II 116th CONGRESS 1st Session S. 3053 IN THE SENATE OF THE UNITED STATES December 16, 2019 Mr. Enzi (for himself and Mr. Tester ) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry A BILL To provide for the regulation, inspection, and labeling of food produced using animal cell culture technology, and for other purposes.

1. Short title This Act may be cited as the Food Safety Modernization for Innovative Technologies Act . 2. Regulation of food produced using animal cell culture technology Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq.) is amended by adding at the end the following: 424. Food produced using animal cell culture technology (a) In general The Secretary shall regulate food intended for humans that is produced using animal cell culture technology derived from cell lines of animals other than livestock or poultry and, in coordination with the Secretary of Agriculture, food intended for humans that is produced using animal cell culture technology derived from cell lines of livestock or poultry. (b) Duties Pursuant to subsection (a), the Secretary shall— (1) conduct premarket consultation processes to evaluate production materials, processes, and manufacturing controls with respect to food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry and food intended for humans that is produced using animal cell culture technology, derived from cell lines of animals other than livestock or poultry, including oversight of tissue collection, cell lines, cell banks, and all components and inputs; (2) oversee initial cell collection and the development and maintenance of qualified cell banks, including by issuing regulations or guidance and conducting inspections, as appropriate; (3) oversee proliferation and differentiation of cells through the time of cell harvest, including by issuing regulations or guidance and conducting inspections, as appropriate; (4) ensure that cell bank and cell culturing facilities comply with facility registration, applicable good manufacturing practices and preventive controls, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food; (5) develop pursuant to notice and comment rulemaking additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe and not adulterated within the meaning of this chapter; (6) conduct appropriate inspections and follow-up activities, including taking enforcement action if necessary, to ensure that cell bank and cell-culturing facilities are in compliance with applicable laws and regulations; (7) coordinate the transfer of regulatory oversight of harvested cells derived from livestock or poultry to the Secretary of the Department of Agriculture during cell harvest, including providing such Secretary with any information necessary to determine whether harvested cells are eligible to be processed into food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry; (8) inspect establishments that process, package, and label food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry; (9) promulgate regulations regarding the safety and accurate labeling of food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry; and (10) establish appropriate nomenclature for food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry. (c) Collaboration with USDA In carrying out this section, the Secretary shall share information, as appropriate, with the Department of Agriculture, including notifying the Department of Agriculture if objectionable conditions are identified at a facility carrying out any of the activities described in subsection (b), including conditions which may result in production of adulterated or misbranded food, collaborating with such department to address such conditions with respect to the harvesting of cell cultures, and rely on the Department of Agriculture to address such conditions with respect to processing, packaging, and labeling. (d) Limitation The Secretary shall not inspect activities of an establishment that are solely regulated by the Secretary of Agriculture. (e) Definitions In this section— (1) the term livestock means cattle, sheep, swine, goats, and fish of the order Siluriformes; and (2) the term poultry means any domesticated bird, whether live or dead. (f) Authorities related to livestock and poultry Notwithstanding any other provision of law, the provisions of this section shall not derogate from any authority under the Federal Meat Inspection Act or Poultry Product Inspection Act, as in effect on the date of enactment of the Food Safety Modernization for Innovative Technologies Act , with respect to the regulation of meat and poultry produced in the traditional manner. (g) No inspection of farms Nothing in this section shall be construed to authorize the Secretary to conduct an inspection of a farm. . 3. Inspection and labeling of food produced using animal cell culture technology from livestock and poultry cell lines (a) Definitions In this section: (1) Adulterated The term adulterated , with respect to food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry, means food— (A) that bears or contains any poisonous or deleterious substance which may render it injurious to health, except that the food shall not be considered adulterated if the substance is not an added substance and the quantity of the substance in the food does not ordinarily render the food injurious to health; (B) (i) that bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, or a color additive) that is unsafe within the meaning of section 406 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 346 ); (ii) that bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a) of that Act ( 21 U.S.C. 346a(a) ); or (iii) that bears or contains— (I) any food additive that is unsafe within the meaning of section 409 of that Act ( 21 U.S.C. 348 ); or (II) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512 of that Act ( 21 U.S.C. 360b ); (C) that consists in whole or in part of any filthy, putrid, or decomposed substance, or if the food is otherwise unfit for food; (D) that has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health; (E) that, in whole or in part, is the product of a diseased animal or of an animal which has died otherwise than by slaughter; (F) the container of which is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; (G) that has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of that Act ( 21 U.S.C. 348 ); (H) (i) of which any valuable constituent has been in whole or in part omitted or abstracted therefrom; (ii) for which any substance has been substituted in whole or in part; (iii) for which damage or inferiority has been concealed in any manner; or (iv) to which any substance has been added or mixed or packed so as to increase the bulk or weight of the food, reduce the quality or strength of the food, or make the food appear better or of greater value than the food is; (I) that bears or contains a color additive which is unsafe within the meaning of section 721(a) of that Act ( 21 U.S.C. 379e(a) ); or (J) that is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416 of that Act ( 21 U.S.C. 350e ). (2) Livestock The term livestock has the meaning given the term in section 424(e) of the Federal Food, Drug, and Cosmetic Act. (3) Misbranded The term misbranded , with respect to food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry, means food— (A) the label of which— (i) does not bear— (I) the name of the food, in accordance with subsection (c); (II) in the case of the food being fabricated from 2 or more ingredients, the common or usual name of each ingredient, except that spices, flavorings, and colorings may, when authorized by the appropriate agency head, be designated as spices, flavorings, and colorings without naming each, provided that to the extent that compliance is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary; or (III) an official inspection legend directly on the food or on the container of the food and such other information as the Secretary requires to assure that the food will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the food in a wholesome condition; (B) the label of which is false or misleading; (C) that is in a package or other container the label of which does not bear— (i) the name and place of business of the manufacturer, packer, or distributor; or (ii) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, subject to— (I) reasonable variations permitted by the Secretary; and (II) in the case of a small package or container, exemptions established by the Secretary by regulation; (D) for which any word, statement, or other information required by the Secretary to appear on the label is not prominently placed on the label with such conspicuousness (compared to any other words, statements, designs, or devices on the label) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (E) that is offered for sale under the name of another food; (F) that is an imitation of another food, unless the label bears the word imitation , in type of uniform size and prominence, and the name of the food imitated immediately after the word imitation ; (G) the container of which is made, formed, or filled as to be misleading; (H) that purports to be or is represented for special dietary uses but the label of which does not bear such information concerning the vitamin, mineral, and other dietary properties of the food as the Secretary, after consultation with the Secretary of Health and Human Services, determines to be, and by regulations prescribes as, necessary in order to inform purchasers fully of the value of the food for those uses; or (I) that bears or contains any artificial flavoring, artificial coloring, or chemical preservative but the label of which does not state that fact, subject to exemptions established by the Secretary by regulation in cases of compliance being impracticable. (4) Official inspection legend The term official inspection legend means the symbol described in subsection (b)(2). (5) Poultry The term poultry has the meaning given the term in section 424(e) of the Federal Food, Drug, and Cosmetic Act. (6) Secretary The term Secretary means the Secretary of Agriculture. (b) Inspections (1) In general The Secretary shall inspect establishments that process, package, and label food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry— (A) to ensure that— (i) the food is— (I) not adulterated; and (II) not misbranded; and (ii) the establishment is operating in accordance with the regulations promulgated under paragraph (3). (2) Official inspection legend The Secretary shall establish an official inspection legend for the food described in paragraph (1), which shall be a symbol that shows that a product made from that food was inspected and passed in accordance with the regulations described in paragraph (3). (3) Regulations The Secretary shall promulgate regulations regarding— (A) the manner and frequency of inspections required for— (i) the food described in paragraph (1); and (ii) establishments that process, package, and label that food; and (B) the requirements for a product of the food described in paragraph (1) to satisfactorily pass an inspection and receive an official inspection legend, including— (i) sanitation and physical product inspection requirements; (ii) food product testing and recordkeeping requirements; and (iii) the requirement for Hazard Analysis and Critical Control Points verification. (4) Limitation The Secretary shall not inspect activities of an establishment under section 424 of the Federal Food, Drug, and Cosmetic Act that are solely regulated by the Secretary of Health and Human Services. (c) Labeling (1) In general The Secretary shall— (A) approve, before introduction into commerce, the labeling of food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry; and (B) verify the accuracy of that labeling through inspection. (2) Requirements The Secretary shall establish, after providing notice and an opportunity for comment, any appropriate requirements in addition to the requirements under paragraph (1) to ensure the safety and accurate labeling of the food described in paragraph (1)(A). (3) Regulations The Secretary shall promulgate regulations— (A) to establish appropriate nomenclature for the labeling approved under paragraph (1)(A); and (B) to carry out paragraph (1)(B). (d) Enforcement The Secretary shall, pursuant to relevant enforcement authorities governing the regulation of amenable species (as defined in section 1 of the Federal Meat Inspection Act ( 21 U.S.C. 601 )), conduct such enforcement action as is necessary to ensure that food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry, that is adulterated or misbranded does not enter or is removed from commerce. (e) Collaboration with HHS In carrying out this section, the Secretary shall— (1) review information shared by the Secretary of Health and Human Services under section 424(c) of the Federal Food, Drug, and Cosmetic Act; (2) share appropriate information relating to food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry, with the Secretary of Health and Human Services, as appropriate; and (3) (A) notify the Secretary of Health and Human Services if objectionable conditions at an establishment are identified under an inspection under subsection (b)(1); (B) collaborate with the Secretary of Health and Human Services to address those conditions with respect to cell harvesting; and (C) rely on the Secretary of Health and Human Services to address those conditions with respect to initial cell collection, development and maintenance of qualified cell banks, and proliferation and differentiation of cells.