[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2080 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2080

To amend the Federal Food, Drug, and Cosmetic Act to require that food 
 that contains a genetically engineered material, or that is produced 
with a genetically engineered material, be labeled accordingly, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 22, 2000

  Mrs. Boxer introduced the following bill; which was read twice and 
   referred to the Committee on Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to require that food 
 that contains a genetically engineered material, or that is produced 
with a genetically engineered material, be labeled accordingly, 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 ``Genetically Engineered Food Right-
to-Know Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) In 1999, 98,600,000 acres in the United States were 
        planted with genetically engineered crops, and more than \1/3\ 
        of the soybean crop, and \1/4\ of the corn crop, in the United 
        States was genetically engineered.
            (2) The process of genetically engineering foods results in 
        the material change of such foods.
            (3) The health and environmental effects of genetically 
        engineered foods are not yet known.
            (4) Individuals in the United States have the right to know 
        whether food contains or has been produced with genetically 
        engineered material.
            (5) Federal law gives individuals in the United States the 
        right to know whether food contains artificial colors and 
        flavors, chemical preservatives, and artificial sweeteners by 
        requiring the labeling of such food.
            (6) Requirements that genetically engineered food be 
        labeled as genetically engineered would increase consumer 
        knowledge about, and consumer control over consumption of, 
        genetically engineered food.
            (7) Genetically engineered material can be detected in food 
        at levels as low as 0.1 percent by reasonably available 
        technology.

SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS 
              TO 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 paragraph:
    ``(t)(1) If it contains a genetically engineered material, or was 
produced with a genetically engineered material, unless it bears a 
label (or labeling, in the case of a raw agricultural commodity) that 
provides notices in accordance with each of the following requirements:
            ``(A) The label or labeling bears the following notice: 
        `GENETICALLY ENGINEERED'.
            ``(B) The label or labeling bears the following notice: 
        `THIS PRODUCT CONTAINS A GENETICALLY ENGINEERED MATERIAL, OR 
        WAS PRODUCED WITH A GENETICALLY ENGINEERED MATERIAL'.
            ``(C) The notice required in clause (A) immediately 
        precedes the notice required in clause (B) and the type for the 
        notice required in clause (A) is not less than twice the size 
        of the type for the notice required in clause (B).
            ``(D) The notice required in clause (B) is the same size as 
        would be required if the notice provided nutrition information 
        that is required in paragraph (q)(1).
            ``(E) The notices required in clauses (A) and (B) are 
        clearly legible and conspicuous.
    ``(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; or
            ``(C) was grown on a tree that was planted before the date 
        of enactment of the Genetically Engineered Food Right-to-Know 
        Act, in a case in which the producer of the food does not know 
        if the food contains a genetically engineered material, or was 
        produced with a genetically engineered material.
    ``(3) In this paragraph:
            ``(A) The term `genetically engineered material' means 
        material derived from any part of a genetically engineered 
        organism, without regard to whether the altered molecular or 
        cellular characteristics of the organism are detectable in the 
        material.
            ``(B) The term `genetically engineered organism' means--
                    ``(i) an organism that has been altered at the 
                molecular or cellular level by means that are not 
                possible under natural conditions or processes 
                (including recombinant DNA and RNA techniques, cell 
                fusion, microencapsulation, macroencapsulation, gene 
                deletion and doubling, introduction of a foreign gene, 
                and a process that changes the positions of genes), 
                other than a means consisting exclusively of breeding, 
                conjugation, fermentation, hybridization, in vitro 
                fertilization, or tissue culture; and
                    ``(ii) an organism made through sexual or asexual 
                reproduction, or both, involving an organism described 
                in subclause (i), if possessing any of the altered 
                molecular or cellular characteristics of the organism 
                so described.
            ``(C) The term `produced with a genetically engineered 
        material', used with respect to a food, means a food if--
                    ``(i) the organism from which the food is derived 
                has been injected or otherwise treated with a 
                genetically engineered material (except that the use of 
                manure as a fertilizer for raw agricultural commodities 
                may not be construed to be production with a 
                genetically engineered material);
                    ``(ii) the animal from which the food is derived 
                has been fed genetically engineered material; or
                    ``(iii) the food contains an ingredient that is a 
                food to which subclause (i) or (ii) applies.''.
    (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 paragraph:
    ``(2)(A) No person shall be subject to the penalties of subsection 
(a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c) 
involving food that is misbranded within the meaning of section 403(t) 
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 
        does not contain a genetically engineered material or was not 
        produced with a genetically engineered material.
    ``(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 section 301(a), 301(b), or 301(c) involving food that is 
misbranded within the meaning of section 403(t) 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 paragraph, the terms `genetically engineered 
material' and `produced with a genetically engineered material' have 
the meanings given the terms in section 403(t).''.
            (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)'' before ``, which guaranty or 
        undertaking is false'' the first place it appears.
    (c) Unintended Contamination.--Section 303(d) of the Federal Food, 
Drug, and Cosmetic Act, as amended by subsection (b)(1), is further 
amended by adding at the end the following paragraph:
    ``(3)(A) No person shall be subject to the penalties of subsection 
(a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c) 
involving food that is misbranded within the meaning of section 403(t) 
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 (including 
        contamination by mingling the 2 foods); 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) Civil Penalties.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following subsection:
    ``(h)(1) With respect to a violation of section 301(a), 301(b), or 
301(c) involving food that is misbranded within the meaning of section 
403(t), any person engaging in such a violation shall be liable to the 
United States for a civil penalty in an amount not to exceed $1,000 for 
each such violation.
    ``(2) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty assessed under paragraph (1) to the same 
extent and in the same manner as such paragraphs (3) through (5) apply 
with respect to a civil penalty assessed under paragraph (1) or (2) of 
subsection (g).''.

SEC. 4. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 908. GRANTS FOR RESEARCH ON GENETICALLY ENGINEERED FOOD.

    ``(a) In General.--The Secretary may make grants to appropriate 
individuals, organizations, and institutions to conduct research into 
the public health and environmental risks associated with genetically 
engineered materials, food that contains a genetically engineered 
material, and food that is produced with a genetically engineered 
material, including risks related to--
            ``(1) increased allergenicity;
            ``(2) increased toxicity;
            ``(3) cross-pollination between genetically engineered 
        materials and materials that are not genetically engineered 
        materials; and
            ``(4) interference with the soil ecosystem and other 
        impacts on the ecosystem.
    ``(b) Authorization of Appropriations.--
            ``(1) In general.--There is authorized to be appropriated 
        $5,000,000 for fiscal year 2001 to carry out the objectives of 
        this section.
            ``(2) Availability.--Any sums appropriated under the 
        authorization contained in this subsection shall remain 
        available, without fiscal year limitation, until expended.
    ``(c) Definitions.--The terms `genetically engineered material' and 
`produced with a genetically engineered material' have the meanings 
given the terms in section 403(t)(3) of the Federal Food, Drug, and 
Cosmetic Act.''.

SEC. 5. CONFORMING AMENDMENTS.

    (a) Section 1(n) of Public Law 90-201 is amended--
            (1) in paragraph (11), by striking ``or'' at the end;
            (2) in paragraph (12), by striking the period at the end 
        and inserting ``; or''; and
            (3) by adding at the end the following:
            ``(13) if--
                    ``(A) it contains a genetically engineered 
                material, or was produced with a genetically engineered 
                material; and
                    ``(B)(i) it does not bear a label or labeling, as 
                appropriate, that provides the notices required under 
                the terms and conditions of section 403(t) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                343(t)); or
                    ``(ii) it is the subject of a false guaranty or 
                undertaking,
        subject to the terms and conditions of section 303(d) of that 
        Act (21 U.S.C. 333(d)) and subject to the penalties described 
        in section 303(h) of that Act (21 U.S.C. 333(h)) and remedies 
        available under this Act.''.
    (b) Section 4(h) of Public Law 85-172 is amended--
            (1) in paragraph (11), by striking ``or'' at the end;
            (2) in paragraph (12), by striking the period at the end 
        and inserting ``; or''; and
            (3) by adding at the end the following:
            ``(13) if--
                    ``(A) it contains a genetically engineered 
                material, or was produced with a genetically engineered 
                material; and
                    ``(B)(i) it does not bear a label or labeling, as 
                appropriate, that provides the notices required under 
                the terms and conditions of section 403(t) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                343(t)); or
                    ``(ii) it is the subject of a false guaranty or 
                undertaking,
        subject to the terms and conditions of section 303(d) of that 
        Act (21 U.S.C. 333(d)) and subject to the penalties described 
        in section 303(h) of that Act (21 U.S.C. 333(h)) and remedies 
        available under this Act.''.

SEC. 6. EFFECTIVE DATE.

    This Act and the amendments made by this Act take effect 180 days 
after the date of enactment of this Act.
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