[Congressional Record Volume 150, Number 84 (Thursday, June 17, 2004)]
[Senate]
[Pages S7019-S7023]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 2546. 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 
will strengthen consumer confidence in the safety of genetically 
engineered food and genetically engineered animals that may enter the 
food supply. This bill, known as the Genetically Engineered Food Act 
(GEFA) of 2004, requires the Federal Food and Drug Administration (FDA) 
to conduct an environmental and safety review of all genetically 
engineered plants and animals that may enter the food supply.
  Our country has been blessed with one of the safest and most abundant 
food supplies in the world but we can do better. Genetically engineered 
foods have become a major portion of the American food supply and 
promise to become a larger part in the future. The next generation of 
genetically engineered foods will be more complex, will possess more 
novel genetic variations and will challenge regulatory agencies' 
ability to assess and manage their food safety and potential 
environmental effects.
  Currently, the FDA screens genetically engineered foods through a 
voluntary consultation program. Despite assurances from the FDA for the 
past two years that the proposed and more stringent ``pre-market 
biotechnology notification'' (PBN) rules governing genetically 
engineered foods were imminent, those rules have yet to appear.
  The Genetically Engineered Food Act of 2004 will create a transparent 
process that promotes public participation as decisions are made 
regarding the safety and environmental impact of genetically engineered 
plants and animals.
  This bill will make the review process mandatory in place of the 
current voluntary system, which will reduce the chance that a 
potentially harmful product could bypass or receive inadequate 
regulatory oversight. The measure will establish unambiguous and 
predictable pathways for developers of genetically modified foods to 
gain approval to go to market and will ensure consumer confidence in 
the integrity of the system through a fully transparent review process.
  An improved regulatory system for genetically engineered foods will 
boost consumer confidence in biotechnology derived foods, give federal 
agencies clear legal authority to deal with new technology and provide 
a process to detect problems even after genetically engineered foods 
are approved.
  The Genetically Engineered Food Act of 2004 will strengthen 
government oversight in several important ways.
  Mandatory Review: Producers of genetically engineered foods will be 
required to receive approval from the FDA before introducing their 
products into interstate commerce. The FDA will ensure, based on the 
best scientific evidence, that genetically engineered foods are just as 
safe as comparable food products before allowing them on the market.
  Public Involvement and Transparency: In order for our country to gain 
the benefits that genetically engineered plants and animals can offer 
as additional sources of food, public confidence must be maintained in 
the safety of these products. My bill will provide for public 
involvement in the approval process by providing information to 
consumers, and giving them 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.
  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 will be 
able to 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 to give the 
public access to all non-confidential information.
  Environmental Review with Respect to Animals: While genetically 
engineered foods such as corn and soybeans are already part of our food 
supply, genetically engineered animals will also soon be ready for 
market approval. These animals hold much promise as an additional 
source of food for our nation. However, we must ensure not only the 
safety of these genetically engineered animals as they enter the food 
supply, but also the impact of these animals as they come in contact 
with the environment.
  The provisions of my bill are consistent with the recommendations 
made in the 2004 National Academy of Sciences report, ``Biological 
Confinement of Genetically Engineered Organisms''; the Pew Initiative 
on Food and Biotechnology 2004 report, ``Issues in the Regulation of 
Genetically Engineered Plants and Animals''; and the 2004 report from 
the Ecological Society of America, ``Genetically Engineered Organisms 
and the Environment''.
  The FDA has a mandatory review process in place that is used to 
review the food safety of genetically engineered animals before they 
enter the food supply. However, this bill will provide the FDA with 
additional oversight authorities to address the potential environmental 
impact of genetically engineered animals prior to their safety 
approval.
  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, the 
developer must include an environmental assessment 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.
  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 of 2004 will help provide the public 
with the added assurance that

[[Page S7020]]

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. 2546

       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;

[[Page S7021]]

       ``(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:

[[Page S7022]]

     ``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:

[[Page S7023]]

       ``(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.

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