S. 3552 (112th): Pesticide Registration Improvement Extension Act of 2012

112th Congress, 2011–2013. Text as of Sep 18, 2012 (Passed Congress/Enrolled Bill).

Status & Summary | PDF | Source: GPO

One Hundred Twelfth Congress of the United States of America

2d Session

S. 3552

IN THE SENATE OF THE UNITED STATES

AN ACT

To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.

1.

Short title

This Act may be cited as the Pesticide Registration Improvement Extension Act of 2012.

2.

Pesticide registration improvement

(a)

Maintenance fees

(1)

Fees

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

(A)

in paragraph (5)—

(i)

in subparagraph (C), by striking aggregate amount of and all that follows through the end of the subparagraph and inserting aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017.;

(ii)

in subparagraph (D)—

(I)

in clause (i), by striking shall be and all that follows through the semicolon and inserting shall be $115,500 for each of fiscal years 2013 through 2017;; and

(II)

in clause (ii), by striking shall be and all that follows through the period and inserting shall be $184,800 for each of fiscal years 2013 through 2017.;

(iii)

in subparagraph (E)(i)—

(I)

in subclause (I), by striking shall be and all that follows through the semicolon and inserting shall be $70,600 for each of fiscal years 2013 through 2017;; and

(II)

in subclause (II), by striking shall be and all that follows through the period and inserting shall be $122,100 for each of fiscal years 2013 through 2017.;

(iv)

in subparagraph (F)—

(I)

by striking paragraph (3) and inserting this paragraph; and

(II)

by striking Humans and inserting Human;

(v)

by redesignating subparagraphs (F) through (H) as subparagraphs (G) through (I), respectively;

(vi)

by inserting after subparagraph (E) the following:

(F)

Fee reduction for certain small businesses

(i)

Definition

In this subparagraph, the term qualified small business entity means a corporation, partnership, or unincorporated business that—

(I)

has 500 or fewer employees;

(II)

during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and

(III)

holds not more than 5 pesticide registrations under this paragraph.

(ii)

Waiver

Except as provided in clause (iii), the Administrator shall waive 25 percent of the fee under this paragraph applicable to the first registration of any qualified small business entity under this paragraph.

(iii)

Limitation

The Administrator shall not grant a waiver under clause (ii) to a qualified small business entity if the Administrator determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver.

; and

(vii)

in subparagraph (I) (as redesignated by clause (v)), by striking 2012 and inserting 2017;

(B)

in paragraph (6)—

(i)

by striking 2014 and inserting 2019; and

(ii)

by striking paragraphs (1) through (5) and inserting paragraph (1);

(C)

by striking paragraphs (1), (2), (3), (4), and (7); and

(D)

by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively.

(2)

Conforming amendments

(A)

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

(i)

in subsection (d)(5)(B)(ii)(III), by striking subsection (i)(1) and inserting this section;

(ii)

in subsection (j), by striking subsection (i)(5) and inserting subsection (i)(1); and

(iii)

in subsection (k)(5)—

(I)

in the first sentence, by striking subsection (i)(5)(C)(ii) and inserting subsection (i)(1)(C)(ii); and

(II)

in the third and sixth sentences, by striking subsection (i)(5)(C) each place it appears and inserting subsection (i)(1)(C).

(B)

Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(7)(F)) is amended—

(i)

by striking section 4(i)(5)(E)(ii) each place it appears in clauses (i), (ii)(I), and (iv)(I) and inserting section 4(i)(1)(E)(ii);

(ii)

by striking section 4(i)(5)(E)(ii)(I)(bb) each place it appears in clauses (ii)(II) and (iv)(II) and inserting section 4(i)(1)(E)(ii)(I)(bb); and

(iii)

in clause (iv)(II)—

(I)

by striking applicable. and inserting applicable; and

(II)

by striking revenues and inserting revenue.

(3)

Extension of prohibition on tolerance fees

Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking September 30, 2012 and inserting September 30, 2017.

(4)

Reregistration and expedited processing fund

(A)

Source and use

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

(i)

by inserting , to enhance the information systems capabilities to improve the tracking of pesticide registration decisions, after paragraph (3) each place it appears; and

(ii)

in clause (i)—

(I)

by inserting offset before the costs of reregistration; and

(II)

by striking in the same portion as appropriated funds.

(B)

Expedited processing of similar applications

Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is amended—

(i)

in the matter preceding clause (i), by striking 2008 through 2012, between 1/8 and 1/7 and inserting 2013 through 2017, between 1/9 and 1/8;

(ii)

in clause (i), by striking new; and

(iii)

in clause (ii), by striking any application and all that follows through that— and inserting any application that—.

(C)

Enhancements of information technology systems for improvement in review of pesticide applications

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

(i)

by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively;

(ii)

by inserting after paragraph (3) the following:

(4)

Enhancements of information technology systems for improvement in review of pesticide applications

(A)

In general

For each of fiscal years 2013 through 2017, the Administrator shall use not more than $800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

(B)

Activities

The Administrator shall use amounts made available from the Reregistration and Expedited Processing Fund to improve the information systems capabilities for the Office of Pesticide Programs to enhance tracking of pesticide registration decisions, which shall include—

(i)

the electronic tracking of—

(I)

registration submissions; and

(II)

the status of conditional registrations;

(ii)

enhancing the database for information regarding endangered species assessments for registration review;

(iii)

implementing the capability to electronically review labels submitted with registration actions; and

(iv)

acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions.

; and

(iii)

in the first sentence of paragraph (6) (as redesignated by clause (i)), by striking to carry out the goals established under subsection (l) and inserting for the purposes described in paragraphs (2), (3), and (4) and to carry out the goals established under subsection (l).

(b)

Pesticide Registration Service Fees

(1)

Amount of fees

Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—

(A)

by striking paragraph (3) and inserting the following:

(3)

Schedule of covered applications and registration service fees

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

TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE INGREDIENTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
R0101New Active Ingredient, Food use (2) (3)24569,221
R0202New Active Ingredient, Food use; reduced risk (2) (3)18569,221
R0403New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)18419,502
R0604New Active Ingredient, Non-food use; outdoor (2) (3)21395,467
R0705New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3)16395,467
R0906New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3)16293,596
R1107New Active Ingredient, Non-food use; indoor (2) (3)20219,949
R1208New Active Ingredient, Non-food use; indoor; reduced risk (2) (3)14219,949
R1219New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)18165,375
R12210Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3)18287,643
R12311New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3)18427,991
R125
New
12New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3)16293,596
TABLE 2. — REGISTRATION DIVISION — NEW USES
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
R13013First food use; indoor; food/food handling (2) (3)21173,644
R14014Additional food use; Indoor; food/food handling (3) (4)1540,518
R15015First food use (2) (3)21239,684
R16016First food use; reduced risk (2) (3)16239,684
R17017Additional food use (3) (4)1559,976
R175
New
18Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4)1059,976
R18019Additional food use; reduced risk (3) (4)1059,976
R19020Additional food uses; 6 or more submitted in one application (3) (4)15359,856
R20021Additional food uses; 6 or more submitted in one application; reduced risk (3) (4)10359,856
R21022Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration (3) (4)1244,431
R22023Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration (3) (4)617,993
R23024Additional use; non-food; outdoor (3) (4)1523,969
R24025Additional use; non-food; outdoor; reduced risk (3) (4)1023,969
R25026Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration (3) (4)617,993
R251
New
27Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis (3)817,993
R26028New use; non-food; indoor (3) (4)1211,577
R27029New use; non-food; indoor; reduced risk (3) (4)911,577
R27130New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration (3) (4)68,820
R27331Additional use; seed treatment; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses (3) (4)1245,754
R27432Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses (3) (4)12274,523
TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER TOLERANCES
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
R28033Establish import tolerance; new active ingredient or first food use (2)21289,407
R29034Establish import tolerance; additional food use1557,882
R29135Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 15347,288
R29236Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 1141,124
R29337Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated 1248,510
R29438Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated 12291,060
R29539Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 1559,976
R29640Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated 15359,856
R297
New
41Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated 11246,744
R298
New
42Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)1353,120
R299
New
43Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)13258,740
TABLE 4. — REGISTRATION DIVISION — NEW PRODUCTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
R30044New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP – only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3)41,434
R30145New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3)41,720
R31046New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• child resistant packaging. (2) (3)
74,807
R314
New
47New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• child resistant packaging. (2) (3)
86,009
R315
New
48New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• animal safety studies and/or
• child resistant packaging (2) (3)
98,000
R32049New product; new physical form; requires data review in science divisions (2) (3)1211,996
R33150New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) (3)32,294
R33251New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions (2) (3)24256,883
R333
New
52New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3)1017,993
R334
New
53New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3)1117,993
TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO REGISTRATION
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
R34054Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3) 4 3,617
R345
New
55Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3)78,000
R35056Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3)911,996
R351
New
57Amendment adding a new unregistered source of active ingredient. (2) (3)811,996
R352
New
58Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data (2) (3)811,996
R37159Amendment to Experimental Use Permit; (does not include extending a permit's time period) (3)69,151
TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
R12460Conditional Ruling on Preapplication Study Waivers; applicant-initiated62,294
R27261Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review32,294
R275
New
62Rebuttal of agency reviewed protocol, applicant initiated32,294
R37063Cancer reassessment; applicant-initiated18179,818
TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
A38064Food use; establish tolerance exemption (2) (3)24104,187
A39065Food use; establish tolerance (2) (3)24173,644
A40066Non-food use; outdoor; FIFRA §2(mm) uses (2) (3)1886,823
A41067Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3)21173,644
A42068Non-food use; indoor; FIFRA §2(mm) uses (2) (3)1857,882
A43069Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3)2086,823
A43170Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3)1260,638
TABLE 8. — ANTIMICROBIALS DIVISION — NEW USES
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.
(4) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
A44071First food use; establish tolerance exemption (2) (3) (4) 21 28,942
A45072First food use; establish tolerance (2) (3) (4)2186,823
A46073Additional food use; establish tolerance exemption (3) (4) (5)1511,577
A47074Additional food use; establish tolerance (3) (4) (5)1528,942
A471
New
75Additional food uses; establish tolerances; 6 or more submitted in one application (3) (4) (5)15173,652
A48076Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5)917,365
A481
New
77Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5)9104,190
A49078Additional use; non-food; outdoor; uses other than FIFRA §2(mm) (4) (5)1528,942
A491
New
79Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5)15173,652
A50080Additional use; non-food, indoor, FIFRA §2(mm) uses (4) (5)911,577
A501
New
81Additional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5)969,462
A51082Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5)1211,577
A511
New
83Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5)1269,462
TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND AMENDMENTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
A53084New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3)41,159
A53185New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3)41,654
A53286New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted (2) (3)54,631
A54087New end use product; FIFRA §2(mm) uses only (2) (3)54,631
A55088New end-use product; uses other than FIFRA §2(mm); non-FQPA product (2) (3)74,631
A56089New manufacturing-use product; registered active ingredient; selective data citation (2) (3)1217,365
A57090Label amendment requiring data review (3) (4)43,474
A572
New
91New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4)911,996
TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.
A52092Experimental Use Permit application, Non-Food Use (2)95,789
A52193Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 132,250
A52294Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 21211,025
A524
New
95New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2)18138,916
A525
New
96New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2)1883,594
A526
New
97New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)1586,823
A527
New
98New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)1558,000
A528
New
99Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2)1520,260
A529
New
100Amendment to Experimental Use Permit; requires data review or risk assessment (2)910,365
A523
New
101Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols)911,025
A571
New
102Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated1886,823
TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active 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.
B580103New active ingredient; food use; petition to establish a tolerance (2) 1946,305
B590104New active ingredient; food use; petition to establish a tolerance exemption (2)1728,942
B600105New active ingredient; non-food use (2) 1317,365
B610106New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption 1011,577
B611
New
107New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption1211,577
B612
New
108New active ingredient; no change to a permanent tolerance exemption (2)1015,918
B613
New
109New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2)1115,918
B620110New active ingredient; Experimental Use Permit application; non-food use including crop destruct75,789
TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.
(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.
B630111First food use; petition to establish a tolerance exemption (2)1311,577
B631112New food use; petition to amend an established tolerance (3)1211,577
B640113First food use; petition to establish a tolerance (2) 1917,365
B643
New
114New Food use; petition to amend tolerance exemption (3)1011,577
B642
New
115First food use; indoor; food/food handling (2)1228,942
B644
New
116New use, no change to an established tolerance or tolerance exemption (3)811,577
B650117New use; non-food (3)75,789
TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.
B652
New
118New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply (2)1311,577
B660119New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2)41,159
B670120New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)74,631
B671121New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)1711,577
B672122New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)138,269
B673
New
123New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2)104,631
B674
New
124New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2)41,159
B675
New
125New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2)108,269
B676
New
126New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 138,269
B677
New
127New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only:
• product chemistry and/or
• acute toxicity and/or
• public health pest efficacy and/or
• animal safety studies and/or
• child resistant packaging (2)
108,000
TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
B621128Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption.74,631
B622
New
129Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption.1111,577
B641130Amendment of an established tolerance or tolerance exemption. 1311,577
B680131Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2) 54,631
B681132Amendment; unregistered source of active ingredient(s). Requires data submission. (2) 75,513
B683
New
133Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) 64,631
B684
New
134Amending non-food animal product that includes submission of target animal safety data; previously registered (2) 88,000
TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active 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.
B690135New active ingredient; food or non-food use. (2)72,316
B700136Experimental Use Permit application; new active ingredient or new use. 71,159
B701137Extend or amend Experimental Use Permit.41,159
B710138New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3) 41,159
B720139New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3)51,159
B721140New product; unregistered source of active ingredient. (3) 72,426
B722141New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5)72,246
B730142Label amendment requiring data submission. (4)51,159
TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — OTHER ACT
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
B614
New
143Conditional Ruling on Preapplication Study Waivers; applicant-initiated32,294
B615
New
144Rebuttal of agency reviewed protocol, applicant initiated32,294
B682145Protocol review; applicant initiated; excludes time for HSRB review32,205
TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — PLANT INCORPORATED PROTECTANTS (PIPS)
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) New PIP = a PIP with an active ingredient that has not been registered.
(3) Registered PIP = a PIP with an active ingredient that is currently registered.
(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.
(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed.
(6) Registered PIPs stacked through conventional breeding.
(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
(8) The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category.
(9) Application can be submitted prior to or concurrently with an application for commercial registration.
(10) For example, IRM plan modifications that are applicant-initiated.
(11) EPA-initiated amendments shall not be charged fees.
B740146Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes:
1) non-food/feed use(s) for a new (2) or registered (3) PIP;
2) food/feed use(s) for a new or registered PIP with crop destruct;
3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4)
686,823
B750147Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4)9115,763
B770148Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5)15173,644
B771149Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows.10115,763
B772150Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected.311,577
B773151Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient.528,942
B780152Registration application; new (2) PIP; non-food/feed.12144,704
B790153Registration application; new (2) PIP; non-food/feed; SAP review. (5)18202,585
B800154Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption.12231,585
B810155Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5)18289,407
B820156Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient.15289,407
B840157Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5)21347,288
B851158Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). 9115,763
B870159Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4)934,729
B880160Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (6) (7)928,942
B881161Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review. (5) (6) (7)1586,823
B883
New
162Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8)9115,763
B884
New
163Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8)12144,704
B885
New
164Registration application; registered (3) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9)986,823
B890165Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s).957,882
B891166Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5)15115,763
B900167Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10) (11)611,577
B901168Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11)1269,458
B902169PIP protocol review35,789
B903170Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.657,882
B904171Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).9115,763
TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS
EPA
No.
New
CR
No.
ActionDecision
Review Time
(Months) (1)
Registration
Service Fee
($)
(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day.
(2) If another covered application is associated with and dependent upon a pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the other associated covered application will be extended to match the PRIA due date of the pending inert ingredient action, unless the PRIA due date for the other associated covered action is further out, in which case it will be subject to its own decision review time. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those 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.
I001172Approval of new food use inert ingredient (2) (3) 1218,000
I002
New
173Amend currently approved inert ingredient tolerance or exemption from tolerance; new data (2)105,000
I003
New
174Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data (2)83,000
I004
New
175Approval of new non-food use inert ingredient (2)810,000
I005
New
176Amend currently approved non-food use inert ingredient with new use pattern; new data (2)85,000
I006
New
177Amend currently approved non-food use inert ingredient with new use pattern; no new data (2)63,000
I007
New
178Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern (2)41,500
I008
New
179Approval of new polymer inert ingredient, food use (2)53,400
I009
New
180Approval of new polymer inert ingredient, non food use (2)42,800
I010
New
181Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2)61,500
M001
New
182Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)97,200
M002
New
183Completed study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)97,200
M003
New
184External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)1258,000
M004
New
185External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)1858,000
M005
New
186New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7)920,000
M006
New
187Request for up to 5 letters of certification (Gold Seal) for one actively registered product.1250
M007
New
188Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii)125,000
M008
New
189Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required101,500

;

(B)

in paragraph (6)—

(i)

in subparagraph (A)—

(I)

by striking October 1, 2008 and inserting October 1, 2013; and

(II)

by striking September 30, 2010 and inserting September 30, 2015; and

(ii)

in subparagraph (B)—

(I)

by striking October 1, 2010 and inserting October 1, 2015; and

(II)

by striking September 30, 2010 and inserting September 30, 2015; and

(C)

in paragraph (8)(C)(ii)—

(i)

in subclause (I), by striking or at the end;

(ii)

in subclause (II), by striking the period at the end and inserting ; or; and

(iii)

by adding at the end the following:

(III)

on the basis that the Administrator rejected the application under subsection (f)(4)(B).

.

(2)

Pesticide registration fund

Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)(3)(B)) is amended—

(A)

in clause (i), by striking 2008 through 2012 and inserting 2013 through 2017;

(B)

in clause (ii), by striking grants and all that follows through the end of the clause and inserting grants, for each of fiscal years 2013 through 2017, $500,000.; and

(C)

in clause (iii), by striking 2008 through 2012 and inserting 2013 through 2017.

(3)

Assessment of fees

Section 33(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)) is amended—

(A)

in paragraph (2), by striking 2002 each place it appears and inserting 2012;

(B)

by striking paragraph (4); and

(C)

by redesignating paragraph (5) as paragraph (4).

(4)

Reforms to reduce decision time review periods

Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amended by striking Pesticide Registration Improvement Act of 2003 and inserting Pesticide Registration Improvement Extension Act of 2012.

(5)

Decision time review periods

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

(A)

in paragraph (1), by striking Pesticide Registration Improvement Renewal Act, the Administrator shall publish in the Federal Register and inserting Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available;

(B)

in paragraph (2), by striking appearing in the Congressional Record on pages S10409 and all that follows through the period and inserting provided under subsection (b)(3).; and

(C)

in paragraph (4)—

(i)

in subparagraph (A), by inserting and fee before the period; and

(ii)

in subparagraph (B)—

(I)

by striking (B) Completeness of application and all that follows through Not later in clause (i) and inserting the following:

(B)

Initial content and preliminary technical screenings

(i)

Screenings

(I)

Initial content

Not later

;

(II)

in clause (i) (as so designated) by adding at the end the following:

(II)

Preliminary technical screening

After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening—

(aa)

not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and

(bb)

not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).

;

(III)

by striking clause (ii) and inserting the following:

(ii)

Rejection

(I)

In general

If the Administrator determines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the application failed the initial content or preliminary technical screening and the applicant does not correct the failure before the date that is 10 business days after the applicant receives a notification of the failure, the Administrator shall reject the application.

(II)

Written notification

The Administrator shall make every effort to provide a written notification of a rejection under subclause (I) during the 10-day period that begins on the date the Administrator completes the preliminary technical screening.

;

(IV)

in clause (iii)—

(aa)

in the heading, by inserting initial content before screening ;

(bb)

in the matter preceding subclause (I), by inserting content after initial; and

(cc)

in subclause (II), by striking contains and inserting appears to contain; and

(V)

by adding at the end the following:

(iv)

Requirements of preliminary technical screening

In conducting a preliminary technical screening of an application, the Administrator shall determine if—

(I)

the application and the data and information submitted with the application are accurate and complete; and

(II)

the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this Act, could result in the granting of the application.

.

(6)

Reports

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

(A)

in paragraph (1), by striking March 1, 2014 and inserting March 1, 2017;

(B)

in paragraph (2)—

(i)

in subparagraph (A)—

(I)

in clause (vi)(V), by striking and at the end;

(II)

in clause (vii)(II), by inserting and at the end; and

(III)

by adding at the end the following:

(viii)

the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;

;

(ii)

in subparagraph (E), by striking and at the end;

(iii)

in subparagraph (F), by striking the period and inserting a semicolon; and

(iv)

by adding at the end the following:

(G)

a review of the progress made toward—

(i)

carrying out section 4(k)(4) and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section;

(ii)

implementing systems for the electronic tracking of registration submissions by December 31, 2013;

(iii)

implementing a system for tracking the status of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013;

(iv)

implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available;

(v)

implementing the capability to electronically submit and review labels submitted with registration actions;

(vi)

acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and

(vii)

facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket;

(H)

the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4);

(I)

a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); and

(J)

an assessment of the public availability of summary pesticide usage data.

; and

(C)

by adding at the end the following:

(4)

Other report

(A)

Scope

In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have—

(i)

10 or fewer employees; and

(ii)

annual global gross revenue that does not exceed $2,000,000.

(B)

Information required

In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on—

(i)

the number of small businesses described in subparagraph (A) that are paying maintenance fees; and

(ii)

the number of registrations each company holds.

.

(7)

Termination of effectiveness

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

(A)

in paragraph (1), by striking 2012 and inserting 2017; and

(B)

in paragraph (2)—

(i)

in subparagraph (A)—

(I)

in the heading, by striking 2013 and inserting 2018;

(II)

by striking 2013, and inserting 2018,; and

(III)

by striking September 30, 2012 and inserting September 30, 2017;

(ii)

in subparagraph (B)—

(I)

in the heading, by striking 2014 and inserting 2019;

(II)

by striking 2014, and inserting 2019,; and

(III)

by striking September 30, 2012 and inserting September 30, 2017;

(iii)

in subparagraph (C)—

(I)

in the heading, by striking 2014 and inserting 2019; and

(II)

by striking September 30, 2014 and inserting September 30, 2019; and

(iv)

in subparagraph (D), by striking 2012 each place it appears and inserting 2017.

(c)

Effective date

This section and the amendments made by this section take effect on October 1, 2012.

(d)

Relationship to other law

In the case of any conflict between this section (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 (including any amendments made by such a joint resolution), this section and the amendments made by this section shall control.

Speaker of the House of Representatives

Vice President of the United States and President of the Senate