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Pesticides; Revised Fee Schedule for Registration Applications
PDF Version (13 pp, 532K, About PDF) [Federal Register: August 5, 2008 (Volume 73, Number 151)] [Notices] [Page 45438-45450] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr05au08-55] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0545; FRL-8375-9] 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 registration service fees for covered pesticide registration applications received on or after October 1, 2008, increase by 5% rounding up to the nearest dollar from the fees published for fiscal year 2008, and certain decision review periods have been reduced. The new fees and decision review periods become effective on October 1, 2008. 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 (32532). Antimicrobial pesticide manufacturers (32561). Antifoulant pesticide manufacturers (32551). Wood preservative manufacturers (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 [[Page 45439]] 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-2008-[0545]. Publicly available docket materials are available either in the electronic docket at http://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 A. What Action is the Agency Taking? The Pesticide Registration Improvement Act of 2003 established a new section 33 of FIFRA creating a registration service fee system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. The Agency began administering the registration service fee system for covered applications received on or after March 23, 2004. On 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. As required by section 33(b)(6)(A) of FIFRA, the registration service fees for covered pesticide registration applications received on or after October 1, 2008, increase by five percent rounding up to the nearest dollar from the fees published in the October 30, 2007, Federal Register Notice (72 FR 61466). In addition, this notice provides shorter decision review periods for certain application categories. B. What is the Agency's Authority for Taking this Action? The publication of this fee schedule is required by section 33(b)(6)(C) of FIFRA as amended. III. Elements of the Fee Schedule This unit explains how 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. 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. 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 2009 and 2010 as these are the only applicable review periods for applications received on or after October 1, 2008. Unit IV. 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'' lists the decision times in months for each type of action for Fiscal Years 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 09/FY 10 Registration Service Fee ($)'' lists the registration service fee for the action for fiscal year 2009 (October 1, 2008 through September 30, 2009) and fiscal year 2010 (October 1, 2009 through September 30, 2010). 2. The following acronyms are used in some of the tables: DART-Dose Adequacy Response Team DNT-Developmental Neurotoxicity HSRB-Human Studies Review Board GW/SW-Ground Water/Surface Water PHI-Pre-Harvest Interval PPE-Personal Protective Equipment REI-Restricted Entry Interval SAP-FIFRA Scientific Advisory Panel [[Page 45440]] IV. PRIRA Fee Schedule Tables--Effective October 1, 2008 A. Registration Division (RD) The Registration Division of OPP is responsible for the processing of pesticide applications and associated tolerance petitions for pesticides that are termed ``conventional chemicals,'' excluding pesticides intended for antimicrobial uses. The term ``conventional chemical'' is a term of art that is intended to distinguish synthetic chemicals from those that are of naturally occurring or non-synthetic origin, synthetic chemicals that are identical to naturally-occurring chemicals and microbial pesticides. Tables 1 through 5 of Unit IV.A. cover RD actions. Table 1.--Registration Division--New Active Ingredients -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- R010 1 Food use\1\ 24 24 542,115 -------------------------------------------------------------------------------------------------------------------------------------------------------- R020 2 Food use; reduced risk\1\ 18 18 542,115 -------------------------------------------------------------------------------------------------------------------------------------------------------- R030 3 Food use; Experimental Use Permit 24 24 599,235 application submitted simultaneously with application for registration; decision time for Experimental Use Permit and temporary tolerance same as #R040\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R040 4 Food use; Experimental Use Permit 18 18 399,525 application; establish temporary tolerance; submitted before application for registration; credit $326,025 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- R050 5 Food use; application submitted 14 14 199,815 after Experimental Use Permit application; decision time begins after Experimental Use Permit and temporary tolerance are granted\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R060 6 Non-food use; outdoor\1\ 21 21 376,635 -------------------------------------------------------------------------------------------------------------------------------------------------------- R070 7 Non-food use; outdoor; reduced 16 16 376,635 risk\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R080 8 Non-food use; outdoor; 21 21 416,640 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; outdoor; 16 16 279,615 Experimental Use Permit application submitted before application for registration; credit $228,225 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- R100 10 Non-food use; outdoor; submitted 12 12 137,025 after Experimental Use Permit application; decision time begins after Experimental Use Permit is granted\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R110 11 Non-food use; indoor\1\ 20 20 209,475 -------------------------------------------------------------------------------------------------------------------------------------------------------- R120 12 Non-food use; indoor; reduced 14 14 209,475 risk\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R121 13 Non-food use; indoor; Experimental 18 18 157,500 Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- R122 14 Enriched isomer(s) of registered 18 18 273,945 mixed-isomer active ingredient\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R123 15 Seed treatment only; includes non- 18 18 407,610 food and food uses; limited uptake into Raw Agricultural Commodities\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R124 16 Conditional Ruling on 6 6 2,184 Preapplication Study Waivers; applicant-initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application. [[Page 45441]] Table 2.--Registration Division--New Uses -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- R130 17 First food use; indoor; food/food 21 21 165,375 handling\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R140 18 Additional food use; indoor; food/ 15 15 38,588 food handling -------------------------------------------------------------------------------------------------------------------------------------------------------- R150 19 First food use\1\ 21 21 228,270 -------------------------------------------------------------------------------------------------------------------------------------------------------- R160 20 First food use; reduced risk\1\ 16 16 228,270 -------------------------------------------------------------------------------------------------------------------------------------------------------- R170 21 Additional food use 15 15 57,120 -------------------------------------------------------------------------------------------------------------------------------------------------------- R180 22 Additional food use; reduced risk 10 10 57,120 -------------------------------------------------------------------------------------------------------------------------------------------------------- R190 23 Additional food uses; 6 or more 15 15 342,720 submitted in one application -------------------------------------------------------------------------------------------------------------------------------------------------------- R200 24 Additional food uses; 6 or more 10 10 342,720 submitted in one application; reduced risk -------------------------------------------------------------------------------------------------------------------------------------------------------- R210 25 Additional food use; Experimental 12 12 42,315 Use Permit application; establish temporary tolerance; no credit toward new use registration -------------------------------------------------------------------------------------------------------------------------------------------------------- R220 26 Additional food use; Experimental 6 6 17,136 Use Permit application; crop destruct basis; no credit toward new use registration -------------------------------------------------------------------------------------------------------------------------------------------------------- R230 27 Additional use; non-food; outdoor 15 15 22,827 -------------------------------------------------------------------------------------------------------------------------------------------------------- R240 28 Additional use; non-food; outdoor; 10 10 22,827 reduced risk -------------------------------------------------------------------------------------------------------------------------------------------------------- R250 29 Additional use; non-food; outdoor; 6 6 17,136 Experimental Use Permit application; no credit toward new use registration -------------------------------------------------------------------------------------------------------------------------------------------------------- R260 30 New use; non-food; indoor 12 12 11,025 -------------------------------------------------------------------------------------------------------------------------------------------------------- R270 31 New use; non-food; indoor; reduced 9 9 11,025 risk -------------------------------------------------------------------------------------------------------------------------------------------------------- R271 32 New use; non-food; indoor; 6 6 8,400 Experimental Use Permit application; no credit toward new use registration -------------------------------------------------------------------------------------------------------------------------------------------------------- R272 33 Review of Study Protocol; 3 3 2,184 applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review -------------------------------------------------------------------------------------------------------------------------------------------------------- R273 34 Additional use; seed treatment; 12 12 43,575 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; seed treatment 12 12 261,450 only; 6 or more submitted in one application; limited uptake into Raw Agricultural Commodities; includes crops with established tolerances (e.g., for soil or foliar application); includes food and/or non-food 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. [[Page 45442]] Table 3.--Registration Division--Import and Other Tolerances -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- R280 36 Establish import tolerance; new 21 21 275,625 active ingredient or first food use\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R290 37 Establish import tolerance; 15 15 55,125 additional food use -------------------------------------------------------------------------------------------------------------------------------------------------------- R291 38 Establish import tolerances; 15 15 330,750 additional food uses; 6 or more crops submitted in one petition -------------------------------------------------------------------------------------------------------------------------------------------------------- R292 39 Amend an established tolerance 10 10 39,165 (e.g., decrease or increase); domestic or import; applicant- initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R293 40 Establish tolerance(s) for 12 12 46,200 inadvertent residues in one crop; applicant-initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R294 41 Establish tolerances for 12 12 277,200 inadvertent residues; 6 or more crops submitted in one application; applicant-initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R295 42 Establish tolerance(s) for 15 15 57,120 residues in one rotational crop in response to a specific rotational crop application; applicant-initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R296 43 Establish tolerances for residues 15 15 342,720 in rotational crops in response to a specific rotational crop petition; 6 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 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- R300 44 New product; identical or 3 3 1,365 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; identical or 4 4 1,638 substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner. -------------------------------------------------------------------------------------------------------------------------------------------------------- R310 46 New end-use or manufacturing-use 6 6 4,578 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; requires approval of 12 12 16,317 new food-use inert; applicant- initiated; excludes approval of safeners -------------------------------------------------------------------------------------------------------------------------------------------------------- R312 50 New product; requires approval of 6 6 8,715 new non-food-use inert; applicant- initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45443]] R313 51 New product; requires amendment to 10 10 11,991 existing inert tolerance exemption (e.g., adding post- harvest use); applicant-initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R320 47 New product; new physical form; 12 12 11,424 requires data review in science divisions -------------------------------------------------------------------------------------------------------------------------------------------------------- R330 48 New manufacturing-use product; 12 12 17,136 registered active ingredient; selective data citation -------------------------------------------------------------------------------------------------------------------------------------------------------- R331 52 New product; repack of identical 3 3 2,184 registered end-use product as a manufacturing-use product; same registered uses only -------------------------------------------------------------------------------------------------------------------------------------------------------- R332 53 New manufacturing-use product; 24 24 244,650 registered active ingredient; unregistered source of active ingredient; submission of completely new generic data package; registered uses only -------------------------------------------------------------------------------------------------------------------------------------------------------- Table 5.--Registration Division--Amendments to Registration -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- R340 54 Amendment requiring data review 4 4 3,444 within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- R350 55 Amendment requiring data review in 8 8 11,424 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 reassessment; applicant- 18 18 171,255 initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- R371 57 Amendment to Experimental Use 6 6 8,715 Permit; requires data review/risk assessment -------------------------------------------------------------------------------------------------------------------------------------------------------- R372 58 Refined ecological and/or 18 12 163,065 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 IV.B. cover AD actions. Table 6.--Antimicrobials Division--New Active Ingredients -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- A380 59 Food use; establish tolerance 24 24 99,225 exemption\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A390 60 Food use; establish tolerance\1\ 24 24 165,375 -------------------------------------------------------------------------------------------------------------------------------------------------------- A400 61 Non-food use; outdoor; FIFRA 18 18 82,688 section 2(mm) uses\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45444]] A410 62 Non-food use; outdoor; uses other 21 21 165,375 than FIFRA section 2(mm)\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A420 63 Non-food use; indoor; FIFRA 18 18 55,125 section 2(mm) uses\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A430 64 Non-food use; indoor; uses other 20 20 82,688 than FIFRA section 2(mm)\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A431 65 Non-food use; indoor; low-risk and 12 12 57,750 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 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- A440 66 First food use; establish 21 21 27,563 tolerance exemption\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A450 67 First food use; establish 21 21 82,688 tolerance\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A460 68 Additional food use; establish 15 15 11,025 tolerance exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- A470 69 Additional food use; establish 15 15 27,563 tolerance -------------------------------------------------------------------------------------------------------------------------------------------------------- A480 70 Additional use; non-food; outdoor; 9 9 16,538 FIFRA section 2(mm) uses -------------------------------------------------------------------------------------------------------------------------------------------------------- A490 71 Additional use; non-food; outdoor; 15 15 27,563 uses other than FIFRA section 2(mm) -------------------------------------------------------------------------------------------------------------------------------------------------------- A500 72 Additional use; non-food; indoor; 9 9 11,025 FIFRA section 2(mm) uses -------------------------------------------------------------------------------------------------------------------------------------------------------- A510 73 Additional use; non-food; indoor; 12 12 11,025 uses other than FIFRA section 2(mm) -------------------------------------------------------------------------------------------------------------------------------------------------------- A520 74 Experimental Use Permit 9 9 5,513 application -------------------------------------------------------------------------------------------------------------------------------------------------------- A521 75 Review of public health efficacy 4 3 2,100 study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- A522 76 Review of public health efficacy 15 12 10,500 study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant- initiated; Tier 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. [[Page 45445]] Table 8.--Antimicrobials Division--New Products and Amendments -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- A530 77 New product; identical or 3 3 1,103 substantially similar in composition and use to a registered product; no data review or only product chemistry data; cite-all data citation, or selective data citation where applicant owns all required data, or applicant submits specific authorization letter from data owner. Category also includes 100% re-package of registered end- use or manufacturing-use product that requires no data submission nor data matrix. -------------------------------------------------------------------------------------------------------------------------------------------------------- A531 78 New product; identical or 4 4 1,575 substantially similar in composition and use to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute toxicity and/or public health pest efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner -------------------------------------------------------------------------------------------------------------------------------------------------------- A532 85 New product; identical or 4 4 4,410 substantially similar in composition and use to a registered product; registered active ingredient; unregistered source of active ingredient; cite- all data citation except for product chemistry; product chemistry data submitted -------------------------------------------------------------------------------------------------------------------------------------------------------- A540 79 New end-use product; FIFRA section 4 4 4,410 2(mm) uses only -------------------------------------------------------------------------------------------------------------------------------------------------------- A550 80 New end-use product; uses other 6 6 4,410 than FIFRA section 2(mm); non- FQPA product -------------------------------------------------------------------------------------------------------------------------------------------------------- A560 81 New manufacturing-use product; 12 12 16,538 registered active ingredient; selective data citation -------------------------------------------------------------------------------------------------------------------------------------------------------- A570 82 Label amendment requiring data 4 4 3,308 submission\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- A571 83 Cancer reassessment; applicant- 18 18 82,688 initiated -------------------------------------------------------------------------------------------------------------------------------------------------------- A572 84 Refined ecological risk and/or 18 12 78,750 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. 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 IV.C. cover BPPD actions. Table 9.--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products and Amendments -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- B580 86 New active ingredient; food use; 18 18 44,100 establish tolerance\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B590 87 New active ingredient; food use; 16 16 27,563 establish tolerance exemption\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45446]] B600 88 New active ingredient; non-food 12 12 16,538 use\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B610 89 Food use; Experimental Use Permit 9 9 11,025 application; establish temporary tolerance exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- B620 90 Non-food use; Experimental Use 6 6 5,513 Permit application -------------------------------------------------------------------------------------------------------------------------------------------------------- B621 91 Extend or amend Experimental Use 6 6 4,410 Permit -------------------------------------------------------------------------------------------------------------------------------------------------------- B630 92 First food use; establish 12 12 11,025 tolerance exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- B631 93 Amend established tolerance 9 9 11,025 exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- B640 94 First food use; establish 18 18 16,538 tolerance\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B641 95 Amend established tolerance (e.g., 12 12 11,025 decrease or increase) -------------------------------------------------------------------------------------------------------------------------------------------------------- B650 96 New use; non-food 6 6 5,513 -------------------------------------------------------------------------------------------------------------------------------------------------------- B660 97 New product; identical or 3 3 1,103 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. -------------------------------------------------------------------------------------------------------------------------------------------------------- B670 98 New product; registered source of 6 6 4,410 active ingredient; all Tier I data 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- B671 99 New product; food use; 16 16 11,025 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- B672 100 New product; non-food use or food 12 12 7,875 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- B680 101 Label amendment requiring data 4 4 4,410 submission\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B681 102 Label amendment; unregistered 6 6 5,250 source of active ingredient; supporting data require scientific review -------------------------------------------------------------------------------------------------------------------------------------------------------- B682 103 Protocol review; applicant- 3 3 2,100 initiated; excludes time for HSRB review (pre-application) -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. [[Page 45447]] \2\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. Table 10.--Biopesticides and Pollution Prevention Division--Straight Chain Lepidopteran Pheromones (SCLPS) -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- B690 104 New active ingredient; food or non- 6 6 2,205 food use\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B700 105 Experimental Use Permit 6 6 1,103 application; new active ingredient or new use -------------------------------------------------------------------------------------------------------------------------------------------------------- B701 106 Extend or amend Experimental Use 3 3 1,103 Permit -------------------------------------------------------------------------------------------------------------------------------------------------------- B710 107 New product; identical or 3 3 1,103 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. -------------------------------------------------------------------------------------------------------------------------------------------------------- B720 108 New product; registered source of 4 4 1,103 active ingredient; all Tier I data 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- B721 109 New product; unregistered source 6 6 2,310 of active ingredient -------------------------------------------------------------------------------------------------------------------------------------------------------- B722 110 New use and/or amendment to 6 6 2,310 tolerance or tolerance exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- B730 111 Label amendment requiring data 4 4 1,103 submission\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. \2\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. Table 11.--Biopesticide and Pollution Prevention Division--Plant Incorporated Protectants (PIPS) -------------------------------------------------------------------------------------------------------------------------------------------------------- Decision time (months) FY 09/FY 10 EPA No. CR No. Action ---------------------------------- Registration FY 09 FY 10 Service Fee ($) -------------------------------------------------------------------------------------------------------------------------------------------------------- B740 112 Experimental Use Permit 6 6 82,688 application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B750 113 Experimental Use Permit 9 9 110,250 application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B760 114 Experimental Use Permit 12 12 137,813 application; new active ingredient; non-food/feed or crop destruct basis; SAP review required; credit $78,750 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- B761 115 Experimental Use Permit 7 7 82,688 application; new active ingredient; non-food/feed or crop destruct; no SAP review required; credit $78,750 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45448]] B770 116 Experimental Use Permit 15 15 165,375 application; new active ingredient; establish temporary tolerance or tolerance exemption; SAP review required; credit $105,000 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- B771 117 Experimental Use Permit 10 10 110,250 application; new active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required; credit $105,000 toward new active ingredient application that follows -------------------------------------------------------------------------------------------------------------------------------------------------------- B772 118 Amend or extend Experimental Use 3 3 11,025 Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected -------------------------------------------------------------------------------------------------------------------------------------------------------- B773 119 Amend or extend existing 5 5 27,563 Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption -------------------------------------------------------------------------------------------------------------------------------------------------------- B860 120 Amend Experimental Use Permit; 6 6 11,025 first food use or major revision of experimental design -------------------------------------------------------------------------------------------------------------------------------------------------------- B780 121 New active ingredient; non-food/ 12 12 137,813 feed; no SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B790 122 New active ingredient; Non-food/ 18 18 192,938 feed; SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B800 123 New active ingredient; establish 12 12 220,500 permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B810 124 New active ingredient; establish 18 18 275,625 permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B820 125 New active ingredient; establish 15 15 275,625 tolerance or tolerance exemption; no SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B840 126 New active ingredient; establish 21 21 330,750 tolerance or tolerance exemption; SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B830 127 New active ingredient; 15 15 330,750 Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B850 128 New active ingredient; 21 21 385,875 Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required\2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B851 129 New active ingredient; different 9 9 110,250 genetic event of a previously approved active ingredient; same crop; no tolerance action required; no SAP review required -------------------------------------------------------------------------------------------------------------------------------------------------------- B852 130 New active ingredient; different 9 9 165,375 genetic event of a previously approved active ingredient; same crop; no tolerance action required; SAP review required -------------------------------------------------------------------------------------------------------------------------------------------------------- B870 131 New use\1\ 9 9 33,075 -------------------------------------------------------------------------------------------------------------------------------------------------------- B880 132 New product; no SAP review 9 9 27,563 required\3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45449]] B881 133 New product; SAP review 15 15 82,688 required\3\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B890 134 Amendment; seed production to 9 9 55,125 commercial registration; no SAP review required -------------------------------------------------------------------------------------------------------------------------------------------------------- B891 135 Amendment; seed production to 15 15 110,250 commercial registration; SAP review required -------------------------------------------------------------------------------------------------------------------------------------------------------- B900 136 Amendment (except #B890); 6 6 11,025 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B901 137 Amendment (except #B890); 12 12 66,150 SAP review required\4\ -------------------------------------------------------------------------------------------------------------------------------------------------------- B902 138 PIP protocol review 3 3 5,513 -------------------------------------------------------------------------------------------------------------------------------------------------------- B903 139 Inert ingredient tolerance 6 6 55,125 exemption; e.g., a marker such as NPT II; reviewed in BPPD -------------------------------------------------------------------------------------------------------------------------------------------------------- B904 140 Import tolerance or tolerance 9 9 110,250 exemption; processed commodities/ food only -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn. \2\May 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. \3\Example: Stacking PIP traits within a crop using traditional breeding techniques. \4\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. V. How to Pay Fees Applicants must submit fee payments at the time of application, and EPA will reject any application that does not contain evidence that the fee has been paid. EPA has developed a web site at http://www.epa.gov/ pesticides/fees/tool/index.htm to help applicants identify the fee category and the fee. All fees should be rounded up to the whole dollar. 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 website www.pay.gov. 1. From the pay.gov home page, under ``Find Public Forms.'' 2. Select ``search by Agency name.'' 3. On the A-Z Index of Forms page, select ``E.'' 4. Select ``Environmental Protection Agency.'' 5. From the list of forms, select ``Pre-payment of Pesticide Registration Improvement Act Fee.'' 6. Complete the form entering the PRIA fee category and fee. 7. Keep a copy of the pay.gov acknowledgement of payment. A copy of the acknowledgement must be printed and attached to the front of the application to assure that EPA can match the application with the payment. B. By Check or Money Order All payments must be in United States currency by check, bank draft, or money order drawn to the order of the Environmental Protection Agency. On the check, the applicant must supply in the information line either the registration number of the product or the company number. A copy of the check must accompany the application to the Agency, specifically attached to the front of the application. The copy of the check ensures that payment has been made at the time of application and will enable the Agency to properly connect the payment with the application sent to the Agency. If you send the Agency a check, it will be converted into an electronic funds transfer (EFT). This means the Agency will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours and will be shown on your regular account statement. You will not receive your original check back. The Agency will destroy your original check but will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize the Agency to process the copy in place of your original check. If 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. VI. How to Submit Applications Submissions to the Agency should be made at the address given in Unit VII. The applicant should attach documentation that the fee has been paid which may be pay.gov payment acknowledgement or a copy of the check. If the applicant is applying for a fee waiver, the applicant should provide sufficient documentation as described [[Page 45450]] in FIFRA section 33(b)(7) and http://www.epa.gov/pesticides/fees/ questions/waivers.htm. The fee waiver request should be easy to identify and separate from the rest of the application and submitted with documentation that at least 25% of the fee has been paid. If evidence of fee payment (electronic acknowledgement or copy of check properly identified as to company) is not submitted with the application, EPA will reject the application and will not process it further. After EPA receives an application and payment, EPA performs a screen on the application to determine that the category is correct and that the proper fee amount has been paid. If either is incorrect, EPA will notify the applicant and require payment of any additional amount due. A refund will be provided in case of an overpayment. EPA will not process the application further until the proper fee has been paid for the category of application or a request for a fee waiver accompanies the application and the appropriate portion of the fee has been paid. EPA will assign a unique identification number to each covered application for which payment has been made. EPA notifies the applicant of the unique identification number. This information is sent by e-mail if EPA has either an e-mail address on file or an e-mail address is provided on the application. VII. 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 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: July 28, 2008. Marty Monell, Acting Director, Office of Pesticide Programs. [FR Doc. E8-17936 Filed 8-4-08; 8:45 am] BILLING CODE 6560-50-S