FLUORIDE ACTION NETWORK PESTICIDE PROJECT

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July 30, 2003. US EPA's Pesticide
Reregistration Performance Measures and Goals.
Federal Register.

Benfluralin
Fluazifop butyl
Lactofen
Sodium acifluorfen
Sodium fluoride
Trifluralin.



Brief summary of Organofluorine and Fluorine (Sodium fluoride) pesticides cited in the following Notice.

Candidate pesticides for EPA decision documents in Fiscal Year 2004 (EPA's fiscal year for 2004 runs from October 1, 2003, through September 30, 2004)

Benfluralin FY 2004. RED: Candidate for Reregistration Eligibility Decision
Fluazifop butyl FY 2004. TRED: Candidate for Tolerance Reassessment Progress and Interim Risk Management Decision
Lactofen FY 2004. TRED: Candidate for Tolerance Reassessment Progress and Interim Risk Management Decision
Sodium acifluorfen FY 2004. RED: Candidate for Reregistration Eligibility Decision
Sodium fluoride FY 2004. RED: Candidate for Reregistration Eligibility Decision
Trifluralin FY 2004. TRED: Candidate for Tolerance Reassessment Progress and Interim Risk Management Decision
Documents completed in 2002 As of Fiscal Year 2002 * As of Fiscal Year 2002 * Total decisions made by US EPA up to Fiscal Year 2002
Oxyfluorfen FY 2002: RED. Reregistration/Risk Management Decisions Completed (Reregistration Eligibility Decision)

REDs completed: 7

-- More information on Oxyfluorfen below

REDs completed: 214
Norflurazon FY 2002: TRED. Reregistration/Risk Management Decisions Completed (Tolerance Reassessment Progress and Interim Risk Management Decision) TREDs completed: 21 TREDs completed: 32
Primisulfuron-methyl FY 2002: TRED. Reregistration/Risk Management Decisions Completed (Tolerance Reassessment Progress and Interim Risk Management Decision)

TREDs completed: 21

-- More information on Primisulfuron-methyl below

TREDs completed: 32
* Note: The fiscal year runs from October 1, 2001, through September 30, 2002.

 

http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19353.htm


[Federal Register: July 30, 2003 (Volume 68, Number 146)]
[Notices]
[Page 44767-44776]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy03-54]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0327; FRL-7284-6]
 
Pesticide Reregistration Performance Measures and Goals

AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  This notice announces EPA's progress in meeting its 
performance measures and goals for pesticide reregistration during 
fiscal year 2002. The Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) requires EPA to publish information about EPA's annual 
achievements in this area. This notice discusses the integration of 
tolerance reassessment with the reregistration process, and describes 
the status of various regulatory activities associated with 
reregistration and tolerance reassessment. The notice gives total 
numbers of chemicals and products reregistered, tolerances reassessed, 
Data Call-Ins issued, and products registered under the ``fast-track'' 
provisions of FIFRA. Finally, this notice contains the schedule for 
completion of activities for specific chemicals during fiscal years 
2003 and 2004.

DATES:  This notice is not subject to a formal comment period. 
Nevertheless, EPA welcomes input from stakeholders and the general 
public. Written comments, identified by the docket ID number [OPP-2002-
0327], should be received on or before September 29, 2003.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION section of this 
notice.

FOR FURTHER INFORMATION CONTACT:  Carol P. Stangel, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460, telephone: (703) 308-8007, e-mail: 
stangel.carol@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Important Information

A. Does this Apply to Me?

    This action is directed to the public in general. Although this 
action may be of particular interest to persons who are interested in 
the progress and status of EPA's pesticide reregistration and tolerance 
reassessment programs, the Agency has not attempted to describe all the 
specific entities that may be affected by this action. If you have any 
questions regarding the information in this notice, consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information or Copies of Support Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2002-0327. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket 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/. To access information about 
pesticide reregistration, go to the home page for the Office of 
Pesticide Programs at www.epa.gov/pesticides and select 
``Reregistration'' under ``Regulating Pesticides,'' or go directly to 
www.epa.gov/pesticides/reregistration/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
     Certain types of information will not be placed in EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although, not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or

[[Page 44768]]

other information whose disclosure is restricted by statute. When EPA 
identifies a comment containing copyrighted material, EPA will provide 
a reference to that material in the version of the comment that is 
placed in EPA's electronic public docket. The entire printed comment, 
including the copyrighted material, will be available in the public 
docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment, and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    2. EPA Dockets--i. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2002-0327. The system is an, ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2002-0327. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), 
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP- 2002-0327.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2002-0327. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

II. Background

    EPA must establish and publish in the Federal Register its annual 
performance measures and goals for pesticide reregistration, tolerance 
reassessment, and expedited registration, under section 4(l) of FIFRA, 
as amended by the Food Quality Protection Act of 1996 (FQPA). 
Specifically, such measures and goals are to include:
    • The status of reregistration.
    • The number of products reregistered, canceled, or amended.
    • The number and type of data requests or Data Call-In (DCI) 
notices under section 3(c)(2)(B) issued to support product 
reregistration by active ingredient.
    • Progress in reducing the number of unreviewed, required 
reregistration studies.
    • The aggregate status of tolerances reassessed.
    • The number of applications for registration submitted under 
subsection (k)(3), expedited processing and review of similar 
applications, that were approved or disapproved.
    • The future schedule for reregistrations in the current and 
succeeding fiscal year.
    • The projected year of completion of the reregistrations 
under section 4.
    FIFRA, as amended in 1988, authorizes EPA to conduct a 
comprehensive pesticide reregistration program--a complete review of 
the human health and environmental effects of older pesticides 
originally registered before November 1, 1984. Pesticides meeting 
today's scientific and regulatory

[[Page 44769]]

standards may be declared ``eligible'' for reregistration. To be 
eligible, an older pesticide must have a substantially complete data 
base, and must not cause unreasonable adverse effects to human health 
or the environment when used according to Agency approved label 
directions and precautions.
    In addition, all pesticides with food uses must meet the safety 
standard of section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) 21 U.S.C. 346a, as amended by the Food Quality Protection Act 
(FQPA) of 1996. Under FFDCA, EPA must make a determination that 
pesticide residues remaining in or on food are ``safe''; that is, 
``that there is reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue'' from dietary and 
other sources. In determining allowable levels of pesticide residues in 
food, EPA must perform a more comprehensive assessment of each 
pesticide's risks, considering:
    • Aggregate exposure (from food, drinking water, and 
residential uses).
    • Cumulative effects from all pesticides sharing a common 
mechanism of toxicity.
    • Possible increased susceptibility of infants and children; 
and
    • Possible endocrine or estrogenic effects.
    As amended by FQPA, FFDCA requires the reassessment of all existing 
tolerances (pesticide residue limits in food) and tolerance exemptions 
within 10 years, to ensure that they meet the safety standard of the 
law. EPA was directed to give priority to the review of those 
pesticides that appear to pose the greatest risk to public health, and 
to reassess 33% of the 9,721 existing tolerances and exemptions within 
3 years (by August 3, 1999), 66% within 6 years (by August 3, 2002), 
and 100% in 10 years (by August 3, 2006). (Note: Although the total 
number of tolerances existing on August 3, 1996, and subject to FQPA 
reassessment was initially reported as 9,728, that number has been 
corrected to 9,721, based on the Agency's Tolerance Reassessment 
Tracking System.)
    EPA is meeting the FFDCA's tolerance reassessment requirements 
through reregistration and several other program activities. In making 
reregistration eligibility decisions, the Agency also is completing 
much of tolerance reassessment, which is helping us meet the time 
frames mandated by the new law. EPA reassessed the first 33% of all 
food tolerances by August 3, 1999, and the second 33% of all food 
tolerances by August 3, 2002. EPA is focusing particularly on priority 
Group 1 pesticides, those identified as posing the greatest potential 
risks. Over half of the universe of tolerances to be reassessed are 
included in this category, including tolerances for the organophosphate 
(OP) pesticides, the Agency's highest priority for review. Carbamate, 
organochlorine, and B2 (probable human) carcinogen pesticides also are 
included in priority Group 1. Although EPA is directing most of its 
resources toward this group, a number of Group 1 pesticides will 
nevertheless be reassessed in the third 33% owing to the challenging 
issues they present. EPA's approach to tolerance reassessment under 
FFDCA, including the three priority Groups, is described fully in the 
Agency's document, ``Raw and Processed Food Schedule for Pesticide 
Tolerance Reassessment'' (62 FR 42020, August 4, 1997) (FRL-5734-6). In 
conducting the pesticide reregistration and tolerance reassessment 
programs at present, EPA is developing measures that show results in 
terms of outcomes, as well as traditional outputs, as directed by OMB.

III. FQPA and Program Accountability

    One of the hallmarks of the FQPA amendments to the FFDCA is 
enhanced accountability. Through this summary of performance measures 
and goals for pesticide reregistration, tolerance reassessment, and 
expedited registration, EPA describes progress made during the past 
year in each of the program areas included in FIFRA section 4(l).

A. Status of Reregistration

    During fiscal year (FY) 2002 (from October 1, 2001, through 
September 30, 2002), EPA made significant progress in completing risk 
assessments and risk management decisions for the OP pesticides, the 
Agency's highest priority chemicals for reregistration and tolerance 
reassessment, and for other pesticides. See Table 1.

  Table 1.--Reregistration/Risk Management Decisions Completed: FY 2002
                                and Total
------------------------------------------------------------------------
           FY 2002: 36 Decisions                Total, End of FY 2002
------------------------------------------------------------------------
7 REDs                                      214 REDs
1,4-Bis(bromoacetoxy)-2-butene............
Endosulfan1...............................
Fenamiphos (Voluntary Cancellation)2......
(HOCH2-)methyldithiocarbamate (Voluntary
 Cancellation).
Lindane1..................................
Oxyfluorfen...............................
Thiabendazole.............................
------------------------------------------------------------------------
8 IREDs                                     21 IREDs
Azinphos-methyl1,2........................
Diazinon1,2...............................
Dicrotophos2..............................
Disulfoton2...............................
Methamidophos2............................
Naled2....................................
Oxydemeton-methyl2........................
Phosmet1,2................................
------------------------------------------------------------------------

[[Page 44770]]

21 TREDs                                    32 TREDs
Asulam....................................
Calcium hypochlorite......................
Chlorine gas..............................
Chlorpropham..............................
Difenzoquat...............................
Diquat dibromide..........................
Diuron (RED to be completed in FY 2003)...
Fenarimol.................................
Fenbutatin-oxide..........................
Hexazinone................................
Imazalil (RED to be completed in FY 2003).
Linuron...................................
Metolachlor...............................
Norflurazon...............................
Primisulfuron-methyl......................
Pronamide.................................
Propanil (RED to be completed in FY 2003).
Sodium hypochlorite.......................
Tebuthiuron...............................
Tetrachlorvinphos2........................
Urea......................................
------------------------------------------------------------------------
1Subject to NRDC consent decree
2Organophosphate (OP) pesticide

    The Agency's decisions are embodied in Reregistration Eligibility 
Decision (RED) documents, Interim Reregistration Eligibility Decisions 
(IREDs), or Reports on FQPA Tolerance Reassessment Progress and Interim 
Risk Management Decisions (TREDs).
    1. REDs. Through the reregistration program, EPA is reviewing 
current scientific data for older pesticides (those initially 
registered before November 1984), reassessing their effects on human 
health and the environment, and requiring risk mitigation measures as 
necessary. Pesticides that have sufficient supporting data and whose 
risks can be successfully mitigated may be declared ``eligible'' for 
reregistration. EPA presents these pesticide findings in a RED 
document.
    i. Overall RED progress. EPA's overall progress at the end of FY 
2002 in completing Reregistration Eligibility Decisions (REDs) is 
summarized in Table 2.

             Table 2.--Overall RED Progress, End of FY 2002
------------------------------------------------------------------------

------------------------------------------------------------------------
REDs completed                              214 (35%)
------------------------------------------------------------------------
Cases canceled                              231 (38%)
------------------------------------------------------------------------
REDs to be completed                        167 (27%)
------------------------------------------------------------------------
Total reregistration cases                  612 (100%)
------------------------------------------------------------------------

    ii. Profile of completed REDs. A profile of the 214 REDs completed 
by the end of FY 2002 is presented in Table 3.

         Table 3.--Profile of 214 REDs Completed, End of FY 2002
------------------------------------------------------------------------

------------------------------------------------------------------------
Pesticide active ingredients                313
------------------------------------------------------------------------
Pesticide products                          8,600+
------------------------------------------------------------------------
REDs with food uses                         107
------------------------------------------------------------------------
Post-FQPA REDs                              73
------------------------------------------------------------------------
Post-FQPA REDs with food uses               54
------------------------------------------------------------------------
Tolerance reassessments completed for post- 1,322
 FQPA REDs*
------------------------------------------------------------------------
*EPA is revisiting tolerances associated with the 53 food use REDs that
  were completed before FQPA was enacted to ensure that they meet the
  safety standard of the new law, as set forth in the Agency's August 4,
  1997, Schedule for Pesticide Tolerance Reassessment.

    iii. Risk reduction in REDs. Reducing pesticide risks is an 
important aspect of the reregistration program. In developing REDs, EPA 
works with stakeholders including pesticide registrants, growers and 
other pesticide users, and environmental and public health interests, 
as well as the States, USDA, and other Federal agencies and others to 
develop voluntary measures or regulatory controls needed to effectively 
reduce risks of concern. Almost every RED includes some measures or 
modifications to reduce risks. The options for such risk reduction are 
extensive and include voluntary cancellation of pesticide products or 
deletion of uses; declaring certain uses ineligible or not yet eligible 
(and then proceeding with follow-up action to cancel the uses or 
require additional supporting data); restricting use of products to 
certified applicators; limiting the amount or frequency of use; 
improving use directions and precautions; adding more protective 
clothing and equipment requirements; requiring special packaging or 
engineering controls; requiring no-treatment buffer zones; employing 
ground water, surface water, or other environmental and ecological 
safeguards; and other measures.
    2. Interim REDs or IREDs. EPA issues IREDs for pesticides that are 
undergoing reregistration, require a reregistration eligibility 
decision, and also must be included in a cumulative assessment under 
FQPA because they are part of a group of pesticides that share a common 
mechanism of toxicity. An IRED is issued for each individual pesticide 
in the cumulative group when EPA completes the pesticide's risk 
assessment and interim risk management decision. An IRED may include 
measures to reduce food, drinking water, residential, occupational, 
and/or ecological risks, to gain the benefit of these changes before 
the final RED can be issued following the Agency's consideration of 
cumulative risks. For example, EPA generally does not consider 
individual

[[Page 44771]]

OP or N-methyl carbamate pesticide decisions to be completed REDs or 
tolerance reassessments. Instead, the Agency is issuing IREDs for these 
chemicals at this time. EPA will make final decisions and may issue 
REDs for these pesticides when the cumulative risks of the OPs or 
carbamates have been considered. Once the Agency completes a cumulative 
evaluation of the OPs, final decisions will be made and REDs may be 
issued for the 24 OP pesticides that initially had IREDs.
    3. Tolerance reassessment ``TREDs.'' EPA issues Reports on FFDCA 
Tolerance Reassessment Progress and Interim Risk Management Decisions, 
known as TREDs, for pesticides that require tolerance reassessment 
decisions under FFDCA, but do not require a reregistration eligibility 
decision at present because:
    • The pesticide was first registered after November 1984 and 
is considered a ``new'' active ingredient, not subject to 
reregistration (e.g., fenarimol and primisulfuron-methyl in FY 2002);
    • EPA completed a RED for the pesticide before FQPA was 
enacted (most FY 2002 TREDs are in this post-RED category); or
    • The pesticide is not registered for use in the U.S. but 
tolerances are established that allow crops treated with the pesticide 
to be imported from other countries (e.g., mevinphos).
    During FY 2002, EPA also completed TREDs for three pesticides 
(diuron, imazalil, and propanil) whose REDs are under development. The 
Agency expects to complete REDs for these pesticides in FY 2003.
    As with IREDs, EPA will not take final action on pesticides subject 
to TREDs that are part of a cumulative group until cumulative risks 
have been considered for the group.
    4. Goals for FY 2003 and future years. EPA's major pesticide 
reregistration and tolerance reassessment goals for FY 2003 and future 
years are as follows. In addition to achieving these traditional 
output-oriented goals, EPA also is working to develop measures that 
show results in terms of outcomes, as directed by OMB.
    i. Complete individual pesticide risk management decisions. EPA's 
goal in conducting the reregistration and tolerance reassessment 
program is to complete 20-35 Reregistration Eligibility Decisions 
(REDs) and Interim REDs each year during fiscal years 2003 through 
2006, giving priority to pesticides with associated tolerances. 
Candidate pesticides for these decisions are listed near the end of 
this document.
    ii. Evaluate OP and other cumulative risks. EPA began developing 
methods for cumulative risk assessment and the components of a 
cumulative risk assessment for the OP pesticides soon after FQPA was 
enacted in August 1996, although the Agency had begun considering this 
approach earlier, when it was recommended by NAS in their 1993 report, 
``Pesticides in the Diets of Infants and Children.'' These efforts came 
to fruition in FY 2002. In addition to completing most of the remaining 
risk assessments and risk management decisions for individual OP 
pesticides, EPA issued the preliminary OP cumulative risk assessment in 
December 2001. After considering public comment, stakeholder input, and 
the results of additional scientific review, EPA issued a revised OP 
cumulative risk assessment in June 2002 and has begun risk management 
actions based on this revised assessment. The Agency plans to review 
public and SAP comments on the revised cumulative risk assessment as 
well as examine newly submitted data in further evaluating OP 
cumulative risks during 2003. The Agency then may issue final 
reregistration eligibility and tolerance reassessment decisions for 
individual OP pesticides with IREDs and TREDs. Consideration of the 
cumulative risks of N-methylcarbamates, chloroacetanilides, and perhaps 
other common mechanism groups of pesticides will follow. For further 
information, see EPA's cumulative risk website, http://www.epa.gov/
pesticides/cumulative/.
    iii. Complete 100% of tolerance reassessment decisions. EPA is 
continuing to reassess tolerances within time frames set forth in FFDCA 
as amended by FQPA, giving priority to those food use pesticides that 
appear to pose the greatest risk. Integration of the reregistration and 
tolerance reassessment programs has added complexity to the 
reregistration process for food use pesticides. The Agency successfully 
reached its first two tolerance reassessment milestones by completing 
over 33% of all tolerance reassessment decisions by August 3, 1999, and 
over 66% by August 3, 2002. EPA is working toward meeting the final 
FQPA tolerance reassessment goal: To complete 100% of all required 
tolerance reassessment decisions by August 3, 2006.

B. Product Reregistration; Numbers of Products Reregistered, Canceled, 
and Amended

    At the end of the reregistration process, after EPA has issued a 
RED and declared a pesticide reregistration case eligible for 
reregistration, individual end-use products that contain pesticide 
active ingredients included in the case still must be reregistered. 
This concluding part of the reregistration process is called ``product 
reregistration.''
    In issuing a completed RED document, EPA sends registrants a Data 
Call-In (DCI) notice requesting any product-specific data and specific 
revised labeling needed to make final reregistration decisions for each 
of the individual pesticide products covered by the RED. Based on the 
results of EPA's review of these data and labeling, products found to 
meet FIFRA and FFDCA standards may be reregistered.
    A variety of outcomes are possible for pesticide products 
completing this final phase of the reregistration process. Ideally, in 
response to the DCI notice accompanying the RED document, the pesticide 
producer, or registrant, will submit the required product-specific data 
and revised labeling, which EPA will review and find acceptable. At 
that point, the Agency may reregister the pesticide product. If, 
however, the product contains multiple active ingredients, the Agency 
instead issues an amendment to the product's registration, 
incorporating the labeling changes specified in the RED; a product with 
multiple active ingredients may not be fully reregistered until the 
last active ingredient in its formulation is eligible for 
reregistration. In other situations, the Agency may temporarily suspend 
a product's registration if the registrant has not submitted required 
product-specific studies within the time frame specified. The Agency 
may cancel a product's registration because the registrant did not pay 
the required registration maintenance fee. Alternatively, the 
registrant may request a voluntary cancellation of their end-use 
product registration.
    1. Product reregistration actions in FY 2002. EPA counts each of 
the post-RED product outcomes described above as a product 
reregistration action. A single pesticide product may be the subject of 
several product reregistration actions within the same year. For 
example, a product's registration initially may be amended, then the 
product may be reregistered, and later the product may be voluntarily 
canceled, all within the same year. During FY 2002, EPA completed the 
product reregistration actions detailed in Table 4. The program's goal 
is to complete 400-450 product reregistration actions in FY 2003.

[[Page 44772]]

    Table 4.--Product Reregistration Actions Completed during FY 2002
------------------------------------------------------------------------

------------------------------------------------------------------------
Product reregistration actions              77
------------------------------------------------------------------------
Product amendment actions                   51
------------------------------------------------------------------------
Product cancellation actions                186
------------------------------------------------------------------------
Total actions                               314
------------------------------------------------------------------------

    2. Status of the product reregistration universe. The status of the 
universe of pesticide products subject to reregistration at the end of 
FY 2002 is shown in Table 5 below. This overall status information is 
not ``cumulative''--it is not derived from summing up a series of 
annual actions. Adding annual actions would result in a larger overall 
number since each individual product is subject to multiple actions--it 
can be amended, reregistered, and/or canceled, over time. Instead, the 
``big picture'' status information in Table 5 should be considered a 
snapshot in time. As registrants and EPA make marketing and regulatory 
decisions in the future, the status of individual products may change, 
and numbers in this table are expected to fluctuate.

     Table 5.--Status of the Universe of Products Subject to Product
         Reregistration, for FY 2002 (as of September 30, 2002)
------------------------------------------------------------------------

------------------------------------------------------------------------
Products reregistered                       1,637
------------------------------------------------------------------------
Products amended                            345
------------------------------------------------------------------------
Products canceled                           3,806
------------------------------------------------------------------------
Products sent for suspension                12
------------------------------------------------------------------------
Total products with actions completed       5,800
------------------------------------------------------------------------
Products with actions pending               2,817
------------------------------------------------------------------------
Total products in product reregistration    8,617
 universe
------------------------------------------------------------------------

    The universe of 8,617 products in product reregistration at the end 
of FY 2002 represented an increase of 745 products from the FY 2001 
universe of 7,872 products. The increase consists of 324 products 
associated with FY 2002 REDs, and 412 products associated with IREDs, 
plus 9 products that were added as a result of DCI activities and 
processing for several previously issued REDs and IREDs.
    At the end of FY 2002, 2,817 products had product reregistration 
decisions pending. Some pending products await science reviews, label 
reviews, or reregistration decisions by EPA. Others are not yet ready 
for product reregistration actions; they are associated with more 
recently completed REDs, and their product-specific data are not yet 
due to be submitted to or reviewed by the Agency. EPA's goal is to 
complete 400-450 product reregistration actions during fiscal year 
2003.

C. Number and Type of DCIs to Support Product Reregistration by Active 
Ingredient

    1. DCIs for REDs. The number and type of data call-in requests or 
DCIs that EPA is preparing to issue under FIFRA section 3(c)(2)(B) to 
support product reregistration for pesticide active ingredients 
included in FY 2002 REDs are shown in Table 6. Starting in FY 2001, for 
the first time, OMB clearance has been required to issue REDs and 
IREDs. Since the Fenamiphos and (HOCH2-)methyldithiocarbamate REDs 
consisted of voluntary cancellations, products containing these 
pesticides will not be reregistered and therefore do not require DCIs.

                                       Table 6.--DCIs Prepared to Support Product Reregistration for FY 2002 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Number of Product       Number of Acute
            Case Number                     Case Name          Number of Products      Chemistry Studies      Toxicology Studies     Number of Efficacy
                                                               Covered by the RED1         Required2              Required3           Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
3030                                 1,4-Bis(bromoacetoxy)-  2                       22                     12 (6 studies x 2      --
                                      2-butene                                                               products)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0014                                 Endosulfan              98 (includes 4 SLN      22                     102 (7 batches/10 not  0
                                                              products)                                      batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0333                                 Fenamiphos (Voluntary   15                      N/A                    N/A                    N/A
                                      Cancellation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
3076                                 (HOCH2-)                0                       N/A                    N/A                    N/A
                                      methyldithiocarbamate
                                      (Voluntary
                                      Cancellation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0315                                 Lindane                 29                      22                     126 (5 batches/16 not  0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2490                                 Oxyfluorfen             117 (includes 8 SLN     22                     60 (4 batches/6 not    0
                                                              products)                                      batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2670                                 Thiabendazole           63                      22                     144 (4 batches/20 not  0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The number of registered products containing a pesticide active ingredient can change over time. The number of products that appears in the RED
  document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later,
  when the RED is issued). This table reflects the final number of products associated with each RED, as they are being tracked for product
  reregistration.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.

[[Page 44773]]

3In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ``batches'' products that can
  be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six acute toxicology
  studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors considered in the
  sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and biological activity), type of
  formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary
  labeling). The Agency does not describe batched products as ``substantially similar,'' because all products within a batch may not be considered
  chemically similar or have identical use patterns.

    2. DCIs for IREDs. The number and type of data requests or DCIs 
that EPA is preparing to issue to support product reregistration for 
pesticide active ingredients included in FY 2002 Interim REDs (IREDs) 
are shown in Table 7.

                                       Table 7.--DCIs Prepared to Support Product Reregistration for FY 2002 IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Number of Product       Number of Acute
            Case Number                     Case Name          Number of Products      Chemistry Studies      Toxicology Studies     Number of Efficacy
                                                               Covered by the IRED          Required               Required           Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
0235                                 Azinphos-methyl         24                      22                     54 (4 batches/5 not    0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0238                                 Diazinon                182                     22                     186 (15 batches/16     0
                                                                                                             not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0145                                 Dicrotophos             3                       22                     6 (1 batch)            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
0102                                 Disulfoton              62                      22                     114 (4 batches/15 not  0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0043                                 Methamidophos           47                      22                     24 (1 batch/3 not      0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0092                                 Naled                   35                      22                     78 (2 batches/11 not   2
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0258                                 Oxydemeton-methyl       19 (includes 2 SLN      22                     12 (2 batches)         0
                                                              products)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0242                                 Phosmet                 40                      22                     42 (6 batches/1 not    2
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in acute toxicity batchings because they are supported by a valid
  parent product (section 3) registration.

    3. DCIs not needed for TREDs. The Agency does not issue product-
specific data requests or DCIs for pesticides included in tolerance 
reassessment decisions or TREDs because, at present, these pesticides 
do not require product reregistration decisions; they are subject to 
tolerance reassessment only.

D. Progress in Reducing the Number of Unreviewed, Required 
Reregistration Studies

    EPA is making progress in reviewing scientific studies submitted by 
pesticide registrants in support of pesticides undergoing 
reregistration. See Table 8.

            Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2002
----------------------------------------------------------------------------------------------------------------
  Pesticide Reregistration Group or       Studies Reviewed +
   List, per FIFRA Section 4(c)(2)           Extraneous1        Studies Awaiting Review   Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A                                 11,237 + 470 = 11,707    2,201 (16%)              13,908
                                        (84%)
-----------------------------------------------------------------------------------------
List B                                 6,453 + 746 = 7,199      2,408 (25%)              9,607
                                        (75%)
-----------------------------------------------------------------------------------------
List C                                 2,271 + 239 = 2,510      938 (27%)                3,448
                                        (73%)
-----------------------------------------------------------------------------------------
List D                                 1,342 + 94 = 1,436       308 (18%)                1,744
                                        (82%)
-----------------------------------------------------------------------------------------
Total Lists A - D                      21,303 + 1,549 = 22,852  5,855 (20%)              28,707
                                        (80%)
----------------------------------------------------------------------------------------------------------------
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data
  requirement has been satisfied by other studies or has changed.

    Studies reviewed by EPA increased (or the study review ``backlog'' 
decreased) during FY 2002. At the end of the fiscal year, over 80% of 
all studies received by the Agency in support of reregistration had 
been reviewed, compared to 79% at the end of FY 2001. During FY 2002, 
the Agency continued an effort to clean up the data base used to track 
the review status of studies submitted for reregistration. The percent 
of studies reviewed should continue to increase in future years.

[[Page 44774]]

E. Aggregate Status of Tolerances Reassessed

    During FY 2002, EPA completed 2,649 tolerance reassessments and 
ended the fiscal year with a total of 6,499 tolerance reassessment 
decisions to date, addressing almost 67% of the 9,721 tolerances that 
require reassessment (See Table 9). Over 60% of the tolerance 
reassessment decisions completed were for pesticides in priority Group 
1.
    Just as EPA reassessed over 33% of all food tolerances by August 3, 
1999, including many tolerances for pesticides identified as posing the 
greatest potential risks, the Agency also met the next FQPA goal during 
FY 2002 and completed over 66% of all required tolerance reassessment 
decisions by August 3, 2002. EPA's general schedule for tolerance 
reassessment (Federal Register, August 4, 1997) identified three groups 
of pesticides to be reviewed; this grouping continues to reflect the 
Agency's overall scheduling priorities. In completing tolerance 
reassessment, EPA continues to give priority to pesticides in Group 1.
    1. Aggregate accomplishments through reregistration and other 
programs. EPA is accomplishing tolerance reassessment through the 
registration and reregistration programs; by revoking tolerances for 
pesticides that have been canceled (many as a result of 
reregistration); by reevaluating pesticides with pre-FQPA REDs, and 
through other decisions not directly related to registration or 
reregistration, described further below. EPA is using the Tolerance 
Reassessment Tracking System (TORTS) to compile this updated 
information and report on the status of tolerance reassessment (See 
Table 9).

                                  Table 9.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2002
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  During Late   During FY    During FY    During FY    During FY    During FY    During FY    Total, End
        Tolerances Reassessed Through...             FY 96         1997         1998         1999         2000         2001         2002      of FY 2002
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs                                        25          339          278          359           44           46          231        1,322
----------------------------------------------------------------------------
Tolerance Reassessments/TREDs                              --           --           --           --           --           --          776          776
----------------------------------------------------------------------------
Registration                                                0          221          308          341           55          215          200        1,340
----------------------------------------------------------------------------
Tolerance revocations                                       3            0          812          513           22           35          545        1,930
----------------------------------------------------------------------------
Other decisions                                             0            1            0          233            0            0          897        1,131
----------------------------------------------------------------------------
Total tolerances reassessed                                28          561        1,398        1,446          121          296        2,649        6,499
--------------------------------------------------------------------------------------------------------------------------------------------------------

    i. Reregistration/REDs. EPA is using the reregistration program to 
accomplish much of tolerance reassessment. For each of the tolerance 
reassessment decisions made through REDs since FQPA, the Agency has 
made the finding as to whether there is a reasonable certainty of no 
harm, as required by FFDCA. Many tolerances reassessed through 
reregistration remain the same while others may be raised, lowered, or 
revoked.
    ii. Tolerance reassessments/TREDs. Tolerances initially evaluated 
through REDs that were completed before FQPA was enacted in August 1996 
now are being reassessed to ensure that they meet the new FFDCA safety 
standard. EPA issues these post-RED tolerance reassessment decisions as 
TREDs. The Agency also issues TREDs summarizing tolerance reassessment 
decisions for some developing REDs, for new pesticide active 
ingredients not subject to reregistration, and for pesticides with 
import tolerances only. Tolerance reassessments in TREDs for pesticides 
that are not part of a cumulative group (i.e., pesticides that are not 
OPs or carbamates) may be counted at present and are included in the FY 
2002 accomplishments. In completing OP IREDs and TREDs during FY 2002, 
the Agency also completed tolerance reassessment decisions for these 
pesticides. Many of these tolerance reassessments will not become 
final, however, until EPA completes a cumulative evaluation of the OPs.
    iii. Registration. Like older pesticides, all new pesticide 
registrations must meet the safety standard of FFDCA. Many of the 
registration applications EPA receives are for new uses of pesticides 
already registered for other uses. To reach a decision on a proposed 
new food use of an already registered pesticide, EPA must reassess the 
existing tolerances, as well as the proposed new tolerances, to make 
sure there is reasonable certainty that no harm will result to the 
public from aggregate exposure from all uses. During FY 2002, the 
Agency has continued to discourage submission of applications and 
petitions for any new uses of the OP pesticides, given the need to 
consider cumulative risks from OP's as a group before any new uses can 
be fully evaluated.
    iv. Tolerance revocations. Revoked tolerances represent uses of 
many different pesticide active ingredients that have been canceled in 
the past. Some pesticides were canceled due to the Agency's risk 
concerns. Others were canceled voluntarily by their manufacturers, 
based on lack of support for reregistration. Tolerance revocations are 
important even if there are no domestic uses of a pesticide because 
residues in or on imported commodities treated with the chemical could 
still present dietary risks that may exceed the FFDCA ``reasonable 
certainty of no harm'' standard, either individually or cumulatively 
with other substances that share a common mechanism of toxicity.
    v. Other reassessment decisions. In addition to the types of 
reassessment actions described above, a total of 1,131 additional 
tolerance reassessment decisions have been made, not directly related 
to registration or reregistration. A list of these other tolerance 
reassessment decisions with their Federal Register citations is 
available in the docket for this Federal Register notice.
    2. Accomplishments for priority pesticides. During FY 2002, EPA 
completed tolerance reassessment decisions for many high priority 
pesticides in review, including OPs, carbamates, organochlorines, and 
carcinogens. (See Table 10.)

[[Page 44775]]

  Table 10.--Tolerance Reassessments Completed for Priority Pesticides
------------------------------------------------------------------------
                                   Tolerances to be    Reassessed by End
         Pesticide Class              Reassessed          of FY 2002
------------------------------------------------------------------------
Organophosphates                  1,691               1,127 (66.65%)
------------------------------------------------------------------------
Carbamates                        545                 303 (55.6%)
------------------------------------------------------------------------
Organochlorines                   253                 253 (100%)
------------------------------------------------------------------------
Carcinogens                       2,008               1,278 (63.65%)
------------------------------------------------------------------------
High hazard inerts                5                   3 (60%)
------------------------------------------------------------------------
Other                             5,219               --
------------------------------------------------------------------------
Total                             9,721               6,499 (66.86%)
------------------------------------------------------------------------

    3. Tolerance reassessment and the organophosphates. EPA has 
developed an approach for assessing cumulative risk for the OPs as a 
group, as required by FFDCA, and applied this methodology in conducting 
the OP cumulative risk assessment during FY 2002. The Agency presented 
a comprehensive guidance document on cumulative risk assessment to the 
Scientific Advisory Panel in December 1999, issued draft guidance in 
2000 for review and comment, and presented a case study on cumulative 
risk assessment to the SAP in December 2000. In 2001, EPA refined the 
methodology and began developing components of the OP cumulative 
preliminary risk assessment. With input from the Committee to Advise on 
Reassessment and Transition (CARAT) workgroup, the Agency developed a 
process to inform stakeholders and encourage their participation during 
the assessment of OP cumulative risks. At CARAT's recommendation, EPA 
held a series of technical briefings to explain and answer questions 
about the Agency's methods for assessing OP cumulative hazard, as well 
as exposure through drinking water, food, and in residential settings. 
An EPA website was established to share updated information on 
pesticide cumulative risk assessment with the public (http://
www.epa.gov/pesticides/cumulative). In FY 2002, the Agency issued a 
preliminary OP cumulative risk assessment on December 3, 2001, and 
issued a revised OP cumulative risk assessment on June 10, 2002, both 
for public comment.
    Through this assessment of the OP pesticides, EPA has evaluated 
1,127 OP tolerances and found that most require no modification to meet 
the new FFDCA safety standard. The Agency's regulatory actions on 
individual OP pesticides during the past few years have substantially 
reduced the risks of these pesticides. The OP cumulative assessment 
strongly supports the Agency's confidence that the U.S. has one of the 
safest food supplies in the world.
    Most of the reregistration and tolerance reassessment decisions 
that EPA is making for the OP pesticides at present will not be 
considered final until after the Agency completes its cumulative 
evaluation of the OPs. The results of individual OP assessments (IRED 
and TRED documents) include significant risk mitigation measures, 
however, and any resulting tolerance revocations are counted as 
completed tolerance reassessments. In addition, some OP tolerances make 
at most a minimal or negligible contribution to the cumulative risk 
from OP pesticides; these tolerances also were counted as reassessed 
during FY 2002. Once EPA completes a cumulative evaluation of the OPs, 
the Agency will reconsider individual OP IREDs and TREDs, and may issue 
final REDs and tolerance reassessments for these pesticides.
    4. Status of individual OP decisions. The status of each of the 49 
known OP pesticides at the end of FY 2002 is reflected in this 
discussion.
    i. OP decisions completed. During FY 2002, through the public 
participation process, EPA completed risk assessments and made 
individual risk management decisions for 10 OP pesticides, bringing the 
number of OPs with individual decisions completed to 35 (See List 1).
List 1.--OP Pesticides with Individual Decisions Completed (35), End of 
FY 2002
20 IREDs
    Acephate
    Azinphos-methyl
    Bensulide
    Chlorpyrifos
    Diazinon
    Dicrotophos
    Disulfoton
    Ethoprop
    Fenthion
    Methamidophos
    Methidathion
    Naled
    Oxydemeton-methyl
    Phorate
    Phosmet
    Pirimiphos methyl
    Profenofos
    Propetamphos
    Terbufos
    Tribufos (DEF)
10 TREDs
    Cadusafos
    Chlorethoxyfos
    Chlorpyrifos methyl
    Coumaphos
    Fenitrothion
    Mevinphos
    Phosalone
    Phostebupirim
    Tetrachlorvinphos
    Trichlorfon
5 REDs
    Ethion
    Ethyl parathion
    Fenamiphos
    Sulfotepp
    Temephos
    ii. OP decisions pending. Four other OP pesticides had completed 
most or all earlier phases of the public participation process and were 
awaiting individual decisions at the end of FY 2002. EPA plans to 
complete individual risk management decisions for these 4 pesticides 
during FY 2003 (See List 2).
List 2.--OP Pesticides with Individual Decisions Pending (4), End of FY 
2002
    Dichlorvos (DDVP)
    Dimethoate
    Malathion
    Methyl parathion
    iii. Early OP cancellations. Ten OP pesticides were canceled prior 
to or early in the pilot public participation process (See List 3).
List 3.--OPs Canceled Prior to/Early in the Pilot Public Participation 
Process (10)
    Chlorfenvinphos
    Chlorthiophos

[[Page 44776]]

    Dialifor
    Dioxathion
    Fonofos
    Isazophos
    Isofenphos
    Monocrotophos
    Phosphamidon
    Sulprofos

F. Applications for Registration Requiring Expedited Processing; 
Numbers Approved and Disapproved

    By law, EPA must expedite its processing of certain types of 
applications for pesticide product registration, i.e., applications for 
end use products that would be identical or substantially similar to a 
currently registered product; amendments to current product 
registrations that do not require review of scientific data; and 
products for public health pesticide uses. During FY 2002, EPA 
considered and approved the numbers of applications for registration 
requiring expedited processing (also known as ``fast track'' 
applications) shown in Table 11.

         Table 11.--Fast Track Applications Approved in FY 2002
------------------------------------------------------------------------

------------------------------------------------------------------------
Me-too product registrations/Fast track     368
------------------------------------------------------------------------
Amendments/Fast track                       3,466
------------------------------------------------------------------------
Total applications processed by expedited   3,834
 means
------------------------------------------------------------------------

    Regarding numbers of applications disapproved, instead the Agency 
generally notifies the registrant of any deficiencies in the 
application that need to be corrected or addressed before the 
application can be approved. Applications may have been withdrawn after 
discussions with the Agency, but none were formally ``disapproved'' 
during FY 2002.
    On a financial accounting basis, EPA devoted approximately 28.7 
full-time equivalents (FTEs) in FY 2002 to reviewing and processing 
applications for fast track me-too product registrations and label 
amendments. The Agency spent approximately $2.87 million in FY 2002 in 
direct costs (i.e., time on task, not including administrative 
expenses, computer systems, management overhead, and other indirect 
costs) on expedited processing and reviews.

 G. Future Schedule for Reregistrations

    During the past several years, EPA has been conducting 
reregistration in conjunction with tolerance reassessment under FFDCA. 
That law requires the Agency to reassess all existing tolerances over a 
10-year period to ensure consistency with the new safety standard, and 
to consider pesticides that appear to pose the greatest risk first. In 
prioritizing pesticides for reregistration eligibility review and 
tolerance reassessment, EPA is continuing to consider their potential 
risks, as reflected in the Agency's tolerance reassessment schedule 
published in the Federal Register on August 4, 1997. EPA is giving 
highest priority to pesticides in Group 1, including the OP pesticides, 
and the carbamates, organochlorines, and B2 (probable human) 
carcinogens.
    1. RED, IRED, and TRED Candidate Pesticides for FY 2003. List 4 
contains candidate pesticides for Reregistration Eligibility Decisions 
(REDs), Interim REDs (IREDs), and Reports on FQPA Tolerance 
Reassessment Progress and Interim Risk Management Decisions (TREDs) in 
FY 2003. As in previous years, any pesticides for which decisions are 
not completed during FY 2003 will automatically become candidates for 
decisions in FY 2004.
List 4.--FY 2003 RED, IRED, and TRED Candidate Pesticides
REDs
    Chlorsulfuron
    Chromated copper arsenate (CCA)
    Coal tar/Creosote
    Dihalodialkylhydantoins
    Dinocap
    Diuron
    Ethoxyquin
    Imazalil
    MGK-326
    Molinate
    Oxadiazon
    Pentachlorophenol
    Poly(hexamethylenebiguanide)(PHMB)
    Propanil
    Thiophanate-methyl (completed 3-28-03)
    Zinc omadine
    Ziram
IREDs
    Atrazine (completed 1-31-03)
    Carbaryl (due 6-30-03)
    Dichlorvos (DDVP)
    Dimethoate
    Malathion
    Methyl parathion
TREDs
    4-CPA (completed 4-3-03)
    Dacthal (DCPA)
    Ethephon
    Fenridazon potassium
    Potassium bromide
    2. RED, IRED, and TRED Candidate Pesticides for FY 2004. The 
pesticides that are in the pipeline for RED, IRED, and TRED decisions 
in FY 2004 are included in List 5.
List 5.--FY 2004 RED, IRED, and TRED Candidate Pesticides
REDs
    2,4-D
    2,4-DB
    Azadioxabicyclo-octane
    Benfluralin
    Benzisothiazolin-3-one (BIT)
    Bioban P-1487
    Busan 77
    Cacodylic acid/DSMA/MSMA
    Carboxin
    Cycloate
    Cypermethrin
    Fenvalerate
    Formaldehyde
    Mancozeb
    Maneb
    MCPA
    Metiram
    PCNB
    Sodium acifluorfen
    Sodium fluoride
    Thiram
    Trichloromelamine
    Triethylene glycol
IREDs
    Aldicarb
    Atrazine revised IRED (due 10-31-03)
    Carbofuran
    Formetanate HCl
TREDs
    Amitraz
    Ethylene glycol monobutyl ether
    Fluazifop butyl
    Lactofen
    Oryzalin
    Sodium xylenesulfonate
    Sulfonated oleic acid, sodium salt
    Trifluralin

H. Projected Year of Completion of Reregistrations

    EPA is now conducting reregistration in conjunction with tolerance 
reassessment, which FFDCA mandates be completed by August 2006. EPA 
plans to complete reregistration of pesticide active ingredients with 
tolerances and as many others as possible in meeting the statutory 
deadline for completing tolerance reassessment.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 11, 2003.
Stephen L. Johnson,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 03-19353 Filed 7-29-03; 8:45 am]
BILLING CODE 6560-50-S