department, the regulated community, and the public.

(c) The department shall respond to questions and comments about a grant or contract described by Subsection (a) to the best of the department's knowledge. If an interested person requests that the department decline to receive future federal funding from the grant or contract, the department shall consider the request and determine whether the benefits of the grant or contract outweigh the person's concerns.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 749 (H.B. 1846), Sec. 1, eff. September 1, 2015.

Subchapter L

Sec. 431.271: Definitions

In this subchapter:

(1) "Distributor" means a person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user. The term includes an importer or an own-label distributor. The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labelling of the finished device or the finished device package.

(2) "Finished device" means a device, or any accessory to a device, that is suitable for use, without regard to whether it is packaged or labelled for commercial distribution.

(3) "Importer" means any person who initially distributes a device imported into the United States.

(4) "Manufacturer" means a person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device.

(5) "Place of business" means each location at which a finished device is manufactured or held for distribution.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 2, eff. Sept. 1, 1995.

Sec. 431.272: License Required; Minimum Standards

(a) Except as provided by Section 431.273, a person may not operate as a distributor or manufacturer of devices in this state unless the person has a license from the department for each place of business.

(b) A distributor or manufacturer of devices in this state must comply with the minimum requirements specified in the federal Act and in this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 2, eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0997, eff. April 2, 2015.

Sec. 431.273: Exemption from Licensing

(a) A person is exempt from licensing under this subchapter if the person engages only in the following types of device distribution:

(1) intracompany sales;

(2) distribution from a place of business located outside of this state; or

(3) the sale, purchase, or trade of a distressed or reconditioned device by a salvage broker or a salvage operator licensed under Chapter 432 (Texas Food, Drug, Device, and Cosmetic Salvage Act).

(a-1) A person is exempt from licensing under this subchapter if the person holds a registration certificate issued under Chapter 266, Occupations Code, and engages only in conduct within the scope of that registration.

(b) An exemption from the licensing requirements under this section does not constitute an exemption from the other provisions of this chapter or the rules adopted by the executive commissioner to administer and enforce this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 1047, Sec. 3, eff. Sept. 1, 1995.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 302 (H.B. 1395), Sec. 1, eff. September 1, 2013.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0998, eff. April 2, 2015.

Sec. 431.274: License Application

(a) A person applying for a license under this subchapter shall provide, at a minimum, the following information on a license application form furnished by the department:

(1) the name under which the business is conducted;

(2) the address of each place of business that is licensed;

(3) the name and residence address of:

(A) the proprietor, if the business is a proprietorship;

(B) all partners, if the business is a partnership; or

(C) all principals, if the business is an association;

(4) the date and place of incorporation if the business is a corporation;

(5) the names and residence addresses of the individuals in an administrative capacity showing:

(A) the managing proprietor, if the business is a proprietorship;

(B) the managing partner, if the business is a partnership;

(C) the officers and directors, if the business is a corporation; or

(D) the persons in a managerial capacity, if the business is an association; and

(6) the residence address of an individual in charge of each place of business.

(b) The license application must be signed, verified, and completed in a manner described in department rules.

(c) A person applying for a license under this subchapter must pay a licensing fee for each place of business.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0999, eff. April 2, 2015.

Sec. 431.276: Fees

(a) The department shall collect fees for:

(1) a license that is filed or renewed;

(2) a license that is amended, including notification of a change of location of a licensed place of business required under Section 431.278, a change of the name of an association or corporation, or a change in the ownership of the licensee; and

(3) an inspection performed to enforce this subchapter and rules adopted under this subchapter.

(b) The department may charge fees every two years.

(c) The executive commissioner by rule shall set the fees in amounts that allow the department to recover the biennial expenditures of state funds by the department in:

(1) reviewing and acting on a license or renewal license;

(2) amending a license;

(3) inspecting a licensed facility; and

(4) implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.

(d) At least half of the licensing fees collected shall be used to inspect an applicant or licensed place of business.

(e) Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and may be appropriated to the department only to carry out this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1000, eff. April 2, 2015.

Sec. 431.278: Change of Location of Place of Business

(a) Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business. The notice shall include the address of the new location and the name and residence address of the individual in charge of the business at the new location.

(b) Not later than the 10th day after the date of completion of the change of location, the licensee shall notify the department in writing to verify the change of location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address.

(c) Notice is adequate if the licensee provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the central office of the department.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1001, eff. April 2, 2015.

Sec. 431.279: Refusal to License; Suspension Or Revocation of License

(a) The department may refuse an application or may suspend or revoke a license if the applicant or licensee:

(1) has been convicted of a felony or misdemeanor that involves moral turpitude;

(2) is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

(3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(4) is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs; or

(5) has not complied with this chapter or the rules implementing this chapter.

(b) The department may refuse an application for a license or may suspend or revoke a license if the department determines from evidence presented during a hearing that the applicant or licensee:

(1) has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(2) has violated Chapter 481 (Texas Controlled Substances Act) or 483 (Dangerous Drugs); or

(3) has violated the rules of the public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or licensee to maintain.

(c) The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the department's formal hearing procedures and the procedures for a contested case hearing under Chapter 2001, Government Code.

Comments

Added by Acts 1993, 73rd Leg., ch. 440, Sec. 3, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1002, eff. April 2, 2015.

Subchapter M

Sec. 431.321: Definitions

(a) "Charitable medical clinic" means a clinic, including a licensed pharmacy that is a community pharmaceutical access program provider, that provides medical care or drugs without charge or for a substantially reduced charge, complies with the insurance requirements of Chapter 84, Civil Practice and Remedies Code, and is exempt from federal income tax under Section 501(a) of the Internal Revenue Code of 1986 by being listed as an exempt organization in Section 501(c)(3) or 501(c)(4) of the code and is operated exclusively for the promotion of social welfare by being primarily engaged in promoting the common good and general welfare of the people in a community.

(b) "Seller" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

(c) "Manufacturer" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

(d) "Charitable drug donor" means a licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or manufacturer that donates drugs pursuant to a qualified patient assistance program, that donates drugs to a charitable medical clinic.

(d-1) In this subchapter, "community pharmaceutical access program" means a program offered by a licensed pharmacy under which the pharmacy assists financially disadvantaged persons to access prescription drugs at no charge or at a substantially reduced charge.

(e) In this subchapter, "patient assistance program" means a qualified program offered by a pharmaceutical manufacturer under which the manufacturer provides drugs to financially disadvantaged persons at no charge or at a substantially reduced cost. The term does not include the provision of a drug as part of a clinical trial.

Comments

Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 820 (S.B. 1896), Sec. 2, eff. June 15, 2007.

Sec. 431.322: Donation of Unused Drugs to Charitable Medical Clinic

(a) A charitable drug donor may donate certain unused prescription drugs to a charitable medical clinic, and a charitable clinic may accept, dispense, or administer the donated drugs in accordance with this subchapter.

(b) A seller or manufacturer of a drug may not donate drugs to a charitable medical clinic except pursuant to a qualified patient assistance program. A seller or manufacturer of a drug that donates drugs through a qualified patient assistance program shall be considered a charitable drug donor.

(c) The charitable drug donor shall use appropriate safeguards established by department rule to ensure that the drugs are not compromised or illegally diverted while being stored or transported to the charitable medical clinic.

(d) The charitable medical clinic may not accept the donated drugs unless:

(1) the charitable drug donor certifies that the drugs have been properly stored while in the possession of the donor or of the person for whom the drugs were originally dispensed;

(2) the charitable drug donor provides the clinic with a verifiable address and telephone number; and

(3) the person transferring possession of the drugs presents the charitable medical clinic with photographic identification.

Comments

Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1003, eff. April 2, 2015.

Sec. 431.323: Circumstances Under Which Donated Drugs May Be Accepted and Dispensed

(a) A charitable medical clinic may accept and dispense or administer donated drugs only in accordance with this subchapter.

(b) The donated drugs must be drugs that require a prescription. A donated drug may not be a controlled substance under Chapter 481.

(c) The donated drugs must be approved by the federal Food and Drug Administration and:

(1) be sealed in the manufacturer's unopened original tamper-evident packaging and either:

(A) individually packaged; or

(B) packaged in unit-dose packaging;

(2) be oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration;

(3) be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration; or

(4) be parenteral medication in sealed multiple-dose containers approved by the federal Food and Drug Administration from which no doses have been withdrawn; and

(5) must not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer.

(d) The charitable medical clinic may dispense or administer the donated drugs only:

(1) before the expiration date or within the recommended shelf life of the donated drugs, as applicable; and

(2) after a licensed pharmacist has determined that the drugs are of an acceptable integrity.

(e) The donated drugs may be accepted and dispensed or administered by the charitable medical clinic only in accordance with department rules.

Comments

Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1004, eff. April 2, 2015.

Sec. 431.324: Rules

The executive commissioner shall adopt rules to implement this subchapter that are designed to protect the public health and safety.

Comments

Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1005, eff. April 2, 2015.

Sec. 431.325: Limitation on Liability

(a) Charitable drug donors, charitable medical clinics, and their employees are not liable for harm caused by the accepting, dispensing, or administering of drugs donated in strict compliance with this subchapter unless the harm is caused by:

(i) willful or wanton acts of negligence;

(ii) conscious indifference or reckless disregard for the safety of others; or

(iii) intentional conduct.

(b) This section does not limit, or in any way affect or diminish, the liability of a drug seller or manufacturer pursuant to Chapter 82, Civil Practice and Remedies Code.

(c) This section shall not apply where harm results from the failure to fully and completely comply with the requirements of this subchapter.

(d) This section shall not apply to a charitable medical clinic that fails to comply with the insurance provisions of Chapter 84, Civil Practice and Remedies Code.

Comments

Added by Acts 2001, 77th Leg., ch. 1138, Sec. 1, eff. Jan. 1, 2002.

Subchapter N

Sec. 431.401: Definitions

In this subchapter:

(1) "Authentication" means to affirmatively verify before any wholesale distribution of a prescription drug occurs that each transaction listed on the pedigree for the drug has occurred.

(2) "Authorized distributor of record" means a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products in accordance with Section 431.4011.

(3) "Pharmacy warehouse" means a location for which a person holds a wholesale drug distribution license under this subchapter, that serves as a central warehouse for drugs or devices, and from which intracompany sales or transfers of drugs or devices are made to a group of pharmacies under common ownership and control.

(3-a) "Co-licensed product partner" means one of two or more parties that have the right to engage in the manufacturing or marketing of a prescription drug consistent with the United States Food and Drug Administration's regulations and guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100-293).

(3-b) "Drop shipment" means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug, or by the manufacturer's co-licensed product partner, third-party logistics provider, or exclusive distributor, in which:

(A) the wholesale distributor takes title but not physical possession of the prescription drug;

(B) the wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the drug to a patient; and

(C) the pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer or the manufacturer's third-party logistics provider or exclusive distributor.

(4) "Logistics provider" means a person that receives prescription drugs only from the original manufacturer, delivers the prescription drugs at the direction of that manufacturer, and does not purchase, sell, trade, or take title to any prescription drug.

(4-a) "Manufacturer" means a person licensed or approved by the United States Food and Drug Administration to engage in the manufacture of drugs or devices, consistent with the federal agency's definition of "manufacturer" under the agency's regulations and guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100-293). The term does not include a pharmacist engaged in compounding that is done within the practice of pharmacy and pursuant to a prescription drug order or initiative from a practitioner for a patient or prepackaging that is done in accordance with Section 562.154, Occupations Code.

(4-b) "Manufacturer's exclusive distributor" means a person who holds a wholesale distributor license under this subchapter, who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, and who takes title to, but does not have general responsibility to direct the sale or disposition of, the manufacturer's prescription drug. A manufacturer's exclusive distributor must be an authorized distributor of record to be considered part of the normal distribution channel.

(5) "Normal distribution channel" means a chain of custody for a prescription drug, either directly or by drop shipment, from the manufacturer of the prescription drug, the manufacturer to the manufacturer's co-licensed product partner, the manufacturer to the manufacturer's third-party logistics provider, or the manufacturer to the manufacturer's exclusive distributor, to:

(A) a pharmacy to:

(i) a patient; or

(ii) another designated person authorized by law to dispense or administer the drug to a patient;

(B) an authorized distributor of record to:

(i) a pharmacy to a patient; or

(ii) another designated person authorized by law to dispense or administer the drug to a patient;

(C) an authorized distributor of record to a wholesale distributor licensed under this chapter to another designated person authorized by law to administer the drug to a patient;

(D) an authorized distributor of record to a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy;

(E) a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy or another designated person authorized by law to dispense or administer the drug to a patient;

(F) a person authorized by law to prescribe a prescription drug that by law may be administered only under the supervision of the prescriber; or

(G) an authorized distributor of record to one other authorized distributor of record to a licensed practitioner for office use.

(6) "Pedigree" means a document or electronic file containing information that records each wholesale distribution of a prescription drug, from sale by a manufacturer, through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the prescription drug.

(7) "Place of business" means each location at which a drug for wholesale distribution is located.

(8) "Prescription drug" has the meaning assigned by 21 C.F.R. Section 203.3.

(9) "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling of a drug to further the distribution of a prescription drug. The term does not include repackaging by a pharmacist to dispense a drug to a patient.

(10) "Repackager" means a person who engages in repackaging.

(10-a) "Third-party logistics provider" means a person who holds a wholesale distributor license under this subchapter, who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, and who does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition. A third-party logistics provider must be an authorized distributor of record to be considered part of the normal distribution channel.

(11) "Wholesale distribution" means distribution of prescription drugs to a person other than a consumer or patient. The term does not include:

(A) intracompany sales of prescription drugs, which means transactions or transfers of prescription drugs between a division, subsidiary, parent, or affiliated or related company that is under common ownership and control, or any transaction or transfer between co-license holders of a co-licensed product;

(B) the sale, purchase, distribution, trade, or transfer of prescription drugs or the offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons;

(C) the distribution of prescription drug samples by a representative of a manufacturer;

(D) the return of drugs by a hospital, health care entity, or charitable institution in accordance with 21 C.F.R. Section 203.23;

(E) the sale of reasonable quantities by a retail pharmacy of a prescription drug to a licensed practitioner for office use;

(F) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug under a prescription;

(G) the sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets;

(H) the sale, purchase, or trade of a drug, or the offer to sell, purchase, or trade a drug, for emergency medical reasons, including a transfer of a prescription drug by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;

(I) the delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug; or

(J) the sale or transfer from a retail pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer or to a third-party returns processor.

(12) "Wholesale distributor" means a person engaged in the wholesale distribution of prescription drugs, including a manufacturer, repackager, own-label distributor, private-label distributor, jobber, broker, manufacturer warehouse, distributor warehouse, or other warehouse, manufacturer's exclusive distributor, authorized distributor of record, drug wholesaler or distributor, independent wholesale drug trader, specialty wholesale distributor, third-party logistics provider, retail pharmacy that conducts wholesale distribution, and pharmacy warehouse that conducts wholesale distribution.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 3, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch. 1384 (S.B. 1645), Sec. 3, eff. June 19, 2009.

Sec. 431.4011: Ongoing Relationship

In this subchapter, "ongoing relationship" means an association that exists when a manufacturer and distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments. If the distributor is not authorized to distribute the manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.4012: Applicability of Subchapter

This subchapter applies only to the wholesale distribution of prescription drugs.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.402: License Required

(a) A person may not engage in wholesale distribution of prescription drugs in this state unless the person holds a wholesale drug distribution license under this subchapter for each place of business.

(b) A license issued under this subchapter expires on the second anniversary of the date of issuance.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.403: Exemption from Licensing

(a) A person who engages in wholesale distribution of prescription drugs in this state for use in humans is exempt from this subchapter if the person is exempt under:

(1) the Prescription Drug Marketing Act of 1987 (21 U.S.C. Section 353(c)(3)(B));

(2) the regulations adopted by the secretary to administer and enforce that Act; or

(3) the interpretations of that Act set out in the compliance policy manual of the United States Food and Drug Administration.

(b) An exemption from the licensing requirements under this section does not constitute an exemption from the other provisions of this chapter or the rules adopted under this chapter to administer and enforce the other provisions of this chapter.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.4031: Exemption from Certain Provisions for Certain Wholesale Distributors

(a) A wholesale distributor that distributes prescription drugs that are medical gases or a wholesale distributor that is a manufacturer or a third-party logistics provider on behalf of a manufacturer is exempt from Sections 431.404(a)(5) and (6), (b), and (c), 431.4045(2), 431.405, 431.407, and 431.408.

(b) A state agency or a political subdivision of this state that distributes prescription drugs using federal or state funding to nonprofit health care facilities or local mental health or mental retardation authorities for distribution to a pharmacy, practitioner, or patient is exempt from Sections 431.405(b), 431.407, 431.408, 431.412, and 431.413.

(c) The executive commissioner by rule may exempt specific purchases of prescription drugs by state agencies and political subdivisions of this state if the executive commissioner determines that the requirements of this subchapter would result in a substantial cost to the state or a political subdivision of the state.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 4, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch. 1384 (S.B. 1645), Sec. 4, eff. June 19, 2009.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1006, eff. April 2, 2015.

Sec. 431.404: License Application

(a) An applicant for a license under this subchapter must submit an application to the department on the form prescribed by the department. The application must contain:

(1) the name, full business address, and telephone number of the applicant;

(2) all trade or business names under which the business is conducted;

(3) the address, telephone number, and name of a contact person for each of the applicant's places of business;

(4) the type of business entity and:

(A) if the business is a sole proprietorship, the name of the proprietor;

(B) if the business is a partnership, the name of the partnership and each of the partners; or

(C) if the business is a corporation, the name of the corporation, the place of incorporation, and the name and title of each corporate officer and director;

(5) the name and telephone number of, and any information necessary to complete a criminal history record check on, a designated representative of each place of business; and

(6) a list of all licenses and permits issued to the applicant by any other state under which the applicant is permitted to purchase or possess prescription drugs.

(b) Each person listed in Subsection (a)(5) shall provide the following to the department:

(1) the person's places of residence for the past seven years;

(2) the person's date and place of birth;

(3) the person's occupations, positions of employment, and offices held during the past seven years;

(4) the business name and address of any business, corporation, or other organization in which the person held an office under Subdivision (3) or in which the person conducted an occupation or held a position of employment;

(5) a statement of whether during the preceding seven years the person was the subject of a proceeding to revoke a license or a criminal proceeding and the nature and disposition of the proceeding;

(6) a statement of whether during the preceding seven years the person has been enjoined, either temporarily or permanently, by a court from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, including the details concerning the event;

(7) a written description of any involvement by the person as an officer or director with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which the businesses were named as a party;

(8) a description of any misdemeanor or felony offense for which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere;

(9) a description of any criminal conviction of the person under appeal, a copy of the notice of appeal for that criminal offense, and a copy of the final written order of an appeal not later than the 15th day after the date of the appeal's disposition; and

(10) a photograph of the person taken not earlier than 180 days before the date the application was submitted.

(c) The information submitted under Subsection (b) must be attested to under oath.

(d) An applicant or license holder shall submit to the department any change in or correction to the information required under this section in the form and manner prescribed by department rule.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 5, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1007, eff. April 2, 2015.

Sec. 431.4045: Inspection Required

The department may not issue a wholesale distributor license to an applicant under this subchapter unless the department:

(1) conducts a physical inspection of the place of business at the address provided by the applicant under Section 431.404 or determines that an inspection is unnecessary after thoroughly evaluating the information in the application, the compliance history of the applicant and the applicant's principals, and the risk of counterfeiting in the applicant's product; and

(2) determines that the designated representative of the place of business meets the qualifications required by Section 431.405.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 6, eff. September 1, 2007.

Sec. 431.405: Qualifications for License

(a) The department may not issue a wholesale distributor license to an applicant without considering the minimum federal information and related qualification requirements published in federal regulations at 21 C.F.R. Part 205, including:

(1) factors in reviewing the qualifications of persons who engage in wholesale distribution, 21 C.F.R. Section 205.6;

(2) appropriate education and experience for personnel employed in wholesale distribution, 21 C.F.R. Section 205.7; and

(3) the storage and handling of prescription drugs and the establishment and maintenance of prescription drug distribution records, 21 C.F.R. Section 205.50.

(b) In addition to meeting the minimum federal requirements as provided by Subsection (a), to qualify for the issuance or renewal of a wholesale distributor license under this subchapter, the designated representative of an applicant or license holder must:

(1) be at least 21 years of age;

(2) have been employed full-time for at least three years by a pharmacy or a wholesale distributor in a capacity related to the dispensing or distributing of prescription drugs, including recordkeeping for the dispensing or distributing of prescription drugs;

(3) be employed by the applicant full-time in a managerial-level position;

(4) be actively involved in and aware of the actual daily operation of the wholesale distributor;

(5) be physically present at the applicant's place of business during regular business hours, except when the absence of the designated representative is authorized, including sick leave and vacation leave;

(6) serve as a designated representative for only one applicant at any one time, except in a circumstance, as the department determines reasonable, in which more than one licensed wholesale distributor is colocated in the same place of business and the wholesale distributors are members of an affiliated group, as defined by Section 1504, Internal Revenue Code of 1986;

(7) not have been convicted of a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or the distribution of controlled substances; and

(8) not have been convicted of a felony under a federal, state, or local law.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 7, eff. September 1, 2007.

Sec. 431.406: Effect of Operation in Other Jurisdictions; Reports

(a) A person who engages in the wholesale distribution of drugs outside this state may engage in the wholesale distribution of drugs in this state if the person holds a license issued by the department.

(b) The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with this subchapter and the minimum standards adopted under this subchapter.

(c) The department may issue a license to a person who engages in the wholesale distribution of drugs outside this state to engage in the wholesale distribution of drugs in this state if, after an examination of the reports of the person's compliance history and current compliance record, the department determines that the person is in compliance with this subchapter and the rules adopted under this subchapter.

(d) The department shall consider each license application and any related documents or reports filed by or in connection with a person who wishes to engage in wholesale distribution of drugs in this state on an individual basis.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.407: Criminal History Record Information

The department shall submit to the Department of Public Safety the fingerprints provided by a person with an initial or a renewal license application to obtain the person's criminal history record information and may forward the fingerprints to the Federal Bureau of Investigation for a federal criminal history check.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Sec. 431.408: Bond

(a) A wholesale distributor applying for or renewing a license shall submit payable to this state a bond or other equivalent security acceptable to the department, including an irrevocable letter of credit or a deposit in a trust account or financial institution, in the amount of $100,000 payable to this state.

(a-1) A pharmacy warehouse that is not engaged in wholesale distribution is exempt from the bond requirement under Subsection (a).

(b) The bond or equivalent security submitted under Subsection (a) shall secure payment of any fines or penalties imposed by the department or imposed in connection with an enforcement action by the attorney general, any fees or other enforcement costs, including attorney's fees payable to the attorney general, and any other fees and costs incurred by this state related to that license holder, that are authorized under the laws of this state and that the license holder fails to pay before the 30th day after the date a fine, penalty, fee, or cost is assessed.

(c) The department or this state may make a claim against a bond or security submitted under Subsection (a) before the first anniversary of the date a license expires or is revoked under this subchapter.

(c-1) A single bond is sufficient to cover all places of business operated by a wholesale distributor in this state.

(d) The department shall deposit the bonds and equivalent securities received under this section in a separate account.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 8, eff. September 1, 2007.

Sec. 431.409: Fees

(a) The department shall collect fees for:

(1) a license that is filed or renewed;

(2) a license that is amended, including a notification of a change in the location of a licensed place of business required under Section 431.410; and

(3) an inspection performed in enforcing this subchapter and rules adopted under this subchapter.

(b) The executive commissioner by rule shall set the fees in amounts that are reasonable and necessary and allow the department to recover the biennial expenditures of state funds by the department in:

(1) reviewing and acting on a license;

(2) amending and renewing a license;

(3) inspecting a licensed facility; and

(4) implementing and enforcing this subchapter, including a rule or order adopted or a license issued under this subchapter.

(c) Fees collected under this section shall be deposited to the credit of the food and drug registration fee account of the general revenue fund and appropriated to the department to carry out this chapter.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1008, eff. April 2, 2015.

Sec. 431.4095: Renewal Notification; Change Or Renewal

(a) Before the expiration of a license issued under this subchapter, the department shall send to each licensed wholesale distributor a form containing a copy of the information the distributor provided to the department under Section 431.404.

(b) Not later than the 30th day after the date the wholesale distributor receives the form under Subsection (a), the wholesale distributor shall identify and state under oath to the department any change in or correction to the information.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 9, eff. September 1, 2007.

Sec. 431.410: Change of Location of Place of Business

(a) Not fewer than 30 days in advance of the change, the license holder shall notify the department in writing of the license holder's intent to change the location of a licensed place of business.

(b) The notice shall include the address of the new location and the name and residence address of the individual in charge of the business at the new location.

(c) Not more than 10 days after the completion of the change of location, the license holder shall notify the department in writing to confirm the completion of the change of location and provide verification of the information previously provided or correct and confirm any information that has changed since providing the notice of intent.

(d) The notice and confirmation required by this section are considered adequate if the license holder sends the notices by certified mail, return receipt requested, to the central office of the department or submits the notices electronically through the state electronic Internet portal.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 973 (H.B. 1504), Sec. 30, eff. June 17, 2011.

Sec. 431.411: Minimum Restrictions on Transactions

(a) A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse in accordance with the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse. An expired, damaged, recalled, or otherwise nonsalable prescription drug that is returned to the wholesale distributor may be distributed by the wholesale distributor only to either the original manufacturer or a third-party returns processor. The returns or exchanges, salable or otherwise, received by the wholesale distributor as provided by this subsection, including any redistribution of returns or exchanges by the wholesale distributor, are not subject to the pedigree requirement under Section 431.412 if the returns or exchanges are exempt from pedigree under:

(1) Section 4, Prescription Drug Marketing Act of 1987 (21 U.S.C. Section 353(c)(3)(B));

(2) the regulations adopted by the secretary to administer and enforce that Act; or

(3) the interpretations of that Act set out in the compliance policy guide of the United States Food and Drug Administration.

(a-1) Each wholesale distributor and pharmacy shall administer the process of drug returns and exchanges to ensure that the process is secure and does not permit the entry of adulterated or counterfeit drugs into the distribution channel.

(a-2) Notwithstanding any provision of state or federal law to the contrary, a person that has not otherwise been required to obtain a wholesale license under this subchapter and that is a pharmacy engaging in the sale or transfer of expired, damaged, returned, or recalled prescription drugs to the originating wholesale distributor or manufacturer and pursuant to federal statute, rules, and regulations, including the United States Food and Drug Administration's applicable guidances implementing the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100-293), is exempt from wholesale licensure requirements under this subchapter.

(b) A manufacturer or wholesale distributor may distribute prescription drugs only to a person licensed by the appropriate state licensing authorities or authorized by federal law to receive the drug. Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must verify that the person is legally authorized by the appropriate state licensing authority to receive the prescription drugs or authorized by federal law to receive the drugs.

(c) Except as otherwise provided by this subsection, prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license. A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if:

(1) the identity and authorization of the recipient is properly established; and

(2) delivery is made only to meet the immediate needs of a particular patient of the authorized person.

(d) Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 10, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1009, eff. April 2, 2015.

Sec. 431.412: Pedigree Required

(a) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, shall provide a pedigree for each prescription drug for human consumption that leaves or at any time has left the normal distribution channel and is sold, traded, or transferred to any other person.

(b) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(b-1) A retail pharmacy or pharmacy warehouse is required to comply with this section only if the pharmacy or warehouse engages in the wholesale distribution of a prescription drug.

(c) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.

(d) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager, but excluding the original manufacturer of the finished form of a prescription drug, and who is in possession of a pedigree for a prescription drug must verify before distributing the prescription drug that each transaction listed on the pedigree has occurred.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 11, eff. September 1, 2007.

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 14 eff. September 1, 2007.

Sec. 431.413: Pedigree Contents

(a) A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer, through acquisition and sale by a wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. At a minimum, the chain of distribution information must include:

(1) the name, address, telephone number, and, if available, the e-mail address of each person who owns the prescription drug and each wholesale distributor of the prescription drug;

(2) the name and address of each location from which the product was shipped, if different from the owner's name and address;

(3) the transaction dates; and

(4) certification that each recipient has authenticated the pedigree.

(b) The pedigree must include, at a minimum, the:

(1) name of the prescription drug;

(2) dosage form and strength of the prescription drug;

(3) size of the container;

(4) number of containers;

(5) lot number of the prescription drug; and

(6) name of the manufacturer of the finished dosage form.

(c) Each pedigree statement must be:

(1) maintained by the purchaser and the wholesale distributor for at least three years; and

(2) available for inspection and photocopying not later than the second business day after the date a request is submitted by the department or a peace officer in this state.

(d) The executive commissioner shall adopt rules to implement this section.

(e-1) If, after consulting with manufacturers, distributors, and pharmacies responsible for the sale and distribution of prescription drugs in this state, the department determines that electronic track and trace pedigree technology is universally available across the entire prescription pharmaceutical supply chain, the department shall establish a targeted implementation date for electronic track and trace pedigree technology. After the department has established a targeted implementation date, the department may revise the date. The targeted implementation date may not be earlier than July 1, 2010.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 12, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1010, eff. April 2, 2015.

Sec. 431.414: Refusal to License; Suspension Or Revocation of License

(a) The department may refuse an application for a license or may suspend or revoke a license if the applicant or license holder:

(1) has been convicted of a felony or misdemeanor that involves moral turpitude;

(2) is an association, partnership, or corporation and the managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

(3) has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(4) is an association, partnership, or corporation and the managing officer has been convicted in a state or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(5) has not complied with this subchapter or the rules implementing this subchapter;

(6) has violated Section 431.021(l)(3), relating to the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(7) has violated Chapter 481 or 483; or

(8) has violated the rules of the public safety director of the Department of Public Safety, including being responsible for a significant discrepancy in the records that state law requires the applicant or license holder to maintain.

(a-1) The department may suspend or revoke a license if the license holder no longer meets the qualifications for obtaining a license under Section 431.405.

(b) The executive commissioner by rule shall establish minimum standards required for the issuance or renewal of a license under this subchapter.

(c) The department shall deny a license application that is incomplete, contains false, misleading, or incorrect information, or contains information that cannot be verified by the department.

(d) The refusal to license an applicant or the suspension or revocation of a license by the department and the appeal from that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 13, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1011, eff. April 2, 2015.

Sec. 431.415: Order to Cease Distribution

(a) The department shall issue an order requiring a person, including a manufacturer, distributor, or retailer of a prescription drug, to immediately cease distribution of the drug if the department determines there is a reasonable probability that:

(1) a wholesale distributor has:

(A) violated this subchapter;

(B) falsified a pedigree; or

(C) sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use that could cause serious adverse health consequences or death; and

(2) other procedures would result in unreasonable delay.

(b) An order under Subsection (a) must provide the person subject to the order with an opportunity for an informal hearing on the actions required by the order to be held not later than the 10th day after the date of issuance of the order.

(c) If, after providing an opportunity for a hearing, the department determines that inadequate grounds exist to support the actions required by the order, the commissioner shall vacate the order.

Comments

Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1012, eff. April 2, 2015.

Subchapter O

Sec. 431.451: Definitions

In this subchapter:

(1) "Charitable drug donor" means:

(A) a licensed convalescent or nursing facility or related institution, licensed hospice, hospital, physician, or pharmacy;

(B) a pharmaceutical seller or manufacturer that donates drugs under a qualified patient assistance program; or

(C) the licensed health care professional responsible for administration of drugs in a penal institution, as defined by Section 1.07, Penal Code, in this state.

(2) "Charitable medical clinic" has the meaning assigned by Section 431.321.

(3) "Manufacturer" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

(4) "Patient assistance program" means a qualified program offered by a pharmaceutical manufacturer under which the manufacturer provides drugs to financially disadvantaged persons at no charge or at a substantially reduced cost. The term does not include the provision of a drug as part of a clinical trial.

(5) "Pilot program" means the prescription drug donation pilot program under this subchapter.

(6) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.

(7) "Seller" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.452: Establishment of Pilot Program

(a) The department shall establish a pilot program for donation and redistribution of prescription drugs under this subchapter.

(b) The department shall conduct the pilot program in one or more municipalities with a population of more than 500,000 but less than one million.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.453: Donation of Unused Drugs

(a) A charitable drug donor may donate certain unused prescription drugs to the department for the pilot program under this subchapter.

(b) A seller or manufacturer of a drug that donates drugs through a qualified patient assistance program is considered a charitable drug donor.

(c) A charitable drug donor shall use appropriate safeguards established by department rule to ensure that the drugs are not compromised or illegally diverted while being stored or transported.

(d) The department may not accept the donated drugs unless:

(1) the charitable drug donor certifies that the drugs have been properly stored while in the possession of the donor or of the person for whom the drugs were originally dispensed;

(2) the charitable drug donor provides the department with a verifiable address and telephone number; and

(3) the person transferring possession of the drugs presents photographic identification.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.454: Circumstances Under Which Donated Drugs May Be Accepted

(a) The department may accept donated drugs only in accordance with this subchapter.

(b) The donated drugs must be:

(1) prescription drugs; and

(2) approved by the federal Food and Drug Administration and:

(A) sealed in unopened tamper-evident unit dose packaging;

(B) be oral medication in sealed single-dose containers approved by the federal Food and Drug Administration; or

(C) be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration.

(c) A drug packaged in single unit doses may be accepted and distributed if the outside packaging is opened but the single unit dose packaging is unopened.

(d) Donated drugs may not:

(1) be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer;

(2) be adulterated or misbranded;

(3) be a controlled substance under Chapter 481;

(4) be a parenteral or injectable medication;

(5) require refrigeration;

(6) expire less than 60 days after the date of the donation; or

(7) be a drug that is prohibited from being dispensed to a patient other than a patient who is registered with the drug's manufacturer in accordance with federal Food and Drug Administration requirements.

(e) The department may distribute the donated drugs only after a licensed pharmacist has determined that the drugs are of an acceptable integrity.

(f) The department may not charge a fee for the drugs donated under the pilot program other than a nominal handling fee to defray the costs incurred in implementing the pilot program under this subchapter.

(g) The department may not resell the drugs donated under the pilot program.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.455: Prescription, Provision, and Administration of Donated Drugs

(a) The donated drugs may be accepted and provided or administered to patients only by:

(1) a charitable medical clinic;

(2) a physician's office using the drugs for patients who receive assistance from the medical assistance program under Chapter 32, Human Resources Code, or for other indigent health care; or

(3) a licensed health care professional responsible for administration of drugs in a penal institution, as defined by Section 1.07, Penal Code, in this state.

(b) A prescription drug provided or administered to a patient under the pilot program must be prescribed by a practitioner for use by that patient.

(c) The clinic or physician providing or administering the drug may charge a nominal handling fee in an amount prescribed by department rule.

(d) A clinic, physician, or other licensed health care professional receiving donated drugs may not resell the drugs.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.456: Central Drug Repository

The department shall establish a location to centrally store drugs donated under this subchapter for distribution to qualifying recipients.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.457: Database of Donated Drugs

The department shall establish and maintain an electronic database in which:

(1) the department shall list the name and quantity of each drug donated to the department under the pilot program; and

(2) a charitable medical clinic, physician, or other licensed health care professional may search for and request donated drugs.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.458: Rules

This subchapter shall be governed by department rules that are designed to protect the public health and safety, including:

(1) the maximum handling fee that may be imposed by a clinic or physician providing or administering a donated drug to a patient;

(2) provisions for maintenance of the database of donated drugs; and

(3) any necessary forms for the administration of the pilot program.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.459: Limitation on Civil and Criminal Liability

(a) Charitable drug donors, manufacturers and sellers of donated drugs, charitable medical clinics, physicians, penal institutions, and their employees acting in good faith in providing or administering prescription drugs under the pilot program are not civilly or criminally liable or subject to professional disciplinary action for harm caused by providing or administering drugs donated under this subchapter unless the harm is caused by:

(1) wilful or wanton acts of negligence;

(2) conscious indifference or reckless disregard for the safety of others; or

(3) intentional conduct.

(b) This section does not apply if the harm results from the failure to comply with the requirements of this subchapter.

(c) This section does not apply to a charitable medical clinic that fails to comply with the insurance provisions of Chapter 84, Civil Practice and Remedies Code.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Sec. 431.460: Reports to Legislature

Not later than January 1 of each odd-numbered year, the department shall report to the legislature on the results of the pilot program. The report must include:

(1) the pilot program's efficacy in expanding access to prescription medications;

(2) any cost savings to the state or local governments resulting from or projected to result from the pilot program;

(3) an evaluation of the pilot program's database and system of distribution;

(4) any health and safety issues posed by providing or administering donated drugs;

(5) recommendations on improvements to the pilot program; and

(6) an evaluation of potential expansion of the pilot program.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 1191 (S.B. 1243), Sec. 1, eff. September 1, 2015.

Chapter 432

Sec. 432.001: Short Title

This chapter may be cited as the Texas Food, Drug, Device, and Cosmetic Salvage Act.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.002: Purpose

The purpose of this chapter is to protect the health of the people of this state by preventing the sale or distribution of adulterated or misbranded food, drugs, devices, or cosmetics.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.003: Definitions

In this chapter:

(1) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(76), eff. April 2, 2015.

(2) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(76), eff. April 2, 2015.

(3) "Cosmetic" means an article or a substance, or a component of an article or substance, that is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. The term does not include soap.

(4) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(76), eff. April 2, 2015.

(5) "Device" means an instrument, apparatus, or contrivance, or a component, part, or accessory of an instrument, apparatus, or contrivance, that is designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, or that is designed or intended to affect the structure or any function of the body of a human or other animal.

(6) "Distressed merchandise" means any food, drug, device, or cosmetic that is adulterated or misbranded for purposes of Section 431.081 (Adulterated Food), 431.082 (Misbranded Food), 431.111 (Adulterated Drug or Device), 431.112 (Misbranded Drug or Device), 431.141 (Adulterated Cosmetic), or 431.142 (Misbranded Cosmetic), as interpreted by department rule and judicial decision. The term includes a food, drug, device, or cosmetic that:

(A) has lost its label or is otherwise unidentified;

(B) has been subjected to prolonged or improper storage;

(C) has been subjected for any reason to abnormal environmental conditions, including temperature extremes, humidity, smoke, water, fumes, pressure, or radiation;

(D) has been subjected to conditions that result in either its strength, purity, or quality falling below that which it purports or is represented to possess; or

(E) may have been rendered unsafe or unsuitable for human consumption or use for any reason other than those specified by this subdivision.

(7) "Drug" means an article or substance, other than a device, that is:

(A) recognized in The United States Pharmacopeia and The National Formulary (USP-NF) or the Homoeopathic Pharmacopoeia of the United States (HPUS), or a supplement to those publications;

(B) designed or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;

(C) intended to affect the structure or any function of the body of a human or other animal, excluding food; or

(D) intended for use as a component of an article or substance specified by this subdivision.

(8) "Food" means an article or a component of an article of human food or drink, and includes chewing gum.

(9) "Manufacture" means the combining, purifying, processing, packing, or repacking of food, drugs, devices, or cosmetics for wholesale or retail sale.

(10) "Manufacturer" includes a person who represents himself as responsible for the purity and proper labeling of a food, drug, device, or cosmetic.

(11) "Nonprofit organization" means an organization that has received an exemption from federal taxation under 26 U.S.C. Section 501 and is described by Subsection (c)(3) of that section.

(12) "Reconditioning" means any appropriate process or procedure by which distressed merchandise can be brought into compliance with departmental standards for the consumption or use of that merchandise by the public.

(13) "Sale or distribution" means the act of selling or distributing, whether or not for compensation. The term includes delivery, holding or offering for sale, transfer, auction, storage, or any other means of handling or trafficking.

(14) "Salvage broker" means a person who engages in the business of selling, distributing, or otherwise trafficking in distressed or salvaged merchandise, but who does not operate a salvage establishment.

(15) "Salvage establishment" means a place of business that is engaged in reconditioning or otherwise salvaging distressed merchandise, or that buys, sells, or distributes salvaged merchandise for human use.

(16) "Salvage operator" means a person who is engaged in the business of operating a salvage establishment.

(17) "Salvage warehouse" means a separate storage facility used by a salvage broker or salvage establishment to hold distressed or salvaged merchandise.

(18) "Salvaged merchandise" means distressed merchandise that has been reconditioned.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2001, 77th Leg., ch. 265, Sec. 5, eff. May 22, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1013, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(76), eff. April 2, 2015.

Sec. 432.004: Exemptions

(a) This chapter does not apply to:

(1) a manufacturer, distributor, or processor of a food, drug, device, or cosmetic who, in the normal course of business, reconditions the items manufactured, distributed, or processed by or for that person and not purchased by that person solely for the purpose of reconditioning and sale;

(2) a common carrier, or the common carrier's agent, who disposes of or otherwise transfers undamaged or distressed food, drugs, devices, or cosmetics to a person who is exempt under this section or to a licensed salvage broker or salvage operator;

(3) a person who transfers distressed merchandise to a licensed salvage broker or salvage operator; or

(4) a nonprofit organization that distributes food to the needy under Chapter 76, Civil Practice and Remedies Code (Good Faith Donor Act), but that does not recondition the food.

(b) In this chapter, a pharmacist licensed under the law of this state is not considered a manufacturer when the pharmacist fills a prescription from a licensed practitioner or when the pharmacist compounds or mixes drugs or medicine in the pharmacist's professional capacity.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.005: License Required

(a) A person may not operate a salvage establishment in this state without a salvage operator license issued by the department.

(b) A person may not act as a salvage broker in this state without a salvage broker license issued by the department.

(c) A salvage operator or salvage broker who is engaging only within the scope of the license issued under this chapter is not required to also be licensed under Chapter 431.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2001, 77th Leg., ch. 265, Sec. 6, eff. May 22, 2001.

Sec. 432.006: License Application

An applicant for a salvage broker license or salvage operator license must:

(1) file a license application on a form prescribed by the department;

(2) pay a nonrefundable license fee to the department; and

(3) cooperate with the department in any required prelicensing inspections.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.007: Issuance of License

(a) The department shall issue a license to an applicant who complies with Section 432.006 and who meets the minimum qualifications established by department rule.

(b) A license issued under this chapter expires two years after the date of issuance.

(c) A separate license is required for each salvage establishment.

(d) A license may not be transferred from one person to another or from one location to another.

(e) A salvage operator or salvage broker shall display the license in accordance with department rules.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1014, eff. April 2, 2015.

Sec. 432.008: License Renewal

(a) A license holder under this chapter may renew the license by filing with the department, before the expiration date of the current license, a renewal application on a form prescribed by the department, accompanied by a nonrefundable renewal fee.

(b) After an inspection to determine the license holder's compliance with department rules, the department shall renew the license of a license holder who submits a renewal application and pays the renewal fee.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1015, eff. April 2, 2015.

Sec. 432.009: Fees

(a) The executive commissioner by rule shall adopt, and the department shall collect, fees for each license application or renewal application submitted under this chapter and for inspections performed to enforce this chapter and the department rules adopted under this chapter.

(b) The executive commissioner by rule shall set the fees in amounts that are reasonable and necessary and allow the department to recover the biennial expenditures of state funds by the department to:

(1) review and act on licenses;

(2) amend and renew licenses;

(3) inspect establishments operated by license holders; and

(4) implement and enforce this chapter and rules and orders adopted and licenses issued under this chapter.

(c) A nonprofit organization is exempt from the payment of a fee imposed under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1016, eff. April 2, 2015.

Sec. 432.0095: Processing of Food Salvage Establishment Licensing Fees

(a) The commissioner shall establish a system for processing food salvage establishment licensing fees.

(b) Under the fee processing system, the maximum time for processing a fee payment made by a negotiable instrument may not exceed 48 hours, beginning at the time that the negotiable instrument is first received by the department and ending at the time that the fee payment is submitted for deposit by the department to the treasury division of the office of the comptroller.

(c) The comptroller shall cooperate with the commissioner in developing the fee processing system.

Comments

Added by Acts 1999, 76th Leg., ch. 697, Sec. 2, eff. Aug. 30, 1999.

Sec. 432.010: Deposit of Fees

A fee collected by the department under this chapter shall be deposited in the state treasury to the credit of the general revenue fund.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1017, eff. April 2, 2015.

Sec. 432.011: Minimum Standards

(a) The executive commissioner shall adopt rules prescribing minimum standards or related requirements for:

(1) the operation of salvage establishments and salvage warehouses; and

(2) qualifications for licenses issued under this chapter.

(b) The rules shall prescribe standards for food, drugs, devices, and cosmetics in separate subchapters.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2001, 77th Leg., ch. 265, Sec. 7, eff. May 22, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1018, eff. April 2, 2015.

Sec. 432.012: Powers of Department

The department may:

(1) enter into contracts or agreements necessary to implement this chapter;

(2) conduct inspections and secure samples;

(3) establish and maintain educational programs for salvage operators and salvage brokers; and

(4) compile and publish statistical and other studies on the nature and scope of the salvage industry in this state.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.013: Denial, Suspension, Or Revocation of License

(a) The department may deny, suspend, or revoke the license of an applicant or license holder who fails to comply with this chapter or the rules adopted under this chapter.

(b) When there is an imminent threat to the health or safety of the public, the department may suspend a license without notice in accordance with rules adopted by the executive commissioner for the emergency suspension of licenses.

(c) The department's hearing rules and the applicable provisions of Chapter 2001, Government Code, govern a hearing for the denial, suspension, emergency suspension, or revocation of a license and any appeal from that hearing.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1019, eff. April 2, 2015.

Sec. 432.014: Reinstatement of License

(a) Not later than the 30th day after the date of the denial or emergency suspension, a person whose license application has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating the license.

(b) The department shall perform the reinspection not later than the 10th day after the date of receipt of a written request for reinspection from the applicant or license holder.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.015: Effect of Operation in Other Jurisdiction; Reports

(a) A person who operates a salvage establishment or acts as a salvage broker outside this state may sell, distribute, or otherwise traffic in distressed or salvaged merchandise in this state if the person holds a license issued by the department.

(b) The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the minimum standards adopted under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.016: Municipal Regulation

A municipality by ordinance may regulate salvage operators, salvage brokers, and salvage establishments. An ordinance may be stricter than the minimum standards established under this chapter or by rules adopted under this chapter, but it may not be less strict.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.017: Use of Salvage Warehouse

A person may not use a salvage warehouse to recondition merchandise or to sell to consumers.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 432.018: Civil Penalty; Injunction

(a) If it appears that a person has violated, is violating, or is threatening to violate this chapter or a rule adopted or order issued under this chapter, the commissioner may request the attorney general or a district, county, or municipal attorney of the municipality or county in which the violation has occurred, is occurring, or may occur to institute a civil suit for:

(1) an order enjoining the act or an order directing compliance;

(2) a permanent or temporary injunction, restraining order, or other appropriate order if the department shows that the person is engaged in or is about to engage in any of the acts;

(3) the assessment and recovery of a civil penalty; or

(4) both the injunctive relief and civil penalty.

(b) The penalty may be in an amount not to exceed $25,000 for each violation. Each day a violation continues is a separate violation.

(c) In determining the amount of the penalty, the court shall consider:

(1) the person's history of previous violations;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the demonstrated good faith of the person charged; and

(5) other matters as justice may require.

(d) Venue for a suit brought under this section is in the municipality or county in which the violation occurred or in Travis County.

(e) A civil penalty recovered in a suit instituted by a local government under this chapter shall be paid to the local government.

(f) The commissioner and the attorney general may each recover reasonable expenses incurred in obtaining injunctive relief, civil penalties, or both under this section, including investigative costs, court costs, reasonable attorney fees, witness fees, and deposition expenses.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Sec. 432.019: Criminal Penalty

(a) A person commits an offense if the person:

(1) operates a salvage establishment or acts as a salvage broker without a license issued under this chapter; or

(2) fails to comply with a rule adopted under Section 432.011.

(b) An offense under this section is a Class A misdemeanor.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Sec. 432.020: Emergency Order

(a) The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed foods, drugs, devices, or cosmetics in the department's jurisdiction if the commissioner or the commissioner's designee determines that:

(1) the sale or distribution of those foods, drugs, devices, or cosmetics creates or poses an immediate and serious threat to human life or health; and

(2) other procedures available to the department to remedy or prevent the occurrence of the situation will result in unreasonable delay.

(b) The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.

(c) If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order is issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be held under departmental formal hearing rules.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Sec. 432.021: Administrative Penalty

(a) The department may assess an administrative penalty against a person who violates a rule adopted under Section 432.011 or an order adopted or license issued under this chapter.

(b) In determining the amount of the penalty, the department shall consider:

(1) the person's previous violations;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the person's demonstrated good faith; and

(5) other matters as justice may require.

(c) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1020, eff. April 2, 2015.

Sec. 432.022: Administrative Penalty Assessment Procedure

(a) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.

(b) If a hearing is held, an administrative law judge of the State Office of Administrative Hearings shall make findings of fact and shall issue a written proposal for decision regarding the occurrence of the violation and the amount of the penalty.

(c) If the person charged with the violation does not request a hearing, the department may assess a penalty after determining that a violation has occurred and the amount of the penalty.

(d) After making a determination under this section that a penalty is to be assessed, the department shall issue an order requiring that the person pay the penalty.

(e) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(76), eff. April 2, 2015.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1021, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(76), eff. April 2, 2015.

Sec. 432.023: Payment of Administrative Penalty

(a) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the department shall inform the person against whom the order is issued of the amount of the penalty.

(b) Not later than the 30th day after the date on which a decision or order charging a person with a penalty is final, the person shall:

(1) pay the penalty in full; or

(2) file a petition for judicial review of the department's order contesting the amount of the penalty, the fact of the violation, or both.

(b-1) Within the period prescribed by Subsection (b), a person who files a petition for judicial review may:

(1) stay enforcement of the penalty by:

(A) paying the penalty to the court for placement in an escrow account; or

(B) posting with the court a supersedeas bond for the amount of the penalty; or

(2) request that the department stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(B) sending a copy of the affidavit to the department.

(b-2) If the department receives a copy of an affidavit under Subsection (b-1)(2), the department may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(c) A bond posted under this section must be in a form approved by the court and be effective until all judicial review of the order or decision is final.

(d) A person who does not send money to, post the bond with, or file the affidavit with the court within the period prescribed by Subsection (b) waives all rights to contest the violation or the amount of the penalty.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1022, eff. April 2, 2015.

Sec. 432.024: Refund of Administrative Penalty

On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order that:

(1) the appropriate amount of any penalty payment plus accrued interest be remitted to the person not later than the 30th day after that date; or

(2) the bond be released, if the person has posted a bond.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1023, eff. April 2, 2015.

Sec. 432.025: Recovery of Administrative Penalty By Attorney General

The attorney general, at the request of the commissioner, may bring a civil action to recover an administrative penalty under this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 556, Sec. 1, eff. Sept. 1, 1993.

Sec. 432.026: Detained Or Embargoed Article

In accordance with Subchapter C, Chapter 431, the department may detain or embargo an article, including an article that is distressed merchandise, that is in the possession of a person licensed under this chapter and that is being held for the purpose of reconditioning in accordance with this chapter if the department makes the finding required by Section 431.048(e).

Comments

Added by Acts 2001, 77th Leg., ch. 265, Sec. 8, eff. May 22, 2001.

Chapter 433

Subchapter A

Sec. 433.001: Short Title

This chapter may be cited as the Texas Meat and Poultry Inspection Act.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.002: Policy

(a) Meat and meat food products are an important source of the nation's total food supply. It is essential in the public interest that the health and welfare of consumers be protected by assuring that meat and meat food products distributed to them are wholesome, unadulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded meat or meat food products:

(1) injure the public welfare;

(2) destroy markets for wholesome, unadulterated, and properly labeled and packaged meat and meat food products;

(3) cause losses to livestock producers and processors of meat and meat food products;

(4) cause injury to consumers; and

(5) can be sold at lower prices and compete unfairly with wholesome, unadulterated, and properly labeled and packaged articles, to the detriment of consumers and the public.

(b) Regulation by the department and cooperation by this state and the United States as provided by this chapter are appropriate to protect the health and welfare of consumers and otherwise accomplish the purposes of this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1024, eff. April 2, 2015.

Sec. 433.003: Definitions

In this chapter:

(1) "Animal food manufacturer" means a person in the business of manufacturing or processing animal food any part of which is derived from a carcass, or a part or product of a carcass, of livestock.

(2) "Capable of use as human food" means:

(A) not naturally inedible by humans; or

(B) not denatured or otherwise identified as required by department rule to deter its use as human food.

(3) "Color additive" has the meaning given by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.).

(4) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(77), eff. April 2, 2015.

(5) "Exotic animal" means a member of a species of game not indigenous to this state, including an axis deer, nilgai antelope, red sheep, or other cloven-hooved ruminant animal.

(6) "Food additive" has the meaning given by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.).

(7) "Inedible animal product" means a product, other than a meat food product, any part of which is made from a carcass, or a part or product of a carcass, of livestock.

(8) "Interstate commerce" means commerce between this state and:

(A) another state of the United States; or

(B) a foreign country.

(9) "Label" means a display of written, printed, or other graphic matter on the product or the immediate container, other than a package liner, of an article.

(10) "Labeling" means:

(A) a label; or

(B) other written, printed, or graphic material on an article or any container or wrapper of an article, or accompanying an article.

(11) "Livestock" means cattle, bison, sheep, swine, goats, horses, mules, other equines, poultry, domestic rabbits, exotic animals, or domesticated game birds.

(12) "Meat broker" means a person in the business of buying or selling, on commission, carcasses, parts of carcasses, meat, or meat food products of livestock, or otherwise negotiating purchases or sales of those articles other than for the person's own account or as an employee of another person.

(13) "Meat food product" means a product that is capable of use as human food and that is made in whole or part from meat or other portion of the carcass of livestock, except a product that:

(A) contains meat or other portions of the carcass only in a relatively small proportion or that historically has not been considered by consumers as a product of the meat food industry; and

(B) is exempted from the definition of meat food product by department rule under conditions assuring that the meat or other portions of the carcass contained in the product are unadulterated and that the product is not represented as a meat food product.

(14) "Official certificate" means a certificate prescribed by department rule for issuance by an inspector or other person performing official functions under this chapter.

(15) "Official marking device" means a device prescribed or authorized by department rule for use in applying an official mark.

(16) "Official establishment" means an establishment designated by the department at which inspection of the slaughter of livestock or the preparation of livestock products is maintained under this chapter.

(17) "Official inspection legend" means a symbol prescribed by department rule showing that an article was inspected and passed as provided by this chapter.

(18) "Official mark" means the official inspection legend or other symbol prescribed by department rule to identify the status of an article or animal under this chapter.

(19) "Pesticide chemical" has the meaning given by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.).

(20) "Poultry" means a live or dead domesticated bird.

(21) "Poultry product" means a poultry carcass, part of a poultry carcass, or a product any part of which is made from a poultry carcass or part of a poultry carcass, except a product that:

(A) contains poultry ingredients only in a relatively small proportion or that historically has not been considered by consumers as a product of the poultry food industry; and

(B) is exempted from the definition of poultry product by department rule under conditions assuring that the poultry ingredients in the product are unadulterated and that the product is not represented as a poultry product.

(22) "Prepared" means slaughtered, canned, salted, rendered, boned, cut up, stuffed, or manufactured or processed in any other manner.

(23) "Processing establishment" means a slaughtering, packing, meat-canning, or rendering establishment or a similar establishment.

(24) "Raw agricultural commodity" has the meaning given by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.).

(25) "Renderer" means a person in the business of rendering carcasses, or parts or products of carcasses, of livestock, other than rendering conducted under inspection under Subchapter B.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2003, 78th Leg., ch. 41, Sec. 2, eff. May 15, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1025, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(77), eff. April 2, 2015.

Sec. 433.004: Adulteration

A carcass, part of a carcass, meat, or a meat food product is adulterated if:

(1) it bears or contains a poisonous or deleterious substance that may render it injurious to health unless:

(A) the substance is not an added substance; and

(B) the quantity of the substance in or on the article does not ordinarily render it injurious to health;

(2) it bears or contains, because of administration of a substance to a live animal or otherwise, an added poisonous or deleterious substance that the department has reason to believe makes the article unfit for human food, other than a:

(A) pesticide chemical in or on a raw agricultural commodity;

(B) food additive; or

(C) color additive;

(3) any part of it is a raw agricultural commodity that bears or contains a pesticide chemical that is unsafe under Section 408, Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 346a);

(4) it bears or contains a food additive that is unsafe under Section 409, Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 348) or a color additive that is unsafe for purposes of Section 721 of that Act (21 U.S.C. Section 379e);

(5) it is not adulterated under Subdivision (3) or (4), but use of the pesticide chemical, food additive, or color additive that the article bears or contains is prohibited by department rule in establishments at which inspection is maintained under Subchapter B;

(6) any part of it consists of a filthy, putrid, or decomposed substance or is for another reason unsound, unhealthy, unwholesome, or otherwise unfit for human food;

(7) it is prepared, packed, or held under unsanitary conditions that may have caused it to become contaminated with filth or rendered injurious to health;

(8) any part of it is the product of an animal, including an exotic animal, that has died in a manner other than slaughter;

(9) any part of its container is composed of a poisonous or deleterious substance that may render the contents injurious to health;

(10) it is intentionally subjected to radiation, unless the use of the radiation is in conformity with a regulation or exemption under Section 409, Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 348);

(11) any part of a valuable constituent is omitted or abstracted from it, or a substance is substituted for all or part of it;

(12) damage or inferiority is concealed;

(13) a substance has been added to or mixed or packed with it in a manner that:

(A) increases its bulk or weight;

(B) reduces its quality or strength; or

(C) makes it appear better or of greater value than it is; or

(14) it is margarine containing animal fat and any part of the raw material used in it consists of a filthy, putrid, or decomposed substance.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1026, eff. April 2, 2015.

Sec. 433.005: Misbranding

(a) A livestock or poultry product is misbranded if:

(1) any part of its labeling is false or misleading;

(2) it is offered for sale under the name of another food;

(3) it is an imitation of another food, unless its label bears, in prominent type of uniform size, the word "imitation" immediately followed by the name of the food imitated;

(4) its container is made, formed, or filled so as to be misleading;

(5) except as provided by Subsection (b), it does not bear a label showing:

(A) the manufacturer's, packer's, or distributor's name and place of business; and

(B) an accurate statement of the quantity of the product by weight, measure, or numerical count;

(6) a word, statement, or other information required by or under the authority of this chapter to appear on the label or labeling is not prominently placed on the label or labeling in sufficient terms and with sufficient conspicuousness, compared with other words, statements, designs, or devices in the label or labeling, to make it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by department rule under Section 433.043 unless:

(A) it conforms to the definition and standard; or

(B) its label bears:

(i) the name of the food specified in the definition and standard; and

(ii) to the extent required by department rule, the common names of optional ingredients present in the food, other than spices, flavoring, and coloring;

(8) it purports to be or is represented as a food for which a standard of fill of container has been prescribed by department rule under Section 433.043 and the food does not meet the standard of fill of container, unless its label bears, in the manner and form prescribed by department rule, a statement that it does not meet the standard;

(9) except as provided by Subsection (c), it does not purport to be or is not represented as a food for which a standard of identity or composition has been prescribed by department rule unless its label bears:

(A) any common or usual name of the food; and

(B) if it is fabricated from two or more ingredients, the common or usual name of each ingredient;

(10) it purports to be or is represented for special dietary uses and its label does not bear the information concerning its vitamin, mineral, and other dietary properties that the department, after the executive commissioner or department consults with the United States Secretary of Agriculture, has determined, and the executive commissioner has prescribed by rule, to be necessary to fully inform purchasers of its value for those uses;

(11) it bears or contains artificial flavoring, artificial coloring, or a chemical preservative unless it bears labeling stating that fact, except as otherwise prescribed by department rule for situations in which compliance with this subdivision is impracticable; or

(12) it does not bear on itself or its container, as prescribed by department rule:

(A) the inspection legend and establishment number of the establishment in which the product was prepared; and

(B) notwithstanding any other provision of this section, other information required by department rule to assure that the product will not have false or misleading labeling and that the public will be informed of the manner of handling required to keep the product in wholesome condition.

(b) The executive commissioner may adopt rules:

(1) exempting from Subsection (a)(5) livestock products not in containers; and

(2) providing reasonable variations from Subsection (a)(5)(B) and exempting from that subsection small packages of livestock products or poultry products.

(c) For products subject to Subsection (a)(9), the department may authorize the designation of spices, flavorings, and colorings without naming them. The executive commissioner may adopt rules establishing exemptions from Subsection (a)(9)(B) to the extent that compliance with that subsection is impracticable or would result in deception or unfair competition.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1027, eff. April 2, 2015.

Sec. 433.006: Personal Use Exemption

(a) The provisions of this chapter requiring inspection of the slaughter of livestock and the preparation of carcasses, parts of carcasses, meat, and meat food products at establishments conducting those operations do not apply to the slaughtering of livestock or the preparation and transportation in intrastate commerce of those articles if:

(1) the articles are exclusively for personal use by the owner of the livestock, a member of the owner's family, or a nonpaying guest of the owner;

(2) the slaughter or preparation is conducted at the owner's premises or at a processing establishment; and

(3) the transportation is limited to moving the carcasses, parts of carcasses, meat, and meat food products to and from the owner's premises and a processing establishment.

(b) The adulteration and misbranding provisions of this chapter, other than the requirement of an inspection legend, apply to articles prepared by a processing establishment under Subsection (a).

(c) This section does not grant a personal use exemption to an owner who intends to give carcasses, parts of carcasses, meat, or meat food products to any person other than a person listed in Subsection (a)(1).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 539, Sec. 1, eff. Sept. 1, 1997.

Sec. 433.007: Construction with Other Law

(a) This chapter prevails over any other law, including Chapter 431 (Texas Food, Drug, and Cosmetic Act), to the extent of any conflict.

(b) This chapter applies to a person, establishment, animal, or article regulated under the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.) or the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 539, Sec. 2, eff. Sept. 1, 1997.

Sec. 433.008: Rules

(a) The executive commissioner shall adopt rules necessary for the efficient execution of this chapter.

(b) The executive commissioner shall adopt and use federal rules, regulations, and procedures for meat and poultry inspection, as applicable.

(c) The executive commissioner may adopt rules requiring a processing establishment that processes livestock under Section 433.006(a)(2) to obtain a grant of custom exemption for that activity.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 539, Sec. 3, eff. Sept. 1, 1997.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1028, eff. April 2, 2015.

Sec. 433.009: Fees

The department may collect fees for overtime and special services rendered to establishments, and may collect a fee for services required to be performed under this chapter relating to the inspection of animals, birds, or products that are not regulated under the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.) or the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.). The executive commissioner by rule shall set the inspection fee in an amount sufficient to recover the department's costs of providing those services.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1029, eff. April 2, 2015.

Subchapter B

Sec. 433.021: Inspection Before Slaughter

(a) To prevent the use in intrastate commerce of adulterated meat and meat food products, the department shall examine and inspect each livestock animal before it is allowed to enter a processing establishment in this state in which slaughtering and preparation of meat and meat food products of livestock are conducted solely for intrastate commerce.

(b) Any livestock animal found on inspection to show symptoms of disease shall be set apart and slaughtered separately from other livestock. The carcass of the animal shall be carefully examined and inspected as provided by department rule.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1030, eff. April 2, 2015.

Sec. 433.022: Inspection of Carcasses

(a) To prevent the use in intrastate commerce of adulterated meat and meat food products, the department shall inspect each livestock carcass or part of a carcass capable of use as human food that is to be prepared at a processing establishment in this state in which those articles are prepared solely for intrastate commerce. If a carcass or part of a carcass is brought into the processing establishment, the inspection shall be made before a carcass or part of a carcass is allowed to enter a department in which it is to be treated and prepared for meat food products. The department shall also inspect products that have left a processing establishment and are returned to a processing establishment in which inspection is maintained.

(b) The inspector shall mark, stamp, tag, or label a carcass or part of a carcass found on inspection to be unadulterated as "inspected and passed," and one found adulterated as "inspected and condemned."

(c) If an inspector considers a subsequent inspection necessary, the inspector may reinspect any carcass or part of a carcass and condemn it if it has become adulterated.

(d) The processing establishment, in the presence of an inspector, shall destroy for food purposes each condemned carcass or part of a carcass. If the establishment fails to destroy a condemned carcass or part of a carcass, the department may remove the inspectors from the establishment.

(e) The executive commissioner may adopt rules that limit the entry of carcasses, parts of carcasses, meat, or meat food products into an establishment in which inspection under this chapter is maintained to assure that entry of the article into the establishment is consistent with the purposes of this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1031, eff. April 2, 2015.

Sec. 433.023: Investigation of Disease Findings; Quarantine

(a) The department may investigate a disease finding by a livestock inspector if the department determines that the investigation is in the best interest of public health.

(b) If a disease adverse to the public health is found under this chapter, the commissioner may quarantine the premises where an animal is located that is afflicted with any stage of a disease that may be transmitted to man or other animals. A quarantined animal may be removed from a quarantined area only on permission from and under supervision by the commissioner.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1032, eff. April 2, 2015.

Sec. 433.024: Inspection of Processing and Slaughtering Establishments

(a) The department shall inspect each processing establishment in which livestock is slaughtered and meat and meat food products of the livestock are prepared solely for intrastate commerce as necessary to obtain information about the establishment's sanitary conditions.

(b) The department shall inspect each slaughtering establishment whose primary business is the selling of livestock to be slaughtered by the purchaser on premises owned or operated by the seller. This subsection does not nullify the provisions in Section 433.006 relating to personal use exemption.

(c) The executive commissioner shall adopt rules governing sanitation maintenance in processing and slaughtering establishments as defined by this section.

(d) If sanitary conditions of a processing establishment render meat or meat food products adulterated, the department shall prohibit the meat or meat food products from being labeled, marked, stamped, or tagged as "Texas inspected and passed."

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 308, Sec. 2, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1033, eff. April 2, 2015.

Sec. 433.0245: Requirements for Certain Low-Volume Livestock Processing Establishments

(a) Except as provided by this section, the inspection and regulatory provisions of this chapter do not apply to a low-volume livestock processing establishment that is exempt from federal inspection.

(a-1) For purposes of this section, a low-volume livestock processing establishment:

(1) includes an establishment that processes fewer than 10,000 domestic rabbits or more than 1,000 but fewer than 10,000 poultry in a calendar year; and

(2) does not include an establishment that processes 1,000 or fewer poultry raised by the operator of the establishment in a calendar year.

(b) Except as provided by Subsections (e) and (f), a low-volume livestock processing establishment that is exempt from federal inspection shall register with the department in accordance with rules adopted by the executive commissioner for registration.

(c) Except as provided by Subsections (e) and (f), a low-volume livestock processing establishment that is exempt from federal inspection shall develop a sanitary operation procedures plan.

(d) Except as provided by Subsection (f), if contaminated livestock can be reasonably traced to a low-volume livestock processing establishment that is exempt from federal inspection, the department may request the attorney general or the district or county attorney in the jurisdiction where the facility is located to institute a civil suit to enjoin the operation of the establishment until the department determines that the establishment has been sanitized and is operating safely.

(e) A low-volume livestock processing establishment that is exempt from federal inspection and processes fewer than 500 domestic rabbits in a calendar year is not required to comply with Subsection (b) or (c).

(f) An establishment described by Subsection (a-1)(2):

(1) is not subject to additional state regulation; and

(2) may sell poultry products directly to consumers.

Comments

Added by Acts 2001, 77th Leg., ch. 730, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1034, eff. April 2, 2015.

Acts 2019, 86th Leg., R.S., Ch. 1032 (H.B. 410), Sec. 1, eff. September 1, 2019.

Sec. 433.025: Inspection of Meat Food Products

(a) To prevent the use in intrastate commerce of adulterated meat food products, the department shall examine and inspect all meat food products prepared in a processing establishment solely for intrastate commerce. To make the examination and inspection, an inspector shall be given access at all times to each part of the establishment, regardless of whether the establishment is being operated.

(b) The inspector shall mark, stamp, tag, or label products found unadulterated as "Texas inspected and passed" and those found adulterated as "Texas inspected and condemned."

(c) The establishment shall, in the manner provided for condemned livestock or carcasses, destroy for food purposes each condemned meat food product. If the establishment does not destroy a condemned meat food product, the department may remove inspectors from the establishment.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1035, eff. April 2, 2015.

Sec. 433.026: Night Inspection; Hours of Operation

(a) The department shall provide for inspection at night of livestock slaughtered at night and food products prepared at night for the purposes of intrastate commerce.

(b) If the department determines that a person's operating hours are capricious or unnecessarily difficult, the department may set the person's time and duration of operation.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1036, eff. April 2, 2015.

Sec. 433.027: Inspectors

(a) The department shall hire inspectors of livestock that is subject to inspection under this chapter, and of carcasses, parts of carcasses, meat, meat food products, and sanitary conditions of establishments in which meat and meat food products are prepared. An inspector is an employee of the department and is under supervision of the chief officer in charge of inspection.

(b) The department shall designate at least one state inspector for each state representative district.

(c) The chief officer in charge of inspection is responsible for animal health as it relates to public health. The chief officer in charge of inspection must be licensed to practice veterinary medicine in this state or must be eligible for such a license when employed and must obtain the license not later than two years after the date of employment.

(d) An inspector shall perform the duties provided by this chapter and department rules. An inspection or examination must be performed as provided by department rules.

(e) An inspector may not stamp, mark, tag, or label a carcass, part of a carcass, or a meat food product unless it has been inspected and found unadulterated.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1037, eff. April 2, 2015.

Sec. 433.028: Refusal to Inspect

(a) The department may withdraw or refuse to provide inspection service under this subchapter from an establishment for the period the department determines necessary to carry out the purposes of this chapter if the department determines after opportunity for hearing that the applicant for or recipient of the service is unfit to engage in a business requiring inspection under this subchapter because the applicant or recipient, or a person responsibly connected with the applicant or recipient, has been convicted in a federal or state court of a felony or more than one violation of another law based on:

(1) acquiring, handling, or distributing unwholesome, mislabeled, or deceptively packaged food; or

(2) fraud in connection with a transaction in food.

(b) The department's determination and order under this section is final unless, not later than the 30th day after the effective date of the order, the affected applicant or recipient files an application for judicial review in the appropriate court as provided by Section 433.082. Judicial review of the order is on the record from which the determination and order was made.

(c) This section does not affect the provisions of this subchapter relating to withdrawal of inspection services from establishments failing to maintain sanitary conditions or to destroy condemned carcasses, parts of carcasses, meat, or meat food products.

(d) For the purposes of this section, a person is responsibly connected with the business if the person is a partner, officer, director, holder or owner of 10 percent or more of the business's voting stock, or managerial or executive employee.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1038, eff. April 2, 2015.

Sec. 433.029: Articles Not Intended for Human Consumption

(a) Under this subchapter, the department may not inspect an establishment for the slaughter of livestock or the preparation of carcasses, parts of carcasses, or products of livestock if the articles are not intended for use as human food. Before offered for sale or transportation in intrastate commerce, those articles, unless naturally inedible by humans, shall be denatured or identified as provided by department rule to deter their use for human food.

(b) A person may not buy, sell, transport, offer for sale or transportation, or receive for transportation in intrastate commerce a carcass, part of a carcass, meat, or a meat food product that is not intended for use as human food unless the article is naturally inedible by humans, denatured, or identified as required by department rule.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1039, eff. April 2, 2015.

Sec. 433.030: Detention

(a) The department may detain a carcass, part of a carcass, meat, a meat food product of livestock, a product exempted from the definition of meat food product, or a dead, dying, disabled, or diseased livestock animal if the department finds the article on premises where it is held for purposes of intrastate commerce, or during or after distribution in intrastate commerce, and there is reason to believe that the article:

(1) is adulterated or misbranded and is capable of use as human food; or

(2) has not been inspected as required by, or has been or is intended to be distributed in violation of:

(A) this subchapter;

(B) the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.);

(C) the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.); or

(D) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.).

(b) An article may be detained for not more than 20 days and only pending action under Section 433.031 or notification of a federal authority having jurisdiction over the article.

(c) A person may not move a detained article from the place where it is detained until the article is released by the department.

(d) The department may require that each official mark be removed from the article before it is released, unless the department determines that the article is eligible to bear the official mark.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1040, eff. April 2, 2015.

Sec. 433.031: Seizure

(a) A carcass, part of a carcass, meat, or a meat food product of livestock, or a dead, dying, disabled, or diseased livestock animal, that is being transported in intrastate commerce or held for sale after transportation in intrastate commerce may be proceeded against, seized, and condemned if the article:

(1) is or has been prepared, sold, transported, or otherwise distributed or offered or received for distribution in violation of this chapter;

(2) is capable of use as human food and is adulterated or misbranded; or

(3) is otherwise in violation of this chapter.

(b) An action against an article under this section must be on a complaint in the proper court in the county in which the article is found. To the extent possible, the law governing admiralty cases applies to a case under this section, except that:

(1) either party may demand trial by jury of an issue of fact in the case; and

(2) the proceedings must be brought by and in the name of this state.

(c) After entry of the decree, a condemned article shall be destroyed or sold as the court directs. If the article is sold, the proceeds, minus court costs, court fees, and storage and other proper expenses, shall be deposited in the state treasury. An article may not be sold in violation of this chapter, the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.), the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.), or the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.). On execution and delivery of a good and sufficient bond conditioned that the article will not be disposed of in violation of this chapter or federal law, the court may direct the article to be delivered to its owner by the department subject to supervision as necessary to ensure compliance with applicable laws.

(d) If a decree of condemnation is entered against the article and it is released under bond or destroyed, the court shall award court costs, court fees, and storage and other proper expenses against any person intervening as claimant of the article.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1041, eff. April 2, 2015.

Sec. 433.032: Storage and Handling

(a) The executive commissioner may adopt rules prescribing conditions under which carcasses, parts of carcasses, meat, and meat food products of livestock must be stored and handled by a person in the business of buying, selling, freezing, storing, or transporting those articles in or for intrastate commerce if the executive commissioner considers the rules necessary to prevent adulterated or misbranded articles from being delivered to a consumer.

(b) A person may not violate a rule adopted under this section.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1042, eff. April 2, 2015.

Sec. 433.033: Equine Products

A person may not sell, transport, offer for sale or transportation, or receive for transportation, in intrastate commerce, a carcass, part of a carcass, meat, or a meat food product of a horse, mule, or other equine unless the article is plainly and conspicuously marked or labeled or otherwise identified, as required by department rule, to show the kind of animal from which the article was derived. The department may require an establishment at which inspection is maintained under this chapter to prepare those articles in an establishment separate from one in which livestock other than equines is slaughtered or carcasses, parts of carcasses, meat, or meat food products of livestock other than equines are prepared.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1043, eff. April 2, 2015.

Sec. 433.034: Records

(a) A person engaged for intrastate commerce in any of the following business activities shall keep records of each of the person's business transactions:

(1) slaughtering livestock;

(2) preparing, freezing, packaging, or labeling a livestock carcass or a part or product of a livestock carcass for use as human food or animal food;

(3) transporting, storing, buying, or selling, as a meat broker, wholesaler, or otherwise, a livestock carcass or a part or product of a livestock carcass;

(4) rendering; or

(5) buying, selling, or transporting dead, dying, disabled, or diseased livestock, or a part of a carcass of a livestock animal that died in a manner other than slaughter.

(b) On notice by the department, a person required to keep records shall at all reasonable times give the department and any representative of the United States Secretary of Agriculture accompanying the department staff:

(1) access to the person's place of business; and

(2) an opportunity to:

(A) examine the facilities, inventory, and records;

(B) copy the records required by this section; and

(C) take a reasonable sample of the inventory, on payment of the fair market value of the sample.

(c) The person shall maintain a record required by this section for the period prescribed by department rule.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1044, eff. April 2, 2015.

Sec. 433.035: Inspection and Other Regulation of Exotic Animals in Interstate Commerce

(a) The department has the same rights of examination, inspection, condemnation, and detention of live exotic animals and carcasses, parts of carcasses, meat, and meat food products of exotic animals slaughtered and prepared for shipment in interstate commerce as the department has with respect to exotic animals slaughtered and prepared for shipment in intrastate commerce.

(b) The department has the same rights of inspection of establishments handling exotic animals slaughtered and prepared for shipment in interstate commerce as the department has with respect to establishments handling exotic animals slaughtered and prepared for intrastate commerce.

(c) The record-keeping requirements of Section 433.034 that apply to persons slaughtering, preparing, buying, selling, transporting, storing, or rendering in intrastate commerce apply to persons performing similar functions with exotic animals in interstate commerce.

(d) A rulemaking power of the executive commissioner relating to animals in intrastate commerce applies to exotic animals in interstate commerce.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1045, eff. April 2, 2015.

Subchapter C

Sec. 433.041: Labeling Passed Products

(a) When meat or a meat food product prepared for intrastate commerce that has been inspected as provided by this chapter and marked "Texas inspected and passed" is placed or packed in a container or covering in an establishment in which inspection is performed under this chapter, the person preparing the product shall attach a label to the container or covering stating that the contents have been "Texas inspected and passed" under this chapter. The inspector shall supervise the attachment of the label and the sealing or enclosing of the meat or meat food product in the container or covering.

(b) When an inspected carcass, part of a carcass, meat, or a meat food product is found to be unadulterated and leaves the establishment, it must bear legible information on itself or its container, as required by department rule, to prevent it from being misbranded.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1046, eff. April 2, 2015.

Sec. 433.042: Sale of Mislabeled Articles Prohibited

A person may not sell an article subject to this chapter or offer the article for sale, in intrastate commerce, under a false or misleading name or other marking or in a container of a misleading form or size. An established trade name, other marking and labeling, or a container that is not false or misleading and that is approved by the department is permitted.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1047, eff. April 2, 2015.

Sec. 433.043: Standards of Labeling, Composition, and Fill

(a) If the executive commissioner determines that standards are necessary to protect the public, the executive commissioner may adopt rules prescribing:

(1) the style and type size that must be used for material required to be incorporated in labeling to avoid false or misleading labeling of an article subject to this subchapter or Subchapter B; and

(2) subject to Subsection (b), a definition or standard of identity or composition or a standard of fill of container for an article subject to this subchapter.

(b) A standard prescribed under Subsection (a)(2) must be consistent with standards established under the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.), the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.). To avoid inconsistency, the department shall consult with the United States Secretary of Agriculture before the standard is prescribed.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1048, eff. April 2, 2015.

Sec. 433.044: Order to Cease False Or Misleading Practice

(a) If the department has reason to believe that a marking or labeling or the size or form of a container in use or proposed for use in relation to an article subject to this subchapter is false or misleading, the department may prohibit the use until the marking, labeling, or container is modified in the manner the department prescribes to prevent it from being false or misleading.

(b) The person using or proposing to use the marking, labeling, or container may request a hearing. The department may prohibit the use pending a final determination by the department.

(c) A hearing and any appeal under this section are governed by the department's rules for a contested case hearing and Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1049, eff. April 2, 2015.

Sec. 433.045: Protection of Official Device, Mark, and Certificate

A person may not:

(1) cast, print, lithograph, or make in any other manner, except as authorized by the department in accordance with department rules:

(A) a device containing or label bearing an official mark or a simulation of an official mark; or

(B) a form of official certificate or simulation of an official certificate;

(2) forge an official device, mark, or certificate;

(3) without the department's authorization, use, alter, detach, deface, or destroy an official device, mark, or certificate or use a simulation of an official device, mark, or certificate;

(4) detach, deface, destroy, or fail to use an official device, mark, or certificate, in violation of a department rule;

(5) knowingly possess, without promptly notifying the department:

(A) an official device;

(B) a counterfeit, simulated, forged, or improperly altered official certificate; or

(C) a device, label, animal carcass, or part or product of an animal carcass, bearing a counterfeit, simulated, forged, or improperly altered official mark;

(6) knowingly make a false statement in a shipper's certificate or other certificate provided for by department rule; or

(7) knowingly represent that an article has been inspected and passed, when it has not, or is exempted, when it is not.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1050, eff. April 2, 2015.

Subchapter D

Sec. 433.051: Slaughter Or Preparation Not in Compliance with Chapter

A person, at an establishment preparing articles only for intrastate commerce, may not slaughter a livestock animal or prepare a carcass, part of a carcass, meat, or a meat food product of a livestock animal, capable of use as human food, except in compliance with this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.052: Sale, Receipt, Or Transportation of Articles Not in Compliance with Chapter

A person may not:

(1) sell, transport, offer for sale or transportation, or receive for transportation, in intrastate commerce, livestock or a carcass, part of a carcass, meat, or a meat food product of livestock that is:

(A) capable of use as human food and is adulterated or misbranded when sold, offered, transported, or received for transportation; or

(B) required to be inspected by this chapter but has not been inspected and passed; or

(2) perform an act with respect to livestock or a carcass, part of a carcass, meat, or a meat food product of livestock, while the article is being transported in intrastate commerce or held for sale after transportation in intrastate commerce, that causes or is intended to cause the article to be adulterated or misbranded.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.053: Sale, Receipt, Or Transportation of Poultry

A person may not sell, transport, offer for sale or transportation, or receive for transportation, in intrastate commerce or from an official establishment, slaughtered poultry from which blood, feathers, feet, head, or viscera have not been removed as provided by department rule, except as authorized by department rule.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1051, eff. April 2, 2015.

Sec. 433.054: Dead, Dying, Disabled, and Diseased Animals; Animals Dying in Manner Other Than Slaughter

(a) If registration is required by department rule, a person may not engage in any of the following businesses, in or for intrastate commerce, unless the person has registered with the department:

(1) meat brokering or rendering;

(2) manufacturing animal food;

(3) wholesaling or warehousing for the public livestock or any part of a carcass of livestock, regardless of whether it is intended for human food; or

(4) buying, selling, or transporting dead, dying, disabled, or diseased livestock or part of a carcass of livestock.

(b) A registration must include the person's name, each of the person's places of business, and each trade name under which the person does business.

(c) A person may not engage in the business of selling, buying, or transporting in intrastate commerce dead, dying, disabled, or diseased livestock or part of the carcass of livestock that died otherwise than by slaughter unless the transaction or transportation complies with department rules adopted to assure that the animals or unwholesome parts or products of the animals are not used for human food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1052, eff. April 2, 2015.

Sec. 433.055: Miscellaneous Prohibitions Applicable to Exotic Animals in Interstate Commerce

The prohibitions of Sections 433.051-433.054 that apply to intrastate commerce also apply to exotic animals in interstate commerce.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.056: Inedible Animal Products

A person in the business of buying, selling, or transporting, in intrastate commerce, may not offer an inedible animal product for sale unless:

(1) the sale is for further sterilization processing; or

(2) the product has been processed in a manner that prevents the survival of disease-producing organisms or deleterious substances in the processed material.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter E

Sec. 433.071: Responsible Agency

(a) The department is the state agency responsible for cooperating with the United States Secretary of Agriculture under Section 301, Federal Meat Inspection Act (21 U.S.C. Section 661), and Section 5, Federal Poultry Products Inspection Act (21 U.S.C. Section 454).

(b) The department shall cooperate with the secretary of agriculture in developing and administering the meat and poultry inspection program of this state under this chapter in a manner that will achieve the purposes of this chapter and federal law and that will ensure that the requirements will be at least equal to those imposed under Titles I and IV, Federal Meat Inspection Act (21 U.S.C. Sections 601 et seq. and 671 et seq.), and Sections 1-4, 6-10, and 12-22, Federal Poultry Products Inspection Act (21 U.S.C. Sections 451-453, 455-459, and 461-467d), not later than the dates prescribed by federal law.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1053, eff. April 2, 2015.

Sec. 433.072: Advisory Committees

The commissioner may recommend to the United States Secretary of Agriculture state officials or employees for appointment to advisory committees provided for by Section 301, Federal Meat Inspection Act (21 U.S.C. Section 661), and Section 5, Federal Poultry Products Inspection Act (21 U.S.C. Section 454). The commissioner shall serve as the representative of the governor for consultation with the secretary of agriculture under those Acts unless the governor selects another representative.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.073: Technical and Laboratory Assistance and Training Program

The department may accept from the United States Secretary of Agriculture:

(1) advisory assistance in planning and otherwise developing the state program;

(2) technical and laboratory assistance;

(3) training, including necessary curricular and instructional materials and equipment; and

(4) financial and other aid for administration of the program.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1054, eff. April 2, 2015.

Sec. 433.074: Financing

The department may spend state funds appropriated for administration of this chapter to pay 50 percent of the estimated total cost of cooperation with the federal government under this subchapter, and all of the costs of performing services in relation to the inspection of animals or products not regulated under the Federal Meat Inspection Act (21 U.S.C. Section 601 et seq.) or the Federal Poultry Products Inspection Act (21 U.S.C. Section 451 et seq.).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1055, eff. April 2, 2015.

Subchapter F

Sec. 433.081: General Criminal Penalty

(a) A person commits an offense if the person violates a provision of this chapter for which this chapter does not provide another criminal penalty.

(b) Except as provided by Subsection (c), an offense under this section is punishable by a fine of not more than $1,000, imprisonment for not more than one year, or both.

(c) If an offense under this section involves intent to defraud or a distribution or attempted distribution of an adulterated article, except adulteration described by Section 433.004(11), (12), or (13), the offense is punishable by a fine of not more than $10,000, imprisonment for not more than three years, or both.

(d) A person does not commit an offense under this section by receiving for transportation an article in violation of this chapter if the receipt is in good faith and if the person furnishes, on request of the department:

(1) the name and address of the person from whom the article is received; and

(2) any document pertaining to the delivery of the article.

(e) This chapter does not require the department to report for prosecution, or for institution of complaint or injunction proceedings, a minor violation of this chapter if the department believes that the public interest will be adequately served by a suitable written warning notice.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1056, eff. April 2, 2015.

Sec. 433.0815: Interference with Inspection; Criminal Penalties

(a) A person commits an offense if the person with criminal negligence interrupts, disrupts, impedes, or otherwise interferes with a livestock inspector while the inspector is performing a duty under this chapter.

(b) An offense under this section is a Class B misdemeanor.

(c) It is a defense to prosecution under this section that the interruption, disruption, impediment, or interference alleged consisted of speech only.

Comments

Added by Acts 2001, 77th Leg., ch. 730, Sec. 1, eff. Sept. 1, 2001.

Sec. 433.082: Jurisdiction for Violation

The district court has jurisdiction of:

(1) an action to enforce and to prevent and restrain a violation of this chapter; and

(2) any other case arising under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 433.083: Investigation By Department

The department may investigate and gather and compile information concerning the organization, business, conduct, practices, and management of a person engaged in intrastate commerce and the person's relation to other persons.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1057, eff. April 2, 2015.

Sec. 433.084: Evidence and Testimony

(a) For the purposes of this chapter, the department at all reasonable times shall be given access to documentary evidence of a person being investigated or proceeded against to examine or copy the evidence. The department by subpoena may require the attendance and testimony of a witness and the production of documentary evidence relating to a matter under investigation, at a designated place of hearing in a county in which the witness resides, is employed, or has a place of business.

(b) The commissioner or the commissioner's designee may sign subpoenas, administer oaths and affirmations, examine witnesses, and receive evidence. On disobedience of a subpoena, the department may request the district court to require attendance and testimony of a witness and the production of documentary evidence, and the district court having jurisdiction over the inquiry may order the compliance. Failure to obey the court's order is punishable as contempt.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1058, eff. April 2, 2015.

Sec. 433.085: Report to Department

The department, by general or special order, may require a person engaged in intrastate commerce to file with the department an annual report, special report, or both, or answers in writing to specific questions furnishing the department information that the department requires concerning the person's organization, business, conduct, practices, management, and relation to other persons filing written answers and reports. The department may prescribe the form of the report or answers, require the report or answers to be given under oath, and prescribe a reasonable deadline for filing the report or answers, subject to the granting of additional time by the department.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1059, eff. April 2, 2015.

Sec. 433.086: Mandamus to Compel Compliance

On application of the attorney general at the request of the department, the district court may issue a writ of mandamus ordering a person to comply with this chapter or an order under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1060, eff. April 2, 2015.

Sec. 433.087: Depositions

(a) The department may order testimony to be taken before a person designated by the department and having power to administer oaths at any stage of a proceeding or investigation under this chapter. A person may be compelled to appear and depose or produce documentary evidence at a deposition in the same manner as a witness may be compelled to appear and testify and produce documentary evidence before the department under this chapter.

(b) The person taking the deposition shall transcribe or supervise the transcription of the testimony. The transcript must be signed by the person deposed.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1061, eff. April 2, 2015.

Sec. 433.088: Compensation of Witness Or Reporter

A witness summoned before the department is entitled to the same fees and mileage paid a witness in a state court. A witness whose deposition is taken and the person taking the deposition are each entitled to the same fees paid for similar services in a state court.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1062, eff. April 2, 2015.

Sec. 433.089: Immunity

(a) A person is not excused from attending and testifying or producing documentary evidence before the department or in obedience to the department's subpoena, whether signed by the commissioner or the commissioner's designee, or in a cause or proceeding based on or growing out of an alleged violation of this chapter, on the ground that the required testimony or evidence may tend to incriminate the person or subject the person to penalty or forfeiture.

(b) A person may not be prosecuted or subjected to a penalty or forfeiture for or because of a transaction or matter concerning which the person is compelled to testify or produce evidence after having claimed a privilege against self-incrimination.

(c) The person testifying under this section is not exempt from prosecution and punishment for perjury committed in that testimony.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1063, eff. April 2, 2015.

Sec. 433.090: Contempt

(a) A person commits an offense if the person neglects or refuses to attend and testify or answer a lawful inquiry or to produce documentary evidence, if the person has the power to do so, in obedience to a subpoena or lawful requirement of the department.

(b) An offense under this section is punishable by a fine of not less than $1,000 or more than $5,000, imprisonment for not more than one year, or both.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1064, eff. April 2, 2015.

Sec. 433.091: False Report; Failure to Report; Criminal Penalty

(a) A person commits an offense if the person intentionally:

(1) makes or causes to be made a false entry in an account, record, or memorandum kept by a person subject to this chapter;

(2) neglects or fails to make or cause to be made full entries in an account, record, or memorandum kept by a person subject to this chapter of all facts and transactions pertaining to the person's business;

(3) removes from the jurisdiction of this state or mutilates, alters, or otherwise falsifies documentary evidence of a person subject to this chapter; or

(4) refuses to submit to the department, for inspection and copying, documentary evidence in the person's possession or control of a person subject to this chapter.

(b) An offense under this section is punishable by a fine of not less than $1,000 or more than $5,000, imprisonment for not more than three years, or both.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1065, eff. April 2, 2015.

Sec. 433.092: Failure to Report; Civil Penalty

(a) If a person required by this chapter to file an annual or special report does not file the report before the deadline for filing set by the department and the failure continues for 30 days after notice of the default, the person forfeits to the state $100 for each day the failure continues.

(b) An amount due under this section is payable to the state treasury and is recoverable in a civil suit in the name of the state brought in the district court of the county in which the person's principal office is located or in which the person does business.

(c) Each district attorney, under the direction of the attorney general, shall prosecute for the recovery of an amount due under this section.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1066, eff. April 2, 2015.

Sec. 433.093: Unlawful Disclosure; Criminal Penalty

(a) A state officer or employee commits an offense if the officer or employee, without the approval of the commissioner, makes public information obtained by the department.

(b) An offense under this section is a misdemeanor punishable by a fine of not more than $5,000, imprisonment for not more than one year, or both.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1067, eff. April 2, 2015.

Sec. 433.094: Administrative Penalty

(a) The department may assess an administrative penalty against a person who violates this chapter, a rule adopted under the authority of this chapter, or an order or license issued under this chapter.

(b) In determining the amount of the penalty, the department shall consider:

(1) the person's previous violations;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the person's demonstrated good faith; and

(5) such other matters as justice may require.

(c) The penalty may not exceed $25,000 a day for each violation.

(d) Each day a violation continues may be considered a separate violation.

Comments

Added by Acts 1991, 72nd Leg., ch. 388, Sec. 1, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1068, eff. April 2, 2015.

Sec. 433.095: Administrative Penalty Assessment Procedure

(a) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.

(b) If a hearing is held, the administrative law judge shall make findings of fact and shall issue to the department a written proposal for decision regarding the occurrence of the violation and the amount of the penalty that may be warranted.

(c) If the person charged with the violation does not request a hearing, the department may assess a penalty after determining that a violation has occurred and the amount of the penalty that may be warranted.

(d) After making a determination under this section that a penalty is to be assessed against a person, the department shall issue an order requiring that the person pay the penalty.

(e) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(77), eff. April 2, 2015.

Comments

Added by Acts 1991, 72nd Leg., ch. 388, Sec. 1, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1069, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(77), eff. April 2, 2015.

Sec. 433.096: Payment of Administrative Penalty

(a) Not later than the 30th day after the date an order finding that a violation has occurred is issued, the department shall inform the person against whom the order is issued of the amount of the penalty for the violation.

(b) Not later than the 30th day after the date on which a decision or order charging a person with a penalty is final, the person shall:

(1) pay the penalty in full; or

(2) file a petition for judicial review of the department's order contesting the amount of the penalty, the fact of the violation, or both.

(b-1) Within the period prescribed by Subsection (b), a person who files a petition for judicial review may:

(1) stay the enforcement of the penalty by:

(A) paying the penalty to the court for placement in an escrow account; or

(B) posting with the court a supersedeas bond for the amount of the penalty; or

(2) request that the department stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(B) sending a copy of the affidavit to the department.

(b-2) If the department receives a copy of an affidavit under Subsection (b-1)(2), the department may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(c) A bond posted under this section must be in a form approved by the court and be effective until all judicial review of the order or decision is final.

(d) A person who does not send money to, post the bond with, or file the affidavit with the court within the period prescribed by Subsection (b) waives all rights to contest the violation or the amount of the penalty.

Comments

Added by Acts 1991, 72nd Leg., ch. 388, Sec. 1, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1070, eff. April 2, 2015.

Sec. 433.097: Refund of Administrative Penalty

On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order that:

(1) the appropriate amount of any penalty payment plus accrued interest be remitted to the person not later than the 30th day after that date; or

(2) the bond be released if the person has posted a bond.

Comments

Added by Acts 1991, 72nd Leg., ch. 388, Sec. 1, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1071, eff. April 2, 2015.

Sec. 433.098: Recovery of Administrative Penalty By Attorney General

The attorney general at the request of the department may bring a civil action to recover an administrative penalty under this subchapter.

Comments

Added by Acts 1991, 72nd Leg., ch. 388, Sec. 1, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1072, eff. April 2, 2015.

Sec. 433.099: Injunction

(a) If it appears that a person has violated or is violating this chapter or a rule adopted under this chapter, the department may request the attorney general or the district attorney or county attorney in the jurisdiction where the violation is alleged to have occurred, is occurring, or may occur to institute a civil suit for:

(1) an order enjoining the violation; or

(2) a permanent or temporary injunction, a temporary restraining order, or other appropriate remedy, if the department shows that the person has engaged in or is engaging in a violation.

(b) Venue for a suit brought under this section is in the county in which the violation occurred or in Travis County.

(c) The department or the attorney general may recover reasonable expenses incurred in obtaining injunctive relief under this section, including investigation and court costs, reasonable attorney's fees, witness fees, and other expenses. The expenses recovered by the department under this section may be used for the administration and enforcement of this chapter. The expenses recovered by the attorney general may be used by the attorney general for any purpose.

Comments

Added by Acts 2001, 77th Leg., ch. 730, Sec. 1, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1073, eff. April 2, 2015.

Sec. 433.100: Emergency Withdrawal of Mark Or Suspension of Inspection Services

(a) The department may immediately withhold the mark of inspection or suspend or withdraw inspection services if:

(1) the department determines that a violation of this chapter presents an imminent threat to public health and safety; or

(2) a person affiliated with the processing establishment impedes an inspection under this chapter.

(b) An affected person is entitled to a review of an action of the department under Subsection (a) in the same manner that a refusal or withdrawal of inspection services may be reviewed under Section 433.028.

Comments

Added by Acts 2001, 77th Leg., ch. 730, Sec. 1, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1074, eff. April 2, 2015.

Chapter 434

Subchapter A

Sec. 434.001: Definition

In this subchapter "bakery" means a business producing, preparing, storing, or displaying bakery products intended for sale for human consumption.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.002: Bakery Requirements

(a) A building used or occupied as a bakery shall be clean and properly lighted, drained, and ventilated.

(b) A bakery shall have adequate plumbing and drainage facilities, including suitable wash sinks and restroom facilities. Restroom facilities shall be separate from the rooms in which the bakery products are produced or handled. Each wash sink area and restroom facility shall be clean, sanitary, well lit, and ventilated.

(c) The floors, walls, and ceilings of a room in which dough is mixed or handled, pastry is prepared for baking, or bakery products or the ingredients of those products are otherwise handled or stored shall be clean, wholesome, and sanitary. Each opening into the room, including a window or door, shall be properly screened or otherwise protected to exclude flies.

(d) A showcase, shelf, or other place from which bakery products are sold shall at all times be clean, wholesome, covered, properly ventilated, and protected from dust and flies.

(e) A workroom may not be used for purposes other than those directly connected with the preparation, baking, storage, or handling of food. A workroom may not be used as a washing, sleeping, or living room and shall at all times be kept separate and closed from living and sleeping rooms.

(f) Each bakery shall provide, separate from the workrooms, a dressing room for the changing and hanging of wearing apparel. Each dressing room shall be kept clean at all times.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.003: Sanitary Requirements

(a) A person may not sit or lie on any table, bench, trough, or shelf intended for dough or bakery products.

(b) Animals or fowl may not be kept or allowed in any bakery or other place where bakery products are produced or stored.

(c) A person engaged in the preparation or handling of bakery products shall wash the person's arms and hands thoroughly before beginning the preparation, mixing, or handling of ingredients used in baking. A bakery shall provide sufficient soap, washbasins, and clean towels for that purpose.

(d) A person may not use tobacco in any form in any room in which a bakery product is manufactured, wrapped, or prepared for sale.

(e) A person with a communicable disease may not work in a bakery, handle any product in the bakery, or deliver a product from the bakery.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.004: Wholesome Ingredients Required

(a) Materials used in the production or preparation of bakery products shall be stored, handled, and maintained in a manner that protects the materials from spoiling and contamination. Materials may not be used if spoiled, contaminated, or otherwise likely to make the bakery product unwholesome or unfit as food.

(b) The ingredients used in the production of bakery products and the sale or offering for sale of those products shall comply with the laws relating to the adulteration and misbranding of food. Ingredients may not be used that may make the bakery product injurious to health.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.005: Requirements for Transportation of Bakery Products

A vehicle, box, basket, or other receptacle in which bakery products are transported shall at all times be kept clean and free from dust, flies, or other contaminants.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.006: Storage Receptacle Requirements

(a) A box or other receptacle for the storage or receipt of bakery products shall be:

(1) constructed and placed to be free from contamination from streets, alleys, and sidewalks;

(2) raised at least 10 inches above the level of the street or sidewalk; and

(3) clean and sanitary.

(b) Bread may not be placed in a storage box with other food except other bakery products.

(c) A storage box shall be equipped with a private lock and shall be kept locked except when opened to receive or remove bakery products or when being cleaned.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.007: Weight Standards for Bread Loaves

(a) Loaves of bread made by persons in the business of wholesaling and retailing bread must comply with the weight standards in this section.

(b) The standard weights for a loaf of bread are:

(1) one pound;

(2) 1-1/2 pounds; or

(3) any other multiple of one pound.

(c) This section does not prohibit the sale of bread slices in properly labeled packages weighing eight ounces or less.

(d) Variations in the weight standard may not exceed one ounce a pound within 24 hours after baking.

(e) This section does not affect the authority of the Department of Agriculture under Subchapter B, Chapter 13, Agriculture Code.

(f) This section does not apply to a food service establishment as defined under Chapter 437 or a food establishment licensed under Chapter 431 as a food manufacturer.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1999, 76th Leg., ch. 1534, Sec. 1, eff. Sept. 1, 1999.

Sec. 434.008: Criminal Penalty

(a) A person who violates this subchapter commits an offense.

(b) An offense under this section is punishable by a fine of not less than $25 or more than $200.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter B

Sec. 434.021: Baking Powder

Baking powder that contains less than 10 percent of available carbon dioxide is adulterated.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 434.022: Self-Rising Flour

(a) In this section, "self-rising flour" means a combination of flour, salt, and chemical leavening ingredients. The flour must be at least of the "straight" grade, and the chemical leavening ingredients must be bicarbonate of soda and:

(1) calcium acid phosphate;

(2) sodium aluminum sulphate;

(3) cream of tartar;

(4) tartaric acid; or

(5) a combination of those ingredients.

(b) A self-rising flour or other compound by that name must produce when sold not less than one-half percent by weight of available carbon dioxide gas and may not contain more than 3-1/2 percent chemical leavening ingredients.

(c) A self-rising flour or other compound by that name that does not meet the requirements of Subsection (b) is adulterated.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Chapter 435

Subchapter A

Sec. 435.001: Definitions

In this subchapter:

(1) "Department" means the Department of State Health Services.

(2) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.

(3) "Person" means an individual, plant operator, partnership, corporation, company, firm, trustee, or association.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1075, eff. April 2, 2015.

Sec. 435.0015: Applicability of Other Law

Except as provided by Section 431.010(c), Chapter 431 applies to a person and milk or a milk product regulated under this chapter.

Comments

Added by Acts 2003, 78th Leg., ch. 757, Sec. 3, eff. Sept. 1, 2003.

Sec. 435.002: Grading of Milk and Milk Products

The executive commissioner may regulate the grading and labeling of milk and milk products. The department shall supervise the grading and labeling of milk and milk products according to the standards, specifications, and requirements adopted by the executive commissioner for each grade and in conformity with this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 5, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1076, eff. April 2, 2015.

Sec. 435.003: Milk Specifications

(a) The executive commissioner by rule may:

(1) define what constitutes Grade "A" raw milk, Grade "A" raw milk products, Grade "A" pasteurized milk, Grade "A" pasteurized milk products, milk for manufacturing purposes, and dairy products; and

(2) provide specifications for the production and handling of milk and milk products listed in Subdivision (1) according to the safety and food value of the milk or milk products and the sanitary conditions under which they are produced and handled.

(b) The rules must be based on and consistent with the most recent federal definitions, specifications, rules, and regulations relating to milk and milk products.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 1, eff. September 1, 2007.

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 2, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1077, eff. April 2, 2015.

Sec. 435.004: Inspection of Milk and Milk Products By Department

(a) The department shall sample, test, or inspect Grade "A" pasteurized milk and milk products, Grade "A" raw milk and milk products for pasteurization, milk for manufacturing purposes, and dairy products that are offered for sale.

(b) Grade "A" pasteurized milk and milk products and Grade "A" raw milk and milk products for pasteurization that come from beyond the limits of state inspection shall be sampled, tested, or inspected to determine if department standards and requirements for milk and milk products are met.

(c) Sampling, testing, and inspection of Grade "A" pasteurized milk and milk products and Grade "A" raw milk and milk for pasteurization shall include, in addition to any other tests that may be required, tests for:

(1) plate count or direct microscopic count;

(2) antibiotics;

(3) sediments;

(4) phosphatase; and

(5) water and any elements foreign to the natural contents of Grade "A" pasteurized milk and milk products and Grade "A" raw milk and milk products for pasteurization.

(d) Repealed by Acts 2007, 80th Leg., R.S., Ch. 1387, Sec. 5, eff. September 1, 2007.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 3, eff. September 1, 2007.

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 5, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1078, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1079, eff. April 2, 2015.

Sec. 435.005: Inspection of Milk and Milk Products By Other Entities

(a) The department may contract with a county or municipality to act as the agent of the department to inspect milk and milk products and to perform other regulatory functions necessary to enforce this subchapter.

(b) A municipality, county, or other political subdivision may test and inspect milk or milk products. In the absence of a contract under Subsection (a), the municipality, county, or other political subdivision must pay the cost of the test or inspection.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1080, eff. April 2, 2015.

Sec. 435.006: Permit to Sell Milk

(a) A person who offers milk or milk products for sale or to be sold in this state must hold a permit issued by the department. The person must apply to the department for a permit.

(b) After receiving the application, the department may determine and award the grade of milk or milk products offered for sale by each applicant according to the specifications for grades established under this chapter.

(c) The department shall maintain a list of the names of all applicants to whom the department has awarded permission to use a Grade "A" label and remove from the list the name of a person whose permit is revoked.

(d) The department may not issue a permit to a person for a producer dairy located in an area infected with or at a high risk for bovine tuberculosis, as determined epidemiologically and defined by rule of the Texas Animal Health Commission.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2001, 77th Leg., ch. 445, Sec. 2, eff. June 4, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1081, eff. April 2, 2015.

Sec. 435.007: Use of Misleading Label

(a) A person may not use a label, device, or design marked Grade "A," or any other grade, statement, device, or design related to the safety, sanitary quality, or food value, on milk or milk products produced, offered for sale, or sold in this state that is misleading or does not conform to the requirements of this subchapter.

(b) A person may not represent, publish, label, or advertise milk or milk products as being Grade "A" unless the milk or milk products are:

(1) produced or processed by a person having a permit to use a Grade "A" label as provided by this subchapter; and

(2) produced, treated, and handled in accordance with the specifications and requirements adopted by the executive commissioner for Grade "A" milk and milk products.

(c) A person may not sell to a consumer milk or a milk product labeled Grade "A" that has not been produced or processed by a person who has a Grade "A" permit under this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1082, eff. April 2, 2015.

Sec. 435.008: Milk for Resale

A person is not required to hold a permit to resell or offer for resale in the same container any milk or milk products that are represented or advertised as a grade of milk or milk products and that are purchased from a person holding a permit authorizing that representation or advertisement.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 435.009: Fees

(a) A political subdivision or agency of this state, other than the department, may not impose a fee on milk or a milk product, or on a person for the movement, distribution, or sale of milk or a milk product.

(b) The department shall impose the following fees only:

(1) a permit fee of $200 every two years for a producer dairy farm;

(2) a permit fee of $800 every two years for a processing or bottling plant;

(3) a permit fee of $800 every two years for a receiving and transfer station;

(4) a permit fee of $200 every two years for a milk transport tanker;

(5) a fee of 4-1/2 cents for each 100 pounds of milk or milk products processed and distributed in this state by a processing or bottling plant in this state, or processed by an out-of-state processing or bottling plant and sold in this state; and

(6) a fee of 1-1/2 cents for each 100 pounds of dairy products processed by a processing or bottling plant in this state.

(c) The executive commissioner shall adopt rules for the department to assess and collect the fees imposed by Subsections (b)(5) and (6) monthly, quarterly, semiannually, or annually according to amounts due by the plant. Monthly fees shall be assessed and collected in accordance with department rules.

(d) A permit issued under this chapter is valid for two years and must be renewed not later than September 1 of the year in which the permit expires.

(e) The department shall prorate fees paid for permits issued under this chapter after the beginning of a permit year.

(f) In this section:

(1) "Dairy farm" means a place where one or more cows or goats are kept and from which milk or milk products are provided, sold, or offered for sale to a milk plant or transfer station.

(2) "Transfer station" means a place where milk or milk products are transferred directly from one transport tank to another.

(g) Subject to legislative appropriation, the department may use money collected under Subsection (b)(5) only for milk inspection.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 411, Sec. 1, eff. Sept. 1, 1997.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1387 (S.B. 1714), Sec. 4, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1083, eff. April 2, 2015.

Sec. 435.010: Records

The executive commissioner by rule shall establish minimum standards for recordkeeping by persons required to pay a fee under this subchapter. Those persons shall make the records available to the department on request.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1084, eff. April 2, 2015.

Sec. 435.011: Hearing

(a) The executive commissioner shall establish a procedure by which a person aggrieved by the application of a department rule may receive a hearing under Chapter 2001, Government Code.

(b) The refusal or the suspension or revocation of a permit by the department and the appeal of that action are governed by the procedures for a contested case hearing under Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995; Acts 2003, 78th Leg., ch. 757, Sec. 4, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1085, eff. April 2, 2015.

Sec. 435.012: Refusal to Grant Permit; Suspension Or Revocation of Permit

(a) The department may refuse an application for a permit under this chapter or may suspend or revoke a permit issued under this chapter.

(b) The department may revoke and regrade permits if on inspection the department finds that the use of the grade label does not conform to the specifications or requirements adopted by the executive commissioner under this chapter.

(c) The executive commissioner by rule shall:

(1) provide for the denial, suspension, or revocation of a permit; and

(2) establish reasonable minimum standards for granting and maintaining a permit issued under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2003, 78th Leg., ch. 757, Sec. 5, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1086, eff. April 2, 2015.

Sec. 435.013: Municipal Regulation Authorized

A municipality by ordinance may allow only pasteurized milk and pasteurized milk products to be sold at retail in that municipality.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 435.014: Criminal Penalty

(a) A person commits an offense if the person violates this chapter.

(b) An offense under this section is punishable by a fine of not less than $25 or more than $200.

(c) Each violation constitutes a separate offense.

(d) The penalty prescribed by this section is subject to either the sanctions prescribed in the Grade A Pasteurized Milk Ordinance for products covered by the ordinance or any civil or administrative penalty or sanction otherwise imposed by Chapter 431 or other law for products not covered by the ordinance.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 2003, 78th Leg., ch. 757, Sec. 6, eff. Sept. 1, 2003.

Subchapter B

Sec. 435.021: Imported Milk

(a) In this section:

(1) "Political subdivision" means a county or municipality or a school, junior college, water, hospital, reclamation, or other special-purpose district.

(2) "State agency" means an agency, department, board, or commission of the state or a state eleemosynary, educational, rehabilitative, correctional, or custodial facility.

(b) A state agency or political subdivision may not purchase milk, cream, butter, or cheese, or a product consisting largely of one or more of those items, that has been imported from outside the United States.

(c) This section does not apply to the purchase of milk powder if domestic milk powder is not readily available in the normal course of business.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Renumbered from Sec. 435.022 by Acts 1989, 71st Leg., ch. 1100, Sec. 5.06(b), eff. Sept. 1, 1989.

Chapter 436

Subchapter A

Sec. 436.001: Short Title

This chapter may be cited as the Texas Aquatic Life Act.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Sec. 436.002: Definitions

In this chapter:

(1) "Approved area" means a molluscan shellfish growing area determined to be acceptable for harvesting of molluscan shellfish for direct marketing according to the National Shellfish Sanitation Program.

(2) "Approved source" means a source of molluscan shellfish acceptable to the department.

(3) "Aquatic life" means animals and plants that live in water.

(4) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(78), eff. April 2, 2015.

(5) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(78), eff. April 2, 2015.

(6) "Closed area" means a molluscan shellfish growing area where the taking including the harvesting for sale, the harvesting for transplant, or the gathering for depuration of molluscan shellfish is temporarily or permanently not permitted. A closed area status may be placed on any one of the five classified area designations established by the National Shellfish Sanitation Program.

(7) "Conditionally approved area" means a molluscan shellfish growing area determined to meet approved area criteria for a predictable period conditioned on performance standards specified in a management plan. A conditionally approved area is a closed area when the area does not meet the approved area criteria.

(8) "Conditionally restricted area" means a molluscan shellfish growing area determined to meet restricted area criteria for a predictable period conditioned on performance standards specified in a management plan. A conditionally restricted area is open for transplanting or gathering for depuration only during the times it meets the restricted area criteria and is specified as a conditionally restricted area by the department. A conditionally restricted area is a closed area at all times for harvesting of molluscan shellfish for direct marketing.

(9) "Container" means the physical material in contact with or immediately surrounding molluscan shellfish or crabmeat that confines it into a single unit.

(10) "Crabmeat" means the edible meat of steamed or cooked crabs that has not been processed other than by picking, packing, and chilling.

(11) "Crabmeat processing license" means a numbered document issued by the department that authorizes a person to process crabmeat for sale.

(12) "Crabmeat processor" means a person who cooks and backs crabs and who picks, packs, or pasteurizes crabmeat.

(13) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(78), eff. April 2, 2015.

(14) "Depletion" means the removal of all existing commercial quantities of market-size molluscan shellfish.

(15) "Depuration" means the process of using any approved artificially controlled aquatic environment to reduce the level of bacteria and viruses in molluscan shellfish.

(16) "Depuration plant" means a place where depuration of molluscan shellfish occurs.

(17) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(78), eff. April 2, 2015.

(18) "Growing area" means an area that supports or could support live molluscan shellfish.

(19) "Health authority" means a physician authorized to administer state or local laws relating to public health.

(20) "Label" means written, printed, or graphic matter appearing on a container of molluscan shellfish or crabmeat, including any written, printed, or graphic matter on any wrappers or accompanying any molluscan shellfish or crabmeat.

(21) "Molluscan shellfish" means an edible species of oyster, clam, or mussel that is shucked, in the shell, fresh, or fresh frozen, in whole or in part, as defined by the National Shellfish Sanitation Program.

(22) "National Shellfish Sanitation Program" means the cooperative program by the states, the United States Food and Drug Administration, and the shellfish industry that classifies molluscan shellfish growing areas and certifies interstate molluscan shellfish shippers according to the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish or its successor program and documents.

(23) "Open area" means a molluscan shellfish growing area where harvesting for sale, harvesting for transplant, or gathering for depuration of molluscan shellfish is permitted. An open area status may be placed on any one of the classified area designations established by the National Shellfish Sanitation Program except for a prohibited area.

(24) "Pasteurization plant" means a place where crabmeat is heat-treated in compliance with department rules, without complete sterilization, to improve the keeping qualities of the meat.

(25) "Picking plant" means a place where crabs are cooked and edible meat is picked from the crabs.

(26) "Possess" means the act of having in possession or control, keeping, detaining, restraining, or holding as owner, agent, bailee, or custodian for another.

(27) "Prohibited area" means an area where the department finds, according to a sanitary, chemical, or bacteriological survey, that the area contains aquatic life that is unfit for human consumption. A prohibited area for molluscan shellfish means a molluscan shellfish growing area determined to be unacceptable for transplanting, gathering for depuration, or harvesting of molluscan shellfish. The only molluscan shellfish removal permitted from a prohibited area is for the purpose of depletion.

(28) "Principal display panel" means the part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for sale.

(29) "Public water" means all bodies of water that are the property of the state under Section 1.011, Parks and Wildlife Code.

(30) "Restricted area" means a molluscan shellfish growing area that is determined to be unacceptable for harvesting of molluscan shellfish for direct marketing but that is acceptable for transplanting or gathering for depuration. A restricted area may be closed for transplanting or gathering for depuration when the area does not meet the restricted area criteria established by the National Shellfish Sanitation Program.

(31) "Sale" means the transfer of ownership or the right of possession of an item to a person for consideration and includes barter.

(32) "Shellfish certificate" means a numbered document issued by the department that authorizes a person to process molluscan shellfish for sale.

(33) "Shellfish processor" means a person who depurates, shucks, packs, or repacks molluscan shellfish.

(34) "Take" means catch, hook, net, snare, trap, kill, or capture by any means, including the attempt to take.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1087, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(78), eff. April 2, 2015.

Sec. 436.003: Health Authority Power to Delegate

A health authority may delegate any power or duty imposed on the health authority in this chapter to an employee of the local health department, the local health unit, or the public health district in which the health authority serves, unless otherwise restricted by law.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1088, eff. April 2, 2015.

Subchapter B

Sec. 436.011: Prohibited Acts

The following acts and the causing of the following acts within this state are unlawful and prohibited:

(1) taking, selling, offering for sale, or holding for sale molluscan shellfish from a closed area;

(2) taking, selling, offering for sale, or holding for sale molluscan shellfish from a restricted or conditionally restricted area without complying with a department rule to ensure that the molluscan shellfish have been purified, unless:

(A) permission is first obtained from the Parks and Wildlife Department and the transplanting is supervised by that department; and

(B) the Parks and Wildlife Department furnishes a copy of the transplant permit to the department before transplanting activities begin;

(3) possessing a species of aquatic life taken from a prohibited area while the area was prohibited for that species;

(4) operating as a molluscan shellfish processor without a shellfish certificate for each plant or place of business;

(5) operating as a crabmeat processor without a crabmeat processing license for each plant;

(6) selling, offering for sale, or holding for sale molluscan shellfish or crabmeat that has not been picked, handled, packaged, or pasteurized in accordance with department rules;

(7) selling, offering for sale, or holding for sale molluscan shellfish or crabmeat from facilities for the handling and packaging of molluscan shellfish or crabmeat that do not comply with department rules;

(8) selling, offering for sale, or holding for sale molluscan shellfish or crabmeat that is not labeled in accordance with department rules;

(9) selling, offering for sale, or holding for sale molluscan shellfish that is not in a container bearing a valid certificate number from a state or nation whose molluscan shellfish certification program conforms to the current National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish issued by the Food and Drug Administration or its successor, except selling molluscan shellfish removed from a container bearing a valid certificate number for on-premises consumption; in the event the Texas Molluscan Shellfish Program is found to be out of conformity with the current guide, selling, offering for sale, or holding for sale molluscan shellfish in a container bearing a valid Texas certificate number shall not be considered a violation of this chapter provided all other requirements of this chapter are complied with and the shellfish have come from an approved source;

(10) processing, transporting, storing for sale, possessing with intent to sell, offering for sale, or selling molluscan shellfish or crabmeat for human consumption that is adulterated or misbranded;

(11) removing or disposing of a detained or embargoed article in violation of Section 436.028;

(12) altering, mutilating, destroying, obliterating, or removing all or part of the labeling of a container;

(13) adulterating or misbranding molluscan shellfish or crabmeat in commerce;

(14) refusing to permit entry or inspection, to permit the taking of a sample, or to permit access to or copying by the department as required by this chapter;

(15) failing to establish or maintain a record or report required by this chapter or by a department rule; or

(16) violating a department rule or order.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1089, eff. April 2, 2015.

Subchapter C

Sec. 436.021: Definition

In this subchapter, "detained or embargoed article" means molluscan shellfish or crabmeat that has been detained or embargoed under Section 436.028.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Sec. 436.022: Inspection

(a) The department or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge:

(1) enter at reasonable times, including when processing is conducted, an establishment or location in which molluscan shellfish or crabmeat is processed, packed, pasteurized, or held for introduction into commerce or held after introduction into commerce;

(2) enter a vehicle being used to transport or hold the molluscan shellfish or crabmeat in commerce; or

(3) inspect the establishment, location, or vehicle, including equipment, records, files, papers, materials, containers, labels, or other items, and obtain samples necessary for enforcement of this chapter.

(b) The inspection of an establishment or location is to determine whether the molluscan shellfish or crabmeat:

(1) is adulterated or misbranded;

(2) may not be processed, introduced into commerce, sold, or offered for sale under this chapter or department rules; or

(3) is otherwise in violation of this chapter.

(c) The department or a health authority may not inspect:

(1) financial data;

(2) sales data, other than shipment data;

(3) pricing data;

(4) personnel data, other than personnel data relating to the qualifications of technical and professional personnel; or

(5) research data.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1090, eff. April 2, 2015.

Sec. 436.023: Access to Records

A person who is required to maintain records under this chapter or a department rule or a person who is in charge or custody of those records on request shall permit the department or health authority at all reasonable times to have access to and to copy the records.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1091, eff. April 2, 2015.

Sec. 436.024: Access to Records Showing Movement in Commerce

(a) A commercial carrier or other person receiving or holding molluscan shellfish or crabmeat in commerce on request shall permit the department or health authority at all reasonable times to have access to and to copy all records showing:

(1) the movement in commerce of the molluscan shellfish or crabmeat;

(2) the holding after movement in commerce of the molluscan shellfish or crabmeat; or

(3) the quantity, shipper, and consignee of the molluscan shellfish or crabmeat.

(b) The carrier or other person may not refuse access to and copying of the requested records if the request is accompanied by a written statement that specifies the nature or kind of molluscan shellfish or crabmeat to which the request relates.

(c) A carrier is not subject to other provisions of this chapter solely because of the carrier's receipt, carriage, holding, or delivery of molluscan shellfish or crabmeat in the usual course of business as a carrier.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1092, eff. April 2, 2015.

Sec. 436.025: Emergency Order

(a) The department may issue an emergency order that mandates or prohibits the taking, processing, or sale of molluscan shellfish or crabmeat in the department's jurisdiction if:

(1) the processing or sale of the molluscan shellfish or crabmeat creates or poses an immediate threat to human life or health; and

(2) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.

(b) The department may issue the emergency order without notice and hearing if the department or a person designated by the department determines that issuing the emergency order without notice and hearing is necessary under the circumstances.

(c) If an emergency order is issued without a hearing, the department shall determine the earliest time and place for a hearing at which the emergency order shall be affirmed, modified, or set aside. The hearing shall be held under department rules.

(d) This section prevails over Section 12.001.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1093, eff. April 2, 2015.

Sec. 436.026: Violation; Injunction

(a) The department or a health authority may petition the district court for a temporary restraining order to restrain a continuing violation or a threat of a continuing violation of Section 436.011 if the department or health authority believes that:

(1) a person has violated, is violating, or is threatening to violate a provision of Section 436.011; and

(2) the violation or threatened violation creates an immediate threat to the health and safety of the public.

(b) If the court finds that a person is violating or threatening to violate Section 436.011, the court shall grant injunctive relief.

(c) Venue for a suit brought under this section is in the county in which the violation or threat of violation is alleged to have occurred or in Travis County.

Comments

Amended by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1094, eff. April 2, 2015.

Sec. 436.027: Civil Penalty

(a) At the request of the department, the attorney general or a district, county, or municipal attorney shall institute an action in district or county court to collect a civil penalty from a person who has violated Section 436.011.

(b) A person who violates Section 436.011 is liable for a civil penalty not to exceed $25,000 a day for each violation. Each day of a continuing violation constitutes a separate violation for purposes of penalty assessment.

(c) In determining the amount of the penalty, the court shall consider:

(1) the person's history of previous violations under this chapter;

(2) the seriousness of the violation;

(3) any hazard to the health and safety of the public;

(4) the demonstrated good faith of the person; and

(5) other matters as justice may require.

(d) A civil penalty recovered in a suit instituted by the attorney general under this chapter shall be deposited in the state treasury to the credit of the general revenue fund. A civil penalty recovered in a suit instituted by a local government under this chapter shall be paid to the local government.

(e) Venue for a suit to collect a civil penalty brought under this section is in the municipality or county in which the violation occurred or in Travis County.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1095, eff. April 2, 2015.

Sec. 436.028: Detained Or Embargoed Article

(a) The department may detain or embargo molluscan shellfish or crabmeat if the department believes or has probable cause to believe that the molluscan shellfish or crabmeat:

(1) is adulterated; or

(2) is misbranded so that the molluscan shellfish or crabmeat is dangerous or fraudulent under this chapter.

(b) The department shall affix to any molluscan shellfish or crabmeat a tag or other appropriate marking that gives notice that the molluscan shellfish or crabmeat is, or is suspected of being, adulterated or misbranded and that the molluscan shellfish or crabmeat has been detained or embargoed.

(c) The tag or marking on a detained or embargoed article must prohibit the removal or disposal of the article unless permission is given by the department or a court.

(d) A person may not remove a detained or embargoed article from the premises or dispose of it without permission of the department or a court. The department may permit perishable goods to be moved to a place suitable for proper storage.

(e) The department shall remove the tag or other marking from a detained or embargoed article if the department believes that the article is not adulterated or misbranded.

(f) The claimant of a detained or embargoed article may move the article to a secure storage area with the permission of the department.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1096, eff. April 2, 2015.

Sec. 436.029: Removal Order for Detained Or Embargoed Article

(a) The department may order the claimant or the claimant's agent to move a detained or embargoed article to a secure place to prevent the unauthorized disposal or removal of the article.

(b) If the claimant fails to carry out the order, the department may move the article.

(c) If the department moves the article, the department shall assess the cost of removal against the claimant.

(d) The department may request the attorney general to bring an action in the district court in Travis County to recover the costs of removal. In a judgment in favor of the state, the court may award costs, attorney fees, and interest from the date the expense was incurred until the date the department is reimbursed.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1097, eff. April 2, 2015.

Sec. 436.030: Recall from Commerce

(a) The department may order a recall of molluscan shellfish or crabmeat with:

(1) the detention or embargo of molluscan shellfish or crabmeat;

(2) the issuance of an emergency order under Section 436.025; or

(3) both.

(b) The recall order may require that the molluscan shellfish or crabmeat be removed to one or more secure areas approved by the department.

(c) The recall order must be in writing and be signed by the commissioner and may be issued:

(1) before or in conjunction with a tag or other marking as provided by Section 436.028;

(2) with an emergency order authorized by Section 436.025; or

(3) both.

(d) The recall order is effective until it expires by its own terms, is withdrawn by the department, is reversed by a court in an order denying condemnation, or is set aside at a hearing authorized by Section 436.025.

(e) The claimant shall pay the costs of the removal and storage of a recalled product. If the claimant or the claimant's agent fails to carry out the recall order, the department may recall the product. The department shall assess the costs of the recall against the claimant.

(f) The department may request the attorney general to bring an action in a district court in Travis County to recover the costs of recall. In a judgment in favor of the state, the court may award costs, attorney fees, and interest from the date the expense was incurred until the date the department is reimbursed.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1098, eff. April 2, 2015.

Sec. 436.031: Condemnation

If molluscan shellfish or crabmeat is adulterated or misbranded, an action for the condemnation of the molluscan shellfish or crabmeat may be filed in a district court in whose jurisdiction the molluscan shellfish or crabmeat is located.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Sec. 436.032: Destruction of Molluscan Shellfish Or Crabmeat

(a) The court may order the destruction of sampled, detained, or embargoed molluscan shellfish or crabmeat if the court finds that the article is adulterated or misbranded.

(b) After entry of the court's order, the department shall supervise the destruction of the article.

(c) The claimant shall pay the cost of the destruction of the article.

(d) The court shall order the claimant or the claimant's agent to pay court costs, storage fees, and other proper expenses.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1099, eff. April 2, 2015.

Sec. 436.033: Correction By Proper Labeling

(a) A court may order the delivery of sampled, detained, or embargoed molluscan shellfish or crabmeat that is misbranded to the claimant for relabeling under the supervision of the department if:

(1) the court costs and other expenses have been paid;

(2) proper labeling can correct the misbranding; and

(3) the claimant executes a bond, conditioned on the correction of the misbranding by proper labeling.

(b) The claimant shall pay the costs of the supervision.

(c) The court shall order the return of the molluscan shellfish or crabmeat to the claimant if the department represents to the court that the molluscan shellfish or crabmeat no longer violates this chapter and that the expenses of supervision are paid.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1100, eff. April 2, 2015.

Sec. 436.034: Administrative Penalty

(a) The department may assess an administrative penalty against a person who violates Section 436.011 or an order issued under this chapter.

(b) In determining the amount of the penalty, the department shall consider:

(1) the person's previous violations;

(2) the seriousness of the violation;

(3) the hazard to the health and safety of the public;

(4) the person's demonstrated good faith; and

(5) other matters as justice may require.

(c) The penalty may not exceed $25,000 a day for each violation.

(d) Each day of a continuing violation constitutes a separate violation.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1101, eff. April 2, 2015.

Sec. 436.035: Administrative Penalty Assessment Procedure

(a) The department may assess an administrative penalty only after a person charged with a violation is given an opportunity for a hearing.

(b) If a hearing is to be held, the department shall refer the matter to the State Office of Administrative Hearings, and an administrative law judge of that office shall make findings of fact and shall issue a written proposal for decision regarding the violation and the amount of the penalty.

(c) If the person charged with the violation does not request a hearing, the department may assess a penalty after determining that a violation has occurred and the amount of the penalty.

(d) The department shall issue an order requiring a person to pay a penalty assessed under this section.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1102, eff. April 2, 2015.

Sec. 436.036: Payment of Administrative Penalty

(a) Not later than the 30th day after the date an order is issued under Section 436.035(d), the department shall notify the person against whom the penalty is assessed of the order and the amount of the penalty.

(b) Not later than the 30th day after the date notice of the order is given to the person, the person shall:

(1) pay the penalty in full; or

(2) file a petition for judicial review of the department's order contesting the amount of the penalty, the findings of the department, or both.

(c) If the person seeks judicial review within the period prescribed by Subsection (b), the person may:

(1) stay enforcement of the penalty by:

(A) paying the penalty to the court for placement in an escrow account; or

(B) posting with the court a supersedeas bond for the amount of the penalty; or

(2) request that the department stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(B) sending a copy of the affidavit to the department.

(c-1) If the department receives a copy of an affidavit under Subsection (c)(2), the department may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(d) A bond posted under this section must be in a form approved by the court and must be effective until judicial review of the order or decision is final.

(e) A person who does not send the money to, post the bond with, or file the affidavit with the court within the period described by Subsection (b) waives all rights to contest the violation or the amount of the penalty.

(f) The attorney general, at the request of the department, may bring a civil action to recover an administrative penalty assessed under this subchapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1103, eff. April 2, 2015.

Sec. 436.037: Refund of Administrative Penalty

On the date the court's judgment that an administrative penalty against a person should be reduced or not assessed becomes final, the court shall order that:

(1) the appropriate amount of any penalty payment plus accrued interest be remitted to the person not later than the 30th day after that date; or

(2) the bond be released, if the person has posted a bond.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1104, eff. April 2, 2015.

Sec. 436.038: Criminal Penalty; Defenses

(a) A person commits an offense if the person intentionally, knowingly, recklessly, or with criminal negligence commits an unlawful act under Section 436.011.

(b) A violation of Section 436.011(1), (2), or (3) is a Class B Parks and Wildlife Code misdemeanor under Section 12.405, Parks and Wildlife Code. Each day of a continuing violation constitutes a separate offense. Commissioned officers of the Parks and Wildlife Department shall enforce Sections 436.011(1), (2), and (3).

(c) If it is shown at trial that the defendant has been convicted once within five years before the trial date of a violation of Section 436.011(1) or (2), a violation by the defendant under Section 436.011(1) or (2) is a Class A Parks and Wildlife Code misdemeanor under Section 12.404, Parks and Wildlife Code.

(d) If it is shown at trial that the defendant has been convicted two or more times within five years before the trial date of a violation of Section 436.011(1) or (2), a violation by the defendant under Section 436.011(1) or (2) is a Parks and Wildlife Code felony under Section 12.407, Parks and Wildlife Code.

(e) A violation of Section 436.011(4), (5), (6), (7), (8), (9), (10), (11), (12), (13), (14), or (15) is a Class A misdemeanor. Each day of a continuing violation constitutes a separate offense.

(f) A person is not subject to the penalties of Subsection (e) if the person received molluscan shellfish or crabmeat in commerce and delivered or offered to deliver the molluscan shellfish or crabmeat in good faith, unless the person refuses to furnish on request of the department or a health authority the name and address of the person from whom the product was received and copies of any documents relating to the receipt of the product.

(g) A publisher, radiobroadcast licensee, or agency or medium for the publication or broadcast of an advertisement, except the harvester, processor, distributor, or seller of molluscan shellfish or crabmeat to which a false advertisement relates, is not liable under this section for the publication or broadcast of the false advertisement unless the person has refused to furnish, on the request of the department, the name and address of the harvester, processor, distributor, seller, or advertising agency residing in this state who caused the person to publish or broadcast the advertisement.

(h) A person is not subject to the penalties of Subsection (e) for a violation of Section 436.011 involving misbranded molluscan shellfish or crabmeat if the violation exists only because the product is misbranded because of a mistake in advertising, unless the violation is committed with intent to defraud or mislead.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1105, eff. April 2, 2015.

Sec. 436.039: Initiation of Proceedings

The attorney general or a district, county, or municipal attorney to whom the department or a health authority reports a violation of this chapter shall prosecute without delay.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1106, eff. April 2, 2015.

Sec. 436.040: Minor Violation

This chapter does not require the department or a health authority to report for prosecution a minor violation of this chapter if the department or health authority believes that the public interest is adequately served by a written warning.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1107, eff. April 2, 2015.

Subchapter D

Sec. 436.061: Adulterated Aquatic Life

(a) A species of aquatic life is adulterated if it has been taken from an area declared prohibited for that species by the department.

(b) Molluscan shellfish or crabmeat is adulterated if:

(1) it bears or contains a poisonous or deleterious substance that may render it injurious to health unless the substance is a naturally occurring substance and the quantity of the substance in the molluscan shellfish or crabmeat does not ordinarily render the substance injurious to health;

(2) it consists in whole or in part of a diseased, contaminated, filthy, or putrid substance or if it is otherwise unfit for human consumption;

(3) it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or may have been rendered diseased, unwholesome, or injurious to health;

(4) it is in whole or in part the product of diseased aquatic life or has died otherwise than by taking;

(5) its container is made in whole or in part of a poisonous or deleterious substance that may render the contents injurious to health;

(6) it has been intentionally exposed to radiation, unless the use of the radiation complied with a regulation or an exemption under Section 409, Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 348);

(7) a substance has been substituted in whole or in part for it;

(8) damage to or inferiority of the product has been concealed;

(9) a substance has been added, mixed, or packed to increase its bulk or weight, to reduce its quality or strength, or to make it appear better or of greater value than it is;

(10) it contains a chemical substance containing sulphites, sulphur dioxide, or any other chemical preservative that is not approved by the Animal and Plant Health Inspection Service or by department rules;

(11) the molluscan shellfish have been taken from a closed area;

(12) the molluscan shellfish have been taken from a restricted or conditionally restricted area and have not been purified under department rules;

(13) the molluscan shellfish have been processed by a person without a shellfish certificate;

(14) the molluscan shellfish have not been handled and packaged in accordance with department rules;

(15) the crabmeat has been processed by a person without a crabmeat processing license; or

(16) the crabmeat was not picked, packed, or pasteurized in accordance with department rules.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1108, eff. April 2, 2015.

Subchapter E

Sec. 436.071: Misbranded Molluscan Shellfish and Crabmeat

Molluscan shellfish or crabmeat is misbranded if:

(1) its labeling is false, misleading, or fails to conform with the requirements of Section 436.081;

(2) it is offered for sale under the name of another food;

(3) its container is made, formed, or filled so as to be misleading;

(4) a word, statement, or other information required by this chapter or a rule adopted under this chapter to appear on a label is not prominently and conspicuously placed on the label and is not likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or

(5) it does not have a label containing:

(A) the name, address, and certification or license number of the processor;

(B) an accurate statement in a uniform location on the principal display panel of the quantity of the contents in terms of weight, measure, or numerical count; and

(C) a date as provided by department rules.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1109, eff. April 2, 2015.

Subchapter F

Sec. 436.081: Fair Packaging and Labeling

(a) A label on molluscan shellfish or crabmeat shall conform to the requirements for the declaration of net quantity of contents under Section 1453, Fair Packaging and Labeling Act (15 U.S.C. Section 1453), and the regulations adopted under that Act.

(b) The label on a package of molluscan shellfish or crabmeat that represents the number of servings contained in the package shall state the net quantity in terms of weight, measure, or numerical count of each serving.

(c) A person may not distribute or cause to be distributed in commerce any molluscan shellfish or crabmeat if a qualifying word or phrase appears with the statement of the net quantity of contents required by Subsection (a). A supplemental statement at another place on the package may contain descriptions in nondeceptive terms of the net quantity of contents, except the supplemental statement of net quantity of contents may not include a term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the shellfish or crabmeat in the package.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Sec. 436.082: False Advertisement

An advertisement of molluscan shellfish or crabmeat is false if it is false or misleading in any manner.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Subchapter G

Sec. 436.091: Declaration of Prohibited Areas

(a) The department by order shall declare a body of public water to be a prohibited area if:

(1) the department finds, according to a sanitary, chemical, or bacteriological survey, that the area contains aquatic life that is unfit for human consumption; or

(2) aquatic life from a prohibited area may have been transferred to that body of public water.

(b) The department shall modify or revoke an order according to the results of a sanitary, chemical, or bacteriological survey conducted by the department. The department shall file the order in the department's office and shall furnish without charge a copy of the order describing prohibited areas on request.

(c) The department shall conspicuously outline prohibited areas on maps and shall furnish the maps without charge on request. The failure of a person to obtain that information does not relieve that person from liability under this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1110, eff. April 2, 2015.

Subchapter H

Sec. 436.101: Classification of Growing Areas

(a) The department by order shall designate an area that is coastal water according to the rules of the Parks and Wildlife Commission as an approved area, a conditionally approved area, a restricted area, a conditionally restricted area, or a prohibited area, according to the classification categories in the current National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish or its successor. Coastal water is a prohibited area for the taking of molluscan shellfish unless designated otherwise by the department.

(b) The department shall prohibit the taking of molluscan shellfish for a specified period from water to which molluscan shellfish may have been transferred from a restricted or conditionally restricted area.

(c) The department by order shall designate growing areas as closed areas or open areas. The department shall modify or revoke an order according to the results of sanitary and bacteriological surveys conducted by the department. The department shall file the order in the department's office and shall furnish without charge a copy of the order describing the open or closed area on request.

(d) The department shall conspicuously outline the classifications of areas for the taking of molluscan shellfish on maps and shall furnish the maps without charge on request. The failure of a person to obtain that information does not relieve that person from liability under this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1111, eff. April 2, 2015.

Sec. 436.102: Depuration

(a) The department may allow depuration by artificial means of molluscan shellfish taken from a restricted or conditionally restricted area, subject to department rules and under the supervision the department considers necessary to protect public health.

(b) A molluscan shellfish plant operator may employ an off-duty peace officer to monitor the gathering of shellfish for depuration from a restricted or conditionally restricted area as provided by the rules adopted under Subsection (a). In this subsection, "peace officer" includes those persons listed in Article 2.12, Code of Criminal Procedure.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1112, eff. April 2, 2015.

Sec. 436.103: Fee on Oyster Sales; Penalties

(a) The first certified shellfish dealer who harvests, purchases, handles, stores, packs, labels, unloads at dockside, or holds oysters taken from the water of this state shall pay the state a fee of $1 for each barrel of oysters harvested, purchased, handled, or processed by the certified shellfish dealer.

(b) For purposes of assessing the fee required by this section, three 100-pound containers of oysters is the equivalent of one barrel of oysters. A certified shellfish dealer may not purchase or pack oysters in containers that, when packed, exceed 110 pounds in weight. A dealer who violates this subsection is liable for a penalty of $5 for each container that exceeds 110 pounds.

(c) A certified shellfish dealer shall pay a fee or penalty imposed by Subsection (a) or (b) not later than the 20th day of the month following the month in which the barrel of oysters was handled. A dealer who fails to pay the fee or penalty in full within the prescribed period is liable for the amount of the fee or penalty and an additional penalty of 10 percent of the amount of the fee or penalty due. On certification by the comptroller that a fee is past due, the department may suspend, until the fee, penalty, or additional penalty is paid, the shellfish certificate of a certified shellfish dealer who fails to timely pay the fee, penalty, or additional penalty in full. The department, on certification from the comptroller that a certified shellfish dealer has refused to pay a fee, penalty, or additional penalty on written demand, may revoke the shellfish certificate of a certified shellfish dealer who refuses to pay a fee, penalty, or additional penalty.

(d) The comptroller shall collect fees and penalties under this section and may adopt rules, forms, and procedures for submission of fees and penalties under this section. Each month the comptroller shall report to the department the fees and penalties that are submitted to the comptroller.

(e) Before any other disposition of the fees and penalties collected under this section is made, two percent of the amount of the fees and penalties shall be deposited in the state treasury for appropriation for the use of the comptroller in the administration and enforcement of this section. The remainder of the fees and penalties collected under this section shall be deposited to the credit of the oyster sales account in the general revenue fund to be allocated each year for oyster-related activities, including:

(1) collecting bay water and shellfish meat samples;

(2) contracting for sample analysis for classification and opening or closing of oyster harvesting areas;

(3) marking the boundaries of areas that are designated open or closed under this subchapter;

(4) studying oyster diseases and other concerns affecting the availability of oysters for harvest;

(5) studying and analyzing organisms that may be associated with human illness and that can be transmitted through the consumption of oysters;

(6) contributing to the support of the oyster shell recovery and replacement program created under Section 76.020, Parks and Wildlife Code; and

(7) other oyster-related activities authorized or required by this chapter.

(f) After deducting the amount deposited into the state treasury for the comptroller's use under Subsection (e), the comptroller at the beginning of each state fiscal year shall allocate $100,000 of the unencumbered balance deposited to the credit of the oyster sales account in the general revenue fund to Texas A&M University at Galveston for use in performing the activities described by Subsection (e)(5). The remainder of the money in the oyster sales account may be allocated only for the purposes described by Subsection (e).

(g) Subtitles A and B, Title 2, Tax Code, apply to the comptroller's administration, collection, and enforcement of this section to the same extent as if the fee imposed under this section were a tax imposed under Title 2, Tax Code.

(h) In monitoring compliance with the payment of fees imposed under this section, the comptroller shall monthly or annually, as determined by the comptroller, compare records of fees collected under this section to data collected by the Parks and Wildlife Department relating to oyster barrel purchases. If the comptroller finds a discrepancy between the two sources of information, the comptroller may consult the dealer's log required by the National Shellfish Sanitation Program to resolve the discrepancy. The comptroller may use the process described by this subsection in place of any other administrative process used by the comptroller in determining compliance with this section.

(i) A finding by the comptroller under Subsection (h) of a discrepancy that reflects an underreporting of oysters harvested, purchased, handled, or processed by a dealer constitutes prima facie evidence of a violation of this section in any administrative proceeding under this chapter.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1999, 76th Leg., ch. 1298, Sec. 2, eff. June 18, 1999; Acts 2001, 77th Leg., ch. 28, Sec. 1, eff. Sept. 1, 2001.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 965 (H.B. 1903), Sec. 1, eff. September 1, 2013.

Sec. 436.104: Oyster Program

(a) The department shall conduct sanitary surveys, bay water and shellfish meat sampling, and any other activities that are necessary to classify the bays from which oysters are harvested from private leases or public reefs as authorized by Section 436.101.

(b) The department shall conduct reasonable and prudent sampling activities at the earliest possible time following the designation as a closed area of an area from which oysters are harvested from private leases or public reefs:

(1) if a question exists about the closure, to confirm the need for the closure; or

(2) if there is reason to believe that the sampling will result in opening the area.

(c) In implementing the oyster program, the department shall follow standards that are at least as stringent as the guidelines adopted by the National Shellfish Sanitation Program. The department's approach shall be consistent with the purpose and intent of the National Shellfish Sanitation Program and the federal Food and Drug Administration policy statements regarding the consumption of raw molluscan shellfish.

(d) Until Vibrio parahaemolyticus guidelines are formally adopted into the National Shellfish Sanitation Program, the department shall follow standards that are at least as stringent as guidelines of the Interim Control Plan for Vibrio parahaemolyticus of the Interstate Shellfish Sanitation Conference for the purpose of designating harvest areas as closed areas related to Vibrio parahaemolyticus.

(e) The department shall open harvest areas designated as closed areas due to excessive levels of Vibrio parahaemolyticus in shellfish meat samples when the levels of Vibrio parahaemolyticus in the shellfish meat samples return to baseline levels.

(f) The department shall open harvest areas designated as closed areas due to sporadic non-outbreak illnesses as specified in the Interim Control Plan when the levels in shellfish meats return to baseline levels or, if tdh+ serotypes were confirmed as the cause of the illnesses, when the virulent serotypes of Vibrio parahaemolyticus are absent in two consecutive samples of shellfish meats collected from the Vibrio parahaemolyticus sample stations in the closed area.

(g) The department shall open harvest areas designated as closed areas due to a confirmed Vibrio parahaemolyticus outbreak when the department determines that Vibrio parahaemolyticus strains of virulent serotypes are absent in those situations where 03:K6 or other tdh+ serotypes were confirmed as the cause of the outbreak. For purposes of this subsection, in Galveston Bay, Vibrio parahaemolyticus virulent strains shall be considered absent when 25 shellfish meat samples from any delineated harvest area that has been designated as a closed area do not result in reporting of the virulent strain that caused the outbreak.

(h) If a second confirmed outbreak of Vibrio parahaemolyticus illness occurs in an area, the department shall open a harvest area designated as closed when 50 shellfish samples do not result in the reporting of the virulent strain that caused the outbreak.

(i) If harvest areas designated as closed areas as a result of Vibrio parahaemolyticus cannot be opened as a result of the sampling under Subsection (f) or (g), the areas may be opened when environmental conditions develop that are unfavorable for Vibrio parahaemolyticus growth or when environmental conditions shift to conditions that are historically unrelated to outbreaks of Vibrio parahaemolyticus.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 3, eff. June 18, 1999.

Sec. 436.105: Temperature Requirements

Following initial refrigeration after unloading from a harvest boat, molluscan shellfish shall be refrigerated in air temperatures at or below 45 degrees Fahrenheit at all times except during transfer from one storage area or transportation vehicle to another. Except for an immediate transfer, molluscan shellfish may not remain unrefrigerated during transfer from one storage area or transportation vehicle to another.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 3, eff. June 18, 1999.

Sec. 436.106: Temperature Abuse

If temperature abuse of oysters associated with possible Vibrio parahaemolyticus illnesses is identified at any point in the market chain from harvest to consumer, the department may not designate a harvest area as a closed area if the temperature abuse is the probable cause of the illness. This section does not preclude closures for investigations conducted in accordance with the National Shellfish Sanitation Program that are necessary to protect public health. If a harvest area has been designated as a closed area because the investigation could not be completed within the time required in the National Shellfish Sanitation Program and temperature abuse is determined, as a result of the investigation, to be the probable cause of the illnesses, the harvest area must be immediately designated as an open area.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 3, eff. June 18, 1999.

Sec. 436.107: Texas Oyster Council

(a) The Texas Oyster Council is created.

(b) The council is composed of:

(1) two members appointed by the executive commissioner as nominated by the Texas Oyster Growers and Dealers Association or a successor organization;

(2) one member appointed by the executive commissioner as nominated by the Coastal Oyster Leaseholder's Association;

(3) two members appointed by the executive commissioner from a list of oyster dealers who have held a shellfish certificate in this state for not less than six months of each of the three years preceding the nomination and who are certified at the time of appointment;

(4) one representative appointed by the chairman of the Interstate Shellfish Sanitation Conference; and

(5) three consumer members, including one person professionally licensed or with work experience in the field of environmental survey, environmental sanitation, environmental engineering, or a similar field related to environmental or pollution conditions and their effect on molluscan shellfish harvest areas, appointed by the speaker of the house of representatives.

(c) Members of the Texas Oyster Council serve one-year terms expiring August 31 of each year and may be reappointed at the end of a term.

(d) A member of the Texas Oyster Council may not receive compensation for service on the council, but is entitled to reimbursement of expenses incurred by the member while conducting the business of the council, as provided by the General Appropriations Act.

(e) A person is not eligible for appointment as a consumer member of the Texas Oyster Council if the person or the person's spouse:

(1) is a harvester, processor, or wholesaler regulated under this chapter;

(2) is employed by a harvester, processor, or wholesaler regulated under this chapter;

(3) is a retailer of molluscan shellfish; or

(4) is employed by a retailer of molluscan shellfish.

(f) The Texas Oyster Council shall elect a presiding officer from among its members.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 3, eff. June 18, 1999. Amended by Acts 2001, 77th Leg., ch. 28, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1113, eff. April 2, 2015.

Sec. 436.108: Powers and Duties of Texas Oyster Council

(a) The Texas Oyster Council shall:

(1) advise the department on the criteria used by the department under Section 436.101 to designate growing areas as open or closed areas;

(2) advise the department on the development of standards and procedures relating to the licensing of molluscan shellfish processors under this chapter;

(3) advise the department on the content of the rules adopted by the executive commissioner to implement the provisions of this chapter relating to molluscan shellfish;

(4) perform any other functions requested by the department in implementing and administering the provisions of this chapter relating to molluscan shellfish; and

(5) review information brought before the council relating to molluscan shellfish.

(b) The Texas Oyster Council is entitled to:

(1) obtain information that is furnished to the department or developed by the department as part of an investigation of a food-borne illness that is suspected of being related to molluscan shellfish, including:

(A) location and handling practices where suspect food may have been served;

(B) product labeling and records;

(C) distribution agent, methods, and handling practices;

(D) sources of product;

(E) sample collection and laboratory analysis; and

(F) any other nonmedical information that may aid in determining causes or routes of transmission of food-borne illness or suspected food-borne illness; and

(2) review the information provided under Subdivision (1) and report to the department on any matter of concern.

(c) The Texas Oyster Council may establish procedures for:

(1) meetings of the council;

(2) submission, consideration, and resolution of issues before the council; and

(3) reporting relating to the council's activities.

(d) The Texas Oyster Council may meet at the request of the department, may meet periodically to review completed activities of the department, or may meet to review ongoing activities of the department if the department appears to have exceeded the guidelines established in the National Shellfish Sanitation Program.

(e) A member of the Texas Oyster Council who receives information under Subsection (b) from confidential communications or records, as identified by the department, may not disclose the information outside of the council or the department. The department, by providing to the council public information that is confidential or otherwise excepted from public disclosure under law, does not waive or affect the confidentiality of the information for the purposes of state or federal law or waive the right to assert exceptions to required disclosure of the information.

(f) The Texas Oyster Council is subject to Chapter 551, Government Code. The Texas Oyster Council is not required to conduct an open meeting to deliberate confidential communications and records provided under this section relating to the investigation of a food-borne illness that is suspected of being related to molluscan shellfish.

(g) A report produced by the Texas Oyster Council is public information.

Comments

Added by Acts 1999, 76th Leg., ch. 1298, Sec. 3, eff. June 18, 1999.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1114, eff. April 2, 2015.

Subchapter I

Sec. 436.111: Definitions

In this subchapter:

(1) "Certificate" means a shellfish certificate issued by the department.

(2) "License" means a crabmeat processing license issued by the department.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Sec. 436.112: Rulemaking Authority

The executive commissioner may adopt rules for the enforcement of this chapter. The executive commissioner shall adopt rules establishing specifications for molluscan shellfish processing and crabmeat processing, and the department shall furnish without charge printed copies of the rules on request.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1115, eff. April 2, 2015.

Sec. 436.113: Certification and Licensing Procedures

(a) A person may not operate as a molluscan shellfish or crabmeat processor unless the person submits an application for a certificate or a license to the department according to department rules and receives a certificate or license for each plant or place of business.

(b) When an application has been properly filed with the department, the department shall inspect the property identified in the application, including buildings and equipment, and the operating procedures under which the product is processed.

(c) The department shall issue a certificate or license to a person who operates a plant or place of business that conforms to the requirements of this chapter and department rules.

(d) A certificate is nontransferrable and expires at 11:59 p.m. on August 31 of the second year of issuance.

(e) A license is nontransferrable and expires at 11:59 p.m. on the last day of February of the second year of issuance.

(f) A person shall apply for a new certificate or license each year for each plant or place of business.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1116, eff. April 2, 2015.

Sec. 436.114: Refusal to Certify Or License; Suspension Or Revocation of Certificate Or License

(a) After notice to the applicant and opportunity for a hearing, the department may refuse an application for a certificate or a license or may suspend or revoke a certificate or license.

(b) The executive commissioner by rule shall establish minimum standards for a certificate or license and criteria for the refusal to issue a certificate or license and the suspension or revocation of a certificate or license.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1117, eff. April 2, 2015.

Sec. 436.115: Hearings and Appeals

(a) A hearing under this chapter is governed by the procedures for a contested case hearing under Chapter 2001, Government Code, and the department's formal hearing rules.

(b) An appeal from a final administrative decision under this chapter shall be conducted under Chapter 2001, Government Code.

Comments

Added by Acts 1993, 73rd Leg., ch. 336, Sec. 1, eff. Sept. 1, 1993. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1118, eff. April 2, 2015.

Chapter 437

Sec. 437.001: Definitions

In this chapter:

(1) "Acidified canned goods" means food with a finished equilibrium pH value of 4.6 or less that is thermally processed before being placed in an airtight container.

(1-a) "Beekeeper" has the meaning assigned by Section 131.001, Agriculture Code.

(2) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(79), eff. April 2, 2015.

(2-a) "Baked good" includes cookies, cakes, breads, Danish, donuts, pastries, pies, and other items that are prepared by baking the item in an oven.

(2-b) "Cottage food production operation" means an individual, operating out of the individual's home, who:

(A) produces at the individual's home, subject to Section 437.0196:

(i) a baked good that is not a time and temperature control for safety food, as defined by Section 437.0196;

(ii) candy;

(iii) coated and uncoated nuts;

(iv) unroasted nut butters;

(v) fruit butters;

(vi) a canned jam or jelly;

(vii) a fruit pie;

(viii) dehydrated fruit or vegetables, including dried beans;

(ix) popcorn and popcorn snacks;

(x) cereal, including granola;

(xi) dry mix;

(xii) vinegar;

(xiii) pickled fruit or vegetables, including beets and carrots, that are preserved in vinegar, brine, or a similar solution at an equilibrium pH value of 4.6 or less;

(xiv) mustard;

(xv) roasted coffee or dry tea;

(xvi) a dried herb or dried herb mix;

(xvii) plant-based acidified canned goods;

(xviii) fermented vegetable products, including products that are refrigerated to preserve quality;

(xix) frozen raw and uncut fruit or vegetables; or

(xx) any other food that is not a time and temperature control for safety food, as defined by Section 437.0196;

(B) has an annual gross income of $50,000 or less from the sale of food described by Paragraph (A);

(C) sells the foods produced under Paragraph (A) only directly to consumers; and

(D) delivers products to the consumer at the point of sale or another location designated by the consumer.

(3) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(79), eff. April 2, 2015.

(3-a) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(79), eff. April 2, 2015.

(3-b) "Farm stand" means a premises owned and operated by a producer of agricultural food products at which the producer or other persons may offer for sale produce or foods described by Subdivision (2-b)(A).

(3-c) "Fermented vegetable product" means a low-acid vegetable food product subjected to the action of certain microorganisms that produce acid during their growth and reduce the pH value of the food to 4.6 or less.

(4) "Food," "food service establishment," "retail food store," "mobile food unit," "roadside food vendor," and "temporary food service establishment" have the meanings assigned to those terms by rules adopted under this chapter.

(5) "Home" means a primary residence that contains a kitchen and appliances designed for common residential usage.

(6) "Produce" means fresh fruits or vegetables.

(7) "Small honey production operation" means a beekeeper that:

(A) produces less than 2,500 pounds of honey each year;

(B) sells or distributes the honey or honeycomb that the beekeeper produces either personally or with the help of the beekeeper's immediate family members;

(C) only sells or distributes honey or honeycomb:

(i) that is produced from a hive that is:

(a) located in the state; and

(b) owned and managed by the beekeeper;

(ii) that is pure honey as defined by Section 131.001, Agriculture Code, and that is raw and not blended with any other product or otherwise adulterated; and

(iii) directly to consumers at the beekeeper's home, a farmer's market, a farm stand, or a municipal, county, or nonprofit fair, festival, or event; and

(D) delivers the honey or honeycomb that the beekeeper produces to the consumer at the point of sale or another location designated by the consumer.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 617, Sec. 1, eff. Sept. 1, 1993.

Amended by:

Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 5, eff. September 1, 2011.

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 1, eff. September 1, 2013.

Acts 2013, 83rd Leg., R.S., Ch. 1275 (H.B. 1382), Sec. 1, eff. September 1, 2013.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1119, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(79), eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 265 (S.B. 1766), Sec. 1, eff. September 1, 2015.

Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 1, eff. September 1, 2019.

Sec. 437.002: Enforcement of State Law By County Or Public Health District

(a) A county or public health district may enforce state law and rules adopted under state law concerning food service establishments, retail food stores, mobile food units, and roadside food vendors.

(b) This chapter does not authorize a county or public health district to adopt orders establishing standards for the operation of food service establishments, retail food stores, mobile food units, or roadside food vendors.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.003: County Authority to Require Permit

To enforce state law and rules adopted under state law, the commissioners court of a county by order may require food service establishments, retail food stores, mobile food units, and roadside food vendors in unincorporated areas of the county, including areas in the extraterritorial jurisdiction of a municipality, to obtain a permit from the county.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.004: Public Health District Authority to Require Permit

(a) A public health district that is established by at least one county and one or more municipalities in the county by order may require food service establishments, retail food stores, mobile food units, and roadside food vendors in the district to obtain a permit from the district.

(b) If the public health district has an administrative board, the administrative board must adopt the order in accordance with its procedures.

(c) If the district does not have an administrative board, the governing body of each member of the district must adopt the order. The order is effective throughout the public health district on the 30th day after the first date on which the governing bodies of all members have adopted the order.

(d) This chapter does not restrict the authority of a municipality that is a member of a public health district to adopt ordinances or administer a permit system concerning food service establishments, retail food stores, mobile food units, and roadside food vendors.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.005: Public Hearing

(a) A commissioners court, governing body, or administrative board, as applicable, may adopt an order under Section 437.003 or 437.004 only after conducting a public hearing on the proposed order.

(b) At least two weeks' public notice must be given before a public hearing may be held.

(c) The notice must be published in a newspaper of general circulation in the county or public health district on three consecutive days and be printed in 10 point bold-faced type.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.0055: Permit from Department Required in Areas Not Regulated By County Or Public Health District

(a) A person may not operate a food service establishment, retail food store, mobile food unit, or temporary food service establishment located in an area in which a county or public health district does not require a permit or conduct inspections under this chapter unless the person has a permit issued by the department.

(b) A person required to obtain a permit under Subsection (a) must apply every two years for the permit and must pay any fees required by the department.

Comments

Added by Acts 1993, 73rd Leg., ch. 617, Sec. 2, eff. Jan. 1, 1994.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1120, eff. April 2, 2015.

Sec. 437.0056: Rulemaking Authority

The executive commissioner may adopt rules for the efficient enforcement of this chapter by the department in an area not regulated under this chapter by a county or public health district. The executive commissioner by rule shall establish minimum standards for granting and maintaining a permit in an area not regulated under this chapter by a county or public health district. The commissioner may refuse an application for a permit or suspend or revoke a permit in an area not regulated under this chapter by a county or public health district.

Comments

Added by Acts 1993, 73rd Leg., ch. 617, Sec. 2, eff. Jan. 1, 1994.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1121, eff. April 2, 2015.

Sec. 437.0057: Regulation of Food Handlers and Other Food Service Employees By Counties, Public Health Districts, and the Department

(a) A county, a public health district, or the department may require certification under Subchapter D, Chapter 438, for each food handler who is employed by a food service establishment in which food is prepared on-site for sale to the public and which holds a permit issued by the county, the public health district, or the department. This section applies without regard to whether the food service establishment is at a fixed location or is a mobile food unit.

(b) The requirements of certification under this section may not be more stringent than the requirements of Subchapter D, Chapter 438.

(c) A county, a public health district, or the department may not require an establishment that handles only prepackaged food and does not prepare or package food to employ certified food handlers under this section.

(d) A county, a public health district, or the department may exempt a food service establishment from the requirement that the county, public health district, or department has imposed under Subsection (a) if the county, the public health district, or the department determines that the application of Subsection (a) to that establishment is not necessary to protect public health and safety.

(e) A county, a public health district, or the department may require a food service establishment to:

(1) post a sign in a place conspicuous to employees, in a form adopted by the executive commissioner, describing a food service employee's responsibilities to report certain health conditions to the permit holder under rules adopted by the executive commissioner; or

(2) require that each food service employee sign a written agreement in a form adopted by the executive commissioner to report those health conditions.

Comments

Added by Acts 2009, 81st Leg., R.S., Ch. 926 (H.B. 3012), Sec. 1, eff. September 1, 2009.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1122, eff. April 2, 2015.

Sec. 437.006: More Than One Permit Prohibited

A food service establishment or retail food store may not be required under this chapter to obtain more than one permit for each location.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.0065: Permits for Certain Farmers and Food Producers

(a) In this section, "farmers' market" has the meaning assigned by Section 437.020.

(b) This section applies only to a permit issued under this chapter to:

(1) a farmer for the sale of food directly to consumers at a farmers' market, a farm stand, or the farmer's farm; and

(2) an individual who prepares food for sale at a farmers' market.

(c) A permit issued under Section 437.003, 437.004, 437.0055, or 437.0201 to a person described by Subsection (b):

(1) must be valid for a term of not less than one year;

(2) may impose an annual fee in an amount not to exceed $100 for the issuance or renewal; and

(3) must cover sales at all locations within the jurisdiction of the permitting authority.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 339 (S.B. 932), Sec. 1, eff. September 1, 2019.

Sec. 437.007: Nonprofit Organizations Exempt

A county or public health district may not require a nonprofit organization to obtain a permit.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.0073: Medallion for Mobile Food Units in Certain Populous Municipalities

(a) This section applies only to a municipality with a population of 1.5 million or more.

(b) Any person desiring to operate one or more mobile food units in a municipality subject to this section other than restricted operations mobile food units shall obtain an individual medallion for each operating mobile food unit from the health officer of the municipality. Each medallion will be issued unit-by-unit only after an inspection reveals satisfactory compliance with the provisions of this chapter and applicable municipal regulations or ordinances relating to mobile food units. The medallions shall remain the property of the municipality.

(c) A person may not operate or cause to be operated any mobile food unit that does not possess a valid medallion issued by the health officer.

(d) A medallion shall be affixed by the health officer or the health officer's authorized agents on the mobile food unit in a conspicuous place where it can be viewed by patrons.

(e) Application for a medallion shall be made on forms provided by the health officer and must include:

(1) the applicant's full name and mailing address;

(2) the address of the location at which the mobile food unit is stationed when not in use;

(3) the business name and address of the commissary or other fixed food service establishment from which potentially hazardous food supplies are obtained;

(4) the address of the servicing area;

(5) a description of the mobile food unit that includes the manufacturer's make, model, and serial number;

(6) the vehicle's state registration number; and

(7) the signature of the applicant.

(f) All of the provisions of this chapter and applicable municipal regulations or ordinances pertaining to food service establishments apply to the commissary or other fixed food service establishment from which the food supplies are obtained. Any suspension or revocation of the food dealer's permit for a food service establishment is cause for suspension or revocation of the medallion of any mobile food unit that is supplied or serviced by the establishment.

Comments

Added by Acts 2009, 81st Leg., R.S., Ch. 403 (H.B. 1802), Sec. 1, eff. June 19, 2009.

Sec. 437.0074: Mobile Food Units in Certain Populous Counties

(a) A county with a population of at least 2.8 million, or a municipality or public health district in the county, shall require a mobile food unit to:

(1) return to the food service establishment or commissary from which the unit operates within the 24-hour period preceding operation of the mobile food unit to have cleaning and other services performed on the unit; and

(2) obtain, on completion of an inspection following servicing, written documentation that the mobile food unit has been serviced daily as required by Subdivision (1).

(b) A county, municipality, or public health district that has installed an electronic tagging system shall register and record confirmation that the unit has been serviced as required by Subsection (a)(1).

(c) A municipality with a population of 1.5 million or more in a county with a population of 2.8 million or more shall require a mobile food unit, other than a mobile food unit that handles only prepackaged food and does not prepare or package food, to obtain a time and date stamp on the documentation required under Subsection (a)(2) from a time and date stamp unit that is constructed to prevent tampering and approved by the municipality's governing body. A record kept by the municipality regarding the time and date stamp on the documentation under Subsection (a)(2) by means of an electronic tagging system under Subsection (b) controls if that record is inconsistent with the record kept by the mobile food unit.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 1276 (H.B. 3672), Sec. 1, eff. September 1, 2007.

Amended by:

Acts 2009, 81st Leg., R.S., Ch. 403 (H.B. 1802), Sec. 2, eff. January 1, 2010.

Sec. 437.0075: Food Managers in Certain Populous Counties

(a) A county with a population of at least four million may require a certified or trained food manager to be on duty during the operating hours of a food establishment.

(b) The training required of food managers can be no more extensive than that specified under Subchapter D, Chapter 438.

(c) A food establishment that handles only prepackaged food and does not prepare or package food may not be required to have a certified food manager under this section.

Comments

Added by Acts 1999, 76th Leg., ch. 1378, Sec. 7, eff. June 19, 1999.

Amended by:

Acts 2017, 85th Leg., R.S., Ch. 911 (S.B. 1158), Sec. 1, eff. September 1, 2017.

Sec. 437.0076: Certified Food Manager

(a) A county or public health district may require each fixed or mobile location retail establishment in which food is prepared on-site for sale to the public that holds a permit issued by the county or public health district to employ a food manager certified under Subchapter G, Chapter 438.

(b) The executive commissioner may require each fixed or mobile location retail establishment in which food is prepared on-site for sale to the public that is required to be operated under a permit under Section 437.0055 to employ a food manager certified under Subchapter G, Chapter 438.

(c) An establishment that handles only prepackaged food and does not prepare or package food may not be required to have a certified food manager under this section.

(d) The executive commissioner by rule may exempt establishments other than the establishments described by Subsection (c) from the requirement imposed under this section if the executive commissioner determines that the application of the requirement to those establishments is not necessary to protect public health and safety.

(e) A county or public health district may exempt establishments other than the establishments exempt under Subsections (c) and (d) from the requirement imposed by the county or public health district under this section if the county or public health district determines that the application of the requirement to those establishments is not necessary to protect public health and safety.

(f) A child-care facility, as that term is defined by Section 42.002, Human Resources Code, is exempt from the requirements imposed under this section.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 1, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1123, eff. April 2, 2015.

Sec. 437.008: Permit Renewal

A county or public health district may require the annual renewal of a permit.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.009: Inspections

Authorized agents or employees of the department, a county, or a public health district may enter the premises of a food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment under the department's, county's, or district's jurisdiction during normal operating hours to conduct inspections to determine compliance with:

(1) state law, including a requirement to hold and display written authorization under Section 437.021;

(2) rules adopted under state law; and

(3) orders adopted by the department, county, or district.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1999, 76th Leg., ch. 448, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1402 (H.B. 3138), Sec. 1, eff. June 15, 2007.

Sec. 437.0095: Detention

The commissioner or an authorized agent may detain an article of food that is located on the premises of a food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment and is adulterated or misbranded under Chapter 431.

Comments

Added by Acts 1999, 76th Leg., ch. 448, Sec. 1, eff. Sept. 1, 1999.

Sec. 437.010: Submission of Plans and Subsequent Inspection

(a) Before issuing a permit, a county or public health district may require an applicant to provide plans of the food preparation, storage, and sales areas to determine if the applicant is in compliance with state law and rules adopted under state law governing the applicant.

(b) The county or public health district may deny the permit after initial inspection only if the applicant is not in compliance with the plans approved by the county or district.

(c) If the county or public health district finds on inspection that an applicant is not in compliance with state law and rules adopted under state law, the county or public health district may reinspect the applicant at a later date to determine if the applicant is in compliance.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.011: Inspection of Existing Entities on Adoption of Order

(a) When a county or public health district requires a permit, the county or district shall make an initial inspection of the facilities of any existing entity applying for the permit.

(b) An existing entity is entitled to continue to operate pending its initial inspection.

(c) If the county or public health district determines on inspection that an entity does not meet the standards established by state law or rules adopted under state law, the county or district may start revocation proceedings as if the entity had obtained a permit.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.012: County and Public Health District Fees

(a) A county or public health district may require the payment of a fee for issuing or renewing a permit.

(b) The fee charged by a county or public health district for issuing or renewing a permit may not exceed the amount necessary to recover the county's or district's cost under Subsection (d).

(c) Fees collected by a county under this chapter shall be deposited to the credit of a special fund of the county. Fees collected by a public health district under this chapter shall be deposited to the credit of a special fund created by the cooperative agreement under which the district operates.

(d) Fees deposited as provided by this section may be spent only for conducting inspections required by this chapter and issuing permits.

(e) This section does not apply to a county or public health district covered by Section 437.0123.

(f) A county or public health district may, by rule or order, adopt a variable scale to determine the fee charged for a permit under this section. In adopting a rule or order under this subsection, the county or public health district may consider:

(1) the size of the food service establishment, retail food store, mobile food unit, or roadside food vendor;

(2) the number of people employed at the food service establishment, retail food store, mobile food unit, or roadside food vendor; and

(3) the gross sales of the food service establishment, retail food store, mobile food unit, or roadside food vendor.

(g) Repealed by Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 4(1), eff. September 1, 2019.

(h) Repealed by Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 4(1), eff. September 1, 2019.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 617, Sec. 3, eff. Sept. 1, 1993; Acts 1997, 75th Leg., ch. 156, Sec. 2, eff. Sept. 1, 1997; Acts 2001, 77th Leg., ch. 72, Sec. 1, eff. Sept. 1, 2001.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 1, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 4(1), eff. September 1, 2019.

Sec. 437.0123: County and Public Health District Fees in Certain Populous Counties

(a) A county that has a population of at least 2.8 million or a public health district at least part of which is in a county that has a population of at least 2.8 million may require the payment of a fee for issuing or renewing a permit or for performing an inspection to enforce this chapter or a rule adopted under this chapter. A county with a population of at least 2.8 million may require a trained food manager to be on duty during each day of operation of a food service establishment. The training required of food managers can be no more extensive than the training offered by an education or training program accredited under Subchapter D, Chapter 438. A food service establishment that handles only prepackaged food and does not prepare or package food may not be required to have a certified food manager under this section.

(b) A county or public health district that requires payment of a fee under Subsection (a) shall set the fee in an amount that does not exceed the amount necessary to recover the annual expenditures by the county or district for:

(1) reviewing and acting on a permit;

(2) amending and renewing a permit;

(3) inspecting a facility as provided by this chapter and rules adopted under this chapter; and

(4) otherwise administering this chapter and rules adopted under this chapter.

(c) Repealed by Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 4(2), eff. September 1, 2019.

(d) Fees collected by a county under this chapter shall be deposited to the credit of a special fund of the county. Fees collected by a public health district under this chapter shall be deposited to the credit of a special fund created by the cooperative agreement under which the district operates.

(e) Fees deposited as provided by this section may be spent only for a purpose described by Subsection (b).

Comments

Added by Acts 1997, 75th Leg., ch. 156, Sec. 1, eff. Sept. 1, 1997. Amended by Acts 1999, 76th Leg., ch. 480, Sec. 1, eff. Aug. 30, 1999.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1124, eff. April 2, 2015.

Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 2, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 4(2), eff. September 1, 2019.

Sec. 437.0124: County and Public Health District Fee Schedule

A county or public health district shall establish a fee schedule for any fees collected under this chapter and revise the fee schedule as necessary.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 458 (H.B. 2755), Sec. 3, eff. September 1, 2019.

Sec. 437.0125: Department Fees

(a) The department shall collect fees for:

(1) filing, renewing, or amending a permit; and

(2) an inspection performed to enforce this chapter or a rule adopted under this chapter.

(b) The department may charge fees every two years.

(c) The executive commissioner by rule shall set the fees for issuing and renewing permits in amounts as prescribed by Section 12.0111 and other fees in amounts that allow the department to recover at least 50 percent of the expenditures by the department for:

(1) reviewing and acting on a permit;

(2) amending a permit;

(3) inspecting a facility as provided by this chapter and rules adopted under this chapter; and

(4) implementing and enforcing this chapter, including a department rule or an order adopted or a license issued by the department.

(d) The department shall spend not less than 50 percent of the permit fees collected to inspect facilities and to enforce and administer this chapter.

(e) All permit fees collected by the department under this chapter shall be deposited in the state treasury to the credit of the food and drug retail fee account.

Comments

Added by Acts 1993, 73rd Leg., ch. 617, Sec. 4, eff. Sept. 1, 1993.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1125, eff. April 2, 2015.

Sec. 437.013: Audited Statement

(a) A county or public health district shall file an audited statement with the department on or before January 15 of each year.

(b) The statement must include the receipts of funds collected under this chapter, all expenditures of funds, and fund balances.

(c) A county or public health district that fails to timely file the statement may not require the payment of a fee for issuing or renewing a permit until the statement is filed.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1126, eff. April 2, 2015.

Sec. 437.014: Denial, Suspension, Or Revocation of Permit

(a) A county or public health district may refuse to issue a permit or may suspend or revoke a permit if the county or district finds that the food service establishment, retail food store, mobile food unit, or roadside food vendor is not in compliance with state law, rules adopted under state law, or orders adopted by the county or district.

(b) A permit may be denied, suspended, or revoked only after notice and an opportunity for a hearing.

(c) A county or public health district that requires a permit to operate a food service establishment, retail food store, mobile food unit, or roadside food vendor shall adopt procedures for denying, suspending, or revoking a permit that afford due process to the applicant or permit holder.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.0145: Emergency Suspension Or Closing Order

(a) The department shall suspend the license of a food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment or order the immediate closing of the food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment if:

(1) the department finds the food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment is operating in violation of the standards prescribed by this chapter; and

(2) the violation creates an immediate threat to the health and safety of the public.

(b) An order suspending a license or closing a food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment under this section is immediately effective on the date on which the license holder receives written notice or a later date specified in the order.

(c) An order suspending a license or ordering an immediate closing of a food service establishment, retail food store, mobile food unit, roadside food vendor, or temporary food service establishment is valid for 10 days after the effective date of the order.

Comments

Added by Acts 1999, 76th Leg., ch. 448, Sec. 1, eff. Sept. 1, 1999.

Sec. 437.015: Injunction

A city attorney, county attorney, or district attorney may sue in district court to enjoin a food service establishment, retail food store, mobile food unit, or roadside food vendor from operating without a permit if a permit is required.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 437.0155: Department Injunction

(a) If it appears that a person has violated, is violating, or threatens to violate this chapter or a rule adopted under this chapter, the department may institute a civil suit in a district court for injunctive relief to restrain the person from continuing the violation or threat of violation.

(b) The department may petition a district court for a temporary restraining order to immediately halt a violation or other action creating an emergency condition if it appears that:

(1) a person is violating or threatening to violate this chapter or a rule or order adopted under this chapter; and

(2) the violation or threatened violation creates an immediate threat to the health and safety of the public.

(c) On the department's request, the attorney general shall institute a suit in the name of the state for injunctive relief.

(d) In an action for injunctive relief under this section, the court may grant any prohibitory or mandatory injunction warranted by the facts, including temporary restraining orders, temporary injunctions, and permanent injunctions. The court shall grant injunctive relief without a bond or other undertaking by the department.

(e) Venue for a suit brought under this section is in the county in which the violation or threat of violation is alleged to have occurred.

Comments

Added by Acts 1999, 76th Leg., ch. 448, Sec. 1, eff. Sept. 1, 1999.

Sec. 437.016: Criminal Penalty: Violation of County and Public Health District Permit Requirements

(a) A person commits an offense if the person operates a food service establishment, retail food store, mobile food unit, or roadside food vendor without a permit required by the county or public health district in which the entity is operating.

(b) An offense under this section is a Class C misdemeanor.

(c) Each day on which a violation occurs constitutes a separate offense.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1993, 73rd Leg., ch. 617, Sec. 5, eff. Sept. 1, 1993.

Sec. 437.0165: Criminal Penalty: Violation of Department Permit Requirement

(a) A person commits an offense if the person operates a food service establishment, retail food store, mobile food unit, or temporary food service establishment without a permit that is required by the department under Section 437.0055.

(b) An offense under this section is a Class A misdemeanor.

(c) Each day on which a violation occurs constitutes a separate offense.

Comments

Added by Acts 1993, 73rd Leg., ch. 617, Sec. 6, eff. Jan. 1, 1994.

Sec. 437.017: Conflict with Alcoholic Beverage Code

The Alcoholic Beverage Code and rules adopted by the Texas Alcoholic Beverage Commission control to the extent of a conflict between this chapter or an order adopted under this chapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1127, eff. April 2, 2015.

Sec. 437.018: Administrative Penalty

(a) The department may impose an administrative penalty against a person who holds a permit or who is regulated under this chapter and who violates this chapter or a rule or order adopted under this chapter.

(b) The penalty for a violation may be in an amount not to exceed $10,000. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty.

(c) The amount of the penalty shall be based on:

(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of any prohibited acts, and the hazard or potential hazard created to the health, safety, or economic welfare of the public;

(2) the enforcement costs relating to the violation;

(3) the history of previous violations;

(4) the amount necessary to deter future violations;

(5) efforts to correct the violation; and

(6) any other matter that justice may require.

(d) If the department determines that a violation has occurred, the department shall issue an order that states the facts on which the determination is based, including an assessment of the penalty.

(e) Within 14 days after the date the order is issued, the department shall give written notice of the order to the person. The notice may be given by certified mail. The notice must include a brief summary of the alleged violation and a statement of the amount of the recommended penalty and must inform the person that the person has a right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(f) Within 20 days after the date the person receives the notice, the person in writing may accept the determination and recommended penalty of the department or may make a written request for a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(g) If the person accepts the determination and recommended penalty, the department by order shall impose the recommended penalty.

(h) If the person requests a hearing or fails to respond timely to the notice, the department shall refer the matter to the State Office of Administrative Hearings and an administrative law judge of that office shall hold the hearing. The department shall give written notice of the hearing to the person. The administrative law judge shall make findings of fact and conclusions of law and promptly issue to the department a written proposal for a decision about the occurrence of the violation and the amount of a proposed penalty. Based on the findings of fact, conclusions of law, and proposal for a decision, the department by order may find that a violation has occurred and impose a penalty or may find that no violation occurred.

(i) The notice of the department's order given to the person under Chapter 2001, Government Code, must include a statement of the right of the person to judicial review of the order.

(j) Within 30 days after the date the department's order is final as provided by Subchapter F, Chapter 2001, Government Code, the person shall:

(1) pay the amount of the penalty;

(2) pay the amount of the penalty and file a petition for judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty; or

(3) without paying the amount of the penalty, file a petition for judicial review contesting the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(k) Within the 30-day period, a person who acts under Subsection (j)(3) of this section may:

(1) stay enforcement of the penalty by:

(A) paying the amount of the penalty to the court for placement in an escrow account; or

(B) giving to the court a supersedeas bond that is approved by the court for the amount of the penalty and that is effective until all judicial review of the department's order is final; or

(2) request the court to stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the amount of the penalty and is financially unable to give the supersedeas bond; and

(B) giving a copy of the affidavit to the department by certified mail.

(l) The department on receipt of a copy of an affidavit under Subsection (k)(2) may file with the court, within five days after the date the copy is received, a contest to the affidavit. The court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the amount of the penalty and to give a supersedeas bond.

(m) If the person does not pay the amount of the penalty and the enforcement of the penalty is not stayed, the department may refer the matter to the attorney general for collection of the amount of the penalty.

(n) Judicial review of the order of the department:

(1) is instituted by filing a petition as provided by Subchapter G, Chapter 2001, Government Code; and

(2) is under the substantial evidence rule.

(o) If the court sustains the occurrence of the violation, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty. If the court does not sustain the occurrence of the violation, the court shall order that no penalty is owed.

(p) When the judgment of the court becomes final, the court shall proceed under this subsection. If the person paid the amount of the penalty and if that amount is reduced or is not upheld by the court, the court shall order that the appropriate amount plus accrued interest be remitted to the person. The rate of the interest is the rate charged on loans to depository institutions by the New York Federal Reserve Bank, and the interest shall be paid for the period beginning on the date the penalty was paid and ending on the date the penalty is remitted. If the person gave a supersedeas bond and if the amount of the penalty is not upheld by the court, the court shall order the release of the bond. If the person gave a supersedeas bond and if the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the amount.

(q) A penalty collected under this section shall be remitted to the comptroller for deposit in the general revenue fund.

(r) All proceedings under this section are subject to Chapter 2001, Government Code.

Comments

Added by Acts 1993, 73rd Leg., ch. 617, Sec. 6, eff. Jan. 1, 1994. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), (53), (59), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1128, eff. April 2, 2015.

Sec. 437.0185: Administrative Penalty By Public Health District Or County

(a) The director of a public health district or the commissioners court of a county may impose an administrative penalty on a person the district or county requires to hold a permit under Section 437.003 or 437.004 if the person violates this chapter or a rule or order adopted under this chapter.

(b) The amount of the penalty may not exceed $500 per day, and each day a violation continues or occurs is a separate violation for the purpose of imposing a penalty. The amount shall be based on:

(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(2) the history of previous violations;

(3) the amount necessary to deter a future violation;

(4) efforts to correct the violation; and

(5) any other matter that justice may require.

(c) The enforcement of the penalty may be stayed during the time the order is under judicial review if the person pays the penalty to the clerk of the court. A person who cannot afford to pay the penalty may stay the enforcement by filing an affidavit in the manner required by the Texas Rules of Civil Procedure for a party who cannot afford to file security for costs.

(d) Not later than the 20th day after the date the person receives notice of the penalty, the person in writing may:

(1) accept the determination and pay the recommended penalty of the director or commissioners court; or

(2) make a request for a hearing on the occurrence of the violation, the amount of the penalty, or both.

(e) The justice of the peace for the justice precinct in which the retail food store or food establishment is located or the mobile food establishment or roadside food vendor is based shall hold a hearing requested under Subsection (d).

(f) If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty.

(g) If the court does not sustain the finding that a violation occurred, the court shall order that a penalty is not owed.

(h) If the person paid the penalty to the clerk of the court and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, that the appropriate amount be remitted to the person.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 1202 (H.B. 1585), Sec. 1, eff. September 1, 2007.

Sec. 437.0186: Assessment of Administrative Penalty

An administrative penalty may be imposed for a violation of this chapter or a rule or order under this chapter by the state under Section 437.018 or by the director of a public health district or commissioners court of a county under Section 437.0185, but not both.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 1202 (H.B. 1585), Sec. 1, eff. September 1, 2007.

Sec. 437.019: Exemption for Certain Bed and Breakfast Establishments

(a) Except as provided by Subsection (c), a bed and breakfast establishment with seven or fewer rooms for rent that serves only breakfast to its overnight guests is not a food service establishment for purposes of this chapter. An owner or manager of a bed and breakfast establishment covered by this subsection shall successfully complete a food manager's certification course accredited by the department.

(b) Except as provided by Subsection (c), a bed and breakfast establishment that has more than seven rooms for rent, or that provides food service other than breakfast to its overnight guests, is a food service establishment for purposes of this chapter but may not be required to meet all criteria applicable to a larger food service establishment such as a restaurant. The executive commissioner, commissioners court, governing body, or administrative board, as applicable, shall adopt minimum standards for a bed and breakfast establishment covered by this subsection.

(c) A bed and breakfast establishment that provides food service other than to overnight guests is a food service establishment for purposes of this chapter and is subject to all rules and regulations applicable to a food service establishment.

Comments

Added by Acts 1995, 74th Leg., ch. 689, Sec. 1, eff. June 15, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1129, eff. April 2, 2015.

Sec. 437.0191: Exemption for Cottage Food Production Operations

(a) A cottage food production operation is not a food service establishment for purposes of this chapter.

(b) The exemption provided by Subsection (a) does not affect the application of Sections 431.045, 431.0495, and 431.247 authorizing the department or other local health authority to act to prevent an immediate and serious threat to human life or health.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 6, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 2, eff. September 1, 2013.

Sec. 437.0192: Regulation of Cottage Food Production Operations By Local Government Authorities Prohibited; Complaints

(a) A local government authority, including a local health department, may not regulate the production of food at a cottage food production operation.

(b) Each local health department and the department shall maintain a record of a complaint made by a person against a cottage food production operation.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 6, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 3, eff. September 1, 2013.

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 4, eff. September 1, 2013.

Sec. 437.0193: Packaging and Labeling Requirements for Cottage Food Production Operations

(a) Food described by Section 437.001(2-b)(A) sold by a cottage food production operation must be packaged in a manner that prevents product contamination, except that a food item is not required to be packaged if it is too large or bulky for conventional packaging.

(b) The executive commissioner shall adopt rules requiring a cottage food production operation to label all of the foods described in Section 437.001(2-b)(A) that the operation sells to consumers. The label must include:

(1) the name and address of the cottage food production operation; and

(2) a statement that the food is not inspected by the department or a local health department.

(c) For foods not required to be packaged under Subsection (a), the information required to be included on the label under Subsection (b) must be provided to the consumer on an invoice or receipt.

(d) A cottage food production operation that sells frozen raw and uncut fruit or vegetables must include on the label of the frozen fruit or vegetables or on an invoice or receipt provided with the frozen fruit or vegetables when sold the following statement in at least 12-point font: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria, keep this food frozen until preparing for consumption."

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 6, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 5, eff. September 1, 2013.

Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 2, eff. September 1, 2019.

Sec. 437.0194: Certain Sales By Cottage Food Production Operations Prohibited Or Restricted

(a) A cottage food production operation may not sell any of the foods described in Section 437.001(2-b)(A) at wholesale.

(b) A cottage food production operation may sell a food described by Section 437.001(2-b)(A) in this state through the Internet or by mail order only if:

(1) the consumer purchases the food through the Internet or by mail order from the operation and the operator personally delivers the food to the consumer; and

(2) subject to Subsection (c), before the operator accepts payment for the food, the operator provides all labeling information required by Section 437.0193(d) and department rules to the consumer by:

(A) posting a legible statement on the operation's Internet website;

(B) publishing the information in a catalog; or

(C) otherwise communicating the information to the consumer.

(c) The operator of a cottage food production operation that sells a food described by Section 437.001(2-b)(A) in this state in the manner described by Subsection (b):

(1) is not required to include the address of the operation in the labeling information required under Subsection (b)(2) before the operator accepts payment for the food; and

(2) shall provide the address of the operation on the label of the food in the manner required by Section 437.0193(b) after the operator accepts payment for the food.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 6, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 5, eff. September 1, 2013.

Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 3, eff. September 1, 2019.

Sec. 437.0195: Production of Cottage Food Products

(a) An individual who operates a cottage food production operation must have successfully completed a basic food safety education or training program for food handlers accredited under Subchapter D, Chapter 438.

(b) An individual may not process, prepare, package, or handle cottage food products unless the individual:

(1) meets the requirements of Subsection (a);

(2) is directly supervised by an individual described by Subsection (a); or

(3) is a member of the household in which the cottage food products are produced.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 6, eff. September 1, 2013.

Sec. 437.01951: Requirements for Sale of Certain Cottage Foods

(a) A cottage food production operation that sells to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods shall:

(1) use a recipe that:

(A) is from a source approved by the department under Subsection (d);

(B) has been tested by an appropriately certified laboratory that confirmed the finished fruit or vegetable, product, or good has an equilibrium pH value of 4.6 or less; or

(C) is approved by a qualified process authority; or

(2) if the operation does not use a recipe described by Subdivision (1), test each batch of the recipe with a calibrated pH meter to confirm the finished fruit or vegetable, product, or good has an equilibrium pH value of 4.6 or less.

(b) A cottage food production operation may not sell to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods before the operator complies with Subsection (a).

(c) For each batch of pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods, a cottage food production operation must:

(1) label the batch with a unique number; and

(2) for a period of at least 12 months, keep a record that includes:

(A) the batch number;

(B) the recipe used by the producer;

(C) the source of the recipe or testing results, as applicable; and

(D) the date the batch was prepared.

(d) The department shall:

(1) approve sources for recipes that a cottage food production operation may use to produce pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods; and

(2) semiannually post on the department's Internet website a list of the approved sources for recipes, appropriately certified laboratories, and qualified process authorities.

(e) The department shall develop and implement a process by which an individual may request that the department approve an additional source for recipes under Subsection (d). The process must allow an individual to submit with the individual's request documentation supporting the request.

(f) A source for recipes approved by the department under Subsection (d) must be scientifically validated and may be from a government entity, academic institution, state extension service, or other qualified source with:

(1) expert knowledge of processing requirements for pickled fruit or vegetables, fermented vegetable products, or acidified canned goods; and

(2) adequate facilities for scientifically validating recipes for pickled fruit or vegetables, fermented vegetable products, or acidified canned goods.

(g) This section does not apply to pickled cucumbers.

(h) For purposes of this section, "process authority" means a person who has expert knowledge acquired through appropriate training and experience in the pickling, fermenting, or acidification and processing of pickled, fermented, or acidified foods.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 4, eff. September 1, 2019.

Sec. 437.01952: Requirements for Sale of Frozen Fruit Or Vegetables

A cottage food production operation that sells to consumers frozen raw and uncut fruit or vegetables shall:

(1) store and deliver the frozen fruit or vegetables at an air temperature of not more than 32 degrees Fahrenheit; and

(2) label the fruit or vegetables in accordance with Section 437.0193(d).

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 4, eff. September 1, 2019.

Sec. 437.0196: Time and Temperature Control for Safety Food; Prohibition for Cottage Food Production Operations; Exception

(a) In this section, "time and temperature control for safety food" means a food that requires time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A time and temperature control for safety food may include a food that contains protein and moisture and is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products, pasteurized and unpasteurized milk and dairy products, raw seed sprouts, baked goods that require refrigeration, including cream or custard pies or cakes, and ice products. The term does not include a food that uses time and temperature control for safety food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production.

(b) Except as otherwise provided by this chapter, a cottage food production operation may not sell to consumers time and temperature control for safety foods.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 653 (H.B. 970), Sec. 6, eff. September 1, 2013.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 590 (S.B. 572), Sec. 5, eff. September 1, 2019.

Sec. 437.0197: Exemption for Small Honey Production Operation

A small honey production operation is not a food service establishment for purposes of this chapter.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 265 (S.B. 1766), Sec. 2, eff. September 1, 2015.

Sec. 437.0198: Regulation of Small Honey Production Operation Prohibited

A local government authority, including a local health department, may not regulate the production of honey or honeycomb at a small honey production operation.

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 265 (S.B. 1766), Sec. 2, eff. September 1, 2015.

Sec. 437.0199: Labeling Requirements for Small Honey Production Operation

Honey or honeycomb sold or distributed by a small honey production operation must be labeled in accordance with Subchapter E, Chapter 131, Agriculture Code. The label must include:

(1) the net weight of the honey expressed in both the avoirdupois and metric systems;

(2) the beekeeper's name and address; and

(3) the statement "Bottled or packaged in a facility not inspected by the Texas Department of State Health Services."

Comments

Added by Acts 2015, 84th Leg., R.S., Ch. 265 (S.B. 1766), Sec. 2, eff. September 1, 2015.

Sec. 437.020: Regulation of Food Samples at Farms and Farmers' Markets

(a) In this section:

(1) "Farmers' market" means a designated location used primarily for the distribution and sale directly to consumers of food by farmers or other producers.

(2) "Food" means an agricultural, apicultural, horticultural, silvicultural, viticultural, or vegetable product for human consumption, in either its natural or processed state, that has been produced or processed or otherwise has had value added to the product in this state. The term includes:

(A) fish or other aquatic species;

(B) livestock, a livestock product, or a livestock by-product;

(C) planting seed;

(D) poultry, a poultry product, or a poultry by-product;

(E) wildlife processed for food or by-products;

(F) a product made from a product described by this subdivision by a farmer or other producer, including a cottage food production operation, who grew or processed the product; or

(G) produce.

(b) Except as provided by this section and Sections 437.0065, 437.0201, 437.0202, and 437.0203:

(1) this chapter does not regulate the provision of samples of food or the sale of food to consumers at a farm or farmers' market; and

(2) a rule adopted under state law may not regulate the provision of samples of food or the sale of food to consumers at a farm or farmers' market.

(b-1) The department or a local government authority, including a local health department, may not require a person to obtain a permit under this chapter to provide samples of food at a farm or farmers' market under this section.

(b-2) A local government authority, including a local health department, may not regulate the provision of samples of food at a farm or farmers' market except as provided by this chapter.

(b-3) The department or a local government authority, including a local health department, may:

(1) perform an inspection to enforce the requirements of this section for preparing and distributing samples of food at a farm or farmers' market; and

(2) require a person to obtain a permit under this chapter to offer for sale or distribution to consumers food cooked at a farm or farmers' market.

(c) Samples of food may be prepared and distributed at a farm or farmers' market if the following sanitary conditions exist:

(1) samples must be distributed in a sanitary manner;

(2) a person preparing produce samples on-site must:

(A) wear clean, disposable plastic gloves when preparing samples; or

(B) observe proper hand washing techniques immediately before preparing samples;

(3) produce intended for sampling must be washed in potable water to remove any soil or other visible material;

(4) potable water must be available for washing;

(5) except as provided by Section 437.0202(b), potentially hazardous food, as determined by rule of the department, must be maintained at or below 41 degrees Fahrenheit or disposed of within two hours after cutting or preparing; and

(6) utensils and cutting surfaces used for cutting samples must be smooth, nonabsorbent, and easily cleaned or disposed of.

(d) A person who sells or provides a sample of meat or poultry or food containing meat or poultry must comply with Chapter 433.

(e) This section does not authorize the sale of or provision of samples of raw milk or raw milk products at a farmers' market.

(f) A cottage food production operation may only provide samples of food described by Section 437.001(2-b)(A) produced by the operation.

(g) This section does not apply to a person who:

(1) provides samples of food at a farm or farmers' market; and

(2) does not sell food directly to consumers at the farm or farmers' market.

Comments

Added by Acts 2005, 79th Leg., Ch. 191 (H.B. 894), Sec. 1, eff. May 27, 2005.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 1275 (H.B. 1382), Sec. 2, eff. September 1, 2013.

Acts 2019, 86th Leg., R.S., Ch. 339 (S.B. 932), Sec. 2, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 373 (H.B. 1694), Sec. 1, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 373 (H.B. 1694), Sec. 2, eff. September 1, 2019.

Sec. 437.0201: Regulation of Food at Farmers' Markets Under Temporary Food Establishment Permits

(a) In this section, "farmers' market" and "food" have the meanings assigned by Section 437.020.

(b) The department or a local health department may issue a temporary food establishment permit to a person who sells food at a farmers' market, subject to Section 437.0065.

(c) Repealed by Acts 2019, 86th Leg., R.S., Ch. 339 (S.B. 932), Sec. 4, eff. September 1, 2019.

(d) This section does not apply to a farmers' market in a county:

(1) that has a population of less than 50,000; and

(2) over which no local health department has jurisdiction.

(e) The executive commissioner, a state enforcement agency, or a local government authority, including a local health department, may not adopt a rule requiring a farmers' market to pay a permit fee for:

(1) conducting a cooking demonstration if the demonstration is conducted for a bona fide educational purpose; or

(2) providing samples of food.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 7, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 1275 (H.B. 1382), Sec. 3, eff. September 1, 2013.

Acts 2019, 86th Leg., R.S., Ch. 339 (S.B. 932), Sec. 3, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 339 (S.B. 932), Sec. 4, eff. September 1, 2019.

Acts 2019, 86th Leg., R.S., Ch. 373 (H.B. 1694), Sec. 3, eff. September 1, 2019.

Sec. 437.0202: Temperature Requirements for Food at Farmers' Markets

(a) In this section, "farmers' market" and "food" have the meanings assigned by Section 437.020.

(b) The executive commissioner by rule may adopt temperature requirements for food sold at, prepared on-site at, or transported to or from a farmers' market under Section 437.020, 437.0201, or 437.0203. Food prepared on-site at a farmers' market may be sold or distributed at the farmers' market only if the food is prepared in compliance with the temperature requirements adopted under this section.

(c) Except as provided by Subsection (d), the executive commissioner or a state or local enforcement agency may not mandate a specific method for complying with the temperature control requirements adopted under Subsection (b).

(d) The municipality in which a municipally owned farmers' market is located may adopt rules specifying the method or methods that must be used to comply with the temperature control requirements adopted under Subsection (b).

(e) This section does not apply to a farmers' market in a county:

(1) that has a population of less than 50,000; and

(2) over which no local health department has jurisdiction.

Comments

Added by Acts 2011, 82nd Leg., R.S., Ch. 1317 (S.B. 81), Sec. 7, eff. September 1, 2011.

Amended by:

Acts 2013, 83rd Leg., R.S., Ch. 1275 (H.B. 1382), Sec. 4, eff. September 1, 2013.

Sec. 437.0203: Regulation of Cooking Demonstrations at Farmers' Markets

(a) In this section, "farmers' market" and "food" have the meanings assigned by Section 437.020.

(b) Except as provided by this section and Sections 437.020, 437.0201, and 437.0202:

(1) this chapter does not regulate cooking demonstrations at a farmers' market; and

(2) a rule adopted under state law may not regulate cooking demonstrations at a farmers' market.

(c) A person may conduct a cooking demonstration at a farmers' market only if:

(1) regardless of whether the demonstrator provides a sample of food to consumers, the farmers' market that hosts the demonstration:

(A) has an establishment operator with a valid certification under Subchapter D, Chapter 438, supervising the demonstration; and

(B) complies with Sections 437.020 and 437.0202, the requirements of a temporary food establishment under this chapter, and rules adopted under this chapter; and

(2) when the demonstrator provides a sample of food to consumers:

(A) the demonstrator provides a sample only and not a full serving; and

(B) samples of food prepared during a demonstration are disposed of not later than two hours after the beginning of the demonstration.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 1275 (H.B. 1382), Sec. 5, eff. September 1, 2013.

Sec. 437.021: Authority to Operate on Certain Property

A person operating a mobile food unit, roadside food vendor, or temporary food service establishment in a county with a population of more than 3.3 million shall acquire written authorization from the owner of the property on which the unit, vendor, or establishment is operating. The written authorization must:

(1) be notarized;

(2) provide that the operator has the property owner's permission to operate the unit, vendor, or establishment on the property; and

(3) be prominently displayed in the unit, vendor, or establishment in plain view of the public at all times.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 1402 (H.B. 3138), Sec. 2, eff. June 15, 2007.

Sec. 437.023: Service Animals

(a) A food service establishment, retail food store, or other entity regulated under this chapter may not deny a service animal admittance into an area of the establishment or store or of the physical space occupied by the entity that is open to customers and is not used to prepare food if:

(1) the service animal is accompanied and controlled by a person with a disability; or

(2) the service animal is in training and is accompanied and controlled by an approved trainer.

(b) If a service animal is accompanied by a person whose disability is not readily apparent, for purposes of admittance to a food service establishment, retail food store, or physical space occupied by another entity regulated under this chapter, a staff member of the establishment, store, or entity may only inquire about:

(1) whether the service animal is required because the person has a disability; and

(2) what type of work the service animal is trained to perform.

(c) In this section, "service animal" means a canine that is specially trained or equipped to help a person with a disability. An animal that provides only comfort or emotional support to a person is not a service animal under this section. The tasks that a service animal may perform in order to help a person with a disability must be directly related to the person's disability and may include:

(1) guiding a person who has a visual impairment;

(2) alerting a person who has a hearing impairment or who is deaf;

(3) pulling a wheelchair;

(4) alerting and protecting a person who has a seizure disorder;

(5) reminding a person who has a mental illness to take prescribed medication; and

(6) calming a person who has post-traumatic stress disorder.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 838 (H.B. 489), Sec. 1, eff. January 1, 2014.

Sec. 437.025: Requirements for Dogs in Outdoor Dining Areas; Municipal Preemption

(a) A food service establishment may permit a customer to be accompanied by a dog in an outdoor dining area if:

(1) the establishment posts a sign in a conspicuous location in the area stating that dogs are permitted;

(2) the customer and dog access the area directly from the exterior of the establishment;

(3) the dog does not enter the interior of the establishment;

(4) the customer keeps the dog on a leash and controls the dog;

(5) the customer does not allow the dog on a seat, table, countertop, or similar surface; and

(6) in the area, the establishment does not:

(A) prepare food; or

(B) permit open food other than food that is being served to a customer.

(b) A municipality may not adopt or enforce an ordinance, rule, or similar measure that imposes a requirement on a food service establishment for a dog in an outdoor dining area that is more stringent than the requirements described by Subsection (a).

(c) The requirements described by Subsection (a) do not apply to a service animal, as defined by Section 437.023(c).

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 423 (S.B. 476), Sec. 1, eff. September 1, 2019.

Chapter 438

Subchapter A

Sec. 438.001: Definitions

In this subchapter:

(1) "Gravity feed type container" means a self-service container in which food is dispensed by operating a mechanism that permits the food to drop into a receptacle.

(2) "Scoop utensil type container" means a self-service container from which food is dispensed by using a utensil provided with the container.

(3) "Unpackaged food" means food that is:

(A) not in individual packaging or wrapping;

(B) offered for sale by a retail food store; and

(C) sold in bulk from a container that permits a customer to dispense the food directly into a receptacle.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.002: Exemptions

This subchapter does not apply to:

(1) a beverage;

(2) fresh fruit or vegetables;

(3) food that is intended to be shelled or cooked before consumption; or

(4) food, such as milk products, eggs, meat, poultry, fish, or shellfish, that is capable of supporting rapid and progressive growth of infectious or toxic microorganisms.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.003: Sale from Self-Service Containers

(a) A person may sell unpackaged food that is displayed and sold in bulk from a self-service container if:

(1) the self-service container has a tight-fitting lid that is securely attached to the container; and

(2) the container, lid, and any utensil are constructed of nontoxic materials that provide for easy cleaning and proper repair.

(b) The lid of a gravity feed type container shall be kept closed except when the container is being serviced or refilled.

(c) The lid of a scoop utensil type container shall be kept closed except during customer service. The container must have a utensil, equipped with a handle, to be used in dispensing the food.

(d) The seller shall:

(1) keep the container, lid, and any utensil sanitary to prevent spoilage and insect infestation; and

(2) post in the immediate display area a conspicuous sign that instructs the customer on the proper procedure for dispensing the food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.004: Stricter Rules

(a) The executive commissioner by rule may establish requirements stricter than the requirements prescribed by Section 438.003 for the display and sale of unpackaged foods if the transmission of a disease infestation or contamination is directly related to a method of displaying and selling unpackaged food authorized by this subchapter.

(b) The stricter requirement must be:

(1) adopted according to laboratory evidence supporting the specific relationship between the disease infestation or contamination and the method of dispensing the unpackaged food; and

(2) applied uniformly to all nonexempted food sources and dispensing methods.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1130, eff. April 2, 2015.

Sec. 438.005: Sale of Unpackaged Food; Criminal Penalty

(a) A person commits an offense if the person knowingly or intentionally sells unpackaged food in a manner that does not comply with Section 438.003 or a rule adopted under Section 438.004.

(b) An offense under this section is a Class C misdemeanor.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.006: Effect on Other Laws

(a) This subchapter supersedes an ordinance or rule adopted by a political subdivision to regulate the method of dispensing unpackaged food.

(b) This subchapter does not affect an ordinance or rule adopted and enforced by a political subdivision to require the maintenance of sanitary conditions in the sale of unpackaged food dispensed in a manner authorized by this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter B

Sec. 438.011: Definitions

In this subchapter:

(1) "Dish" includes a vessel of any shape or size, made of any type of material, commonly used in eating or drinking.

(2) "Food factory" includes a place in which, as a business, food is manufactured or prepared for human consumption.

(3) "Receptacle" includes a vessel, tray, pot, pan, or other article used for holding food.

(4) "Utensil" includes a vessel or article of any shape or size, made of any material, commonly used in preparing, holding, storing, transporting, serving, or eating food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.012: Use of Unclean Dishes

A person who operates or manages a food factory may not use or keep for use a dish or utensil or a food-grinding machine or implement that after its previous use has not been cleaned in the manner required by Section 438.013(a).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.013: Cleaning Dishes, Receptacles, and Utensils

(a) A person who operates or manages a hotel, cafe, restaurant, dining car, drugstore, soda fountain, meat market, bakery, confectionery, liquor dispensary, or other establishment where food or drink is served to the public may not furnish to a person a dish, receptacle, or utensil that after its previous use has not been washed in warm water containing soap or alkali cleanser until the item is clean to the sight and touch.

(b) A dish or utensil that has been cleaned or polished with a poisonous substance may not be offered for use to a person or used in the manufacturing of food unless all traces of the poisonous substance have been removed from the dish or utensil.

Text of subsection effective until September 01, 2021

(c) In this section, "liquor dispensary" means a place where beer, ale, wine, or any other alcoholic beverage is stored, prepared, labeled, bottled, served, or handled.

Text of subsection effective on September 01, 2021

(c) In this section, "liquor dispensary" means a place where malt beverages, wine, or any other alcoholic beverage is stored, prepared, labeled, bottled, served, or handled.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 1359 (H.B. 1545), Sec. 393, eff. September 1, 2021.

Sec. 438.014: Sterilization of Food Service Items

(a) After cleaning dishes, receptacles, utensils, food-grinding machines, and implements as required by Section 438.012 or 438.013, the items shall be:

(1) placed in a wire cage and immersed in a still bath of clear water for at least:

(A) three minutes in water heated to a minimum temperature of 170 degrees Fahrenheit; or

(B) two minutes in water heated to a minimum temperature of 180 degrees Fahrenheit;

(2) immersed for at least two minutes in a lukewarm chlorine bath made up at a strength of 100 parts per milliliter or more of hypochlorites and not reduced to less than 50 parts per milliliter available chlorine, or a concentration of equal bacteriacidal strength if chloramines are used; or

(3) sterilized by any other chemical method approved by the department.

(b) A three-compartment vat shall be used to sterilize dishes, receptacles, and utensils if a chlorine solution is used. The first compartment of the vat shall be used for washing, the second compartment for plain rinsing, and the third compartment for chlorine immersion. A satisfactory rinsing or spraying device may be substituted for the second rinsing compartment on an existing installation.

(c) The same chlorine solution may not be used as bacteriacidal treatment for more than one day.

(d) After sterilization, all dishes, receptacles, and utensils shall be stored in a manner that protects the food service items from contaminants.

(e) Subsections (a)-(d) do not apply to an establishment that uses electrically operated dishwashing and glasswashing machines that clean and sterilize mechanically.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1131, eff. April 2, 2015.

Sec. 438.015: Use of Damaged Dishes, Receptacles, Or Utensils

A public eating or drinking establishment or a person who operates or manages a food factory may not use or keep for use a dish, receptacle, or utensil that is made or damaged in a manner that makes cleaning or sterilizing the item impossible or doubtful.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.016: Napkins

A napkin, cloth, or other article used by a person shall be laundered or sterilized before it is furnished for use to another person.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.017: Protection of Other Food Service Items

(a) A paper receptacle, ice cream cone, or other single service utensil to be used for serving food or drink shall be kept in a sanitary manner, protected from dust, flies, and other contaminants.

(b) A napkin, straw, toothpick, or other article may not be offered for the use of a person unless the article has been securely protected from dust, dirt, insects, rodents, and, as necessary and by all reasonable means, other contaminants.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.018: Criminal Penalty

(a) A person commits an offense if the person violates this subchapter.

(b) An offense under this subchapter is punishable by a fine of not less than $5 or more than $100.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter C

Sec. 438.031: Definition

In this subchapter, "food" includes simple, mixed, or compounded articles used for food, drink, flavoring, confectionery, and condiment for human consumption.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.032: Infected Persons; Food Handling Prohibited

(a) A person may not handle food, utensils, dishes, or serving implements that are for public sale or for the consumption or use by another if the person:

(1) is infected with a disease that is transmissible through the handling of food;

(2) resides in a household in which there is a transmissible case of a communicable disease that may be food borne;

(3) is known to be a carrier of the organisms causing a communicable disease that may be food borne; or

(4) has a local infection that is commonly transmitted through the handling of food.

(b) A person, firm, corporation, or organization operating or managing a public eating place or vehicle or other place where food is manufactured, processed, prepared, dispensed, or handled in a manner or under circumstances that would permit the probable transmission of disease from a handler to a consumer may not employ a person described in Subsection (a) to handle the food, utensils, dishes, or serving implements.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.033: Physical Examination; Doctor's Certificate

(a) On the request of an employer, the department or the department's representative, or the local health authority or the local health authority's representative, a person employed or seeking employment in an activity regulated under Section 438.032:

(1) shall be examined by a licensed physician; and

(2) must receive a certificate signed by the physician stating that the examination has been performed and that to the best of the physician's knowledge the person examined did not have on the date of the examination a transmissible condition of a communicable disease or a local infection commonly transmitted through the handling of food.

(b) The examination must be actual and thorough and conducted with practical scientific procedures to determine the existence of a communicable disease that may be transmitted through the handling of food.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1132, eff. April 2, 2015.

Sec. 438.034: Employee Cleanliness

(a) A person handling food or unsealed food containers shall:

(1) maintain personal cleanliness;

(2) wear clean outer garments;

(3) keep the person's hands clean; and

(4) wash the person's hands and exposed portions of the person's arms with soap and water:

(A) before starting work;

(B) during work as often as necessary to avoid cross-contaminating food; and

(C) to maintain cleanliness, after smoking, eating, and each visit to the toilet.

(b) A person handling food or unsealed food containers may not contact with bare hands exposed ready-to-eat food unless:

(1) documentation is maintained at the food service establishment listing the foods and food handling activities that involve bare-hand contact; and

(2) the food service establishment uses two or more of the following contamination control measures:

(A) requiring employees to perform double hand washing;

(B) requiring employees to use fingernail brushes while hand washing;

(C) requiring employees to use a hand sanitizer after hand washing;

(D) implementing an incentive program that encourages employees not to come to work when ill; and

(E) any other contamination control measure approved by the regulatory authority.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1997, 75th Leg., ch. 1068, Sec. 2, eff. Sept. 1, 1997.

Amended by:

Acts 2009, 81st Leg., R.S., Ch. 926 (H.B. 3012), Sec. 2, eff. September 1, 2009.

Sec. 438.035: Use of Unlaundered Towels

A person at a place where food for public consumption is handled or sold may not use a towel unless the towel has been thoroughly laundered after it has been previously used by another person.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.036: Criminal Penalty

(a) A person, firm, corporation, or organization commits an offense if the person, firm, corporation, or organization violates this subchapter.

(b) An offense under this section is punishable by a fine of not less than $10 or more than $200.

(c) Each day of a violation constitutes a separate offense.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.037: Municipal Ordinances

This subchapter does not affect the authority granted under Section 5, Article XI, Texas Constitution, Subchapter F of this chapter, and the applicable chapters of the Local Government Code to a Type A general-law municipality or a home-rule municipality to adopt an ordinance relating to this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 467 (H.B. 4170), Sec. 18.002(c), eff. September 1, 2019.

Subchapter D

Sec. 438.041: Definition

In this subchapter:

(1) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(80), eff. April 2, 2015.

(2) "Food handler" means a food service employee who works with unpackaged food, food equipment or utensils, or food-contact surfaces.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2007, 80th Leg., R.S., Ch. 1299 (S.B. 552), Sec. 1, eff. September 1, 2007.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(80), eff. April 2, 2015.

Sec. 438.042: Duties of Executive Commissioner

(a) The executive commissioner shall adopt standards and procedures for the accreditation of education and training programs for persons employed in the food service industry.

(b) The executive commissioner shall adopt standards and procedures for the accreditation of education and training programs for recertification of persons employed in the food service industry who have previously completed a program accredited in accordance with this subchapter or have been certified by a local health jurisdiction and have completed training and testing requirements substantially similar to those required by this subchapter for program accreditation. The requirements for accreditation in Section 438.043 need not be met by an education or training program for recertification.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 15, eff. Sept. 1, 1991; Acts 1991, 72nd Leg., ch. 885, Sec. 1, eff. Aug. 26, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1133, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1134, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1135, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(81), eff. April 2, 2015.

Sec. 438.043: Requirements for Accreditation

(a) The department may not accredit an education or training program unless the program includes:

(1) four hours of training on the subject of food, including:

(A) a description of food-borne disease and its cause and prevention; and

(B) protection of food in location, receipt, storage, preparation, service, and transportation;

(2) four hours of training on the subject of food service facilities, including:

(A) waste disposal and sanitary plumbing and water;

(B) cleaning and sanitization of dishes and utensils;

(C) storage of equipment and utensils;

(D) housekeeping procedures and schedules;

(E) proper handling of nonfood supplies, including single service items, linens, and toxic materials; and

(F) cleanliness of the physical plant, including building construction, ventilation, lighting, pest control, and general safety of the environment;

(3) two hours of training on the subject of sanitary habits for food handlers, including:

(A) personal hygiene, including proper dress, handwashing, personal habits, and illness;

(B) food handling practices, including minimum handling and proper use of food service utensils; and

(C) operational problems, including identification and correction of commonly occurring deficiencies; and

(4) four hours of training on the subject of management in the food service industry, including:

(A) self-inspection promotion and techniques;

(B) motivation, including safety, the economics of safe food handling, and planning to meet sanitation guidelines; and

(C) personnel training, including management responsibility, resources, and methods.

(b) In addition to the course requirements in Subsection (a), the department shall require that, to receive accreditation, a course include an examination of at least one hour to allow the instructor to evaluate the students' comprehension of the subject matter covered.

(c) The department shall ensure that each accredited program may be presented in not less than 15 hours.

(d) The course requirements in Subsection (a) do not apply to an education or training program for recertification.

(e) The department may modify the requirements of Subsection (a), (b), or (c) for a course used in training employees under the common control of a single entity.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 885, Sec. 2, eff. Aug. 26, 1991; Acts 1995, 74th Leg., ch. 822, Sec. 1, eff. Aug. 28, 1995.

Sec. 438.0431: Basic Food Safety Accreditation

(a) Notwithstanding Section 438.043, the department may accredit an education or training program for basic food safety for food handlers as provided by this section.

(b) The executive commissioner shall by rule define the basic food safety training or education required to be included in a course curriculum. The course length may not exceed two hours.

(c) A training or education program accredited under this section may require a participant to achieve a passing score on an examination to successfully complete the course for certification.

(d) A program accredited under this section may be delivered through the Internet.

Comments

Added by Acts 2007, 80th Leg., R.S., Ch. 1299 (S.B. 552), Sec. 2, eff. September 1, 2007.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1136, eff. April 2, 2015.

Sec. 438.044: Application for Accreditation

(a) A person seeking accreditation for an education or training program must apply to the department for accreditation. The applicant must demonstrate to the department the contents of the course.

(b) The department shall accredit a course that meets the minimum requirements of this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.045: Audit of Education and Training Programs

The department shall conduct a regular audit of each program accredited under this subchapter to ensure compliance with this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 438.046: List of Accredited Programs

(a) The department shall maintain a registry of course programs accredited under this subchapter.

(b) A food service worker trained in a course for the employees of a single entity is considered to have met a local health jurisdiction's training, testing, and permitting requirements only as to food service performed for that entity.

(b-1) A food service worker trained in a food handler training course that is accredited by the American National Standards Institute or that is accredited by the department and listed with the registry is considered to have met a local health jurisdiction's training, testing, and permitting requirements. A local health jurisdiction may require a food establishment, as that term is defined by Section 438.101, to maintain on the premises of the food establishment a certificate of completion of the training course for employees of the food establishment.

(c) A local health jurisdiction may not charge a fee or require or issue a local food handler card for a certificate issued to a food service worker who provides proof of completion of an accredited course described by Subsection (b-1).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 16, eff. Sept. 1, 1991; Acts 1995, 74th Leg., ch. 822, Sec. 2, eff. Aug. 28, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 843 (S.B. 582), Sec. 1, eff. June 17, 2015.

Acts 2017, 85th Leg., R.S., Ch. 728 (S.B. 1089), Sec. 1, eff. June 12, 2017.

Sec. 438.047: Fees

The department in accordance with department rules shall charge an application fee and an audit fee sufficient to cover the entire cost of accreditation, audit, and maintenance of the registry.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1137, eff. April 2, 2015.

Subchapter F

Sec. 438.061: Food Inspections By Type a General-Law Municipality

(a) The governing body of a Type A general-law municipality may regulate the inspection of beef, pork, flour, meal, salt, and other provisions.

(b) The governing body of a Type A general-law municipality may appoint weighers, gaugers, and inspectors, and may prescribe their duties and regulate their fees.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter G

Sec. 438.101: Definitions

In this subchapter:

(1) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(82), eff. April 2, 2015.

(2) "Food establishment" means a fixed or mobile location retail establishment in which food is prepared on-site for sale to the public.

(3) "Food manager" means an individual who conducts, manages, or operates a food establishment.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(82), eff. April 2, 2015.

Sec. 438.102: Certification Program

(a) The executive commissioner shall establish a certification program for food managers in accordance with this subchapter.

(b) The executive commissioner by rule shall prescribe the requirements for issuance and renewal of a food manager certificate under this subchapter.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1138, eff. April 2, 2015.

Sec. 438.103: Certification and Renewal of Certification; Examination Required

A person who satisfies the requirements of this subchapter may receive and renew a food manager certificate by passing a state-approved examination.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Sec. 438.104: Approval of Examinations; Selection of Examination Sites

(a) The executive commissioner shall adopt criteria to approve examinations.

(b) In administering this subchapter, the department shall consider the impact of the traveling distance and time required for a food manager to obtain certification. The department shall give particular consideration to mitigating the impact of this subchapter on food managers in rural areas. The department shall use the Internet to implement the certification and may develop a system to permit administration of the examination using the Internet.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1139, eff. April 2, 2015.

Sec. 438.105: Certificate As Evidence of Compliance with Other Law

A food manager certificate, including a renewal certificate, obtained under this subchapter shall be accepted as meeting the training and testing requirements under Section 438.046(b).

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Sec. 438.106: Powers and Duties of Executive Commissioner; Fees

(a) The executive commissioner by rule may adopt a fee for issuance or renewal of a food manager certificate under this subchapter in amounts reasonable and necessary to administer this subchapter, but not to exceed $35.

(b) The executive commissioner by rule may adopt a fee, in an amount not to exceed $10, for an examination administered by the department under this subchapter.

(c) The executive commissioner may adopt rules for the denial, suspension, and revocation of a food manager certificate issued under this subchapter.

(d) The executive commissioner by rule may prescribe standards for:

(1) examination sites;

(2) expenses of administration of examinations under this subchapter; and

(3) site audits for administration of this subchapter.

Comments

Added by Acts 2001, 77th Leg., ch. 317, Sec. 2, eff. Sept. 1, 2001.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1140, eff. April 2, 2015.

Subchapter H

Sec. 438.151: Definition

In this subchapter, "local health jurisdiction" means a public health district, county, or municipality that regulates food service establishments, retail food stores, mobile food units, temporary food service establishments, or roadside food vendors.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 2, eff. September 1, 2019.

Sec. 438.152: Request for Information

Unless otherwise prohibited by state or federal law, on receipt of a written request for information pertaining to the regulation of food under this subtitle, the department or a local health jurisdiction shall provide a reasonable and substantial response to the request not later than the 30th day after the date the department or local health jurisdiction receives the request.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 3, eff. September 1, 2019.

Sec. 438.153: Request for Official Determination

(a) On receipt of a written request regarding the applicability to a specific circumstance of a regulation or the requirements for compliance with the regulation, the department or local health jurisdiction shall provide an official written determination regarding the applicability of the regulation or the requirements for compliance with the regulation to the requestor not later than the 30th day after the date the department or local health jurisdiction receives the request.

(b) An official determination made under this section is valid until the regulation that is the subject of the determination is amended by statute, department rule, or local health jurisdiction regulation.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 309 (H.B. 2107), Sec. 4, eff. September 1, 2019.

Sec. 438.154: Effect of Official Determination

An inspector may not issue to a person a citation for a violation of a food regulation governed by this subtitle if the person provides the inspector with an official determination made under Section 438.153 that contradicts the opinion of the inspector.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.

Sec. 438.155: Rules

(a) The executive commissioner shall adopt rules to implement this subchapter.

(b) The executive commissioner periodically shall evaluate the department's food safety rules and modify the rules as necessary to improve consistency and communication in food regulation in this state.

Comments

Added by Acts 2013, 83rd Leg., R.S., Ch. 918 (H.B. 1392), Sec. 1, eff. September 1, 2013.

Chapter 439

Subchapter A

Sec. 439.001: Definition

In this chapter, "laetrile" means amygdalin.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.002: Manufacture and Sale

Unless prohibited by federal law, laetrile may be manufactured in this state in accordance with Chapter 431 (Texas Food, Drug, and Cosmetic Act) and may be sold in this state for distribution by licensed physicians.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1141, eff. April 2, 2015.

Sec. 439.003: Prescription and Administration

(a) Unless prohibited by federal law, a licensed physician may prescribe or administer laetrile in the treatment of cancer.

(b) A physician acting in accordance with federal and state law is not subject to disciplinary action by the Texas Medical Board for prescribing or administering laetrile to a patient under the physician's care who has requested the substance unless that board makes a formal finding that the substance is harmful.

(c) A finding under Subsection (b) must be made in a hearing conducted as provided by Chapter 2001, Government Code.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1142, eff. April 2, 2015.

Sec. 439.005: Records; Disciplinary Actions

(a) A physician shall keep records of the physician's purchases and disposals, including sales and dispensations, of laetrile. The records shall include the date of each purchase or disposal by the physician, the name and address of the person receiving laetrile, and the reason for the disposal of laetrile to that person.

(b) The Texas Medical Board may suspend, cancel, or revoke the license of any physician who:

(1) fails to keep complete and accurate records of purchases and disposals of laetrile;

(2) prescribes or dispenses laetrile to a person known to be a habitual user of narcotic or dangerous drugs or to a person who the physician should have known was a habitual user of narcotic or dangerous drugs;

(3) uses any advertising that tends to mislead or deceive the public; or

(4) is unable to practice medicine with reasonable skill and safety to patients because of any mental or physical condition, including age, illness, or drunkenness, or because of excessive use of drugs, narcotics, chemicals, or any other type of material.

(c) Subsection (b)(2) does not apply to a person being treated by the physician for narcotic use after the physician notifies the Texas Medical Board in writing of the name and address of the patient being treated.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1143, eff. April 2, 2015.

Subchapter B

Sec. 439.011: Definition

In this subchapter, "DMSO" means sterile and pyrogen-free dimethyl sulfoxide.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.012: Manufacture and Sale

DMSOmay be manufactured in this state and may be sold in this state for human use when prescribed or administered by a licensed physician or dispensed by a licensed pharmacist as prescribed by a licensed physician.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.013: Prescription, Administration, and Dispensation

(a) Except as prohibited by Subsection (b), a licensed physician may prescribe or administer DMSO.

(b) A physician may not prescribe or administer DMSO in a formulation not approved for human use by the Food and Drug Administration of the United States Department of Health and Human Services unless the physician:

(1) provides a written statement to the patient informing the patient that DMSO, in the formulation to be prescribed or administered, has not been approved for human use by the United States Food and Drug Administration; and

(2) informs the patient of the alternative methods of treatment for the patient's disorder and the potential of alternative methods for cure.

(c) A licensed pharmacist may dispense DMSO on the written prescription of a licensed physician.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.014: Regulation By Health Care Facility

(a) A hospital or health care facility may not forbid or restrict the use of DMSO prescribed or administered by a licensed physician having staff privileges at that hospital or facility unless the hospital or facility:

(1) makes a formal finding that the DMSO as prescribed or administered by the physician is or will be harmful to the patient; or

(2) determines that the prescription or administration of DMSO creates an immediate danger to the public.

(b) A hospital or health care facility that forbids or restricts the use of DMSO under Subsection (a)(2) shall conduct a hearing on the restriction or prohibition as soon as practicable after its determination.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.015: Records; Disciplinary Actions

(a) A physician shall keep records of the physician's purchases and disposals, including sales and dispensations, of DMSO. The records shall include the date of each purchase or disposal by the physician, the name and address of the person receiving DMSO, and the reason for the disposal of DMSO to that person.

(b) The Texas Medical Board may suspend, cancel, or revoke the license of any physician who:

(1) fails to keep complete and accurate records of purchases and disposals of DMSO in a formulation not approved for human use; or

(2) prescribes or administers DMSO in a manner that has been proven, in a formal hearing held by the board, to be harmful to the patient.

(c) The Texas Medical Board may temporarily suspend the license of a physician who prescribes or administers DMSO in a manner that, in the board's opinion, creates an immediate danger to the public. The board must conduct a hearing on the temporary suspension as soon as practicable after the suspension.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1144, eff. April 2, 2015.

Sec. 439.016: Misrepresentation; Criminal Penalty

(a) A person commits an offense if, in connection with advertising or promoting the sale of DMSO, the person knowingly or intentionally represents DMSO as a cure for any human disease, ailment, or disorder.

(b) An offense under this section is a Class B misdemeanor.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 439.017: Restrictions on Manufacture, Distribution, and Sale; Criminal Penalty

(a) A person commits an offense if the person manufactures, distributes, or sells a dimethyl sulfoxide formulation that is not sterile and pyrogen-free unless the substance is packaged in a container with a label that includes:

(1) information about the concentration of the dimethyl sulfoxide; and

(2) the following statement: "Avoid contact with your skin. This dimethyl sulfoxide is not sterile and pyrogen-free DMSO approved for human use. It may contain harmful impurities that can be absorbed through the skin. Dimethyl sulfoxide is a potent solvent that may have adverse effects on fabrics, plastics, and other materials."

(b) An offense under this section is a Class B misdemeanor.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Subchapter C

Sec. 439.021: Shipment to Foreign Countries

(a) A consulting pharmacist of a nursing home may select, from a supply of drugs due for destruction, certain drugs to be used for shipment to a foreign country as provided by this subchapter.

(b) The supply of drugs due for destruction are those drugs accumulated because of the death of a resident of the nursing home or because a physician has ordered the use of the drug to be discontinued.

(c) Quarterly, before the drugs are destroyed, the consulting pharmacist may, in the pharmacist's professional judgment, select the drugs to be used under this subchapter and seal them in a box for shipment.

(d) The consulting pharmacist shall account to the department for all drugs selected for shipment under this subchapter.

(e) This subchapter does not apply if the unused drug is a controlled substance as defined by Chapter 481 (Texas Controlled Substances Act).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1145, eff. April 2, 2015.

Sec. 439.022: Administration

(a) The executive commissioner shall adopt rules consistent with federal and state law to implement this subchapter, including rules relating to:

(1) the packaging and inventory of drugs for shipment;

(2) the manner of shipment of the drugs from original shipment under this subchapter until the final destination; and

(3) safeguards to ensure the proper handling of and accounting for all drugs shipped.

(b) The executive commissioner by rule shall determine, in consultation with the United States Department of State and other appropriate federal agencies, the foreign countries to receive the drugs.

(c) The salvaging of drugs under this subchapter is not subject to Chapter 431 (Texas Food, Drug, and Cosmetic Act).

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1146, eff. April 2, 2015.

Sec. 439.023: Contracts; Funds

(a) The department may contract with other entities, including local governments and civic organizations, to implement this subchapter.

(b) The department may accept gifts, grants, and any other funds to implement this subchapter.

Comments

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1147, eff. April 2, 2015.

Chapter 440

Subchapter A

Sec. 440.001: Short Title

This chapter may be cited as the Frozen Desserts Manufacturer Licensing Act.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.002: Purpose

The legislature finds that a statewide licensing act is needed to:

(1) regulate manufacturers of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products;

(2) provide for uniformity of inspections of the premises of frozen dessert manufacturers;

(3) protect the health and safety of consumers by preventing the manufacture or distribution of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products that do not meet state standards or related requirements of purity or labeling; and

(4) assist manufacturers in meeting state standards or related requirements.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.003: Definitions

In this Act:

(1) "Adulterated or misbranded frozen desserts mix" means any frozen dessert or mix that contains an unwholesome substance or, if defined in this standard, that does not conform with its definition or that does not comply with Chapter 431 (Texas Food, Drug, and Cosmetic Act) or any other applicable regulation.

(2) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(85), eff. April 2, 2015.

(3) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(85), eff. April 2, 2015.

(4) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(85), eff. April 2, 2015.

(5) "Frozen dessert" means any of the following: ice cream, ice milk, fruit sherbet, water ice, nonfruit sherbet, nonfruit water ice, frozen dietary dairy desserts, frozen yogurt, quiescently frozen confection, quiescently frozen dairy confection, mellorine, lorine, parevine, freezer-made milk shake, freezer-made shake, or nondairy frozen dessert. The term includes the mix used in the freezing of one of those frozen desserts.

(6) "Frozen desserts manufacturer" means a person who manufactures, processes, converts, partially freezes, or freezes any mix (regardless of whether it is dairy, nondairy, imitation, pasteurized or unpasteurized), frozen desserts, imitation frozen desserts, or nondairy frozen desserts for distribution or sale at wholesale. The term does not include a frozen desserts retail establishment.

(7) "Frozen desserts plant" means premises where a frozen dessert or mix is manufactured, processed, or frozen for sale.

(8) "Frozen desserts retail establishment" means premises, including a retail store, approved type stand, hotel, restaurant, vehicle, or mobile unit, where frozen dessert mixes are frozen or partially frozen and dispensed for retail sale or distribution.

(9) "Health authority" means the department, the municipal or county health officer or the officer's representative, or any other agency having jurisdiction or control over the matters embraced within the specifications and requirements of this chapter.

(10) "Imitation frozen dessert" means any frozen substance, mixture, or compound, regardless of the name under which it is represented, that is made in imitation or semblance of any of the following products or is prepared or frozen in the manner in which any of the following products is customarily prepared or frozen and that is not the product: ice cream, ice milk, fruit sherbet, water ice, nonfruit sherbet, nonfruit ice, frozen low fat yogurt, nonfat yogurt, frozen yogurt, quiescently frozen confection, quiescently frozen dairy confection, mellorine, lorine, parevine, freezer-made milk shake, freezer-made shake, or nondairy frozen dessert.

(11) "Manufacture" means the processing, freezing, or packaging of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products for sale at wholesale. The term does not include a retailer purchasing those products from a manufacturer displaying the retailer's brand name.

(12) "Mix" means the pasteurized or unpasteurized, liquid or dry, unfrozen combination of the ingredients permitted in a frozen dessert with or without fruits, fruit juices, candy, baked goods and confections, nutmeats, or other harmless flavor or color.

(13) "Official laboratory" means a biological, chemical, or physical laboratory that is under the supervision of a state or local health authority.

(14) "Sale" means the:

(A) manufacture, production, processing, packing, exposure, offer, or holding of any frozen dessert product for sale;

(B) sale, dispensing, or giving of any frozen dessert product; or

(C) supplying or applying of any frozen dessert product in the conduct of any frozen desserts retail establishment.

(15) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(85), eff. April 2, 2015.

(16) "Wholesale" means the exposing, offering, possessing, selling, dispensing, holding, or giving of any frozen dessert, imitation frozen dessert, product sold in semblance of frozen dessert, or a mix for one of those products to other than the ultimate consumer. The term does not include sale by a retail store.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1148, eff. April 2, 2015.

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1639(85), eff. April 2, 2015.

Sec. 440.004: Exemptions

This chapter does not apply to:

(1) a person operating a frozen desserts retail establishment; or

(2) a person operating a retail store unless the person is also a manufacturer.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.005: Hearings

A hearing conducted in the administration of this chapter is governed by Chapter 2001, Government Code.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1149, eff. April 2, 2015.

Sec. 440.006: Powers of Executive Commissioner

The executive commissioner may:

(1) adopt rules prescribing standards or related requirements for the operation of establishments for the manufacture of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products, including standards or requirements for the:

(A) health, cleanliness, education, and training of personnel who are employed in the establishments;

(B) protection of raw materials, manufactured merchandise, and merchandise held for sale;

(C) design, construction, installation, and cleanliness of equipment and utensils;

(D) sanitary facilities and controls of the establishments;

(E) establishment construction and maintenance, including vehicles;

(F) production processes and controls; and

(G) institution and content of a system of records to be maintained by the establishment; and

(2) adopt rules prescribing procedures for the enforcement of the standards or related requirements prescribed under Subdivision (1), including procedures for the:

(A) requirement of a valid license to operate an establishment;

(B) issuance, suspension, revocation, and reinstatement of licenses;

(C) administrative hearings held under this chapter;

(D) institution of certain court proceedings by the department or its designee;

(E) inspection of establishments and securing of samples of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or mixes for those products;

(F) access to the establishments and to the vehicles used in operations;

(G) compliance by manufacturers outside the jurisdiction of the state; and

(H) review of plans for future construction.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1150, eff. April 2, 2015.

Sec. 440.007: Applicability of Other Law

Except as provided by Section 431.009(c), Chapter 431 applies to a person or product regulated under this chapter, including a frozen dessert manufacturer, a frozen dessert, an imitation frozen dessert, a product sold in semblance of a frozen dessert, and a mix for one of those products.

Comments

Added by Acts 2003, 78th Leg., ch. 112, Sec. 3, eff. Sept. 1, 2003.

Subchapter B

Sec. 440.011: Prohibited Act

(a) A person may not operate an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products in this state unless the person has a valid license issued under this chapter.

(b) A political subdivision or agency of the state, other than the department, may not impose a license fee on any manufacturer covered by this section.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.012: License

(a) A person desiring to operate an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products may apply to the department for a license. A license shall be granted under the department's procedural rules and shall be issued only for the purpose and use as stated on the application for a license.

(b) The department shall inspect the establishment under Section 440.031 before issuing a license.

(c) A license may not be issued to a person who does not comply with the standards prescribed by department rule under this chapter.

(d) A license issued under this chapter must be renewed every two years in accordance with department rules.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1151, eff. April 2, 2015.

Sec. 440.013: Fees

(a) A nonrefundable fee for each establishment in an amount set by the executive commissioner by rule as prescribed by Section 12.0111 must accompany each application for a license.

(b) The department also shall assess the following fees in the amounts set by the executive commissioner by rule as prescribed by Section 12.0111:

(1) a fee for a frozen dessert manufacturer located in this state in an amount per 100 pounds of manufactured or processed frozen dessert manufactured or processed and distributed in this state by that manufacturer;

(2) a fee for a frozen dessert manufacturer not located in this state in an amount per 100 pounds of frozen desserts manufactured or processed by the manufacturer in another state and imported for sale in this state; and

(3) a fee for the actual cost of analyzing samples of frozen desserts for a frozen dessert manufacturer not located in this state.

(c) The executive commissioner shall adopt rules to collect fees imposed under this section monthly based on amounts due by the frozen dessert manufacturer.

(d) The department may revoke a license to operate a frozen desserts plant if the licensee fails to make a timely payment of the monthly fees required under this section. The department's rules of procedure for a contested case hearing and Chapter 2001, Government Code govern the revocation of a license.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff. Sept. 1, 1995.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1152, eff. April 2, 2015.

Sec. 440.014: Recordkeeping

The executive commissioner shall adopt rules establishing minimum standards for recordkeeping by persons required to pay fees under this chapter and the records shall be made available to the department on request.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1153, eff. April 2, 2015.

Sec. 440.015: Establishments Outside State

A frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products from a manufacturer located outside this state may be sold or distributed in this state if the manufacturer complies with this chapter or complies with other regulatory requirements that are substantially equivalent to those of this state. To determine the extent of the manufacturer's compliance, the department may accept reports from responsible authorities in the jurisdiction in which the manufacturer is located.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.016: Temporary Permit

The department may issue a temporary permit to continue the operation of an establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or mix for one of those products until the department performs the inspection required by this chapter.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991.

Sec. 440.017: Refusal to Grant License; Suspension Or Revocation of License

In accordance with rules adopted under Section 440.006, the department may refuse an application for a license under this chapter or may suspend or revoke a license issued under this chapter.

Comments

Added by Acts 2003, 78th Leg., ch. 112, Sec. 4, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1154, eff. April 2, 2015.

Subchapter C

Sec. 440.031: Inspection By Department

(a) Under rules adopted by the executive commissioner, the department's authorized representatives have free access at all reasonable hours to any establishment for the manufacture of a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products or to any vehicle being used to transport in commerce a frozen dessert, imitation frozen dessert, product sold in semblance of a frozen dessert, or a mix for one of those products for the purpose of:

(1) inspecting the establishment or vehicle to determine compliance with the standards or related requirements prescribed under this chapter; or

(2) securing samples of frozen desserts, imitation frozen desserts, products sold in semblance of frozen desserts, or a mix for one of those products for the purpose of making or causing to be made an examination of the samples to determine compliance with the standards or related requirements prescribed under this chapter.

(b) A political subdivision or an agency other than the department that collects samples described by Subsection (a)(2) shall bear the cost of the samples and any analyses of the samples.

(c) The inspection procedures provided by this section are in addition to the procedures provided by Chapter 431.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991. Amended by Acts 2003, 78th Leg., ch. 112, Sec. 5, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1155, eff. April 2, 2015.

Sec. 440.032: Penalties

(a) A person commits an offense if the person knowingly or intentionally violates Section 440.011 or a rule adopted under this chapter.

(b) An offense under this section is a Class C misdemeanor.

(c) The penalty prescribed by this section is in addition to any civil or administrative penalty or sanction otherwise imposed under Chapter 431 or other law.

Comments

Added by Acts 1991, 72nd Leg., ch. 14, Sec. 167, eff. Sept. 1, 1991. Amended by Acts 2003, 78th Leg., ch. 112, Sec. 6, eff. Sept. 1, 2003.

Amended by:

Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1156, eff. April 2, 2015.

Chapter 441

Subchapter A

Sec. 441.0001: Definitions

In this chapter:

(1) "Animal health product" means a medical product approved and licensed for use in animal or veterinary medicine, including a pharmaceutical, a biologic, an insecticide, and a parasiticide.

(2) "Pharmaceutical drug manufacturer" means a person engaged in the business of producing, preparing, propagating, compounding, converting, processing, packaging, labeling, or distributing a drug. The term does not include a wholesale distributor or retailer of prescription drugs or a pharmacist licensed under Subtitle J, Title 3, Occupations Code.

(3) "Prescription drug" and "drug" have the meanings assigned by Section 551.003, Occupations Code, except that the term "prescription drug" does not include a device or an animal health product.

(4) "Wholesale acquisition cost" means, with respect to a drug, the pharmaceutical drug manufacturer's list price for the drug charged to wholesalers or direct purchasers in the United States, as reported in wholesale price guides or other publications of drug pricing data. The cost does not include any rebates, prompt pay or other discounts, or other reductions in price.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.

Sec. 441.0002: Disclosure of Drug Pricing Information

(a) Not later than the 15th day of each calendar year, a pharmaceutical drug manufacturer shall submit a report to the executive commissioner stating the current wholesale acquisition cost information for the United States Food and Drug Administration-approved drugs sold in or into this state by that manufacturer.

(b) The executive commissioner shall develop an Internet website to provide to the general public drug price information submitted under Subsection (a). The Internet website shall be made available on the Health and Human Services Commission's Internet website with a dedicated link that is prominently displayed on the home page or by a separate easily identifiable Internet address.

(c) This subsection applies only to a drug with a wholesale acquisition cost of at least $100 for a 30-day supply before the effective date of an increase described by this subsection. Not later than the 30th day after the effective date of an increase of 40 percent or more over the preceding three calendar years or 15 percent or more in the preceding calendar year in the wholesale acquisition cost of a drug to which this subsection applies, a pharmaceutical drug manufacturer shall submit a report to the executive commissioner. The report must include the following information:

(1) the name of the drug;

(2) whether the drug is a brand name or generic;

(3) the effective date of the change in wholesale acquisition cost;

(4) aggregate, company-level research and development costs for the most recent year for which final audit data is available;

(5) the name of each of the manufacturer's prescription drugs approved by the United States Food and Drug Administration in the previous three calendar years;

(6) the name of each of the manufacturer's prescription drugs that lost patent exclusivity in the United States in the previous three calendar years; and

(7) a statement regarding the factor or factors that caused the increase in the wholesale acquisition cost and an explanation of the role of each factor's impact on the cost.

(d) The quality and types of information and data that a pharmaceutical drug manufacturer submits to the executive commissioner under Subsection (c) must be consistent with the quality and types of information and data that the manufacturer includes in the manufacturer's annual consolidated report on Securities and Exchange Commission Form 10-K or any other public disclosure.

(e) Not later than the 60th day after receipt of the report submitted under Subsection (c), the executive commissioner shall publish the report on the Health and Human Services Commission's Internet website described by Subsection (b).

(f) The executive commissioner may adopt rules to implement this section.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 1291 (H.B. 2536), Sec. 1, eff. September 1, 2019.

Chapter 442

Subchapter A

Sec. 442.001: Definitions

In this chapter:

(1) "Donor" means an individual who donates unused prescription drugs under this chapter to a participating provider.

(2) "Health care facility" means a facility that provides health care services to patients and maintains a pharmacy in the facility. The term includes the following facilities if a pharmacy is maintained in the facility:

(A) a general or special hospital as defined by Chapter 241;

(B) an ambulatory surgical center licensed under Chapter 243; and

(C) an institution licensed under Chapter 242.

(3) "Health care professional" means an individual licensed, certified, or otherwise authorized to administer health care and prescribe prescription drugs, for profit or otherwise, in the ordinary course of business or professional practice. The term does not include a health care facility.

(4) "Participating provider" means a health care facility or pharmacy, or a pharmacist who is an employee of the facility or pharmacy, that elects to participate in the collection and redistribution of donated prescription drugs under this chapter.

(5) "Pharmacist" means a person licensed under Chapter 558, Occupations Code.

(6) "Pharmacy" means an entity licensed under Chapter 560, Occupations Code.

(7) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.

(8) "Recipient" means an individual who voluntarily receives donated prescription drugs under this chapter.

(9) "Tamper-evident" means packaging that allows for detection of unauthorized access to a prescription drug.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.002: Rulemaking Authority

The executive commissioner may adopt rules to implement this chapter.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.003: Construction with Other Law

This chapter does not limit the authority of this state or a political subdivision of this state to regulate or prohibit a prescription drug.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Subchapter B

Sec. 442.051: Donation and Redistribution of Prescription Drugs

(a) A donor may donate unused prescription drugs to a participating provider in accordance with this chapter and rules adopted under this chapter.

(b) A participating provider may dispense donated prescription drugs to a recipient in accordance with this chapter and rules adopted under this chapter.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.052: Standards for Donation and Redistribution

(a) The executive commissioner by rule shall adopt standards and procedures for:

(1) accepting, storing, labeling, and dispensing donated prescription drugs; and

(2) inspecting donated prescription drugs to determine whether the drugs are adulterated and whether the drugs are safe and suitable for redistribution.

(b) In adopting standards and procedures under this section, the executive commissioner shall ensure that the donation and redistribution process is consistent with public health and safety standards.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.053: Requirements for Donated Prescription Drugs

(a) A donated prescription drug may be accepted or dispensed under this chapter only if the drug is in its original, unopened, sealed, and tamper-evident unit-dose packaging. A drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single unit-dose packaging is unopened.

(b) A donated prescription drug may not be accepted or dispensed under this chapter if:

(1) the drug is a controlled substance;

(2) the drug is adulterated or misbranded;

(3) the drug is not stored in compliance with the drug's product label; or

(4) the United States Food and Drug Administration requires the drug to have a risk evaluation or mitigation strategy.

(c) A participating provider shall comply with all applicable provisions of state and federal law relating to the inspection, storage, labeling, and dispensing of prescription drugs.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.054: Donation Process

(a) Before being dispensed to a recipient, a prescription drug donated under this chapter must be inspected by the participating provider in accordance with federal law, laws of this state, and department rule to determine whether the drug is adulterated or misbranded and whether the drug has been stored in compliance with the requirements of the product label.

(b) A donated prescription drug dispensed to a recipient under this chapter must be prescribed by a health care professional for use by the recipient.

(c) A participating provider may charge a handling fee not to exceed $20 to a recipient to cover the costs of inspecting, storing, labeling, and dispensing the donated prescription drug. A participating provider may not resell a prescription drug donated under this chapter. A donor may not sell a prescription drug to a participating provider.

(d) A participating provider may not submit a claim or otherwise seek reimbursement from any public or private third-party payor for donated prescription drugs dispensed to a recipient under this chapter. A public or private third-party payor is not required to provide reimbursement for donated drugs dispensed to a recipient under this chapter.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.055: Donor Form

Before donating a prescription drug under this chapter, a donor shall sign a form prescribed by the department stating that:

(1) the donor is the owner of the donated prescription drug;

(2) the donated prescription drug has been properly stored and the container has not been opened or tampered with;

(3) the donated prescription drug has not been adulterated or misbranded; and

(4) the donor is voluntarily donating the prescription drug.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.056: Recipient Form

Before accepting a donated prescription drug under this chapter, a recipient shall sign a form prescribed by the department stating that:

(1) the recipient acknowledges that the donor is not a pharmacist and the donor took ordinary care of the prescription drug;

(2) the recipient acknowledges that the donor is known to the participating provider and that there is no reason to believe that the prescription drug was improperly handled or stored;

(3) by accepting the prescription drug, the recipient accepts any risk that an accidental mishandling could create; and

(4) the recipient releases the donor, participating provider, and manufacturer of the drug from liability related to the prescription drug.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.057: Limitation of Liability

(a) A donor or participating provider who acts in good faith in donating, accepting, storing, labeling, distributing, or dispensing prescription drugs under this chapter:

(1) is not criminally liable and is not subject to professional disciplinary action for those activities; and

(2) is not civilly liable for damages for bodily injury, death, or property damage that arises from those activities unless the injury, death, or damage arises from the donor or participating provider's recklessness or intentional conduct.

(b) A manufacturer of a prescription drug that donates a drug under this chapter is not, in the absence of bad faith, criminally or civilly liable for bodily injury, death, or property damage arising from the donation, acceptance, or dispensing of the drug, including the manufacturer's failure to communicate to a donor or other person:

(1) product or consumer information about the donated prescription drug; or

(2) the expiration date of the donated prescription drug.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Sec. 442.058: Database of Participating Providers

The department shall establish and maintain an electronic database that lists each participating provider. The department shall post the database on its Internet website.

Comments

Added by Acts 2017, 85th Leg., R.S., Ch. 485 (H.B. 2561), Sec. 7(a), eff. September 1, 2017.

Chapter 443

Subchapter A

Sec. 443.001: Definitions

In this chapter:

(1) "Consumable hemp product" means food, a drug, a device, or a cosmetic, as those terms are defined by Section 431.002, that contains hemp or one or more hemp-derived cannabinoids, including cannabidiol.

(2) "Department" means the Department of State Health Services.

(3) "Establishment" means each location where a person processes hemp or manufactures a consumable hemp product.

(4) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission.

(5) "Hemp" has the meaning assigned by Section 121.001, Agriculture Code.

(6) "License" means a consumable hemp product manufacturer's license issued under this chapter.

(7) "License holder" means an individual or business entity holding a license.

(8) "Manufacture" has the meaning assigned by Section 431.002.

(9) "Process" means to extract a component of hemp, including cannabidiol or another cannabinoid, that is:

(A) sold as a consumable hemp product;

(B) offered for sale as a consumable hemp product;

(C) incorporated into a consumable hemp product; or

(D) intended to be incorporated into a consumable hemp product.

(10) "QR code" means a quick response machine-readable code that can be read by a camera, consisting of an array of black and white squares used for storing information or directing or leading a user to additional information.

(11) "Smoking" means burning or igniting a substance and inhaling the smoke or heating a substance and inhaling the resulting vapor or aerosol.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.002: Applicability of Other Law

Except as provided by Section 431.011(c), Chapter 431 applies to a license holder and a consumable hemp product regulated under this chapter.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.003: Local Regulation Prohibited

A municipality, county, or other political subdivision of this state may not enact, adopt, or enforce a rule, ordinance, order, resolution, or other regulation that prohibits the processing of hemp or the manufacturing or sale of a consumable hemp product as authorized by this chapter.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.004: Severability

(a) A provision of this chapter or its application to any person or circumstance is invalid if the secretary of the United States Department of Agriculture determines that the provision or application conflicts with 7 U.S.C. Chapter 38, Subchapter VII, and prevents the approval of the state plan submitted under Chapter 121, Agriculture Code.

(b) The invalidity of a provision or application under Subsection (a) does not affect the other provisions or applications of this chapter that can be given effect without the invalid provision or application, and to this end the provisions of this chapter are declared to be severable.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Subchapter B

Sec. 443.051: Rulemaking Authority of Executive Commissioner

The executive commissioner shall adopt rules and procedures necessary to administer and enforce this chapter. Rules and procedures adopted under this section must be consistent with:

(1) an approved state plan submitted to the United States Department of Agriculture under Chapter 121, Agriculture Code; and

(2) 7 U.S.C. Chapter 38, Subchapter VII, and federal regulations adopted under that subchapter.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Subchapter C

Sec. 443.101: License Required; Exceptions

A person may not process hemp or manufacture a consumable hemp product in this state unless the person holds a license under this subchapter.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.102: License Ineligibility

(a) An individual who is or has been convicted of a felony relating to a controlled substance under federal law or the law of any state may not, before the 10th anniversary of the date of the conviction:

(1) hold a license under this subchapter; or

(2) be a governing person of an establishment that holds a license under this subchapter.

(b) The department may not issue a license under this subchapter to a person who materially falsifies any information contained in an application submitted to the department under Section 443.103.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.103: Application; Issuance

An individual or establishment may apply for a license under this subchapter by submitting an application to the department on a form and in the manner prescribed by the department. The application must be accompanied by:

(1) a legal description of each location where the applicant intends to process hemp or manufacture consumable hemp products and the global positioning system coordinates for the perimeter of each location;

(2) written consent from the applicant or the property owner if the applicant is not the property owner allowing the department, the Department of Public Safety, and any other state or local law enforcement agency to enter onto all premises where hemp is processed or consumable hemp products are manufactured to conduct a physical inspection or to ensure compliance with this chapter and rules adopted under this chapter;

(3) any fees required by the department to be submitted with the application; and

(4) any other information required by department rule.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.104: Term; Renewal

(a) A license is valid for one year and may be renewed as provided by this section.

(b) The department shall renew a license if the license holder:

(1) is not ineligible to hold the license under Section 443.102;

(2) submits to the department any license renewal fee; and

(3) does not owe any outstanding fees to the department.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.105: Revocation

The department shall revoke a license if the license holder is convicted of a felony relating to a controlled substance under federal law or the law of any state.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Subchapter D

Sec. 443.151: Testing Required

(a) A consumable hemp product must be tested as provided by:

(1) Subsections (b) and (c); or

(2) Subsection (d).

(b) Before a hemp plant is processed or otherwise used in the manufacture of a consumable hemp product, a sample representing the plant must be tested, as required by the executive commissioner, to determine:

(1) the concentration of various cannabinoids; and

(2) the presence or quantity of heavy metals, pesticides, and any other substance prescribed by the department.

(c) Before material extracted from hemp by processing is sold as, offered for sale as, or incorporated into a consumable hemp product, the material must be tested, as required by the executive commissioner, to determine:

(1) the presence of harmful microorganisms; and

(2) the presence or quantity of:

(A) any residual solvents used in processing, if applicable; and

(B) any other substance prescribed by the department.

(d) Except as otherwise provided by Subsection (e), before a consumable hemp product is sold at retail or otherwise introduced into commerce in this state, a sample representing the hemp product must be tested:

(1) by a laboratory that is accredited by an accreditation body in accordance with International Organization for Standardization ISO/IEC 17025 or a comparable or successor standard to determine the delta-9 tetrahydrocannabinol concentration of the product; and

(2) by an appropriate laboratory to determine that the product does not contain a substance described by Subsection (b) or (c) in a quantity prohibited for purposes of those subsections.

(e) A consumable hemp product is not required to be tested under Subsection (d) if each hemp-derived ingredient of the product:

(1) has been tested in accordance with:

(A) Subsections (b) and (c); or

(B) Subsection (d); and

(2) does not have a delta-9 tetrahydrocannabinol concentration of more than 0.3 percent.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.152: Provisions Related to Testing

(a) A consumable hemp product that has a delta-9 tetrahydrocannabinol concentration of more than 0.3 percent may not be sold at retail or otherwise introduced into commerce in this state.

(b) A person licensed under Chapter 122, Agriculture Code, shall provide to a license holder who is processing hemp harvested by the person or otherwise using that hemp to manufacture a consumable hemp product the results of a test conducted under that chapter, if available, as proof that the delta-9 tetrahydrocannabinol concentration of the hemp does not exceed 0.3 percent, including for purposes of Section 443.151(b)(1).

(c) A license holder shall make available to a seller of a consumable hemp product processed or manufactured by the license holder the results of testing required by Section 443.151. The results may accompany a shipment to the seller or be made available to the seller electronically. If the results are not able to be made available, the seller may have the testing required under Section 443.151 performed on the product and shall make the results available to a consumer.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Subchapter E

Sec. 443.201: Possession, Transportation, and Sale of Consumable Hemp Products

(a) A person may possess, transport, sell, or purchase a consumable hemp product processed or manufactured in compliance with this chapter.

(b) The executive commissioner by rule must provide to a retailer of consumable hemp products fair notice of a potential violation concerning consumable hemp products sold by the retailer and an opportunity to cure a violation made unintentionally or negligently.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.202: Regulation of Certain Cannabinoid Oils

(a) This section does not apply to low-THC cannabis regulated under Chapter 487.

(b) Notwithstanding any other law, a person may not sell, offer for sale, possess, distribute, or transport a cannabinoid oil, including cannabidiol oil, in this state:

(1) if the oil contains any material extracted or derived from the plant Cannabis sativa L., other than from hemp produced in compliance with 7 U.S.C. Chapter 38, Subchapter VII; and

(2) unless a sample representing the oil has been tested by a laboratory that is accredited by an independent accreditation body in accordance with International Organization for Standardization ISO/IEC 17025 or a comparable or successor standard and found to have a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent.

(c) The department and the Department of Public Safety shall establish a process for the random testing of cannabinoid oil, including cannabidiol oil, at various retail and other establishments that sell, offer for sale, distribute, or use the oil to ensure that the oil:

(1) does not contain harmful ingredients;

(2) is produced in compliance with 7 U.S.C. Chapter 38, Subchapter VII; and

(3) has a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.2025: Registration Required for Retailers of Certain Products

(a) This section does not apply to low-THC cannabis regulated under Chapter 487.

(b) A person may not sell consumable hemp products containing cannabidiol at retail in this state unless the person registers with the department each location owned, operated, or controlled by the person at which those products are sold. A person is not required to register a location associated with an employee or independent contractor described by Subsection (d).

(c) The department may issue a single registration under Subsection (b) covering multiple locations owned, operated, or controlled by a person.

(d) A person is not required to register with the department under Subsection (b) if the person is:

(1) an employee of a registrant; or

(2) an independent contractor of a registrant who sells the registrant's products at retail.

(e) A registration is valid for one year and may be renewed as prescribed by department rule.

(f) The department by rule may adopt a registration fee schedule that establishes reasonable fee amounts for the registration of:

(1) a single location at which consumable hemp products containing cannabidiol are sold; and

(2) multiple locations at which consumable hemp products containing cannabidiol are sold under a single registration.

(g) The department shall adopt rules to implement and administer this section.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.203: Deceptive Trade Practice

(a) A person who sells, offers for sale, or distributes a cannabinoid oil, including cannabidiol oil, that the person claims is processed or manufactured in compliance with this chapter commits a false, misleading, or deceptive act or practice actionable under Subchapter E, Chapter 17, Business & Commerce Code, if the oil is not processed or manufactured in accordance with this chapter.

(b) A person who sells, offers for sale, or distributes a cannabinoid oil commits a false, misleading, or deceptive act or practice actionable under Subchapter E, Chapter 17, Business & Commerce Code, if the oil:

(1) contains harmful ingredients;

(2) is not produced in compliance with 7 U.S.C. Chapter 38, Subchapter VII; or

(3) has a delta-9 tetrahydrocannabinol concentration of more than 0.3 percent.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.204: Rules Related to Sale of Consumable Hemp Products

Rules adopted by the executive commissioner regulating the sale of consumable hemp products must to the extent allowable by federal law reflect the following principles:

(1) hemp-derived cannabinoids, including cannabidiol, are not considered controlled substances or adulterants;

(2) products containing one or more hemp-derived cannabinoids, such as cannabidiol, intended for ingestion are considered foods, not controlled substances or adulterated products;

(3) consumable hemp products must be packaged and labeled in the manner provided by Section 443.205; and

(4) the processing or manufacturing of a consumable hemp product for smoking is prohibited.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.205: Packaging and Labeling Requirements

(a) Before a consumable hemp product that contains or is marketed as containing more than trace amounts of cannabinoids may be distributed or sold, the product must be labeled in the manner provided by this section with the following information:

(1) batch identification number;

(2) batch date;

(3) product name;

(4) a uniform resource locator (URL) that provides or links to a certificate of analysis for the product or each hemp-derived ingredient of the product;

(5) the name of the product's manufacturer; and

(6) a certification that the delta-9 tetrahydrocannabinol concentration of the product or each hemp-derived ingredient of the product is not more than 0.3 percent.

(b) The label required by Subsection (a) may be in the form of:

(1) a uniform resource locator (URL) for the manufacturer's Internet website that provides or links to the information required by that subsection; and

(2) a QR code or other bar code that may be scanned and that leads to the information required by that subsection.

(c) The label required by Subsection (a) must appear on each unit of the product intended for individual retail sale. If that unit includes inner and outer packaging, the label may appear on any of that packaging.

(d) This section does not apply to sterilized seeds incapable of beginning germination.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.206: Retail Sale of Out-of-State Consumable Hemp Products

Retail sales of consumable hemp products processed or manufactured outside of this state may be made in this state when the products were processed or manufactured in another state or jurisdiction in compliance with:

(1) that state or jurisdiction's plan approved by the United States Department of Agriculture under 7 U.S.C. Section 1639p;

(2) a plan established under 7 U.S.C. Section 1639q if that plan applies to the state or jurisdiction; or

(3) the laws of that state or jurisdiction if the products are tested in accordance with, or in a manner similar to, Section 443.151.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.

Sec. 443.207: Transportation and Exportation of Consumable Hemp Products Out of State

Consumable hemp products may be legally transported across state lines and exported to foreign jurisdictions in a manner that is consistent with federal law and the laws of respective foreign jurisdictions.

Comments

Added by Acts 2019, 86th Leg., R.S., Ch. 764 (H.B. 1325), Sec. 7, eff. June 10, 2019.