[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55842-55851]
From the Federal Register Online via the Government Publishing 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:[email protected].
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 [email protected],
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
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[[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%)
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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
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Pesticide products about 10,400
------------------------------------------------------------------------
REDs with food uses 128
------------------------------------------------------------------------
Post-FQPA REDs 103
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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
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).
List of Subjects
Environmental protection, Pesticides and pests.
Dated: September 15, 2005.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 05-18961 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S