Public Law 116-8

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Public Law 116-8
Pesticide Registration Improvement Extension Act of 2018
by the 116th Congress of the United States

Pub.L. 116−8, 133 Stat. 484, S. 483, enacted March 8, 2019

Public Law 116-9

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Note: This is the original legislation as it was initially enacted. Any subsequent amendments hosted on Wikisource may be listed using What Links Here.

3611389Pesticide Registration Improvement Extension Act of 2018 —

Pub.L. 116−8, 133 Stat. 484, S. 483, enacted March 8, 2019

2019the 116th Congress of the United States

116^TH UNITED STATES CONGRESS
1^ST SESSION

An Act
To enact into law a bill by reference.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.—This Act may be cited as the "Pesticide Registration Improvement Extension Act of 2018".

(b) Table of Contents.—The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Extension and modification of maintenance fee authority.

Sec. 3. Reregistration and Expedited Processing Fund.

Sec. 4. Experimental use permits for pesticides.

Sec. 5. Pesticide registration service fees.

Sec. 6. Revision of tables regarding covered pesticide registration applications and other covered actions and their corresponding registration service fees.

Sec. 7. Agricultural worker protection standard; certification of pesticide applicators.

SEC. 2. EXTENSION AND MODIFICATION OF MAINTENANCE FEE AUTHORITY.

(a) Maintenance Fee.—Section 4(i)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(1)) is amended—

(1) in subparagraph (C), by striking "an aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017" and inserting "an average amount of $31,000,000 for each of fiscal years 2019 through 2023";

(2) in subparagraph (D)—

(A) in clause (i), by striking "$115,500 for each of fiscal years 2013 through 2017" and inserting "$129,400 for each of fiscal years 2019 through 2023"; and

(B) in clause (ii), by striking "$184,800 for each of fiscal years 2013 through 2017" and inserting "$207,000 for each of fiscal years 2019 through 2023";

(3) in subparagraph (E)(i)—

(A) in subclause (I), by striking "$70,600 for each of fiscal years 2013 through 2017" and inserting "$79,100 for each of fiscal years 2019 through 2023"; and

(B) in subclause (II), by striking "$122,100 for each of fiscal years 2013 through 2017" and inserting "$136,800 for each of fiscal years 2019 through 2023"; and

(4) in subparagraph (I), by striking "2017.." and inserting "2023.".

(b) Prohibition on Other Fees.—Section 4(i)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(2)) is amended—

(1) 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

(2) by inserting after "registration of a pesticide under this Act" the following: "or any other action covered under a table specified in section 33(b)(3),".

(c) Extension of Prohibition on Tolerance Fees.—Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking "2017" and inserting "2023".

SEC. 3. REREGISTRATION AND EXPEDITED PROCESSING FUND.

(a) Authorized Use of Fund.—Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(2)(A)) is amended—

(1) in the first sentence, by striking "the fund" and inserting "the Reregistration and Expedited Processing Fund";

(2) by striking "paragraph (3)," in the first sentence and all that follows through the period at the end of the second sentence and inserting the following: "paragraph (3), to offset the costs of registration review under section 3(g), including the costs associated with any review under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part of the registration review, to offset the costs associated with tracking and implementing registration review decisions, including registration review decisions designed to reduce risk, for the purposes specified in paragraphs (4) and (5), and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions.";

(3) in clause (i), by striking "are allocated solely" and all that follows through "3(g);" and inserting the following: "are allocated solely for the purposes specified in the first sentence of this subparagraph;"; and

(4) in clause (ii), by striking "necessary to achieve" and all that follows through "3(g);" and inserting the following: "necessary to achieve the purposes specified in the first sentence of this subparagraph;".

(b) Set-Aside for Review of Inert Ingredients and Expedited Processing of Similar Applications.—Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) is amended, in the matter preceding clause (i), by striking "The Administrator shall use" and all that follows through "personnel and resources—" and inserting the following: "For each of fiscal years 2018 through 2023, the Administrator shall use between \1/9\ and \1/8\ of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources—".

(c) Set-Aside for Expedited Rulemaking and Guidance Development for Certain Purposes.—Paragraph (4) of section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is amended to read as follows:

"(4) Expedited rulemaking and guidance development for certain product performance data requirements.—

"(A) Set-aside.—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

"(B) Products claiming efficacy against invertebrate pests of significant public health or economic importance.—The Administrator shall use amounts made available under subparagraph (A) to develop, receive comments with respect to, finalize, and implement the necessary rulemaking and guidance for product performance data requirements to evaluate products claiming efficacy against the following invertebrate pests of significant public health or economic importance (in order of importance):

"(i) Bed bugs.

"(ii) Premise (including crawling insects, flying insects, and baits).

"(iii) Pests of pets (including pet pests controlled by spot-ons, collars, shampoos, powders, or dips).

"(iv) Fire ants.

"(C) Deadlines for guidance.—The Administrator shall develop, and publish guidance required by subparagraph (B), with respect to claims of efficacy against pests described in such subparagraph as follows:

"(i) With respect to bed bugs, issue final guidance not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2018.

"(ii) With respect to pests specified in clause (ii) of such subparagraph—

"(I) submit draft guidance to the Scientific Advisory Panel and for public comment not later than June 30, 2018; and

"(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than September 30, 2019.

"(iii) With respect to pests specified in clauses (iii) and (iv) of such subparagraph—

"(I) submit draft guidance to the Scientific Advisory Panel and for public comment not later than June 30, 2019; and

"(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than March 31, 2021.

"(D) Revision.—The Administrator shall revise the guidance required by subparagraph (B) from time to time, but shall permit applicants and registrants sufficient time to obtain data that meet the requirements specified in such revised guidance.

"(E) Deadline for product performance data requirements.—The Administrator shall, not later than September 30, 2021, issue regulations prescribing product performance data requirements for any pesticide intended for preventing, destroying, repelling, or mitigating any invertebrate pest of significant public health or economic importance specified in clauses (i) through (iv) of subparagraph (B).".

(d) Set-Aside for Good Laboratory Practices Inspections.—Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(k)) is amended—

(1) by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively;

(2) by inserting after paragraph (4) the following new paragraph:

"(5) Good laboratory practices inspections.—

"(A) Set-aside.—For each of fiscal years 2018 through 2023, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

"(B) Activities.—The Administrator shall use amounts made available under subparagraph (A) for enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations), with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under this Act. As part of such monitoring program, the Administrator shall make available to each laboratory inspected under such program in support of such registrations a preliminary summary of inspection observations not later than 60 days after the date on which such an inspection is completed."; and

(3) in paragraph (7), as so redesignated, by striking "paragraphs (2), (3), and (4)" and inserting "paragraphs (2), (3), (4), and (5)".

SEC. 4. EXPERIMENTAL USE PERMITS FOR PESTICIDES.

Section 5(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136c(a)) is amended—

(1) by striking "permit for a pesticide." and inserting "permit for a pesticide. An application for an experimental use permit for a covered application under section 33(b) shall conform with the requirements of that section."; and

(2) by inserting "(or in the case of an application for an experimental use permit for a covered application under section 33(b), not later than the last day of the applicable timeframe for such application specified in such section)" after "all required supporting data".

SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.

(a) Extension and Modification of Fee Authority.—Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended—

(1) in paragraph (2)—

(A) in the heading, by striking "pesticide registration"; and

(B) in subparagraph (A), by inserting "or for any other action covered by a table specified in paragraph (3)" after "covered by this Act that is received by the Administrator on or after the effective date of the Pesticide Registration Improvement Act of 2003";

(2) in paragraph (5)—

(A) in the heading, by striking "pesticide registration applications" and inserting "covered applications"; and

(B) by striking "pesticide registration application" both places it appears and inserting "covered application";

(3) in paragraph (6)—

(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

(C) in subparagraph (C), by striking "revised registration service fee schedules" and inserting "service fee schedules revised pursuant to this paragraph";

(4) in paragraph (7)—

(A) in subparagraph (A)—

(i) by striking "covered pesticide registration" and inserting "covered application"; and

(ii) by inserting before the period at the end the following: ", except that no waiver or fee reduction shall be provided in connection with a request for a letter of certification (commonly referred to as a Gold Seal letter)"; and

(B) in subparagraph (F)(i), by striking "pesticide registration"; and

(5) in paragraph (8)—

(A) in subparagraph (A), by striking "pesticide registration";

(B) in subparagraph (B)(i), by striking "pesticide registration"; and

(C) in subparagraph (C)—

(i) in clause (i), by striking "pesticide registration" and inserting "covered"; and

(ii) in clause (ii)(I), by striking "pesticide registration" and inserting "covered".

(b) Pesticide Registration Fund Set-Asides for Worker Protection, Partnership Grants, and Pesticide Safety Education.—Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)(3)(B)) is amended—

(1) in the heading, by inserting ", partnership grants, and pesticide safety education" after "Worker protection";

(2) in clause (i)—

(A) by striking "2017" and inserting "2023"; and

(B) by inserting before the period at the end the following:", with an emphasis on field-worker populations in the United States";

(3) in clause (ii), by striking "2017" and inserting "2023"; and

(4) in clause (iii), by striking "2017" and inserting "2023".

(c) Reforms To Reduce Decision Time Review Periods.—Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(e)) is amended—

(1) by striking "Pesticide Registration Improvement Extension Act of 2012" and inserting "Pesticide Registration Improvement Extension Act of 2018"; and

(2) by inserting at the end the following new sentence: "Such reforms shall include identifying opportunities for streamlining review processes for applications for a new active ingredient or a new use and providing prompt feedback to applicants during such review process.".

(d) Decision Time Review Periods.—Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is amended—

(1) in paragraph (1)—

(A) by striking "Pesticide Registration Improvement Extension Act of 2012" and inserting "Pesticide Registration Improvement Extension Act of 2018"; and

(B) by inserting after "covered pesticide registration actions" the following: "or for any other action covered by a table specified in subsection (b)(3)";

(2) in paragraph (3), by striking subparagraph (C) and inserting the following new subparagraph:

"(C) applications for any other action covered by a table specified in subsection (b)(3)."; and

(3) in paragraph (4)(A)—

(A) by striking "a pesticide registration application" and inserting "a covered application"; and

(B) by striking "covered pesticide registration application" and inserting "covered application".

(e) Reporting Requirements.—Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended—

(1) in paragraph (1) by striking "2017" and inserting "2023"; and

(2) in paragraph (2)—

(A) in subparagraph (D), by striking clause (i) and inserting the following new clause:

"(i) the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—

"(I) the number of cases cancelled;

"(II) the number of cases requiring risk mitigation measures;

"(III) the number of cases removing risk mitigation measures;

"(IV) the number of cases with no risk mitigation needed; and

"(V) the number of cases in which risk mitigation has been fully implemented;";

(B) in subparagraph (G)—

(i) in clause (i)—

(I) by striking "section 4(k)(4)" and inserting "paragraphs (4) and (5) of section 4(k)"; and

(II) by striking "that section" and inserting "such paragraphs";

(ii) by striking clauses (ii), (iii), (iv), (v), and (vi);

(iii) by inserting after clause (i) the following new clause:

"(ii) implementing enhancements to—

"(I) the electronic tracking of covered applications;

"(II) the electronic tracking of conditional registrations;

"(III) the endangered species database;

"(IV) the electronic review of labels submitted with covered applications; and

"(V) the electronic review and assessment of confidential statements of formula submitted with covered applications; and"; and

(iv) by redesignating clause (vii) as clause (iii);

(C) in subparagraph (I), by striking "and" at the end;

(D) in subparagraph (J), by striking the period at the end and inserting a semicolon; and

(E) by adding at the end the following new subparagraphs:

"(K) a review of the progress made in developing, updating, and implementing product performance test guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and, by regulation, prescribing product performance data requirements for such pesticide products registered under section 3;

"(L) a review of the progress made in the priority review and approval of new pesticides to control invertebrate public health pests that may transmit vector-borne disease for use in the United States, including each territory or possession of the United States, and United States military installations globally;

"(M) a review of the progress made in implementing enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations);

"(N) the number of approvals for active ingredients, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency; and

"(O) with respect to funds in the Pesticide Registration Fund reserved under subsection (c)(3), a review that includes—

"(i) a description of the amount and use of such funds—

"(I) to carry out activities relating to worker protection under clause (i) of subsection (c)(3)(B);

"(II) to award partnership grants under clause (ii) of such subsection; and

"(III) to carry out the pesticide safety education program under clause (iii) of such subsection;

"(ii) an evaluation of the appropriateness and effectiveness of the activities, grants, and program described in clause (i);

"(iii) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program; and

"(iv) with respect to activities relating to worker protection carried out under subparagraph (B)(i) of such subsection, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.".

(f) Termination of Effectiveness.—Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is amended—

(1) in paragraph (1), by striking "2017" and inserting "2023"; and

(2) in paragraph (2)—

(A) in subparagraph (A)—

(i) by striking "Fiscal year 2018.—During fiscal year 2018" and inserting "Fiscal year 2024.—During fiscal year 2024"; and

(ii) by striking "2017" and inserting "2023";

(B) in subparagraph (B)—

(i) by striking "Fiscal year 2019.—During fiscal year 2019" and inserting "Fiscal year 2025.—During fiscal year 2025"; and

(ii) by striking "2017" and inserting "2023";

(C) in subparagraph (C), by striking "September 30, 2019.—Effective September 30, 2019" and inserting "September 30, 2025.—Effective September 30, 2025"; and

(D) in subparagraph (D), by striking "2017" both places it appears and inserting "2023".

SEC. 6. REVISION OF TABLES REGARDING COVERED PESTICIDE REGISTRATION APPLICATIONS AND OTHER COVERED ACTIONS AND THEIR CORRESPONDING REGISTRATION SERVICE FEES.

Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended to read as follows:

"(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.	Action	Decision Review Time (Months)^[1]	Registration Service Fee ($)
R010	1	New Active Ingredient, Food use.^[2]^[3]	24	753,082
R020	2	New Active Ingredient, Food use; reduced risk.^[2]^[3]	18	627,568
R040	3	New 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]	18	462,502
R060	4	New Active Ingredient, Non-food use; outdoor.^[2]^[3]	21	523,205
R070	5	New Active Ingredient, Non-food use; outdoor; reduced risk.^[2]^[3]	16	436,004
R090	6	New 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]	16	323,690
R110	7	New Active Ingredient, Non-food use; indoor.^[2]^[3]	20	290,994
R120	8	New Active Ingredient, Non-food use; indoor; reduced risk.^[2]^[3]	14	242,495
R121	9	New 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]	18	182,327
R122	10	Enriched isomer(s) of registered mixed-isomer active ingredient.^[2]^[3]	18	317,128
R123	11	New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities.^[2]^[3]	18	471,861
R125	12	New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows.^[2]^[2]	16	323,690

↑ 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.
↑ ^2.00 ^2.01 ^2.02 ^2.03 ^2.04 ^2.05 ^2.06 ^2.07 ^2.08 ^2.09 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.
↑ ^3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant's written or electronic confirmation of agreement to the Agency.

"TABLE 2. — REGISTRATION DIVISION — NEW USES
EPA No.	New CR No.	Action	Decision Review Time (Months)^[1]	Registration Service Fee ($)
R130	13	First food use; indoor; food/food handling.^[2]^[3]	21	191,444
R140	14	Additional food use; Indoor; food/food handling.^[3]^[4]	15	44,672
R150	15	First food use.^[2]^[3]	21	317,104
R155	16 (new)	First food use, Experimental Use Permit application; a.i. registered for non-food outdoor use.^[3]^[4]	21	264,253
R160	17	First food use; reduced risk.^[2]^[3]	16	264,253
R170	18	Additional food use.^[3]^[4]	15	79,349
R175	19	Additional 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]	10	66,124
R180	20	Additional food use; reduced risk.^[3]^[4]	10	66,124
R190	21	Additional food uses; 6 or more submitted in one application.^[3]^[4]	15	476,090
R200	22	Additional Food Use; 6 or more submitted in one application; Reduced Risk.^[3]^[4]	10	396,742
R210	23	Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration.^[3]^[4]	12	48,986
R220	24	Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration.^[3]^[4]	6	19,838
R230	25	Additional use; non-food; outdoor.^[3]^[4]	15	31,713
R240	26	Additional use; non-food; outdoor; reduced risk.^[3]^[4]	10	26,427
R250	27	Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration.^[3]^[4]	6	19,838
R251	28	Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis.^[3]	8	19,838
R260	29	New use; nonfood; indoor.^[3]^[4]	12	15,317
R270	30	New use; nonfood; indoor; reduced risk.^[3]^[4]	9	12,764
R271	31	New use; nonfood; indoor; Experimental Use Permit application; no credit toward new use registration.^[3]^[4]	6	9,725
R273	32	Additional 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]	12	50,445
R274	33	Additional 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]	12	302,663

↑ 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.
↑ ^2.0 ^2.1 ^2.2 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.
↑ ^3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 ^3.11 ^3.12 ^3.13 ^3.14 ^3.15 ^3.16 ^3.17 ^3.18 ^3.19 ^3.20 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.
↑ ^4.00 ^4.01 ^4.02 ^4.03 ^4.04 ^4.05 ^4.06 ^4.07 ^4.08 ^4.09 ^4.10 ^4.11 ^4.12 ^4.13 ^4.14 ^4.15 ^4.16 Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

"TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER TOLERANCES
EPA No.	New CR No.	Action	Decision Review Time (Months)^[1]	Registration Service Fee ($)
R280	34	Establish import tolerance; new active ingredient or first food use.^[2]	21	319,072
R290	35	Establish Import tolerance; Additional new food use.	15	63,816
R291	36	Establish import tolerances; additional food uses; 6 or more crops submitted in one petition.	15	382,886
R292	37	Amend an established tolerance (e.g., decrease or increase) and/or harmonize established tolerances with Codex MRLs; domestic or import; applicant-initiated.	11	45,341
R293	38	Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated.	12	53,483
R294	39	Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated.	12	320,894
R295	40	Establish 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]	15	66,124
R296	41	Establish 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]	15	396,742
R297	42	Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated	11	272,037
R298	43	Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review).^[3]^[4]	13	58,565
R299	44	Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review).^[3]^[4]	13	285,261

↑ 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.
↑ 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.
↑ ^3.0 ^3.1 ^3.2 ^3.3 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.
↑ ^4.0 ^4.1 ^4.2 ^4.3 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.

"TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPA No.	New CR No.	Action	Decision Review Time (Months)^[1]	Registration Service Fee ($)
R300	45	New 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% repackage of registered end-use or manufacturing-use product that requires no data submission nor data matrix.^[2]^[3]	4	1,582
R301	46	New 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]	4	1,897
R310	47	New 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]	7	7,301
R314	48	New 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]	8	8,626
R319	49	New 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]	10	12,626
R318	50 (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]	9	13,252
R321	51 (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]	11	17,252
R315	52	New 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]	9	9,820
R316	53 (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]	9	11,301
R317	54 (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]	10	15,301
R320	55	New product; new physical form; requires data review in science divisions.^[2]^[3]	12	13,226
R331	56	New 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]	3	2,530
R332	57	New 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]	24	283,215
R333	58	New 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]	10	19,838
R334	59	New 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]	11	23,100

↑ 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.
↑ ^2.00 ^2.01 ^2.02 ^2.03 ^2.04 ^2.05 ^2.06 ^2.07 ^2.08 ^2.09 ^2.10 ^2.11 ^2.12 ^2.13 ^2.14 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.
↑ ^3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 ^3.11 ^3.12 ^3.13 ^3.14 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.
↑ ^4.0 ^4.1 ^4.2 ^4.3 ^4.4 ^4.5 ^4.6 ^4.7 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.

"TABLE 5. — REGISTRATION DIVISION — AMENDMENTS
EPA No.	New CR No.	Action	Decision Review Time (Months)^[1]	Registration Service Fee ($)
R340	60	Amendment 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]	4	4,988
R341	61 (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]	6	5,988
R345	62	Amending 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]	7	8,820
R350	63	Amendment 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]	9	13,226
R351	64	Amendment adding a new unregistered source of active ingredient.^[2]^[3]	8	13,226
R352	65	Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data.^[2]^[3]	8	13,226
R371	66	Amendment to Experimental Use Permit; (does not include extending a permit’s time period).^[3]	6	10,090

↑ 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.
↑ ^2.0 ^2.1 ^2.2 ^2.3 ^2.4 ^2.5 (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.
↑ ^3.0 ^3.1 ^3.2 ^3.3 ^3.4 ^3.5 ^3.6 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.
↑ ^4.0 ^4.1 ^4.2 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.

                             "TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS

                                                                                                  Registration
EPA  No.     New  CR                    Action                       Decision Review  Time        Service Fee
               No.                                                        (Months)(1)                 ($)

    R124          67   Conditional Ruling on Pre-application    6                                        2,530
                        Study Waivers; applicant-initiated.

    R272          68   Review of Study Protocol applicant-      3                                        2,530
                        initiated; excludes DART, pre-
                        registration conference, Rapid
                        Response review, DNT protocol review,
                        protocol needing HSRB review.

    R275          69   Rebuttal of agency reviewed protocol,    3                                        2,530
                        applicant initiated.

    R370          70   Cancer reassessment; applicant-          18                                     198,250
                        initiated.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

                        "TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS

                                                                                                  Registration
 EPA  No.    New  CR                     Action                       Decision  Review Time       Service Fee
               No.                                                         (Months)(1)                ($)

     A380         71   New Active Ingredient; Indirect Food use;  24                                   137,841
                        establish tolerance or tolerance
                        exemption if required. (2)(3)

     A390         72   New Active Ingredient; Direct Food use;    24                                   229,733
                        establish tolerance or tolerance
                        exemption if required. (2)(3)

     A410         73   New Active Ingredient Non-food use.(2)(3)  21                                   229,733

     A431         74   New Active Ingredient, Non-food use; low-  12                                    80,225
                        risk. (2)(3)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or

 a first food use are covered by the base fee for that new active ingredient or first food use application and
 retain the same decision time review period as the new active ingredient or first food use application. The
 application must be received by the agency in one package. The base fee for the category covers a maximum of
 five new products. Each application for an additional new product registration and new inert approval that is
 submitted in the new active ingredient application package or first food use application package is subject to
 the registration service fee for a new product or a new inert approval. All such associated applications that
 are submitted together will be subject to the new active ingredient or first food use decision review time. In
 the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
 application for another new product containing the same active ingredient or an amendment to the proposed
 labeling will be deemed a new active ingredient application, subject to the registration service fee and
 decision review time for a new active ingredient. In the case of a first food use application, until that
 first food use is approved, any subsequent application for an additional new food use or uses will be subject
 to the registration service fee and decision review time for a first food use. Any information that (a) was
 neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
 initiative to support the application after completion of the technical deficiency screening, and (c) is not
 itself a covered registration application, must be assessed 25% of the full registration service fee for the
 new active ingredient or first food use application.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

                               "TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES

                                                                                                  Registration
   EPA  No.        New  CR                  Action                    Decision  Review Time       Service Fee
                     No.                                                   (Months)(1)                ($)

A440 75 New Use, Indirect Food Use, 21 31,910

                               establish tolerance or tolerance
                               exemption. (2)(3)(4)

A441 76 Additional Indirect food uses; 21 114,870

                               establish tolerances or tolerance
                               exemptions if required; 6 or more
                               submitted in one application.
                               (3)(4)(5)

A450 77 New use, Direct food use, 21 95,724

                               establish tolerance or tolerance
                               exemption. (2)(3)(4)

A451 78 Additional Direct food uses; 21 182,335

                               establish tolerances or tolerance
                               exemptions if required; 6 or more
                               submitted in one application.
                               (3)(4)(5)

A500 79 New use, non-food. (4)(5) 12 31,910

A501 80 New use, non-food; 6 or more 15 76,583

                               submitted in one application.
                               (4)(5)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or

 a first food use are covered by the base fee for that new active ingredient or first food use application and
 retain the same decision time review period as the new active ingredient or first food use application. The
 application must be received by the agency in one package. The base fee for the category covers a maximum of
 five new products. Each application for an additional new product registration and new inert approval that is
 submitted in the new active ingredient application package or first food use application package is subject to
 the registration service fee for a new product or a new inert approval. All such associated applications that
 are submitted together will be subject to the new active ingredient or first food use decision review time. In
 the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
 application for another new product containing the same active ingredient or an amendment to the proposed
 labeling will be deemed a new active ingredient application, subject to the registration service fee and
 decision review time for a new active ingredient. In the case of a first food use application, until that
 first food use is approved, any subsequent application for an additional new food use or uses will be subject
 to the registration service fee and decision review time for a first food use. Any information that (a) was
 neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
 initiative to support the application after completion of the technical deficiency screening, and (c) is not
 itself a covered registration application, must be assessed 25% of the full registration service fee for the
 new active ingredient or first food use application.

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of

 an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
 the data for such clearance of such product is not subject to a registration service fee for the tolerance
 action for two years from the effective date of the rule.

(4) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for

 the new use(s). All items in the covered application must be submitted together in one package. Each
 application for an additional new product registration and new inert approval(s) that is submitted in the new
 use application package is subject to the registration service fee for a new product or a new inert approval.
 However, if a new use application only proposes to register the new use for a new product and there are no
 amendments in the application, then review of one new product application is covered by the new use fee. All
 such associated applications that are submitted together will be subject to the new use decision review time.
 Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
 submission of the new use application and (b) prior to conclusion of its decision review time and (c)
 containing the same new uses, will be deemed a separate new-use application, subject to a separate
 registration service fee and new decision review time for a new use. If the new-use application includes non-
 food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
 of new use and the longest decision review time applies to all of the new uses requested in the application.
 Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
 applicant at the applicant's initiative to support the application after completion of the technical
 deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
 registration service fee for the new use application.

                     "TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND AMENDMENTS

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     A530          81    New product, identical or              4                                        1,278
                         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)

     A531          82    New product; identical or              4                                        1,824
                         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)

     A532          83   New product; identical or               5                                        5,107
                         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)

     A540          84    New end use product; FIFRA Sec. 2(mm)  5                                        5,107
                         uses only; up to 25 public health
                         organisms. (2)(3)(5)(6)

     A541    85 (new)    New end use product; FIFRA Sec. 2(mm)  7                                        8,500
                         uses only; 26-50 public health
                         organisms. (2)(3)(5)(6)

     A542    86 (new)    New end use product; FIFRA Sec. 2(mm)  10                                      15,000
                         uses only; $ 51 public health
                         organisms. (2)(3)(5)

     A550          87    New end-use product; uses other than   9                                       13,226
                         FIFRA Sec. 2(mm); non-FQPA product.
                         (2)(3)(5)

     A560          88    New manufacturing use product;         6                                       12,596
                         registered active ingredient;
                         selective data citation. (2)(3)

     A565    89 (new)    New manufacturing-use product;         12                                      18,234
                         registered active ingredient;
                         unregistered source of active
                         ingredient; submission of new generic
                         data package; registered uses only;
                         requires science review. (2)(3)

     A570          90    Label amendment requiring data         4                                        3,831
                         review; up to 25 public health
                         organisms. (3)(4)(5)(6)

     A573    91 (new)    Label amendment requiring data         6                                        6,350
                         review; 26-50 public health
                         organisms. (2)(3)(5)(7)

     A574    92 (new)    Label amendment requiring data         9                                       11,000
                         review; $ 51 public health organisms.
                         (2)(3)(5)(7)

     A572          93   New Product or amendment requiring      9                                       13,226
                         data review for risk assessment by
                         Science Branch (e.g., changes to REI,
                         or PPE, or use rate). (2)(3)(4)

(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.

             "TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     A520          94    Experimental Use Permit application,   9                                        6,383
                         non-food use. (2)

     A521          95   Review of public health efficacy study  4                                        4,726
                         protocol within AD, per AD Internal
                         Guidance for the Efficacy Protocol
                         Review Process; Code will also
                         include review of public health
                         efficacy study protocol and data
                         review for devices making pesticidal
                         claims; applicant-initiated; Tier 1.

     A522          96    Review of public health efficacy       12                                      12,156
                         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.

     A537    97 (new)    New Active Ingredient/New Use,         18                                     153,156
                         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.

     A538    98 (new)    New Active Ingredient/New Use,         18                                      95,724
                         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.

     A539    99 (new)    New Active Ingredient/New Use,         15                                      92,163
                         Experimental Use Permit application;
                         Nonfood use. Credit 45% of fee toward
                         new active ingredient/new use
                         application that follows.

     A529         100    Amendment to Experimental Use Permit;  9                                       11,429
                         requires data review or risk
                         assessment. (2)

     A523         101    Review of protocol other than a        9                                       12,156
                         public health efficacy study (i.e.,
                         Toxicology or Exposure Protocols).

     A571         102    Science reassessment: Cancer risk,     18                                      95,724
                         refined ecological risk, and/or
                         endangered species; applicant-
                         initiated.

     A533   103 (new)   Exemption from the requirement of an    4                                        2,482
                         Experimental Use Permit. (2)

     A534   104 (new)    Rebuttal of agency reviewed protocol,  4                                        4,726
                         applicant initiated.

     A535   105 (new)    Conditional Ruling on Pre-application  6                                        2,409
                         Study Waiver or Data Bridging
                         Argument; applicant-initiated.

     A536   106 (new)   Conditional Ruling on Pre-application   4                                        2,482
                         Direct Food, Indirect Food, Nonfood
                         use determination; applicant-
                         initiated.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

                        "TABLE 11. — BIOPESTICIDES DIVISION — NEW ACTIVE INGREDIENTS

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     B580         107   New active ingredient; food use;        20                                      51,053
                         petition to establish a tolerance.
                         (2)(3)

     B590         108    New active ingredient; food use;       18                                      31,910
                         petition to establish a tolerance
                         exemption. (2)(3)

     B600         109    New active ingredient; non-food use.   13                                      19,146
                         (2)(3)

     B610         110    New active ingredient; Experimental    10                                      12,764
                         Use Permit application; petition to
                         establish a temporary tolerance or
                         temporary tolerance exemption. (3)

     B611         111    New active ingredient; Experimental    12                                      12,764
                         Use Permit application; petition to
                         establish permanent tolerance
                         exemption. (3)

     B612         112    New active ingredient; no change to a  10                                      17,550
                         permanent tolerance exemption. (2)(3)

     B613         113    New active ingredient; petition to     11                                      17,550
                         convert a temporary tolerance or a
                         temporary tolerance exemption to a
                         permanent tolerance or tolerance
                         exemption. (2)(3)

     B620         114    New active ingredient; Experimental    7                                        6,383
                         Use Permit application; non-food use
                         including crop destruct. (3)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or

 a first food use are covered by the base fee for that new active ingredient or first food use application and
 retain the same decision time review period as the new active ingredient or first food use application. The
 application must be received by the agency in one package. The base fee for the category covers a maximum of
 five new products. Each application for an additional new product registration and new inert approval that is
 submitted in the new active ingredient application package or first food use application package is subject to
 the registration service fee for a new product or a new inert approval. All such associated applications that
 are submitted together will be subject to the new active ingredient or first food use decision review time. In
 the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
 application for another new product containing the same active ingredient or an amendment to the proposed
 labeling will be deemed a new active ingredient application, subject to the registration service fee and
 decision review time for a new active ingredient. In the case of a first food use application, until that
 first food use is approved, any subsequent application for an additional new food use or uses will be subject
 to the registration service fee and decision review time for a first food use. Any information that (a) was
 neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant's
 initiative to support the application after completion of the technical deficiency screening, and (c) is not
 itself a covered registration application, must be assessed 25% of the full registration service fee for the
 new active ingredient or first food use application.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

                               "TABLE 12. — BIOPESTICIDES DIVISION — NEW USES

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     B630         115    First food use; petition to establish  13                                      12,764
                         a tolerance exemption. (2)(4)

     B631         116    New food use; petition to amend an     12                                      12,764
                         established tolerance. (3)(4)

     B640         117   First food use; petition to establish   19                                      19,146
                         a tolerance. (2)(4)

     B643         118   New Food use; petition to amend an      10                                      12,764
                         established tolerance exemption.
                         (3)(4)

     B642         119   First food use; indoor; food/food       12                                      31,910
                         handling. (2)(4)

     B644         120   New use, no change to an established    8                                       12,764
                         tolerance or tolerance exemption.
                         (3)(4)

     B650         121   New use; non-food. (3)(4)               7                                        6,383

     B645   122 (new)    New food use; Experimental Use Permit  12                                      12,764
                         application; petition to amend or add
                         a tolerance exemption. (4)

     B646   123 (new)   New use; non-food use including crop    7                                        6,383
                         destruct; Experimental Use Permit
                         application. (4)

(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.

                             "TABLE 13. — BIOPESTICIDES DIVISION — NEW PRODUCTS

                                                                                                  Registration
EPA  No.     New  CR                     Action                       Decision  Review Time       Service Fee
               No.                                                         (Months)(1)                ($)

    B652         124   New product; registered source of active   13                                    12,764
                        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)

    B660         125    New product; registered source of active  4                                      1,278
                        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)

    B670         126    New product; registered source of active  7                                      5,107
                        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)

    B671         127    New product; unregistered source of       17                                    12,764
                        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)

    B672         128    New product; unregistered source of       13                                     9,118
                        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)

    B673         129    New product MUP/EP; unregistered source   10                                     5,107
                        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)

    B674         130    New product MUP; Repack of identical      4                                      1,278
                        registered end-use product as a
                        manufacturing-use product; same
                        registered uses only. (2)(3)

    B675         131    New Product MUP; registered source of     10                                     9,118
                        active ingredient; submission of
                        completely new generic data package;
                        registered uses only. (2)(3)

    B676         132    New product; more than one active         13                                     9,118
                        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)

    B677         133   New end-use non-food animal product with   10                                     8,820
                        submission of two or more target animal
                        safety studies; includes data and/or
                        waivers of data for only:
                       <bullet> product chemistry and/or
                       <bullet> acute toxicity and/or
                       <bullet> public health pest efficacy and/
                        or
                       <bullet> animal safety studies and/or
                       <bullet> child resistant packaging.
                        (2)(3)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered

 but (b) has an application pending with the Agency for review, will be considered an application for a new
 product with an unregistered source of active ingredient.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

                              "TABLE 14. — BIOPESTICIDES DIVISION — AMENDMENTS

                                                                                                  Registration
 EPA  No.     New  CR                     Action                       Decision  Review Time      Service Fee
                No.                                                         (Months)(1)               ($)

     B621         134   Amendment; Experimental Use Permit; no      7                                    5,107
                         change to an established temporary
                         tolerance or tolerance exemption. (3)

     B622         135   Amendment; Experimental Use Permit;         11                                  12,764
                         petition to amend an established or
                         temporary tolerance or tolerance
                         exemption. (3)

     B641         136   Amendment of an established tolerance or    13                                  12,764
                         tolerance exemption.

     B680         137    Amendment; registered sources of active    5                                    5,107
                         ingredient(s); no new use(s); no changes
                         to an established tolerance or tolerance
                         exemption. Requires data submission.
                         (2)(3)

     B681         138    Amendment; unregistered source of active   7                                    6,079
                         ingredient(s). Requires data submission.
                         (2)(3)

     B683         139    Label amendment; requires review/update    6                                    5,107
                         of previous risk assessment(s) without
                         data submission (e.g., labeling changes
                         to REI, PPE, PHI). (2)(3)

     B684         140    Amending non-food animal product that      8                                    8,820
                         includes submission of target animal
                         safety data; previously registered.
                         (2)(3)

     B685   141 (new)    Amendment; add a new biochemical           5                                    5,107
                         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)

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-

 track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not
 subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
 Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not
 subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
 Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
 service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision

 review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
 the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
 The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
 the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
 stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
 Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
 prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
 described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
 final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
 in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
 stamped label to the registrant within 2 business days following the registrant's written or electronic
 confirmation of agreement to the Agency.

                                 "TABLE 15. — BIOPESTICIDES DIVISION — SCLP

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     B690         142   New active ingredient; food or non-     7                                        2,554
                         food use. (2)(6)

     B700         143    Experimental Use Permit application;   7                                        1,278
                         new active ingredient or new use. (6)

     B701         144    Extend or amend Experimental Use       4                                        1,278
                         Permit. (6)

     B710         145    New product; registered source of      4                                        1,278
                         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)

     B720         146    New product; registered source of      5                                        1,278
                         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)

     B721         147    New product; unregistered source of    7                                        2,676
                         active ingredient. (3)(6)

     B722         148   New use and/or amendment; petition to   7                                        2,477
                         establish a tolerance or tolerance
                         exemption. (4)(5)(6)

     B730         149   Label amendment requiring data          5                                        1,278
                         submission. (4)(6)

(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.

                            "TABLE 16. — BIOPESTICIDES DIVISION — OTHER ACTIONS

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     B614         150   Pre-application; Conditional Ruling on  3                                        2,530
                         rationales for addressing a data
                         requirement in lieu of data;
                         applicant-initiated; applies to one
                         rationale at a time.

     B615         151   Rebuttal of agency reviewed protocol,   3                                        2,530
                         applicant initiated.

     B682         152   Protocol review; applicant initiated;   3                                        2,432
                         excludes time for HSRB review.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended

 to end on the next business day.

                                 "TABLE 17. — BIOPESTICIDES DIVISION — PIP

                                                                                                  Registration
 EPA  No.   New  CR                     Action                        Decision  Review Time       Service Fee
               No.                                                         (Months)(1)                ($)

     B740      153   Experimental Use Permit application; no      6                                     95,724
                      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)

     B741      154   Experimental Use Permit application; no      12                                   159,538
             (new)    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)

     B750      155   Experimental Use Permit application; with a  9                                    127,630
                      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)

     B770      156   Experimental Use Permit application; new     15                                   191,444
                      (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)

     B771      157   Experimental Use Permit application; new     10                                   127,630
                      (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)

     B772      158   Application to amend or extend an            3                                     12,764
                      Experimental Use Permit; no petition since
                      the established tolerance/tolerance
                      exemption for the active ingredient is
                      unaffected. (12)

     B773      159   Application to amend or extend an            5                                     31,910
                      Experimental Use Permit; with petition to
                      extend a temporary tolerance/tolerance
                      exemption for the active ingredient. (12)

     B780      160   Registration application; new (2) PIP; non-  12                                   159,537
                      food/feed. (12)

     B790      161   Registration application; new (2) PIP; non-  18                                   223,351
                      food/feed; SAP review. (5)(12)

     B800      162   Registration application; new (2) PIP; with  13                                   172,300
                      petition to establish permanent tolerance/
                      tolerance exemption for the active
                      ingredient based on an existing temporary
                      tolerance/tolerance exemption. (12)

     B810      163   Registration application; new (2) PIP; with  19                                   236,114
                      petition to establish permanent tolerance/
                      tolerance exemption for the active
                      ingredient based on an existing temporary
                      tolerance/tolerance exemption. SAP review.
                      (5)(12)

     B820      164   Registration application; new (2) PIP; with  15                                   204,208
                      petition to establish or amend a permanent
                      tolerance/tolerance exemption of an active
                      ingredient. (12)

     B840      165   Registration application; new (2) PIP; with  21                                   268,022
                      petition to establish or amend a permanent
                      tolerance/tolerance exemption of an active
                      ingredient. SAP review. (5)(12)

     B851      166   Registration application; new event of a     9                                    127,630
                      previously registered PIP active
                      ingredient(s); no petition since permanent
                      tolerance/tolerance exemption is already
                      established for the active ingredient(s).
                      (12)

     B870      167   Registration application; registered (3)     9                                     38,290
                      PIP; new product; new use; no petition
                      since a permanent tolerance/tolerance
                      exemption is already established for the
                      active ingredient(s). (4) (12)

     B880      168   Registration application; registered (3)     9                                     31,910
                      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)

     B881      169   Registration application; registered (3)     15                                    95,724
                      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)

     B882      170   Registration application; new (2) PIP, seed  15                                   191,444
             (new)    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)

     B883      171   Registration application; new (2) PIP, seed  9                                    127,630
                      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)

     B884      172   Registration application; new (2) PIP, seed  12                                   159,537
                      increase with negotiated acreage cap and
                      time-limited registration; with petition
                      to establish a permanent tolerance/
                      tolerance exemption for the active
                      ingredient. (8)(12)

     B885      173   Registration application; registered (3)     6                                     31,910
                      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)

     B886      174   Registration application; new (2) PIP, seed  18                                   223,351
             (new)    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)

     B890      175   Application to amend a seed increase         9                                     63,816
                      registration; converts registration to
                      commercial registration; no petition since
                      permanent tolerance/tolerance exemption is
                      already established for the active
                      ingredient(s). (12)

     B891      176   Application to amend a seed increase         15                                   127,630
                      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)

     B900      177   Application to amend a registration,         6                                     12,764
                      including actions such as extending an
                      expiration date, modifying an IRM plan, or
                      adding an insect to be controlled.
                      (10)(11)(12)

     B901      178   Application to amend a registration,         12                                    76,578
                      including actions such as extending an
                      expiration date, modifying an IRM plan, or
                      adding an insect to be controlled. SAP
                      review. (10) (11) (12)

     B902      179   PIP Protocol review.                         3                                      6,383

     B903      180   Inert ingredient tolerance exemption; e.g.,  6                                     63,816
                      a marker such as NPT II; reviewed in BPPD.

     B904      181   Import tolerance or tolerance exemption;     9                                    127,630
                      processed commodities/food only (inert or
                      active ingredient).

     B905      182   SAP Review.                                  6                                     63,816
             (new)

     B906      183   Petition to establish a temporary tolerance/ 3                                     31,907
             (new)    tolerance exemption for one or more active
                      ingredients.

     B907      184   Petition to establish a temporary tolerance/ 3                                     12,764
             (new)    tolerance exemption for one or more active
                      ingredients based on an existing temporary
                      tolerance/tolerance exemption.

     B908      185   Petition to establish a temporary tolerance/ 3                                     44,671
             (new)    tolerance exemption for one or more active
                      ingredients or inert ingredients.

(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.

                                       "TABLE 18. — INERT INGREDIENTS

                                                                                                  Registration
 EPA  No.    New  CR                    Action                       Decision  Review Time        Service Fee
               No.                                                        (Months)(1)                 ($)

     I001        186   Approval of new food use inert            13                                     27,000
                        ingredient. (2)(3)

     I002        187   Amend currently approved inert            11                                      7,500
                        ingredient tolerance or exemption from
                        tolerance; new data. (2)

     I003        188   Amend currently approved inert            9                                       3,308
                        ingredient tolerance or exemption from
                        tolerance; no new data. (2)

     I004        189   Approval of new non-food use inert        6                                      11,025
                        ingredient. (2)

     I005        190   Amend currently approved non-food use     6                                       5,513
                        inert ingredient with new use pattern;
                        new data. (2)

     I006        191   Amend currently approved non-food use     3                                       3,308
                        inert ingredient with new use pattern;
                        no new data. (2)

     I007        192   Approval of substantially similar non-    4                                       1,654
                        food use inert ingredients when
                        original inert is compositionally
                        similar with similar use pattern. (2)

     I008        193   Approval of new or amended polymer inert  5                                       3,749
                        ingredient, food use. (2)

     I009        194   Approval of new or amended polymer inert  4                                       3,087
                        ingredient, non-food use. (2)

     I010        195   Petition to amend a single tolerance      6                                       1,654
                        exemption descriptor, or single non-
                        food use descriptor, to add  10 CASRNs;
                        no new data. (2)

     I011   196 (new)  Approval of new food use safener with     24                                    597,683
                        tolerance or exemption from tolerance.
                        (2)(8)

     I012   197 (new)  Approval of new non-food use safener.     21                                    415,241
                        (2)(8)

     I013   198 (new)  Approval of additional food use for       15                                     62,975
                        previously approved safener with
                        tolerance or exemption from tolerance.
                        (2)

     I014   199 (new)  Approval of additional non-food use for   15                                     25,168
                        previously approved safener. (2)

     I015   200 (new)  Approval of new generic data for          24                                    269,728
                        previously approved food use safener.
                        (2)

     I016   201 (new)  Approval of amendment(s) to tolerance     13                                     55,776
                        and label for previously approved
                        safener. (2)

(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.

                           "TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS

                                                                                                  Registration
 EPA  No.     New  CR                   Action                       Decision  Review Time        Service Fee
                No.                                                       (Months)(1)                 ($)

     M001         202   Study protocol requiring Human Studies  9                                        7,938
                         Review Board review as defined in 40
                         CFR Part 26 in support of an active
                         ingredient. (4)

     M002         203   Completed study requiring Human         9                                        7,938
                         Studies Review Board review as
                         defined in 40 CFR Part 26 in support
                         of an active ingredient. (4)

     M003         204   External technical peer review of new   12                                      63,945
                         active ingredient, product, or
                         amendment (e.g., consultation with
                         FIFRA Scientific Advisory Panel) for
                         an action with a decision timeframe
                         of less than 12 months. Applicant
                         initiated request based on a
                         requirement of the Administrator, as
                         defined by FIFRA Sec.  25(d), in
                         support of a novel active ingredient,
                         or unique use pattern or application
                         technology. Excludes PIP active
                         ingredients. (5)

     M004         205   External technical peer review of new   18                                      63,945
                         active ingredient, product, or
                         amendment (e.g., consultation with
                         FIFRA Scientific Advisory Panel) for
                         an action with a decision timeframe
                         of greater than 12 months. Applicant
                         initiated request based on a
                         requirement of the Administrator, as
                         defined by FIFRA Sec.  25(d), in
                         support of a novel active ingredient,
                         or unique use pattern or application
                         technology. Excludes PIP active
                         ingredients. (5)

     M005         206   New Product: Combination, Contains a    9                                       22,050
                         combination of active ingredients
                         from a registered and/or unregistered
                         source; conventional, antimicrobial
                         and/or biopesticide. Requires
                         coordination with other regulatory
                         divisions to conduct review of data,
                         label and/or verify the validity of
                         existing data as cited. Only existing
                         uses for each active ingredient in
                         the combination product. (6)(7)

     M006         207   Request for up to 5 letters of          1                                          277
                         certification (Gold Seal) for one
                         actively registered product (excludes
                         distributor products). (8)

     M007         208   Request to extend Exclusive Use of      12                                       5,513
                         data as provided by FIFRA Section
                         3(c)(1)(F)(ii).

     M008         209   Request to grant Exclusive Use of data  15                                       1,654
                         as provided by FIFRA Section
                         3(c)(1)(F)(vi) for a minor use, when
                         a FIFRA Section 2(ll)(2)
                         determination is required.

     M009   210 (new)   Non-FIFRA Regulated Determination:      4                                        2,363
                         Applicant initiated, per product.

     M010   211 (new)   Conditional ruling on pre-application,  4                                        2,363
                         product substantial similarity.

     M011   212 (new)   Label amendment to add the DfE logo;    4                                        3,648
                         requires data review; no other label
                         changes. (9)

(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.".

SEC. 7. 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.

LEGISLATIVE HISTORY

S. 483:

CONGRESSIONAL RECORD, Vol. 165 (2019):

Feb. 14, considered and passed Senate.

Feb. 25, considered and passed House, amended.

Feb. 28, Senate concurred in House amendment.

This work is in the public domain in the U.S. because it is an edict of a government, local or foreign. See § 313.6(C)(2) of the Compendium II: Copyright Office Practices. Such documents include "legislative enactments, judicial decisions, administrative rulings, public ordinances, or similar types of official legal materials" as well as "any translation prepared by a government employee acting within the course of his or her official duties."

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Public domainPublic domainfalsefalse

[T1:1-1] 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.

[T1:2-2] 2.00 ^2.01 ^2.02 ^2.03 ^2.04 ^2.05 ^2.06 ^2.07 ^2.08 ^2.09 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.

[T1:3-3] 3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 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.

[T2:1-4] 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.

[T2:2-5] 2.0 ^2.1 ^2.2 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.

[T2:3-6] 3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 ^3.11 ^3.12 ^3.13 ^3.14 ^3.15 ^3.16 ^3.17 ^3.18 ^3.19 ^3.20 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.

[T2:4-7] 4.00 ^4.01 ^4.02 ^4.03 ^4.04 ^4.05 ^4.06 ^4.07 ^4.08 ^4.09 ^4.10 ^4.11 ^4.12 ^4.13 ^4.14 ^4.15 ^4.16 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.

[T3:1-8] 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.

[T3:2-9] 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.

[T3:3-10] 3.0 ^3.1 ^3.2 ^3.3 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.

[T3:4-11] 4.0 ^4.1 ^4.2 ^4.3 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.

[T4:1-12] 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.

[T4:2-13] 2.00 ^2.01 ^2.02 ^2.03 ^2.04 ^2.05 ^2.06 ^2.07 ^2.08 ^2.09 ^2.10 ^2.11 ^2.12 ^2.13 ^2.14 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.

[T4:3-14] 3.00 ^3.01 ^3.02 ^3.03 ^3.04 ^3.05 ^3.06 ^3.07 ^3.08 ^3.09 ^3.10 ^3.11 ^3.12 ^3.13 ^3.14 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.

[T4:4-15] 4.0 ^4.1 ^4.2 ^4.3 ^4.4 ^4.5 ^4.6 ^4.7 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.

[T5:1-16] 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.

[T5:2-17] 2.0 ^2.1 ^2.2 ^2.3 ^2.4 ^2.5 (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.

[T5:3-18] 3.0 ^3.1 ^3.2 ^3.3 ^3.4 ^3.5 ^3.6 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.

[T5:4-19] 4.0 ^4.1 ^4.2 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.

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