EPA ICR No. 1759.05                                       OMB Control
No. 2070-0148

ATTACHMENT A

Section 25 of the Federal Insecticide, Fungicide, and Rodenticide Act

Attachment A

Section 25 of the Federal Insecticide, Fungicide, and Rodenticide Act

SEC. 25. [7 U.S.C. 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 Act. 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 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 microorganisms 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 paragraph 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.— 

(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 6(b) and of the
proposed and final form of regulations issued under section 25(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. When

ever 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.

