7 USC 136w-8: Pesticide registration service fees Text contains those laws in effect on May 4, 2015

From Title 7-AGRICULTURE CHAPTER 6-INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL SUBCHAPTER II-ENVIRONMENTAL PESTICIDE CONTROL Jump To: Source Credit References In Text Prior Provisions Amendments Effective Date



## §136w–8. Pesticide regi stration service fees
(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 pers ons 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 managementof information, and the acquisition, ma intenance, and repair of computer and telecommunication resources (including software), used to support review of pestici de 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 co vered by this subchapter t hat is received by the Administrator on or after the effect ive date of the Pesticide Registrati on 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 regist ration of a pesticide that was submitted to the Administrator before the effective date of the Pest icide Registration Improvement Act of 2003 and is pending on that effective date shall be subject to a service fee under this se ction if the application is for the registration of a new active ingredient that is not list ed 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 appl ication described in clause (i) under this section shall be reduced by the amount of any fees paid to support the related pet ition 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 regist ration 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 subs ection 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 regist ration service fee and decision review period;

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 1 of 28 5/5/2015(ii) after review of a waiver request, the Administrator denies the waiver request; or (iii) after review of the application, the Administrato r determines that a differentregistration 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 regi stration 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 receiv e 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 sche dule of covered pesticide regist ration applications and corresponding registration service fees shall be as follows:

(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 applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 TABLE 1. - REGISTRATION DIVISION - NEW ACTIVE INGREDIENTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 010 1 New Active Ingredient, Food use (2) (3) 24 569,221
R 020 2 New Active Ingredient, Food use; reduced risk (2) (3) 18 569,221
R 040 3 New Active Ingredient, Food use; Ex perimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee towa rd new active ingredient application that follows (3) 18 419,502

R 060 4 New Active Ingredient, Non-food use; outdoor (2) (3) 21 395,467
R 070 5 New Active Ingredient, Non-food us e; outdoor; reduced risk (2) (3) 16 395,467
R 090 6 New Active Ingredient, Non-food use; outdoor; Experim ental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient (3) 16 293,596

R 110 7 New Active Ingredient, Non- food use; indoor (2) (3) 20 219,949
R 120 8 New Active Ingredient, Non-food use; indoor; reduced ri sk (2) (3) 14 219,949
R 12 1 9 New Active Ingredient, Non-food us e; indoor; Experim ental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredientapplication that follows (3) 18 165,375

R 12 2 10 Enriched isomer(s) of registered mixed- isomer active ingredient (2) (3) 18 287,643
R 12 3 11 ew Active Ingredient, Seed treatmentonly; includes agricultural and nonagricultural seeds; residues not expected in raw agricultural commodities (2) (3) 18 427,991

R 125 New 12 New Active Ingredient, Seed treatment; Experiment al Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredientapplication that follows (3) 16 293,596

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 2 of 28 5/5/2015applicant at the applicant's initiative to support the application after comp letion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(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 applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active TABLE 2. - REGISTRATION DIVISION - NEW USES

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 130 13 First food use; indoor; food/food handling (2) (3) 21 173,644
R 140 14 Additional food use; Indoor; food/food handling (3) (4) 15 40,518
R 150 15 First food use (2) (3) 21 239,684
R 160 16 First food use; reduced risk (2) (3) 16 239,684
R 170 17 Additional food use (3) (4) 15 59,976
R 175 New 18 Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups. (3) (4) 10 59,976

R 180 19 Additional food use; reduced risk (3) (4) 10 59,976
R 190 20 Additional food uses; 6 or more s ubmitted in one application (3) (4) 15 359,856
R 200 21 Additional food uses; 6 or more submitted in one application; reduced risk (3) (4) 10 359,856

R 210 22 Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration (3) (4) 12 44,431

R 220 23 Additional food use; Experimental Us e Permit application; crop destruct basis; no credit toward new use registration (3) (4) 6 17,993

R 230 24 Additional use; non-food; outdoor (3) (4) 15 23,969
R 240 25 Additional use; non-food; outdoor; reduced risk (3) (4) 10 23,969
R 250 26 d ditional use; non-food; outdoor; Experim ental Use Permit application; no credit toward new use registration (3) (4) 6 17,993

R 251 New 27 Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis (3) 8 17,993

R 260 28 New use; non-food; indoor (3) (4) 12 11,577
R 270 29 New use; non-food; indoor; reduced risk (3) (4) 9 11,577
R 27 1 30 N ew use; non-food; indoor; Experimenta l Use Permit application; no credit toward new use registration (3) (4) 6 8,820

R 27 3 31 Additional use; seed treatment; lim ited uptake into raw agricultural commodities; includes crops with esta blished tolerances (e.g., for soil or foliar application); includes food or non-food uses (3) (4) 12 45,754

R 274 32 Additional uses; seed treatment onl y; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes

crops with established tolerances (e .g., for soil or foliar application); includes food and/or non-food uses (3) (4) 12 274,523

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 3 of 28 5/5/2015ingredient application, subject to the registration se rvice 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. An y information that (a) was neither req uested 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 regi stration 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(4) Amendment applications to add the new use(s) to regi stered product labels are covered by the base fee for the new use(s). All items in the covered application mustbe 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) c ontaining the same new uses, will be deemed a separate new-use application, subject to a sepa rate 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 in formation that (a) was neither requested nor required by the Agency, and (b) is subm itted 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 se rvice fee for the new use application.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended TABLE 3. - REGISTRATION DIVISION - IMPORT AND OTHER TOLERANCES

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 280 33 Establish import tolerance; new acti ve ingredient or first food use (2) 21 289,407
R 290 34 Establish import toleranc e; additional food use 15 57,882
R 29 1 35 Establish import tolerances; additional food uses; 6 or more crops submitted in one petition 15 347,288

R 29 2 36 A mend an established tolerance (e.g., de crease or increase); domestic or import; applicant-initiated 11 41,124

R 29 3 37 Establish tolerance(s) for inadvertent residues in one crop; applicantinitiated 12 48,510

R 294 38 s tablish tolerances for inadvertent resi dues; 6 or more crops submitted in one application; applicant-initiated 12 291,060

R 29 5 39 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop applic ation; applicant-initiated 15 59,976

R 29 6 40 Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated 15 359,856

R 297 New 41 Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or im port; applicant-initiated 11 246,744

R 298 New 42 A mend an established tolerance (e.g., de crease or increase); domestic or import; submission of amended label s (requiring science review) inaddition to those associated with the amended tolerance; applicantinitiated (3) 13 53,120

R 299 New 43 Amend 6 or more established tolerances (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated (3) 13 258,740

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 4 of 28 5/5/2015to end on the next business day. (2) All requests for new uses (food and/or nonfood) contained in any applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 ap plication after completion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

TABLE 4. - REGISTRATION DIVISION - NEW PRODUCTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 300 44 New product; or similar combinat ion product (already registered) to an identical or substantiallysimilar in compositi on 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 s pecific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing-use productthat requires no data submission nor data matrix. (2) (3) 4 1,434

R 30 1 45 New product; or similar combinati on product (already registered) to an identical or substantiallysimilar in compositi on and use to a registered

product; registered source of active ingredient; selective data citation only for data on product chemistry and/ or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) 4 1,720

R 310 46 New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; requires review of data package within RD only; includes data and/or waivers of data for only:

product chemistry and/or

acute toxicity and/or

public health pest efficacy and/or

child resistant packaging. (2) (3) 7 4,807

R 314 New 47 New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantia lly similar to the labels of currently registered products which separately contain the respective component active ingredients; requires revi ew of data package within RD only; includes data and/or waivers of data for only: 8 6,009

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 5 of 28 5/5/2015(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 revi ew, will be considered an application for a new product with an unregistered source of active ingredient.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency. product chemistry and/or

acute toxicity and/or

public health pest efficacy and/or

child resistant packaging. (2) (3)
R 315 New 48 New end-use non-food animal product wi th submission of two or more target animal safety studies; incl udes data and/or waivers of data for only:

product chemistry and/or

acute toxicity and/or

public health pest efficacy and/or

animal safety studies and/or

child resistant packaging (2) (3) 9 8,000

R 320 49 New product; new physical form; requires data review in science divisions (2) (3) 12 11,996

R 33 1 50 New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only (2) (3) 3 2,294

R 33 2 51 N ew manufacturin g -use product; registered ac tive ingredient; unregistered source of active ingredient; submis sion of completely new generic data package; registered uses only; requires review in RD and science divisions (2) (3) 24 256,883

R 333 New 52 New product; MUP or End use product wi th unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. (2) (3) 10 17,993

R 334 New 53 New product; MUP or End use product with unregistered source of the active ingredient; requires science dat a review; new phys ical form; etc. Selective data citation. (2) (3) 11 17,993

TABLE 5. - REGISTRATION DIVISION - AMENDMENTS TO REGISTRATION

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 340 54 Amendment requiring data review within RD (e.g., changes to precautionary label statements) (2) (3) 4 3,617

R 345 New 55 Amending non-food animal product t hat includes subm ission of target animal safety data; previously registered (2) (3) 7 8,000

R 350 56 Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate , or number of applications; or add aerial application; or modify GW/SW advisory statement) (2) (3) 9 11,996

R 351 New 57 A mendment adding a new unregis tered source of active ingredient. (2) (3) 8 11,996

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 6 of 28 5/5/2015(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 regi stration service fees. (b) Registrant-initiated fasttrack 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-ini tiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines spec ified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments subm itted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to regist ration service fees. (e) Submissions with data and requiring data revieware subject to registration service fees.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(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.

(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 applicati on 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 ingredi ent or first food use applicat ion. The application must be received by the agency in one package. The base fee for the category covers a maximum of five new products. R 352 New 58 A mendment adding already approved uses ; selective method of support; does not apply if the applicant owns all cited data (2) (3) 8 11,996

R 37 1 59 Amendment to Experimental Use Pe rmit; (does not include extending a permit's time period) (3) 6 9,151

TABLE 6. - REGISTRATION DIVISION - OTHER ACTIONS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

R 124 60 Conditional Ruling on Preapplication St udy Waivers; applicant-initiated 6 2,294
R 27 2 61 Review of Study Protocol applic ant-initiated; excludes DART, preregistration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review 3 2,294

R 275 New 62 Rebuttal of agency reviewed protocol, applicant initiated 3 2,294

R 370 63 Cancer reassessment; applicant-initiated 18 179,818

TABLE 7. - ANTIMICROBIALS DIVISION - NEW ACTIVE INGREDIENTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

A 380 64 Food use; establish tolerance exemption (2) (3) 24 104,187
A 390 65 Food use; establish tolerance (2) (3) 24 173,644
A400 66 Non-food use; outdoor; FIFRA §2(mm) uses (2) (3) 18 86,823
A410 67 Non-food use; outdoor; uses other than FIFRA §2(mm) (2) (3) 21 173,644
A420 68 Non-food use; indoor; FIFRA §2(mm) uses (2) (3) 18 57,882
A430 69 Non-food use; indoor; uses ot her than FIFRA §2(mm) (2) (3) 20 86,823
A43 1 70 o n-food use; indoor; low-risk, low-toxi city food-grade acti ve ingredient(s); efficacy testing for public healt h claims required under GLP and following DIS/TSS or AD-approved study protocol (2) (3) 12 60,638

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 7 of 28 5/5/2015Each application for an additional new product registrati on and new inert approval that is submitted in the new active ingredient application package or first food use applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 ap plication after completion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(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 applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 ap plication after completion of the technical deficiency TABLE 8. - ANTIMICROBIALS DIVISION - NEW USES

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

A440 71 First food use; establish tolerance exemption (2) (3) (4) 21 28,942
A450 72 First food use; establish tolerance (2) (3) (4) 21 86,823
A460 73 Additional food use; establish tolerance exemption (3) (4) (5) 15 11,577
A470 74 Additional food use; establish tolerance (3) (4) (5) 15 28,942
A471 New 75 Additional food uses; establish tole rances; 6 or more submitted in one application (3) (4) (5) 15 173,652

A480 76 Additional use; non-food; outdoor; FIFRA §2(mm) uses (4) (5) 9 17,365
A481 New 77 Additional non-food outdoor uses; FIFRA §2(mm) uses; 6 or more submitted in one application (4) (5) 9 104,190

A490 78 Additional use; non-food; outdoor ; uses other than FIFRA §2(mm) (4) (5) 15 28,942

A491 New 79 Additional non-food; outdoor; uses other than FIFRA §2(mm); 6 or more submitted in one application (4) (5) 15 173,652

A 500 80 Additional use; non-food, indoor , FIFRA §2(mm) uses (4) (5) 9 11,577
A 501 New 81 d ditional non-food; indoor; FIFRA §2( mm) uses; 6 or more submitted in one application (4) (5) 9 69,462

A 510 82 Additional use; non-food; indoor; uses other than FIFRA §2(mm) (4) (5) 12 11,577
A 511 New 83 Additional non-food; indoor; uses ot her than FIFRA §2(mm); 6 or more submitted in one application (4) (5) 12 69,462

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 8 of 28 5/5/2015screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or first food use application.

(3) If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effe ctive 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(5) Amendment applications to add the new use(s) to regi stered product labels are covered by the base fee for the new use(s). All items in the covered application mustbe 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) c ontaining the same new uses, will be deemed a separate new-use application, subject to a sepa rate 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 in formation that (a) was neither requested nor required by the Agency, and (b) is subm itted 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 se rvice fee for the new use application.

(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 TABLE 9. - ANTIMICROBIALS DIVISION - NEW PRODUCTS AND AMENDMENTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

A 530 84 New product; identical or substantia lly similar in composition and use to a registered product; no data review or only product chemistry data; citeall data citation, or selective da ta citation when applicant owns all required data, or applicant submits spec ific authorization letter for data owner. Category also includes 100% re -package of registered end-use or manufacturing-use product that requires no data submission nor data matrix. (2) (3) 4 1,159

A 53 1 85 New product; identical or substantia lly similar in composition and use to a registered product; registered source of active in gredient: selective data

citation only for data on product chem istry and/or acute toxicity and/or public health pest efficacy, where a pplicant does not own all required data and does not have a specific authorization letter from data owner. (2) (3) 4 1,654

A 53 2 86 New product; identical or substantia lly similar in composition and use to a registered product; regist ered active ingredient; unregistered source of active ingredient; cite-all data ci tation except for product chemistry; product chemistry data submitted (2) (3) 5 4,631

A 540 87 New end use product; FIFRA §2(mm) uses only (2) (3) 5 4,631
A 550 88 N ew en d -use product; uses other than FIFRA §2(mm); non-FQPA product (2) (3) 7 4,631

A 560 89 e w manufacturin g -use product; registered acti ve ingredient; selective data citation (2) (3) 12 17,365

A 570 90 Label amendment requiring data review (3) (4) 4 3,474
A 572 New 91 New Product or amendment requiring dat a review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate) (2) (3) (4) 9 11,996

http://uscode.house.gov/v iew.xhtml?hl=false&... Page 9 of 28 5/5/2015(b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

(3) Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(4) (a) EPA-initiated amendments shall not be charged regi stration service fees. (b) Registrant-initiated fasttrack 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-ini tiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines spec ified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments subm itted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to regist ration service fees. (e) Submissions with data and requiring data revieware subject to registration service fees.

(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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the TABLE 10. - ANTIMICROBIALS DIVISION - EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

A 520 92 Experimental Use Pe rmit application, N on-Food Use (2) 9 5,789
A 52 1 93 Review of public health efficacy study protocol wi thin AD, per AD Internal Guidance for the EfficacyProtocol Review Process; Code will also include review of public health effica cy study protocol and data review for devices making pesticidal clai ms; applicant-initiated; Tier 1 3 2,250

A 52 2 94 R eview of public health effi cacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims ; applicant-initiated; Tier 2 12 11,025

A 524 New 95 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. (2) 18 138,916

A 525 New 96 New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credi t 45% of fee toward new active ingredient application that follows. (2) 18 83,594

A 526 New 97 New Active Ingredient, Experimental Use Permit applic ation; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) 15 86,823

A 527 New 98 New Active Ingredient, Experimental Use Permit applic ation; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows. (2) 15 58,000

A 528 New 99 Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption (2) 15 20,260

A 529 New 100 Amendment to Experimental Use Perm it; requires data review or risk assessment (2) 9 10,365

A 523 New 101 Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols) 9 11,025

A 571 New 102 Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated 18 86,823

http://uscode.house.gov/view.xhtml?hl=false&... Page 10 of 28 5/5/2015applicant shall have up to 30 calendar days to reach ag reement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of th e terms of the accepted label as in (a), including upon resolution of differences in (b), th e Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant's written or electronic co nfirmation of agreement to the Agency.

(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 applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 ap plication after completion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 25% of the full registration service fee for the new active ingredient or first food use application.

(1) A decision review time that would otherwise end on a Saturday, Sunday, or feder al holiday, will be extended TABLE 11. - BIOPESTICIDES AND POLLUTION PREVEN TION DIVISION - MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

B 580 103 New active ingredient; food use; pet ition to establish a tolerance (2) 19 46,305
B 590 104 New active ingredient; food use; petition to establish a tolerance exemption (2) 17 28,942

B 600 105 New active ingredient; non-food use (2) 13 17,365
B 610 106 New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption 10 11,577

B 611 New 107 New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption 12 11,577

B 612 New 108 e w active ingredient; no change to a perm anent tolerance exemption (2) 10 15,918

B 613 New 109 New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption (2) 11 15,918

B 620 110 New active ingredient; Experiment al Use Permit ap plication; non-food use including crop destruct 7 5,789

TABLE 12. - BIOPESTICIDES AND POLLUTION PREVEN TION DIVISION - MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW USES

EPA

No. New CR No. Action Decision Review Time (Months) (1) Registration Service Fee

($)
B 630 111 First food use; petition to estab lish a tolerance exemption (2) 13 11,577
B 63 1 112 New food use; petition to amend an established tolerance (3) 12 11,577
B 640 113 First food use; petition to establish a tolerance (2) 19 17,365
B 643 New 114 New Food use; petition to am end tolerance exemption (3) 10 11,577

B 642 New 115 First food use; indoor; food/food handling (2) 12 28,942

B 644 New 116 New use, no change to an est ablished tolerance or tolerance exemption (3) 8 11,577

B 650 117 New use; non-food (3) 7 5,789

http://uscode.house.gov/view.xhtml?hl=false&... Page 11 of 28 5/5/2015to end on the next business day. (2) All requests for new uses (food and/or nonfood) contained in any applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 ap plication after completion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 25% of the full registration service fee for the new active ingredient or first food use application.

(3) Amendment applications to add the new use(s) to regi stered product labels are covered by the base fee for the new use(s). All items in the covered application mustbe 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) c ontaining the same new uses, will be deemed a separate new-use application, subject to a sepa rate 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 in formation that (a) was neither requested nor required by the Agency, and (b) is subm itted 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 se rvice fee for the new use application.

TABLE 13. - BIOPESTICIDES AND POLLUTION PREVEN TION DIVISION - MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

B 652 New 118 New product; registered source of active ingredient; requires petition to amend established tolerance or tole rance exemption; requires 1) submission of product spec ific 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 avail able 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 scientificallysound rationale explaining why the data requirement does not apply (2) 13 11,577

B 660 119 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; ci te-all data citation, or selective data citation where applicant owns al l required data or authorization from data owner is demonstrated. Cat egory includes 100% re-package of registered end-use or manufacturi ng-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient (s) must not be re-isolated. (2) 4 1,159

B 670 120 New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exem ption; requires: 1) submission of product specific data; or 2) citati on of previously reviewed and accepted data; or 3) submission or citati on of data generated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply. (2) 7 4,631

B 67 1 121 N ew product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: 1) submission of product spec ific data; or 2) citation of previously reviewed 17 11,577

http://uscode.house.gov/view.xhtml?hl=false&... Page 12 of 28 5/5/2015(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 revi ew, will be considered an application for a new product with an unregistered source of active ingredient. and accepted data; or 3) submission or citation of data generated atgovernment expense; or 4) submission or citation of a scientificallysound rationale based on publicly avai lable 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 scientificallysound rationale explaining why the data requirement does not apply. (2)
B 67 2 122 New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or toleranc e exemption previ ously established

for the active ingredient(s); require s: 1) submission of product specific data; or 2) citation of previouslyreviewed and accepted data; or 3) submission or citation of data gene rated at government expense; or 4) submission or citation of a scientifically-sound rationale based on publicly

available literature or other relevantinformation that addresses the data requirement; or 5) submission of a re quest for a data requirement to be waived supported by a scientifically-s ound rationale explaining why the data requirement does not apply. (2) 13 8,269

B 673 New 123 New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Require s an Agency determination that the cited data supports the new product. (2) 10 4,631

B 674 New 124 New product MUP; Repack of identic al registered end-use product as a manufacturing-use product; same registered uses only (2) 4 1,159

B 675 New 125 New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. (2) 10 8,269

B 676 New 126 New product; more than one active ingredient where one active ingredient is an unregistered source; product chem istry 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 informati on that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale ex plaining why the data requirement does not apply. (2) 13 8,269

B 677 New 127 New end-use non-food animal product with submission of two or more target animal safety studies; incl udes data and/or waivers of data for only:

product chemistry and/or

acute toxicity and/or

public health pest efficacy and/or

animal safety studies and/or

child resistant packaging (2) 10 8,000

TABLE 14. - BIOPESTICIDES AND POLLUTION PREVEN TION DIVISION - MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

B 62 1 128 Amendment; Experimental Use Perm it; no change to an established temporary tolerance or tolerance exemption. 7 4,631

B 622 New 129 A mendment; Experiment al Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. 11 11,577

B 64 1 130 Amendment of an established toleranc e or tolerance exemption. 13 11,577
B 680 131 A mendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires 5 4,631

http://uscode.house.gov/view.xhtml?hl=false&... Page 13 of 28 5/5/2015(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 regi stration service fees. (b) Registrant-initiated fasttrack 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-ini tiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines spec ified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments subm itted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to regist ration service fees. (e) Submissions with data and requiring data revieware subject to registration service fees.

(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 applicati on 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 ingredi ent or first food use applicat ion. 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 applic ation package is subject to the registration service fee for a new product or a new inert approval. All such asso ciated 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 subsequentapplication for another new product containing the same active ingredient or an amendm ent to the proposed labeling will be deemed a new active ingredient application, subject to the registration service fee and decision revi ew time for a new active ingredient. In the case of a first food use applic ation, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the regist ration 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 data submission. (2)
B 68 1 132 Amendment; unregistered source of active ingredient(s). Requires data submission. (2) 7 5,513

B 683 New 133 a bel amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeli ng changes to REI, PPE, PHI). (2) 6 4,631

B 684 New 134 Amending non-food animal product that includes submission of target animal safety data; previously registered (2) 8 8,000

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

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

B 690 135 New active ingredient; fo od or non-food use. (2) 7 2,316
B 700 136 Experimental Use Permit application; new active ingredient or new use. 7 1,159
B 70 1 137 Extend or amend Experim ental Use Permit. 4 1,159
B 710 138 New product; registered source of active ingredient(s); identical or substantially similar in compositi on 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. Cat egory includes 100% re-package of registered end-use or manufacturing-us e product that requires no data submission or data matrix. (3) 4 1,159

B 720 139 New product; registered source of active ingredient(s); requires: 1) submission of product specif ic data; or 2) citation of previously reviewed and accepted data; or 3) submissi on or citation of data generated at government expense; or 4) submission or citation of a scientificallysound 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 wa ived supported by a scientificallysound rationale explaining why the data requirement does not apply. (3) 5 1,159

B 72 1 140 New product; unregistered source of active ingredient. (3) 7 2,426
B 72 2 141 New use and/or amendment; petition to establish a tolerance or tolerance exemption. (4) (5) 7 2,246

B 730 142 Label amendment requiring data submission. (4) 5 1,159

http://uscode.house.gov/view.xhtml?hl=false&... Page 14 of 28 5/5/2015applicant at the applicant's initiative to support the application after comp letion of the technical deficiency screening, and (c) is not itself a covere d registration application, must be a ssessed 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 revi ew, will be considered an application for a new product with an unregistered source of active ingredient.

(4) (a) EPA-initiated amendments shall not be charged regi stration service fees. (b) Registrant-initiated fasttrack 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-ini tiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines spec ified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments subm itted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to regist ration service fees. (e) Submissions with data and requiring data revieware subject to registration service fees.

(5) Amendment applications to add the new use(s) to regi stered product labels are covered by the base fee for the new use(s). All items in the covered application mustbe 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) c ontaining the same new uses, will be deemed a separate new-use application, subject to a sepa rate 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 in formation that (a) was neither requested nor required by the Agency, and (b) is subm itted 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 se rvice fee for the new use application.

(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 16. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - OTHER ACT

EPA

No. New CR No. Action Decision Review Time (Months) (1) Registration Service Fee

($)
B 614 New 143 Conditional Ruling on Preapplicat ion Study Waivers; applicantinitiated 3 2,294

B 615 New 144 Rebuttal of agency reviewed prot ocol, applicant initiated 3 2,294

B 68 2 145 Protocol review; applicant initiated; excludes time for HSRB review 3 2,205

TABLE 17. - BIOPESTICIDES AND POLLUTION PREVENTION DIVISION - PLANT INCORPORATED PROTECTANTS (PIPS)

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

B 740 146 Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: ) non-food/feed use(s) for a new(2) or registered (3) PIP; ) food/feed use(s) for a new or registered PIP with crop destruct; ) food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exis ts for the intended use(s). (4) 6 86,823

B 750 147 Experimental Use Permit applicati on; with a petition to establish a temporary or permanent tolerance/to lerance exemption for the active ingredient. Includes new food/feed use for a registered (3) PIP. (4) 9 115,763

B 770 148 x perimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exem ption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review. (5) 15 173,644

B 77 1 149 x perimental Use Permit application; new (2) PIP; with petition to establish a temporary tolerance/tolerance exem ption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows. 10 115,763

B 77 2 150 Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tole rance exemption for the active 3 11,577

http://uscode.house.gov/view.xhtml?hl=false&... Page 15 of 28 5/5/2015(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 in gredient 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 ingredient is unaffected.
B 77 3 151 Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/to lerance exemption for the active ingredient. 5 28,942

B 780 152 Registration application; new (2) PIP; non-food/feed. 12 144,704
B 790 153 Registration application; new (2) PI P; non-food/feed; SAP review. (5) 18 202,585
B 800 154 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. 12 231,585

B 810 155 Registration application; new (2) PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an

existing temporary tolerance/tole rance exemption. SAP review. (5) 18 289,407

B 820 156 R egistration application; new (2) PIP; wi th petition to establish or amend a permanent tolerance/tolerance exem ption of an active ingredient. 15 289,407

B 840 157 R egistration application; new (2) PIP; wi th petition to establish or amend a permanent tolerance/tolerance exempt ion of an active ingredient. SAP review. (5) 21 347,288

B 85 1 158 Registration application; new event of a previous ly registered PIP active ingredient(s); no petition sinc e permanent tolerance/tolerance

exemption is already established for the active ingredient(s). 9 115,763

B 870 159 Registration application; registered (3) PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (4) 9 34,729

B 880 160 Registration application; registered (3) PIP; new product or new terms of registration; additional data submit ted; no petition since a permanent

tolerance/tolerance exemption is already established for the active ingredient(s). (6) (7) 9 28,942

B 88 1 161 Registration application; registered (3) PIP; new product or new terms of registration; additional data submit ted; no petition since a permanent

tolerance/tolerance exemption is already established for the active ingredient(s). SAP review. (5) (6) (7) 15 86,823

B 883 New 162 Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registrati on; with petition to establish a

permanent tolerance/tolerance exempt ion for the active ingredient based on an existing temporary tole rance/tolerance exemption. (8) 9 115,763

B 884 New 163 Registration application; new (2) PIP, seed increase with negotiated acreage cap and time-limited registrati on; with petition to establish a permanent tolerance/tolerance exempt ion for the active ingredient. (8) 12 144,704

B 885 New 164 R egistration application; registered (3) PIP, seed increase; breeding stack of previously approved PIPs, same crop; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). (9) 9 86,823

B 890 165 A pplication to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). 9 57,882

B 89 1 166 A pplication to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption al ready established for the active ingredient(s); SAP review. (5) 15 115,763

B 900 167 pplication to amend a registration, in cluding actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. (10) (11) 6 11,577

B 90 1 168 pplication to amend a registration, incl uding actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. (10) (11) 12 69,458

B 90 2 169 PIP protocol review 3 5,789
B 90 3 170 Inert ingredient tolerance exempti on; e.g., a marker such as NPT II; reviewed in BPPD. 6 57,882

B 904 171 m port tolerance or tolerance exempti on; processed commodities/food only (inert or active ingredient). 9 115,763

http://uscode.house.gov/view.xhtml?hl=false&... Page 16 of 28 5/5/2015sweet 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, pestici de applicators, non-target species, as well as insect resistance, and novel scientif ic issues surrounding new tech nologies. The scientists of the SAP neither make nor recommend policy decisions. T hey provide advice on the sc ience 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 schedul e and prepare for meetings with the SAP, additional time and costs are needed.

(6) Registered PIPs stack ed 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 determi nation of the potential environmental exposure, risk(s) to non-target organisms, and the risk of targeted pest developing resi stance to the pesticidal substance. The uncertainty of these risks may reduce the allow able acreage, based upon the quantity and type of non-target organism data submitted and the lack of insect resist ance 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 applic ation for commercial registration. (10) For example, IRM plan modifica tions that are applicant-initiated. (11) EPA-initiated amendments shall not be charged fees.

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

EPA

No. New CR No. Action Decision Review Time (Months)

(1) Registration Service Fee

($)

00 1 172 Approval of new food use i nert ingredient (2) (3) 12 18,000
002 New 173 Amend currently approved inert ingred ient tolerance or exemption from tolerance; new data (2) 10 5,000

003 New 174 Amend currently approved inert ingred ient tolerance or exemption from tolerance; no new data (2) 8 3,000

004 New 175 Approval of new non-food us e inert ingredient (2) 8 10,000

005 New 176 Amend currently approved non-food us e inert ingredient with new use pattern; new data (2) 8 5,000

006 New 177 Amend currently approved non-food us e inert ingredient with new use pattern; no new data (2) 6 3,000

007 New 178 Approval of substantially similar non-food use inert ingredients when original inert is compositionally si milar with similar use pattern (2) 4 1,500

008 New 179 Approval of new polymer inert ingredient, food use (2) 5 3,400

009 New 180 Approval of new polymer inert ingredient, non food use (2) 4 2,800

010 New 181 Petition to amend a tolerance exempt ion descriptor to add one or more CASRNs; no new data (2) 6 1,500

M 001 New 182 t udy protocol requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) 9 7,200

M 002 New 183 o mpleted study requiring Human Studies Review Board review as defined in 40 CFR 26 in support of an active ingredient (4) 9 7,200

M 003 New 184 External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FI FRA 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. Ex cludes PIP active ingredients. (5) 12 58,000

M 004 New 185 External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FI FRA 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. Ex cludes PIP active ingredients. (5) 18 58,000

M 005 New 186 New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordina tion with other regulatory divisions

to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. (6) (7) 9 20,000

M 006 New 187 Request for up to 5 letters of cert ification (Gold Seal) for one actively registered product. 1 250

http://uscode.house.gov/view.xhtml?hl=false&... Page 17 of 28 5/5/2015(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 wi th and dependent upon a pending application for an inert ingredient action, each application will be subject to its respective registra tion 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 asso ciated covered action is further out, in which case it will be subject to its own decision review time. If the app lication covers multiple ingredients grouped by EPA into one chemical class, a single regist ration service fee will be assessed for approval of those ingredients.

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

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

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

(6) An application for a new end-use product using a source of active ingredient that (a ) is not yet registered but (b) has an application pending with the Agency for revi ew, 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 provi de to the applicant a draft accepted l abel, including any changes made by the Agency that differ from the applicant -submitted label and relevant supporti ng 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 t hat it be issued as the a ccepted final Agency-stamped label; or (b) does not agree to one or more of the term s of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the applicati on 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 agreem ent with the Agency on the final terms of the Agencyaccepted label. If the applicantagrees to all of the term s of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accept ed final Agency-stamped label to the registrant within 2 business days following the registrant's written or el ectronic confirmation of agreement to the Agency.

(4) Pending pesticide registration applications

(A) In general

An applicant that submitt ed a registration application to the Admi nistrator before the ef fective 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, paya registration service fee in accordance with paragraph (2)(B). (B) Voluntary fee

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

An application for which a voluntary registration serv ice 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 pest icide 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 applicat ion received during the period beginning on October 1, 2013, and ending on September 30, 2015, the Administra tor shall increase by 5 percent the registration service fee payable for the ap plication under paragraph (3). (B) Additional adjustment

Effective for a covered pesticide registration applic ation received on or after October 1, 2015, the M 007 New 188 Request to extend Exclusive Use of data as provided by FIFRA Section 3 (c)(1)(F)(ii) 12 5,000

M 008 New 189 R equest to grant Exclusive Use of data as provided by FIFRA Section 3(c) (1)(F)(vi) for a minor use, when a FIFRA Section 2( ll)(2) determination is required 10 1,500

http://uscode.house.gov/view.xhtml?hl=false&... Page 18 of 28 5/5/2015Administrator 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 Regi ster 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 th is section under the ci rcumstances 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 dem onstrating 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 payabl e 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 inform ation, 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 se rvice fee under this paragraph, the Administrator shall- (i) determine whether to grantor 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 porti on of, the registration service fee for an application for minor uses for a pesticide. (ii) Supporting documentation

An applicant requesting a waiver or exemption un der this subparagraph shall provide supporting documentation that demons trates, to the satisfaction of the Admini strator, 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 InterRegional Project Number 4 (IR–4) as described in section 2 of Public Law 89–106 (7 U.S.C. 450i(e)); and

(ii) the exemption is in the public interest. (F) Small businesses

(i) In general

The Administrator shall waive 50 percent of the r egistration service fees payable by an entity for a covered pesticide registration application under this se ction 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 fe es 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 ormanipulated primarily for the purpose of qualifying for the waiver. (iv) Documentation

An entity requesting a waiver under this s ubparagraph shall provide to the Administrator-

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

http://uscode.house.gov/view.xhtml?hl=false&... Page 19 of 28 5/5/2015(II) if the entity is requesting a waiver of 75 percentof 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 gove rnment 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 applic ation is withdrawn by the applicant, the Administrator shall refund all but 25 percent. 1 of the total registration service fe e 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 wi thdrawn after the first 60 days of the applicable decision time review period, the Administrator shall dete rmine what portion, if any, of the total registration service fee payable under paragraph (3) for the applic ation 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) notlater 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 th at has been filed with t he Administrator and has not been withdrawn by the applicant, butfor which the Administrator has not yet made a final determination, the Administrator may refund a portion of a covered regi stration 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, t he Administrator has considered data submitted in support of another pesticide registration application;

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

(III) on the basis that the Ad ministrator rejected the application under subsection (f)(4)(B). (D) Credited fees

In determining whether to grant a re fund under this paragraph, the Administra tor 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 Stat es a Pesticide Registration Fund to be used in carrying out this section (referred to in this section as the "Fund"), consisting of- (A) such amounts as are deposited in the Fund under paragraph (2); (B) any interest earned on investment of amounts in the Fund under paragraph (5); and (C) any proceeds from the sale or redemption of investments held in the Fund. (2) Deposits in Fund

Subject to paragraph (4), the Administrator shall depo sit 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 Admini strator shall use approxim ately 1/17 of the amount in the Fund (but not less than $1,000,000) to enhance sci entific and regulatory activities relating to worker protection. (ii) Partnership grant s

http://uscode.house.gov/view.xhtml?hl=false&... Page 20 of 28 5/5/2015Of 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 s hall 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 sect ion and amounts deposited in the Fund-

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

(B) shall be available withoutfiscal 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 St ates or guaranteed by the United States; or (iii) invested in obligations, participations, or other in struments 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 s ubparagraph (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 Of fice 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 th e 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 fi scal year under this section unless the amount of appropriations for salaries, contracts, and expenses for the functions (as in ex istence in fiscal year 2012) of the Office of Pesticide Programs of the Environmental Prot ection 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 appropria ted for the fiscal year). (3) Use of fees

Registration service fees authorized by this section s hall 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 activi ties) 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 s ubsection (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 co llect the fees, without any modification in rate, at any time during the fiscal year, notwith standing 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 co nsistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks, the Administrato r shall identify and evaluate reforms to the pesticide registration process under this subchapter with the goal of reducing decision reviewperiods in effect on the effective date of the Pesticide Regist ration Improvement Extensi on Act of 2012 for pesticide registration actions for covered pesticide registration applicat ions (including reduced risk applications). (f) Decision time review periods

(1) In general

Not later than 30 days after the effective date of t he Pesticide Registration Improvement Extension Act of 2012, the Administrator shall make publicly availabl e a schedule of decision review periods for covered pesticide registration actions and corresponding regi stration service fees under this subchapter. (2) Report

The schedule shall be the same as the applic able 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 wh ich an applicant has voluntarily paid registration service fees under subsection (b)(4); and

http://uscode.house.gov/view.xhtml?hl=false&... Page 21 of 28 5/5/2015(C) covered pesticide registration applications list ed in the Registration Divi sion 2003 Work Plan of the Office of Pesticide Programs of t he 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 u nder this section, the decision time review period begins 21 days after the date on which the Administra tor 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 describ ed 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 deter mines at any time before the Administrator completes the preliminary technical screening under clause (i)(II) that the app lication 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 appl ication, the Administrator shall determine whether-

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

(II) the application appears to contain all the necessa ry forms, data, and draft labeling, formatted in accordance with guidance publis hed by the Administrator. (iv) Requirements of preliminary technical screening

In conducting a preliminary technical screening of an application, the Administ rator 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 fo r 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 o f this subchapter, could result in the granting of the application. (C) Applications with waiv er or reduction requests

(i) In general

In the case of an application submitted with a reques t for a waiver or reduction of registration service fees under subsection (b)(7), the decis ion 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 th e date of receipt of the application. (iii) Request granted with additional fees required

If the Administrator grants the waiver or reducti on 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 paymentof 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

http://uscode.house.gov/view.xhtml?hl=false&... Page 22 of 28 5/5/2015date on which the Administrator rece ives certification of payment of the applicable registration service fee. (D) Pending applications

(i) In general

The start of the decision time review period for appl ications 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 t he effective date of the Pesticide Registration Improvement Act of 2003 but submitted without the app licable 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 applic ation listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environm ental Protection Agency, the decision time review period begins on the date that is 30 days after the effectiv e date of the Pesticide Regi stration 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 Ad ministrator to make a determination on the application of the applicant for registration of a newactive ingredient or new use for wh ich a registration service fee is paid under this section may obtain judicial reviewof the failure solely under this section. (2) Scope

(A) In general

In an action brought under this subsection, the only issu e on review is whether the Administrator failed to make a determination on the application specified in pa ragraph (1) by the end of the applicable decision time review period required under subs ection (f) for the application. (B) Other actions

No other action authorized or required under this secti on 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 expira tion 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 s ubsection, a person seeking th e review shall first request in writing, at least 120 days before fili ng the complaint for judicial review, a decision review meeting with the Administrator. (4) Remedies

The Administrator may not be required or permitted to re fund any portion of a registration service fee paid in response to a complaint that the Ad ministrator has failed to make a det ermination on the covered pesticide registration application specified in paragraph (1) bythe end of the applicable decision review period. (h) Accounting

The Administrator shall-

(1) provide an annual accounting of the registration serv ice 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 (P ublic 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 collecti ons 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

http://uscode.house.gov/view.xhtml?hl=false&... Page 23 of 28 5/5/2015agency. (2) Components

The annual audit required under sections 3515(b) and 3521 of t hat 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); (C) the amount appropriated to meet the requirements of subsection (d)(1); and (D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and decisionmaking pertaining to applications under this section. (3) Inspector General

The Inspector General of the Envi ronmental Protection Agency shall-

(A) conduct the annual audit required under this subsection; and (B) report the findings and recommendations of the audi t 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 goal s of the Environmental Protection Agency. (k) Reports

(1) In general

Not later than March 1, 2005, and eac h 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 t he decision times for each application specified in subsection (f);

(ii) the number of label amendments thathave been reviewed using electronic means; (iii) the amount of money from t he Reregistration and Expedited Processing Fund used to carry out inert ingredient review and review of similar applic ations under section 136a–1(k)(3) of this title;

(iv) the number of applications co mpleted for identical or substantia lly 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 Ad ministrator and consistent wi th 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 proces s improvements to further enhance the procedures used in electronic label review; and

(V) the allowance and use of summ aries 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 revi ew of applications for registration are met; and (II) the registration program is administered in the most produc tive 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 Administrato r was unable to make a decision within the initial decision time review period;

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

(C) a review of the progr ess in meeting the timeline requirement s of section 136a–1(g) of this title; (D) a review of the progress in carrying out section 136a( g) of this title, including-

(i) the number of pesticides or pesticide cases reviewed; (ii) a description of the staffi ng and resources relating to the costs associated with the review and decision making relating to reregistration and regi stration review for compliance with the deadlines specified in this subchapter;

(iii) to the extent determined appropriate by the Admi nistrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for- (I) process improvements in the hand ling of registration review under section 136a(g) of this title; (II) providing for accreditation of outside reviewers an d the use of outside review ers in the registration review process; and

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

http://uscode.house.gov/view.xhtml?hl=false&... Page 24 of 28 5/5/2015(E) a review of the progress in m eeting 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 re view of inert ingredients, including the number of applications pending, the number of new applications, the number of appl ications reviewed, staffing, and resources devoted to the review of inert ingredients an d 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 an d 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 stat us of conditional registrations, including making nonconfidential information related to the conditional registrations public ly available by December 31, 2013;

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

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

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

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

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

(I) a review of the progress made in updating the Pe sticide Incident Data System, including progress toward making the information contained in the Syst em 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 met hod as the Administrator determines to be the most effective for efficiently disseminating the report, in cluding 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 par agraph (1), not later than October 1, 2016, the Administrator shall submit to t he 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 s ubparagraph (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, obligat ions, or authorities established by any other section of this subchapter, including the right to judicial review of duties, obligations, or authorit ies 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 colle ct 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 colle ct 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

http://uscode.house.gov/view.xhtml?hl=false&... Page 25 of 28 5/5/2015In 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 se ction on or after September 30, 2017, subsection (f) shall not apply to the application. (June 25, 1947, ch. 125, §33, as added Pub. L. 108–199, div. G, title V, §501( f)(2), Jan. 23, 2004, 118 Stat. 422 ; amended Pub. L. 110–94, §5, Oct. 9, 2007, 121 Stat. 1002 ; Pub. L. 110–193, §1(a), Mar. 6, 2008, 122 Stat. 649 ; Pub. L. 112–177, §2(a)(2)(B), (b), Sept. 28, 2012, 126 Stat. 1328, 1330.)


## R EFERENCES IN 

## T EXT 

### The effective date of the Pesticide Registration Improvement Act of 2003, and the effective date of this section, referred to in text, is the effectiv e date of section 501 of Pub. L. 108–199, which is the date that is 60 days after Jan. 23, 2004, unless ot herwise provided, see sect ion 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.

The effective date of the Pesticide Registration Im provement 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.



## P RIOR

## P ROVISIONS



### A prior section 33 of act June 25, 1947, ch. 125, was renumbered section 34 and is classified to section 136x of this title



### . 

## A MENDMENTS

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 app lications 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 "secti on 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), subs tituted "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 expensesfor the functions (as in existenc e in fiscal year 2002) of the

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### Office of Pesticide Programs of the Environmental Protection Agen cy 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 fisc al year 2002 (excluding the amount of any fees appropriated for the fiscal year)." Subsec. (e). Pub. L. 112–177, §2(b)(4), substitu ted "Pesticide Registrati on 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 makepublicly available" for "Pesticide Registration Improvement Renewal Act, the Administrato r shall publish in the Federal Register".

Subsec. (f)(2). Pub. L. 112–177, §2(b)(5)(B), su bstituted "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 "Complet eness of application" in heading. Subsec. (f)(4)(B)(i). Pub. L. 112–177, §2(b)(5)(C )(ii)(I), (II), substitu ted "Screenings" for "In general" in cl. heading, designated existing provisio ns 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)(I II), 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. 11 2–177, §2(b)(5)(C)(ii)(V), added cl. (iv). Subsec. (k)(1). Pub. L. 112–177, §2(b)(6)(A), subs tituted "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)(i i), 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)(ii i), 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 Ad ministrator 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 registrati on 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 struckout 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 Regist ration 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: "Effe ctive for a covered pesticide registration application received on or after October 1, 2005, the Administrator shall- "(A) increase by 5 percent the service fee pay able 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), s ubstituted "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".

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### Subsec. (c)(1)(B). Pub. L. 110–94, §5(e)(1), s ubstituted "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), st ruck 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 assubpar. (A), inserted heading, redesignated former subpars. (A) to (C) as cl s. (i) to (iii), respectively, of subpar. (A) and added subpar. (B). Subsec. (d)(2). Pub. L. 110–94, §5(f), which directed substitution of "Registrat ion" for "For fiscal years 2004, 2005 and 2006 only, registration", wa s 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), substitu ted "Pesticide Registration Improvement Renewal Act" for "Pesticide Registra tion Improvement Act of 2003". Subsec. (f)(2). Pub. L. 110–94, §5(g)(2), subs tituted "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), a dded subpar. (B) and struck out former subpar. (B) which provided criteria for determining comple teness of pesticide regi stration 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) redesi gnated (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), redesignat ed 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), s ubstituted "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.



## E FFECTIVE 

## D ATE OF

## 2012 A MENDMENT 

### 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



### . 

## E FFECTIVE 

## D ATE OF

## 2008 A MENDMENT 

### 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."



## E FFECTIVE 

## D ATE OF

## 2007 A MENDMENT 

### 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



### . 

## E FFECTIVE 

## D ATE 

### Section effective on the date that is 60 days after Jan. 23, 2004, except asotherwise 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



### .

1 So in original. The period probably should not appear.

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