Pesticide registration service fees

7 U.S. Code § 136w-8. Pesticide registration service fees

(a) Definition of costsIn 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) and reporting, auditing, and accounting under this section.
(b) Fees
(1) In general
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.
(2) Covered applications
(A) In general
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 or for any other action covered by a table specified in paragraph (3)(B) shall be subject to a registration service fee under this section.
(B) Existing applications
(i) In general
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.
(ii) Tolerance or exemption fees
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.).
(C) DocumentationAn 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.
(D) Payment
The registration service fee required under this subsection shall be due upon submission of the application.
(E) Applications subject to additional feesAn 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)
on completion of, where appropriate, the initial screening of the contents of the application or the preliminary technical screening of the application, the Administrator determines that a different registration service fee and decision review period apply to the application.
(F) Effect of failure to pay fees
The Administrator shall reject any application submitted without the required registration service fee.
(G) Non-refundable portion of fees
(i) In general
The Administrator shall retain 25 percent of the applicable registration service fee.
(ii) Limitation
Any waiver, refund, credit or other reduction in the registration service fee shall not exceed 75 percent of the registration service fee.
(H) Collection of unpaid fees
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.
(3) Schedule of covered applications and other actions and their registration service fees
(A) Data evaluation recordsAt the decision review time under a fee table specified in subparagraph (B) or as agreed upon under subsection (f)(5), for each covered application under a fee table specified in such subparagraph (B), the Administrator shall—
(i)
complete data evaluation records for studies submitted by the applicant in support of the application; and
(ii)
release those data evaluation records to the applicant, using appropriate protections for confidential business information.
(B) Schedule, actions, and fees
Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:

TABLE 1. — REGISTRATION DIVISION (RD) — NEW ACTIVE INGREDIENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R010

1

New Active Ingredient, Food use. (2)(3)

36

1,079,356

R020

2

New Active Ingredient, Food use; reduced risk. (2)(3)

27

899,464

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)(4)

18

662,883

R060

4

New Active Ingredient, Non-food use; outdoor. (2)(3)

30

749,886

R070

5

New Active Ingredient, Non-food use; outdoor; reduced risk. (2)(3)

24

624,905

R090

6

New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. (3)(4)

16

463,930

R110

7

New Active Ingredient, Non-food use; indoor. (2)(3)(4)

20

417,069

R120

8

New Active Ingredient, Non-food use; indoor; reduced risk. (2)(3)(4)

14

347,556

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)(4)

18

261,322

R122

10

Enriched isomer(s) of registered mixed-isomer active ingredient. (2)(3)

27

454,526

R123

11

New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; non-food use, not requiring a tolerance. (2)(3)

27

676,296

R126

12

(new)

New Active Ingredient, Seed treatment only; limited uptake into raw agricultural commodities; use requiring a tolerance. (2)(3)

31

743,925

R125

13

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)(4)

16

463,930

(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 preliminary technical 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) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 2. — REGISTRATION DIVISION (RD) — NEW USES

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R130

14

First food use; indoor; food/food handling. (2)(3)(5)

23

274,388

R140

15

Additional food use; Indoor; food/food handling. (3)(4)(5)

17

64,028

R150

16

First food use. (2)(3)(5)

23

454,490

R155

17

First food use, Experimental Use Permit application; active ingredient registered for non-food use. (3)(4)(5)

21

378,742

R160

18

First food use; reduced risk. (2)(3)(5)

18

378,742

R170

19

Additional food use. (3)(4)(5)

17

113,728

R175

20

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)(5)

14

94,774

R180

21

Additional food use; reduced risk. (3)(4)(5)

12

94,774

R190

22

Additional food uses; 6 or more submitted in one application. (3)(4)(5)

17

682,357

R200

23

Additional Food Use; 6 or more submitted in one application; Reduced Risk. (3)(4)(5)

12

568,632

R210

24

Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration. (3)(4)(5)

12

70,210

R220

25

Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration. (3)(4)(5)

6

28,434

R230

26

Additional use; non-food; outdoor. (3)(4)(5)

16

45,453

R240

27

Additional use; non-food; outdoor; reduced risk. (3)(4)(5)

10

37,878

R250

28

Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration. (3)(4)(5)

6

28,434

R251

29

Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis. (3)(5)

8

28,434

R260

30

New use; non-food; indoor. (3)(4)(5)

12

21,954

R270

31

New use; non-food; indoor; reduced risk. (3)(4)(5)

9

18,296

R271

32

New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration. (3)(4)(5)

6

13,940

R273

33

Additional use; seed treatment only; use not requiring a new tolerance; includes crops with established tolerances (e.g., for soil or foliar application). (3)(4)(5)

12

72,302

R274

34

Additional use; seed treatment only; 6 or more submitted in one application; uses not requiring new tolerances; includes crops with established tolerances (e.g., for soil or foliar application). (3)(4)(5)

12

433,793

R276

35

(new)

Additional use, seed treatment only; limited uptake into raw agricultural commodities; use requiring a tolerance. (3)(4)(5)

14

79,560

R277

36

(new)

Additional use, seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; use requiring a tolerance. (3)(4)(5)

14

477,360

(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 preliminary technical 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 preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 3. — REGISTRATION DIVISION (RD) — IMPORT AND OTHER TOLERANCES

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R280

37

Establish tolerances for residues in imported commodities; new active ingredient or first food use. (2)

22

457,311

R290

38

Establish tolerances for residues in imported commodities; Additional new food use.

16

91,465

R291

39

Establish tolerances for residues in imported commodities; additional food uses; 6 or more crops submitted in one petition.

16

548,773

R292

40

Amend an established tolerance (e.g., decrease or increase) and/or harmonize established tolerances with Codex Maximum Residue Limits; domestic or import; applicant-initiated.

12

64,987

R293

41

Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated.

13

76,656

R294

42

Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated.

13

459,922

R295

43

Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3)(4)

16

94,774

R296

44

Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; submission of corresponding label amendments which specify the necessary plant-back restrictions; applicant-initiated. (3)(4)

16

568,632

R297

45

Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated.

12

389,897

R298

46

Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3)(4)

14

83,940

R299

47

Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of corresponding amended labels (requiring science review). (3)(4)

14

408,853

R281

48

(new)

Establish tolerances for residues in imported commodities; additional new food use; submission of residue chemistry data review conducted by Codex or other competent national regulatory authority.

12

68,599

R282

49

(new)

Establish tolerances for residues in imported commodities; additional new food uses; 6 or more crops submitted in one petition; submission of residue chemistry data review conducted by Codex or other competent national regulatory authority.

12

411,580

(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 preliminary technical 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 revised use pattern(s) to registered product labels are covered by the base fee for the category. All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the amendment application package is subject to the registration service fee for a new product or a new inert approval. However, if an amendment application only proposes to register the amendment for a new product and there are no amendments in the application, then review of one new product application is covered by the base fee. All such associated applications that are submitted together will be subject to the category decision review time.

TABLE 4. — REGISTRATION DIVISION (RD) — NEW PRODUCTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R300

50

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 child-resistant packaging — 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

2,270

R301

51

New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy (identical data citation and claims to cited product(s)), where applicant does not own all required data and does not have a specific authorization letter from data owner. (2)(3)

4

2,720

R310

52

New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

4.[sic] Child-resistant packaging and/or

4. pest(s) requiring efficacy – for up to 3 target pests. (2)(3)(4)

7

10,466

R314

53

New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. pest(s) requiring efficacy (4) for up to 3 target pests. (2)(3)

8

12,364

R319

54

New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2)(3)

10

18,097

R318

55

New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. pest(s) requiring efficacy – for up to 3 target pests. (2)(3)(4)

9

18,994

R321

56

New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. pest(s) requiring efficacy (4) - for 4 to 7 target pests. (2)(3)

11

24,727

R315

57

New end-use on-animal product, registered source of active ingredient(s) with submission of data and/or waivers for only:

1. animal safety and

2. pest(s) requiring efficacy and/or

3. product chemistry and/or

4. acute toxicity and/or

5. child resistant packaging. (2)(3)(4)

9

14,075

R316

58

New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. pest(s) requiring efficacy - for 4 to 7 target pests. (2)(3)(4)

9

16,199

R317

59

New end-use or manufacturing-use product with registered source(s) of active ingredient(s) including products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; and requires review of data and/or waivers for only:

1. product chemistry and/or

2. acute toxicity and/or

3. child resistant packaging and/or

4. Pest(s) requiring efficacy - for greater than 7 target pests, (2)(3)(4)

10

21,932

R320

60

New product; new physical form; requires data review in science divisions. (2)(3)(5)

12

18,958

R331

61

New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only. (2)(3)

3

3,627

R332

62

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

405,919

R333

63

New product; manufacturing-use product 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)

11

28,434

R334

64

New product; manufacturing-use product or end-use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. (2)(3)

12

33,108

R361

65

(new)

New end-use product containing up to three registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. Child resistant packaging and/or

4. pest(s) requiring efficacy – for more than 7 target pests. (2)(3)(4)

12

23,400

R362

66

(new)

New end-use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

1. product chemistry and/or

2. acute toxicity and/or

3. Child resistant packaging and/or

4. pest(s) requiring efficacy – for more than 7 target pests. (2)(3)(4)

13

25,350

R363

67

(new)

New product; repack of identical registered manufacturing-use product as an end-use product; same registered uses only, with no additional data. (2)(3)

6

7,800

(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) For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations. This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 2002-1. To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each subgroup or specific pest will count as 1.

(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 5. — REGISTRATION DIVISION (RD) — AMENDMENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R340

68

Amendment requiring data review within RD (e.g., changes to precautionary label statements); includes adding/modifying pest(s) claims for up to 2 target pests; excludes products requiring or citing an animal safety study. (2)(3)

4

7,150

R341

69

Amendment requiring data review within RD (e.g., changes to precautionary label statements), includes adding/modifying pest(s) claims for greater than 2 target pests; excludes products requiring or citing an animal safety study. (2)(3)

6

8,584

R345

70

Amending on-animal products previously registered, with the submission of data and/or waivers for only:

1. animal safety and

2. pest(s) requiring efficacy and/or

3. product chemistry and/or

4. acute toxicity and/or

5. child resistant packaging. (2)(3)(4)

7

12,643

R350

71

Amendment requiring data review in science divisions (e.g., changes to Restricted Entry Interval, or Personal Protective Equipment, or Preharvest Interval, or use rate, or number of applications; or add aerial application; or modify Ground Water/Surface Water advisory statement). (2)(3)(5)

9

18,958

R351

72

Amendment adding a new unregistered source of active ingredient. (2)(3)

8

18,958

R352

73

Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. (2)(3)

8

18,958

R371

74

Amendment to Experimental Use Permit; (does not include extending a permit’s time period). (3)

6

14,463

(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 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 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.

(4) For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” are both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, subpart R of part 158 of title 40, Code of Federal Regulations. This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in the Pesticide Registration Notice 2002-1. To determine the number of pests for the PRIA categories, pest groups, subgroups, and pest specific claims as listed in part 158 of title 40, Code of Federal Regulations, should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, etc.), each group will count as 1. If seeking a claim against a pest subgroup (e.g., small biting flies, filth flies, etc.) or specific pests (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each subgroup or specific pest will count as 1.

(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 6. — REGISTRATION DIVISION (RD) — OTHER ACTIONS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

R124

75

Conditional Ruling on Pre-application Study Waivers; applicant-initiated.

6

3,627

R272

76

Review of Study Protocol applicant-initiated; excludes Data Analysis Reporting Tool, pre-registration conference, Rapid Response review, developmental neurotoxicity protocol review, protocol needing Human Studies Review Board review, companion animal safety protocol.

3

3,627

R275

77

Rebuttal of Agency reviewed protocol, applicant initiated.

3

3,627

R278

78

(new)

Review of Protocol for companion animal safety study.

5

4,927

R279

79

(new)

Comparative product determination for reduced risk submission, applicant initiated; submitted before application for reduced risk new active ingredient or reduced risk new use.

3

5,200

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

TABLE 7. — ANTIMICROBIAL DIVISION (AD) — NEW ACTIVE INGREDIENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

A380

80

New Active Ingredient; Indirect Food use; establish tolerance or tolerance exemption if required. (2)(3)(4)

26

227,957

A390

81

New Active Ingredient; Direct Food use; establish tolerance or tolerance exemption if required. (2)(3)(4)

26

329,265

A410

82

New Active Ingredient Non-food use. (2)(3)(4)

23

278,659

A431

83

New Active Ingredient, Non-food use; low-risk. (2)(3)(4)

14

114,984

(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 preliminary technical 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) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 8. — ANTIMICROBIAL DIVISION (AD) — NEW USES

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

A440

84

New Use, Indirect Food Use, establish tolerance or tolerance exemption. (2)(3)(4)(6)

23

45,737

A441

85

Additional Indirect food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3)(4)(5)(6)

23

164,639

A450

86

New use, Direct food use, establish tolerance or tolerance exemption. (2)(3)(4)(6)

23

137,198

A451

87

Additional Direct food uses; establish tolerances or tolerance exemptions if required; 6 or more submitted in one application. (3)(4)(5)(6)

22

261,333

A500

88

New use, non-food. (4)(5)(6)

15

45,737

A501

89

New use, non-food; 6 or more submitted in one application. (4)(5)(6)

17

109,764

(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 preliminary technical 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) 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 preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

(6) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 9. — ANTIMICROBIAL DIVISION (AD) — NEW PRODUCTS AND AMENDMENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

A530

90

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 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

1,833

A531

91

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

2,616

A532

92

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

7,322

A550

93

New end-use product; uses other than FIFRA § 2(mm); non-FQPA product. (2)(3)(5)

9

18,958

A560

94

New manufacturing-use product; registered active ingredient; selective data citation. (2)(3)

6

18,054

A565

95

New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of new generic data package; registered uses only; requires science review. (2)(3)

18

26,135

A572

96

New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to Restricted Entry Interval, or Personal Protective Equipment, or use rate). (2)(3)(4)(7)

9

18,958

A460

97

(new)

New end-use product; FIFRA §2(mm) uses only; 0 to 10 public health organisms. (2)(3)(5)(6)

5

7,322

A461

98

(new)

New end-use product; FIFRA §2(mm) uses only; 11 to 20 public health organisms. (2)(3)(5)(6)

6

10,158

A462

99

(new)

New end-use product; FIFRA §2(mm) uses only; 21 to 30 public health organisms. (2)(3)(5)(6)

7

12,995

A463

100

(new)

New end-use product; FIFRA §2(mm) uses only; 31 to 40 public health organisms. (2)(3)(5)(6)

9

15,831

A464

101

(new)

New end-use product; FIFRA §2(mm) uses only; 41 to 50 public health organisms. (2)(3)(5)(6)

10

18,668

A465

102

(new)

New end-use product; FIFRA §2(mm) uses only; 51 or more public health organisms. (2)(3)(5)(6)

11

21,505

A470

103

(new)

Label amendment requiring data review; 0 to 10 public health organisms. (3)(4)(5)(6)

4

5,493

A471

104

(new)

Label amendment requiring data review; 11 to 20 public health organisms. (3)(4)(5)(6)

5

8,506

A472

105

(new)

Label amendment requiring data review; 21 to 30 public health organisms. (3)(4)(5)(6)

6

10,219

A473

106

(new)

Label amendment requiring data review; 31 to 40 public health organisms. (3)(4)(5)(6)

7

11,933

A474

107

(new)

Label amendment requiring data review; 41 to 50 public health organisms. (3)(4)(5)(6)

8

13,646

A475

108

(new)

Label amendment requiring data review; 51 or more public health organisms. (3)(4)(5)(6)

9

15,766

(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 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 section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (PR) Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

(5) The applicant must identify the substantially similar product if opting to use cite-all or the selective method to support acute toxicity data requirements.

(6) Once an application for an amendment or a new product with public health organisms has been submitted and classified into any of categories A460 through A465 or A470 through A475, additional organisms submitted for the same product before the first application is granted will result in combination and reclassification of both the original and subsequent submissions into the appropriate new category based on the sum of the number of organisms in both submissions. Submission of additional organisms would result in a new PRIA start date and may require additional fees to meet the fee of a new category.

(7) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 10. — ANTIMICROBIAL DIVISION (AD) — EXPERIMENTAL USE PERMITS AND OTHER ACTIONS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

A520

109

Experimental Use Permit application, non-food use. (2)(3)

9

9,151

A521

110

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; applicant-initiated; Tier 1.

6

6,776

A522

111

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; applicant-initiated; Tier 2.

12

17,424

A537

112

New Active Ingredient/New Use, Experimental Use Permit application; Direct food use; Establish tolerance or tolerance exemption if required. Credit 45% of fee toward new active ingredient/new use application that follows. (3)

18

219,512

A538

113

New Active Ingredient/New Use, Experimental Use Permit application; Indirect food use; Establish tolerance or tolerance exemption if required Credit 45% of fee toward new active ingredient/new use application that follows. (3)

18

137,198

A539

114

New Active Ingredient/New Use, Experimental Use Permit application; Nonfood use. Credit 45% of fee toward new active ingredient/new use application that follows. (3)

15

132,094

A529

115

Amendment to Experimental Use Permit; requires data review or risk assessment. (2)(3)

9

16,383

A523

116

Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols).

9

17,424

A571

117

Science reassessment: refined ecological risk, and/or endangered species; applicant-initiated. (3)

18

137,198

A533

118

Exemption from the requirement of an Experimental Use Permit. (2)

4

3,559

A534

119

Rebuttal of Agency reviewed protocol, applicant initiated.

4

6,776

A535

120

Conditional ruling on pre-application study waiver or data bridging argument; applicant-initiated.

6

3,454

A536

121

Conditional ruling on pre-application direct food, indirect food, nonfood use determination; applicant-initiated.

4

3,559

A575

122

(new)

Efficacy similarity determination; if two products can be bridged or if confirmatory efficacy data are needed.

4

3,389

(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.

3) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW ACTIVE INGREDIENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B580

123

New active ingredient; petition to establish a tolerance. (2)(3)(4)

22

73,173

B590

124

New active ingredient; petition to establish a tolerance exemption. (2)(3)(4)

20

45,737

B600

125

New active ingredient; no change to a permanent tolerance or tolerance exemption (includes non-food uses). (2)(3)(4)

15

27,443

B610

126

New active ingredient; Experimental Use Permit application; petition to establish a permanent or temporary tolerance or temporary tolerance exemption. (3)(4)

12

18,296

B620

127

New active ingredient; Experimental Use Permit application; non-food use (includes crop destruct). (3)(4)

9

9,151

(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 preliminary technical 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) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW USES

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B630

128

First food use; petition to establish/amend a tolerance exemption. (2)(4)(5)

13

18,296

B640

129

First food use; petition to establish/amend a tolerance. (2)(4)(5)

19

27,443

B644

130

New use, no change to an established tolerance or tolerance exemption (includes non-food uses). (3)(4)(5)

8

18,296

B645

131

New use; Experimental Use Permit; petition to establish a permanent or temporary tolerance or tolerance exemption. (4)(5)

12

18,296

B646

132

New use; Experimental Use Permit; non-food use (includes crop destruct). (4)(5)

7

9,151

(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 preliminary technical 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 preliminary technical screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

(4) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

(5) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — NEW PRODUCTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B660

133

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 submission or data matrix (or submission of product chemistry data only). (2)(3)

6

1,833

B670

134

New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; (including non-food); Must address Product-Specific Data Requirements. (2)(3)

9

7,322

B672

135

New product; unregistered source of at least one active ingredient (or registered source with new generic data package); no change in an established tolerance or tolerance exemption (including non-food); must address Product-Specific and Generic Data Requirements. (2)(3)

15

13,069

B673

136

New product; 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 support the new product. (2)(3)

12

7,322

B674

137

New product; repack of identical registered end-use product or repack of an end-use product as a manufacturing-use product; same registered uses only. (2)(3)

4

1,833

B677

138

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:

1. product chemistry and/or

2. acute toxicity and/or

3. public health pest efficacy and/or

4. animal safety studies and/or

5. child resistant packaging. (2)(3)

12

12,643

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

TABLE 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — AMENDMENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B621

139

Amendment; Experimental Use Permit; no change to an established temporary or permanent tolerance or tolerance exemption. (3)(4)

7

7,322

B622

140

Amendment; Experimental Use Permit; petition to amend a permanent or temporary tolerance or tolerance exemption. (3)(4)

11

18,296

B641

141

Amendment; changes to an established tolerance or tolerance exemption. (4)

13

18,296

B680

142

Amendment; registered sources of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption; requires data submission. (2)(3)

5

7,322

B681

143

Amendment; unregistered source of active ingredient(s); no change to an established tolerance or tolerance exemption; requires data submission. (2)(3)

7

8,714

B683

144

Amendment; no change to an established tolerance or tolerance exemption; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to Restricted Entry Interval, Personal Protective Equipment, Preharvest Interval). (2)(3)

6

7,322

B684

145

Amending non-food animal product that includes submission of target animal safety data; previously registered. (2)(3)

8

12,643

B685

146

Amendment; add a new biochemical unregistered source of active ingredient or a new microbial production site; requires submission of analysis of samples data and source/production site-specific manufacturing process description. (3)

5

7,322

(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 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 section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (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.

(4) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — STRAIGHT-CHAIN LEPIDOPTERAN PHEROMONES (SCLP)

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B690

147

SCLP; new active ingredient; food or non-food use. (2)(6)(7)

7

3,662

B700

148

SCLP; Experimental Use Permit application; new active ingredient or new use. (6)(7)

7

1,833

B701

149

SCLP; Extend or amend Experimental Use Permit. (6)(7)

4

1,833

B710

150

SCLP; 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 submission or data matrix (or only product chemistry data); (Includes 100% re-pack; repack of registered end-use product as a manufacturing-use product). (3)(6)

4

1,833

B720

151

SCLP; new product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption (including non-food); Must address Product-Specific Data Requirements. (3)(6)

5

1,833

B721

152

SCLP: new product; unregistered source of active ingredient; no change in an established tolerance or tolerance exemption (including non-food); must address Product-Specific and Generic Data Requirements. (3)(6)

7

3,836

B722

153

SCLP; new use and/or amendment; petition to establish a tolerance or tolerance exemption. (4)(5)(6)(7)

7

3,552

B730

154

SCLP; amendment requiring data submission. (4)(6)

5

1,833

(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 preliminary technical 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 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 section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (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 preliminary technical screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

(6) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

(7) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — OTHER ACTIONS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B614

155

Pre-application; Conditional Ruling on rationales for addressing a data requirement in lieu of data; applicant-initiated; applies to one (1) rationale at a time.

3

3,627

B682

156

Protocol review; applicant initiated; excludes time for Human Studies Review Board review (Includes rebuttal of protocol review).

3

3,487

B616

157

(new)

Pre-application; Conditional Ruling on a non-food use determination.

5

4,715

B617

158

(new)

Pre-application; biochemical classification determination.

5

4,715

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

TABLE 17. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION (BPPD) — PLANT-INCORPORATED PROTECTANTS (PIP)

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

B740

159

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 (12);

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)(5)(12)

9

137,198

B750

160

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)(12)

12

182,927

B771

161

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. (5)(12)

13

182,927

B772

162

Application to amend or extend a PIP Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12)

3

18,296

B773

163

Application to amend or extend a PIP Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12)

9

45,737

B780

164

Registration application; new (2) PIP; non-food/feed or food/feed without tolerance petition based on an existing permanent tolerance exemption. (5)(12)(14)

16

228,657

B800

165

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. (5)(12)(14)

17

246,949

B820

166

Registration application; new (2) PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. (5)(12)(14)

19

292,682

B851

167

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). (12)

9

182,927

B870

168

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)(12)(14)

9

54,881

B880

169

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). (5)(6)(7)(12)(14)

9

45,737

B883

170

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. (5)(8)(12)(14)

13

182,927

B884

171

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. (5)(8)(12)(14)

19

228,657

B885

172

Registration application; registered (2) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9)(12)

6

45,737

B890

173

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). (5)(12)(14)

9

91,465

B900

174

Application to amend a registration, including actions such as modifying an IRM plan, or adding an insect to be controlled. (5)(10)(11)(12)

6

18,296

B902

175

PIP Protocol review.

3

9,151

B903

176

Inert ingredient permanent tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD.

12

91,465

B904

177

Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient).

12

182,927

B905

178

FIFRA Scientific Advisory Panel Review.

6

91,465

B906

179

Petition to establish a temporary tolerance/tolerance exemption for one or more active ingredients.

9

45,733

B907

180

Petition to establish a permanent tolerance/tolerance exemption for one or more active ingredients based on an existing temporary tolerance/tolerance exemption.

9

18,296

B909

181

(new)

PIP tolerance exemption determination; applicant-initiated; request to determine if an existing tolerance exemption applies to a PIP.

6

18,296

B910

182

(new)

Biotechnology Notification for small-scale field testing of genetically engineered microbes.

3

9,151

B921

183

(new)

Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B921 fee toward registration application for the new active ingredient that follows (B922). (5)(12)(13)

12

182,927

B922

184

(new)

Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); non-food/feed. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. (5)(12)(13)(14)

16

228,657

B923

185

(new)

Experimental Use Permit application; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. Credit 75% of B923 fee toward registration application for the new active ingredient that follows (B924). (5)(12)(13)(14)

15

228,658

B924

186

(new)

Registration application; new active ingredient; genetic modifications in animals intended for use as a pesticide (e.g., for pest population control); with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. This category would cover substances produced and used in animals that are intended for use as a pesticide, such as for pest population control, including the genetic material in such animals. (5)(12)(13)(14)

19

292,682

B925

187

(new)

Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed; credit 75% of B925 fee toward registration application for the new active ingredient that follows (B926). (5)(12)

11

27,452

B926

188

(new)

Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; non-food/feed. (5)(12)(14)

17

82,329

B927

189

(new)

Experimental Use Permit application; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a temporary or permanent tolerance/tolerance exemption of an active ingredient; credit 75% of B927 fee toward registration application for the new active ingredient that follows (B928). (5)(12)

14

54,889

B928

190

(new)

Registration application; new active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; with petition to establish a permanent tolerance/tolerance exemption of an active ingredient. (5)(12)(14)

22

137,210

B929

191

(new)

Registration application; new product, registered active ingredient; exogenous applications of RNA to elicit the RNA interference pathway in pests; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (5)(12)

10

7,322

B930

192

(new)

Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. (12)

3

18,296

B931

193

(new)

Application to amend or extend a non-PIP Emerging Technologies Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. (12)

9

45,737

B932

194

(new)

Amendment; application to amend a non-PIP Emerging Technologies registration. (4)(5)(12)

6

18,296

(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” means a PIP with an active ingredient that has not been registered.

(3) “Registered PIP” means 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) If, during review of the application, it is determined that review by the FIFRA Scientific Advisory Panel (SAP) is needed, the applicant will submit an application for category B905, which will be processed concurrently, and the decision review time for both applications will be the longer of the two associated applications. The scientific data involved in this category are complex. EPA often seeks technical advice from the SAP on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, 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 Insecticide Resistance Management (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) (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 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 section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under Pesticide Registration (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.

(12) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

(13) This category does not include genetic modifications in animals not intended for use as a pesticide, e.g., genetic modifications in animals intended for food use or animals intended for use as companion animals.

(14) If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.

TABLE 18. — INERT INGREDIENTS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

I001

195

Approval of new food use inert ingredient. (2)(3)

15

38,698

I002

196

Amend currently approved inert ingredient tolerance or exemption from tolerance; new data. (2)

13

10,750

I003

197

Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data. (2)

11

4,742

I004

198

Approval of new non-food use inert ingredient. (2)

6

15,803

I005

199

Amend currently approved non-food use inert ingredient with new use pattern; new data. (2)

6

7,903

I006

200

Amend currently approved non-food use inert ingredient with new use pattern; no new data. (2)

4

4,742

I007

201

Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern. (2)

5

2,371

I008

202

Approval of new or amended polymer inert ingredient, food use. (2)

7

5,374

I009

203

Approval of new or amended polymer inert ingredient, non-food use. (2)

4

4,427

I010

204

Petition to amend a single tolerance exemption descriptor, or single non-food use descriptor, to add ≤ 10 CASRNs; no new data. (2)

7

2,371

I011

205

Approval of new food use safener with tolerance or exemption from tolerance. (2)

26

856,631

I012

206

Approval of new non-food use safener. (2)

21

595,147

I013

207

Approval of additional food use for previously approved safener with tolerance or exemption from tolerance. (2)

17

90,260

I014

208

Approval of additional non-food use for previously approved safener. (2)

15

36,074

I015

209

Approval of new generic data for previously approved food use safener. (2)

26

386,589

I016

210

Approval of amendment(s) to tolerance and label for previously approved safener. (2)

15

79,942

I017

211

(new)

Add new source of previously approved safener.

8

18,958

I018

212

(new)

Petition to add one approved inert ingredient (CASRN) to the Commodity Inert Ingredient List; no data. (4)

3

2,371

(1) A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to end on the next business day.

(2) If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.

(3) If EPA data rules are amended to newly require clearance under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) 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) Due to low fee and short time frame this category is not eligible for small business waivers.

TABLE 19. — EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS

EPA

No.

New

CR

No.

Action

Decision

Review Time

(Months)(1)

Registration

Service Fee

($)

M001

213

Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of a currently registered active ingredient.

14

11,378

M002

214

Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient. (2)

14

11,378

M003

215

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. (3)

12

91,651

M004

216

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. (3)

18

91,651

M005

217

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. (4)(5)(6)

9

31,604

M006

218

Request for up to 5 letters of certification (Gold Seal) for one actively registered product (excludes distributor products). (7)

1

398

M007

219

Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii).

12

7,903

M008

220

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.

15

2,371

M009

221

Non-FIFRA Regulated Determination; applicant-initiated, per product.

6

3,389

M010

222

Conditional ruling on pre-application, product substantial similarity.

4

3,389

M011

223

Label amendment to add the DfE logo; requires data review; no other label changes. (8)

4

5,230

M012

224

(new)

Request for up to 5 letters of certification (Certificate of Establishment) for one actively registered product or one product produced for export (excludes distributor products). (7)

1

398

M013

225

(new)

Cancer reassessment; applicant-initiated.

18

284,144

M014

227

(new)

Pre-application nano-particle determination.

8

17,424

(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) Any other covered application that is associated with and dependent on the review by the Human Studies Review Board 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.

(3) Any other covered application that is associated with and dependent on the FIFRA Scientific Advisory Panel 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.

(4) If another covered application is submitted that depends upon an application to approve an inert ingredient, each application will be subject to its respective registration service fee. The decision review time for both submissions will be the longest of the associated applications. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.

(5) 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.

(6) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

(7) Due to low fee and short time frame this category is not eligible for small business waivers.

(8) This category includes amendments the sole purpose of which is to add “Design for the Environment” (DfE) (or equivalent terms that do not use “safe” or derivatives of “safe”) logos to a label. DfE is a voluntary program. A label bearing a DfE logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet objective, scientific criteria established and widely publicized by EPA.

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