I 

112TH CONGRESS 

1ST SESSION H. R. 3554 

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 

DECEMBER 2, 2011 

Mr. KUCINICH (for himself, Mr. GRIJALVA, and Mr. STARK) 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 expomstockstill on DSK4VPTVN1PROD with BILLS

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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 2011’’. 

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 more than 270 permits for more than 300 outdoor 

18 field trials of plants genetically engineered to 

19 produce experimental pharmaceuticals, industrial en20 zymes and novel proteins. More than 80 percent of 

21 the field trial permits involved feed crops, including 

22 corn, soybeans, rice, safflower, barley, alfalfa, mus23 tard greens, peas, sugarcane, tomatoes, and wheat. 

24 (3) Many of the novel substances produced in 

25 pharmaceutical crops and industrial crops exhibit 

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1 high levels of biological activity and are intended to 

2 be used for particular medical or industrial pur3 poses, under very controlled circumstances. None of 

4 these substances is intended to be incorporated in 

5 food or to be spread into the environment. 

6 (4) The magnitude of the risks posed by phar7 maceutical crops and industrial crops depends on 

8 many factors, including the chemicals involved, the 

9 organisms or environments exposed, and the level 

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

11 the environment at large could be at risk from con12 tamination, a major concern of which is that bio13 active nonfood substances, which have not been test14 ed, will contaminate or otherwise adversely affect the 

15 food supply. Substances intended for use as human 

16 drugs are especially problematic because they are in17 tended to be biologically active in people. 

18 (5) Pharmaceutical crops and industrial crops 

19 also pose substantial liability and other economic 

20 risks to farmers, grain handlers, food companies, 

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

22 These risks include liability for contamination epi23 sodes, costly food recalls, losses in export markets, 

24 reduced prices for a contaminated food or feed crop, 

25 and loss of confidence in the safety of the American 

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1 food supply among foreign importers and consumers 

2 of American agricultural commodities. 

3 (6) These risks necessitate a zero tolerance 

4 standard for the presence of pharmaceutical crops 

5 and industrial crops and their byproducts in crops 

6 used to produce human food or animal feed. 

7 (7) While there presently exists a pro forma 

8 zero tolerance standard, the Department of Agri9 culture and experts in the field acknowledge that 

10 contamination of human food and animal feed is in11 evitable due to the inherent imprecision of biological 

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

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

14 the Department of Agriculture’s regulations, which 

15 aim not for prevention (recognized as unattainable), 

16 but rather mitigation of the gene flow that results 

17 in contamination of food/feed crops with these sub18 stances. Some experts in the field are calling for es19 tablishment of tolerances, despite the potential risks 

20 involved. 

21 (8) The rapidly emerging field of synthetic biol22 ogy is an extreme form of genetic engineering that 

23 has been heralded as a remedy for numerous societal 

24 ills ranging from climate change to environmental 

25 pollutants. The goal of synthetic biology is to create 

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1 life from scratch with synthetic DNA or without the 

2 use of DNA entirely. DNA is synthesized by a com3 puter is then inserted into organisms. There are a 

4 range of practices which can be classified as syn5 thetic biology, but such practices are more commonly 

6 defined as the design and construction of new bio7 logical parts, devices and systems that do not exist 

8 in the natural world and also the redesign of exist9 ing biological systems to perform specific tasks. 

10 (9) Proponents of synthetic biology are devel11 oping products that they may soon seek approval for 

12 entry into the food supply of the United States. 

13 (10) Therefore, appropriate regulatory controls, 

14 as established by this title, are urgently needed to 

15 ensure that the byproducts of pharmaceutical crops, 

16 industrial crops and organisms created as a result of 

17 synthetic biology, as well as their byproducts, do not 

18 enter human food or animal feed crops at any level. 

19 SEC. 103. DEFINITIONS. 

20 In this title: 

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

22 means a plant that contains a genetically engineered 

23 material or was produced from a genetically engi24 neered seed. A plant shall be considered to contain 

25 a genetically engineered material if the plant has 

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1 been injected or otherwise treated with a genetically 

2 engineered material (except that the use of manure 

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

4 mean that the plant is produced with a genetically 

5 engineered material). 

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

7 means material that has been altered at the molec8 ular or cellular level by means that are not possible 

9 under natural conditions or processes (including re10 combinant DNA and RNA techniques, cell fusion, 

11 microencapsulation, macroencapsulation, gene dele12 tion and doubling, introducing a foreign gene, and 

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

14 consisting exclusively of breeding, conjugation, fer15 mentation, hybridization, in vitro fertilization, tissue 

16 culture, or mutagenesis. 

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

18 means a seed that contains a genetically engineered 

19 material or was produced with a genetically engi20 neered material. A seed shall be considered to con21 tain a genetically engineered material or to have 

22 been produced with a genetically engineered material 

23 if the seed (or the plant from which the seed is de24 rived) has been injected or otherwise treated with a 

25 genetically engineered material (except that the use 

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

2 construed to mean that any resulting seeds are pro3 duced with a genetically engineered material). 

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

5 genetically engineered plant that is designed to 

6 produce medical products, including human and vet7 erinary drugs and biologics. The term includes a 

8 crop intentionally treated with genetically engineered 

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

10 (5) The term ‘‘industrial crop’’ means a geneti11 cally engineered plant that is designed to produce in12 dustrial products, including industrial and research 

13 chemicals and enzymes. The term includes a crop in14 tentionally treated with genetically engineered mate15 rial that, in turn, produces an industrial substance. 

16 SEC. 104. REGULATION OF PRODUCTION OF PHARMA17 CEUTICAL CROPS AND INDUSTRIAL CROPS. 

18 (a) TEMPORARY MORATORIUM PENDING REGULA19 TIONS.—No pharmaceutical crop or industrial crop may 

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

21 regulations and tracking system required by this section 

22 are in effect. 

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

24 person may grow, raise or otherwise cultivate a pharmamstockstill on DSK4VPTVN1PROD with BILLS

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1 ceutical crop or industrial crop in an open air environ2 ment. 

3 (c) PROHIBITION ON USE OF COMMON HUMAN

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

5 or otherwise cultivate a pharmaceutical crop or industrial 

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

7 animal feed. 

8 (d) BIOTECH TRACKING SYSTEM.—The United 

9 States Department of Agriculture shall establish a track10 ing system to regulate the growing, handling, transpor11 tation, and disposal of all pharmaceutical and industrial 

12 crops and their byproducts to prevent contamination. 

13 (e) REGULATIONS.—The Secretary of Agriculture 

14 shall issue regulations— 

15 (1) to enforce the prohibitions imposed by sub16 sections (b) and (c); 

17 (2) to designate the foods commonly used for 

18 human food or domestic animal feed, the use of 

19 which as a source of a pharmaceutical crop or indus20 trial crop is prohibited by subsection (c); and 

21 (3) to establish the tracking system required by 

22 subsection (d). 

23 SEC. 105. CIVIL PENALTIES FOR VIOLATION. 

24 (a) AUTHORITY TO ACCESS PENALTIES.—The Sec25 retary of Agriculture may assess, by written order, a civil 

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1 penalty against a person that violates a provision of sec2 tion 105, including a regulation promulgated or order 

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

4 during which a violation continues, shall be a separate of5 fense. 

6 (b) AMOUNT AND FACTORS IN ACCESSING PEN7 ALTIES.—The maximum amount that may be accessed 

8 under this section for a violation may not exceed 

9 $1,000,000. In determining the amount of the civil pen10 alty, the Secretary shall take into account— 

11 (1) the gravity of the violation; 

12 (2) the degree of culpability; 

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

14 (4) any history of prior offenses under such sec15 tion or other laws administered by the Secretary. 

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

17 Secretary shall not assess a civil penalty under this section 

18 against a person unless the company is given notice and 

19 opportunity for a hearing on the record before the Sec20 retary in accordance with sections 554 and 556 of title 

21 5, United States Code. 

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

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

24 be reviewed only in accordance with this subsection. The 

25 order shall be final and conclusive unless the person— 

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

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

3 in the United States court of appeals for the circuit 

4 in which the person resides or has its principal place 

5 of business or in the United States Court of Appeals 

6 for the District of Columbia; and 

7 (B) simultaneously sends a copy of the petition 

8 by certified mail to the Secretary. 

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

10 certified copy of the record on which the violation was 

11 found and the civil penalty assessed. 

12 (e) COLLECTION ACTION FOR FAILURE TO PAY AS13 SESSMENT.—If a person fails to pay a civil penalty after 

14 the order assessing the civil penalty has become final and 

15 unappealable, the Secretary shall refer the matter to the 

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

17 the amount of the civil penalty in United States district 

18 court. In the collection action, the validity and appro19 priateness of the order of the Secretary imposing the civil 

20 penalty shall not be subject to review. 

21 SEC. 106. REPORT TO CONGRESS ON ALTERNATIVE METH22 ODS TO PRODUCE PHARMACEUTICAL AND IN23 DUSTRIAL CROPS. 

24 The National Academy of Sciences shall submit to 

25 Congress a report that explores alternative methods to 

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1 produce pharmaceuticals or industrial chemicals that have 

2 the advantage of being conducted in controlled production 

3 facilities and do not present the risk of contamination. 

4 TITLE II—GENETICALLY 

5 ENGINEERED FOOD SAFETY 

6 SEC. 201. SHORT TITLE. 

7 This title may be cited as the ‘‘Genetically Engi8 neered Food Safety Act’’. 

9 SEC. 202. FINDINGS. 

10 The Congress finds as follows: 

11 (1) Genetic engineering is an artificial gene 

12 transfer process wholly different from traditional 

13 breeding. 

14 (2) Genetic engineering can be used to produce 

15 new versions of virtually all plant and animal foods. 

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

17 consist almost entirely of genetically engineered 

18 products. 

19 (3) This conversion from a food supply based 

20 on traditionally bred organisms to one based on or21 ganisms produced through genetic engineering could 

22 be one of the most important changes in our food 

23 supply in this century. 

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1 (4) Genetically engineered foods present new 

2 issues of safety that have not been adequately stud3 ied. 

4 (5) The Congress has previously required that 

5 food additives be analyzed for their safety prior to 

6 their placement on the market. 

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

8 considered adding a food additive, thus requiring an 

9 analysis of safety factors. 

10 (7) Federal agencies have failed to uphold con11 gressional intent of the Food Additives Amendment 

12 of 1958 by allowing genetically engineered foods to 

13 be marketed, sold and otherwise used without re14 quiring pre-market safety testing addressing their 

15 unique characteristics. 

16 (8) The food additive process gives the Food 

17 and Drug Administration discretion in applying the 

18 safety factors that are generally recognized as ap19 propriate to evaluate the safety of food and food in20 gredients. 

21 (9) Given the consensus among the scientific 

22 community that genetic engineering can potentially 

23 introduce hazards, such as allergens or toxins, ge24 netically engineered foods need to be evaluated on a 

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

2 generally recognized as safe. 

3 SEC. 203. FEDERAL DETERMINATION OF SAFETY OF GE4 NETICALLY ENGINEERED FOOD; REGULA5 TION AS FOOD ADDITIVE. 

6 (a) INCLUSION IN DEFINITION OF FOOD ADDI7 TIVE.—Section 201 of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 321) is amended— 

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

10 subparagraph (6) the following sentence: 

11 ‘‘Such term includes the different genetic constructs, pro12 teins of such constructs, vectors, promoters, marker sys13 tems, and other appropriate terms that are used or cre14 ated as a result of the creation of a genetically engineered 

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

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

17 other appropriate term for which an application under sec18 tion 505 or 512 has been filed. For purposes of this Act, 

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

20 protein, vector, promoter, or marker system or other ap21 propriate term that is so included.’’; and 

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

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

24 food that contains or was produced with a genetically engi25 neered material. 

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

2 means material derived from any part of a genetically en3 gineered organism, without regard to whether the altered 

4 molecular or cellular characteristics of the organism are 

5 detectable in the material. 

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

7 means— 

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

9 molecular or cellular level by means that are not 

10 possible under natural conditions or processes (in11 cluding but not limited to recombinant DNA and 

12 RNA techniques, cell fusion, microencapsulation, 

13 macroencapsulation, gene deletion and doubling, in14 troducing a foreign gene, and changing the positions 

15 of genes), other than a means consisting exclusively 

16 of breeding, conjugation, fermentation, hybridiza17 tion, in vitro fertilization, tissue culture, or 

18 mutagenesis; and 

19 ‘‘(B) an organism made through sexual or asex20 ual reproduction (or both) involving an organism de21 scribed in clause (A), if possessing any of the altered 

22 molecular or cellular characteristics of the organism 

23 so described. 

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

25 be considered to have been produced with a genetically enmstockstill on DSK4VPTVN1PROD with BILLS

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1 gineered material if the organism from which the food is 

2 derived has been injected or otherwise treated with a ge3 netically engineered material (except that the use of ma4 nure as a fertilizer for raw agricultural commodities may 

5 not be construed to mean that such commodities are pro6 duced with a genetically engineered material).’’. 

7 (b) PETITION TO ESTABLISH SAFETY.— 

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

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

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

11 below subparagraph (E) the following sentence: 

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

13 include all data that was collected or developed pursuant 

14 to the investigations, including data that does not support 

15 the claim of safety for use.’’. 

16 (2) NOTICES; PUBLIC AVAILABILITY OF INFOR17 MATION.—Section 409(b)(5) of the Federal Food, 

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

19 amended— 

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

21 ‘‘(5)(A)’’; and 

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

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

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

2 subparagraph (A), the Secretary shall make avail3 able to the public all reports and data described in 

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

5 involved, and all other information in the petition to 

6 the extent that the information is relevant to a de7 termination of the safety for use of the additive. 

8 ‘‘(ii) Such notice shall state whether any infor9 mation in the petition is not being made available to 

10 the public because the Secretary has made a deter11 mination that the information does not relate to the 

12 safety for use of the additive. Any person may peti13 tion the Secretary for a reconsideration of such a de14 termination. 

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

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

17 available to the public through telecommunications a 

18 list of petitions that are pending under this sub19 section and a list of petitions for which regulations 

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

21 Such list shall include information on the additives 

22 involved, including the source of the additives, and 

23 including any information received by the Secretary 

24 pursuant to clause (ii). 

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1 ‘‘(ii) If a regulation is in effect under sub2 section (c)(1)(A) for a genetic food additive, any 

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

5 of any knowledge of data that relate to the adverse 

6 health effects of the additive, when knowledge is ac7 quired by the person after the date on which the 

8 regulation took effect. If the manufacturer is in pos9 session of the data, the notification shall include the 

10 data. The Secretary shall by regulation establish the 

11 scope of the responsibilities of manufacturers under 

12 this clause, including such limits on the responsibil13 ities as the Secretary determines to be appropriate.’’. 

14 (3) EFFECTIVE DATE OF REGULATION REGARD15 ING SAFE USE; OPPORTUNITY FOR PUBLIC COM16 MENT.—Section 409(c)(2) of the Federal Food, 

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

18 amended— 

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

20 ‘‘(2)(A)’’; and 

21 (B) by adding at the end the following sub22 paragraph: 

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

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

25 the petition involved before the expiration of the applicable 

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1 period under clause (ii). During such period, and con2 tinuing until an order under paragraph (1) is issued, the 

3 Secretary shall provide interested persons an opportunity 

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

5 publishing such notice, the Secretary shall inform the pub6 lic of such opportunity. 

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

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

9 beginning on the date on which the Secretary has under 

10 subparagraph (B)(i) of subsection (b)(5) made informa11 tion available to the public regarding the petition, except 

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

13 Secretary finds in favor of a person who files for reconsid14 eration (relating to a determination by the Secretary that 

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

16 is extended by an additional period of 30-days. For pur17 poses of the preceding sentence, a discrete 30-day exten18 sion applies to each such reconsideration for which the 

19 Secretary finds in favor of the person filing for reconsider20 ation.’’. 

21 (4) CONSIDERATION OF CERTAIN FACTORS.— 

22 Section 409(c) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 348(c)) is amended by adding 

24 at the end the following paragraph: 

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

2 considered by the Secretary regarding safety for use shall 

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

4 analyses: 

5 ‘‘(A) Allergenicity effects resulting from the 

6 added proteins, including proteins not found in the 

7 food supply. 

8 ‘‘(B) Pleiotropic effects. The Secretary shall re9 quire tests to determine the potential for such ef10 fects (using molecular characterization, biochemical 

11 characterization, mRNA profiling, or other tech12 niques, or as appropriate, combinations of such tech13 niques). 

14 ‘‘(C) Appearance of new toxins or increased lev15 els of existing toxins. 

16 ‘‘(D) Changes in the functional characteristics 

17 of food. 

18 ‘‘(E) Changes in the levels of important nutri19 ents. 

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

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

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

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

24 the following paragraph: 

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

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

2 a commonly or severely allergenic food, the Sec3 retary may not establish a regulation under para4 graph (1)(A) if the petition under subsection (b)(1) 

5 fails to include full reports of investigations that 

6 used serum or skin tests (or other advanced tech7 niques) on a sensitive population to determine 

8 whether such additive is commonly or severely aller9 genic. 

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

11 that has not undergone the investigations described 

12 in subparagraph (A), the Secretary may not estab13 lish a regulation under paragraph (1)(A) if the peti14 tion under subsection (b)(1) fails to include full re15 ports of investigations that used the best available 

16 biochemical and physiological protocols to evaluate 

17 whether it is likely that the protein involved is an al18 lergen. 

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

20 shall by regulation determine the best available bio21 chemical and physiological protocols. In carrying out 

22 rulemaking under the preceding sentence, the Sec23 retary shall consult with the Director of the Na24 tional Institutes of Health.’’. 

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

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

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

4 the end the following paragraph: 

5 ‘‘(8) In the case of a genetic food additive, the Sec6 retary may not establish a regulation under paragraph 

7 (1)(A) if— 

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

9 an investigation finds that the additive is likely to be 

10 commonly or severely allergenic; 

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

12 an investigation that uses a protocol described in 

13 paragraph (7)(B) fails to find with reasonable cer14 tainty that the additive is unlikely to be an allergen; 

15 or 

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

17 is used with respect to the additive, the selective 

18 marker will remain in the food involved when the 

19 food is marketed, and the selective marker inhibits 

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

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

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

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

24 the end the following paragraph: 

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

2 food additives, the Secretary may (directly or through con3 tract) conduct investigations of such additives for pur4 poses of supplementing the information provided to the 

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

6 ‘‘(B) To provide the Congress with a periodic inde7 pendent, external review of the Secretary’s formulation of 

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

9 to genetic food additives, the Secretary shall enter into 

10 an agreement with the Institute of Medicine. Such agree11 ment shall provide that, if the Institute of Medicine has 

12 any concerns regarding the approval process, the Institute 

13 of Medicine will submit to the Congress a report describ14 ing such concerns.’’. 

15 (c) REGULATION ISSUED ON SECRETARY’S INITIA16 TIVE.—Section 409(d) of the Federal Food, Drug, and 

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

18 (1) by striking ‘‘(d) The Secretary’’ and insert19 ing ‘‘(d)(1) Subject to paragraph (2), the Sec20 retary’’; and 

21 (2) by adding at the end the following para22 graph: 

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

24 expressly reference genetic food additives apply with re25 spect to a regulation proposed by the Secretary under 

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

2 as such provisions apply with respect to a petition filed 

3 under subsection (b)(1).’’. 

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

5 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend6 ed by adding at the end the following subsection: 

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

8 301(b), or 301(c) involving the adulteration of food by rea9 son of failure to comply with the provisions of section 409 

10 that relate to genetic food additives, any person engaging 

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

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

13 each such violation. 

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

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

16 of this subsection to the same extent and in the same man17 ner as such paragraphs (5) through (7) apply with respect 

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

19 (9) of subsection (f).’’. 

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

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

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

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1 ‘‘SEC. 311. CITIZEN SUITS REGARDING GENETIC FOOD AD2 DITIVES. 

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

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

5 action in an appropriate district court of the United States 

6 against— 

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

8 a violation of section 301(a), 301(b), or 301(c) in9 volving the adulteration of food by reason of failing 

10 to comply with the provisions of section 409 that re11 late to genetic food additives; or 

12 ‘‘(2) the Secretary where there is alleged a fail13 ure of the Secretary to perform any act or duty 

14 under section 409 that relates to such additives and 

15 is not discretionary. 

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

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

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

19 the applicable provisions referred to paragraph (1) 

20 of such subsection; or 

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

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

23 ‘‘(c) LIMITATIONS.— 

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

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

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1 to 60 days after the plaintiff has provided to the 

2 Secretary notice of the violation involved. 

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

4 A civil action may not be commenced under sub5 section (a)(2) if the Secretary has commenced and 

6 is diligently prosecuting a civil or criminal action in 

7 a district court of the United States to enforce com8 pliance with the applicable provisions referred to in 

9 subsection (a)(1). 

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

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

12 party, may intervene as a matter of right. 

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

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

15 may award costs of litigation (including reasonable attor16 ney and expert witness fees) to any party whenever the 

17 court determines such an award is appropriate. The court 

18 may, if a temporary restraining order or preliminary in19 junction is sought, require the filing of a bond or equiva20 lent security in accordance with the Federal Rules of Civil 

21 Procedure. 

22 ‘‘(f) SAVINGS PROVISION.—This section does not re23 strict any right that a person (or class of persons) may 

24 have under any statute or common law to seek enforce25 ment of the provisions referred to subsection (a)(1), or to 

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1 seek any other relief (including relief against the Sec2 retary).’’. 

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

5 as amended by this section, compliance with the provisions 

6 of such section 409 that relate to genetic food additives 

7 does not constitute an affirmative defense in any cause 

8 of action under Federal or State law for personal injury 

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

10 SEC. 204. USER FEES REGARDING DETERMINATION OF 

11 SAFETY OF GENETIC FOOD ADDITIVES. 

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

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

14 section 409 the following section: 

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

16 FOOD ADDITIVES. 

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

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

20 section 409(b)(1). The fee shall be collected from the per21 son who submits the petition, is due upon submission of 

22 the petition, and shall be assessed in an amount deter23 mined under subsection (c). This section applies as of the 

24 first fiscal year that begins after the date of promulgation 

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

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1 Engineered Food Safety Act (referred to in this section 

2 as the ‘first applicable fiscal year’). 

3 ‘‘(b) PURPOSE OF FEES.— 

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

5 subsection (a) are as follows: 

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

7 the resources allocated for carrying out section 

8 409 for the first applicable fiscal year over the 

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

11 not attributable to the responsibilities of the 

12 Secretary with respect to genetic food additives. 

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

14 and applied research on the safety of genetic 

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

20 genetic food additives, and shall not directly 

21 support the development of new genetically en22 gineered foods. 

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

24 total fee revenues collected under subsection (a) for 

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1 a fiscal year, the Secretary shall reserve and ex2 pend— 

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

4 in paragraph (1)(A); and 

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

6 in paragraph (1)(B). 

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

9 fees under subsection (a): 

10 ‘‘(A) Increases referred to in paragraph 

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

13 409(c)(9)(A). 

14 ‘‘(B) Increases referred to in paragraph 

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

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

19 with respect to genetic food additives. 

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

21 AMOUNTS.—The total fee revenues collected under sub22 section (a) for a fiscal year shall be the amounts appro23 priated under subsection (f)(2) for such fiscal year. Indi24 vidual fees shall be assessed by the Secretary on the basis 

25 of an estimate by the Secretary of the amount necessary 

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

2 year equals the amount so appropriated. In assessing the 

3 individual fees, the Secretary shall by regulation provide 

4 for the assessment of reduced fee amounts for entities that 

5 are small businesses, or nonprofit private entities, as de6 fined by the Secretary for purposes of this section. 

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

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

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

10 to be paid will exceed the anticipated present and future 

11 costs incurred by the Secretary in carrying out the pur12 poses described in subsection (b) (which finding may be 

13 made by the Secretary using standard costs). 

14 ‘‘(e) ASSESSMENT OF FEES.— 

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

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

17 the first applicable fiscal year unless the amount ap18 propriated for salaries and expenses of the Food and 

19 Drug Administration for such fiscal year is equal to 

20 or greater than the amount appropriated for salaries 

21 and expenses of the Food and Drug Administration 

22 for the first applicable fiscal year multiplied by the 

23 adjustment factor applicable to the fiscal year in24 volved, except that in making determinations under 

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1 this paragraph for the fiscal years involved there 

2 shall be excluded— 

3 ‘‘(A) the amounts appropriated under sub4 section (f)(2) for the fiscal years involved; and 

5 ‘‘(B) the amounts appropriated under sec6 tions 736(g), 738(h), 740(g), and 741(g) for 

7 such fiscal years. 

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

9 Secretary does not have authority to assess fees 

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

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

12 have such authority, the Secretary, notwithstanding 

13 the due date under such subsection for fees, may as14 sess and collect such fees at any time in such fiscal 

15 year, without any modification in the rate of the 

16 fees. 

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

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

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

20 the appropriation account for salaries and expenses 

21 of the Food and Drug Administration and shall be 

22 available in accordance with appropriation Acts until 

23 expended without fiscal year limitation. Such sums 

24 as may be necessary may be transferred from the 

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1 penses appropriation account without fiscal year lim2 itation to such appropriation account for salaries 

3 and expenses with such fiscal year limitation. The 

4 sums transferred shall be available solely for the 

5 purposes described in paragraph (1) of subsection 

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

7 paragraph (2) of such subsection. 

8 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

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

10 applicable fiscal year— 

11 ‘‘(i) there is authorized to be appro12 priated for fees under subsection (a) an 

13 amount equal to the amount of increase 

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

15 the Secretary (which amount shall be pub16 lished in the Federal Register); and 

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

18 be appropriated for fees under subsection 

19 (a) an amount determined by the Secretary 

20 to be necessary to carry out the purpose 

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

22 amount shall be so published). 

23 ‘‘(B) SUBSEQUENT FISCAL YEARS.—For 

24 each of the four fiscal years following the first 

25 applicable fiscal year— 

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1 ‘‘(i) there is authorized to be appro2 priated for fees under subsection (a) an 

3 amount equal to the amount that applied 

4 under subparagraph (A)(i) for the first ap5 plicable fiscal year, except that such 

6 amount shall be adjusted under paragraph 

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

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

9 be appropriated for fees under subsection 

10 (a) an amount equal to the amount that 

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

12 first applicable fiscal year, except that such 

13 amount shall be adjusted under paragraph 

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

15 ‘‘(3) ADJUSTMENTS.— 

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

17 each fiscal year other than the first applicable 

18 fiscal year, the amount that applied under para19 graph (2)(A)(i) for the first applicable fiscal 

20 year shall be multiplied by the adjustment fac21 tor (as defined in subsection (i)). 

22 ‘‘(B) RESEARCH PROGRAM.—For each fis23 cal year other than the first applicable fiscal 

24 year, the amount that applied under paragraph 

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

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1 shall be adjusted by the Secretary (and as ad2 justed shall be published in the Federal Reg3 ister) to reflect the greater of— 

4 ‘‘(i) the total percentage change that 

5 occurred during the preceding fiscal year 

6 in the Consumer Price Index for all urban 

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

8 ‘‘(ii) the total percentage change for 

9 such fiscal year in basic pay under the 

10 General Schedule in accordance with sec11 tion 5332 of title 5, United States Code, 

12 as adjusted by any locality-based com13 parability payment pursuant to section 

14 5304 of such title for Federal employees 

15 stationed in the District of Columbia. 

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

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

18 the amount of fees specified in appropriation Acts 

19 for such fiscal year shall be credited to the appro20 priation account of the Food and Drug Administra21 tion as provided in paragraph (1), and shall be sub22 tracted from the amount of fees that would other23 wise be authorized to be collected under this section 

24 pursuant to appropriation Acts for a subsequent fis25 cal year. 

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

2 where the Secretary does not receive payment of a fee as3 sessed under subsection (a) within 30 days after it is due, 

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

5 Government subject to subchapter II of chapter 37 of title 

6 31, United States Code. 

7 ‘‘(h) CONSTRUCTION.—This section may not be con8 strued as requiring that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employers, and advisory committees not 

11 engaged in carrying out section 409 with respect to ge12 netic food additives be reduced to offset the number of 

13 officers, employees, and advisory committees so engaged. 

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

15 purposes of this section, the term ‘adjustment factor’ ap16 plicable to a fiscal year is the lower of— 

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

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

19 April of the preceding fiscal year divided by such 

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

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

22 provided for programs in categories other than the 

23 defense category for the immediately preceding fiscal 

24 year (as reported in the Office of Management and 

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1 quired under section 254(c) of the Balanced Budget 

2 and Emergency Deficit Control Act of 1985) divided 

3 by such budget authority for the first applicable fis4 cal year (as reported in the Office of Management 

5 and Budget final sequestration report submitted for 

6 such year). 

7 For purposes of this subsection, the terms ‘budget author8 ity’ and ‘category’ have the meaning given such terms in 

9 the Balanced Budget and Emergency Deficit Control Act 

10 of 1985.’’. 

11 SEC. 205. EMBARGO AUTHORITY. 

12 (a) EMBARGO.— 

13 (1) TEMPORARY DETENTION.—Section 

14 304(g)(1) of the Federal Food, Drug, and Cosmetic 

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

16 (A) in the first sentence— 

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

18 that follows through ‘‘order the device or 

19 tobacco product detained’’ and inserting 

20 the following: ‘‘If, during an inspection 

21 conducted under section 704, an officer or 

22 employee of the Department has reason to 

23 believe that a food, device, or tobacco prod24 uct is in violation of this Act, such officer 

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1 or employee may order the food, device, or 

2 tobacco product detained’’; and 

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

4 and inserting ‘‘the Secretary may author5 ize’’; 

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

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

8 it appears and inserting ‘‘food, device, or to9 bacco product’’; 

10 (C) by striking the fourth and fifth sen11 tences; and 

12 (D) by adding at the end the following sen13 tence: ‘‘A detention order under this paragraph 

14 shall be considered final agency action.’’. 

15 (2) CONFORMING AMENDMENTS.—Chapter III 

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

17 U.S.C. 331 et seq.) is amended— 

18 (A) in section 301(r)— 

19 (i) by striking ‘‘device or tobacco 

20 product’’ the first place such term appears 

21 and inserting ‘‘food, device, or tobacco 

22 product’’; and 

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

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

25 or tobacco product’’; and 

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1 (B) in section 304(g)(2)— 

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

3 ‘‘device or tobacco product’’ and inserting 

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

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

6 ‘‘device’’ each place it appears and insert7 ing ‘‘food or device’’. 

8 (b) DATE CERTAIN FOR PROPOSED AND FINAL

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

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

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

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

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

14 date such proposed revision is published in the Federal 

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

16 regulations. 

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

18 seized, or recalled under the Federal Food, Drug, and Cos19 metic Act, the Food and Drug Administration shall dis20 close all necessary information without regard to business 

21 confidentiality, if such disclosure is necessary to fully em22 bargo, seize, or recall any adulterated food. 

23 (d) FOOD RETAILER REGISTRATION.—All food re24 tailers shall register with the Food and Drug Administramstockstill on DSK4VPTVN1PROD with BILLS

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1 tion for the purpose of expediting recalls, embargoes, and 

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

3 SEC. 206. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY 

4 UNREGULATED MARKETED ADDITIVES. 

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

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

7 the Secretary of Health and Human Services shall by reg8 ulation establish criteria for carrying out section 409 of 

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

10 with the amendments made by section 203, and criteria 

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

12 section 204). Such amendments take effect upon the expi13 ration of the 30-day period beginning on the date on which 

14 the Secretary promulgates the final rule under the pre15 ceding sentence, subject to subsection (b). 

16 (b) PREVIOUSLY UNREGULATED MARKETED ADDI17 TIVES.— 

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

19 additive (as defined pursuant to the amendments 

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

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

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

23 promulgated, the amendments made by this title 

24 apply to the additive upon the expiration of the twomstockstill on DSK4VPTVN1PROD with BILLS

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1 year period beginning on the date on which the final 

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

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

4 food additive described in paragraph (1), such para5 graph does not waive the applicability of section 

6 409A of the Federal Food, Drug, and Cosmetic Act 

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

8 that is filed before the expiration of the two-year pe9 riod described in such paragraph. 

Æ 

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