I 

109TH CONGRESS 

2D SESSION H. R. 5268 

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 

MAY 2, 2006 

Mr. KUCINICH (for himself, Mr. CONYERS, Ms. LEE, Mr. SANDERS, Ms. WATERS, Mr. OLVER, Mr. NADLER, and Mr. GEORGE MILLER of California) 

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 creVerDate Aug 31 2005 20:48 May 07, 2006 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5268.IH H5268

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1 ated as a result of the creation of a genetically engineered 

2 food (as defined in paragraph (rr)), 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 ‘‘(rr)(1) The term ‘genetically engineered food’ means 

11 food that contains or was produced with a genetically engi12 neered 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, inVerDate Aug 31 2005 20:48 May 07, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5268.IH H5268

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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) of 

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

22 U.S.C. 348(b)(2)) is amended by adding after and 

23 below subparagraph (E) the following sentence: 

24 ‘‘In the case of a genetic food additive, such reports shall 

25 include all data that was collected or developed pursuant 


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1 to the investigations, including data that does not support 

2 the claim 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 COMVerDate Aug 31 2005 08:19 May 03, 2006 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5268.IH H5268

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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 ‘‘(g)(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 (f) 

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 (f).’’. 

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 ‘‘SEC. 311. CITIZEN SUITS REGARDING GENETIC FOOD AD11 DITIVES. 

12 ‘‘(a) IN GENERAL.—Except as provided in subsection 

13 (c), any person may on his or her behalf commence a civil 

14 action in an appropriate district court of the United States 

15 against— 

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

17 a violation of section 301(a), 301(b), or 301(c) in18 volving the adulteration of food by reason of failing 

19 to comply with the provisions of section 409 that re20 late to genetic food additives; or 

21 ‘‘(2) the Secretary where there is alleged a fail22 ure of the Secretary to perform any act or duty 

23 under section 409 that relates to such additives and 

24 is not discretionary. 


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

2 the district court involved may, as the case may be— 

3 ‘‘(1) enforce the compliance of a person with 

4 the applicable provisions referred to paragraph (1) 

5 of such subsection; or 

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

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

8 ‘‘(c) LIMITATIONS.— 

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

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

11 to 60 days after the plaintiff has provided to the 

12 Secretary notice of the violation involved. 

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

14 A civil action may not be commenced under sub15 section (a)(2) if the Secretary has commenced and 

16 is diligently prosecuting a civil or criminal action in 

17 a district court of the United States to enforce com18 pliance with the applicable provisions referred to in 

19 subsection (a)(1). 

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

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

22 party, may intervene as a matter of right. 

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

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

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1 ney and expert witness fees) to any party whenever the 

2 court determines such an award is appropriate. The court 

3 may, if a temporary restraining order or preliminary in4 junction is sought, require the filing of a bond or equiva5 lent security in accordance with the Federal Rules of Civil 

6 Procedure. 

7 ‘‘(f) SAVINGS PROVISION.—This section does not re8 strict any right that a person (or class of persons) may 

9 have under any statute or common law to seek enforce10 ment of the provisions referred to subsection (a)(1), or to 

11 seek any other relief (including relief against the Sec12 retary).’’. 

13 (f) RULE OF CONSTRUCTION.—With respect to sec14 tion 409 of the Federal Food, Drug, and Cosmetic Act 

15 as amended by this section, compliance with the provisions 

16 of such section 409 that relate to genetic food additives 

17 does not constitute an affirmative defense in any cause 

18 of action under Federal or State law for personal injury 

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

20 SEC. 4. USER FEES REGARDING DETERMINATION OF SAFE21 TY OF GENETIC FOOD ADDITIVES. 

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

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

24 section 409 the following section: 


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

2 FOOD ADDITIVES. 

3 ‘‘(a) IN GENERAL.—In the case of genetic food addi4 tives, the Secretary shall in accordance with this section 

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

6 section 409(b)(1). The fee shall be collected from the per7 son who submits the petition, is due upon submission of 

8 the petition, and shall be assessed in an amount deter9 mined under subsection (c). This section applies as of the 

10 first fiscal year that begins after the date of promulgation 

11 of the final rule required in section 6 of the Genetically 

12 Engineered Food Safety Act (referred to in this section 

13 as the ‘first applicable fiscal year’). 

14 ‘‘(b) PURPOSE OF FEES.— 

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

16 subsection (a) are as follows: 

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

18 the resources allocated for carrying out section 

19 409 for the first applicable fiscal year over the 

20 costs of carrying out such section for the pre21 ceding fiscal year, other than increases that are 

22 not attributable to the responsibilities of the 

23 Secretary with respect to genetic food additives. 

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

25 and applied research on the safety of genetic 

26 food additives (to be carried out by the ComVerDate Aug 31 2005 08:19 May 03, 2006 Jkt 049200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H5268.IH H5268

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1 missioner). The program shall address funda2 mental questions and problems that arise re3 peatedly during the process of reviewing peti4 tions under section 409(b)(1) with respect to 

5 genetic food additives, and shall not directly 

6 support the development of new genetically en7 gineered foods. 

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

9 total fee revenues collected under subsection (a) for 

10 a fiscal year, the Secretary shall reserve and ex11 pend— 

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

13 in paragraph (1)(A) and 

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

15 in paragraph (1)(B). 

16 ‘‘(3) CERTAIN PROVISIONS REGARDING IN17 CREASED ADMINISTRATIVE COSTS.—With respect to 

18 fees under subsection (a): 

19 ‘‘(A) Increases referred to in paragraph 

20 (1)(A) include the costs of the Secretary in pro21 viding for investigations under section 

22 409(c)(9)(A). 

23 ‘‘(B) Increases referred to in paragraph 

24 (1)(A) include increases in costs for an addi25 tional number of full-time equivalent positions 


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1 in the Department of Health and Human Serv2 ices to be engaged in carrying out section 409 

3 with respect to genetic food additives. 

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

5 AMOUNTS.—The total fee revenues collected under sub6 section (a) for a fiscal year shall be the amounts appro7 priated under subsection (f)(2) for such fiscal year. Indi8 vidual fees shall be assessed by the Secretary on the basis 

9 of an estimate by the Secretary of the amount necessary 

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

11 year equals the amount so appropriated. In assessing the 

12 individual fees, the Secretary shall by regulation provide 

13 for the assessment of reduced fee amounts for entities that 

14 are small businesses, or nonprofit private entities, as de15 fined by the Secretary for purposes of this section. 

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

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

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

19 to be paid will exceed the anticipated present and future 

20 costs incurred by the Secretary in carrying out the pur21 poses described in subsection (b) (which finding may be 

22 made by the Secretary using standard costs). 

23 ‘‘(e) ASSESSMENT OF FEES.— 

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

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


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1 the first applicable fiscal year unless the amount ap2 propriated for salaries and expenses of the Food and 

3 Drug Administration for such fiscal year is equal to 

4 or greater than the amount appropriated for salaries 

5 and expenses of the Food and Drug Administration 

6 for the first applicable fiscal year multiplied by the 

7 adjustment factor applicable to the fiscal year in8 volved, except that in making determinations under 

9 this paragraph for the fiscal years involved there 

10 shall be excluded— 

11 ‘‘(A) the amounts appropriated under sub12 section (f)(2) for the fiscal years involved; and 

13 ‘‘(B) the amounts appropriated under sec14 tion 736(g) for such fiscal years. 

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

16 Secretary does not have authority to assess fees 

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

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

19 have such authority, the Secretary, notwithstanding 

20 the due date under such subsection for fees, may as21 sess and collect such fees at any time in such fiscal 

22 year, without any modification in the rate of the 

23 fees. 

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


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

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

3 the appropriation account for salaries and expenses 

4 of the Food and Drug Administration and shall be 

5 available in accordance with appropriation Acts until 

6 expended without fiscal year limitation. Such sums 

7 as may be necessary may be transferred from the 

8 Food and Drug Administration salaries and ex9 penses appropriation account without fiscal year lim10 itation to such appropriation account for salaries 

11 and expenses with such fiscal year limitation. The 

12 sums transferred shall be available solely for the 

13 purposes described in paragraph (1) of subsection 

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

15 paragraph (2) of such subsection. 

16 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

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

18 applicable fiscal year— 

19 ‘‘(i) there is authorized to be appro20 priated for fees under subsection (a) an 

21 amount equal to the amount of increase 

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

23 the Secretary (which amount shall be pub24 lished in the Federal Register); and 


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

2 be appropriated for fees under subsection 

3 (a) an amount determined by the Secretary 

4 to be necessary to carry out the purpose 

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

6 amount shall be so published). 

7 ‘‘(B) SUBSEQUENT FISCAL YEARS.—For 

8 each of the four fiscal years following the first 

9 applicable fiscal year— 

10 ‘‘(i) there is authorized to be appro11 priated for fees under subsection (a) an 

12 amount equal to the amount that applied 

13 under subparagraph (A)(i) for the first ap14 plicable fiscal year, except that such 

15 amount shall be adjusted under paragraph 

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

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

18 be appropriated for fees under subsection 

19 (a) an amount equal to the amount that 

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

21 first applicable fiscal year, except that such 

22 amount shall be adjusted under paragraph 

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

24 ‘‘(3) ADJUSTMENTS.— 


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

2 each fiscal year other than the first applicable 

3 fiscal year, the amount that applied under para4 graph (2)(A)(i) for the first applicable fiscal 

5 year shall be multiplied by the adjustment fac6 tor (as defined in subsection (i)). 

7 ‘‘(B) RESEARCH PROGRAM.—For each fis8 cal year other than the first applicable fiscal 

9 year, the amount that applied under paragraph 

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

11 shall be adjusted by the Secretary (and as ad12 justed shall be published in the Federal Reg13 ister) to reflect the greater of— 

14 ‘‘(i) the total percentage change that 

15 occurred during the preceding fiscal year 

16 in the Consumer Price Index for all urban 

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

18 ‘‘(ii) the total percentage change for 

19 such fiscal year in basic pay under the 

20 General Schedule in accordance with sec21 tion 5332 of title 5, United States Code, 

22 as adjusted by any locality-based com23 parability payment pursuant to section 

24 5304 of such title for Federal employees 

25 stationed in the District of Columbia. 


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

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

3 the amount of fees specified in appropriation Acts 

4 for such fiscal year shall be credited to the appro5 priation account of the Food and Drug Administra6 tion as provided in paragraph (1), and shall be sub7 tracted from the amount of fees that would other8 wise be authorized to be collected under this section 

9 pursuant to appropriation Acts for a subsequent fis10 cal year. 

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

12 where the Secretary does not receive payment of a fee as13 sessed under subsection (a) within 30 days after it is due, 

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

15 Government subject to subchapter II of chapter 37 of title 

16 31, United States Code. 

17 ‘‘(h) CONSTRUCTION.—This section may not be con18 strued as requiring that the number of full-time equivalent 

19 positions in the Department of Health and Human Serv20 ices, for officers, employers, and advisory committees not 

21 engaged in carrying out section 409 with respect to ge22 netic food additives be reduced to offset the number of 

23 officers, employees, and advisory committees so engaged. 


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

2 purposes of this section, the term ‘adjustment factor’ ap3 plicable to a fiscal year is the lower of— 

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

5 consumers (all items; United States city average) for 

6 April of the preceding fiscal year divided by such 

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

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

9 provided for programs in categories other than the 

10 defense category for the immediately preceding fiscal 

11 year (as reported in the Office of Management and 

12 Budget sequestration preview report, if available, re13 quired under section 254(c) of the Balanced Budget 

14 and Emergency Deficit Control Act of 1985) divided 

15 by such budget authority for the first applicable fis16 cal year (as reported in the Office of Management 

17 and Budget final sequestration report submitted for 

18 such year). 

19 For purposes of this subsection, the terms ‘budget author20 ity’ and ‘category’ have the meaning given such terms in 

21 the Balanced Budget and Emergency Deficit Control Act 

22 of 1985.’’. 

23 SEC. 5. EMBARGO AUTHORITY. 

24 (a) EMBARGO.— 


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1 (1) TEMPORARY DETENTION.—Section 

2 304(g)(1) of the Federal Food, Drug, and Cosmetic 

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

4 (A) in the first sentence— 

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

6 that follows through ‘‘order the device de7 tained’’ and inserting the following: ‘‘If, 

8 during an inspection conducted under sec9 tion 704, an officer or employee of the De10 partment has reason to believe that a food 

11 or device is in violation of this Act, such 

12 officer or employee may order the food or 

13 device detained’’; and 

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

15 and inserting ‘‘the Secretary may author16 ize’’; 

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

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

19 and inserting ‘‘food or device’’; 

20 (C) by striking the fourth and fifth sen21 tences; and 

22 (D) by adding at the end the following sen23 tence: ‘‘A detention order under this paragraph 

24 shall be considered final agency action.’’. 


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•HR 5268 IH 

1 (2) CONFORMING AMENDMENTS.—Chapter III 

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

3 U.S.C. 331 et seq.) is amended— 

4 (A) in section 301(r)— 

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

6 such term appears and inserting ‘‘food or 

7 device’’; and 

8 (ii) by striking ‘‘the device’’ and in9 serting ‘‘such food or device’’; and 

10 (B) in section 304(g)(2), by striking ‘‘de11 vice’’ each place such term appears and insert12 ing ‘‘food or device’’. 

13 (b) DATE CERTAIN FOR PROPOSED AND FINAL

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

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

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

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

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

19 date such proposed revision is published in the Federal 

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

21 regulations. 

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

23 seized, or recalled under the Federal Food, Drug, and Cos24 metic Act, the Food and Drug Administration shall dis25 close all necessary information without regard to business 


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•HR 5268 IH 

1 confidentiality, if such disclosure is necessary to fully em2 bargo, seize, or recall any adulterated food. 

3 (d) FOOD RETAILER REGISTRATION.—All food re4 tailers shall register with the Food and Drug Administra5 tion for the purpose of expediting recalls, embargoes, and 

6 seizures under the Federal Food, Drug, and Cosmetic Act. 

7 SEC. 6. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UN8 REGULATED MARKETED ADDITIVES. 

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

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

11 the Secretary of Health and Human Services shall by reg12 ulation establish criteria for carrying out section 409 of 

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

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

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

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

17 the 30-day period beginning on the date on which the Sec18 retary promulgates the final rule under the preceding sen19 tence, subject to subsection (b). 

20 (b) PREVIOUSLY UNREGULATED MARKETED ADDI21 TIVES.— 

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

23 additive (as defined pursuant to the amendments 

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

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


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•HR 5268 IH 

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

2 promulgated, the amendments made by this Act 

3 apply to the additive upon the expiration of the two4 year period beginning on the date on which the final 

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

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

7 food additive described in paragraph (1), such para8 graph does not waive the applicability of section 

9 409A of the Federal Food, Drug, and Cosmetic Act 

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

11 that is filed before the expiration of the two-year pe12 riod described in such paragraph. 

Æ 


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