I 

108TH CONGRESS 

1ST SESSION H. R. 2917

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

safety of genetically engineered foods, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 25, 2003

Mr. KUCINICH (for himself, Mr. DEFAZIO, Mr. SANDERS, Ms. LEE, Mr. CONYERS, Mr. OLVER, Mr. GEORGE MILLER of California, Mr. HONDA, Mr. 

ACEVEDO-VILA ́, Mr. GUTIERREZ, Mr. NADLER, Mr. OWENS, Ms. 

VELA ́ZQUEZ, Ms. WATERS, Ms. WATSON, and Ms. WOOLSEY) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the safety of genetically engineered foods, and 

for other purposes.

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 The Congress finds as follows: 
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1 (1) Genetic engineering is an artificial gene 

2 transfer process wholly different from traditional 

3 breeding. 

4 (2) Genetic engineering can be used to produce 

5 new versions of virtually all plant and animal foods. 

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

7 consist almost entirely of genetically engineered 

8 products. 

9 (3) This conversion from a food supply based 

10 on traditionally bred organisms to one based on or11 ganisms produced through genetic engineering could 

12 be one of the most important changes in our food 

13 supply in this century. 

14 (4) Genetically engineered foods present new 

15 issues of safety that have not been adequately stud16 ied. 

17 (5) The Congress has previously required that 

18 food additives be analyzed for their safety prior to 

19 their placement on the market. 

20 (6) Adding new genes into a food should be 

21 considered adding a food additive, thus requiring an 

22 analysis of safety factors. 

23 (7) Federal agencies have failed to uphold con24 gressional intent of the Food Additives Amendment 

25 of 1958 by allowing genetically engineered foods to 
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1 be marketed, sold and otherwise used without re2 quiring pre-market safety testing addressing their 

3 unique characteristics. 

4 (8) The food additive process gives the Food 

5 and Drug Administration discretion in applying the 

6 safety factors that are generally recognized as ap7 propriate to evaluate the safety of food and food in8 gredients. 

9 (9) Given the consensus among the scientific 

10 community that genetic engineering can potentially 

11 introduce hazards, such as allergens or toxins, ge12 netically engineered foods need to be evaluated on a 

13 case-by-case basis and cannot be presumed to be 

14 generally recognized as safe. 

15 SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETI16 CALLY ENGINEERED FOOD; REGULATION AS 

17 FOOD ADDITIVE. 

18 (a) INCLUSION IN DEFINITION OF FOOD ADDI19 TIVE.—Section 201 of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 321) is amended—

21 (1) in paragraph (s), by adding after and below 

22 subparagraph (6) the following sentence: 

23 ‘‘Such term includes the different genetic constructs, pro24 teins of such constructs, vectors, promoters, marker sys25 tems, and other appropriate terms that are used or cre-
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1 ated as a result of the creation of a genetically engineered 

2 food (as defined in paragraph (nn)), other than a genetic 

3 construct, protein, vector, promoter, or marker system or 

4 other appropriate term for which an application under sec5 tion 505 or 512 has been filed. For purposes of this Act, 

6 the term ‘genetic food additive’ means a genetic construct, 

7 protein, vector, promoter, or marker system or other ap8 propriate term that is so included.’’; and 

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

10 ‘‘(nn)(1) The term ‘genetically engineered food’ 

11 means food that contains or was produced with a geneti12 cally engineered material. 

13 ‘‘(2) The term ‘genetically engineered material’ 

14 means material derived from any part of a genetically en15 gineered organism, without regard to whether the altered

16 molecular or cellular characteristics of the organism are 

17 detectable in the material. 

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

19 means—

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

21 molecular or cellular level by means that are not 

22 possible under natural conditions or processes (in23 cluding but not limited to recombinant DNA and 

24 RNA techniques, cell fusion, microencapsulation, 

25 macroencapsulation, gene deletion and doubling, in-
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1 troducing a foreign gene, and changing the positions 

2 of genes), other than a means consisting exclusively 

3 of breeding, conjugation, fermentation, hybridiza4 tion, in vitro fertilization, tissue culture, or 

5 mutagenesis; and 

6 ‘‘(B) an organism made through sexual or asex7 ual reproduction (or both) involving an organism de8 scribed in clause (A), if possessing any of the altered 

9 molecular or cellular characteristics of the organism 

10 so described. 

11 ‘‘(4) For purposes of subparagraph (1), a food shall 

12 be considered to have been produced with a genetically en13 gineered material if the organism from which the food is 

14 derived has been injected or otherwise treated with a ge15 netically engineered material (except that the use of ma16 nure as a fertilizer for raw agricultural commodities may 

17 not be construed to mean that such commodities are pro18 duced with a genetically engineered material).’’. 

19 (b) PETITION TO ESTABLISH SAFETY.—

20 (1) DATA IN PETITION.—Section 409(b)(2)(E) 

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

22 U.S.C. 348(b)(2)(E)) is amended by adding at the 

23 end the following sentence: ‘‘In the case of a genetic 

24 food additive, such reports shall include all data that 

25 was collected or developed pursuant to the investiga-
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1 tions, including data that does not support the claim 

2 of safety for use.’’. 

3 (2) NOTICES; PUBLIC AVAILABILITY OF INFOR4 MATION.—Section 409(b)(5) of the Federal Food, 

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

6 amended—

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

8 ‘‘(5)(A)’’; and 

9 (B) by adding at the end the following sub10 paragraphs: 

11 ‘‘(B) In the case of a genetic food additive: 

12 ‘‘(i) Promptly after providing the notice under 

13 subparagraph (A), the Secretary shall make avail14 able to the public all reports and data described in 

15 paragraph (2)(E) that are contained in the petition 

16 involved, and all other information in the petition to 

17 the extent that the information is relevant to a de18 termination of the safety for use of the additive. 

19 ‘‘(ii) Such notice shall state whether any infor20 mation in the petition is not being made available to 

21 the public because the Secretary has made a deter22 mination that the information does not relate to the 

23 safety for use of the additive. Any person may peti24 tion the Secretary for a reconsideration of such a de25 termination. 
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1 ‘‘(C) In the case of genetic food additives: 

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

3 available to the public through telecommunications a 

4 list of petitions that are pending under this sub5 section and a list of petitions for which regulations 

6 under subsection (c)(1)(A) have been established. 

7 Such list shall include information on the additives 

8 involved, including the source of the additives, and 

9 including any information received by the Secretary 

10 pursuant to clause (ii). 

11 ‘‘(ii) If a regulation is in effect under sub12 section (c)(1)(A) for a genetic food additive, any 

13 person who manufactures such additive for commer14 cial use shall submit to the Secretary a notification 

15 of any knowledge of data that relate to the adverse 

16 health effects of the additive, when knowledge is ac17 quired by the person after the date on which the 

18 regulation took effect. If the manufacturer is in pos19 session of the data, the notification shall include the 

20 data. The Secretary shall by regulation establish the 

21 scope of the responsibilities of manufacturers under 

22 this clause, including such limits on the responsibil23 ities as the Secretary determines to be appropriate.’’. 

24 (3) EFFECTIVE DATE OF REGULATION REGARD25 ING SAFE USE; OPPORTUNITY FOR PUBLIC COM-
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1 MENT.—Section 409(c)(2) of the Federal Food, 

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

3 amended—

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

5 ‘‘(2)(A)’’; and 

6 (B) by adding at the end the following sub7 paragraph: 

8 ‘‘(B)(i) In the case of a genetic food additive, an 

9 order under paragraph (1)(A) may not be issued regarding 

10 the petition involved before the expiration of the applicable 

11 period under clause (ii). During such period, and con12 tinuing until an order under paragraph (1) is issued, the 

13 Secretary shall provide interested persons an opportunity 

14 to submit to the Secretary comments on the petition. In 

15 publishing such notice, the Secretary shall inform the pub16 lic of such opportunity. 

17 ‘‘(ii) For purposes of clause (i), the applicable period 

18 under this clause regarding a petition is the 30-day period 

19 beginning on the date on which the Secretary has under 

20 subparagraph (B)(i) of subsection (b)(5) made informa21 tion available to the public regarding the petition, except 

22 that, if under subparagraph (B)(ii) of such subsection the 

23 Secretary finds in favor of a person who files for reconsid24 eration (relating to a determination by the Secretary that 

25 information does not relate to safety), such 30-day period 
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1 is extended by an additional period of 30-days. For pur2 poses of the preceding sentence, a discrete 30-day exten3 sion applies to each such reconsideration for which the 

4 Secretary finds in favor of the person filing for reconsider5 ation.’’. 

6 (4) CONSIDERATION OF CERTAIN FACTORS.—

7 Section 409(c) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 348(c)) is amended by adding 

9 at the end the following paragraph: 

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

11 considered by the Secretary regarding safety for use shall 

12 include (but not be limited to) the results of the following 

13 analyses:

14 ‘‘(A) Allergenicity effects resulting from the 

15 added proteins, including proteins not found in the 

16 food supply. 

17 ‘‘(B) Pleiotropic effects. The Secretary shall re18 quire tests to determine the potential for such ef19 fects (using molecular characterization, biochemical 

20 characterization, mRNA profiling, or other tech21 niques, or as appropriate, combinations of such tech22 niques). 

23 ‘‘(C) Appearance of new toxins or increased lev24 els of existing toxins. 
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1 ‘‘(D) Changes in the functional characteristics 

2 of food. 

3 ‘‘(E) Changes in the levels of important nutri4 ents. 

5 ‘‘(F) Changes in the levels of anti-nutrients.’’. 

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

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

8 by paragraph (4), is amended by adding at the end 

9 the following paragraph: 

10 ‘‘(7) In the case of genetic food additives: 

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) if the petition under subsection (b)(1) 

15 fails to include full reports of investigations that 

16 used serum or skin tests (or other advanced tech17 niques) on a sensitive population to determine 

18 whether such additive is commonly or severely aller19 genic. 

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) if the peti24 tion under subsection (b)(1) fails to include full re25 ports of investigations that used the best available 
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1 biochemical and physiological protocols to evaluate 

2 whether it is likely that the protein involved is an al3 lergen. 

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

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

7 rulemaking under the preceding sentence, the Sec8 retary shall consult with the Director of the Na9 tional 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 amended by adding at 

13 the end the following paragraph: 

14 ‘‘(8) In the case of a genetic food additive, the Sec15 retary may not establish a regulation under paragraph 

16 (1)(A) if—

17 ‘‘(A) the additive is a protein and a report of 

18 an investigation finds that the additive is likely to be 

19 commonly or severely allergenic; 

20 ‘‘(B) the additive is a protein and a report of 

21 an investigation that uses a protocol described in 

22 paragraph (7)(B) fails to find with reasonable cer23 tainty that the additive is unlikely to be an allergen; 

24 or 
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1 ‘‘(C) effective June 1, 2006, a selective marker 

2 is used with respect to the additive, the selective 

3 marker will remain in the food involved when the 

4 food is marketed, and the selective marker inhibits 

5 the function of one or more antibiotics.’’. 

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

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

8 amended by paragraph (6), is amended by adding at 

9 the end the following paragraph: 

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

11 food additives, the Secretary may (directly or through con12 tract) conduct investigations of such additives for pur13 poses of supplementing the information provided to the 

14 Secretary pursuant to petitions under subsection (b)(1). 

15 ‘‘(B) To provide the Congress with a periodic inde16 pendent, external review of the Secretary’s formulation of 

17 the approval process under paragraph (1)(A) that relates 

18 to genetic food additives, the Secretary shall enter into 

19 an agreement with the Institute of Medicine. Such agree20 ment shall provide that, if the Institute of Medicine has 

21 any concerns regarding the approval process, the Institute 

22 of Medicine will submit to the Congress a report describ23 ing such concerns.’’. 
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1 (c) REGULATION ISSUED ON SECRETARY’S INITIA2 TIVE.—Section 409(d) of the Federal Food, Drug, and 

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

4 (1) by striking ‘‘(d) The Secretary’’ and insert5 ing ‘‘(d)(1) Subject to paragraph (2), the Sec6 retary’’; and 

7 (2) by adding at the end the following para8 graph: 

9 ‘‘(2) The provisions of subsections (b) and (c) that 

10 expressly reference genetic food additives apply with re11 spect to a regulation proposed by the Secretary under 

12 paragraph (1) to the same extent and in the same manner 

13 as such provisions apply with respect to a petition filed 

14 under subsection (b)(1).’’.

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

16 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend17 ed by adding at the end the following subsection: 

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

19 301(b), or 301(c) involving the adulteration of food by rea20 son of failure to comply with the provisions of section 409 

21 that relate to genetic food additives, any person engaging 

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

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

24 each such violation. 
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1 ‘‘(2) Paragraphs (3) through (5) of subsection (g) 

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

3 of this subsection to the same extent and in the same man4 ner as such paragraphs (3) through (5) apply with respect 

5 to a civil penalty under paragraph (1) or (2) of subsection 

6 (g).’’. 

7 (e) CITIZEN SUITS.—Chapter III of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) 

9 is amended by adding at the end the following section: 

10 ‘‘CITIZEN SUITS REGARDING GENETIC FOOD ADDITIVES

11 ‘‘SEC. 311. (a) IN GENERAL.—Except as provided in 

12 subsection (c), any person may on his or her behalf com13 mence a civil action in an appropriate district court of the 

14 United States against—

15 ‘‘(1) a person who is alleged to have engaged in 

16 a violation of section 301(a), 301(b), or 301(c) in17 volving the adulteration of food by reason of failing 

18 to comply with the provisions of section 409 that re19 late to genetic food additives; or 

20 ‘‘(2) the Secretary where there is alleged a fail21 ure of the Secretary to perform any act or duty 

22 under section 409 that relates to such additives and 

23 is not discretionary. 

24 ‘‘(b) RELIEF.—In a civil action under subsection (a), 

25 the district court involved may, as the case may be—
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1 ‘‘(1) enforce the compliance of a person with 

2 the applicable provisions referred to paragraph (1) 

3 of such subsection; or 

4 ‘‘(2) order the Secretary to perform an act or 

5 duty referred to in paragraph (2) of such subsection. 

6 ‘‘(c) LIMITATIONS.—

7 ‘‘(1) NOTICE TO SECRETARY.—A civil action 

8 may not be commenced under subsection (a)(1) prior 

9 to 60 days after the plaintiff has provided to the 

10 Secretary notice of the violation involved. 

11 ‘‘(2) RELATION TO ACTIONS OF SECRETARY.—

12 A civil action may not be commenced under sub13 section (a)(2) if the Secretary has commenced and 

14 is diligently prosecuting a civil or criminal action in 

15 a district court of the United States to enforce com16 pliance with the applicable provisions referred to in 

17 subsection (a)(1). 

18 ‘‘(d) RIGHT OF SECRETARY TO INTERVENE.—In any 

19 civil action under subsection (a), the Secretary, if not a 

20 party, may intervene as a matter of right. 

21 ‘‘(e) AWARD OF COSTS; FILING OF BOND.—In a civil 

22 action under subsection (a), the district court involved 

23 may award costs of litigation (including reasonable attor24 ney and expert witness fees) to any party whenever the 

25 court determines such an award is appropriate. The court 
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1 may, if a temporary restraining order or preliminary in2 junction is sought, require the filing of a bond or equiva3 lent security in accordance with the Federal Rules of Civil 

4 Procedure. 

5 ‘‘(f) SAVINGS PROVISION.—This section does not re6 strict any right that a person (or class of persons) may 

7 have under any statute or common law to seek enforce8 ment of the provisions referred to subsection (a)(1), or to 

9 seek any other relief (including relief against the Sec10 retary).’’. 

11 (f) RULE OF CONSTRUCTION.—With respect to sec12 tion 409 of the Federal Food, Drug, and Cosmetic Act 

13 as amended by this section, compliance with the provisions 

14 of such section 409 that relate to genetic food additives 

15 does not constitute an affirmative defense in any cause 

16 of action under Federal or State law for personal injury 

17 resulting in whole or in part from a genetic food additive. 

18 SEC. 4. USER FEES REGARDING DETERMINATION OF SAFE19 TY OF GENETIC FOOD ADDITIVES. 

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

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

22 section 409 the following section: 

23 ‘‘USER FEES REGARDING SAFETY OF GENETIC FOOD

24 ADDITIVES

25 ‘‘SEC. 409A. (a) IN GENERAL.—In the case of ge26 netic food additives, the Secretary shall in accordance with 
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1 this section assess and collect a fee on each petition that 

2 is filed under section 409(b)(1). The fee shall be collected 

3 from the person who submits the petition, is due upon sub4 mission of the petition, and shall be assessed in an amount 

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

6 of the first fiscal year that begins after the date of promul7 gation of the final rule required in section 6 of the Geneti8 cally Engineered Food Safety Act (referred to in this sec9 tion as the ‘first applicable fiscal year’). 

10 ‘‘(b) PURPOSE OF FEES.—

11 ‘‘(1) IN GENERAL.—The purposes of fees under 

12 subsection (a) are as follows: 

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

14 the resources allocated for carrying out section 

15 409 for the first applicable fiscal year over the 

16 costs of carrying out such section for the pre17 ceding fiscal year, other than increases that are 

18 not attributable to the responsibilities of the 

19 Secretary with respect to genetic food additives. 

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

21 and applied research on the safety of genetic 

22 food additives (to be carried out by the Com23 missioner). The program shall address funda24 mental questions and problems that arise re25 peatedly during the process of reviewing peti-
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1 tions under section 409(b)(1) with respect to 

2 genetic food additives, and shall not directly 

3 support the development of new genetically en4 gineered foods. 

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

6 total fee revenues collected under subsection (a) for 

7 a fiscal year, the Secretary shall reserve and ex8 pend—

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

10 in paragraph (1)(A) and 

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

12 in paragraph (1)(B). 

13 ‘‘(3) CERTAIN PROVISIONS REGARDING IN14 CREASED ADMINISTRATIVE COSTS.—With respect to 

15 fees under subsection (a):

16 ‘‘(A) Increases referred to in paragraph 

17 (1)(A) include the costs of the Secretary in pro18 viding for investigations under section 

19 409(c)(9)(A). 

20 ‘‘(B) Increases referred to in paragraph 

21 (1)(A) include increases in costs for an addi22 tional number of full-time equivalent positions 

23 in the Department of Health and Human Serv24 ices to be engaged in carrying out section 409 

25 with respect to genetic food additives. 
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1 ‘‘(c) TOTAL FEE REVENUES; INDIVIDUAL FEE

2 AMOUNTS.—The total fee revenues collected under sub3 section (a) for a fiscal year shall be the amounts appro4 priated under subsection (f)(2) for such fiscal year. Indi5 vidual fees shall be assessed by the Secretary on the basis 

6 of an estimate by the Secretary of the amount necessary 

7 to ensure that the sum of the fees collected for such fiscal 

8 year equals the amount so appropriated. In assessing the 

9 individual fees, the Secretary shall by regulation provide 

10 for the assessment of reduced fee amounts for entities that 

11 are small businesses, or nonprofit private entities, as de12 fined by the Secretary for purposes of this section. 

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

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

15 under subsection (a) if the Secretary finds that the fee 

16 to be paid will exceed the anticipated present and future 

17 costs incurred by the Secretary in carrying out the pur18 poses described in subsection (b) (which finding may be 

19 made by the Secretary using standard costs). 

20 ‘‘(e) ASSESSMENT OF FEES.—

21 ‘‘(1) LIMITATION.—Fees may not be assessed 

22 under subsection (a) for a fiscal year beginning after 

23 the first applicable fiscal year unless the amount ap24 propriated for salaries and expenses of the Food and 

25 Drug Administration for such fiscal year is equal to 
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1 or greater than the amount appropriated for salaries 

2 and expenses of the Food and Drug Administration 

3 for the first applicable fiscal year multiplied by the 

4 adjustment factor applicable to the fiscal year in5 volved, except that in making determinations under 

6 this paragraph for the fiscal years involved there 

7 shall be excluded—

8 ‘‘(A) the amounts appropriated under sub9 section (f)(2) for the fiscal years involved; and 

10 ‘‘(B) the amounts appropriated under sec11 tion 736(g) for such fiscal years. 

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

13 Secretary does not have authority to assess fees 

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

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

16 have such authority, the Secretary, notwithstanding 

17 the due date under such subsection for fees, may as18 sess and collect such fees at any time in such fiscal 

19 year, without any modification in the rate of the 

20 fees. 

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

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

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

24 the appropriation account for salaries and expenses 

25 of the Food and Drug Administration and shall be 
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1 available in accordance with appropriation Acts until 

2 expended without fiscal year limitation. Such sums 

3 as may be necessary may be transferred from the 

4 Food and Drug Administration salaries and ex5 penses appropriation account without fiscal year lim6 itation to such appropriation account for salaries 

7 and expenses with such fiscal year limitation. The 

8 sums transferred shall be available solely for the 

9 purposes described in paragraph (1) of subsection 

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

11 paragraph (2) of such subsection. 

12 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

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

14 applicable fiscal year—

15 ‘‘(i) there is authorized to be appro16 priated for fees under subsection (a) an 

17 amount equal to the amount of increase 

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

19 the Secretary (which amount shall be pub20 lished in the Federal Register); and 

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

22 be appropriated for fees under subsection 

23 (a) an amount determined by the Secretary 

24 to be necessary to carry out the purpose 
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1 described in subsection (b)(1)(B) (which 

2 amount shall be so published). 

3 ‘‘(B) SUBSEQUENT FISCAL YEARS.—For 

4 each of the four fiscal years following the first 

5 applicable fiscal year—

6 ‘‘(i) there is authorized to be appro7 priated for fees under subsection (a) an 

8 amount equal to the amount that applied 

9 under subparagraph (A)(i) for the first ap10 plicable fiscal year, except that such 

11 amount shall be adjusted under paragraph 

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

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

14 be appropriated for fees under subsection 

15 (a) an amount equal to the amount that 

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

17 first applicable fiscal year, except that such 

18 amount shall be adjusted under paragraph 

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

20 ‘‘(3) ADJUSTMENTS.—

21 ‘‘(A) AGENCY COST OF RESOURCES.—For 

22 each fiscal year other than the first applicable 

23 fiscal year, the amount that applied under para24 graph (2)(A)(i) for the first applicable fiscal 
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1 year shall be multiplied by the adjustment fac2 tor (as defined in subsection (i)). 

3 ‘‘(B) RESEARCH PROGRAM.—For each fis4 cal year other than the first applicable fiscal 

5 year, the amount that applied under paragraph 

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

7 shall be adjusted by the Secretary (and as ad8 justed shall be published in the Federal Reg9 ister) to reflect the greater of—

10 ‘‘(i) the total percentage change that 

11 occurred during the preceding fiscal year 

12 in the Consumer Price Index for all urban 

13 consumers (all items; U.S. city average); or 

14 ‘‘(ii) the total percentage change for 

15 such fiscal year in basic pay under the 

16 General Schedule in accordance with sec17 tion 5332 of title 5, United States Code, 

18 as adjusted by any locality-based com19 parability payment pursuant to section 

20 5304 of such title for Federal employees 

21 stationed in the District of Columbia. 

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

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

24 the amount of fees specified in appropriation Acts 

25 for such fiscal year shall be credited to the appro-
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1 priation account of the Food and Drug Administra2 tion as provided in paragraph (1), and shall be sub3 tracted from the amount of fees that would other4 wise be authorized to be collected under this section 

5 pursuant to appropriation Acts for a subsequent fis6 cal year. 

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

8 where the Secretary does not receive payment of a fee as9 sessed under subsection (a) within 30 days after it is due, 

10 such fee shall be treated as a claim of the United States 

11 Government subject to subchapter II of chapter 37 of title 

12 31, United States Code. 

13 ‘‘(h) CONSTRUCTION.—This section may not be con14 strued as requiring that the number of full-time equivalent 

15 positions in the Department of Health and Human Serv16 ices, for officers, employers, and advisory committees not 

17 engaged in carrying out section 409 with respect to ge18 netic food additives be reduced to offset the number of 

19 officers, employees, and advisory committees so engaged. 

20 ‘‘(i) DEFINITION OF ADJUSTMENT FACTOR.—For 

21 purposes of this section, the term ‘adjustment factor’ ap22 plicable to a fiscal year is the lower of—

23 ‘‘(1) the Consumer Price Index for all urban 

24 consumers (all items; United States city average) for 
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1 April of the preceding fiscal year divided by such 

2 Index for April of the first applicable fiscal year; or 

3 ‘‘(2) the total of discretionary budget authority 

4 provided for programs in categories other than the 

5 defense category for the immediately preceding fiscal 

6 year (as reported in the Office of Management and 

7 Budget sequestration preview report, if available, re8 quired under section 254(c) of the Balanced Budget 

9 and Emergency Deficit Control Act of 1985) divided 

10 by such budget authority for the first applicable fis11 cal year (as reported in the Office of Management 

12 and Budget final sequestration report submitted for 

13 such year). 

14 For purposes of this subsection, the terms ‘budget author15 ity’ and ‘category’ have the meaning given such terms in 

16 the Balanced Budget and Emergency Deficit Control Act 

17 of 1985.’’. 

18 SEC. 5. EMBARGO AUTHORITY. 

19 (a) EMBARGO.—

20 (1) TEMPORARY DETENTION.—Section 

21 304(g)(1) of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 334(g)(1)) is amended—

23 (A) in the first sentence—

24 (i) by striking ‘‘If during’’ and all 

25 that follows through ‘‘order the device de-
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1 tained’’ and inserting the following: ‘‘If, 

2 during an inspection conducted under sec3 tion 704, an officer or employee of the De4 partment has reason to believe that a food 

5 or device is in violation of this Act, such 

6 officer or employee may order the food or 

7 device detained’’; and 

8 (ii) by striking ‘‘he may authorize’’ 

9 and inserting ‘‘the Secretary may author10 ize’’; 

11 (B) in the second and third sentences, by 

12 striking ‘‘device’’ each place such term appears 

13 and inserting ‘‘food or device’’; 

14 (C) by striking the fourth and fifth sen15 tences; and 

16 (D) by adding at the end the following sen17 tence: ‘‘A detention order under this paragraph 

18 shall be considered final agency action.’’.

19 (2) CONFORMING AMENDMENTS.—Chapter III 

20 of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 331 et seq.) is amended—

22 (A) in section 301(r)—

23 (i) by striking ‘‘device’’ the first place 

24 such term appears and inserting ‘‘food or 

25 device’’; and 
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1 (ii) by striking ‘‘the device’’ and in2 serting ‘‘such food or device’’; and 

3 (B) in section 304(g)(2), by striking ‘‘de4 vice’’ each place such term appears and insert5 ing ‘‘food or device’’. 

6 (b) DATE CERTAIN FOR PROPOSED AND FINAL

7 RULES.—Within six months of the date of the enactment 

8 of this Act, the Secretary of Health and Human Services 

9 shall propose a revision to the regulations in effect on such 

10 date under section 304(g) of the Federal Food, Drug, and 

11 Cosmetic Act to include food. Within three months of the 

12 date such proposed revision is published in the Federal 

13 Register, the Secretary shall issue a final revision of such 

14 regulations. 

15 (c) CONFIDENTIALITY.—For any food embargoed, 

16 seized, or recalled under the Federal Food, Drug, and Cos17 metic Act, the Food and Drug Administration shall dis18 close all necessary information without regard to business 

19 confidentiality, if such disclosure is necessary to fully em20 bargo, seize, or recall any adulterated food. 

21 (d) FOOD RETAILER REGISTRATION.—All food re22 tailers shall register with the Food and Drug Administra23 tion for the purpose of expediting recalls, embargoes, and 

24 seizures under the Federal Food, Drug, and Cosmetic Act. 
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1 SEC. 6. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UN2 REGULATED MARKETED ADDITIVES. 

3 (a) RULEMAKING; EFFECTIVE DATE.—Not later 

4 than one year after the date of the enactment of this Act, 

5 the Secretary of Health and Human Services shall by reg6 ulation establish criteria for carrying out section 409 of 

7 the Federal Food, Drug, and Cosmetic Act in accordance 

8 with the amendments made by section 3, and criteria for 

9 carrying out section 409A of such Act (as added by section 

10 4). Such amendments take effect upon the expiration of 

11 the 30-day period beginning on the date on which the Sec12 retary promulgates the final rule under the preceding sen13 tence, subject to subsection (b). 

14 (b) PREVIOUSLY UNREGULATED MARKETED ADDI15 TIVES.—

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

17 additive (as defined pursuant to the amendments 

18 made by section (3)) that in the United States was 

19 in commercial use in food as of the day before the 

20 date on which the final rule under subsection (a) is 

21 promulgated, the amendments made by this Act 

22 apply to the additive upon the expiration of the two23 year period beginning on the date on which the final 

24 rule is promulgated, subject to paragraph (2). 

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

26 food additive described in paragraph (1), such para-
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1 graph does not waive the applicability of section 

2 409A of the Federal Food, Drug, and Cosmetic Act 

3 to a petition under section 409(b)(1) of such Act 

4 that is filed before the expiration of the two-year pe5 riod described in such paragraph.

Æ