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H.R. 1029: Pesticide Registration Improvement Extension Act of 2018

The text of the bill below is as of Jun 28, 2018 (Passed the Senate with an Amendment).


115th CONGRESS

2d Session

H.R. 1029

In the Senate of the United States,

June 28, 2018.

Amendments:

That the bill from the House of Representatives (H.R. 1029) entitled An Act to amend the Federal Insecticide, Fungicide, and Rodenticide Act to improve pesticide registration and other activities under the Act, to extend and modify fee authorities, and for other purposes., do pass with the following

(1)

On page 2, line 3, strike Pesticide Registration Enhancement Act of 2017 and insert Pesticide Registration Improvement Extension Act of 2018.

(2)

On page 2, line14 and 15, strike 2017 through 2023 and insert 2019 through 2023

(3)

On page 2, line 20, strike 2017 through 2023 and insert 2019 through 2023

(4)

On page 3, line 2, strike 2017 through 2023 and insert 2019 through 2023

(5)

On page 3, line 7, strike 2017 through 2023 and insert 2019 through 2023

(6)

On page 3, line 11, strike 2017 through 2023 and insert 2019 through 2023

(7)

On page 3, line 13, strike 2023 and insert 2020

(8)

On page 3, line17 through line 20, strike and insert:

(1)
(A)

by striking the date of enactment of this section and ending on September 30, 2019 and inserting the effective date of the Pesticide Registration Improvement Extension Act of 2018 and ending on September 30, 2025; and

(9)

On page 4, line 4, strike 2023 and insert 2020

(10)

On page 4, line 14, after through insert: the period at the end of

(11)

On page 5, line 20 and 21, strike 2017 through 2023 and insert 2018 through 2020

(12)

On page 6, line 8, strike 2017 through 2021 and insert 2018 through 2020

(13)

On page 7, line 5, after powders, insert or

(14)

On page 7, line 13 and 14, strike June 30, 2017 and insert:

30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2018.

(15)

On page 7, line 25, strike 2020 and insert 2019.

(16)

On page 8, line 15, strike time-to-time and insert time to time

(17)

On page 9, line 15, strike 2017 through 2023 and insert 2018 through 2020

(18)

On page 11, line 20 strikecovered application and insertcovered applications

(19)

On page 11, strike lines 25 through page 12 through line 11 and insert

(A)

in subparagraph (A)—

(i)

by striking pesticide registration; and

(ii)

by striking October 1, 2013, and ending on September 30, 2015 and inserting October 1, 2019, and ending on September 30, 2021;

(B)

in subparagraph (B)—

(i)

by striking pesticide registration; and

(ii)

by striking 2015 each place it appears and inserting 2021; and

(20)

On page 14 line 2 strike 2023 and insert 2020

(21)

On page 14 line 7 strike 2023 and insert 2020

(22)

On page 14 line 9 strike 2023 and insert 2020

(23)

On page 14 line 16 strike Enhancement and insert Improvement Extension

(24)

On page 14 line 25 strike (7 U.S.C. 136w–8(f)(1)) and insert (7 U.S.C. 136w–8(f))

(25)

On page 15 line 4 strike Enhancement and insert Improvement Extension

(26)

On page 16 line 2 strike 2023 and insert 2020

(27)

On page 18 line 18 strike vector-born public health pests and insert invertebrate public health pests that may transmit vector-borne disease

(28)

On page 20 line 17 strike 2023 and insert 2020

(29)

On page 20, strike lines 22 and 23 and insert Fiscal year 2024.—During fiscal year 2024; and

(30)

On page 20 line 25 strike 2023 and insert 2020

(31)

On page 21, strike lines 4 and 5 and insert Fiscal year 2025.—During fiscal year 2025; and

(32)

On page 21 line 7 strike 2023 and insert 2020

(33)

On page 21 lines 10 and 11 strike 2019” and inserting September 30, 2025.—Effective September 30, 2025; and and insert 2019” and inserting September 30, 2025.—Effective September 30, 2025; and

(34)

On page 21 line 14 strike 2023 and insert 2020

(35)

On page 21 line 22 through page 105 to the end strike and insert:

(3)

Schedule of covered applications and other actions and their registration service fees

Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:

TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE INGREDIENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
R0101New Active Ingredient, Food use. (2)(3)24 753,082
R0202New Active Ingredient, Food use; reduced risk. (2)(3)18627,568
R0403New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)18462,502
R0604New Active Ingredient, Non-food use; outdoor. (2)(3)21 523,205
R0705New Active Ingredient, Non-food use; outdoor; reduced risk. (2)(3)16436,004
R0906New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)16323,690
R1107New Active Ingredient, Non-food use; indoor. (2)(3)20290,994
R1208New Active Ingredient, Non-food use; indoor; reduced risk. (2)(3)14242,495
R1219New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)18182,327
R12210Enriched isomer(s) of registered mixed-isomer active ingredient. (2)(3)18317,128
R12311New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities. (2)(3)18471,861
R12512New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)16323,690
TABLE 2. — REGISTRATION DIVISION — NEW USES
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
R13013First food use; indoor; food/food handling. (2) (3)21191,444
R14014Additional food use; Indoor; food/food handling. (3) (4)1544,672
R15015First food use. (2)(3)21 317,104
R15516 (new)First food use, Experimental Use Permit application; a.i. registered for non-food outdoor use. (3)(4)21264,253
R16017First food use; reduced risk. (2)(3)16264,253
R17018Additional food use. (3) (4)1579,349
R17519Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3)(4)1066,124
R18020Additional food use; reduced risk. (3)(4)1066,124
R19021Additional food uses; 6 or more submitted in one application. (3)(4)15476,090
R20022Additional Food Use; 6 or more submitted in one application; Reduced Risk. (3)(4)10396,742
R21023Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration. (3)(4)1248,986
R22024Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration. (3)(4)619,838
R23025Additional use; non-food; outdoor. (3) (4)1531,713
R24026Additional use; non-food; outdoor; reduced risk. (3)(4)1026,427
R25027Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration. (3)(4)619,838
R25128Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis. (3)819,838
R26029New use; non-food; indoor. (3) (4)1215,317
R27030New use; non-food; indoor; reduced risk. (3)(4)912,764
R27131New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration. (3)(4)69,725
R27332Additional use; seed treatment; 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)1250,445
R27433Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses. (3)(4) 12302,663
TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER TOLERANCES
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for the category. All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the amendment application package is subject to the registration service fee for a new product or a new inert approval. However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee. All such associated applications that are submitted together will be subject to the category decision review time.
R28034Establish import tolerance; new active ingredient or first food use. (2)21319,072
R29035Establish Import tolerance; Additional new food use.1563,816
R29136Establish import tolerances; additional food uses; 6 or more crops submitted in one petition.15382,886
R29237Amend an established tolerance (e.g., decrease or increase) and/or harmonize established tolerances with Codex MRLs; domestic or import; applicant-initiated.1145,341
R29338Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated.1253,483
R29439Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated.12320,894
R29540Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3) (4)1566,124
R29641Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3) (4)15396,742
R29742Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated.11272,037
R29843Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3) (4)1358,565
R29944Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3) (4)13285,261
TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against a pest group (general), use the group listing below and each group will count as 1. The general pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites, arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without a general claim then each specific pest will count as 1.
R30045New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP – only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2)(3)41,582
R30146New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy (identical data citation and claims to cited product(s)), where applicant does not own all required data and does not have a specific authorization letter from data owner. (2)(3)41,897
R31047New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for up to 3 target pests. (2)(3)
77,301
R31448New end use product containing up to three 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; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for up to 3 target pests. (2)(3)
88,626
R31949New end use product containing up to three 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; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2)(3)
1012,626
R31850 (new)New end use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for up to 3 target pests. (2)(3)
913,252
R32151 (new)New end use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2)(3)
1117,252
R31552New end-use, on-animal product, registered source of active ingredient(s), with the submission of data and/or waivers for only:
• animal safety and
• pest(s) requiring efficacy (4) and/or
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging. (2) (3)
99,820
R31653 (new)New end-use or manufacturing product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for greater than 3 and up to 7 target pests. (2)(3)
911,301
R31754 (new)New end-use or manufacturing product with registered source(s) of active ingredient(s) including products containing 2 or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only:
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging and/or
• pest(s) requiring efficacy (4) - for greater than 7 target pests. (2)(3)
1015,301
R32055New product; new physical form; requires data review in science divisions. (2)(3)1213,226
R33156New product; repack of identical registered end-use product as a manufacturing-use product, or identical registered manufacturing-use product as an end use product; same registered uses only. (2)(3)32,530
R33257New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions. (2)(3)24283,215
R33358New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2)(3)1019,838
R33459New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2)(3)1123,100
TABLE 5. — REGISTRATION DIVISION — AMENDMENTS
EPA
No
.
New
CR
No.
ActionDecision Review
Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are: public health pests listed in PR Notice 2002-1, livestock pests (e.g. Horn flies, Stable flies), wood-destroying pests (e.g. termites, carpenter ants, wood-boring beetles) and certain invasive species (e.g. Asian Longhorned beetle, Emerald Ashborer). This list may be updated/refined as invasive pest needs arise. To determine the number of pests for the PRIA categories, pests have been placed into groups (general; e.g., cockroaches) and pest specific (specifically a test species). If seeking a label claim against a pest group (general), use the group listing below and each group will count as 1. The general pests groups are: mites, dust mites, chiggers, ticks, hard ticks, soft ticks, cattle ticks, scorpions, spiders, centipedes, lice, fleas, cockroaches, keds, bot flies, screwworms, filth flies, blow flies, house flies, flesh flies, mosquitoes, biting flies, horse flies, stable flies, deer flies, sand flies, biting midges, black flies, true bugs, bed bugs, stinging bees, wasps, yellow jackets, hornets, ants (excluding carpenter ants), fire and harvester ants, wood destroying beetles, carpenter ants, termites, subterranean termites, dry wood termites, arboreal termites, damp wood termites and invasive species. If seeking a claim against a specific pest without a general claim then each specific pest will count as 1.
R34060Amendment requiring data review within RD (e.g., changes to precautionary label statements); includes adding/modifying pest(s) claims for up to 2 target pests, excludes products requiring or citing an animal safety study. (2)(3)(4)44,988
R34161 (New)Amendment requiring data review within RD (e.g., changes to precautionary label statements), includes adding/modifying pest(s) claims for greater than 2 target pests, excludes products requiring or citing an animal safety study. (2)(3)(4)65,988
R34562Amending on-animal products previously registered, with the submission of data and/or waivers for only:
• animal safety and
• pest(s) requiring efficacy (4) and/or
• product chemistry and/or
• acute toxicity and/or
• child resistant packaging. (2)(3)
78,820
R35063Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement). (2)(3)913,226
R35164Amendment adding a new unregistered source of active ingredient. (2)(3)813,226
R35265Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. (2) (3)813,226
R37166Amendment to Experimental Use Permit; (does not include extending a permit's time period). (3)610,090
TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS
EPA
No
.
New
CR
No.
ActionDecision Review
Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
R12467Conditional Ruling on Pre-application Study Waivers; applicant-initiated.62,530
R27268Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review.32,530
R27569Rebuttal of agency reviewed protocol, applicant initiated.32,530
R37070Cancer reassessment; applicant-initiated.18198,250
TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
A38071New Active Ingredient; Indirect Food use; establish tolerance or tolerance exemption if required. (2)(3)24137,841
A39072New Active Ingredient; Direct Food use; establish tolerance or tolerance exemption if required. (2)(3)24229,733
A41073New Active Ingredient Non-food use.(2)(3)21229,733
A43174New Active Ingredient, Non-food use; low-risk. (2)(3)1280,225
TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
A44075New Use, Indirect Food Use, establish tolerance or tolerance exemption. (2)(3)(4)2131,910
A44176Additional Indirect food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3)(4)(5)21114,870
A45077New use, Direct food use, establish tolerance or tolerance exemption. (2)(3)(4)2195,724
A45178Additional Direct food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3)(4)(5)21182,335
A50079New use, non-food. (4)(5)1231,910
A50180New use, non-food; 6 or more submitted in one application. (4)(5)1576,583
TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND AMENDMENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements.
(6) Once a submission for a new product with public health organisms has been submitted and classified in either A540 or A541, additional organisms submitted for the same product before expiration of the first submission’s original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number of organisms in both submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the new category.
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in either A570 or A573, additional organisms submitted for the same product before expiration of the first submission’s original decision review time period will result in reclassification of both the original and subsequent submission into the appropriate new category based on the sum of the number of organisms in both submissions. A reclassification would result in a new PRIA start date and require additional fees to meet the fee of the new category.
A53081 New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation 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) 4 1,278
A53182 New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2)(3)41,824
A53283New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted. (2)(3) 55,107
A54084 New end use product; FIFRA §2(mm) uses only; up to 25 public health organisms. (2)(3)(5)(6)5 5,107
A54185 (new) New end use product; FIFRA §2(mm) uses only; 26-50 public health organisms. (2)(3)(5)(6)78,500
A54286 (new) New end use product; FIFRA §2(mm) uses only; ≥ 51 public health organisms. (2)(3)(5)1015,000
A55087 New end-use product; uses other than FIFRA §2(mm); non-FQPA product. (2)(3)(5)913,226
A56088 New manufacturing use product; registered active ingredient; selective data citation. (2)(3)612,596
A56589 (new) New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review. (2)(3) 1218,234
A57090 Label amendment requiring data review; up to 25 public health organisms. (3)(4)(5)(6)43,831
A57391 (new) Label amendment requiring data review; 26-50 public health organisms. (2)(3)(5)(7)66,350
A57492 (new) Label amendment requiring data review; ≥ 51 public health organisms. (2)(3)(5)(7)911,000
A57293New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate). (2)(3)(4)913,226
TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
A52094 Experimental Use Permit application, non-food use. (2) 9 6,383
A52195Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1.44,726
A52296 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2.1212,156
A53797 (new) New Active Ingredient/New Use, Experimental Use Permit application; Direct food use; Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new use application that follows.18 153,156
A53898 (new) New Active Ingredient/New Use, Experimental Use Permit application; Indirect food use; Establish tolerance or tolerance exemption if required Credit 45% of fee toward new active ingredient/new use application that follows.1895,724
A53999 (new) New Active Ingredient/New Use, Experimental Use Permit application; Nonfood use. Credit 45% of fee toward new active ingredient/new use application that follows.1592,163
A529100 Amendment to Experimental Use Permit; requires data review or risk assessment. (2) 911,429
A523101 Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols).912,156
A571102 Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated. 1895,724
A533103 (new)Exemption from the requirement of an Experimental Use Permit. (2) 42,482
A534104 (new) Rebuttal of agency reviewed protocol, applicant initiated. 44,726
A535105 (new) Conditional Ruling on Pre-application Study Waiver or Data Bridging Argument; applicant-initiated. 62,409
A536106 (new)Conditional Ruling on Pre-application Direct Food, Indirect Food, Nonfood use determination; applicant-initiated.42,482
TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE INGREDIENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B580107New active ingredient; food use; petition to establish a tolerance. (2)(3) 20 51,053
B590108 New active ingredient; food use; petition to establish a tolerance exemption. (2)(3)1831,910
B600109 New active ingredient; non-food use. (2)(3) 1319,146
B610110 New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption. (3) 10 12,764
B611111 New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption. (3)1212,764
B612112 New active ingredient; no change to a permanent tolerance exemption. (2)(3)1017,550
B613113 New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption. (2)(3)1117,550
B620114 New active ingredient; Experimental Use Permit application; non-food use including crop destruct. (3)76,383
TABLE 12. — BIOPESTICIDES DIVISION — NEW USES
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B630115 First food use; petition to establish a tolerance exemption. (2)(4) 13 12,764
B631116 New food use; petition to amend an established tolerance. (3)(4)1212,764
B640117First food use; petition to establish a tolerance. (2)(4) 1919,146
B643118New Food use; petition to amend an established tolerance exemption. (3)(4) 10 12,764
B642119First food use; indoor; food/food handling. (2)(4)1231,910
B644120New use, no change to an established tolerance or tolerance exemption. (3)(4)812,764
B650121New use; non-food. (3)(4)76,383
B645122 (new) New food use; Experimental Use Permit application; petition to amend or add a tolerance exemption. (4)1212,764
B646123 (new)New use; non-food use including crop destruct; Experimental Use Permit application. (4) 76,383
TABLE 13. — BIOPESTICIDES DIVISION — NEW PRODUCTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B652124New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)(3) 13 12,764
B660125 New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product. No data review, or only product chemistry data; cite-all data citation, or selective data citation 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)(3)41,278
B670126 New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)(3) 75,107
B671127 New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)(3) 17 12,764
B672128 New product; unregistered source of active ingredient(s); non-food use or food use 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)(3)139,118
B673129 New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2)(3)105,107
B674130 New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only. (2)(3)41,278
B675131 New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2)(3)109,118
B676132 New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)(3) 139,118
B677133New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• animal safety studies and/or
• child resistant packaging. (2)(3)
108,820
TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B621134Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption. (3)7 5,107
B622135Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. (3)1112,764
B641136Amendment of an established tolerance or tolerance exemption.1312,764
B680137 Amendment; registered sources of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2)(3) 5 5,107
B681138 Amendment; unregistered source of active ingredient(s). Requires data submission. (2)(3)76,079
B683139 Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2)(3)65,107
B684140 Amending non-food animal product that includes submission of target animal safety data; previously registered. (2)(3)88,820
B685141 (new) Amendment; add a new biochemical unregistered source of active ingredient or a new microbial production site. Requires submission of analysis of samples data and source/production site-specific manufacturing process description. (3)55,107
TABLE 15. — BIOPESTICIDES DIVISION — SCLP
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B690142New active ingredient; food or non-food use. (2)(6) 7 2,554
B700143 Experimental Use Permit application; new active ingredient or new use. (6) 71,278
B701144 Extend or amend Experimental Use Permit. (6) 41,278
B710145 New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3)(6) 4 1,278
B720146 New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3)(6)51,278
B721147 New product; unregistered source of active ingredient. (3)(6)72,676
B722148New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4)(5)(6)72,477
B730149Label amendment requiring data submission. (4)(6)51,278
TABLE 16. — BIOPESTICIDES DIVISION — OTHER ACTIONS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
B614150Pre-application; Conditional Ruling on rationales for addressing a data requirement in lieu of data; applicant-initiated; applies to one rationale at a time.3 2,530
B615151Rebuttal of agency reviewed protocol, applicant initiated.32,530
B682152Protocol review; applicant initiated; excludes time for HSRB review. 32,432
TABLE 17. — BIOPESTICIDES DIVISION — PIP
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
(12) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
B740153Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes:

1. non-food/feed use(s) for a new (2) or registered (3) PIP (12);
2. food/feed use(s) for a new or registered PIP with crop destruct (12);
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)(12)
6 95,724
B741154 (new)Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes:

1. non-food/feed use(s) for a new (2) or registered (3) PIP;
2. food/feed use(s) for a new or registered PIP with crop destruct;
3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s);
SAP Review. (12)
12159,538
B750155Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4)(12)9127,630
B770156Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5)(12) 15 191,444
B771157Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. (12)10127,630
B772158Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12)312,764
B773159Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12)531,910
B780160Registration application; new (2) PIP; non-food/feed. (12)12159,537
B790161Registration application; new (2) PIP; non-food/feed; SAP review. (5)(12) 18223,351
B800162Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (12)13172,300
B810163Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5)(12)19236,114
B820164Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. (12)15204,208
B840165Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5)(12)21268,022
B851166Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). (12)9127,630
B870167Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) (12)938,290
B880168Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (6) (7) (12)931,910
B881169Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review. (5)(6)(7)(12)1595,724
B882170 (new)Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption; SAP Review. (8)(12)15191,444
B883171Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8) (12)9127,630
B884172Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8)(12)12159,537
B885173Registration application; registered (3) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9)(12)631,910
B886174 (new)Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. SAP Review. (8) (12)18223,351
B890175Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). (12)963,816
B891176Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5)(12)15127,630
B900177Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10)(11)(12)612,764
B901178Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) (12)1276,578
B902179PIP Protocol review.36,383
B903180Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.663,816
B904181Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).9127,630
B905182 (new)SAP Review.663,816
B906183 (new)Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients.331,907
B907184 (new)Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption.312,764
B908185 (new)Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients or inert ingredients.344,671
TABLE 18. — INERT INGREDIENTS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time line for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active ingredient.
I001186Approval of new food use inert ingredient. (2)(3)13 27,000
I002187Amend currently approved inert ingredient tolerance or exemption from tolerance; new data. (2)117,500
I003188Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data. (2)93,308
I004189Approval of new non-food use inert ingredient. (2) 6 11,025
I005190Amend currently approved non-food use inert ingredient with new use pattern; new data. (2)65,513
I006191Amend currently approved non-food use inert ingredient with new use pattern; no new data. (2)33,308
I007192Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern. (2)41,654
I008193Approval of new or amended polymer inert ingredient, food use. (2)53,749
I009194Approval of new or amended polymer inert ingredient, non-food use. (2) 43,087
I010195Petition to amend a single tolerance exemption descriptor, or single non-food use descriptor, to add ≤ 10 CASRNs; no new data. (2)61,654
I011196 (new)Approval of new food use safener with tolerance or exemption from tolerance. (2)(8)24597,683
I012197 (new)Approval of new non-food use safener. (2)(8)21415,241
I013198 (new)Approval of additional food use for previously approved safener with tolerance or exemption from tolerance. (2)1562,975
I014199 (new)Approval of additional non-food use for previously approved safener. (2)1525,168
I015200 (new)Approval of new generic data for previously approved food use safener. (2)24269,728
I016201 (new)Approval of amendment(s) to tolerance and label for previously approved safener. (2)1355,776
TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
EPA
No
.
New
CR
No.
ActionDecision
Review Time
(Months)(1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time line for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time.
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review.
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(8) Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal applies to one registered product.
(9) This category includes amendments the sole purpose of which is to add DfE (or equivalent terms that do not use “safe” or derivatives of “safe”) logos to a label. DfE is a voluntary program. A label bearing a DfE logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet objective, scientific criteria established and widely publicized by EPA.
M001202Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient. (4)9 7,938
M002203Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient. (4)97,938
M003204External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)1263,945
M004205External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5) 1863,945
M005206New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6)(7)922,050
M006207Request for up to 5 letters of certification (Gold Seal) for one actively registered product (excludes distributor products). (8)1277
M007208Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii).125,513
M008209Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required.151,654
M009210 (new)Non-FIFRA Regulated Determination: Applicant initiated, per product.42,363
M010211 (new)Conditional ruling on pre-application, product substantial similarity.42,363
M011212 (new)Label amendment to add the DfE logo; requires data review; no other label changes. (9)43,648

.

7.

Extension

Notwithstanding any other provision of this Act or amendment made by this Act, any reference in this Act or an amendment made by this Act to 2020 shall be deemed to be a reference to 2023.

8.

Agricultural worker protection standard; certification of pesticide applicators

(a)

In general

Except as provided in subsection (b), during the period beginning on the date of enactment of this Act and ending not earlier than October 1, 2021, the Administrator of the Environmental Protection Agency (referred to in this section as the Administrator)—

(1)

shall carry out—

(A)

the final rule of the Administrator entitled Pesticides; Agricultural Worker Protection Standard Revisions (80 Fed. Reg. 67496 (November 2, 2015)); and

(B)

the final rule of the Administrator entitled Pesticides; Certification of Pesticide Applicators (82 Fed. Reg. 952 (January 4, 2017)); and

(2)

shall not revise or develop revisions to the rules described in subparagraphs (A) and (B) of paragraph (1).

(b)

Exceptions

Prior to October 1, 2021, the Administrator may propose, and after a notice and public comment period of not less than 90 days, promulgate revisions to the final rule described in subsection (a)(1)(A) addressing application exclusion zones under part 170 of title 40, Code of Federal Regulations, consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.).

(c)

GAO report

The Comptroller General of the United States shall—

(1)

conduct a study on the use of the designated representative, including the effect of that use on the availability of pesticide application and hazard information and worker health and safety; and

(2)

not later than October 1, 2021, make publically available a report describing the study under paragraph (1), including any recommendations to prevent the misuse of pesticide application and hazard information, if that misuse is identified.

Secretary