In this section, the term "costs", when used with respect to review and decisionmaking pertaining to an application for which registration service fees are paid under this section, means—
(1) costs to the extent that—
(A) officers and employees provide direct support for the review and decisionmaking for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses;
(B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and
(C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications;
(2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and
(3) costs of collecting registration service fees under subsections (b) and (c) of this section and reporting, auditing, and accounting under this section.
Effective beginning on the effective date of the Pesticide Registration Improvement Act of 2003, the Administrator shall assess and collect covered pesticide registration service fees in accordance with this section.
An application for the registration of a pesticide covered by this subchapter that is received by the Administrator on or after the effective date of the Pesticide Registration Improvement Act of 2003 shall be subject to a registration service fee under this section.
Subject to clause (ii), an application for the registration of a pesticide that was submitted to the Administrator before the effective date of the Pesticide Registration Improvement Act of 2003 and is pending on that effective date shall be subject to a service fee under this section if the application is for the registration of a new active ingredient that is not listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.
The amount of any fee otherwise payable for an application described in clause (i) under this section shall be reduced by the amount of any fees paid to support the related petition for a pesticide tolerance or exemption under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
An application subject to a registration service fee under this section shall be submitted with documentation certifying—
(i) payment of the registration service fee; or
(ii) payment of at least 25 percent of the registration service fee and a request for a waiver from or reduction of the remaining amount of the registration service fee.
The registration service fee required under this subsection shall be due upon submission of the application.
An application may be subject to additional fees if—
(i) the applicant identified the incorrect registration service fee and decision review period;
(ii) after review of a waiver request, the Administrator denies the waiver request; or
(iii) after review of the application, the Administrator determines that a different registration service fee and decision review period apply to the application.
The Administrator shall reject any application submitted without the required registration service fee.
The Administrator shall retain 25 percent of the applicable registration service fee.
Any waiver, refund, credit or other reduction in the registration service fee shall not exceed 75 percent of the registration service fee.
In any case in which the Administrator does not receive payment of a registration service fee (or applicable portion of the registration service fee) by the date that is 30 days after the fee is due, the fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
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 ($) |
|---|---|---|---|---|
| R010 | 1 | New Active Ingredient, Food use (2) (3) | 24 | 569,221 |
| R020 | 2 | New Active Ingredient, Food use; reduced risk (2) (3) | 18 | 569,221 |
| R040 | 3 | New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 18 | 419,502 |
| R060 | 4 | New Active Ingredient, Non-food use; outdoor (2) (3) | 21 | 395,467 |
| R070 | 5 | New Active Ingredient, Non-food use; outdoor; reduced risk (2) (3) | 16 | 395,467 |
| R090 | 6 | New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) | 16 | 293,596 |
| R110 | 7 | New Active Ingredient, Non-food use; indoor (2) (3) | 20 | 219,949 |
| R120 | 8 | New Active Ingredient, Non-food use; indoor; reduced risk (2) (3) | 14 | 219,949 |
| R121 | 9 | New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 18 | 165,375 |
| R122 | 10 | Enriched isomer(s) of registered mixed-isomer active ingredient (2) (3) | 18 | 287,643 |
| R123 | 11 | New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3) | 18 | 427,991 |
| R125 New |
12 | New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows (3) | 16 | 293,596 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| R280 | 33 | Establish import tolerance; new active ingredient or first food use (2) | 21 | 289,407 |
| R290 | 34 | Establish import tolerance; additional food use | 15 | 57,882 |
| R291 | 35 | Establish import tolerances; additional food uses; 6 or more crops submitted in one petition | 15 | 347,288 |
| R292 | 36 | Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated | 11 | 41,124 |
| R293 | 37 | Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated | 12 | 48,510 |
| R294 | 38 | Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated | 12 | 291,060 |
| R295 | 39 | Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated | 15 | 59,976 |
| R296 | 40 | Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated | 15 | 359,856 |
| R297 New |
41 | Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated | 11 | 246,744 |
| R298 New |
42 | Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) | 13 | 53,120 |
| R299 New |
43 | Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) | 13 | 258,740 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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: g product chemistry and/org acute toxicity and/org public health pest efficacy and/org 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: g product chemistry and/org acute toxicity and/org public health pest efficacy and/org 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: g product chemistry and/org acute toxicity and/org public health pest efficacy and/org animal safety studies and/org 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 ($) |
|---|---|---|---|---|
| R340 | 54 | Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3) | 4 | 3,617 |
| R345 New |
55 | Amending non-food animal product that includes submission of target animal safety data; previously registered (2) (3) | 7 | 8,000 |
| R350 | 56 | Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3) | 9 | 11,996 |
| R351 New |
57 | Amendment adding a new unregistered source of active ingredient. (2) (3) | 8 | 11,996 |
| R352 New |
58 | Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data (2) (3) | 8 | 11,996 |
| R371 | 59 | Amendment to Experimental Use Permit; (does not include extending a permit's time period) (3) | 6 | 9,151 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| A380 | 64 | Food use; establish tolerance exemption (2) (3) | 24 | 104,187 |
| A390 | 65 | Food use; establish tolerance (2) (3) | 24 | 173,644 |
| A400 | 66 | Non-food use; outdoor; FIFRA §2(mm) uses (2) (3) | 18 | 86,823 |
| A410 | 67 | Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3) | 21 | 173,644 |
| A420 | 68 | Non-food use; indoor; FIFRA §2(mm) uses (2) (3) | 18 | 57,882 |
| A430 | 69 | Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3) | 20 | 86,823 |
| A431 | 70 | Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3) | 12 | 60,638 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| A530 | 84 | New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) | 4 | 1,159 |
| A531 | 85 | New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) | 4 | 1,654 |
| A532 | 86 | New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted (2) (3) | 5 | 4,631 |
| A540 | 87 | New end use product; FIFRA §2(mm) uses only (2) (3) | 5 | 4,631 |
| A550 | 88 | New end-use product; uses other than FIFRA §2(mm); non-FQPA product (2) (3) | 7 | 4,631 |
| A560 | 89 | New manufacturing-use product; registered active ingredient; selective data citation (2) (3) | 12 | 17,365 |
| A570 | 90 | Label amendment requiring data review (3) (4) | 4 | 3,474 |
| A572 New |
91 | New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4) | 9 | 11,996 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| B580 | 103 | New active ingredient; food use; petition to establish a tolerance (2) | 19 | 46,305 |
| B590 | 104 | New active ingredient; food use; petition to establish a tolerance exemption (2) | 17 | 28,942 |
| B600 | 105 | New active ingredient; non-food use (2) | 13 | 17,365 |
| B610 | 106 | New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption | 10 | 11,577 |
| B611 New |
107 | New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption | 12 | 11,577 |
| B612 New |
108 | New active ingredient; no change to a permanent tolerance exemption (2) | 10 | 15,918 |
| B613 New |
109 | New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) | 11 | 15,918 |
| B620 | 110 | New active ingredient; Experimental Use Permit application; non-food use including crop destruct | 7 | 5,789 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| 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: g product chemistry and/org acute toxicity and/org public health pest efficacy and/org animal safety studies and/org child resistant packaging (2) |
10 | 8,000 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| B690 | 135 | New active ingredient; food or non-food use. (2) | 7 | 2,316 |
| B700 | 136 | Experimental Use Permit application; new active ingredient or new use. | 7 | 1,159 |
| B701 | 137 | Extend or amend Experimental Use Permit. | 4 | 1,159 |
| B710 | 138 | New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. (3) | 4 | 1,159 |
| B720 | 139 | New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3) | 5 | 1,159 |
| B721 | 140 | New product; unregistered source of active ingredient. (3) | 7 | 2,426 |
| B722 | 141 | New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) | 7 | 2,246 |
| B730 | 142 | Label amendment requiring data submission. (4) | 5 | 1,159 |
| EPA No. | New CR No. | Action | Decision Review Time (Months) (1) | Registration Service Fee ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| 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 ($) |
|---|---|---|---|---|
| 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 |
An applicant that submitted a registration application to the Administrator before the effective date of the Pesticide Registration Improvement Act of 2003, but that is not required to pay a registration service fee under paragraph (2)(B), may, on a voluntary basis, pay a registration service fee in accordance with paragraph (2)(B).
The Administrator may not compel payment of a registration service fee for an application described in subparagraph (A).
An application for which a voluntary registration service fee is paid under this paragraph shall be submitted with documentation certifying—
(i) payment of the registration service fee; or
(ii) a request for a waiver from or reduction of the registration service fee.
If a pesticide registration application is submitted by a person that paid the fee for the application under paragraph (2), is determined by the Administrator to be complete, and is not approved or is withdrawn (without a waiver or refund), the submission of the same pesticide registration application by the same person (or a licensee, assignee, or successor of the person) shall not be subject to a fee under paragraph (2).
Effective for a covered pesticide registration application received during the period beginning on October 1, 2013, and ending on September 30, 2015, the Administrator shall increase by 5 percent the registration service fee payable for the application under paragraph (3).
Effective for a covered pesticide registration application received on or after October 1, 2015, the Administrator shall increase by an additional 5 percent the registration service fee in effect as of September 30, 2015.
The Administrator shall publish in the Federal Register the revised registration service fee schedules.
An applicant for a covered pesticide registration may request the Administrator to waive or reduce the amount of a registration service fee payable under this section under the circumstances described in subparagraphs (D) through (G).
A request for a waiver from or reduction of the registration service fee shall be accompanied by appropriate documentation demonstrating the basis for the waiver or reduction.
The applicant shall provide to the Administrator a written certification, signed by a responsible officer, that the documentation submitted to support the waiver or reduction request is accurate.
An application shall be subject to the applicable registration service fee payable under paragraph (3) if, at any time, the Administrator determines that—
(I) the documentation supporting the waiver or reduction request is not accurate; or
(II) based on the documentation or any other information, the waiver or reduction should not have been granted or should not be granted.
As soon as practicable, but not later than 60 days, after the date on which the Administrator receives a request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall—
(i) determine whether to grant or deny the request; and
(ii) notify the applicant of the determination.
The Administrator may exempt from, or waive a portion of, the registration service fee for an application for minor uses for a pesticide.
An applicant requesting a waiver or exemption under this subparagraph shall provide supporting documentation that demonstrates, to the satisfaction of the Administrator, that anticipated revenues from the uses that are the subject of the application would be insufficient to justify imposition of the full application fee.
The Administrator shall exempt an application from the registration service fee if the Administrator determines that—
(i) the application is solely associated with a tolerance petition submitted in connection with the Inter-Regional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)); and
(ii) the exemption is in the public interest.
The Administrator shall waive 50 percent of the registration service fees payable by an entity for a covered pesticide registration application under this section if the entity is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application.
The Administrator shall waive 75 percent of the registration service fees payable by an entity under this section if the entity—
(I) is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and
(II) has average annual global gross revenues described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.
The Administrator shall not grant a waiver under this subparagraph if the Administrator determines that the entity submitting the application has been formed or manipulated primarily for the purpose of qualifying for the waiver.
An entity requesting a waiver under this subparagraph shall provide to the Administrator—
(I) documentation demonstrating that the entity is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and
(II) if the entity is requesting a waiver of 75 percent of the applicable registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenue described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.
An agency of the Federal Government or a State government shall be exempt from covered registration service fees under this section.
If, during the first 60 days after the beginning of the applicable decision time review period under subsection (f)(3) of this section, a covered pesticide registration application is withdrawn by the applicant, the Administrator shall refund all but 25 percent.1 of the total registration service fee payable under paragraph (3) for the application.
If a covered pesticide registration application is withdrawn after the first 60 days of the applicable decision time review period, the Administrator shall determine what portion, if any, of the total registration service fee payable under paragraph (3) for the application may be refunded based on the proportion of the work completed at the time of withdrawal.
The Administrator shall—
(I) make the determination described in clause (i) not later than 90 days after the date the application is withdrawn; and
(II) provide any refund as soon as practicable after the determination.
In the case of a pesticide registration application that has been filed with the Administrator and has not been withdrawn by the applicant, but for which the Administrator has not yet made a final determination, the Administrator may refund a portion of a covered registration service fee if the Administrator determines that the refund is justified.
The Administrator may provide a refund for an application under this subparagraph—
(I) on the basis that, in reviewing the application, the Administrator has considered data submitted in support of another pesticide registration application;
(II) on the basis that the Administrator completed portions of the review of the application before the effective date of this section; or
(III) on the basis that the Administrator rejected the application under subsection (f)(4)(B).
In determining whether to grant a refund under this paragraph, the Administrator shall take into account any portion of the registration service fees credited under paragraph (2) or (4).
There is established in the Treasury of the United States a Pesticide Registration Fund to be used in carrying out this section (referred to in this section as the "Fund"), consisting of—
(A) such amounts as are deposited in the Fund under paragraph (2);
(B) any interest earned on investment of amounts in the Fund under paragraph (5); and
(C) any proceeds from the sale or redemption of investments held in the Fund.
Subject to paragraph (4), the Administrator shall deposit fees collected under this section in the Fund.
Subject to subparagraphs (B) and (C) and paragraph (4), the Administrator may make expenditures from the Fund—
(i) to cover the costs associated with the review and decisionmaking pertaining to all applications for which registration service fees have been paid under this section; and
(ii) to otherwise carry out this section.
For each of fiscal years 2013 through 2017, the Administrator shall use approximately 1/17 of the amount in the Fund (but not less than $1,000,000) to enhance scientific and regulatory activities relating to worker protection.
Of the amounts in the Fund, the Administrator shall use for partnership grants, for each of fiscal years 2013 through 2017, $500,000.
Of the amounts in the Fund, the Administrator shall use $500,000 for each of fiscal years 2013 through 2017 to carry out the pesticide safety education program.
The fees authorized by this section and amounts deposited in the Fund—
(A) shall be collected and made available for obligation only to the extent provided in advance in appropriations Acts; and
(B) shall be available without fiscal year limitation.
Amounts in the Fund not currently needed to carry out this section shall be—
(i) maintained readily available or on deposit;
(ii) invested in obligations of the United States or guaranteed by the United States; or
(iii) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.
After consultation with the Secretary of the Treasury, the Administrator may use income from investments described in clauses (ii) and (iii) of subparagraph (A) to carry out this section.
In this subsection, the term "covered functions" means functions of the Office of Pesticide Programs of the Environmental Protection Agency, as identified in key programs and projects of the final operating plan for the Environmental Protection Agency submitted as part of the budget process for fiscal year 2002, regardless of any subsequent transfer of 1 or more of the functions to another office or agency or the subsequent transfer of a new function to the Office of Pesticide Programs.
Registration service fees may not be assessed for a fiscal year under this section unless the amount of appropriations for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2012) of the Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).
Registration service fees authorized by this section shall be available, in the aggregate, only to defray increases in the costs associated with the review and decisionmaking for the review of pesticide registration applications and associated tolerances (including increases in the number of full-time equivalent positions in the Environmental Protection Agency engaged in those activities) over the costs for fiscal year 2002, excluding costs paid from fees appropriated for the fiscal year.
If the Administrator does not assess registration service fees under subsection (b) of this section during any portion of a fiscal year as the result of paragraph (2) and is subsequently permitted to assess the fees under subsection (b) of this section during the fiscal year, the Administrator shall assess and collect the fees, without any modification in rate, at any time during the fiscal year, notwithstanding any provisions of subsection (b) of this section relating to the date fees are to be paid.
To the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks, the Administrator shall identify and evaluate reforms to the pesticide registration process under this subchapter with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Extension Act of 2012 for pesticide registration actions for covered pesticide registration applications (including reduced risk applications).
Not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available a schedule of decision review periods for covered pesticide registration actions and corresponding registration service fees under this subchapter.
The schedule shall be the same as the applicable schedule provided under subsection (b)(3).
The decision time review periods specified in paragraph (1) shall apply to—
(A) covered pesticide registration applications subject to registration service fees under subsection (b)(2) of this section;
(B) covered pesticide registration applications for which an applicant has voluntarily paid registration service fees under subsection (b)(4) of this section; and
(C) covered pesticide registration applications listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.
Except as provided in subparagraphs (C), (D), and (E), in the case of a pesticide registration application accompanied by the registration service fee required under this section, the decision time review period begins 21 days after the date on which the Administrator receives the covered pesticide registration application and fee.
Not later than 21 days after receiving an application and the required registration service fee, the Administrator shall conduct an initial screening of the contents of the application in accordance with clause (iii).
After conducting the initial content screening described in subclause (I) and in accordance with clause (iv), the Administrator shall conduct a preliminary technical screening—
(aa) not later than 45 days after the date on which the decision time review period begins (for applications with decision time review periods of not more than 180 days); and
(bb) not later than 90 days after the date on which the decision time review period begins (for applications with decision time review periods greater than 180 days).
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.
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 conducting an initial content screening of an application, the Administrator shall determine whether—
(I)(aa) the applicable registration service fee has been paid; or
(bb) at least 25 percent of the applicable registration service fee has been paid and the application contains a waiver or refund request for the outstanding amount and documentation establishing the basis for the waiver request; and
(II) the application appears to contain all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.
In conducting a preliminary technical screening of an application, the Administrator shall determine if—
(I) the application and the data and information submitted with the application are accurate and complete; and
(II) the application, data, and information are consistent with the proposed labeling and any proposal for a tolerance or exemption from the requirement for a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), and are such that, subject to full review under the standards of this subchapter, could result in the granting of the application.
In the case of an application submitted with a request for a waiver or reduction of registration service fees under subsection (b)(7) of this section, the decision time review period shall be determined in accordance with this subparagraph.
If the Administrator grants the waiver or reduction request and no additional fee is required, the decision time review period begins on the earlier of—
(I) the date on which the Administrator grants the request; or
(II) the date that is 60 days after the date of receipt of the application.
If the Administrator grants the waiver or reduction request, in whole or in part, but an additional registration service fee is required, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.
If the Administrator denies the waiver or reduction request, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.
The start of the decision time review period for applications described in clause (ii) shall be the date on which the Administrator receives certification of payment of the applicable registration service fee.
Clause (i) applies to—
(I) covered pesticide registration applications for which voluntary fees have been paid under subsection (b)(4) of this section; and
(II) covered pesticide registration applications received on or after the effective date of the Pesticide Registration Improvement Act of 2003 but submitted without the applicable registration service fee required under this section due to the inability of the Administrator to assess fees under subsection (d)(1) of this section.
In the case of a covered pesticide registration application listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency, the decision time review period begins on the date that is 30 days after the effective date of the Pesticide Registration Improvement Act of 2003.
The Administrator and the applicant may mutually agree in writing to extend a decision time review period under this subsection.
Any applicant adversely affected by the failure of the Administrator to make a determination on the application of the applicant for registration of a new active ingredient or new use for which a registration service fee is paid under this section may obtain judicial review of the failure solely under this section.
In an action brought under this subsection, the only issue on review is whether the Administrator failed to make a determination on the application specified in paragraph (1) by the end of the applicable decision time review period required under subsection (f) of this section for the application.
No other action authorized or required under this section shall be judicially reviewable by a Federal or State court.
A person may not obtain judicial review of the failure of the Administrator to make a determination on the application specified in paragraph (1) before the expiration of the 2-year period that begins on the date on which the decision time review period for the application ends.
To be eligible to seek judicial review under this subsection, a person seeking the review shall first request in writing, at least 120 days before filing the complaint for judicial review, a decision review meeting with the Administrator.
The Administrator may not be required or permitted to refund any portion of a registration service fee paid in response to a complaint that the Administrator has failed to make a determination on the covered pesticide registration application specified in paragraph (1) by the end of the applicable decision review period.
The Administrator shall—
(1) provide an annual accounting of the registration service fees paid to the Administrator and disbursed from the Fund, by providing financial statements in accordance with—
(A) the Chief Financial Officers Act of 1990 (Public Law 101–576; 104 Stat. 2838) and amendments made by that Act; and
(B) the Government Management Reform Act of 1994 (Public Law 103–356; 108 Stat. 3410) and amendments made by that Act;
(2) provide an accounting describing expenditures from the Fund authorized under subsection (c) of this section; and
(3) provide an annual accounting describing collections and expenditures authorized under subsection (d) of this section.
For the purpose of section 3515(c) of title 31, the Fund shall be considered a component of an executive agency.
The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this section shall include an analysis of—
(A) the fees collected under subsection (b) of this section and disbursed;
(B) compliance with subsection (f) of this section;
(C) the amount appropriated to meet the requirements of subsection (d)(1) of this section; and
(D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and decisionmaking pertaining to applications under this section.
The Inspector General of the Environmental Protection Agency shall—
(A) conduct the annual audit required under this subsection; and
(B) report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress.
All full-time equivalent positions supported by fees authorized and collected under this section shall not be counted against the agency-wide personnel level goals of the Environmental Protection Agency.
Not later than March 1, 2005, and each March 1 thereafter through March 1, 2017, the Administrator shall publish an annual report describing actions taken under this section.
The report shall include—
(A) a review of the progress made in carrying out each requirement of subsections (e) and (f) of this section, including—
(i) the number of applications reviewed, including the decision times for each application specified in subsection (f) of this section;
(ii) the number of label amendments that have been reviewed using electronic means;
(iii) the amount of money from the Reregistration and Expedited Processing Fund used to carry out inert ingredient review and review of similar applications under section 136a–1(k)(3) of this title;
(iv) the number of applications completed for identical or substantially similar applications under section 136a(c)(3)(B) of this title, including the number of such applications completed within 90 days pursuant to that section;
(v) the number of actions pending in each category of actions described in subsection (f)(3) of this section, as well as the number of inert ingredients;
(vi) to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for—
(I) expanding the use of self-certification in all appropriate areas of the registration process;
(II) providing for accreditation of outside reviewers and the use of outside reviewers to conduct the review of major portions of applications;
(III) reviewing the scope of use of the notification process to cover broader categories of registration actions;
(IV) providing for electronic submission and review of labels, including process improvements to further enhance the procedures used in electronic label review; and
(V) the allowance and use of summaries of acute toxicity studies;
(vii) the use of performance-based contracts, other contracts, and procurement to ensure that—
(I) the goals of this subchapter for the timely review of applications for registration are met; and
(II) the registration program is administered in the most productive and cost effective manner practicable; and
(viii) the number of extensions of decision time review periods agreed to under subsection (f)(5) along with a description of the reason that the Administrator was unable to make a decision within the initial decision time review period;
(B) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications;
(C) a review of the progress in meeting the timeline requirements of section 136a–1(g) of this title;
(D) a review of the progress in carrying out section 136a(g) of this title, including—
(i) the number of pesticides or pesticide cases reviewed;
(ii) a description of the staffing and resources relating to the costs associated with the review and decision making relating to reregistration and registration review for compliance with the deadlines specified in this subchapter;
(iii) to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for—
(I) process improvements in the handling of registration review under section 136a(g) of this title;
(II) providing for accreditation of outside reviewers and the use of outside reviewers in the registration review process; and
(III) streamlining the registration review process, consistent with section 136a(g) of this title;
(E) a review of the progress in meeting the timeline requirements for the review of antimicrobial pesticide products under section 136a(h) of this title;
(F) a review of the progress in carrying out the review of inert ingredients, including the number of applications pending, the number of new applications, the number of applications reviewed, staffing, and resources devoted to the review of inert ingredients and recommendations to improve the timeliness of review of inert ingredients;
(G) a review of the progress made toward—
(i) carrying out section 136a–1(k)(4) of this title and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section;
(ii) implementing systems for the electronic tracking of registration submissions by December 31, 2013;
(iii) implementing a system for tracking the status of conditional registrations, including making nonconfidential information related to the conditional registrations publicly available by December 31, 2013;
(iv) implementing enhancements to the endangered species knowledge database, including making nonconfidential information related to the database publicly available;
(v) implementing the capability to electronically submit and review labels submitted with registration actions;
(vi) acquiring and implementing the capability to electronically assess and evaluate confidential statements of formula submitted with registration actions by December 31, 2014; and
(vii) facilitating public participation in certain registration actions and the registration review process by providing electronic notification to interested parties of additions to the public docket;
(H) the number of applications rejected by the Administrator under the initial content and preliminary technical screening conducted under subsection (f)(4);
(I) a review of the progress made in updating the Pesticide Incident Data System, including progress toward making the information contained in the System available to the public (as the Administrator determines is appropriate); and
(J) an assessment of the public availability of summary pesticide usage data.
The Administrator shall publish a report required by this subsection by such method as the Administrator determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet site of the Environmental Protection Agency.
In addition to the annual report described in paragraph (1), not later than October 1, 2016, the Administrator shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes an analysis of the impact of maintenance fees on small businesses that have—
(i) 10 or fewer employees; and
(ii) annual global gross revenue that does not exceed $2,000,000.
In conducting the analysis described in subparagraph (A), the Administrator shall collect, and include in the report under that subparagraph, information on—
(i) the number of small businesses described in subparagraph (A) that are paying maintenance fees; and
(ii) the number of registrations each company holds.
Nothing in this section affects any other duties, obligations, or authorities established by any other section of this subchapter, including the right to judicial review of duties, obligations, or authorities established by any other section of this subchapter.
Except as provided in paragraph (2), the authority provided by this section terminates on September 30, 2017.
During fiscal year 2018, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 40 percent below the level in effect on September 30, 2017.
During fiscal year 2019, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 70 percent below the level in effect on September 30, 2017.
Effective September 30, 2019, the requirement to pay and collect registration service fees terminates.
In the case of an application received under this section before September 30, 2017, the application shall be reviewed in accordance with subsection (f) of this section.
In the case of an application received under this section on or after September 30, 2017, subsection (f) of this section shall not apply to the application.
(June 25, 1947, ch. 125, §33, as added Pub. L. 108–199, div. G, title V, §501(f)(2), Jan. 23, 2004, 118 Stat. 422; amended Pub. L. 110–94, §5, Oct. 9, 2007, 121 Stat. 1002; Pub. L. 110–193, §1(a), Mar. 6, 2008, 122 Stat. 649; Pub. L. 112–177, §2(a)(2)(B), (b), Sept. 28, 2012, 126 Stat. 1328, 1330.)
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