Pesticides; Revised Fee Schedule for Registration Applications, 45438-45450 [E8-17936]
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[FR Doc. E8–17925 Filed 8–4–08; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0545; FRL–8375–9]
Pesticides; Revised Fee Schedule for
Registration Applications
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: EPA is publishing a revised
list of pesticide registration service fees
applicable to specified pesticide
applications and tolerance actions.
Under the Pesticide Registration
Improvement Renewal Act, the
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
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you have any questions regarding the
applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
periods for certain application
categories.
B. How Can I Get Copies of this
Document and Other Related
Information?
The publication of this fee schedule is
required by section 33(b)(6)(C) of FIFRA
as amended.
B. What is the Agency’s Authority for
Taking this Action?
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 https://
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
https://www.epa.gov/fedrgstr.
II. Background
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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
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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:
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• 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 ($)’’ lists the
registration service fee for the action for
fiscal year 2009 (October 1, 2008
through September 30, 2009) and fiscal
year 2010 (October 1, 2009 through
September 30, 2010).
2. The following acronyms are used in
some of the tables:
• DART–Dose Adequacy Response
Team
• DNT–Developmental Neurotoxicity
• HSRB–Human Studies Review
Board
• GW/SW–Ground Water/Surface
Water
• PHI–Pre-Harvest Interval
• PPE–Personal Protective Equipment
• REI–Restricted Entry Interval
• SAP–FIFRA Scientific Advisory
Panel
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IV. PRIRA Fee Schedule Tables—
Effective October 1, 2008
A. Registration Division (RD)
The Registration Division of OPP is
responsible for the processing of
pesticide applications and associated
tolerance petitions for pesticides that
are termed ‘‘conventional chemicals,’’
excluding pesticides intended for
antimicrobial uses. The term
‘‘conventional chemical’’ is a term of art
that is intended to distinguish synthetic
chemicals from those that are of
naturally occurring or non-synthetic
origin, synthetic chemicals that are
identical to naturally-occurring
chemicals and microbial pesticides.
Tables 1 through 5 of Unit IV.A. cover
RD actions.
TABLE 1.—REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
1
Food use1
24
24
542,115
R020
2
Food use; reduced risk1
18
18
542,115
R030
3
Food use; Experimental Use Permit application
submitted simultaneously with application for
registration; decision time for Experimental
Use Permit and temporary tolerance same as
#R0401
24
24
599,235
R040
4
Food use; Experimental Use Permit application;
establish temporary tolerance; submitted before application for registration; credit
$326,025 toward new active ingredient application that follows
18
18
399,525
R050
5
Food use; application submitted after Experimental Use Permit application; decision time
begins after Experimental Use Permit and temporary tolerance are granted1
14
14
199,815
R060
6
Non-food use; outdoor1
21
21
376,635
R070
7
Non-food use; outdoor; reduced risk1
16
16
376,635
R080
8
Non-food use; outdoor; Experimental Use Permit
application submitted simultaneously with application for registration; decision time for Experimental Use Permit same as #R0901
21
21
416,640
R090
9
Non-food use; outdoor; Experimental Use Permit
application submitted before application for
registration; credit $228,225 toward new active
ingredient application that follows
16
16
279,615
R100
10
Non-food use; outdoor; submitted after Experimental Use Permit application; decision time
begins after Experimental Use Permit is granted1
12
12
137,025
R110
11
Non-food use; indoor1
20
20
209,475
R120
12
Non-food use; indoor; reduced risk1
14
14
209,475
R121
13
Non-food use; indoor; Experimental Use Permit
application submitted before application for
registration; credit $100,000 toward new active
ingredient application that follows
18
18
157,500
R122
14
Enriched isomer(s) of registered mixed-isomer
active ingredient1
18
18
273,945
R123
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R010
15
Seed treatment only; includes non-food and food
uses; limited uptake into Raw Agricultural
Commodities1
18
18
407,610
R124
16
Conditional Ruling on Preapplication Study Waivers; applicant-initiated
6
6
2,184
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
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TABLE 2.—REGISTRATION DIVISION—NEW USES
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
R130
17
First food use; indoor; food/food handling1
21
21
165,375
R140
18
Additional food use; indoor; food/food handling
15
15
38,588
R150
19
First food use1
21
21
228,270
R160
20
First food use; reduced risk1
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 submitted in one
application
15
15
342,720
R200
24
Additional food uses; 6 or more submitted in one
application; reduced risk
10
10
342,720
R210
25
Additional food use; Experimental Use Permit
application; establish temporary tolerance; no
credit toward new use registration
12
12
42,315
R220
26
Additional food use; Experimental Use Permit
application; crop destruct basis; no credit toward new use registration
6
6
17,136
R230
27
Additional use; non-food; outdoor
15
15
22,827
R240
28
Additional use; non-food; outdoor; reduced risk
10
10
22,827
R250
29
Additional use; non-food; outdoor; Experimental
Use Permit application; no credit toward new
use registration
6
6
17,136
R260
30
New use; non-food; indoor
12
12
11,025
R270
31
New use; non-food; indoor; reduced risk
9
9
11,025
R271
32
New use; non-food; indoor; Experimental Use
Permit application; no credit toward new use
registration
6
6
8,400
R272
33
Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences,
Rapid Response review, DNT protocol review,
protocols needing HSRB review
3
3
2,184
R273
34
Additional use; seed treatment; limited uptake
into Raw Agricultural Commodities; includes
crops with established tolerances (e.g., for soil
or foliar application); includes food or non-food
uses
12
12
43,575
R274
35
Additional uses; seed treatment 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 nonfood uses
12
12
261,450
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1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
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TABLE 3.—REGISTRATION DIVISION—IMPORT AND OTHER TOLERANCES
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
R280
36
Establish import tolerance; new active ingredient
or first food use1
21
21
275,625
R290
37
Establish import tolerance; additional food use
15
15
55,125
R291
38
Establish import tolerances; additional food uses;
6 or more crops submitted in one petition
15
15
330,750
R292
39
Amend an established tolerance (e.g., decrease
or increase); domestic or import; applicant-initiated
10
10
39,165
R293
40
Establish tolerance(s) for inadvertent residues in
one crop; applicant-initiated
12
12
46,200
R294
41
Establish tolerances for inadvertent residues; 6
or more crops submitted in one application;
applicant-initiated
12
12
277,200
R295
42
Establish tolerance(s) for residues in one rotational crop in response to a specific rotational
crop application; applicant-initiated
15
15
57,120
R296
43
Establish tolerances for residues in rotational
crops in response to a specific rotational crop
petition; 6 or more crops submitted in one application; applicant-initiated
15
15
342,720
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 4.—REGISTRATION DIVISION—NEW PRODUCTS
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
44
New product; identical or substantially similar in
composition and use to a registered product;
no data review or only product chemistry data;
cite-all data citation, or selective data citation
where applicant owns all required data, or applicant submits specific authorization letter
from data owner. Category also includes 100%
re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
1,365
R301
45
New product; identical or substantially similar in
composition and use to a registered product;
registered source of active ingredient; selective
data citation only for data on product chemistry
and/or acute toxicity and/or public health pest
efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner.
4
4
1,638
R310
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R300
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
4,578
R311
49
New product; requires approval of new food-use
inert; applicant-initiated; excludes approval of
safeners
12
12
16,317
R312
50
New product; requires approval of new non-fooduse inert; applicant-initiated
6
6
8,715
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TABLE 4.—REGISTRATION DIVISION—NEW PRODUCTS—Continued
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
R313
51
New product; requires amendment to existing
inert tolerance exemption (e.g., adding postharvest use); applicant-initiated
10
10
11,991
R320
47
New product; new physical form; requires data
review in science divisions
12
12
11,424
R330
48
New manufacturing-use product; registered active ingredient; selective data citation
12
12
17,136
R331
52
New product; repack of identical registered enduse product as a manufacturing-use product;
same registered uses only
3
3
2,184
R332
53
New manufacturing-use product; registered active ingredient; unregistered source of active
ingredient; submission of completely new generic data package; registered uses only
24
24
244,650
TABLE 5.—REGISTRATION DIVISION—AMENDMENTS TO REGISTRATION
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
R340
54
Amendment requiring data review within RD
(e.g., changes to precautionary label statements, or source changes to an unregistered
source of active ingredient)1
4
4
3,444
R350
55
Amendment requiring data review in science divisions (e.g., changes to REI, or PPE, or PHI, or
use rate, or number of applications; or add
aerial application; or modify GW/SW advisory
statement)1
8
8
11,424
R370
56
Cancer reassessment; applicant-initiated
18
18
171,255
R371
57
Amendment to Experimental Use Permit; requires data review/risk assessment
6
6
8,715
R372
58
Refined ecological and/or endangered species
assessment; applicant-initiated
18
12
163,065
1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is
responsible for the processing of
pesticide applications and associated
tolerances for conventional chemicals
intended for antimicrobial uses, that is,
uses that are defined under FIFRA
section 2(mm)(1)(A), including products
for use against bacteria, protozoa, nonagricultural fungi, and viruses. AD is
also responsible for a selected set of
conventional chemicals intended for
other uses, including most wood
preservatives and antifoulants. Tables 6
through 8 of Unit IV.B. cover AD
actions.
TABLE 6.—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS
Decision time (months)
EPA No.
CR No.
FY 09
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FY 09/FY 10
Registration
Service Fee ($)
Action
FY 10
A380
59
Food use; establish tolerance exemption1
24
24
99,225
A390
60
Food use; establish tolerance1
24
24
165,375
A400
61
Non-food use; outdoor; FIFRA section 2(mm)
uses1
18
18
82,688
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TABLE 6.—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS—Continued
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
A410
62
Non-food use; outdoor; uses other than FIFRA
section 2(mm)1
21
21
165,375
A420
63
Non-food use; indoor; FIFRA section 2(mm)
uses1
18
18
55,125
A430
64
Non-food use; indoor; uses other than FIFRA
section 2(mm)1
20
20
82,688
A431
65
Non-food use; indoor; low-risk and low-toxicity
food-grade active ingredient(s); efficacy testing
for public health claims required under GLP
and following DIS/TSS or AD-approved study
protocol
12
12
57,750
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 7.—ANTIMICROBIALS DIVISION—NEW USES
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
A440
66
First food use; establish tolerance exemption1
21
21
27,563
A450
67
First food use; establish tolerance1
21
21
82,688
A460
68
Additional food use; establish tolerance exemption
15
15
11,025
A470
69
Additional food use; establish tolerance
15
15
27,563
A480
70
Additional use; non-food; outdoor; FIFRA section
2(mm) uses
9
9
16,538
A490
71
Additional use; non-food; outdoor; uses other
than FIFRA section 2(mm)
15
15
27,563
A500
72
Additional use; non-food; indoor; FIFRA section
2(mm) uses
9
9
11,025
A510
73
Additional use; non-food; indoor; uses other than
FIFRA section 2(mm)
12
12
11,025
A520
74
Experimental Use Permit application
9
9
5,513
A521
75
Review of public health efficacy study protocol
within AD; per AD Internal Guidance for the
Efficacy Protocol Review Process; applicantinitiated; Tier 1
4
3
2,100
A522
76
Review of public health efficacy study protocol
outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated;
Tier 2
15
12
10,500
dwashington3 on PRODPC61 with NOTICES
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
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TABLE 8.—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
A530
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
1,103
A531
78
New product; identical or substantially similar in
composition and use to a registered product;
registered source of active ingredient; selective
data citation only for data on product chemistry
and/or acute toxicity and/or public health pest
efficacy, where applicant does not own all required data and does not have a specific authorization letter from data owner
4
4
1,575
A532
85
New product; identical or substantially similar in
composition and use to a registered product;
registered active ingredient; unregistered
source of active ingredient; cite-all data citation
except for product chemistry; product chemistry data submitted
4
4
4,410
A540
79
New end-use product; FIFRA section 2(mm)
uses only
4
4
4,410
A550
80
New end-use product; uses other than FIFRA
section 2(mm); non-FQPA product
6
6
4,410
A560
81
New manufacturing-use product; registered active ingredient; selective data citation
12
12
16,538
A570
82
Label amendment requiring data submission1
4
4
3,308
A571
83
Cancer reassessment; applicant-initiated
18
18
82,688
A572
84
Refined ecological risk and/or endangered species assessment; applicant-initiated
18
12
78,750
1EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
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)
EPA No.
CR No.
FY 09
dwashington3 on PRODPC61 with NOTICES
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 10
B580
86
New active ingredient; food use; establish tolerance1
18
18
44,100
B590
87
New active ingredient; food use; establish tolerance exemption1
16
16
27,563
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TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS AND AMENDMENTS—Continued
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
B600
88
New active ingredient; non-food use1
B610
89
B620
FY 10
12
16,538
Food use; Experimental Use Permit application;
establish temporary tolerance exemption
9
9
11,025
90
Non-food use; Experimental Use Permit application
6
6
5,513
B621
91
Extend or amend Experimental Use Permit
6
6
4,410
B630
92
First food use; establish tolerance exemption
12
12
11,025
B631
93
Amend established tolerance exemption
9
9
11,025
B640
94
First food use; establish tolerance1
18
18
16,538
B641
95
Amend established tolerance (e.g., decrease or
increase)
12
12
11,025
B650
96
New use; non-food
6
6
5,513
B660
97
New product; identical or substantially similar in
composition and use to a registered product;
no data review or only product chemistry data;
cite-all data citation, or selective data citation
where applicant owns all required data, or applicant submits specific authorization letter
from data owner. Category also includes 100%
re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
1,103
B670
98
New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with productspecific data or with request for data waivers
supported by scientific rationales
6
6
4,410
B671
99
New product; food use; unregistered source of
active ingredient; requires amendment of established tolerance or tolerance exemption; all
Tier I data requirements for product chemistry,
toxicology, non-target organisms, and product
performance must be addressed with productspecific data or with request for data waivers
supported by scientific rationales
16
16
11,025
B672
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
7,875
B680
101
Label amendment requiring data submission2
4
4
4,410
B681
dwashington3 on PRODPC61 with NOTICES
12
102
Label amendment; unregistered source of active
ingredient; supporting data require scientific review
6
6
5,250
B682
103
Protocol review; applicant-initiated; excludes time
for HSRB review (pre-application)
3
3
2,100
1All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
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2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 10.—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES
(SCLPS)
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
B690
104
New active ingredient; food or non-food use1
6
6
2,205
B700
105
Experimental Use Permit application; new active
ingredient or new use
6
6
1,103
B701
106
Extend or amend Experimental Use Permit
3
3
1,103
B710
107
New product; identical or substantially similar in
composition and use to a registered product;
no data review or only product chemistry data;
cite-all data citation, or selective data citation
where applicant owns all required data, or applicant submits specific authorization letter
from data owner. Category also includes 100%
re-package of registered end-use or manufacturing-use product that requires no data submission nor data matrix.
3
3
1,103
B720
108
New product; registered source of active ingredient; all Tier I data for product chemistry, toxicology, non-target organisms, and product performance must be addressed with product
specific data or with request for data waivers
supported by scientific rationales
4
4
1,103
B721
109
New product; unregistered source of active ingredient
6
6
2,310
B722
110
New use and/or amendment to tolerance or tolerance exemption
6
6
2,310
B730
111
Label amendment requiring data submission2
4
4
1,103
1All
uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
112
Experimental Use Permit application; registered
active ingredient; non-food/feed or crop destruct basis; no SAP review required1
6
6
82,688
B750
113
Experimental Use Permit application; registered
active ingredient; establish temporary tolerance or tolerance exemption; no SAP review
required1
9
9
110,250
B760
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B740
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
137,813
B761
115
Experimental Use Permit application; new active
ingredient; non-food/feed or crop destruct; no
SAP review required; credit $78,750 toward
new active ingredient application that follows
7
7
82,688
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TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)—
Continued
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
FY 10
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
165,375
B771
117
Experimental Use Permit application; new active
ingredient; establish temporary tolerance or
tolerance exemption; no SAP review required;
credit $105,000 toward new active ingredient
application that follows
10
10
110,250
B772
118
Amend or extend Experimental Use Permit;
minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected
3
3
11,025
B773
119
Amend or extend existing Experimental Use Permit; minor changes to experimental design; extend established temporary tolerance or tolerance exemption
5
5
27,563
B860
120
Amend Experimental Use Permit; first food use
or major revision of experimental design
6
6
11,025
B780
121
New active ingredient; non-food/feed; no SAP review required2
12
12
137,813
B790
122
New active ingredient; Non-food/feed; SAP review required2
18
18
192,938
B800
123
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no
SAP review required2
12
12
220,500
B810
124
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP
review required2
18
18
275,625
B820
125
New active ingredient; establish tolerance or tolerance exemption; no SAP review required2
15
15
275,625
B840
126
New active ingredient; establish tolerance or tolerance exemption; SAP review required2
21
21
330,750
B830
127
New active ingredient; Experimental Use Permit
application submitted simultaneously; establish
tolerance or tolerance exemption; no SAP review required2
15
15
330,750
B850
128
New active ingredient; Experimental Use Permit
requested simultaneously; establish tolerance
or tolerance exemption; SAP review required2
21
21
385,875
B851
129
New active ingredient; different genetic event of
a previously approved active ingredient; same
crop; no tolerance action required; no SAP review required
9
9
110,250
B852
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B770
130
New active ingredient; different genetic event of
a previously approved active ingredient; same
crop; no tolerance action required; SAP review
required
9
9
165,375
B870
131
New use1
9
9
33,075
B880
132
New product; no SAP review required3
9
9
27,563
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TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)—
Continued
Decision time (months)
EPA No.
CR No.
FY 09/FY 10
Registration
Service Fee ($)
Action
FY 09
B881
133
New product; SAP review required3
B890
134
B891
FY 10
15
15
82,688
Amendment; seed production to commercial registration; no SAP review required
9
9
55,125
135
Amendment; seed production to commercial registration; SAP review required
15
15
110,250
B900
136
Amendment (except #B890); no SAP review required; (e.g., new IRM requirements that are
applicant-initiated; or amending a conditional
registration to extend the registration expiration
date with additional data submitted) 4
6
6
11,025
B901
137
Amendment (except #B890); SAP review required4
12
12
66,150
B902
138
PIP protocol review
3
3
5,513
B903
139
Inert ingredient tolerance exemption; e.g., a
marker such as NPT II; reviewed in BPPD
6
6
55,125
B904
140
Import tolerance or tolerance exemption; processed commodities/food only
9
9
110,250
1Example:
Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial
registration is obtained using B890.
3Example: Stacking PIP traits within a crop using traditional breeding techniques.
4EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
2May
dwashington3 on PRODPC61 with NOTICES
V. How to Pay Fees
Applicants must submit fee payments
at the time of application, and EPA will
reject any application that does not
contain evidence that the fee has been
paid. EPA has developed a web site at
https://www.epa.gov/pesticides/fees/
tool/index.htm to help applicants
identify the fee category and the fee. All
fees should be rounded up to the whole
dollar. Payments may be made by check,
bank draft, or money order or online
with a credit card or wire transfer.
A. Online
You may pay electronically through
the government payment 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 ‘‘Prepayment of Pesticide Registration
Improvement Act Fee.’’
6. Complete the form entering the
PRIA fee category and fee.
7. Keep a copy of the pay.gov
acknowledgement of payment. A copy
of the acknowledgement must be
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14:19 Aug 04, 2008
Jkt 214001
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.
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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
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in FIFRA section 33(b)(7) and https://
www.epa.gov/pesticides/fees/questions/
waivers.htm. The fee waiver request
should be easy to identify and separate
from the rest of the application and
submitted with documentation that at
least 25% of the fee has been paid.
If evidence of fee payment (electronic
acknowledgement or copy of check
properly identified as to company) is
not submitted with the application, EPA
will reject the application and will not
process it further.
After EPA receives an application and
payment, EPA performs a screen on the
application to determine that the
category is correct and that the proper
fee amount has been paid. If either is
incorrect, EPA will notify the applicant
and require payment of any additional
amount due. A refund will be provided
in case of an overpayment. EPA will not
process the application further until the
proper fee has been paid for the category
of application or a request for a fee
waiver accompanies the application and
the appropriate portion of the fee has
been paid.
EPA will assign a unique
identification number to each covered
application for which payment has been
made. EPA notifies the applicant of the
unique identification number. This
information is sent by e-mail if EPA has
either an e-mail address on file or an email address is provided on the
application.
dwashington3 on PRODPC61 with NOTICES
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.
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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
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPA–2008–0563 FRL–8701–1]
Relocation of National Oil and
Hazardous Substance Pollution
Contingency Plan, Subpart J
Confidential Business Information
Files
Environmental Protection
Agency.
ACTION: Notice of Availability.
AGENCY:
SUMMARY: The Environmental Protection
Agency (EPA) Office of Solid Waste and
Emergency Response, Office of
Emergency Management announces that
the Confidential Business Information
(CBI) for products listed on the National
Oil and Hazardous Substance Pollution
Contingency Plan, under 40 CFR 300,
Subpart J will be moved to a new
contractor’s office location. System
Research and Applications Corporation
(SRA) was awarded the new contract to
support work on 40 CFR 300, Subpart J.
The CBI files will be moved from the
Computer Sciences Corporation (CSC)
office in Alexandria, VA to SRA’s office
in Arlington, VA.
DATES: Comments must be received on
or before August 11, 2008. The CBI files
will be moved from the Computer
Sciences Corporation (CSC) office in
Alexandria, VA to SRA’s office in
Arlington, VA on Tuesday, August 12,
2008.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OPA–2008–0563 by one of the following
methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comment.
• Mail: The mailing address of the
docket for this rule making is the EPA
Docket Center (EPA/DC), Docket ID No.
EPA–HQ–OPA–2008–0563, EPA West,
Room 3334, 1301 Constitution Ave.,
NW., Washington, DC 20460.
• Hand Delivery: Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OPA–2008–
0563. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
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made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or
superfund.docket@epa.gov. The https://
www.regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy
form at the EPA Docket Center, EPA/DC,
EPA West, Room 3334, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the EPA
Docket Center, EPA/DC is (202) 566–
0276.
FOR FURTHER INFORMATION CONTACT:
Leigh DeHaven, Office of Solid Waste
and Emergency Response, Office of
Emergency Management (5104A),
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45438-45450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17936]
-----------------------------------------------------------------------
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 https://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 https://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
