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

[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