Pesticide Reregistration Performance Measures and Goals

[Federal Register: June 23, 2006 (Volume 71, Number 121)]
[Notices]
[Page 36075-36085]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn06-44]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0484; FRL-8068-1]

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 2005. 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
2006 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 [EPA-HQ-
OPP-2005-0484], should be received on or before August 22, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0484, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2005-0484. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov
or e-mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you send
an e-mail comment directly to EPA without going through http://www.regulations.gov,
your e-mail address will be captured automatically
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm.
Docket: All documents in the docket are listed in the index.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Special Review and
Reregistration Division (7508P), 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. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying

[[Page 36076]]

information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived
at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity, obscene language, or personal threats.
viii. Make sure to submit your comments by the comment period deadline.

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 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 is available on the Agency's website at
http://www.epa.gov/pesticides/reregistration/decision_schedule.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) 2005 (from October 1, 2004, through
September 30, 2005), EPA made significant progress in completing risk
assessments and risk management decisions for pesticide reregistration
(See Table 1).

[[Page 36077]]

Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2005
and FY 1991 through FY 2005
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2005 Decisions 2005
------------------------------------------------------------------------
28 REDs (27 countable) 271 REDs
2,4-D.....................................
2,4-DB....................................
Ametryn...................................
4-Amylphenol..............................
Aquashade.................................
Azadioxabicyclooctane.....................
Benzisothiazolin-3-one....................
Chloroneb.................................
Chlorsulfuron.............................
Dimethipin................................
Dodine....................................
Endothall.................................
Ethofumesate..............................
Ferbam (case 2180 already counted with
Ziram).
Fluometuron...............................
Inorganic polysulfides....................
Maneb.....................................
Mancozeb..................................
Metiram...................................
Napropamide...............................
Nitrapyrin................................
Phenmedipham..............................
Pyrazon...................................
Sethoxydim................................
Tau-fluvalinate...........................
Thidiazuron...............................
Trichloromelamine.........................
Xylene (Aromatic solvents)................
------------------------------------------------------------------------
0 IREDs 23 IREDs
------------------------------------------------------------------------
13 TREDs 83 TREDs
Ammonia...................................
Bromine...................................
Cyhexatin.................................
Fluazifop-p-butyl.........................
Flumiclorac-pentyl........................
Imazamethabenz-methyl.....................
Maleic hydrazide..........................
Methyl eugenol............................
Nicosulfuron..............................
Procymidone...............................
Putrescent whole egg solids...............
Sulfuric acid monourea....................
Tanol derivatives.........................
------------------------------------------------------------------------

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
2005 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 2005
------------------------------------------------------------------------

------------------------------------------------------------------------
REDs completed 271 (44%)
------------------------------------------------------------------------
Cases canceled 231 (38%)
------------------------------------------------------------------------
REDs to be completed 110 (18%)
------------------------------------------------------------------------
Total reregistration cases 612 (100%)
------------------------------------------------------------------------

ii. Profile of completed REDs. A profile of the 271 REDs completed
by the end of FY 2005 is presented in Table 3.

Table 3.--Profile of 271 REDs Completed, FY 1991 through FY 2005
------------------------------------------------------------------------

------------------------------------------------------------------------
Pesticide active ingredients 45
------------------------------------------------------------------------
Pesticide products about 11,600
------------------------------------------------------------------------
REDs with food uses 155
------------------------------------------------------------------------
Post-FQPA REDs 130
------------------------------------------------------------------------

[[Page 36078]]

Post-FQPA REDs with food uses* 102
------------------------------------------------------------------------
*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 has issued IREDs
for these chemicals. 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, 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 2005, in addition to completing 13 TREDs, EPA also
completed 168 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 573 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 2005, AD completed
35 tolerance exemption reassessments decisions for 22 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 2006 and future years. EPA's major pesticide
reregistration and tolerance reassessment goals for FY 2006 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 about 45 Reregistration Eligibility Decisions
(REDs) and Interim REDs (IREDs) during FY 2006, for pesticides with
associated tolerances, and to complete a total of about 45 REDs in FY
2007 and 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 Web site at
http://www.epa.gov/pesticides/reregistration/decision_schedule.htm.
ii. Complete 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.
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

[[Page 36079]]

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 2005. 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 2005, EPA completed the
product reregistration actions detailed in Table 4.

Table 4.--Product Reregistration Actions Completed during FY 2005
------------------------------------------------------------------------

------------------------------------------------------------------------
Product reregistration actions 99
------------------------------------------------------------------------
Product amendment actions 63
------------------------------------------------------------------------
Product cancellation actions 342
------------------------------------------------------------------------
Product suspension actions 0
------------------------------------------------------------------------
Total actions 504
------------------------------------------------------------------------

2. Status of the product reregistration universe. The status of the
universe of pesticide products subject to reregistration at the end of
FY 2005 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 multipleactions--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 2005 (as of September 30, 2005)
------------------------------------------------------------------------

------------------------------------------------------------------------
Products reregistered 1,875
------------------------------------------------------------------------
Products amended 505
------------------------------------------------------------------------
Products canceled 4,375
------------------------------------------------------------------------
Products sent for suspension 30
------------------------------------------------------------------------
Total products with actions completed 6,785
------------------------------------------------------------------------
Products with actions pending 4,828
------------------------------------------------------------------------
Total products in product reregistration 11,613
universe
------------------------------------------------------------------------

The universe of 11,613 products in product reregistration at the
end of FY 2005 represented an increase of 1,210 products from the FY
2004 universe of 10,403 products. The increase consists of 1,150
products associated with FY 2005 REDs, 35 products associated with
TREDs, and 25 products that were added as a result of DCI activities
and processing for several previously issued REDs and IREDs.
At the end of FY 2005, 4,828 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 2006.

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 2005 REDs are shown in Table 6.

Table 6.--DCIs Issued to Support Product Reregistration for FY 2005 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,4-D 0073 696 31 Not Completed Yet 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,4-DB 0196 22 31 48 (6 batches/2 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 36080]]

4-t Amylphenol and Salts 3016 37 PDCI has not been Antimicrobial RED-- PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ametryn 2010 4 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aquashade 4010 4 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Azadioxabicylclooctane 3023 2 PDCI has not been Antimicrobial RED-- PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzisothiazolin-3-one 3026 47 PDCI has not been 108 (5 batches/13 not PDCI has not been
completed yet batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloroneb 0007 12 31 60 (2 batches/8 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorsulfuron 0631 16 31 72 (2 batches/10 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dimethipin 3063 5 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dodine 0161 5 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endothall 2245 30 31 36 (2 batches/4 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethofumesate 2265 18 31 66 (3 batches/8 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ferbam 2180 7 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluometuron 0049 19 31 36 (5 batches/1 0
product not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Polysulfides 4054 17 31 96 (16 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mancozeb 0643 100 31 144 (5 batches/19 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maneb 0642 21 31 60 (3 batches/7 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metiram 0644 4 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Napropamide 2450 15 31 48 (5 batches/3 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nitrapyrin 0213 4 31 12 (1 batch/1 product 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 36081]]

Phenmedipham 0277 16 31 96 (16 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyrazon 2570 3 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sethoxydim 2600 10 31 48 (1 batch/7 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tau-Fluvalinate 2295 5 31 18 (3 products not 5
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thidiazuron 4092 18 31 42 (4 batches/3 0
products not batched
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trichloromelamine 3144 8 PDCI has not been 36 (1 batch/5 not PDCI has not been
completed yet batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Xylene 3020 5 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products 1,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The 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.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.
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.(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 for TREDs. There are special cases where product-specific
DCIs may be required for TREDs, particularly if the Agency believes
that adequate product chemistry or acute toxicity data are not
currently on file to support the reregistration of the products
associated with the TREDs. The Agency is requiring a product-specific
DCI for the following TRED:

Table 7.--DCIs Issued to Support Product Reregistration for FY 2005 TRED
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case Number Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the TRED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluazifop-p-butyl 2285 35 31 84 (4 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the TRED document
(counted when the TRED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when
the TRED is issued). This table reflects the final number of products associated with each TRED, 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 TRED.
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.(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.)

[[Page 36082]]

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

EPA has made progress in reviewing scientific studies submitted by
pesticide registrants in support of pesticides undergoing
reregistration (See Table 8). The percent of studies reviewed by EPA
remained constant in FY 2005.

Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2005
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration List, per Studies Reviewed +
FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A 11,238 + 589 = 11,827 1,788 (13%) 13,615
(87%)
----------------------------------------------------------------------------------------------------------------
List B 6,542 + 1,033 = 7,575 1,748 (19%) 9,323
(81%)
----------------------------------------------------------------------------------------------------------------
List C 2,096 + 334 = 2,430 464 (16%) 2,894
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,248 + 133 = 1,381 229 (14%) 1,610
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A-D 21,124 + 2,089 = 23,213 4,229 (15.4%) 27,442 (100%)
(84.6%)
----------------------------------------------------------------------------------------------------------------
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.

E. Aggregate Status of Tolerances Reassessed

During FY 2005, EPA completed 772 tolerance reassessments and ended
the fiscal year with a total of 7,817 tolerance reassessment decisions
to date, addressing over 80% of the 9,721 tolerances that require
reassessment (See Table 9).
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 9).

Table 9.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2005*
--------------------------------------------------------------------------------------------------------------------------------------------------------
During Total,
Tolerances Reassessed Through... Late FY During During During During During During During During During End of
96 FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2005
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 277 359 44 46 231 79 87 413 1,897
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance Reassessments/TREDs 0 0 0 0 0 0 776 14 119 69 970
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration 0 224 308 340 55 216 200 0 71 -- 1,412
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 35 545 0 172 75 2,239
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions 0 1 0 233 0 0 905 26 18 165 1,299
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 119 467 722 7,817
--------------------------------------------------------------------------------------------------------------------------------------------------------
*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

[[Page 36083]]

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 2005 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 1,299 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 EPA-HQ-OPP-2002-0162.
2. Accomplishments for priority pesticides. During FY 2005, EPA
completed tolerance reassessment decisions for many high priority
pesticides in review, including OPs, carbamates, organochlorines, and
carcinogens (See Table 10).

Table 10.--Tolerance Reassessments Completed for Priority Pesticides
------------------------------------------------------------------------
Tolerances to be Reassessed by End
Pesticide Class Reassessed of FY 2005
------------------------------------------------------------------------
Carbamates 545 317 (58.17%)
------------------------------------------------------------------------
Carcinogens 2,008 1,530 (76.20%)
------------------------------------------------------------------------
High hazard inerts 5 5 (100%)
------------------------------------------------------------------------
Organochlorines 253 253 (100%)
------------------------------------------------------------------------
Organophosphates (OPs) 1,691 1,147 (67.83%)
------------------------------------------------------------------------
Other 5,219 4,565 (87.47%)
------------------------------------------------------------------------
Total 9,721 7,817 (80.41%)
------------------------------------------------------------------------

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 Web site 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 and REDs 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 2005, EPA
considered and approved the numbers of applications for registration
requiring expedited processing (also known as ``fast track''
applications) shown in Table 11.

[[Page 36084]]

Table 11.--Fast Track Applications Approved in FY 2005
------------------------------------------------------------------------

------------------------------------------------------------------------
Me-too product registrations/Fast track 340
------------------------------------------------------------------------
Amendments/Fast track 2,639
------------------------------------------------------------------------
Total applications processed by fast track 2,979
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 2005.
On a financial accounting basis, EPA devoted 31.7 full-time
equivalents (FTEs) in FY 2005 to reviewing and processing applications
for fast track me-too product registrations and label amendments. The
Agency spent approximately $3.56 million in FY 2005 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/decision_schedule.htm.
1. RED, IRED, and TRED Schedules for FY 2006. List 1 contains
pesticides scheduled for Reregistration Eligibility Decisions (REDs),
Interim REDs (IREDs), and Reports on FQPA Tolerance Reassessment
Progress and Risk Management Decisions (TREDs) in FY 2006. Although
this list 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 2006 RED, IRED, and TRED Schedule
REDs
ADBAC
Aliphatic alkyl quarternaries
Aliphatic solvents
Alkylbenzene sulfonates
Cacodylic acid
Chlorine dioxide
Copper compounds II
Copper salts
Copper sulfate
Cypermethrin
Dicamba
Dichloran (DCNA)
Ethylene oxide
Glutaraldehyde
Imazapyr
Inorganic chlorates
Inorganic sulfites
Iodine
MCPB
Metaldehyde
Methanearsonic acid, salts (DSMA, MSMA, CAMA)
MGK-264
Mineral acids, weak (sodium carbonate)
PCNB
Permethrin
2-Phenylphenol and salts
Phytophtora palmivora
Piperonyl butoxide
Propiconazole
Propylene oxide
Pyrethrins
Resmethrin
Rotenone
Salicylic acid
TCMB
Triadimefon
IREDs
Aldicarb
Carbofuran
Dichlorvos (DDVP)
Dimethoate
Formetanate HCl
Malathion
Simazine
TREDs
Acetochlor
Amitraz
Azadirachtin
Benzaldehyde
Bitertanol
Boric acid group
CP enolpyruvylshikimate-3-phosphate
Ethephon
Fomesafen
Imazaquin
Methyl bromide
Neomycinphosphotransferase II
Oxytetracycline
Propazine
Sodium cyanide
Streptomycin
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 2 and 3 contain
pesticides scheduled for REDs in FY 2007 and FY 2008.
List 2.--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
Chloropicrin
Chromated arsenicals (CCA)
Coal tar/creosote
Copper and oxides
Dazomet
Dikegulac sodium
Formaldehyde
Grotan
Irgasan
MCPP
Methyl bromide
Methyldithiocarbamate salts (metam sodium/metam potassium)
MITC
Octhilinone
Pentachlorophenol
List 3.--FY 2008 RED Schedule
4-Aminopyradine
Busan 77
Flumetralin
Mefluidide
Naphthalene
Naphthalene salts
Nicotine
Organic esters of phosphoric acid (new case)
p-Dichlorobenzene
Polypropylene glycol
Prometon
Siduron
Sodium fluoride
Sodium/potassium dimethyldithiocarbamate salts (case 2180 already
counted with ziram)
Sulfometuron methyl
Sumithrin
TBT-containing compounds
Tetramethrin
Triforine

[[Page 36085]]

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
reassessment, and in so doing, to complete reregistration eligibility
decisions for pesticides with tolerances, as required by PRIA. The
Agency expects to complete remaining reregistration eligibility
decisions for pesticides with no food uses or tolerances during FY 2007
and FY 2008 (by October 3, 2008).Product reregistration, which takes
place only after the reregistration eligibility decisions have been
completed for the active ingredients, will not likely be completed
before 2012.

List of Subjects

Environmental protection, Pesticides and pests.

Dated: June 16, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E6-9956 Filed 6-22-06; 8:45 am]
BILLING CODE 6560-50-S

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Pesticide Reregistration Performance Measures and Goals

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