Home > 106th Congressional Bills > H.R. 2918 (ih) To amend Public Law 89-108 to increase authorization levels for State [Introduced in House] ...

H.R. 2918 (ih) To amend Public Law 89-108 to increase authorization levels for State [Introduced in House] ...


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108th CONGRESS
  1st Session
                                H. R. 2917

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
    safety of genetically engineered foods, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 25, 2003

   Mr. Kucinich (for himself, Mr. DeFazio, Mr. Sanders, Ms. Lee, Mr. 
  Conyers, Mr. Olver, Mr. George Miller of California, Mr. Honda, Mr. 
Acevedo-Vila, Mr. Gutierrez, Mr. Nadler, Mr. Owens, Ms. Velazquez, Ms. 
  Waters, Ms. Watson, and Ms. Woolsey) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
    safety of genetically engineered foods, 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 Safety 
Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Genetic engineering is an artificial gene transfer 
        process wholly different from traditional breeding.
            (2) Genetic engineering can be used to produce new versions 
        of virtually all plant and animal foods. Thus, within a short 
        time, the food supply could consist almost entirely of 
        genetically engineered products.
            (3) This conversion from a food supply based on 
        traditionally bred organisms to one based on organisms produced 
        through genetic engineering could be one of the most important 
        changes in our food supply in this century.
            (4) Genetically engineered foods present new issues of 
        safety that have not been adequately studied.
            (5) The Congress has previously required that food 
        additives be analyzed for their safety prior to their placement 
        on the market.
            (6) Adding new genes into a food should be considered 
        adding a food additive, thus requiring an analysis of safety 
        factors.
            (7) Federal agencies have failed to uphold congressional 
        intent of the Food Additives Amendment of 1958 by allowing 
        genetically engineered foods to be marketed, sold and otherwise 
        used without requiring pre-market safety testing addressing 
        their unique characteristics.
            (8) The food additive process gives the Food and Drug 
        Administration discretion in applying the safety factors that 
        are generally recognized as appropriate to evaluate the safety 
        of food and food ingredients.
            (9) Given the consensus among the scientific community that 
        genetic engineering can potentially introduce hazards, such as 
        allergens or toxins, genetically engineered foods need to be 
        evaluated on a case-by-case basis and cannot be presumed to be 
        generally recognized as safe.

SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETICALLY ENGINEERED FOOD; 
              REGULATION AS FOOD ADDITIVE.

    (a) Inclusion in Definition of Food Additive.--Section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
            (1) in paragraph (s), by adding after and below 
        subparagraph (6) the following sentence:
``Such term includes the different genetic constructs, proteins of such 
constructs, vectors, promoters, marker systems, and other appropriate 
terms that are used or created as a result of the creation of a 
genetically engineered food (as defined in paragraph (nn)), other than 
a genetic construct, protein, vector, promoter, or marker system or 
other appropriate term for which an application under section 505 or 
512 has been filed. For purposes of this Act, the term `genetic food 
additive' means a genetic construct, protein, vector, promoter, or 
marker system or other appropriate term that is so included.''; and
            (2) by adding at the end the following:
    ``(nn)(1) The term `genetically engineered food' means food that 
contains or was produced with a genetically engineered material.
    ``(2) 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.
    ``(3) The term `genetically engineered organism' means--
            ``(A) an organism that has been altered at the molecular or 
        cellular level by means that are not possible under natural 
        conditions or processes (including but not limited to 
        recombinant DNA and RNA techniques, cell fusion, 
        microencapsulation, macroencapsulation, gene deletion and 
        doubling, introducing a foreign gene, and changing the 
        positions of genes), other than a means consisting exclusively 
        of breeding, conjugation, fermentation, hybridization, in vitro 
        fertilization, tissue culture, or mutagenesis; and
            ``(B) an organism made through sexual or asexual 
        reproduction (or both) involving an organism described in 
        clause (A), if possessing any of the altered molecular or 
        cellular characteristics of the organism so described.
    ``(4) For purposes of subparagraph (1), a food shall be considered 
to have been produced with a genetically engineered material if 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 mean that such commodities are produced with a genetically 
engineered material).''.
    (b) Petition To Establish Safety.--
            (1) Data in petition.--Section 409(b)(2)(E) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(2)(E)) is 
        amended by adding at the end the following sentence: ``In the 
        case of a genetic food additive, such reports shall include all 
        data that was collected or developed pursuant to the 
        investigations, including data that does not support the claim 
        of safety for use.''.
            (2) Notices; public availability of information.--Section 
        409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 348(b)(5)) is amended--
                    (A) by striking ``(5)'' and inserting ``(5)(A)''; 
                and
                    (B) by adding at the end the following 
                subparagraphs:
    ``(B) In the case of a genetic food additive:
            ``(i) Promptly after providing the notice under 
        subparagraph (A), the Secretary shall make available to the 
        public all reports and data described in paragraph (2)(E) that 
        are contained in the petition involved, and all other 
        information in the petition to the extent that the information 
        is relevant to a determination of the safety for use of the 
        additive.
            ``(ii) Such notice shall state whether any information in 
        the petition is not being made available to the public because 
        the Secretary has made a determination that the information 
        does not relate to the safety for use of the additive. Any 
        person may petition the Secretary for a reconsideration of such 
        a determination.
    ``(C) In the case of genetic food additives:
            ``(i) The Secretary shall maintain and make available to 
        the public through telecommunications a list of petitions that 
        are pending under this subsection and a list of petitions for 
        which regulations under subsection (c)(1)(A) have been 
        established. Such list shall include information on the 
        additives involved, including the source of the additives, and 
        including any information received by the Secretary pursuant to 
        clause (ii).
            ``(ii) If a regulation is in effect under subsection 
        (c)(1)(A) for a genetic food additive, any person who 
        manufactures such additive for commercial use shall submit to 
        the Secretary a notification of any knowledge of data that 
        relate to the adverse health effects of the additive, when 
        knowledge is acquired by the person after the date on which the 
        regulation took effect. If the manufacturer is in possession of 
        the data, the notification shall include the data. The 
        Secretary shall by regulation establish the scope of the 
        responsibilities of manufacturers under this clause, including 
        such limits on the responsibilities as the Secretary determines 
        to be appropriate.''.
            (3) Effective date of regulation regarding safe use; 
        opportunity for public comment.--Section 409(c)(2) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is 
        amended--
                    (A) by striking ``(2)'' and inserting ``(2)(A)''; 
                and
                    (B) by adding at the end the following 
                subparagraph:
    ``(B)(i) In the case of a genetic food additive, an order under 
paragraph (1)(A) may not be issued regarding the petition involved 
before the expiration of the applicable period under clause (ii). 
During such period, and continuing until an order under paragraph (1) 
is issued, the Secretary shall provide interested persons an 
opportunity to submit to the Secretary comments on the petition. In 
publishing such notice, the Secretary shall inform the public of such 
opportunity.
    ``(ii) For purposes of clause (i), the applicable period under this 
clause regarding a petition is the 30-day period beginning on the date 
on which the Secretary has under subparagraph (B)(i) of subsection 
(b)(5) made information available to the public regarding the petition, 
except that, if under subparagraph (B)(ii) of such subsection the 
Secretary finds in favor of a person who files for reconsideration 
(relating to a determination by the Secretary that information does not 
relate to safety), such 30-day period is extended by an additional 
period of 30-days. For purposes of the preceding sentence, a discrete 
30-day extension applies to each such reconsideration for which the 
Secretary finds in favor of the person filing for reconsideration.''.
            (4) Consideration of certain factors.--Section 409(c) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) is 
        amended by adding at the end the following paragraph:
    ``(6) In the case of a genetic food additive, the factors 
considered by the Secretary regarding safety for use shall include (but 
not be limited to) the results of the following analyses:
            ``(A) Allergenicity effects resulting from the added 
        proteins, including proteins not found in the food supply.
            ``(B) Pleiotropic effects. The Secretary shall require 
        tests to determine the potential for such effects (using 
        molecular characterization, biochemical characterization, mRNA 
        profiling, or other techniques, or as appropriate, combinations 
        of such techniques).
            ``(C) Appearance of new toxins or increased levels of 
        existing toxins.
            ``(D) Changes in the functional characteristics of food.
            ``(E) Changes in the levels of important nutrients.
            ``(F) Changes in the levels of anti-nutrients.''.
            (5) Certain tests.--Section 409(c) of the Federal Food, 
        Drug, and Cosmetic Act, as amended by paragraph (4), is amended 
        by adding at the end the following paragraph:
    ``(7) In the case of genetic food additives:
            ``(A) If a genetic food additive is a protein from a 
        commonly or severely allergenic food, the Secretary may not 
        establish a regulation under paragraph (1)(A) if the petition 
        under subsection (b)(1) fails to include full reports of 
        investigations that used serum or skin tests (or other advanced 
        techniques) on a sensitive population to determine whether such 
        additive is commonly or severely allergenic.
            ``(B)(i) If a genetic food additive is a protein that has 
        not undergone the investigations described in subparagraph (A), 
        the Secretary may not establish a regulation under paragraph 
        (1)(A) if the petition under subsection (b)(1) fails to include 
        full reports of investigations that used the best available 
        biochemical and physiological protocols to evaluate whether it 
        is likely that the protein involved is an allergen.
            ``(ii) For purposes of clause (i), the Secretary shall by 
        regulation determine the best available biochemical and 
        physiological protocols. In carrying out rulemaking under the 
        preceding sentence, the Secretary shall consult with the 
        Director of the National Institutes of Health.''.
            (6) Prohibited additives.--Section 409(c) of the Federal 
        Food, Drug, and Cosmetic Act, as amended by paragraph (5), is 
        amended by adding at the end the following paragraph:
    ``(8) In the case of a genetic food additive, the Secretary may not 
establish a regulation under paragraph (1)(A) if--
            ``(A) the additive is a protein and a report of an 
        investigation finds that the additive is likely to be commonly 
        or severely allergenic;
            ``(B) the additive is a protein and a report of an 
        investigation that uses a protocol described in paragraph 
        (7)(B) fails to find with reasonable certainty that the 
        additive is unlikely to be an allergen; or
            ``(C) effective June 1, 2006, a selective marker is used 
        with respect to the additive, the selective marker will remain 
        in the food involved when the food is marketed, and the 
        selective marker inhibits the function of one or more 
        antibiotics.''.
            (7) Additional provisions.--Section 409(c) of the Federal 
        Food, Drug, and Cosmetic Act, as amended by paragraph (6), is 
        amended by adding at the end the following paragraph:
    ``(9)(A) In determining the safety for use of genetic food 
additives, the Secretary may (directly or through contract) conduct 
investigations of such additives for purposes of supplementing the 
information provided to the Secretary pursuant to petitions under 
subsection (b)(1).
    ``(B) To provide the Congress with a periodic independent, external 
review of the Secretary's formulation of the approval process under 
paragraph (1)(A) that relates to genetic food additives, the Secretary 
shall enter into an agreement with the Institute of Medicine. Such 
agreement shall provide that, if the Institute of Medicine has any 
concerns regarding the approval process, the Institute of Medicine will 
submit to the Congress a report describing such concerns.''.
    (c) Regulation Issued on Secretary's Initiative.--Section 409(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(d)) is 
amended--
            (1) by striking ``(d) The Secretary'' and inserting 
        ``(d)(1) Subject to paragraph (2), the Secretary''; and
            (2) by adding at the end the following paragraph:
    ``(2) The provisions of subsections (b) and (c) that expressly 
reference genetic food additives apply with respect to a regulation 
proposed by the Secretary under paragraph (1) to the same extent and in 
the same manner as such provisions apply with respect to a petition 
filed under subsection (b)(1).''.
    (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 the adulteration of food by reason of failure to 
comply with the provisions of section 409 that relate to genetic food 
additives, any person engaging in such a violation shall be liable to 
the United States for a civil penalty in an amount not to exceed 
$100,000 for each such violation.
    ``(2) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty under paragraph (1) of this subsection to 
the same extent and in the same manner as such paragraphs (3) through 
(5) apply with respect to a civil penalty under paragraph (1) or (2) of 
subsection (g).''.

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