[112th Congress Public Law 177] [From the U.S. Government Printing Office] [[Page 126 STAT. 1327]] Public Law 112-177 112th Congress An Act To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act. <<NOTE: Sept. 28, 2012 - [S. 3552]>> Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, <<NOTE: Pesticide Registration Improvement Extension Act of 2012. 7 USC 136 note.>> SECTION 1. SHORT TITLE. This Act may be cited as the ``Pesticide Registration Improvement Extension Act of 2012''. SEC. 2. PESTICIDE REGISTRATION IMPROVEMENT. (a) Maintenance Fees.-- (1) Fees.--Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)) is amended-- (A) in paragraph (5)-- (i) in subparagraph (C), by striking ``aggregate amount of'' and all that follows through the end of the subparagraph and inserting ``aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017.''; (ii) in subparagraph (D)-- (I) in clause (i), by striking ``shall be'' and all that follows through the semicolon and inserting ``shall be $115,500 for each of fiscal years 2013 through 2017;''; and (II) in clause (ii), by striking ``shall be'' and all that follows through the period and inserting ``shall be $184,800 for each of fiscal years 2013 through 2017.''; (iii) in subparagraph (E)(i)-- (I) in subclause (I), by striking ``shall be'' and all that follows through the semicolon and inserting ``shall be $70,600 for each of fiscal years 2013 through 2017;''; and (II) in subclause (II), by striking ``shall be'' and all that follows through the period and inserting ``shall be $122,100 for each of fiscal years 2013 through 2017.''; (iv) in subparagraph (F)-- (I) by striking ``paragraph (3)'' and inserting ``this paragraph''; and (II) by striking ``Humans'' and inserting ``Human''; (v) by redesignating subparagraphs (F) through (H) as subparagraphs (G) through (I), respectively; [[Page 126 STAT. 1328]] (vi) by inserting after subparagraph (E) the following: ``(F) Fee reduction for certain small businesses.-- ``(i) Definition.--In this subparagraph, the term `qualified small business entity' means a corporation, partnership, or unincorporated business that-- ``(I) has 500 or fewer employees; ``(II) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and ``(III) holds not more than 5 pesticide registrations under this paragraph. ``(ii) Waiver.--Except as provided in clause (iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified small business entity under this paragraph. ``(iii) Limitation.--The Administrator shall not grant a waiver under clause (ii) to a qualified small business entity if the Administrator determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver.''; and (vii) in subparagraph (I) (as redesignated by clause (v)), by striking ``2012'' and inserting ``2017''; (B) in paragraph (6)-- (i) by striking ``2014'' and inserting ``2019''; and (ii) by striking ``paragraphs (1) through (5)'' and inserting ``paragraph (1)''; (C) by striking paragraphs (1), (2), (3), (4), and (7); and (D) by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively. (2) Conforming amendments.-- (A) Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1) is amended-- (i) in subsection (d)(5)(B)(ii)(III), by striking ``subsection (i)(1)'' and inserting ``this section''; (ii) in subsection (j), by striking ``subsection (i)(5)'' and inserting ``subsection (i)(1)''; and (iii) in subsection (k)(5)-- (I) in the first sentence, by striking ``subsection (i)(5)(C)(ii)'' and inserting ``subsection (i)(1)(C)(ii)''; and (II) in the third and sixth sentences, by striking ``subsection (i)(5)(C)'' each place it appears and inserting ``subsection (i)(1)(C)''. (B) Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w- 8(b)(7)(F)) is amended-- (i) by striking ``section 4(i)(5)(E)(ii)'' each place it appears in clauses (i), (ii)(I), and (iv)(I) and inserting ``section 4(i)(1)(E)(ii)''; (ii) by striking ``section 4(i)(5)(E)(ii)(I)(bb)'' each place it appears in clauses (ii)(II) and (iv)(II) and inserting ``section 4(i)(1)(E)(ii)(I)(bb)''; and (iii) in clause (iv)(II)-- [[Page 126 STAT. 1329]] (I) by striking ``applicable.'' and inserting ``applicable''; and (II) by striking ``revenues'' and inserting ``revenue''. (3) Extension of prohibition on tolerance fees.--Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking ``September 30, 2012'' and inserting ``September 30, 2017''. (4) Reregistration and expedited processing fund.-- (A) Source and use.--Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) is amended-- (i) by inserting ``, to enhance the information systems capabilities to improve the tracking of pesticide registration decisions,'' after ``paragraph (3)'' each place it appears; and (ii) in clause (i)-- (I) by inserting ``offset'' before ``the costs of reregistration''; and (II) by striking ``in the same portion as appropriated funds''. (B) Expedited processing of similar applications.-- Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a- 1(k)(3)(A)) is amended-- (i) in the matter preceding clause (i), by striking ``2008 through 2012, between \1/8\ and \1/7\'' and inserting ``2013 through 2017, between \1/9\ and \1/8\''; (ii) in clause (i), by striking ``new''; and (iii) in clause (ii), by striking ``any application'' and all that follows through ``that--'' and inserting ``any application that-- ''. (C) Enhancements of information technology systems for improvement in review of pesticide applications.-- Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is amended-- (i) by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively; (ii) by inserting after paragraph (3) the following: ``(4) Enhancements of information technology systems for improvement in review of pesticide applications.-- ``(A) In general.--For each of fiscal years 2013 through 2017, the Administrator shall use not more than $800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B). ``(B) Activities.--The Administrator shall use amounts made available from the Reregistration and Expedited Processing Fund to improve the information systems capabilities for the Office of Pesticide Programs to enhance tracking of pesticide registration decisions, which shall include-- ``(i) the electronic tracking of-- ``(I) registration submissions; and ``(II) the status of conditional registrations; ``(ii) enhancing the database for information regarding endangered species assessments for registration review; [[Page 126 STAT. 1330]] ``(iii) implementing the capability to electronically review labels submitted with registration actions; and ``(iv) acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions.''; and (iii) in the first sentence of paragraph (6) (as redesignated by clause (i)), by striking ``to carry out the goals established under subsection (l)'' and inserting ``for the purposes described in paragraphs (2), (3), and (4) and to carry out the goals established under subsection (l)''. (b) Pesticide Registration Service Fees.-- (1) Amount of fees.--Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended-- (A) by striking paragraph (3) and inserting the following: ``(3) Schedule of covered applications and registration service fees.--Subject to paragraph (6), the schedule of covered pesticide registration applications and corresponding registration service fees shall be as follows: ``TABLE 1. -- REGISTRATION DIVISION -- NEW ACTIVE INGREDIENTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R010 1 New Active Ingredient, Food use (2) (3) 24 569,221 ---------------------------------------------------------------------------------------------------------------- R020 2 New Active Ingredient, Food use; reduced 18 569,221 risk (2) (3) ---------------------------------------------------------------------------------------------------------------- R040 3 New Active Ingredient, Food use; 18 419,502 Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1331]] R060 4 New Active Ingredient, Non-food use; 21 395,467 outdoor (2) (3) ---------------------------------------------------------------------------------------------------------------- R070 5 New Active Ingredient, Non-food use; 16 395,467 outdoor; reduced risk (2) (3) ---------------------------------------------------------------------------------------------------------------- R090 6 New Active Ingredient, Non-food use; 16 293,596 outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) ---------------------------------------------------------------------------------------------------------------- R110 7 New Active Ingredient, Non-food use; 20 219,949 indoor (2) (3) ---------------------------------------------------------------------------------------------------------------- R120 8 New Active Ingredient, Non-food use; 14 219,949 indoor; reduced risk (2) (3) ---------------------------------------------------------------------------------------------------------------- R121 9 New Active Ingredient, Non-food use; 18 165,375 indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1332]] R122 10 Enriched isomer(s) of registered mixed- 18 287,643 isomer active ingredient (2) (3) ---------------------------------------------------------------------------------------------------------------- R123 11 New Active Ingredient, Seed treatment 18 427,991 only; includes agricultural and non- agricultural seeds; residues not expected in raw agricultural commodities (2) (3) ---------------------------------------------------------------------------------------------------------------- R125 12 New Active Ingredient, Seed treatment; 16 293,596 New Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1333]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1334]] ``TABLE 2. -- REGISTRATION DIVISION -- NEW USES ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R130 13 First food use; indoor; food/food handling 21 173,644 (2) (3) ---------------------------------------------------------------------------------------------------------------- R140 14 Additional food use; Indoor; food/food 15 40,518 handling (3) (4) ---------------------------------------------------------------------------------------------------------------- R150 15 First food use (2) (3) 21 239,684 ---------------------------------------------------------------------------------------------------------------- R160 16 First food use; reduced risk (2) (3) 16 239,684 ---------------------------------------------------------------------------------------------------------------- R170 17 Additional food use (3) (4) 15 59,976 ---------------------------------------------------------------------------------------------------------------- R175 18 Additional food uses covered within a crop 10 59,976 New group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4) ---------------------------------------------------------------------------------------------------------------- R180 19 Additional food use; reduced risk (3) (4) 10 59,976 ---------------------------------------------------------------------------------------------------------------- R190 20 Additional food uses; 6 or more submitted 15 359,856 in one application (3) (4) ---------------------------------------------------------------------------------------------------------------- R200 21 Additional food uses; 6 or more submitted 10 359,856 in one application; reduced risk (3) (4) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1335]] R210 22 Additional food use; Experimental Use 12 44,431 Permit application; establish temporary tolerance; no credit toward new use registration (3) (4) ---------------------------------------------------------------------------------------------------------------- R220 23 Additional food use; Experimental Use 6 17,993 Permit application; crop destruct basis; no credit toward new use registration (3) (4) ---------------------------------------------------------------------------------------------------------------- R230 24 Additional use; non-food; outdoor (3) (4) 15 23,969 ---------------------------------------------------------------------------------------------------------------- R240 25 Additional use; non-food; outdoor; reduced 10 23,969 risk (3) (4) ---------------------------------------------------------------------------------------------------------------- R250 26 Additional use; non-food; outdoor; 6 17,993 Experimental Use Permit application; no credit toward new use registration (3) (4) ---------------------------------------------------------------------------------------------------------------- R251 27 Experimental Use Permit application which 8 17,993 New requires no changes to the tolerance(s); non-crop destruct basis (3) ---------------------------------------------------------------------------------------------------------------- R260 28 New use; non-food; indoor (3) (4) 12 11,577 ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1336]] R270 29 New use; non-food; indoor; reduced risk 9 11,577 (3) (4) ---------------------------------------------------------------------------------------------------------------- R271 30 New use; non-food; indoor; Experimental 6 8,820 Use Permit application; no credit toward new use registration (3) (4) ---------------------------------------------------------------------------------------------------------------- R273 31 Additional use; seed treatment; limited 12 45,754 uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses (3) (4) ---------------------------------------------------------------------------------------------------------------- R274 32 Additional uses; seed treatment only; 6 or 12 274,523 more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses (3) (4) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1337]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1338]] (4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registra- tion and new inert approval(s) that is submitted in the new use ap- plication package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associ- ated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a sepa- rate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's ini- tiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use application. ``TABLE 3. -- REGISTRATION DIVISION -- IMPORT AND OTHER TOLERANCES ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R280 33 Establish import tolerance; new active 21 289,407 ingredient or first food use (2) ---------------------------------------------------------------------------------------------------------------- R290 34 Establish import tolerance; additional 15 57,882 food use ---------------------------------------------------------------------------------------------------------------- R291 35 Establish import tolerances; additional 15 347,288 food uses; 6 or more crops submitted in one petition ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1339]] R292 36 Amend an established tolerance (e.g., 11 41,124 decrease or increase); domestic or import; applicant-initiated ---------------------------------------------------------------------------------------------------------------- R293 37 Establish tolerance(s) for inadvertent 12 48,510 residues in one crop; applicant-initiated ---------------------------------------------------------------------------------------------------------------- R294 38 Establish tolerances for inadvertent 12 291,060 residues; 6 or more crops submitted in one application; applicant-initiated ---------------------------------------------------------------------------------------------------------------- R295 39 Establish tolerance(s) for residues in one 15 59,976 rotational crop in response to a specific rotational crop application; applicant- initiated ---------------------------------------------------------------------------------------------------------------- R296 40 Establish tolerances for residues in 15 359,856 rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1340]] R297 41 Amend 6 or more established tolerances 11 246,744 New (e.g., decrease or increase) in one petition; domestic or import; applicant- initiated ---------------------------------------------------------------------------------------------------------------- R298 42 Amend an established tolerance (e.g., 13 53,120 New decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) ---------------------------------------------------------------------------------------------------------------- R299 43 Amend 6 or more established tolerances 13 258,740 New (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1341]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency- accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1342]] ``TABLE 4. -- REGISTRATION DIVISION -- NEW PRODUCTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R300 44 New product; or similar combination 4 1,434 product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP - only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1343]] R301 45 New product; or similar combination 4 1,720 product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1344]] R310 46 New end-use or manufacturing-use product 7 4,807 with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: <bullet> product chemistry and/or <bullet> acute toxicity and/or <bullet> public health pest efficacy and/ or <bullet> child resistant packaging. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1345]] R314 47 New end use product containing two or more 8 6,009 New registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: <bullet> product chemistry and/or <bullet> acute toxicity and/or <bullet> public health pest efficacy and/ or <bullet> child resistant packaging. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1346]] R315 48 New end-use non-food animal product with 9 8,000 New submission of two or more target animal safety studies; includes data and/or waivers of data for only: <bullet> product chemistry and/or <bullet> acute toxicity and/or <bullet> public health pest efficacy and/ or <bullet> animal safety studies and/or <bullet> child resistant packaging (2) (3) ---------------------------------------------------------------------------------------------------------------- R320 49 New product; new physical form; requires 12 11,996 data review in science divisions (2) (3) ---------------------------------------------------------------------------------------------------------------- R331 50 New product; repack of identical 3 2,294 registered end-use product as a manufacturing-use product; same registered uses only (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1347]] R332 51 New manufacturing-use product; registered 24 256,883 active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions (2) (3) ---------------------------------------------------------------------------------------------------------------- R333 52 New product; MUP or End use product with 10 17,993 New unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1348]] R334 53 New product; MUP or End use product with 11 17,993 New unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) An application for a new end-use product using a source of ac- tive ingredient that (a) is not yet registered but (b) has an applica- tion pending with the Agency for review, will be considered an ap- plication for a new product with an unregistered source of active ingredient. (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1349]] ``TABLE 5. -- REGISTRATION DIVISION -- AMENDMENTS TO REGISTRATION ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R340 54 Amendment requiring data review within RD 4 3,617 (e.g., changes to precautionary label statements) (2) (3) ---------------------------------------------------------------------------------------------------------------- R345 55 Amending non-food animal product that 7 8,000 New includes submission of target animal safety data; previously registered (2) (3) ---------------------------------------------------------------------------------------------------------------- R350 56 Amendment requiring data review in science 9 11,996 divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3) ---------------------------------------------------------------------------------------------------------------- R351 57 Amendment adding a new unregistered source 8 11,996 New of active ingredient. (2) (3) ---------------------------------------------------------------------------------------------------------------- R352 58 Amendment adding already approved uses; 8 11,996 New selective method of support; does not apply if the applicant owns all cited data (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1350]] R371 59 Amendment to Experimental Use Permit; 6 9,151 (does not include extending a permit's time period) (3) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) (a) EPA-initiated amendments shall not be charged registra- tion service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by no- tification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration serv- ice fees. (e) Submissions with data and requiring data review are subject to registration service fees. (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1351]] ``TABLE 6. -- REGISTRATION DIVISION -- OTHER ACTIONS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- R124 60 Conditional Ruling on Preapplication Study 6 2,294 Waivers; applicant-initiated ---------------------------------------------------------------------------------------------------------------- R272 61 Review of Study Protocol applicant- 3 2,294 initiated; excludes DART, pre- registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review ---------------------------------------------------------------------------------------------------------------- R275 62 Rebuttal of agency reviewed protocol, 3 2,294 New applicant initiated ---------------------------------------------------------------------------------------------------------------- R370 63 Cancer reassessment; applicant-initiated 18 179,818 ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. ``TABLE 7. -- ANTIMICROBIALS DIVISION -- NEW ACTIVE INGREDIENTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- A380 64 Food use; establish tolerance exemption 24 104,187 (2) (3) ---------------------------------------------------------------------------------------------------------------- A390 65 Food use; establish tolerance (2) (3) 24 173,644 ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1352]] A400 66 Non-food use; outdoor; FIFRA Sec. 2(mm) 18 86,823 uses (2) (3) ---------------------------------------------------------------------------------------------------------------- A410 67 Non-food use; outdoor; uses other than 21 173,644 FIFRA Sec. 2(mm) (2) (3) ---------------------------------------------------------------------------------------------------------------- A420 68 Non-food use; indoor; FIFRA Sec. 2(mm) 18 57,882 uses (2) (3) ---------------------------------------------------------------------------------------------------------------- A430 69 Non-food use; indoor; uses other than 20 86,823 FIFRA Sec. 2(mm) (2) (3) ---------------------------------------------------------------------------------------------------------------- A431 70 Non-food use; indoor; low-risk, low- 12 60,638 toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1353]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) <<NOTE: Labeling. Deadline.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency- accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1354]] ``TABLE 8. -- ANTIMICROBIALS DIVISION -- NEW USES ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- A440 71 First food use; establish tolerance 21 28,942 exemption (2) (3) (4) ---------------------------------------------------------------------------------------------------------------- A450 72 First food use; establish tolerance (2) 21 86,823 (3) (4) ---------------------------------------------------------------------------------------------------------------- A460 73 Additional food use; establish tolerance 15 11,577 exemption (3) (4) (5) ---------------------------------------------------------------------------------------------------------------- A470 74 Additional food use; establish tolerance 15 28,942 (3) (4) (5) ---------------------------------------------------------------------------------------------------------------- A471 75 Additional food uses; establish 15 173,652 New tolerances; 6 or more submitted in one application (3) (4) (5) ---------------------------------------------------------------------------------------------------------------- A480 76 Additional use; non-food; outdoor; FIFRA 9 17,365 Sec. 2(mm) uses (4) (5) ---------------------------------------------------------------------------------------------------------------- A481 77 Additional non-food outdoor uses; FIFRA 9 104,190 New Sec. 2(mm) uses; 6 or more submitted in one application (4) (5) ---------------------------------------------------------------------------------------------------------------- A490 78 Additional use; non-food; outdoor; uses 15 28,942 other than FIFRA Sec. 2(mm) (4) (5) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1355]] A491 79 Additional non-food; outdoor; uses other 15 173,652 New than FIFRA Sec. 2(mm); 6 or more submitted in one application (4) (5) ---------------------------------------------------------------------------------------------------------------- A500 80 Additional use; non-food, indoor, FIFRA 9 11,577 Sec. 2(mm) uses (4) (5) ---------------------------------------------------------------------------------------------------------------- A501 81 Additional non-food; indoor; FIFRA Sec. 9 69,462 New 2(mm) uses; 6 or more submitted in one application (4) (5) ---------------------------------------------------------------------------------------------------------------- A510 82 Additional use; non-food; indoor; uses 12 11,577 other than FIFRA Sec. 2(mm) (4) (5) ---------------------------------------------------------------------------------------------------------------- A511 83 Additional non-food; indoor; uses other 12 69,462 New than FIFRA Sec. 2(mm); 6 or more submitted in one application (4) (5) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1356]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) <<NOTE: Time period.>> If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an anti- microbial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule. (4) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1357]] (5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registra- tion and new inert approval(s) that is submitted in the new use ap- plication package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associ- ated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a sepa- rate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's ini- tiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use application. [[Page 126 STAT. 1358]] ``TABLE 9. -- ANTIMICROBIALS DIVISION -- NEW PRODUCTS AND AMENDMENTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- A530 84 New product; identical or substantially 4 1,159 similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1359]] A531 85 New product; identical or substantially 4 1,654 similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) ---------------------------------------------------------------------------------------------------------------- A532 86 New product; identical or substantially 5 4,631 similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted (2) (3) ---------------------------------------------------------------------------------------------------------------- A540 87 New end use product; FIFRA Sec. 2(mm) uses 5 4,631 only (2) (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1360]] A550 88 New end-use product; uses other than FIFRA 7 4,631 Sec. 2(mm); non-FQPA product (2) (3) ---------------------------------------------------------------------------------------------------------------- A560 89 New manufacturing-use product; registered 12 17,365 active ingredient; selective data citation (2) (3) ---------------------------------------------------------------------------------------------------------------- A570 90 Label amendment requiring data review (3) 4 3,474 (4) ---------------------------------------------------------------------------------------------------------------- A572 91 New Product or amendment requiring data 9 11,996 New review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) An application for a new end-use product using a source of ac- tive ingredient that (a) is not yet registered but (b) has an applica- tion pending with the Agency for review, will be considered an ap- plication for a new product with an unregistered source of active ingredient. [[Page 126 STAT. 1361]] (3) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. (4) (a) EPA-initiated amendments shall not be charged registra- tion service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by no- tification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration serv- ice fees. (e) Submissions with data and requiring data review are subject to registration service fees. ``TABLE 10. -- ANTIMICROBIALS DIVISION -- EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- A520 92 Experimental Use Permit application, Non- 9 5,789 Food Use (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1362]] A521 93 Review of public health efficacy study 3 2,250 protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1 ---------------------------------------------------------------------------------------------------------------- A522 94 Review of public health efficacy study 12 11,025 protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2 ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1363]] A524 95 New Active Ingredient, Experimental Use 18 138,916 New Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) ---------------------------------------------------------------------------------------------------------------- A525 96 New Active Ingredient, Experimental Use 18 83,594 New Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2) ---------------------------------------------------------------------------------------------------------------- A526 97 New Active Ingredient, Experimental Use 15 86,823 New Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) ---------------------------------------------------------------------------------------------------------------- A527 98 New Active Ingredient, Experimental Use 15 58,000 New Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1364]] A528 99 Experimental Use Permit application, Food 15 20,260 New Use; Requires Tolerance or Tolerance Exemption (2) ---------------------------------------------------------------------------------------------------------------- A529 100 Amendment to Experimental Use Permit; 9 10,365 New requires data review or risk assessment (2) ---------------------------------------------------------------------------------------------------------------- A523 101 Review of protocol other than a public 9 11,025 New health efficacy study (i.e., Toxicology or Exposure Protocols) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1365]] A571 102 Science reassessment: Cancer risk, refined 18 86,823 New ecological risk, and/or endangered species; applicant-initiated ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency. [[Page 126 STAT. 1366]] ``TABLE 11. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B580 103 New active ingredient; food use; petition 19 46,305 to establish a tolerance (2) ---------------------------------------------------------------------------------------------------------------- B590 104 New active ingredient; food use; petition 17 28,942 to establish a tolerance exemption (2) ---------------------------------------------------------------------------------------------------------------- B600 105 New active ingredient; non-food use (2) 13 17,365 ---------------------------------------------------------------------------------------------------------------- B610 106 New active ingredient; Experimental Use 10 11,577 Permit application; petition to establish a temporary tolerance or temporary tolerance exemption ---------------------------------------------------------------------------------------------------------------- B611 107 New active ingredient; Experimental Use 12 11,577 New Permit application; petition to establish permanent tolerance exemption ---------------------------------------------------------------------------------------------------------------- B612 108 New active ingredient; no change to a 10 15,918 New permanent tolerance exemption (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1367]] B613 109 New active ingredient; petition to convert 11 15,918 New a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1368]] B620 110 New active ingredient; Experimental Use 7 5,789 Permit application; non-food use including crop destruct ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active in- gredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an addi- tional new food use or uses will be subject to the registration serv- ice fee and decision review time for a first food use. Any informa- tion that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. [[Page 126 STAT. 1369]] ``TABLE 12. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B630 111 First food use; petition to establish a 13 11,577 tolerance exemption (2) ---------------------------------------------------------------------------------------------------------------- B631 112 New food use; petition to amend an 12 11,577 established tolerance (3) ---------------------------------------------------------------------------------------------------------------- B640 113 First food use; petition to establish a 19 17,365 tolerance (2) ---------------------------------------------------------------------------------------------------------------- B643 114 New Food use; petition to amend tolerance 10 11,577 New exemption (3) ---------------------------------------------------------------------------------------------------------------- B642 115 First food use; indoor; food/food handling 12 28,942 New (2) ---------------------------------------------------------------------------------------------------------------- B644 116 New use, no change to an established 8 11,577 New tolerance or tolerance exemption (3) ---------------------------------------------------------------------------------------------------------------- B650 117 New use; non-food (3) 7 5,789 ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1370]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new ac- tive ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither re- quested nor required by the Agency, and (b) is submitted by the ap- plicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registra- tion and new inert approval(s) that is submitted in the new use ap- plication package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associ- ated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a sepa- rate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's ini- tiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use application. [[Page 126 STAT. 1371]] ``TABLE 13. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B652 118 New product; registered source of active 13 11,577 New ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically- sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1372]] B660 119 New product; registered source of active 4 1,159 ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re- package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1373]] B670 120 New product; registered source of active 7 4,631 ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1374]] B671 121 New product; unregistered source of active 17 11,577 ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1375]] B672 122 New product; unregistered source of active 13 8,269 ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1376]] B673 123 New product MUP/EP; unregistered source of 10 4,631 New active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2) ---------------------------------------------------------------------------------------------------------------- B674 124 New product MUP; Repack of identical 4 1,159 New registered end-use product as a manufacturing-use product; same registered uses only (2) ---------------------------------------------------------------------------------------------------------------- B675 125 New Product MUP; registered source of 10 8,269 New active ingredient; submission of completely new generic data package; registered uses only. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1377]] B676 126 New product; more than one active 13 8,269 New ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1378]] B677 127 New end-use non-food animal product with 10 8,000 New submission of two or more target animal safety studies; includes data and/or waivers of data for only: <bullet> product chemistry and/or <bullet> acute toxicity and/or <bullet> public health pest efficacy and/ or <bullet> animal safety studies and/or <bullet> child resistant packaging (2) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) An application for a new end-use product using a source of ac- tive ingredient that (a) is not yet registered but (b) has an applica- tion pending with the Agency for review, will be considered an ap- plication for a new product with an unregistered source of active ingredient. [[Page 126 STAT. 1379]] ``TABLE 14. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B621 128 Amendment; Experimental Use Permit; no 7 4,631 change to an established temporary tolerance or tolerance exemption. ---------------------------------------------------------------------------------------------------------------- B622 129 Amendment; Experimental Use Permit; 11 11,577 New petition to amend an established or temporary tolerance or tolerance exemption. ---------------------------------------------------------------------------------------------------------------- B641 130 Amendment of an established tolerance or 13 11,577 tolerance exemption. ---------------------------------------------------------------------------------------------------------------- B680 131 Amendment; registered source of active 5 4,631 ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2) ---------------------------------------------------------------------------------------------------------------- B681 132 Amendment; unregistered source of active 7 5,513 ingredient(s). Requires data submission. (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1380]] B683 133 Label amendment; requires review/update of 6 4,631 New previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) ---------------------------------------------------------------------------------------------------------------- B684 134 Amending non-food animal product that 8 8,000 New includes submission of target animal safety data; previously registered (2) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) (a) EPA-initiated amendments shall not be charged registra- tion service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by no- tification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration serv- ice fees. (e) Submissions with data and requiring data review are subject to registration service fees. [[Page 126 STAT. 1381]] ``TABLE 15. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS) ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B690 135 New active ingredient; food or non-food 7 2,316 use. (2) ---------------------------------------------------------------------------------------------------------------- B700 136 Experimental Use Permit application; new 7 1,159 active ingredient or new use. ---------------------------------------------------------------------------------------------------------------- B701 137 Extend or amend Experimental Use Permit. 4 1,159 ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1382]] B710 138 New product; registered source of active 4 1,159 ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re- package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1383]] B720 139 New product; registered source of active 5 1,159 ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically- sound rationale explaining why the data requirement does not apply. (3) ---------------------------------------------------------------------------------------------------------------- B721 140 New product; unregistered source of active 7 2,426 ingredient. (3) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1384]] B722 141 New use and/or amendment; petition to 7 2,246 establish a tolerance or tolerance exemption. (4) (5) ---------------------------------------------------------------------------------------------------------------- B730 142 Label amendment requiring data submission. 5 1,159 (4) ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. [[Page 126 STAT. 1385]] (2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The applica- tion must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each ap- plication 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 reg- istration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision re- view time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active in- gredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an addi- tional new food use or uses will be subject to the registration serv- ice fee and decision review time for a first food use. Any informa- tion that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application. (3) An application for a new end-use product using a source of ac- tive ingredient that (a) is not yet registered but (b) has an applica- tion pending with the Agency for review, will be considered an ap- plication for a new product with an unregistered source of active ingredient. (4) (a) EPA-initiated amendments shall not be charged registra- tion service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by no- tification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration serv- ice fees. (e) Submissions with data and requiring data review are subject to registration service fees. [[Page 126 STAT. 1386]] (5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registra- tion and new inert approval(s) that is submitted in the new use ap- plication package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associ- ated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a sepa- rate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's ini- tiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration applica- tion, must be assessed 25% of the full registration service fee for the new use application. ``TABLE 16. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- OTHER ACT ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B614 143 Conditional Ruling on Preapplication Study 3 2,294 New Waivers; applicant-initiated ---------------------------------------------------------------------------------------------------------------- B615 144 Rebuttal of agency reviewed protocol, 3 2,294 New applicant initiated ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1387]] B682 145 Protocol review; applicant initiated; 3 2,205 excludes time for HSRB review ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. ``TABLE 17. -- BIOPESTICIDES AND POLLUTION PREVENTION DIVISION -- PLANT INCORPORATED PROTECTANTS (PIPS) ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- B740 146 Experimental Use Permit application; no 6 86,823 petition for tolerance/tolerance exemption. Includes: 1) non-food/feed use(s) for a new (2) or registered (3) PIP; 2) food/feed use(s) for a new or registered PIP with crop destruct; 3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1388]] B750 147 Experimental Use Permit application; with 9 115,763 a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4) ---------------------------------------------------------------------------------------------------------------- B770 148 Experimental Use Permit application; new 15 173,644 (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5) ---------------------------------------------------------------------------------------------------------------- B771 149 Experimental Use Permit application; new 10 115,763 (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1389]] B772 150 Application to amend or extend an 3 11,577 Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. ---------------------------------------------------------------------------------------------------------------- B773 151 Application to amend or extend an 5 28,942 Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. ---------------------------------------------------------------------------------------------------------------- B780 152 Registration application; new (2) PIP; non- 12 144,704 food/feed. ---------------------------------------------------------------------------------------------------------------- B790 153 Registration application; new (2) PIP; non- 18 202,585 food/feed; SAP review. (5) ---------------------------------------------------------------------------------------------------------------- B800 154 Registration application; new (2) PIP; 12 231,585 with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1390]] B810 155 Registration application; new (2) PIP; 18 289,407 with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5) ---------------------------------------------------------------------------------------------------------------- B820 156 Registration application; new (2) PIP; 15 289,407 with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. ---------------------------------------------------------------------------------------------------------------- B840 157 Registration application; new (2) PIP; 21 347,288 with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1391]] B851 158 Registration application; new event of a 9 115,763 previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). ---------------------------------------------------------------------------------------------------------------- B870 159 Registration application; registered (3) 9 34,729 PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) ---------------------------------------------------------------------------------------------------------------- B880 160 Registration application; registered (3) 9 28,942 PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/ tolerance exemption is already established for the active ingredient(s). (6) (7) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1392]] B881 161 Registration application; registered (3) 15 86,823 PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/ tolerance exemption is already established for the active ingredient(s). SAP review. (5) (6) (7) ---------------------------------------------------------------------------------------------------------------- B883 162 Registration application; new (2) PIP, 9 115,763 New seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1393]] B884 163 Registration application; new (2) PIP, 12 144,704 New seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8) ---------------------------------------------------------------------------------------------------------------- B885 164 Registration application; registered (3) 9 86,823 New PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/ tolerance exemption is already established for the active ingredient(s). (9) ---------------------------------------------------------------------------------------------------------------- B890 165 Application to amend a seed increase 9 57,882 registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1394]] B891 166 Application to amend a seed increase 15 115,763 registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5) ---------------------------------------------------------------------------------------------------------------- B900 167 Application to amend a registration, 6 11,577 including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10) (11) ---------------------------------------------------------------------------------------------------------------- B901 168 Application to amend a registration, 12 69,458 including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) ---------------------------------------------------------------------------------------------------------------- B902 169 PIP protocol review 3 5,789 ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1395]] B903 170 Inert ingredient tolerance exemption; 6 57,882 e.g., a marker such as NPT II; reviewed in BPPD. ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1396]] B904 171 Import tolerance or tolerance exemption; 9 115,763 processed commodities/food only (inert or active ingredient). ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) New PIP = a PIP with an active ingredient that has not been registered. (3) Registered PIP = a PIP with an active ingredient that is cur- rently registered. (4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn. (5) The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide appli- cators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the envi- ronment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed. (6) Registered PIPs stacked through conventional breeding. (7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend). (8) The negotiated acreage cap will depend upon EPA's deter- mination of the potential environmental exposure, risk(s) to non- target organisms, and the risk of targeted pest developing resist- ance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category. (9) Application can be submitted prior to or concurrently with an application for commercial registration. (10) For example, IRM plan modifications that are applicant-ini- tiated. (11) EPA-initiated amendments shall not be charged fees. [[Page 126 STAT. 1397]] ``TABLE 18. -- INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS ---------------------------------------------------------------------------------------------------------------- Registration EPA No. New CR No. Action Decision Review Service Fee Time (Months) (1) ($) ---------------------------------------------------------------------------------------------------------------- I001 172 Approval of new food use inert ingredient 12 18,000 (2) (3) ---------------------------------------------------------------------------------------------------------------- I002 173 Amend currently approved inert ingredient 10 5,000 New tolerance or exemption from tolerance; new data (2) ---------------------------------------------------------------------------------------------------------------- I003 174 Amend currently approved inert ingredient 8 3,000 New tolerance or exemption from tolerance; no new data (2) ---------------------------------------------------------------------------------------------------------------- I004 175 Approval of new non-food use inert 8 10,000 New ingredient (2) ---------------------------------------------------------------------------------------------------------------- I005 176 Amend currently approved non-food use 8 5,000 New inert ingredient with new use pattern; new data (2) ---------------------------------------------------------------------------------------------------------------- I006 177 Amend currently approved non-food use 6 3,000 New inert ingredient with new use pattern; no new data (2) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1398]] I007 178 Approval of substantially similar non-food 4 1,500 New use inert ingredients when original inert is compositionally similar with similar use pattern (2) ---------------------------------------------------------------------------------------------------------------- I008 179 Approval of new polymer inert ingredient, 5 3,400 New food use (2) ---------------------------------------------------------------------------------------------------------------- I009 180 Approval of new polymer inert ingredient, 4 2,800 New non food use (2) ---------------------------------------------------------------------------------------------------------------- I010 181 Petition to amend a tolerance exemption 6 1,500 New descriptor to add one or more CASRNs; no new data (2) ---------------------------------------------------------------------------------------------------------------- M001 182 Study protocol requiring Human Studies 9 7,200 New Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) ---------------------------------------------------------------------------------------------------------------- M002 183 Completed study requiring Human Studies 9 7,200 New Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1399]] M003 184 External technical peer review of new 12 58,000 New active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA Sec. 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1400]] M004 185 External technical peer review of new 18 58,000 New active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA Sec. 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1401]] M005 186 New Product: Combination, Contains a 9 20,000 New combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7) ---------------------------------------------------------------------------------------------------------------- M006 187 Request for up to 5 letters of 1 250 New certification (Gold Seal) for one actively registered product. ---------------------------------------------------------------------------------------------------------------- M007 188 Request to extend Exclusive Use of data as 12 5,000 New provided by FIFRA Section 3(c)(1)(F)(ii) ---------------------------------------------------------------------------------------------------------------- [[Page 126 STAT. 1402]] M008 189 Request to grant Exclusive Use of data as 10 1,500 New provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required ---------------------------------------------------------------------------------------------------------------- (1) <<NOTE: Extension.>> A decision review time that would otherwise end on a Satur- day, Sunday, or federal holiday, will be extended to end on the next business day. (2) If another covered application is associated with and depend- ent upon a pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the other associated covered applica- tion will be extended to match the PRIA due date of the pending inert ingredient action, unless the PRIA due date for the other as- sociated covered action is further out, in which case it will be sub- ject to its own decision review time. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingre- dients. (3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tol- erance action for two years from the effective date of the rule. (4) Any other covered application that is associated with and de- pendent on the HSRB review will be subject to its separate reg- istration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest re- view time. (5) Any other covered application that is associated with and de- pendent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review. (6) An application for a new end-use product using a source of ac- tive ingredient that (a) is not yet registered but (b) has an applica- tion pending with the Agency for review, will be considered an ap- plication for a new product with an unregistered source of active ingredient. [[Page 126 STAT. 1403]] (7) <<NOTE: Labeling. Deadlines.>> Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, includ- ing any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The <<NOTE: Notification.>> applicant will notify the Agency that the applicant ei- ther (a) agrees to all of the terms associated with the draft accept- ed label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the dif- ference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon reso- lution of differences in (b), the Agency shall provide an accepted final Agency- stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency.''; (B) in paragraph (6)-- (i) in subparagraph (A)-- (I) by striking ``October 1, 2008'' and inserting ``October 1, 2013''; and (II) by striking ``September 30, 2010'' and inserting ``September 30, 2015''; and (ii) in subparagraph (B)-- (I) by striking ``October 1, 2010'' and inserting ``October 1, 2015''; and (II) by striking ``September 30, 2010'' and inserting ``September 30, 2015''; and (C) in paragraph (8)(C)(ii)-- (i) in subclause (I), by striking ``or'' at the end; (ii) in subclause (II), by striking the period at the end and inserting ``; or''; and (iii) by adding at the end the following: ``(III) on the basis that the Administrator rejected the application under subsection (f)(4)(B).''. (2) Pesticide registration fund.--Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is amended-- (A) in clause (i), by striking ``2008 through 2012'' and inserting ``2013 through 2017''; (B) in clause (ii), by striking ``grants'' and all that follows through the end of the clause and inserting ``grants, for each of fiscal years 2013 through 2017, $500,000.''; and (C) in clause (iii), by striking ``2008 through 2012'' and inserting ``2013 through 2017''. (3) Assessment of fees.--Section 33(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d)) is amended-- (A) in paragraph (2), by striking ``2002'' each place it appears and inserting ``2012''; [[Page 126 STAT. 1404]] (B) by striking paragraph (4); and (C) by redesignating paragraph (5) as paragraph (4). (4) Reforms to reduce decision time review periods.--Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(e)) is amended by striking ``Pesticide Registration Improvement Act of 2003'' and inserting ``Pesticide Registration Improvement Extension Act of 2012''. (5) Decision time review periods.--Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is amended-- (A) in paragraph (1), by striking ``Pesticide Registration Improvement Renewal Act, the Administrator shall publish in the Federal Register'' and inserting ``Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available''; (B) in paragraph (2), by striking ``appearing in the Congressional Record on pages S10409'' and all that follows through the period and inserting ``provided under subsection (b)(3).''; and (C) in paragraph (4)-- (i) in subparagraph (A), by inserting ``and fee'' before the period; and (ii) in subparagraph (B)-- (I) by striking ``(B) Completeness of application'' and all that follows through ``Not later'' in clause (i) and inserting the following: ``(B) Initial content and preliminary technical screenings.-- ``(i) Screenings.-- ``(I) Initial content.--Not later''; (II) in clause (i) (as so designated) by adding at the end the following: ``(II) <<NOTE: Deadlines.>> Preliminary technical screening.--After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening-- ``(aa) not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and ``(bb) not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).''; (III) by striking clause (ii) and inserting the following: ``(ii) Rejection.-- ``(I) <<NOTE: Determination.>> In general.--If the Administrator determines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant does not correct the failure before the date that is 10 business days after the applicant [[Page 126 STAT. 1405]] receives a notification of the failure, the Administrator shall reject the application. ``(II) <<NOTE: Time period.>> Written notification.--The Administrator shall make every effort to provide a written notification of a rejection under subclause (I) during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.''; (IV) in clause (iii)-- (aa) in the heading, by inserting ``initial content'' before ``screening'' ; (bb) in the matter preceding subclause (I), by inserting ``content'' after ``initial''; and (cc) in subclause (II), by striking ``contains'' and inserting ``appears to contain''; and (V) by adding at the end the following: ``(iv) Requirements of preliminary technical screening.--In <<NOTE: Determination.>> conducting a preliminary technical screening of an application, the Administrator shall determine if-- ``(I) the application and the data and information submitted with the application are accurate and complete; and ``(II) the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this Act, could result in the granting of the application.''. (6) Reports.--Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended-- (A) in paragraph (1), by striking ``March 1, 2014'' and inserting ``March 1, 2017''; (B) in paragraph (2)-- (i) in subparagraph (A)-- (I) in clause (vi)(V), by striking ``and'' at the end; (II) in clause (vii)(II), by inserting ``and'' at the end; and (III) by adding at the end the following: ``(viii) the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;''; (ii) in subparagraph (E), by striking ``and'' at the end; (iii) in subparagraph (F), by striking the period and inserting a semicolon; and (iv) by adding at the end the following: ``(G) a review of the progress made toward-- ``(i) carrying out section 4(k)(4) and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section; [[Page 126 STAT. 1406]] ``(ii) implementing systems for the electronic tracking of registration submissions by December 31, 2013; ``(iii) <<NOTE: Public information. Deadline.>> implementing a system for tracking the status of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013; ``(iv) implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available; ``(v) implementing the capability to electronically submit and review labels submitted with registration actions; ``(vi) <<NOTE: Assessment. Evaluation. Deadline.>> acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and ``(vii) <<NOTE: Notification.>> facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket; ``(H) the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4); ``(I) <<NOTE: Review.>> a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); and ``(J) <<NOTE: Assessment.>> an assessment of the public availability of summary pesticide usage data.''; and (C) by adding at the end the following: ``(4) Other report.-- ``(A) Scope.--In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have-- ``(i) 10 or fewer employees; and ``(ii) annual global gross revenue that does not exceed $2,000,000. ``(B) Information required.--In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on-- ``(i) the number of small businesses described in subparagraph (A) that are paying maintenance fees; and ``(ii) the number of registrations each company holds.''. (7) Termination of effectiveness.--Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is amended-- [[Page 126 STAT. 1407]] (A) in paragraph (1), by striking ``2012'' and inserting ``2017''; and (B) in paragraph (2)-- (i) in subparagraph (A)-- (I) in the heading, by striking ``2013'' and inserting ``2018''; (II) by striking ``2013,'' and inserting ``2018,''; and (III) by striking ``September 30, 2012'' and inserting ``September 30, 2017''; (ii) in subparagraph (B)-- (I) in the heading, by striking ``2014'' and inserting ``2019''; (II) by striking ``2014,'' and inserting ``2019,''; and (III) by striking ``September 30, 2012'' and inserting ``September 30, 2017''; (iii) in subparagraph (C)-- (I) in the heading, by striking ``2014'' and inserting ``2019''; and (II) by striking ``September 30, 2014'' and inserting ``September 30, 2019''; and (iv) in subparagraph (D), by striking ``2012'' each place it appears and inserting ``2017''. (c) <<NOTE: 7 USC 136a-1 note.>> Effective Date.--This section and the amendments made by this section take effect on October 1, 2012. (d) <<NOTE: 7 USC 136a-1 note.>> Relationship to Other Law.--In the case of any conflict between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 (including any amendments made by such a joint resolution), this section and the amendments made by this section shall control. Approved September 28, 2012. LEGISLATIVE HISTORY--S. 3552: --------------------------------------------------------------------------- CONGRESSIONAL RECORD, Vol. 158 (2012): Sept. 13, considered and passed Senate. Sept. 14, considered and passed House. <all>