Home > 106th Congressional Bills > S. 2547 (enr) To provide for the establishment of the Great Sand Dunes National Park and Preserve and the Baca National Wildlife Refuge in the State of Colorado, and for other purposes. [Enrolled bill] ...S. 2547 (enr) To provide for the establishment of the Great Sand Dunes National Park and Preserve and the Baca National Wildlife Refuge in the State of Colorado, and for other purposes. [Enrolled bill] ...
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
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