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

Section Text

(a) Definition of costs

In this section, the term "costs", when used with respect to review and decisionmaking pertaining to an application for which registration service fees are paid under this section, means—

(1) costs to the extent that—

(A) officers and employees provide direct support for the review and decisionmaking for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses;

(B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and

(C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered pesticide applications;

(2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources (including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and

(3) costs of collecting registration service fees under subsections (b) and (c) 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 pesticide registration 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 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) Documentation

An application subject to a registration service fee under this section shall be submitted with documentation certifying—

(i) payment of the registration service fee; or

(ii) payment of at least 25 percent of the registration service fee and a request for a waiver from or reduction of the remaining amount of the registration service fee.

(D) Payment

The registration service fee required under this subsection shall be due upon submission of the application.

(E) Applications subject to additional fees

An application may be subject to additional fees if—

(i) the applicant identified the incorrect registration service fee and decision review period;

(ii) after review of a waiver request, the Administrator denies the waiver request; or

(iii) after review of the application, the Administrator determines that a different registration service fee and decision review period apply to the application.

(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 registration service fees

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

TABLE 1. — REGISTRATION DIVISION — NEW ACTIVE INGREDIENTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R010

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

569,221

R020

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

569,221

R040

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)

419,502

R060

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

395,467

R070

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

395,467

R090

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

293,596

R110

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

219,949

R120

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

219,949

R121

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)

165,375

R122

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

287,643

R123

New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities (2) (3)

427,991

R125New

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)

293,596

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

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

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

TABLE 2. — REGISTRATION DIVISION — NEW USES

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R130

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

173,644

R140

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

40,518

R150

First food use (2) (3)

239,684

R160

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

239,684

R170

Additional food use (3) (4)

59,976

R175New

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)

59,976

R180

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

59,976

R190

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

359,856

R200

Additional food uses; 6 or more submitted in one application; reduced risk (3) (4)

359,856

R210

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

44,431

R220

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

17,993

R230

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

23,969

R240

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

23,969

R250

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

17,993

R251New

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

17,993

R260

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

11,577

R270

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

11,577

R271

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

8,820

R273

Additional use; seed treatment; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses (3) (4)

45,754

R274

Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses (3) (4)

274,523

(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.

(4) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

TABLE 3. — REGISTRATION DIVISION — IMPORT AND OTHER TOLERANCES

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R280

Establish import tolerance; new active ingredient or first food use (2)

289,407

R290

Establish import tolerance; additional food use

57,882

R291

Establish import tolerances; additional food uses; 6 or more crops submitted in one petition

347,288

R292

Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated

41,124

R293

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

48,510

R294

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

291,060

R295

Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated

59,976

R296

Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated

359,856

R297New

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

246,744

R298New

Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)

53,120

R299New

Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3)

258,740

(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 4. — REGISTRATION DIVISION — NEW PRODUCTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R300

New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP – only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3)

1,434

R301

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

1,720

R310

New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • child resistant packaging. (2) (3)

4,807

R314New

New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • child resistant packaging. (2) (3)

6,009

R315New

New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • animal safety studies and/or • child resistant packaging (2) (3)

8,000

R320

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

11,996

R331

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

2,294

R332

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)

256,883

R333New

New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3)

17,993

R334New

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

17,993

(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.

TABLE 5. — REGISTRATION DIVISION — AMENDMENTS TO REGISTRATION

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R340

Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3)

3,617

R345New

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

8,000

R350

Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3)

11,996

R351New

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

11,996

R352New

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

11,996

R371

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

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) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

TABLE 6. — REGISTRATION DIVISION — OTHER ACTIONS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

R124

Conditional Ruling on Preapplication Study Waivers; applicant-initiated

2,294

R272

Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review

2,294

R275New

Rebuttal of agency reviewed protocol, applicant initiated

2,294

R370

Cancer reassessment; applicant-initiated

179,818

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

TABLE 7. — ANTIMICROBIALS DIVISION — NEW ACTIVE INGREDIENTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

A380

Food use; establish tolerance exemption (2) (3)

104,187

A390

Food use; establish tolerance (2) (3)

173,644

A400

Non-food use; outdoor; FIFRA §2(mm) uses (2) (3)

86,823

A410

Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3)

173,644

A420

Non-food use; indoor; FIFRA §2(mm) uses (2) (3)

57,882

A430

Non-food use; indoor; uses other than FIFRA §2(mm) (2) (3)

86,823

A431

Non-food use; indoor; low-risk, low-toxicity food-grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3)

60,638

(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 8. — ANTIMICROBIALS DIVISION — NEW USES

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

A440

First food use; establish tolerance exemption (2) (3) (4)

28,942

A450

First food use; establish tolerance (2) (3) (4)

86,823

A460

Additional food use; establish tolerance exemption (3) (4) (5)

11,577

A470

Additional food use; establish tolerance (3) (4) (5)

28,942

A471New

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

173,652

A480

Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5)

17,365

A481New

Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5)

104,190

A490

Additional use; non-food; outdoor; uses other than FIFRA §2(mm) (4) (5)

28,942

A491New

Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5)

173,652

A500

Additional use; non-food, indoor, FIFRA §2(mm) uses (4) (5)

11,577

A501New

Additional non-food; indoor; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5)

69,462

A510

Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5)

11,577

A511New

Additional non-food; indoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5)

69,462

(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.

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.

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

(5) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

TABLE 9. — ANTIMICROBIALS DIVISION — NEW PRODUCTS AND AMENDMENTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

A530

New product; identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation when applicant owns all required data, or applicant submits specific authorization letter for data owner. Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3)

1,159

A531

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)

1,654

A532

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)

4,631

A540

New end use product; FIFRA §2(mm) uses only (2) (3)

4,631

A550

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

4,631

A560

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

17,365

A570

Label amendment requiring data review (3) (4)

3,474

A572New

New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4)

11,996

(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.

(4) (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

TABLE 10. — ANTIMICROBIALS DIVISION — EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

A520

Experimental Use Permit application, Non-Food Use (2)

5,789

A521

Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1

2,250

A522

Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2

11,025

A524New

New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2)

138,916

A525New

New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows. (2)

83,594

A526New

New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)

86,823

A527New

New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2)

58,000

A528New

Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2)

20,260

A529New

100

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

10,365

A523New

101

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

11,025

A571New

102

Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated

86,823

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

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

TABLE 11. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B580

103

New active ingredient; food use; petition to establish a tolerance (2)

46,305

B590

104

New active ingredient; food use; petition to establish a tolerance exemption (2)

28,942

B600

105

New active ingredient; non-food use (2)

17,365

B610

106

New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption

11,577

B611New

107

New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption

11,577

B612New

108

New active ingredient; no change to a permanent tolerance exemption (2)

15,918

B613New

109

New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2)

15,918

B620

110

New active ingredient; Experimental Use Permit application; non-food use including crop destruct

5,789

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

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

TABLE 12. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B630

111

First food use; petition to establish a tolerance exemption (2)

11,577

B631

112

New food use; petition to amend an established tolerance (3)

11,577

B640

113

First food use; petition to establish a tolerance (2)

17,365

B643New

114

New Food use; petition to amend tolerance exemption (3)

11,577

B642New

115

First food use; indoor; food/food handling (2)

28,942

B644New

116

New use, no change to an established tolerance or tolerance exemption (3)

11,577

B650

117

New use; non-food (3)

5,789

(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.

(3) Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the new use(s). All items in the covered application must be submitted together in one package. Each application for an additional new product registration and new inert approval(s) that is submitted in the new use application package is subject to the registration service fee for a new product or a new inert approval. However, if a new use application only proposes to register the new use for a new product and there are no amendments in the application, then review of one new product application is covered by the new use fee. All such associated applications that are submitted together will be subject to the new use decision review time. Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to submission of the new use application and (b) prior to conclusion of its decision review time and (c) containing the same new uses, will be deemed a separate new-use application, subject to a separate registration service fee and new decision review time for a new use. If the new-use application includes non-food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use and the longest decision review time applies to all of the new uses requested in the application. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new use application.

TABLE 13. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B652New

118

New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply (2)

11,577

B660

119

New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. (2)

1,159

B670

120

New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)

4,631

B671

121

New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)

11,577

B672

122

New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)

8,269

B673New

123

New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. (2)

4,631

B674New

124

New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2)

1,159

B675New

125

New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2)

8,269

B676New

126

New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: 1) submission of product specific data, and 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2)

8,269

B677New

127

8,000

(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 14. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B621

128

Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption.

4,631

B622New

129

Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption.

11,577

B641

130

Amendment of an established tolerance or tolerance exemption.

11,577

B680

131

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

4,631

B681

132

Amendment; unregistered source of active ingredient(s). Requires data submission. (2)

5,513

B683New

133

Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). (2)

4,631

B684New

134

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

8,000

(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 15. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES(SCLPS)

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B690

135

New active ingredient; food or non-food use. (2)

2,316

B700

136

Experimental Use Permit application; new active ingredient or new use.

1,159

B701

137

Extend or amend Experimental Use Permit.

1,159

B710

138

1,159

B720

139

New product; registered source of active ingredient(s); requires: 1) submission of product specific data; or 2) citation of previously reviewed and accepted data; or 3) submission or citation of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (3)

1,159

B721

140

New product; unregistered source of active ingredient. (3)

2,426

B722

141

New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5)

2,246

B730

142

Label amendment requiring data submission. (4)

1,159

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

(2) All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a first food use are covered by the base fee for that new active ingredient or first food use application and retain the same decision time review period as the new active ingredient or first food use application. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. Each application for an additional new product registration and new inert approval that is submitted in the new active ingredient application package or first food use application package is subject to the registration service fee for a new product or a new inert approval. All such associated applications that are submitted together will be subject to the new active ingredient or first food use decision review time, except where the new inert approval decision review time is greater than that for the new active ingredient, in which case the associated new active ingredient will be subject to the new inert approval decision review time. In the case of a new active ingredient application, until that new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision review time for a new active ingredient. In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use. Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

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

TABLE 16. — BIOPESTICIDES AND POLLUTION PREVENTION DIVISION — OTHER ACT

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B614New

143

Conditional Ruling on Preapplication Study Waivers; applicant-initiated

2,294

B615New

144

Rebuttal of agency reviewed protocol, applicant initiated

2,294

B682

145

Protocol review; applicant initiated; excludes time for HSRB review

2,205

(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 — PLANT INCORPORATED PROTECTANTS (PIPS)

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

B740

146

Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: 1) non-food/feed use(s) for a new (2) or registered (3) PIP; 2) food/feed use(s) for a new or registered PIP with crop destruct; 3) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s). (4)

86,823

B750

147

Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4)

115,763

B770

148

Experimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5)

173,644

B771

149

115,763

B772

150

Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected.

11,577

B773

151

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

28,942

B780

152

Registration application; new (2) PIP; non-food/feed.

144,704

B790

153

Registration application; new (2) PIP; non-food/feed; SAP review. (5)

202,585

B800

154

Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption.

231,585

B810

155

Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. (5)

289,407

B820

156

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

289,407

B840

157

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

347,288

B851

158

Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s).

115,763

B870

159

Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4)

34,729

B880

160

Registration application; registered (3) PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (6) (7)

28,942

B881

161

86,823

B883New

162

Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. (8)

115,763

B884New

163

144,704

B885New

164

Registration application; registered (3) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9)

86,823

B890

165

Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s).

57,882

B891

166

Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review. (5)

115,763

B900

167

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

11,577

B901

168

Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11)

69,458

B902

169

PIP protocol review

5,789

B903

170

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

57,882

B904

171

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

115,763

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

(2) New PIP = a PIP with an active ingredient that has not been registered.

(3) Registered PIP = a PIP with an active ingredient that is currently registered.

(4) Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet corn.

(5) The scientific data involved in this category are complex. EPA often seeks technical advice from the Scientific Advisory Panel on risks that pesticides pose to wildlife, farm workers, pesticide applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare for meetings with the SAP, additional time and costs are needed.

(6) Registered PIPs stacked through conventional breeding.

(7) Deployment of a registered PIP with a different IRM plan (e.g., seed blend).

(8) The negotiated acreage cap will depend upon EPA’s determination of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resistance management data, which is usually not required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission of a registration application in this category.

(9) Application can be submitted prior to or concurrently with an application for commercial registration.

(10) For example, IRM plan modifications that are applicant-initiated.

(11) EPA-initiated amendments shall not be charged fees.

TABLE 18. — INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS

EPANo.

New_CR_No.

Action

Decision_Review Time_(Months) (1)

Registration_Service Fee_($)

I001

172

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

18,000

I002New

173

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

5,000

I003New

174

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

3,000

I004New

175

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

10,000

I005New

176

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

5,000

I006New

177

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

3,000

I007New

178

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

1,500

I008New

179

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

3,400

I009New

180

Approval of new polymer inert ingredient, non food use (2)

2,800

I010New

181

Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2)

1,500

M001New

182

Study protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)

7,200

M002New

183

Completed study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4)

7,200

M003New

184

External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA §25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)

58,000

M004New

185

External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA §25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. (5)

58,000

M005New

186

New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7)

20,000

M006New

187

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

250

M007New

188

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

5,000

M008New

189

Request to grant Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(vi) for a minor use, when a FIFRA Section 2(ll)(2) determination is required

1,500

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

(2) If another covered application is associated with and dependent upon a pending application for an inert ingredient action, each application will be subject to its respective registration service fee. The decision review time for the other associated covered application will be extended to match the PRIA due date of the pending inert ingredient action, unless the PRIA due date for the other associated covered action is further out, in which case it will be subject to its own decision review time. If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.

(4) Any other covered application that is associated with and dependent on the HSRB review will be subject to its separate registration service fee. The decision review times for the associated actions run concurrently, but will end at the date of the latest review time.

(5) Any other covered application that is associated with and dependent on the SAP review will be subject to its separate registration service fee. The decision review time for the associated action will be extended by the decision review time for the SAP review.

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

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

(4) Pending pesticide registration applications (A) In general

An applicant that submitted a registration application to the Administrator before the effective date of the Pesticide Registration Improvement Act of 2003, but that is not required to pay a registration service fee under paragraph (2)(B), may, on a voluntary basis, pay a registration service fee in accordance with paragraph (2)(B).

(B) Voluntary fee

The Administrator may not compel payment of a registration service fee for an application described in subparagraph (A).

(C) Documentation

An application for which a voluntary registration service fee is paid under this paragraph shall be submitted with documentation certifying—

(i) payment of the registration service fee; or

(ii) a request for a waiver from or reduction of the registration service fee.

(5) Resubmission of pesticide registration applications

If a pesticide registration application is submitted by a person that paid the fee for the application under paragraph (2), is determined by the Administrator to be complete, and is not approved or is withdrawn (without a waiver or refund), the submission of the same pesticide registration application by the same person (or a licensee, assignee, or successor of the person) shall not be subject to a fee under paragraph (2).

(6) Fee adjustment (A) In general

Effective for a covered pesticide registration application received during the period beginning on October 1, 2013, and ending on September 30, 2015, the Administrator shall increase by 5 percent the registration service fee payable for the application under paragraph (3).

(B) Additional adjustment

Effective for a covered pesticide registration application received on or after October 1, 2015, the Administrator shall increase by an additional 5 percent the registration service fee in effect as of September 30, 2015.

(C) Publication

The Administrator shall publish in the Federal Register the revised registration service fee schedules.

(7) Waivers and reductions (A) In general

An applicant for a covered pesticide registration may request the Administrator to waive or reduce the amount of a registration service fee payable under this section under the circumstances described in subparagraphs (D) through (G).

(B) Documentation (i) In general

A request for a waiver from or reduction of the registration service fee shall be accompanied by appropriate documentation demonstrating the basis for the waiver or reduction.

(ii) Certification

The applicant shall provide to the Administrator a written certification, signed by a responsible officer, that the documentation submitted to support the waiver or reduction request is accurate.

(iii) Inaccurate documentation

An application shall be subject to the applicable registration service fee payable under paragraph (3) if, at any time, the Administrator determines that—

(I) the documentation supporting the waiver or reduction request is not accurate; or

(II) based on the documentation or any other information, the waiver or reduction should not have been granted or should not be granted.

(C) Determination to grant or deny request

As soon as practicable, but not later than 60 days, after the date on which the Administrator receives a request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall—

(i) determine whether to grant or deny the request; and

(ii) notify the applicant of the determination.

(D) Minor uses (i) In general

The Administrator may exempt from, or waive a portion of, the registration service fee for an application for minor uses for a pesticide.

(ii) Supporting documentation

An applicant requesting a waiver or exemption under this subparagraph shall provide supporting documentation that demonstrates, to the satisfaction of the Administrator, that anticipated revenues from the uses that are the subject of the application would be insufficient to justify imposition of the full application fee.

(E) IR–4 exemption

The Administrator shall exempt an application from the registration service fee if the Administrator determines that—

(i) the application is solely associated with a tolerance petition submitted in connection with the Inter-Regional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)); 1 and

(ii) the exemption is in the public interest.

(F) Small businesses (i) In general

The Administrator shall waive 50 percent of the registration service fees payable by an entity for a covered pesticide registration application under this section if the entity is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application.

(ii) Waiver of fees

The Administrator shall waive 75 percent of the registration service fees payable by an entity under this section if the entity—

(I) is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and

(II) has average annual global gross revenues described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.

(iii) Formation for waiver

The Administrator shall not grant a waiver under this subparagraph if the Administrator determines that the entity submitting the application has been formed or manipulated primarily for the purpose of qualifying for the waiver.

(iv) Documentation

An entity requesting a waiver under this subparagraph shall provide to the Administrator—

(I) documentation demonstrating that the entity is a small business (as defined in section 136a–1(i)(1)(E)(ii) of this title) at the time of application; and

(II) if the entity is requesting a waiver of 75 percent of the applicable registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenue described in section 136a–1(i)(1)(E)(ii)(I)(bb) of this title that does not exceed $10,000,000, at the time of application.

(G) Federal and State agency exemptions

An agency of the Federal Government or a State government shall be exempt from covered registration service fees under this section.

(8) Refunds (A) Early withdrawals

If, during the first 60 days after the beginning of the applicable decision time review period under subsection (f)(3), a covered pesticide registration application is withdrawn by the applicant, the Administrator shall refund all but 25 percent.2 of the total registration service fee payable under paragraph (3) for the application.

(B) Withdrawals after the first 60 days of decision review time period (i) In general

If a covered pesticide registration application is withdrawn after the first 60 days of the applicable decision time review period, the Administrator shall determine what portion, if any, of the total registration service fee payable under paragraph (3) for the application may be refunded based on the proportion of the work completed at the time of withdrawal.

(ii) Timing

The Administrator shall—

(I) make the determination described in clause (i) not later than 90 days after the date the application is withdrawn; and

(II) provide any refund as soon as practicable after the determination.

(C) Discretionary refunds (i) In general

In the case of a pesticide registration application that has been filed with the Administrator and has not been withdrawn by the applicant, but for which the Administrator has not yet made a final determination, the Administrator may refund a portion of a covered registration service fee if the Administrator determines that the refund is justified.

(ii) Basis

The Administrator may provide a refund for an application under this subparagraph—

(I) on the basis that, in reviewing the application, the Administrator has considered data submitted in support of another pesticide registration application;

(II) on the basis that the Administrator completed portions of the review of the application before the effective date of this section; or

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

(D) Credited fees

In determining whether to grant a refund under this paragraph, the Administrator shall take into account any portion of the registration service fees credited under paragraph (2) or (4).

(c) Pesticide Registration Fund (1) Establishment

There is established in the Treasury of the United States a Pesticide Registration Fund to be used in carrying out this section (referred to in this section as the "Fund"), consisting of—

(A) such amounts as are deposited in the Fund under paragraph (2);

(B) any interest earned on investment of amounts in the Fund under paragraph (5); and

(2) Deposits in Fund

Subject to paragraph (4), the Administrator shall deposit fees collected under this section in the Fund.

(3) Expenditures from Fund (A) In general

Subject to subparagraphs (B) and (C) and paragraph (4), the Administrator may make expenditures from the Fund—

(i) to cover the costs associated with the review and decisionmaking pertaining to all applications for which registration service fees have been paid under this section; and

(ii) to otherwise carry out this section.

(B) Worker protection (i) In general

For each of fiscal years 2013 through 2017, the Administrator shall use approximately 1/17 of the amount in the Fund (but not less than $1,000,000) to enhance scientific and regulatory activities relating to worker protection.

(ii) Partnership grants

Of the amounts in the Fund, the Administrator shall use for partnership grants, for each of fiscal years 2013 through 2017, $500,000.

(iii) Pesticide safety education program

Of the amounts in the Fund, the Administrator shall use $500,000 for each of fiscal years 2013 through 2017 to carry out the pesticide safety education program.

(4) Collections and appropriations Acts

The fees authorized by this section and amounts deposited in the Fund—

(A) shall be collected and made available for obligation only to the extent provided in advance in appropriations Acts; and

(B) shall be available without fiscal year limitation.

(5) Unused funds (A) In general

Amounts in the Fund not currently needed to carry out this section shall be—

(i) maintained readily available or on deposit;

(ii) invested in obligations of the United States or guaranteed by the United States; or

(iii) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.

(B) Use of investment income

After consultation with the Secretary of the Treasury, the Administrator may use income from investments described in clauses (ii) and (iii) of subparagraph (A) to carry out this section.

(d) Assessment of fees (1) Definition of covered functions

In this subsection, the term "covered functions" means functions of the Office of Pesticide Programs of the Environmental Protection Agency, as identified in key programs and projects of the final operating plan for the Environmental Protection Agency submitted as part of the budget process for fiscal year 2002, regardless of any subsequent transfer of 1 or more of the functions to another office or agency or the subsequent transfer of a new function to the Office of Pesticide Programs.

(2) Minimum amount of appropriations

Registration service fees may not be assessed for a fiscal year under this section unless the amount of appropriations for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2012) of the Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for covered functions for fiscal year 2012 (excluding the amount of any fees appropriated for the fiscal year).

(3) Use of fees

Registration service fees authorized by this section shall be available, in the aggregate, only to defray increases in the costs associated with the review and decisionmaking for the review of pesticide registration applications and associated tolerances (including increases in the number of full-time equivalent positions in the Environmental Protection Agency engaged in those activities) over the costs for fiscal year 2002, excluding costs paid from fees appropriated for the fiscal year.

(4) Subsequent authority

If the Administrator does not assess registration service fees under subsection (b) during any portion of a fiscal year as the result of paragraph (2) and is subsequently permitted to assess the fees under subsection (b) during the fiscal year, the Administrator shall assess and collect the fees, without any modification in rate, at any time during the fiscal year, notwithstanding any provisions of subsection (b) relating to the date fees are to be paid.

(e) Reforms to reduce decision time review periods

To the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks, the Administrator shall identify and evaluate reforms to the pesticide registration process under this subchapter with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Extension Act of 2012 for pesticide registration actions for covered pesticide registration applications (including reduced risk applications).

(f) Decision time review periods (1) In general

Not later than 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available a schedule of decision review periods for covered pesticide registration actions and corresponding registration service fees under this subchapter.

(2) Report

The schedule shall be the same as the applicable schedule provided under subsection (b)(3).

(3) Applications subject to decision time review periods

The decision time review periods specified in paragraph (1) shall apply to—

(A) covered pesticide registration applications subject to registration service fees under subsection (b)(2);

(B) covered pesticide registration applications for which an applicant has voluntarily paid registration service fees under subsection (b)(4); and

(C) covered pesticide registration applications listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.

(4) Start of decision time review period (A) In general

Except as provided in subparagraphs (C), (D), and (E), in the case of a pesticide registration application accompanied by the registration service fee required under this section, the decision time review period begins 21 days after the date on which the Administrator receives the covered pesticide registration application and fee.

(B) Initial content and preliminary technical screenings (i) Screenings (I) Initial content

Not later than 21 days after receiving an application and the required registration service fee, the Administrator shall conduct an initial screening of the contents of the application in accordance with clause (iii).

(II) Preliminary technical screening

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

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

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

(ii) Rejection (I) In general

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

(II) Written notification

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

(iii) Requirements of initial content screening

In conducting an initial content screening of an application, the Administrator shall determine whether—

(I)(aa) the applicable registration service fee has been paid; or

(bb) at least 25 percent of the applicable registration service fee has been paid and the application contains a waiver or refund request for the outstanding amount and documentation establishing the basis for the waiver request; and

(II) the application appears to contain all the necessary forms, data, and draft labeling, formatted in accordance with guidance published by the Administrator.

(iv) Requirements of preliminary technical screening

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

(I) the application and the data and information submitted with the application are accurate and complete; and

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

(C) Applications with waiver or reduction requests (i) In general

In the case of an application submitted with a request for a waiver or reduction of registration service fees under subsection (b)(7), the decision time review period shall be determined in accordance with this subparagraph.

(ii) Request granted with no additional fees required

If the Administrator grants the waiver or reduction request and no additional fee is required, the decision time review period begins on the earlier of—

(I) the date on which the Administrator grants the request; or

(II) the date that is 60 days after the date of receipt of the application.

(iii) Request granted with additional fees required

If the Administrator grants the waiver or reduction request, in whole or in part, but an additional registration service fee is required, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.

(iv) Request denied

If the Administrator denies the waiver or reduction request, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.

(D) Pending applications (i) In general

The start of the decision time review period for applications described in clause (ii) shall be the date on which the Administrator receives certification of payment of the applicable registration service fee.

(ii) Applications

Clause (i) applies to—

(I) covered pesticide registration applications for which voluntary fees have been paid under subsection (b)(4); and

(II) covered pesticide registration applications received on or after the effective date of the Pesticide Registration Improvement Act of 2003 but submitted without the applicable registration service fee required under this section due to the inability of the Administrator to assess fees under subsection (d)(1).

(E) 2003 work plan

In the case of a covered pesticide registration application listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency, the decision time review period begins on the date that is 30 days after the effective date of the Pesticide Registration Improvement Act of 2003.

(5) Extension of decision time review period

The Administrator and the applicant may mutually agree in writing to extend a decision time review period under this subsection.

(g) Judicial review (1) In general

Any applicant adversely affected by the failure of the Administrator to make a determination on the application of the applicant for registration of a new active ingredient or new use for which a registration service fee is paid under this section may obtain judicial review of the failure solely under this section.

(2) Scope (A) In general

In an action brought under this subsection, the only issue on review is whether the Administrator failed to make a determination on the application specified in paragraph (1) by the end of the applicable decision time review period required under subsection (f) for the application.

(B) Other actions

No other action authorized or required under this section shall be judicially reviewable by a Federal or State court.

(3) Timing (A) In general

A person may not obtain judicial review of the failure of the Administrator to make a determination on the application specified in paragraph (1) before the expiration of the 2-year period that begins on the date on which the decision time review period for the application ends.

(B) Meeting with Administrator

To be eligible to seek judicial review under this subsection, a person seeking the review shall first request in writing, at least 120 days before filing the complaint for judicial review, a decision review meeting with the Administrator.

(4) Remedies

The Administrator may not be required or permitted to refund any portion of a registration service fee paid in response to a complaint that the Administrator has failed to make a determination on the covered pesticide registration application specified in paragraph (1) by the end of the applicable decision review period.

(h) Accounting

The Administrator shall—

(1) provide an annual accounting of the registration service fees paid to the Administrator and disbursed from the Fund, by providing financial statements in accordance with—

(A) the Chief Financial Officers Act of 1990 (Public Law 101–576; 104 Stat. 2838) and amendments made by that Act; and

(B) the Government Management Reform Act of 1994 (Public Law 103–356; 108 Stat. 3410) and amendments made by that Act;

(2) provide an accounting describing expenditures from the Fund authorized under subsection (c); and

(3) provide an annual accounting describing collections and expenditures authorized under subsection (d).

(i) Auditing (1) Financial statements of agencies

For the purpose of section 3515(c) of title 31, the Fund shall be considered a component of an executive agency.

(2) Components

The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this section shall include an analysis of—

(A) the fees collected under subsection (b) and disbursed;

(B) compliance with subsection (f);

(D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and decisionmaking pertaining to applications under this section.

(3) Inspector General

The Inspector General of the Environmental Protection Agency shall—

(A) conduct the annual audit required under this subsection; and

(B) report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress.

(j) Personnel levels

All full-time equivalent positions supported by fees authorized and collected under this section shall not be counted against the agency-wide personnel level goals of the Environmental Protection Agency.

(k) Reports (1) In general

Not later than March 1, 2005, and each March 1 thereafter through March 1, 2017, the Administrator shall publish an annual report describing actions taken under this section.

(2) Contents

The report shall include—

(A) a review of the progress made in carrying out each requirement of subsections (e) and (f), including—

(i) the number of applications reviewed, including the decision times for each application specified in subsection (f);

(ii) the number of label amendments that have been reviewed using electronic means;

(iii) the amount of money from the Reregistration and Expedited Processing Fund used to carry out inert ingredient review and review of similar applications under section 136a–1(k)(3) of this title;

(iv) the number of applications completed for identical or substantially similar applications under section 136a(c)(3)(B) of this title, including the number of such applications completed within 90 days pursuant to that section;

(v) the number of actions pending in each category of actions described in subsection (f)(3), as well as the number of inert ingredients;

(vi) to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for—

(I) expanding the use of self-certification in all appropriate areas of the registration process;

(II) providing for accreditation of outside reviewers and the use of outside reviewers to conduct the review of major portions of applications;

(III) reviewing the scope of use of the notification process to cover broader categories of registration actions;

(IV) providing for electronic submission and review of labels, including process improvements to further enhance the procedures used in electronic label review; and

(V) the allowance and use of summaries of acute toxicity studies;

(vii) the use of performance-based contracts, other contracts, and procurement to ensure that—

(I) the goals of this subchapter for the timely review of applications for registration are met; and

(II) the registration program is administered in the most productive and cost effective manner practicable; and

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

(B) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications;

(D) a review of the progress in carrying out section 136a(g) of this title, including—

(i) the number of pesticides or pesticide cases reviewed;

(ii) a description of the staffing and resources relating to the costs associated with the review and decision making relating to reregistration and registration review for compliance with the deadlines specified in this subchapter;

(iii) to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for—

(I) process improvements in the handling of registration review under section 136a(g) of this title;

(II) providing for accreditation of outside reviewers and the use of outside reviewers in the registration review process; and

(III) streamlining the registration review process, consistent with section 136a(g) of this title;

(E) a review of the progress in meeting the timeline requirements for the review of antimicrobial pesticide products under section 136a(h) of this title;

(F) a review of the progress in carrying out the review of inert ingredients, including the number of applications pending, the number of new applications, the number of applications reviewed, staffing, and resources devoted to the review of inert ingredients and recommendations to improve the timeliness of review of inert ingredients;

(G) a review of the progress made toward—

(i) carrying out section 136a–1(k)(4) of this title and the amounts from the Reregistration and Expedited Processing Fund used for the purposes described in that section;

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

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

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

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

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

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

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

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

(J) an assessment of the public availability of summary pesticide usage data.

(3) Method

The Administrator shall publish a report required by this subsection by such method as the Administrator determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet site of the Environmental Protection Agency.

(4) Other report (A) Scope

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

(i) 10 or fewer employees; and

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

(B) Information required

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

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

(ii) the number of registrations each company holds.

(l) Savings clause

Nothing in this section affects any other duties, obligations, or authorities established by any other section of this subchapter, including the right to judicial review of duties, obligations, or authorities established by any other section of this subchapter.

(m) Termination of effectiveness (1) In general

Except as provided in paragraph (2), the authority provided by this section terminates on September 30, 2017.

(2) Phase out (A) Fiscal year 2018

During fiscal year 2018, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 40 percent below the level in effect on September 30, 2017.

(B) Fiscal year 2019

During fiscal year 2019, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 70 percent below the level in effect on September 30, 2017.

(C) September 30, 2019

Effective September 30, 2019, the requirement to pay and collect registration service fees terminates.

(D) Decision review periods (i) Pending applications

In the case of an application received under this section before September 30, 2017, the application shall be reviewed in accordance with subsection (f).

(ii) New applications

In the case of an application received under this section on or after September 30, 2017, subsection (f) shall not apply to the application.

Editorial Notes

REFERENCES IN TEXT The effective date of the Pesticide Registration Improvement Act of 2003, and the effective date of this section, referred to in text, is the effective date of section 501 of Pub. L. 108–199, which is the date that is 60 days after Jan. 23, 2004, unless otherwise provided, see section 501(h) of Pub. L. 108–199, set out as an Effective Date of 2004 Amendment note under section 136a of this title. The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2)(B)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. Section 2 of Public Law 89–106, referred to in subsec. (b)(7)(E)(i), was formerly classified to secton 450i of this title prior to editorial reclassification and renumbering as section 3157 of this title. The effective date of the Pesticide Registration Improvement Extension Act of 2012, referred to in subsecs. (e) and (f)(1), probably means the effective date of section 2 of Pub. L. 112–177, which is Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set out as a note under section 136a–1 of this title. The Chief Financial Officers Act of 1990, referred to in subsec. (h)(1)(A), is Pub. L. 101–576, Nov. 15, 1990, 104 Stat. 2838. For complete classification of this Act to the Code, see Short Title of 1990 Amendment note set out under section 501 of Title 31, Money and Finance, and Tables. The Government Management Reform Act of 1994, referred to in subsec. (h)(1)(B), is Pub. L. 103–356, Oct. 13, 1994, 108 Stat. 3410, as amended. For complete classification of this Act to the Code, see Short Title of 1994 Amendment note set out under section 3301 of Title 31, Money and Finance, and Tables.PRIOR PROVISIONS A prior section 33 of act June 25, 1947, ch. 125, was renumbered section 34 and is classified to section 136x of this title.AMENDMENTS 2012—Subsec. (b)(3). Pub. L. 112–177, §2(b)(1)(A), added par. (3) and struck out former par. (3) which related to schedule of covered applications and registration service fees. Subsec. (b)(6)(A). Pub. L. 112–177, §2(b)(1)(B)(i), substituted "October 1, 2013" for "October 1, 2008" and "September 30, 2015" for "September 30, 2010". Subsec. (b)(6)(B). Pub. L. 112–177, §2(b)(1)(B)(ii), substituted "October 1, 2015" for "October 1, 2010" and "September 30, 2015" for "September 30, 2010". Subsec. (b)(7)(F)(i). Pub. L. 112–177, §2(a)(2)(B)(i), substituted "section 136a–1 (i)(1)(E)(ii)" for "section 136a–1(i)(5)(E)(ii)". Subsec. (b)(7)(F)(ii). Pub. L. 112–177, §2(a)(2)(B)(i), (ii), substituted "section 136a–1 (i)(1)(E)(ii)" for "section 136a–1(i)(5)(E)(ii)" in subcl. (I) and "section 136a–1(i)(1)(E)(ii)(I)(bb)" for "136a–1(i)(5)(E)(ii)(I)(bb)" in subcl. (II). Subsec. (b)(7)(F)(iv)(I). Pub. L. 112–177, §2(a)(2)(B)(i), substituted "section 136a–1 (i)(1)(E)(ii)" for "section 136a–1(i)(5)(E)(ii)". Subsec. (b)(7)(F)(iv)(II). Pub. L. 112–177, §2(a)(2)(B)(ii), (iii), substituted "applicable" for "applicable.", "revenue" for "revenues", and "section 136a–1(i)(1)(E)(ii)(I)(bb)" for "section 136a–1(i)(5)(E)(ii)(I)(bb)". Subsec. (b)(8)(C)(ii)(III). Pub. L. 112–177, §2(b)(1)(C), added subcl. (III). Subsec. (c)(3)(B)(i). Pub. L. 112–177, §2(b)(2)(A), substituted "2013 through 2017" for "2008 through 2012". Subsec. (c)(3)(B)(ii). Pub. L. 112–177, §2(b)(2)(B), substituted "grants, for each of fiscal years 2013 through 2017, $500,000." for "grants— "(I) for each of fiscal years 2008 and 2009, $750,000; and "(II) for each of fiscal years 2010 through 2012, $500,000." Subsec. (c)(3)(B)(iii). Pub. L. 112–177, §2(b)(2)(C), substituted "2013 through 2017" for "2008 through 2012". Subsec. (d)(2). Pub. L. 112–177, §2(b)(3)(A), substituted "2012" for "2002" in two places. Subsec. (d)(4), (5). Pub. L. 112–177, §2(b)(3)(B), (C), redesignated par. (5) as (4) and struck out former par. (4). Prior to amendment, text of par. (4) read as follows: "The requirements of paragraph (2) shall have been considered to have been met for any fiscal year if the amount of appropriations for salaries, contracts, and expenses for the functions (as in existence in fiscal year 2002) of the Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) is not more than 3 percent below the amount of appropriations for covered functions for fiscal year 2002 (excluding the amount of any fees appropriated for the fiscal year)." Subsec. (e). Pub. L. 112–177, §2(b)(4), substituted "Pesticide Registration Improvement Extension Act of 2012" for "Pesticide Registration Improvement Act of 2003". Subsec. (f)(1). Pub. L. 112–177, §2(b)(5)(A), substituted "Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly available" for "Pesticide Registration Improvement Renewal Act, the Administrator shall publish in the Federal Register". Subsec. (f)(2). Pub. L. 112–177, §2(b)(5)(B), substituted "provided under subsection (b)(3)." for "appearing in the Congressional Record on pages S10409 through S10411, dated July 31, 2007." Subsec. (f)(4)(A). Pub. L. 112–177, §2(b)(5)(C)(i), inserted "and fee" before period at end. Subsec. (f)(4)(B). Pub. L. 112–177, §2(b)(5)(C)(ii)(I), substituted "Initial content and preliminary technical screenings" for "Completeness of application" in heading. Subsec. (f)(4)(B)(i). Pub. L. 112–177, §2(b)(5)(C)(ii)(I), (II), substituted "Screenings" for "In general" in cl. heading, designated existing provisions as subcl. (I) and inserted subcl. heading, and added subcl. (II). Subsec. (f)(4)(B)(ii). Pub. L. 112–177, §2(b)(5)(C)(ii)(III), added cl. (ii) and struck out former cl. (ii). Prior to amendment, text read as follows: "If the Administrator determines under clause (i) that the application does not pass the initial screening and cannot be corrected within the 21-day period, the Administrator shall reject the application not later than 10 days after making the determination." Subsec. (f)(4)(B)(iii). Pub. L. 112–177, §2(b)(5)(C)(ii)(IV), inserted "initial content" before "screening" in heading, "content" before "screening" in introductory provisions, and substituted "appears to contain" for "contains" in subcl. (II). Subsec. (f)(4)(B)(iv). Pub. L. 112–177, §2(b)(5)(C)(ii)(V), added cl. (iv). Subsec. (k)(1). Pub. L. 112–177, §2(b)(6)(A), substituted "March 1, 2017" for "March 1, 2014". Subsec. (k)(2)(A)(viii). Pub. L. 112–177, §2(b)(6)(B)(i), added cl. (viii). Subsec. (k)(2)(G) to (J). Pub. L. 112–177, §2(b)(6)(B)(ii)–(iv), added subpars. (G) to (J). Subsec. (k)(4). Pub. L. 112–177, §2(b)(6)(C), added par. (4). Subsec. (m)(1). Pub. L. 112–177, §2(b)(7)(A), substituted "2017" for "2012". Subsec. (m)(2)(A). Pub. L. 112–177, §2(b)(7)(B)(i), substituted "2018" for "2013" in heading and "2018," for "2013," and "September 30, 2017" for "September 30, 2012" in text. Subsec. (m)(2)(B). Pub. L. 112–177, §2(b)(7)(B)(ii), substituted "2019" for "2014" in heading and "2019," for "2014," and "September 30, 2017" for "September 30, 2012" in text. Subsec. (m)(2)(C). Pub. L. 112–177, §2(b)(7)(B)(iii), substituted "2019" for "2014" in heading and "September 30, 2019" for "September 30, 2014" in text. Subsec. (m)(2)(D). Pub. L. 112–177, §2(b)(7)(B)(iv), substituted "2017" for "2012" in cls. (i) and (ii). 2008—Subsec. (b)(7)(D)(i). Pub. L. 110–193, §1(a)(1)(A)(i), added cl. (i) and struck out former cl. (i). Prior to amendment, text read as follows: "The Administrator may waive or reduce a registration service fee for an application for minor uses for a pesticide." Subsec. (b)(7)(D)(ii). Pub. L. 110–193, §1(a)(1)(A)(ii), inserted "or exemption" after "waiver". Subsec. (b)(7)(E). Pub. L. 110–193, §1(a)(1)(B)(ii), substituted "exempt an application from the registration service fee" for "waive the registration service fee for an application" in introductory provisions. Pub. L. 110–193, §1(a)(1)(B)(i), substituted "exemption" for "waiver" in heading. Subsec. (b)(7)(E)(ii). Pub. L. 110–193, §1(a)(1)(B)(iii), substituted "exemption" for "waiver". Subsec. (m)(2)(A), (B). Pub. L. 110–193, §1(a)(2), substituted "2012" for "2008". 2007—Subsec. (b)(2)(C)(ii). Pub. L. 110–94, §5(a)(1), added cl. (ii) and struck out former cl. (ii) which read as follows: "a request for a waiver from or reduction of the registration service fee." Subsec. (b)(2)(D) to (H). Pub. L. 110–94, §5(a)(2), added subpars. (D) to (H). Subsec. (b)(3)(A). Pub. L. 110–94, §5(b)(1)(A), substituted "Pesticide Registration Improvement Renewal Act" for "Pesticide Registration Improvement Act of 2003". Subsec. (b)(3)(B). Pub. L. 110–94, §5(b)(1)(B), substituted "S10409 through S10411, dated July 31, 2007." for "S11631 through S11633, dated September 17, 2003." Subsec. (b)(6). Pub. L. 110–94, §5(b)(2), added par. (6) and struck out former par. (6). Prior to amendment, text of par. (6) read as follows: "Effective for a covered pesticide registration application received on or after October 1, 2005, the Administrator shall— "(A) increase by 5 percent the service fee payable for the application under paragraph (3); and "(B) publish in the Federal Register the revised registration service fee schedule." Subsec. (b)(7)(F)(ii). Pub. L. 110–94, §5(c)(1), substituted "75 percent" for "all" in introductory provisions. Subsec. (b)(7)(F)(iv)(II). Pub. L. 110–94, §5(c)(2), substituted "75 percent of the applicable." for "all". Subsec. (b)(8)(A). Pub. L. 110–94, §5(d), substituted "25 percent." for "10 percent". Subsec. (c)(1)(B). Pub. L. 110–94, §5(e)(1), substituted "paragraph (5)" for "paragraph (4)". Subsec. (c)(3)(B). Pub. L. 110–94, §5(e)(2)(A), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "For each of fiscal years 2004 through 2008, the Administrator shall use approximately 1/17 of the amount in the Fund (but not more than $1,000,000, and not less than $750,000, for any fiscal year) to enhance current scientific and regulatory activities related to worker protection." Subsec. (c)(3)(C). Pub. L. 110–94, §5(e)(2)(B), struck out subpar. (C). Text read as follows: "For each of fiscal years 2004 and 2005, the Administrator shall use approximately 1/34 of the amount in the Fund (but not to exceed $500,000 for any fiscal year) for the review and evaluation of new inert ingredients." Subsec. (c)(5). Pub. L. 110–94, §5(e)(3), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A) and added subpar. (B). Subsec. (d)(2). Pub. L. 110–94, §5(f), which directed substitution of "Registration" for "For fiscal years 2004, 2005 and 2006 only, registration", was executed by making the substitution for text which contained a comma after "2005" to reflect the probable intent of Congress. Subsec. (f)(1). Pub. L. 110–94, §5(g)(1), substituted "Pesticide Registration Improvement Renewal Act" for "Pesticide Registration Improvement Act of 2003". Subsec. (f)(2). Pub. L. 110–94, §5(g)(2), substituted "S10409 through S10411, dated July 31, 2007." for "S11631 through S11633, dated September 17, 2003." Subsec. (f)(4)(B). Pub. L. 110–94, §5(g)(3), added subpar. (B) and struck out former subpar. (B) which provided criteria for determining completeness of pesticide registration applications. Subsec. (k)(1). Pub. L. 110–94, §5(h)(1), substituted "March 1, 2014" for "March 1, 2009". Subsec. (k)(2)(A)(ii) to (v). Pub. L. 110–94, §5(h)(2)(A)(i), (ii), added cls. (ii) to (iv) and redesignated former cl. (ii) as (v). Former cls. (iii) and (iv) redesignated (vi) and (vii), respectively. Subsec. (k)(2)(A)(vi). Pub. L. 110–94, §5(h)(2)(A)(i), (iii), redesignated cl. (iii) as (vi) and added subcls. (IV) and (V). Subsec. (k)(2)(A)(vii). Pub. L. 110–94, §5(h)(2)(A)(i), redesignated cl. (iv) as (vii). Subsec. (k)(2)(D) to (F). Pub. L. 110–94, §5(h)(2)(B)–(D), added subpars. (D) to (F). Subsec. (m)(1). Pub. L. 110–94, §5(i)(1), substituted "2012" for "2008". Subsec. (m)(2)(A). Pub. L. 110–94, §5(i)(2)(A), substituted "2013" for "2009" in heading and text. Subsec. (m)(2)(B), (C). Pub. L. 110–94, §5(i)(2)(B), substituted "2014" for "2010" in headings and text. Subsec. (m)(2)(D). Pub. L. 110–94, §5(i)(2)(C), substituted "2012" for "2008" in two places.EFFECTIVE DATE OF 2012 AMENDMENT Amendment by Pub. L. 112–177 effective Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set out as a note under section 136a–1 of this title. EFFECTIVE DATE OF 2008 AMENDMENT Pub. L. 110–193, §1(b), Mar. 6, 2008, 122 Stat. 650, provided that: "The amendments made by subsection (a) [amending this section] take effect on October 1, 2007." EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 110–94 effective Oct. 1, 2007, see section 6 of Pub. L. 110–94, set out as a note under section 136a of this title.EFFECTIVE DATE Section effective on the date that is 60 days after Jan. 23, 2004, except as otherwise provided, see section 501(h) of Pub. L. 108–199, set out as an Effective Date of 2004 Amendment note under section 136a of this title.EXTENSION OF LIMITATIONS ON FEE AMOUNTS AND USAGE OF FEES Subsection (c)(3)(B) of this section to continue in effect through Sept. 30, 2018, see section 401(a) of Pub. L. 115–141, set out as a note under section 136a–1 of this title. Pub. L. 115–141, div. M, title IV, §401(b)(2), Mar. 23, 2018, 132 Stat. 1050, provided that: "Notwithstanding section 33(m)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)(2)), section 33(m)(1) of such Act (7 U.S.C. 136w–8(m)(1)) shall be applied by substituting ‘September 30, 2018’ for ‘September 30, 2017’."

Citation

7 U.S.C. § 136w-8 (2018)