Pesticides; Revised Fee Schedule for Registration Applications, 61466-61477 [07-5381]

Download as PDF 61466 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2007–1066; FRL–8155–6] Pesticides; Revised Fee Schedule for Registration Applications Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 Renewal Act, the number of fee categories has been increased, the registration service fees for some covered pesticide registration applications received on or after October 1, 2007, have been increased, and certain new procedures have been established. The new fees became effective on October 1, 2007. FOR FURTHER INFORMATION CONTACT: Elizabeth Leovey (7501P), Immediate Office, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7328; fax number: (703) 308– 4776;e-mail address: leovey.elizabeth@epa.gov. SUPPLEMENTARY INFORMATION: sroberts on PROD1PC70 with NOTICES I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you register pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially affected entities may include, but are not limited to: • Agricultural pesticide manufacturers (NAICS code 32532). • Antimicrobial pesticide manufacturers (NAICS code 32561). • Antifoulant pesticide manufacturers (NAICS code 32551). • Wood preservative manufacturers (NAICS code 32519). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the notice and in FIFRA section 33. If you have any questions regarding the VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–1066. Publicly available docket materials are available either in the electronic docket athttp:// www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. II. Background In accordance with FIFRA section 33(b)(3), EPA published in the Federal Register of March 17, 2004 (69 FR 12772) (FRL–7348–2), a schedule of the fees and decision times for review of a covered application. Section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), establishes 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 established a schedule of decision review times for applications covered by the service fee system. Since March 23, 2004, the Agency has been administering the registration service fee system. The schedule of fees and decision review times was published in the Federal Register of March 17, 2004 (69 FR 12772). Subsequently, as authorized by FIFRA section 33, fees were increased by 5% in a notice issued in the Federal Register of June 2, 2005 (70 FR 32327) (FRL–7706–1). III. The Pesticide Registration Improvement Renewal Act (PRIRA) On October 9, 2007, the Pesticide Registration Improvement Renewal Act was signed by the President, revising, among other things, FIFRA section 33. The new law reauthorized the service fee system through 2012 and established fees and review times for applications PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 received during fiscal years 2008 through 2012. The publication of this fee schedule is required by section 33(f)(1) of FIFRA as amended. Key changes in the new law include the following: 1. The number of fee categories has been increased from 90 to 140. In so doing, new categories were added, particularly in the area of tolerances, review of study protocols, risk assessments not associated with an application, and plant-incorporated protectants (PIPs). In addition, some current categories were split into several new categories to provide more specific listings. 2. The EPA identification system for fee categories has been revised to a 3digit system to accommodate the increased number of categories. The new fee schedule continues to preface fee categories according to the Divisional responsibilities within OPP (e.g., R for Registration Division). As an example, the fee category for the new category ‘‘Enriched isomer(s) of registered mixed-isomer active ingredient’’ is R122. 3. Fees are due at application. Previously, the application could be submitted to the Agency in advance of fee submittal and EPA would ‘‘invoice’’ or ‘‘bill’’ the applicant for the fee. Units VI. and VII. discuss how the Agency intends to implement this new provision. 4. EPA must within 21 days after receipt of the application and payment reject any application that does not pass the initial content screen and that cannot be corrected. EPA must screen the application within 21 days and make a determination, and verify appropriate fee submission (or a waiver request with at least 25% of the applicable fee accompanying the waiver request). 5. A portion of the fee, 25%, is nonrefundable. The amount of a refund for an early withdrawal during the first 60 days of the decision time review period is now 75% of the fee. Previously, the Agency was required to refund 90% for an early withdrawal. 6. A small business fee waiver cannot reduce the fee more than 75% of the appropriate registration service fee instead of 100%, previously. 7. Fees will be increased by 5% for applications received during the period October 1, 2008 through September 30, 2010, and thereafter increased by an additional 5% for applications received as of October 1, 2010. EPA will issue notice in the Federal Register of the new fee schedules as appropriate. E:\FR\FM\30OCN2.SGM 30OCN2 61467 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices IV. Elements of the Fee Schedule This unit explains how EPA has organized the fee schedule identified in the statute and how to read the fee schedule tables, and includes a key to terminology published with the table in the Congressional Review. EPA’s organization and presentation of the fee schedule information does not affect the categories of registration service fees, or the structure or procedures for submitting applications or petitions for tolerance. A. The Congressional Record Fee Schedule The fee schedule published in the Congressional Record of July 21, 2007 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 and examples include: 1. The re-establishment of a timelimited tolerance. 2. Review of confirmatory data submitted in support of an alreadyissued registration. 3. Submission of a sub-registrant/ supplemental distributor label. 4. Special Local Needs Registrations submitted under FIFRA section 24(c). 5. Emergency Exemption Requests submitted under FIFRA section 18. 6. Notifications as described in Pesticide Registration Notice 98–10. 7. Fast track amendments or label amendments that require no data review. 8. Minor formulation amendments as described in Pesticide Registration Notice 98–10. 9. 6(a)2 evaluations. B. Fee Schedule and Decision Review Times In today’s notice, EPA has retained the format of previous schedule notices and included the corrections to the schedule published in the September 24, 2007 issue of the Congressional Record. These corrections included: The registration service fee for new category No. 133 should be $78,750, rather than $278,250; the decision time for new category No. 47 in fiscal year 3 should be 12 months; and the action description for the new category No. 61 should read: ‘‘Non-food use; outdoor; FIFRA, subsection 2(mm) uses (1).’’ The schedules are presented as 11 tables, organized by OPP Division and by type of application or pesticide subject to the fee. These tables only list the decision time review periods for fiscal years 2008, 2009, and 2010 as these are the only applicable review periods for applications received on or after October 1, 2008. Unit V. presents fee tables for the Registration Division (RD) (5 tables), the Antimicrobials Division (AD) (3 tables), and the Biopesticides and Pollution Prevention Division (BPPD) (3 tables). C. How to Read the Tables 1. Each table consists of the following columns: • The column entitled ‘‘EPA No.’’ assigns an EPA identifier to each fee category. There are 140 categories spread across the 3 Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD categories. For tracking purposes, OPP has assigned a 3-digit identifier to each category, beginning with RD categories, followed by AD and BPPD 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). • The column entitled ‘‘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 entitled ‘‘Action’’ describes the categories of action. In establishing the expanded fee schedule categories, Congress eliminated some of the more confusing terminology of the original categories. For example, instead of the term ‘‘fast-track,’’ the schedule in the Congressional Record uses the regulatory phrase ‘‘identical or substantially similar in composition and use to a registered product.’’ • The column entitled ‘‘Decision Time’’ list the decision times in months for each type of action for Fiscal Years 2008, 2009, and 2010. The 2010 decision times apply to 2011 and 2012. The decision review periods in the tables are based upon EPA fiscal years (FY), which run from October 1 through September 30. • The column entitled ‘‘FY 08 Registration Service Fee ($)’’ lists the registration service fee for the action for fiscal year 2008 (October 1, 2007 through September 30, 2008). 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 V. PRIRA Fee Schedule Tables— Effective October 1, 2007 A. Registration Division (RD) The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed ‘‘conventional chemicals,’’ excluding pesticides intended for antimicrobial uses. The term ‘‘conventional chemical’’ is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally-occurring chemicals and microbial pesticides. Tables 1 through 5 of Unit V.A. cover RD actions. TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS sroberts on PROD1PC70 with NOTICES Decision time (in months) EPA No. CR No. Action FY 08 R010 VerDate Aug<31>2005 1 Food use1 22:56 Oct 29, 2007 Jkt 214001 FY 09 24 PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 24 30OCN2 FY 10 24 FY 08 Registration Service Fee ($) 516,300 61468 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS—Continued Decision time (in months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 R020 2 Food use; reduced risk1 18 18 18 516,300 R030 3 Food use; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit and temporary tolerance same as #R0401 24 24 24 570,700 R040 4 Food use; Experimental Use Permit application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows 18 18 18 380,500 R050 5 Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted1 14 14 14 190,300 R060 6 Non-food use; outdoor1 21 21 21 358,700 16 16 16 358,700 risk1 R070 7 Non-food use; outdoor; reduced R080 8 Non-food use; outdoor; Experimental Use Permit application submitted simultaneously with application for registration; decision time for Experimental Use Permit same as #R0901 21 21 21 396,800 R090 9 Non-food use; outdoor; Experimental Use Permit application submitted before application for registration; credit $228,225 toward new active ingredient application that follows 16 16 16 266,300 R100 10 Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit isgranted1 12 12 12 130,500 R110 11 Non-food use; indoor1 20 20 20 199,500 14 14 14 199,500 risk1 R120 12 Non-food use; indoor; reduced R121 13 Non-food use; indoor; Experimental Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows 18 18 18 150,000 R122 14 Enriched isomer(s) activeingredient1 mixed-isomer 18 18 18 260,900 R123 15 Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1 18 18 18 388,200 R124 16 Conditional Ruling on Preapplication Study Waivers; applicantinitiated 6 6 6 2,080 of registered 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. TABLE 2.—REGISTRATION DIVISION—NEW USES Decision time (months) EPA No. CR No. Action FY 08 FY 09 FY 10 FY 08 Registration Service Fee ($) 17 First food use; indoor; food/food handling1 21 21 21 157,500 R140 18 Additional food use; Indoor; food/food handling 15 15 15 36,750 R150 sroberts on PROD1PC70 with NOTICES R130 19 First food use1 21 21 21 217,400 16 16 16 217,400 risk1 R160 20 First food use; reduced R170 21 Additional food use 15 15 15 54,400 R180 22 Additional food use; reduced risk 10 10 10 54,400 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61469 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 2.—REGISTRATION DIVISION—NEW USES—Continued Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 R190 23 Additional food uses; six or more submitted in one application 15 15 15 326,400 R200 24 Additional food uses; six or more submitted in one application; reduced risk 10 10 10 326,400 R210 25 Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration 12 12 12 40,300 R220 26 Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration 6 6 6 16,320 R230 27 Additional use; non-food; outdoor 15 15 15 21,740 R240 28 Additional use; non-food; outdoor; reduced risk 10 10 10 21,740 R250 29 Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration 6 6 6 16,320 R260 30 New use; non-food; indoor 12 12 12 10,500 R270 31 New use; non-food; indoor; reduced risk 9 9 9 10,500 R271 32 New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration 6 6 6 8,000 R272 33 Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review 3 3 3 2,080 R273 34 Additional use; seed treatment; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food or non-food uses 12 12 12 41,500 R274 35 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 12 12 12 249,000 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. TABLE 3.—REGISTRATION DIVISION—IMPORT AND OTHER TOLERANCES Decision time (months) EPA No. CR No. Action FY 08 FY 09 FY 10 FY 08 Registration Service Fee ($) 36 Establish import tolerance; new active ingredient or first food use1 21 21 21 262,500 R290 37 Establish import tolerance; additional food use 15 15 15 52,500 R291 38 Establish import tolerances; additional food uses; six or more crops submitted in one petition 15 15 15 315,000 R292 sroberts on PROD1PC70 with NOTICES R280 39 Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated 10 10 10 37,300 R293 40 Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated 12 12 12 44,000 R294 41 Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated 12 12 12 264,000 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61470 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 3.—REGISTRATION DIVISION—IMPORT AND OTHER TOLERANCES—Continued Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 R295 42 Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated 15 15 15 54,400 R296 43 Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated 15 15 15 326,400 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. TABLE 4.—REGISTRATION DIVISION—NEW PRODUCTS Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 44 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 enduse or manufacturing-use product that requires no data submission nor data matrix. 3 3 3 1,300 R301 45 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 4 4 4 1,560 R310 46 New end-use or manufacturing-use product; requires review of data package within RD; includes reviews and/or waivers of data for only: • Product chemistry and/or • Acute toxicity and/or • Public health pest efficacy 6 6 6 4,360 R311 49 New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners 12 12 12 15,540 R312 50 New product; requires approval of new non-food-use inert; applicant-initiated 6 6 6 8,300 R313 51 New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated 10 10 10 11,420 R320 47 New product; new physical form; requires data review in science divisions 12 12 12 10,880 R330 48 New manufacturing-use product; registered active ingredient; selective data citation 12 12 12 16,320 R331 52 New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only 3 3 3 2,080 R332 sroberts on PROD1PC70 with NOTICES R300 53 New manufacturing-use product; registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only 24 24 24 233,000 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61471 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 5.—REGISTRATION DIVISION—AMENDMENTS TO REGISTRATION Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 R340 54 Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)1 4 4 4 3,280 R350 55 Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)1 8 8 8 10,880 R370 56 Cancer reassessment; applicant-initiated 18 18 18 163,100 R371 57 Amendment to Experimental Use Permit; requires data review/ risk assessment 6 6 6 8,300 R372 58 Refined ecological and/or endangered species assessment; applicant-initiated 18 18 12 155,300 1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees. B. Antimicrobials Division (AD) The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, nonagricultural fungi, and viruses. AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants. Tables 6 through 8 of Unit V.B. cover AD actions. TABLE 6.—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS Decision time (months) EPA No. CR No. Action FY 08 A380 59 Food use; establish tolerance exemption1 FY 09 FY 10 FY 08 Registration Service Fee ($) 24 24 24 94,500 tolerance1 24 24 24 157,500 A390 60 Food use; establish A400 61 Non-food use; outdoor; FIFRA section 2(mm) uses1 18 18 18 78,750 A410 62 Non-food use; outdoor; uses other than FIFRAsection 2(mm)1 21 21 21 157,500 A420 63 Non-food use; indoor; FIFRA section 2(mm) uses1 18 18 18 52,500 A430 64 Non-food use; indoor; uses other than FIFRAsection 2(mm)1 20 20 20 78,750 A431 65 Non-food use; indoor; low-risk and 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 12 12 12 55,000 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. TABLE 7.—ANTIMICROBIALS DIVISION—NEW USES Decision time (months) EPA No. CR No. Action FY 08 sroberts on PROD1PC70 with NOTICES A440 66 First food use; establish tolerance exemption1 FY 09 FY 10 FY 08 Registration Service Fee ($) 21 21 21 26,250 21 tolerance1 21 21 78,750 A450 67 First food use; establish A460 68 Additional food use; establish tolerance exemption 15 15 15 10,500 A470 69 Additional food use; establish tolerance 15 15 15 26,250 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61472 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 7.—ANTIMICROBIALS DIVISION—NEW USES—Continued Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 A480 70 Additional use; non-food; outdoor; FIFRA section 2(mm) uses 9 9 9 15,750 A490 71 Additional use; non-food; outdoor; uses other than FIFRA section 2(mm) 15 15 15 26,250 A500 72 Additional use; non-food; indoor; FIFRA section 2(mm) uses 9 9 9 10,500 A510 73 Additional use; non-food; indoor; uses other than FIFRA section 2(mm) 12 12 12 10,500 A520 74 Experimental Use Permit application 9 9 9 5,250 A521 75 Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 6 4 3 2,000 A522 76 Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2 18 15 12 10,000 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. TABLE 8.—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 77 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 enduse or manufacturing-use product that requires no data submission nor data matrix. 3 3 3 1,050 A531 78 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 4 4 4 1,500 A532 85 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 4 4 4 4,200 A540 79 New end use product; FIFRA section 2(mm) uses only 4 4 4 4,200 A550 80 New end-use product; uses other than FIFRA section 2(mm); non-FQPA product 6 6 6 4,200 A560 81 New manufacturing-use product; registered active ingredient; selective data citation 12 12 12 15,750 A570 82 Label amendment requiring data submission1 4 4 4 3,150 A571 sroberts on PROD1PC70 with NOTICES A530 83 Cancer reassessment; applicant-initiated 18 18 18 78,750 A572 84 Refined ecological risk and/or endangered species assessment; applicant-initiated 18 18 12 75,000 1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees. VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61473 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices 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 tables 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 and use the same terminology as in Unit III. Tables 9 through 11 of Unit V.C. cover BPPD actions. TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS AND AMENDMENTS Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 86 New active ingredient; food use; establish tolerance1 18 18 18 42,000 B590 87 New active ingredient; food use; establish toleranceexemption1 16 16 16 26,250 B600 88 New active ingredient; non-food use1 12 12 12 15,750 B610 89 Food use; Experimental Use Permit application; establish temporary tolerance exemption 9 9 9 10,500 B620 90 Non-food use; Experimental Use Permit application 6 6 6 5,250 B621 91 Extend or amend Experimental Use Permit 6 6 6 4,200 B630 92 First food use; establish tolerance exemption 12 12 12 10,500 B631 93 Amend established tolerance exemption 9 9 9 10,500 B640 94 First food use; establish tolerance1 18 18 18 15,750 B641 95 Amend established tolerance (e.g., decrease or increase) 12 12 12 10,500 B650 96 New use; non-food 6 6 6 5,250 B660 97 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 enduse or manufacturing-use product that requires no data submission nor data matrix. 3 3 3 1,050 B670 98 New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with productspecific data or with request for data waivers supported by scientific rationales 6 6 6 4,200 B671 99 New product; food use; unregistered source of active ingredient; requires amendment of established tolerance or tolerance exemption; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales 16 16 16 10,500 B672 sroberts on PROD1PC70 with NOTICES B580 100 New product; non-food use or food use having established tolerance or tolerance exemption; unregistered source of active ingredient; no data compensation issues; all Tier I data requirements for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request for data waivers supported by scientific rationales 12 12 12 7,500 B680 101 Label amendment requiring data submission2 4 4 4 4,200 B681 102 Label amendment; unregistered source of active ingredient; supporting data require scientific review 6 6 6 5,000 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61474 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW PRODUCTS AND AMENDMENTS—Continued Decision time (months) EPA No. CR No. FY 08 B682 103 FY 08 Registration Service Fee ($) Action Protocol review; applicant-initiated; excludes time for HSRB review (preapplication) FY 09 3 FY 10 3 3 2,000 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. 2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees. TABLE 10.—BIOPESTICIDES AND POLLUTION PREVENTIONDIVISION—STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES (SCLPS) Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 B690 104 New active ingredient; food or non-food use1 6 6 6 2,100 B700 105 Experimental Use Permit application; new active ingredient or new use 6 6 6 1,050 B701 106 Extend or amend Experimental Use Permit 3 3 3 1,050 B710 107 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 enduse or manufacturing-use product that requires no data submission nor data matrix. 3 3 3 1,050 B720 108 New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with productspecific data or with request for data waivers supported by scientific rationales 4 4 4 1,050 B721 109 New product; unregistered source of active ingredient 6 6 6 2,200 B722 110 New use and/or amendment to tolerance or tolerance exemption 6 6 6 2,200 B730 111 Label amendment requiring data submission2 4 4 4 1,050 1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. 2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees. TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS) Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 sroberts on PROD1PC70 with NOTICES B740 112 Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required1 6 6 6 78,750 B750 113 Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP reviewrequired1 9 9 9 105,000 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61475 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)— Continued Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 FY 09 FY 10 B760 114 Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct basis; SAP review required; credit $78,750 toward new active ingredient application that follows 12 12 12 131,250 B761 115 Experimental Use Permit application; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows 7 7 7 78,750 B770 116 Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; SAP review required; credit $105,000 toward new active ingredient application that follows 15 15 15 157,500 B771 117 Experimental Use Permit application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; credit $105,000 toward new active ingredient application that follows 10 10 10 105,000 B772 118 Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected 3 3 3 10,500 B773 119 Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption 5 5 5 26,250 B860 120 Amend Experimental Use Permit; first food use or major revision of experimental design 6 6 6 10,500 B780 121 New active ingredient; non-food/feed; no SAP reviewrequired2 12 12 12 131,250 18 18 18 183,750 reviewrequired2 122 New active ingredient; Non-food/feed; SAP B800 123 New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2 12 12 12 210,000 B810 124 New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2 18 18 18 262,500 B820 125 New active ingredient; establish tolerance or tolerance exemption; no SAP review required2 15 15 15 262,500 B840 126 New active ingredient; establish tolerance or tolerance exemption; SAP review required2 21 21 21 315,000 B830 127 New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required2 15 15 15 315,000 B850 128 New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2 21 21 21 367,500 B851 129 New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required 9 9 9 105,000 B852 sroberts on PROD1PC70 with NOTICES B790 130 New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required 9 9 9 157,500 B870 131 New use1 9 9 9 31,500 B880 132 New product; no SAP review required3 9 9 9 26,250 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4703 E:\FR\FM\30OCN2.SGM 30OCN2 61476 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTIONDIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)— Continued Decision time (months) EPA No. CR No. FY 08 Registration Service Fee ($) Action FY 08 B881 133 New product; SAP review required3 B890 134 B891 FY 09 FY 10 15 15 15 78,750 Amendment; seed production to commercial registration; no SAP review required 9 9 9 52,500 135 Amendment; seed production to commercial registration; SAP review required 15 15 15 105,000 B900 136 Amendment (except B890); No SAP review required; (e.g., new IRM requirements that are applicant initiated; or amending a conditional registration to extend the registration expiration date with additional data submitted)4 6 6 6 10,500 B901 137 Amendment (except B890); SAP review required4 12 12 12 63,000 B902 138 PIP Protocol review 3 3 3 5,250 B903 139 Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD 6 6 6 52,500 B904 140 Import tolerance or tolerance exemption; processed commodities/food only 9 9 9 105,000 1Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn. be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial registration is obtained using B890. 3Example: Stacking PIP traits within a crop using traditional breeding techniques. 4EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees. 2May sroberts on PROD1PC70 with NOTICES VI. How to Pay Fees Applicants must now 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 athttp://www.epa.gov/ pesticides/fees/tool/index.htm to help applicants identify the fee category and the fee. All fees (and other amounts) 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 websitewww.pay.gov. 1. From the pay.gov home page, under ‘‘Find Public Forms.’’ 2. Select ‘‘search by form name.’’ 3. On the A-Z Index of Forms page, select ‘‘P.’’ 4. From the list of forms on the second page, select ‘‘Pre-payment of Pesticide Registration Improvement Act Fee.’’ 5. Complete the form entering the PRIA fee category and fee. 6. 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 VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 application to assure that EPA can match the application with the payment. B. By Check or Money Order All payments should 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 PO 00000 Frm 00012 Fmt 4701 Sfmt 4703 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 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: 1. 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. 2. 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. VII. How to Submit Applications Submissions to the Agency should be made at the address given in Unit VIII. The applicant should attach documentation that the fee has been paid which may be a copy of the check or pay.gov payment acknowledgement. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described in FIFRA section 33(b)(7) andhttp:// www.epa.gov/pesticides/fees/questions/ waivers.htm. The fee waiver request should be easy to identify and separate E:\FR\FM\30OCN2.SGM 30OCN2 Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices sroberts on PROD1PC70 with NOTICES 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. VerDate Aug<31>2005 22:56 Oct 29, 2007 Jkt 214001 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 e-mail if EPA has either an e-mail address on file or an email address is provided on the application. VIII. Addresses New covered applications should be identified in the title line with the mail code REGFEE. 1. By USPS mail. Document Processing Desk (REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460–0001. 2. By courier. Document Processing Desk (REGFEE), Office of Pesticide Programs, U.S. Environmental Protection Agency, Room S–4400,One PO 00000 Frm 00013 Fmt 4701 Sfmt 4703 61477 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: October 23, 2007. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. 07–5381 Filed 10–29–07; 8:45 am] BILLING CODE 6560–50–S E:\FR\FM\30OCN2.SGM 30OCN2

Agencies

[Federal Register Volume 72, Number 209 (Tuesday, October 30, 2007)]
[Notices]
[Pages 61466-61477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-5381]



[[Page 61465]]

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Part III





Environmental Protection Agency





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Pesticides; Revised Fee Schedule for Registration Applications; Notice

Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / 
Notices

[[Page 61466]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1066; FRL-8155-6]


Pesticides; Revised Fee Schedule for Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:  EPA is publishing a revised list of pesticide registration 
service fees applicable to specified pesticide applications and 
tolerance actions. Under the Pesticide Registration Improvement Renewal 
Act, the number of fee categories has been increased, the registration 
service fees for some covered pesticide registration applications 
received on or after October 1, 2007, have been increased, and certain 
new procedures have been established. The new fees became effective on 
October 1, 2007.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Leovey (7501P), Immediate 
Office, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7328; fax number: (703) 308-4776;e-mail address: 
leovey.elizabeth@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 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?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2007-1066. Publicly 
available docket materials are available either in the electronic 
docket athttp://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The hours of operation of this Docket Facility are 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket Facility telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr.

II. Background

    In accordance with FIFRA section 33(b)(3), EPA published in the 
Federal Register of March 17, 2004 (69 FR 12772) (FRL-7348-2), a 
schedule of the fees and decision times for review of a covered 
application. Section 33 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), establishes 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 
established a schedule of decision review times for applications 
covered by the service fee system. Since March 23, 2004, the Agency has 
been administering the registration service fee system. The schedule of 
fees and decision review times was published in the Federal Register of 
March 17, 2004 (69 FR 12772). Subsequently, as authorized by FIFRA 
section 33, fees were increased by 5% in a notice issued in the Federal 
Register of June 2, 2005 (70 FR 32327) (FRL-7706-1).

III. The Pesticide Registration Improvement Renewal Act (PRIRA)

    On October 9, 2007, the Pesticide Registration Improvement Renewal 
Act was signed by the President, revising, among other things, FIFRA 
section 33. The new law reauthorized the service fee system through 
2012 and established fees and review times for applications received 
during fiscal years 2008 through 2012. The publication of this fee 
schedule is required by section 33(f)(1) of FIFRA as amended.
    Key changes in the new law include the following:
    1. The number of fee categories has been increased from 90 to 140. 
In so doing, new categories were added, particularly in the area of 
tolerances, review of study protocols, risk assessments not associated 
with an application, and plant-incorporated protectants (PIPs). In 
addition, some current categories were split into several new 
categories to provide more specific listings.
    2. The EPA identification system for fee categories has been 
revised to a 3-digit system to accommodate the increased number of 
categories. The new fee schedule continues to preface fee categories 
according to the Divisional responsibilities within OPP (e.g., R for 
Registration Division). As an example, the fee category for the new 
category ``Enriched isomer(s) of registered mixed-isomer active 
ingredient'' is R122.
    3. Fees are due at application. Previously, the application could 
be submitted to the Agency in advance of fee submittal and EPA would 
``invoice'' or ``bill'' the applicant for the fee. Units VI. and VII. 
discuss how the Agency intends to implement this new provision.
    4. EPA must within 21 days after receipt of the application and 
payment reject any application that does not pass the initial content 
screen and that cannot be corrected. EPA must screen the application 
within 21 days and make a determination, and verify appropriate fee 
submission (or a waiver request with at least 25% of the applicable fee 
accompanying the waiver request).
    5. A portion of the fee, 25%, is non-refundable. The amount of a 
refund for an early withdrawal during the first 60 days of the decision 
time review period is now 75% of the fee. Previously, the Agency was 
required to refund 90% for an early withdrawal.
    6. A small business fee waiver cannot reduce the fee more than 75% 
of the appropriate registration service fee instead of 100%, 
previously.
    7. Fees will be increased by 5% for applications received during 
the period October 1, 2008 through September 30, 2010, and thereafter 
increased by an additional 5% for applications received as of October 
1, 2010. EPA will issue notice in the Federal Register of the new fee 
schedules as appropriate.

[[Page 61467]]

IV. Elements of the Fee Schedule

    This unit explains how EPA has organized the fee schedule 
identified in the statute and how to read the fee schedule tables, and 
includes a key to terminology published with the table in the 
Congressional Review. EPA's organization and presentation of the fee 
schedule information does not affect the categories of registration 
service fees, or the structure or procedures for submitting 
applications or petitions for tolerance.

A. The Congressional Record Fee Schedule

    The fee schedule published in the Congressional Record of July 21, 
2007 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 and examples include:
    1. The re-establishment of a time-limited tolerance.
    2. Review of confirmatory data submitted in support of an already-
issued registration.
    3. Submission of a sub-registrant/supplemental distributor label.
    4. Special Local Needs Registrations submitted under FIFRA section 
24(c).
    5. Emergency Exemption Requests submitted under FIFRA section 18.
    6. Notifications as described in Pesticide Registration Notice 98-
10.
    7. Fast track amendments or label amendments that require no data 
review.
    8. Minor formulation amendments as described in Pesticide 
Registration Notice 98-10.
    9. 6(a)2 evaluations.

B. Fee Schedule and Decision Review Times

    In today's notice, EPA has retained the format of previous schedule 
notices and included the corrections to the schedule published in the 
September 24, 2007 issue of the Congressional Record. These corrections 
included: The registration service fee for new category No. 133 should 
be $78,750, rather than $278,250; the decision time for new category 
No. 47 in fiscal year 3 should be 12 months; and the action description 
for the new category No. 61 should read: ``Non-food use; outdoor; 
FIFRA, subsection 2(mm) uses (1).'' The schedules are presented as 11 
tables, organized by OPP Division and by type of application or 
pesticide subject to the fee. These tables only list the decision time 
review periods for fiscal years 2008, 2009, and 2010 as these are the 
only applicable review periods for applications received on or after 
October 1, 2008. Unit V. presents fee tables for the Registration 
Division (RD) (5 tables), the Antimicrobials Division (AD) (3 tables), 
and the Biopesticides and Pollution Prevention Division (BPPD) (3 
tables).

C. How to Read the Tables

    1. Each table consists of the following columns:
     The column entitled ``EPA No.'' assigns an EPA identifier 
to each fee category. There are 140 categories spread across the 3 
Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD 
categories. For tracking purposes, OPP has assigned a 3-digit 
identifier to each category, beginning with RD categories, followed by 
AD and BPPD 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).
     The column entitled ``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 entitled ``Action'' describes the categories of 
action. In establishing the expanded fee schedule categories, Congress 
eliminated some of the more confusing terminology of the original 
categories. For example, instead of the term ``fast-track,'' the 
schedule in the Congressional Record uses the regulatory phrase 
``identical or substantially similar in composition and use to a 
registered product.''
     The column entitled ``Decision Time'' list the decision 
times in months for each type of action for Fiscal Years 2008, 2009, 
and 2010. The 2010 decision times apply to 2011 and 2012. The decision 
review periods in the tables are based upon EPA fiscal years (FY), 
which run from October 1 through September 30.
     The column entitled ``FY 08 Registration Service Fee ($)'' 
lists the registration service fee for the action for fiscal year 2008 
(October 1, 2007 through September 30, 2008).
    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

V. PRIRA Fee Schedule Tables--Effective October 1, 2007

A. Registration Division (RD)

    The Registration Division of OPP is responsible for the processing 
of pesticide applications and associated tolerance petitions for 
pesticides that are termed ``conventional chemicals,'' excluding 
pesticides intended for antimicrobial uses. The term ``conventional 
chemical'' is a term of art that is intended to distinguish synthetic 
chemicals from those that are of naturally occurring or non-synthetic 
origin, synthetic chemicals that are identical to naturally-occurring 
chemicals and microbial pesticides. Tables 1 through 5 of Unit V.A. 
cover RD actions.

                             Table 1.-Registration Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                      Decision time (in months)         FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
R010                                       1  Food use\1\                 24         24         24       516,300
----------------------------------------------------------------------------------------------------------------

[[Page 61468]]

 
R020                                       2  Food use; reduced           18         18         18       516,300
                                               risk\1\
----------------------------------------------------------------------------------------------------------------
R030                                       3  Food use;                   24         24         24       570,700
                                               Experimental Use
                                               Permit application
                                               submitted
                                               simultaneously
                                               with application
                                               for registration;
                                               decision time for
                                               Experimental Use
                                               Permit and
                                               temporary
                                               tolerance same as
                                               R040\1\
----------------------------------------------------------------------------------------------------------------
R040                                       4  Food use;                   18         18         18       380,500
                                               Experimental Use
                                               Permit
                                               application;
                                               establish
                                               temporary
                                               tolerance;
                                               submitted before
                                               application for
                                               registration;
                                               credit $326,025
                                               toward new active
                                               ingredient
                                               application that
                                               follows
----------------------------------------------------------------------------------------------------------------
R050                                       5  Food use;                   14         14         14       190,300
                                               application
                                               submitted after
                                               Experimental Use
                                               Permit
                                               application;
                                               decision time
                                               begins after
                                               Experimental Use
                                               Permit and
                                               temporary
                                               tolerance are
                                               granted\1\
----------------------------------------------------------------------------------------------------------------
R060                                       6  Non-food use;               21         21         21       358,700
                                               outdoor\1\
----------------------------------------------------------------------------------------------------------------
R070                                       7  Non-food use;               16         16         16       358,700
                                               outdoor; reduced
                                               risk\1\
----------------------------------------------------------------------------------------------------------------
R080                                       8  Non-food use;               21         21         21       396,800
                                               outdoor;
                                               Experimental Use
                                               Permit application
                                               submitted
                                               simultaneously
                                               with application
                                               for registration;
                                               decision time for
                                               Experimental Use
                                               Permit same as
                                               R090\1\
----------------------------------------------------------------------------------------------------------------
R090                                       9  Non-food use;               16         16         16       266,300
                                               outdoor;
                                               Experimental Use
                                               Permit application
                                               submitted before
                                               application for
                                               registration;
                                               credit $228,225
                                               toward new active
                                               ingredient
                                               application that
                                               follows
----------------------------------------------------------------------------------------------------------------
R100                                      10  Non-food use;               12         12         12       130,500
                                               outdoor; submitted
                                               after Experimental
                                               Use Permit
                                               application;
                                               decision time
                                               begins after
                                               Experimental Use
                                               Permit
                                               isgranted\1\
----------------------------------------------------------------------------------------------------------------
R110                                      11  Non-food use;               20         20         20       199,500
                                               indoor\1\
----------------------------------------------------------------------------------------------------------------
R120                                      12  Non-food use;               14         14         14       199,500
                                               indoor; reduced
                                               risk\1\
----------------------------------------------------------------------------------------------------------------
R121                                      13  Non-food use;               18         18         18       150,000
                                               indoor;
                                               Experimental Use
                                               Permit application
                                               submitted before
                                               application for
                                               registration;
                                               credit $100,000
                                               toward new active
                                               ingredient
                                               application that
                                               follows
----------------------------------------------------------------------------------------------------------------
R122                                      14  Enriched isomer(s)          18         18         18       260,900
                                               of registered
                                               mixed-isomer
                                               activeingredient\1
                                               \
----------------------------------------------------------------------------------------------------------------
R123                                      15  Seed treatment              18         18         18       388,200
                                               only; includes non-
                                               food and food
                                               uses; limited
                                               uptake into Raw
                                               Agricultural
                                               Commodities\1\
----------------------------------------------------------------------------------------------------------------
R124                                      16  Conditional Ruling           6          6          6         2,080
                                               on Preapplication
                                               Study Waivers;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
  or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
  that application.


                                    TABLE 2.--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
R130                                      17  First food use;             21         21         21       157,500
                                               indoor; food/food
                                               handling\1\
----------------------------------------------------------------------------------------------------------------
R140                                      18  Additional food             15         15         15        36,750
                                               use; Indoor; food/
                                               food handling
----------------------------------------------------------------------------------------------------------------
R150                                      19  First food use\1\           21         21         21       217,400
----------------------------------------------------------------------------------------------------------------
R160                                      20  First food use;             16         16         16       217,400
                                               reduced risk\1\
----------------------------------------------------------------------------------------------------------------
R170                                      21  Additional food use         15         15         15        54,400
----------------------------------------------------------------------------------------------------------------
R180                                      22  Additional food             10         10         10        54,400
                                               use; reduced risk
----------------------------------------------------------------------------------------------------------------

[[Page 61469]]

 
R190                                      23  Additional food             15         15         15       326,400
                                               uses; six or more
                                               submitted in one
                                               application
----------------------------------------------------------------------------------------------------------------
R200                                      24  Additional food             10         10         10       326,400
                                               uses; six or more
                                               submitted in one
                                               application;
                                               reduced risk
----------------------------------------------------------------------------------------------------------------
R210                                      25  Additional food             12         12         12        40,300
                                               use; Experimental
                                               Use Permit
                                               application;
                                               establish
                                               temporary
                                               tolerance; no
                                               credit toward new
                                               use registration
----------------------------------------------------------------------------------------------------------------
R220                                      26  Additional food              6          6          6        16,320
                                               use; Experimental
                                               Use Permit
                                               application; crop
                                               destruct basis; no
                                               credit toward new
                                               use registration
----------------------------------------------------------------------------------------------------------------
R230                                      27  Additional use; non-        15         15         15        21,740
                                               food; outdoor
----------------------------------------------------------------------------------------------------------------
R240                                      28  Additional use; non-        10         10         10        21,740
                                               food; outdoor;
                                               reduced risk
----------------------------------------------------------------------------------------------------------------
R250                                      29  Additional use; non-         6          6          6        16,320
                                               food; outdoor;
                                               Experimental Use
                                               Permit
                                               application; no
                                               credit toward new
                                               use registration
----------------------------------------------------------------------------------------------------------------
R260                                      30  New use; non-food;          12         12         12        10,500
                                               indoor
----------------------------------------------------------------------------------------------------------------
R270                                      31  New use; non-food;           9          9          9        10,500
                                               indoor; reduced
                                               risk
----------------------------------------------------------------------------------------------------------------
R271                                      32  New use; non-food;           6          6          6         8,000
                                               indoor;
                                               Experimental Use
                                               Permit
                                               application; no
                                               credit toward new
                                               use registration
----------------------------------------------------------------------------------------------------------------
R272                                      33  Review of Study              3          3          3         2,080
                                               Protocol;
                                               applicant-
                                               initiated;
                                               excludes DART, pre-
                                               registration
                                               conferences, Rapid
                                               Response review,
                                               DNT protocol
                                               review, protocols
                                               needing HSRB
                                               review
----------------------------------------------------------------------------------------------------------------
R273                                      34  Additional use;             12         12         12        41,500
                                               seed treatment;
                                               limited uptake
                                               into Raw
                                               Agricultural
                                               Commodities;
                                               includes crops
                                               with established
                                               tolerances (e.g.,
                                               for soil or foliar
                                               application);
                                               includes food or
                                               non-food uses
----------------------------------------------------------------------------------------------------------------
R274                                      35  Additional uses;            12         12         12       249,000
                                               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
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
  or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
  that application.


                           Table 3.--Registration Division--Import and Other Tolerances
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
R280                                      36  Establish import            21         21         21       262,500
                                               tolerance; new
                                               active ingredient
                                               or first food
                                               use\1\
----------------------------------------------------------------------------------------------------------------
R290                                      37  Establish import            15         15         15        52,500
                                               tolerance;
                                               additional food
                                               use
----------------------------------------------------------------------------------------------------------------
R291                                      38  Establish import            15         15         15       315,000
                                               tolerances;
                                               additional food
                                               uses; six or more
                                               crops submitted in
                                               one petition
----------------------------------------------------------------------------------------------------------------
R292                                      39  Amend an                    10         10         10        37,300
                                               established
                                               tolerance (e.g.,
                                               decrease or
                                               increase);
                                               domestic or
                                               import; applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R293                                      40  Establish                   12         12         12        44,000
                                               tolerance(s) for
                                               inadvertent
                                               residues in one
                                               crop; applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R294                                      41  Establish                   12         12         12       264,000
                                               tolerances for
                                               inadvertent
                                               residues; six or
                                               more crops
                                               submitted in one
                                               application;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------

[[Page 61470]]

 
R295                                      42  Establish                   15         15         15        54,400
                                               tolerance(s) for
                                               residues in one
                                               rotational crop in
                                               response to a
                                               specific
                                               rotational crop
                                               application;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R296                                      43  Establish                   15         15         15       326,400
                                               tolerances for
                                               residues in
                                               rotational crops
                                               in response to a
                                               specific
                                               rotational crop
                                               petition; six or
                                               more crops
                                               submitted in one
                                               application;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
  or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
  that application.


                                  Table 4.--Registration Division--New Products
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
R300                                      44  New product;                 3          3          3         1,300
                                               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.
----------------------------------------------------------------------------------------------------------------
R301                                      45  New product;                 4          4          4         1,560
                                               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               6          6          6         4,360
                                               manufacturing-use
                                               product; requires
                                               review of data
                                               package within RD;
                                               includes reviews
                                               and/or waivers of
                                               data for only:
                                               Product
                                               chemistry and/or.
                                               Acute
                                               toxicity and/or.
                                               Public
                                               health pest
                                               efficacy.
----------------------------------------------------------------------------------------------------------------
R311                                      49  New product;                12         12         12        15,540
                                               requires approval
                                               of new food-use
                                               inert; applicant-
                                               initiated;
                                               excludes approval
                                               of safeners
----------------------------------------------------------------------------------------------------------------
R312                                      50  New product;                 6          6          6         8,300
                                               requires approval
                                               of new non-food-
                                               use inert;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R313                                      51  New product;                10         10         10        11,420
                                               requires amendment
                                               to existing inert
                                               tolerance
                                               exemption (e.g.,
                                               adding post-
                                               harvest use);
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R320                                      47  New product; new            12         12         12        10,880
                                               physical form;
                                               requires data
                                               review in science
                                               divisions
----------------------------------------------------------------------------------------------------------------
R330                                      48  New manufacturing-          12         12         12        16,320
                                               use product;
                                               registered active
                                               ingredient;
                                               selective data
                                               citation
----------------------------------------------------------------------------------------------------------------
R331                                      52  New product; repack          3          3          3         2,080
                                               of identical
                                               registered end-use
                                               product as a
                                               manufacturing-use
                                               product; same
                                               registered uses
                                               only
----------------------------------------------------------------------------------------------------------------
R332                                      53  New manufacturing-          24         24         24       233,000
                                               use product;
                                               registered active
                                               ingredient;
                                               unregistered
                                               source of active
                                               ingredient;
                                               submission of
                                               completely new
                                               generic data
                                               package;
                                               registered uses
                                               only
----------------------------------------------------------------------------------------------------------------


[[Page 61471]]


                           Table 5.--Registration Division--Amendments to Registration
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
R340                                      54  Amendment requiring          4          4          4         3,280
                                               data review within
                                               RD (e.g., changes
                                               to precautionary
                                               label statements,
                                               or source changes
                                               to an unregistered
                                               source of active
                                               ingredient)\1\
----------------------------------------------------------------------------------------------------------------
R350                                      55  Amendment requiring          8          8          8        10,880
                                               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)\1\
----------------------------------------------------------------------------------------------------------------
R370                                      56  Cancer                      18         18         18       163,100
                                               reassessment;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
R371                                      57  Amendment to                 6          6          6         8,300
                                               Experimental Use
                                               Permit; requires
                                               data review/risk
                                               assessment
----------------------------------------------------------------------------------------------------------------
R372                                      58  Refined ecological          18         18         12       155,300
                                               and/or endangered
                                               species
                                               assessment;
                                               applicant-
                                               initiated
----------------------------------------------------------------------------------------------------------------
\1\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials
  Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to
  PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice
  98-10, continue under PR Notice timelines and are not subject to PRIA fees.

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 6 through 8 of Unit V.B. cover AD actions.

                            Table 6.--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
A380                                      59  Food use; establish         24         24         24        94,500
                                               tolerance
                                               exemption\1\
----------------------------------------------------------------------------------------------------------------
A390                                      60  Food use; establish         24         24         24       157,500
                                               tolerance\1\
----------------------------------------------------------------------------------------------------------------
A400                                      61  Non-food use;               18         18         18        78,750
                                               outdoor; FIFRA
                                               section 2(mm)
                                               uses\1\
----------------------------------------------------------------------------------------------------------------
A410                                      62  Non-food use;               21         21         21       157,500
                                               outdoor; uses
                                               other than
                                               FIFRAsection
                                               2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A420                                      63  Non-food use;               18         18         18        52,500
                                               indoor; FIFRA
                                               section 2(mm)
                                               uses\1\
----------------------------------------------------------------------------------------------------------------
A430                                      64  Non-food use;               20         20         20        78,750
                                               indoor; uses other
                                               than FIFRAsection
                                               2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A431                                      65  Non-food use;               12         12         12        55,000
                                               indoor; low-risk
                                               and 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
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
  or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
  that application.


                                   Table 7.--Antimicrobials Division--New Uses
----------------------------------------------------------------------------------------------------------------
                                                                        Decision time (months)          FY 08
                                                                  --------------------------------- Registration
             EPA No.                 CR No.          Action                                          Service Fee
                                                                     FY 08      FY 09      FY 10         ($)
----------------------------------------------------------------------------------------------------------------
A440                                      66  First food use;             21         21         21        26,250
                                               establish
                                               tolerance
                                               exemption\1\
----------------------------------------------------------------------------------------------------------------
A450                                      67  First food use;             21         21         21        78,750
                                               establish
                                               tolerance\1\
----------------------------------------------------------------------------------------------------------------
A460                                      68  Additional food             15         15         15        10,500
                                               use; establish
                                               tolerance
                                               exemption
----------------------------------------------------------------------------------------------------------------
A470                                      69  Additional food             15         15         15        26,250
                                               use; establish
                                               tolerance
----------------------------------------------------------------------------------------------------------------

[[Page 61472]]

 
A480                                      70  Additional use; non-         9          9          9        15,750
                                               food; outdoor;
                                               FIFRA section
                                               2(mm) uses
----------------------------------------------------------------------------------------------------------------
A490                                      71  Additional use; non-        15         15         15        26,250
                                               food; outdoor;
                                               uses other than
                                               FIFRA section
                                               2(mm)
----------------------------------------------------------------------------------------------------------------
A500                                      72  Additional use; non-         9          9          9        10,500
                                               food; indoor;
                                               FIFRA section
                                               2(mm) uses
----------------------------------------------------------------------------------------------------------------
A510                                      73  Additional use; non-        12         12         12        10,500
                                               food; indoor; uses
                                               other than FIFRA
                                               section 2(mm)
----------------------------------------------------------------------------------------------------------------
A520                                      74  Experimental Use             9          9          9         5,250
                                               Permit application
----------------------------------------------------------------------------------------------------------------
A521                                      75  Review of public             6          4          3         2,000
                                               health efficacy
                                               study protocol
                                               within AD; per AD
                                               Internal Guidance
                                               for the Efficacy
                                               Protocol Review
                                               Process; applicant-
                                               initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522                                      76  Review of public            18         15         12        10,000
                                               health efficacy
                                               study protocol