[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 3184 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Genetically Engineered Foods Act''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) genetically engineered food is rapidly becoming an 
        integral part of the United States and international food 
        supplies;
            (2) the potential positive effects of genetically 
        engineered foods are enormous;
            (3) the potential for negative effects, both anticipated 
        and unexpected, exists with genetic engineering of foods;
            (4) evidence suggests that unapproved genetically 
        engineered foods are entering the food supply;
            (5) it is essential to maintain public confidence in the 
        safety of the food supplies and in the ability of the Federal 
        government to exercise adequate oversight of genetically 
        engineered foods;
            (6) public confidence can best be maintained through 
        careful review of new genetically engineered foods, and 
        monitoring of the positive and negative effects of genetically 
        engineered foods as the foods become integrated into the food 
        supplies, through a review and monitoring process that is 
        scientifically sound, open, and transparent, and that fully 
        involves the general public; and
            (7) since genetically engineered foods are developed 
        worldwide and imported into the United States, it is also 
        imperative to ensure that imported genetically engineered foods 
        are subject to the same level of oversight as domestic 
        genetically engineered foods.

SEC. 3. PREMARKET REVIEW OF GENETICALLY ENGINEERED FOODS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by adding at the end the following:

``SEC. 414. GENETICALLY ENGINEERED FOODS.

    ``(a) Definitions.--In this section:
            ``(1) Genetic engineering.--The term `genetic engineering' 
        means the application of a recombinant DNA technique or a 
        related technology to modify genetic material with a degree of 
        specificity or precision that is not usually available with a 
        conventional breeding technique or another form of genetic 
        modification.
            ``(2) Genetically engineered food.--The term `genetically 
        engineered food' means a food or dietary supplement that--
                    ``(A)(i) is produced in a State; or
                    ``(ii) is offered for import into the United 
                States; and
                    ``(B) is created by genetic engineering.
            ``(3) Producer.--The term `producer', used with respect to 
        a genetically engineered food means a person, company, or other 
        entity that develops, manufactures, imports, or takes other 
        action to introduce into interstate commerce, a genetically 
        engineered food.
            ``(4) Safe.--The term `safe', used with respect to a 
        genetically engineered food, means that the food is considered 
        to be as safe as the appropriate comparable food that is not 
        created by genetic engineering.
    ``(b) Regulations for Genetically Engineered Foods.--
            ``(1) Premarket consultation and approval.--
                    ``(A) In general.--The Secretary shall issue 
                regulations that require a producer of a genetically 
                engineered food, in order to obtain the approval 
                described in subparagraph (B), to use a premarket 
                consultation and approval process described in 
                subparagraph (C).
                    ``(B) Approval.--The regulations shall require the 
                producer to use the process in order to obtain approval 
                to introduce the food into interstate commerce, except 
                in cases where the producer has previously successfully 
                completed the process described in subparagraph (C) or 
                the voluntary premarket consultation process described 
                in paragraph (2).
                    ``(C) Process.--The regulations shall require the 
                producer to use a premarket consultation and approval 
                process that--
                            ``(i) includes the procedures of the 
                        voluntary premarket consultation process 
                        described in paragraph (2); and
                            ``(ii) meets the requirements of this 
                        subsection.
            ``(2) Voluntary premarket consultation process.--The 
        process referred to in paragraph (1)(C)(i) is the voluntary 
        premarket consultation process described in--
                    ``(A) the guidance document entitled `Guidance on 
                Consultation Procedures: Foods Derived From New Plant 
                Varieties', issued in October 1997, by the Office of 
                Premarket Approval of the Center for Food Safety and 
                Applied Nutrition, and the Office of Surveillance and 
                Compliance of the Center for Veterinary Medicine, of 
                the Food and Drug Administration (or any corresponding 
                similar guidance document);
                    ``(B) the statement of policy entitled `Foods 
                Derived From New Plant Varieties', published in the 
                Federal Register on May 29, 1992, 57 Fed. Reg. 22984 
(or any corresponding similar statement of policy); and
                    ``(C) such other documents issued by the 
                Commissioner relating to such process as the Secretary 
                may determine to be appropriate.
            ``(3) Submission and dissemination of materials.--
                    ``(A) Submission.--The regulations shall require 
                that, as part of the consultation and approval process, 
                each producer of a genetically engineered food submit 
                to the Secretary--
                            ``(i) each summary of research, test 
                        results, and other materials that the producer 
                        is required to submit under the process 
                        described in paragraph (2); and
                            ``(ii) a copy of the research, test 
                        results, and other materials.
                    ``(B) Dissemination.--On receipt of a request for 
                the initiation of a consultation and approval process, 
                or on receipt of such summary, research, results, or 
                other materials for a food, the Secretary shall provide 
                public notice regarding the initiation of the process, 
                including making the notice available on the Internet. 
                The Secretary shall make the summaries, research, 
                results, and other materials relating to the food 
                publicly available, including, to the extent 
                practicable, available on the Internet, prior to making 
                any determination under paragraph (4).
                    ``(C) Protection of trade secrets.--The regulations 
                shall ensure that laws in effect on the date of 
                enactment of the Genetically Engineered Foods Act that 
                protect trade secrets apply with respect to the 
                information submitted to the Secretary under 
                subparagraph (A). Such regulations may provide for the 
                submission of sanitized information in appropriate 
                cases, and the dissemination of such sanitized 
                information.
            ``(4) Determinations.--The regulations shall require that, 
        as part of the consultation and approval process for a 
        genetically engineered food, the Secretary shall--
                    ``(A) determine whether the producer of the food 
                has submitted, during the consultation, materials and 
                information that are adequate to enable the Secretary 
                to fully assess the safety of the food, and make a 
                description of the determination publicly available; 
                and
                    ``(B) if the Secretary determines that the producer 
                has submitted adequate materials and information, 
                conduct a review of the materials and information, and, 
                in conducting the review--
                            ``(i) prepare a response that--
                                    ``(I) summarizes the materials and 
                                information;
                                    ``(II) explains the determination; 
                                and
                                    ``(III) contains a finding by the 
                                Secretary that the genetically 
                                engineered food--
                                            ``(aa) is considered to be 
                                        safe and may be introduced into 
                                        interstate commerce;
                                            ``(bb) is considered to be 
                                        conditionally safe and may be 
                                        so introduced if certain stated 
                                        conditions are met; or
                                            ``(cc) is not considered to 
                                        be safe and may not be so 
                                        introduced;
                            ``(ii) make the response publicly 
                        available; and
                            ``(iii) provide an opportunity for the 
                        submission of additional views or data by 
                        interested persons on the response.
            ``(5) Review for cause.--
                    ``(A) Request for additional review.--The 
                regulations shall provide that any person may request 
                that the Secretary conduct an additional review, of the 
                type described in paragraph (4)(B), for a food on the 
                basis of materials and information that were not 
                available during an earlier review described in 
                paragraph (4)(B) or that were not considered during the 
                review.
                    ``(B) Finding for additional review.--The Secretary 
                shall conduct the additional review, on the basis of 
                the materials and information described in subparagraph 
                (A) if the Secretary finds that the materials and 
                information--
                            ``(i) are scientifically credible;
                            ``(ii) represent significant materials and 
                        information that was not available or 
                        considered during the earlier review; and
                            ``(iii) suggest potential negative impacts 
                        relating to the food that were not considered 
                        in the earlier review or demonstrate that the 
                        materials and information considered during the 
                        earlier review were inadequate for the 
                        Secretary to make a safety finding.
                    ``(C) Additional materials and information.--In 
                conducting the additional review, the Secretary may 
                require the producer of the genetically engineered food 
                to provide additional materials and information, as 
                needed to facilitate the review.
                    ``(D) Finding.--In conducting the review, the 
                Secretary shall--
                            ``(i) issue a response described in 
                        paragraph (4)(B) that revises the finding made 
                        in the earlier review with respect to the 
                        safety of the food; or
                            ``(ii) make a determination, and issue an 
                        explanation stating, that no revision to the 
                        finding is needed.
                    ``(E) Action of secretary.--If, based on a review 
                under this paragraph, the Secretary determines that the 
                food involved is not safe, the Secretary may withdraw 
                the approval of the food for introduction into 
                interstate commerce or take other action under this Act 
as the Secretary determines to be appropriate.
            ``(6) Exemptions.--
                    ``(A) Categories of genetically engineered foods.--
                            ``(i) Proposed rule.--The Secretary may 
                        issue a proposed rule that exempts a category 
                        of genetically engineered foods from the 
                        regulations described in paragraph (1) if--
                                    ``(I) the rule contains a narrowly 
                                specified definition of the category;
                                    ``(II) the rule specifies the 
                                particular foods included in the 
                                category;
                                    ``(III) the rule specifies the 
                                particular genes, proteins, and adjunct 
                                technologies (such as use of markers or 
                                promoters) that are involved in the 
                                genetic engineering for the foods 
                                included in the category; and
                                    ``(IV) not less than 10 foods in 
                                the category have been reviewed under 
                                paragraph (4)(B) and found to be safe.
                            ``(ii) Public comment period.--The 
                        Secretary shall provide an opportunity, for not 
                        less than 90 days, for the submission of 
                        comments by interested persons on the proposed 
                        rule.
                            ``(iii) Final rule.--At the end of the 
                        comment period described in clause (ii), the 
                        Secretary shall issue a final rule described in 
                        clause (i).
                    ``(B) Regulated genetically engineered foods.--
                            ``(i) Proposed rule.--The Secretary may 
                        issue a proposed rule that exempts from the 
                        regulations described in paragraph (1) 
                        genetically engineered foods that the Secretary 
                        determines are subject to regulation under 
                        Federal law other than this section, such as 
                        foods from pharmaceutical-producing plants.
                            ``(ii) Public comment period.--The 
                        Secretary shall provide an opportunity, for not 
                        less than 90 days, for the submission of 
                        comments by interested persons on the proposed 
                        rule.
                            ``(iii) Final rule.--At the end of the 
                        comment period described in clause (ii), the 
                        Secretary shall issue a final rule described in 
                        clause (i).
            ``(7) Issuance dates.--The Secretary shall issue proposed 
        regulations described in paragraph (1) not later than 6 months 
        after the date of enactment of the Genetically Engineered Foods 
        Act, and final regulations described in paragraph (1) not later 
        than 18 months after such date of enactment.

``SEC. 415. REPORTS ON GENETICALLY ENGINEERED FOODS.

    ``(a) Definitions.--In this section, the terms `genetic 
engineering' and `genetically engineered food' have the meanings given 
the terms in section 414.
    ``(b) General Authority.--The Secretary, the Administrator, and the 
Secretary of Agriculture (referred to in this section as the `covered 
officers'), after consultation with the Secretary of Commerce, the 
Secretary of the Interior, the Council on Environmental Quality, and 
the heads of such other agencies as the covered officers may determine 
to be appropriate, shall jointly prepare and submit to the appropriate 
committees of Congress reports on genetically engineered foods and 
related concerns.
    ``(c) Contents.--The reports shall contain--
            ``(1) information on the types and quantities of 
        genetically engineered foods being offered for sale or being 
        developed, domestically and internationally;
            ``(2) information on current and emerging issues of concern 
        relating to genetic engineering, including issues relating to--
                    ``(A) the ecological impacts of, antibiotic markers 
                for, insect resistance to, nongerminating or terminator 
                seeds for, or cross-species gene transfer for, 
                genetically engineered foods;
                    ``(B) foods from animals created by genetic 
                engineering;
                    ``(C) non-food crops, such as cotton, created by 
                genetic engineering; and
                    ``(D) socioeconomic concerns (such as the impact of 
                genetically engineered foods on small farms), and 
                liability issues;
            ``(3) information on options for labeling genetically 
        engineered foods, the benefits and drawbacks of each option, 
        and an assessment of the authorities under which such labeling 
        might be required;
            ``(4) a response to and information on the status of 
        implementation of the recommendations contained in a report 
        entitled `Genetically Modified Pest Protected Plants', issued 
        in April 2000, by the National Academy of Sciences;
            ``(5) an assessment of data needs relating to genetically 
        engineered foods;
            ``(6) a projection of the number of genetically engineered 
        foods that will require regulatory review in the next 5 years, 
        and the adequacy of the resources of the Food and Drug 
        Administration, Environmental Protection Agency, and Department 
        of Agriculture to conduct the review; and
            ``(7) an evaluation of the national capacity to test foods 
        for the presence of genetically engineered ingredients.
    ``(d) Submission of Reports.--The covered officers shall submit 
reports described in this section not later than 2 years, 4 years, and 
6 years after the date of enactment of the Genetically Engineered Foods 
Act.

``SEC. 416. MARKETPLACE TESTING.

    ``(a) In General.--The Secretary, in conjunction with the Secretary 
of Agriculture and the Administer of the Environmental Protection 
Agency, shall establish a program to conduct testing, as determined 
necessary by the Secretary, to identify genetically engineered foods at 
all stages of production (from the farm to the retail store).
    ``(b) Permissible Testing.--Under the program under subsection (a), 
the Secretary may conduct tests on foods --
            ``(1) to identify genetically engineered ingredients that 
        have not been approved for use pursuant to this Act, including 
        foods that are developed in foreign countries that have not 
        been approved for marketing in the United States under this 
        Act; and
            ``(2) to identify the presence of genetically engineered 
        ingredients the use of which is restricted under this Act 
        (including approval for animal feed only, approval only if 
        properly labeled, approval for growing or marketing only in 
        selected regions).

``SEC. 417. GENETICALLY ENGINEERED FOOD REGISTRY.

    ``(a) Establishment.--The Secretary, in conjunction with the 
Secretary of Agriculture and the Administer of the Environmental 
Protection Agency, shall establish a registry for genetically 
engineered foods that contains a description of the regulatory status 
of all such foods that have been submitted to the Secretary for 
premarket approval and that meets the requirements of subsection (b).
    ``(b) Requirement.--The registry established under subsection (a) 
shall--
            ``(1) identify all genetically engineered food that have 
        been submitted to the Secretary for premarket approval;
            ``(2) contain the technical and common names of each of the 
        foods identified under paragraph (1)
            ``(3) contain a description of the regulatory status under 
        this Act of each of the foods identified under paragraph (1);
            ``(4) contain a technical and non-technical summary of the 
        types of genetic changes made to each of the foods identified 
        under paragraph (1) and the reasons for such changes;
            ``(5) identify an appropriate public contact official at 
        each entity that has created each of the foods identified in 
        paragraph (1);
            ``(6) identify an appropriate public contact official at 
        each Federal agency with oversight responsibility over each of 
        the foods identified in paragraph (1); and
            ``(7) be accessible by the public.''.

SEC. 4. PROHIBITED ACTS.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342) is amended by adding at the end the following:
    ``(h) If it is a food containing a genetically engineered food as 
an ingredient, or is a genetically engineered food (as defined in 
section 414(a)) that is subject to section 414(b) that--
            ``(1) does not meet the requirements of section 414(b); and
            ``(2)(A) is produced in the United States and introduced 
        into interstate commerce by a producer (as defined in section 
        414(a)); or
            ``(B) is introduced into interstate commerce by an 
        importer.''.

SEC. 5. GRANTS FOR RESEARCH ON ECONOMIC AND ENVIRONMENTAL RISKS AND 
              BENEFITS OF USING BIOTECHNOLOGY IN FOOD PRODUCTION.

    (a) In General.--Section 1668 of the Food, Agriculture, 
Conservation, and Trade Act of 1990 (7 U.S.C. 5921) is amended by 
striking subsections (a) and (b) and inserting the following:
    ``(a) Purposes.--The purposes of this section are--
            ``(1) to authorize and support research intended to 
        identify and analyze technological developments in the area of 
        biotechnology for the purpose of evaluating the potential 
        positive and adverse effects of the developments on the United 
        States farm economy and the environment, and addressing public 
        concerns about potential adverse environmental effects, of 
        using biotechnology in food production; and
            ``(2) to authorize research to help regulatory agencies 
        develop policies, as soon as practicable, concerning the 
        introduction and use of biotechnology.
    ``(b) Grant Program.--The Secretary of Agriculture, acting through 
the Cooperative State Research, Education, and Extension Service and 
the Agricultural Research Service, shall establish a competitive grant 
program to conduct research to promote the purposes described in 
subsection (a).''.
    (b) Types of Research.--Section 1668(c) of the Food, Agriculture, 
Conservation, and Trade Act of 1990 (7 U.S.C. 5921(c)) is amended--
            (1) by redesignating paragraph (4) as paragraph (5); and
            (2) by inserting after paragraph (3) the following:
            ``(4) Research designed to evaluate--
                    ``(A) the potential effect of biotechnology 
                developments on the United States farm economy;
                    ``(B) the competitive status of United States 
                agricultural commodities and foods in foreign markets; 
                and
                    ``(C) consumer confidence in the healthfulness and 
                safety of agricultural commodities and foods.''.
    (c) Priority.--Section 1668(d)(1) of the Food, Agriculture, 
Conservation, and Trade Act of 1990 (7 U.S.C. 5921(d)(1)) is amended by 
inserting before the semicolon the following: ``, but giving priority 
to projects designed to develop improved methods for identifying 
potential allergens in pest-protected plants, with particular emphasis 
on the development of tests with human immune-system endpoints and of 
more reliable animal models''.
    (d) Conforming Amendments.--
            (1) Section 1668 of the Food, Agriculture, Conservation, 
        and Trade Act of 1990 (7 U.S.C. 5921) is amended by striking 
        the section heading and inserting the following:

``SEC. 1668. GRANTS FOR RESEARCH ON ECONOMIC AND ENVIRONMENTAL RISKS 
              AND BENEFITS OF USING BIOTECHNOLOGY IN FOOD 
              PRODUCTION.''.

            (2) Section 1668(g)(2) of the Food, Agriculture, 
        Conservation, and Trade Act of 1990 (7 U.S.C. 5921(g)(2)) is 
        amended by striking ``for research on biotechnology risk 
        assessment''.
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