One Hundred Twelfth Congress of the United States of America
2d Session
Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and twelve
S. 3552
AN ACT
To reauthorize the Federal Insecticide, Fungicide, and Rodenticide Act.
Short title
This Act may be cited as the
Pesticide Registration Improvement
Extension Act of 2012
.
Pesticide registration improvement
Maintenance fees
Fees
Section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)) is amended—
in paragraph (5)—
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.
;
in subparagraph (D)—
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
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.
;
in subparagraph (E)(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
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.
;
in subparagraph (F)—
by striking paragraph (3)
and inserting this paragraph
; and
by striking Humans
and
inserting Human
;
by redesignating subparagraphs (F) through (H) as subparagraphs (G) through (I), respectively;
by inserting after subparagraph (E) the following:
Fee reduction for certain small businesses
Definition
In this subparagraph, the term qualified small business entity means a corporation, partnership, or unincorporated business that—
has 500 or fewer employees;
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
holds not more than 5 pesticide registrations under this paragraph.
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.
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
in subparagraph (I) (as redesignated by
clause (v)), by striking 2012
and inserting
2017
;
in paragraph (6)—
by striking 2014
and
inserting 2019
; and
by striking paragraphs (1) through
(5)
and inserting paragraph (1)
;
by striking paragraphs (1), (2), (3), (4), and (7); and
by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively.
Conforming amendments
Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1) is amended—
in subsection (d)(5)(B)(ii)(III), by
striking subsection (i)(1)
and inserting this
section
;
in subsection (j), by striking
subsection (i)(5)
and inserting subsection
(i)(1)
; and
in subsection (k)(5)—
in the first sentence, by striking
subsection (i)(5)(C)(ii)
and inserting subsection
(i)(1)(C)(ii)
; and
in the third and sixth sentences, by
striking subsection (i)(5)(C)
each place it appears and
inserting subsection (i)(1)(C)
.
Section 33(b)(7)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)(7)(F)) is amended—
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)
;
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
in clause (iv)(II)—
by striking applicable.
and
inserting applicable
; and
by striking revenues
and
inserting revenue
.
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
.
Reregistration and expedited processing fund
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—
by inserting , to enhance the
information systems capabilities to improve the tracking of pesticide
registration decisions,
after paragraph (3)
each place
it appears; and
in clause (i)—
by inserting offset
before
the costs of reregistration
; and
by striking in the same portion as
appropriated funds
.
Expedited processing of similar applications
Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is amended—
in the matter preceding clause (i), by
striking 2008 through 2012, between 1/8 and
1/7
and inserting 2013 through 2017,
between 1/9 and 1/8
;
in clause (i), by striking
new
; and
in clause (ii), by striking any
application
and all that follows through that—
and
inserting any application that—
.
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—
by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively;
by inserting after paragraph (3) the following:
Enhancements of information technology systems for improvement in review of pesticide applications
In general
For each of fiscal years 2013 through 2017, the Administrator shall use not more than $800,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).
Activities
The Administrator shall use amounts made available from the Reregistration and Expedited Processing Fund to improve the information systems capabilities for the Office of Pesticide Programs to enhance tracking of pesticide registration decisions, which shall include—
the electronic tracking of—
registration submissions; and
the status of conditional registrations;
enhancing the database for information regarding endangered species assessments for registration review;
implementing the capability to electronically review labels submitted with registration actions; and
acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions.
; and
in the first sentence of paragraph (6) (as
redesignated by clause (i)), by striking to carry out the goals
established under subsection (l)
and inserting for the purposes
described in paragraphs (2), (3), and (4) and to carry out the goals
established under subsection (l)
.
Pesticide Registration Service Fees
Amount of fees
Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
by striking paragraph (3) and inserting the following:
Schedule of covered applications and registration service fees
Subject to paragraph (6), the schedule of covered pesticide registration applications and corresponding registration service fees shall be as follows:
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
| (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. | ||||
| R010 | 1 | New Active Ingredient, Food use (2) (3) | 24 | 569,221 |
| R020 | 2 | New Active Ingredient, Food use; reduced risk (2) (3) | 18 | 569,221 |
| R040 | 3 | New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 18 | 419,502 |
| R060 | 4 | New Active Ingredient, Non-food use; outdoor (2) (3) | 21 | 395,467 |
| R070 | 5 | New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3) | 16 | 395,467 |
| R090 | 6 | New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) | 16 | 293,596 |
| R110 | 7 | New Active Ingredient, Non-food use; indoor (2) (3) | 20 | 219,949 |
| R120 | 8 | New Active Ingredient, Non-food use; indoor; reduced risk (2) (3) | 14 | 219,949 |
| R121 | 9 | New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 18 | 165,375 |
| R122 | 10 | Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3) | 18 | 287,643 |
| R123 | 11 | New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3) | 18 | 427,991 |
| R125 New | 12 | New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 16 | 293,596 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| R130 | 13 | First food use; indoor; food/food handling (2) (3) | 21 | 173,644 |
| R140 | 14 | Additional food use; Indoor; food/food handling (3) (4) | 15 | 40,518 |
| R150 | 15 | First food use (2) (3) | 21 | 239,684 |
| R160 | 16 | First food use; reduced risk (2) (3) | 16 | 239,684 |
| R170 | 17 | Additional food use (3) (4) | 15 | 59,976 |
| R175 New | 18 | Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4) | 10 | 59,976 |
| R180 | 19 | Additional food use; reduced risk (3) (4) | 10 | 59,976 |
| R190 | 20 | Additional food uses; 6 or more submitted in one application (3) (4) | 15 | 359,856 |
| R200 | 21 | Additional food uses; 6 or more submitted in one application; reduced risk (3) (4) | 10 | 359,856 |
| R210 | 22 | Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration (3) (4) | 12 | 44,431 |
| R220 | 23 | Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration (3) (4) | 6 | 17,993 |
| R230 | 24 | Additional use; non-food; outdoor (3) (4) | 15 | 23,969 |
| R240 | 25 | Additional use; non-food; outdoor; reduced risk (3) (4) | 10 | 23,969 |
| R250 | 26 | Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration (3) (4) | 6 | 17,993 |
| R251 New | 27 | Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis (3) | 8 | 17,993 |
| R260 | 28 | New use; non-food; indoor (3) (4) | 12 | 11,577 |
| R270 | 29 | New use; non-food; indoor; reduced risk (3) (4) | 9 | 11,577 |
| R271 | 30 | New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration (3) (4) | 6 | 8,820 |
| R273 | 31 | Additional 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) | 12 | 45,754 |
| R274 | 32 | Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses (3) (4) | 12 | 274,523 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| R280 | 33 | Establish import tolerance; new active ingredient or first food use (2) | 21 | 289,407 |
| R290 | 34 | Establish import tolerance; additional food use | 15 | 57,882 |
| R291 | 35 | Establish import tolerances; additional food uses; 6 or more crops submitted in one petition | 15 | 347,288 |
| R292 | 36 | Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated | 11 | 41,124 |
| R293 | 37 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated | 12 | 48,510 |
| R294 | 38 | Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated | 12 | 291,060 |
| R295 | 39 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated | 15 | 59,976 |
| R296 | 40 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated | 15 | 359,856 |
| R297 New | 41 | Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated | 11 | 246,744 |
| R298 New | 42 | Amend 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) | 13 | 53,120 |
| R299 New | 43 | Amend 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) | 13 | 258,740 |
| EPA No. | New CR No. | Action | Decision 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. |
||||
| R300 | 44 | New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP – only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) | 4 | 1,434 |
| R301 | 45 | New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; 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) | 4 | 1,720 |
| R310 | 46 | New end-use or manufacturing-use product with
registered source(s) of active ingredient(s); includes products containing two
or more registered active ingredients previously combined in other registered
products; 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) | 7 | 4,807 |
| R314 New | 47 | New 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) | 8 | 6,009 |
| R315 New | 48 | New 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) | 9 | 8,000 |
| R320 | 49 | New product; new physical form; requires data review in science divisions (2) (3) | 12 | 11,996 |
| R331 | 50 | New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) (3) | 3 | 2,294 |
| R332 | 51 | New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions (2) (3) | 24 | 256,883 |
| R333 New | 52 | New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3) | 10 | 17,993 |
| R334 New | 53 | New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2) (3) | 11 | 17,993 |
| EPA No. | New CR No. | Action | Decision 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. |
||||
| R340 | 54 | Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3) | 4 | 3,617 |
| R345 New | 55 | Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3) | 7 | 8,000 |
| R350 | 56 | Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3) | 9 | 11,996 |
| R351 New | 57 | Amendment adding a new unregistered source of active ingredient. (2) (3) | 8 | 11,996 |
| R352 New | 58 | Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data (2) (3) | 8 | 11,996 |
| R371 | 59 | Amendment to Experimental Use Permit; (does not include extending a permit's time period) (3) | 6 | 9,151 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
| (1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. | ||||
| R124 | 60 | Conditional Ruling on Preapplication Study Waivers; applicant-initiated | 6 | 2,294 |
| R272 | 61 | Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review | 3 | 2,294 |
| R275 New | 62 | Rebuttal of agency reviewed protocol, applicant initiated | 3 | 2,294 |
| R370 | 63 | Cancer reassessment; applicant-initiated | 18 | 179,818 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
| (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. | ||||
| A380 | 64 | Food use; establish tolerance exemption (2) (3) | 24 | 104,187 |
| A390 | 65 | Food use; establish tolerance (2) (3) | 24 | 173,644 |
| A400 | 66 | Non-food use; outdoor; FIFRA §2(mm) uses (2) (3) | 18 | 86,823 |
| A410 | 67 | Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3) | 21 | 173,644 |
| A420 | 68 | Non-food use; indoor; FIFRA §2(mm) uses (2) (3) | 18 | 57,882 |
| A430 | 69 | Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3) | 20 | 86,823 |
| A431 | 70 | Non-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) | 12 | 60,638 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| A440 | 71 | First food use; establish tolerance exemption (2) (3) (4) | 21 | 28,942 |
| A450 | 72 | First food use; establish tolerance (2) (3) (4) | 21 | 86,823 |
| A460 | 73 | Additional food use; establish tolerance exemption (3) (4) (5) | 15 | 11,577 |
| A470 | 74 | Additional food use; establish tolerance (3) (4) (5) | 15 | 28,942 |
| A471 New | 75 | Additional food uses; establish tolerances; 6 or more submitted in one application (3) (4) (5) | 15 | 173,652 |
| A480 | 76 | Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5) | 9 | 17,365 |
| A481 New | 77 | Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5) | 9 | 104,190 |
| A490 | 78 | Additional use; non-food; outdoor; uses other than FIFRA §2(mm) (4) (5) | 15 | 28,942 |
| A491 New | 79 | Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5) | 15 | 173,652 |
| A500 | 80 | Additional use; non-food, indoor, FIFRA §2(mm) uses (4) (5) | 9 | 11,577 |
| A501 New | 81 | Additional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5) | 9 | 69,462 |
| A510 | 82 | Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5) | 12 | 11,577 |
| A511 New | 83 | Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5) | 12 | 69,462 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| A530 | 84 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation 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) | 4 | 1,159 |
| A531 | 85 | New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) | 4 | 1,654 |
| A532 | 86 | New 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) | 5 | 4,631 |
| A540 | 87 | New end use product; FIFRA §2(mm) uses only (2) (3) | 5 | 4,631 |
| A550 | 88 | New end-use product; uses other than FIFRA §2(mm); non-FQPA product (2) (3) | 7 | 4,631 |
| A560 | 89 | New manufacturing-use product; registered active ingredient; selective data citation (2) (3) | 12 | 17,365 |
| A570 | 90 | Label amendment requiring data review (3) (4) | 4 | 3,474 |
| A572 New | 91 | New 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) | 9 | 11,996 |
| EPA No. | New CR No. | Action | Decision 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. |
||||
| A520 | 92 | Experimental Use Permit application, Non-Food Use (2) | 9 | 5,789 |
| A521 | 93 | Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1 | 3 | 2,250 |
| A522 | 94 | Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2 | 12 | 11,025 |
| A524 New | 95 | New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) | 18 | 138,916 |
| A525 New | 96 | New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2) | 18 | 83,594 |
| A526 New | 97 | New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) | 15 | 86,823 |
| A527 New | 98 | New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) | 15 | 58,000 |
| A528 New | 99 | Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) | 15 | 20,260 |
| A529 New | 100 | Amendment to Experimental Use Permit; requires data review or risk assessment (2) | 9 | 10,365 |
| A523 New | 101 | Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols) | 9 | 11,025 |
| A571 New | 102 | Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated | 18 | 86,823 |
| EPA No. | New CR No. | Action | Decision 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. |
||||
| B580 | 103 | New active ingredient; food use; petition to establish a tolerance (2) | 19 | 46,305 |
| B590 | 104 | New active ingredient; food use; petition to establish a tolerance exemption (2) | 17 | 28,942 |
| B600 | 105 | New active ingredient; non-food use (2) | 13 | 17,365 |
| B610 | 106 | New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption | 10 | 11,577 |
| B611 New | 107 | New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption | 12 | 11,577 |
| B612 New | 108 | New active ingredient; no change to a permanent tolerance exemption (2) | 10 | 15,918 |
| B613 New | 109 | New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) | 11 | 15,918 |
| B620 | 110 | New active ingredient; Experimental Use Permit application; non-food use including crop destruct | 7 | 5,789 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| B630 | 111 | First food use; petition to establish a tolerance exemption (2) | 13 | 11,577 |
| B631 | 112 | New food use; petition to amend an established tolerance (3) | 12 | 11,577 |
| B640 | 113 | First food use; petition to establish a tolerance (2) | 19 | 17,365 |
| B643 New | 114 | New Food use; petition to amend tolerance exemption (3) | 10 | 11,577 |
| B642 New | 115 | First food use; indoor; food/food handling (2) | 12 | 28,942 |
| B644 New | 116 | New use, no change to an established tolerance or tolerance exemption (3) | 8 | 11,577 |
| B650 | 117 | New use; non-food (3) | 7 | 5,789 |
| EPA No. | New CR No. | Action | Decision 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 | 118 | New 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) | 13 | 11,577 |
| B660 | 119 | New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2) | 4 | 1,159 |
| B670 | 120 | New 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) | 7 | 4,631 |
| B671 | 121 | New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) | 17 | 11,577 |
| B672 | 122 | New 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) | 13 | 8,269 |
| B673 New | 123 | New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2) | 10 | 4,631 |
| B674 New | 124 | New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) | 4 | 1,159 |
| B675 New | 125 | New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2) | 10 | 8,269 |
| B676 New | 126 | New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) | 13 | 8,269 |
| B677 New | 127 | New 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) | 10 | 8,000 |
| EPA No. | New CR No. | Action | Decision 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. |
||||
| B621 | 128 | Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption. | 7 | 4,631 |
| B622 New | 129 | Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. | 11 | 11,577 |
| B641 | 130 | Amendment of an established tolerance or tolerance exemption. | 13 | 11,577 |
| B680 | 131 | Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. (2) | 5 | 4,631 |
| B681 | 132 | Amendment; unregistered source of active ingredient(s). Requires data submission. (2) | 7 | 5,513 |
| B683 New | 133 | Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2) | 6 | 4,631 |
| B684 New | 134 | Amending non-food animal product that includes submission of target animal safety data; previously registered (2) | 8 | 8,000 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| B690 | 135 | New active ingredient; food or non-food use. (2) | 7 | 2,316 |
| B700 | 136 | Experimental Use Permit application; new active ingredient or new use. | 7 | 1,159 |
| B701 | 137 | Extend or amend Experimental Use Permit. | 4 | 1,159 |
| B710 | 138 | New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3) | 4 | 1,159 |
| B720 | 139 | New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3) | 5 | 1,159 |
| B721 | 140 | New product; unregistered source of active ingredient. (3) | 7 | 2,426 |
| B722 | 141 | New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) | 7 | 2,246 |
| B730 | 142 | Label amendment requiring data submission. (4) | 5 | 1,159 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
| (1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to end on the next business day. | ||||
| B614 New | 143 | Conditional Ruling on Preapplication Study Waivers; applicant-initiated | 3 | 2,294 |
| B615 New | 144 | Rebuttal of agency reviewed protocol, applicant initiated | 3 | 2,294 |
| B682 | 145 | Protocol review; applicant initiated; excludes time for HSRB review | 3 | 2,205 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
| (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. |
||||
| B740 | 146 | Experimental Use Permit application;
no petition for tolerance/tolerance exemption. Includes: 1) non-food/feed use(s) for a new (2) or registered (3) PIP; 2) food/feed use(s) for a new or registered PIP with crop destruct; 3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4) | 6 | 86,823 |
| B750 | 147 | Experimental 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) | 9 | 115,763 |
| B770 | 148 | Experimental 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) | 15 | 173,644 |
| B771 | 149 | Experimental 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. | 10 | 115,763 |
| B772 | 150 | Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. | 3 | 11,577 |
| B773 | 151 | Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. | 5 | 28,942 |
| B780 | 152 | Registration application; new (2) PIP; non-food/feed. | 12 | 144,704 |
| B790 | 153 | Registration application; new (2) PIP; non-food/feed; SAP review. (5) | 18 | 202,585 |
| B800 | 154 | Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. | 12 | 231,585 |
| B810 | 155 | Registration 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) | 18 | 289,407 |
| B820 | 156 | Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. | 15 | 289,407 |
| B840 | 157 | Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. (5) | 21 | 347,288 |
| B851 | 158 | Registration 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). | 9 | 115,763 |
| B870 | 159 | Registration 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) | 9 | 34,729 |
| B880 | 160 | Registration 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) | 9 | 28,942 |
| B881 | 161 | Registration 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) | 15 | 86,823 |
| B883 New | 162 | Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8) | 9 | 115,763 |
| B884 New | 163 | Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient. (8) | 12 | 144,704 |
| B885 New | 164 | Registration 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) | 9 | 86,823 |
| B890 | 165 | Application 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). | 9 | 57,882 |
| B891 | 166 | Application 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) | 15 | 115,763 |
| B900 | 167 | Application 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) | 6 | 11,577 |
| B901 | 168 | Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) | 12 | 69,458 |
| B902 | 169 | PIP protocol review | 3 | 5,789 |
| B903 | 170 | Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD. | 6 | 57,882 |
| B904 | 171 | Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient). | 9 | 115,763 |
| EPA No. | New CR No. | Action | Decision 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. | ||||
| I001 | 172 | Approval of new food use inert ingredient (2) (3) | 12 | 18,000 |
| I002 New | 173 | Amend currently approved inert ingredient tolerance or exemption from tolerance; new data (2) | 10 | 5,000 |
| I003 New | 174 | Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data (2) | 8 | 3,000 |
| I004 New | 175 | Approval of new non-food use inert ingredient (2) | 8 | 10,000 |
| I005 New | 176 | Amend currently approved non-food use inert ingredient with new use pattern; new data (2) | 8 | 5,000 |
| I006 New | 177 | Amend currently approved non-food use inert ingredient with new use pattern; no new data (2) | 6 | 3,000 |
| I007 New | 178 | Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern (2) | 4 | 1,500 |
| I008 New | 179 | Approval of new polymer inert ingredient, food use (2) | 5 | 3,400 |
| I009 New | 180 | Approval of new polymer inert ingredient, non food use (2) | 4 | 2,800 |
| I010 New | 181 | Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2) | 6 | 1,500 |
| M001 New | 182 | Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) | 9 | 7,200 |
| M002 New | 183 | Completed study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) | 9 | 7,200 |
| M003 New | 184 | External 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) | 12 | 58,000 |
| M004 New | 185 | External 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) | 18 | 58,000 |
| M005 New | 186 | New 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) | 9 | 20,000 |
| M006 New | 187 | Request for up to 5 letters of certification (Gold Seal) for one actively registered product. | 1 | 250 |
| M007 New | 188 | Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii) | 12 | 5,000 |
| M008 New | 189 | Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required | 10 | 1,500 |
;
in paragraph (6)—
in subparagraph (A)—
by striking October 1, 2008
and inserting October 1, 2013
; and
by striking September 30,
2010
and inserting September 30, 2015
; and
in subparagraph (B)—
by striking October 1, 2010
and inserting October 1, 2015
; and
by striking September 30,
2010
and inserting September 30, 2015
; and
in paragraph (8)(C)(ii)—
in subclause (I), by striking
or
at the end;
in subclause (II), by striking the period
at the end and inserting ; or
; and
by adding at the end the following:
on the basis that the Administrator rejected the application under subsection (f)(4)(B).
.
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—
in clause (i), by striking 2008
through 2012
and inserting 2013 through 2017
;
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
in clause (iii), by striking 2008
through 2012
and inserting 2013 through 2017
.
Assessment of fees
Section 33(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(d)) is amended—
in paragraph (2), by striking
2002
each place it appears and inserting
2012
;
by striking paragraph (4); and
by redesignating paragraph (5) as paragraph (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
.
Decision time review periods
Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)) is amended—
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
;
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
in paragraph (4)—
in subparagraph (A), by inserting
and fee
before the period; and
in subparagraph (B)—
by striking (B)
Completeness of
application
and all that follows through Not
later
in clause (i) and inserting the following:
Initial content and preliminary technical screenings
Screenings
Initial content
Not later
;
in clause (i) (as so designated) by adding at the end the following:
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—
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
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).
;
by striking clause (ii) and inserting the following:
Rejection
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.
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.
;
in clause (iii)—
in the heading, by inserting
initial
content
before screening
;
in the matter preceding subclause (I), by
inserting content
after initial
; and
in subclause (II), by striking
contains
and inserting appears to contain
;
and
by adding at the end the following:
Requirements of preliminary technical screening
In conducting a preliminary technical screening of an application, the Administrator shall determine if—
the application and the data and information submitted with the application are accurate and complete; and
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.
.
Reports
Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
in paragraph (1), by striking March
1, 2014
and inserting March 1, 2017
;
in paragraph (2)—
in subparagraph (A)—
in clause (vi)(V), by striking
and
at the end;
in clause (vii)(II), by inserting
and
at the end; and
by adding at the end the following:
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;
;
in subparagraph (E), by striking
and
at the end;
in subparagraph (F), by striking the period and inserting a semicolon; and
by adding at the end the following:
a review of the progress made toward—
carrying out section 4(k)(4) and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section;
implementing systems for the electronic tracking of registration submissions by December 31, 2013;
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;
implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available;
implementing the capability to electronically submit and review labels submitted with registration actions;
acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and
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;
the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4);
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
an assessment of the public availability of summary pesticide usage data.
; and
by adding at the end the following:
Other report
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—
10 or fewer employees; and
annual global gross revenue that does not exceed $2,000,000.
Information required
In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on—
the number of small businesses described in subparagraph (A) that are paying maintenance fees; and
the number of registrations each company holds.
.
Termination of effectiveness
Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
in paragraph (1), by striking
2012
and inserting 2017
; and
in paragraph (2)—
in subparagraph (A)—
in the heading, by striking
2013
and inserting 2018
;
by striking 2013,
and
inserting 2018,
; and
by striking September 30,
2012
and inserting September 30, 2017
;
in subparagraph (B)—
in the heading, by striking
2014
and inserting 2019
;
by striking 2014,
and
inserting 2019,
; and
by striking September 30,
2012
and inserting September 30, 2017
;
in subparagraph (C)—
in the heading, by striking
2014
and inserting 2019
; and
by striking September 30,
2014
and inserting September 30, 2019
; and
in subparagraph (D), by striking
2012
each place it appears and inserting
2017
.
Effective date
This section and the amendments made by this section take effect on October 1, 2012.
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