[Congressional Record Volume 146, Number 37 (Wednesday, March 29, 2000)]
[Senate]
[Pages S1894-S1897]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. MOYNIHAN (for himself, Mr. Reid, and Mrs. Boxer):
  S. 2315. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to the safety of genetically engineered foods, and for 
other purposes; to the Committee on Agriculture, Nutrition, and 
Forestry.


                 GENETICALLY ENGINEERED FOOD SAFETY ACT

 Mr. MOYNIHAN. Mr. President, today I am joined with Senator 
Reid and Senator Boxer to introduce the Genetically Engineered Food 
Safety Act (S. 2315), a bill to require food safety testing for 
genetically engineered foods.
  The ability to alter an organism by specifically transferring genetic 
codes between plants and animals is a new realm of science that we have 
only begun investigating. This technology has the promise to deliver 
real public goods: increased crop yields and products which combat 
disease and improve nutrition. But the technology also has the 
potential to pose a number of threats to the nation's public health, 
environment, and economy, and U.S. consumers are understandably 
concerned.
  The Federal Government has a duty to ensure that genetically 
engineered foods (GEFs) are safe to eat. The Food and Drug 
Administration (FDA) currently requires rigorous pre-market review for 
pharmaceutical drugs, biological products, and medical devices 
introduced in the U.S. market. For GEFs, however, FDA only asks the 
industry to submit safety data voluntarily. Even if industry fully 
complies, our concern is that a conflict of interest exists when an 
industry determines its own level of safety review for products it 
wants to promote.
  S. 2315 would simply give FDA discretion to conduct its own safety 
testing of new GEFs and requires that certain factors are examined. 
GEFs on the market today will remain on the market as long as FDA also 
reviews these products for health safety. Much like the current 
practice, funding for these tests will come primarily from industry. A 
fee system will be developed that is modeled after FDA's current 
program for reviewing pharmaceuticals and supplemented by Federal 
funding.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2315

       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

[[Page S1895]]

     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

[[Page S1896]]

     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

[[Page S1897]]

     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.
                                 ______