Pesticides; Revised Fee Schedule for Registration Applications
PDF Version (13 pp, 532K, About PDF)
[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45438-45450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au08-55]
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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.
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SUMMARY: EPA is publishing a revised list of pesticide registration
service fees applicable to specified pesticide applications and
tolerance actions. Under the Pesticide Registration Improvement Renewal
Act, the registration service fees for covered pesticide registration
applications received on or after October 1, 2008, increase by 5%
rounding up to the nearest dollar from the fees published for fiscal
year 2008, and certain decision review periods have been reduced. The
new fees and decision review periods become effective on October 1, 2008.
FOR FURTHER INFORMATION CONTACT: Elizabeth Leovey (7501P), Immediate
Office, Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7328; fax number: (703) 308-4776; e-mail address:
leovey.elizabeth@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you register
pesticide products under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Potentially affected entities may include, but
are not limited to:
Agricultural pesticide manufacturers (32532).
Antimicrobial pesticide manufacturers (32561).
Antifoulant pesticide manufacturers (32551).
Wood preservative manufacturers (32519).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in the notice and in
FIFRA section 33. If
[[Page 45439]]
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2008-[0545]. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Background
A. What Action is the Agency Taking?
The Pesticide Registration Improvement Act of 2003 established a
new section 33 of FIFRA creating a registration service fee system for
certain types of pesticide applications, establishment of tolerances,
and certain other regulatory decisions under FIFRA and the Federal
Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a
schedule of decision review times for applications covered by the
service fee system. The Agency began administering the registration
service fee system for covered applications received on or after March
23, 2004.
On October 9, 2007, the Pesticide Registration Improvement Renewal
Act was signed by the President, revising, among other things, FIFRA
section 33. The new law reauthorized the service fee system through
2012 and established fees and review times for applications received
during fiscal years 2008 through 2012. As required by section
33(b)(6)(A) of FIFRA, the registration service fees for covered
pesticide registration applications received on or after October 1,
2008, increase by five percent rounding up to the nearest dollar from
the fees published in the October 30, 2007, Federal Register Notice (72
FR 61466). In addition, this notice provides shorter decision review
periods for certain application categories.
B. What is the Agency's Authority for Taking this Action?
The publication of this fee schedule is required by section
33(b)(6)(C) of FIFRA as amended.
III. Elements of the Fee Schedule
This unit explains how EPA has organized the fee schedule
identified in the statute and how to read the fee schedule tables, and
includes a key to terminology published with the table in the
Congressional Review. EPA's organization and presentation of the fee
schedule information does not affect the categories of registration
service fees or the structure or procedures for submitting applications
or petitions for tolerance.
A. The Congressional Record Fee Schedule
The fee schedule published in the Congressional Record of July 21,
2007 identifies the registration service fees and decision times and is
organized according to the organizational units of the Office of
Pesticide Programs (OPP) within EPA. Thereafter, the categories within
the organizational unit sections of the table are further categorized
according to the type of application being submitted, the use patterns
involved, or, in some cases, upon the type of pesticide that is the
subject of the application. The fee categories differ by Division. Not
all application types are covered by, or subject to, the fee system.
B. Fee Schedule and Decision Review Times
In today's notice, EPA has retained the format of previous schedule
notices and included the corrections to the schedule published in the
September 24, 2007 issue of the Congressional Record. The schedules are
presented as 11 tables, organized by OPP Division and by type of
application or pesticide subject to the fee. These tables only list the
decision time review periods for fiscal years 2009 and 2010 as these
are the only applicable review periods for applications received on or
after October 1, 2008. Unit IV. presents fee tables for the
Registration Division (RD) (5 tables), the Antimicrobials Division (AD)
(3 tables), and the Biopesticides and Pollution Prevention Division
(BPPD) (3 tables).
C. How to Read the Tables
1. Each table consists of the following columns:
The column entitled ``EPA No.'' assigns an EPA identifier
to each fee category. There are 140 categories spread across the 3
Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD
categories. For tracking purposes, OPP has assigned a 3-digit
identifier to each category, beginning with RD categories, followed by
AD and BPPD categories. The categories are prefaced with a letter
designation indicating which Division of OPP is responsible for
applications in that category (R= Registration Division,
A=Antimicrobials Division, B=Biopesticides and Pollution Prevention
Division).
The column entitled ``CR No.'' cross-references the
current Congressional Record category number for convenience. However,
EPA will be using the categories as numbered in the ``EPA No.'' column
in its tracking systems.
The column entitled ``Action'' describes the categories of
action. In establishing the expanded fee schedule categories, Congress
eliminated some of the more confusing terminology of the original
categories. For example, instead of the term ``fast-track,'' the
schedule in the Congressional Record uses the regulatory phrase
``identical or substantially similar in composition and use to a
registered product.''
The column entitled ``Decision Time'' lists the decision
times in months for each type of action for Fiscal Years 2009 and 2010.
The 2010 decision times apply to 2011 and 2012. The decision review
periods in the tables are based upon EPA fiscal years (FY), which run
from October 1 through September 30.
The column entitled ``FY 09/FY 10 Registration Service Fee
($)'' lists the registration service fee for the action for fiscal year
2009 (October 1, 2008 through September 30, 2009) and fiscal year 2010
(October 1, 2009 through September 30, 2010).
2. The following acronyms are used in some of the tables:
DART-Dose Adequacy Response Team
DNT-Developmental Neurotoxicity
HSRB-Human Studies Review Board
GW/SW-Ground Water/Surface Water
PHI-Pre-Harvest Interval
PPE-Personal Protective Equipment
REI-Restricted Entry Interval
SAP-FIFRA Scientific Advisory Panel
[[Page 45440]]
IV. PRIRA Fee Schedule Tables--Effective October 1, 2008
A. Registration Division (RD)
The Registration Division of OPP is responsible for the processing
of pesticide applications and associated tolerance petitions for
pesticides that are termed ``conventional chemicals,'' excluding
pesticides intended for antimicrobial uses. The term ``conventional
chemical'' is a term of art that is intended to distinguish synthetic
chemicals from those that are of naturally occurring or non-synthetic
origin, synthetic chemicals that are identical to naturally-occurring
chemicals and microbial pesticides. Tables 1 through 5 of Unit IV.A.
cover RD actions.
Table 1.--Registration Division--New Active Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
R010 1 Food use\1\ 24 24 542,115
--------------------------------------------------------------------------------------------------------------------------------------------------------
R020 2 Food use; reduced risk\1\ 18 18 542,115
--------------------------------------------------------------------------------------------------------------------------------------------------------
R030 3 Food use; Experimental Use Permit 24 24 599,235
application submitted
simultaneously with application
for registration; decision time
for Experimental Use Permit and
temporary tolerance same as
#R040\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R040 4 Food use; Experimental Use Permit 18 18 399,525
application; establish temporary
tolerance; submitted before
application for registration;
credit $326,025 toward new active
ingredient application that
follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
R050 5 Food use; application submitted 14 14 199,815
after Experimental Use Permit
application; decision time begins
after Experimental Use Permit and
temporary tolerance are
granted\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R060 6 Non-food use; outdoor\1\ 21 21 376,635
--------------------------------------------------------------------------------------------------------------------------------------------------------
R070 7 Non-food use; outdoor; reduced 16 16 376,635
risk\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R080 8 Non-food use; outdoor; 21 21 416,640
Experimental Use Permit
application submitted
simultaneously with application
for registration; decision time
for Experimental Use Permit same
as #R090\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R090 9 Non-food use; outdoor; 16 16 279,615
Experimental Use Permit
application submitted before
application for registration;
credit $228,225 toward new active
ingredient application that
follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
R100 10 Non-food use; outdoor; submitted 12 12 137,025
after Experimental Use Permit
application; decision time begins
after Experimental Use Permit is
granted\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R110 11 Non-food use; indoor\1\ 20 20 209,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
R120 12 Non-food use; indoor; reduced 14 14 209,475
risk\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R121 13 Non-food use; indoor; Experimental 18 18 157,500
Use Permit application submitted
before application for
registration; credit $100,000
toward new active ingredient
application that follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
R122 14 Enriched isomer(s) of registered 18 18 273,945
mixed-isomer active ingredient\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R123 15 Seed treatment only; includes non- 18 18 407,610
food and food uses; limited
uptake into Raw Agricultural
Commodities\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R124 16 Conditional Ruling on 6 6 2,184
Preapplication Study Waivers;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
[[Page 45441]]
Table 2.--Registration Division--New Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
R130 17 First food use; indoor; food/food 21 21 165,375
handling\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R140 18 Additional food use; indoor; food/ 15 15 38,588
food handling
--------------------------------------------------------------------------------------------------------------------------------------------------------
R150 19 First food use\1\ 21 21 228,270
--------------------------------------------------------------------------------------------------------------------------------------------------------
R160 20 First food use; reduced risk\1\ 16 16 228,270
--------------------------------------------------------------------------------------------------------------------------------------------------------
R170 21 Additional food use 15 15 57,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
R180 22 Additional food use; reduced risk 10 10 57,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
R190 23 Additional food uses; 6 or more 15 15 342,720
submitted in one application
--------------------------------------------------------------------------------------------------------------------------------------------------------
R200 24 Additional food uses; 6 or more 10 10 342,720
submitted in one application;
reduced risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
R210 25 Additional food use; Experimental 12 12 42,315
Use Permit application; establish
temporary tolerance; no credit
toward new use registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
R220 26 Additional food use; Experimental 6 6 17,136
Use Permit application; crop
destruct basis; no credit toward
new use registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
R230 27 Additional use; non-food; outdoor 15 15 22,827
--------------------------------------------------------------------------------------------------------------------------------------------------------
R240 28 Additional use; non-food; outdoor; 10 10 22,827
reduced risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
R250 29 Additional use; non-food; outdoor; 6 6 17,136
Experimental Use Permit
application; no credit toward new
use registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
R260 30 New use; non-food; indoor 12 12 11,025
--------------------------------------------------------------------------------------------------------------------------------------------------------
R270 31 New use; non-food; indoor; reduced 9 9 11,025
risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
R271 32 New use; non-food; indoor; 6 6 8,400
Experimental Use Permit
application; no credit toward new
use registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
R272 33 Review of Study Protocol; 3 3 2,184
applicant-initiated; excludes
DART, pre-registration
conferences, Rapid Response
review, DNT protocol review,
protocols needing HSRB review
--------------------------------------------------------------------------------------------------------------------------------------------------------
R273 34 Additional use; seed treatment; 12 12 43,575
limited uptake into Raw
Agricultural Commodities;
includes crops with established
tolerances (e.g., for soil or
foliar application); includes
food or non-food uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
R274 35 Additional uses; seed treatment 12 12 261,450
only; 6 or more submitted in one
application; limited uptake into
Raw Agricultural Commodities;
includes crops with established
tolerances (e.g., for soil or
foliar application); includes
food and/or non-food uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
[[Page 45442]]
Table 3.--Registration Division--Import and Other Tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
R280 36 Establish import tolerance; new 21 21 275,625
active ingredient or first food
use\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R290 37 Establish import tolerance; 15 15 55,125
additional food use
--------------------------------------------------------------------------------------------------------------------------------------------------------
R291 38 Establish import tolerances; 15 15 330,750
additional food uses; 6 or more
crops submitted in one petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
R292 39 Amend an established tolerance 10 10 39,165
(e.g., decrease or increase);
domestic or import; applicant-
initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R293 40 Establish tolerance(s) for 12 12 46,200
inadvertent residues in one crop;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R294 41 Establish tolerances for 12 12 277,200
inadvertent residues; 6 or more
crops submitted in one
application; applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R295 42 Establish tolerance(s) for 15 15 57,120
residues in one rotational crop
in response to a specific
rotational crop application;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R296 43 Establish tolerances for residues 15 15 342,720
in rotational crops in response
to a specific rotational crop
petition; 6 or more crops
submitted in one application;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
Table 4.--Registration Division--New Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
R300 44 New product; identical or 3 3 1,365
substantially similar in
composition and use to a
registered product; no data
review or only product chemistry
data; cite-all data citation, or
selective data citation where
applicant owns all required data,
or applicant submits specific
authorization letter from data
owner. Category also includes
100% re-package of registered end-
use or manufacturing-use product
that requires no data submission
nor data matrix.
--------------------------------------------------------------------------------------------------------------------------------------------------------
R301 45 New product; identical or 4 4 1,638
substantially similar in
composition and use to a
registered product; registered
source of active ingredient;
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy, where
applicant does not own all
required data and does not have a
specific authorization letter
from data owner.
--------------------------------------------------------------------------------------------------------------------------------------------------------
R310 46 New end-use or manufacturing-use 6 6 4,578
product; requires review of data
package within RD; includes
reviews and/or waivers of data
for only:
Product chemistry and/or.
Acute toxicity and/or....
Public health pest
efficacy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
R311 49 New product; requires approval of 12 12 16,317
new food-use inert; applicant-
initiated; excludes approval of
safeners
--------------------------------------------------------------------------------------------------------------------------------------------------------
R312 50 New product; requires approval of 6 6 8,715
new non-food-use inert; applicant-
initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45443]]
R313 51 New product; requires amendment to 10 10 11,991
existing inert tolerance
exemption (e.g., adding post-
harvest use); applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R320 47 New product; new physical form; 12 12 11,424
requires data review in science
divisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
R330 48 New manufacturing-use product; 12 12 17,136
registered active ingredient;
selective data citation
--------------------------------------------------------------------------------------------------------------------------------------------------------
R331 52 New product; repack of identical 3 3 2,184
registered end-use product as a
manufacturing-use product; same
registered uses only
--------------------------------------------------------------------------------------------------------------------------------------------------------
R332 53 New manufacturing-use product; 24 24 244,650
registered active ingredient;
unregistered source of active
ingredient; submission of
completely new generic data
package; registered uses only
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 5.--Registration Division--Amendments to Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring data review 4 4 3,444
within RD (e.g., changes to
precautionary label statements,
or source changes to an
unregistered source of active
ingredient)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R350 55 Amendment requiring data review in 8 8 11,424
science divisions (e.g., changes
to REI, or PPE, or PHI, or use
rate, or number of applications;
or add aerial application; or
modify GW/SW advisory
statement)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
R370 56 Cancer reassessment; applicant- 18 18 171,255
initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
R371 57 Amendment to Experimental Use 6 6 8,715
Permit; requires data review/risk
assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
R372 58 Refined ecological and/or 18 12 163,065
endangered species assessment;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA
stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR
Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is responsible for the
processing of pesticide applications and associated tolerances for
conventional chemicals intended for antimicrobial uses, that is, uses
that are defined under FIFRA section 2(mm)(1)(A), including products
for use against bacteria, protozoa, non-agricultural fungi, and
viruses. AD is also responsible for a selected set of conventional
chemicals intended for other uses, including most wood preservatives
and antifoulants. Tables 6 through 8 of Unit IV.B. cover AD actions.
Table 6.--Antimicrobials Division--New Active Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A380 59 Food use; establish tolerance 24 24 99,225
exemption\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A390 60 Food use; establish tolerance\1\ 24 24 165,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
A400 61 Non-food use; outdoor; FIFRA 18 18 82,688
section 2(mm) uses\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45444]]
A410 62 Non-food use; outdoor; uses other 21 21 165,375
than FIFRA section 2(mm)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A420 63 Non-food use; indoor; FIFRA 18 18 55,125
section 2(mm) uses\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A430 64 Non-food use; indoor; uses other 20 20 82,688
than FIFRA section 2(mm)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A431 65 Non-food use; indoor; low-risk and 12 12 57,750
low-toxicity food-grade active
ingredient(s); efficacy testing
for public health claims required
under GLP and following DIS/TSS
or AD-approved study protocol
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
Table 7.--Antimicrobials Division--New Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A440 66 First food use; establish 21 21 27,563
tolerance exemption\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A450 67 First food use; establish 21 21 82,688
tolerance\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A460 68 Additional food use; establish 15 15 11,025
tolerance exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
A470 69 Additional food use; establish 15 15 27,563
tolerance
--------------------------------------------------------------------------------------------------------------------------------------------------------
A480 70 Additional use; non-food; outdoor; 9 9 16,538
FIFRA section 2(mm) uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
A490 71 Additional use; non-food; outdoor; 15 15 27,563
uses other than FIFRA section
2(mm)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A500 72 Additional use; non-food; indoor; 9 9 11,025
FIFRA section 2(mm) uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
A510 73 Additional use; non-food; indoor; 12 12 11,025
uses other than FIFRA section
2(mm)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A520 74 Experimental Use Permit 9 9 5,513
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
A521 75 Review of public health efficacy 4 3 2,100
study protocol within AD; per AD
Internal Guidance for the
Efficacy Protocol Review Process;
applicant-initiated; Tier 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
A522 76 Review of public health efficacy 15 12 10,500
study protocol outside AD by
members of AD Efficacy Protocol
Review Expert Panel; applicant-
initiated; Tier 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
[[Page 45445]]
Table 8.--Antimicrobials Division--New Products and Amendments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A530 77 New product; identical or 3 3 1,103
substantially similar in
composition and use to a
registered product; no data
review or only product chemistry
data; cite-all data citation, or
selective data citation where
applicant owns all required data,
or applicant submits specific
authorization letter from data
owner. Category also includes
100% re-package of registered end-
use or manufacturing-use product
that requires no data submission
nor data matrix.
--------------------------------------------------------------------------------------------------------------------------------------------------------
A531 78 New product; identical or 4 4 1,575
substantially similar in
composition and use to a
registered product; registered
source of active ingredient;
selective data citation only for
data on product chemistry and/or
acute toxicity and/or public
health pest efficacy, where
applicant does not own all
required data and does not have a
specific authorization letter
from data owner
--------------------------------------------------------------------------------------------------------------------------------------------------------
A532 85 New product; identical or 4 4 4,410
substantially similar in
composition and use to a
registered product; registered
active ingredient; unregistered
source of active ingredient; cite-
all data citation except for
product chemistry; product
chemistry data submitted
--------------------------------------------------------------------------------------------------------------------------------------------------------
A540 79 New end-use product; FIFRA section 4 4 4,410
2(mm) uses only
--------------------------------------------------------------------------------------------------------------------------------------------------------
A550 80 New end-use product; uses other 6 6 4,410
than FIFRA section 2(mm); non-
FQPA product
--------------------------------------------------------------------------------------------------------------------------------------------------------
A560 81 New manufacturing-use product; 12 12 16,538
registered active ingredient;
selective data citation
--------------------------------------------------------------------------------------------------------------------------------------------------------
A570 82 Label amendment requiring data 4 4 3,308
submission\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
A571 83 Cancer reassessment; applicant- 18 18 82,688
initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
A572 84 Refined ecological risk and/or 18 12 78,750
endangered species assessment;
applicant-initiated
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA
stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR
Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
C. Biopesticides and Pollution Prevention Division (BPPD)
The Biopesticides and Pollution Prevention Division of OPP is
responsible for the processing of pesticide applications for
biochemical pesticides, microbial pesticides, and plant-incorporated
protectants (PIPs).
The fee tables for BPPD tables are presented by type of pesticide
rather than by type of action: Microbial and biochemical pesticides,
straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each
table, the types of application are the same as those in other
divisions and use the same terminology as in Unit III. Tables 9 through
11 of Unit IV.C. cover BPPD actions.
Table 9.--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products and Amendments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
B580 86 New active ingredient; food use; 18 18 44,100
establish tolerance\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B590 87 New active ingredient; food use; 16 16 27,563
establish tolerance exemption\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45446]]
B600 88 New active ingredient; non-food 12 12 16,538
use\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B610 89 Food use; Experimental Use Permit 9 9 11,025
application; establish temporary
tolerance exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
B620 90 Non-food use; Experimental Use 6 6 5,513
Permit application
--------------------------------------------------------------------------------------------------------------------------------------------------------
B621 91 Extend or amend Experimental Use 6 6 4,410
Permit
--------------------------------------------------------------------------------------------------------------------------------------------------------
B630 92 First food use; establish 12 12 11,025
tolerance exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
B631 93 Amend established tolerance 9 9 11,025
exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
B640 94 First food use; establish 18 18 16,538
tolerance\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B641 95 Amend established tolerance (e.g., 12 12 11,025
decrease or increase)
--------------------------------------------------------------------------------------------------------------------------------------------------------
B650 96 New use; non-food 6 6 5,513
--------------------------------------------------------------------------------------------------------------------------------------------------------
B660 97 New product; identical or 3 3 1,103
substantially similar in
composition and use to a
registered product; no data
review or only product chemistry
data; cite-all data citation, or
selective data citation where
applicant owns all required data,
or applicant submits specific
authorization letter from data
owner. Category also includes
100% re-package of registered end-
use or manufacturing-use product
that requires no data submission
nor data matrix.
--------------------------------------------------------------------------------------------------------------------------------------------------------
B670 98 New product; registered source of 6 6 4,410
active ingredient; all Tier I
data for product chemistry,
toxicology, non-target organisms,
and product performance must be
addressed with product-specific
data or with request for data
waivers supported by scientific
rationales
--------------------------------------------------------------------------------------------------------------------------------------------------------
B671 99 New product; food use; 16 16 11,025
unregistered source of active
ingredient; requires amendment of
established tolerance or
tolerance exemption; all Tier I
data requirements for product
chemistry, toxicology, non-target
organisms, and product
performance must be addressed
with product-specific data or
with request for data waivers
supported by scientific
rationales
--------------------------------------------------------------------------------------------------------------------------------------------------------
B672 100 New product; non-food use or food 12 12 7,875
use having established tolerance
or tolerance exemption;
unregistered source of active
ingredient; no data compensation
issues; all Tier I data
requirements for product
chemistry, toxicology, non-target
organisms, and product
performance must be addressed
with product-specific data or
with request for data waivers
supported by scientific
rationales
--------------------------------------------------------------------------------------------------------------------------------------------------------
B680 101 Label amendment requiring data 4 4 4,410
submission\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B681 102 Label amendment; unregistered 6 6 5,250
source of active ingredient;
supporting data require
scientific review
--------------------------------------------------------------------------------------------------------------------------------------------------------
B682 103 Protocol review; applicant- 3 3 2,100
initiated; excludes time for HSRB
review (pre-application)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
[[Page 45447]]
\2\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA
stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR
Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
Table 10.--Biopesticides and Pollution Prevention Division--Straight Chain Lepidopteran Pheromones (SCLPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
B690 104 New active ingredient; food or non- 6 6 2,205
food use\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B700 105 Experimental Use Permit 6 6 1,103
application; new active
ingredient or new use
--------------------------------------------------------------------------------------------------------------------------------------------------------
B701 106 Extend or amend Experimental Use 3 3 1,103
Permit
--------------------------------------------------------------------------------------------------------------------------------------------------------
B710 107 New product; identical or 3 3 1,103
substantially similar in
composition and use to a
registered product; no data
review or only product chemistry
data; cite-all data citation, or
selective data citation where
applicant owns all required data,
or applicant submits specific
authorization letter from data
owner. Category also includes
100% re-package of registered end-
use or manufacturing-use product
that requires no data submission
nor data matrix.
--------------------------------------------------------------------------------------------------------------------------------------------------------
B720 108 New product; registered source of 4 4 1,103
active ingredient; all Tier I
data for product chemistry,
toxicology, non-target organisms,
and product performance must be
addressed with product specific
data or with request for data
waivers supported by scientific
rationales
--------------------------------------------------------------------------------------------------------------------------------------------------------
B721 109 New product; unregistered source 6 6 2,310
of active ingredient
--------------------------------------------------------------------------------------------------------------------------------------------------------
B722 110 New use and/or amendment to 6 6 2,310
tolerance or tolerance exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
B730 111 Label amendment requiring data 4 4 1,103
submission\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient or a first food use that otherwise
satisfy the conditions for the category are covered by the base fee for that application.
\2\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA
stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR
Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
Table 11.--Biopesticide and Pollution Prevention Division--Plant Incorporated Protectants (PIPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decision time (months) FY 09/FY 10
EPA No. CR No. Action ---------------------------------- Registration
FY 09 FY 10 Service Fee ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
B740 112 Experimental Use Permit 6 6 82,688
application; registered active
ingredient; non-food/feed or crop
destruct basis; no SAP review
required\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B750 113 Experimental Use Permit 9 9 110,250
application; registered active
ingredient; establish temporary
tolerance or tolerance exemption;
no SAP review required\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B760 114 Experimental Use Permit 12 12 137,813
application; new active
ingredient; non-food/feed or crop
destruct basis; SAP review
required; credit $78,750 toward
new active ingredient application
that follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
B761 115 Experimental Use Permit 7 7 82,688
application; new active
ingredient; non-food/feed or crop
destruct; no SAP review required;
credit $78,750 toward new active
ingredient application that
follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45448]]
B770 116 Experimental Use Permit 15 15 165,375
application; new active
ingredient; establish temporary
tolerance or tolerance exemption;
SAP review required; credit
$105,000 toward new active
ingredient application that
follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
B771 117 Experimental Use Permit 10 10 110,250
application; new active
ingredient; establish temporary
tolerance or tolerance exemption;
no SAP review required; credit
$105,000 toward new active
ingredient application that
follows
--------------------------------------------------------------------------------------------------------------------------------------------------------
B772 118 Amend or extend Experimental Use 3 3 11,025
Permit; minor changes to
experimental design; established
temporary tolerance or tolerance
exemption is unaffected
--------------------------------------------------------------------------------------------------------------------------------------------------------
B773 119 Amend or extend existing 5 5 27,563
Experimental Use Permit; minor
changes to experimental design;
extend established temporary
tolerance or tolerance exemption
--------------------------------------------------------------------------------------------------------------------------------------------------------
B860 120 Amend Experimental Use Permit; 6 6 11,025
first food use or major revision
of experimental design
--------------------------------------------------------------------------------------------------------------------------------------------------------
B780 121 New active ingredient; non-food/ 12 12 137,813
feed; no SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B790 122 New active ingredient; Non-food/ 18 18 192,938
feed; SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B800 123 New active ingredient; establish 12 12 220,500
permanent tolerance or tolerance
exemption based on temporary
tolerance or tolerance exemption;
no SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B810 124 New active ingredient; establish 18 18 275,625
permanent tolerance or tolerance
exemption based on temporary
tolerance or tolerance exemption;
SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B820 125 New active ingredient; establish 15 15 275,625
tolerance or tolerance exemption;
no SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B840 126 New active ingredient; establish 21 21 330,750
tolerance or tolerance exemption;
SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B830 127 New active ingredient; 15 15 330,750
Experimental Use Permit
application submitted
simultaneously; establish
tolerance or tolerance exemption;
no SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B850 128 New active ingredient; 21 21 385,875
Experimental Use Permit requested
simultaneously; establish
tolerance or tolerance exemption;
SAP review required\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B851 129 New active ingredient; different 9 9 110,250
genetic event of a previously
approved active ingredient; same
crop; no tolerance action
required; no SAP review required
--------------------------------------------------------------------------------------------------------------------------------------------------------
B852 130 New active ingredient; different 9 9 165,375
genetic event of a previously
approved active ingredient; same
crop; no tolerance action
required; SAP review required
--------------------------------------------------------------------------------------------------------------------------------------------------------
B870 131 New use\1\ 9 9 33,075
--------------------------------------------------------------------------------------------------------------------------------------------------------
B880 132 New product; no SAP review 9 9 27,563
required\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45449]]
B881 133 New product; SAP review 15 15 82,688
required\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B890 134 Amendment; seed production to 9 9 55,125
commercial registration; no SAP
review required
--------------------------------------------------------------------------------------------------------------------------------------------------------
B891 135 Amendment; seed production to 15 15 110,250
commercial registration; SAP
review required
--------------------------------------------------------------------------------------------------------------------------------------------------------
B900 136 Amendment (except #B890); 6 6 11,025
no SAP review required; (e.g.,
new IRM requirements that are
applicant-initiated; or amending
a conditional registration to
extend the registration
expiration date with additional
data submitted) \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B901 137 Amendment (except #B890); 12 12 66,150
SAP review required\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
B902 138 PIP protocol review 3 3 5,513
--------------------------------------------------------------------------------------------------------------------------------------------------------
B903 139 Inert ingredient tolerance 6 6 55,125
exemption; e.g., a marker such as
NPT II; reviewed in BPPD
--------------------------------------------------------------------------------------------------------------------------------------------------------
B904 140 Import tolerance or tolerance 9 9 110,250
exemption; processed commodities/
food only
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Example: Transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
\2\May be either a registration for seed increase or a full commercial registration. If a seed increase registration is granted first, full commercial
registration is obtained using B890.
\3\Example: Stacking PIP traits within a crop using traditional breeding techniques.
\4\EPA-initiated amendments shall not be charged fees. Fast-track amendments handled by the Antimicrobials Division are to be completed within the FIFRA
stated timelines listed in section 3(h) and are not subject to PRIA fees. Label amendments submitted by notification under PR Notices, such as PR
Notice 95-2 and PR Notice 98-10, continue under PR Notice timelines and are not subject to PRIA fees.
V. How to Pay Fees
Applicants must submit fee payments at the time of application, and
EPA will reject any application that does not contain evidence that the
fee has been paid. EPA has developed a web site at http://www.epa.gov/
pesticides/fees/tool/index.htm to help applicants identify the fee
category and the fee. All fees should be rounded up to the whole
dollar. Payments may be made by check, bank draft, or money order or
online with a credit card or wire transfer.
A. Online
You may pay electronically through the government payment website
www.pay.gov.
1. From the pay.gov home page, under ``Find Public Forms.''
2. Select ``search by Agency name.''
3. On the A-Z Index of Forms page, select ``E.''
4. Select ``Environmental Protection Agency.''
5. From the list of forms, select ``Pre-payment of Pesticide
Registration Improvement Act Fee.''
6. Complete the form entering the PRIA fee category and fee.
7. Keep a copy of the pay.gov acknowledgement of payment. A copy of
the acknowledgement must be printed and attached to the front of the
application to assure that EPA can match the application with the payment.
B. By Check or Money Order
All payments must be in United States currency by check, bank
draft, or money order drawn to the order of the Environmental
Protection Agency. On the check, the applicant must supply in the
information line either the registration number of the product or the
company number. A copy of the check must accompany the application to
the Agency, specifically attached to the front of the application. The
copy of the check ensures that payment has been made at the time of
application and will enable the Agency to properly connect the payment
with the application sent to the Agency.
If you send the Agency a check, it will be converted into an
electronic funds transfer (EFT). This means the Agency will copy your
check and use the account information on it to electronically debit
your account for the amount of the check. The debit from your account
will usually occur within 24 hours and will be shown on your regular
account statement.
You will not receive your original check back. The Agency will
destroy your original check but will keep the copy of it. If the EFT
cannot be processed for technical reasons, you authorize the Agency to
process the copy in place of your original check. If the EFT cannot be
completed because of insufficient funds, the Agency may try to make the
transfer up to two times.
All paper-based payments should be sent to the following address:
1. By U.S. Postal Service. U.S. Environmental Protection Agency,
Washington Finance Center, FIFRA Service Fees, P.O. Box 979074, St.
Louis, MO 63197-9000.
2. By courier or personal delivery. U.S. Bank, Government Lockbox
979074, 1005 Convention Plaza, SL-MO-C2-GL, St. Louis, MO 63197, (314)
418-4990.
VI. How to Submit Applications
Submissions to the Agency should be made at the address given in
Unit VII. The applicant should attach documentation that the fee has
been paid which may be pay.gov payment acknowledgement or a copy of the
check. If the applicant is applying for a fee waiver, the applicant
should provide sufficient documentation as described
[[Page 45450]]
in FIFRA section 33(b)(7) and http://www.epa.gov/pesticides/fees/
questions/waivers.htm. The fee waiver request should be easy to
identify and separate from the rest of the application and submitted
with documentation that at least 25% of the fee has been paid.
If evidence of fee payment (electronic acknowledgement or copy of
check properly identified as to company) is not submitted with the
application, EPA will reject the application and will not process it
further.
After EPA receives an application and payment, EPA performs a
screen on the application to determine that the category is correct and
that the proper fee amount has been paid. If either is incorrect, EPA
will notify the applicant and require payment of any additional amount
due. A refund will be provided in case of an overpayment. EPA will not
process the application further until the proper fee has been paid for
the category of application or a request for a fee waiver accompanies
the application and the appropriate portion of the fee has been paid.
EPA will assign a unique identification number to each covered
application for which payment has been made. EPA notifies the applicant
of the unique identification number. This information is sent by e-mail
if EPA has either an e-mail address on file or an e-mail address is
provided on the application.
VII. Addresses
New covered applications should be identified in the title line
with the mail code REGFEE.
1. By USPS mail. Document Processing Desk (REGFEE), Office of
Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460-0001.
2. By courier. Document Processing Desk (REGFEE), Office of
Pesticide Programs, U.S. Environmental Protection Agency, Room S-4400,
One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA
22202-4501.
Couriers and delivery personnel must present a valid picture
identification card to gain access to the building. Hours of operation
for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday
through Friday, excluding Federal holidays.
List of Subjects
Environmental protection, Administrative practice and procedure,
Pesticides.
Dated: July 28, 2008.
Marty Monell,
Acting Director, Office of Pesticide Programs.
[FR Doc. E8-17936 Filed 8-4-08; 8:45 am]
BILLING CODE 6560-50-S