SECOND REGULAR SESSION

HOUSE BILL NO. 2617 103RD GENERAL ASSEMBLY

INTRODUCED BY REPRESENTATIVE GRAGG.

6095H.01I JOSEPH ENGLER, Chief Clerk

AN ACT To repeal sections 196.010, 196.045, and 196.050, RSMo, and to enact in lieu thereof four new sections relating to cultivated meat, with penalty provisions.

Be it enacted by the General Assembly of the state of Missouri, as follows:

Section A. Sections 196.010, 196.045, and 196.050, RSMo, are repealed and four 2 new sections enacted in lieu thereof, to be known as sections 196.010, 196.016, 196.045, and 3 196.050, to read as follows: 196.010. 1. For the purpose of sections 196.010 to 196.120: 2 (1) The term "cultivated meat" means any edible product that: 3 (a) Is or is intended to be consumed as animal muscle, fat, connective tissue, or 4 other meat tissue; and 5 (b) Is produced by the in vitro cultivation or propagation of animal cells outside 6 of a living animal through the use of scaffolding materials, growth factors, or other 7 substances or through any other process. 8 9 The term "cultivated meat" includes, but is not limited to, products derived from 10 livestock, poultry, game animals, fish, or any other animal traditionally raised for food; 11 (2) The term "contaminated with filth" applies to any food, drug, device, or cosmetic 12 not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, 13 from all foreign or injurious contaminations; 14 [(2)] (3) The term "cosmetic" means articles intended to be rubbed, poured, sprinkled, 15 or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for 16 cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles

EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language. HB 2617 2

17 intended for use as a component of any such articles, except that such term shall not include 18 soap; 19 [(3)] (4) The term "device" except when used in subsection 2 of this section and in 20 sections 196.015(10), 196.075(6), 196.100(3) and 196.115(3), means instruments, apparatus, 21 and contrivances, including their components, parts, and accessories, intended for use in the 22 diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or to 23 affect the structure or any function of the body of man or other animals; 24 [(4)] (5) The term "department" shall be construed to mean the department of health 25 and senior services; 26 [(5)] (6) The term "drug" means (a) articles recognized in the official United States 27 Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official 28 National Formulary, or any supplement to any of them; and (b) articles intended for use in the 29 diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and 30 (c) articles, other than food, intended to affect the structure or any function of the body of man 31 or other animals; and (d) articles intended for use as a component of any articles specified in 32 clause (a), (b), or (c); but does not include devices or their components, parts or accessories; 33 [(6)] (7) The term "federal act" means the Federal Food, Drug and Cosmetic Act 34 (Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.); 35 [(7)] (8) The term "food" means articles used for food or drink for man or other 36 animals, chewing gum, and articles used for components of any such article; 37 [(8)] (9) The term "immediate container" does not include package liners; 38 [(9)] (10) The term "label" means a display of written, printed, or graphic matter upon 39 the immediate container of any article; and a requirement made by or under authority of 40 sections 196.010 to 196.120 that any word, statement, or other information appearing on the 41 label shall not be considered to be complied with unless such word, statement, or other 42 information also appears on the outside container or wrapper, if any there be, of the retail 43 package of such article, or is easily legible through the outside container or wrapper; 44 [(10)] (11) The term "labeling" means all labels and other written, printed, or graphic 45 matter upon any article or any of its containers or wrappers, or accompanying such article; 46 [(11)] (12) The term "new drug" means any drug the composition of which is such 47 that such drug is not generally recognized, among experts qualified by scientific training and 48 experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, 49 recommended or suggested in the labeling thereof; or any drug the composition of which is 50 such that such drug, as a result of investigations to determine its safety for use under such 51 conditions, has become so recognized, but which has not, otherwise than in such 52 investigations, been used to a material extent or for a material time under such conditions; HB 2617 3

53 [(12)] (13) The term "official compendium" means the official United States 54 Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National 55 Formulary, or any supplement to any of them; 56 [(13)] (14) The term "person" includes individual, partnership, corporation, and 57 association. 58 2. If an article is alleged to be misbranded because the labeling is misleading, then in 59 determining whether the labeling is misleading, there shall be taken into account, among 60 other things, not only representations made or suggested by statement, word, design, device, 61 sound, or in any combination thereof, but also the extent to which the labeling fails to reveal 62 facts material in the light of such representations or material with respect to consequences 63 which may result from the use of the article to which the labeling relates under the conditions 64 of use prescribed in the labeling thereof or under such conditions of use as are customary or 65 usual. 66 3. The representation of a drug, in its labeling, as an antiseptic shall be considered to 67 be a representation that it is a germicide, except in the case of a drug purporting to be, or 68 represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or 69 such other use as involves prolonged contact with the body. 70 4. The provisions of sections 196.010 to 196.120 regarding the selling of food, drugs, 71 devices, or cosmetics, shall be considered to include the manufacture, production, processing, 72 packing, exposure, offer, possession, and holding of any such article for sale and the sale, 73 dispensing, and giving of any such article, and the supplying of any such articles in the 74 conduct of any food, drug, or cosmetic establishment. 196.016. 1. A person shall not knowingly manufacture, sell, offer for sale, hold 2 for sale, deliver, or distribute cultivated meat within this state. 3 2. Any person who violates this section shall be guilty of a class C misdemeanor 4 for the first offense and a class A misdemeanor for any subsequent offense. Each day of 5 violation shall constitute a separate offense. 196.045. 1. The authority to promulgate regulations for the efficient enforcement of 2 sections 196.010 to 196.120 is hereby vested in the department of health and senior services. 3 The department shall make the regulations promulgated under said sections conform, insofar 4 as practicable, with those promulgated under the federal act. 5 2. Hearings authorized or required by sections 196.010 to 196.120 shall be conducted 6 by the department of health and senior services or such officer, agent, or employee as the 7 department may designate for the purpose. 8 3. The department of health and senior services, in coordination with the 9 department of agriculture, shall enforce section 196.016 and may promulgate rules for 10 the implementation and administration of section 196.016. The rules promulgated in HB 2617 4

11 accordance with this subsection may impose requirements that are not imposed under 12 federal law, and compliance with section 196.016 shall be required regardless of whether 13 the federal act or the rules promulgated under the federal act impose such 14 requirements. 15 4. Regulations shall be promulgated pursuant to the requirements of this section and 16 chapter 536. No rule or portion of a rule promulgated under the authority of this chapter shall 17 become effective unless it has been promulgated pursuant to the provisions of section 18 536.024. 196.050. Except as otherwise provided in section 196.045, in no event shall the said 2 department of health and senior services prescribe or promulgate any regulation fixing or 3 establishing any definitions or standards which are more rigid or more stringent than those 4 prescribed by the federal act applying to any commodity covered by sections 196.010 to 5 196.120 and if any product or commodity covered by said sections shall comply with the 6 definitions and standards prescribed by the federal act for such product or commodity, such 7 product or commodity shall be deemed in all respects to comply with sections 196.010 to 8 196.120. ✔

Statutes affected:
Introduced (6095H.01): 196.010, 196.016, 196.045, 196.050