Sec.
25. [136w] Authority of Administrator.
(s) (a) In General.-- (1) Regulations.--The Administrator is
authorized, in accordance with the procedure described in paragraph
(2), to prescribe regulations to carry out the provisions of
this Act. Such regulations shall take into account the difference
in concept and usage between various classes of pesticides and
differences in environmental risk and the appropriate data for
evaluating such risk between agricultural and nonagricultural
pesticides. (2) Procedure.-- (A) Proposed Regulations.--At least
60 days prior to signing any proposed regulation for publication
in the Federal Register, the Administrator shall provide the
Secretary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator regarding
any such regulation within 30 days after receiving it, the Administrator
shall publish in the Federal Register (with the proposed regulation)
the comments of the Secretary and the response of the Administrator
with regard to the Secretary's comments. If the Secretary does
not comment in writing to the Administrator regarding the regulation
within 30 days after receiving it, the Administrator may sign
such regulation for publication in the Federal Register any time
after such 30-day period notwithstanding the foregoing 60-day
time requirement. (B) Final Regulations--At least 30 days prior
to signing any regulation in final form for publication in the
Federal Register, the Administrator shall provide the Secretary
of Agriculture with a copy of such regulation. If the Secretary
comments in writing to the Administrator regarding any such final
regulation within 15 days after receiving it, the Administrator
shall publish in the Federal Register (with the final regulation)
the comments of the Secretary, if requested by the Secretary,
and the response of the Administrator concerning the Secretary's
comments. If the Secretary does not comment in writing to the
Administrator regarding the regulation within 15 days after receiving
it, the Administrator may sign such regulation for publication
in the Federal Register at any time after such 15-day period
notwithstanding the foregoing 30-day time requirement. In taking
any final action under this subsection, the Administrator shall
include among those factors to be taken into account the effect
of the regulation on production and prices of agricultural commodities,
retail food prices, and otherwise on the agricultural economy,
and the Administrator shall publish in the Federal Register an
analysis of such effect. (C) Time Requirements.--The time requirements
imposed by subparagraphs (A) and (B) may be waived or modified
to the extent agreed upon by the Administrator and the Secretary.
(D) Publication in the Federal Register.--The Administrator shall,
simultaneously with any notification to the Secretary of Agriculture
under this paragraph prior to the issuance of any proposed or
final regulation, publish such notification in the Federal Register.
(3) Congressional Committees.--At such time as the Administrator
is required under paragraph (2) of this subsection to provide
the Secretary of Agriculture with a copy of proposed regulations
and a copy of the final form of regulations, the Administrator
shall also furnish a copy of such regulations to the Committee
on Agriculture of the House of Representatives and the Committee
on Agriculture, Nutrition, and Forestry of the Senate. (4) Congressional
Review of Regulations.--Simultaneously with the promulgation
of any rule or regulation under this Act, the Administrator shall
transmit a copy thereof to the Secretary of the Senate and the
Clerk of the House of Representatives. The rule or regulation
shall not become effective until the passage of 60 calendar days
after the rule or regulation is so transmitted. (b) Exemption
of Pesticides.--The Administrator may exempt from the requirements
of this Act by regulation any pesticide which the Administrator
determines either (1) to be adequately regulated by another Federal
agency, or (2) to be of a character which is unnecessary to be
subject to this Act in order to carry out the purposes of this
Act. (c) Other Authority.--The Administrator, after notice and
opportunity for hearing, is authorized-- (1) to declare a pest
any form of plant or animal life (other than man and other than
bacteria, virus, and other micro-organisms on or in living man
or other living animals) which is injurious to health or the
environment; (2) to determine any pesticide which contains any
substance or substances in quantities highly toxic to man; (3)
to establish standards (which shall be consistent with those
established under the authority of the Poison Prevention Packaging
Act (Public Law 91-601) with respect to the package, container,
or wrapping in which a pesticide or device is enclosed for use
or consumption, in order to protect children and adults from
serious injury or illness resulting from accidental ingestion
or contact with pesticides or devices regulated by this Act as
well as to accomplish the other purposes of this Act; (4) to
specify those classes of devices which shall be subject to any
provision of section 2(q)(1) or section 7 of this Act upon the
Administrator's determination that application of such provision
is necessary to effectuate the purposes of this Act; (5) to prescribe
regulations requiring any pesticide to be colored or discolored
if the Administrator determines that such requirement is feasible
and is necessary for the protection of health and the environment;
and (6) to determine and establish suitable names to be used
in the ingredient statement. (d) Scientific Advisory Panel.--The
Administrator shall submit to an advisory panel for comment as
to the impact on health and the environment of the action proposed
in notices of intent issued under section 6(b) and of the proposed
and final form of regulations issued under 26(a) within the same
time periods as provided for the comments of the Secretary of
Agriculture under such sections. The time requirements for notices
of intent and proposed and final forms of regulation may not
be modified or waived unless in addition to meeting the requirements
of section 6(b) or 25(a), as applicable, the advisory panel has
failed to comment on the proposed action within the prescribed
time period or has agreed to the modification or waiver. The
Administrator shall also solicit from the advisory panel comments,
evaluations, and recommendations for operating guidelines to
improve the effectiveness and quality of scientific analyses
made by personnel of the Environmental Protection Agency that
lead to decisions by the Administrator in carrying out the provisions
of this Act. The comments, evaluations, and recommendations of
the advisory panel submitted under this subsection and the response
of the Administrator shall be published in the Federal Register
in the same manner as provided for publication of the comments
of the Secretary of Agriculture under such sections. The chairman
of the advisory panel, after consultation with the Administrator,
may create temporary subpanels on specific projects to assist
the full advisory panel in expediting and preparing its evaluations,
comments, and recommendations. The subpanels may be composed
of scientists other than members of the advisory panel, as deemed
necessary for the purpose of evaluating scientific studies relied
upon by the Administrator with respect to proposed action. Such
additional scientists shall be selected by the advisory panel.
The panel referred to in this subsection shall consist of 7 members
appointed by the Administrator from a list of 12 nominees, 6
nominated by the National Institutes of Health and 6 by the National
Science Foundation, utilizing a system of staggered terms of
appointment. Members of the panel shall be selected on the basis
of their professional qualifications to assess the effects of
the impact of pesticides on health and the environment. To the
extent feasible to insure multidisciplinary representation, the
panel membership shall include representation from the disciplines
of toxicology, pathology, environmental biology, and related
sciences. If a vacancy occurs on the panel due to expiration
of a term, resignation, or any other reason, each replacement
shall be selected by the Administrator from a group of 4 nominees,
2 submitted by each of the nominating entities named in this
subsection. The Administrator may extend the term of a panel
member until the new member is appointed to fill the vacancy.
If a vacancy occurs due to resignation, or reason other than
expiration of a term, the Administrator shall appoint a member
to serve during the unexpired term utilizing the nomination process
set forth in this subsection. Should the list of nominees provided
under this subsection be unsatisfactory, the Administrator may
request an additional set of nominees from the nominating entities.
The Administrator may require such information from the nominees
to the advisory panel as the Administrator deems necessary, and
the Administrator shall publish in the Federal Register the name,
address, and professional affiliations of each nominee. Each
member of the panel shall receive per diem compensation at a
rate not in excess of that fixed for GS-18 of the General Schedule
as may be determined by the Administrator, except that any such
member who holds another office or position under the Federal
Government the compensation for which exceeds such rate may elect
to receive compensation at the rate provided for such other office
or position in lieu of the compensation provided by this subsection.
In order to assure the objectivity of the advisory panel, the
Administrator shall promulgate regulations regarding conflicts
of interest with respect to the members of the panel. The advisory
panel established under this section shall be permanent. In performing
the functions assigned by this Act, the panel shall consult and
coordinate its activities with the Science Advisory Board established
under the Environmental Research, Development, and Demonstration
Authorization Act of 1978. Whenever the Administrator exercises
authority under section 6(c) of this Act to immediately suspend
the registration of any pesticide to prevent an imminent hazard,
the Administrator shall promptly submit to the advisory panel
for comment, as to the impact on health and the environment,
the action taken to suspend the registration of such pesticide.
(2) Science Review Board.--There is established a Science Review
Board to consist of 60 scientists who shall be available to the
Scientific Advisory Panel to assist in reviews conducted by the
Panel. Members of the Board shall be selected in the same manner
as members of temporary subpanels created under paragraph (1).
Members of the Board shall be compensated in the same manner
as members of the Panel. (e) Peer Review.--The Administrator
shall, by written procedures, provide for peer review with respect
to the design, protocols, and conduct of major scientific studies
conducted under this Act by the Environmental Protection Agency
or by any other Federal agency, any State or political subdivision
thereof, or any institution or individual under grant, contract,
or cooperative agreement from or with the Environmental Protection
Agency. In such procedures, the Administrator shall also provide
for peer review, using the advisory panel established under subsection
(d) of this section or appropriate experts appointed by the Administrator
from a current list of nominees maintained by such panel, with
respect to the results of any such scientific studies relied
upon by the Administrator with respect to actions the Administrator
may take relating to the change in classification, suspension,
or cancellation of a pesticide. Whenever the Administrator determines
that circumstances do not permit the peer review of the results
of any such scientific study prior to the Administrator's exercising
authority under section 6(c) of this Act to immediately suspend
the registration of any pesticide to prevent an imminent hazard,
the Administrator shall promptly thereafter provide for the conduct
of peer review as provided in this sentence. The evaluations
and relevant documentation constituting the peer review that
relate to the proposed scientific studies and the results of
the completed scientific studies shall be included in the submission
for comment forwarded by the Administrator to the advisory panel
as provided in subsection (d). As used in this subsection, the
term "peer review" shall mean an independent evaluation
by scientific experts, either within or outside the Environmental
Protection Agency, in the appropriate disciplines. |
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