# Public Law 116-8

Note: This is the original legislation as it was initially enacted. Any subsequent amendments hosted on Wikisource may be listed using What Links Here.
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) | Registration Service Fee ($) |
| R010 | 1 | New Active Ingredient, Food use. | 24 | 753,082 |
| R020 | 2 | New Active Ingredient, Food use; reduced risk. | 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. | 18 | 462,502 |
| R060 | 4 | New Active Ingredient, Non-food use; outdoor. | 21 | 523,205 |
| R070 | 5 | New Active Ingredient, Non-food use; outdoor; reduced risk. | 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. | 16 | 323,690 |
| R110 | 7 | New Active Ingredient, Non-food use; indoor. | 20 | 290,994 |
| R120 | 8 | New Active Ingredient, Non-food use; indoor; reduced risk. | 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. | 18 | 182,327 |
| R122 | 10 | Enriched isomer(s) of registered mixed-isomer active ingredient. | 18 | 317,128 |
| R123 | 11 | New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities. | 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. | 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.
* 1 2 3 4 5 6 7 8 9 10 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.
* 1 2 3 4 5 6 7 8 9 10 11 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) | Registration Service Fee ($) |
| R130 | 13 | First food use; indoor; food/food handling. | 21 | 191,444 |
| R140 | 14 | Additional food use; Indoor; food/food handling. | 15 | 44,672 |
| R150 | 15 | First food use. | 21 | 317,104 |
| R155 | 16 (new) | First food use, Experimental Use Permit application; a.i. registered for non-food outdoor use. | 21 | 264,253 |
| R160 | 17 | First food use; reduced risk. | 16 | 264,253 |
| R170 | 18 | Additional food use. | 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. | 10 | 66,124 |
| R180 | 20 | Additional food use; reduced risk. | 10 | 66,124 |
| R190 | 21 | Additional food uses; 6 or more submitted in one application. | 15 | 476,090 |
| R200 | 22 | Additional Food Use; 6 or more submitted in one application; Reduced Risk. | 10 | 396,742 |
| R210 | 23 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration. | 12 | 48,986 |
| R220 | 24 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration. | 6 | 19,838 |
| R230 | 25 | Additional use; non-food; outdoor. | 15 | 31,713 |
| R240 | 26 | Additional use; non-food; outdoor; reduced risk. | 10 | 26,427 |
| R250 | 27 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration. | 6 | 19,838 |
| R251 | 28 | Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis. | 8 | 19,838 |
| R260 | 29 | New use; nonfood; indoor. | 12 | 15,317 |
| R270 | 30 | New use; nonfood; indoor; reduced risk. | 9 | 12,764 |
| R271 | 31 | New use; nonfood; indoor; Experimental Use Permit application; no credit toward new use registration. | 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. | 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. | 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.
* 1 2 3 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.
* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 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.
* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 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) | Registration Service Fee ($) |
| R280 | 34 | Establish import tolerance; new active ingredient or first food use. | 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. | 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. | 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). | 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). | 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.
* 1 2 3 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.
* 1 2 3 4 Amendment applications to add the revised use pattern(s) to registered product labels are covered by the base fee for the category. All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the amendment application package is subject to the registration service fee for a new product or a new inert approval. However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee. All such associated applications that are submitted together will be subject to the category decision review time.
"TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS :
| EPA No. | New CR No. | Action | Decision Review Time (Months) | 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. | 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. | 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 - for up to 3 target pests. | 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 - for up to 3 target pests. | 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 - for 4 to 7 target pests. | 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 - for up to 3 target pests. | 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 - for 4 to 7 target pests. | 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 and/or product chemistry and/or acute toxicity and/or child resistant packaging. | 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 - for greater than 3 and up to 7 target pests. | 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 - for greater than 7 target pests. | 10 | 15,301 |
| R320 | 55 | New product; new physical form; requires data review in science divisions. | 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. | 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. | 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. | 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. | 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.
* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 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.
* 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 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.
* 1 2 3 4 5 6 7 8 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) | 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. | 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. | 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 and/or product chemistry and/or acute toxicity and/or child resistant packaging. | 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). | 9 | 13,226 |
| R351 | 64 | Amendment adding a new unregistered source of active ingredient. | 8 | 13,226 |
| R352 | 65 | Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. | 8 | 13,226 |
| R371 | 66 | Amendment to Experimental Use Permit; (does not include extending a permit’s time period). | 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.
* 1 2 3 4 5 6 (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.
* 1 2 3 4 5 6 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.
* 1 2 3 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.
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
A440 75 New Use, Indirect Food Use, 21 31,910
A441 76 Additional Indirect food uses; 21 114,870
A450 77 New use, Direct food use, 21 95,724
A451 78 Additional Direct food uses; 21 182,335
A500 79 New use, non-food. (4)(5) 12 31,910
A501 80 New use, non-food; 6 or more 15 76,583
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
(4)(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective
(6) Once a submission for a new product with public health organisms has been submitted and classified in either
(7) Once a submission for a label amendment with public health organisms has been submitted and classified in
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or
(3) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for
(6) Where the action involves approval of a new or amended label, on or before the end date of the decision
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(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
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the
(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,
(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
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
(8) If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended
(2) If another covered application is submitted that depends upon an application to approve an inert ingredient,
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to
(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its
(6) An application for a new end-use product using a source of active ingredient that (a) is not yet registered
(7) Where the action involves approval of a new or amended label, on or before the end date of the decision
(8) Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
(9) This category includes amendments the sole purpose of which is to add DfE (or equivalent terms that do not

## SEC. 7. AGRICULTURAL WORKER PROTECTION STANDARD; CERTIFICATION OF PESTICIDE APPLICATORS.

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")—"
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.).
shall—

## 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.
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