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] ...
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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