I 

116TH CONGRESS 

2D SESSION H. R. 5728 

To provide for the regulation, inspection, and labeling of food produced 

using animal cell culture technology, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 30, 2020 

Mr. JOHNSON of South Dakota (for himself and Mr. SOTO) introduced the 

following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to 

be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To provide for the regulation, inspection, and labeling of 

food produced using animal cell culture technology, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Safety Mod5 ernization for Innovative Technologies Act’’. 


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1 SEC. 2. REGULATION OF FOOD PRODUCED USING ANIMAL 

2 CELL CULTURE TECHNOLOGY. 

3 Chapter IV of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 341 et seq.) is amended by adding at the 

5 end the following: 

6 ‘‘SEC. 424. FOOD PRODUCED USING ANIMAL CELL CULTURE 

7 TECHNOLOGY. 

8 ‘‘(a) IN GENERAL.—The Secretary shall regulate 

9 food intended for humans that is produced using animal 

10 cell culture technology derived from cell lines of animals 

11 other than livestock or poultry and, in coordination with 

12 the Secretary of Agriculture, food intended for humans 

13 that is produced using animal cell culture technology de14 rived from cell lines of livestock or poultry. 

15 ‘‘(b) DUTIES.—Pursuant to subsection (a), the Sec16 retary shall— 

17 ‘‘(1) conduct premarket consultation processes 

18 to evaluate production materials, processes, and 

19 manufacturing controls with respect to food intended 

20 for humans that is produced using animal cell cul21 ture technology, derived from cell lines of livestock 

22 or poultry and food intended for humans that is pro23 duced using animal cell culture technology, derived 

24 from cell lines of animals other than livestock or 

25 poultry, including oversight of tissue collection, cell 

26 lines, cell banks, and all components and inputs; 


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1 ‘‘(2) oversee initial cell collection and the devel2 opment and maintenance of qualified cell banks, in3 cluding by issuing regulations or guidance and con4 ducting inspections, as appropriate; 

5 ‘‘(3) oversee proliferation and differentiation of 

6 cells through the time of cell harvest, including by 

7 issuing regulations or guidance and conducting in8 spections, as appropriate; 

9 ‘‘(4) ensure that cell bank and cell culturing fa10 cilities comply with facility registration, applicable 

11 good manufacturing practices and preventive con12 trols, and requirements applicable to substances that 

13 become a component of food or otherwise affect the 

14 characteristics of food; 

15 ‘‘(5) develop pursuant to notice and comment 

16 rulemaking additional requirements for cell bank 

17 and cell culturing facility conditions and processes to 

18 ensure that biological material exiting the culture 

19 process is safe and not adulterated within the mean20 ing of this chapter; 

21 ‘‘(6) conduct appropriate inspections and fol22 low-up activities, including taking enforcement ac23 tion if necessary, to ensure that cell bank and cell24 culturing facilities are in compliance with applicable 

25 laws and regulations; 


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1 ‘‘(7) coordinate the transfer of regulatory over2 sight of harvested cells derived from livestock or 

3 poultry to the Secretary of the Department of Agri4 culture during cell harvest, including providing such 

5 Secretary with any information necessary to deter6 mine whether harvested cells are eligible to be proc7 essed into food intended for humans that is pro8 duced using animal cell culture technology, derived 

9 from cell lines of livestock or poultry; 

10 ‘‘(8) inspect establishments that process, pack11 age, and label food intended for humans that is pro12 duced using animal cell culture technology, derived 

13 from cell lines other than livestock or poultry; 

14 ‘‘(9) promulgate regulations regarding the safe15 ty and accurate labeling of food intended for humans 

16 that is produced using animal cell culture tech17 nology, derived from cell lines other than livestock or 

18 poultry; and 

19 ‘‘(10) establish appropriate nomenclature for 

20 food intended for humans that is produced using 

21 animal cell culture technology, derived from cell lines 

22 other than livestock or poultry. 

23 ‘‘(c) COLLABORATION WITH USDA.—In carrying out 

24 this section, the Secretary shall share information, as ap25 propriate, with the Department of Agriculture, including 


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1 notifying the Department of Agriculture if objectionable 

2 conditions are identified at a facility carrying out any of 

3 the activities described in subsection (b), including condi4 tions which may result in production of adulterated or 

5 misbranded food, collaborating with such department to 

6 address such conditions with respect to the harvesting of 

7 cell cultures, and rely on the Department of Agriculture 

8 to address such conditions with respect to processing, 

9 packaging, and labeling. 

10 ‘‘(d) LIMITATION.—The Secretary shall not inspect 

11 activities of an establishment that are solely regulated by 

12 the Secretary of Agriculture. 

13 ‘‘(e) DEFINITIONS.—In this section— 

14 ‘‘(1) the term ‘livestock’ means cattle, sheep, 

15 swine, goats, and fish of the order Siluriformes; and 

16 ‘‘(2) the term ‘poultry’ means any domesticated 

17 bird, whether live or dead. 

18 ‘‘(f) AUTHORITIES RELATED TO LIVESTOCK AND

19 POULTRY.—Notwithstanding any other provision of law, 

20 the provisions of this section shall not derogate from any 

21 authority under the Federal Meat Inspection Act or Poul22 try Product Inspection Act, as in effect on the date of 

23 enactment of the Food Safety Modernization for Innova24 tive Technologies Act, with respect to the regulation of 

25 meat and poultry produced in the traditional manner. 


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1 ‘‘(g) NO INSPECTION OF FARMS.—Nothing in this 

2 section shall be construed to authorize the Secretary to 

3 conduct an inspection of a farm.’’. 

4 SEC. 3. INSPECTION AND LABELING OF FOOD PRODUCED 

5 USING ANIMAL CELL CULTURE TECHNOLOGY 

6 FROM LIVESTOCK AND POULTRY CELL 

7 LINES. 

8 (a) DEFINITIONS.—In this section: 

9 (1) ADULTERATED.—The term ‘‘adulterated’’, 

10 with respect to food intended for humans that is 

11 produced using animal cell culture technology, de12 rived from cell lines of livestock or poultry, means 

13 food— 

14 (A) that bears or contains any poisonous 

15 or deleterious substance which may render it in16 jurious to health, except that the food shall not 

17 be considered adulterated if the substance is 

18 not an added substance and the quantity of the 

19 substance in the food does not ordinarily render 

20 the food injurious to health; 

21 (B)(i) that bears or contains any added 

22 poisonous or added deleterious substance (other 

23 than a substance that is a pesticide chemical 

24 residue in or on a raw agricultural commodity 

25 or processed food, a food additive, or a color 


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1 additive) that is unsafe within the meaning of 

2 section 406 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 346); 

4 (ii) that bears or contains a pesticide 

5 chemical residue that is unsafe within the 

6 meaning of section 408(a) of that Act (21 

7 U.S.C. 346a(a)); or 

8 (iii) that bears or contains— 

9 (I) any food additive that is unsafe 

10 within the meaning of section 409 of that 

11 Act (21 U.S.C. 348); or 

12 (II) a new animal drug (or conversion 

13 product thereof) that is unsafe within the 

14 meaning of section 512 of that Act (21 

15 U.S.C. 360b); 

16 (C) that consists in whole or in part of any 

17 filthy, putrid, or decomposed substance, or if 

18 the food is otherwise unfit for food; 

19 (D) that has been prepared, packed, or 

20 held under insanitary conditions whereby it may 

21 have become contaminated with filth or ren22 dered injurious to health; 

23 (E) that, in whole or in part, is the prod24 uct of a diseased animal or of an animal which 

25 has died otherwise than by slaughter; 


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1 (F) the container of which is composed, in 

2 whole or in part, of any poisonous or deleterious 

3 substance which may render the contents inju4 rious to health; 

5 (G) that has been intentionally subjected 

6 to radiation, unless the use of the radiation was 

7 in conformity with a regulation or exemption in 

8 effect pursuant to section 409 of that Act (21 

9 U.S.C. 348); 

10 (H)(i) of which any valuable constituent 

11 has been in whole or in part omitted or ab12 stracted therefrom; 

13 (ii) for which any substance has been sub14 stituted in whole or in part; 

15 (iii) for which damage or inferiority has 

16 been concealed in any manner; or 

17 (iv) to which any substance has been added 

18 or mixed or packed so as to increase the bulk 

19 or weight of the food, reduce the quality or 

20 strength of the food, or make the food appear 

21 better or of greater value than the food is; 

22 (I) that bears or contains a color additive 

23 which is unsafe within the meaning of section 

24 721(a) of that Act (21 U.S.C. 379e(a)); or 


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1 (J) that is transported or offered for 

2 transport by a shipper, carrier by motor vehicle 

3 or rail vehicle, receiver, or any other person en4 gaged in the transportation of food under con5 ditions that are not in compliance with regula6 tions promulgated under section 416 of that 

7 Act (21 U.S.C. 350e). 

8 (2) LIVESTOCK.—The term ‘‘livestock’’ has the 

9 meaning given the term in section 424(e) of the 

10 Federal Food, Drug, and Cosmetic Act. 

11 (3) MISBRANDED.—The term ‘‘misbranded’’, 

12 with respect to food intended for humans that is 

13 produced using animal cell culture technology, de14 rived from cell lines of livestock or poultry, means 

15 food— 

16 (A) the label of which— 

17 (i) does not bear— 

18 (I) the name of the food, in ac19 cordance with subsection (c); 

20 (II) in the case of the food being 

21 fabricated from two or more ingredi22 ents, the common or usual name of 

23 each ingredient, except that spices, 

24 flavorings, and colorings may, when 

25 authorized by the appropriate agency 


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1 head, be designated as spices, flavor2 ings, and colorings without naming 

3 each, provided that to the extent that 

4 compliance is impracticable, or results 

5 in deception or unfair competition, ex6 emptions shall be established by regu7 lations promulgated by the Secretary; 

8 or 

9 (III) an official inspection legend 

10 directly on the food or on the con11 tainer of the food and such other in12 formation as the Secretary requires to 

13 assure that the food will not have 

14 false or misleading labeling and that 

15 the public will be informed of the 

16 manner of handling required to main17 tain the food in a wholesome condi18 tion; 

19 (B) the label of which is false or mis20 leading; 

21 (C) that is in a package or other container 

22 the label of which does not bear— 

23 (i) the name and place of business of 

24 the manufacturer, packer, or distributor; 

25 or 


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1 (ii) an accurate statement of the 

2 quantity of the contents in terms of 

3 weight, measure, or numerical count, sub4 ject to— 

5 (I) reasonable variations per6 mitted by the Secretary; and 

7 (II) in the case of a small pack8 age or container, exemptions estab9 lished by the Secretary by regulation; 

10 (D) for which any word, statement, or 

11 other information required by the Secretary to 

12 appear on the label is not prominently placed 

13 on the label with such conspicuousness (com14 pared to any other words, statements, designs, 

15 or devices on the label) and in such terms as 

16 to render it likely to be read and understood by 

17 the ordinary individual under customary condi18 tions of purchase and use; 

19 (E) that is offered for sale under the name 

20 of another food; 

21 (F) that is an imitation of another food, 

22 unless the label bears the word ‘‘imitation’’, in 

23 type of uniform size and prominence, and the 

24 name of the food imitated immediately after the 

25 word ‘‘imitation’’; 


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1 (G) the container of which is made, 

2 formed, or filled as to be misleading; 

3 (H) that purports to be or is represented 

4 for special dietary uses but the label of which 

5 does not bear such information concerning the 

6 vitamin, mineral, and other dietary properties 

7 of the food as the Secretary, after consultation 

8 with the Secretary of Health and Human Serv9 ices, determines to be, and by regulations pre10 scribes as, necessary in order to inform pur11 chasers fully of the value of the food for those 

12 uses; or 

13 (I) that bears or contains any artificial fla14 voring, artificial coloring, or chemical preserva15 tive but the label of which does not state that 

16 fact, subject to exemptions established by the 

17 Secretary by regulation in cases of compliance 

18 being impracticable. 

19 (4) OFFICIAL INSPECTION LEGEND.—The term 

20 ‘‘official inspection legend’’ means the symbol de21 scribed in subsection (b)(2). 

22 (5) POULTRY.—The term ‘‘poultry’’ has the 

23 meaning given the term in section 424(e) of the 

24 Federal Food, Drug, and Cosmetic Act. 


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1 (6) SECRETARY.—The term ‘‘Secretary’’ means 

2 the Secretary of Agriculture. 

3 (b) INSPECTIONS.— 

4 (1) IN GENERAL.—The Secretary shall inspect 

5 establishments that process, package, and label food 

6 intended for humans that is produced using animal 

7 cell culture technology, derived from cell lines of live8 stock or poultry— 

9 (A) to ensure that— 

10 (i) the food is— 

11 (I) not adulterated; and 

12 (II) not misbranded; and 

13 (ii) the establishment is operating in 

14 accordance with the regulations promul15 gated under paragraph (3). 

16 (2) OFFICIAL INSPECTION LEGEND.—The Sec17 retary shall establish an official inspection legend for 

18 the food described in paragraph (1), which shall be 

19 a symbol that shows that a product made from that 

20 food was inspected and passed in accordance with 

21 the regulations described in paragraph (3). 

22 (3) REGULATIONS.—The Secretary shall pro23 mulgate regulations regarding— 

24 (A) the manner and frequency of inspec25 tions required for— 


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1 (i) the food described in paragraph 

2 (1); and 

3 (ii) establishments that process, pack4 age, and label that food; and 

5 (B) the requirements for a product of the 

6 food described in paragraph (1) to satisfactorily 

7 pass an inspection and receive an official in8 spection legend, including— 

9 (i) sanitation and physical product in10 spection requirements; 

11 (ii) food product testing and record12 keeping requirements; and 

13 (iii) the requirement for Hazard Anal14 ysis and Critical Control Points verifica15 tion. 

16 (4) LIMITATION.—The Secretary shall not in17 spect activities of an establishment under section 

18 424 of the Federal Food, Drug, and Cosmetic Act 

19 that are solely regulated by the Secretary of Health 

20 and Human Services. 

21 (c) LABELING.— 

22 (1) IN GENERAL.—The Secretary shall— 

23 (A) approve, before introduction into com24 merce, the labeling of food intended for humans 

25 that is produced using animal cell culture techVerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728

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1 nology, derived from cell lines of livestock or 

2 poultry; and 

3 (B) verify the accuracy of that labeling 

4 through inspection. 

5 (2) REQUIREMENTS.—The Secretary shall es6 tablish, after providing notice and an opportunity for 

7 comment, any appropriate requirements in addition 

8 to the requirements under paragraph (1) to ensure 

9 the safety and accurate labeling of the food de10 scribed in paragraph (1)(A). 

11 (3) REGULATIONS.—The Secretary shall pro12 mulgate regulations— 

13 (A) to establish appropriate nomenclature 

14 for the labeling approved under paragraph 

15 (1)(A); and 

16 (B) to carry out paragraph (1)(B). 

17 (d) ENFORCEMENT.—The Secretary shall, pursuant 

18 to relevant enforcement authorities governing the regula19 tion of amenable species (as defined in section 1 of the 

20 Federal Meat Inspection Act (21 U.S.C. 601)), conduct 

21 such enforcement action as is necessary to ensure that 

22 food intended for humans that is produced using animal 

23 cell culture technology, derived from cell lines of livestock 

24 or poultry, that is adulterated or misbranded does not 

25 enter or is removed from commerce. 


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1 (e) COLLABORATION WITH HHS.—In carrying out 

2 this section, the Secretary shall— 

3 (1) review information shared by the Secretary 

4 of Health and Human Services under section 424(c) 

5 of the Federal Food, Drug, and Cosmetic Act; 

6 (2) share appropriate information relating to 

7 food intended for humans that is produced using 

8 animal cell culture technology, derived from cell lines 

9 of livestock or poultry, with the Secretary of Health 

10 and Human Services, as appropriate; and 

11 (3)(A) notify the Secretary of Health and 

12 Human Services if objectionable conditions at an es13 tablishment are identified under an inspection under 

14 subsection (b)(1); 

15 (B) collaborate with the Secretary of Health 

16 and Human Services to address those conditions 

17 with respect to cell harvesting; and 

18 (C) rely on the Secretary of Health and Human 

19 Services to address those conditions with respect to 

20 initial cell collection, development and maintenance 

21 of qualified cell banks, and proliferation and dif22 ferentiation of cells. 

Æ 


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