#aafth ,,congress #ast ,session ,in the ,house of ,representatives1 ,u4 ,s41 ,february #be1 #bjai ,,amendment3 ,that the bill from the ,senate 7,s4 #dhc7 entitled ,an ,act to enact into law a bill by reference41 do pass with the following ,strike out all after the enacting clause and insert3 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,pesticide ,registration ,improvement ,extension ,act of #bjah4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,extension and modification of maintenance fee authority4 ,sec4 #c4 ,reregistration and ,expedited ,processing ,fund4 ,sec4 #d4 ,experimental use permits for pesticides4 ,sec4 #e4 ,pesticide registration service fees4 ,sec4 #f4 ,revision of tables regarding covered pesticide registration applications and other covered actions and their corresponding registration service fees4 ,sec4 #g4 ,agricultural worker protection standard2 certification of pesticide applicators4 #b4 ,extension and modification of maintenance fee authority 7a7 ,maintenance fee ,section #d7;i77#a7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7;i77#a77 is amended-- 7#a7 in subparagraph 7,c71 by striking an aggregate amount of #bg1hjj1jjj for each of fiscal years #bjac through #bjag and inserting an average amount of #ca1jjj1jjj for each of fiscal years #bjai through #bjbc2 7#b7 in subparagraph 7,d7-- 7,a7 in clause 7i71 by striking #aae1ejj for each of fiscal years #bjac through #bjag and inserting #abi1djj for each of fiscal years #bjai through #bjbc2 and 7,b7 in clause 7ii71 by striking #ahd1hjj for each of fiscal years #bjac through #bjag and inserting #bjg1jjj for each of fiscal years #bjai through #bjbc2 7#c7 in subparagraph 7,e77i7-- 7,a7 in subclause 7,i71 by striking #gj1fjj for each of fiscal years #bjac through #bjag and inserting #gi1ajj for each of fiscal years #bjai through #bjbc2 and 7,b7 in subclause 7,,ii71 by striking #abb1ajj for each of fiscal years #bjac through #bjag and inserting #acf1hjj for each of fiscal years #bjai through #bjbc2 and 7#d7 in subparagraph 7,i71 by striking #bjag44 and inserting #bjbc44 7b7 ,prohibition on other fees ,section #d7;i77#b7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7;i77#b77 is amended-- 7#a7 by striking the date of enactment of this section and ending on ,september #cj1 #bjai and inserting the effective date of the ,pesticide ,registration ,improvement ,extension ,act of #bjah and ending on ,september #cj1 #bjbe2 and 7#b7 by inserting after registration of a pesticide under this ,act the following3 or any other action covered under a table specified in section #cc7;b77#c714 7c7 ,extension of prohibition on tolerance fees ,section #djh7m77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdf;a7m77#c77 is amended by striking #bjag and inserting #bjbc4 #c4 ,reregistration and ,expedited ,processing ,fund 7a7 ,authorized use of fund ,section #d7k77#b77;,a7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7k77#b77;,a77 is amended-- 7#a7 in the first sentence1 by striking the fund and inserting the ,reregistration and ,expedited ,processing ,fund2 7#b7 by striking paragraph 7#c71 in the first sentence and all that follows through the period at the end of the second sentence and inserting the following3 paragraph 7#c71 to offset the costs of registration review under section #c7;g71 including the costs associated with any review under the ,endangered ,species ,act of #aigc 7#af ,u4,s4,c4 #aeca et seq47 required as part of the registration review1 to offset the costs associated with tracking and implementing registration review decisions1 including registration review decisions designed to reduce risk1 for the purposes specified in paragraphs 7#d7 and 7#e71 and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions42 7#c7 in clause 7i71 by striking are allocated solely and all that follows through #c7;g72 and inserting the following3 are allocated solely for the purposes specified in the first sentence of this subparagraph22 and 7#d7 in clause 7ii71 by striking necessary to achieve and all that follows through #c7;g72 and inserting the following3 necessary to achieve the purposes specified in the first sentence of this subparagraph24 7b7 ,set-,aside for review of inert ingredients and expedited processing of similar applications ,section #d7k77#c77;,a7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7k77#c77;,a77 is amended1 in the matter preceding clause 7i71 by striking ,the ,administrator shall use and all that follows through personnel and resources-- and inserting the following3 ,for each of fiscal years #bjah through #bjbc1 the ,administrator shall use between #a_/i and #a_/h of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources--4 7c7 ,set-,aside for ,expedited ,rulemaking and ,guidance ,development for certain purposes ,paragraph 7#d7 of section #d7k7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7k77 is amended to read as follows3 7#d7 ,expedited rulemaking and guidance development for certain product performance data requirements 7,a7 ,set-aside ,for each of fiscal years #bjah through #bjbc1 the ,administrator shall use not more than #ejj1jjj of the amounts made available to the ,administrator in the ,reregistration and ,expedited ,processing ,fund for the activities described in subparagraph 7,b74 7,b7 ,products claiming efficacy against invertebrate pests of significant public health or economic importance ,the ,administrator shall use amounts made available under subparagraph 7,a7 to develop1 receive comments with respect to1 finalize1 and implement the necessary rulemaking and guidance for product performance data requirements to evaluate products claiming efficacy against the following invertebrate pests of significant public health or economic importance 7in order of importance73 7i7 ,bed bugs4 7ii7 ,premise 7including crawling insects1 flying insects1 and baits74 7iii7 ,pests of pets 7including pet pests controlled by spot-ons1 collars1 shampoos1 powders1 or dips74 7iv7 ,fire ants4 7,c7 ,deadlines for guidance ,the ,administrator shall develop1 and publish guidance required by subparagraph 7,b71 with respect to claims of efficacy against pests described in such subparagraph as follows3 7i7 ,with respect to bed bugs1 issue final guidance not later than #cj days after the effective date of the ,pesticide ,registration ,improvement ,extension ,act of #bjah4 7ii7 ,with respect to pests specified in clause 7ii7 of such subparagraph-- 7,i7 submit draft guidance to the ,scientific ,advisory ,panel and for public comment not later than ,june #cj1 #bjah2 and 7,,ii7 complete any response to comments received with respect to such draft guidance and finalize the guidance not later than ,september #cj1 #bjai4 7iii7 ,with respect to pests specified in clauses 7iii7 and 7iv7 of such subparagraph-- 7,i7 submit draft guidance to the ,scientific ,advisory ,panel and for public comment not later than ,june #cj1 #bjai2 and 7,,ii7 complete any response to comments received with respect to such draft guidance and finalize the guidance not later than ,march #ca1 #bjba4 7,d7 ,revision ,the ,administrator shall revise the guidance required by subparagraph 7,b7 from time to time1 but shall permit applicants and registrants sufficient time to obtain data that meet the requirements specified in such revised guidance4 7,e7 ,deadline for product performance data requirements ,the ,administrator shall1 not later than ,september #cj1 #bjba1 issue regulations prescribing product performance data requirements for any pesticide intended for preventing1 destroying1 repelling1 or mitigating any invertebrate pest of significant public health or economic importance specified in clauses 7i7 through 7iv7 of subparagraph 7,b74 4 7d7 ,set-,aside for ,good laboratory practices inspections ,section #d7k7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a-#a7k77 is amended-- 7#a7 by redesignating paragraphs 7#e7 and 7#f7 as paragraphs 7#f7 and 7#g71 respectively2 7#b7 by inserting after paragraph 7#d7 the following new paragraph3 7#e7 ,good laboratory practices inspections 7,a7 ,set-aside ,for each of fiscal years #bjah through #bjbc1 the ,administrator shall use not more than #ejj1jjj of the amounts made available to the ,administrator in the ,reregistration and ,expedited ,processing ,fund for the activities described in subparagraph 7,b74 7,b7 ,activities ,the ,administrator shall use amounts made available under subparagraph 7,a7 for enhancements to the good laboratory practices standards compliance monitoring program established under part #afj of title #dj of the ,code of ,federal ,regulations 7or successor regulations71 with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under this ,act4 ,as part of such monitoring program1 the ,administrator shall make available to each laboratory inspected under such program in support of such registrations a preliminary summary of inspection observations not later than #fj days after the date on which such an inspection is completed4 2 and 7#c7 in paragraph 7#g71 as so redesignated1 by striking paragraphs 7#b71 7#c71 and 7#d7 and inserting paragraphs 7#b71 7#c71 7#d71 and 7#e74 #d4 ,experimental use permits for pesticides ,section #e7;a7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;c7a77 is amended-- 7#a7 by striking permit for a pesticide4 and inserting permit for a pesticide4 ,an application for an experimental use permit for a covered application under section #cc7;b7 shall conform with the requirements of that section42 and 7#b7 by inserting 7or in the case of an application for an experimental use permit for a covered application under section #cc7;b71 not later than the last day of the applicable timeframe for such application specified in such section7 after all required supporting data4 #e4 ,pesticide registration service fees 7a7 ,extension and modification of fee authority ,section #cc7;b7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in the heading1 by striking pesticide registration2 and 7,b7 in subparagraph 7,a71 by inserting or for any other action covered by a table specified in paragraph 7#c7 after covered by this ,act that is received by the ,administrator on or after the effective date of the ,pesticide ,registration ,improvement ,act of #bjjc2 7#b7 in paragraph 7#e7-- 7,a7 in the heading1 by striking pesticide registration applications and inserting covered applications2 and 7,b7 by striking pesticide registration application both places it appears and inserting covered application2 7#c7 in paragraph 7#f7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking pesticide registration2 and 7ii7 by striking ,october #a1 #bjac1 and ending on ,september #cj1 #bjae and inserting ,october #a1 #bjai1 and ending on ,september #cj1 #bjba2 7,b7 in subparagraph 7,b7-- 7i7 by striking pesticide registration2 and 7ii7 by striking #bjae each place it appears and inserting #bjba2 and 7,c7 in subparagraph 7,c71 by striking revised registration service fee schedules and inserting service fee schedules revised pursuant to this paragraph2 7#d7 in paragraph 7#g7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking covered pesticide registration and inserting covered application2 and 7ii7 by inserting before the period at the end the following3 1 except that no waiver or fee reduction shall be provided in connection with a request for a letter of certification 7commonly referred to as a ,gold ,seal letter72 and 7,b7 in subparagraph 7,f77i71 by striking pesticide registration2 and 7#e7 in paragraph 7#h7-- 7,a7 in subparagraph 7,a71 by striking pesticide registration2 7,b7 in subparagraph 7,b77i71 by striking pesticide registration2 and 7,c7 in subparagraph 7,c7-- 7i7 in clause 7i71 by striking pesticide registration and inserting covered2 and 7ii7 in clause 7ii77,i71 by striking pesticide registration and inserting covered4 7b7 ,pesticide registration fund set-,asides for worker protection1 partnership grants1 and pesticide safety education ,section #cc7;c77#c77;,b7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7;c77#c77;,b77 is amended-- 7#a7 in the heading1 by inserting 1 partnership grants1 and pesticide safety education after ,worker protection2 7#b7 in clause 7i7-- 7,a7 by striking #bjag and inserting #bjbc2 and 7,b7 by inserting before the period at the end the following31 with an emphasis on field-worker populations in the ,united ,states2 7#c7 in clause 7ii71 by striking #bjag and inserting #bjbc2 and 7#d7 in clause 7iii71 by striking #bjag and inserting #bjbc4 7c7 ,reforms ,to reduce decision time review periods ,section #cc7;e7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7;e77 is amended-- 7#a7 by striking ,pesticide ,registration ,improvement ,extension ,act of #bjab and inserting ,pesticide ,registration ,improvement ,extension ,act of #bjah2 and 7#b7 by inserting at the end the following new sentence3 ,such reforms shall include identifying opportunities for streamlining review processes for applications for a new active ingredient or a new use and providing prompt feedback to applicants during such review process44 7d7 ,decision time review periods ,section #cc7;f7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7;f77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking ,pesticide ,registration ,improvement ,extension ,act of #bjab and inserting ,pesticide ,registration ,improvement ,extension ,act of #bjah2 and 7,b7 by inserting after covered pesticide registration actions the following3 or for any other action covered by a table specified in subsection 7b77#c72 7#b7 in paragraph 7#c71 by striking subparagraph 7,c7 and inserting the following new subparagraph3 7,c7 applications for any other action covered by a table specified in subsection 7b77#c74 2 and 7#c7 in paragraph 7#d77;,a7-- 7,a7 by striking a pesticide registration application and inserting a covered application2 and 7,b7 by striking covered pesticide registration application and inserting covered application4 7e7 ,reporting requirements ,section #cc7k7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7k77 is amended-- 7#a7 in paragraph 7#a7 by striking #bjag and inserting #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,d71 by striking clause 7i7 and inserting the following new clause3 7i7 the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed1 including-- 7,i7 the number of cases cancelled2 7,,ii7 the number of cases requiring risk mitigation measures2 7,,iii7 the number of cases removing risk mitigation measures2 7,,iv7 the number of cases with no risk mitigation needed2 and 7,v7 the number of cases in which risk mitigation has been fully implemented2 2 7,b7 in subparagraph 7,g7-- 7i7 in clause 7i7-- 7,i7 by striking section #d7k77#d7 and inserting paragraphs 7#d7 and 7#e7 of section #d7k72 and 7,,ii7 by striking that section and inserting such paragraphs2 7ii7 by striking clauses 7ii71 7iii71 7iv71 7v71 and 7vi72 7iii7 by inserting after clause 7i7 the following new clause3 7ii7 implementing enhancements to-- 7,i7 the electronic tracking of covered applications2 7,,ii7 the electronic tracking of conditional registrations2 7,,iii7 the endangered species database2 7,,iv7 the electronic review of labels submitted with covered applications2 and 7,v7 the electronic review and assessment of confidential statements of formula submitted with covered applications2 and 2 and 7iv7 by redesignating clause 7vii7 as clause 7iii72 7,c7 in subparagraph 7,i71 by striking and at the end2 7,d7 in subparagraph 7,j71 by striking the period at the end and inserting a semicolon2 and 7,e7 by adding at the end the following new subparagraphs3 7,k7 a review of the progress made in developing1 updating1 and implementing product performance test guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and1 by regulation1 prescribing product performance data requirements for such pesticide products registered under section #c2 7,l7 a review of the progress made in the priority review and approval of new pesticides to control invertebrate public health pests that may transmit vector-borne disease for use in the ,united ,states1 including each territory or possession of the ,united ,states1 and ,united ,states military installations globally2 7,m7 a review of the progress made in implementing enhancements to the good laboratory practices standards compliance monitoring program established under part #afj of title #dj of the ,code of ,federal ,regulations 7or successor regulations72 7,n7 the number of approvals for active ingredients1 new uses1 and pesticide end use products granted in connection with the ,design for the ,environment program 7or any successor program7 of the ,environmental ,protection ,agency2 and 7,o7 with respect to funds in the ,pesticide ,registration ,fund reserved under subsection 7c77#c71 a review that includes-- 7i7 a description of the amount and use of such funds-- 7,i7 to carry out activities relating to worker protection under clause 7i7 of subsection 7c77#c77;,b72 7,,ii7 to award partnership grants under clause 7ii7 of such subsection2 and 7,,iii7 to carry out the pesticide safety education program under clause 7iii7 of such subsection2 7ii7 an evaluation of the appropriateness and effectiveness of the activities1 grants1 and program described in clause 7i72 7iii7 a description of how stakeholders are engaged in the decision to fund such activities1 grants1 and program2 and 7iv7 with respect to activities relating to worker protection carried out under subparagraph 7,b77i7 of such subsection1 a summary of the analyses from stakeholders1 including from worker community-based organizations1 on the appropriateness and effectiveness of such activities4 4 7f7 ,termination of effectiveness ,section #cc7m7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7m77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjag and inserting #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking ,fiscal year #bjah4--;,during fiscal year #bjah and inserting ,fiscal year #bjbd4--;,during fiscal year #bjbd2 and 7ii7 by striking #bjag and inserting #bjbc2 7,b7 in subparagraph 7,b7-- 7i7 by striking ,fiscal year #bjai4--;,during fiscal year #bjai and inserting ,fiscal year #bjbe4--;,during fiscal year #bjbe2 and 7ii7 by striking #bjag and inserting #bjbc2 7,c7 in subparagraph 7,c71 by striking ,september #cj1 #bjai4--;,effective ,september #cj1 #bjai and inserting ,september #cj1 #bjbe4--;,effective ,september #cj1 #bjbe2 and 7,d7 in subparagraph 7,d71 by striking #bjag both places it appears and inserting #bjbc4 #f4 ,revision of tables regarding covered pesticide registration applications and other covered actions and their corresponding registration service fees ,paragraph 7#c7 of section #cc7;b7 of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acfw-#h7;b77 is amended to read as follows3 7#c7 ,schedule of covered applications and other actions and their registration service fees ,subject to paragraph 7#f71 the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows3 ,,table #a4 -- ,,registration ,,division -- ,,new ,,active ,,ingredients ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,r#jaja,new ,active ,ingredient1 ,food use4 7#b77c7bd #gec1jhb ,r#jbjb,new ,active ,ingredient1 ,food use2 reduced risk4 7#b77c7ahfbg1efh ,r#jdjc,new ,active ,ingredient1 ,food use2 ,experimental ,use ,permit application2 establish temporary tolerance2 submitted before application for registration2 credit #de of fee toward new active ingredient application that follows4 7#c7ahdfb1ejb ,r#jfjd,new ,active ,ingredient1 ,non-food use2 outdoor4 7#b77c7ba #ebc1bje ,r#jgje,new ,active ,ingredient1 ,non-food use2 outdoor2 reduced risk4 7#b77c7afdcf1jjd ,r#jijf,new ,active ,ingredient1 ,non-food use2 outdoor2 ,experimental ,use ,permit application2 submitted before application for registration2 credit #de of fee toward new active ingredient application that follows4 7#c7afcbc1fij ,r#aajg,new ,active ,ingredient1 ,non-food use2 indoor4 7#b77c7bjbij1iid ,r#abjh,new ,active ,ingredient1 ,non-food use2 indoor2 reduced risk4 7#b77c7adbdb1die ,r#abai,new ,active ,ingredient1 ,non-food use2 indoor2 ,experimental ,use ,permit application2 submitted before application for registration2 credit #de of fee toward new active ingredient application that follows4 7#c7ahahb1cbg ,r#abbaj;,enriched isomer7s7 of registered mixed-isomer active ingredient4 7#b77c7ahcag1abh ,r#abcaa,new ,active ,ingredient1 ,seed treatment only2 includes agricultural and non-agricultural seeds2 residues not expected in raw agricultural commodities4 7#b77c7ahdga1hfa ,r#abeab,new ,active ,ingredient1 ,seed treatment2 ,experimental ,use ,permit application2 submitted before application for registration2 credit #de of fee toward new active ingredient application that follows4 7#c7afcbc1fij ,,table #b4 -- ,,registration ,,division -- ,,new ,,uses ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#d7 ,amendment applications to add the new use7s7 to registered product labels are covered by the base fee for the new use7s74 ,all items in the covered application must be submitted together in one package4 ,each application for an additional new product registration and new inert approval7s7 that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval4 ,however1 if a new use application only proposes to register the new use for a new product and there are no amendments in the application1 then review of one new product application is covered by the new use fee4 ,all such associated applications that are submitted together will be subject to the new use decision review time4 ,any application for a new product or an amendment to the proposed labeling 7a7 submitted subsequent to submission of the new use application and 7b7 prior to conclusion of its decision review time and 7c7 containing the same new uses1 will be deemed a separate new-use application1 subject to a separate registration service fee and new decision review time for a new use4 ,if the new-use application includes non-food 7indoor and_/or outdoor71 and food 7outdoor and_/or indoor7 uses1 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 application4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screen1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new use application4 ,r#acjac;,first food use2 indoor2 food_/food handling4 7#b7 7#c7baaia1ddd ,r#adjad;,additional food use2 ,indoor2 food_/food handling4 7#c7 7#d7aedd1fgb ,r#aejae;,first food use4 7#b77c7ba #cag1ajd ,r#aeeaf 7new7,first food use1 ,experimental ,use ,permit application2 a4i4 registered for non-food outdoor use4 7#c77d7babfd1bec ,r#afjag;,first food use2 reduced risk4 7#b77c7afbfd1bec ,r#agjah;,additional food use4 7#c7 7#d7aegi1cdi ,r#ageai;,additional food uses covered within a crop group resulting from the conversion of existing approved crop group7s7 to one or more revised crop groups4 7#c77d7ajff1abd ,r#ahjbj;,additional food use2 reduced risk4 7#c77d7ajff1abd ,r#aijba;,additional food uses2 #f or more submitted in one application4 7#c77d7aedgf1jij ,r#bjjbb;,additional ,food ,use2 #f or more submitted in one application2 ,reduced ,risk4 7#c77d7ajcif1gdb ,r#bajbc;,additional food use2 ,experimental ,use ,permit application2 establish temporary tolerance2 no credit toward new use registration4 7#c77d7abdh1ihf ,r#bbjbd;,additional food use2 ,experimental ,use ,permit application2 crop destruct basis2 no credit toward new use registration4 7#c77d7fai1hch ,r#bcjbe;,additional use2 non-food2 outdoor4 7#c7 7#d7aeca1gac ,r#bdjbf;,additional use2 non-food2 outdoor2 reduced risk4 7#c77d7ajbf1dbg ,r#bejbg;,additional use2 non-food2 outdoor2 ,experimental ,use ,permit application2 no credit toward new use registration4 7#c77d7fai1hch ,r#beabh;,experimental ,use ,permit application which requires no changes to the tolerance7s72 non-crop destruct basis4 7#c7hai1hch ,r#bfjbi,new use2 non-food2 indoor4 7#c7 7#d7abae1cag ,r#bgjcj,new use2 non-food2 indoor2 reduced risk4 7#c77d7iab1gfd ,r#bgaca,new use2 non-food2 indoor2 ,experimental ,use ,permit application2 no credit toward new use registration4 7#c77d7fi1gbe ,r#bgccb;,additional use2 seed treatment2 limited uptake into ,raw ,agricultural ,commodities2 includes crops with established tolerances 7e4g41 for soil or foliar application72 includes food and_/or non-food uses4 7#c77d7abej1dde ,r#bgdcc;,additional uses2 seed treatment only2 #f or more submitted in one application2 limited uptake into raw agricultural commodities2 includes crops with established tolerances 7e4g41 for soil or foliar application72 includes food and_/or non-food uses4 7#c77d7 #abcjb1ffc ,,table #c4 -- ,,registration ,,division -- ,,import ,,and ,,other ,,tolerances ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#d7 ,amendment applications to add the revised use pattern7s7 to registered product labels are covered by the base fee for the category4 ,all items in the covered application must be submitted together in one package4 ,each application for an additional new product registration and new inert approval7s7 that is submitted in the amendment application package is subject to the registration service fee for a new product or a new inert approval4 ,however1 if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application1 then review of one new product application is covered by the base fee4 ,all such associated applications that are submitted together will be subject to the category decision review time4 ,r#bhjcd;,establish import tolerance2 new active ingredient or first food use4 7#b7bacai1jgb ,r#bijce;,establish ,import tolerance2 ,additional new food use4#aefc1haf ,r#biacf;,establish import tolerances2 additional food uses2 #f or more crops submitted in one petition4#aechb1hhf ,r#bibcg;,amend an established tolerance 7e4g41 decrease or increase7 and_/or harmonize established tolerances with ,codex ,m,r,ls2 domestic or import2 applicant-initiated4#aade1cda ,r#bicch;,establish tolerance7s7 for inadvertent residues in one crop2 applicant-initiated4#abec1dhc ,r#bidci;,establish tolerances for inadvertent residues2 #f or more crops submitted in one application2 applicant-initiated4#abcbj1hid ,r#biedj;,establish tolerance7s7 for residues in one rotational crop in response to a specific rotational crop application2 submission of corresponding label amendments which specify the necessary plant-back restrictions2 applicant-initiated4 7#c7 7#d7aeff1abd ,r#bifda;,establish tolerances for residues in rotational crops in response to a specific rotational crop petition2 #f or more crops submitted in one application2 submission of corresponding label amendments which specify the necessary plant-back restrictions2 applicant-initiated4 7#c7 7#d7aecif1gdb ,r#bigdb;,amend #f or more established tolerances 7e4g41 decrease or increase7 in one petition2 domestic or import2 applicant-initiated4#aabgb1jcg ,r#bihdc;,amend an established tolerance 7e4g41 decrease or increase72 domestic or import2 submission of corresponding amended labels 7requiring science review74 7#c7 7#d7aceh1efe ,r#biidd;,amend #f or more established tolerances 7e4g41 decrease or increase72 domestic or import2 submission of corresponding amended labels 7requiring science review74 7#c7 7#d7acbhe1bfa ,,table #d4 -- ,,registration ,,division -- ,,new ,,products ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#d7 ,for the purposes of classifying proposed registration actions into ,,pria categories1 8pest7s7 requiring efficacy0 are3 public health pests listed in ,,pr ,notice #bjjb-a1 livestock pests 7e4g4 ,horn flies1 ,stable flies71 wood-destroying pests 7e4g4 termites1 carpenter ants1 wood-boring beetles7 and certain invasive species 7e4g4 ,asian ,longhorned beetle1 ,emerald ,ashborer74 ,this list may be updated_/refined as invasive pest needs arise4 ,to determine the number of pests for the ,,pria categories1 pests have been placed into groups 7general2 e4g41 cockroaches7 and pest specific 7specifically a test species74 ,if seeking a label claim against a pest group 7general71 use the group listing below and each group will count as #a4 ,the general pests groups are3 mites1 dust mites1 chiggers1 ticks1 hard ticks1 soft ticks1 cattle ticks1 scorpions1 spiders1 centipedes1 lice1 fleas1 cockroaches1 keds1 bot flies1 screwworms1 filth flies1 blow flies1 house flies1 flesh flies1 mosquitoes1 biting flies1 horse flies1 stable flies1 deer flies1 sand flies1 biting midges1 black flies1 true bugs1 bed bugs1 stinging bees1 wasps1 yellow jackets1 hornets1 ants 7excluding carpenter ants71 fire and harvester ants1 wood destroying beetles1 carpenter ants1 termites1 subterranean termites1 dry wood termites1 arboreal termites1 damp wood termites and invasive species4 ,if seeking a claim against a specific pest without a general claim then each specific pest will count as #a4 ,r#cjjde,new product2 or similar combination product 7already registered7 to an identical or substantially similar in composition and use to a registered product2 registered source of active ingredient2 no data review on acute toxicity1 efficacy or ,,crp - only product chemistry data2 cite-all data citation1 or selective data citation where applicant owns all required data1 or applicant submits specific authorization letter from data owner4 ,category also includes #ajj re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix4 7#b77c7da1ehb ,r#cjadf,new product2 or similar combination product 7already registered7 to an identical or substantially similar in composition and use to a registered product2 registered source of active ingredient2 selective data citation only for data on product chemistry and_/or acute toxicity and_/or public health pest efficacy 7identical data citation and claims to cited product7s771 where applicant does not own all required data and does not have a specific authorization letter from data owner4 7#b77c7da1hig ,r#cajdg,new end-use or manufacturing-use product with registered source7s7 of active ingredient7s72 includes products containing two or more registered active ingredients previously combined in other registered products2 excludes products requiring or citing an animal safety study2 requires review of data package within ,,rd only2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for up to #c target pests4 7#b77c7gg1cja ,r#caddh,new end use product containing up to three registered active ingredients never before registered as this combination in a formulated product2 new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients2 excludes products requiring or citing an animal safety study2 requires review of data package within ,,rd only2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for up to #c target pests4 7#b77c7hh1fbf ,r#caidi,new end use product containing up to three registered active ingredients never before registered as this combination in a formulated product2 new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients2 excludes products requiring or citing an animal safety study2 requires review of data package within ,,rd only2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for #d to #g target pests4 7#b77c7ajab1fbf ,r#cahej 7new7,new end use product containing four or more registered active ingredients never before registered as this combination in a formulated product2 new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients2 excludes products requiring or citing an animal safety study2 requires review of data package within ,,rd only2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for up to #c target pests4 7#b77c7iac1beb ,r#cbaea 7new7,new end use product containing four or more registered active ingredients never before registered as this combination in a formulated product2 new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients2 excludes products requiring or citing an animal safety study2 requires review of data package within ,,rd only2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for #d to #g target pests4 7#b77c7aaag1beb ,r#caeeb,new end-use1 on-animal product1 registered source of active ingredient7s71 with the submission of data and_/or waivers for only3 animal safety and pest7s7 requiring efficacy 7#d7 and_/or product chemistry and_/or acute toxicity and_/or child resistant packaging4 7#b7 7#c7ii1hbj ,r#cafec 7new7,new end-use or manufacturing product with registered source7s7 of active ingredient7s7 including products containing two or more registered active ingredients previously combined in other registered products2 excludes products requiring or citing an animal safety study2 and requires review of data and_/or waivers for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for greater than #c and up to #g target pests4 7#b77c7iaa1cja ,r#caged 7new7,new end-use or manufacturing product with registered source7s7 of active ingredient7s7 including products containing #b or more registered active ingredients previously combined in other registered products2 excludes products requiring or citing an animal safety study2 and requires review of data and_/or waivers for only3 product chemistry and_/or acute toxicity and_/or child resistant packaging and_/or pest7s7 requiring efficacy 7#d7 - for greater than #g target pests4 7#b77c7ajae1cja ,r#cbjee,new product2 new physical form2 requires data review in science divisions4 7#b77c7abac1bbf ,r#ccaef,new product2 repack of identical registered end-use product as a manufacturing-use product1 or identical registered manufacturing-use product as an end use product2 same registered uses only4 7#b77c7cb1ecj ,r#ccbeg,new manufacturing-use product2 registered active ingredient2 unregistered source of active ingredient2 submission of completely new generic data package2 registered uses only2 requires review in ,,rd and science divisions4 7#b77c7bdbhc1bae ,r#ccceh,new product2 ,,mup or ,end use product with unregistered source of active ingredient2 requires science data review2 new physical form2 etc4 ,cite-all or selective data citation where applicant owns all required data4 7#b77c7ajai1hch ,r#ccdei,new product2 ,,mup or ,end use product with unregistered source of the active ingredient2 requires science data review2 new physical form2 etc4 ,selective data citation4 7#b77c7aabc1ajj ,,table #e4 -- ,,registration ,,division -- ,,amendments ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 7a7 ,,epa-initiated amendments shall not be charged registration service fees4 7b7 ,registrant-initiated fast-track amendments are to be completed within the timelines specified in ,,fifra ,section #c7;c77#c77;,b7 and are not subject to registration service fees4 7c7 ,registrant-initiated fast-track amendments handled by the ,antimicrobials ,division are to be completed within the timelines specified in ,,fifra ,section #c7;h7 and are not subject to registration service fees4 7d7 ,registrant initiated amendments submitted by notification under ,,pr ,notices1 such as ,,pr ,notice #ih-aj1 continue under ,,pr ,notice timelines and are not subject to registration service fees4 7e7 ,submissions with data and requiring data review are subject to registration service fees4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#d7 ,for the purposes of classifying proposed registration actions into ,,pria categories1 8pest7s7 requiring efficacy0 are3 public health pests listed in ,,pr ,notice #bjjb-a1 livestock pests 7e4g4 ,horn flies1 ,stable flies71 wood-destroying pests 7e4g4 termites1 carpenter ants1 wood-boring beetles7 and certain invasive species 7e4g4 ,asian ,longhorned beetle1 ,emerald ,ashborer74 ,this list may be updated_/refined as invasive pest needs arise4 ,to determine the number of pests for the ,,pria categories1 pests have been placed into groups 7general2 e4g41 cockroaches7 and pest specific 7specifically a test species74 ,if seeking a label claim against a pest group 7general71 use the group listing below and each group will count as #a4 ,the general pests groups are3 mites1 dust mites1 chiggers1 ticks1 hard ticks1 soft ticks1 cattle ticks1 scorpions1 spiders1 centipedes1 lice1 fleas1 cockroaches1 keds1 bot flies1 screwworms1 filth flies1 blow flies1 house flies1 flesh flies1 mosquitoes1 biting flies1 horse flies1 stable flies1 deer flies1 sand flies1 biting midges1 black flies1 true bugs1 bed bugs1 stinging bees1 wasps1 yellow jackets1 hornets1 ants 7excluding carpenter ants71 fire and harvester ants1 wood destroying beetles1 carpenter ants1 termites1 subterranean termites1 dry wood termites1 arboreal termites1 damp wood termites and invasive species4 ,if seeking a claim against a specific pest without a general claim then each specific pest will count as #a4 ,r#cdjfj;,amendment requiring data review within ,,rd 7e4g41 changes to precautionary label statements72 includes adding_/modifying pest7s7 claims for up to #b target pests1 excludes products requiring or citing an animal safety study4 7#b77c77d7dd1ihh ,r#cdafa 7,new7,amendment requiring data review within ,,rd 7e4g41 changes to precautionary label statements71 includes adding_/modifying pest7s7 claims for greater than #b target pests1 excludes products requiring or citing an animal safety study4 7#b77c77d7fe1ihh ,r#cdefb;,amending on-animal products previously registered1 with the submission of data and_/or waivers for only3 animal safety and pest7s7 requiring efficacy 7#d7 and_/or product chemistry and_/or acute toxicity and_/or child resistant packaging4 7#b77c7gh1hbj ,r#cejfc;,amendment requiring data review in science divisions 7e4g41 changes to ,,rei1 or ,,ppe1 or ,,phi1 or use rate1 or number of applications2 or add aerial application2 or modify ,,gw_/,,sw advisory statement74 7#b77c7iac1bbf ,r#ceafd;,amendment adding a new unregistered source of active ingredient4 7#b77c7hac1bbf ,r#cebfe;,amendment adding already approved uses2 selective method of support2 does not apply if the applicant owns all cited data4 7#b7 7#c7hac1bbf ,r#cgaff;,amendment to ,experimental ,use ,permit2 7does not include extending a permit's time period74 7#c7faj1jij ,,table #f4 -- ,,registration ,,division -- ,,other ,,actions ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 ,r#abdfg;,conditional ,ruling on ,pre-application ,study ,waivers2 applicant-initiated4#fb1ecj ,r#bgbfh,review of ,study ,protocol applicant-initiated2 excludes ,,dart1 pre-registration conference1 ,rapid ,response review1 ,,dnt protocol review1 protocol needing ,,hsrb review4#cb1ecj ,r#bgefi,rebuttal of agency reviewed protocol1 applicant initiated4#cb1ecj ,r#cgjgj;,cancer reassessment2 applicant-initiated4#ahaih1bej ,,table #g4 -- ,,antimicrobials ,,division -- ,,new ,,active ,,ingredients ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,a#chjga,new ,active ,ingredient2 ,indirect ,food use2 establish tolerance or tolerance exemption if required4 7#b77c7bdacg1hda ,a#cijgb,new ,active ,ingredient2 ,direct ,food use2 establish tolerance or tolerance exemption if required4 7#b77c7bdbbi1gcc ,a#dajgc,new ,active ,ingredient ,non-food use47#b77c7babbi1gcc ,a#dcagd,new ,active ,ingredient1 ,non-food use2 low-risk4 7#b77c7abhj1bbe ,,table #h4 -- ,,antimicrobials ,,division -- ,,new ,,uses ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,if ,,epa data rules are amended to newly require clearance under section #djh of the ,,ffdca for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance1 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 rule4 7#d7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#e7 ,amendment applications to add the new use7s7 to registered product labels are covered by the base fee for the new use7s74 ,all items in the covered application must be submitted together in one package4 ,each application for an additional new product registration and new inert approval7s7 that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval4 ,however1 if a new use application only proposes to register the new use for a new product and there are no amendments in the application1 then review of one new product application is covered by the new use fee4 ,all such associated applications that are submitted together will be subject to the new use decision review time4 ,any application for a new product or an amendment to the proposed labeling 7a7 submitted subsequent to submission of the new use application and 7b7 prior to conclusion of its decision review time and 7c7 containing the same new uses1 will be deemed a separate new-use application1 subject to a separate registration service fee and new decision review time for a new use4 ,if the new-use application includes non-food 7indoor and_/or outdoor71 and food 7outdoor and_/or indoor7 uses1 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 application4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screen1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new use application4 ,a#ddjge,new ,use1 ,indirect ,food ,use1 establish tolerance or tolerance exemption4 7#b77c77d7baca1iaj ,a#ddagf;,additional ,indirect food uses2 establish tolerances or tolerance exemptions if required2 #f or more submitted in one application4 7#c77d77e7baaad1hgj ,a#dejgg,new use1 ,direct food use1 establish tolerance or tolerance exemption4 7#b77c77d7baie1gbd ,a#deagh;,additional ,direct food uses2 establish tolerances or tolerance exemptions if required2 #f or more submitted in one application4 7#c77d77e7baahb1cce ,a#ejjgi,new use1 non-food4 7#d77e7abca1iaj ,a#ejahj,new use1 non-food2 #f or more submitted in one application4 7#d77e7aegf1ehc ,,table #i4 -- ,,antimicrobials ,,division -- ,,new ,,products ,,and ,,amendments ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#d77;a7 ,,epa-initiated amendments shall not be charged registration service fees4 7b7 ,registrant-initiated fast-track amendments are to be completed within the timelines specified in ,,fifra ,section #c7;c77#c77;,b7 and are not subject to registration service fees4 7c7 ,registrant-initiated fast-track amendments handled by the ,antimicrobials ,division are to be completed within the timelines specified in ,,fifra ,section #c7;h7 and are not subject to registration service fees4 7d7 ,registrant initiated amendments submitted by notification under ,,pr ,notices1 such as ,,pr ,notice #ih-aj1 continue under ,,pr ,notice timelines and are not subject to registration service fees4 7e7 ,submissions with data and requiring data review are subject to registration service fees4 7#e7 ,the applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements4 7#f7 ,once a submission for a new product with public health organisms has been submitted and classified in either ,a#edj or ,a#eda1 additional organisms submitted for the same product before expiration of the first submission's original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number of organisms in both submissions4 ,a reclassification would result in a new ,,pria start date and require additional fees to meet the fee of the new category4 7#g7 ,once a submission for a label amendment with public health organisms has been submitted and classified in either ,a#egj or ,a#egc1 additional organisms submitted for the same product before expiration of the first submission's original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number of organisms in both submissions4 ,a reclassification would result in a new ,,pria start date and require additional fees to meet the fee of the new category4 ,a#ecjha ,new product1 identical or substantially similar in composition and use to a registered product2 no data review or only product chemistry data2 cite all data citation or selective data citation where applicant owns all required data2 or applicant submits specific authorization letter from data owner4 ,category also includes #ajj re-package of registered end-use or manufacturing use product that requires no data submission nor data matrix4 7#b77c7 #d #a1bgh ,a#ecahb ,new product2 identical or substantially similar in composition and use to a registered product2 registered source of active ingredient3 selective data citation only for data on product chemistry and_/or acute toxicity and_/or public health pest efficacy1 where applicant does not own all required data and does not have a specific authorization letter from data owner4 7#b77c7da1hbd ,a#ecbhc,new product2 identical or substantially similar in composition and use to a registered product2 registered active ingredient2 unregistered source of active ingredient2 cite-all data citation except for product chemistry2 product chemistry data submitted4 7#b77c7 #ee1ajg ,a#edjhd ,new end use product2 ,,fifra #b7mm7 uses only2 up to #be public health organisms4 7#b77c77e77f7e #e1ajg ,a#edahe 7new7 ,new end use product2 ,,fifra #b7mm7 uses only2 #bf-ej public health organisms4 7#b77c77e77f7gh1ejj ,a#edbhf 7new7 ,new end use product2 ,,fifra #b7mm7 uses only2 #ea public health organisms4 7#b77c77e7ajae1jjj ,a#eejhg ,new end-use product2 uses other than ,,fifra #b7mm72 non-,,fqpa product4 7#b77c77e7iac1bbf ,a#efjhh ,new manufacturing use product2 registered active ingredient2 selective data citation4 7#b77c7fab1eif ,a#efehi 7new7 ,new manufacturing-use product2 registered active ingredient2 unregistered source of active ingredient2 submission of new generic data package2 registered uses only2 requires science review4 7#b77c7 #abah1bcd ,a#egjij ,label amendment requiring data review2 up to #be public health organisms4 7#c77d77e77f7dc1hca ,a#egcia 7new7 ,label amendment requiring data review2 #bf-ej public health organisms4 7#b77c77e77g7ff1cej ,a#egdib 7new7 ,label amendment requiring data review2 #ea public health organisms4 7#b77c77e77g7iaa1jjj ,a#egbic,new ,product or amendment requiring data review for risk assessment by ,science ,branch 7e4g41 changes to ,,rei1 or ,,ppe1 or use rate74 7#b77c77d7iac1bbf ,,table #aj4 -- ,,antimicrobials ,,division -- ,,experimental ,,use ,,permits ,,and ,,other ,,actions ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,a#ebjid ,experimental ,use ,permit application1 non-food use4 7#b7 #i #f1chc ,a#ebaie,review of public health efficacy study protocol within ,,ad1 per ,,ad ,internal ,guidance for the ,efficacy ,protocol ,review ,process2 ,code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims2 applicant-initiated2 ,tier #a4dd1gbf ,a#ebbif ,review of public health efficacy study protocol outside ,,ad by members of ,,ad ,efficacy ,protocol ,review ,expert ,panel2 ,code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims2 applicant-initiated2 ,tier #b4abab1aef ,a#ecgig 7new7 ,new ,active ,ingredient_/,new ,use1 ,experimental ,use ,permit application2 ,direct food use2 ,establish tolerance or tolerance exemption if required4 ,credit #de of fee toward new active ingredient_/new use application that follows4#ah #aec1aef ,a#echih 7new7 ,new ,active ,ingredient_/,new ,use1 ,experimental ,use ,permit application2 ,indirect food use2 ,establish tolerance or tolerance exemption if required ,credit #de of fee toward new active ingredient_/new use application that follows4#ahie1gbd ,a#eciii 7new7 ,new ,active ,ingredient_/,new ,use1 ,experimental ,use ,permit application2 ,nonfood use4 ,credit #de of fee toward new active ingredient_/new use application that follows4#aeib1afc ,a#ebiajj ,amendment to ,experimental ,use ,permit2 requires data review or risk assessment4 7#b7 #iaa1dbi ,a#ebcaja ,review of protocol other than a public health efficacy study 7i4e41 ,toxicology or ,exposure ,protocols74#iab1aef ,a#egaajb ,science reassessment3 ,cancer risk1 refined ecological risk1 and_/or endangered species2 applicant-initiated4 #ahie1gbd ,a#eccajc 7new7,exemption from the requirement of an ,experimental ,use ,permit4 7#b7 #db1dhb ,a#ecdajd 7new7 ,rebuttal of agency reviewed protocol1 applicant initiated4 #dd1gbf ,a#eceaje 7new7 ,conditional ,ruling on ,pre-application ,study ,waiver or ,data ,bridging ,argument2 applicant-initiated4 #fb1dji ,a#ecfajf 7new7,conditional ,ruling on ,pre-application ,direct ,food1 ,indirect ,food1 ,nonfood use determination2 applicant-initiated4#db1dhb ,,table #aa4 -- ,,biopesticides ,,division -- ,,new ,,active ,,ingredients ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#ehjajg,new active ingredient2 food use2 petition to establish a tolerance4 7#b77c7 #bj #ea1jec ,b#eijajh ,new active ingredient2 food use2 petition to establish a tolerance exemption4 7#b77c7ahca1iaj ,b#fjjaji ,new active ingredient2 non-food use4 7#b77c7 #acai1adf ,b#fajaaj ,new active ingredient2 ,experimental ,use ,permit application2 petition to establish a temporary tolerance or temporary tolerance exemption4 7#c7 #aj #ab1gfd ,b#faaaaa ,new active ingredient2 ,experimental ,use ,permit application2 petition to establish permanent tolerance exemption4 7#c7abab1gfd ,b#fabaab ,new active ingredient2 no change to a permanent tolerance exemption4 7#b77c7ajag1eej ,b#facaac ,new active ingredient2 petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption4 7#b77c7aaag1eej ,b#fbjaad ,new active ingredient2 ,experimental ,use ,permit application2 non-food use including crop destruct4 7#c7gf1chc ,,table #ab4 -- ,,biopesticides ,,division -- ,,new ,,uses ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,amendment applications to add the new use7s7 to registered product labels are covered by the base fee for the new use7s74 ,all items in the covered application must be submitted together in one package4 ,each application for an additional new product registration and new inert approval7s7 that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval4 ,however1 if a new use application only proposes to register the new use for a new product and there are no amendments in the application1 then review of one new product application is covered by the new use fee4 ,all such associated applications that are submitted together will be subject to the new use decision review time4 ,any application for a new product or an amendment to the proposed labeling 7a7 submitted subsequent to submission of the new use application and 7b7 prior to conclusion of its decision review time and 7c7 containing the same new uses1 will be deemed a separate new-use application1 subject to a separate registration service fee and new decision review time for a new use4 ,if the new-use application includes non-food 7indoor and_/or outdoor71 and food 7outdoor and_/or indoor7 uses1 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 application4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screen1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new use application4 7#d7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#fcjaae ,first food use2 petition to establish a tolerance exemption4 7#b77d7 #ac #ab1gfd ,b#fcaaaf ,new food use2 petition to amend an established tolerance4 7#c77d7abab1gfd ,b#fdjaag;,first food use2 petition to establish a tolerance4 7#b77d7 #aiai1adf ,b#fdcaah,new ,food use2 petition to amend an established tolerance exemption4 7#c77d7 #aj #ab1gfd ,b#fdbaai;,first food use2 indoor2 food_/food handling4 7#b77d7abca1iaj ,b#fddabj,new use1 no change to an established tolerance or tolerance exemption4 7#c77d7hab1gfd ,b#fejaba,new use2 non-food4 7#c77d7gf1chc ,b#fdeabb 7new7 ,new food use2 ,experimental ,use ,permit application2 petition to amend or add a tolerance exemption4 7#d7abab1gfd ,b#fdfabc 7new7,new use2 non-food use including crop destruct2 ,experimental ,use ,permit application4 7#d7 #gf1chc ,,table #ac4 -- ,,biopesticides ,,division -- ,,new ,,products ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#febabd,new product2 registered source of active ingredient2 requires petition to amend established tolerance or tolerance exemption2 requires #a7 submission of product specific data2 or #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#b77c7 #ac #ab1gfd ,b#ffjabe ,new product2 registered source of active ingredient7s72 identical or substantially similar in composition and use to a registered product4 ,no data review1 or only product chemistry data2 cite-all data citation1 or selective data citation where applicant owns all required data or authorization from data owner is demonstrated4 ,category includes #ajj re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix4 ,for microbial pesticides1 the active ingredient7s7 must not be re-isolated4 7#b77c7da1bgh ,b#fgjabf ,new product2 registered source of active ingredient7s72 requires3 #a7 submission of product specific data2 or #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#b77c7 #ge1ajg ,b#fgaabg ,new product2 unregistered source of active ingredient7s72 requires a petition to amend an established tolerance or tolerance exemption2 requires3 #a7 submission of product specific data2 or #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#b77c7 #ag #ab1gfd ,b#fgbabh ,new product2 unregistered source of active ingredient7s72 non-food use or food use requires3 #a7 submission of product specific data2 or #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#b77c7aci1aah ,b#fgcabi ,new product ,,mup_/,,ep2 unregistered source of active ingredient7s72 citation of ,technical ,grade ,active ,ingredient 7,,tgai7 data previously reviewed and accepted by the ,agency4 ,requires an ,agency determination that the cited data supports the new product4 7#b77c7aje1ajg ,b#fgdacj ,new product ,,mup2 ,repack of identical registered end-use product as a manufacturing-use product2 same registered uses only4 7#b77c7da1bgh ,b#fgeaca ,new ,product ,,mup2 registered source of active ingredient2 submission of completely new generic data package2 registered uses only4 7#b77c7aji1aah ,b#fgfacb ,new product2 more than one active ingredient where one active ingredient is an unregistered source2 product chemistry data must be submitted2 requires3 #a7 submission of product specific data1 and #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#b77c7 #aci1aah ,b#fggacc,new end-use non-food animal product with submission of two or more target animal safety studies2 includes data and_/or waivers of data for only3 product chemistry and_/or acute toxicity and_/or public health pest efficacy and_/or animal safety studies and_/or child resistant packaging4 7#b77c7ajh1hbj ,,table #ad4 -- ,,biopesticides ,,division -- ,,amendments ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 7a7 ,,epa-initiated amendments shall not be charged registration service fees4 7b7 ,registrant-initiated fast-track amendments are to be completed within the timelines specified in ,,fifra ,section #c7;c77#c77;,b7 and are not subject to registration service fees4 7c7 ,registrant-initiated fast-track amendments handled by the ,antimicrobials ,division are to be completed within the timelines specified in ,,fifra ,section #c7;h7 and are not subject to registration service fees4 7d7 ,registrant initiated amendments submitted by notification under ,,pr ,notices1 such as ,,pr ,notice #ih-aj1 continue under ,,pr ,notice timelines and are not subject to registration service fees4 7e7 ,submissions with data and requiring data review are subject to registration service fees4 7#c7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#fbaacd;,amendment2 ,experimental ,use ,permit2 no change to an established temporary tolerance or tolerance exemption4 7#c7g #e1ajg ,b#fbbace;,amendment2 ,experimental ,use ,permit2 petition to amend an established or temporary tolerance or tolerance exemption4 7#c7aaab1gfd ,b#fdaacf;,amendment of an established tolerance or tolerance exemption4#acab1gfd ,b#fhjacg ,amendment2 registered sources of active ingredient7s72 no new use7s72 no changes to an established tolerance or tolerance exemption4 ,requires data submission4 7#b77c7 #e #e1ajg ,b#fhaach ,amendment2 unregistered source of active ingredient7s74 ,requires data submission4 7#b77c7gf1jgi ,b#fhcaci ,label amendment2 requires review_/update of previous risk assessment7s7 without data submission 7e4g41 labeling changes to ,,rei1 ,,ppe1 ,,phi74 7#b77c7fe1ajg ,b#fhdadj ,amending non-food animal product that includes submission of target animal safety data2 previously registered4 7#b77c7hh1hbj ,b#fheada 7new7 ,amendment2 add a new biochemical unregistered source of active ingredient or a new microbial production site4 ,requires submission of analysis of samples data and source_/production site-specific manufacturing process description4 7#c7ee1ajg ,,table #ae4 -- ,,biopesticides ,,division -- ,,sclp ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,all requests for new uses 7food and_/or nonfood7 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 application4 ,the application must be received by the agency in one package4 ,the base fee for the category covers a maximum of five new products4 ,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 approval4 ,all such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time4 ,in the case of a new active ingredient application1 until that new active ingredient is approved1 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 application1 subject to the registration service fee and decision review time for a new active ingredient4 ,in the case of a first food use application1 until that first food use is approved1 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 use4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new active ingredient or first food use application4 7#c7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#d7 7a7 ,,epa-initiated amendments shall not be charged registration service fees4 7b7 ,registrant-initiated fast-track amendments are to be completed within the timelines specified in ,,fifra ,section #c7;c77#c77;,b7 and are not subject to registration service fees4 7c7 ,registrant-initiated fast-track amendments handled by the ,antimicrobials ,division are to be completed within the timelines specified in ,,fifra ,section #c7;h7 and are not subject to registration service fees4 7d7 ,registrant initiated amendments submitted by notification under ,,pr ,notices1 such as ,,pr ,notice #ih-aj1 continue under ,,pr ,notice timelines and are not subject to registration service fees4 7e7 ,submissions with data and requiring data review are subject to registration service fees4 7#e7 ,amendment applications to add the new use7s7 to registered product labels are covered by the base fee for the new use7s74 ,all items in the covered application must be submitted together in one package4 ,each application for an additional new product registration and new inert approval7s7 that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval4 ,however1 if a new use application only proposes to register the new use for a new product and there are no amendments in the application1 then review of one new product application is covered by the new use fee4 ,all such associated applications that are submitted together will be subject to the new use decision review time4 ,any application for a new product or an amendment to the proposed labeling 7a7 submitted subsequent to submission of the new use application and 7b7 prior to conclusion of its decision review time and 7c7 containing the same new uses1 will be deemed a separate new-use application1 subject to a separate registration service fee and new decision review time for a new use4 ,if the new-use application includes non-food 7indoor and_/or outdoor71 and food 7outdoor and_/or indoor7 uses1 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 application4 ,any information that 7a7 was neither requested nor required by the ,agency1 and 7b7 is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screen1 and 7c7 is not itself a covered registration application1 must be assessed #be of the full registration service fee for the new use application4 7#f7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#fijadb,new active ingredient2 food or non-food use4 7#b77f7 #g #b1eed ,b#gjjadc ,experimental ,use ,permit application2 new active ingredient or new use4 7#f7 #ga1bgh ,b#gjaadd ,extend or amend ,experimental ,use ,permit4 7#f7 #da1bgh ,b#gajade ,new product2 registered source of active ingredient7s72 identical or substantially similar in composition and use to a registered product2 no change in an established tolerance or tolerance exemption4 ,no data review1 or only product chemistry data2 cite-all data citation1 or selective data citation where applicant owns all required data or authorization from data owner is demonstrated4 ,category includes #ajj re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix4 7#c77f7 #d #a1bgh ,b#gbjadf ,new product2 registered source of active ingredient7s72 requires3 #a7 submission of product specific data2 or #b7 citation of previously reviewed and accepted data2 or #c7 submission or citation of data generated at government expense2 or #d7 submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement2 or #e7 submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply4 7#c77f7ea1bgh ,b#gbaadg ,new product2 unregistered source of active ingredient4 7#c77f7gb1fgf ,b#gbbadh,new use and_/or amendment2 petition to establish a tolerance or tolerance exemption4 7#d77e77f7gb1dgg ,b#gcjadi,label amendment requiring data submission4 7#d77f7ea1bgh ,,table #af4 -- ,,biopesticides ,,division -- ,,other ,,actions ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 ,b#fadaej,pre-application2 ,conditional ,ruling on rationales for addressing a data requirement in lieu of data2 applicant-initiated2 applies to one rationale at a time4#c #b1ecj ,b#faeaea,rebuttal of agency reviewed protocol1 applicant initiated4#cb1ecj ,b#fhbaeb,protocol review2 applicant initiated2 excludes time for ,,hsrb review4 #cb1dcb ,,table #ag4 -- ,,biopesticides ,,division -- ,,pip ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,new ,,pip a ,,pip with an active ingredient that has not been registered4 7#c7 ,registered ,,pip a ,,pip with an active ingredient that is currently registered4 7#d7 ,transfer registered ,,pip through conventional breeding for new food_/feed use1 such as from field corn to sweet corn4 7#e7 ,the scientific data involved in this category are complex4 ,,epa often seeks technical advice from the ,scientific ,advisory ,panel on risks that pesticides pose to wildlife1 farm workers1 pesticide applicators1 non-target species1 as well as insect resistance1 and novel scientific issues surrounding new technologies4 ,the scientists of the ,,sap neither make nor recommend policy decisions4 ,they provide advice on the science used to make these decisions4 ,their advice is invaluable to the ,,epa as it strives to protect humans and the environment from risks posed by pesticides4 ,due to the time it takes to schedule and prepare for meetings with the ,,sap1 additional time and costs are needed4 7#f7 ,registered ,p,i,ps stacked through conventional breeding4 7#g7 ,deployment of a registered ,,pip with a different ,,irm plan 7e4g41 seed blend74 7#h7 ,the negotiated acreage cap will depend upon ,,epa's determination of the potential environmental exposure1 risk7s7 to non-target organisms1 and the risk of targeted pest developing resistance to the pesticidal substance4 ,the uncertainty of these risks may reduce the allowable acreage1 based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data1 which is usually not required for seed-increase registrations4 ,registrants are encouraged to consult with ,,epa prior to submission of a registration application in this category4 7#i7 ,application can be submitted prior to or concurrently with an application for commercial registration4 7#aj7 ,for example1 ,,irm plan modifications that are applicant-initiated4 7#aa7 ,,epa-initiated amendments shall not be charged fees4 7#ab7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 ,b#gdjaec;,experimental ,use ,permit application2 no petition for tolerance_/tolerance exemption4 ,includes3#a4 non-food_/feed use7s7 for a new 7#b7 or registered 7#c7 ,,pip 7#ab72b4 food_/feed use7s7 for a new or registered ,,pip with crop destruct 7#ab72c4 food_/feed use7s7 for a new or registered ,,pip in which an established tolerance_/tolerance exemption exists for the intended use7s74 7#d77ab7f #ie1gbd ,b#gdaaed 7new7,experimental ,use ,permit application2 no petition for tolerance_/tolerance exemption4 ,includes3#a4 non-food_/feed use7s7 for a new 7#b7 or registered 7#c7 ,,pip2#b4 food_/feed use7s7 for a new or registered ,,pip with crop destruct2#c4 food_/feed use7s7 for a new or registered ,,pip in which an established tolerance_/tolerance exemption exists for the intended use7s72,,sap ,review4 7#ab7 #abaei1ech ,b#gejaee;,experimental ,use ,permit application2 with a petition to establish a temporary or permanent tolerance_/tolerance exemption for the active ingredient4 ,includes new food_/feed use for a registered 7#c7 ,,pip4 7#d77ab7iabg1fcj ,b#ggjaef;,experimental ,use ,permit application2 new 7#b7 ,,pip2 with petition to establish a temporary tolerance_/tolerance exemption for the active ingredient2 credit #ge of ,b#gga fee toward registration application for a new active ingredient that follows2 ,,sap review4 7#e77ab7 #ae #aia1ddd ,b#ggaaeg;,experimental ,use ,permit application2 new 7#b7 ,,pip2 with petition to establish a temporary tolerance_/tolerance exemption for the active ingredient2 credit #ge of ,b#gga fee toward registration application for a new active ingredient that follows4 7#ab7ajabg1fcj ,b#ggbaeh;,application to amend or extend an ,experimental ,use ,permit2 no petition since the established tolerance_/tolerance exemption for the active ingredient is unaffected4 7#ab7cab1gfd ,b#ggcaei;,application to amend or extend an ,experimental ,use ,permit2 with petition to extend a temporary tolerance_/tolerance exemption for the active ingredient4 7#ab7eca1iaj ,b#ghjafj,registration application2 new 7#b7 ,,pip2 non-food_/feed4 7#ab7abaei1ecg ,b#gijafa,registration application2 new 7#b7 ,,pip2 non-food_/feed2 ,,sap review4 7#e77ab7 #ahbbc1cea ,b#hjjafb,registration application2 new 7#b7 ,,pip2 with petition to establish permanent tolerance_/tolerance exemption for the active ingredient based on an existing temporary tolerance_/tolerance exemption4 7#ab7acagb1cjj ,b#hajafc,registration application2 new 7#b7 ,,pip2 with petition to establish permanent tolerance_/tolerance exemption for the active ingredient based on an existing temporary tolerance_/tolerance exemption4 ,,sap review4 7#e77ab7aibcf1aad ,b#hbjafd,registration application2 new 7#b7 ,,pip2 with petition to establish or amend a permanent tolerance_/tolerance exemption of an active ingredient4 7#ab7aebjd1bjh ,b#hdjafe,registration application2 new 7#b7 ,,pip2 with petition to establish or amend a permanent tolerance_/tolerance exemption of an active ingredient4 ,,sap review4 7#e77ab7babfh1jbb ,b#heaaff,registration application2 new event of a previously registered ,,pip active ingredient7s72 no petition since permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 7#ab7iabg1fcj ,b#hgjafg,registration application2 registered 7#c7 ,,pip2 new product2 new use2 no petition since a permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 7#d7 7#ab7ich1bij ,b#hhjafh,registration application2 registered 7#c7 ,,pip2 new product or new terms of registration2 additional data submitted2 no petition since a permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 7#f7 7#g7 7#ab7ica1iaj ,b#hhaafi,registration application2 registered 7#c7 ,,pip2 new product or new terms of registration2 additional data submitted2 no petition since a permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 ,,sap review4 7#e77f77g77ab7aeie1gbd ,b#hhbagj 7new7,registration application2 new 7#b7 ,,pip1 seed increase with negotiated acreage cap and time-limited registration2 with petition to establish a permanent tolerance_/tolerance exemption for the active ingredient based on an existing temporary tolerance_/tolerance exemption2 ,,sap ,review4 7#h77ab7aeaia1ddd ,b#hhcaga,registration application2 new 7#b7 ,,pip1 seed increase with negotiated acreage cap and time-limited registration2 with petition to establish a permanent tolerance_/tolerance exemption for the active ingredient based on an existing temporary tolerance_/tolerance exemption4 7#h7 7#ab7iabg1fcj ,b#hhdagb,registration application2 new 7#b7 ,,pip1 seed increase with negotiated acreage cap and time-limited registration2 with petition to establish a permanent tolerance_/tolerance exemption for the active ingredient4 7#h77ab7abaei1ecg ,b#hheagc,registration application2 registered 7#c7 ,,pip1 seed increase2 breeding stack of previously approved ,p,i,ps1 same crop2 no petition since a permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 7#i77ab7fca1iaj ,b#hhfagd 7new7,registration application2 new 7#b7 ,,pip1 seed increase with negotiated acreage cap and time-limited registration2 with petition to establish a permanent tolerance_/tolerance exemption for the active ingredient4 ,,sap ,review4 7#h7 7#ab7ahbbc1cea ,b#hijage;,application to amend a seed increase registration2 converts registration to commercial registration2 no petition since permanent tolerance_/tolerance exemption is already established for the active ingredient7s74 7#ab7ifc1haf ,b#hiaagf;,application to amend a seed increase registration2 converts registration to a commercial registration2 no petition since a permanent tolerance_/tolerance exemption already established for the active ingredient7s72 ,,sap review4 7#e77ab7aeabg1fcj ,b#ijjagg;,application to amend a registration1 including actions such as extending an expiration date1 modifying an ,,irm plan1 or adding an insect to be controlled4 7#aj77aa77ab7fab1gfd ,b#ijaagh;,application to amend a registration1 including actions such as extending an expiration date1 modifying an ,,irm plan1 or adding an insect to be controlled4 ,,sap review4 7#aj7 7#aa7 7#ab7abgf1egh ,b#ijbagi,,pip ,protocol review4#cf1chc ,b#ijcahj;,inert ingredient tolerance exemption2 e4g41 a marker such as ,,npt ,,ii2 reviewed in ,,bppd4#ffc1haf ,b#ijdaha;,import tolerance or tolerance exemption2 processed commodities_/food only 7inert or active ingredient74#iabg1fcj ,b#ijeahb 7new7,,sap ,review4#ffc1haf ,b#ijfahc 7new7,petition to establish a temporary tolerance_/tolerance exemption for one or more active ingredients4#cca1ijg ,b#ijgahd 7new7,petition to establish a temporary tolerance_/tolerance exemption for one or more active ingredients based on an existing temporary tolerance_/tolerance exemption4#cab1gfd ,b#ijhahe 7new7,petition to establish a temporary tolerance_/tolerance exemption for one or more active ingredients or inert ingredients4#cdd1fga ,,table #ah4 -- ,,inert ,,ingredients ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,if another covered application is submitted that depends upon an application to approve an inert ingredient1 each application will be subject to its respective registration service fee4 ,the decision review time line for both submissions will be the longest of the associated applications4 ,if the application covers multiple ingredients grouped by ,,epa into one chemical class1 a single registration service fee will be assessed for approval of those ingredients4 7#c7 ,if ,,epa data rules are amended to newly require clearance under section #djh of the ,,ffdca for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance1 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 rule4 7#d7 ,any other covered application that is associated with and dependent on the ,,hsrb review will be subject to its separate registration service fee4 ,the decision review times for the associated actions run concurrently1 but will end at the date of the latest review time4 7#e7 ,any other covered application that is associated with and dependent on the ,,sap review will be subject to its separate registration service fee4 ,the decision review time for the associated action will be extended by the decision review time for the ,,sap review4 7#f7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#g7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#h7 ,if a new safener is submitted in the same package as a new active ingredient1 and that new active ingredient is determined to be reduced risk1 then the safener would get the same reduced timeframe as the new active ingredient4 ,i#jjaahf;,approval of new food use inert ingredient4 7#b77c7ac #bg1jjj ,i#jjbahg;,amend currently approved inert ingredient tolerance or exemption from tolerance2 new data4 7#b7aag1ejj ,i#jjcahh;,amend currently approved inert ingredient tolerance or exemption from tolerance2 no new data4 7#b7ic1cjh ,i#jjdahi;,approval of new non-food use inert ingredient4 7#b7 #f #aa1jbe ,i#jjeaij;,amend currently approved non-food use inert ingredient with new use pattern2 new data4 7#b7fe1eac ,i#jjfaia;,amend currently approved non-food use inert ingredient with new use pattern2 no new data4 7#b7cc1cjh ,i#jjgaib;,approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern4 7#b7da1fed ,i#jjhaic;,approval of new or amended polymer inert ingredient1 food use4 7#b7ec1gdi ,i#jjiaid;,approval of new or amended polymer inert ingredient1 non-food use4 7#b7 #dc1jhg ,i#jajaie,petition to amend a single tolerance exemption descriptor1 or single non-food use descriptor1 to add #aj ,c,a,s,r,ns2 no new data4 7#b7fa1fed ,i#jaaaif 7new7,approval of new food use safener with tolerance or exemption from tolerance4 7#b77h7bdeig1fhc ,i#jabaig 7new7,approval of new non-food use safener4 7#b77h7badae1bda ,i#jacaih 7new7,approval of additional food use for previously approved safener with tolerance or exemption from tolerance4 7#b7aefb1ige ,i#jadaii 7new7,approval of additional non-food use for previously approved safener4 7#b7aebe1afh ,i#jaebjj 7new7,approval of new generic data for previously approved food use safener4 7#b7bdbfi1gbh ,i#jafbja 7new7,approval of amendment7s7 to tolerance and label for previously approved safener4 7#b7acee1ggf ,,table #ai4 -- ,,external ,,review ,,and ,,miscellaneous ,,actions ,,epa ,no4,new ,,cr ,no4,action,decision ,review ,time 7,months77#a7 ,registration ,service ,fee 77 7#a7 ,a decision review time that would otherwise end on a ,saturday1 ,sunday1 or federal holiday1 will be extended to end on the next business day4 7#b7 ,if another covered application is submitted that depends upon an application to approve an inert ingredient1 each application will be subject to its respective registration service fee4 ,the decision review time line for both submissions will be the longest of the associated applications4 ,if the application covers multiple ingredients grouped by ,,epa into one chemical class1 a single registration service fee will be assessed for approval of those ingredients4 7#c7 ,if ,,epa data rules are amended to newly require clearance under section #djh of the ,,ffdca for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance1 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 rule4 7#d7 ,any other covered application that is associated with and dependent on the ,,hsrb review will be subject to its separate registration service fee4 ,the decision review times for the associated actions run concurrently1 but will end at the date of the latest review time4 7#e7 ,any other covered application that is associated with and dependent on the ,,sap review will be subject to its separate registration service fee4 ,the decision review time for the associated action will be extended by the decision review time for the ,,sap review4 7#f7 ,an application for a new end-use product using a source of active ingredient that 7a7 is not yet registered but 7b7 has an application pending with the ,agency for review1 will be considered an application for a new product with an unregistered source of active ingredient4 7#g7 ,where the action involves approval of a new or amended label1 on or before the end date of the decision review time1 the ,agency shall provide to the applicant a draft accepted label1 including any changes made by the ,agency that differ from the applicant-submitted label and relevant supporting data reviewed by the ,agency4 ,the applicant will notify the ,agency that the applicant either 7a7 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 label2 or 7b7 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 difference7s72 or 7c7 withdraws the application without prejudice for subsequent resubmission1 but forfeits the associated registration service fee4 ,for cases described in 7b71 the applicant shall have up to #cj calendar days to reach agreement with the ,agency on the final terms of the ,agency-accepted label4 ,if the applicant agrees to all of the terms of the accepted label as in 7a71 including upon resolution of differences in 7b71 the ,agency shall provide an accepted final ,agency-stamped label to the registrant within #b business days following the registrant's written or electronic confirmation of agreement to the ,agency4 7#h7 ,due to low fee and short time frame this category is not eligible for small business waivers4 ,gold seal applies to one registered product4 7#i7 ,this category includes amendments the sole purpose of which is to add ,df,e 7or equivalent terms that do not use 8safe0 or derivatives of 8safe07 logos to a label4 ,df,e is a voluntary program4 ,a label bearing a ,df,e logo is not considered an ,agency endorsement because the ingredients in the qualifying product must meet objective1 scientific criteria established and widely publicized by ,,epa4 ,m#jjabjb,study protocol requiring ,human ,studies ,review ,board review as defined in #dj ,,cfr ,part #bf in support of an active ingredient4 7#d7i #g1ich ,m#jjbbjc;,completed study requiring ,human ,studies ,review ,board review as defined in #dj ,,cfr ,part #bf in support of an active ingredient4 7#d7ig1ich ,m#jjcbjd;,external technical peer review of new active ingredient1 product1 or amendment 7e4g41 consultation with ,,fifra ,scientific ,advisory ,panel7 for an action with a decision timeframe of less than #ab months4 ,applicant initiated request based on a requirement of the ,administrator1 as defined by ,,fifra #be7;d71 in support of a novel active ingredient1 or unique use pattern or application technology4 ,excludes ,,pip active ingredients4 7#e7abfc1ide ,m#jjdbje;,external technical peer review of new active ingredient1 product1 or amendment 7e4g41 consultation with ,,fifra ,scientific ,advisory ,panel7 for an action with a decision timeframe of greater than #ab months4 ,applicant initiated request based on a requirement of the ,administrator1 as defined by ,,fifra #be7;d71 in support of a novel active ingredient1 or unique use pattern or application technology4 ,excludes ,,pip active ingredients4 7#e7 #ahfc1ide ,m#jjebjf,new ,product3 ,combination1 ,contains a combination of active ingredients from a registered and_/or unregistered source2 conventional1 antimicrobial and_/or biopesticide4 ,requires coordination with other regulatory divisions to conduct review of data1 label and_/or verify the validity of existing data as cited4 ,only existing uses for each active ingredient in the combination product4 7#f77g7ibb1jej ,m#jjfbjg,request for up to #e letters of certification 7,gold ,seal7 for one actively registered product 7excludes distributor products74 7#h7abgg ,m#jjgbjh,request to extend ,exclusive ,use of data as provided by ,,fifra ,section #c7;c77#a77;,f77ii74#abe1eac ,m#jjhbji,request to grant ,exclusive ,use of data as provided by ,,fifra ,section #c7;c77#a77;,f77vi7 for a minor use1 when a ,,fifra ,section #b7ll77#b7 determination is required4#aea1fed ,m#jjibaj 7new7,non-,,fifra ,regulated ,determination3 ,applicant initiated1 per product4#db1cfc ,m#jajbaa 7new7,conditional ruling on pre-application1 product substantial similarity4#db1cfc ,m#jaabab 7new7,label amendment to add the ,df,e logo2 requires data review2 no other label changes4 7#i7dc1fdh 4 #g4 ,agricultural worker protection standard2 certification of pesticide applicators 7a7 ,in general ,except as provided in subsection 7b71 during the period beginning on the date of enactment of this ,act and ending not earlier than ,october #a1 #bjba1 the ,administrator of the ,environmental ,protection ,agency 7referred to in this section as the ,administrator7-- 7#a7 shall carry out-- 7,a7 the final rule of the ,administrator entitled ,pesticides2 ,agricultural ,worker ,protection ,standard ,revisions 7#hj ,fed4 ,reg4 #fgdif 7,november #b1 #bjae772 and 7,b7 the final rule of the ,administrator entitled ,pesticides2 ,certification of ,pesticide ,applicators 7#hb ,fed4 ,reg4 #ieb 7,january #d1 #bjag772 and 7#b7 shall not revise or develop revisions to the rules described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a74 7b7 ,exceptions ,prior to ,october #a1 #bjba1 the ,administrator may propose1 and after a notice and public comment period of not less than #ij days1 promulgate revisions to the final rule described in subsection 7a77#a77;,a7 addressing application exclusion zones under part #agj of title #dj1 ,code of ,federal ,regulations1 consistent with the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf et seq474 7c7 ,,gao report ,the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct a study on the use of the designated representative1 including the effect of that use on the availability of pesticide application and hazard information and worker health and safety2 and 7#b7 not later than ,october #a1 #bjba1 make publically available a report describing the study under paragraph 7#a71 including any recommendations to prevent the misuse of pesticide application and hazard information1 if that misuse is identified4 ,clerk4