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U.S. Code as of:
01/03/05
Section 136w. Authority of Administrator
(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 subchapter. Such regulations
shall take into account the difference in concept and usage
between various classes of pesticides, including public health
pesticides, and differences in environmental risk and the
appropriate data for evaluating such risk between agricultural,
nonagricultural, and public health 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 subchapter, 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
subchapter 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 subchapter in order to carry out the purposes of
this subchapter.
(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) [15 U.S.C. 1471 et seq.]) 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 subchapter as well as to accomplish the
other purposes of this subchapter;
(4) to specify those classes of devices which shall be subject
to any provision of section 136(q)(1) or section 136e of this
title upon the Administrator's determination that application of
such provision is necessary to effectuate the purposes of this
subchapter;
(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
(1) In general
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 136d(b) of
this title and of the proposed and final form of regulations
issued under subsection (a) of this section within the same time
periods as provided for the comments of the Secretary of
Agriculture under such section 136d(b) and subsection (a) of this
section. 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 136d(b)
of this title or subsection (a) of this section, 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 subchapter. 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 subchapter, 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 [42
U.S.C. 4365]. Whenever the Administrator exercises authority
under section 136d(c) of this title 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 subchapter 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 136d(c) of this title 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) of this section. 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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