[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2315 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2315

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 29, 2000

  Mr. Moynihan (for himself, Mr. Reid, and 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 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.

    Congress finds the following:
            (1) Genetic engineering is an artificial gene transfer 
        process 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 the food supply in this century.
            (4) Genetically engineered foods present new issues of 
        safety that have not been adequately studied.
            (5) United States consumers are increasing concerned that 
        food safety issues regarding genetically engineered foods are 
        not being adequately addressed.
            (6) Congress has previously required that food additives be 
        analyzed for their safety prior to their placement on the 
        market.
            (7) Adding new genes, and the substances that the genes 
        code for, into a food should be considered adding a food 
        additive, thus requiring an analysis of safety factors.
            (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 subparagraph (6) the 
        following:
``Such term includes the different genetic constructs, proteins of or 
other substances produced by 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, other than a 
genetic construct, protein or other substance, vector, promoter, marker 
system, or other appropriate term for which an application has been 
filed under section 505 or 512.''; 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.
    ``(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 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
            ``(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) The term `genetic food additive' means a genetic construct, 
protein or other substance, vector, promoter, marker system, or other 
appropriate term that is a food additive.''.
    (b) Petition To Establish Safety.--
            (1) Data in petition.--Section 409(b)(2) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(2)) is amended--
                    (A) in subparagraph (D), by striking ``and'' at the 
                end;
                    (B) in subparagraph (E), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(F) in the case of a genetic food additive, 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 subparagraphs 
(E) and (F) of paragraph (2) 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 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 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 information shall be made 
available to the public and the period for public comment described in 
subsection (c)(2)(B) shall be extended until the end of the 30th day 
after the information is made available.
    ``(C) In the case of a genetic food additive, the following rules 
shall apply:
            ``(i) The Secretary shall maintain and make available to 
        the public through electronic and non-electronic means a list 
        of petitions that are pending under this subsection and a list 
        of petitions for which regulations have been established under 
        subsection (c)(1)(A). 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, in a case 
        in which the 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 may not be 
issued under paragraph (1)(A) before the expiration of the 30-day 
period beginning on the date on which the Secretary has made 
information available to the public under subsection (b)(5)(B) 
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 a notice for the additive under 
subsection (b)(5), the Secretary shall inform the public of such 
opportunity.''.
            (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 the 
following:
            ``(A) Allergenicity effects resulting from added proteins, 
        including proteins not found in the food supply.
            ``(B) Appropriate types of toxicity of proteins or other 
        substances added to genetically engineered foods.
            ``(C) Pleiotropic effects. The Secretary shall require 
        tests to determine the potential for such effects, including 
        increased levels of toxins, or changes in the levels of 
        nutrients.
            ``(D) Changes in the functional characteristics of food.''.
            (5) Certain tests.--Section 409(c) of the Federal Food, 
        Drug, and Cosmetic Act, as amended by paragraph (4), is further 
        amended by adding at the end the following paragraph:
    ``(7) In the case of a genetic food additive, the following rules 
shall apply:
            ``(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) for the additive 
        if the petition filed under subsection (b)(1) for the additive 
        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) for the additive if the petition filed 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)(I) For purposes of clause (i), the Secretary shall 
        by regulation determine the best available biochemical and 
        physiological protocols.
            ``(II) In carrying out rulemaking under subclause (I), 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 
        further amended by adding at the end the following paragraph:
    ``(8)(A) In the case of a genetic food additive, the Secretary may 
only establish a regulation under paragraph (1)(A) for the additive if 
the regulation requires that a food containing the additive meet the 
requirements of subparagraph (C), in a case in which--
            ``(i) the additive is a protein and a report of an 
        investigation described in subsection (b)(2)(E) finds that the 
        additive is likely to be commonly or severely allergenic; or
            ``(ii) the additive is a protein and such 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.
    ``(B) Effective June 1, 2004, in the case of a genetic food 
additive, the Secretary may not establish a regulation under paragraph 
(1)(A), and shall repeal any regulation in effect under that paragraph, 
for the additive if 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 
1 or more antimicrobial drugs.
    ``(C) In a case described in clause (i) or (ii) of subparagraph 
(A), in order to meet the requirements of this subparagraph, a food 
that contains a genetic food additive shall--
            ``(i) bear a label or labeling that clearly and 
        conspicuously states the name of the allergen involved; or
            ``(ii) be offered for sale under a name that includes the 
        name of the allergen.''.
            (7) Additional provisions.--Section 409(c) of the Federal 
        Food, Drug, and Cosmetic Act, as amended by paragraph (6), is 
        further amended by adding at the end the following paragraph:
    ``(9)(A) In determining the safety for use of a genetic food 
additive under this subsection, the Secretary may (directly or through 
contract) conduct an investigation of such additive for purposes of 
supplementing the information provided to the Secretary pursuant to a 
petition filed under subsection (b)(1).
    ``(B) To provide Congress with a periodic independent, external 
review of the Secretary's formulation of the approval process carried 
out under paragraph (1)(A) that relates to genetic food additives, the 
Secretary shall enter into an agreement with the Institute of Medicine 
of the National Academy of Sciences. Such agreement shall provide that, 
if the Institute of Medicine has any concerns regarding the approval 
process, the Institute of Medicine will submit to Congress a report 
describing such concerns.
    ``(C) In the case of genetic food additives, petitions filed under 
subsection (b)(1) may not be categorically excluded from the 
application of the National Environmental Policy Act of 1969 (42 U.S.C. 
4321 et seq.).''.
    (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 
refer to 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 regulation 
issued under subsection (c) in response to a petition filed under 
subsection (b)(1). For purposes of this subsection, references in such 
provisions to information contained in such a petition shall be 
considered to be references to similar information in the possession of 
the Secretary.''.
    (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, 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:

``SEC. 409A. USER FEES REGARDING SAFETY OF GENETIC FOOD ADDITIVES.

    ``(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, shall be 
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 
regulation 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 required 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). 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 required 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); and
                    ``(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 subparagraph (A) or (B) of 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--
            ``(1) 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); or
            ``(2) collection of the fee would result in substantial 
        hardship for the person assessed for the fee.
    ``(e) Assessment of Fees.--
            ``(1) Limitation.--
                    ``(A) In general.--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 later fiscal year.
                    ``(B) Determinations.--In making determinations 
                under this paragraph for the fiscal years involved, the 
                Secretary shall exclude--
                            ``(i) the amounts appropriated under 
                        subsection (f)(2) for the fiscal years 
                        involved; and
                            ``(ii) 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)(A) 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)(1)(B) (which amount shall be so 
                        published).
                    ``(B) Subsequent fiscal years.--For each of the 4 
                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.
                    ``(C) Supplemental authorization of 
                appropriations.--In addition to sums authorized to be 
                appropriated under subparagraphs (A) and (B), there are 
                authorized to be appropriated, for the purposes 
                described in subsection (b)(1)(A), such sums as may be 
                necessary for the first applicable fiscal year and each 
                of the 4 subsequent fiscal years.
            ``(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.
                    ``(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 since the beginning of the first 
                        applicable fiscal year in the Consumer Price 
                        Index for All Urban Consumers (all items; 
                        United States city average); or
                            ``(ii) the total percentage change that 
                        occurred since the beginning of the first 
                        applicable 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 in which the 
Secretary does not receive payment of a fee assessed under subsection 
(a) within 30 days after the fee 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.--
            ``(1) In general.--In this section, the term `adjustment 
        factor' applicable to a fiscal year means the lower of--
                    ``(A) 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
                    ``(B) the total of discretionary budget authority 
                provided for programs in categories other than the 
                defense category for the 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 (2 U.S.C. 
                904(c))) 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 under section 254(f) of such 
                Act).
            ``(2) Budget authority; category.--In this subsection, the 
        terms `budget authority' and `category' have the meanings given 
        such terms in section 250 of the Balanced Budget and Emergency 
        Deficit Control Act of 1985 (2 U.S.C. 900).''.

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

    (a) Rulemaking; Effective Date.--
            (1) Rulemaking.--Not later than 1 year after the date of 
        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 (21 
        U.S.C. 349) in accordance with the amendments made by section 
        3, and criteria for carrying out section 409A of such Act (as 
        added by section 4).
            (2) Effective date.--Such amendments take effect on the 
        first day of the first fiscal year that begins after the date 
        of promulgation of the final regulation described in paragraph 
        (1).
    (b) Previously Unregulated Marketed Additives.--
            (1) In general.--In the case of a genetic food additive (as 
        defined in section 201(kk)(4) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321(kk)(4))) that in the United States 
        was in commercial use in food as of the day before the date on 
        which the final regulation described in subsection (a) is 
        promulgated, the amendments made by this Act apply to the 
        additive on the expiration of the 2-year period beginning on 
        the date on which the final regulation 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 filed under section 409(b)(1) of 
        such Act (21 U.S.C. 348(b)(1)) that is filed before the 
        expiration of the 2-year period described in such paragraph.
                                 <all>