**EPA ICR No. 2195.04 OMB Control No. 2070** 

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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**

**FI FRA S**  **ection 3(c)(5)** 

**(5) A**  **PPROVAL OF R** **EGISTRATION**

**.** —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 an y lack of essentiality a criterion for denying registration of an y pesticide. Where two pesticides meet the requirements of this
para graph, 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 pest icide 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.

**FI FRA S**  **ection 3(**  **g )** 

**(g) R** **EGISTRATION R** **EVIEW**

**. —**  **(1)(A) G**  **ENERAL R** **ULE**

**. —** The registrations of pesticides are to be periodically reviewed. The Administrator shall b y regulation establish a procedure for accomplishing the periodic review of registrations. The goal of these regulations shall be a review of a pesticide’s registratio n every 15 y ears. 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) L**  **IMITATION**

**. —** 

Nothing in this subsection shall prohibit the Administrator from undertaking an y other review of a pesticide pursuant to this Act. **(2)(A) D**  **ATA**

**. —** 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 )**  **D ATA**  **S UBMISSION**  **, C**  **OMPENSATION ,**  **AND E**  **XEMPTION**

**. —**  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 re quired for registration review.**EPA ICR No. 2195.04 OMB Control No. 2070** 

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Page **2** of **6 FI**  **FRA S ection**  **4(g)(2)**

**(g) P**  **HASE F**  **IVE**

**. —**  * * * * **(2) R** **EREGISTRATION AND O**  **THER A**  **CTIONS**

**. —**  **(A) I**  **N G**  **ENERAL**

**. —** 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) P**  **RODUCT**

**- S**  **PECIFIC D**  **ATA**

**. —**  **(i) I**  **N G**  **ENERAL**

**. —** Before reregistering a pesticide, the Adm inistrator 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 day s after its submission. **(ii) T**  **IMING**

**. —**  **(I) I**  **N G**  **ENERAL**

**. —**  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 t hat a longer period is required for the generation of the data. **(II) E**  **XTRAORDINARY C**  **IRCUMSTANCES**

**. —**  In the case of extraordinary circumstances, the Administrator may provide such a longer period, of not more than 2 additional y ears, for submission of data t o the Administrator under this subparagraph. **(C)** After conducting the review required b y paragraph (1) for each active ingredient of a pesticide and the review required b y subparagraph (B) of this paragraph, the Administrator shall determine whether to rer egister a pesticide b y 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 th e submission of the data concerning such pesticide under subparagraph (B). **(D) D**  **ETERMINATION TO N**  **OT R** **EREGISTER**

**. —**  **(i) I**  **N G**  **ENERAL**

**. —**  If after conducting a review under paragraph (1) or subparagraph (B) of this paragraph the Administrator determines that a pe sticide should not be reregistered, the Administrator shall take appropriate regulatory action. **(ii) T**  **IMING FOR R** **EGULATORY A**  **CTION**

**. —** Regulatory action under clause (i) shall be completed as expeditiously as possible. **(E)** As soon as the Administrator has su fficient 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** 

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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 o r 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 p romptly

such proceedings under this Act and section 408 of the Federal Food, Drug, and Cosmetic Act as are warranted b y such determinations.

**FI FRA S**  **ection 25** 

**A UTHORITY OF**  **A DMINISTRATOR** 

**. (a)**  **I N**  **G ENERAL** 

**. —**  **(1) R** **EGULATIONS**

**. —** The Administrator is authorized in accordance with the
p rocedure 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 clas ses 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) P**  **ROCEDURE**

**. —**  **(A) P**  **ROPOSED R** **EGULATIONS**

**. —**  At least 60 day s 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 regard ing any such regulation within 30 day s 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. I f the Secretary does not comment in writing to the Administrator regarding the regulation within 30 day s after receiving it, the Administrator may sign such regulation for publication in the Federal Register an y time after such 30

- day period notwithstandin g the foregoing 60

- day time requirement. **(B) F**  **INAL R** **EGULATIONS**

**. —**  At least 30 day s prior to signing any regulation in final form for publication in the Federal Register, the Administrator shall provide the S ecretary of Agriculture with a copy of such regulation. If the Secretary comments in writing to the Administrator re garding an y 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 day s after receiving it, the Administrator may sign suc h regulation for publication in the Federal Register at any time after such 15

- day

period notwithstanding the foregoing 30

- day

time requirement. In taking an y final action under this subsection, the Administrator shall include among those factors to be tak en into account the effect of the regulation on production and prices of agricultural commodities, retail**EPA ICR No. 2195.04 OMB Control No. 2070** 

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Page **4** of **6** food prices, and otherwise on the agricultural economy , and the Administrator shall publish in the Federal Register an anal ys is of such effect. **(C) T**  **IME R** **EQUIREMENTS**

**. —** The time requirements imposed by subparagraphs (A) and (B) may

be waived or modified to the extent agreed upon b y the Administrator and the Secretary

. **(D) P**  **UBLICATION IN THE F**  **EDERAL R** **EGISTER**

**.** —The Administrator shall, simultaneously

with an y notification to the Secretary of Agriculture under this paragraph prior to the issuance of an y proposed or final regulation, publish such notification in the Federal Register. **(3) C**  **ONGRESSIONAL C**  **OMMITTEES**

**. —**  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 cop y 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) C**  **ONGRESSIONAL R** **EVIEW OF R** **EGULATIONS**

**. —**  Simultaneously with the promulgation of an y rule or regulation under this Act, the Administrator shall
trans mit a cop y 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 day s after the rule or regulation is so transmitted. **(b) E**  **XEMPTION OF P**  **ESTI CIDES** 

**. —** The Administrator may exempt from the

r equirements of this Act by regulation any

pesticide which the Administrator determines either (1) to be adequatel y regulated by another Federal agency, or (2) to be of a c haracter which is unnecessary to be subject to this Act in order to carry out the purposes of this Act. **(c) O**  **THER A**  **UTHORITY**

**. —** The Administrator, after notice and opportunity for h earing, is authorized

— **(1)** to declare a pest an y form of plant or animal lif e (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

pe sticide which contains any sub stance or substances in quantitie s 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 L aw 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 b y this Act as well as to accomplish the other purposes o f 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 an y 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 estab lish suitable names to be used in the ingredient statement. **(d) S**  **CIENTIFIC A**  **DVISORY P**  **ANEL**

**. —** **EPA ICR No. 2195.04 OMB Control No. 2070** 

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Page **5** of **6 (1)**  **I N**  **G ENERAL** 

**. —** 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 o f 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 p roposed 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 prescrib ed 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 anal yses ma de b y personnel of the Environmental Protection Agency that lead to decisions by

the Administrator in carrying out the provisions of this Act. The c omments, evaluations, and recommendations of the advisory panel submitted under this subsection and the res ponse 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 Admini strator, 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 b y the Administrator with respect to proposed action. Such additional scientists shall be selected b y the advisory panel. The panel referred to in this subsection shall consi st 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 s elec ted 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 an y other reason, each replacement shall be selected b y 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 Administrato r 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 Regist er 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** 

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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 objectivit y 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, D evelopment, and Demonstration Authorization Act of 1978. Whene ver 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) S**  **CIENCE R** **EVIEW B**  **OARD**

**. —** 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) P**  **EER R** **EV IEW** 

**. —** 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 b y any

other Federal agency , an y State or political subdivision thereof, or an y 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 a dvisory panel established under subsection (d) of this section or appropriate experts appointed b y 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 Adm inistrator 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 an y such scientific study prior to the Administrator’s exercising authorit y under section 6(c) of this Act to immediately

suspend the registration of an y pesticide to prevent an imminent hazard, the Administrator shall promptly thereafter provide for the cond uct 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 b y 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 b y scientific experts, either within or outside the Environmental Protec tion Agency , in the appropriate disciplines.