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Code · STATUTE-COMPILATIONS · Pesticide Registration Improvement Extension Act of 2012 · Sec. 2

Sec. 2. PESTICIDE REGISTRATION IMPROVEMENT

15,294 words·~70 min read·/statute-compilations/comps-10022/sec-2

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

## SEC. 2 PESTICIDE REGISTRATION IMPROVEMENT ###
(a)Maintenance Fees ####
(1)Fees Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is amended— #####
(A)in paragraph (5)— ######
(i)in subparagraph (C), by striking “aggregate amount of” and all that follows through the end of the subparagraph and inserting “aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017.”; ######
(ii)in subparagraph (D)— ######
(I)in clause (i), by striking “shall be” and all that follows through the semicolon and inserting “shall be $115,500 for each of fiscal years 2013 through 2017;”; and ######
(II)in clause (ii), by striking “shall be” and all that follows through the period and inserting “shall be $184,800 for each of fiscal years 2013 through 2017.”; ######
(iii)in subparagraph (E)(i)— ######
(I)in subclause (I), by striking “shall be” and all that follows through the semicolon and inserting “shall be $70,600 for each of fiscal years 2013 through 2017;”; and ######
(II)in subclause (II), by striking “shall be” and all that follows through the period and inserting “shall be $122,100 for each of fiscal years 2013 through 2017.”; ######
(iv)in subparagraph (F)— ######
(I)by striking “paragraph (3)” and inserting “this paragraph”; and ######
(II)by striking “Humans” and inserting “Human”; ######
(v)by redesignating subparagraphs
(F)through
(H)as subparagraphs
(G)through (I), respectively; ######
(vi)by inserting after subparagraph
(E)the following: > > ##### “(F) Fee reduction for certain small businesses > > > ###### “(i) Definition > > In this subparagraph, the term ‘qualified small business entity’ means a corporation, partnership, or unincorporated business that— > > > ###### “(I) > > has 500 or fewer employees; > > > ###### “(II) > > during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and > > > ###### “(III) > > holds not more than 5 pesticide registrations under this paragraph. > > > ###### “(ii) Waiver > > Except as provided in clause (iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified small business entity under this paragraph. > > > ###### “(iii) Limitation > > The Administrator shall not grant a waiver under clause
(ii)to a qualified small business entity if the Administrator determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver.” > ; and ######
(vii)in subparagraph
(I)(as redesignated by clause (v)), by striking “2012” and inserting “2017”; #####
(B)in paragraph (6)— ######
(i)by striking “2014” and inserting “2019”; and ######
(ii)by striking “paragraphs
(1)through (5)” and inserting “paragraph (1)”; #####
(C)by striking paragraphs (1), (2), (3), (4), and (7); and #####
(D)by redesignating paragraphs
(5)and
(6)as paragraphs
(1)and (2), respectively. ####
(2)Conforming amendments #####
(A)Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1) is amended— ######
(i)in subsection (d)(5)(B)(ii)(III), by striking “subsection (i)(1)” and inserting “this section”; ######
(ii)in subsection (j), by striking “subsection (i)(5)” and inserting “subsection (i)(1)”; and ######
(iii)in subsection (k)(5)— ######
(I)in the first sentence, by striking “subsection (i)(5)(C)(ii)” and inserting “subsection (i)(1)(C)(ii)”; and ######
(II)in the third and sixth sentences, by striking “subsection (i)(5)(C)” each place it appears and inserting “subsection (i)(1)(C)”. #####
(B)Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(7)(F)) is amended— ######
(i)by striking “section 4(i)(5)(E)(ii)” each place it appears in clauses (i), (ii)(I), and (iv)(I) and inserting “section 4(i)(1)(E)(ii)”; ######
(ii)by striking “section 4(i)(5)(E)(ii)(I)(bb)” each place it appears in clauses (ii)(II) and (iv)(II) and inserting “section 4(i)(1)(E)(ii)(I)(bb)”; and ######
(iii)in clause (iv)(II)— ######
(I)by striking “applicable.” and inserting “applicable”; and ######
(II)by striking “revenues” and inserting “revenue”. ####
(3)Extension of prohibition on tolerance fees Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking “September 30, 2012” and inserting “September 30, 2017”. ####
(4)Reregistration and expedited processing fund #####
(A)Source and use Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) is amended— ######
(i)by inserting “, to enhance the information systems capabilities to improve the tracking of pesticide registration decisions,” after “paragraph (3)” each place it appears; and ######
(ii)in clause (i)— ######
(I)by inserting “offset” before “the costs of reregistration”; and ######
(II)by striking “in the same portion as appropriated funds”. #####
(B)Expedited processing of similar applications Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) is amended— ######
(i)in the matter preceding clause (i), by striking “2008 through 2012, between ⅛ and ⅐” and inserting “2013 through 2017, between ⅑ and ⅛”; ######
(ii)in clause (i), by striking “new”; and ######
(iii)in clause (ii), by striking “any application” and all that follows through “that—” and inserting “any application that—”. #####
(C)Enhancements of information technology systems for improvement in review of pesticide applications Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is amended— ######
(i)by redesignating paragraphs
(4)and
(5)as paragraphs
(5)and (6), respectively; ######
(ii)by inserting after paragraph
(3)the following: > > #### “(4) Enhancements of information technology systems for improvement in review of pesticide applications > > > ##### “(A) In general > > For each of fiscal years 2013 through 2017, the Administrator shall use not more than $800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B). > > > ##### “(B) Activities > > The Administrator shall use amounts made available from the Reregistration and Expedited Processing Fund to improve the information systems capabilities for the Office of Pesticide Programs to enhance tracking of pesticide registration decisions, which shall include— > > > ###### “(i) > > the electronic tracking of— > > > ###### “(I) > > registration submissions; and > > > ###### “(II) > > the status of conditional registrations; > > > ###### “(ii) > > enhancing the database for information regarding endangered species assessments for registration review; > > > ###### “(iii) > > implementing the capability to electronically review labels submitted with registration actions; and > > > ###### “(iv) > > acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions.” > ; and ######
(iii)in the first sentence of paragraph
(6)(as redesignated by clause (i)), by striking “to carry out the goals established under subsection (l)” and inserting “for the purposes described in paragraphs (2), (3), and
(4)and to carry out the goals established under subsection (l)”. ###
(b)Pesticide Registration Service Fees ####
(1)Amount of fees Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended— #####
(A)by striking paragraph
(3)and inserting the following: > > #### “(3) Schedule of covered applications and registration service fees > > Subject to paragraph (6), the schedule of covered pesticide registration applications and corresponding registration service fees shall be as follows:``TABLE 1. _ REGISTRATION DIVISION _ NEW ACTIVE INGREDIENTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R0101New Active Ingredient, Food use
(2)(3)24569,221R0202New Active Ingredient, Food use; reduced risk
(2)(3)18569,221R0403New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)18419,502R0604New Active Ingredient, Non-food use; outdoor
(2)(3)21395,467R0705New Active Ingredient, Non-food use; outdoor; reduced risk
(2)(3)16395,467R0906New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3)16293,596R1107New Active Ingredient, Non-food use; indoor
(2)(3)20219,949R1208New Active Ingredient, Non-food use; indoor; reduced risk
(2)(3)14219,949R1219New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)18165,375R12210Enriched isomer(s) of registered mixed-isomer active ingredient
(2)(3)18287,643R12311New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities
(2)(3)18427,991R125New12New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)16293,596 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 2. _ REGISTRATION DIVISION _ NEW USESEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R13013First food use; indoor; food/food handling
(2)(3)21173,644R14014Additional food use; Indoor; food/food handling
(3)(4)1540,518R15015First food use
(2)(3)21239,684R16016First food use; reduced risk
(2)(3)16239,684R17017Additional food use
(3)(4)1559,976R175New18Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups.
(3)(4)1059,976R18019Additional food use; reduced risk
(3)(4)1059,976R19020Additional food uses; 6 or more submitted in one application
(3)(4)15359,856R20021Additional food uses; 6 or more submitted in one application; reduced risk
(3)(4)10359,856R21022Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration
(3)(4)1244,431R22023Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration
(3)(4)617,993R23024Additional use; non-food; outdoor
(3)(4)1523,969R24025Additional use; non-food; outdoor; reduced risk
(3)(4)1023,969R25026Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration
(3)(4)617,993R251New27Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis (3)817,993R26028New use; non-food; indoor
(3)(4)1211,577R27029New use; non-food; indoor; reduced risk
(3)(4)911,577R27130New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration
(3)(4)68,820R27331Additional use; seed treatment; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses
(3)(4)1245,754R27432Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses
(3)(4)12274,523 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. > > > #### “(4) > > Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling
(a)submitted subsequent to submission of the new use application and
(b)prior to conclusion of its decision review time and
(c)containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.``TABLE 3. _ REGISTRATION DIVISION _ IMPORT AND OTHER TOLERANCESEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R28033Establish import tolerance; new active ingredient or first food use (2)21289,407R29034Establish import tolerance; additional food use1557,882R29135Establish import tolerances; additional food uses; 6 or more crops submitted in one petition15347,288R29236Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated1141,124R29337Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated1248,510R29438Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated12291,060R29539Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated1559,976R29640Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated15359,856R297New41Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated11246,744R298New42Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)1353,120R299New43Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)13258,740 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 4. _ REGISTRATION DIVISION _ NEW PRODUCTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R30044New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
(2)(3)41,434R30145New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner.
(2)(3)41,720R31046New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: **g** product chemistry and/or**g** acute toxicity and/or **g** public health pest efficacy and/or **g** child resistant packaging.
(2)(3)74,807R314New47New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: **g** product chemistry and/or **g** acute toxicity and/or **g** public health pest efficacy and/or **g** child resistant packaging.
(2)(3)86,009R315New48New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: **g** product chemistry and/or **g** acute toxicity and/or **g** public health pest efficacy and/or **g** animal safety studies and/or **g** child resistant packaging
(2)(3)98,000R32049New product; new physical form; requires data review in science divisions
(2)(3)1211,996R33150New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only
(2)(3)32,294R33251New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions
(2)(3)24256,883R333New52New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data.
(2)(3)1017,993R334New53New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation.
(2)(3)1117,993 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > An application for a new end-use product using a source of active ingredient that
(a)is not yet registered but
(b)has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 5. _ REGISTRATION DIVISION _ AMENDMENTS TO REGISTRATIONEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R34054Amendment requiring data review within RD (e.g., changes to precautionary label statements)
(2)(3)43,617R345New55Amending non-food animal product that includes submission of target animal safety data; previously registered
(2)(3)78,000R35056Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)
(2)(3)911,996R351New57Amendment adding a new unregistered source of active ingredient.
(2)(3)811,996R352New58Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data
(2)(3)811,996R37159Amendment to Experimental Use Permit; (does not include extending a permit's time period) (3)69,151 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > > #####
(a)> > EPA-initiated amendments shall not be charged registration service fees.
(b)Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees.
(c)Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees.
(d)Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.
(e)Submissions with data and requiring data review are subject to registration service fees. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 6. _ REGISTRATION DIVISION _ OTHER ACTIONSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)R12460Conditional Ruling on Preapplication Study Waivers; applicant-initiated62,294R27261Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review32,294R275New62Rebuttal of agency reviewed protocol, applicant initiated32,294R37063Cancer reassessment; applicant-initiated18179,818 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.``TABLE 7. _ ANTIMICROBIALS DIVISION _ NEW ACTIVE INGREDIENTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)A38064Food use; establish tolerance exemption
(2)(3)24104,187A39065Food use; establish tolerance
(2)(3)24173,644A40066Non-food use; outdoor; FIFRA 2(mm) uses
(2)(3)1886,823A41067Non-food use; outdoor; uses other than FIFRA 2(mm)
(2)(3)21173,644A42068Non-food use; indoor; FIFRA 2(mm) uses
(2)(3)1857,882A43069Non-food use; indoor; uses other than FIFRA 2(mm)
(2)(3)2086,823A43170Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol
(2)(3)1260,638 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 8. _ ANTIMICROBIALS DIVISION _ NEW USESEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)A44071First food use; establish tolerance exemption
(3)(4)2128,942A45072First food use; establish tolerance
(3)(4)2186,823A46073Additional food use; establish tolerance exemption
(4)(5)1511,577A47074Additional food use; establish tolerance
(4)(5)1528,942A471New75Additional food uses; establish tolerances; 6 or more submitted in one application
(4)(5)15173,652A48076Additional use; non-food; outdoor; FIFRA 2(mm) uses
(4)(5)917,365A481New77Additional non-food outdoor uses; FIFRA 2(mm) uses; 6 or more submitted in one application
(4)(5)9104,190A49078Additional use; non-food; outdoor; uses other than FIFRA 2(mm)
(4)(5)1528,942A491New79Additional non-food; outdoor; uses other than FIFRA 2(mm); 6 or more submitted in one application
(4)(5)15173,652A50080Additional use; non-food, indoor, FIFRA 2(mm) uses
(4)(5)911,577A501New81Additional non-food; indoor; FIFRA 2(mm) uses; 6 or more submitted in one application
(4)(5)969,462A51082Additional use; non-food; indoor; uses other than FIFRA 2(mm)
(4)(5)1211,577A511New83Additional non-food; indoor; uses other than FIFRA 2(mm); 6 or more submitted in one application
(4)(5)1269,462 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. > > > #### “(4) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. > > > #### “(5) > > Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling
(a)submitted subsequent to submission of the new use application and
(b)prior to conclusion of its decision review time and
(c)containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.``TABLE 9. _ ANTIMICROBIALS DIVISION _ NEW PRODUCTS AND AMENDMENTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)A53084New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
(2)(3)41,159A53185New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner.
(2)(3)41,654A53286New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted
(2)(3)54,631A54087New end use product; FIFRA 2(mm) uses only
(2)(3)54,631A55088New end-use product; uses other than FIFRA 2(mm); non-FQPA product
(2)(3)74,631A56089New manufacturing-use product; registered active ingredient; selective data citation
(2)(3)1217,365A57090Label amendment requiring data review
(3)(4)43,474A572New91New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate)
(3)(4)911,996 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > An application for a new end-use product using a source of active ingredient that
(a)is not yet registered but
(b)has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. > > > #### “(3) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency. > > > #### “(4) > > > #####
(a)> > EPA-initiated amendments shall not be charged registration service fees.
(b)Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees.
(c)Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees.
(d)Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.
(e)Submissions with data and requiring data review are subject to registration service fees.``TABLE 10. _ ANTIMICROBIALS DIVISION _ EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)A52092Experimental Use Permit application, Non-Food Use (2)95,789A52193Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 132,250A52294Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 21211,025A524New95New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2)18138,916A525New96New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2)1883,594A526New97New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)1586,823A527New98New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)1558,000A528New99Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2)1520,260A529New100Amendment to Experimental Use Permit; requires data review or risk assessment (2)910,365A523New101Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols)911,025A571New102Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated1886,823 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.``TABLE 11. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B580103New active ingredient; food use; petition to establish a tolerance (2)1946,305B590104New active ingredient; food use; petition to establish a tolerance exemption (2)1728,942B600105New active ingredient; non-food use (2)1317,365B610106New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption1011,577B611New107New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption1211,577B612New108New active ingredient; no change to a permanent tolerance exemption (2)1015,918B613New109New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2)1115,918B620110New active ingredient; Experimental Use Permit application; non-food use including crop destruct75,789 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.``TABLE 12. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USESEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B630111First food use; petition to establish a tolerance exemption (2)1311,577B631112New food use; petition to amend an established tolerance (3)1211,577B640113First food use; petition to establish a tolerance (2)1917,365B643New114New Food use; petition to amend tolerance exemption (3)1011,577B642New115First food use; indoor; food/food handling (2)1228,942B644New116New use, no change to an established tolerance or tolerance exemption (3)811,577B650117New use; non-food (3)75,789 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling
(a)submitted subsequent to submission of the new use application and
(b)prior to conclusion of its decision review time and
(c)containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.``TABLE 13. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B652New118New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply (2)1311,577B660119New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2)41,159B670120New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)74,631B671121New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)1711,577B672122New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)138,269B673New123New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient
(TGAI)data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2)104,631B674New124New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2)41,159B675New125New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2)108,269B676New126New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)138,269B677New127New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: **g** product chemistry and/or **g** acute toxicity and/or **g** public health pest efficacy and/or **g** animal safety studies and/or **g** child resistant packaging (2)108,000 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > An application for a new end-use product using a source of active ingredient that
(a)is not yet registered but
(b)has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.``TABLE 14. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B621128Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption.74,631B622New129Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption.1111,577B641130Amendment of an established tolerance or tolerance exemption.1311,577B680131Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2)54,631B681132Amendment; unregistered source of active ingredient(s). Requires data submission. (2)75,513B683New133Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2)64,631B684New134Amending non-food animal product that includes submission of target animal safety data; previously registered (2)88,000 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > > #####
(a)> > EPA-initiated amendments shall not be charged registration service fees.
(b)Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees.
(c)Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees.
(d)Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.
(e)Submissions with data and requiring data review are subject to registration service fees.``TABLE 15. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)EPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B690135New active ingredient; food or non-food use. (2)72,316B700136Experimental Use Permit application; new active ingredient or new use.71,159B701137Extend or amend Experimental Use Permit.41,159B710138New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3)41,159B720139New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3)51,159B721140New product; unregistered source of active ingredient. (3)72,426B722141New use and/or amendment; petition to establish a tolerance or tolerance exemption.
(4)(5)72,246B730142Label amendment requiring data submission. (4)51,159 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. > > > #### “(3) > > An application for a new end-use product using a source of active ingredient that
(a)is not yet registered but
(b)has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. > > > #### “(4) > > > #####
(a)> > EPA-initiated amendments shall not be charged registration service fees.
(b)Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees.
(c)Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees.
(d)Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees.
(e)Submissions with data and requiring data review are subject to registration service fees. > > > #### “(5) > > Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling
(a)submitted subsequent to submission of the new use application and
(b)prior to conclusion of its decision review time and
(c)containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that
(a)was neither requested nor required by the Agency, and
(b)is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and
(c)is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.``TABLE 16. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ OTHER ACTEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B614New143Conditional Ruling on Preapplication Study Waivers; applicant-initiated32,294B615New144Rebuttal of agency reviewed protocol, applicant initiated32,294B682145Protocol review; applicant initiated; excludes time for HSRB review32,205 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.``TABLE 17. _ BIOPESTICIDES AND POLLUTION PREVENTION DIVISION _ PLANT INCORPORATED PROTECTANTS (PIPS)EPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)B740146Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: 1) non-food/feed use(s) for a new
(2)or registered
(3)PIP; 2) food/feed use(s) for a new or registered PIP with crop destruct; 3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4)686,823B750147Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered
(3)PIP. (4)9115,763B770148Experimental Use Permit application; new
(2)PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5)15173,644B771149Experimental Use Permit application; new
(2)PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows.10115,763B772150Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected.311,577B773151Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient.528,942B780152Registration application; new
(2)PIP; non-food/feed.12144,704B790153Registration application; new
(2)PIP; non-food/feed; SAP review. (5)18202,585B800154Registration application; new
(2)PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption.12231,585B810155Registration application; new
(2)PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5)18289,407B820156Registration application; new
(2)PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient.15289,407B840157Registration application; new
(2)PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5)21347,288B851158Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s).9115,763B870159Registration application; registered
(3)PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4)934,729B880160Registration application; registered
(3)PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s).
(6)(7)928,942B881161Registration application; registered
(3)PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review.
(6)(7)1586,823B883New162Registration application; new
(2)PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8)9115,763B884New163Registration application; new
(2)PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8)12144,704B885New164Registration application; registered
(3)PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9)986,823B890165Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s).957,882B891166Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5)15115,763B900167Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled.
(10)(11)611,577B901168Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review.
(10)(11)1269,458B902169PIP protocol review35,789B903170Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.657,882B904171Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).9115,763 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > New PIP = a PIP with an active ingredient that has not been registered. > > > #### “(3) > > Registered PIP = a PIP with an active ingredient that is currently registered. > > > #### “(4) > > Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn. > > > #### “(5) > > The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed. > > > #### “(6) > > Registered PIPs stacked through conventional breeding. > > > #### “(7) > > Deployment of a registered PIP with a different IRM plan (e.g., seed blend). > > > #### “(8) > > The negotiated acreage cap will depend upon EPA’s determination of the potential environmental exposure, risk(s) to nontarget organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category. > > > #### “(9) > > Application can be submitted prior to or concurrently with an application for commercial registration. > > > #### “(10) > > For example, IRM plan modifications that are applicant-initiated. > > > #### “(11) > > EPA-initiated amendments shall not be charged fees.``TABLE 18. _ INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONSEPANo.NewCRNo.ActionDecisionReview Time(Months) (1)RegistrationService Fee($)I001172Approval of new food use inert ingredient
(2)(3)1218,000I002New173Amend currently approved inert ingredient tolerance or exemption from tolerance; new data (2)105,000I003New174Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data (2)83,000I004New175Approval of new non-food use inert ingredient (2)810,000I005New176Amend currently approved non-food use inert ingredient with new use pattern; new data (2)85,000I006New177Amend currently approved non-food use inert ingredient with new use pattern; no new data (2)63,000I007New178Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern (2)41,500I008New179Approval of new polymer inert ingredient, food use (2)53,400I009New180Approval of new polymer inert ingredient, non food use (2)42,800I010New181Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2)61,500M001New182Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)97,200M002New183Completed study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)97,200M003New184External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)1258,000M004New185External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)1858,000M005New186New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product.
(6)(7)920,000M006New187Request for up to 5 letters of certification (Gold Seal) for one actively registered product.1250M007New188Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii)125,000M008New189Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required101,500 > > > #### “(1) > > A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. > > > #### “(2) > > If another covered application is associated with and dependent upon a pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the other associated covered application will be extended to match the PRIA due date of the pending inert ingredient action, unless the PRIA due date for the other associated covered action is further out, in which case it will be subject to its own decision review time. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients. > > > #### “(3) > > If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. > > > #### “(4) > > Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time. > > > #### “(5) > > Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review. > > > #### “(6) > > An application for a new end-use product using a source of active ingredient that
(a)is not yet registered but
(b)has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient. > > > #### “(7) > > Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either
(a)agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or
(b)does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or
(c)withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.” > ; #####
(B)in paragraph (6)— ######
(i)in subparagraph (A)— ######
(I)by striking “October 1, 2008” and inserting “October 1, 2013”; and ######
(II)by striking “September 30, 2010” and inserting “September 30, 2015”; and ######
(ii)in subparagraph (B)— ######
(I)by striking “October 1, 2010” and inserting “October 1, 2015”; and ######
(II)by striking “September 30, 2010” and inserting “September 30, 2015”; and #####
(C)in paragraph (8)(C)(ii)— ######
(i)in subclause (I), by striking “or” at the end; ######
(ii)in subclause (II), by striking the period at the end and inserting “; or”; and ######
(iii)by adding at the end the following: > > ###### “(III) > > on the basis that the Administrator rejected the application under subsection (f)(4)(B).” > . ####
(2)Pesticide registration fund Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is amended— #####
(A)in clause (i), by striking “2008 through 2012” and inserting “2013 through 2017”; #####
(B)in clause (ii), by striking “grants” and all that follows through the end of the clause and inserting “grants, for each of fiscal years 2013 through 2017, $500,000.”; and #####
(C)in clause (iii), by striking “2008 through 2012” and inserting “2013 through 2017”. ####
(3)Assessment of fees Section 33(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d)) is amended— #####
(A)in paragraph (2), by striking “2002” each place it appears and inserting “2012”; #####
(B)by striking paragraph (4); and #####
(C)by redesignating paragraph
(5)as paragraph (4). ####
(4)Reforms to reduce decision time review periods Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(e)) is amended by striking “Pesticide Registration Improvement Act of 2003” and inserting “Pesticide Registration Improvement Extension Act of 2012”. ####
(5)Decision time review periods Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is amended— #####
(A)in paragraph (1), by striking “Pesticide Registration Improvement Renewal Act, the Administrator shall publish in the Federal Register” and inserting “Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available”; #####
(B)in paragraph (2), by striking “appearing in the Congressional Record on pages S10409” and all that follows through the period and inserting “provided under subsection (b)(3).”; and #####
(C)in paragraph (4)— ######
(i)in subparagraph (A), by inserting “and fee” before the period; and ######
(ii)in subparagraph (B)— ######
(I)by striking “
(B)Completeness of application ” and all that follows through “ Not later ” in clause
(i)and inserting the following: > > ##### “(B) Initial content and preliminary technical screenings > > > ###### “(i) Screenings > > > ###### “(I) Initial content > > Not later” > ; ######
(II)in clause
(i)(as so designated) by adding at the end the following: > > ###### “(II) Preliminary technical screening > > After conducting the initial content screening described in subclause
(I)and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening— > > > ###### “(aa) > > not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and > > > ###### “(bb) > > not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).” > ; ######
(III)by striking clause
(ii)and inserting the following: > > ###### “(ii) Rejection > > > ###### “(I) In general > > If the Administrator determines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant does not correct the failure before the date that is 10 business days after the applicant receives a notification of the failure, the Administrator shall reject the application. > > > ###### “(II) Written notification > > The Administrator shall make every effort to provide a written notification of a rejection under subclause
(I)during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.” > ; ######
(IV)in clause (iii)— ######
(aa)in the heading, by inserting “initial content” before “screening” ; ######
(bb)in the matter preceding subclause (I), by inserting “content” after “initial”; and ######
(cc)in subclause (II), by striking “contains” and inserting “appears to contain”; and ######
(V)by adding at the end the following: > > ###### “(iv) Requirements of preliminary technical screening > > In conducting a preliminary technical screening of an application, the Administrator shall determine if— > > > ###### “(I) > > the application and the data and information submitted with the application are accurate and complete; and > > > ###### “(II) > > the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this Act, could result in the granting of the application.” > . ####
(6)Reports Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended— #####
(A)in paragraph (1), by striking “March 1, 2014” and inserting “March 1, 2017”; #####
(B)in paragraph (2)— ######
(i)in subparagraph (A)— ######
(I)in clause (vi)(V), by striking “and” at the end; ######
(II)in clause (vii)(II), by inserting “and” at the end; and ######
(III)by adding at the end the following: > > ###### “(viii) > > the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;” > ; ######
(ii)in subparagraph (E), by striking “and” at the end; ######
(iii)in subparagraph (F), by striking the period and inserting a semicolon; and ######
(iv)by adding at the end the following: > > ##### “(G) > > a review of the progress made toward— > > > ###### “(i) > > carrying out section 4(k)(4) and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section; > > > ###### “(ii) > > implementing systems for the electronic tracking of registration submissions by December 31, 2013; > > > ###### “(iii) > > implementing a system for tracking the status of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013; > > > ###### “(iv) > > implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available; > > > ###### “(v) > > implementing the capability to electronically submit and review labels submitted with registration actions; > > > ###### “(vi) > > acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and > > > ###### “(vii) > > facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket; > > > ##### “(H) > > the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4); > > > ##### “(I) > > a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); and > > > ##### “(J) > > an assessment of the public availability of summary pesticide usage data.” > ; and #####
(C)by adding at the end the following: > > #### “(4) Other report > > > ##### “(A) Scope > > In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have— > > > ###### “(i) > > 10 or fewer employees; and > > > ###### “(ii) > > annual global gross revenue that does not exceed $2,000,000. > > > ##### “(B) Information required > > In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on— > > > ###### “(i) > > the number of small businesses described in subparagraph
(A)that are paying maintenance fees; and > > > ###### “(ii) > > the number of registrations each company holds.” > . ####
(7)Termination of effectiveness Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is amended— #####
(A)in paragraph (1), by striking “2012” and inserting “2017”; and #####
(B)in paragraph (2)— ######
(i)in subparagraph (A)— ######
(I)in the heading, by striking “2013” and inserting “2018”; ######
(II)by striking “2013,” and inserting “2018,”; and ######
(III)by striking “September 30, 2012” and inserting “September 30, 2017”; ######
(ii)in subparagraph (B)— ######
(I)in the heading, by striking “2014” and inserting “2019”; ######
(II)by striking “2014,” and inserting “2019,”; and ######
(III)by striking “September 30, 2012” and inserting “September 30, 2017”; ######
(iii)in subparagraph (C)— ######
(I)in the heading, by striking “2014” and inserting “2019”; and ######
(II)by striking “September 30, 2014” and inserting “September 30, 2019”; and ######
(iv)in subparagraph (D), by striking “2012” each place it appears and inserting “2017”. ###
(c)Effective Date **[**[7 U.S.C. 136a-1 note](/us/usc/t7/s136a-1)**]** This section and the amendments made by this section take effect on October 1, 2012. ###
(d)Relationship to Other Law **[**[7 U.S.C. 136a-1 note](/us/usc/t7/s136a-1)**]** In the case of any conflict between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 (including any amendments made by such a joint resolution), this section and the amendments made by this section shall control.
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  • 40 CFR 26
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Sec. 2
PESTICIDE REGISTRATION IMPROVEMENT
U.S.C.§ 136a–1
U.S.C.§ 136w–8
U.S.C.§ 346a
Cite40 CFR 26
Cites 4Cited by 0 across 0 sources
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