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Notice

Pesticides; Revised Fee Schedule for Registration Applications

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is publishing a revised list of pesticide registration service fees applicable to specified pesticide applications and tolerance actions. Under the Pesticide Registration Improvement Extension Act, the registration service fees for covered pesticide registration applications received on or after October 1, 2015, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2015. The new fees for FY'2016 become effective on October 1, 2015.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Peter Caulkins (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-6550; fax number: (703) 308-4776; email address: caulkins.peter@epa.gov.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you register pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially affected entities may include, but are not limited to:

  • Agricultural pesticide manufacturers (NAICS code 32532).
  • Antimicrobial pesticide manufacturers (NAICS code 32561).
  • Antifoulant pesticide manufacturers (NAICS code 32551).
  • Wood preservative manufacturers (NAICS code 32519).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the notice and in FIFRA section 33. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0614, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional Start Printed Page 57167information about the docket available at http://www.epa.gov/​dockets.

II. Background

A. What action is the agency taking?

The Pesticide Registration Improvement Act of 2003 established a new section 33 of FIFRA creating a registration service fee system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004.

On September 28, 2012, the Pesticide Registration Improvement Extension Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through fiscal year 2017 and established fees and review times for applications received during fiscal years 2013 through 2017. As required by section 33(b)(6)(A) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2015, increase by 5% rounding up to the nearest dollar from the fees published in the September 26, 2013, “Pesticides: Fee Schedule for Registration Applications,” FRN Vol. 78. No. 187 pp. 59347-59359.

B. What is the agency's authority for taking this action?

The publication of this fee schedule is required by section 33(b)(6)(C) of FIFRA as amended.

III. Elements of the Fee Schedule

This unit explains how to read the fee schedule tables, and includes a key to terminology published with the table.

A. The Pesticide Registration Improvement Extension Act Fee Schedule

The fee schedule published in the Pesticide Registration Improvement Extension Act of September 28, 2012, identifies the registration service fees and decision times and is organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. Thereafter, the categories within the organizational unit sections of the table are further categorized according to the type of application being submitted, the use patterns involved, or, in some cases, upon the type of pesticide that is the subject of the application. The fee categories differ by Division. Not all application types are covered by, or subject to, the fee system.

B. Fee Schedule and Decision Review Times

In today's notice, EPA has retained the format of the tables included in the Pesticide Registration Improvement Extension Act of September 28, 2012. The schedules are presented as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee. Unit IV presents fee tables for the Registration Division (RD) (6 tables), the Antimicrobials Division (AD) (4 tables), the Biopesticides and Pollution Prevention Division (BPPD) (7 tables), Inert Ingredients (1 table), Miscellaneous (1 table).

C. How To Read the Tables

1. Each table consists of the following columns:

  • The column titled “EPA No.” assigns an EPA identifier to each fee category. There are 189 categories spread across the 3 Divisions. There are 63 RD categories, 39 AD categories, 69 BPPD categories, 10 inert categories, and 8 miscellaneous categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD, BPPD, inert and miscellaneous categories. The categories are prefaced with a letter designation indicating which Division of OPP is responsible for applications in that category (R=Registration Division, A=Antimicrobials Division, B=Biopesticides and Pollution Prevention Division, I=inert ingredients, M=miscellaneous).
  • The column titled “CR No.” cross-references the current Congressional Record category number for convenience. However, EPA will be using the categories as numbered in the “EPA No.” column in its tracking systems.
  • The column titled “Action” ' describes what registration actions are covered by each category.
  • The column titled “Decision Time” lists the decision times in months for each type of action.
  • The column titled “FY' 2016/17 Registration Service Fee ($)” lists the registration service fee for the action for fiscal year 2016 (October 1, 2015 through September 30, 2016) and fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • Footnote text has been removed to save on Federal Register costs but remains unchanged from what was published in FY' 2013. The tables and footnote text will be available in full after October 1, 2015 at http://www.epa.gov/​pesticides/​regulating/​fees/​tool/​category-table.html.

2. The following acronyms are used in some of the tables:

  • DART—Dose Adequacy Response Team.
  • DNT—Developmental Neurotoxicity.
  • HSRB—Human Studies Review Board.
  • GW/SW—Ground Water/Surface Water.
  • PHI-Pre—Harvest Interval.
  • PPE—Personal Protective Equipment.
  • REI—Restricted Entry Interval.
  • SAP—FIFRA Scientific Advisory Panel.

IV. PRIA Fee Schedule Tables—Effective October 1, 2015

A. Registration Division (RD)

The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed “conventional chemicals,” excluding pesticides intended for antimicrobial uses. The term “conventional chemical” is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally occurring chemicals and microbial pesticides. Tables 1 through 6 cover RD actions.

Table 1—Registration Division—New Active Ingredients

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
R0101New Active Ingredient, Food use24627,568
R0202New Active Ingredient, Food use; reduced risk18627,568
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R0403New Active Ingredient, Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows18462,502
R0604New Active Ingredient, Non-food use; outdoor21436,004
R0705New Active Ingredient, Non-food use; outdoor; reduced risk16436,004
R0906New Active Ingredient, Non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows16323,690
R1107New Active Ingredient, Non-food use; indoor20242,495
R1208New Active Ingredient, Non-food use; indoor; reduced risk14242,495
R1219New Active Ingredient, Non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows18182,327
R12210Enriched isomer(s) of registered mixed-isomer active ingredient18317,128
R12311New Active Ingredient, Seed treatment only; includes agricultural and non-agricultural seeds; residues not expected in raw agricultural commodities18471,861
R12512New Active Ingredient, Seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows16323,690

Table 2—Registration Division—New Uses

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
R13013First food use; indoor; food/food handling21191,444
R14014Additional food use; Indoor; food/food handling1544,672
R15015First food use21264,253
R16016First food use; reduced risk16264,253
R17017Additional food use1566,124
R17518Additional food uses covered within a crop group resulting from the conversion of existing approved crop group(s) to one or more revised crop groups.1066,124
R18019Additional food use; reduced risk1066,124
R19020Additional food uses; 6 or more submitted in one application15396,742
R20021Additional food use; 6 or more submitted in one application; reduced risk10396,742
R21022Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration1248,986
R22023Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration619,838
R23024Additional use; non-food; outdoor1526,427
R24025Additional use; non-food; outdoor; reduced risk1026,427
R25026Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration619,838
R25127Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis819,838
R26028New use; non-food; indoor1212,764
R27029New use; non-food; indoor; reduced risk912,764
R27130New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration69,725
R27331Additional use; seed treatment; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses1250,445
R27432Additional uses; seed treatment only; 6 or more submitted in one application; limited uptake into raw agricultural commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food uses12302,663

Table 3—Registration Division—Import and Other Tolerances

EPA No.New CR No.ActionDecision review time (months)FY '16/17— registration service fee ($)
R28033Establish import tolerance; new active ingredient or first food use21319,072
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R29034Establish Import tolerance; Additional new food use1563,816
R29135Establish import tolerances; additional food uses; 6 or more crops submitted in one petition15382,886
R29236Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated1145,341
R29337Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated1253,483
R29438Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated12320,894
R29539Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated1566,124
R29640Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; 6 or more crops submitted in one application; applicant-initiated15396,742
R29741Amend 6 or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated11272,037
R29842Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated)1358,565
R29943Amend 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)13285,261

Table 4—Registration Division—New Products

EPA No.New CR No.ActionDecision review time (months)FY'16/17 registration service fee ($)
R30044New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP—only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner Category also includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix41,582
R30145New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner41,897
R31046New 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 packaging75,301
R31447New end use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: Product chemistry and/or acute toxicity and/or public health pest efficacy and/or child resistant packaging86,626
R31548New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: Product chemistry and/or acute toxicity and/or public health pest efficacy and/or animal safety studies and/or child resistant packaging98,820
R32049New product; new physical form; requires data review in science divisions1213,226
R33150New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only32,530
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R33251New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions24283,215
R33352New product; MUP or End use product with unregistered source of active ingredient; requires science data review; new physical form; etc Cite-all or selective data citation where applicant owns all required data1019,838
R33453New product; MUP or End use product with unregistered source of the active ingredient; requires science data review; new physical form; etc Selective data citation1119,838

Table 5—Registration Division—Amendments to Registration

EPA No.New CR No.ActionDecision review time (months)FY'16/17 registration service fee ($)
R34054Amendment requiring data review within RD (e.g., changes to precautionary label statements)43,988
R34555Amending non-food animal product that includes submission of target animal safety data; previously registered78,820
R35056Amendment 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)913,226
R35157Amendment adding a new unregistered source of active ingredient813,226
R35258Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data813,226
R37159Amendment to Experimental Use Permit; (does not include extending a permit's time period)610,090

Table 6—Registration Division—Other Actions

EPA No.New CR No.ActionDecision review time (Months)FY'16/17 registration service fee ($)
R12460Conditional Ruling on Preapplication Study Waivers; applicant-initiated62,530
R27261Review of Study Protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review32,530
R27562Rebuttal of agency reviewed protocol, applicant initiated32,530
R37063Cancer reassessment; applicant-initiated18198,250

B. Antimicrobials Division (AD)

The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2 (mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 7 through 10 cover AD actions.

Table 7—Antimicrobials Division—New Active Ingredients

EPA No.New CR No.ActionDecision review time (Months)FY'16/17 registration service fee ($)
A38064New Active Ingredient Food use, establish tolerance exemption24114,867
A39065New Active Ingredient Food use, establish tolerance24191,444
A40066New Active Ingredient, Non-food use, outdoor, FIFRA § 2 (mm) uses1895,724
A41067New Active Ingredient Non-food use, outdoor, uses other than FIFRA § 2(mm)21191,444
A42068New Active Ingredient Non-food use, indoor, FIFRA § 2(mm) uses1863,816
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A43069New Active Ingredient, Non-Food Use Indoor, uses other than FIFRA § 2(mm) uses2095,724
A43170New Active Ingredient, Non-food use; indoor; low-risk; low-toxicity food grade active ingredient(s); efficacy testing for public health claims required under GLP and following DIS/TSS or AD-approved study protocol1266,854

Table 8—Antimicrobials Division—New Uses

EPA No.New CR No.ActionDecision review time (Months)FY'16/17 registration service fee ($)
A44071New Use, First Food Use, establish tolerance exemption2131,910
A45072New use, First food use, establish tolerance2195,724
A46073New use, additional food use; establish tolerance exemption1512,764
A47074New use, additional food use, establish tolerance1531,910
A47175Additional food uses; establish tolerances; 6 or more submitted in one application15191,452
A48076New use, Additional use, non-food, outdoor; FIFRA § 2(mm) uses919,146
A48177Additional non-food outdoor uses; FIFRA § 2(mm) uses; 6 or more submitted in one application9114,870
A49078New use, additional use, non-food, outdoor, uses other than FIFRA § 2(mm)1531,910
A49179Additional non-food; outdoor; uses other than FIFRA § 2(mm); 6 or more submitted in one application15191,452
A50080New use, additional use, non-food, indoor FIFRA § 2(mm) uses912,764
A50181Additional non-food; indoor; FIFRA § 2(mm) uses; 6 or more submitted in one application976,583
A51082New use, additional use, non-food, indoor, other than FIFRA § 2(mm)1212,764
A51183Additional non-food; indoor; uses other than FIFRA § 2(mm); 6 or more submitted in one application1276,583

Table 9—Antimicrobials Division-New Products and Amendments

EPA No.New CR No.ActionDecision review time (Months)FY'16/17 registration service fee ($)
A53084New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where applicant owns all required data; or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing use product that requires no data submission nor data matrix41,278
A53185New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: Selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner41,824
A53286New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted55,107
A54087New end use product; FIFRA § 2(mm) uses only (2) (3)55,107
A55088New end-use product; uses other than FIFRA § 2(mm); non-FQPA product75,107
A56089New manufacturing use product; registered active ingredient; selective data citation1219,146
A57090Label amendment requiring data review43,831
A57291New Product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate)913,226
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Table 10—Antimicrobials Division—Experimental Use Permits and Other Type of Actions

EPA No.New CR No.ActionDecision review time (Months)FY'16/17 registration service fee ($)
A52092Experimental Use Permit application, non-food use96,383
A52193Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 132,482
A52294Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2.1212,156
A523101Review of protocol other than a public health efficacy study (i.e., Toxicology or Exposure Protocols)912,156
A52495New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows18153,156
A52596New Active Ingredient, Experimental Use Permit application; Food Use Requires Tolerance Exemption. Credit 45% of fee toward new active ingredient application that follows1892,163
A52697New Active Ingredient, Experimental Use Permit application; Non-Food, Outdoor Use. Credit 45% of fee toward new active ingredient application that follows1595,724
A52798New Active Ingredient, Experimental Use Permit application; Non-Food, Indoor Use. Credit 45% of fee toward new active ingredient application that follows1563,945
A52899Experimental Use Permit application, Food Use; Requires Tolerance or Tolerance Exemption1522,337
A529100Amendment to Experimental Use Permit; requires data review or risk assessment911,429
A571102Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated1895,724

C. Biopesticides and Pollution Prevention Division (BPPD)

The Biopesticides and Pollution Prevention Division of OPP is responsible for the processing of pesticide applications for biochemical pesticides, microbial pesticides, and plant-incorporated protectants (PIPs).

The fee tables for BPPD actions are presented by type of pesticide rather than by type of action: Microbial and biochemical pesticides, straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each table, the types of application are the same as those in other divisions. Tables 11 through 17 cover BPPD actions.

Table 11—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Active Ingredients

EPA No.New CR No.ActionDecision review time (months)FY'16/17 registration service fee ($)
B580103New active ingredient; food use; petition to establish a tolerance1951,053
B590104New active ingredient; food use; petition to establish a tolerance exemption1731,910
B600105New active ingredient; non-food use1319,146
B610106New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption1012,764
B611107New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption1212,764
B612108New active ingredient; no change to a permanent tolerance exemption1017,550
B613109New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption1117,550
B620110New active ingredient; Experimental Use Permit application; non-food use including crop destruct76,383
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Table 12—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Uses

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B630111First food use; petition to establish a tolerance exemption1312,764
B631112New food use; petition to amend an established tolerance1212,764
B640113New food use; petition to amend an established tolerance1919,146
B642115First food use; indoor; food/food handling1231,910
B643114New Food use; petition to amend tolerance exemption1012,764
B644116New use, no change to an established tolerance or tolerance exemption812,764
B650117New use; non-food76,383

Table 13—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B652118New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires (1) submission of product specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply1312,764
B660119New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix For microbial pesticides, the active ingredient(s) must not be re-isolated41,278
B670120New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: (1) Submission of product specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply75,107
B671121New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: (1) Submission of product specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply1712,764
B672122New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: (1) Submission of product specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply139,118
B673123New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency Requires an Agency determination that the cited data supports the new product105,107
B674124New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only41,278
Start Printed Page 57174
B675125New Product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only109,118
B676126New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: (1) Submission of product specific data, and (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply139,118
B677127New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data108,820

Table 14—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; Amendments

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B621128Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption75,107
B622129Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption1112,764
B641130Amendment of an established tolerance or tolerance exemption1312,764
B680131Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption Requires data submission55,107
B681132Amendment; unregistered source of active ingredient(s) Requires data submission76,079
B683133Label amendment; requires review/update of previous risk assessment(s) without data submission (eg., labeling changes to REI, PPE, PHI)65,107
B684134Amending non-food animal product that includes submission of target animal safety data; previously registered88,820

Table 15—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPS)

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B690135New active ingredient; food or non-food use72,554
B700136Experimental Use Permit application; new active ingredient or new use71,278
B701137Extend or amend Experimental Use Permit41,278
B710138New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated Category includes 100% re-package of registered end-use or manufacturing-use product that requires no data submission or data matrix41,278
B720139New product; registered source of active ingredient(s); requires: (1) Submission of product specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply51,278
B721140New product; unregistered source of active ingredient72,676
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B722141New use and/or amendment; petition to establish a tolerance or tolerance exemption72,477
B730142Label amendment requiring data submission51,278

Table 16—Biopesticides and Pollution Prevention Division—Other Actions

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B614143Conditional Ruling on Preapplication Study Waivers; applicant-initiated32,530
B615144Rebuttal of agency reviewed protocol, applicant initiated32,530
B682145Protocol review; applicant initiated; excludes time for HSRB review32,432

Table 17—Biopesticides and Pollution Prevention Division—Plant Incorporated Protectants (PIPS)

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
B740146Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: Non-food/feed use(s) for a new or registered 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 exists for the intended use(s)695,724
B750147Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered PIP9127,630
B770148Experimental Use Permit application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows; SAP review15191,444
B771149Experimental Use Permit application; new PIP; with petition to establish a temporary tolerance/tolerance exemption for the active ingredient; credit 75% of B771 fee toward registration application for a new active ingredient that follows10127,630
B772150Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected312,764
B773151Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient531,910
B780152Registration application; new PIP; non-food/feed12159,537
B790153Registration application; new PIP; non-food/feed; SAP review18223,351
B800154Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption12255,324
B810155Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review18319,072
B820156Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient15319,072
B840157Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review21382,886
B851158Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s)9127,630
B870159Registration application; registered PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s)938,290
Start Printed Page 57176
B880160Registration application; registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s)931,910
B881161Registration application; registered PIP; new product or new terms of registration; additional data submitted; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). SAP review1595,724
B883162Registration application; new PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption9127,630
B884163Registration application; new PIP, seed increase with negotiated acreage cap and time-limited registration; with petition to establish a permanent tolerance/tolerance exemption for the active ingredient12159,537
B885164Registration application; registered 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)995,724
B890165Application 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)963,816
B891166Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s); SAP review15127,630
B900167Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled612,764
B901168Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review1276,578
B902169PIP Protocol review36,383
B903170Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD663,816
B904171Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient)9127,630

Table 18—Inert Ingredients

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
I001172Approval of new food use inert ingredient1219,845
I002173Amend currently approved inert ingredient tolerance or exemption from tolerance; new data105,513
I003174Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data83,308
I004175Approval of new non-food use inert ingredient811,025
I005176Amend currently approved non-food use inert ingredient with new use pattern; new data85,513
I006177Amend currently approved non-food use inert ingredient with new use pattern; no new data63,308
I007178Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern41,654
I008179Approval of new polymer inert ingredient, food use53,749
I009180Approval of new polymer inert ingredient, non food use43,087
I010181Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data61,654
Start Printed Page 57177

Table 19—Miscellaneous Actions

EPA No.New CR No.ActionDecision review time (months)FY '16/17 registration service fee ($)
M001182Study protocol requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient97,938
M002183Completed study requiring Human Studies Review Board review as defined in 40 CFR Part 26 in support of an active ingredient97,938
M003184External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients1263,945
M004185External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant initiated request based on a requirement of the Administrator, as defined by FIFRA § 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients1863,945
M005186New Product: Combination, Contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product922,050
M006187Request for up to 5 letters of certification (Gold Seal) for one actively registered product1277
M007188Request to extend Exclusive Use of data as provided by FIFRA Section 3(c)(1)(F)(ii)125,513
M008189Request 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 required101,654

V. How To Pay Fees

Applicants must submit fee payments at the time of application, and EPA will reject any application that does not contain evidence that the fee has been paid. EPA has developed a Web site at http://www.epa.gov/​pesticides/​fees/​tool/​index.htm to help applicants identify the fee category and the fee. All fees should be rounded up to the whole dollar. Due to changes mandated by the U.S. Department of the Treasury, checks, bank drafts and money orders are no longer acceptable as of September 30, 2015. Credit card payments are only acceptable for amounts less than or equal to $25,000. All payments above $25,000 can be made by electronic funds transfer via www.pay.gov.

A. Online

You may pay electronically through the government payment Web site www.pay.gov.

1. From the pay.gov home page, under “Find Public Forms.”

2. Select “search by Agency name.”

3. On the A-Z Index of Forms page, select “E.”

4. Select “Environmental Protection Agency.”

5. From the list of forms, select “Pre-payment of Pesticide Registration Improvement Act Fee.”

6. Complete the form entering the PRIA fee category and fee.

7. Keep a copy of the pay.gov acknowledgement of payment. A copy of the acknowledgement must be printed and attached to the front of the application to assure that EPA can match the application with the payment.

VI. How To Submit Applications

Submissions to the Agency should be made at the address given in Unit VII. The applicant should attach documentation that the fee has been paid which in most cases will be pay.gov payment acknowledgement. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described in FIFRA section 33(b)(7) and http://www.epa.gov/​pesticides/​fees/​questions/​waivers.htm. The fee waiver request should be easy to identify and separate from the rest of the application and submitted with documentation that at least 25% of the fee has been paid.

If evidence of fee payment (electronic acknowledgement) is not submitted with the application, EPA will reject the application and will not process it further.

After EPA receives an application and payment, EPA performs a screen on the application to determine that the category is correct and that the proper fee amount has been paid. If either is incorrect, EPA will notify the applicant and require payment of any additional amount due. A refund will be provided in case of an overpayment. EPA will not process the application further until the proper fee has been paid for the category of application or a request for a fee waiver accompanies the application and the appropriate portion of the fee has been paid.

EPA will assign a unique identification number to each covered application for which payment has been made. EPA notifies the applicant of the unique identification number. This information is sent by email if EPA has either an email address on file or an email address is provided on the application.

VII. Addresses for Applications

New covered applications should be identified in the title line with the mail code REGFEE.

  • By U.S. Postal Service mail. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460-0001.Start Printed Page 57178
  • By courier. Document Processing Desk (REGFEE), Office of Pesticide Programs, U.S. Environmental Protection Agency, Room S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202-4501.

Couriers and delivery personnel must present a valid picture identification card to gain access to the building. Hours of operation for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.

Start List of Subjects

List of Subjects

  • Environmental protection
  • Administrative practice and procedure
  • Pesticides
End List of Subjects Start Signature

Dated: September 15, 2015.

Marty Monell,

Acting Director, Office of Pesticide Programs.

End Signature End Supplemental Information

[FR Doc. 2015-24064 Filed 9-21-15; 8:45 am]

BILLING CODE 6560-50-P