Public Law 116-8

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

(b) .—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) .—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) .—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) .—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) .—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) .—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) .—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) .—
 * "(A) .—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) .—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) .—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) .—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) .—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) .—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) .—
 * "(A) .—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) .—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) .—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 ""; 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 "" and inserting ""; 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) .—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 "" after "";
 * (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) .—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) .—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) .—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) .—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 ".—During fiscal year 2018" and inserting ".—During fiscal year 2024"; and
 * (ii) by striking "2017" and inserting "2023";
 * (B) in subparagraph (B)—
 * (i) by striking ".—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 ".—Effective September 30, 2019" and inserting ".—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 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: product chemistry and/or acute toxicity and/or public health pest efficacy and/ or                       animal safety studies and/or 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.