EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 1 of 6

ATTACHMENT B

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of the Federal Insecticide, Fungicide, and 

Rodenticide Act

FIFRA Section 3(c)(5)

(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)

(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.
EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 2 of 6

FIFRA Section 4(g)(2)

(g) PHASE FIVE.—

* * * *

(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 
EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 3 of 6

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 
EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 4 of 6

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.—
EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 5 of 6

(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 
EPA ICR No. 2195.04 OMB Control No. 2070-0169

Page 6 of 6

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.