Document ID: EPA-HQ-OPP-2008-0414-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-12T05:00Z

EPA ICR No. 2195.03                                       OMB Control
No. 2070-0169

ATTACHMENT A

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of the Federal Insecticide,
Fungicide, and Rodenticide Act ATTACHMENT A:  FIFRA SECTIONS 3(c)(5),
3(g), 4(g)(2), and 25

FIFRA Section 3(c)(5)

  SEQ CHAPTER \h \r 1 (5) Approval of Registration.—The Administrator
shall register a pesticide if the Administrator determines that, when
considered with any restrictions imposed under subsection (d) of this
section— 

(A) its composition is such as to warrant the proposed claims for it;

(B) its labeling and other material required to be submitted comply with
the requirements of this Act;

(C) it will perform its intended function without unreasonable adverse
effects on the environment; and

(D) when used in accordance with widespread and commonly recognized
practice it will not generally cause unreasonable adverse effects on the
environment.

The Administrator shall not make any lack of essentiality a criterion
for denying registration of any pesticide.  Where two pesticides meet
the requirements of this paragraph, one should not be registered in
preference to the other.  In considering an application for the
registration of a pesticide, the Administrator may waive data
requirements pertaining to efficacy, in which event the Administrator
may register the pesticide without determining that the pesticide's
composition is such as to warrant proposed claims of efficacy.  If a
pesticide is found to be efficacious by any State under section 24(c) of
this Act, a presumption is established that the Administrator shall
waive data requirements pertaining to efficacy for use of the pesticide
in such State.

FIFRA Section 3(g)

  SEQ CHAPTER \h \r 1 (g) Registration Review.— 

(1)(A) General Rule.—The registrations of pesticides are to be
periodically reviewed.  The Administrator shall by regulation establish
a procedure for accomplishing the periodic review of registrations.  The
goal of these regulations shall be a review of a pesticide’s
registration every 15 years.  No registration shall be canceled as a
result of the registration review process unless the Administrator
follows the procedures and substantive requirements of section 6. 

(B) Limitation.—Nothing in this subsection shall prohibit the
Administrator from undertaking any other review of a pesticide pursuant
to this Act. 

(2)(A) Data.—The Administrator shall use the authority in subsection
(c)(2)(B) to require the submission of data when such data are necessary
for a registration review. 

(B) Data Submission, Compensation, and Exemption.— 

For purposes of this subsection, the provisions of subsections (c)(1),
(c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to any
data required for registration review.

FIFRA Section 4(g)(2)

  SEQ CHAPTER \h \r 1 (g) Phase Five.—

* * * *

  SEQ CHAPTER \h \r 1 (2) Reregistration and Other Actions.— 

(A) In General.—The Administrator shall make a determination as to
eligibility for reregistration— 

(i) for all active ingredients subject to reregistration under this
section for which tolerances or exemptions from tolerances are required
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
not later than the last date for tolerance reassessment established
under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and 

(ii) for all other active ingredients subject to reregistration under
this section, not later than October 3, 2008. 

(B) Product-Specific Data.— 

(i) In General.—Before reregistering a pesticide, the Administrator
shall obtain any needed product-specific data regarding the pesticide by
use of section 3(c)(2)(B) and shall review such data within 90 days
after its submission.

(ii) Timing.— 

(I) In General.—Subject to subclause (II), the Administrator shall
require that data under this subparagraph be submitted to the
Administrator not later than 8 months after a determination of
eligibility under subparagraph (A) has been made for each active
ingredient of the pesticide, unless the Administrator determines that a
longer period is required for the generation of the data.

(II) Extraordinary Circumstances.—In the case of extraordinary
circumstances, the  Administrator may provide such a longer period, of
not more than 2 additional years, for submission of data to the
Administrator under this subparagraph.

(C) After conducting the review required by paragraph (1) for each
active ingredient of a pesticide and the review required by subparagraph
(B) of this paragraph, the Administrator shall determine whether to
reregister a pesticide by determining whether such pesticide meets the
requirements of section 3(c)(5). If the Administrator determines that a
pesticide is eligible to be reregistered, the Administrator shall
reregister such pesticide within 6 months after the submission of the
data concerning such pesticide under subparagraph (B). 

(D) Determination to Not Reregister.— 

(i) In General.—If after conducting a review under paragraph (1) or
subparagraph (B) of this paragraph the Administrator determines that a
pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action. 

(ii) Timing for Regulatory Action.—Regulatory action under clause (i)
shall be completed as expeditiously as possible. 

(E) As soon as the Administrator has sufficient information with respect
to the dietary risk of a particular active ingredient, but in any event
no later than the time the Administrator makes a determination under
subparagraph (C) or (D) with respect to pesticides containing a
particular active ingredient, the Administrator shall— 

(i) reassess each associated tolerance and exemption from the
requirement for a tolerance issued under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a); 

(ii) determine whether such tolerance or exemption meets the
requirements of that Act; 

(iii) determine whether additional tolerances or exemptions should be
issued; 

(iv) publish in the Federal Register a notice setting forth the
determinations made under this subparagraph; and 

(v) commence promptly such proceedings under this Act and section 408 of
the Federal Food, Drug, and Cosmetic Act as are warranted by such
determinations.

FIFRA Section 25 

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. 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.