Pesticide Reregistration Performance Measures and Goals, 55842-55851 [05-18961]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55842-55851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18961]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0013; FRL-7696-1]


Pesticide Reregistration Performance Measures and Goals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's progress in meeting its 
performance measures and goals for pesticide reregistration during 
fiscal year 2004. 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 
2005 through 2008.

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-2005-
0013], should be received on or before November 22, 2005.

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. General Information

A. Does this Action 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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2005-0013. 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, 
CrystalMall 2, 1801 S. Bell St., 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/.
     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. 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 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

[[Page 55843]]

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. 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.
    i. EPA Dockets. 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-2005-0013. 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-2005-0013. 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) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP- 2005-0013.
    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 
Mall2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0013. 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.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide any technical information and/or data you used that 
support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket 
ID number in the subject line on the first page of your response. It 
would also be helpful if you provided the name, date, and Federal 
Register citation related to your comments.

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

[[Page 55844]]

human health and environmental effects of older pesticides originally 
registered before November 1, 1984. Pesticides meeting today's 
scientific and regulatory 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).The Agency met the first two 
statutory deadlines and is on schedule to meet the third. EPA's 
approach to tolerance reassessment under FFDCA 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).
    The Pesticide Registration Improvement Act (PRIA) of 2003 became 
effective on March 23, 2004. Among other things, PRIA directs EPA to 
complete Reregistration Eligibility Decisions (REDs) for pesticides 
with food uses/tolerances by August 3, 2006, and to complete all non-
food use pesticide REDs by October 3, 2008. EPA's schedule for meeting 
these deadlines are available on the Agency's website atwww.epa.gov/
pesticides/reregistration/candidates.htm.

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) 2004 (from October 1, 2003, through 
September 30, 2004), EPA made significant progress in completing risk 
assessments and risk management decisions for pesticide reregistration 
(See Table 1).

Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2004
                       and FY 1991 through FY 2004
------------------------------------------------------------------------
                                              Total, FY 1991 through FY
             FY 2004 Decisions                          2004
------------------------------------------------------------------------
17 REDs                                     244 REDs
Benfluralin...............................
Carboxin..................................
Cycloate..................................
Dihalodialkylhydantoins...................
Ethoxyquin................................
MCPA......................................
Methoxychlor (Voluntary Cancellation).....
Naphthalene Acetic Acid...................
Naptalam..................................
Oleic Acid Sulfonates.....................
Phenol and Salts..........................
PHMB or Poly(hexamethylenebiguanide)......
Pine Oil..................................
Propylene Glycol and Dipropylene Glycol...
Sabadilla Alkaloids.......................
Thiram....................................
Zinc Pyrithione (Omadine Salts)...........
------------------------------------------------------------------------
0 IREDs                                     23 IREDs
------------------------------------------------------------------------

[[Page 55845]]

 
18 TREDs                                    63 TREDs
Bacillus thuringiensis var. Kurstaki
 (delta endotoxin).
Bacillus thuringiensis var. San Diego.....
Carbon dioxide............................
Chlorimuron ethyl.........................
DCPA (Dacthal)............................
Desmedipham...............................
Dimethenamid..............................
Flumetsulam...............................
Fluridone.................................
Limonene..................................
Nitrogen..................................
Oil of Lemon..............................
Oil of Menthol............................
Oil of Orange.............................
Oryzalin..................................
Thifensulfuron-methyl.....................
Tribenuron methyl.........................
Trifluralin...............................
------------------------------------------------------------------------

    The Agency's decisions are embodied in Reregistration Eligibility 
Decision (RED) documents, Interim Reregistration Eligibility Decisions 
(IREDs), and 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 
2004 in completing Reregistration Eligibility Decisions (REDs) for 
groups of related pesticide active ingredients or cases is summarized 
in Table 2.

         Table 2.--Overall RED Progress, FY 1991 through FY 2004
------------------------------------------------------------------------
 
------------------------------------------------------------------------
REDs completed                              244 (40%)
------------------------------------------------------------------------
Cases canceled                              231 (38%)
------------------------------------------------------------------------
REDs to be completed                        137 (22%)
------------------------------------------------------------------------
Total reregistration cases                  612 (100%)
------------------------------------------------------------------------

    ii. Profile of completed REDs. A profile of the 244 REDs completed 
by the end of FY 2004 is presented in Table 3.

    Table 3.--Profile of 244 REDs Completed, FY 1991 through FY 2004
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Pesticide active ingredients                357
------------------------------------------------------------------------
Pesticide products                          about 10,400
------------------------------------------------------------------------
REDs with food uses                         128
------------------------------------------------------------------------
Post-FQPA REDs                              103
------------------------------------------------------------------------
Post-FQPA REDs with food uses*              75
------------------------------------------------------------------------
*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. Through the reregistration program, 
EPA seeks to reduce risks associated with the use of older pesticides. 
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 measures 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 has not considered 
individual organophosphate (OP) pesticide decisions to be completed 
REDs or tolerance reassessments. Instead, the Agency is issuing IREDs 
for these chemicals at this time. EPA will complete the risk 
assessments and reregistration eligibility decisions for OP pesticides 
with IREDs, once the Agency completes a cumulative assessment of the 
OPs.
    3. Tolerance reassessment ``TREDs.'' EPA issues Reports on FFDCA 
Tolerance Reassessment Progress and [Interim] Risk Management 
Decisions,

[[Page 55846]]

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 1, 1984, 
and is considered a ``new'' active ingredient, not subject to 
reregistration;
     EPA completed a RED for the pesticide before FQPA was 
enacted; 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.
    As with IREDs, EPA will not complete risk assessment and risk 
management for pesticides subject to TREDs that are part of a 
cumulative group until cumulative risks have been considered for the 
group.
    During FY 2004, in addition to completing 18 TREDs, EPA also 
completed 27 tolerance assessment decisions for pesticide inert 
ingredients that are exempted from the tolerance requirement. Almost 
900 of the 9,721 tolerance reassessment decisions required by the 
amended FFDCA are for such inert ingredient tolerance exemptions. EPA 
has reassessed 404 of these inert ingredient tolerance exemptions to 
date, and plans to complete the reassessment of all the inert 
ingredient tolerance exemptions by August 2006.
    As a result of the Food Quality Protection Act of 1996, food-
contact surface sanitizers previously regulated by both EPA and the 
Food and Drug Administration were transferred to EPA's sole 
jurisdiction. Consequently, the approximately 107 ingredients that made 
up these sanitizer solutions in 21 CFR 178.1010 were transferred to 40 
CFR part 180, subpart D. In addition to reassessing the 9,721 
tolerances and exemptions for food and feed commodities, EPA also must 
reassess these sanitizer tolerance exemptions by August 3, 2006. The 
Antimicrobials Division (AD) in EPA's Office of Pesticide Programs is 
responsible for reassessing exemptions from the requirement of a 
tolerance for the food-contact surface sanitizing solutions requiring 
reassessment. AD is reassessing 60 of the 107 exemptions, either as 
free-standing decisions or through REDs. During FY 2004, AD completed 
tolerance exemption reassessments for 14 of these 60 food-contact 
surface sanitizing solution ingredients. EPA is reassessing tolerance 
exemptions for the other food-contact surface sanitizing solutions 
through other REDs and inert exemption decisions.
    4. Goals for FY 2005 and future years. EPA's major pesticide 
reregistration and tolerance reassessment goals for FY 2005 and future 
years are as follows.
    i. Complete individual pesticide risk management decisions. EPA's 
goal in conducting the reregistration and tolerance reassessment 
program is to complete 30-40 Reregistration Eligibility Decisions 
(REDs) and Interim REDs each year during fiscal years 2005 and 2006, 
for pesticides with associated tolerances, and to complete a total of 
40 REDs in FY 2007 and in FY 2008 for pesticides with no food uses or 
tolerances. This will satisfy PRIA requirements and support the 
Agency's tolerance reassessment goal. EPA's schedule for completing 
these decisions appears near the end of this document, and also is 
available on the Agency's website at http://www.epa.gov/pesticides/
reregistration/candidates.htm.
    ii. 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 plans to meet the final FQPA tolerance 
reassessment goal: To complete 100% of all required tolerance 
reassessment decisions by August 3, 2006.
    iii. Evaluate cumulative risks. Once EPA completes individual risk 
assessments for the OPs, carbamates and others, the Agency will make 
cumulative risk findings for each of these common mechanism groups of 
pesticides. For further information, see EPA's cumulative risk website, 
http://www.epa.gov/pesticides/cumulative/.

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 complete reregistration 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 2004. 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 2004, EPA completed the 
product reregistration actions detailed in Table 4.

    Table 4.--Product Reregistration Actions Completed during FY 2004
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Product reregistration actions              78
------------------------------------------------------------------------
Product amendment actions                   35
------------------------------------------------------------------------
Product cancellation actions                14
------------------------------------------------------------------------

[[Page 55847]]

Status of the product reregistration universe. The status of the
Products reregistered                       1,770
------------------------------------------------------------------------
Products amended                            427
------------------------------------------------------------------------
Products canceled                           4,033
------------------------------------------------------------------------
Products sent for suspension                30
------------------------------------------------------------------------
Total products with actions completed       6,260
------------------------------------------------------------------------
Products with actions pending               4,143
------------------------------------------------------------------------
Total products in product reregistration    10,403
 universe
------------------------------------------------------------------------

    The universe of 10,403 products in product reregistration at the 
end of FY 2004 represented an increase of 747 products from the FY 2003 
universe of 9,656 products. The increase consists of 713 products 
associated with FY 2004 REDs, and 34 products that were added as a 
result of DCI activities and processing for several previously issued 
REDs and IREDs.
    At the end of FY 2004, 4,143 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 450 product reregistration actions during fiscal year 2005.

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 2004 REDs are shown in Table 6.

                                       Table 6.--DCIs Prepared to Support Product Reregistration for FY 2004 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Number of Product       Number of Acute
             Case Name                     Case Number         Number of Products      Chemistry Studies      Toxicology Studies     Number of Efficacy
                                                               Covered by the RED1         Required2              Required3           Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benfluralin                          2030                    119                     31                     138 (15 batches/8      0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carboxin                             0012                    44                      31                     186 (2 batches/29      0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cycloate                             2125                    9                       31                     6 (1 Batch)            0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dihalodialkyldantoins                3955                    106                     34                     Antimicrobial RED -    2
                                                                                                             Acute toxicity
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethoxyquin                           0003                    4                       31                     18 (No batch)          0
--------------------------------------------------------------------------------------------------------------------------------------------------------
MCPA                                 0017                    170                     31                     Acute toxicity         0
                                                                                                             batching not
                                                                                                             completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methoxychlor (Voluntary              0249                    2                       NA                     NA                     NA
 Cancellation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Napthalene acetic acid (NAA)         0379                    46                      31                     Acute toxicity         0
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naptalam                             0183                    1                       31                     6 (No Batch)           0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oleic acid sulfonates                4069                    1                       34                     6 (No Batch)           1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phenol and salts                     4074                    6                       34                     Antimicrobial RED -    5
                                                                                                             Acute toxicity
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 55848]]

 
PHMB                                 3122                    17                      34                     42 (3 batches/4        4
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pine oils                            3113                    89                      34                     Antimicrobial RED -    4
                                                                                                             Acute toxicity
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propylene/Dipropylene glycol         3126                    14                      34                     Antimicrobial RED -    5
                                                                                                             Acute toxicity
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sabadilla alkaloids                  3128                    1                       31                     6 ( No Batch)          0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thiram                               0122                    66                      31                     Acute toxicity         0
                                                                                                             batching not
                                                                                                             completed yet.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zinc pyrithione                      2480                    18                      34                     84 (3 batches/11       0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products                                                 713
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 The number of registered products containing a pesticide active ingredient can change over time. The product total 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.
2 This column shows the number of product chemistry studies that are required for each product covered by the RED.
3 In 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.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in
  the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)

    2. DCIs for IREDs. EPA completed no IREDs during FY 2004.
    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 has made making progress in reviewing scientific studies 
submitted by pesticide registrants in support of pesticides undergoing 
reregistration (See Table 7). The percent of studies reviewed by EPA 
remained constant in FY 2004.

            Table 7.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2004
----------------------------------------------------------------------------------------------------------------
  Pesticide Reregistration List, per      Studies Reviewed +
        FIFRA Section 4(c)(2)                Extraneous 1       Studies Awaiting Review   Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A                                 11,220 + 583 = 11,803    1,786 (13%)              13,589
                                        (87%)
-----------------------------------------------------------------------------------------
List B                                 6,520 + 1,032 = 7,552    1,748 (19%)              9,300
                                        (81%)
-----------------------------------------------------------------------------------------
List C                                 2,087 + 334 = 2,421      464 (16%)                2,885
                                        (84%)
-----------------------------------------------------------------------------------------
List D                                 1,233 + 133 = 1,366      229 (14%)                1,595
                                        (86%)
-----------------------------------------------------------------------------------------
Total Lists A - D                      21,060 + 2,082 = 23,142  4,227 (15.4%)            27,369 (100%)
                                        (84.6%)
----------------------------------------------------------------------------------------------------------------
1 Extraneous 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.


[[Page 55849]]

E. Aggregate Status of Tolerances Reassessed

    During FY 2004, EPA completed 467 tolerance reassessments and ended 
the fiscal year with a total of 7,093 tolerance reassessment decisions 
to date, addressing 73% of the 9,721 tolerances that require 
reassessment (See Table 8).
    EPA reassessed over 33% of all food tolerances by August 3, 1999, 
and completed over 66% of all required tolerance reassessment decisions 
by August 3, 2002, meeting two important statutory deadlines 
established by the FQPA. EPA's general schedule for tolerance 
reassessment (62 FR 42020, 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, 
the Agency's highest priority group for reassessment.
    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 8).

                                 Table 8.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2004*
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              During                                                                                             Total,
     Tolerances Reassessed Through...        Late FY   During FY  During FY  During FY  During FY  During FY  During FY  During FY  During FY  End of FY
                                                96        1997       1998       1999       2000       2001       2002       2003       2004       2004
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs                                25        339        277        359         44         46        231         79         87      1,487
------------------------------------------------------------------
Tolerance Reassessments/TREDs                       0          0          0          0          0          0        776         14        119        909
------------------------------------------------------------------
Registration                                        0        224        308        340         55        216        200          0         71      1,414
------------------------------------------------------------------
Tolerance revocations                               3          0        810        513         22         35        545          0        172      2,100
------------------------------------------------------------------
Other decisions                                     0          1          0        233          0          0        905         26         18      1,183
------------------------------------------------------------------
Total tolerances reassessed                        28        564      1,395      1,445        121        297      2,657        119        467      7,093
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Includes corrected counts for some previous years.

    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 enactment of the 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 for pesticides that are 
not part of a cumulative group may be counted at present and are 
included in the FY 2004 accomplishments. Tolerance reassessments for 
pesticides that are part of a cumulative group are not included in the 
Agency's lists of accomplishments. These tolerances will be considered 
again and their reassessment will be completed after EPA completes a 
cumulative risk evaluation for the group.
    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 
aggregate risk of the 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.
    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 1,182 additional 
tolerance reassessment decisions have been made, some for inert 
ingredient tolerance exemptions, through actions 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. Other support 
documents are available in docket ID number OPP-2002-0162.
    2. Accomplishments for priority pesticides. During FY 2004, EPA 
completed tolerance reassessment decisions for many high priority 
pesticides in review, including OPs, carbamates, organochlorines, and 
carcinogens (See Table 9).

[[Page 55850]]



   Table 9.--Tolerance Reassessments Completed for Priority Pesticides
------------------------------------------------------------------------
                                   Tolerances to be    Reassessed by End
         Pesticide Class              Reassessed          of FY 2004
------------------------------------------------------------------------
Carbamates                        545                 309 (56.7%)
------------------------------------------------------------------------
Carcinogens                       2,008               1,425 (70.97%)
------------------------------------------------------------------------
High hazard inerts                5                   5 (100%)
------------------------------------------------------------------------
Organochlorines                   253                 253 (100%)
------------------------------------------------------------------------
Organophosphates (OPs)            1,691               1,131 (66.88%)
------------------------------------------------------------------------
Other                             5,219               3,970 (76.07%)
------------------------------------------------------------------------
Total                             9,721               7,093 (72.97%)
------------------------------------------------------------------------

    3. Tolerance reassessment and the organophosphates. EPA developed 
an approach for assessing cumulative risk for the OP pesticides as a 
group, as required by FFDCA, and applied this methodology in conducting 
an OP cumulative risk assessment. The Agency issued preliminary and 
revised OP cumulative risk assessment documents in December 2001 and 
June 2002, available on EPA's website at http://www.epa.gov/pesticides/
cumulative.
    Through this assessment of the OP pesticides, EPA has evaluated 
several hundred 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. EPA 
plans to complete IREDs for the three remaining individual OP 
pesticides (DDVP, dimethoate, and malathion) in FY 2006.
    Most of the reregistration and tolerance reassessment decisions 
that EPA has made for the OP pesticides will not be considered complete 
until after the Agency concludes 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 that make at most a 
minimal or negligible contribution to the cumulative risk from OP 
pesticides 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 complete reregistration 
eligibility and tolerance reassessment decisions for these pesticides.

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 2004, EPA 
considered and approved the numbers of applications for registration 
requiring expedited processing (also known as ``fast track'' 
applications) shown in Table 10.

         Table 10.--Fast Track Applications Approved in FY 2004
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Me-too product registrations/Fast track                              328
------------------------------------------------------------------------
Amendments/Fast track                                              4,379
------------------------------------------------------------------------
Total applications processed by fast track                         4,707
 means
------------------------------------------------------------------------

    For those applications not approved, 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 2004.
    On a financial accounting basis, EPA devoted over 32.7 full-time 
equivalents (FTEs) in FY 2004 to reviewing and processing applications 
for fast track me-too product registrations and label amendments. The 
Agency spent approximately $3.6 million in FY 2004 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

    EPA plans to complete tolerance reassessment by August 3, 2006, as 
required by FFDCA, and also to complete reregistration eligibility 
decisions for pesticides with food uses by that date. REDs for 
pesticides that have no food uses or tolerances will be completed by 
October 3, 2008. The Agency's schedule for completing these decisions 
is as follows. This schedule also is available on EPA's website at 
http://www.epa.gov/pesticides/reregistration/candidates.htm.
    1. RED, IRED, and TRED Schedules for FY 2005 and FY 2006. Lists 1 
and 2 contain pesticides scheduled for Reregistration Eligibility 
Decisions (REDs), Interim REDs (IREDs), and Reports on FQPA Tolerance 
Reassessment Progress and Risk Management Decisions (TREDs) in FY 2005 
and FY 2006. Although these lists may change due to the dynamic nature 
of the review process, EPA is committed to meeting the reregistration 
and tolerance reassessment deadlines. Any pesticides for which 
decisions are not completed during the current fiscal year will be 
rescheduled for decisions the following year.
List 1.--FY 2005 RED, IRED, and TRED Schedule
REDs
    2,4-D

[[Page 55851]]

    2,4-DB
    Ametryn
    4-t-Amylphenol
    Aquashade
    Aromatic solvents
    Azadioxabicyclo-octane
    Benzisothiazoline-3-one
    Chloroneb
    Chlorsulfuron
    Dimethipin
    Endothall
    Ethofumesate
    Ferbam (Dimethyldithiocarbamate salts; case has completed RED)
    Fluometuron
    Inorganic polysulfides
    Inorganic sulfites
    Iodine
    Mancozeb
    Maneb
    Metiram
    Napropamide
    Nitrapyrin
    PCNB
    Phenmedipham
    Phytophtora palmivora
    Pyrazon
    Trichloromelamine
IREDs
    None
TREDs
    Bromine
    Cyhexatin
    Fluazifop-p-butyl
    Flumiclorac-pentyl
    Imazamethabenz methyl
    Imazaquin
    Maleic hydrazide
    Methyl eugenol
    Nicosulfuron
    Procymidone
    Putrescent whole egg solids
    Sulfuric acid monourea
List 2.--FY 2006 RED, IRED, and TRED Schedule
REDs
    ADBAC
    Aliphatic alkyl quarternaries
    Aliphatic solvents
    Alkylbenzene sulfonates
    Aromatic solvents
    Cacodylic acid
    Chlorine dioxide
    Chloropicrin
    Chromated arsenicals (CCA)
    Coal tar/creosote
    Copper and oxides
    Copper compounds
    Copper sulfate
    Cypermethrin
    Dicamba
    Dichloran (DCNA)
    Dodine
    Ethylene oxide
    Fluvalinate
    Formaldehyde
    Glutaraldehyde
    Imazapyr
    Inorganic chlorates
    MCPB
    Metaldehyde
    Methanearsonic acid, salts (DSMA, MSMA, CAMA)
    Methyl bromide
    Methyldithiocarbamate salts (Metam sodium/metam potassium)
    MGK-264
    MITC
    Pentachlorophenol
    Permethrin
    2-Phenylphenol and salts
    Piperonyl butoxide
    Propiconazole
    Propylene oxide
    Pyrethrins
    Resmethrin
    Rotenone
    Salicylic acid
    Sethoxydim
    TCMB
    Thiadiazuron
    Triadimefon
IREDs
    Aldicarb
    Carbofuran
    Dichlorvos (DDVP)
    Dimethoate
    Formetanate
    Malathion
    Simazine
TREDs
    Acetochlor
    Amitraz
    Ammonia
    Azadirachtin
    Benzaldehyde
    Bitertanol
    Boric acid group
    Ethephon
    Fomesafen
    Oxytetracycline
    Propazine (Interim TRED for triazine pesticide)
    Sodium cyanide
    Streptomycin
    Tetradifon
    Triadimenol
    Tridemorph
    2. Post-2006 REDs. REDs for pesticides with no associated 
tolerances will be completed in FY 2007 and FY 2008, unless decisions 
for these pesticides can be completed sooner. Lists 3 and 4 contain 
pesticides scheduled for REDs in FY 2007 and FY 2008.
List 3.--FY 2007 RED Schedule
    2,4-DP
    Acrolein
    Aliphatic alcohols
    Aliphatic esters
    Alkyl trimethylenediamine
    Allethrin stereoisomers
    Amical 48
    Antimycin A
    Benzoic acid
    Bioban-p-1487
    Bromonitrostyrene
    Chlorflurenol
    Copper salts
    Dazomet
    Dikegulac sodium
    Grotan
    Irgasan
    MCPP
    Octhilinone
List 4.--FY 2008 RED Schedule
    4-Aminopyradine
    Busan 77
    Flumetralin
    Mefluidide
    Naphthalene
    Naphthalene salts
    Nicotine
    p-Dichlorobenzene
    Polypropylene glycol
    Prometon
    Siduron
    Sodium fluoride
    Sodium/potassium dimethyldithiocarbamate salts (case has completed 
RED)
    Sulfometuron methyl
    Sumithrin
    TBT-containing compounds
    Tetramethrin
    Triforine
    Trimethoxysilyl quats

H. Projected Year of Completion of Reregistrations

    EPA generally is conducting reregistration in conjunction with 
tolerance reassessment, which FFDCA mandates be completed by August 
2006. EPA plans to meet the statutory deadline for completing tolerance 
reassessme