bill banning cell-cultured protein in Texas

The text as introduced · 2,982 words

89R4500 SRA-F

By: Gerdes
H.B. No. 1431

A BILL TO BE ENTITLED

AN ACT

relating to the prohibited manufacture, processing, possession,

distribution, offer for sale, and sale of cell-cultured protein.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Section 431.002, Health and Safety Code, is

amended by adding Subdivision (5-a) to read as follows:

(5-a) "Cell-cultured protein" means a food product

derived from harvesting animal cells and artificially replicating

those cells in a growth medium to produce tissue.

SECTION 2. Section 431.021, Health and Safety Code, is

amended to read as follows:

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 ; or

(ll) the manufacture, processing, possession,

distribution, offer for sale, or sale of cell-cultured protein .

SECTION 3. Section 431.081, Health and Safety Code, is

amended to read as follows:

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; or

(8) it contains, in whole or in part, cell-cultured

protein;

(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.

SECTION 4. Subchapter D, Chapter 433, Health and Safety

Code, is amended by adding Section 433.057 to read as follows:

Sec. 433.057. PROHIBITION ON CELL-CULTURED PROTEIN. (a)

In this section, "cell-cultured protein" has the meaning assigned

by Section 431.002.

(b) A person may not manufacture, process, possess,

distribute, offer for sale, or sell cell-cultured protein.

(c) To the extent another state law conflicts with this

section, this section controls.

SECTION 5. As soon as practicable after the effective date

of this Act, the executive commissioner of the Health and Human

Services Commission shall adopt any rules necessary to implement

the changes in law made by this Act.

SECTION 6. This Act takes effect September 1, 2025.