Pesticides; Revised Fee Schedule for Registration Applications, 59347-59359 [2013-23368]

Download as PDF Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices with or deny a section 301(h) decision made by the EPA Regional Office. Form Numbers: ‘‘None.’’ Respondents/affected Entities: Entities potentially affected by this action are those municipalities that currently have section 301(h) waivers from secondary treatment, or have applied for a renewal of a section 301(h) waiver, and the states within which these municipalities are located. Respondent’s Obligation To Respond: Required To Obtain or retain a benefit. Estimated Number of Respondents: Est. 50 (total). Frequency of Response: From once every five years, to varies case-by-case, depending on the category of information. Total Estimated Burden: 59,370 hours (per year). Burden is defined at 5 CFR 1320.3(b). Total Estimated Cost: $1.3 million (per year), includes $0 annualized capital or operation & maintenance costs. Changes in Estimates: There is a decrease of hours in the total estimated respondent burden compared with the ICR currently approved by OMB. EPA expects the numbers will decrease due to changes in respondent universe, use of technology, etc. Dated: September 18, 2013. Benita Best-Wong, Acting Director, Office of Wetlands, Oceans and Watersheds. [FR Doc. 2013–23509 Filed 9–25–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9901–46–OA; EPA–HQ–OA–2013– 0125] National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation Environmental Protection Agency (EPA). ACTION: Notice of advisory committee meeting teleconference call. AGENCY: Under the Federal Advisory Committee Act, Public Law 92–463, EPA gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC). The National and Governmental Advisory Committees advise the EPA Administrator in her capacity as the U.S. Representative to the CEC Council. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:17 Sep 25, 2013 Jkt 229001 The Committees are authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC), North American Free Trade Agreement Implementation Act, Public Law 103–182, and as directed by Executive Order 12915, entitled ‘‘Federal Implementation of the North American Agreement on Environmental Cooperation.’’ The NAC is composed of 14 members representing academia, environmental non-governmental organizations, and private industry. The GAC consists of 15 members representing state, local, and Tribal governments. The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related to implementation and further elaboration of the NAAEC. The purpose of this meeting is to provide advice on the 20th anniversary of the NAAEC and to discuss other trade and environment issues in North America. The meeting will also include a public comment session. The agenda and meeting materials will be available at https://www.regulations.gov under Docket ID: EPA–HQ–OA–2013–0125. General information about NAC and GAC can be found at https:// www.epa.gov/ofacmo/nacgac-page.htm. DATES: The NAC/GAC will hold a public teleconference on October 16, 2013, from 1:00 p.m. to 4:00 p.m. Eastern Standard Time. ADDRESSES: The meeting will be held at the U.S. EPA East Building, 1201 Constitution Avenue NW., Room 1132, Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Designated Federal Officer, carrillo.oscar@epa.gov, 202– 564–0347, U.S. EPA, Office of Diversity, Advisory Committee Management and Outreach (1601–M), 1200 Pennsylvania Avenue NW., Washington, DC 20004. SUPPLEMENTARY INFORMATION: Requests to make oral comments or to provide written comments to NAC/GAC should be sent to Oscar Carrillo at carrillo.oscar@epa.gov by Wednesday, October 9, 2013. The meeting is open to the public, with limited seating on a first-come, first-served basis. Members of the public wishing to participate in the teleconference should contact Oscar Carrillo at carrillo.oscar@epa.gov or 202–564–0347 by October 9, 2013. Meeting Access: For information on access or services for individuals with disabilities, please contact Oscar Carrillo at 202–564–0347 or carrillo.oscar@epa.gov. To request accommodation of a disability, please contact Oscar Carrillo, preferably at PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 59347 least 10 days prior to the meeting, to give EPA as much time as possible to process your request. Dated: September 17, 2013. Oscar Carrillo, Designated Federal Officer. [FR Doc. 2013–23502 Filed 9–25–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2013–0621; FRL–9399–5] Pesticides; Revised Fee Schedule for Registration Applications Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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, 2013, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2012. The new fees become effective on October 1, 2013. 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. SUMMARY: 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 E:\FR\FM\26SEN1.SGM 26SEN1 59348 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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. increase by 5% rounding up to the nearest dollar from the fees published in the September 28, 2012 Pesticide Registration Improvement Extension Act. 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 B. How can I get copies of this document terminology published with the table. and other related information? A. The Pesticide Registration The docket for this action, identified Improvement Extension Act Fee by docket identification (ID) number Schedule EPA–HQ–OPP–2013–0621, is available The fee schedule published in the at https://www.regulations.gov or at the Pesticide Registration Improvement Office of Pesticide Programs Regulatory Extension Act of September 28, 2013, Public Docket (OPP Docket) in the identifies the registration service fees Environmental Protection Agency and decision times and is organized Docket Center (EPA/DC), EPA West according to the organizational units of Bldg., Rm. 3334, 1301 Constitution Ave. the Office of Pesticide Programs (OPP) NW., Washington, DC 20460–0001. The within EPA. Thereafter, the categories Public Reading Room is open from 8:30 within the organizational unit sections a.m. to 4:30 p.m., Monday through of the table are further categorized Friday, excluding legal holidays. The according to the type of application telephone number for the Public being submitted, the use patterns Reading Room is (202) 566–1744, and involved, or, in some cases, upon the the telephone number for the OPP type of pesticide that is the subject of Docket is (703) 305–5805. Please review the application. The fee categories differ the visitor instructions and additional by Division. Not all application types information about the docket available are covered by, or subject to, the fee at https://www.epa.gov/dockets. system. II. Background B. Fee Schedule and Decision Review Times A. What action is the Agency taking? In today’s notice, EPA has retained The Pesticide Registration the format of the tables included in the Improvement Act of 2003 established a Pesticide Registration Improvement new section 33 of FIFRA creating a Extension Act of September 28, 2012. registration service fee system for The schedules are presented as 18 certain types of pesticide applications, establishment of tolerances, and certain tables, organized by OPP Division and other regulatory decisions under FIFRA by type of application or pesticide subject to the fee. Unit IV. presents fee and the Federal Food, Drug, and tables for the Registration Division (RD) Cosmetic Act (FFDCA). Section 33 also (6 tables), the Antimicrobials Division created a schedule of decision review (AD) (4 tables), the Biopesticides and times for applications covered by the Pollution Prevention Division (BPPD) (7 service fee system. The Agency began tables), and Inert Ingredients, External administering the registration service Review and Miscellaneous (1 table). fee system for covered applications received on or after March 23, 2004. C. How To Read the Tables On September 28, 2012, the Pesticide Registration Improvement Extension Act 1. Each table consists of the following columns: was signed by the President, revising, • The column titled ‘‘EPA No.’’’ among other things, FIFRA section 33. assigns an EPA identifier to each fee The new law reauthorized the service category. There are 189 categories fee system through fiscal year 2017 and spread across the 3 Divisions. There are established fees and review times for applications received during fiscal years 63 RD categories, 39 AD categories, 69 BPPD categories, 10 inert categories, and 2013 through 2017. As required by 8 miscellaneous categories. For tracking section 33(b)(6)(A) of FIFRA, the purposes, OPP has assigned a 3-digit registration service fees for covered identifier to each category, beginning pesticide registration applications with RD categories, followed by AD, received on or after October 1, 2013, VerDate Mar<15>2010 18:19 Sep 25, 2013 Jkt 229001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 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.’’ crossreferences 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 2014/FY 2015 Registration Service Fee ($)’’ lists the registration service fee for the action for fiscal year 2014 (October 1, 2013 through September 30, 2014) and fiscal year 2015 (October 1, 2014 through September 30, 2015). • 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 at https://www.epa.gov/ pesticides/regulating/fees/tool/categorytable.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, 2013 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 E:\FR\FM\26SEN1.SGM 26SEN1 59349 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices 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. R010 ............. R020 ............. R040 ............. 1 2 3 R060 ............. R070 ............. R090 ............. 4 5 6 R110 ............. R120 ............. R121 ............. 7 8 9 R122 ............. R123 ............. 10 11 R125 ............. 12 FY ’14/15 registration service fee ($) Decision review time (months) Action New active ingredient, food use ....................................................................... New active ingredient, food use; reduced risk ................................................. New active ingredient, food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. New active ingredient, non-food use; outdoor ................................................. New active ingredient, non-food use; outdoor; reduced risk ........................... New active ingredient, non-food use; outdoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. New active ingredient, non-food use; indoor ................................................... New active ingredient, non-food use; indoor; reduced risk ............................. New active ingredient, non-food use; indoor; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. Enriched isomer(s) of registered mixed-isomer active ingredient .................... New active ingredient, seed treatment only; includes agricultural and nonagricultural seeds; residues not expected in raw agricultural commodities. New active ingredient, seed treatment; Experimental Use Permit application; submitted before application for registration; credit 45% of fee toward new active ingredient application that follows. 24 18 18 597,683 597,683 440,478 21 16 16 415,241 415,241 308,276 20 14 18 230,947 230,947 173,644 18 18 302,026 449,391 16 308,276 TABLE 2—REGISTRATION DIVISION—NEW USES EPA No. New CR No. ............. ............. ............. ............. ............. ............. 13 14 15 16 17 18 R180 R190 R200 R210 ............. ............. ............. ............. 19 20 21 22 R220 ............. 23 R230 ............. R240 ............. R250 ............. 24 25 26 R251 ............. 27 R260 ............. R270 ............. R271 ............. tkelley on DSK3SPTVN1PROD with NOTICES R130 R140 R150 R160 R170 R175 28 29 30 R273 ............. 31 R274 ............. 32 VerDate Mar<15>2010 18:19 Sep 25, 2013 First food use; indoor; food/food handling ....................................................... Additional food use; indoor; food/food handling ............................................... First food use .................................................................................................... First food use; reduced risk .............................................................................. Additional food use ........................................................................................... 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. Additional food use; reduced risk ..................................................................... Additional food uses; six or more submitted in one application ...................... Additional food use; six or more submitted in one application; reduced risk .. Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration. Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration. Additional use; non-food; outdoor .................................................................... Additional use; non-food; outdoor; reduced risk .............................................. Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration. Experimental Use Permit application which requires no changes to the tolerance(s); non-crop destruct basis. New use; non-food; indoor ............................................................................... New use; non-food; indoor; reduced risk ......................................................... New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration. Additional 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 uses. Additional uses; seed treatment only; six 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. Jkt 229001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 21 15 21 16 15 10 182,327 42,544 251,669 251,669 62,975 62,975 10 15 10 12 62,975 377,849 377,849 46,653 6 18,893 15 10 6 25,168 25,168 18,893 8 18,893 12 9 6 12,156 12,156 9,261 12 48,042 12 288,250 59350 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 3—REGISTATION DIVISION—IMPORT AND OTHER TOLERANCES EPA No. New CR No. R280 ............. R290 ............. R291 ............. 33 34 35 R292 ............. 36 R293 ............. 37 R294 ............. 38 R295 ............. 39 R296 ............. 40 R297 ............. 41 R298 ............. 42 R299 ............. 43 FY ’14/15 registration service fee ($) Decision review time (months) Action Establish import tolerance; new active ingredient or first food use ................. Establish Import tolerance; additional new food use ....................................... Establish import tolerances; additional food uses; six or more crops submitted in one petition. Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated. Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated. Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated. Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated. Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated. Amend six or more established tolerances (e.g., decrease or increase) in one petition; domestic or import; applicant-initiated. Amend an established tolerance (e.g., decrease or increase); domestic or import; submission of amended labels (requiring science review) in addition to those associated with the amended tolerance; applicant-initiated). Amend six 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). 21 15 15 303,878 60,777 364,653 11 43,181 12 50,936 12 305,613 15 62,975 15 377,849 11 259,082 13 55,776 13 271,677 TABLE 4—REGISTRATION DIVISION—NEW PRODUCTS EPA No. New CR No. 44 R301 ............. 45 R310 ............. 46 R314 ............. tkelley on DSK3SPTVN1PROD with NOTICES R300 ............. 47 VerDate Mar<15>2010 18:19 Sep 25, 2013 New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; no data review on acute toxicity, efficacy or CRP—only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% repackage of registered end-use or manufacturing-use product that requires no data submission nor data matrix. New product; or similar combination product (already registered) to an identical or substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. 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 New end-use product containing two or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients; requires review of data package within RD only; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • child resistant packaging Jkt 229001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 4 1,506 4 1,806 7 5,048 8 6,310 59351 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 4—REGISTRATION DIVISION—NEW PRODUCTS—Continued EPA No. New CR No. R315 ............. 48 R320 ............. R331 ............. 49 50 R332 ............. 51 R333 ............. 52 R334 ............. 53 FY ’14/15 registration service fee ($) Decision review time (months) Action New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: • product chemistry and/or • acute toxicity and/or • public health pest efficacy and/or • animal safety studies and/or • child resistant packaging New product; new physical form; requires data review in science divisions ... New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only. New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only; requires review in RD and science divisions. New product; MUP or end-use product with unregistered source of active ingredient; requires science data review; new physical form; etc. Cite-all or selective data citation where applicant owns all required data. New product; MUP or end-use product with unregistered source of the active ingredient; requires science data review; new physical form; etc. Selective data citation. 9 8,400 12 3 12,596 2,409 24 269,728 10 18,893 11 18,893 TABLE 5—REGISTRATION DIVISION—AMENDMENTS TO REGISTRATION EPA No. New CR No. R340 ............. 54 R345 ............. 55 R350 ............. 56 R351 ............. R352 ............. 57 58 R371 ............. 59 FY ’14/15 registration service fee ($) Decision review time (months) Action Amendment requiring data review within RD (e.g., changes to precautionary label statements). Amending non-food animal product that includes submission of target animal safety data; previously registered. 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). Amendment adding a new unregistered source of active ingredient .............. Amendment adding already approved uses; selective method of support; does not apply if the applicant owns all cited data. Amendment to Experimental Use Permit; (does not include extending a permit’s time period). 4 3,798 7 8,400 9 12,596 8 8 12,596 12,596 6 9,609 TABLE 6—REGISTRATION DIVISION—OTHER ACTIONS EPA No. New CR No. R124 60 R272 61 R275 R370 62 63 tkelley on DSK3SPTVN1PROD with NOTICES B. Antimicrobials Division (AD) The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals VerDate Mar<15>2010 18:19 Sep 25, 2013 Jkt 229001 Conditional ruling on pre-application study waivers; applicant-initiated. Review of study protocol applicant-initiated; excludes DART, pre-registration conference, Rapid Response review, DNT protocol review, protocol needing HSRB review. Rebuttal of agency reviewed protocol, applicant-initiated ..... Cancer reassessment; applicant-initiated .............................. intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, nonagricultural fungi, and viruses. AD is PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action 6 2,409 3 2,409 3 18 2,409 188,809 also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 7 through 10 cover AD actions. E:\FR\FM\26SEN1.SGM 26SEN1 59352 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 7—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS EPA No. A380 A390 A400 A410 New CR No. ............. ............. ............. ............. 64 65 66 67 A420 ............. A430 ............. 68 69 A431 ............. 70 FY ’14/15 registration service fee ($) Decision review time (months) Action New active ingredient food use, establish tolerance exemption ...................... New active ingredient food use, establish tolerance ....................................... New active ingredient, non-food use, outdoor, FIFRA section 2(mm) uses .... New active ingredient non-food use, outdoor, uses other than FIFRA section 2(mm). New active ingredient non-food use, indoor, FIFRA section 2(mm) uses ....... New active ingredient, non-food use indoor, uses other than FIFRA section 2(mm) uses. New 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 protocol. 24 24 18 21 109,397 182,327 91,165 182,327 18 20 60,777 91,165 12 63,670 TABLE 8—ANTIMICROBIALS DIVISION—NEW USES EPA No. A440 A450 A460 A470 A471 New CR No. ............. ............. ............. ............. ............. 71 72 73 74 75 A480 ............. A481 ............. 76 77 A490 ............. 78 A491 ............. 79 A500 ............. A501 ............. 80 81 A510 ............. A511 ............. 82 83 FY ’14/15 registration service fee ($) Decision review time (months) Action New use, first food use; establish tolerance exemption .................................. New use, first food use; establish tolerance .................................................... New use, additional food use; establish tolerance exemption ......................... New use, additional food use; establish tolerance .......................................... Additional food uses; establish tolerances; six or more submitted in one application. New use, additional use, non-food, outdoor; FIFRA section 2(mm) uses ....... Additional non-food outdoor uses; FIFRA section 2(mm) uses; six or more submitted in one application. New use, additional use, non-food, outdoor, uses other than FIFRA section 2(mm). Additional non-food; outdoor; uses other than FIFRA section 2(mm); six or more submitted in one application. New use, additional use, non-food, indoor FIFRA section 2(mm) uses .......... Additional non-food; indoor; FIFRA section 2(mm) uses; six or more submitted in one application. New use, additional use, non-food, indoor, other than FIFRA section 2(mm) Additional non-food; indoor; uses other than FIFRA section 2(mm); six or more submitted in one application. 21 21 15 15 15 30,390 91,165 12,156 30,390 182,335 9 9 18,234 109,400 15 30,390 15 182,335 9 9 12,156 72,936 12 12 12,156 72,936 TABLE 9—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS EPA No. New CR No. 84 A531 ............. 85 A532 ............. tkelley on DSK3SPTVN1PROD with NOTICES A530 ............. 86 A540 ............. A550 ............. 87 88 A560 ............. 89 A570 ............. 90 VerDate Mar<15>2010 18:19 Sep 25, 2013 New product, identical or substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite all data citation or selective data citation where applicant owns all required data; or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end-use or manufacturing use product that requires no data submission nor data matrix. New product; identical or substantially similar in composition and use to a registered product; registered source of active ingredient: selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. New product; identical or substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite-all data citation except for product chemistry; product chemistry data submitted. New end-use product; FIFRA section 2(mm) uses only .................................. New end-use product; uses other than FIFRA section 2(mm); non-FQPA product. New manufacturing use product; registered active ingredient; selective data citation. Label amendment requiring data review .......................................................... Jkt 229001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 4 1,217 4 1,737 5 4,863 5 7 4,863 4,863 12 18,234 4 3,648 59353 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 9—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS—Continued EPA No. New CR No. A572 ............. 91 FY ’14/15 registration service fee ($) Decision review time (months) Action New product or amendment requiring data review for risk assessment by Science Branch (e.g., changes to REI, or PPE, or use rate). 9 12,596 TABLE 10—ANTIMICROBIALS DIVISION—EXPERIMENTAL USE PERMITS AND OTHER TYPE OF ACTIONS EPA No. New CR No. A520 ............. A521 ............. 92 93 A522 ............. 94 A524 ............. 95 A525 ............. 96 A526 ............. 97 A527 ............. 98 A528 ............. 99 A529 ............. 100 A523 ............. 101 A571 ............. 102 Experimental Use Permit application ............................................................... Review of public health efficacy study protocol within AD, per AD Internal Guidance for the Efficacy Protocol Review Process; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 1. Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; Code will also include review of public health efficacy study protocol and data review for devices making pesticidal claims; applicant-initiated; Tier 2. New active ingredient, Experimental Use Permit application; Food Use Requires Tolerance. Credit 45% of fee toward new active ingredient application that follows. New active ingredient, Experimental Use Permit application; food use requires tolerance exemption. Credit 45% of fee toward new active ingredient application that follows. New active ingredient, Experimental Use Permit application; non-food, outdoor use. Credit 45% of fee toward new active ingredient application that follows. New active ingredient, Experimental Use Permit application; non-food, indoor use. Credit 45% of fee toward new active ingredient application that follows. Experimental Use Permit application, food use; requires tolerance or tolerance exemption. Amendment to Experimental Use Permit; requires data review or risk assessment. Review of protocol other than a public health efficacy study (i.e., toxicology or exposure protocols). Science reassessment: Cancer risk, refined ecological risk, and/or endangered species; applicant-initiated. C. Biopesticides and Pollution Prevention Division (BPPD) The Biopesticides and Pollution Prevention Division of OPP is responsible for the processing of FY ’14/15 registration service fee ($) Decision review time (months) Action 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 9 3 6,079 2,363 12 11,577 18 145,862 18 87,774 15 91,165 15 60,900 15 21,273 9 10,884 9 11,577 18 91,165 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 tkelley on DSK3SPTVN1PROD with NOTICES EPA No. B580 B590 B600 B610 New CR No. ............. ............. ............. ............. 103 104 105 106 B611 ............. 107 B612 ............. B613 ............. 108 109 VerDate Mar<15>2010 18:19 Sep 25, 2013 Decision review time (months) Action New active ingredient; food use; petition to establish a tolerance .................. New active ingredient; food use; petition to establish a tolerance exemption New active ingredient; non-food use ................................................................ New active ingredient; Experimental Use Permit application; petition to establish a temporary tolerance or temporary tolerance exemption. New active ingredient; Experimental Use Permit application; petition to establish permanent tolerance exemption. New active ingredient; no change to a permanent tolerance exemption ........ New active ingredient; petition to convert a temporary tolerance or a temporary tolerance exemption to a permanent tolerance or tolerance exemption. Jkt 229001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1 FY ’14/15 registration service fee ($) 19 17 13 10 48,621 30,390 18,234 12,156 12 12,156 10 11 16,714 16,714 59354 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 11—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS—Continued EPA No. B620 ............. New CR No. 110 FY ’14/15 registration service fee ($) Decision review time (months) Action New active ingredient; Experimental Use Permit application; non-food use including crop destruct. 7 6,079 TABLE 12—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW ACTIVE INGREDIENTS EPA No. B630 B631 B640 B643 B642 B644 B650 ............. ............. ............. ............. ............. ............. ............. New CR No. 111 112 113 114 115 116 117 FY ’14/15 registration service fee ($) Decision review time (months) Action First food use; petition to establish a tolerance exemption ............................. New food use; petition to amend an established tolerance ............................. New food use; petition to amend an established tolerance ............................. New food use; petition to amend tolerance exemption ................................... First food use; indoor; food/food handling ....................................................... New use, no change to an established tolerance or tolerance exemption ..... New use; non-food ........................................................................................... 13 12 19 10 12 8 7 12,156 12,156 18,234 12,156 30,390 12,156 6,079 TABLE 13—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS EPA No. New CR No. 118 B660 ............. 119 B670 ............. 120 B671 ............. tkelley on DSK3SPTVN1PROD with NOTICES B652 ............. 121 VerDate Mar<15>2010 18:19 Sep 25, 2013 New product; registered source of active ingredient; requires petition to amend established tolerance or tolerance exemption; requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered enduse or manufacturing-use product that requires no data submission or data matrix. For microbial pesticides, the active ingredient(s) must not be re-isolated. New product; registered source of active ingredient(s); no change in an established tolerance or tolerance exemption; requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. New product; unregistered source of active ingredient(s); requires a petition to amend an established tolerance or tolerance exemption; requires: (1) Submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. Jkt 229001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 13 12,156 4 1,217 7 4,863 17 12,156 59355 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 13—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS—Continued EPA No. New CR No. B672 ............. 122 B673 ............. 123 B674 ............. 124 B675 ............. 125 B676 ............. 126 B677 ............. 127 FY ’14/15 registration service fee ($) Decision review time (months) Action New product; unregistered source of active ingredient(s); non-food use or food use with a tolerance or tolerance exemption previously established for the active ingredient(s); requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. New product MUP/EP; unregistered source of active ingredient(s); citation of Technical Grade Active Ingredient (TGAI) data previously reviewed and accepted by the Agency. Requires an Agency determination that the cited data supports the new product. New product MUP; Repack of identical registered end-use product as a manufacturing-use product; same registered uses only. New product MUP; registered source of active ingredient; submission of completely new generic data package; registered uses only. New product; more than one active ingredient where one active ingredient is an unregistered source; product chemistry data must be submitted; requires: (1) Submission of product-specific data, and (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. New end-use non-food animal product with submission of two or more target animal safety studies; includes data and/or waivers of data for only: • product chemistry and/or .............................................................................. • acute toxicity and/or ...................................................................................... • public health pest efficacy and/or ................................................................. • animal safety studies and/or ......................................................................... • child resistant packaging .............................................................................. 13 8,683 10 4,863 4 1,217 10 8,683 13 8,683 10 8,400 TABLE 14—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; AMENDMENTS EPA No. New CR No. 128 B622 ............. 129 B641 ............. B680 ............. 130 131 B681 ............. 132 B683 ............. 133 B684 ............. tkelley on DSK3SPTVN1PROD with NOTICES B621 ............. 134 VerDate Mar<15>2010 18:19 Sep 25, 2013 Amendment; Experimental Use Permit; no change to an established temporary tolerance or tolerance exemption. Amendment; Experimental Use Permit; petition to amend an established or temporary tolerance or tolerance exemption. Amendment of an established tolerance or tolerance exemption ................... Amendment; registered source of active ingredient(s); no new use(s); no changes to an established tolerance or tolerance exemption. Requires data submission. Amendment; unregistered source of active ingredient(s). Requires data submission. Label amendment; requires review/update of previous risk assessment(s) without data submission (e.g., labeling changes to REI, PPE, PHI). Amending non-food animal product that includes submission of target animal safety data; previously registered. Jkt 229001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 7 4,863 11 12,156 13 5 12,156 4,863 7 5,789 6 4,863 8 8,400 59356 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 15—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES (SCLPS) EPA No. B690 B700 B701 B710 New CR No. ............. ............. ............. ............. 135 136 137 138 B720 ............. 139 B721 ............. B722 ............. 140 141 B730 ............. 142 FY ’14/15 registration service fee ($) Decision review time (months) Action New active ingredient; food or non-food use ................................................... Experimental Use Permit application; new active ingredient or new use ........ Extend or amend Experimental Use Permit ..................................................... New product; registered source of active ingredient(s); identical or substantially similar in composition and use to a registered product; no change in an established tolerance or tolerance exemption. No data review, or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data or authorization from data owner is demonstrated. Category includes 100% re-package of registered enduse or manufacturing-use product that requires no data submission or data matrix. New product; registered source of active ingredient(s); requires: (1) submission of product-specific data; or (2) citation of previously reviewed and accepted data; or (3) submission or citation of data generated at government expense; or (4) submission or citation of a scientifically sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or (5) submission of a request for a data requirement to be waived supported by a scientifically sound rationale explaining why the data requirement does not apply. New product; unregistered source of active ingredient ................................... New use and/or amendment; petition to establish a tolerance or tolerance exemption. Label amendment requiring data submission .................................................. 7 7 4 4 2,432 1,217 1,217 1,217 5 1,217 7 7 2,548 2,359 5 1,217 TABLE 16—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—OTHER ACTIONS EPA No. B614 ............. B615 ............. B682 ............. New CR No. 143 144 145 FY ’14/15 registration service fee ($) Decision review time (months) Action Conditional ruling on pre-application study waivers; applicant-initiated .......... Rebuttal of agency reviewed protocol, applicant-initiated ................................ Protocol review; applicant-initiated; excludes time for HSRB review .............. 3 3 3 2,409 2,409 2,316 TABLE 17—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS) EPA No. New CR No. 146 B750 ............. 147 B770 ............. 148 B771 ............. tkelley on DSK3SPTVN1PROD with NOTICES B740 ............. 149 B772 ............. 150 B773 ............. 151 B780 ............. 152 VerDate Mar<15>2010 18:19 Sep 25, 2013 Experimental Use Permit application; no petition for tolerance/tolerance exemption. Includes: 1. non-food/feed use(s) for a new or registered PIP; 2. food/feed use(s) for a new or registered PIP with crop destruct; 3. food/feed use(s) for a new or registered PIP in which an established tolerance/tolerance exemption exists for the intended use(s) Experimental Use Permit application; with a petition to establish a temporary or permanent tolerance/tolerance exemption for the active ingredient. Includes new food/feed use for a registered PIP. Experimental 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 review. Experimental 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. Application to amend or extend an Experimental Use Permit; no petition since the established tolerance/tolerance exemption for the active ingredient is unaffected. Application to amend or extend an Experimental Use Permit; with petition to extend a temporary tolerance/tolerance exemption for the active ingredient. Registration application; new PIP; non-food/feed ............................................ Jkt 229001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 FY ’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 6 91,165 9 121,552 15 182,327 10 121,552 3 12,156 5 30,390 12 151,940 59357 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 17—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)— Continued EPA No. New CR No. B790 ............. B800 ............. 153 154 B810 ............. 155 B820 ............. 156 B840 ............. 157 B851 ............. 158 B870 ............. 159 B880 ............. 160 B881 ............. 161 B883 ............. 162 B884 ............. 163 B885 ............. 164 B890 ............. 165 B891 ............. 166 B900 ............. 167 B901 ............. 168 B902 ............. B903 ............. 169 170 B904 ............. 171 FY ’14/15 registration service fee ($) Decision review time (months) Action Registration application; new PIP; non-food/feed; SAP review ....................... Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. Registration application; new PIP; with petition to establish permanent tolerance/tolerance exemption for the active ingredient based on an existing temporary tolerance/tolerance exemption. SAP review. Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. Registration application; new PIP; with petition to establish or amend a permanent tolerance/tolerance exemption of an active ingredient. SAP review. Registration application; new event of a previously registered PIP active ingredient(s); no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). Registration application; registered PIP; new product; new use; no petition since a permanent tolerance/tolerance exemption is already established for the active ingredient(s). Registration 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). Registration 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 review. Registration 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 exemption. Registration 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. Registration 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). Application to amend a seed increase registration; converts registration to commercial registration; no petition since permanent tolerance/tolerance exemption is already established for the active ingredient(s). Application to amend a seed increase registration; converts registration to a commercial registration; no petition since a permanent tolerance/tolerance exemption already established for the active ingredient(s), SAP review. Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. Application to amend a registration, including actions such as extending an expiration date, modifying an IRM plan, or adding an insect to be controlled. SAP review. PIP Protocol review .......................................................................................... Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD. Import tolerance or tolerance exemption; processed commodities/food only (inert or active ingredient). 18 12 212,715 243,165 18 303,878 15 303,878 21 364,653 9 121,552 9 36,466 9 30,390 15 91,165 9 121,552 12 151,940 9 91,165 9 60,777 15 121,552 6 12,156 12 72,931 3 6 6,079 60,777 9 121,552 TABLE 18—INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS tkelley on DSK3SPTVN1PROD with NOTICES EPA No. New CR No. I001 ............... I002 ............... 172 173 I003 ............... 174 I004 ............... 175 VerDate Mar<15>2010 18:19 Sep 25, 2013 Approval of new food use inert ingredient ....................................................... Amend currently approved inert ingredient tolerance or exemption from tolerance; new data. Amend currently approved inert ingredient tolerance or exemption from tolerance; no new data. Approval of new non-food use inert ingredient ................................................ Jkt 229001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 FY’14/15 registration service fee ($) Decision review time (months) Action E:\FR\FM\26SEN1.SGM 26SEN1 12 10 18,900 5,250 8 3,150 8 10,500 59358 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices TABLE 18—INERT INGREDIENTS, EXTERNAL REVIEW AND MISCELLANEOUS ACTIONS—Continued EPA No. New CR No. I005 ............... 176 I006 ............... 177 I007 ............... 178 I008 ............... I009 ............... I010 ............... 179 180 181 M001 ............. 182 M002 ............. 183 M003 ............. 184 M004 ............. 185 M005 ............. 186 M006 ............. 187 M007 ............. 188 M008 ............. 189 Amend currently approved non-food use inert ingredient with new use pattern; new data. Amend currently approved non-food use inert ingredient with new use pattern; no new data. Approval of substantially similar non-food use inert ingredients when original inert is compositionally similar with similar use pattern. Approval of new polymer inert ingredient, food use ........................................ Approval of new polymer inert ingredient, non-food use ................................. Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data. Study protocol requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient. Completed study requiring Human Studies Review Board review as defined in 40 CFR part 26 in support of an active ingredient. External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of less than 12 months. Applicant-initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. External technical peer review of new active ingredient, product, or amendment (e.g., consultation with FIFRA Scientific Advisory Panel) for an action with a decision timeframe of greater than 12 months. Applicant-initiated request based on a requirement of the Administrator, as defined by FIFRA section 25(d), in support of a novel active ingredient, or unique use pattern or application technology. Excludes PIP active ingredients. New product: combination, contains a combination of active ingredients from a registered and/or unregistered source; conventional, antimicrobial and/ or biopesticide. Requires coordination with other regulatory divisions to conduct review of data, label and/or verify the validity of existing data as cited. Only existing uses for each active ingredient in the combination product. Request for up to 5 letters of certification (Gold Seal) for one actively registered product. Request to extend Exclusive Use of data as provided by FIFRA section 3(c)(1)(F)(ii). Request to grant Exclusive Use of data as provided by FIFRA section 3(c)(1)(F)(vi) for a minor use, when a FIFRA section 2(ll)(2) determination is required. 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 https://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. Payments may be made by check, bank draft, or money order or online with a credit card or wire transfer. tkelley on DSK3SPTVN1PROD with NOTICES 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.’’ VerDate Mar<15>2010 18:19 Sep 25, 2013 Jkt 229001 4. Select ‘‘Environmental Protection Agency.’’ 5. From the list of forms, select ‘‘Prepayment 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. B. By Check or Money Order All payments must be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. On the check, the applicant must supply in the information line either the registration number of the product or the company number. A copy of the check must accompany the application PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 FY’14/15 registration service fee ($) Decision review time (months) Action 8 5,250 6 3,150 4 1,575 5 4 6 3,570 2,940 1,575 9 7,560 9 7,560 12 60,900 18 60,900 9 21,000 1 263 12 5,250 10 1,575 to the Agency, specifically attached to the front of the application. The copy of the check ensures that payment has been made at the time of application and will enable the Agency to properly connect the payment with the application sent to the Agency. If you send the Agency a check, it will be converted into an electronic funds transfer (EFT). This means the Agency will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours and will be shown on your regular account statement. You will not receive your original check back. The Agency will destroy your original check but will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize the Agency to process the copy in place of your original check. If E:\FR\FM\26SEN1.SGM 26SEN1 Federal Register / Vol. 78, No. 187 / Thursday, September 26, 2013 / Notices the EFT cannot be completed because of insufficient funds, the Agency may try to make the transfer up to two times. All paper-based payments should be sent to the following address: • By U.S. Postal Service. U.S. Environmental Protection Agency, Washington Finance Center, FIFRA Service Fees, P.O. Box 979074, St. Louis, MO 63197–9000. • By courier or personal delivery. U.S. Bank, Government Lockbox 979074, 1005 Convention Plaza, SL– MO–C2–GL, St. Louis, MO 63197, (314) 418–4990. tkelley on DSK3SPTVN1PROD with NOTICES 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 may be pay.gov payment acknowledgement or a copy of the check. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described in FIFRA section 33(b)(7) and https:// 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 or copy of check properly identified as to company) 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. VerDate Mar<15>2010 18:19 Sep 25, 2013 Jkt 229001 • 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. • 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. List of Subjects Environmental protection, Administrative practice and procedure, Pesticides. Dated: September 18, 2013. Martha Monell, Acting Director, Office of Pesticide Programs. [FR Doc. 2013–23368 Filed 9–25–13; 8:45 am] BILLING CODE 6560–50–P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the Federal Register. Copies of the agreements are available through the Commission’s Web site (www.fmc.gov) or by contacting the Office of Agreements at (202) 523–5793 or tradeanalysis@fmc.gov. Agreement No.: 010979–057. Title: Caribbean Shipowners Association. Parties: CMA CGM, S.A.; Crowley Caribbean Services LLC; Hybur Ltd.; King Ocean Services Limited; Seaboard Marine, Ltd.; Seafreight Line, Ltd.; Tropical Shipping and Construction Company Limited; and Zim Integrated Shipping Services, Ltd. Filing Party: Wayne R. Rohde, Esq.; Cozen O’Connor, 1627 I Street, NW; Washington, DC 20006. Synopsis: The amendment deletes Saint Barthelemy and both the French and Dutch portions of St. Martin from the geographic scope of the agreement. Agreement No.: 012224. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 59359 Title: Seaboard/King Ocean Space Charter Agreement. Parties: Seaboard Marine, Ltd. and King Ocean Services Limited, Inc. Filing Party: Wayne R. Rohde, Esq.; Cozen O’Connor; 1627 I Street NW., Suite 1100; Washington, DC 20006. Synopsis: The agreement would authorize Seaboard to charter space to King Ocean in the trade between Miami and Port Everglades on the one hand, and ports on the Caribbean/Atlantic Coast of Costa Rica and Panama, on the other hand. Agreement No.: 012225. Title: King Ocean/Seaboard Space Charter Agreement. Parties: Seaboard Marine, Ltd. and King Ocean Services Limited, Inc. Filing Party: Wayne R. Rohde, Esq.; Cozen O’Connor; 1627 I Street NW., Suite 1100; Washington, DC 20006. Synopsis: The agreement would authorize King Ocean to charter space to Seaboard in the trade between Port Everglades on the one hand, and ports in Aruba and Curacao, on the other hand. Agreement No.: 012226. Title: ELJSA-Hanjin Vessel Sharing Agreement. Parties: Evergreen Line Joint Service Agreement and Hanjin Shipping Co., Ltd. Filing Party: Robert B. Yoshitomi, Esq., Nixon Peabody LLP, Gas Company Tower, 555 West Fifth Street 46th Floor, Los Angeles, CA 90013. Synopsis: The agreement authorizes Evergreen and Hanjin to share vessels and exchange slots in the trades between Korea, China, and Japan, on the one hand, and the U.S. West Coast, on the other hand. By Order of the Federal Maritime Commission. Dated: September 20, 2013. Karen V. Gregory, Secretary. [FR Doc. 2013–23403 Filed 9–25–13; 8:45 am] BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants The Commission gives notice that the following applicants have filed an application for an Ocean Transportation Intermediary (OTI) license as a NonVessel-Operating Common Carrier (NVO) and/or Ocean Freight Forwarder (OFF) pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101). Notice is also given of the filing of applications to amend an existing OTI E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Notices]
[Pages 59347-59359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23368]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0621; FRL-9399-5]

Pesticides; Revised Fee Schedule for Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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, 2013,
increase by 5% rounding up to the nearest dollar from the fees
published for fiscal year 2012. The new fees become effective on
October 1, 2013.

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.

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

[[Page 59348]]

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-2013-0621, is available at https://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 information
about the docket available at https://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, 2013, increase by 5% rounding up to the nearest dollar from
the fees published in the September 28, 2012 Pesticide Registration
Improvement Extension Act.

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, 2013, 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 18 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), and Inert
Ingredients, External Review and 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 2014/FY 2015 Registration Service
Fee ($)'' lists the registration service fee for the action for fiscal
year 2014 (October 1, 2013 through September 30, 2014) and fiscal year
2015 (October 1, 2014 through September 30, 2015).
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 at
https://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, 2013

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

[[Page 59349]]

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
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R010......................... 1 New active ingredient, food use.. 24 597,683
R020......................... 2 New active ingredient, food use; 18 597,683
reduced risk.
R040......................... 3 New active ingredient, food use; 18 440,478
Experimental Use Permit
application; establish temporary
tolerance; submitted before
application for registration;
credit 45% of fee toward new
active ingredient application
that follows.
R060......................... 4 New active ingredient, non-food 21 415,241
use; outdoor.
R070......................... 5 New active ingredient, non-food 16 415,241
use; outdoor; reduced risk.
R090......................... 6 New active ingredient, non-food 16 308,276
use; outdoor; Experimental Use
Permit application; submitted
before application for
registration; credit 45% of fee
toward new active ingredient
application that follows.
R110......................... 7 New active ingredient, non-food 20 230,947
use; indoor.
R120......................... 8 New active ingredient, non-food 14 230,947
use; indoor; reduced risk.
R121......................... 9 New active ingredient, non-food 18 173,644
use; indoor; Experimental Use
Permit application; submitted
before application for
registration; credit 45% of fee
toward new active ingredient
application that follows.
R122......................... 10 Enriched isomer(s) of registered 18 302,026
mixed-isomer active ingredient.
R123......................... 11 New active ingredient, seed 18 449,391
treatment only; includes
agricultural and non-
agricultural seeds; residues not
expected in raw agricultural
commodities.
R125......................... 12 New active ingredient, seed 16 308,276
treatment; Experimental Use
Permit application; submitted
before application for
registration; credit 45% of fee
toward new active ingredient
application that follows.
----------------------------------------------------------------------------------------------------------------

Table 2--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R130......................... 13 First food use; indoor; food/food 21 182,327
handling.
R140......................... 14 Additional food use; indoor; food/ 15 42,544
food handling.
R150......................... 15 First food use................... 21 251,669
R160......................... 16 First food use; reduced risk..... 16 251,669
R170......................... 17 Additional food use.............. 15 62,975
R175......................... 18 Additional food uses covered 10 62,975
within a crop group resulting
from the conversion of existing
approved crop group(s) to one or
more revised crop groups.
R180......................... 19 Additional food use; reduced risk 10 62,975
R190......................... 20 Additional food uses; six or more 15 377,849
submitted in one application.
R200......................... 21 Additional food use; six or more 10 377,849
submitted in one application;
reduced risk.
R210......................... 22 Additional food use; Experimental 12 46,653
Use Permit application;
establish temporary tolerance;
no credit toward new use
registration.
R220......................... 23 Additional food use; Experimental 6 18,893
Use Permit application; crop
destruct basis; no credit toward
new use registration.
R230......................... 24 Additional use; non-food; outdoor 15 25,168
R240......................... 25 Additional use; non-food; 10 25,168
outdoor; reduced risk.
R250......................... 26 Additional use; non-food; 6 18,893
outdoor; Experimental Use Permit
application; no credit toward
new use registration.
R251......................... 27 Experimental Use Permit 8 18,893
application which requires no
changes to the tolerance(s); non-
crop destruct basis.
R260......................... 28 New use; non-food; indoor........ 12 12,156
R270......................... 29 New use; non-food; indoor; 9 12,156
reduced risk.
R271......................... 30 New use; non-food; indoor; 6 9,261
Experimental Use Permit
application; no credit toward
new use registration.
R273......................... 31 Additional use; seed treatment; 12 48,042
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.
R274......................... 32 Additional uses; seed treatment 12 288,250
only; six 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.
----------------------------------------------------------------------------------------------------------------

[[Page 59350]]

Table 3--Registation Division--Import and Other Tolerances
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R280......................... 33 Establish import tolerance; new 21 303,878
active ingredient or first food
use.
R290......................... 34 Establish Import tolerance; 15 60,777
additional new food use.
R291......................... 35 Establish import tolerances; 15 364,653
additional food uses; six or
more crops submitted in one
petition.
R292......................... 36 Amend an established tolerance 11 43,181
(e.g., decrease or increase);
domestic or import; applicant-
initiated.
R293......................... 37 Establish tolerance(s) for 12 50,936
inadvertent residues in one
crop; applicant-initiated.
R294......................... 38 Establish tolerances for 12 305,613
inadvertent residues; six or
more crops submitted in one
application; applicant-initiated.
R295......................... 39 Establish tolerance(s) for 15 62,975
residues in one rotational crop
in response to a specific
rotational crop application;
applicant-initiated.
R296......................... 40 Establish tolerances for residues 15 377,849
in rotational crops in response
to a specific rotational crop
petition; six or more crops
submitted in one application;
applicant-initiated.
R297......................... 41 Amend six or more established 11 259,082
tolerances (e.g., decrease or
increase) in one petition;
domestic or import; applicant-
initiated.
R298......................... 42 Amend an established tolerance 13 55,776
(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).
R299......................... 43 Amend six or more established 13 271,677
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).
----------------------------------------------------------------------------------------------------------------

Table 4--Registration Division--New Products
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R300......................... 44 New product; or similar 4 1,506
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% repackage of
registered end-use or
manufacturing-use product that
requires no data submission nor
data matrix.
R301......................... 45 New product; or similar 4 1,806
combination product (already
registered) to an identical or
substantially similar in
composition and use to a
registered product; registered
source of active ingredient;
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy, where
applicant does not own all
required data and does not have
a specific authorization letter
from data owner.
R310......................... 46 New end-use or manufacturing-use 7 5,048
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.
R314......................... 47 New end-use product containing 8 6,310
two or more registered active
ingredients never before
registered as this combination
in a formulated product; new
product label is identical or
substantially similar to the
labels of currently registered
products which separately
contain the respective component
active ingredients; requires
review of data package within RD
only; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or...
public health pest
efficacy and/or.
child resistant
packaging.

[[Page 59351]]

R315......................... 48 New end-use non-food animal 9 8,400
product with submission of two
or more target animal safety
studies; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or...
public health pest
efficacy and/or.
animal safety studies
and/or.
child resistant
packaging.
R320......................... 49 New product; new physical form; 12 12,596
requires data review in science
divisions.
R331......................... 50 New product; repack of identical 3 2,409
registered end-use product as a
manufacturing-use product; same
registered uses only.
R332......................... 51 New manufacturing-use product; 24 269,728
registered active ingredient;
unregistered source of active
ingredient; submission of
completely new generic data
package; registered uses only;
requires review in RD and
science divisions.
R333......................... 52 New product; MUP or end-use 10 18,893
product with unregistered source
of active ingredient; requires
science data review; new
physical form; etc. Cite-all or
selective data citation where
applicant owns all required data.
R334......................... 53 New product; MUP or end-use 11 18,893
product with unregistered source
of the active ingredient;
requires science data review;
new physical form; etc.
Selective data citation.
----------------------------------------------------------------------------------------------------------------

Table 5--Registration Division--Amendments to Registration
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R340......................... 54 Amendment requiring data review 4 3,798
within RD (e.g., changes to
precautionary label statements).
R345......................... 55 Amending non-food animal product 7 8,400
that includes submission of
target animal safety data;
previously registered.
R350......................... 56 Amendment requiring data review 9 12,596
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).
R351......................... 57 Amendment adding a new 8 12,596
unregistered source of active
ingredient.
R352......................... 58 Amendment adding already approved 8 12,596
uses; selective method of
support; does not apply if the
applicant owns all cited data.
R371......................... 59 Amendment to Experimental Use 6 9,609
Permit; (does not include
extending a permit's time
period).
----------------------------------------------------------------------------------------------------------------

Table 6--Registration Division--Other Actions
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
R124 60 Conditional ruling on pre- 6 2,409
application study waivers;
applicant-initiated.
R272 61 Review of study protocol 3 2,409
applicant-initiated; excludes
DART, pre-registration
conference, Rapid Response
review, DNT protocol review,
protocol needing HSRB review.
R275 62 Rebuttal of agency reviewed 3 2,409
protocol, applicant-initiated.
R370 63 Cancer reassessment; applicant- 18 188,809
initiated.
----------------------------------------------------------------------------------------------------------------

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.

[[Page 59352]]

Table 7--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
A380......................... 64 New active ingredient food use, 24 109,397
establish tolerance exemption.
A390......................... 65 New active ingredient food use, 24 182,327
establish tolerance.
A400......................... 66 New active ingredient, non-food 18 91,165
use, outdoor, FIFRA section
2(mm) uses.
A410......................... 67 New active ingredient non-food 21 182,327
use, outdoor, uses other than
FIFRA section 2(mm).
A420......................... 68 New active ingredient non-food 18 60,777
use, indoor, FIFRA section 2(mm)
uses.
A430......................... 69 New active ingredient, non-food 20 91,165
use indoor, uses other than
FIFRA section 2(mm) uses.
A431......................... 70 New active ingredient, non-food 12 63,670
use; indoor; low-risk; low-
toxicity food-grade active
ingredient(s); efficacy testing
for public health claims
required under GLP and following
DIS/TSS or AD-approved study
protocol.
----------------------------------------------------------------------------------------------------------------

Table 8--Antimicrobials Division--New Uses
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
A440......................... 71 New use, first food use; 21 30,390
establish tolerance exemption.
A450......................... 72 New use, first food use; 21 91,165
establish tolerance.
A460......................... 73 New use, additional food use; 15 12,156
establish tolerance exemption.
A470......................... 74 New use, additional food use; 15 30,390
establish tolerance.
A471......................... 75 Additional food uses; establish 15 182,335
tolerances; six or more
submitted in one application.
A480......................... 76 New use, additional use, non- 9 18,234
food, outdoor; FIFRA section
2(mm) uses.
A481......................... 77 Additional non-food outdoor uses; 9 109,400
FIFRA section 2(mm) uses; six or
more submitted in one
application.
A490......................... 78 New use, additional use, non- 15 30,390
food, outdoor, uses other than
FIFRA section 2(mm).
A491......................... 79 Additional non-food; outdoor; 15 182,335
uses other than FIFRA section
2(mm); six or more submitted in
one application.
A500......................... 80 New use, additional use, non- 9 12,156
food, indoor FIFRA section 2(mm)
uses.
A501......................... 81 Additional non-food; indoor; 9 72,936
FIFRA section 2(mm) uses; six or
more submitted in one
application.
A510......................... 82 New use, additional use, non- 12 12,156
food, indoor, other than FIFRA
section 2(mm).
A511......................... 83 Additional non-food; indoor; uses 12 72,936
other than FIFRA section 2(mm);
six or more submitted in one
application.
----------------------------------------------------------------------------------------------------------------

Table 9--Antimicrobials Division--New Products and Amendments
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
A530......................... 84 New product, identical or 4 1,217
substantially similar in
composition and use to a
registered product; no data
review or only product chemistry
data; cite all data citation or
selective data citation where
applicant owns all required
data; or applicant submits
specific authorization letter
from data owner. Category also
includes 100% re-package of
registered end-use or
manufacturing use product that
requires no data submission nor
data matrix.
A531......................... 85 New product; identical or 4 1,737
substantially similar in
composition and use to a
registered product; registered
source of active ingredient:
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy, where
applicant does not own all
required data and does not have
a specific authorization letter
from data owner.
A532......................... 86 New product; identical or 5 4,863
substantially similar in
composition and use to a
registered product; registered
active ingredient; unregistered
source of active ingredient;
cite-all data citation except
for product chemistry; product
chemistry data submitted.
A540......................... 87 New end-use product; FIFRA 5 4,863
section 2(mm) uses only.
A550......................... 88 New end-use product; uses other 7 4,863
than FIFRA section 2(mm); non-
FQPA product.
A560......................... 89 New manufacturing use product; 12 18,234
registered active ingredient;
selective data citation.
A570......................... 90 Label amendment requiring data 4 3,648
review.

[[Page 59353]]

A572......................... 91 New product or amendment 9 12,596
requiring data review for risk
assessment by Science Branch
(e.g., changes to REI, or PPE,
or use rate).
----------------------------------------------------------------------------------------------------------------

Table 10--Antimicrobials Division--Experimental Use Permits and Other Type of Actions
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
A520......................... 92 Experimental Use Permit 9 6,079
application.
A521......................... 93 Review of public health efficacy 3 2,363
study protocol within AD, per AD
Internal Guidance for the
Efficacy Protocol Review
Process; Code will also include
review of public health efficacy
study protocol and data review
for devices making pesticidal
claims; applicant-initiated;
Tier 1.
A522......................... 94 Review of public health efficacy 12 11,577
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.
A524......................... 95 New active ingredient, 18 145,862
Experimental Use Permit
application; Food Use Requires
Tolerance. Credit 45% of fee
toward new active ingredient
application that follows.
A525......................... 96 New active ingredient, 18 87,774
Experimental Use Permit
application; food use requires
tolerance exemption. Credit 45%
of fee toward new active
ingredient application that
follows.
A526......................... 97 New active ingredient, 15 91,165
Experimental Use Permit
application; non-food, outdoor
use. Credit 45% of fee toward
new active ingredient
application that follows.
A527......................... 98 New active ingredient, 15 60,900
Experimental Use Permit
application; non-food, indoor
use. Credit 45% of fee toward
new active ingredient
application that follows.
A528......................... 99 Experimental Use Permit 15 21,273
application, food use; requires
tolerance or tolerance exemption.
A529......................... 100 Amendment to Experimental Use 9 10,884
Permit; requires data review or
risk assessment.
A523......................... 101 Review of protocol other than a 9 11,577
public health efficacy study
(i.e., toxicology or exposure
protocols).
A571......................... 102 Science reassessment: Cancer 18 91,165
risk, refined ecological risk,
and/or endangered species;
applicant-initiated.
----------------------------------------------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B580......................... 103 New active ingredient; food use; 19 48,621
petition to establish a
tolerance.
B590......................... 104 New active ingredient; food use; 17 30,390
petition to establish a
tolerance exemption.
B600......................... 105 New active ingredient; non-food 13 18,234
use.
B610......................... 106 New active ingredient; 10 12,156
Experimental Use Permit
application; petition to
establish a temporary tolerance
or temporary tolerance exemption.
B611......................... 107 New active ingredient; 12 12,156
Experimental Use Permit
application; petition to
establish permanent tolerance
exemption.
B612......................... 108 New active ingredient; no change 10 16,714
to a permanent tolerance
exemption.
B613......................... 109 New active ingredient; petition 11 16,714
to convert a temporary tolerance
or a temporary tolerance
exemption to a permanent
tolerance or tolerance exemption.

[[Page 59354]]

B620......................... 110 New active ingredient; 7 6,079
Experimental Use Permit
application; non-food use
including crop destruct.
----------------------------------------------------------------------------------------------------------------

Table 12--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Active
Ingredients
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B630......................... 111 First food use; petition to 13 12,156
establish a tolerance exemption.
B631......................... 112 New food use; petition to amend 12 12,156
an established tolerance.
B640......................... 113 New food use; petition to amend 19 18,234
an established tolerance.
B643......................... 114 New food use; petition to amend 10 12,156
tolerance exemption.
B642......................... 115 First food use; indoor; food/food 12 30,390
handling.
B644......................... 116 New use, no change to an 8 12,156
established tolerance or
tolerance exemption.
B650......................... 117 New use; non-food................ 7 6,079
----------------------------------------------------------------------------------------------------------------

Table 13--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B652......................... 118 New product; registered source of 13 12,156
active ingredient; requires
petition to amend established
tolerance or tolerance
exemption; requires: (1)
submission of product-specific
data; or (2) citation of
previously reviewed and accepted
data; or (3) submission or
citation of data generated at
government expense; or (4)
submission or citation of
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.
B660......................... 119 New product; registered source of 4 1,217
active ingredient(s); identical
or substantially similar in
composition and use to a
registered product; no change in
an established tolerance or
tolerance exemption. No data
review, or only product
chemistry data; cite-all data
citation, or selective data
citation where applicant owns
all required data or
authorization from data owner is
demonstrated. Category includes
100% re-package of registered
end-use or manufacturing-use
product that requires no data
submission or data matrix. For
microbial pesticides, the active
ingredient(s) must not be re-
isolated.
B670......................... 120 New product; registered source of 7 4,863
active ingredient(s); no change
in an established tolerance or
tolerance exemption; requires:
(1) submission of product-
specific data; or (2) citation
of previously reviewed and
accepted data; or (3) submission
or citation of data generated at
government expense; or (4)
submission or citation of a
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.
B671......................... 121 New product; unregistered source 17 12,156
of active ingredient(s);
requires a petition to amend an
established tolerance or
tolerance exemption; requires:
(1) Submission of product-
specific data; or (2) citation
of previously reviewed and
accepted data; or (3) submission
or citation of data generated at
government expense; or (4)
submission or citation of a
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.

[[Page 59355]]

B672......................... 122 New product; unregistered source 13 8,683
of active ingredient(s); non-
food use or food use with a
tolerance or tolerance exemption
previously established for the
active ingredient(s); requires:
(1) submission of product-
specific data; or (2) citation
of previously reviewed and
accepted data; or (3) submission
or citation of data generated at
government expense; or (4)
submission or citation of a
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.
B673......................... 123 New product MUP/EP; unregistered 10 4,863
source of active ingredient(s);
citation of Technical Grade
Active Ingredient (TGAI) data
previously reviewed and accepted
by the Agency. Requires an
Agency determination that the
cited data supports the new
product.
B674......................... 124 New product MUP; Repack of 4 1,217
identical registered end-use
product as a manufacturing-use
product; same registered uses
only.
B675......................... 125 New product MUP; registered 10 8,683
source of active ingredient;
submission of completely new
generic data package; registered
uses only.
B676......................... 126 New product; more than one active 13 8,683
ingredient where one active
ingredient is an unregistered
source; product chemistry data
must be submitted; requires: (1)
Submission of product-specific
data, and (2) citation of
previously reviewed and accepted
data; or (3) submission or
citation of data generated at
government expense; or (4)
submission or citation of a
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.
B677......................... 127 New end-use non-food animal 10 8,400
product with submission of two
or more target animal safety
studies; includes data and/or
waivers of data for only:
product chemistry and/or
acute toxicity and/or...
public health pest
efficacy and/or.
animal safety studies
and/or.
child resistant
packaging.
----------------------------------------------------------------------------------------------------------------

Table 14--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; Amendments
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B621......................... 128 Amendment; Experimental Use 7 4,863
Permit; no change to an
established temporary tolerance
or tolerance exemption.
B622......................... 129 Amendment; Experimental Use 11 12,156
Permit; petition to amend an
established or temporary
tolerance or tolerance exemption.
B641......................... 130 Amendment of an established 13 12,156
tolerance or tolerance exemption.
B680......................... 131 Amendment; registered source of 5 4,863
active ingredient(s); no new
use(s); no changes to an
established tolerance or
tolerance exemption. Requires
data submission.
B681......................... 132 Amendment; unregistered source of 7 5,789
active ingredient(s). Requires
data submission.
B683......................... 133 Label amendment; requires review/ 6 4,863
update of previous risk
assessment(s) without data
submission (e.g., labeling
changes to REI, PPE, PHI).
B684......................... 134 Amending non-food animal product 8 8,400
that includes submission of
target animal safety data;
previously registered.
----------------------------------------------------------------------------------------------------------------

[[Page 59356]]

Table 15--Biopesticides and Pollution Prevention Division--Straight Chain Lepidopteran Pheromones (SCLPS)
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B690......................... 135 New active ingredient; food or 7 2,432
non-food use.
B700......................... 136 Experimental Use Permit 7 1,217
application; new active
ingredient or new use.
B701......................... 137 Extend or amend Experimental Use 4 1,217
Permit.
B710......................... 138 New product; registered source of 4 1,217
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.
B720......................... 139 New product; registered source of 5 1,217
active ingredient(s); requires:
(1) submission of product-
specific data; or (2) citation
of previously reviewed and
accepted data; or (3) submission
or citation of data generated at
government expense; or (4)
submission or citation of a
scientifically sound rationale
based on publicly available
literature or other relevant
information that addresses the
data requirement; or (5)
submission of a request for a
data requirement to be waived
supported by a scientifically
sound rationale explaining why
the data requirement does not
apply.
B721......................... 140 New product; unregistered source 7 2,548
of active ingredient.
B722......................... 141 New use and/or amendment; 7 2,359
petition to establish a
tolerance or tolerance exemption.
B730......................... 142 Label amendment requiring data 5 1,217
submission.
----------------------------------------------------------------------------------------------------------------

Table 16--Biopesticides and Pollution Prevention Division--Other Actions
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B614......................... 143 Conditional ruling on pre- 3 2,409
application study waivers;
applicant-initiated.
B615......................... 144 Rebuttal of agency reviewed 3 2,409
protocol, applicant-initiated.
B682......................... 145 Protocol review; applicant- 3 2,316
initiated; excludes time for
HSRB review.
----------------------------------------------------------------------------------------------------------------

Table 17--Biopesticides and Pollution Prevention Division--Plant Incorporated Protectants (PIPS)
----------------------------------------------------------------------------------------------------------------
FY '14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
B740......................... 146 Experimental Use Permit 6 91,165
application; no petition for
tolerance/tolerance exemption.
Includes:
1. non-food/feed use(s) for a new
or registered PIP;.
2. food/feed use(s) for a new or
registered PIP with crop
destruct;.
3. food/feed use(s) for a new or
registered PIP in which an
established tolerance/tolerance
exemption exists for the
intended use(s).
B750......................... 147 Experimental Use Permit 9 121,552
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 PIP.
B770......................... 148 Experimental Use Permit 15 182,327
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
review.
B771......................... 149 Experimental Use Permit 10 121,552
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.
B772......................... 150 Application to amend or extend an 3 12,156
Experimental Use Permit; no
petition since the established
tolerance/tolerance exemption
for the active ingredient is
unaffected.
B773......................... 151 Application to amend or extend an 5 30,390
Experimental Use Permit; with
petition to extend a temporary
tolerance/tolerance exemption
for the active ingredient.
B780......................... 152 Registration application; new 12 151,940
PIP; non-food/feed.

[[Page 59357]]

B790......................... 153 Registration application; new 18 212,715
PIP; non-food/feed; SAP review.
B800......................... 154 Registration application; new 12 243,165
PIP; with petition to establish
permanent tolerance/tolerance
exemption for the active
ingredient based on an existing
temporary tolerance/tolerance
exemption.
B810......................... 155 Registration application; new 18 303,878
PIP; with petition to establish
permanent tolerance/tolerance
exemption for the active
ingredient based on an existing
temporary tolerance/tolerance
exemption. SAP review.
B820......................... 156 Registration application; new 15 303,878
PIP; with petition to establish
or amend a permanent tolerance/
tolerance exemption of an active
ingredient.
B840......................... 157 Registration application; new 21 364,653
PIP; with petition to establish
or amend a permanent tolerance/
tolerance exemption of an active
ingredient. SAP review.
B851......................... 158 Registration application; new 9 121,552
event of a previously registered
PIP active ingredient(s); no
petition since permanent
tolerance/tolerance exemption is
already established for the
active ingredient(s).
B870......................... 159 Registration application; 9 36,466
registered PIP; new product; new
use; no petition since a
permanent tolerance/tolerance
exemption is already established
for the active ingredient(s).
B880......................... 160 Registration application; 9 30,390
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).
B881......................... 161 Registration application; 15 91,165
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 review.
B883......................... 162 Registration application; new 9 121,552
PIP, seed increase with
negotiated acreage cap and time-
limited registration; with
petition to establish a
permanent tolerance/tolerance
exemption for the active
ingredient based on an existing
temporary tolerance/tolerance
exemption.
B884......................... 163 Registration application; new 12 151,940
PIP, seed increase with
negotiated acreage cap and time-
limited registration; with
petition to establish a
permanent tolerance/tolerance
exemption for the active
ingredient.
B885......................... 164 Registration application; 9 91,165
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).
B890......................... 165 Application to amend a seed 9 60,777
increase registration; converts
registration to commercial
registration; no petition since
permanent tolerance/tolerance
exemption is already established
for the active ingredient(s).
B891......................... 166 Application to amend a seed 15 121,552
increase registration; converts
registration to a commercial
registration; no petition since
a permanent tolerance/tolerance
exemption already established
for the active ingredient(s),
SAP review.
B900......................... 167 Application to amend a 6 12,156
registration, including actions
such as extending an expiration
date, modifying an IRM plan, or
adding an insect to be
controlled.
B901......................... 168 Application to amend a 12 72,931
registration, including actions
such as extending an expiration
date, modifying an IRM plan, or
adding an insect to be
controlled. SAP review.
B902......................... 169 PIP Protocol review.............. 3 6,079
B903......................... 170 Inert ingredient tolerance 6 60,777
exemption; e.g., a marker such
as NPT II; reviewed in BPPD.
B904......................... 171 Import tolerance or tolerance 9 121,552
exemption; processed commodities/
food only (inert or active
ingredient).
----------------------------------------------------------------------------------------------------------------

Table 18--Inert Ingredients, External Review and Miscellaneous Actions
----------------------------------------------------------------------------------------------------------------
FY'14/15
Decision registration
EPA No. New CR No. Action review time service fee
(months) ($)
----------------------------------------------------------------------------------------------------------------
I001......................... 172 Approval of new food use inert 12 18,900
ingredient.
I002......................... 173 Amend currently approved inert 10 5,250
ingredient tolerance or
exemption from tolerance; new
data.
I003......................... 174 Amend currently approved inert 8 3,150
ingredient tolerance or
exemption from tolerance; no new
data.
I004......................... 175 Approval of new non-food use 8 10,500
inert ingredient.

[[Page 59358]]

I005......................... 176 Amend currently approved non-food 8 5,250
use inert ingredient with new
use pattern; new data.
I006......................... 177 Amend currently approved non-food 6 3,150
use inert ingredient with new
use pattern; no new data.
I007......................... 178 Approval of substantially similar 4 1,575
non-food use inert ingredients
when original inert is
compositionally similar with
similar use pattern.
I008......................... 179 Approval of new polymer inert 5 3,570
ingredient, food use.
I009......................... 180 Approval of new polymer inert 4 2,940
ingredient, non-food use.
I010......................... 181 Petition to amend a tolerance 6 1,575
exemption descriptor to add one
or more CASRNs; no new data.
M001......................... 182 Study protocol requiring Human 9 7,560
Studies Review Board review as
defined in 40 CFR part 26 in
support of an active ingredient.
M002......................... 183 Completed study requiring Human 9 7,560
Studies Review Board review as
defined in 40 CFR part 26 in
support of an active ingredient.
M003......................... 184 External technical peer review of 12 60,900
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 section 25(d), in
support of a novel active
ingredient, or unique use
pattern or application
technology. Excludes PIP active
ingredients.
M004......................... 185 External technical peer review of 18 60,900
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 section 25(d), in support
of a novel active ingredient, or
unique use pattern or
application technology. Excludes
PIP active ingredients.
M005......................... 186 New product: combination, 9 21,000
contains a combination of active
ingredients from a registered
and/or unregistered source;
conventional, antimicrobial and/
or biopesticide. Requires
coordination with other
regulatory divisions to conduct
review of data, label and/or
verify the validity of existing
data as cited. Only existing
uses for each active ingredient
in the combination product.
M006......................... 187 Request for up to 5 letters of 1 263
certification (Gold Seal) for
one actively registered product.
M007......................... 188 Request to extend Exclusive Use 12 5,250
of data as provided by FIFRA
section 3(c)(1)(F)(ii).
M008......................... 189 Request to grant Exclusive Use of 10 1,575
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.
----------------------------------------------------------------------------------------------------------------

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 https://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. Payments may be made by check, bank draft, or money order or
online with a credit card or wire transfer.

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.

B. By Check or Money Order

All payments must be in United States currency by check, bank
draft, or money order drawn to the order of the Environmental
Protection Agency. On the check, the applicant must supply in the
information line either the registration number of the product or the
company number. A copy of the check must accompany the application to
the Agency, specifically attached to the front of the application. The
copy of the check ensures that payment has been made at the time of
application and will enable the Agency to properly connect the payment
with the application sent to the Agency.
If you send the Agency a check, it will be converted into an
electronic funds transfer (EFT). This means the Agency will copy your
check and use the account information on it to electronically debit
your account for the amount of the check. The debit from your account
will usually occur within 24 hours and will be shown on your regular
account statement.
You will not receive your original check back. The Agency will
destroy your original check but will keep the copy of it. If the EFT
cannot be processed for technical reasons, you authorize the Agency to
process the copy in place of your original check. If

[[Page 59359]]

the EFT cannot be completed because of insufficient funds, the Agency
may try to make the transfer up to two times.
All paper-based payments should be sent to the following address:
By U.S. Postal Service. U.S. Environmental Protection
Agency, Washington Finance Center, FIFRA Service Fees, P.O. Box 979074,
St. Louis, MO 63197-9000.
By courier or personal delivery. U.S. Bank, Government
Lockbox 979074, 1005 Convention Plaza, SL-MO-C2-GL, St. Louis, MO
63197, (314) 418-4990.

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 may be pay.gov payment acknowledgement or a copy of the
check. If the applicant is applying for a fee waiver, the applicant
should provide sufficient documentation as described in FIFRA section
33(b)(7) and https://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 or copy of
check properly identified as to company) 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.
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.

List of Subjects

Environmental protection, Administrative practice and procedure,
Pesticides.

Dated: September 18, 2013.
Martha Monell,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2013-23368 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P

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