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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 809 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                 S. 809

   To amend the Federal Food, Drug, and Cosmetic Act to require that 
    genetically engineered food and foods that contain genetically 
             engineered ingredients be labeled accordingly.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 24, 2013

     Mrs. Boxer (for herself, Ms. Murkowski, Mrs. Gillibrand, Mr. 
   Blumenthal, Mr. Begich, Mr. Tester, Mr. Sanders, Mr. Merkley, Mr. 
Schatz, and Mr. Heinrich) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

_______________________________________________________________________

                                 A BILL

 
   To amend the Federal Food, Drug, and Cosmetic Act to require that 
    genetically engineered food and foods that contain genetically 
             engineered ingredients be labeled accordingly.

    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 ``Genetically Engineered Food Right-
to-Know Act''.

SEC. 2. PURPOSE AND FINDINGS.

    (a) Purpose.--The purpose of this Act is to establish a consistent 
and enforceable standard for labeling of foods produced using genetic 
engineering, including fish, thereby providing consumers with knowledge 
of how their food is produced.
    (b) Findings.--Congress finds that--
            (1) the process of genetically engineering food organisms 
        results in material changes to food derived from those 
        organisms;
            (2) the Food and Drug Administration requires the labeling 
        of more than 3,000 ingredients, additives, and processes;
            (3) individuals in the United States have a right to know 
        if their food was produced with genetic engineering for a 
        variety of reasons, including health, economic, environmental, 
        religious, and ethical;
            (4) more than 60 countries, including the United Kingdom 
        and all other countries of the European Union, South Korea, 
        Japan, Brazil, Australia, India, China, and other key United 
        States trading partners have laws or regulations mandating 
        disclosure of genetically engineered food on food labels;
            (5) in 2011, Codex Alimentarius, the food standards 
        organization of the United Nations, adopted a text that 
        indicates that governments can decide on whether and how to 
        label foods produced with genetic engineering; and
            (6) mandatory identification of food produced with genetic 
        engineering can be a critical method of preserving the economic 
        value of exports or domestically sensitive markets with 
        labeling requirements for genetically engineered foods.

SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) In General.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(z)(1) If it is a food that has been genetically engineered or 
contains 1 or more genetically engineered ingredients, unless such 
information is clearly disclosed, as determined by the Secretary.
    ``(2) This paragraph does not apply to food that--
            ``(A) is served in restaurants or other similar eating 
        establishments, such as cafeterias and carryouts;
            ``(B) is a medical food (as defined in section 5(b) of the 
        Orphan Drug Act);
            ``(C) is a food that would be subject to this paragraph 
        solely because it was produced using a genetically engineered 
        vaccine; or
            ``(D) is a food or processed food that would be subject to 
        this paragraph solely because it includes the use of a 
        genetically engineered processing aid (including yeast) or 
        enzyme.
    ``(3) In this paragraph:
            ``(A) The term `genetic engineering' means a process 
        involving the application of--
                    ``(i) in vitro nucleic acid techniques, including 
                recombinant deoxyribonucleic acid (DNA) and direct 
                injection of nucleic acid into cells or organelles; or
                    ``(ii) fusion of cells beyond the taxonomic family 
                that--
                            ``(I) overcome natural physiological 
                        reproductive or recombinant barriers; and
                            ``(II) are not techniques used in 
                        traditional breeding and selection.
            ``(B) The term `genetically engineered', used with respect 
        to a food, means a material intended for human consumption that 
        is--
                    ``(i) an organism that is produced through the 
                intentional use of genetic engineering; or
                    ``(ii) the progeny of intended sexual or asexual 
                reproduction (or both) of 1 or more organisms that is 
                the product of genetic engineering.
            ``(C) The term `genetically engineered ingredient' means a 
        material that is an ingredient in a food that is derived from 
        any part of an organism that has been genetically engineered, 
        without regard to whether--
                    ``(i) the altered molecular or cellular 
                characteristics of the organism are detectable in the 
                material; and
                    ``(ii) the organism is capable for use as human 
                food.''.
    (b) Guaranty.--
            (1) In general.--Section 303(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 333(d)) is amended--
                    (A) by striking ``(d)'' and inserting ``(d)(1)''; 
                and
                    (B) by adding at the end the following:
            ``(2)(A) No person shall be subject to the penalties of 
        subsection (a)(1) for a violation of subsection (a), (b), or 
        (c) of section 301 involving food that is misbranded within the 
        meaning of section 403(z) if such person (referred to in this 
        paragraph as the `recipient') establishes a guaranty or 
        undertaking that--
                    ``(i) is signed by, and contains the name and 
                address of, a person residing in the United States from 
                whom the recipient received in good faith the food 
                (including the receipt of seeds to grow raw 
                agricultural commodities); and
                    ``(ii) contains a statement to the effect that the 
                food is not genetically engineered or does not contain 
                a genetically engineered ingredient.
            ``(B) In the case of a recipient who, with respect to a 
        food, establishes a guaranty or undertaking in accordance with 
        subparagraph (A), the exclusion under such subparagraph from 
        being subject to penalties applies to the recipient without 
        regard to the manner in which the recipient uses the food, 
        including whether the recipient is--
                    ``(i) processing the food;
                    ``(ii) using the food as an ingredient in a food 
                product;
                    ``(iii) repacking the food; or
                    ``(iv) growing, raising, or otherwise producing the 
                food.
            ``(C) No person may avoid responsibility or liability for a 
        violation of subsection (a), (b), or (c) of section 301 
        involving food that is misbranded within the meaning of section 
        403(z) by entering into a contract or other agreement that 
        specifies that another person shall bear such responsibility or 
        liability, except that a recipient may require a guaranty or 
        undertaking as described in this subsection.
            ``(D) In this subsection, the terms `genetically 
        engineered' and `genetically engineered ingredient' have the 
        meanings given the terms in section 403(z).''.
            (2) False guaranty.--Section 301(h) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(h)) is amended by 
        inserting ``or 303(d)(2)'' after ``section 303(c)(2)''.
    (c) Unintended Contamination.--Section 303(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333(d)), as amended by subsection 
(b), is further amended by adding at the end the following:
            ``(3)(A) No person shall be subject to the penalties of 
        subsection (a)(1) for a violation of subsection (a), (b), or 
        (c) of section 301 involving food that is misbranded within the 
        meaning of section 403(z) if--
                    ``(i) such person is an agricultural producer and 
                the violation occurs because food that is grown, 
                raised, or otherwise produced by such producer, which 
                food does not contain a genetically engineered material 
                and was not produced with a genetically engineered 
                material, is contaminated with a food that contains a 
                genetically engineered material or was produced with a 
                genetically engineered material; and
                    ``(ii) such contamination is not intended by the 
                agricultural producer.
            ``(B) Subparagraph (A) does not apply to an agricultural 
        producer to the extent that the contamination occurs as a 
        result of the negligence of the producer.''.
    (d) Promulgation of Regulations.--Not later than 1 year after the 
date of enactment of this Act, the Secretary shall promulgate proposed 
regulations establishing labeling requirements for compliance in 
accordance with section 403(z) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a).
                                 <all>
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