II

106TH CONGRESS

2D SESSION S. 3184

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

OCTOBER 11 (legislative day, SEPTEMBER 22), 2000

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 the United States and

3 international food supplies;

4 (2) the potential positive effects of genetically

5 engineered foods are enormous;

6 (3) the potential for negative effects, both an7 ticipated and unexpected, exists with genetic engi8 neering of foods;

9 (4) evidence suggests that unapproved geneti10 cally engineered foods are entering the food supply;

11 (5) it is essential to maintain public confidence

12 in the safety of the food supplies and in the ability

13 of the Federal government to exercise adequate over14 sight of genetically engineered foods;

15 (6) public confidence can best be maintained

16 through careful review of new genetically engineered

17 foods, and monitoring of the positive and negative

18 effects of genetically engineered foods as the foods

19 become integrated into the food supplies, through a

20 review and monitoring process that is scientifically

21 sound, open, and transparent, and that fully involves

22 the general public; and

23 (7) since genetically engineered foods are devel24 oped worldwide and imported into the United States,

25 it is also imperative to ensure that imported geneti-
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1 cally engineered foods are subject to the same level

2 of oversight as domestic genetically engineered

3 foods.

4 SEC. 3. PREMARKET REVIEW OF GENETICALLY ENGI5 NEERED FOODS.

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

7 Act (21 U.S.C. 341 et seq.) is amended by adding at the

8 end the following:

9 ‘‘SEC. 414. GENETICALLY ENGINEERED FOODS.

10 ‘‘(a) DEFINITIONS.—In this section:

11 ‘‘(1) GENETIC ENGINEERING.—The term ‘ge12 netic engineering’ means the application of a recom13 binant DNA technique or a related technology to

14 modify genetic material with a degree of specificity

15 or precision that is not usually available with a con16 ventional breeding technique or another form of ge17 netic modification.

18 ‘‘(2) GENETICALLY ENGINEERED FOOD.—The

19 term ‘genetically engineered food’ means a food or

20 dietary supplement that—

21 ‘‘(A)(i) is produced in a State; or

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

23 States; and

24 ‘‘(B) is created by genetic engineering.
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1 ‘‘(3) PRODUCER.—The term ‘producer’, used

2 with respect to a genetically engineered food means

3 a person, company, or other entity that develops,

4 manufactures, imports, or takes other action to in5 troduce into interstate commerce, a genetically engi6 neered food.

7 ‘‘(4) SAFE.—The term ‘safe’, used with respect

8 to a genetically engineered food, means that the food

9 is considered to be as safe as the appropriate com10 parable food that is not created by genetic engineer11 ing.

12 ‘‘(b) REGULATIONS FOR GENETICALLY ENGINEERED

13 FOODS.—

14 ‘‘(1) PREMARKET CONSULTATION AND AP15 PROVAL.—

16 ‘‘(A) IN GENERAL.—The Secretary shall

17 issue regulations that require a producer of a

18 genetically engineered food, in order to obtain

19 the approval described in subparagraph (B), to

20 use a premarket consultation and approval

21 process described in subparagraph (C).

22 ‘‘(B) APPROVAL.—The regulations shall

23 require the producer to use the process in order

24 to obtain approval to introduce the food into

25 interstate commerce, except in cases where the
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1 producer has previously successfully completed

2 the process described in subparagraph (C) or

3 the voluntary premarket consultation process

4 described in paragraph (2).

5 ‘‘(C) PROCESS.—The regulations shall re6 quire the producer to use a premarket consulta7 tion and approval process that—

8 ‘‘(i) includes the procedures of the vol9 untary premarket consultation process de10 scribed in paragraph (2); and

11 ‘‘(ii) meets the requirements of this

12 subsection.

13 ‘‘(2) VOLUNTARY PREMARKET CONSULTATION

14 PROCESS.—The process referred to in paragraph

15 (1)(C)(i) is the voluntary premarket consultation

16 process described in—

17 ‘‘(A) the guidance document entitled

18 ‘Guidance on Consultation Procedures: Foods

19 Derived From New Plant Varieties’, issued in

20 October 1997, by the Office of Premarket Ap21 proval of the Center for Food Safety and Ap22 plied Nutrition, and the Office of Surveillance

23 and Compliance of the Center for Veterinary

24 Medicine, of the Food and Drug Administration
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1 (or any corresponding similar guidance docu2 ment);

3 ‘‘(B) the statement of policy entitled

4 ‘Foods Derived From New Plant Varieties’,

5 published in the Federal Register on May 29,

6 1992, 57 Fed. Reg. 22984 (or any cor7 responding similar statement of policy); and

8 ‘‘(C) such other documents issued by the

9 Commissioner relating to such process as the

10 Secretary may determine to be appropriate.

11 ‘‘(3) SUBMISSION AND DISSEMINATION OF MA12 TERIALS.—

13 ‘‘(A) SUBMISSION.—The regulations shall

14 require that, as part of the consultation and ap15 proval process, each producer of a genetically

16 engineered food submit to the Secretary—

17 ‘‘(i) each summary of research, test

18 results, and other materials that the pro19 ducer is required to submit under the proc20 ess described in paragraph (2); and

21 ‘‘(ii) a copy of the research, test re22 sults, and other materials.

23 ‘‘(B) DISSEMINATION.—On receipt of a re24 quest for the initiation of a consultation and

25 approval process, or on receipt of such sum-
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1 mary, research, results, or other materials for a

2 food, the Secretary shall provide public notice

3 regarding the initiation of the process, including

4 making the notice available on the Internet.

5 The Secretary shall make the summaries, re6 search, results, and other materials relating to

7 the food publicly available, including, to the ex8 tent practicable, available on the Internet, prior

9 to making any determination under paragraph

10 (4).

11 ‘‘(C) PROTECTION OF TRADE SECRETS.—

12 The regulations shall ensure that laws in effect

13 on the date of enactment of the Genetically En14 gineered Foods Act that protect trade secrets

15 apply with respect to the information submitted

16 to the Secretary under subparagraph (A). Such

17 regulations may provide for the submission of

18 sanitized information in appropriate cases, and

19 the dissemination of such sanitized information.

20 ‘‘(4) DETERMINATIONS.—The regulations shall

21 require that, as part of the consultation and ap22 proval process for a genetically engineered food, the

23 Secretary shall—

24 ‘‘(A) determine whether the producer of

25 the food has submitted, during the consultation,
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1 materials and information that are adequate to

2 enable the Secretary to fully assess the safety

3 of the food, and make a description of the de4 termination publicly available; and

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

6 producer has submitted adequate materials and

7 information, conduct a review of the materials

8 and information, and, in conducting the

9 review—

10 ‘‘(i) prepare a response that—

11 ‘‘(I) summarizes the materials

12 and information;

13 ‘‘(II) explains the determination;

14 and

15 ‘‘(III) contains a finding by the

16 Secretary that the genetically engi17 neered food—

18 ‘‘(aa) is considered to be

19 safe and may be introduced into

20 interstate commerce;

21 ‘‘(bb) is considered to be

22 conditionally safe and may be so

23 introduced if certain stated con24 ditions are met; or
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1 ‘‘(cc) is not considered to be

2 safe and may not be so intro3 duced;

4 ‘‘(ii) make the response publicly avail5 able; and

6 ‘‘(iii) provide an opportunity for the

7 submission of additional views or data by

8 interested persons on the response.

9 ‘‘(5) REVIEW FOR CAUSE.—

10 ‘‘(A) REQUEST FOR ADDITIONAL RE11 VIEW.—The regulations shall provide that any

12 person may request that the Secretary conduct

13 an additional review, of the type described in

14 paragraph (4)(B), for a food on the basis of

15 materials and information that were not avail16 able during an earlier review described in para17 graph (4)(B) or that were not considered dur18 ing the review.

19 ‘‘(B) FINDING FOR ADDITIONAL RE20 VIEW.—The Secretary shall conduct the addi21 tional review, on the basis of the materials and

22 information described in subparagraph (A) if

23 the Secretary finds that the materials and

24 information—

25 ‘‘(i) are scientifically credible;
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1 ‘‘(ii) represent significant materials

2 and information that was not available or

3 considered during the earlier review; and

4 ‘‘(iii) suggest potential negative im5 pacts relating to the food that were not

6 considered in the earlier review or dem7 onstrate that the materials and informa8 tion considered during the earlier review

9 were inadequate for the Secretary to make

10 a safety finding.

11 ‘‘(C) ADDITIONAL MATERIALS AND INFOR12 MATION.—In conducting the additional review,

13 the Secretary may require the producer of the

14 genetically engineered food to provide additional

15 materials and information, as needed to facili16 tate the review.

17 ‘‘(D) FINDING.—In conducting the review,

18 the Secretary shall—

19 ‘‘(i) issue a response described in

20 paragraph (4)(B) that revises the finding

21 made in the earlier review with respect to

22 the safety of the food; or

23 ‘‘(ii) make a determination, and issue

24 an explanation stating, that no revision to

25 the finding is needed.
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1 ‘‘(E) ACTION OF SECRETARY.—If, based

2 on a review under this paragraph, the Secretary

3 determines that the food involved is not safe,

4 the Secretary may withdraw the approval of the

5 food for introduction into interstate commerce

6 or take other action under this Act as the Sec7 retary determines to be appropriate.

8 ‘‘(6) EXEMPTIONS.—

9 ‘‘(A) CATEGORIES OF GENETICALLY ENGI10 NEERED FOODS.—

11 ‘‘(i) PROPOSED RULE.—The Secretary

12 may issue a proposed rule that exempts a

13 category of genetically engineered foods

14 from the regulations described in para15 graph (1) if—

16 ‘‘(I) the rule contains a narrowly

17 specified definition of the category;

18 ‘‘(II) the rule specifies the par19 ticular foods included in the category;

20 ‘‘(III) the rule specifies the par21 ticular genes, proteins, and adjunct

22 technologies (such as use of markers

23 or promoters) that are involved in the

24 genetic engineering for the foods in25 cluded in the category; and
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1 ‘‘(IV) not less than 10 foods in

2 the category have been reviewed under

3 paragraph (4)(B) and found to be

4 safe.

5 ‘‘(ii) PUBLIC COMMENT PERIOD.—The

6 Secretary shall provide an opportunity, for

7 not less than 90 days, for the submission

8 of comments by interested persons on the

9 proposed rule.

10 ‘‘(iii) FINAL RULE.—At the end of the

11 comment period described in clause (ii),

12 the Secretary shall issue a final rule de13 scribed in clause (i).

14 ‘‘(B) REGULATED GENETICALLY ENGI15 NEERED FOODS.—

16 ‘‘(i) PROPOSED RULE.—The Secretary

17 may issue a proposed rule that exempts

18 from the regulations described in para19 graph (1) genetically engineered foods that

20 the Secretary determines are subject to

21 regulation under Federal law other than

22 this section, such as foods from pharma23 ceutical-producing plants.

24 ‘‘(ii) PUBLIC COMMENT PERIOD.—The

25 Secretary shall provide an opportunity, for
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1 not less than 90 days, for the submission

2 of comments by interested persons on the

3 proposed rule.

4 ‘‘(iii) FINAL RULE.—At the end of the

5 comment period described in clause (ii),

6 the Secretary shall issue a final rule de7 scribed in clause (i).

8 ‘‘(7) ISSUANCE DATES.—The Secretary shall

9 issue proposed regulations described in paragraph

10 (1) not later than 6 months after the date of enact11 ment of the Genetically Engineered Foods Act, and

12 final regulations described in paragraph (1) not later

13 than 18 months after such date of enactment.

14 ‘‘SEC. 415. REPORTS ON GENETICALLY ENGINEERED

15 FOODS.

16 ‘‘(a) DEFINITIONS.—In this section, the terms ‘ge17 netic engineering’ and ‘genetically engineered food’ have

18 the meanings given the terms in section 414.

19 ‘‘(b) GENERAL AUTHORITY.—The Secretary, the Ad20 ministrator, and the Secretary of Agriculture (referred to

21 in this section as the ‘covered officers’), after consultation

22 with the Secretary of Commerce, the Secretary of the Inte23 rior, the Council on Environmental Quality, and the heads

24 of such other agencies as the covered officers may deter25 mine to be appropriate, shall jointly prepare and submit
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1 to the appropriate committees of Congress reports on ge2 netically engineered foods and related concerns.

3 ‘‘(c) CONTENTS.—The reports shall contain—

4 ‘‘(1) information on the types and quantities of

5 genetically engineered foods being offered for sale or

6 being developed, domestically and internationally;

7 ‘‘(2) information on current and emerging

8 issues of concern relating to genetic engineering, in9 cluding issues relating to—

10 ‘‘(A) the ecological impacts of, antibiotic

11 markers for, insect resistance to, nongermi12 nating or terminator seeds for, or cross-species

13 gene transfer for, genetically engineered foods;

14 ‘‘(B) foods from animals created by genetic

15 engineering;

16 ‘‘(C) non-food crops, such as cotton, cre17 ated by genetic engineering; and

18 ‘‘(D) socioeconomic concerns (such as the

19 impact of genetically engineered foods on small

20 farms), and liability issues;

21 ‘‘(3) information on options for labeling geneti22 cally engineered foods, the benefits and drawbacks of

23 each option, and an assessment of the authorities

24 under which such labeling might be required;
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1 ‘‘(4) a response to and information on the sta2 tus of implementation of the recommendations con3 tained in a report entitled ‘Genetically Modified Pest

4 Protected Plants’, issued in April 2000, by the Na5 tional Academy of Sciences;

6 ‘‘(5) an assessment of data needs relating to ge7 netically engineered foods;

8 ‘‘(6) a projection of the number of genetically

9 engineered foods that will require regulatory review

10 in the next 5 years, and the adequacy of the re11 sources of the Food and Drug Administration, Envi12 ronmental Protection Agency, and Department of

13 Agriculture to conduct the review; and

14 ‘‘(7) an evaluation of the national capacity to

15 test foods for the presence of genetically engineered

16 ingredients.

17 ‘‘(d) SUBMISSION OF REPORTS.—The covered offi18 cers shall submit reports described in this section not later

19 than 2 years, 4 years, and 6 years after the date of enact20 ment of the Genetically Engineered Foods Act.

21 ‘‘SEC. 416. MARKETPLACE TESTING.

22 ‘‘(a) IN GENERAL.—The Secretary, in conjunction

23 with the Secretary of Agriculture and the Administer of

24 the Environmental Protection Agency, shall establish a

25 program to conduct testing, as determined necessary by
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1 the Secretary, to identify genetically engineered foods at

2 all stages of production (from the farm to the retail store).

3 ‘‘(b) PERMISSIBLE TESTING.—Under the program

4 under subsection (a), the Secretary may conduct tests on

5 foods —

6 ‘‘(1) to identify genetically engineered ingredi7 ents that have not been approved for use pursuant

8 to this Act, including foods that are developed in

9 foreign countries that have not been approved for

10 marketing in the United States under this Act; and

11 ‘‘(2) to identify the presence of genetically engi12 neered ingredients the use of which is restricted

13 under this Act (including approval for animal feed

14 only, approval only if properly labeled, approval for

15 growing or marketing only in selected regions).

16 ‘‘SEC. 417. GENETICALLY ENGINEERED FOOD REGISTRY.

17 ‘‘(a) ESTABLISHMENT.—The Secretary, in conjunc18 tion with the Secretary of Agriculture and the Administer

19 of the Environmental Protection Agency, shall establish

20 a registry for genetically engineered foods that contains

21 a description of the regulatory status of all such foods that

22 have been submitted to the Secretary for premarket ap23 proval and that meets the requirements of subsection (b).

24 ‘‘(b) REQUIREMENT.—The registry established under

25 subsection (a) shall—
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1 ‘‘(1) identify all genetically engineered food that

2 have been submitted to the Secretary for premarket

3 approval;

4 ‘‘(2) contain the technical and common names

5 of each of the foods identified under paragraph (1)

6 ‘‘(3) contain a description of the regulatory sta7 tus under this Act of each of the foods identified

8 under paragraph (1);

9 ‘‘(4) contain a technical and non-technical sum10 mary of the types of genetic changes made to each

11 of the foods identified under paragraph (1) and the

12 reasons for such changes;

13 ‘‘(5) identify an appropriate public contact offi14 cial at each entity that has created each of the foods

15 identified in paragraph (1);

16 ‘‘(6) identify an appropriate public contact offi17 cial at each Federal agency with oversight responsi18 bility over each of the foods identified in paragraph

19 (1); and

20 ‘‘(7) be accessible by the public.’’.

21 SEC. 4. PROHIBITED ACTS.

22 Section 402 of the Federal Food, Drug, and Cosmetic

23 Act (21 U.S.C. 342) is amended by adding at the end the

24 following:
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1 ‘‘(h) If it is a food containing a genetically engineered

2 food as an ingredient, or is a genetically engineered food

3 (as defined in section 414(a)) that is subject to section

4 414(b) that—

5 ‘‘(1) does not meet the requirements of section

6 414(b); and

7 ‘‘(2)(A) is produced in the United States and

8 introduced into interstate commerce by a producer

9 (as defined in section 414(a)); or

10 ‘‘(B) is introduced into interstate commerce by

11 an importer.’’.

12 SEC. 5. GRANTS FOR RESEARCH ON ECONOMIC AND ENVI13 RONMENTAL RISKS AND BENEFITS OF USING

14 BIOTECHNOLOGY IN FOOD PRODUCTION.

15 (a) IN GENERAL.—Section 1668 of the Food, Agri16 culture, Conservation, and Trade Act of 1990 (7 U.S.C.

17 5921) is amended by striking subsections (a) and (b) and

18 inserting the following:

19 ‘‘(a) PURPOSES.—The purposes of this section are—

20 ‘‘(1) to authorize and support research intended

21 to identify and analyze technological developments in

22 the area of biotechnology for the purpose of evalu23 ating the potential positive and adverse effects of the

24 developments on the United States farm economy

25 and the environment, and addressing public concerns
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1 about potential adverse environmental effects, of

2 using biotechnology in food production; and

3 ‘‘(2) to authorize research to help regulatory

4 agencies develop policies, as soon as practicable, con5 cerning the introduction and use of biotechnology.

6 ‘‘(b) GRANT PROGRAM.—The Secretary of Agri7 culture, acting through the Cooperative State Research,

8 Education, and Extension Service and the Agricultural

9 Research Service, shall establish a competitive grant pro10 gram to conduct research to promote the purposes de11 scribed in subsection (a).’’.

12 (b) TYPES OF RESEARCH.—Section 1668(c) of the

13 Food, Agriculture, Conservation, and Trade Act of 1990

14 (7 U.S.C. 5921(c)) is amended—

15 (1) by redesignating paragraph (4) as para16 graph (5); and

17 (2) by inserting after paragraph (3) the fol18 lowing:

19 ‘‘(4) Research designed to evaluate—

20 ‘‘(A) the potential effect of biotechnology

21 developments on the United States farm econ22 omy;

23 ‘‘(B) the competitive status of United

24 States agricultural commodities and foods in

25 foreign markets; and
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1 ‘‘(C) consumer confidence in the healthful2 ness and safety of agricultural commodities and

3 foods.’’.

4 (c) PRIORITY.—Section 1668(d)(1) of the Food, Ag5 riculture, Conservation, and Trade Act of 1990 (7 U.S.C.

6 5921(d)(1)) is amended by inserting before the semicolon

7 the following: ‘‘, but giving priority to projects designed

8 to develop improved methods for identifying potential al9 lergens in pest-protected plants, with particular emphasis

10 on the development of tests with human immune-system

11 endpoints and of more reliable animal models’’.

12 (d) CONFORMING AMENDMENTS.—

13 (1) Section 1668 of the Food, Agriculture, Con14 servation, and Trade Act of 1990 (7 U.S.C. 5921)

15 is amended by striking the section heading and in16 serting the following:

17 ‘‘SEC. 1668. GRANTS FOR RESEARCH ON ECONOMIC AND

18 ENVIRONMENTAL RISKS AND BENEFITS OF

19 USING BIOTECHNOLOGY IN FOOD PRODUC20 TION.’’.

21 (2) Section 1668(g)(2) of the Food, Agri22 culture, Conservation, and Trade Act of 1990 (7

23 U.S.C. 5921(g)(2)) is amended by striking ‘‘for re24 search on biotechnology risk assessment’’.

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