Texas 2025 - 89th Regular

Texas Senate Bill SB261 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	By: Perry, et al. S.B. No. 261
2		-	(In the Senate - Filed November 12, 2024; February 3, 2025,
3		-	read first time and referred to Committee on Water, Agriculture and
4		-	Rural Affairs; April 1, 2025, reported adversely, with favorable
5		-	Committee Substitute by the following vote: Yeas 8, Nays 1;
6		-	April 1, 2025, sent to printer.)
7		-	Click here to see the committee vote
8		-	COMMITTEE SUBSTITUTE FOR S.B. No. 261 By: Perry
	1	+	89R4500 SRA-F
	2	+	By: Perry S.B. No. 261
	3	+
	4	+
9	5
10	6
11	7		A BILL TO BE ENTITLED
12	8		AN ACT
13	9		relating to the prohibited manufacture, processing, possession,
14		-	distribution, ~~offering~~ for sale, and sale of cell-cultured protein.
	10	+	distribution, offer for sale, and sale of cell-cultured protein.
15	11		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
16	12		SECTION 1. Section 431.002, Health and Safety Code, is
17	13		amended by adding Subdivision (5-a) to read as follows:
18	14		(5-a) "Cell-cultured protein" means a food product
19	15		derived from harvesting animal cells and artificially replicating
20	16		those cells in a growth medium to produce tissue.
21	17		SECTION 2. Section 431.021, Health and Safety Code, is
22	18		amended to read as follows:
23	19		Sec. 431.021. PROHIBITED ACTS. The following acts and the
24	20		causing of the following acts within this state are unlawful and
25	21		prohibited:
26	22		(a) the introduction or delivery for introduction into
27	23		commerce of any food, drug, device, or cosmetic that is adulterated
28	24		or misbranded;
29	25		(b) the adulteration or misbranding of any food, drug,
30	26		device, or cosmetic in commerce;
31	27		(c) the receipt in commerce of any food, drug, device, or
32	28		cosmetic that is adulterated or misbranded, and the delivery or
33	29		proffered delivery thereof for pay or otherwise;
34	30		(d) the distribution in commerce of a consumer commodity, if
35	31		such commodity is contained in a package, or if there is affixed to
36	32		that commodity a label that does not conform to the provisions of
37	33		this chapter and of rules adopted under the authority of this
38	34		chapter; provided, however, that this prohibition shall not apply
39	35		to persons engaged in business as wholesale or retail distributors
40	36		of consumer commodities except to the extent that such persons:
41	37		(1) are engaged in the packaging or labeling of such
42	38		commodities; or
43	39		(2) prescribe or specify by any means the manner in
44	40		which such commodities are packaged or labeled;
45	41		(e) the introduction or delivery for introduction into
46	42		commerce of any article in violation of Section 431.084, 431.114,
47	43		or 431.115;
48	44		(f) the dissemination of any false advertisement;
49	45		(g) the refusal to permit entry or inspection, or to permit
50	46		the taking of a sample or to permit access to or copying of any
51	47		record as authorized by Sections 431.042-431.044; or the failure to
52	48		establish or maintain any record or make any report required under
53	49		Section 512(j), (l), or (m) of the federal Act, or the refusal to
54	50		permit access to or verification or copying of any such required
55	51		record;
56	52		(h) the manufacture within this state of any food, drug,
57	53		device, or cosmetic that is adulterated or misbranded;
58	54		(i) the giving of a guaranty or undertaking referred to in
59	55		Section 431.059, which guaranty or undertaking is false, except by
60	56		a person who relied on a guaranty or undertaking to the same effect
61	57		signed by, and containing the name and address of the person
62	58		residing in this state from whom the person received in good faith
63	59		the food, drug, device, or cosmetic; or the giving of a guaranty or
64	60		undertaking referred to in Section 431.059, which guaranty or
65	61		undertaking is false;
66	62		(j) the use, removal, or disposal of a detained or embargoed
67	63		article in violation of Section 431.048;
68	64		(k) the alteration, mutilation, destruction, obliteration,
69	65		or removal of the whole or any part of the labeling of, or the doing
70	66		of any other act with respect to a food, drug, device, or cosmetic,
71	67		if such act is done while such article is held for sale after
72	68		shipment in commerce and results in such article being adulterated
73	69		or misbranded;
74	70		(l)(1) forging, counterfeiting, simulating, or falsely
75	71		representing, or without proper authority using any mark, stamp,
76	72		tag, label, or other identification device authorized or required
77	73		by rules adopted under this chapter or the regulations promulgated
78	74		under the provisions of the federal Act;
79	75		(2) making, selling, disposing of, or keeping in
80	76		possession, control, or custody, or concealing any punch, die,
81	77		plate, stone, or other thing designed to print, imprint, or
82	78		reproduce the trademark, trade name, or other identifying mark,
83	79		imprint, or device of another or any likeness of any of the
84	80		foregoing on any drug or container or labeling thereof so as to
85	81		render such drug a counterfeit drug;
86	82		(3) the doing of any act that causes a drug to be a
87	83		counterfeit drug, or the sale or dispensing, or the holding for sale
88	84		or dispensing, of a counterfeit drug;
89	85		(m) the using by any person to the person's own advantage,
90	86		or revealing, other than to the department, to a health authority,
91	87		or to the courts when relevant in any judicial proceeding under this
92	88		chapter, of any information acquired under the authority of this
93	89		chapter concerning any method or process that as a trade secret is
94	90		entitled to protection;
95	91		(n) the using, on the labeling of any drug or device or in
96	92		any advertising relating to such drug or device, of any
97	93		representation or suggestion that approval of an application with
98	94		respect to such drug or device is in effect under Section 431.114 or
99	95		Section 505, 515, or 520(g) of the federal Act, as the case may be,
100	96		or that such drug or device complies with the provisions of such
101	97		sections;
102	98		(o) the using, in labeling, advertising or other sales
103	99		promotion of any reference to any report or analysis furnished in
104	100		compliance with Sections 431.042-431.044 or Section 704 of the
105	101		federal Act;
106	102		(p) in the case of a prescription drug distributed or
107	103		offered for sale in this state, the failure of the manufacturer,
108	104		packer, or distributor of the drug to maintain for transmittal, or
109	105		to transmit, to any practitioner licensed by applicable law to
110	106		administer such drug who makes written request for information as
111	107		to such drug, true and correct copies of all printed matter that is
112	108		required to be included in any package in which that drug is
113	109		distributed or sold, or such other printed matter as is approved
114	110		under the federal Act. Nothing in this subsection shall be
115	111		construed to exempt any person from any labeling requirement
116	112		imposed by or under other provisions of this chapter;
117	113		(q)(1) placing or causing to be placed on any drug or device
118	114		or container of any drug or device, with intent to defraud, the
119	115		trade name or other identifying mark, or imprint of another or any
120	116		likeness of any of the foregoing;
121	117		(2) selling, dispensing, disposing of or causing to be
122	118		sold, dispensed, or disposed of, or concealing or keeping in
123	119		possession, control, or custody, with intent to sell, dispense, or
124	120		dispose of, any drug, device, or any container of any drug or
125	121		device, with knowledge that the trade name or other identifying
126	122		mark or imprint of another or any likeness of any of the foregoing
127	123		has been placed thereon in a manner prohibited by Subdivision (1);
128	124		or
129	125		(3) making, selling, disposing of, causing to be made,
130	126		sold, or disposed of, keeping in possession, control, or custody,
131	127		or concealing with intent to defraud any punch, die, plate, stone,
132	128		or other thing designed to print, imprint, or reproduce the
133	129		trademark, trade name, or other identifying mark, imprint, or
134	130		device of another or any likeness of any of the foregoing on any
135	131		drug or container or labeling of any drug or container so as to
136	132		render such drug a counterfeit drug;
137	133		(r) dispensing or causing to be dispensed a different drug
138	134		in place of the drug ordered or prescribed without the express
139	135		permission in each case of the person ordering or prescribing;
140	136		(s) the failure to register in accordance with Section 510
141	137		of the federal Act, the failure to provide any information required
142	138		by Section 510(j) or (k) of the federal Act, or the failure to
143	139		provide a notice required by Section 510(j)(2) of the federal Act;
144	140		(t)(1) the failure or refusal to:
145	141		(A) comply with any requirement prescribed under
146	142		Section 518 or 520(g) of the federal Act; or
147	143		(B) furnish any notification or other material or
148	144		information required by or under Section 519 or 520(g) of the
149	145		federal Act;
150	146		(2) with respect to any device, the submission of any
151	147		report that is required by or under this chapter that is false or
152	148		misleading in any material respect;
153	149		(u) the movement of a device in violation of an order under
154	150		Section 304(g) of the federal Act or the removal or alteration of
155	151		any mark or label required by the order to identify the device as
156	152		detained;
157	153		(v) the failure to provide the notice required by Section
158	154		412(b) or 412(c), the failure to make the reports required by
159	155		Section 412(d)(1)(B), or the failure to meet the requirements
160	156		prescribed under Section 412(d)(2) of the federal Act;
161	157		(w) except as provided under Subchapter M of this chapter
162	158		and Section 562.1085, Occupations Code, the acceptance by a person
163	159		of an unused prescription or drug, in whole or in part, for the
164	160		purpose of resale, after the prescription or drug has been
165	161		originally dispensed, or sold;
166	162		(x) engaging in the wholesale distribution of drugs or
167	163		operating as a distributor or manufacturer of devices in this state
168	164		without obtaining a license issued by the department under
169	165		Subchapter I, L, or N, as applicable;
170	166		(y) engaging in the manufacture of food in this state or
171	167		operating as a warehouse operator in this state without having a
172	168		license as required by Section 431.222 or operating as a food
173	169		wholesaler in this state without having a license under Section
174	170		431.222 or being registered under Section 431.2211, as appropriate;
175	171		(z) unless approved by the United States Food and Drug
176	172		Administration pursuant to the federal Act, the sale, delivery,
177	173		holding, or offering for sale of a self-testing kit designed to
178	174		indicate whether a person has a human immunodeficiency virus
179	175		infection, acquired immune deficiency syndrome, or a related
180	176		disorder or condition;
181	177		(aa) making a false statement or false representation in an
182	178		application for a license or in a statement, report, or other
183	179		instrument to be filed with or requested by the department under
184	180		this chapter;
185	181		(bb) failing to comply with a requirement or request to
186	182		provide information or failing to submit an application, statement,
187	183		report, or other instrument required by the department;
188	184		(cc) performing, causing the performance of, or aiding and
189	185		abetting the performance of an act described by Subsection (x);
190	186		(dd) purchasing or otherwise receiving a prescription drug
191	187		from a pharmacy in violation of Section 431.411(a);
192	188		(ee) selling, distributing, or transferring a prescription
193	189		drug to a person who is not authorized under state or federal law to
194	190		receive the prescription drug in violation of Section 431.411(b);
195	191		(ff) failing to deliver prescription drugs to specified
196	192		premises as required by Section 431.411(c);
197	193		(gg) failing to maintain or provide pedigrees as required by
198	194		Section 431.412 or 431.413;
199	195		(hh) failing to obtain, pass, or authenticate a pedigree as
200	196		required by Section 431.412 or 431.413;
201	197		(ii) the introduction or delivery for introduction into
202	198		commerce of a drug or prescription device at a flea market;
203	199		(jj) the receipt of a prescription drug that is adulterated,
204	200		misbranded, stolen, obtained by fraud or deceit, counterfeit, or
205	201		suspected of being counterfeit, and the delivery or proffered
206	202		delivery of such a drug for payment or otherwise; [or]
207	203		(kk) the alteration, mutilation, destruction,
208	204		obliteration, or removal of all or any part of the labeling of a
209	205		prescription drug or the commission of any other act with respect to
210	206		a prescription drug that results in the prescription drug being
211	207		misbranded; or
212	208		(ll) the manufacture, processing, possession,
213		-	distribution, offering for sale, or sale of cell-cultured protein.
214		-	SECTION 3. Section 431.0211, Health and Safety Code, is
215		-	amended to read as follows:
216		-	Sec. 431.0211. EXCEPTIONS [EXCEPTION]. (a) Any provision
217		-	of Section 431.021 that relates to a prescription drug does not
218		-	apply to a prescription drug manufacturer, or an agent of a
219		-	prescription drug manufacturer, who is obtaining or attempting to
220		-	obtain a prescription drug for the sole purpose of testing the
221		-	prescription drug for authenticity.
222		-	(b) Section 431.021(ll) does not apply to scientific
223		-	research using or regarding cell-cultured protein conducted by or
224		-	at an institution of higher education or a private or independent
225		-	institution of higher education, as those terms are defined by
226		-	Section 61.003, Education Code, provided that the research does not
227		-	further or relate to the sale or distribution of cell-cultured
228		-	protein for human consumption in this state.
229		-	SECTION 4. Sections 431.0805(4), (5), (6), (7), (8), (9),
230		-	and (10), Health and Safety Code, are amended to read as follows:
231		-	(4) "Egg" has the meaning assigned by Section 4(g),
232		-	Egg Products Inspection Act (21 U.S.C. Section 1033(g)). The term
233		-	does not include an analogue product or [a] cell-cultured protein
234		-	[product].
235		-	(5) "Egg product" has the meaning assigned by Section
236		-	4(f), Egg Products Inspection Act (21 U.S.C. Section 1033(f)). The
237		-	term does not include an analogue product or [a] cell-cultured
238		-	protein [product].
239		-	(6) "Fish" has the meaning assigned by Section 403 of
240		-	the federal Act (21 U.S.C. Section 343(q)(4)(E)). The term does not
241		-	include an analogue product or [a] cell-cultured protein [product].
242		-	(7) "Meat" has the meaning assigned by 9 C.F.R.
243		-	Section 301.2. The term does not include an analogue product or [a]
244		-	cell-cultured protein [product].
245		-	(8) "Meat food product" has the meaning assigned by
246		-	Section 1(j), Federal Meat Inspection Act (21 U.S.C. Section
247		-	601(j)). The term does not include an analogue product or [a]
248		-	cell-cultured protein [product].
249		-	(9) "Poultry" has the meaning assigned by Section
250		-	4(e), Poultry Products Inspection Act (21 U.S.C. Section 453(e)).
251		-	The term does not include an analogue product or [a] cell-cultured
252		-	protein [product].
253		-	(10) "Poultry product" has the meaning assigned by
254		-	Section 4(f), Poultry Products Inspection Act (21 U.S.C. Section
255		-	453(f)). The term does not include an analogue product or [a]
256		-	cell-cultured protein [product].
257		-	SECTION 5. Section 431.081, Health and Safety Code, is
	209	+	distribution, offer for sale, or sale of cell-cultured protein.
	210	+	SECTION 3. Section 431.081, Health and Safety Code, is
258	211		amended to read as follows:
259	212		Sec. 431.081. ADULTERATED FOOD. A food shall be deemed to
260	213		be adulterated:
261	214		(a) if:
262	215		(1) it bears or contains any poisonous or deleterious
263	216		substance which may render it injurious to health; but in case the
264	217		substance is not an added substance the food shall not be considered
265	218		adulterated under this subdivision if the quantity of the substance
266	219		in the food does not ordinarily render it injurious to health;
267	220		(2) it:
268	221		(A) bears or contains any added poisonous or
269	222		added deleterious substance, other than one that is a pesticide
270	223		chemical in or on a raw agricultural commodity, a food additive, a
271	224		color additive, or a new animal drug which is unsafe within the
272	225		meaning of Section 431.161;
273	226		(B) is a raw agricultural commodity and it bears
274	227		or contains a pesticide chemical which is unsafe within the meaning
275	228		of Section 431.161(a);
276	229		(C) is, or it bears or contains, any food
277	230		additive which is unsafe within the meaning of Section 431.161(a);
278	231		provided, that where a pesticide chemical has been used in or on a
279	232		raw agricultural commodity in conformity with an exemption granted
280	233		or a tolerance prescribed under Section 431.161(a), and such raw
281	234		agricultural commodity has been subjected to processing such as
282	235		canning, cooking, freezing, dehydrating, or milling, the residue of
283	236		such pesticide chemical remaining in or on such processed food
284	237		shall, notwithstanding the provisions of Section 431.161 and
285	238		Section 409 of the federal Act, not be deemed unsafe if such residue
286	239		in or on the raw agricultural commodity has been removed to the
287	240		extent possible in good manufacturing practice, and the
288	241		concentration of such residue in the processed food, when ready to
289	242		eat, is not greater than the tolerance prescribed for the raw
290	243		agricultural commodity; or
291	244		(D) is, or it bears or contains, a new animal
292	245		drug, or a conversion product of a new animal drug, that is unsafe
293	246		under Section 512 of the federal Act;
294	247		(3) it consists in whole or in part of a diseased,
295	248		contaminated, filthy, putrid, or decomposed substance, or if it is
296	249		otherwise unfit for foods;
297	250		(4) it has been produced, prepared, packed or held
298	251		under unsanitary conditions whereby it may have become contaminated
299	252		with filth, or whereby it may have been rendered diseased,
300	253		unwholesome, or injurious to health;
301	254		(5) it is, in whole or in part, the product of a
302	255		diseased animal, an animal which has died otherwise than by
303	256		slaughter, or an animal that has been fed upon the uncooked offal
304	257		from a slaughterhouse;
305	258		(6) its container is composed, in whole or in part, of
306	259		any poisonous or deleterious substance which may render the
307	260		contents injurious to health; [or]
308	261		(7) it has been intentionally subjected to radiation,
309	262		unless the use of the radiation was in conformity with a regulation
310	263		or exemption in effect in accordance with Section 409 of the federal
311	264		Act; or
312	265		(8) it contains, in whole or in part, cell-cultured
313	266		protein;
314	267		(b) if:
315	268		(1) any valuable constituent has been in whole or in
316	269		part omitted or abstracted therefrom;
317	270		(2) any substance has been substituted wholly or in
318	271		part therefor;
319	272		(3) damage or inferiority has been concealed in any
320	273		manner;
321	274		(4) any substance has been added thereto or mixed or
322	275		packed therewith so as to increase its bulk or weight, or reduce its
323	276		quality or strength or make it appear better or of greater value
324	277		than it is;
325	278		(5) it contains saccharin, dulcin, glucin, or other
326	279		sugar substitutes except in dietary foods, and when so used shall be
327	280		declared; or
328	281		(6) it be fresh meat and it contains any chemical
329	282		substance containing sulphites, sulphur dioxide, or any other
330	283		chemical preservative which is not approved by the United States
331	284		Department of Agriculture, the Animal and Plant Health Inspection
332	285		Service (A.P.H.I.S.) or by department rules;
333	286		(c) if it is, or it bears or contains, a color additive that
334	287		is unsafe under Section 431.161(a); or
335	288		(d) if it is confectionery and:
336	289		(1) has any nonnutritive object partially or
337	290		completely imbedded in it; provided, that this subdivision does not
338	291		apply if, in accordance with department rules, the object is of
339	292		practical, functional value to the confectionery product and would
340	293		not render the product injurious or hazardous to health;
341	294		(2) bears or contains any alcohol, other than alcohol
342	295		not in excess of five percent by volume. Any confectionery that
343	296		bears or contains any alcohol in excess of one-half of one percent
344	297		by volume derived solely from the use of flavoring extracts and less
345	298		than five percent by volume:
346	299		(A) may not be sold to persons under the legal age
347	300		necessary to consume an alcoholic beverage in this state;
348	301		(B) must be labeled with a conspicuous, readily
349	302		legible statement that reads, "Sale of this product to a person
350	303		under the legal age necessary to consume an alcoholic beverage is
351	304		prohibited";
352	305		(C) may not be sold in a form containing liquid
353	306		alcohol such that it is capable of use for beverage purposes as that
354	307		term is used in the Alcoholic Beverage Code;
355	308		(D) may not be sold through a vending machine;
356	309		(E) must be labeled with a conspicuous, readily
357	310		legible statement that the product contains not more than five
358	311		percent alcohol by volume; and
359	312		(F) may not be sold in a business establishment
360	313		which derives less than 50 percent of its gross sales from the sale
361	314		of confectioneries; or
362	315		(3) bears or contains any nonnutritive substance;
363	316		provided, that this subdivision does not apply to a nonnutritive
364	317		substance that is in or on the confectionery by reason of its use
365	318		for a practical, functional purpose in the manufacture, packaging,
366	319		or storage of the confectionery if the use of the substance does not
367	320		promote deception of the consumer or otherwise result in
368	321		adulteration or misbranding in violation of this chapter; and
369	322		provided further, that the executive commissioner may, for the
370	323		purpose of avoiding or resolving uncertainty as to the application
371	324		of this subdivision, adopt rules allowing or prohibiting the use of
372	325		particular nonnutritive substances.
373		-	SECTION 6. Section 433.0415, Health and Safety Code, is
374		-	amended to read as follows:
375		-	Sec. 433.0415. LABELING CELL-CULTURED PROTEIN [PRODUCT].
376		-	(a) In this section:
377		-	(1) "Cell-cultured protein [product]" has the meaning
378		-	assigned by Section 431.002 [431.0805].
379		-	(2) "Close proximity" means:
380		-	(A) immediately before or after the name of the
381		-	product;
382		-	(B) in the line of the label immediately before
383		-	or after the line containing the name of the product; or
384		-	(C) within the same phrase or sentence containing
385		-	the name of the product.
386		-	(b) Cell-cultured protein [A cell-cultured product] must be
387		-	labeled in prominent type equal to or greater in size than the
388		-	surrounding type and in close proximity to the name of the protein
389		-	[product] using one of the following:
390		-	(1) "cell-cultured";
391		-	(2) "lab-grown"; or
392		-	(3) a similar qualifying term or disclaimer intended
393		-	to clearly communicate to a consumer the contents of the protein
394		-	[product].
395		-	(c) The provisions of this subchapter apply to [a]
396		-	cell-cultured protein [product], as applicable.
397		-	SECTION 7. Subchapter D, Chapter 433, Health and Safety
	326	+	SECTION 4. Subchapter D, Chapter 433, Health and Safety
398	327		Code, is amended by adding Section 433.057 to read as follows:
399	328		Sec. 433.057. PROHIBITION ON CELL-CULTURED PROTEIN. (a)
400	329		In this section, "cell-cultured protein" has the meaning assigned
401	330		by Section 431.002.
402	331		(b) A person may not manufacture, process, possess,
403	332		distribute, offer for sale, or sell cell-cultured protein.
404		-	(c) This section does not prohibit scientific research
405		-	using or regarding cell-cultured protein conducted by or at an
406		-	institution of higher education or a private or independent
407		-	institution of higher education, as those terms are defined by
408		-	Section 61.003, Education Code, provided that the research does not
409		-	further or relate to the sale or distribution of cell-cultured
410		-	protein for human consumption in this state.
411		-	(d) To the extent another state law conflicts with this
	333	+	(c) To the extent another state law conflicts with this
412	334		section, this section controls.
413		-	SECTION 8. Section 431.0805(2), Health and Safety Code, is
414		-	repealed.
415		-	SECTION 9. As soon as practicable after the effective date
	335	+	SECTION 5. As soon as practicable after the effective date
416	336		of this Act, the executive commissioner of the Health and Human
417	337		Services Commission shall adopt any rules necessary to implement
418	338		the changes in law made by this Act.
419		-	SECTION 10. This Act takes effect September 1, 2025.
420		-	* * * * *
	339	+	SECTION 6. This Act takes effect September 1, 2025.