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 Environmental Protection Agency [EPA-HQ-OPP-2007-1066; FRL-8155-6]
 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 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 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.
                        ( print 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**
EPA No.
CR No.
Action
Decision time (in months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10R010
1
Food use1
24
24
24
516,300( print page 61468)R020
2
Food use; reduced risk1
18
18
18
516,300R030
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
570,700R040
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
380,500R050
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
190,300R060
6
Non-food use; outdoor1
21
21
21
358,700R070
7
Non-food use; outdoor; reduced risk1
16
16
16
358,700R080
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
396,800R090
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
266,300R100
10
Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit is granted1
12
12
12
130,500R110
11
Non-food use; indoor1
20
20
20
199,500R120
12
Non-food use; indoor; reduced risk1
14
14
14
199,500R121
13
Non-food use; indoor; Experimental Use Permit application submitted before application for registration; credit $100,000 toward new active ingredient application that follows
18
18
18
150,000R122
14
Enriched isomer(s) of registered mixed-isomer active ingredient1
18
18
18
260,900R123
15
Seed treatment only; includes non-food and food uses; limited uptake into Raw Agricultural Commodities1
18
18
18
388,200R124
16
Conditional Ruling on Preapplication Study Waivers; applicant-initiated
6
6
6
2,0801
                            All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 **TABLE 2.—Registration Division—New Uses**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10R130
17
First food use; indoor; food/food handling1
21
21
21
157,500R140
18
Additional food use; Indoor; food/food handling
15
15
15
36,750R150
19
First food use1
21
21
21
217,400R160
20
First food use; reduced risk1
16
16
16
217,400R170
21
Additional food use
15
15
15
54,400R180
22
Additional food use; reduced risk
10
10
10
54,400( print page 61469)R190
23
Additional food uses; six or more submitted in one application
15
15
15
326,400R200
24
Additional food uses; six or more submitted in one application; reduced risk
10
10
10
326,400R210
25
Additional food use; Experimental Use Permit application; establish temporary tolerance; no credit toward new use registration
12
12
12
40,300R220
26
Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration
6
6
6
16,320R230
27
Additional use; non-food; outdoor
15
15
15
21,740R240
28
Additional use; non-food; outdoor; reduced risk
10
10
10
21,740R250
29
Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration
6
6
6
16,320R260
30
New use; non-food; indoor
12
12
12
10,500R270
31
New use; non-food; indoor; reduced risk
9
9
9
10,500R271
32
New use; non-food; indoor; Experimental Use Permit application; no credit toward new use registration
6
6
6
8,000R272
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
2,080R273
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
41,500R274
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
249,0001
                            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**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10R280
36
Establish import tolerance; new active ingredient or first food use1
21
21
21
262,500R290
37
Establish import tolerance; additional food use
15
15
15
52,500R291
38
Establish import tolerances; additional food uses; six or more crops submitted in one petition
15
15
15
315,000R292
39
Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated
10
10
10
37,300R293
40
Establish tolerance(s) for inadvertent residues in one crop; applicant-initiated
12
12
12
44,000R294
41
Establish tolerances for inadvertent residues; six or more crops submitted in one application; applicant-initiated
12
12
12
264,000( print page 61470)R295
42
Establish tolerance(s) for residues in one rotational crop in response to a specific rotational crop application; applicant-initiated
15
15
15
54,400R296
43
Establish tolerances for residues in rotational crops in response to a specific rotational crop petition; six or more crops submitted in one application; applicant-initiated
15
15
15
326,4001
                            All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 **Table 4.—Registration Division—New Products**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10R300
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 end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,300R301
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
1,560R310
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
4,360R311
49
New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners
12
12
12
15,540R312
50
New product; requires approval of new non-food-use inert; applicant-initiated
6
6
6
8,300R313
51
New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated
10
10
10
11,420R320
47
New product; new physical form; requires data review in science divisions
12
12
12
10,880R330
48
New manufacturing-use product; registered active ingredient; selective data citation
12
12
12
16,320R331
52
New product; repack of identical registered end-use product as a manufacturing-use product; same registered uses only
3
3
3
2,080R332
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
 
 
 **Table 5.—Registration Division—Amendments to Registration**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10R340
54
Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered source of active ingredient)1
4
4
4
3,280R350
55
Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or use rate, or number of applications; or add aerial application; or modify GW/SW advisory statement)1
8
8
8
10,880R370
56
Cancer reassessment; applicant-initiated
18
18
18
163,100R371
57
Amendment to Experimental Use Permit; requires data review/risk assessment
6
6
6
8,300R372
58
Refined ecological and/or endangered species assessment; applicant-initiated
18
18
12
155,3001
                            EPA-initiated amendments shall not be charged fees.  Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees.  Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
 B.  Antimicrobials Division (AD) The Antimicrobials Division of OPP is responsible for the processing of pesticide applications and associated tolerances for conventional chemicals intended for antimicrobial uses, that is, uses that are defined under FIFRA section 2(mm)(1)(A), including products for use against bacteria, protozoa, non-agricultural fungi, and viruses.  AD is also responsible for a selected set of conventional chemicals intended for other uses, including most wood preservatives and antifoulants.    Tables 6 through 8 of Unit V.B. cover AD actions. **Table 6.—Antimicrobials Division—New Active Ingredients**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10A380
59
Food use; establish tolerance exemption1
24
24
24
94,500A390
60
Food use; establish tolerance1
24
24
24
157,500A400
61
Non-food use; outdoor; FIFRA section 2(mm) uses1
18
18
18
78,750A410
62
Non-food use; outdoor; uses other than FIFRA section 2(mm)1
21
21
21
157,500A420
63
Non-food use; indoor; FIFRA section 2(mm) uses1
18
18
18
52,500A430
64
Non-food use; indoor; uses other than FIFRA section 2(mm)1
20
20
20
78,750A431
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
55,0001
                            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**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10A440
66
First food use; establish tolerance exemption1
21
21
21
26,250A450
67
First food use; establish tolerance1
21
21
21
78,750A460
68
Additional food use; establish tolerance exemption
15
15
15
10,500A470
69
Additional food use; establish tolerance
15
15
15
26,250( print page 61472)A480
70
Additional use; non-food; outdoor; FIFRA section 2(mm) uses
9
9
9
15,750A490
71
Additional use; non-food; outdoor; uses other than FIFRA section 2(mm)
15
15
15
26,250A500
72
Additional use; non-food; indoor; FIFRA  section 2(mm) uses
9
9
9
10,500A510
73
Additional use; non-food; indoor; uses other than FIFRA section 2(mm)
12
12
12
10,500A520
74
Experimental Use Permit application
9
9
9
5,250A521
75
Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1
6
4
3
2,000A522
76
Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2
18
15
12
10,0001
                            All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
 **Table 8.—Antimicrobials Division—New Products And Amendments**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10A530
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 end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050A531
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
1,500A532
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
4,200A540
79
New end use product; FIFRA section 2(mm) uses only
4
4
4
4,200A550
80
New end-use product; uses other than FIFRA section 2(mm); non-FQPA product
6
6
6
4,200A560
81
New manufacturing-use product; registered active ingredient; selective data citation
12
12
12
15,750A570
82
Label amendment requiring data submission1
4
4
4
3,150A571
83
Cancer reassessment; applicant-initiated
18
18
18
78,750A572
84
Refined ecological risk and/or endangered species assessment; applicant-initiated
18
18
12
75,0001
                            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 V.C. cover BPPD actions. **Table 9.—Biopesticides and Pollution Prevention Division—Microbial and Biochemical Pesticides; New Products and Amendments**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10B580
86
New active ingredient; food use; establish tolerance1
18
18
18
42,000B590
87
New active ingredient; food use; establish tolerance exemption1
16
16
16
26,250B600
88
New active ingredient; non-food use1
12
12
12
15,750B610
89
Food use; Experimental Use Permit application; establish temporary tolerance exemption
9
9
9
10,500B620
90
Non-food use; Experimental Use Permit application
6
6
6
5,250B621
91
Extend or amend Experimental Use Permit
6
6
6
4,200B630
92
First food use; establish tolerance exemption
12
12
12
10,500B631
93
Amend established tolerance exemption
9
9
9
10,500B640
94
First food use; establish tolerance1
18
18
18
15,750B641
95
Amend established tolerance (e.g., decrease or increase)
12
12
12
10,500B650
96
New use; non-food
6
6
6
5,250B660
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 end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050B670
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 product-specific data or with request for data waivers supported by scientific rationales
6
6
6
4,200B671
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
10,500B672
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
7,500B680
101
Label amendment requiring data submission2
4
4
4
4,200B681
102
Label amendment; unregistered source of active ingredient; supporting data require scientific review
6
6
6
5,000( print page 61474)B682
103
Protocol review; applicant-initiated; excludes time for HSRB review (preapplication)
3
3
3
2,0001
                            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 10.—Biopesticides and Pollution Prevention Division—Straight Chain Lepidopteran Pheromones (SCLPs)**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10B690
104
New active ingredient; food or non-food use1
6
6
6
2,100B700
105
Experimental Use Permit application; new active ingredient or new use
6
6
6
1,050B701
106
Extend or amend Experimental Use Permit
3
3
3
1,050B710
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 end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
3
1,050B720
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 product-specific data or with request for data waivers supported by scientific rationales
4
4
4
1,050B721
109
New product; unregistered source of active ingredient
6
6
6
2,200B722
110
New use and/or amendment to tolerance or tolerance exemption
6
6
6
2,200B730
111
Label amendment requiring data submission2
4
4
4
1,0501
                            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)**
EPA No.
CR No.
Action
Decision time (months)
FY 08 Registration Service Fee ($)FY 08
FY 09
FY 10B740
112
Experimental Use Permit application; registered active ingredient; non-food/feed or crop destruct basis; no SAP review required1
6
6
6
78,750B750
113
Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review required1
9
9
9
105,000( print page 61475)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
131,250B761
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
78,750B770
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
157,500B771
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
105,000B772
118
Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected
3
3
3
10,500B773
119
Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption
5
5
5
26,250B860
120
Amend Experimental Use Permit; first food use or major revision of experimental design
6
6
6
10,500B780
121
New active ingredient; non-food/feed; no SAP review required2
12
12
12
131,250B790
122
New active ingredient; Non-food/feed; SAP review required2
18
18
18
183,750B800
123
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no SAP review required2
12
12
12
210,000B810
124
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP review required2
18
18
18
262,500B820
125
New active ingredient; establish tolerance or tolerance exemption; no SAP review required2
15
15
15
262,500B840
126
New active ingredient; establish tolerance or tolerance exemption; SAP review required2
21
21
21
315,000B830
127
New active ingredient; Experimental Use Permit application submitted simultaneously; establish tolerance or tolerance exemption; no SAP review required2
15
15
15
315,000B850
128
New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2
21
21
21
367,500B851
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
105,000B852
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
157,500B870
131
New use1
9
9
9
31,500B880
132
New product; no SAP review required3
9
9
9
26,250( print page 61476)B881
133
New product; SAP review required3
15
15
15
78,750B890
134
Amendment; seed production to commercial registration; no SAP review required
9
9
9
52,500B891
135
Amendment; seed production to commercial registration; SAP review required
15
15
15
105,000B900
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
10,500B901
137
Amendment (except B890); SAP review required4
12
12
12
63,000B902
138
PIP Protocol review
3
3
3
5,250B903
139
Inert ingredient tolerance exemption; e.g., a marker such as NPT II; reviewed in BPPD
6
6
6
52,500B904
140
Import tolerance or tolerance exemption; processed commodities/food only
9
9
9
105,0001
                            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.
 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 at
                        *http://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 website
                        *www.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 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 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) and
                        *http://www.epa.gov/​pesticides/​fees/​questions/​waivers.htm.*
                         The fee waiver request should be easy to identify and separate 
                        ( print page 61477)
                        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. 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 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