II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Genetically Engineered

5 Food Safety Act’’.

6 SEC. 2. FINDINGS.

7 Congress finds the following:

8 (1) Genetic engineering is an artificial gene

9 transfer process different from traditional breeding.
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1 (2) Genetic engineering can be used to produce

2 new versions of virtually all plant and animal foods.

3 Thus, within a short time, the food supply could

4 consist almost entirely of genetically engineered

5 products.

6 (3) This conversion from a food supply based

7 on traditionally bred organisms to one based on or8 ganisms produced through genetic engineering could

9 be one of the most important changes in the food

10 supply in this century.

11 (4) Genetically engineered foods present new

12 issues of safety that have not been adequately stud13 ied.

14 (5) United States consumers are increasing

15 concerned that food safety issues regarding geneti16 cally engineered foods are not being adequately ad17 dressed.

18 (6) Congress has previously required that food

19 additives be analyzed for their safety prior to their

20 placement on the market.

21 (7) Adding new genes, and the substances that

22 the genes code for, into a food should be considered

23 adding a food additive, thus requiring an analysis of

24 safety factors.
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1 (8) The food additive process gives the Food

2 and Drug Administration discretion in applying the

3 safety factors that are generally recognized as ap4 propriate to evaluate the safety of food and food in5 gredients.

6 SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETI7 CALLY ENGINEERED FOOD; REGULATION AS

8 FOOD ADDITIVE.

9 (a) INCLUSION IN DEFINITION OF FOOD ADDI10 TIVE.—Section 201 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 321) is amended—

12 (1) in paragraph (s), by adding after subpara13 graph (6) the following:

14 ‘‘Such term includes the different genetic constructs, pro15 teins of or other substances produced by such constructs,

16 vectors, promoters, marker systems, and other appropriate

17 terms that are used or created as a result of the creation

18 of a genetically engineered food, other than a genetic con19 struct, protein or other substance, vector, promoter, mark20 er system, or other appropriate term for which an applica21 tion has been filed under section 505 or 512.’’; and

22 (2) by adding at the end the following:

23 ‘‘(kk)(1) The term ‘genetically engineered food’

24 means food that contains or was produced with a geneti25 cally engineered material.
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1 ‘‘(2) The term ‘genetically engineered material’

2 means material derived from any part of a genetically en3 gineered organism.

4 ‘‘(3) The term ‘genetically engineered organism’

5 means—

6 ‘‘(A) an organism that has been altered at the

7 molecular or cellular level by means that are not

8 possible under natural conditions or processes (in9 cluding recombinant DNA and RNA techniques, cell

10 fusion, microencapsulation, macroencapsulation,

11 gene deletion and doubling, introduction of a foreign

12 gene, and a process that changes the positions of

13 genes), other than a means consisting exclusively of

14 breeding, conjugation, fermentation, hybridization,

15 in vitro fertilization, or tissue culture; and

16 ‘‘(B) an organism made through sexual or asex17 ual reproduction (or both) involving an organism de18 scribed in clause (A), if possessing any of the altered

19 molecular or cellular characteristics of the organism

20 so described.

21 ‘‘(4) The term ‘genetic food additive’ means a genetic

22 construct, protein or other substance, vector, promoter,

23 marker system, or other appropriate term that is a food

24 additive.’’.

25 (b) PETITION TO ESTABLISH SAFETY.—
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1 (1) DATA IN PETITION.—Section 409(b)(2) of

2 the Federal Food, Drug, and Cosmetic Act (21

3 U.S.C. 348(b)(2)) is amended—

4 (A) in subparagraph (D), by striking

5 ‘‘and’’ at the end;

6 (B) in subparagraph (E), by striking the

7 period and inserting ‘‘; and’’; and

8 (C) by adding at the end the following:

9 ‘‘(F) in the case of a genetic food additive, all

10 data that was collected or developed pursuant to the

11 investigations, including data that does not support

12 the claim of safety for use.’’.

13 (2) NOTICES; PUBLIC AVAILABILITY OF INFOR14 MATION.—Section 409(b)(5) of the Federal Food,

15 Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)) is

16 amended—

17 (A) by striking ‘‘(5)’’ and inserting

18 ‘‘(5)(A)’’; and

19 (B) by adding at the end the following sub20 paragraphs:

21 ‘‘(B) In the case of a genetic food additive, the Sec22 retary, promptly after providing the notice under subpara23 graph (A), shall make available to the public all reports

24 and data described in subparagraphs (E) and (F) of para25 graph (2) that are contained in the petition involved, and
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1 all other information in the petition to the extent that the

2 information is relevant to a determination of safety for

3 use of the additive. Such notice shall state whether any

4 information in the petition is not being made available to

5 the public because the Secretary has made a determination

6 that the information does not relate to safety for use of

7 the additive. Any person may petition the Secretary for

8 a reconsideration of such a determination, and if the Sec9 retary finds in favor of such person, the information shall

10 be made available to the public and the period for public

11 comment described in subsection (c)(2)(B) shall be ex12 tended until the end of the 30th day after the information

13 is made available.

14 ‘‘(C) In the case of a genetic food additive, the fol15 lowing rules shall apply:

16 ‘‘(i) The Secretary shall maintain and make

17 available to the public through electronic and non18 electronic means a list of petitions that are pending

19 under this subsection and a list of petitions for

20 which regulations have been established under sub21 section (c)(1)(A). Such list shall include information

22 on the additives involved, including the source of the

23 additives, and including any information received by

24 the Secretary pursuant to clause (ii).
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1 ‘‘(ii) If a regulation is in effect under sub2 section (c)(1)(A) for a genetic food additive, any

3 person who manufactures such additive for commer4 cial use shall submit to the Secretary a notification

5 of any knowledge of data that relate to the adverse

6 health effects of the additive, in a case in which the

7 knowledge is acquired by the person after the date

8 on which the regulation took effect. If the manufac9 turer is in possession of the data, the notification

10 shall include the data. The Secretary shall by regula11 tion establish the scope of the responsibilities of

12 manufacturers under this clause, including such lim13 its on the responsibilities as the Secretary deter14 mines to be appropriate.’’.

15 (3) EFFECTIVE DATE OF REGULATION REGARD16 ING SAFE USE; OPPORTUNITY FOR PUBLIC COM17 MENT.—Section 409(c)(2) of the Federal Food,

18 Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is

19 amended—

20 (A) by striking ‘‘(2)’’ and inserting

21 ‘‘(2)(A)’’; and

22 (B) by adding at the end the following sub23 paragraph:

24 ‘‘(B) In the case of a genetic food additive, an order

25 may not be issued under paragraph (1)(A) before the expi-
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1 ration of the 30-day period beginning on the date on which

2 the Secretary has made information available to the public

3 under subsection (b)(5)(B) regarding the petition in4 volved. During such period (or such longer period as the

5 Secretary may designate), the Secretary shall provide in6 terested persons an opportunity to submit to the Secretary

7 comments on the petition. In publishing a notice for the

8 additive under subsection (b)(5), the Secretary shall in9 form the public of such opportunity.’’.

10 (4) CONSIDERATION OF CERTAIN FACTORS.—

11 Section 409(c) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 348(c)) is amended by adding

13 at the end the following paragraph:

14 ‘‘(6) In the case of a genetic food additive, the factors

15 considered by the Secretary regarding safety for use shall

16 include the following:

17 ‘‘(A) Allergenicity effects resulting from added

18 proteins, including proteins not found in the food

19 supply.

20 ‘‘(B) Appropriate types of toxicity of proteins or

21 other substances added to genetically engineered

22 foods.

23 ‘‘(C) Pleiotropic effects. The Secretary shall re24 quire tests to determine the potential for such ef-
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1 fects, including increased levels of toxins, or changes

2 in the levels of nutrients.

3 ‘‘(D) Changes in the functional characteristics

4 of food.’’.

5 (5) CERTAIN TESTS.—Section 409(c) of the

6 Federal Food, Drug, and Cosmetic Act, as amended

7 by paragraph (4), is further amended by adding at

8 the end the following paragraph:

9 ‘‘(7) In the case of a genetic food additive, the fol10 lowing rules shall apply:

11 ‘‘(A) If a genetic food additive is a protein from

12 a commonly or severely allergenic food, the Sec13 retary may not establish a regulation under para14 graph (1)(A) for the additive if the petition filed

15 under subsection (b)(1) for the additive fails to in16 clude full reports of investigations that used serum

17 or skin tests (or other advanced techniques) on a

18 sensitive population to determine whether such addi19 tive is commonly or severely allergenic.

20 ‘‘(B)(i) If a genetic food additive is a protein

21 that has not undergone the investigations described

22 in subparagraph (A), the Secretary may not estab23 lish a regulation under paragraph (1)(A) for the ad24 ditive if the petition filed under subsection (b)(1)

25 fails to include full reports of investigations that
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1 used the best available biochemical and physiological

2 protocols to evaluate whether it is likely that the

3 protein involved is an allergen.

4 ‘‘(ii)(I) For purposes of clause (i), the Secretary

5 shall by regulation determine the best available bio6 chemical and physiological protocols.

7 ‘‘(II) In carrying out rulemaking under sub8 clause (I), the Secretary shall consult with the Di9 rector of the National Institutes of Health.’’.

10 (6) PROHIBITED ADDITIVES.—Section 409(c) of

11 the Federal Food, Drug, and Cosmetic Act, as

12 amended by paragraph (5), is further amended by

13 adding at the end the following paragraph:

14 ‘‘(8)(A) In the case of a genetic food additive, the

15 Secretary may only establish a regulation under paragraph

16 (1)(A) for the additive if the regulation requires that a

17 food containing the additive meet the requirements of sub18 paragraph (C), in a case in which—

19 ‘‘(i) the additive is a protein and a report of an

20 investigation described in subsection (b)(2)(E) finds

21 that the additive is likely to be commonly or severely

22 allergenic; or

23 ‘‘(ii) the additive is a protein and such a report

24 of an investigation that uses a protocol described in
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1 paragraph (7)(B) fails to find with reasonable cer2 tainty that the additive is unlikely to be an allergen.

3 ‘‘(B) Effective June 1, 2004, in the case of a genetic

4 food additive, the Secretary may not establish a regulation

5 under paragraph (1)(A), and shall repeal any regulation

6 in effect under that paragraph, for the additive if a selec7 tive marker is used with respect to the additive, the selec8 tive marker will remain in the food involved when the food

9 is marketed, and the selective marker inhibits the function

10 of 1 or more antimicrobial drugs.

11 ‘‘(C) In a case described in clause (i) or (ii) of sub12 paragraph (A), in order to meet the requirements of this

13 subparagraph, a food that contains a genetic food additive

14 shall—

15 ‘‘(i) bear a label or labeling that clearly and

16 conspicuously states the name of the allergen in17 volved; or

18 ‘‘(ii) be offered for sale under a name that in19 cludes the name of the allergen.’’.

20 (7) ADDITIONAL PROVISIONS.—Section 409(c)

21 of the Federal Food, Drug, and Cosmetic Act, as

22 amended by paragraph (6), is further amended by

23 adding at the end the following paragraph:

24 ‘‘(9)(A) In determining the safety for use of a genetic

25 food additive under this subsection, the Secretary may (di-
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1 rectly or through contract) conduct an investigation of

2 such additive for purposes of supplementing the informa3 tion provided to the Secretary pursuant to a petition filed

4 under subsection (b)(1).

5 ‘‘(B) To provide Congress with a periodic inde6 pendent, external review of the Secretary’s formulation of

7 the approval process carried out under paragraph (1)(A)

8 that relates to genetic food additives, the Secretary shall

9 enter into an agreement with the Institute of Medicine of

10 the National Academy of Sciences. Such agreement shall

11 provide that, if the Institute of Medicine has any concerns

12 regarding the approval process, the Institute of Medicine

13 will submit to Congress a report describing such concerns.

14 ‘‘(C) In the case of genetic food additives, petitions

15 filed under subsection (b)(1) may not be categorically ex16 cluded from the application of the National Environmental

17 Policy Act of 1969 (42 U.S.C. 4321 et seq.).’’.

18 (c) REGULATION ISSUED ON SECRETARY’S INITIA19 TIVE.—Section 409(d) of the Federal Food, Drug, and

20 Cosmetic Act (21 U.S.C. 348(d)) is amended—

21 (1) by striking ‘‘(d) The Secretary’’ and insert22 ing ‘‘(d)(1) Subject to paragraph (2), the Sec23 retary’’; and

24 (2) by adding at the end the following para25 graph:
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1 ‘‘(2) The provisions of subsections (b) and (c) that

2 expressly refer to genetic food additives apply with respect

3 to a regulation proposed by the Secretary under paragraph

4 (1) to the same extent and in the same manner as such

5 provisions apply with respect to a regulation issued under

6 subsection (c) in response to a petition filed under sub7 section (b)(1). For purposes of this subsection, references

8 in such provisions to information contained in such a peti9 tion shall be considered to be references to similar infor10 mation in the possession of the Secretary.’’.

11 (d) CIVIL PENALTIES.—Section 303 of the Federal

12 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend13 ed by adding at the end the following subsection:

14 ‘‘(h)(1) With respect to a violation of section 301(a),

15 301(b), or 301(c) involving the adulteration of food by rea16 son of failure to comply with the provisions of section 409

17 that relate to genetic food additives, any person engaging

18 in such a violation shall be liable to the United States for

19 a civil penalty in an amount not to exceed $100,000 for

20 each such violation.

21 ‘‘(2) Paragraphs (3) through (5) of subsection (g)

22 apply with respect to a civil penalty under paragraph (1)

23 of this subsection to the same extent and in the same man24 ner as such paragraphs (3) through (5) apply with respect
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1 to a civil penalty under paragraph (1) or (2) of subsection

2 (g).’’.

3 (e) RULE OF CONSTRUCTION.—With respect to sec4 tion 409 of the Federal Food, Drug, and Cosmetic Act,

5 compliance with the provisions of such section 409 that

6 relate to genetic food additives does not constitute an af7 firmative defense in any cause of action under Federal or

8 State law for personal injury resulting in whole or in part

9 from a genetic food additive.

10 SEC. 4. USER FEES REGARDING DETERMINATION OF SAFE11 TY OF GENETIC FOOD ADDITIVES.

12 Chapter IV of the Federal Food, Drug, and Cosmetic

13 Act (21 U.S.C. 341 et seq.) is amended by inserting after

14 section 409 the following section:

15 ‘‘SEC. 409A. USER FEES REGARDING SAFETY OF GENETIC

16 FOOD ADDITIVES.

17 ‘‘(a) IN GENERAL.—In the case of genetic food addi18 tives, the Secretary shall, in accordance with this section,

19 assess and collect a fee on each petition that is filed under

20 section 409(b)(1). The fee shall be collected from the per21 son who submits the petition, shall be due upon submis22 sion of the petition, and shall be assessed in an amount

23 determined under subsection (c). This section applies as

24 of the first fiscal year that begins after the date of promul25 gation of the final regulation required in section 5 of the
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1 Genetically Engineered Food Safety Act (referred to in

2 this section as the ‘first applicable fiscal year’).

3 ‘‘(b) PURPOSE OF FEES.—

4 ‘‘(1) IN GENERAL.—The purposes of fees re5 quired under subsection (a) are as follows:

6 ‘‘(A) To defray increases in the costs of

7 the resources allocated for carrying out section

8 409 for the first applicable fiscal year over the

9 costs of carrying out such section for the pre10 ceding fiscal year, other than increases that are

11 not attributable to the responsibilities of the

12 Secretary with respect to genetic food additives.

13 ‘‘(B) To provide for a program of basic

14 and applied research on the safety of genetic

15 food additives (to be carried out by the Com16 missioner). The program shall address funda17 mental questions and problems that arise re18 peatedly during the process of reviewing peti19 tions under section 409(b)(1) with respect to

20 genetic food additives, and shall not directly

21 support the development of new genetically en22 gineered foods.

23 ‘‘(2) ALLOCATIONS BY SECRETARY.—Of the

24 total fee revenues collected under subsection (a) for
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1 a fiscal year, the Secretary shall reserve and

2 expend—

3 ‘‘(A) 95 percent for the purpose described

4 in paragraph (1)(A); and

5 ‘‘(B) 5 percent for the purpose described

6 in paragraph (1)(B).

7 ‘‘(3) CERTAIN PROVISIONS REGARDING IN8 CREASED ADMINISTRATIVE COSTS.—With respect to

9 fees required under subsection (a)—

10 ‘‘(A) increases referred to in paragraph

11 (1)(A) include the costs of the Secretary in pro12 viding for investigations under section

13 409(c)(9)(A); and

14 ‘‘(B) increases referred to in paragraph

15 (1)(A) include increases in costs for an addi16 tional number of full-time equivalent positions

17 in the Department of Health and Human Serv18 ices to be engaged in carrying out section 409

19 with respect to genetic food additives.

20 ‘‘(c) TOTAL FEE REVENUES; INDIVIDUAL FEE

21 AMOUNTS.—The total fee revenues collected under sub22 section (a) for a fiscal year shall be the amounts appro23 priated under subparagraph (A) or (B) of subsection

24 (f)(2) for such fiscal year. Individual fees shall be assessed

25 by the Secretary on the basis of an estimate by the Sec-
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1 retary of the amount necessary to ensure that the sum

2 of the fees collected for such fiscal year equals the amount

3 so appropriated.

4 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary

5 shall grant a waiver from or a reduction of a fee assessed

6 under subsection (a) if the Secretary finds that—

7 ‘‘(1) the fee to be paid will exceed the antici8 pated present and future costs incurred by the Sec9 retary in carrying out the purposes described in sub10 section (b) (which finding may be made by the Sec11 retary using standard costs); or

12 ‘‘(2) collection of the fee would result in sub13 stantial hardship for the person assessed for the fee.

14 ‘‘(e) ASSESSMENT OF FEES.—

15 ‘‘(1) LIMITATION.—

16 ‘‘(A) IN GENERAL.—Fees may not be as17 sessed under subsection (a) for a fiscal year be18 ginning after the first applicable fiscal year un19 less the amount appropriated for salaries and

20 expenses of the Food and Drug Administration

21 for such fiscal year is equal to or greater than

22 the amount appropriated for salaries and ex23 penses of the Food and Drug Administration

24 for the first applicable fiscal year multiplied by
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1 the adjustment factor applicable to the later fis2 cal year.

3 ‘‘(B) DETERMINATIONS.—In making de4 terminations under this paragraph for the fiscal

5 years involved, the Secretary shall exclude—

6 ‘‘(i) the amounts appropriated under

7 subsection (f)(2) for the fiscal years in8 volved; and

9 ‘‘(ii) the amounts appropriated under

10 section 736(g) for such fiscal years.

11 ‘‘(2) AUTHORITY.—If under paragraph (1) the

12 Secretary does not have authority to assess fees

13 under subsection (a) during a portion of a fiscal

14 year, but does at a later date in such fiscal year

15 have such authority, the Secretary, notwithstanding

16 the due date under such subsection for fees, may as17 sess and collect such fees at any time in such fiscal

18 year, without any modification in the rate of the

19 fees.

20 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.—

21 ‘‘(1) IN GENERAL.—Fees collected for a fiscal

22 year pursuant to subsection (a) shall be credited to

23 the appropriation account for salaries and expenses

24 of the Food and Drug Administration and shall be

25 available in accordance with appropriation Acts until
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1 expended without fiscal year limitation. Such sums

2 as may be necessary may be transferred from the

3 Food and Drug Administration salaries and ex4 penses appropriation account without fiscal year lim5 itation to such appropriation account for salaries

6 and expenses with such fiscal year limitation. The

7 sums transferred shall be available solely for the

8 purposes described in paragraph (1) of subsection

9 (b), and the sums are subject to allocations under

10 paragraph (2) of such subsection.

11 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

12 ‘‘(A) FIRST FISCAL YEAR.—For the first

13 applicable fiscal year—

14 ‘‘(i) there is authorized to be appro15 priated for fees under subsection (a) an

16 amount equal to the amount of increase

17 determined under subsection (b)(1)(A) by

18 the Secretary (which amount shall be pub19 lished in the Federal Register); and

20 ‘‘(ii) in addition, there is authorized to

21 be appropriated for fees under subsection

22 (a) an amount determined by the Secretary

23 to be necessary to carry out the purpose

24 described in subsection (b)(1)(B) (which

25 amount shall be so published).
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1 ‘‘(B) SUBSEQUENT FISCAL YEARS.—For

2 each of the 4 fiscal years following the first ap3 plicable fiscal year—

4 ‘‘(i) there is authorized to be appro5 priated for fees under subsection (a) an

6 amount equal to the amount that applied

7 under subparagraph (A)(i) for the first ap8 plicable fiscal year, except that such

9 amount shall be adjusted under paragraph

10 (3)(A) for the fiscal year involved; and

11 ‘‘(ii) in addition, there is authorized to

12 be appropriated for fees under subsection

13 (a) an amount equal to the amount that

14 applied under subparagraph (A)(ii) for the

15 first applicable fiscal year, except that such

16 amount shall be adjusted under paragraph

17 (3)(B) for the fiscal year involved.

18 ‘‘(C) SUPPLEMENTAL AUTHORIZATION OF

19 APPROPRIATIONS.—In addition to sums author20 ized to be appropriated under subparagraphs

21 (A) and (B), there are authorized to be appro22 priated, for the purposes described in sub23 section (b)(1)(A), such sums as may be nec24 essary for the first applicable fiscal year and

25 each of the 4 subsequent fiscal years.
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1 ‘‘(3) ADJUSTMENTS.—

2 ‘‘(A) AGENCY COST OF RESOURCES.—For

3 each fiscal year other than the first applicable

4 fiscal year, the amount that applied under para5 graph (2)(A)(i) for the first applicable fiscal

6 year shall be multiplied by the adjustment fac7 tor.

8 ‘‘(B) RESEARCH PROGRAM.—For each fis9 cal year other than the first applicable fiscal

10 year, the amount that applied under paragraph

11 (2)(A)(ii) for the first applicable fiscal year

12 shall be adjusted by the Secretary (and as ad13 justed shall be published in the Federal Reg14 ister) to reflect the greater of—

15 ‘‘(i) the total percentage change that

16 occurred since the beginning of the first

17 applicable fiscal year in the Consumer

18 Price Index for All Urban Consumers (all

19 items; United States city average); or

20 ‘‘(ii) the total percentage change that

21 occurred since the beginning of the first

22 applicable fiscal year in basic pay under

23 the General Schedule in accordance with

24 section 5332 of title 5, United States

25 Code, as adjusted by any locality-based
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1 comparability payment pursuant to section

2 5304 of such title for Federal employees

3 stationed in the District of Columbia.

4 ‘‘(4) OFFSET.—Any amount of fees collected

5 for a fiscal year under subsection (a) that exceeds

6 the amount of fees specified in appropriation Acts

7 for such fiscal year shall be credited to the appro8 priation account of the Food and Drug Administra9 tion as provided in paragraph (1), and shall be sub10 tracted from the amount of fees that would other11 wise be authorized to be collected under this section

12 pursuant to appropriation Acts for a subsequent fis13 cal year.

14 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case in

15 which the Secretary does not receive payment of a fee as16 sessed under subsection (a) within 30 days after the fee

17 is due, such fee shall be treated as a claim of the United

18 States Government subject to subchapter II of chapter 37

19 of title 31, United States Code.

20 ‘‘(h) CONSTRUCTION.—This section may not be con21 strued as requiring that the number of full-time equivalent

22 positions in the Department of Health and Human Serv23 ices, for officers, employers, and advisory committees not

24 engaged in carrying out section 409 with respect to ge-
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1 netic food additives be reduced to offset the number of

2 officers, employees, and advisory committees so engaged.

3 ‘‘(i) DEFINITION OF ADJUSTMENT FACTOR.—

4 ‘‘(1) IN GENERAL.—In this section, the term

5 ‘adjustment factor’ applicable to a fiscal year means

6 the lower of—

7 ‘‘(A) the Consumer Price Index for All

8 Urban Consumers (all items; United States city

9 average) for April of the preceding fiscal year

10 divided by such Index for April of the first ap11 plicable fiscal year; or

12 ‘‘(B) the total of discretionary budget au13 thority provided for programs in categories

14 other than the defense category for the pre15 ceding fiscal year (as reported in the Office of

16 Management and Budget sequestration preview

17 report, if available, required under section

18 254(c) of the Balanced Budget and Emergency

19 Deficit Control Act of 1985 (2 U.S.C. 904(c)))

20 divided by such budget authority for the first

21 applicable fiscal year (as reported in the Office

22 of Management and Budget final sequestration

23 report submitted for such year under section

24 254(f) of such Act).
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1 ‘‘(2) BUDGET AUTHORITY; CATEGORY.—In this

2 subsection, the terms ‘budget authority’ and ‘cat3 egory’ have the meanings given such terms in sec4 tion 250 of the Balanced Budget and Emergency

5 Deficit Control Act of 1985 (2 U.S.C. 900).’’.

6 SEC. 5. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UN7 REGULATED MARKETED ADDITIVES.

8 (a) RULEMAKING; EFFECTIVE DATE.—

9 (1) RULEMAKING.—Not later than 1 year after

10 the date of enactment of this Act, the Secretary of

11 Health and Human Services shall by regulation es12 tablish criteria for carrying out section 409 of the

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

14 349) in accordance with the amendments made by

15 section 3, and criteria for carrying out section 409A

16 of such Act (as added by section 4).

17 (2) EFFECTIVE DATE.—Such amendments take

18 effect on the first day of the first fiscal year that be19 gins after the date of promulgation of the final regu20 lation described in paragraph (1).

21 (b) PREVIOUSLY UNREGULATED MARKETED ADDI22 TIVES.—

23 (1) IN GENERAL.—In the case of a genetic food

24 additive (as defined in section 201(kk)(4) of the

25 Federal Food, Drug, and Cosmetic Act (21 U.S.C.
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1 321(kk)(4))) that in the United States was in com2 mercial use in food as of the day before the date on

3 which the final regulation described in subsection (a)

4 is promulgated, the amendments made by this Act

5 apply to the additive on the expiration of the 2-year

6 period beginning on the date on which the final reg7 ulation is promulgated, subject to paragraph (2).

8 (2) USER FEES.—With respect to a genetic

9 food additive described in paragraph (1), such para10 graph does not waive the applicability of section

11 409A of the Federal Food, Drug, and Cosmetic Act

12 to a petition filed under section 409(b)(1) of such

13 Act (21 U.S.C. 348(b)(1)) that is filed before the ex14 piration of the 2-year period described in such para15 graph.

Æ