[Federal Register: October 30, 2007 (Volume 72, Number 209)]
[Notices]
[Page 61465-61477]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc07-83]
[[Page 61465]]
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Part III
Environmental Protection Agency
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Pesticides; Revised Fee Schedule for Registration Applications; Notice
[[Page 61466]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1066; FRL-8155-6]
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 number of fee categories has been increased, the registration
service fees for some covered pesticide registration applications
received on or after October 1, 2007, have been increased, and certain
new procedures have been established. The new fees became effective on
October 1, 2007.
FOR FURTHER INFORMATION CONTACT: Elizabeth Leovey (7501P), Immediate
Office, Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7328; fax number: (703) 308-4776;e-mail address:
leovey.elizabeth@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you register
pesticide products under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Potentially affected entities may include, but
are not limited to:
Agricultural pesticide manufacturers (NAICS code 32532).
Antimicrobial pesticide manufacturers (NAICS code 32561).
Antifoulant pesticide manufacturers (NAICS code 32551).
Wood preservative manufacturers (NAICS code 32519).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in the notice and in
FIFRA section 33. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-1066. Publicly
available docket materials are available either in the electronic
docket athttp://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Background
In accordance with FIFRA section 33(b)(3), EPA published in the
Federal Register of March 17, 2004 (69 FR 12772) (FRL-7348-2), a
schedule of the fees and decision times for review of a covered
application. Section 33 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), establishes a registration service fee system
for certain types of pesticide applications, establishment of
tolerances and certain other regulatory decisions under FIFRA and the
Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also
established a schedule of decision review times for applications
covered by the service fee system. Since March 23, 2004, the Agency has
been administering the registration service fee system. The schedule of
fees and decision review times was published in the Federal Register of
March 17, 2004 (69 FR 12772). Subsequently, as authorized by FIFRA
section 33, fees were increased by 5% in a notice issued in the Federal
Register of June 2, 2005 (70 FR 32327) (FRL-7706-1).
III. The Pesticide Registration Improvement Renewal Act (PRIRA)
On October 9, 2007, the Pesticide Registration Improvement Renewal
Act was signed by the President, revising, among other things, FIFRA
section 33. The new law reauthorized the service fee system through
2012 and established fees and review times for applications received
during fiscal years 2008 through 2012. The publication of this fee
schedule is required by section 33(f)(1) of FIFRA as amended.
Key changes in the new law include the following:
1. The number of fee categories has been increased from 90 to 140.
In so doing, new categories were added, particularly in the area of
tolerances, review of study protocols, risk assessments not associated
with an application, and plant-incorporated protectants (PIPs). In
addition, some current categories were split into several new
categories to provide more specific listings.
2. The EPA identification system for fee categories has been
revised to a 3-digit system to accommodate the increased number of
categories. The new fee schedule continues to preface fee categories
according to the Divisional responsibilities within OPP (e.g., R for
Registration Division). As an example, the fee category for the new
category ``Enriched isomer(s) of registered mixed-isomer active
ingredient'' is R122.
3. Fees are due at application. Previously, the application could
be submitted to the Agency in advance of fee submittal and EPA would
``invoice'' or ``bill'' the applicant for the fee. Units VI. and VII.
discuss how the Agency intends to implement this new provision.
4. EPA must within 21 days after receipt of the application and
payment reject any application that does not pass the initial content
screen and that cannot be corrected. EPA must screen the application
within 21 days and make a determination, and verify appropriate fee
submission (or a waiver request with at least 25% of the applicable fee
accompanying the waiver request).
5. A portion of the fee, 25%, is non-refundable. The amount of a
refund for an early withdrawal during the first 60 days of the decision
time review period is now 75% of the fee. Previously, the Agency was
required to refund 90% for an early withdrawal.
6. A small business fee waiver cannot reduce the fee more than 75%
of the appropriate registration service fee instead of 100%,
previously.
7. Fees will be increased by 5% for applications received during
the period October 1, 2008 through September 30, 2010, and thereafter
increased by an additional 5% for applications received as of October
1, 2010. EPA will issue notice in the Federal Register of the new fee
schedules as appropriate.
[[Page 61467]]
IV. Elements of the Fee Schedule
This unit explains how EPA has organized the fee schedule
identified in the statute and how to read the fee schedule tables, and
includes a key to terminology published with the table in the
Congressional Review. EPA's organization and presentation of the fee
schedule information does not affect the categories of registration
service fees, or the structure or procedures for submitting
applications or petitions for tolerance.
A. The Congressional Record Fee Schedule
The fee schedule published in the Congressional Record of July 21,
2007 identifies the registration service fees and decision times and is
organized according to the organizational units of the Office of
Pesticide Programs (OPP) within EPA. Thereafter, the categories within
the organizational unit sections of the table are further categorized
according to the type of application being submitted, the use patterns
involved, or, in some cases, upon the type of pesticide that is the
subject of the application. The fee categories differ by Division.
Not all application types are covered by, or subject to, the fee
system and examples include:
1. The re-establishment of a time-limited tolerance.
2. Review of confirmatory data submitted in support of an already-
issued registration.
3. Submission of a sub-registrant/supplemental distributor label.
4. Special Local Needs Registrations submitted under FIFRA section
24(c).
5. Emergency Exemption Requests submitted under FIFRA section 18.
6. Notifications as described in Pesticide Registration Notice 98-
10.
7. Fast track amendments or label amendments that require no data
review.
8. Minor formulation amendments as described in Pesticide
Registration Notice 98-10.
9. 6(a)2 evaluations.
B. Fee Schedule and Decision Review Times
In today's notice, EPA has retained the format of previous schedule
notices and included the corrections to the schedule published in the
September 24, 2007 issue of the Congressional Record. These corrections
included: The registration service fee for new category No. 133 should
be $78,750, rather than $278,250; the decision time for new category
No. 47 in fiscal year 3 should be 12 months; and the action description
for the new category No. 61 should read: ``Non-food use; outdoor;
FIFRA, subsection 2(mm) uses (1).'' The schedules are presented as 11
tables, organized by OPP Division and by type of application or
pesticide subject to the fee. These tables only list the decision time
review periods for fiscal years 2008, 2009, and 2010 as these are the
only applicable review periods for applications received on or after
October 1, 2008. Unit V. presents fee tables for the Registration
Division (RD) (5 tables), the Antimicrobials Division (AD) (3 tables),
and the Biopesticides and Pollution Prevention Division (BPPD) (3
tables).
C. How to Read the Tables
1. Each table consists of the following columns:
The column entitled ``EPA No.'' assigns an EPA identifier
to each fee category. There are 140 categories spread across the 3
Divisions. There are 58 RD categories, 27 AD categories, and 55 BPPD
categories. For tracking purposes, OPP has assigned a 3-digit
identifier to each category, beginning with RD categories, followed by
AD and BPPD categories. The categories are prefaced with a letter
designation indicating which Division of OPP is responsible for
applications in that category (R= Registration Division,
A=Antimicrobials Division, B=Biopesticides and Pollution Prevention
Division).
The column entitled ``CR No.'' cross-references the
current Congressional Record category number for convenience. However,
EPA will be using the categories as numbered in the ``EPA No.'' column
in its tracking systems.
The column entitled ``Action'' describes the categories of
action. In establishing the expanded fee schedule categories, Congress
eliminated some of the more confusing terminology of the original
categories. For example, instead of the term ``fast-track,'' the
schedule in the Congressional Record uses the regulatory phrase
``identical or substantially similar in composition and use to a
registered product.''
The column entitled ``Decision Time'' list the decision
times in months for each type of action for Fiscal Years 2008, 2009,
and 2010. The 2010 decision times apply to 2011 and 2012. The decision
review periods in the tables are based upon EPA fiscal years (FY),
which run from October 1 through September 30.
The column entitled ``FY 08 Registration Service Fee ($)''
lists the registration service fee for the action for fiscal year 2008
(October 1, 2007 through September 30, 2008).
2. The following acronyms are used in some of the tables:
DART-Dose Adequacy Response Team
DNT-Developmental Neurotoxicity
HSRB-Human Studies Review Board
GW/SW-Ground Water/Surface Water
PHI-Pre-Harvest Interval
PPE-Personal Protective Equipment
REI-Restricted Entry Interval
SAP-FIFRA Scientific Advisory Panel
V. PRIRA Fee Schedule Tables--Effective October 1, 2007
A. Registration Division (RD)
The Registration Division of OPP is responsible for the processing
of pesticide applications and associated tolerance petitions for
pesticides that are termed ``conventional chemicals,'' excluding
pesticides intended for antimicrobial uses. The term ``conventional
chemical'' is a term of art that is intended to distinguish synthetic
chemicals from those that are of naturally occurring or non-synthetic
origin, synthetic chemicals that are identical to naturally-occurring
chemicals and microbial pesticides. Tables 1 through 5 of Unit V.A.
cover RD actions.
Table 1.-Registration Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision time (in months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R010 1 Food use\1\ 24 24 24 516,300
----------------------------------------------------------------------------------------------------------------
[[Page 61468]]
R020 2 Food use; reduced 18 18 18 516,300
risk\1\
----------------------------------------------------------------------------------------------------------------
R030 3 Food use; 24 24 24 570,700
Experimental Use
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; 18 18 18 380,500
Experimental Use
Permit
application;
establish
temporary
tolerance;
submitted before
application for
registration;
credit $326,025
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R050 5 Food use; 14 14 14 190,300
application
submitted after
Experimental Use
Permit
application;
decision time
begins after
Experimental Use
Permit and
temporary
tolerance are
granted\1\
----------------------------------------------------------------------------------------------------------------
R060 6 Non-food use; 21 21 21 358,700
outdoor\1\
----------------------------------------------------------------------------------------------------------------
R070 7 Non-food use; 16 16 16 358,700
outdoor; reduced
risk\1\
----------------------------------------------------------------------------------------------------------------
R080 8 Non-food use; 21 21 21 396,800
outdoor;
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; 16 16 16 266,300
outdoor;
Experimental Use
Permit application
submitted before
application for
registration;
credit $228,225
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R100 10 Non-food use; 12 12 12 130,500
outdoor; submitted
after Experimental
Use Permit
application;
decision time
begins after
Experimental Use
Permit
isgranted\1\
----------------------------------------------------------------------------------------------------------------
R110 11 Non-food use; 20 20 20 199,500
indoor\1\
----------------------------------------------------------------------------------------------------------------
R120 12 Non-food use; 14 14 14 199,500
indoor; reduced
risk\1\
----------------------------------------------------------------------------------------------------------------
R121 13 Non-food use; 18 18 18 150,000
indoor;
Experimental Use
Permit application
submitted before
application for
registration;
credit $100,000
toward new active
ingredient
application that
follows
----------------------------------------------------------------------------------------------------------------
R122 14 Enriched isomer(s) 18 18 18 260,900
of registered
mixed-isomer
activeingredient\1
\
----------------------------------------------------------------------------------------------------------------
R123 15 Seed treatment 18 18 18 388,200
only; includes non-
food and food
uses; limited
uptake into Raw
Agricultural
Commodities\1\
----------------------------------------------------------------------------------------------------------------
R124 16 Conditional Ruling 6 6 6 2,080
on Preapplication
Study Waivers;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
\1\All uses (food and/or non-food) included in any original application or petition for a new active ingredient
or a first food use that otherwise satisfy the conditions for the category are covered by the base fee for
that application.
TABLE 2.--Registration Division--New Uses
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R130 17 First food use; 21 21 21 157,500
indoor; food/food
handling\1\
----------------------------------------------------------------------------------------------------------------
R140 18 Additional food 15 15 15 36,750
use; Indoor; food/
food handling
----------------------------------------------------------------------------------------------------------------
R150 19 First food use\1\ 21 21 21 217,400
----------------------------------------------------------------------------------------------------------------
R160 20 First food use; 16 16 16 217,400
reduced risk\1\
----------------------------------------------------------------------------------------------------------------
R170 21 Additional food use 15 15 15 54,400
----------------------------------------------------------------------------------------------------------------
R180 22 Additional food 10 10 10 54,400
use; reduced risk
----------------------------------------------------------------------------------------------------------------
[[Page 61469]]
R190 23 Additional food 15 15 15 326,400
uses; six or more
submitted in one
application
----------------------------------------------------------------------------------------------------------------
R200 24 Additional food 10 10 10 326,400
uses; six or more
submitted in one
application;
reduced risk
----------------------------------------------------------------------------------------------------------------
R210 25 Additional food 12 12 12 40,300
use; Experimental
Use Permit
application;
establish
temporary
tolerance; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R220 26 Additional food 6 6 6 16,320
use; Experimental
Use Permit
application; crop
destruct basis; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R230 27 Additional use; non- 15 15 15 21,740
food; outdoor
----------------------------------------------------------------------------------------------------------------
R240 28 Additional use; non- 10 10 10 21,740
food; outdoor;
reduced risk
----------------------------------------------------------------------------------------------------------------
R250 29 Additional use; non- 6 6 6 16,320
food; outdoor;
Experimental Use
Permit
application; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R260 30 New use; non-food; 12 12 12 10,500
indoor
----------------------------------------------------------------------------------------------------------------
R270 31 New use; non-food; 9 9 9 10,500
indoor; reduced
risk
----------------------------------------------------------------------------------------------------------------
R271 32 New use; non-food; 6 6 6 8,000
indoor;
Experimental Use
Permit
application; no
credit toward new
use registration
----------------------------------------------------------------------------------------------------------------
R272 33 Review of Study 3 3 3 2,080
Protocol;
applicant-
initiated;
excludes DART, pre-
registration
conferences, Rapid
Response review,
DNT protocol
review, protocols
needing HSRB
review
----------------------------------------------------------------------------------------------------------------
R273 34 Additional use; 12 12 12 41,500
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
----------------------------------------------------------------------------------------------------------------
R274 35 Additional uses; 12 12 12 249,000
seed treatment
only; six or more
submitted in one
application;
limited uptake
into Raw
Agricultural
Commodities;
includes crops
with established
tolerances (e.g.,
for soil or foliar
application);
includes food and/
or non-food uses
----------------------------------------------------------------------------------------------------------------
\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 3.--Registration Division--Import and Other Tolerances
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R280 36 Establish import 21 21 21 262,500
tolerance; new
active ingredient
or first food
use\1\
----------------------------------------------------------------------------------------------------------------
R290 37 Establish import 15 15 15 52,500
tolerance;
additional food
use
----------------------------------------------------------------------------------------------------------------
R291 38 Establish import 15 15 15 315,000
tolerances;
additional food
uses; six or more
crops submitted in
one petition
----------------------------------------------------------------------------------------------------------------
R292 39 Amend an 10 10 10 37,300
established
tolerance (e.g.,
decrease or
increase);
domestic or
import; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R293 40 Establish 12 12 12 44,000
tolerance(s) for
inadvertent
residues in one
crop; applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R294 41 Establish 12 12 12 264,000
tolerances for
inadvertent
residues; six or
more crops
submitted in one
application;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
[[Page 61470]]
R295 42 Establish 15 15 15 54,400
tolerance(s) for
residues in one
rotational crop in
response to a
specific
rotational crop
application;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R296 43 Establish 15 15 15 326,400
tolerances for
residues in
rotational crops
in response to a
specific
rotational crop
petition; six 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 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R300 44 New product; 3 3 3 1,300
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.
----------------------------------------------------------------------------------------------------------------
R301 45 New product; 4 4 4 1,560
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
----------------------------------------------------------------------------------------------------------------
R310 46 New end-use or 6 6 6 4,360
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.
----------------------------------------------------------------------------------------------------------------
R311 49 New product; 12 12 12 15,540
requires approval
of new food-use
inert; applicant-
initiated;
excludes approval
of safeners
----------------------------------------------------------------------------------------------------------------
R312 50 New product; 6 6 6 8,300
requires approval
of new non-food-
use inert;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R313 51 New product; 10 10 10 11,420
requires amendment
to existing inert
tolerance
exemption (e.g.,
adding post-
harvest use);
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R320 47 New product; new 12 12 12 10,880
physical form;
requires data
review in science
divisions
----------------------------------------------------------------------------------------------------------------
R330 48 New manufacturing- 12 12 12 16,320
use product;
registered active
ingredient;
selective data
citation
----------------------------------------------------------------------------------------------------------------
R331 52 New product; repack 3 3 3 2,080
of identical
registered end-use
product as a
manufacturing-use
product; same
registered uses
only
----------------------------------------------------------------------------------------------------------------
R332 53 New manufacturing- 24 24 24 233,000
use product;
registered active
ingredient;
unregistered
source of active
ingredient;
submission of
completely new
generic data
package;
registered uses
only
----------------------------------------------------------------------------------------------------------------
[[Page 61471]]
Table 5.--Registration Division--Amendments to Registration
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
R340 54 Amendment requiring 4 4 4 3,280
data 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 8 8 8 10,880
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\
----------------------------------------------------------------------------------------------------------------
R370 56 Cancer 18 18 18 163,100
reassessment;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
R371 57 Amendment to 6 6 6 8,300
Experimental Use
Permit; requires
data review/risk
assessment
----------------------------------------------------------------------------------------------------------------
R372 58 Refined ecological 18 18 12 155,300
and/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.
B. Antimicrobials Division (AD)
The Antimicrobials Division of OPP is responsible for the
processing of pesticide applications and associated tolerances for
conventional chemicals intended for antimicrobial uses, that is, uses
that are defined under FIFRA section 2(mm)(1)(A), including products
for use against bacteria, protozoa, non-agricultural fungi, and
viruses. AD is also responsible for a selected set of conventional
chemicals intended for other uses, including most wood preservatives
and antifoulants. Tables 6 through 8 of Unit V.B. cover AD actions.
Table 6.--Antimicrobials Division--New Active Ingredients
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
A380 59 Food use; establish 24 24 24 94,500
tolerance
exemption\1\
----------------------------------------------------------------------------------------------------------------
A390 60 Food use; establish 24 24 24 157,500
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A400 61 Non-food use; 18 18 18 78,750
outdoor; FIFRA
section 2(mm)
uses\1\
----------------------------------------------------------------------------------------------------------------
A410 62 Non-food use; 21 21 21 157,500
outdoor; uses
other than
FIFRAsection
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A420 63 Non-food use; 18 18 18 52,500
indoor; FIFRA
section 2(mm)
uses\1\
----------------------------------------------------------------------------------------------------------------
A430 64 Non-food use; 20 20 20 78,750
indoor; uses other
than FIFRAsection
2(mm)\1\
----------------------------------------------------------------------------------------------------------------
A431 65 Non-food use; 12 12 12 55,000
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
----------------------------------------------------------------------------------------------------------------
\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 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
A440 66 First food use; 21 21 21 26,250
establish
tolerance
exemption\1\
----------------------------------------------------------------------------------------------------------------
A450 67 First food use; 21 21 21 78,750
establish
tolerance\1\
----------------------------------------------------------------------------------------------------------------
A460 68 Additional food 15 15 15 10,500
use; establish
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
A470 69 Additional food 15 15 15 26,250
use; establish
tolerance
----------------------------------------------------------------------------------------------------------------
[[Page 61472]]
A480 70 Additional use; non- 9 9 9 15,750
food; outdoor;
FIFRA section
2(mm) uses
----------------------------------------------------------------------------------------------------------------
A490 71 Additional use; non- 15 15 15 26,250
food; outdoor;
uses other than
FIFRA section
2(mm)
----------------------------------------------------------------------------------------------------------------
A500 72 Additional use; non- 9 9 9 10,500
food; indoor;
FIFRA section
2(mm) uses
----------------------------------------------------------------------------------------------------------------
A510 73 Additional use; non- 12 12 12 10,500
food; indoor; uses
other than FIFRA
section 2(mm)
----------------------------------------------------------------------------------------------------------------
A520 74 Experimental Use 9 9 9 5,250
Permit application
----------------------------------------------------------------------------------------------------------------
A521 75 Review of public 6 4 3 2,000
health efficacy
study protocol
within AD; per AD
Internal Guidance
for the Efficacy
Protocol Review
Process; applicant-
initiated; Tier 1
----------------------------------------------------------------------------------------------------------------
A522 76 Review of public 18 15 12 10,000
health 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 time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
A530 77 New product; 3 3 3 1,050
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.
----------------------------------------------------------------------------------------------------------------
A531 78 New product; 4 4 4 1,500
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
----------------------------------------------------------------------------------------------------------------
A532 85 New product; 4 4 4 4,200
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
----------------------------------------------------------------------------------------------------------------
A540 79 New end use 4 4 4 4,200
product; FIFRA
section 2(mm) uses
only
----------------------------------------------------------------------------------------------------------------
A550 80 New end-use 6 6 6 4,200
product; uses
other than FIFRA
section 2(mm); non-
FQPA product
----------------------------------------------------------------------------------------------------------------
A560 81 New manufacturing- 12 12 12 15,750
use product;
registered active
ingredient;
selective data
citation
----------------------------------------------------------------------------------------------------------------
A570 82 Label amendment 4 4 4 3,150
requiring data
submission\1\
----------------------------------------------------------------------------------------------------------------
A571 83 Cancer 18 18 18 78,750
reassessment;
applicant-
initiated
----------------------------------------------------------------------------------------------------------------
A572 84 Refined ecological 18 18 12 75,000
risk and/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.
[[Page 61473]]
C. Biopesticides and Pollution Prevention Division (BPPD)
The Biopesticides and Pollution Prevention Division of OPP is
responsible for the processing of pesticide applications for
biochemical pesticides, microbial pesticides, and plant-incorporated
protectants (PIPs).
The fee tables for BPPD tables are presented by type of pesticide
rather than by type of action: Microbial and biochemical pesticides,
straight chain lepidopteran pheromones (SCLPs), and PIPs. Within each
table, the types of application are the same as those in other
divisions and use the same terminology as in Unit III. Tables 9 through
11 of Unit V.C. cover BPPD actions.
Table 9.--Biopesticides and Pollution Prevention Division--Microbial and Biochemical Pesticides; New Products
and Amendments
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
B580 86 New active 18 18 18 42,000
ingredient; food
use; establish
tolerance\1\
----------------------------------------------------------------------------------------------------------------
B590 87 New active 16 16 16 26,250
ingredient; food
use; establish
toleranceexemption
\1\
----------------------------------------------------------------------------------------------------------------
B600 88 New active 12 12 12 15,750
ingredient; non-
food use\1\
----------------------------------------------------------------------------------------------------------------
B610 89 Food use; 9 9 9 10,500
Experimental Use
Permit
application;
establish
temporary
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
B620 90 Non-food use; 6 6 6 5,250
Experimental Use
Permit application
----------------------------------------------------------------------------------------------------------------
B621 91 Extend or amend 6 6 6 4,200
Experimental Use
Permit
----------------------------------------------------------------------------------------------------------------
B630 92 First food use; 12 12 12 10,500
establish
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
B631 93 Amend established 9 9 9 10,500
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
B640 94 First food use; 18 18 18 15,750
establish
tolerance\1\
----------------------------------------------------------------------------------------------------------------
B641 95 Amend established 12 12 12 10,500
tolerance (e.g.,
decrease or
increase)
----------------------------------------------------------------------------------------------------------------
B650 96 New use; non-food 6 6 6 5,250
----------------------------------------------------------------------------------------------------------------
B660 97 New product; 3 3 3 1,050
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.
----------------------------------------------------------------------------------------------------------------
B670 98 New product; 6 6 6 4,200
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
----------------------------------------------------------------------------------------------------------------
B671 99 New product; food 16 16 16 10,500
use; unregistered
source of active
ingredient;
requires amendment
of established
tolerance or
tolerance
exemption; all
Tier I data
requirements for
product chemistry,
toxicology, non-
target organisms,
and product
performance must
be addressed with
product-specific
data or with
request for data
waivers supported
by scientific
rationales
----------------------------------------------------------------------------------------------------------------
B672 100 New product; non- 12 12 12 7,500
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 4 4 4 4,200
requiring data
submission\2\
----------------------------------------------------------------------------------------------------------------
B681 102 Label amendment; 6 6 6 5,000
unregistered
source of active
ingredient;
supporting data
require scientific
review
----------------------------------------------------------------------------------------------------------------
[[Page 61474]]
B682 103 Protocol review; 3 3 3 2,000
applicant-
initiated;
excludes time for
HSRB review
(preapplication)
----------------------------------------------------------------------------------------------------------------
\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)
----------------------------------------------------------------------------------------------------------------
Decision time (months) FY 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
B690 104 New active 6 6 6 2,100
ingredient; food
or non-food use\1\
----------------------------------------------------------------------------------------------------------------
B700 105 Experimental Use 6 6 6 1,050
Permit
application; new
active ingredient
or new use
----------------------------------------------------------------------------------------------------------------
B701 106 Extend or amend 3 3 3 1,050
Experimental Use
Permit
----------------------------------------------------------------------------------------------------------------
B710 107 New product; 3 3 3 1,050
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.
----------------------------------------------------------------------------------------------------------------
B720 108 New product; 4 4 4 1,050
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
----------------------------------------------------------------------------------------------------------------
B721 109 New product; 6 6 6 2,200
unregistered
source of active
ingredient
----------------------------------------------------------------------------------------------------------------
B722 110 New use and/or 6 6 6 2,200
amendment to
tolerance or
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
B730 111 Label amendment 4 4 4 1,050
requiring data
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 08
--------------------------------- Registration
EPA No. CR No. Action Service Fee
FY 08 FY 09 FY 10 ($)
----------------------------------------------------------------------------------------------------------------
B740 112 Experimental Use 6 6 6 78,750
Permit
application;
registered active
ingredient; non-
food/feed or crop
destruct basis; no
SAP review
required\1\
----------------------------------------------------------------------------------------------------------------
B750 113 Experimental Use 9 9 9 105,000
Permit
application;
registered active
ingredient;
establish
temporary
tolerance or
tolerance
exemption; no SAP
reviewrequired\1\
----------------------------------------------------------------------------------------------------------------
[[Page 61475]]
B760 114 Experimental Use 12 12 12 131,250
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
----------------------------------------------------------------------------------------------------------------
B761 115 Experimental Use 7 7 7 78,750
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
----------------------------------------------------------------------------------------------------------------
B770 116 Experimental Use 15 15 15 157,500
Permit
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 10 10 10 105,000
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
----------------------------------------------------------------------------------------------------------------
B772 118 Amend or extend 3 3 3 10,500
Experimental Use
Permit; minor
changes to
experimental
design;
established
temporary
tolerance or
tolerance
exemption is
unaffected
----------------------------------------------------------------------------------------------------------------
B773 119 Amend or extend 5 5 5 26,250
existing
Experimental Use
Permit; minor
changes to
experimental
design; extend
established
temporary
tolerance or
tolerance
exemption
----------------------------------------------------------------------------------------------------------------
B860 120 Amend Experimental 6 6 6 10,500
Use Permit; first
food use or major
revision of
experimental
design
----------------------------------------------------------------------------------------------------------------
B780 121 New active 12 12 12 131,250
ingredient; non-
food/feed; no SAP
reviewrequired\2\
----------------------------------------------------------------------------------------------------------------
B790 122 New active 18 18 18 183,750
ingredient; Non-
food/feed; SAP
reviewrequired\2\
----------------------------------------------------------------------------------------------------------------
B800 123 New active 12 12 12 210,000
ingredient;
establish
permanent
tolerance or
tolerance
exemption based on
temporary
tolerance or
tolerance
exemption; no SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B810 124 New active 18 18 18 262,500
ingredient;
establish
permanent
tolerance or
tolerance
exemption based on
temporary
tolerance or
tolerance
exemption; SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B820 125 New active 15 15 15 262,500
ingredient;
establish
tolerance or
tolerance
exemption; no SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B840 126 New active 21 21 21 315,000
ingredient;
establish
tolerance or
tolerance
exemption; SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B830 127 New active 15 15 15 315,000
ingredient;
Experimental Use
Permit application
submitted
simultaneously;
establish
tolerance or
tolerance
exemption; no SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B850 128 New active 21 21 21 367,500
ingredient;
Experimental Use
Permit requested
simultaneously;
establish
tolerance or
tolerance
exemption; SAP
review required\2\
----------------------------------------------------------------------------------------------------------------
B851 129 New active 9 9 9 105,000
ingredient;
different genetic
event of a
previously
approved active
ingredient; same
crop; no tolerance
action required;
no SAP review
required
----------------------------------------------------------------------------------------------------------------
B852 130 New active 9 9 9 157,500
ingredient;
different genetic
event of a
previously
approved active
ingredient; same
crop; no tolerance
action required;
SAP review
required
----------------------------------------------------------------------------------------------------------------
B870 131 New use\1\ 9 9 9 31,500
----------------------------------------------------------------------------------------------------------------
B880 132 New product; no SAP 9 9 9 26,250
review required\3\
----------------------------------------------------------------------------------------------------------------
[[Page 61476]]
B881 133 New product; SAP 15 15 15 78,750
review required\3\
----------------------------------------------------------------------------------------------------------------
B890 134 Amendment; seed 9 9 9 52,500
production to
commercial
registration; no
SAP review
required
----------------------------------------------------------------------------------------------------------------
B891 135 Amendment; seed 15 15 15 105,000
production to
commercial
registration; SAP
review required
----------------------------------------------------------------------------------------------------------------
B900 136 Amendment (except 6 6 6 10,500
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\
----------------------------------------------------------------------------------------------------------------
B901 137 Amendment (except 12 12 12 63,000
B890); SAP review
required\4\
----------------------------------------------------------------------------------------------------------------
B902 138 PIP Protocol review 3 3 3 5,250
----------------------------------------------------------------------------------------------------------------
B903 139 Inert ingredient 6 6 6 52,500
tolerance
exemption; e.g., a
marker such as NPT
II; reviewed in
BPPD
----------------------------------------------------------------------------------------------------------------
B904 140 Import tolerance or 9 9 9 105,000
tolerance
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.
VI. How to Pay Fees
Applicants must now submit fee payments at the time of application,
and EPA will reject any application that does not contain evidence that
the fee has been paid. EPA has developed a web site athttp://www.epa.gov/pesticides/fees/tool/index.htm
to help applicants identify
the fee category and the fee. All fees (and other amounts) should be
rounded up to the whole dollar. Payments may be made by check, bank
draft, or money order or online with a credit card or wire transfer.
A. Online
You may pay electronically through the government payment
websitehttp://www.pay.gov.
1. From the pay.gov home page, under ``Find Public Forms.''
2. Select ``search by form name.''
3. On the A-Z Index of Forms page, select ``P.''
4. From the list of forms on the second page, select ``Pre-payment
of Pesticide Registration Improvement Act Fee.''
5. Complete the form entering the PRIA fee category and fee.
6. Keep a copy of the pay.gov acknowledgement of payment. A copy of
the acknowledgement must be printed and attached to the front of the
application to assure that EPA can match the application with the
payment.
B. By Check or Money Order
All payments should be in United States currency by check, bank
draft, or money order drawn to the order of the Environmental
Protection Agency. On the check, the applicant must supply in the
information line either the registration number of the product or the
company number. A copy of the check must accompany the application to
the Agency, specifically attached to the front of the application. The
copy of the check ensures that payment has been made at the time of
application and will enable the Agency to properly connect the payment
with the application sent to the Agency.
If you send the Agency a check, it will be converted into an
electronic funds transfer (EFT). This means the Agency will copy your
check and use the account information on it to electronically debit
your account for the amount of the check. The debit from your account
will usually occur within 24 hours, and will be shown on your regular
account statement.
You will not receive your original check back. The Agency will
destroy your original check, but will keep the copy of it. If the EFT
cannot be processed for technical reasons, you authorize the Agency to
process the copy in place of your original check. If the EFT cannot be
completed because of insufficient funds, the Agency may try to make the
transfer up to two times.
All paper-based payments should be sent to the following address:
1. By U.S. Postal Service. U.S. Environmental Protection Agency,
Washington Finance Center, FIFRA Service Fees, P.O. Box 979074,St.
Louis, MO 63197-9000.
2. By courier or personal delivery. U.S. Bank, Government Lockbox
979074, 1005 Convention Plaza, SL-MO-C2-GL, St. Louis, MO 63197, (314)
418-4990.
VII. How to Submit Applications
Submissions to the Agency should be made at the address given in
Unit VIII. The applicant should attach documentation that the fee has
been paid which may be a copy of the check or pay.gov payment
acknowledgement. If the applicant is applying for a fee waiver, the
applicant should provide sufficient documentation as described in FIFRA
section 33(b)(7) andhttp://www.epa.gov/pesticides/fees/questions/waivers.htm.
The fee waiver request should be easy to identify and
separate
[[Page 61477]]
from the rest of the application and submitted with documentation that
at least 25% of the fee has been paid.
If evidence of fee payment (electronic acknowledgement or copy of
check properly identified as to company) is not submitted with the
application, EPA will reject the application and will not process it
further.
After EPA receives an application and payment, EPA performs a
screen on the application to determine that the category is correct and
that the proper fee amount has been paid. If either is incorrect, EPA
will notify the applicant and require payment of any additional amount
due. A refund will be provided in case of an overpayment. EPA will not
process the application further until the proper fee has been paid for
the category of application or a request for a fee waiver accompanies
the application and the appropriate portion of the fee has been paid.
EPA will assign a unique identification number to each covered
application for which payment has been made. EPA notifies the applicant
of the unique identification number. This information is sent by e-mail
if EPA has either an e-mail address on file or an e-mail address is
provided on the application.
VIII. Addresses
New covered applications should be identified in the title line
with the mail code REGFEE.
1. By USPS mail. Document Processing Desk (REGFEE), Office of
Pesticide Programs (7504P), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460-0001.
2. By courier. Document Processing Desk (REGFEE), Office of
Pesticide Programs, U.S. Environmental Protection Agency, Room S-
4400,One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington,
VA 22202-4501.
Couriers and delivery personnel must present a valid picture
identification card to gain access to the building. Hours of operation
for the Document Processing Desk are 8 a.m. to 4:30 p.m., Monday
through Friday, excluding Federal holidays.
List of Subjects
Environmental protection, Administrative practice and procedure,
Pesticides.
Dated: October 23, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. 07-5381 Filed 10-29-07; 8:45 am]
BILLING CODE 6560-50-S