II 

108TH CONGRESS 

2D SESSION S. 2546 

To amend the Federal Food, Drug, and Cosmetic Act to require premarket 

consultation and approval with respect to genetically engineered foods, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 17, 2004 

Mr. DURBIN introduced the following bill; which was read twice and referred 

to the Committee on Agriculture, Nutrition, and Forestry 

A BILL 

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

require premarket consultation and approval with respect 

to genetically engineered foods, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

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

5 Foods Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 
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1 (1) genetically engineered food is rapidly be2 coming an integral part of domestic and inter3 national food supplies; 

4 (2) the potential positive effects of genetically 

5 engineered foods are enormous; 

6 (3) the potential for both anticipated and unan7 ticipated effects exists with genetic engineering of 

8 foods; 

9 (4) genetically engineered food not approved for 

10 human consumption has, in the past, entered the 

11 human food supply; 

12 (5) environmental issues have been identified as 

13 a major science-based concern associated with ani14 mal biotechnology; 

15 (6) it is essential to maintain— 

16 (A) public confidence in— 

17 (i) the safety of the food supply; and 

18 (ii) the ability of the Federal Govern19 ment to exercise adequate oversight of ge20 netically engineered foods; and 

21 (B) the ability of agricultural producers 

22 and other food producers of the United States 

23 to market, domestically and internationally, 

24 foods that have been genetically engineered; 
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1 (7) public confidence can best be maintained 

2 through careful review and formal determination of 

3 the safety of genetically engineered foods, and moni4 toring of the positive and negative effects of geneti5 cally engineered foods as the foods become inte6 grated into the food supply, through a review and 

7 monitoring process that— 

8 (A) is scientifically sound, open, and trans9 parent; 

10 (B) fully involves the general public; and 

11 (C) does not subject most genetically engi12 neered foods to the lengthy food additive ap13 proval process; and 

14 (8) because genetically engineered foods are de15 veloped worldwide and imported into the United 

16 States, it is imperative that imported genetically en17 gineered food be subject to the same level of over18 sight as domestic genetically engineered food. 

19 SEC. 3. DEFINITIONS. 

20 (a) THIS ACT.—In this Act, the terms ‘‘genetic engi21 neering technique’’, ‘‘genetically engineered animal’’, ‘‘ge22 netically engineered food’’, ‘‘interstate commerce’’, ‘‘pro23 ducer’’, ‘‘safe’’, and ‘‘Secretary’’ have the meanings given 

24 those terms in section 201 of the Federal Food, Drug, 
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1 and Cosmetic Act (21 U.S.C. 321) (as amended by sub2 section (b)). 

3 (b) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

4 Section 201 of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 321) is amended— 

6 (1) in subsection (v)— 

7 (A) by striking ‘‘(v) The term’’ and insert8 ing the following: 

9 ‘‘(v) NEW ANIMAL DRUG.— 

10 ‘‘(1) IN GENERAL.—The term’’; 

11 (B) by striking ‘‘(1) the composition’’ and 

12 inserting ‘‘(A) the composition’’; 

13 (C) by striking ‘‘(2) the composition’’ and 

14 inserting ‘‘(B) the composition’’; and 

15 (D) by adding at the end the following: 

16 ‘‘(2) INCLUSION.—The term ‘new animal drug’ 

17 includes— 

18 ‘‘(A) a genetic engineering technique in19 tended to be used to produce an animal; and 

20 ‘‘(B) a genetically engineered animal.’’; 

21 and 

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

23 ‘‘(nn) GENETICALLY ENGINEERED ANIMAL.— 

24 ‘‘(1) IN GENERAL.—The term ‘genetically engi25 neered animal’ means an animal that— 
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1 ‘‘(A) is intended to be used— 

2 ‘‘(i) in the production of a food or die3 tary supplement; or 

4 ‘‘(ii) for any other purpose; 

5 ‘‘(B)(i) is produced in the United States; 

6 or 

7 ‘‘(ii) is offered for import into the United 

8 States; and 

9 ‘‘(C) is produced using a genetic engineer10 ing technique. 

11 ‘‘(2) EXCLUSION.—The term ‘genetically engi12 neered animal’ does not include an established line 

13 of a genetically modified animal that— 

14 ‘‘(A) is used solely in scientific research; 

15 and 

16 ‘‘(B) is not intended or expected— 

17 ‘‘(i) to enter the food supply; or 

18 ‘‘(ii) to be released into the environ19 ment. 

20 ‘‘(oo) GENETICALLY ENGINEERED FOOD.— 

21 ‘‘(1) IN GENERAL.—The term ‘genetically engi22 neered food’ means a food or dietary supplement, or 

23 a seed, microorganism, or ingredient intended to be 

24 used to produce a food or dietary supplement, 

25 that— 
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1 ‘‘(A)(i) is produced in the United States; 

2 or 

3 ‘‘(ii) is offered for import into the United 

4 States; and 

5 ‘‘(B) is produced using a genetic engineer6 ing technique. 

7 ‘‘(2) INCLUSION.—The term ‘genetically engi8 neered food’ includes a split use food. 

9 ‘‘(3) EXCLUSION.—The term ‘genetically engi10 neered food’ does not include a genetically engi11 neered animal. 

12 ‘‘(pp) GENETIC ENGINEERING TECHNIQUE.—The 

13 term ‘genetic engineering technique’ means the use of a 

14 transformation event to derive food from a plant or animal 

15 or to produce an animal. 

16 ‘‘(qq) PRODUCER.—The term ‘producer’, with respect 

17 to a genetically engineered animal, genetically engineered 

18 food, or genetic engineering technique, means a person 

19 that— 

20 ‘‘(1) develops, manufactures, or imports the ge21 netically engineered animal or genetically engineered 

22 food; 

23 ‘‘(2) uses the genetic engineering technique; or 

24 ‘‘(3) takes other action to introduce the geneti25 cally engineered animal, genetically engineered food, 
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1 or genetic engineering technique into interstate com2 merce. 

3 ‘‘(rr) SAFE.—The term ‘safe’, with respect to a ge4 netically engineered food, means— 

5 ‘‘(1) as safe as comparable food that is not pro6 duced using a genetic engineering technique; or 

7 ‘‘(2) if there is no such comparable food, having 

8 a reasonable certainty of causing no harm. 

9 ‘‘(ss) SPLIT USE FOOD.—The term ‘split use food’ 

10 means a product that— 

11 ‘‘(1)(A) is produced in the United States; or 

12 ‘‘(B) is offered for import into the United 

13 States; 

14 ‘‘(2) is produced using a genetic engineering 

15 technique; and 

16 ‘‘(3) could be used as food by both humans and 

17 animals but that the producer does not intend to 

18 market as food for humans. 

19 ‘‘(tt) TRANSFORMATION EVENT.—The term ‘trans20 formation event’ means the introduction into a plant or 

21 an animal of genetic material that has been manipulated 

22 in vitro.’’. 

23 SEC. 4. GENETICALLY ENGINEERED FOODS. 

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

25 Act (21 U.S.C. 341 et seq.) is amended— 
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1 (1) by inserting after the chapter heading the 

2 following: 

3 ‘‘Subchapter A—General Provisions’’; 

4 and 

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

6 ‘‘Subchapter B—Genetically Engineered 

7 Foods 

8 ‘‘SEC. 421. PREMARKET CONSULTATION AND APPROVAL. 

9 ‘‘(a) IN GENERAL.—A producer of genetically engi10 neered food, before introducing a genetically engineered 

11 food into interstate commerce, shall first obtain approval 

12 through the use of a premarket consultation and approval 

13 process. 

14 ‘‘(b) REGULATIONS.—The Secretary shall promul15 gate regulations that describe— 

16 ‘‘(1) all information that is required to be sub17 mitted for the premarketing approval process, in18 cluding— 

19 ‘‘(A) specification of the species or other 

20 taxonomic classification of plants for which ap21 proval is sought; 

22 ‘‘(B) identification of the genetically engi23 neered food; 
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1 ‘‘(C)(i) a description of each type of ge2 netic manipulation made to the genetically engi3 neered food; 

4 ‘‘(ii) identification of the manipulated ge5 netic material; and 

6 ‘‘(iii) the techniques used in making the 

7 manipulation; 

8 ‘‘(D) the effect of the genetic manipulation 

9 on the composition of the genetically engineered 

10 food (including information describing the spe11 cific substances that were expressed, removed, 

12 or otherwise manipulated); 

13 ‘‘(E) a description of the actual or pro14 posed applications and uses of the genetically 

15 engineered food; 

16 ‘‘(F) information pertaining to— 

17 ‘‘(i) the safety of the genetically engi18 neered food as a whole; and 

19 ‘‘(ii) the safety of any specific sub20 stances introduced, altered, or produced as 

21 a result of the genetic manipulation (in22 cluding information on allergenicity and 

23 toxicity); 

24 ‘‘(G) test methods for detection of the ge25 netically engineered ingredients in food; 
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1 ‘‘(H) a summary and overview of informa2 tion and issues that have been or will be ad3 dressed by other regulatory programs for the 

4 review of genetically engineered food; 

5 ‘‘(I) procedures to be followed to initiate 

6 and complete the premarket approval process 

7 (including any preconsultation and consultation 

8 procedures); and 

9 ‘‘(J) any other matters that the Secretary 

10 determines to be necessary. 

11 ‘‘(2) SPLIT USE FOOD.— 

12 ‘‘(A) IN GENERAL.—The regulations under 

13 paragraph (1) shall provide for the approval 

14 of— 

15 ‘‘(i) split use foods that are not ap16 proved for human consumption; 

17 ‘‘(ii) split use foods that are intended 

18 for human use but are marketed under re19 stricted conditions; and 

20 ‘‘(iii) other categories of split use 

21 food. 

22 ‘‘(B) ISSUES.—For each category of split 

23 use food, the regulations shall address— 
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1 ‘‘(i)(I) whether a protocol is needed 

2 for segregating a restricted split use food 

3 from the food supply; and 

4 ‘‘(II) if so, what the protocol shall be; 

5 ‘‘(ii)(I) whether action is needed to 

6 ensure the purity of any seed to prevent 

7 unintended introduction of a genetically en8 gineered trait into a seed that is not de9 signed for that trait; and 

10 ‘‘(II) if so, what action is needed and 

11 what industry practices represent the best 

12 practices for maintaining the purity of the 

13 seed; 

14 ‘‘(iii)(I) whether a tolerance level 

15 should exist regarding cross-mixing of seg16 regated split use foods; and 

17 ‘‘(II) if so, the means by which the 

18 tolerance level shall be determined; 

19 ‘‘(iv) the manner in which the food 

20 safety analysis under this section should be 

21 conducted, specifying different standards 

22 and procedures that are permitted to be 

23 applied for nonfood products grown in food 

24 crops depending on the degree of contain-
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1 ment for that product and the likelihood of 

2 the product to enter the food supply; 

3 ‘‘(v)(I) the kinds of surveillance that 

4 are needed to ensure that appropriate seg5 regation of split use foods is being main6 tained; 

7 ‘‘(II) the manner in which and by 

8 whom the surveillance shall be conducted; 

9 and 

10 ‘‘(III) the manner in which the results 

11 of surveillance shall be reported; and 

12 ‘‘(vi) clarification of responsibility in 

13 cases of breakdown of segregation of a 

14 split use food. 

15 ‘‘(C) RECALL AUTHORITY.—The regula16 tions shall provide that, in addition to other au17 thority that the Secretary has regarding split 

18 use food, the Secretary may order a recall of 

19 any split use food (whether or not the split use 

20 food has been approved under this section) 

21 that— 

22 ‘‘(i) is not approved, but has entered 

23 the food supply; or 
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1 ‘‘(ii) has entered the food supply in 

2 violation of a condition of restriction under 

3 an approval. 

4 ‘‘(c) APPLICATION.—The regulations shall require 

5 that, as part of the consultation and approval process, a 

6 producer submit to the Secretary an application that in7 cludes a summary and a complete copy of each research 

8 study, test result, or other information referenced by the 

9 producer. 

10 ‘‘(d) REVIEW.— 

11 ‘‘(1) IN GENERAL.—After receiving an applica12 tion under subsection (c), the Secretary shall— 

13 ‘‘(A) determine whether the producer sub14 mitted information that appears to be adequate 

15 to enable the Secretary to fully assess the safe16 ty of the genetically engineered food, and make 

17 a description of the determination publicly 

18 available; and 

19 ‘‘(B) if the Secretary determines that the 

20 producer submitted adequate information— 

21 ‘‘(i) provide public notice regarding 

22 the initiation of the consultation and ap23 proval process; 

24 ‘‘(ii) make the notice, application, 

25 summaries submitted by the producer, and 
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1 research, test results, and other informa2 tion referenced by the producer publicly 

3 available, including, to the maximum ex4 tent practicable, publication in the Federal 

5 Register and on the Internet; and 

6 ‘‘(iii) provide the public with an op7 portunity, for not less than 45 days, to 

8 submit comments on the application. 

9 ‘‘(2) EXCEPTION.—The Secretary may withhold 

10 information in an application from public dissemina11 tion to protect a trade secret (not including any in12 formation disclosing the results of testing to deter13 mine whether the genetically engineered food is safe) 

14 if— 

15 ‘‘(A) the information is exempt from dis16 closure under section 522 of title 5, United 

17 States Code, or applicable trade secret law; 

18 ‘‘(B) the applicant— 

19 ‘‘(i) identifies with specificity the 

20 trade secret information in the application; 

21 and 

22 ‘‘(ii) provides the Secretary with a de23 tailed justification for each trade secret 

24 claim; and 

25 ‘‘(C) the Secretary— 
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1 ‘‘(i) determines that the information 

2 qualifies as a trade secret subject to with3 holding from public dissemination; and 

4 ‘‘(ii) makes the determination avail5 able to the public. 

6 ‘‘(3) DETERMINATION.—Not later than 180 

7 days after determining adequacy of an application 

8 under paragraph (1)(A), the Secretary shall issue 

9 and make publicly available a determination that— 

10 ‘‘(A) summarizes the information ref11 erenced by the producer in light of the public 

12 comments; and 

13 ‘‘(B) contains a finding that the genetically 

14 engineered food— 

15 ‘‘(i) is safe and may be introduced 

16 into interstate commerce; 

17 ‘‘(ii) is safe under specified conditions 

18 of use and may be introduced into inter19 state commerce if those conditions are met; 

20 or 

21 ‘‘(iii) is not safe and may not be in22 troduced into interstate commerce, because 

23 the genetically engineered food— 

24 ‘‘(I) contains genes that confer 

25 antibiotic resistance; 
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1 ‘‘(II) contains an allergen; or 

2 ‘‘(III) presents 1 or more other 

3 safety concerns described by the Sec4 retary. 

5 ‘‘(4) EXTENSION.—The Secretary may extend 

6 the period specified in paragraph (3) if the Secretary 

7 determines that an extension of the period is nec8 essary to allow the Secretary to— 

9 ‘‘(A) review additional information; or 

10 ‘‘(B) address 1 or more issues or concerns 

11 of unusual complexity. 

12 ‘‘(e) RESCISSION OF APPROVAL.— 

13 ‘‘(1) RECONSIDERATION.—On the petition of 

14 any person, or on the Secretary’s own motion, the 

15 Secretary may reconsider an approval of a geneti16 cally engineered food on the basis of information 

17 that was not available before the approval. 

18 ‘‘(2) FINDING FOR RECONSIDERATION.—The 

19 Secretary shall conduct a reconsideration on the 

20 basis of the information described in paragraph (1) 

21 if the Secretary finds that the information— 

22 ‘‘(A) is scientifically credible; 

23 ‘‘(B) represents significant information 

24 that was not available before the approval; and 
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1 ‘‘(C)(i) suggests potential impacts relating 

2 to the genetically engineered food that were not 

3 considered in the earlier review; or 

4 ‘‘(ii) demonstrates that the information 

5 considered before the approval was inadequate 

6 for the Secretary to make a safety finding. 

7 ‘‘(3) INFORMATION FROM THE PRODUCER.— 

8 ‘‘(A) IN GENERAL.—In conducting the re9 consideration, the Secretary may require the 

10 producer to provide, within a reasonable period 

11 of time specified by the Secretary, information 

12 needed to facilitate the reconsideration. 

13 ‘‘(B) INFORMATION NOT PROVIDED.—If a 

14 producer fails to provide information required 

15 under subparagraph (A) within the period spec16 ified by the Secretary, the Secretary shall take 

17 1 or more of the actions described in paragraph 

18 (5). 

19 ‘‘(4) DETERMINATION.—After reviewing the in20 formation by the petitioner and the producer, the 

21 Secretary shall issue a determination that— 

22 ‘‘(A) revises the finding made in connec23 tion with the approval with respect to the safety 

24 of the genetically engineered food; or 
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1 ‘‘(B) states that, for reasons stated by the 

2 Secretary, no revision of the finding is needed. 

3 ‘‘(5) ACTION BY THE SECRETARY.—If, based on 

4 a reconsideration under this section, the Secretary 

5 determines that the genetically engineered food is 

6 not safe, the Secretary shall— 

7 ‘‘(A) rescind the approval of the genetically 

8 engineered food for introduction into interstate 

9 commerce; 

10 ‘‘(B) recall the genetically engineered food; 

11 or 

12 ‘‘(C) take such other action as the Sec13 retary determines to be appropriate. 

14 ‘‘SEC. 422. MARKETPLACE TESTING AND POST-MARKETING 

15 OVERSIGHT. 

16 ‘‘(a) TESTING.— 

17 ‘‘(1) IN GENERAL.—The Secretary, in consulta18 tion with the Secretary of Agriculture and the Ad19 ministrator of the Environmental Protection Agency, 

20 shall establish a program to conduct testing that the 

21 Secretary determines to be necessary to detect, at all 

22 stages of production and distribution (from agricul23 tural production to retail sale), the presence of ge24 netically engineered ingredients in food. 
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1 ‘‘(2) PERMISSIBLE TESTING.—Under the pro2 gram, the Secretary may conduct tests on foods to 

3 detect genetically engineered ingredients— 

4 ‘‘(A) that have not been approved for use 

5 under this Act, including foods that are devel6 oped in foreign countries that have not been ap7 proved for marketing in the United States 

8 under this Act; or 

9 ‘‘(B) the use of which is restricted under 

10 this Act (including approval for use as animal 

11 feed only, approval only if properly labeled, and 

12 approval for growing or marketing only in cer13 tain regions). 

14 ‘‘(b) POST-MARKET OVERSIGHT.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall estab16 lish a program to monitor and evaluate the contin17 ued safety after commercialization of genetically en18 gineered foods approved under section 421. 

19 ‘‘(2) ACTIVITIES.—Under the program, the Sec20 retary shall— 

21 ‘‘(A) take appropriate actions to ensure 

22 that each split-use food complies with any re23 striction or other condition on the approval of 

24 the split-use food; and 
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1 ‘‘(B) conduct inspections and monitoring 

2 of genetically engineered foods and facilities 

3 that produce genetically engineered foods to en4 sure that only approved genetically engineered 

5 foods are marketed to humans. 

6 ‘‘SEC. 423. REGISTRY. 

7 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta8 tion with the Secretary of Agriculture, the Administrator 

9 of the Environmental Protection Agency, and the heads 

10 of other agencies, as appropriate, shall establish a registry 

11 for genetically engineered food that contains a description 

12 of the regulatory status of all genetically engineered foods 

13 approved under section 421. 

14 ‘‘(b) REQUIREMENTS.—The registry under sub15 section (a) shall contain, for each genetically engineered 

16 food— 

17 ‘‘(1) the technical and common names of the 

18 genetically engineered food; 

19 ‘‘(2) a description of the regulatory status, 

20 under all Federal programs pertaining to the testing 

21 and approval of genetically engineered foods, of the 

22 genetically engineered food; 

23 ‘‘(3) a technical and nontechnical summary of 

24 the type of, and a statement of the reason for, each 
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1 genetic manipulation made to the genetically engi2 neered food; 

3 ‘‘(4) the name, title, address, and telephone 

4 number of an official at each producer of the geneti5 cally engineered food whom members of the public 

6 may contact for information about the genetically 

7 engineered food; 

8 ‘‘(5) the name, title, address, and telephone 

9 number of an official at each Federal agency with 

10 oversight responsibility over the genetically engi11 neered food whom members of the public may con12 tact for information about the genetically engineered 

13 food; and 

14 ‘‘(6) such other information as the Secretary 

15 determines should be included. 

16 ‘‘(c) PUBLIC AVAILABILITY.—The registry under 

17 subsection (a) shall be made available to the public, includ18 ing availability on the Internet.’’. 

19 SEC. 5. GENETICALLY ENGINEERED ANIMALS. 

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

21 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

22 section 512 the following: 

23 ‘‘SEC. 512A. GENETICALLY ENGINEERED ANIMALS. 

24 ‘‘(a) IN GENERAL.—Section 512 shall apply to ge25 netic engineering techniques intended to be used to 
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1 produce an animal, and to genetically engineered animals, 

2 as provided in this section. 

3 ‘‘(b) APPLICATION.—An application under section 

4 512(b)(1) shall include— 

5 ‘‘(1) specification of the species or other taxo6 nomic classification of the animal for which approval 

7 is sought; 

8 ‘‘(2) an environmental assessment that analyzes 

9 the potential effects of the genetically engineered 

10 animal on the environment, including the potential 

11 effect on any nongenetically engineered animal or 

12 other part of the environment as a result of any in13 tentional or unintentional exposure of the genetically 

14 engineered animal to the environment; and 

15 ‘‘(3) a plan to eliminate or mitigate the poten16 tial effects to the environment from the release of 

17 the genetically engineered animal. 

18 ‘‘(c) DISSEMINATION OF APPLICATION AND OPPOR19 TUNITY FOR PUBLIC COMMENT.— 

20 ‘‘(1) IN GENERAL.—On receipt of an applica21 tion under section 512(b)(1), the Secretary shall— 

22 ‘‘(A) provide public notice regarding the 

23 application, including making the notice avail24 able on the Internet; 
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1 ‘‘(B) make the application and all sup2 porting material available to the public, includ3 ing availability on the Internet; and 

4 ‘‘(C) provide the public with an oppor5 tunity, for not less than 45 days, to submit 

6 comments on the application. 

7 ‘‘(2) EXCEPTION.— 

8 ‘‘(A) IN GENERAL.—The Secretary may 

9 withhold information in an application from 

10 public dissemination to protect a trade secret 

11 (not including any information disclosing the 

12 results of testing to determine whether the ge13 netically engineered food is safe) if— 

14 ‘‘(i) the information is exempt from 

15 disclosure under section 522 of title 5, 

16 United States Code, or applicable trade se17 cret law; 

18 ‘‘(ii) the applicant— 

19 ‘‘(I) identifies with specificity the 

20 trade secret information in the appli21 cation; and 

22 ‘‘(II) provides the Secretary with 

23 a detailed justification for each trade 

24 secret claim; and 

25 ‘‘(iii) the Secretary— 
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1 ‘‘(I) determines that the informa2 tion qualifies as a trade secret subject 

3 to withholding from public dissemina4 tion; and 

5 ‘‘(II) makes the determination 

6 available to the public. 

7 ‘‘(B) RISK ASSESSMENT INFORMATION.— 

8 This paragraph does not apply to information 

9 that assesses risks from the release into the en10 vironment of a genetically engineered animal 

11 (including any environmental assessment or en12 vironmental impact statement performed to 

13 comply with the National Environmental Policy 

14 Act of 1969 (42 U.S.C. 4321 et seq.)). 

15 ‘‘(d) DENIAL OF APPLICATION.—Under section 

16 512(d)(1), the Secretary shall deny an application if— 

17 ‘‘(1) the environmental assessment for a geneti18 cally engineered animal is not adequate; or 

19 ‘‘(2) the plan to eliminate or mitigate the po20 tential environmental effects to the environment 

21 from the release of the genetically engineered animal 

22 does not adequately protect the environment. 

23 ‘‘(e) ENVIRONMENTAL ASSESSMENT.— 

24 ‘‘(1) IN GENERAL.—Before determining wheth25 er to approve an application under section 512 for 
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1 approval of a genetic engineering technique intended 

2 to be used to produce an animal, or of a genetically 

3 engineered animal, the Secretary shall— 

4 ‘‘(A) conduct an environmental assessment 

5 to evaluate the potential effects of such a ge6 netically engineered animal on the environment; 

7 and 

8 ‘‘(B) determine that the genetically engi9 neered animal will not have an unreasonable 

10 adverse effect on the environment. 

11 ‘‘(2) CONSULTATION.—In conducting an envi12 ronmental assessment under paragraph (1), the Sec13 retary shall— 

14 ‘‘(A) consult, as appropriate, with the De15 partment of Agriculture, the United States Fish 

16 and Wildlife Service, and any other Federal 

17 agency that has expertise relating to the animal 

18 species that is the subject of the application; 

19 and 

20 ‘‘(B) disclose the results of the consulta21 tion in the environmental assessment. 

22 ‘‘(f) SAFETY DETERMINATION.—In determining the 

23 safety of a genetic engineering technique or genetically en24 gineered animal, the Secretary shall consider the potential 

25 effects of the genetically engineered animal on the environ-
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1 ment, including the potential effect on nongenetically engi2 neered animals. 

3 ‘‘(g) PROGENY.—If an application for approval of a 

4 genetic engineering technique to produce an animal of a 

5 species or other taxonomic classification, or genetically en6 gineered animal, has been approved, no additional applica7 tion shall be required for animals of that species or other 

8 taxonomic classification produced using that genetic engi9 neering technique or for the progeny of that genetically 

10 engineered animal. 

11 ‘‘(h) SCOPE OF APPROVAL.—The scope of the genetic 

12 engineering technique that the Secretary may approve 

13 shall be limited to the precise procedures described in the 

14 application for approval. 

15 ‘‘(i) CONDITIONS OF APPROVAL.—The Secretary may 

16 require as a condition of approval of an application that 

17 any producer of a genetically engineered animal that is 

18 the subject of the application— 

19 ‘‘(1) take specified actions to eliminate or miti20 gate any potential harm to the environment that 

21 would be caused by a release of the genetically engi22 neered animal, including actions specified in the plan 

23 submitted by the applicant; and 
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1 ‘‘(2) conduct post-approval monitoring for envi2 ronmental effects of any release of the genetically 

3 engineered animal. 

4 ‘‘(j) RECALL; SUSPENSION OF APPROVAL.— 

5 ‘‘(1) RECALL.—The Secretary may order a re6 call of any genetically engineered animal (whether or 

7 not the genetically engineered animal, or a genetic 

8 engineering technique used to produce the genetically 

9 engineered animal, has been approved) that the Sec10 retary determines is harmful to— 

11 ‘‘(A) humans; 

12 ‘‘(B) the environment; 

13 ‘‘(C) any animal that is subjected to a ge14 netic engineering technique; or 

15 ‘‘(D) any animal that is not subjected to a 

16 genetic engineering technique. 

17 ‘‘(2) SUSPENSION OF APPROVAL.—If the Sec18 retary determines that a genetically engineered ani19 mal is harmful to the health of humans or animals 

20 or to the environment, the Secretary may— 

21 ‘‘(A) immediately suspend the approval of 

22 application for the genetically engineered ani23 mal; 

24 ‘‘(B) give the applicant prompt notice of 

25 the action; and 
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1 ‘‘(C) afford the applicant an opportunity 

2 for an expedited hearing. 

3 ‘‘(k) RESCISSION OF APPROVAL.— 

4 ‘‘(1) RECONSIDERATION.—On the motion of 

5 any person, or on the Secretary’s own motion, the 

6 Secretary may reconsider an approval of a genetic 

7 engineering technique or genetically engineered ani8 mal on the basis of information that was not avail9 able during an earlier review. 

10 ‘‘(2) FINDING FOR RECONSIDERATION.—The 

11 Secretary shall conduct a reconsideration on the 

12 basis of the information described in paragraph (1) 

13 if the Secretary finds that the information— 

14 ‘‘(A) is scientifically credible; 

15 ‘‘(B) represents significant information 

16 that was not available before the approval; and 

17 ‘‘(C)(i) suggests potential impacts relating 

18 to the genetically engineered animal that were 

19 not considered before the approval; or 

20 ‘‘(ii) demonstrates that the information 

21 considered before the approval was inadequate 

22 for the Secretary to make a safety finding. 

23 ‘‘(3) INFORMATION FROM THE PRODUCER.— 

24 ‘‘(A) IN GENERAL.—In conducting the re25 consideration, the Secretary may require the 
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1 producer to provide, within a reasonable period 

2 of time specified by the Secretary, information 

3 needed to facilitate the reconsideration. 

4 ‘‘(B) INFORMATION NOT PROVIDED.—If a 

5 producer fails to provide information required 

6 under subparagraph (A) within the period spec7 ified by the Secretary, the Secretary shall take 

8 1 or more of the actions described in paragraph 

9 (5). 

10 ‘‘(4) DETERMINATION.—After reviewing the in11 formation by the petitioner and the producer, the 

12 Secretary shall issue a determination that— 

13 ‘‘(A) revises the finding made in connec14 tion with the approval with respect to the safety 

15 of the genetically engineered animal; or 

16 ‘‘(B) states that, for reasons stated by the 

17 Secretary, no revision of the finding is needed. 

18 ‘‘(5) ACTION BY THE SECRETARY.—If, based on 

19 a review under this subsection, the Secretary deter20 mines that the genetically engineered animal is not 

21 safe, the Secretary shall— 

22 ‘‘(A) rescind the approval of the genetic 

23 engineering technique or genetically engineered 

24 animal for introduction into interstate com25 merce; 
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1 ‘‘(B) recall the genetically engineered ani2 mal; or 

3 ‘‘(C) take such other action as the Sec4 retary determines to be appropriate. 

5 ‘‘(l) ANIMALS USED IN DEVELOPMENT.—An animal 

6 that is used in connection with an investigation intended 

7 to support approval of an application under section 512 

8 and this section or that is otherwise used in connection 

9 with the development of a genetic engineering technique 

10 or production of a genetically engineered animal for which 

11 approval is sought shall be deemed unsafe for the purposes 

12 of sections 501(a)(5) and 402(a)(2)(C)(ii) unless— 

13 ‘‘(1) the applicant submits information required 

14 by the Secretary that addresses the food safety of 

15 the animal; 

16 ‘‘(2) the Secretary publishes the information in 

17 the Federal Register and provides a public comment 

18 period of not less than 60 days; and 

19 ‘‘(3) based on the information provided under 

20 paragraph (1), any public comment, and other infor21 mation available to the Secretary, the Secretary— 

22 ‘‘(A) makes a determination that the ani23 mal is safe; and 

24 ‘‘(B) publishes the determination in the 

25 Federal Register and on the Internet.’’. 
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1 SEC. 6. PROHIBITED ACTS. 

2 (a) UNLAWFUL USE OF TRADE SECRET INFORMA3 TION.—Section 301(j) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 331(j)) is amended in the first 

5 sentence— 

6 (1) by inserting ‘‘421,’’ after ‘‘414,’’; and 

7 (2) by inserting ‘‘512A,’’ after ‘‘512,’’. 

8 (b) ADULTERATED FOOD.—Section 402 of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 342) is 

10 amended by adding at the end the following: 

11 ‘‘(i) GENETICALLY ENGINEERED ANIMALS.—If it is 

12 a genetically engineered animal, or is a genetically engi13 neered animal produced using a genetic engineering tech14 nique, that is not approved under sections 512 and 512A. 

15 ‘‘(j) GENETICALLY ENGINEERED FOODS.— 

16 ‘‘(1) IN GENERAL.—If it is a genetically engi17 neered food, or is a genetically engineered food pro18 duced using a genetic engineering technique, that is 

19 not approved under section 421. 

20 ‘‘(2) SPLIT USE FOODS.—If it is a split use 

21 food that does not maintain proper segregation as 

22 required under regulations promulgated under sec23 tion 421.’’. 

24 SEC. 7. TRANSITION PROVISION. 

25 (a) IN GENERAL.—A genetic engineering technique, 

26 genetically engineered animal, or genetically engineered 
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1 food that entered interstate commerce before the date of 

2 enactment of this Act shall not require approval under the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

4 et seq.), but shall be considered to have been so approved, 

5 if— 

6 (1) the producer, not later than 90 days after 

7 the date of enactment of this Act, submits to the 

8 Secretary— 

9 (A) a notice stating that the genetic engi10 neering technique, genetically engineered ani11 mal, or genetically engineered food entered 

12 interstate commerce before the date of enact13 ment of this Act, providing such information as 

14 the Secretary may require; and 

15 (B) a request that the Secretary conduct a 

16 review of the genetic engineering technique, ge17 netically engineered animal, or genetically engi18 neered food under subsection (b); and 

19 (2) the Secretary does not issue, on or before 

20 the date that is 2 years after the date of enactment 

21 of this Act, a notice under subsection (b)(2) that an 

22 application for approval is required. 

23 (b) REVIEW BY THE SECRETARY.— 

24 (1) IN GENERAL.—Not later than 21 months 

25 after the date on which the Secretary receives a no-
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1 tice and request for review under subsection (a), the 

2 Secretary shall review all relevant information in the 

3 possession of the Secretary, all information provided 

4 by the producer, and other relevant public informa5 tion to determine whether a review of new scientific 

6 information is necessary to ensure that the genetic 

7 engineering technique, genetically engineered animal, 

8 or genetically engineered food is safe. 

9 (2) NOTICE THAT APPLICATION IS RE10 QUIRED.—If the Secretary determines that new sci11 entific information is necessary to determine whether 

12 a genetic engineering technique, genetically engi13 neered animal, or genetically engineered food is safe, 

14 the Secretary, not later than 2 years after the date 

15 of enactment of this Act, shall issue to the producer 

16 a notice stating that the producer is required to sub17 mit an application for approval of the genetic engi18 neering technique, genetically engineered animal, or 

19 genetically engineered food under the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

21 (c) FAILURE TO SUBMIT APPLICATION.— 

22 (1) IN GENERAL.—Except as provided in para23 graph (2), a genetically engineered animal or geneti24 cally engineered food with respect to which the Sec25 retary issues a notice that an application is required 
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1 under subsection (b)(2) shall be considered adulter2 ated under section 402 or 501, as the case may be, 

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

4 U.S.C. 342, 351) unless— 

5 (A) not later than 45 days after the pro6 ducer receives the notice, the producer submits 

7 an application for approval; and 

8 (B) the Secretary approves the application. 

9 (2) PENDING APPLICATION.—A genetically en10 gineered animal or genetically engineered food with 

11 respect to which the producer submits an application 

12 for approval shall not be considered to be adulter13 ated during the pendency of the application. 

14 SEC. 8. GENETICALLY ENGINEERED CROPS. 

15 To the maximum extent practicable, the Secretary of 

16 Agriculture shall ensure that standards for the regulation 

17 of genetically engineered field test crops to prevent cross18 pollenation with non-genetically engineered crops and pre19 vent adverse effects on the environment are based on the 

20 most recent scientific knowledge available. 

21 SEC. 9. REPORTS. 

22 (a) IN GENERAL.—Not later than 2 years, 4 years, 

23 and 6 years after the date of enactment of this Act, the 

24 Secretary and the heads of other Federal agencies, as ap25 propriate, shall jointly submit to Congress a report on ge-
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1 netically engineered animals, genetically engineered foods, 

2 and genetic engineering techniques. 

3 (b) CONTENTS.—A report under subsection (a) shall 

4 contain— 

5 (1) information on the types and quantities of 

6 genetically engineered foods being offered for sale or 

7 being developed, domestically and internationally; 

8 (2) a summary (including discussion of new de9 velopments and trends) of the legal status and ac10 ceptability of genetically engineered foods in major 

11 markets, including the European Union and Japan; 

12 (3) information on current and emerging issues 

13 of concern relating to genetic engineering tech14 niques, including issues relating to— 

15 (A) the ecological impact of, antibiotic 

16 markers for, insect resistance to, nongermi17 nating or terminator seeds for, or cross-species 

18 gene transfer for genetically engineered foods; 

19 (B) foods from genetically engineered ani20 mals; 

21 (C) nonfood crops (such as cotton) pro22 duced using a genetic engineering technique; 

23 and 
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1 (D) socioeconomic concerns (such as the 

2 impact of genetically engineered animals and 

3 genetically engineered foods on small farms); 

4 (4) a response to, and information concerning 

5 the status of implementation of, the recommenda6 tions contained in the reports entitled ‘‘Genetically 

7 Modified Pest Protected Plants’’, ‘‘Environmental 

8 Effects of Transgenic Plants’’, ‘‘Animal Bio9 technology Identifying Science-Based Concerns’’, 

10 and ‘‘Biological Containment of Genetically Engi11 neered Organisms (2004)’’, issued by the National 

12 Academy of Sciences; 

13 (5) an assessment of the need for data relating 

14 to genetically engineered animals and genetically en15 gineered foods; 

16 (6) a projection of— 

17 (A) the number of genetically engineered 

18 animals, genetically engineered foods, and ge19 netic engineering techniques that will require 

20 regulatory review during the 5-year period fol21 lowing the date of the report; and 

22 (B) the adequacy of the resources of the 

23 Food and Drug Administration; and 
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1 (7) an evaluation of the national capacity to 

2 test foods for the presence of genetically engineered 

3 ingredients in food. 

4 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

5 There are authorized to be appropriated such sums 

6 as are necessary to carry out this Act and the amendments 

7 made by this Act. 

Æ