Food Safety Modernization for Innovative Technologies Act

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 Com- merce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consider- ation 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Food Safety Mod- 4 ernization for Innovative Technologies Act’’. 5 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 5728 IH SEC. 2. REGULATION OF FOOD PRODUCED USING ANIMAL 1 CELL CULTURE TECHNOLOGY. 2 Chapter IV of the Federal Food, Drug, and Cosmetic 3 Act (21 U.S.C. 341 et seq.) is amended by adding at the 4 end the following: 5 ‘‘SEC. 424. FOOD PRODUCED USING ANIMAL CELL CULTURE 6 TECHNOLOGY. 7 ‘‘(a) IN GENERAL.—The Secretary shall regulate 8 food intended for humans that is produced using animal 9 cell culture technology derived from cell lines of animals 10 other than livestock or poultry and, in coordination with 11 the Secretary of Agriculture, food intended for humans 12 that is produced using animal cell culture technology de- 13 rived from cell lines of livestock or poultry. 14 ‘‘(b) DUTIES.—Pursuant to subsection (a), the Sec- 15 retary shall— 16 ‘‘(1) conduct premarket consultation processes 17 to evaluate production materials, processes, and 18 manufacturing controls with respect to food intended 19 for humans that is produced using animal cell cul- 20 ture technology, derived from cell lines of livestock 21 or poultry and food intended for humans that is pro- 22 duced using animal cell culture technology, derived 23 from cell lines of animals other than livestock or 24 poultry, including oversight of tissue collection, cell 25 lines, cell banks, and all components and inputs; 26 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 5728 IH ‘‘(2) oversee initial cell collection and the devel- 1 opment and maintenance of qualified cell banks, in- 2 cluding by issuing regulations or guidance and con- 3 ducting inspections, as appropriate; 4 ‘‘(3) oversee proliferation and differentiation of 5 cells through the time of cell harvest, including by 6 issuing regulations or guidance and conducting in- 7 spections, as appropriate; 8 ‘‘(4) ensure that cell bank and cell culturing fa- 9 cilities comply with facility registration, applicable 10 good manufacturing practices and preventive con- 11 trols, and requirements applicable to substances that 12 become a component of food or otherwise affect the 13 characteristics of food; 14 ‘‘(5) develop pursuant to notice and comment 15 rulemaking additional requirements for cell bank 16 and cell culturing facility conditions and processes to 17 ensure that biological material exiting the culture 18 process is safe and not adulterated within the mean- 19 ing of this chapter; 20 ‘‘(6) conduct appropriate inspections and fol- 21 low-up activities, including taking enforcement ac- 22 tion if necessary, to ensure that cell bank and cell- 23 culturing facilities are in compliance with applicable 24 laws and regulations; 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 5728 IH ‘‘(7) coordinate the transfer of regulatory over- 1 sight of harvested cells derived from livestock or 2 poultry to the Secretary of the Department of Agri- 3 culture during cell harvest, including providing such 4 Secretary with any information necessary to deter- 5 mine whether harvested cells are eligible to be proc- 6 essed into food intended for humans that is pro- 7 duced using animal cell culture technology, derived 8 from cell lines of livestock or poultry; 9 ‘‘(8) inspect establishments that process, pack- 10 age, and label food intended for humans that is pro- 11 duced using animal cell culture technology, derived 12 from cell lines other than livestock or poultry; 13 ‘‘(9) promulgate regulations regarding the safe- 14 ty and accurate labeling of food intended for humans 15 that is produced using animal cell culture tech- 16 nology, derived from cell lines other than livestock or 17 poultry; and 18 ‘‘(10) establish appropriate nomenclature for 19 food intended for humans that is produced using 20 animal cell culture technology, derived from cell lines 21 other than livestock or poultry. 22 ‘‘(c) COLLABORATION WITH USDA.—In carrying out 23 this section, the Secretary shall share information, as ap- 24 propriate, with the Department of Agriculture, including 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 5728 IH notifying the Department of Agriculture if objectionable 1 conditions are identified at a facility carrying out any of 2 the activities described in subsection (b), including condi- 3 tions which may result in production of adulterated or 4 misbranded food, collaborating with such department to 5 address such conditions with respect to the harvesting of 6 cell cultures, and rely on the Department of Agriculture 7 to address such conditions with respect to processing, 8 packaging, and labeling. 9 ‘‘(d) LIMITATION.—The Secretary shall not inspect 10 activities of an establishment that are solely regulated by 11 the Secretary of Agriculture. 12 ‘‘(e) DEFINITIONS.—In this section— 13 ‘‘(1) the term ‘livestock’ means cattle, sheep, 14 swine, goats, and fish of the order Siluriformes; and 15 ‘‘(2) the term ‘poultry’ means any domesticated 16 bird, whether live or dead. 17 ‘‘(f) AUTHORITIES RELATED TO LIVESTOCK AND 18 POULTRY.—Notwithstanding any other provision of law, 19 the provisions of this section shall not derogate from any 20 authority under the Federal Meat Inspection Act or Poul- 21 try Product Inspection Act, as in effect on the date of 22 enactment of the Food Safety Modernization for Innova- 23 tive Technologies Act, with respect to the regulation of 24 meat and poultry produced in the traditional manner. 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 5728 IH ‘‘(g) NO INSPECTION OF FARMS.—Nothing in this 1 section shall be construed to authorize the Secretary to 2 conduct an inspection of a farm.’’. 3 SEC. 3. INSPECTION AND LABELING OF FOOD PRODUCED 4 USING ANIMAL CELL CULTURE TECHNOLOGY 5 FROM LIVESTOCK AND POULTRY CELL 6 LINES. 7 (a) DEFINITIONS.—In this section: 8 (1) ADULTERATED.—The term ‘‘adulterated’’, 9 with respect to food intended for humans that is 10 produced using animal cell culture technology, de- 11 rived from cell lines of livestock or poultry, means 12 food— 13 (A) that bears or contains any poisonous 14 or deleterious substance which may render it in- 15 jurious to health, except that the food shall not 16 be considered adulterated if the substance is 17 not an added substance and the quantity of the 18 substance in the food does not ordinarily render 19 the food injurious to health; 20 (B)(i) that bears or contains any added 21 poisonous or added deleterious substance (other 22 than a substance that is a pesticide chemical 23 residue in or on a raw agricultural commodity 24 or processed food, a food additive, or a color 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 5728 IH additive) that is unsafe within the meaning of 1 section 406 of the Federal Food, Drug, and 2 Cosmetic Act (21 U.S.C. 346); 3 (ii) that bears or contains a pesticide 4 chemical residue that is unsafe within the 5 meaning of section 408(a) of that Act (21 6 U.S.C. 346a(a)); or 7 (iii) that bears or contains— 8 (I) any food additive that is unsafe 9 within the meaning of section 409 of that 10 Act (21 U.S.C. 348); or 11 (II) a new animal drug (or conversion 12 product thereof) that is unsafe within the 13 meaning of section 512 of that Act (21 14 U.S.C. 360b); 15 (C) that consists in whole or in part of any 16 filthy, putrid, or decomposed substance, or if 17 the food is otherwise unfit for food; 18 (D) that has been prepared, packed, or 19 held under insanitary conditions whereby it may 20 have become contaminated with filth or ren- 21 dered injurious to health; 22 (E) that, in whole or in part, is the prod- 23 uct of a diseased animal or of an animal which 24 has died otherwise than by slaughter; 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 5728 IH (F) the container of which is composed, in 1 whole or in part, of any poisonous or deleterious 2 substance which may render the contents inju- 3 rious to health; 4 (G) that has been intentionally subjected 5 to radiation, unless the use of the radiation was 6 in conformity with a regulation or exemption in 7 effect pursuant to section 409 of that Act (21 8 U.S.C. 348); 9 (H)(i) of which any valuable constituent 10 has been in whole or in part omitted or ab- 11 stracted therefrom; 12 (ii) for which any substance has been sub- 13 stituted in whole or in part; 14 (iii) for which damage or inferiority has 15 been concealed in any manner; or 16 (iv) to which any substance has been added 17 or mixed or packed so as to increase the bulk 18 or weight of the food, reduce the quality or 19 strength of the food, or make the food appear 20 better or of greater value than the food is; 21 (I) that bears or contains a color additive 22 which is unsafe within the meaning of section 23 721(a) of that Act (21 U.S.C. 379e(a)); or 24 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 5728 IH (J) that is transported or offered for 1 transport by a shipper, carrier by motor vehicle 2 or rail vehicle, receiver, or any other person en- 3 gaged in the transportation of food under con- 4 ditions that are not in compliance with regula- 5 tions promulgated under section 416 of that 6 Act (21 U.S.C. 350e). 7 (2) LIVESTOCK.—The term ‘‘livestock’’ has the 8 meaning given the term in section 424(e) of the 9 Federal Food, Drug, and Cosmetic Act. 10 (3) MISBRANDED.—The term ‘‘misbranded’’, 11 with respect to food intended for humans that is 12 produced using animal cell culture technology, de- 13 rived from cell lines of livestock or poultry, means 14 food— 15 (A) the label of which— 16 (i) does not bear— 17 (I) the name of the food, in ac- 18 cordance with subsection (c); 19 (II) in the case of the food being 20 fabricated from two or more ingredi- 21 ents, the common or usual name of 22 each ingredient, except that spices, 23 flavorings, and colorings may, when 24 authorized by the appropriate agency 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 5728 IH head, be designated as spices, flavor- 1 ings, and colorings without naming 2 each, provided that to the extent that 3 compliance is impracticable, or results 4 in deception or unfair competition, ex- 5 emptions shall be established by regu- 6 lations promulgated by the Secretary; 7 or 8 (III) an official inspection legend 9 directly on the food or on the con- 10 tainer of the food and such other in- 11 formation as the Secretary requires to 12 assure that the food will not have 13 false or misleading labeling and that 14 the public will be informed of the 15 manner of handling required to main- 16 tain the food in a wholesome condi- 17 tion; 18 (B) the label of which is false or mis- 19 leading; 20 (C) that is in a package or other container 21 the label of which does not bear— 22 (i) the name and place of business of 23 the manufacturer, packer, or distributor; 24 or 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 5728 IH (ii) an accurate statement of the 1 quantity of the contents in terms of 2 weight, measure, or numerical count, sub- 3 ject to— 4 (I) reasonable variations per- 5 mitted by the Secretary; and 6 (II) in the case of a small pack- 7 age or container, exemptions estab- 8 lished by the Secretary by regulation; 9 (D) for which any word, statement, or 10 other information required by the Secretary to 11 appear on the label is not prominently placed 12 on the label with such conspicuousness (com- 13 pared to any other words, statements, designs, 14 or devices on the label) and in such terms as 15 to render it likely to be read and understood by 16 the ordinary individual under customary condi- 17 tions of purchase and use; 18 (E) that is offered for sale under the name 19 of another food; 20 (F) that is an imitation of another food, 21 unless the label bears the word ‘‘imitation’’, in 22 type of uniform size and prominence, and the 23 name of the food imitated immediately after the 24 word ‘‘imitation’’; 25 VerDate Sep 11 2014 02:50 Jan 31, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5728.IH H5728 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 5728 IH (G) the container of which is made, 1 formed, or filled as to be misleading; 2 (H) that purports to be or is represented 3 for special dietary uses but the label of which 4 does not bear such information concerning the 5 vitamin, mineral, and other dietary properties 6 of the food as the Secretary, after consultation 7 with the Secretary of Health and Human Serv- 8 ices, determines to be, and by regulations pre- 9 scribes as, necessary in order to inform pur- 10 chasers fully of the value of the food for those 11 uses; or 12 (I) that bears or contains any artificial fla- 13 voring, artificial coloring, or chemical preserva- 14 tive but the label of which does not state that 15 fact, subject to exemptions established by the 16 Secretar [Text truncated for display. 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