[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3883 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 3883

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2000

 Mr. Kucinich (for himself, Mr. Metcalf, Mr. Hinchey, Mr. Conyers, Mr. 
Sanders, Ms. Woolsey, and Ms. Lee) introduced the following bill; which 
               was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


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

    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 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.

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 (kk)), 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:
    ``(kk)(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, or tissue culture, 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, the Secretary, 
promptly after providing the notice under subparagraph (A), 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. 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, and if the Secretary finds in 
favor of such person, the period for public comment under subsection 
(c)(2)(B) shall be extended accordingly.
    ``(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) In the case of a genetic food additive, an order under 
paragraph (1)(A) may not be issued before the expiration of the 30-day 
period beginning on the date on which the Secretary has under 
subsection (b)(5) made information available to the public pursuant to 
a notification under such subsection regarding the petition involved. 
During such period (or such longer period as the Secretary may 
designate), 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.''.
            (3) 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.''.
            (4) Certain tests.--Section 409(c) of the Federal Food, 
        Drug, and Cosmetic Act, as amended by paragraph (3), 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.''.
            (5) Prohibited additives.--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:
    ``(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, 2004, 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.''.
            (6) Additional provisions.--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:
    ``(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) In the case of genetic food additives, petitions under 
subsection (b)(1) may not be categorically excluded for purposes of the 
National Environmental Policy Act.''.
    (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).''.
    (e) Rule of Construction.--With respect to section 409 of the 
Federal Food, Drug, and Cosmetic Act as amended by this section, 
compliance with the provisions of such section 409 that relate to 
genetic food additives does not constitute an affirmative defense in 
any cause of action under Federal or State law for personal injury 
resulting in whole or in part from a genetic food additive.

SEC. 4. USER FEES REGARDING DETERMINATION OF SAFETY OF GENETIC FOOD 
              ADDITIVES.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by inserting after section 409 the following 
section:

         ``user fees regarding safety of genetic food additives

    ``Sec. 409A. (a) In General.--In the case of genetic food 
additives, the Secretary shall in accordance with this section assess 
and collect a fee on each petition that is filed under section 
409(b)(1). The fee shall be collected from the person who submits the 
petition, is due upon submission of the petition, and shall be assessed 
in an amount determined under subsection (c). This section applies as 
of the first fiscal year that begins after the date of promulgation of 
the final rule required in section 5 of the Genetically Engineered Food 
Safety Act (referred to in this section as the `first applicable fiscal 
year').
    ``(b) Purpose of Fees.--
            ``(1) In general.--The purposes of fees under subsection 
        (a) are as follows:
                    ``(A) To defray increases in the costs of the 
                resources allocated for carrying out section 409 for 
                the first applicable fiscal year over the costs of 
                carrying out such section for the preceding fiscal 
                year, other than increases that are not attributable to 
                the responsibilities of the Secretary with respect to 
                genetic food additives.
                    ``(B) To provide for a program of basic and applied 
                research on the safety of genetic food additives (to be 
                carried out by the Commissioner of Food and Drugs). The 
                program shall address fundamental questions and 
                problems that arise repeatedly during the process of 
                reviewing petitions under section 409(b)(1) with 
                respect to genetic food additives, and shall not 
                directly support the development of new genetically 
                engineered foods.
            ``(2) Allocations by secretary.--Of the total fee revenues 
        collected under subsection (a) for a fiscal year, the Secretary 
        shall reserve and expend--
                    ``(A) 95 percent for the purpose described in 
                paragraph (1)(A) and
                    ``(B) 5 percent for the purpose described in 
                paragraph (1)(B).
            ``(3) Certain provisions regarding increased administrative 
        costs.--With respect to fees under subsection (a):
                    ``(A) Increases referred to in paragraph (1)(A) 
                include the costs of the Secretary in providing for 
                investigations under section 409(c)(9)(A).
                    ``(B) Increases referred to in paragraph (1)(A) 
                include increases in costs for an additional number of 
                full-time equivalent positions in the Department of 
                Health and Human Services to be engaged in carrying out 
                section 409 with respect to genetic food additives.
    ``(c) Total Fee Revenues; Individual Fee Amounts.--The total fee 
revenues collected under subsection (a) for a fiscal year shall be the 
amounts appropriated under subsection (f)(2) for such fiscal year. 
Individual fees shall be assessed by the Secretary on the basis of an 
estimate by the Secretary of the amount necessary to ensure that the 
sum of the fees collected for such fiscal year equals the amount so 
appropriated.
    ``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver 
from or a reduction of a fee assessed under subsection (a) if the 
Secretary finds that the fee to be paid will exceed the anticipated 
present and future costs incurred by the Secretary in carrying out the 
purposes described in subsection (b) (which finding may be made by the 
Secretary using standard costs).
    ``(e) Assessment of Fees.--
            ``(1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after the first 
        applicable fiscal year unless the amount appropriated for 
        salaries and expenses of the Food and Drug Administration for 
        such fiscal year is equal to or greater than the amount 
        appropriated for salaries and expenses of the Food and Drug 
        Administration for the first applicable fiscal year multiplied 
        by the adjustment factor applicable to the fiscal year 
        involved, except that in making determinations under this 
        paragraph for the fiscal years involved there shall be 
        excluded--
                    ``(A) the amounts appropriated under subsection 
                (f)(2) for the fiscal years involved; and
                    ``(B) the amounts appropriated under section 736(g) 
                for such fiscal years.
            ``(2) Authority.--If under paragraph (1) the Secretary does 
        not have authority to assess fees under subsection (a) during a 
        portion of a fiscal year, but does at a later date in such 
        fiscal year have such authority, the Secretary, notwithstanding 
        the due date under such subsection for fees, may assess and 
        collect such fees at any time in such fiscal year, without any 
        modification in the rate of the fees.
    ``(f) Crediting and Availability of Fees.--
            ``(1) In general.--Fees collected for a fiscal year 
        pursuant to subsection (a) shall be credited to the 
        appropriation account for salaries and expenses of the Food and 
        Drug Administration and shall be available in accordance with 
        appropriation Acts until expended without fiscal year 
        limitation. Such sums as may be necessary may be transferred 
        from the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the purposes described in paragraph (1) of 
        subsection (b), and the sums are subject to allocations under 
        paragraph (2) of such subsection.
            ``(2) Authorization of appropriations.--
                    ``(A) First fiscal year.--For the first applicable 
                fiscal year--
                            ``(i) there is authorized to be 
                        appropriated for fees under subsection (a) an 
                        amount equal to the amount of increase 
                        determined under subsection (b)(1) by the 
                        Secretary (which amount shall be published in 
                        the Federal Register); and
                            ``(ii) in addition, there is authorized to 
                        be appropriated for fees under subsection (a) 
                        an amount determined by the Secretary to be 
                        necessary to carry out the purpose described in 
                        subsection (b)(2) (which amount shall be so 
                        published).
                    ``(B) Subsequent fiscal years.--For each of the 
                four fiscal years following the first applicable fiscal 
                year--
                            ``(i) there is authorized to be 
                        appropriated for fees under subsection (a) an 
                        amount equal to the amount that applied under 
                        subparagraph (A)(i) for the first applicable 
                        fiscal year, except that such amount shall be 
                        adjusted under paragraph (3)(A) for the fiscal 
                        year involved; and
                            ``(ii) in addition, there is authorized to 
                        be appropriated for fees under subsection (a) 
                        an amount equal to the amount that applied 
                        under subparagraph (A)(ii) for the first 
                        applicable fiscal year, except that such amount 
                        shall be adjusted under paragraph (3)(B) for 
                        the fiscal year involved.
            ``(3) Adjustments.--
                    ``(A) Agency cost of resources.--For each fiscal 
                year other than the first applicable fiscal year, the 
                amount that applied under paragraph (2)(A)(i) for the 
                first applicable fiscal year shall be multiplied by the 
                adjustment factor (as defined in subsection (i)).
                    ``(B) Research program.--For each fiscal year other 
                than the first applicable fiscal year, the amount that 
                applied under paragraph (2)(A)(ii) for the first 
                applicable fiscal year shall be adjusted by the 
                Secretary (and as adjusted shall be published in the 
                Federal Register) to reflect the greater of--
                            ``(i) the total percentage change that 
                        occurred during the preceding fiscal year in 
                        the Consumer Price Index for all urban 
                        consumers (all items; U.S. city average); or
                            ``(ii) the total percentage change for such 
                        fiscal year in basic pay under the General 
                        Schedule in accordance with section 5332 of 
                        title 5, United States Code, as adjusted by any 
                        locality-based comparability payment pursuant 
                        to section 5304 of such title for Federal 
                        employees stationed in the District of 
                        Columbia.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under subsection (a) that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for a subsequent fiscal year.
    ``(g) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(h) Construction.--This section may not be construed as requiring 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employers, and advisory 
committees not engaged in carrying out section 409 with respect to 
genetic food additives be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
    ``(i) Definition of Adjustment Factor.--For purposes of this 
section, the term `adjustment factor' applicable to a fiscal year is 
the lower of--
            ``(1) the Consumer Price Index for all urban consumers (all 
        items; United States city average) for April of the preceding 
        fiscal year divided by such Index for April of the first 
        applicable fiscal year; or
            ``(2) the total of discretionary budget authority provided 
        for programs in categories other than the defense category for 
        the immediately preceding fiscal year (as reported in the 
        Office of Management and Budget sequestration preview report, 
        if available, required under section 254(c) of the Balanced 
        Budget and Emergency Deficit Control Act of 1985) divided by 
        such budget authority for the first applicable fiscal year (as 
        reported in the Office of Management and Budget final 
        sequestration report submitted for such year).
For purposes of this subsection, the terms `budget authority' and 
`category' have the meaning given such terms in the Balanced Budget and 
Emergency Deficit Control Act of 1985.''.

SEC. 5. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UNREGULATED MARKETED 
              ADDITIVES.

    (a) Rulemaking; Effective Date.--Not later than one year after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall by regulation establish criteria for carrying out 
section 409 of the Federal Food, Drug, and Cosmetic Act in accordance 
with the amendments made by section 3, and criteria for carrying out 
section 409A of such Act (as added by section 4). Such amendments take 
effect upon the expiration of the 30-day period beginning on the date 
on which the Secretary promulgates the final rule under the preceding 
sentence, subject to subsection (b).
    (b) Previously Unregulated Marketed Additives.--
            (1) In general.--In the case of a genetic food additive (as 
        defined pursuant to the amendments made by section (3)) that in 
        the United States was in commercial use in food as of the day 
        before the date on which the final rule under subsection (a) is 
        promulgated, the amendments made by this Act apply to the 
        additive upon the expiration of the two-year period beginning 
        on the date on which the final rule is promulgated, subject to 
        paragraph (2).
            (2) User fees.--With respect to a genetic food additive 
        described in paragraph (1), such paragraph does not waive the 
        applicability of section 409A of the Federal Food, Drug, and 
        Cosmetic Act to a petition under section 409(b)(1) of such Act 
        that is filed before the expiration of the two-year period 
        described in such paragraph.
                                 <all>