Pesticides; Revised Fee Schedule for Registration Applications, 48672-48683 [2010-19720]
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48672
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
TABLE 2. —REGISTRANTS OF
CANCELLED PRODUCTS
EPA Co. Number
TABLE 2. —REGISTRANTS OF
CANCELLED PRODUCTS—Continued
Company Name and
Address
4
Bonide Products,
Inc.
Agent Registrations
By Design, Inc.
PO Box 1019
Salem, VA 24153–
3805
279
FMC Corp. Agricultural Products
Group
1735 Market St, RM
1978
Philadelphia, PA
19103
655
Prentiss, INC.
3600 Mansell Rd,
Suite 350
Alpharetta, GA
30022
Buhach Company
14336 SE 84 CT
Newcastle, WA
98059
2517
Sergeant’s Pet Care
Products, Inc.
2625 South 158th
Plaza
Omaha, NE 68130–
1703
4822
S.C. Johnson and
Son, Inc.
1525 Howe St.
Racine, WI 53403
8536
8660
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9816
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Soil Chemicals Corporation
P.O, Box 782
Hollister, CA 95024
Fiebing Company,
Inc.
P.O, Box 694
Milwaukee, WI
53201–0694
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Church and Dwight
Co. Inc.
469 North Harrison
St.
Princeton, NJ
08543–5297
13799
Four Paws Products
Ltd.
50 Wireless Boulevard
Hauppauge, NY
11788
35138
AeroChem
1396 Lee Lane
Raymond, MS
39154
During the public comment period
provided, EPA received no comments in
response to the January 26, 2010
Federal Register notice announcing the
Agency’s receipt of the requests for
voluntary cancellations of products
listed in Table 1 of Unit II. The request
for the voluntary cancellation of product
66330–220 was withdrawn by the
registrant.
IV. Cancellation Order
CP Aeroscience,
Inc.
P.O. BOX 667770
Pompano Beach, FL
33066
United Industries
Corp.
d/b/a Sylorr Plant
Corp
P.O, Box 14642
St. Louis, MO
63114–0642
Company Name and
Address
III. Summary of Public Comments
Received and Agency Response to
Comments
703
7405
EPA Co. Number
Pursuant to FIFRA section 6(f), EPA
hereby approves the requested
cancellations of the registrations
identified in Table 1 of Unit II.
Accordingly, the Agency hereby orders
that the product registrations identified
in Table 1 of Unit II. are canceled. The
effective date of the cancellations that
are subject of this notice is August 11,
2010. Any distribution, sale, or use of
existing stocks of the products
identified in Table 1 of Unit II. in a
manner inconsistent with any of the
provisions for disposition of existing
stocks set forth in Unit VI. will be a
violation of FIFRA.
V. What is the Agency’s Authority for
Taking this Action?
Section 6(f)(1) of FIFRA provides that
a registrant of a pesticide product may
at any time request that any of its
pesticide registrations be canceled or
amended to terminate one or more uses.
FIFRA further provides that, before
acting on the request, EPA must publish
a notice of receipt of any such request
in the Federal Register. Thereafter,
following the public comment period,
the EPA Administrator may approve
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such a request. The notice of receipt for
this action was published for comment
in the Federal Register of January 26,
2010 (75 FR 4072) (FRL–8808–2). The
comment period closed on July 26,
2010.
VI. Provisions for Disposition of
Existing Stocks
Existing stocks are those stocks of
registered pesticide products which are
currently in the United States and
which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
The existing stocks provisions for the
products subject to this order are as
follows.
The registrants may continue to sell
and distribute existing stocks of
products listed in Table 1 of Unit II.
until August 11, 2011, which is 1 year
after the publication of the Cancellation
Order in the Federal Register
Thereafter, the registrants are prohibited
from selling or distributing products
listed in Table 1, except for export in
accordance with FIFRA section 17, or
proper disposal. Persons other than the
registrants may sell, distribute, or use
existing stocks of products listed in
Table 1 of Unit II. until existing stocks
are exhausted, provided that such sale,
distribution, or use is consistent with
the terms of the previously approved
labeling on, or that accompanied, the
canceled products.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: August 2, 2010.
Richard P. Keigwin, Jr.
Director, Pesticide Re-evaluation Division,
Office of Pesticide Programs.
[FR Doc. 2010–19575 Filed 8–10–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2010–0599; FRL–8840–7]
Pesticides; Revised Fee Schedule for
Registration Applications
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
EPA is publishing a revised
list of pesticide registration service fees
applicable to specified pesticide
applications and tolerance actions. In
accordance with the Pesticide
Registration Improvement Renewal Act,
the registration service fees for covered
pesticide registration applications
received on or after October 1, 2010,
SUMMARY:
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will increase by 5 percent, rounded up
to the nearest dollar amount, from the
fees published for fiscal years 2009 and
2010. The new fees become effective on
October 1, 2010.
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
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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
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?
EPA has established a docket for this
action under docket identification (ID)
number EPA–HQ–OPP–2010–0599.
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
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from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
II. Background
A. What Action is the Agency Taking?
The Pesticide Registration
Improvement Act of 2003 (PRIA),
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)(B) of FIFRA, the registration
service fees for covered pesticide
registration applications received on or
after October 1, 2010, will increase by
5 percent, rounded up to the nearest
dollar amount, from the fees published
in the August 5, 2008, Federal Register
Notice (73 FR 45438).
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
(Divisions) of the Office of Pesticide
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48673
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 2011 and 2012 as these are
the only applicable review periods for
applications received on or after
October 1, 2010. 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.’’ crossreferences the current Congressional
Record category number for
convenience. However, EPA will be
using the categories as numbered in the
‘‘EPA No.’’ column in its tracking
systems.
• The column 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
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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
2011 and 2012. 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 11/12
Registration Service Fee ($)’’ lists the
registration service fee for the action for
fiscal year 2010 (October 1, 2010
through September 30, 2011) and fiscal
year 2011 (October 1, 2011 through
September 30, 2012).
2. The following acronyms are used in
some of the tables:
• DART = Dose Adequacy Response
Team
• DNT = Developmental Neurotoxicity
• GW/SW = Ground Water/Surface
Water
• HSRB = Human Studies Review
Board
• PHI = Pre-Harvest Interval
• PPE = Personal Protective
Equipment
• REI = Restricted Entry Interval
• SAP = FIFRA Scientific Advisory
Panel
IV. PRIRA Fee Schedule Tables—
Effective October 1, 2010
tolerance petitions for pesticides that
are termed ‘‘conventional chemicals,’’
excluding pesticides intended for
antimicrobial uses. The term
‘‘conventional chemical’’ is a term of art
that is intended to distinguish synthetic
chemicals from those that are of
naturally occurring or non-synthetic
origin, synthetic chemicals that are
identical to naturally-occurring
chemicals and microbial pesticides.
Tables 1 through 5 of Unit V.A. cover
RD actions.
A. Registration Division
The Registration Division of OPP is
responsible for the processing of
pesticide applications and associated
TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
1
Food use1
24
569,221
R020
2
Food use; reduced risk1
18
569,221
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
629,197
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
419,502
R050
5
Food use; application submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit and
temporary tolerance are granted1
14
209,806
R060
6
Non-food use; outdoor1
21
395,467
R070
7
Non-food use; outdoor; reduced risk1
16
395,467
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
437,472
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
293,596
R100
10
Non-food use; outdoor; submitted after Experimental Use Permit application; decision time begins after Experimental Use Permit is
granted1
12
143,877
R110
11
Non-food use; indoor1
20
219,949
R120
12
Non-food use; indoor; reduced risk1
14
219,949
R121
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R010
13
Non-food use; indoor; Experimental Use Permit application submitted
before application for registration; credit $100,000 toward new active ingredient application that follows
18
165,375
R122
14
Enriched isomer(s) of registered mixed-isomer active ingredient1
18
287,643
R123
15
Seed treatment only; includes non-food and food uses; limited uptake
into Raw Agricultural Commodities1
18
427,991
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TABLE 1.–REGISTRATION DIVISION—NEW ACTIVE INGREDIENTS—Continued
EPA No.
CR No.
R124
Decision
Time
(months)
FY 11/12
Action
16
Conditional Ruling on Preapplication Study Waivers; applicant-initiated
FY 11/12
Registration
Service Fee
($)
6
2,294
1 All
uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 2.—REGISTRATION DIVISION—NEW USES
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
17
First food use; indoor; food/food handling1
21
173,644
R140
18
Additional food use; Indoor; food/food handling
15
40,518
R150
19
First food use1
21
239,684
R160
20
First food use; reduced risk1
16
239,684
R170
21
Additional food use
15
59,976
R180
22
Additional food use; reduced risk
10
59,976
R190
23
Additional food uses; 6 or more submitted in one application
15
359,856
R200
24
Additional food uses; 6 or more submitted in one application; reduced
risk
10
359,856
R210
25
Additional food use; Experimental Use Permit application; establish
temporary tolerance; no credit toward new use registration
12
44,431
R220
26
Additional food use; Experimental Use Permit application; crop destruct basis; no credit toward new use registration
6
17,993
R230
27
Additional use; non-food; outdoor
15
23,969
R240
28
Additional use; non-food; outdoor; reduced risk
10
23,969
R250
29
Additional use; non-food; outdoor; Experimental Use Permit application; no credit toward new use registration
6
17,993
R260
30
New use; non-food; indoor
12
11,577
R270
31
New use; non-food; indoor; reduced risk
9
11,577
R271
32
New use; non-food; indoor; Experimental Use Permit application; no
credit toward new use registration
6
8,820
R272
33
Review of Study Protocol; applicant-initiated; excludes DART, pre-registration conferences, Rapid Response review, DNT protocol review, protocols needing HSRB review
3
2,294
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
45,754
R274
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R130
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 non-food uses
12
274,523
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.
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TABLE 3.—REGISTRATION DIVISION—IMPORT AND OTHER TOLERANCES
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
R280
36
Establish import tolerance; new active ingredient or first food use1
21
289,407
R290
37
Establish import tolerance; additional food use
15
57,882
R291
38
Establish import tolerances; additional food uses; 6 or more crops
submitted in one petition
15
347,288
R292
39
Amend an established tolerance (e.g., decrease or increase); domestic or import; applicant-initiated
10
41,124
R293
40
Establish tolerance(s) for inadvertent residues in one crop; applicantinitiated
12
48,510
R294
41
Establish tolerances for inadvertent residues; 6 or more crops submitted in one application; applicant-initiated
12
291,060
R295
42
Establish tolerance(s) for residues in one rotational crop in response
to a specific rotational crop application; applicant-initiated
15
59,976
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
359,856
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
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
44
New product; identical or substantially similar in composition and use
to a registered product; no data review or only product chemistry
data; cite-all data citation, or selective data citation where applicant
owns all required data, or applicant submits specific authorization
letter from data owner. Category also includes 100% re-package of
registered end-use or manufacturing-use product that requires no
data submission nor data matrix.
3
1,434
R301
45
New product; identical or substantially similar in composition and use
to a registered product; registered source of active ingredient; selective data citation only for data on product chemistry and/or acute
toxicity and/or public health pest efficacy, where applicant does not
own all required data and does not have a specific authorization letter from data owner.
4
1,720
R310
46
New end-use or manufacturing-use product; requires review of data
package within RD; includes reviews and/or waivers of data for
only: Product chemistry and/or Acute toxicity and/or Public health
pest efficacy
6
4,807
R311
49
New product; requires approval of new food-use inert; applicant-initiated; excludes approval of safeners
12
17,133
R312
50
New product; requires approval of new non-food-use inert; applicantinitiated
6
9,151
R313
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R300
51
New product; requires amendment to existing inert tolerance exemption (e.g., adding post-harvest use); applicant-initiated
10
12,591
R320
47
New product; new physical form; requires data review in science divisions
12
11,996
R330
48
New manufacturing-use product; registered active ingredient; selective
data citation
12
17,993
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TABLE 4.—REGISTRATION DIVISION—NEW PRODUCTS—Continued
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
R331
52
New product; repack of identical registered end-use product as a
manufacturing-use product; same registered uses only
3
2,294
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
256,883
Decision
Time
(months)
FY 11/12
FY 11/12
Registration
Service Fee
($)
TABLE 5.—REGISTRATION DIVISION—AMENDMENTS TO REGISTRATION
EPA No.
CR No.
Action
R340
54
Amendment requiring data review within RD (e.g., changes to precautionary label statements, or source changes to an unregistered
source of active ingredient)1
4
3,617
R350
55
Amendment requiring data review in science divisions (e.g., changes
to REI, or PPE, or PHI, or use rate, or number of applications; or
add aerial application; or modify GW/SW advisory statement)1
8
11,996
R370
56
Cancer reassessment; applicant-initiated
18
179,818
R371
57
Amendment to Experimental Use Permit; requires data review / risk
assessment
6
9,151
R372
58
Refined ecological and/or endangered species assessment; applicantinitiated
12
171,219
1 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
B. Antimicrobials Division
The Antimicrobials Division of OPP is
responsible for the processing of
pesticide applications and associated
tolerances for conventional chemicals
intended for antimicrobial uses, that is,
uses that are defined under FIFRA
section 2(mm)(1)(A), including products
for use against bacteria, protozoa, nonagricultural fungi, and viruses. AD is
also responsible for a selected set of
conventional chemicals intended for
other uses, including most wood
preservatives and antifoulants. Tables 6
through 8 of Unit V.B. cover AD actions.
TABLE 6.—ANTIMICROBIALS DIVISION—NEW ACTIVE INGREDIENTS
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
59
Food use; establish tolerance exemption1
24
104,187
A390
60
Food use; establish tolerance1
24
173,644
A400
61
Non-food use; outdoor; FIFRA section 2(mm) uses1
18
86,823
A410
62
Non-food use; outdoor; uses other than FIFRA section 2(mm)1
21
173,644
A420
63
Non-food use; indoor; FIFRA section 2(mm) uses1
18
57,882
A430
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A380
64
Non-food use; indoor; uses other than FIFRA section 2(mm)1
20
86,823
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
60,638
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.
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TABLE 7.—ANTIMICROBIALS DIVISION—NEW USES
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
A440
66
First food use; establish tolerance exemption1
21
28,942
A450
67
First food use; establish tolerance1
21
86,823
A460
68
Additional food use; establish tolerance exemption
15
11,577
A470
69
Additional food use; establish tolerance
15
28,942
A480
70
Additional use; non-food; outdoor; FIFRA section 2(mm) uses
9
17,365
A490
71
Additional use; non-food; outdoor; uses other than FIFRA section
2(mm)
15
28,942
A500
72
Additional use; non-food; indoor; FIFRA section 2(mm) uses
9
11,577
A510
73
Additional use; non-food; indoor; uses other than FIFRA section
2(mm)
12
11,577
A520
74
Experimental Use Permit application
9
5,789
A521
75
Review of public health efficacy study protocol within AD; per AD Internal Guidance for the Efficacy Protocol Review Process; applicant-initiated; Tier 1
3
2,205
A522
76
Review of public health efficacy study protocol outside AD by members of AD Efficacy Protocol Review Expert Panel; applicant-initiated; Tier 2
12
11,025
1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
TABLE 8.—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
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
1,159
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
1,654
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
4,631
A540
79
New end use product; FIFRA section 2(mm) uses only
4
4,631
A550
sroberts on DSKD5P82C1PROD with NOTICES
A530
80
New end-use product; uses other than FIFRA section 2(mm); nonFQPA product
6
4,631
A560
81
New manufacturing-use product; registered active ingredient; selective
data citation
12
17,365
A570
82
Label amendment requiring data submission1
4
3,474
A571
83
Cancer reassessment; applicant-initiated
18
86,823
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TABLE 8.—ANTIMICROBIALS DIVISION—NEW PRODUCTS AND AMENDMENTS—Continued
EPA No.
CR No.
A572
Decision
Time
(months)
FY 11/12
Action
84
Refined ecological risk and/or endangered species assessment; applicant-initiated
FY 11/12
Registration
Service Fee
($)
12
82,688
1 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
C. Biopesticides and Pollution
Prevention Division
The Biopesticides and Pollution
Prevention Division of OPP is
responsible for the processing of
pesticide applications for biochemical
pesticides, microbial pesticides, and
plant-incorporated protectants (PIPs).
The fee tables for BPPD actions are
presented by type of pesticide rather
than by type of action: Table 9—
Microbial and biochemical pesticides;
Table 10—straight chain lepidopteran
pheromones (SCLPs), and Table 11—
PIPs. Within each table, the types of
application are the same as those in
other divisions and use the same
terminology as in Unit III.
TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS AND AMENDMENTS
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
86
New active ingredient; food use; establish tolerance1
18
46,305
B590
87
New active ingredient; food use; establish tolerance exemption1
16
28,942
B600
88
New active ingredient; non-food use1
12
17,365
B610
89
Food use; Experimental Use Permit application; establish temporary
tolerance exemption
9
11,577
B620
90
Non-food use; Experimental Use Permit application
6
5,789
B621
91
Extend or amend Experimental Use Permit
6
4,631
B630
92
First food use; establish tolerance exemption
12
11,577
B631
93
Amend established tolerance exemption
9
11,577
B640
94
First food use; establish tolerance1
18
17,365
B641
95
Amend established tolerance (e.g., decrease or increase)
12
11,577
B650
96
New use; non-food
6
5,789
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
1,159
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 product specific data or with
request for data waivers supported by scientific rationales
6
4,631
B671
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B580
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, nontarget organisms, and product performance must be addressed with
product-specific data or with request for data waivers supported by
scientific rationales
16
11,577
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TABLE 9.—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—MICROBIAL AND BIOCHEMICAL PESTICIDES; NEW
PRODUCTS AND AMENDMENTS—Continued
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
12
8,269
B672
100
New product; non-food use or food use having established tolerance
or tolerance exemption; unregistered source of active ingredient; no
data compensation issues; all Tier I data requirements for product
chemistry, toxicology, non-target organisms, and product performance must be addressed with product-specific data or with request
for data waivers supported by scientific rationales
B680
101
Label amendment requiring data submission2
4
4,631
B681
102
Label amendment; unregistered source of active ingredient; supporting data require scientific review
6
5,513
B682
103
Protocol review; applicant-initiated; excludes time for HSRB review
(pre application)
3
2,205
1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
TABLE 10.—BIOPESTICIDES AND POLLUTION PREVENTION DIVISION—STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES
(SCLPS)
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
B690
104
New active ingredient; food or non-food use1
6
2,316
B700
105
Experimental Use Permit application; new active ingredient or new
use
6
1,159
B701
106
Extend or amend Experimental Use Permit
3
1,159
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
1,159
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
1,159
B721
109
New product; unregistered source of active ingredient
6
2,426
B722
110
New use and/or amendment to tolerance or tolerance exemption
6
2,426
B730
111
Label amendment requiring data submission2
4
1,159
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1 All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.
2 EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed
within the FIFRA stated timelines listed in Section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR
Notices, such as PR Notice 95–2 and PR Notice 98–10, continue under PR Notice timelines and are not subject to PRIA fees.
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TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)
EPA No.
CR No.
Decision
Time
(months)
FY 11/12
Action
FY 11/12
Registration
Service Fee
($)
112
Experimental Use Permit application; registered active ingredient;
non-food/feed or crop destruct basis; no SAP review required1
6
86,823
B750
113
Experimental Use Permit application; registered active ingredient; establish temporary tolerance or tolerance exemption; no SAP review
required1
9
115,763
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
144,704
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
86,823
B770
116
Experimental Use Permit application; new active ingredient; establish
temporary tolerance or tolerance exemption; SAP review required;
credit $105,000 toward new active ingredient application that follows
15
173,644
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
115,763
B772
118
Amend or extend Experimental Use Permit; minor changes to experimental design; established temporary tolerance or tolerance exemption is unaffected
3
11,577
B773
119
Amend or extend existing Experimental Use Permit; minor changes to
experimental design; extend established temporary tolerance or tolerance exemption
5
28,942
B860
120
Amend Experimental Use Permit; first food use or major revision of
experimental design
6
11,577
B780
121
New active ingredient; non-food/feed; no SAP review required2
12
144,704
B790
122
New active ingredient; Non-food/feed; SAP review required2
18
202,585
B800
123
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; no
SAP review required2
12
231,525
B810
124
New active ingredient; establish permanent tolerance or tolerance exemption based on temporary tolerance or tolerance exemption; SAP
review required2
18
289,407
B820
125
New active ingredient; establish tolerance or tolerance exemption; no
SAP review required2
15
289,407
B840
126
New active ingredient; establish tolerance or tolerance exemption;
SAP review required2
21
347,288
B830
127
New active ingredient; Experimental Use Permit application submitted
simultaneously; establish tolerance or tolerance exemption; no SAP
review required2
15
347,288
B850
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B740
128
New active ingredient; Experimental Use Permit requested simultaneously; establish tolerance or tolerance exemption; SAP review required2
21
405,169
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
115,763
B852
130
New active ingredient; different genetic event of a previously approved active ingredient; same crop; no tolerance action required;
SAP review required
9
173,644
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TABLE 11.—BIOPESTICIDE AND POLLUTION PREVENTION DIVISION—PLANT INCORPORATED PROTECTANTS (PIPS)—
Continued
EPA No.
Decision
Time
(months)
FY 11/12
131
New use1
B880
132
New product; no SAP review required3
required3
28,942
15
B870
34,729
9
Action
FY 11/12
Registration
Service Fee
($)
9
CR No.
86,823
B881
133
New product; SAP review
B890
134
Amendment; seed production to commercial registration; no SAP review required
9
57,882
B891
135
Amendment; seed production to commercial registration; SAP review
required
15
115,763
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
11,577
B901
137
Amendment (except #B890); SAP review required4
12
69,458
B902
138
PIP Protocol review
3
5,789
B903
139
Inert ingredient tolerance exemption; e.g., a marker such as NPT II;
reviewed in BPPD
6
57,882
B904
140
Import tolerance or tolerance exemption; processed commodities/food
only
9
115,763
1 Example:
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.
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.
2 May
V. How to Pay Fees
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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. The 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 nearest
whole dollar. Payments may be made by
check, bank draft, or money order, or
online with a credit card or wire
transfer.
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 must be in U.S.
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
A. Online
the information line either the
You may pay electronically through
registration number of the product or
the government payment website at
the company number. A copy of the
https://www.pay.gov as follows:
check must accompany the application
1. From the pay.gov home page, under to the Agency, specifically attached to
‘‘Find Public Forms.’’ select ‘‘search by
the front of the application. The copy of
Agency name.’’
the check ensures that payment has
2. On the A-Z Index of Forms page,
been made at the time of application
select ‘‘E.’’
and will enable the Agency to properly
3. Select ‘‘Environmental Protection
connect the payment with the
Agency.’’
application sent to the Agency.
If you send the Agency a check, it will
4. From the list of forms, select
‘‘Pesticide Registration Improvement Act be converted into an electronic funds
transfer (EFT). This means the Agency
Fee – Pre-Payment.’’
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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 by one of the following methods:
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.
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VI. 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 pay.gov payment
acknowledgement or a copy of the
check. If the applicant is applying for a
fee waiver, the applicant should provide
sufficient documentation as described
in FIFRA section 33(b)(7) and https://
www.epa.gov/pesticides/fees/questions/
waivers.htm. The fee waiver request
should be easy to identify and separate
from the rest of the application and
submitted with documentation that at
least 25 percent 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 will notify 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.
sroberts on DSKD5P82C1PROD with NOTICES
VII. Addresses
New covered applications should be
identified in the title line with the mail
code REGFEE and sent by one of the
following methods:
1. By USPS mail. Document
Processing Desk (REGFEE), Office of
Pesticide Programs (7504P), U.S.
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, D.C. 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
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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: August 4, 2010.
Steven Bradbury,
Director, Office of Pesticides Programs.
[FR Doc. 2010–19720 Filed 8–10–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2010–0617; FRL–9188–3]
Human Studies Review Board (HSRB);
Notification of a Public Teleconference
To Review Draft Final Report From the
June 23, 2010 HSRB Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The EPA Human Studies
Review Board (HSRB) announces a
public teleconference meeting to discuss
its Draft HSRB Final Report from the
June 23, 2010 HSRB meeting.
DATES: The teleconference will be held
on Thursday, September 9, 2010, from
1:30–3 p.m. (Eastern Time).
Location: The meeting will take place
via telephone only.
Meeting Access: For information on
access or services for individuals with
disabilities, please contact Lu-Ann
Kleibacker at least 10 business days
prior to the meeting using the
information under FOR FURTHER
INFORMATION CONTACT, so that
appropriate arrangements can be made.
Procedures for Providing Public Input:
Interested members of the public may
submit relevant written or oral
comments for the HSRB to consider
during the advisory process. Additional
information concerning submission of
relevant written or oral comments is
provided in section I., under subsection
D., ‘‘How I May Participate in this
Meeting’’ of this notice.
FOR FURTHER INFORMATION CONTACT:
Members of the public who wish to
obtain the call-in number and access
code to participate in the telephone
conference, request a current draft copy
of the Board’s report or who wish
further information may contact Lu-Ann
Kleibacker, EPA, Office of the Science
Advisor, (8105R), Environmental
SUMMARY:
PO 00000
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48683
Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460;
or via telephone/voice mail at (202)
564–7189 or via e-mail at kleibacker.luann@epa.gov. General information
concerning the EPA HSRB can be found
on the EPA Web site at https://
www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2010–0617, by one of
the following methods: https://
www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
Mail: ORD Docket, Environmental
Protection Agency, Mailcode: 28221T,
1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
Hand Delivery: EPA Docket Center
(EPA/DC), Public Reading Room,
Infoterra Room (Room Number 3334),
EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA–ORD–
2010–0617. Deliveries are accepted
between 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. Special arrangements should
be made for deliveries of boxed
information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–ORD–2010–
0617. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comments include 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 e-mail. 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 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. 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
E:\FR\FM\11AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48672-48683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19720]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0599; FRL-8840-7]
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. In accordance with the Pesticide Registration
Improvement Renewal Act, the registration service fees for covered
pesticide registration applications received on or after October 1,
2010,
[[Page 48673]]
will increase by 5 percent, rounded up to the nearest dollar amount,
from the fees published for fiscal years 2009 and 2010. The new fees
become effective on October 1, 2010.
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 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?
EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0599. 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.
II. Background
A. What Action is the Agency Taking?
The Pesticide Registration Improvement Act of 2003 (PRIA),
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)(B) of FIFRA, the registration service fees for covered
pesticide registration applications received on or after October 1,
2010, will increase by 5 percent, rounded up to the nearest dollar
amount, from the fees published in the August 5, 2008, Federal Register
Notice (73 FR 45438).
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 (Divisions) 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 2011 and 2012 as these
are the only applicable review periods for applications received on or
after October 1, 2010. 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
[[Page 48674]]
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 2011 and 2012.
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 11/12 Registration Service Fee
($)'' lists the registration service fee for the action for fiscal year
2010 (October 1, 2010 through September 30, 2011) and fiscal year 2011
(October 1, 2011 through September 30, 2012).
2. The following acronyms are used in some of the tables:
DART = Dose Adequacy Response Team
DNT = Developmental Neurotoxicity
GW/SW = Ground Water/Surface Water
HSRB = Human Studies Review Board
PHI = Pre-Harvest Interval
PPE = Personal Protective Equipment
REI = Restricted Entry Interval
SAP = FIFRA Scientific Advisory Panel
IV. PRIRA Fee Schedule Tables--Effective October 1, 2010
A. Registration Division
The Registration Division of OPP is responsible for the processing
of pesticide applications and associated tolerance petitions for
pesticides that are termed ``conventional chemicals,'' excluding
pesticides intended for antimicrobial uses. The term ``conventional
chemical'' is a term of art that is intended to distinguish synthetic
chemicals from those that are of naturally occurring or non-synthetic
origin, synthetic chemicals that are identical to naturally-occurring
chemicals and microbial pesticides. Tables 1 through 5 of Unit V.A.
cover RD actions.
TABLE 1.-Registration Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
R010 1 Food use\1\ 24 569,221
----------------------------------------------------------------------------------------------------------------
R020 2 Food use; reduced risk\1\ 18 569,221
----------------------------------------------------------------------------------------------------------------
R030 3 Food use; Experimental Use 24 629,197
Permit application
submitted simultaneously
with application for
registration; decision time
for Experimental Use Permit
and temporary tolerance
same as R040\1\
----------------------------------------------------------------------------------------------------------------
R040 4 Food use; Experimental Use 18 419,502
Permit application;
establish temporary
tolerance; submitted before
application for
registration; credit
$326,025 toward new active
ingredient application that
follows
----------------------------------------------------------------------------------------------------------------
R050 5 Food use; application 14 209,806
submitted 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\ 21 395,467
----------------------------------------------------------------------------------------------------------------
R070 7 Non-food use; outdoor; 16 395,467
reduced risk\1\
----------------------------------------------------------------------------------------------------------------
R080 8 Non-food use; outdoor; 21 437,472
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; 16 293,596
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; 12 143,877
submitted after
Experimental Use Permit
application; decision time
begins after Experimental
Use Permit is granted\1\
----------------------------------------------------------------------------------------------------------------
R110 11 Non-food use; indoor\1\ 20 219,949
----------------------------------------------------------------------------------------------------------------
R120 12 Non-food use; indoor; 14 219,949
reduced risk\1\
----------------------------------------------------------------------------------------------------------------
R121 13 Non-food use; indoor; 18 165,375
Experimental Use Permit
application submitted
before application for
registration; credit
$100,000 toward new active
ingredient application that
follows
----------------------------------------------------------------------------------------------------------------
R122 14 Enriched isomer(s) of 18 287,643
registered mixed-isomer
active ingredient\1\
----------------------------------------------------------------------------------------------------------------
R123 15 Seed treatment only; 18 427,991
includes non-food and food
uses; limited uptake into
Raw Agricultural
Commodities\1\
----------------------------------------------------------------------------------------------------------------
[[Page 48675]]
R124 16 Conditional Ruling on 6 2,294
Preapplication Study
Waivers; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\ All uses (food and/or non-food) included in any original application or petition for a new active ingredient
or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
that application.
TABLE 2.--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
R130 17 First food use; indoor; food/ 21 173,644
food handling\1\
----------------------------------------------------------------------------------------------------------------
R140 18 Additional food use; Indoor; 15 40,518
food/food handling
----------------------------------------------------------------------------------------------------------------
R150 19 First food use\1\ 21 239,684
----------------------------------------------------------------------------------------------------------------
R160 20 First food use; reduced 16 239,684
risk\1\
----------------------------------------------------------------------------------------------------------------
R170 21 Additional food use 15 59,976
----------------------------------------------------------------------------------------------------------------
R180 22 Additional food use; reduced 10 59,976
risk
----------------------------------------------------------------------------------------------------------------
R190 23 Additional food uses; 6 or 15 359,856
more submitted in one
application
----------------------------------------------------------------------------------------------------------------
R200 24 Additional food uses; 6 or 10 359,856
more submitted in one
application; reduced risk
----------------------------------------------------------------------------------------------------------------
R210 25 Additional food use; 12 44,431
Experimental Use Permit
application; establish
temporary tolerance; no
credit toward new use
registration
----------------------------------------------------------------------------------------------------------------
R220 26 Additional food use; 6 17,993
Experimental Use Permit
application; crop destruct
basis; no credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R230 27 Additional use; non-food; 15 23,969
outdoor
----------------------------------------------------------------------------------------------------------------
R240 28 Additional use; non-food; 10 23,969
outdoor; reduced risk
----------------------------------------------------------------------------------------------------------------
R250 29 Additional use; non-food; 6 17,993
outdoor; Experimental Use
Permit application; no
credit toward new use
registration
----------------------------------------------------------------------------------------------------------------
R260 30 New use; non-food; indoor 12 11,577
----------------------------------------------------------------------------------------------------------------
R270 31 New use; non-food; indoor; 9 11,577
reduced risk
----------------------------------------------------------------------------------------------------------------
R271 32 New use; non-food; indoor; 6 8,820
Experimental Use Permit
application; no credit
toward new use registration
----------------------------------------------------------------------------------------------------------------
R272 33 Review of Study Protocol; 3 2,294
applicant-initiated;
excludes DART, pre-
registration conferences,
Rapid Response review, DNT
protocol review, protocols
needing HSRB review
----------------------------------------------------------------------------------------------------------------
R273 34 Additional use; seed 12 45,754
treatment; limited uptake
into raw agricultural
commodities; includes crops
with established tolerances
(e.g., for soil or foliar
application); includes food
or non-food uses
----------------------------------------------------------------------------------------------------------------
R274 35 Additional uses; seed 12 274,523
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 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 48676]]
TABLE 3.--Registration Division--Import And Other Tolerances
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
R280 36 Establish import tolerance; 21 289,407
new active ingredient or
first food use\1\
----------------------------------------------------------------------------------------------------------------
R290 37 Establish import tolerance; 15 57,882
additional food use
----------------------------------------------------------------------------------------------------------------
R291 38 Establish import tolerances; 15 347,288
additional food uses; 6 or
more crops submitted in one
petition
----------------------------------------------------------------------------------------------------------------
R292 39 Amend an established 10 41,124
tolerance (e.g., decrease
or increase); domestic or
import; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R293 40 Establish tolerance(s) for 12 48,510
inadvertent residues in one
crop; applicant-initiated
----------------------------------------------------------------------------------------------------------------
R294 41 Establish tolerances for 12 291,060
inadvertent residues; 6 or
more crops submitted in one
application; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R295 42 Establish tolerance(s) for 15 59,976
residues in one rotational
crop in response to a
specific rotational crop
application; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R296 43 Establish tolerances for 15 359,856
residues 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 FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
R300 44 New product; identical or 3 1,434
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 1,720
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- 6 4,807
use product; requires
review of data package
within RD; includes reviews
and/or waivers of data for
only: Product chemistry and/
or Acute toxicity and/or
Public health pest efficacy
----------------------------------------------------------------------------------------------------------------
R311 49 New product; requires 12 17,133
approval of new food-use
inert; applicant-initiated;
excludes approval of
safeners
----------------------------------------------------------------------------------------------------------------
R312 50 New product; requires 6 9,151
approval of new non-food-
use inert; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R313 51 New product; requires 10 12,591
amendment to existing inert
tolerance exemption (e.g.,
adding post-harvest use);
applicant-initiated
----------------------------------------------------------------------------------------------------------------
R320 47 New product; new physical 12 11,996
form; requires data review
in science divisions
----------------------------------------------------------------------------------------------------------------
R330 48 New manufacturing-use 12 17,993
product; registered active
ingredient; selective data
citation
----------------------------------------------------------------------------------------------------------------
[[Page 48677]]
R331 52 New product; repack of 3 2,294
identical registered end-
use product as a
manufacturing-use product;
same registered uses only
----------------------------------------------------------------------------------------------------------------
R332 53 New manufacturing-use 24 256,883
product; 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 FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring data 4 3,617
review within RD (e.g.,
changes to precautionary
label statements, or source
changes to an unregistered
source of active
ingredient)\1\
----------------------------------------------------------------------------------------------------------------
R350 55 Amendment requiring data 8 11,996
review in science divisions
(e.g., changes to REI, or
PPE, or PHI, or use rate,
or number of applications;
or add aerial application;
or modify GW/SW advisory
statement)\1\
----------------------------------------------------------------------------------------------------------------
R370 56 Cancer reassessment; 18 179,818
applicant-initiated
----------------------------------------------------------------------------------------------------------------
R371 57 Amendment to Experimental 6 9,151
Use Permit; requires data
review / risk assessment
----------------------------------------------------------------------------------------------------------------
R372 58 Refined ecological and/or 12 171,219
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
The Antimicrobials Division of OPP is responsible for the
processing of pesticide applications and associated tolerances for
conventional chemicals intended for antimicrobial uses, that is, uses
that are defined under FIFRA section 2(mm)(1)(A), including products
for use against bacteria, protozoa, non-agricultural fungi, and
viruses. AD is also responsible for a selected set of conventional
chemicals intended for other uses, including most wood preservatives
and antifoulants. Tables 6 through 8 of Unit V.B. cover AD actions.
Table 6.--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
A380 59 Food use; establish 24 104,187
tolerance exemption\1\
----------------------------------------------------------------------------------------------------------------
A390 60 Food use; establish 24 173,644
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A400 61 Non-food use; outdoor; FIFRA 18 86,823
section 2(mm) uses\1\
----------------------------------------------------------------------------------------------------------------
A410 62 Non-food use; outdoor; uses 21 173,644
other than FIFRA section
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A420 63 Non-food use; indoor; FIFRA 18 57,882
section 2(mm) uses\1\
----------------------------------------------------------------------------------------------------------------
A430 64 Non-food use; indoor; uses 20 86,823
other than FIFRA section
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A431 65 Non-food use; indoor; low- 12 60,638
risk and low-toxicity food-
grade active ingredient(s);
efficacy testing for public
health claims required
under GLP and following DIS/
TSS or AD-approved study
protocol
----------------------------------------------------------------------------------------------------------------
\1\ All uses (food and/or non-food) included in any original application or petition for a new active ingredient
or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
that application.
[[Page 48678]]
Table 7.--Antimicrobials Division--New Uses
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
A440 66 First food use; establish 21 28,942
tolerance exemption\1\
----------------------------------------------------------------------------------------------------------------
A450 67 First food use; establish 21 86,823
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A460 68 Additional food use; 15 11,577
establish tolerance
exemption
----------------------------------------------------------------------------------------------------------------
A470 69 Additional food use; 15 28,942
establish tolerance
----------------------------------------------------------------------------------------------------------------
A480 70 Additional use; non-food; 9 17,365
outdoor; FIFRA section
2(mm) uses
----------------------------------------------------------------------------------------------------------------
A490 71 Additional use; non-food; 15 28,942
outdoor; uses other than
FIFRA section 2(mm)
----------------------------------------------------------------------------------------------------------------
A500 72 Additional use; non-food; 9 11,577
indoor; FIFRA section 2(mm)
uses
----------------------------------------------------------------------------------------------------------------
A510 73 Additional use; non-food; 12 11,577
indoor; uses other than
FIFRA section 2(mm)
----------------------------------------------------------------------------------------------------------------
A520 74 Experimental Use Permit 9 5,789
application
----------------------------------------------------------------------------------------------------------------
A521 75 Review of public health 3 2,205
efficacy study protocol
within AD; per AD Internal
Guidance for the Efficacy
Protocol Review Process;
applicant-initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522 76 Review of public health 12 11,025
efficacy 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.
Table 8.--Antimicrobials Division--New Products And Amendments
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
A530 77 New product; identical or 3 1,159
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 1,654
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 4,631
substantially similar in
composition and use to a
registered product;
registered active
ingredient; unregistered
source of active
ingredient; cite-all data
citation except for product
chemistry; product
chemistry data submitted
----------------------------------------------------------------------------------------------------------------
A540 79 New end use product; FIFRA 4 4,631
section 2(mm) uses only
----------------------------------------------------------------------------------------------------------------
A550 80 New end-use product; uses 6 4,631
other than FIFRA section
2(mm); non-FQPA product
----------------------------------------------------------------------------------------------------------------
A560 81 New manufacturing-use 12 17,365
product; registered active
ingredient; selective data
citation
----------------------------------------------------------------------------------------------------------------
A570 82 Label amendment requiring 4 3,474
data submission\1\
----------------------------------------------------------------------------------------------------------------
A571 83 Cancer reassessment; 18 86,823
applicant-initiated
----------------------------------------------------------------------------------------------------------------
[[Page 48679]]
A572 84 Refined ecological risk and/ 12 82,688
or endangered species
assessment; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\ EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials
Division are to be completed within the FIFRA stated timelines listed in Section 3(h) and are not subject to
PRIA fees. Label amendments submitted by notification under PR Notices, such as PR Notice 95-2 and PR Notice
98-10, continue under PR Notice timelines and are not subject to PRIA fees.
C. Biopesticides and Pollution Prevention Division
The Biopesticides and Pollution Prevention Division of OPP is
responsible for the processing of pesticide applications for
biochemical pesticides, microbial pesticides, and plant-incorporated
protectants (PIPs).
The fee tables for BPPD actions are presented by type of pesticide
rather than by type of action: Table 9--Microbial and biochemical
pesticides; Table 10--straight chain lepidopteran pheromones (SCLPs),
and Table 11--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.
Table 9.--Biopesticides And Pollution Prevention Division--Microbial And Biochemical Pesticides; New Products
And Amendments
----------------------------------------------------------------------------------------------------------------
Decision FY 11/12
Time Registration
EPA No. CR No. Action (months) Service Fee
FY 11/12 ($)
----------------------------------------------------------------------------------------------------------------
B580 86 New active ingredient; food 18 46,305
use; establish tolerance\1\
----------------------------------------------------------------------------------------------------------------
B590 87 New active ingredient; food 16 28,942
use; establish tolerance
exemption\1\
------
