I 

111TH CONGRESS 

2D SESSION H. R. 5578 

To prohibit the open-air cultivation of genetically engineered pharmaceutical 

and industrial crops, to prohibit the use of common human food or 

animal feed as the host plant for a genetically engineered pharmaceutical 

or industrial chemical, to establish a tracking system to regulate the 

growing, handling, transportation, and disposal of pharmaceutical and 

industrial crops and their byproducts to prevent human, animal, and 

general environmental exposure to genetically engineered pharmaceutical 

and industrial crops and their byproducts, 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 

JUNE 23, 2010 

Mr. KUCINICH (for himself, Mr. DEFAZIO, Mr. FRANK of Massachusetts, Mr. 

GRIJALVA, Mr. STARK, and Ms. WOOLSEY) introduced the following bill; 

which was referred to the Committee on Agriculture, and in addition to 

the Committee on Energy and Commerce, for a period to be subsequently 

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To prohibit the open-air cultivation of genetically engineered 

pharmaceutical and industrial crops, to prohibit the use 

of common human food or animal feed as the host plant 

for a genetically engineered pharmaceutical or industrial 

chemical, to establish a tracking system to regulate the 

growing, handling, transportation, and disposal of pharmaceutical and industrial crops and their byproducts to 

prevent human, animal, and general environmental expoVerDate Mar 15 2010 05:01 Jun 24, 2010 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H5578.IH H5578

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sure to genetically engineered pharmaceutical and industrial crops and their byproducts, 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Genetically Engineered Safety Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—GENETICALLY ENGINEERED PHARMACEUTICAL AND 

INDUSTRIAL CROP SAFETY 

Sec. 101. Short title. 

Sec. 102. Findings. 

Sec. 103. Definitions. 

Sec. 104. Regulation of production of pharmaceutical crops and industrial 

crops. 

Sec. 105. Civil penalties for violation. 

Sec. 106. Report to Congress on alternative methods to produce pharmaceutical 

and industrial crops. 

TITLE II—GENETICALLY ENGINEERED FOOD SAFETY 

Sec. 201. Short title. 

Sec. 202. Findings. 

Sec. 203. Federal determination of safety of genetically engineered food; regulation as food additive. 

Sec. 204. User fees regarding determination of safety of genetic food additives. 

Sec. 205. Embargo authority. 

Sec. 206. Rulemaking; effective date; previously unregulated marketed additives. 


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1 TITLE I—GENETICALLY ENGI2 NEERED PHARMACEUTICAL 

3 AND INDUSTRIAL CROP SAFE4 TY 

5 SEC. 101. SHORT TITLE. 

6 This title may be cited as the ‘‘Genetically Engi7 neered Pharmaceutical and Industrial Crop Safety Act of 

8 2010’’. 

9 SEC. 102. FINDINGS. 

10 Congress finds the following: 

11 (1) A pharmaceutical crop or industrial crop is 

12 a plant that has been genetically engineered to 

13 produce a medical or industrial product, including a 

14 human or veterinary drug, biologic, industrial, or re15 search chemical, or enzyme. 

16 (2) The Department of Agriculture has issued 

17 ‘‘split approval’’ permits to allow the cultivation of 

18 10 food crops genetically engineered to produce bio19 pharmaceuticals or chemicals that are not approved 

20 for human consumption. As of January 1, 2003, 

21 more than 300 field trials have been conducted in 

22 the United States. In nearly 70 percent of these 

23 tests, corn has been the crop used, but other crops 

24 tested include soybean, tobacco, rice, alfalfa, barley, 


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1 rapeseed (canola), wheat, tomato, safflower, and 

2 sugercane. 

3 (3) Many of the novel substances produced in 

4 pharmaceutical crops and industrial crops exhibit 

5 high levels of biological activity and are intended to 

6 be used for particular medical or industrial pur7 poses, under very controlled circumstances. None of 

8 these substances is intended to be incorporated in 

9 food or to be spread into the environment. 

10 (4) The magnitude of the risks posed by phar11 maceutical crops and industrial crops depends on 

12 many factors, including the chemicals involved, the 

13 organisms or environments exposed, and the level 

14 and duration of the exposure. Humans, animals, and 

15 the environment at large could be at risk from con16 tamination, a major concern of which is that bio17 active nonfood substances, which have not been test18 ed, will contaminate or otherwise adversely affect the 

19 food supply. Substances intended for use as human 

20 drugs are especially problematic because they are in21 tended to be biologically active in people. 

22 (5) Pharmaceutical crops and industrial crops 

23 also pose substantial liability and other economic 

24 risks to farmers, grain handlers, food companies, 

25 and other persons in the food and feed supply chain. 


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1 These risks include liability for contamination epi2 sodes, costly food recalls, losses in export markets, 

3 reduced prices for a contaminated food or feed crop, 

4 and loss of confidence in the safety of the American 

5 food supply among foreign importers and consumers 

6 of American agricultural commodities. 

7 (6) These risks necessitate a zero tolerance 

8 standard for the presence of pharmaceutical crops 

9 and industrial crops and their byproducts in crops 

10 used to produce human food or animal feed. 

11 (7) While there presently exists a pro forma 

12 zero tolerance standard, the Department of Agri13 culture and experts in the field acknowledge that 

14 contamination of human food and animal feed is in15 evitable due to the inherent imprecision of biological 

16 and agricultural systems, as well as the laxity of the 

17 regulatory regime. This is illustrated, for example, in 

18 the Department of Agriculture’s regulations, which 

19 aim not for prevention (recognized as unattainable), 

20 but rather mitigation of the gene flow that results 

21 in contamination of food/feed crops with these sub22 stances. Some experts in the field are calling for es23 tablishment of tolerances, despite the potential risks 

24 involved. 


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1 (8) Therefore, appropriate regulatory controls, 

2 as established by this title, are urgently needed to 

3 ensure that pharmaceutical crops and industrial 

4 crops and their byproducts do not enter human food 

5 or animal feed crops at any level. 

6 SEC. 103. DEFINITIONS. 

7 In this title: 

8 (1) The term ‘‘genetically engineered plant’’ 

9 means a plant that contains a genetically engineered 

10 material or was produced from a genetically engi11 neered seed. A plant shall be considered to contain 

12 a genetically engineered material if the plant has 

13 been injected or otherwise treated with a genetically 

14 engineered material (except that the use of manure 

15 as a fertilizer for the plant may not be construed to 

16 mean that the plant is produced with a genetically 

17 engineered material). 

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

19 means material that has been altered at the molec20 ular or cellular level by means that are not possible 

21 under natural conditions or processes (including re22 combinant DNA and RNA techniques, cell fusion, 

23 microencapsulation, macroencapsulation, gene dele24 tion and doubling, introducing a foreign gene, and 

25 changing the positions of genes), other than a means 


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1 consisting exclusively of breeding, conjugation, fer2 mentation, hybridization, in vitro fertilization, tissue 

3 culture, or mutagenesis. 

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

5 means a seed that contains a genetically engineered 

6 material or was produced with a genetically engi7 neered material. A seed shall be considered to con8 tain a genetically engineered material or to have 

9 been produced with a genetically engineered material 

10 if the seed (or the plant from which the seed is de11 rived) has been injected or otherwise treated with a 

12 genetically engineered material (except that the use 

13 of manure as a fertilizer for the plant may not be 

14 construed to mean that any resulting seeds are pro15 duced with a genetically engineered material). 

16 (4) The term ‘‘pharmaceutical crop’’ means a 

17 genetically engineered plant that is designed to 

18 produce medical products, including human and vet19 erinary drugs and biologics. The term includes a 

20 crop intentionally treated with genetically engineered 

21 material that, in turn, produces a medical substance. 

22 (5) The term ‘‘industrial crop’’ means a geneti23 cally engineered plant that is designed to produce in24 dustrial products, including industrial and research 

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1 tentionally treated with genetically engineered mate2 rial that, in turn, produces an industrial substance. 

3 SEC. 104. REGULATION OF PRODUCTION OF PHARMA4 CEUTICAL CROPS AND INDUSTRIAL CROPS. 

5 (a) TEMPORARY MORATORIUM PENDING REGULA6 TIONS.—No pharmaceutical crop or industrial crop may 

7 be grown, raised, or otherwise cultivated until the final 

8 regulations and tracking system required by this section 

9 are in effect. 

10 (b) PROHIBITION ON OPEN-AIR CULTIVATION.—No 

11 person may grow, raise or otherwise cultivate a pharma12 ceutical crop or industrial crop in an open air environ13 ment. 

14 (c) PROHIBITION ON USE OF COMMON HUMAN

15 FOODS OR ANIMAL FEEDS.—No person may grow, raise, 

16 or otherwise cultivate a pharmaceutical crop or industrial 

17 crop in a food commonly used for human food or domestic 

18 animal feed. 

19 (d) BIOTECH TRACKING SYSTEM.—The United 

20 States Department of Agriculture shall establish a track21 ing system to regulate the growing, handling, transpor22 tation, and disposal of all pharmaceutical and industrial 

23 crops and their byproducts to prevent contamination. 

24 (e) REGULATIONS.—The Secretary of Agriculture 

25 shall issue regulations— 


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1 (1) to enforce the prohibitions imposed by sub2 sections (b) and (c); 

3 (2) to designate the common foods whose use as 

4 a source of a pharmaceutical crop or industrial crop 

5 is prohibited by subsection (c); and 

6 (3) to establish the tracking system required by 

7 subsection (d). 

8 SEC. 105. CIVIL PENALTIES FOR VIOLATION. 

9 (a) AUTHORITY TO ACCESS PENALTIES.—The Sec10 retary of Agriculture may assess, by written order, a civil 

11 penalty against a person that violates a provision of sec12 tion 105, including a regulation promulgated or order 

13 issued under such section. Each violation, and each day 

14 during which a violation continues, shall be a separate of15 fense. 

16 (b) AMOUNT AND FACTORS IN ACCESSING PEN17 ALTIES.—The maximum amount that may be accessed 

18 under this section for a violation may not exceed 

19 $1,000,000. In determining the amount of the civil pen20 alty, the Secretary shall take into account— 

21 (1) the gravity of the violation; 

22 (2) the degree of culpability; 

23 (3) the size and type of the business; and 

24 (4) any history of prior offenses under such sec25 tion or other laws administered by the Secretary. 


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1 (c) NOTICE AND OPPORTUNITY FOR HEARING.—The 

2 Secretary shall not assess a civil penalty under this section 

3 against a person unless the company is given notice and 

4 opportunity for a hearing on the record before the Sec5 retary in accordance with sections 554 and 556 of title 

6 5, United States Code. 

7 (d) JUDICIAL REVIEW.—(1) An order assessing a 

8 civil penalty against a person under subsection (a) may 

9 be reviewed only in accordance with this subsection. The 

10 order shall be final and conclusive unless the person— 

11 (A) not later than 30 days after the effective 

12 date of the order, files a petition for judicial review 

13 in the United States court of appeals for the circuit 

14 in which the person resides or has its principal place 

15 of business or in the United States Court of Appeals 

16 for the District of Columbia; and 

17 (B) simultaneously sends a copy of the petition 

18 by certified mail to the Secretary. 

19 (2) The Secretary shall promptly file in the court a 

20 certified copy of the record on which the violation was 

21 found and the civil penalty assessed. 

22 (e) COLLECTION ACTION FOR FAILURE TO PAY AS23 SESSMENT.—If a person fails to pay a civil penalty after 

24 the order assessing the civil penalty has become final and 

25 unappealable, the Secretary shall refer the matter to the 


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1 Attorney General, who shall bring a civil action to recover 

2 the amount of the civil penalty in United States district 

3 court. In the collection action, the validity and appro4 priateness of the order of the Secretary imposing the civil 

5 penalty shall not be subject to review. 

6 SEC. 106. REPORT TO CONGRESS ON ALTERNATIVE METH7 ODS TO PRODUCE PHARMACEUTICAL AND IN8 DUSTRIAL CROPS. 

9 The National Academy of Sciences shall submit to 

10 Congress a report that explores alternative methods to 

11 produce pharmaceuticals or industrial chemicals that have 

12 the advantage of being conducted in controlled production 

13 facilities and do not present the risk of contamination. 

14 TITLE II—GENETICALLY 

15 ENGINEERED FOOD SAFETY 

16 SEC. 201. SHORT TITLE. 

17 This title may be cited as the ‘‘Genetically Engi18 neered Food Safety Act’’. 

19 SEC. 202. FINDINGS. 

20 The Congress finds as follows: 

21 (1) Genetic engineering is an artificial gene 

22 transfer process wholly different from traditional 

23 breeding. 

24 (2) Genetic engineering can be used to produce 

25 new versions of virtually all plant and animal foods. 


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

2 consist almost entirely of genetically engineered 

3 products. 

4 (3) This conversion from a food supply based 

5 on traditionally bred organisms to one based on or6 ganisms produced through genetic engineering could 

7 be one of the most important changes in our food 

8 supply in this century. 

9 (4) Genetically engineered foods present new 

10 issues of safety that have not been adequately stud11 ied. 

12 (5) The Congress has previously required that 

13 food additives be analyzed for their safety prior to 

14 their placement on the market. 

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

16 considered adding a food additive, thus requiring an 

17 analysis of safety factors. 

18 (7) Federal agencies have failed to uphold con19 gressional intent of the Food Additives Amendment 

20 of 1958 by allowing genetically engineered foods to 

21 be marketed, sold and otherwise used without re22 quiring pre-market safety testing addressing their 

23 unique characteristics. 

24 (8) The food additive process gives the Food 

25 and Drug Administration discretion in applying the 


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1 safety factors that are generally recognized as ap2 propriate to evaluate the safety of food and food in3 gredients. 

4 (9) Given the consensus among the scientific 

5 community that genetic engineering can potentially 

6 introduce hazards, such as allergens or toxins, ge7 netically engineered foods need to be evaluated on a 

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

9 generally recognized as safe. 

10 SEC. 203. FEDERAL DETERMINATION OF SAFETY OF GE11 NETICALLY ENGINEERED FOOD; REGULA12 TION AS FOOD ADDITIVE. 

13 (a) INCLUSION IN DEFINITION OF FOOD ADDI14 TIVE.—Section 201 of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 321) is amended— 

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

17 subparagraph (6) the following sentence: 

18 ‘‘Such term includes the different genetic constructs, pro19 teins of such constructs, vectors, promoters, marker sys20 tems, and other appropriate terms that are used or cre21 ated as a result of the creation of a genetically engineered 

22 food (as defined in paragraph (ss)), other than a genetic 

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

24 other appropriate term for which an application under sec25 tion 505 or 512 has been filed. For purposes of this Act, 


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

2 protein, vector, promoter, or marker system or other ap3 propriate term that is so included.’’; and 

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

5 ‘‘(ss)(1) The term ‘genetically engineered food’ means 

6 food that contains or was produced with a genetically engi7 neered material. 

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

9 means material derived from any part of a genetically en10 gineered organism, without regard to whether the altered 

11 molecular or cellular characteristics of the organism are 

12 detectable in the material. 

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

14 means— 

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

16 molecular or cellular level by means that are not 

17 possible under natural conditions or processes (in18 cluding but not limited to recombinant DNA and 

19 RNA techniques, cell fusion, microencapsulation, 

20 macroencapsulation, gene deletion and doubling, in21 troducing a foreign gene, and changing the positions 

22 of genes), other than a means consisting exclusively 

23 of breeding, conjugation, fermentation, hybridiza24 tion, in vitro fertilization, tissue culture, or 

25 mutagenesis; and 


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1 ‘‘(B) an organism made through sexual or asex2 ual reproduction (or both) involving an organism de3 scribed in clause (A), if possessing any of the altered 

4 molecular or cellular characteristics of the organism 

5 so described. 

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

7 be considered to have been produced with a genetically en8 gineered material if the organism from which the food is 

9 derived has been injected or otherwise treated with a ge10 netically engineered material (except that the use of ma11 nure as a fertilizer for raw agricultural commodities may 

12 not be construed to mean that such commodities are pro13 duced with a genetically engineered material).’’. 

14 (b) PETITION TO ESTABLISH SAFETY.— 

15 (1) DATA IN PETITION.—Section 409(b)(2) of 

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

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

18 below subparagraph (E) the following sentence: 

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

20 include all data that was collected or developed pursuant 

21 to the investigations, including data that does not support 

22 the claim of safety for use.’’. 

23 (2) NOTICES; PUBLIC AVAILABILITY OF INFOR24 MATION.—Section 409(b)(5) of the Federal Food, 


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

2 amended— 

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

4 ‘‘(5)(A)’’; and 

5 (B) by adding at the end the following sub6 paragraphs: 

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

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

9 subparagraph (A), the Secretary shall make avail10 able to the public all reports and data described in 

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

12 involved, and all other information in the petition to 

13 the extent that the information is relevant to a de14 termination of the safety for use of the additive. 

15 ‘‘(ii) Such notice shall state whether any infor16 mation in the petition is not being made available to 

17 the public because the Secretary has made a deter18 mination that the information does not relate to the 

19 safety for use of the additive. Any person may peti20 tion the Secretary for a reconsideration of such a de21 termination. 

22 ‘‘(C) In the case of genetic food additives: 

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

24 available to the public through telecommunications a 

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1 section and a list of petitions for which regulations 

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

3 Such list shall include information on the additives 

4 involved, including the source of the additives, and 

5 including any information received by the Secretary 

6 pursuant to clause (ii). 

7 ‘‘(ii) If a regulation is in effect under sub8 section (c)(1)(A) for a genetic food additive, any 

9 person who manufactures such additive for commer10 cial use shall submit to the Secretary a notification 

11 of any knowledge of data that relate to the adverse 

12 health effects of the additive, when knowledge is ac13 quired by the person after the date on which the 

14 regulation took effect. If the manufacturer is in pos15 session of the data, the notification shall include the 

16 data. The Secretary shall by regulation establish the 

17 scope of the responsibilities of manufacturers under 

18 this clause, including such limits on the responsibil19 ities as the Secretary determines to be appropriate.’’. 

20 (3) EFFECTIVE DATE OF REGULATION REGARD21 ING SAFE USE; OPPORTUNITY FOR PUBLIC COM22 MENT.—Section 409(c)(2) of the Federal Food, 

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

24 amended— 


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

2 ‘‘(2)(A)’’; and 

3 (B) by adding at the end the following sub4 paragraph: 

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

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

7 the petition involved before the expiration of the applicable 

8 period under clause (ii). During such period, and con9 tinuing until an order under paragraph (1) is issued, the 

10 Secretary shall provide interested persons an opportunity 

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

12 publishing such notice, the Secretary shall inform the pub13 lic of such opportunity. 

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

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

16 beginning on the date on which the Secretary has under 

17 subparagraph (B)(i) of subsection (b)(5) made informa18 tion available to the public regarding the petition, except 

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

20 Secretary finds in favor of a person who files for reconsid21 eration (relating to a determination by the Secretary that 

22 information does not relate to safety), such 30-day period 

23 is extended by an additional period of 30 days. For pur24 poses of the preceding sentence, a discrete 30-day exten25 sion applies to each such reconsideration for which the 


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1 Secretary finds in favor of the person filing for reconsider2 ation.’’. 

3 (4) CONSIDERATION OF CERTAIN FACTORS.— 

4 Section 409(c) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 348(c)) is amended by adding 

6 at the end the following paragraph: 

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

8 considered by the Secretary regarding safety for use shall 

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

10 analyses: 

11 ‘‘(A) Allergenicity effects resulting from the 

12 added proteins, including proteins not found in the 

13 food supply. 

14 ‘‘(B) Pleiotropic effects. The Secretary shall re15 quire tests to determine the potential for such ef16 fects (using molecular characterization, biochemical 

17 characterization, mRNA profiling, or other tech18 niques, or as appropriate, combinations of such tech19 niques). 

20 ‘‘(C) Appearance of new toxins or increased lev21 els of existing toxins. 

22 ‘‘(D) Changes in the functional characteristics 

23 of food. 

24 ‘‘(E) Changes in the levels of important nutri25 ents. 


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

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

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

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

5 the following paragraph: 

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

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

8 a commonly or severely allergenic food, the Sec9 retary may not establish a regulation under para10 graph (1)(A) if the petition under subsection (b)(1) 

11 fails to include full reports of investigations that 

12 used serum or skin tests (or other advanced tech13 niques) on a sensitive population to determine 

14 whether such additive is commonly or severely aller15 genic. 

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

17 that has not undergone the investigations described 

18 in subparagraph (A), the Secretary may not estab19 lish a regulation under paragraph (1)(A) if the peti20 tion under subsection (b)(1) fails to include full re21 ports of investigations that used the best available 

22 biochemical and physiological protocols to evaluate 

23 whether it is likely that the protein involved is an al24 lergen. 


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

2 shall by regulation determine the best available bio3 chemical and physiological protocols. In carrying out 

4 rulemaking under the preceding sentence, the Sec5 retary shall consult with the Director of the Na6 tional Institutes of Health.’’. 

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

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

9 amended by paragraph (5), is amended by adding at 

10 the end the following paragraph: 

11 ‘‘(8) In the case of a genetic food additive, the Sec12 retary may not establish a regulation under paragraph 

13 (1)(A) if— 

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

15 an investigation finds that the additive is likely to be 

16 commonly or severely allergenic; 

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

18 an investigation that uses a protocol described in 

19 paragraph (7)(B) fails to find with reasonable cer20 tainty that the additive is unlikely to be an allergen; 

21 or 

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

23 is used with respect to the additive, the selective 

24 marker will remain in the food involved when the 


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1 food is marketed, and the selective marker inhibits 

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

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

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

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

6 the end the following paragraph: 

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

8 food additives, the Secretary may (directly or through con9 tract) conduct investigations of such additives for pur10 poses of supplementing the information provided to the 

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

12 ‘‘(B) To provide the Congress with a periodic inde13 pendent, external review of the Secretary’s formulation of 

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

15 to genetic food additives, the Secretary shall enter into 

16 an agreement with the Institute of Medicine. Such agree17 ment shall provide that, if the Institute of Medicine has 

18 any concerns regarding the approval process, the Institute 

19 of Medicine will submit to the Congress a report describ20 ing such concerns.’’. 

21 (c) REGULATION ISSUED ON SECRETARY’S INITIA22 TIVE.—Section 409(d) of the Federal Food, Drug, and 

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


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1 (1) by striking ‘‘(d) The Secretary’’ and insert2 ing ‘‘(d)(1) Subject to paragraph (2), the Sec3 retary’’; and 

4 (2) by adding at the end the following para5 graph: 

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

7 expressly reference genetic food additives apply with re8 spect to a regulation proposed by the Secretary under 

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

10 as such provisions apply with respect to a petition filed 

11 under subsection (b)(1).’’. 

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

13 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend14 ed by adding at the end the following subsection: 

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

16 301(b), or 301(c) involving the adulteration of food by rea17 son of failure to comply with the provisions of section 409 

18 that relate to genetic food additives, any person engaging 

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

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

21 each such violation. 

22 ‘‘(2) Paragraphs (5) through (7) of subsection (f) 

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

24 of this subsection to the same extent and in the same man25 ner as such paragraphs (5) through (7) apply with respect 


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1 to a civil penalty under paragraph (1), (2), (3), (4), or 

2 (9) of subsection (f).’’. 

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

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

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

6 ‘‘SEC. 311. CITIZEN SUITS REGARDING GENETIC FOOD AD7 DITIVES. 

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

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

10 action in an appropriate district court of the United States 

11 against— 

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

13 a violation of section 301(a), 301(b), or 301(c) in14 volving the adulteration of food by reason of failing 

15 to comply with the provisions of section 409 that re16 late to genetic food additives; or 

17 ‘‘(2) the Secretary where there is alleged a fail18 ure of the Secretary to perform any act or duty 

19 under section 409 that relates to such additives and 

20 is not discretionary. 

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

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

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

24 the applicable provisions referred to paragraph (1) 

25 of such subsection; or 


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

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

3 ‘‘(c) LIMITATIONS.— 

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

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

6 to 60 days after the plaintiff has provided to the 

7 Secretary notice of the violation involved. 

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

9 A civil action may not be commenced under sub10 section (a)(2) if the Secretary has commenced and 

11 is diligently prosecuting a civil or criminal action in 

12 a district court of the United States to enforce com13 pliance with the applicable provisions referred to in 

14 subsection (a)(1). 

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

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

17 party, may intervene as a matter of right. 

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

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

20 may award costs of litigation (including reasonable attor21 ney and expert witness fees) to any party whenever the 

22 court determines such an award is appropriate. The court 

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1 lent security in accordance with the Federal Rules of Civil 

2 Procedure. 

3 ‘‘(f) SAVINGS PROVISION.—This section does not re4 strict any right that a person (or class of persons) may 

5 have under any statute or common law to seek enforce6 ment of the provisions referred to subsection (a)(1), or to 

7 seek any other relief (including relief against the Sec8 retary).’’. 

9 (f) RULE OF CONSTRUCTION.—With respect to sec10 tion 409 of the Federal Food, Drug, and Cosmetic Act 

11 as amended by this section, compliance with the provisions 

12 of such section 409 that relate to genetic food additives 

13 does not constitute an affirmative defense in any cause 

14 of action under Federal or State law for personal injury 

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

16 SEC. 204. USER FEES REGARDING DETERMINATION OF 

17 SAFETY OF GENETIC FOOD ADDITIVES. 

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

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

20 section 409 the following section: 

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

22 FOOD ADDITIVES. 

23 ‘‘(a) IN GENERAL.—In the case of genetic food addi24 tives, the Secretary shall in accordance with this section 

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


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1 section 409(b)(1). The fee shall be collected from the per2 son who submits the petition, is due upon submission of 

3 the petition, and shall be assessed in an amount deter4 mined under subsection (c). This section applies as of the 

5 first fiscal year that begins after the date of promulgation 

6 of the final rule required in section 206 of the Genetically 

7 Engineered Food Safety Act (referred to in this section 

8 as the ‘first applicable fiscal year’). 

9 ‘‘(b) PURPOSE OF FEES.— 

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

11 subsection (a) are as follows: 

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

13 the resources allocated for carrying out section 

14 409 for the first applicable fiscal year over the 

15 costs of carrying out such section for the pre16 ceding fiscal year, other than increases that are 

17 not attributable to the responsibilities of the 

18 Secretary with respect to genetic food additives. 

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

20 and applied research on the safety of genetic 

21 food additives (to be carried out by the Com22 missioner). The program shall address funda23 mental questions and problems that arise re24 peatedly during the process of reviewing peti25 tions under section 409(b)(1) with respect to 


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1 genetic food additives, and shall not directly 

2 support the development of new genetically en3 gineered foods. 

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

5 total fee revenues collected under subsection (a) for 

6 a fiscal year, the Secretary shall reserve and ex7 pend— 

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

9 in paragraph (1)(A); and 

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

11 in paragraph (1)(B). 

12 ‘‘(3) CERTAIN PROVISIONS REGARDING IN13 CREASED ADMINISTRATIVE COSTS.—With respect to 

14 fees under subsection (a): 

15 ‘‘(A) Increases referred to in paragraph 

16 (1)(A) include the costs of the Secretary in pro17 viding for investigations under section 

18 409(c)(9)(A). 

19 ‘‘(B) Increases referred to in paragraph 

20 (1)(A) include increases in costs for an addi21 tional number of full-time equivalent positions 

22 in the Department of Health and Human Serv23 ices to be engaged in carrying out section 409 

24 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 tions 736(g), 738(h), 740(g), and 741(g) for 

12 such fiscal years. 

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

14 Secretary does not have authority to assess fees 

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

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

17 have such authority, the Secretary, notwithstanding 

18 the due date under such subsection for fees, may as19 sess and collect such fees at any time in such fiscal 

20 year, without any modification in the rate of the 

21 fees. 

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

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

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

25 the appropriation account for salaries and expenses 


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1 of the Food and Drug Administration and shall be 

2 available in accordance with appropriation Acts until 

3 expended without fiscal year limitation. Such sums 

4 as may be necessary may be transferred from the 

5 Food and Drug Administration salaries and ex6 penses appropriation account without fiscal year lim7 itation to such appropriation account for salaries 

8 and expenses with such fiscal year limitation. The 

9 sums transferred shall be available solely for the 

10 purposes described in paragraph (1) of subsection 

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

12 paragraph (2) of such subsection. 

13 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

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

15 applicable fiscal year— 

16 ‘‘(i) there is authorized to be appro17 priated for fees under subsection (a) an 

18 amount equal to the amount of increase 

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

20 the Secretary (which amount shall be pub21 lished in the Federal Register); and 

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

23 be appropriated for fees under subsection 

24 (a) an amount determined by the Secretary 

25 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 

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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. 205. 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 or 


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1 tobacco product detained’’ and inserting 

2 the following: ‘‘If, during an inspection 

3 conducted under section 704, an officer or 

4 employee of the Department has reason to 

5 believe that a food, device, or tobacco prod6 uct is in violation of this Act, such officer 

7 or employee may order the food, device, or 

8 tobacco product detained’’; and 

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

10 and inserting ‘‘the Secretary may author11 ize’’; 

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

13 striking ‘‘device or tobacco product’’ each place 

14 it appears and inserting ‘‘food, device, or to15 bacco product’’; 

16 (C) by striking the fourth and fifth sen17 tences; and 

18 (D) by adding at the end the following sen19 tence: ‘‘A detention order under this paragraph 

20 shall be considered final agency action.’’. 

21 (2) CONFORMING AMENDMENTS.—Chapter III 

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

23 U.S.C. 331 et seq.) is amended— 

24 (A) in section 301(r)— 


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1 (i) by striking ‘‘device or tobacco 

2 product’’ the first place such term appears 

3 and inserting ‘‘food, device, or tobacco 

4 product’’; and 

5 (ii) by striking ‘‘the device or tobacco 

6 product’’ and inserting ‘‘such food, device, 

7 or tobacco product’’; and 

8 (B) in section 304(g)(2)— 

9 (i) in subparagraph (A), by striking 

10 ‘‘device or tobacco product’’ and inserting 

11 ‘‘food, device, or tobacco product’’; and 

12 (ii) in subparagraph (B), by striking 

13 ‘‘device’’ each place it appears and insert14 ing ‘‘food or device’’. 

15 (b) DATE CERTAIN FOR PROPOSED AND FINAL

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

17 of this title, the Secretary of Health and Human Services 

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

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

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

21 date such proposed revision is published in the Federal 

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

23 regulations. 

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

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1 metic Act, the Food and Drug Administration shall dis2 close all necessary information without regard to business 

3 confidentiality, if such disclosure is necessary to fully em4 bargo, seize, or recall any adulterated food. 

5 (d) FOOD RETAILER REGISTRATION.—All food re6 tailers shall register with the Food and Drug Administra7 tion for the purpose of expediting recalls, embargoes, and 

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

9 SEC. 206. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY 

10 UNREGULATED MARKETED ADDITIVES. 

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

12 than one year after the date of the enactment of this title, 

13 the Secretary of Health and Human Services shall by reg14 ulation establish criteria for carrying out section 409 of 

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

16 with the amendments made by section 203, and criteria 

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

18 section 204). Such amendments take effect upon the expi19 ration of the 30-day period beginning on the date on which 

20 the Secretary promulgates the final rule under the pre21 ceding sentence, subject to subsection (b). 

22 (b) PREVIOUSLY UNREGULATED MARKETED ADDI23 TIVES.— 

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

25 additive (as defined pursuant to the amendments 


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1 made by section 203) that in the United States was 

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

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

4 promulgated, the amendments made by this title 

5 apply to the additive upon the expiration of the two6 year period beginning on the date on which the final 

7 rule 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 under section 409(b)(1) of such Act 

13 that is filed before the expiration of the two-year pe14 riod described in such paragraph. 

Æ 


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