[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3053 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 3053

    To provide for the regulation, inspection, and labeling of food 
 produced using animal cell culture technology, and for other purposes.


_______________________________________________________________________


                   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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food Safety Modernization for 
Innovative Technologies Act''.

SEC. 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:

``SEC. 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.''.

SEC. 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.
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