[Congressional Record Volume 148, Number 133 (Thursday, October 10, 2002)]
[Senate]
[Pages S10371-S10375]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 3095. 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; to the Committee on 
Agriculture, Nutrition, and Forestry.
  Mr. DURBIN. Mr. President, today I am introducing legislation that 
would strengthen consumer confidence in the safety of genetically 
engineered foods and genetically engineered animals that may enter the 
food supply. This bill, known as the Genetically Engineered Foods Act, 
requires an FDA review of all genetically engineered foods, and 
requires an environmental review to be conducted as part of the safety 
review for genetically engineered animals. In addition, the Genetically 
Engineered Foods Act creates a transparent process that will better 
inform and involve the public as decisions are made regarding the 
safety of all genetically engineered foods and animals.
  Make no mistake, our country has been blessed with one of the safest 
and most abundant food supplies in the world, but we can always do 
better. Genetically engineered foods have become a major part of the 
American food supply in recent years. Many of the foods we consume now 
contain genetically engineered ingredients such as corn and soy. These 
foods have been enhanced with important qualities that help farmers 
grow crops more efficiently. However, their development has raised 
important questions about the safety of these foods and the adequacy of 
government oversight.
  Currently, genetically engineered foods are screened by the Federal 
Food and Drug Administration under a voluntary consultation program. 
The Genetically Engineered Foods Act will make this review program 
mandatory, and will strengthen government oversight in several 
important ways.
  Mandatory Review: Producers of genetically engineered foods must 
receive approval from the FDA before introducing their products into 
interstate

[[Page S10372]]

commerce. The FDA will scientifically ensure that genetically 
engineered foods are just as safe as comparable food products before 
allowing them on the market.
  Public Involvement: Scientific studies and other materials submitted 
to the FDA as part of the mandatory review of genetically engineered 
foods will be made available for public review and comment. Members of 
the public can submit any new information on genetically engineered 
foods not previously available to the FDA and request a new review of a 
particular genetically engineered food product even if that food is 
already on the market.
  Testing: The FDA, in conjunction with other Federal agencies, will be 
given the authority to conduct scientifically-sound testing to 
determine whether genetically engineered foods are inappropriately 
entering the food supply.
  Communication: The FDA and other Federal agencies will establish a 
registry of genetically engineered foods for easy access to information 
about those foods that have been cleared for market. The genetically 
engineered food review process will be fully transparent so that the 
public has access to all non-confidential information.
  Environmental Review with respect to Animals: While genetically 
engineered foods such as corn and soy are already part of our food 
supply, genetically engineered animals will also soon be ready for 
market approval. These animals hold much promise for serving as an 
additional source of food for our nation. However, in the case of 
animals, we must ensure not only the safety of these products as they 
enter the food supply, but also the safety of these products as they 
come in contact with the environment.
  The FDA has a mandatory review process in place that will be used to 
review the safety of genetically engineered animals before they enter 
the food supply. However, this bill will provide the FDA will 
additional oversight authorities to be used during the safety approval 
of genetically engineered animals.
  Environmental issues have been identified as a major science-based 
concern associated with genetically engineered animals. Therefore, to 
obtain approval to market a genetically engineered animal, an 
environmental assessment must be conducted that analyzes the potential 
effects of the genetically engineered animal on the environment. A plan 
must also be in place to reduce or eliminate any negative effects. If 
the environmental assessment is not adequate, approval will not be 
granted.
  Transparency: In order to gain the benefits that genetically 
engineered animals can offer as an additional source of food, public 
confidence must be maintained in the safety of the product. This bill 
will provide for public involvement in the approval process by 
providing information to consumers, as well as the opportunity to 
provide comments. Adding transparency will increase the public's 
understanding and confidence in the safety of these animals as they 
enter the food supply.
  I urge my colleagues to join me in this effort to strengthen consumer 
confidence in the safety of genetically engineered foods and 
genetically engineered animals that may enter the food supply. The 
Genetically Engineered Foods Act can help provide the public with the 
added assurance that genetically engineered foods and animals are safe 
to produce and consume. I ask unanimous consent that the text of the 
legislation be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 3095

       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:
       ``(ll) 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.
       ``(mm) Genetically Engineered Animal.--The term 
     `genetically engineered animal' means an animal that--
       ``(1) is intended to be used--
       ``(A) in the production of a food or dietary supplement; or
       ``(B) for any other purpose;
       ``(2)(A) is produced in the United States; or
       ``(B) is offered for import into the United States; and
       ``(3) is produced using a genetic engineering technique.
       ``(nn) 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.
       ``(oo) Producer.--The term `producer', with respect to a 
     genetically engineered animal, genetically engineered food, 
     or genetic engineering technique, means a person, company, or 
     other entity that--
       ``(1) develops, manufactures, or imports the genetically 
     engineered animal, genetically engineered food, or genetic 
     engineering technique; or
       ``(2) takes other action to introduce the genetically 
     engineered animal, genetically engineered food, or genetic 
     engineering technique into interstate commerce.
       ``(pp) Safe.--The term `safe', with respect to a 
     genetically engineered food, means as safe as comparable food 
     that is not produced using a genetic engineering technique.
       ``(qq) 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.
       ``(rr) Transformation Event.--The term `transformation 
     event' means the introduction into an organism 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--

[[Page S10373]]

       (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 or 
     altered 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 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 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 
     receiving the application, 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.--In conducting the 
     reconsideration, the Secretary may require the producer to 
     provide information needed to facilitate the reconsideration.
       ``(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.
       ``(f) Exemptions.--
       ``(1) In general.--The Secretary may by regulation exempt a 
     category of genetically engineered food from the regulations 
     under subsection (b) if the Secretary determines that the 
     category of food does not pose a food safety risk.
       ``(2) Requirements.--A regulation under paragraph (1) 
     shall--
       ``(A) contain a narrowly specified definition of the 
     category that is exempted;
       ``(B) describe with specificity the genetically engineered 
     foods that are included in the category; and
       ``(C) describe with specificity the genes, proteins, and 
     adjunct technologies (including

[[Page S10374]]

     use of markers or promoters) that are involved in the genetic 
     engineering of the foods included in the category.
       ``(3) Public comment.--The Secretary shall provide an 
     opportunity for the submission of comments by interested 
     persons on a proposed regulation under paragraph (1).

     ``SEC. 422. MARKETPLACE TESTING.

       ``(a) 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.
       ``(b) Permissible Testing.--Under the program, the 
     Secretary may conduct tests on foods to detect genetically 
     engineered ingredients--
       ``(1) 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
       ``(2) 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).

     ``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; and
       ``(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 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 may 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.
       ``(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) 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
       ``(i) 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.
       ``(j) 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.--In conducting the 
     reconsideration, the Secretary may require the producer to 
     provide information needed to facilitate the reconsideration.

[[Page S10375]]

       ``(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.''.

     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. 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'', and 
     ``Animal Biotechnology Identifying Science-Based Concerns'', 
     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.
                                 ______