S.2546 - Genetically Engineered Foods Act108th Congress (2003-2004)
Bill
Hide Overview| Sponsor: | Sen. Durbin, Richard J. [D-IL] (Introduced 06/17/2004) |
|---|---|
| Committees: | Senate - Agriculture, Nutrition, and Forestry |
| Latest Action: | Senate - 06/17/2004 Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR 6/18/2004 S7020-7023) (All Actions) |
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Introduced in Senate (06/17/2004)
[Congressional Bills 108th Congress]
[From the U.S. Government Printing 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.
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