[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2546 Introduced in Senate (IS)]







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.

    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 domestic and international food supplies;
            (2) the potential positive effects of genetically 
        engineered foods are enormous;
            (3) the potential for both anticipated and unanticipated 
        effects exists with genetic engineering of foods;
            (4) genetically engineered food not approved for human 
        consumption has, in the past, entered the human food supply;
            (5) environmental issues have been identified as a major 
        science-based concern associated with animal biotechnology;
            (6) it is essential to maintain--
                    (A) public confidence in--
                            (i) the safety of the food supply; and
                            (ii) the ability of the Federal Government 
                        to exercise adequate oversight of genetically 
                        engineered foods; and
                    (B) the ability of agricultural producers and other 
                food producers of the United States to market, 
                domestically and internationally, foods that have been 
                genetically engineered;
            (7) public confidence can best be maintained through 
        careful review and formal determination of the safety of 
        genetically engineered foods, and monitoring of the positive 
        and negative effects of genetically engineered foods as the 
        foods become integrated into the food supply, through a review 
        and monitoring process that--
                    (A) is scientifically sound, open, and transparent;
                    (B) fully involves the general public; and
                    (C) does not subject most genetically engineered 
                foods to the lengthy food additive approval process; 
                and
            (8) because genetically engineered foods are developed 
        worldwide and imported into the United States, it is imperative 
        that imported genetically engineered food be subject to the 
        same level of oversight as domestic genetically engineered 
        food.

SEC. 3. DEFINITIONS.

    (a) This Act.--In this Act, the terms ``genetic engineering 
technique'', ``genetically engineered animal'', ``genetically 
engineered food'', ``interstate commerce'', ``producer'', ``safe'', and 
``Secretary'' have the meanings given those terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by 
subsection (b)).
    (b) Federal Food, Drug, and Cosmetic Act.--Section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
            (1) in subsection (v)--
                    (A) by striking ``(v) The term'' and inserting the 
                following:
    ``(v) New Animal Drug.--
            ``(1) In general.--The term'';
                    (B) by striking ``(1) the composition'' and 
                inserting ``(A) the composition'';
                    (C) by striking ``(2) the composition'' and 
                inserting ``(B) the composition''; and
                    (D) by adding at the end the following:
            ``(2) Inclusion.--The term `new animal drug' includes--
                    ``(A) a genetic engineering technique intended to 
                be used to produce an animal; and
                    ``(B) a genetically engineered animal.''; and
            (2) by adding at the end the following:
    ``(nn) Genetically Engineered Animal.--
            ``(1) In general.--The term `genetically engineered animal' 
        means an animal that--
                    ``(A) is intended to be used--
                            ``(i) in the production of a food or 
                        dietary supplement; or
                            ``(ii) for any other purpose;
                    ``(B)(i) is produced in the United States; or
                    ``(ii) is offered for import into the United 
                States; and
                    ``(C) is produced using a genetic engineering 
                technique.
            ``(2) Exclusion.--The term `genetically engineered animal' 
        does not include an established line of a genetically modified 
        animal that--
                    ``(A) is used solely in scientific research; and
                    ``(B) is not intended or expected--
                            ``(i) to enter the food supply; or
                            ``(ii) to be released into the environment.
    ``(oo) Genetically Engineered Food.--
            ``(1) In general.--The term `genetically engineered food' 
        means a food or dietary supplement, or a seed, microorganism, 
        or ingredient intended to be used to produce a food or dietary 
        supplement, that--
                    ``(A)(i) is produced in the United States; or
                    ``(ii) is offered for import into the United 
                States; and
                    ``(B) is produced using a genetic engineering 
                technique.
            ``(2) Inclusion.--The term `genetically engineered food' 
        includes a split use food.
            ``(3) Exclusion.--The term `genetically engineered food' 
        does not include a genetically engineered animal.
    ``(pp) Genetic Engineering Technique.--The term `genetic 
engineering technique' means the use of a transformation event to 
derive food from a plant or animal or to produce an animal.
    ``(qq) Producer.--The term `producer', with respect to a 
genetically engineered animal, genetically engineered food, or genetic 
engineering technique, means a person that--
            ``(1) develops, manufactures, or imports the genetically 
        engineered animal or genetically engineered food;
            ``(2) uses the genetic engineering technique; or
            ``(3) takes other action to introduce the genetically 
        engineered animal, genetically engineered food, or genetic 
        engineering technique into interstate commerce.
    ``(rr) Safe.--The term `safe', with respect to a genetically 
engineered food, means--
            ``(1) as safe as comparable food that is not produced using 
        a genetic engineering technique; or
            ``(2) if there is no such comparable food, having a 
        reasonable certainty of causing no harm.
    ``(ss) Split Use Food.--The term `split use food' means a product 
that--
            ``(1)(A) is produced in the United States; or
            ``(B) is offered for import into the United States;
            ``(2) is produced using a genetic engineering technique; 
        and
            ``(3) could be used as food by both humans and animals but 
        that the producer does not intend to market as food for humans.
    ``(tt) Transformation Event.--The term `transformation event' means 
the introduction into a plant or an animal of genetic material that has 
been manipulated in vitro.''.

SEC. 4. GENETICALLY ENGINEERED FOODS.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended--
            (1) by inserting after the chapter heading the following:

                 ``Subchapter A--General Provisions'';

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

              ``Subchapter B--Genetically Engineered Foods

``SEC. 421. PREMARKET CONSULTATION AND APPROVAL.

    ``(a) In General.--A producer of genetically engineered food, 
before introducing a genetically engineered food into interstate 
commerce, shall first obtain approval through the use of a premarket 
consultation and approval process.
    ``(b) Regulations.--The Secretary shall promulgate regulations that 
describe--
            ``(1) all information that is required to be submitted for 
        the premarketing approval process, including--
                    ``(A) specification of the species or other 
                taxonomic classification of plants for which approval 
                is sought;
                    ``(B) identification of the genetically engineered 
                food;
                    ``(C)(i) a description of each type of genetic 
                manipulation made to the genetically engineered food;
                    ``(ii) identification of the manipulated genetic 
                material; and
                    ``(iii) the techniques used in making the 
                manipulation;
                    ``(D) the effect of the genetic manipulation on the 
                composition of the genetically engineered food 
                (including information describing the specific 
                substances that were expressed, removed, or otherwise 
                manipulated);
                    ``(E) a description of the actual or proposed 
                applications and uses of the genetically engineered 
                food;
                    ``(F) information pertaining to--
                            ``(i) the safety of the genetically 
                        engineered food as a whole; and
                            ``(ii) the safety of any specific 
                        substances introduced, altered, or produced as 
                        a result of the genetic manipulation (including 
                        information on allergenicity and toxicity);
                    ``(G) test methods for detection of the genetically 
                engineered ingredients in food;
                    ``(H) a summary and overview of information and 
                issues that have been or will be addressed by other 
                regulatory programs for the review of genetically 
                engineered food;
                    ``(I) procedures to be followed to initiate and 
                complete the premarket approval process (including any 
                preconsultation and consultation procedures); and
                    ``(J) any other matters that the Secretary 
                determines to be necessary.
            ``(2) Split use food.--
                    ``(A) In general.--The regulations under paragraph 
                (1) shall provide for the approval of--
                            ``(i) split use foods that are not approved 
                        for human consumption;
                            ``(ii) split use foods that are intended 
                        for human use but are marketed under restricted 
                        conditions; and
                            ``(iii) other categories of split use food.
                    ``(B) Issues.--For each category of split use food, 
                the regulations shall address--
                            ``(i)(I) whether a protocol is needed for 
                        segregating a restricted split use food from 
                        the food supply; and
                            ``(II) if so, what the protocol shall be;
                            ``(ii)(I) whether action is needed to 
                        ensure the purity of any seed to prevent 
                        unintended introduction of a 
genetically engineered trait into a seed that is not designed for that 
trait; and
                            ``(II) if so, what action is needed and 
                        what industry practices represent the best 
                        practices for maintaining the purity of the 
                        seed;
                            ``(iii)(I) whether a tolerance level should 
                        exist regarding cross-mixing of segregated 
                        split use foods; and
                            ``(II) if so, the means by which the 
                        tolerance level shall be determined;
                            ``(iv) the manner in which the food safety 
                        analysis under this section should be 
                        conducted, specifying different standards and 
                        procedures that are permitted to be applied for 
                        nonfood products grown in food crops depending 
                        on the degree of containment for that product 
                        and the likelihood of the product to enter the 
                        food supply;
                            ``(v)(I) the kinds of surveillance that are 
                        needed to ensure that appropriate segregation 
                        of split use foods is being maintained;
                            ``(II) the manner in which and by whom the 
                        surveillance shall be conducted; and
                            ``(III) the manner in which the results of 
                        surveillance shall be reported; and
                            ``(vi) clarification of responsibility in 
                        cases of breakdown of segregation of a split 
                        use food.
                    ``(C) Recall authority.--The regulations shall 
                provide that, in addition to other authority that the 
                Secretary has regarding split use food, the Secretary 
                may order a recall of any split use food (whether or 
                not the split use food has been approved under this 
                section) that--
                            ``(i) is not approved, but has entered the 
                        food supply; or
                            ``(ii) has entered the food supply in 
                        violation of a condition of restriction under 
                        an approval.
    ``(c) Application.--The regulations shall require that, as part of 
the consultation and approval process, a producer submit to the 
Secretary an application that includes a summary and a complete copy of 
each research study, test result, or other information referenced by 
the producer.
    ``(d) Review.--
            ``(1) In general.--After receiving an application under 
        subsection (c), the Secretary shall--
                    ``(A) determine whether the producer submitted 
                information that appears to be adequate to enable the 
                Secretary to fully assess the safety of the genetically 
                engineered food, and make a description of the 
                determination publicly available; and
                    ``(B) if the Secretary determines that the producer 
                submitted adequate information--
                            ``(i) provide public notice regarding the 
                        initiation of the consultation and approval 
                        process;
                            ``(ii) make the notice, application, 
                        summaries submitted by the producer, and 
                        research, test results, and other information 
                        referenced by the producer publicly available, 
                        including, to the maximum extent practicable, 
                        publication in the Federal Register and on the 
                        Internet; and
                            ``(iii) provide the public with an 
                        opportunity, for not less than 45 days, to 
                        submit comments on the application.
            ``(2) Exception.--The Secretary may withhold information in 
        an application from public dissemination to protect a trade 
        secret (not including any information disclosing the results of 
        testing to determine whether the genetically engineered food is 
        safe) if--
                    ``(A) the information is exempt from disclosure 
                under section 522 of title 5, United States Code, or 
                applicable trade secret law;
                    ``(B) the applicant--
                            ``(i) identifies with specificity the trade 
                        secret information in the application; and
                            ``(ii) provides the Secretary with a 
                        detailed justification for each trade secret 
                        claim; and
                    ``(C) the Secretary--
                            ``(i) determines that the information 
                        qualifies as a trade secret subject to 
                        withholding from public dissemination; and
                            ``(ii) makes the determination available to 
                        the public.
            ``(3) Determination.--Not later than 180 days after 
        determining adequacy of an application under paragraph (1)(A), 
        the Secretary shall issue and make publicly available a 
        determination that--
                    ``(A) summarizes the information referenced by the 
                producer in light of the public comments; and
                    ``(B) contains a finding that the genetically 
                engineered food--
                            ``(i) is safe and may be introduced into 
                        interstate commerce;
                            ``(ii) is safe under specified conditions 
                        of use and may be introduced into interstate 
                        commerce if those conditions are met; or
                            ``(iii) is not safe and may not be 
                        introduced into interstate commerce, because 
                        the genetically engineered food--
                                    ``(I) contains genes that confer 
                                antibiotic resistance;
                                    ``(II) contains an allergen; or
                                    ``(III) presents 1 or more other 
                                safety concerns described by the 
                                Secretary.
            ``(4) Extension.--The Secretary may extend the period 
        specified in paragraph (3) if the Secretary determines that an 
        extension of the period is necessary to allow the Secretary 
        to--
                    ``(A) review additional information; or
                    ``(B) address 1 or more issues or concerns of 
                unusual complexity.
    ``(e) Rescission of Approval.--
            ``(1) Reconsideration.--On the petition of any person, or 
        on the Secretary's own motion, the Secretary may reconsider an 
        approval of a genetically engineered food on the basis of 
        information that was not available before the approval.
            ``(2) Finding for reconsideration.--The Secretary shall 
        conduct a reconsideration on the basis of the information 
        described in paragraph (1) if the Secretary finds that the 
        information--
                    ``(A) is scientifically credible;
                    ``(B) represents significant information that was 
                not available before the approval; and
                    ``(C)(i) suggests potential impacts relating to the 
                genetically engineered food that were not considered in 
                the earlier review; or
                    ``(ii) demonstrates that the information considered 
                before the approval was inadequate for the Secretary to 
                make a safety finding.
            ``(3) Information from the producer.--
                    ``(A) In general.--In conducting the 
                reconsideration, the Secretary may require the producer 
                to provide, within a reasonable period of time 
                specified by the Secretary, information needed to 
                facilitate the reconsideration.
                    ``(B) Information not provided.--If a producer 
                fails to provide information required under 
                subparagraph (A) within the period specified by the 
                Secretary, the Secretary shall take 1 or more of the 
                actions described in paragraph (5).
            ``(4) Determination.--After reviewing the information by 
        the petitioner and the producer, the Secretary shall issue a 
        determination that--
                    ``(A) revises the finding made in connection with 
                the approval with respect to the safety of the 
                genetically engineered food; or
                    ``(B) states that, for reasons stated by the 
                Secretary, no revision of the finding is needed.
            ``(5) Action by the secretary.--If, based on a 
        reconsideration under this section, the Secretary determines 
        that the genetically engineered food is not safe, the Secretary 
        shall--
                    ``(A) rescind the approval of the genetically 
                engineered food for introduction into interstate 
                commerce;
                    ``(B) recall the genetically engineered food; or
                    ``(C) take such other action as the Secretary 
                determines to be appropriate.

``SEC. 422. MARKETPLACE TESTING AND POST-MARKETING OVERSIGHT.

    ``(a) Testing.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Agriculture and the Administrator of the 
        Environmental Protection Agency, shall establish a program to 
        conduct testing that the Secretary determines to be necessary 
        to detect, at all stages of production and distribution (from 
        agricultural production to retail sale), the presence of 
        genetically engineered ingredients in food.
            ``(2) Permissible testing.--Under the program, the 
        Secretary may conduct tests on foods to detect genetically 
        engineered ingredients--
                    ``(A) that have not been approved for use under 
                this Act, including foods that are developed in foreign 
                countries that have not been approved for marketing in 
                the United States under this Act; or
                    ``(B) the use of which is restricted under this Act 
                (including approval for use as animal feed only, 
                approval only if properly labeled, and approval for 
                growing or marketing only in certain regions).
    ``(b) Post-Market Oversight.--
            ``(1) In general.--The Secretary shall establish a program 
        to monitor and evaluate the continued safety after 
        commercialization of genetically engineered foods approved 
        under section 421.
            ``(2) Activities.--Under the program, the Secretary shall--
                    ``(A) take appropriate actions to ensure that each 
                split-use food complies with any restriction or other 
                condition on the approval of the split-use food; and
                    ``(B) conduct inspections and monitoring of 
                genetically engineered foods and facilities that 
                produce genetically engineered foods to ensure that 
                only approved genetically engineered foods are marketed 
                to humans.

``SEC. 423. REGISTRY.

    ``(a) Establishment.--The Secretary, in consultation with the 
Secretary of Agriculture, the Administrator of the Environmental 
Protection Agency, and the heads of other agencies, as appropriate, 
shall establish a registry for genetically engineered food that 
contains a description of the regulatory status of all genetically 
engineered foods approved under section 421.
    ``(b) Requirements.--The registry under subsection (a) shall 
contain, for each genetically engineered food--
            ``(1) the technical and common names of the genetically 
        engineered food;
            ``(2) a description of the regulatory status, under all 
        Federal programs pertaining to the testing and approval of 
        genetically engineered foods, of the genetically engineered 
        food;
            ``(3) a technical and nontechnical summary of the type of, 
        and a statement of the reason for, each genetic manipulation 
        made to the genetically engineered food;
            ``(4) the name, title, address, and telephone number of an 
        official at each producer of the genetically engineered food 
        whom members of the public may contact for information about 
        the genetically engineered food;
            ``(5) the name, title, address, and telephone number of an 
        official at each Federal agency with oversight responsibility 
        over the genetically engineered food whom members of the public 
        may contact for information about the genetically engineered 
        food; and
            ``(6) such other information as the Secretary determines 
        should be included.
    ``(c) Public Availability.--The registry under subsection (a) shall 
be made available to the public, including availability on the 
Internet.''.

SEC. 5. GENETICALLY ENGINEERED ANIMALS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 512 the following:

``SEC. 512A. GENETICALLY ENGINEERED ANIMALS.

    ``(a) In General.--Section 512 shall apply to genetic engineering 
techniques intended to be used to produce an animal, and to genetically 
engineered animals, as provided in this section.
    ``(b) Application.--An application under section 512(b)(1) shall 
include--
            ``(1) specification of the species or other taxonomic 
        classification of the animal for which approval is sought;
            ``(2) an environmental assessment that analyzes the 
        potential effects of the genetically engineered animal on the 
        environment, including the potential effect on any 
        nongenetically engineered animal or other part of the 
        environment as a result of any intentional or unintentional 
        exposure of the genetically engineered animal to the 
        environment; and
            ``(3) a plan to eliminate or mitigate the potential effects 
        to the environment from the release of the genetically 
        engineered animal.
    ``(c) Dissemination of Application and Opportunity for Public 
Comment.--
            ``(1) In general.--On receipt of an application under 
        section 512(b)(1), the Secretary shall--
                    ``(A) provide public notice regarding the 
                application, including making the notice available on 
                the Internet;
                    ``(B) make the application and all supporting 
                material available to the public, including 
                availability on the Internet; and
                    ``(C) provide the public with an opportunity, for 
                not less than 45 days, to submit comments on the 
                application.
            ``(2) Exception.--
                    ``(A) In general.--The Secretary may withhold 
                information in an application from public dissemination 
                to protect a trade secret (not including any 
                information disclosing the results of testing to 
                determine whether the genetically engineered food is 
                safe) if--
                            ``(i) the information is exempt from 
                        disclosure under section 522 of title 5, United 
                        States Code, or applicable trade secret law;
                            ``(ii) the applicant--
                                    ``(I) identifies with specificity 
                                the trade secret information in the 
                                application; and
                                    ``(II) provides the Secretary with 
                                a detailed justification for each trade 
                                secret claim; and
                            ``(iii) the Secretary--
                                    ``(I) determines that the 
                                information qualifies as a trade secret 
                                subject to withholding from public 
                                dissemination; and
                                    ``(II) makes the determination 
                                available to the public.
                    ``(B) Risk assessment information.--This paragraph 
                does not apply to information that assesses risks from 
                the release into the environment of a genetically 
                engineered animal (including any environmental 
                assessment or environmental impact statement performed 
                to comply with the National Environmental Policy Act of 
                1969 (42 U.S.C. 4321 et seq.)).
    ``(d) Denial of Application.--Under section 512(d)(1), the 
Secretary shall deny an application if--
            ``(1) the environmental assessment for a genetically 
        engineered animal is not adequate; or
            ``(2) the plan to eliminate or mitigate the potential 
        environmental effects to the environment from the release of 
        the genetically engineered animal does not adequately protect 
        the environment.
    ``(e) Environmental Assessment.--
            ``(1) In general.--Before determining whether to approve an 
        application under section 512 for approval of a genetic 
        engineering technique intended to be used to produce an animal, 
        or of a genetically engineered animal, the Secretary shall--
                    ``(A) conduct an environmental assessment to 
                evaluate the potential effects of such a genetically 
                engineered animal on the environment; and
                    ``(B) determine that the genetically engineered 
                animal will not have an unreasonable adverse effect on 
                the environment.
            ``(2) Consultation.--In conducting an environmental 
        assessment under paragraph (1), the Secretary shall--
                    ``(A) consult, as appropriate, with the Department 
                of Agriculture, the United States Fish and Wildlife 
                Service, and any other Federal agency that has 
                expertise relating to the animal species that is the 
                subject of the application; and
                    ``(B) disclose the results of the consultation in 
                the environmental assessment.
    ``(f) Safety Determination.--In determining the safety of a genetic 
engineering technique or genetically engineered animal, the Secretary 
shall consider the potential effects of the genetically engineered 
animal on the environment, including the potential effect on 
nongenetically engineered animals.
    ``(g) Progeny.--If an application for approval of a genetic 
engineering technique to produce an animal of a species or other 
taxonomic classification, or genetically engineered animal, has been 
approved, no additional application shall be required for animals of 
that species or other taxonomic classification produced using that 
genetic engineering technique or for the progeny of that genetically 
engineered animal.
    ``(h) Scope of Approval.--The scope of the genetic engineering 
technique that the Secretary may approve shall be limited to the 
precise procedures described in the application for approval.
    ``(i) Conditions of Approval.--The Secretary may require as a 
condition of approval of an application that any producer of a 
genetically engineered animal that is the subject of the application--
            ``(1) take specified actions to eliminate or mitigate any 
        potential harm to the environment that would be caused by a 
        release of the genetically engineered animal, including actions 
        specified in the plan submitted by the applicant; and
            ``(2) conduct post-approval monitoring for environmental 
        effects of any release of the genetically engineered animal.
    ``(j) Recall; Suspension of Approval.--
            ``(1) Recall.--The Secretary may order a recall of any 
        genetically engineered animal (whether or not the genetically 
        engineered animal, or a genetic engineering technique used to 
produce the genetically engineered animal, has been approved) that the 
Secretary determines is harmful to--
                    ``(A) humans;
                    ``(B) the environment;
                    ``(C) any animal that is subjected to a genetic 
                engineering technique; or
                    ``(D) any animal that is not subjected to a genetic 
                engineering technique.
            ``(2) Suspension of approval.--If the Secretary determines 
        that a genetically engineered animal is harmful to the health 
        of humans or animals or to the environment, the Secretary may--
                    ``(A) immediately suspend the approval of 
                application for the genetically engineered animal;
                    ``(B) give the applicant prompt notice of the 
                action; and
                    ``(C) afford the applicant an opportunity for an 
                expedited hearing.
    ``(k) Rescission of Approval.--
            ``(1) Reconsideration.--On the motion of any person, or on 
        the Secretary's own motion, the Secretary may reconsider an 
        approval of a genetic engineering technique or genetically 
        engineered animal on the basis of information that was not 
        available during an earlier review.
            ``(2) Finding for reconsideration.--The Secretary shall 
        conduct a reconsideration on the basis of the information 
        described in paragraph (1) if the Secretary finds that the 
        information--
                    ``(A) is scientifically credible;
                    ``(B) represents significant information that was 
                not available before the approval; and
                    ``(C)(i) suggests potential impacts relating to the 
                genetically engineered animal that were not considered 
                before the approval; or
                    ``(ii) demonstrates that the information considered 
                before the approval was inadequate for the Secretary to 
                make a safety finding.
            ``(3) Information from the producer.--
                    ``(A) In general.--In conducting the 
                reconsideration, the Secretary may require the producer 
                to provide, within a reasonable period of time 
                specified by the Secretary, information needed to 
                facilitate the reconsideration.
                    ``(B) Information not provided.--If a producer 
                fails to provide information required under 
                subparagraph (A) within the period specified by the 
                Secretary, the Secretary shall take 1 or more of the 
                actions described in paragraph (5).
            ``(4) Determination.--After reviewing the information by 
        the petitioner and the producer, the Secretary shall issue a 
        determination that--
                    ``(A) revises the finding made in connection with 
                the approval with respect to the safety of the 
                genetically engineered animal; or
                    ``(B) states that, for reasons stated by the 
                Secretary, no revision of the finding is needed.
            ``(5) Action by the secretary.--If, based on a review under 
        this subsection, the Secretary determines that the genetically 
        engineered animal is not safe, the Secretary shall--
                    ``(A) rescind the approval of the genetic 
                engineering technique or genetically engineered animal 
                for introduction into interstate commerce;
                    ``(B) recall the genetically engineered animal; or
                    ``(C) take such other action as the Secretary 
                determines to be appropriate.
    ``(l) Animals Used in Development.--An animal that is used in 
connection with an investigation intended to support approval of an 
application under section 512 and this section or that is otherwise 
used in connection with the development of a genetic engineering 
technique or production of a genetically engineered animal for which 
approval is sought shall be deemed unsafe for the purposes of sections 
501(a)(5) and 402(a)(2)(C)(ii) unless--
            ``(1) the applicant submits information required by the 
        Secretary that addresses the food safety of the animal;
            ``(2) the Secretary publishes the information in the 
        Federal Register and provides a public comment period of not 
        less than 60 days; and
            ``(3) based on the information provided under paragraph 
        (1), any public comment, and other information available to the 
        Secretary, the Secretary--
                    ``(A) makes a determination that the animal is 
                safe; and
                    ``(B) publishes the determination in the Federal 
                Register and on the Internet.''.

SEC. 6. PROHIBITED ACTS.

    (a) Unlawful Use of Trade Secret Information.--Section 301(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended 
in the first sentence--
            (1) by inserting ``421,'' after ``414,''; and
            (2) by inserting ``512A,'' after ``512,''.
    (b) Adulterated Food.--Section 402 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the 
following:
    ``(i) Genetically Engineered Animals.--If it is a genetically 
engineered animal, or is a genetically engineered animal produced using 
a genetic engineering technique, that is not approved under sections 
512 and 512A.
    ``(j) Genetically Engineered Foods.--
            ``(1) In general.--If it is a genetically engineered food, 
        or is a genetically engineered food produced using a genetic 
        engineering technique, that is not approved under section 421.
            ``(2) Split use foods.--If it is a split use food that does 
        not maintain proper segregation as required under regulations 
        promulgated under section 421.''.

SEC. 7. TRANSITION PROVISION.

    (a) In General.--A genetic engineering technique, genetically 
engineered animal, or genetically engineered food that entered 
interstate commerce before the date of enactment of this Act shall not 
require approval under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), but shall be considered to have been so approved, 
if--
            (1) the producer, not later than 90 days after the date of 
        enactment of this Act, submits to the Secretary--
                    (A) a notice stating that the genetic engineering 
                technique, genetically engineered animal, or 
                genetically engineered food entered interstate commerce 
                before the date of enactment of this Act, providing 
                such information as the Secretary may require; and
                    (B) a request that the Secretary conduct a review 
                of the genetic engineering technique, genetically 
                engineered animal, or genetically engineered food under 
                subsection (b); and
            (2) the Secretary does not issue, on or before the date 
        that is 2 years after the date of enactment of this Act, a 
        notice under subsection (b)(2) that an application for approval 
        is required.
    (b) Review by the Secretary.--
            (1) In general.--Not later than 21 months after the date on 
        which the Secretary receives a notice and request for review 
        under subsection (a), the Secretary shall review all relevant 
        information in the possession of the Secretary, all information 
        provided by the producer, and other relevant public information 
        to determine whether a review of new scientific information is 
        necessary to ensure that the genetic engineering technique, 
        genetically engineered animal, or genetically engineered food 
        is safe.
            (2) Notice that application is required.--If the Secretary 
        determines that new scientific information is necessary to 
        determine whether a genetic engineering technique, genetically 
        engineered animal, or genetically engineered food is safe, the 
        Secretary, not later than 2 years after the date of enactment 
        of this Act, shall issue to the producer a notice stating that 
        the producer is required to submit an application for approval 
        of the genetic engineering technique, genetically engineered 
        animal, or genetically engineered food under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Failure To Submit Application.--
            (1) In general.--Except as provided in paragraph (2), a 
        genetically engineered animal or genetically engineered food 
        with respect to which the Secretary issues a notice that an 
        application is required under subsection (b)(2) shall be 
        considered adulterated under section 402 or 501, as the case 
        may be, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        342, 351) unless--
                    (A) not later than 45 days after the producer 
                receives the notice, the producer submits an 
                application for approval; and
                    (B) the Secretary approves the application.
            (2) Pending application.--A genetically engineered animal 
        or genetically engineered food with respect to which the 
        producer submits an application for approval shall not be 
        considered to be adulterated during the pendency of the 
        application.

SEC. 8. GENETICALLY ENGINEERED CROPS.

    To the maximum extent practicable, the Secretary of Agriculture 
shall ensure that standards for the regulation of genetically 
engineered field test crops to prevent cross-pollenation with non-
genetically engineered crops and prevent adverse effects on the 
environment are based on the most recent scientific knowledge 
available.

SEC. 9. REPORTS.

    (a) In General.--Not later than 2 years, 4 years, and 6 years after 
the date of enactment of this Act, the Secretary and the heads of other 
Federal agencies, as appropriate, shall jointly submit to Congress a 
report on genetically engineered animals, genetically engineered foods, 
and genetic engineering techniques.
    (b) Contents.--A report under subsection (a) shall contain--
            (1) information on the types and quantities of genetically 
        engineered foods being offered for sale or being developed, 
        domestically and internationally;
            (2) a summary (including discussion of new developments and 
        trends) of the legal status and acceptability of genetically 
        engineered foods in major markets, including the European Union 
        and Japan;
            (3) information on current and emerging issues of concern 
        relating to genetic engineering techniques, including issues 
        relating to--
                    (A) the ecological impact of, antibiotic markers 
                for, insect resistance to, nongerminating or terminator 
                seeds for, or cross-species gene transfer for 
                genetically engineered foods;
                    (B) foods from genetically engineered animals;
                    (C) nonfood crops (such as cotton) produced using a 
                genetic engineering technique; and
                    (D) socioeconomic concerns (such as the impact of 
                genetically engineered animals and genetically 
                engineered foods on small farms);
            (4) a response to, and information concerning the status of 
        implementation of, the recommendations contained in the reports 
        entitled ``Genetically Modified Pest Protected Plants'', 
        ``Environmental Effects of Transgenic Plants'', ``Animal 
        Biotechnology Identifying Science-Based Concerns'', and 
        ``Biological Containment of Genetically Engineered Organisms 
        (2004)'', issued by the National Academy of Sciences;
            (5) an assessment of the need for data relating to 
        genetically engineered animals and genetically engineered 
        foods;
            (6) a projection of--
                    (A) the number of genetically engineered animals, 
                genetically engineered foods, and genetic engineering 
                techniques that will require regulatory review during 
                the 5-year period following the date of the report; and
                    (B) the adequacy of the resources of the Food and 
                Drug Administration; and
            (7) an evaluation of the national capacity to test foods 
        for the presence of genetically engineered ingredients in food.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as are necessary 
to carry out this Act and the amendments made by this Act.
                                 <all>