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September 13,
2002. EPA status of reregistration and tolerance reassessments
for 7 organofluorine pesticides. Federal Register.
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http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-13/p23265.htm
[Federal Register: September 13, 2002 (Volume 67, Number 178)]
[Notices]
[Page 58041-58051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se02-56]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0121; FRL-6803[dash]5]
Pesticide Reregistration Performance Measures and Goals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal years 2000 and 2001. 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
2002 and 2003.
DATES: This notice is not subject to a formal comment period.
Nevertheless, EPA welcomes input from stakeholders and the general
public. Written comments, identified by the docket ID number [OPP-2002-
0121], should be received on or before November 12, 2002.
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
Registration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, telephone: (703) 308-8007, e-mail:
stangel.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Important Information
A. Does this Apply to Me?
This action is directed to the public in general. Although this
action may be of particular interest to persons who are interested in
the progress and status of EPA's pesticide reregistration and tolerance
reassessment programs, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the information in this notice, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information or Copies of Support Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents from the EPA Internet website,
www.epa.gov. On EPA's home page, select ``Laws and Regulations,'' and
then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal
Register listings at www.epa.gov/fedrgstr. To access information about
pesticide reregistration, go to the home page for the Office of
Pesticide Programs at www.epa.gov/pesticides and select
``Reregistration'' under ``Topics,'' at the top of the screen, or go
directly to www.epa.gov/pesticides/reregistration/.
2. In person. The official record for this notice, as well as the
public version, has been established under docket ID number [OPP-2002-
0121]
(including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of any electronic comments, which does not include any
information claimed as Confidential Business Information (CBI), is
available for inspection in Room 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Public Information
and Records Integrity Branch telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically:
1. By mail. Submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
2. In person. Deliver written comments to Public Information and
Records Integrity Branch, in Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA.
3. Electronically. Submit your comments and/or data electronically
to opp-docket@epa.gov. Please note that you should not submit any
information electronically that you consider to be CBI. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comment and data will also be
accepted on disks in Wordperfect 6.1/8.0/9.0 or ASCII file format. All
comments and data in
[[Page 58042]]
electronic form must be identified by the docket ID number [OPP-20002-
0121]. Electronic comments on this notice may also be filed online at
many Federal Depository Libraries.
D. How Should I Handle Information that I Believe is Confidential?
You may claim information that you submit in response to this
document as confidential by marking any part or all of that information
as CBI. Information so marked will not be disclosed, except in
accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential will be included
in the public docket by EPA without prior notice.
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:
[sbull]
The status of reregistration.
[sbull]
The number of products reregistered, canceled, or amended.
[sbull]
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.
[sbull]
Progress in reducing the number of unreviewed, required
reregistration studies.
[sbull]
The aggregate status of tolerances reassessed.
[sbull]
The number of applications for registration submitted under
subsection (k)(3), expedited processing and review of similar
applications, that were approved or disapproved.
[sbull]
The future schedule for reregistrations in the current and
succeeding fiscal year.
[sbull]
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:
[sbull]
Aggregate exposure (from food, drinking water, and
residential uses).
[sbull]
Cumulative effects from all pesticides sharing a common
mechanism of toxicity.
[sbull]
Possible increased susceptibility of infants and children;
and
[sbull]
Possible endocrine or estrogenic effects.
As amended by FQPA, FFDCA requires the reassessment of all existing
tolerances (pesticide residue limits in food) and tolerance exemptions
within 10 years, to ensure that they meet the safety standard of the
law. EPA was directed to give priority to the review of those
pesticides that appear to pose the greatest risk to public health, and
to reassess 33% of the 9,721 existing tolerances and exemptions within
3 years (by August 3, 1999), 66% within 6 years (by August 3, 2002),
and 100% in 10 years (by August 3, 2006). (Note: Although the total
number of tolerances existing on August 3, 1996, and subject to FQPA
reassessment was initially reported as 9,728, that number has been
corrected to 9,721, based on the Agency's Tolerance Reassessment
Tracking System.)
EPA is meeting the FFDCA's tolerance reassessment requirements
through reregistration and several other program activities. In making
reregistration eligibility decisions, the Agency also is completing
much of tolerance reassessment, within the time frames mandated by the
new law. EPA reassessed the first 33% of all food tolerances by August
3, 1999, and the second 33% of all food tolerances by August 3, 2002.
EPA is focusing particularly on priority Group 1 pesticides, those
identified as posing the greatest potential risks. Over half of the
universe of tolerances to be reassessed are included in this category,
including tolerances for the organophosphate (OP) pesticides, the
Agency's highest priority for review. Carbamate, organochlorine, and B2
(probable human) carcinogen pesticides also are included in priority
Group 1. Although EPA is directing most of its resources toward this
group, a number of Group 1 pesticides will nevertheless be reassessed
in the third 33% owing to the challenging issues they present. EPA's
approach to tolerance reassessment under FFDCA, including the three
priority Groups, is described fully in the Agency's document, ``Raw and
Processed Food Schedule for Pesticide Tolerance Reassessment'' (62 FR
42020, August 4, 1997) (FRL-5734-6).
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 each of the
past 2 years in each of the program areas included in FIFRA section
4(l).
A. Status of Reregistration
During fiscal years (FYs) 2000 and 2001 (from October 1, 1999,
through September 30, 2001), EPA made significant progress in
completing risk assessments and risk management decisions for the OP
pesticides, the Agency's highest priority chemicals for reregistration
and tolerance reassessment, and for other pesticides. See Table 1.
[[Page 58043]]
Table 1.--Reregistration/Risk Management Decisions Completed: FY 2000,
FY 2001, and Total
------------------------------------------------------------------------
FY 2001: 14 Total, End of FY
FY 2000: 19 Decisions Decisions 2001
------------------------------------------------------------------------
6 REDs 3 REDs 207 REDs
Diclofop-methyl................. Benomyl (voluntary
Ethyl parathion (voluntary cancellation).
cancellation)*. Ethion (voluntary
Etridiazole (Terrazole)......... cancellation)*.
Temephos*....................... Propargite........
Triallate**.....................
Vinclozolin.....................
------------------------------------------------------------------------
7 IREDs 6 IREDs 12 OP IREDs
Bensulide*...................... Acephate*......... 1 carbamate IRED
Fenthion*....................... Chlorpyrifos*.....
**Oxamyl**...................... Ethoprop*.........
Phorate*........................ Methidathion*.....
Profenofos*..................... Pirimiphos-methyl*
Propetamphos*................... Terbufos*.........
Tribufos*.......................
------------------------------------------------------------------------
6 TREDs 5 TREDs 9 OP TREDs
Cadusafos*...................... Butylate**........ 1 thiocarbamate
Chlorethoxyfos*................. Chlorpyrifos- TRED
Coumaphos*...................... methyl (voluntary 1 other TRED
Fenitrothion*................... cancellation)*. (Oxadixyl)
Mevinphos*...................... Oxadixyl
Phostebupirim*.................. (voluntary
cancellation).
Phosalone*........
Trichlorfon*......
------------------------------------------------------------------------
*Organophosphate (OP) pesticide.
**Carbamate or thiocarbamate pesticide.
The Agency's decisions are embodied in Reregistration Eligibility
Decision (RED) documents, Interim Reregistration Eligibility Decisions
(IREDs), or Reports on FQPA Tolerance Reassessment Progress and Interim
Risk Management Decisions (TREDs).
1. REDs. Through the reregistration program, EPA is reviewing
current scientific data for older pesticides (those initially
registered before November 1984), reassessing their effects on human
health and the environment, and requiring risk mitigation measures as
necessary. Pesticides that have sufficient supporting data and whose
risks can be successfully mitigated may be declared ``eligible'' for
reregistration. EPA presents these pesticide findings in a RED
document.
i. Overall RED progress. EPA's overall progress at the end of FY
2000 and FY 2001 in completing Reregistration Eligibility Decisions
(REDs) is summarized in Table 2.
Table 2.--Overall RED Progress, End of FY 2000 and FY 2001
------------------------------------------------------------------------
End of FY 2000 End of FY 2001
------------------------------------------------------------------------
REDs completed 204 (33%) 207 (34%)
------------------------------------------------------------------------
Cases canceled 231 (38%) 231 (38%)
------------------------------------------------------------------------
REDs to be completed 177 (29%) 174 (28%)
------------------------------------------------------------------------
Total reregistration cases 612 (100%) 612 (100%)
------------------------------------------------------------------------
ii. Profile of completed REDs. A profile of the 204 REDs completed
by the end of FY 2000 and 207 REDs completed by the end of FY 2001 is
presented in Table 3.
Table 3.--Profile of REDs Completed, End of FY 2000 and FY 2001
------------------------------------------------------------------------
FY 2000/204 REDs FY 2001/207 REDs
Include Include
------------------------------------------------------------------------
Pesticide active ingredients 302 305
------------------------------------------------------------------------
Pesticide products 7,200+ 7,800+
------------------------------------------------------------------------
REDs with food uses 99 102
------------------------------------------------------------------------
Post-FQPA REDs 63 66
------------------------------------------------------------------------
Post-FQPA REDs with food uses 46 49
------------------------------------------------------------------------
[[Page 58044]]
Tolerance reassessments 1,045 1,091
completed for post-FQPA REDs*
------------------------------------------------------------------------
*EPA will revisit tolerances associated with the 53 food use REDs that
were completed before FQPA was enacted to ensure that they meet the
safety standard of the new law, as set forth in the Agency's August 4,
1997, Schedule for Pesticide Tolerance Reassessment.
iii. Risk reduction in REDs. Reducing pesticide risks is an
important aspect of the reregistration program. In developing REDs, EPA
works with stakeholders including pesticide registrants, growers, and
other pesticide users, environmental and public health interests, the
States, USDA and other Federal agencies, and others to develop
voluntary measures or regulatory controls needed to effectively reduce
risks of concern. Almost every RED includes some measures or
modifications to reduce risks. The options for such risk reduction are
extensive and include voluntary cancellation of pesticide products or
deletion of uses; declaring certain uses ineligible or not yet eligible
(and then proceeding with follow-up action to cancel the uses or
require additional supporting data); restricting use of products to
certified applicators; limiting the amount or frequency of use;
improving use directions and precautions; adding more protective
clothing and equipment requirements; requiring special packaging or
engineering controls; requiring no-treatment buffer zones; employing
ground water, surface water, or other environmental and ecological
safeguards; and other measures.
2. Interim REDs or IREDs. EPA issues IREDs for pesticides that are
undergoing reregistration, require a reregistration eligibility
decision, and also must be included in a cumulative assessment under
FQPA because they are part of a group of pesticides that share a common
mechanism of toxicity. An IRED is issued for each individual pesticide
in the cumulative group when EPA completes the pesticide's risk
assessment and 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 will not consider individual OP or N-
methyl carbamate pesticide decisions to be completed REDs or tolerance
reassessments, but instead will issue IREDs for these chemicals until
the cumulative risks of the OPs or carbamates have been considered.
3. Tolerance reassessment ``TREDs.'' EPA also 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:
[sbull]
The pesticide was first registered after November 1984 and
is considered a ``new'' active ingredient, not subject to
reregistration (e.g., oxadixyl in FY 2001);
[sbull]
EPA completed a RED for the pesticide before FQPA was
enacted (e.g., trichlorfon); or
[sbull]
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 (for example, mevinphos).
As with IREDs, EPA will not take final action on pesticides subject to
TREDs that are part of a cumulative group until cumulative risks have
been considered for the group.
5. Goals for FY 2002 and FY 2003. EPA's major pesticide
reregistration and tolerance reassessment goals for FY 2002 and FY 2003
are as follows.
i. Complete individual pesticide risk management decisions. EPA's
goal in conducting the reregistration and tolerance reassessment
program was to complete about 30 Reregistration Eligibility Decisions
(REDs) in FY 2002, and about 17 REDs in FY 2003. Candidate pesticides
for these and other individual pesticide decisions are listed near the
end of this document.
ii. Consider OP and other cumulative risks. EPA began developing
methods for cumulative risk assessment several years ago and components
of a cumulative risk assessment for the OP pesticides in FY 2001. This
effort continued through FY 2002. In addition to completing risk
assessments and risk management decisions for most individual OP
pesticides, the Agency issued the preliminary OP cumulative risk
assessment in December 2001 (see http://www.epa.gov/pesticides/
cumulative/pra-op/ ). After considering public comment, stakeholder
input, and the results of additional scientific review, EPA issued a
revised OP cumulative risk assessment in June 2002, and expects to
consider OP cumulative risks during 2002. The Agency then may issue
final reregistration eligibility and tolerance reassessment decisions
for individual OP pesticides with IREDs and TREDs. Consideration of the
cumulative risks of N-methylcarbamates, chloroacetanilides, and perhaps
other common mechanism groups of pesticides will follow. For further
information, see EPA's cumulative risk website, http://www.epa.gov/
pesticides/cumulative.htm.
iii. Complete 66% of tolerance reassessment decisions. EPA is
continuing to reassess tolerances within time frames set forth in FFDCA
as amended by FQPA, building on the reassessment of 33% of existing
tolerances by August 3, 1999, and giving priority to those food use
pesticides that appear to pose the greatest risk. The Agency
successfully reached its next tolerance reassessment milestone by
completing 66% of all tolerance reassessment decisions by August 3,
2002. Integration of the reregistration and tolerance reassessment
programs has added complexity to the reregistration process for food
use pesticides.
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 calls in any product-
specific data and revised labeling needed to make final reregistration
decisions for each of the individual pesticide products covered by the
RED. Based on the results of EPA's review of these data and labeling,
products found to meet FIFRA and FFDCA standards may be reregistered.
[[Page 58045]]
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 2000 and FY 2001. 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 2000 and FY
2001, EPA completed the product reregistration actions detailed in
Table 4. The program's goal has been to complete 750 product
reregistration actions each fiscal year.
Table 4.--Product Reregistration Actions Completed during FY 2000 and FY
2001
------------------------------------------------------------------------
FY 2000 FY 2001
------------------------------------------------------------------------
Product reregistration actions 139 180
------------------------------------------------------------------------
Product amendment actions 53 63
------------------------------------------------------------------------
Product cancellation actions 360 613*
------------------------------------------------------------------------
Total actions 552 856
------------------------------------------------------------------------
*Includes 387 product cancellations resulting from chlorpyrifos
regulatory action.
2. Status of the product reregistration universe. The status of the
universe of pesticide products subject to reregistration at the end of
FY 2000 and FY 2001 is shown in Table 5 below. This overall status
information is not ``cumulative''--it is not derived from summing up a
series of annual actions. Adding annual actions would result in a
larger overall number since each individual product is subject to
multiple actions--it can be amended, reregistered, and/or canceled,
over time. Instead, the ``big picture'' status information in Table 5
should be considered a snapshot in time. As registrants and EPA make
marketing and regulatory decisions in the future, the status of
individual products may change, and numbers in this table are expected
to fluctuate.
Table 5.--Status of the Universe of Products Subject to Product
Reregistration, for FY 2000 (as of September 30, 2000) and FY 2001 (as
of September 30, 2001)
------------------------------------------------------------------------
FY 2000 FY 2001
------------------------------------------------------------------------
Products reregistered 1,369 1,549
------------------------------------------------------------------------
Products amended 227 290
------------------------------------------------------------------------
Products canceled 3,007 3,620
------------------------------------------------------------------------
Products sent for suspension -- 8
------------------------------------------------------------------------
Total products with actions 4,603 5,467
completed
------------------------------------------------------------------------
Products with actions pending 2,652 2,405
------------------------------------------------------------------------
Total products in product 7,255 7,872
reregistration universe
------------------------------------------------------------------------
The universe of 7,255 products in product reregistration at the end
of FY 2000 represented an increase of 210 products from the FY 1999
universe of 7,045 products. The increase consists of 108 products
associated with FY 2000 REDs, and 96 products associated with IREDs,
plus 6 products that were added as a result of DCI activities and
processing for two previously issued REDs.
The universe of 7,872 products in product reregistration at the end
of FY 2001 represents an increase of 617 products from the FY 2000
universe of 7,255 products. The increase consists of 75 products
associated with FY 2001 REDs, and 523 products associated with IREDs,
plus 19 products that were added as a result of DCI activities and
processing for a previously-issued RED (thiobencarb).
At the end of FY 2000, 2,652 products had product reregistration
decisions pending. At the end of FY 2001, this number had been reduced
to 2,405 products. Some pending products await science reviews, label
reviews, or reregistration decisions by EPA. Others
[[Page 58046]]
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 again is to complete 750 product reregistration
actions during fiscal year 2002.
3. Pre-RED product-specific actions for chlorpyrifos. During FY
2000 and FY 2001, EPA devoted considerable resources to implementing
the June 2000 agreement with registrants to phase out and cancel many
uses of the OP pesticide, chlorpyrifos. Although the Agency had not yet
completed an IRED or RED for chlorpyrifos when the agreement was
signed, approximately 840 individual chlorpyrifos products required
cancellation, replacement, and/or amendment within specific time
frames. Timely completion of these actions was essential to
successfully implementing the chlorpyrifos agreement and achieving the
desired risk mitigation measures. Devoting staff time and resources to
the chlorpyrifos project reduced the Agency's ability to complete
routine product reregistration actions during FY 2000 and FY 2001. EPA
succeeded, however, in completing all necessary chlopyrifos product-
specific actions and decisions by early in 2002.
C. Number and Type of DCIs to Support Product Reregistration by Active
Ingredient
1. DCIs for REDs. The number and type of data requests or DCIs that
EPA issued under FIFRA section 3(c)(2)(B) to support product
reregistration for pesticide active ingredients included in FY 2000 and
FY 2001 REDs are shown in Table 6. For the first time, OMB clearance
was required and obtained in issuing the FY 2001 REDs and IREDs. Since
the Ethyl Parathion, Benomyl, and Ethion REDs consisted of voluntary
cancellations, products containing these pesticides will not be
reregistered and therefore do not require DCIs.
Table 6.--DCIs to Support Product Reregistration for FY 2000 and FY 2001 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Number Case Name Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the RED\1\ Required\2\ Required\3\ Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
DCIs Issued to Support FY 2000 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2160 Diclofop-methyl 16 22 96 (16 not batched) 0
------------------------------------
0009 Etridiazole 31 22 102 (6 batches/11 not 0
(Terrazole) batched)
-------------------------------------------------------------------------------------
0155 Ethyl Parathion 19 -- -- --
(voluntary
cancellation)
-------------------------------------------------------------------------------------
0006 Temephos 27 22 48 (7 batches/1 not 2
batched)
-------------------------------------------------------------------------------------
2695 Triallate 7 21 42 (7 not batched) 0
-------------------------------------------------------------------------------------
2740 Vinclozolin 8 22 30 (5 not batched) 0
-------------------------------------------------------------------------------------
DCIs Issued to Support FY 2001 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
0119 Benomyl (voluntary 2 -- -- --
cancellation)
------------------------------------
0090 Ethion (voluntary 10 -- -- --
cancellation)
-------------------------------------------------------------------------------------
0234 Propargite 63 22 36 (1 batch/5 not --
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\The number of registered products containing a pesticide active ingredient can change over time. The number of products that appears in the RED
document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later,
when the RED is issued). This table reflects the final number of products associated with each RED, as they are being tracked for product
reregistration.
\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.
2. DCIs for IREDs. The number and type of data requests or DCIs
issued by EPA to support product reregistration for pesticide active
ingredients included in FY 2000 and FY 2001 Interim REDs (IREDs) are
shown in Table 7.
[[Page 58047]]
Table 7.--DCIs to Support Product Reregistration for FY 2000 and FY 2001 IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Number Case Name Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the IRED Required Required Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
DCIs Issued to Support FY 2000 IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2035 Bensulide 47 21 84 (7 batches/7 not 0
batched)
------------------------------------
0290 Fenthion 11 22 36 (2 batches/4 not 2
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0253 Oxamyl 6 22 12 (1 batch/1 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0103 Phorate 22 22 21 (7 batches) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
2540 Profenofos 2 22 12 (2 not batched) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
2550 Propetamphos 2 22 12 (2 not batched) 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
2145 Tribufos (DEF) 6 22 12 (2 batches) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
DCIs Prepared to Support FY 2001 IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
0042 Acephate 141 22 108 (7 batches/11 not 4
batched)
------------------------------------
0100 Chlorpyrifos 326 22 546 (34 batches/57 2
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0106 Ethoprop 15 22 36 (4 batches/2 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0034 Methidathion 31 22 30 (3 batches/2 not 0
batched)
-------------------------------------------------------------------------------------
2535 Pirimiphos-methyl 5 22 24 (4 not batched) 0
-------------------------------------------------------------------------------------
0109 Terbufos 5 22 18 (3 batches) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in acute toxicity batchings when they are supported by a valid
parent product (section 3) registration.
3. DCIs not needed for TREDs. The Agency does not issue product-
specific data requests or DCIs for pesticides included in tolerance
reassessment decisions or TREDs because, at present, these pesticides
do not require product reregistration decisions; they are subject to
tolerance reassessment only.
D. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
EPA is making progress in reviewing scientific studies submitted by
pesticide registrants in support of pesticides undergoing
reregistration. See Table 8.
Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2000 and FY 2001
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration Group or Studies Reviewed +
List, per FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
Review Status of Studies Received, October 2000
----------------------------------------------------------------------------------------------------------------
List A 10,705 + 319 = 11,024 2,592 (19%) 13,616
(81%)
--------------------------------------
List B 5,951 + 654 = 6,605 2,815 (30%) 9,420
(70%)
-----------------------------------------------------------------------------------------
List C 2,149 + 228 = 2,377 1,013 (30%) 3,390
(70%)
-----------------------------------------------------------------------------------------
List D 1,307 + 94 = 1,401 333 (19%) 1,734
(81%)
-----------------------------------------------------------------------------------------
Total Lists A - D 20,112 + 1,295 = 21,407 6,753 (23.98%) 28,160
(76.02%)
-----------------------------------------------------------------------------------------
[[Page 58048]]
Review Status of Studies Received, October 2001
----------------------------------------------------------------------------------------------------------------
List A 11,109 + 471 = 11,580 2,204 (16%) 13,784
(84%)
--------------------------------------
List B 5,357 + 744 = 7,101 2,447 (26%) 9,548
(74%)
-----------------------------------------------------------------------------------------
List C 2,264 + 239 = 2,503 943 (27%) 3,446
(73%)
-----------------------------------------------------------------------------------------
List D 1,342 + 94 = 1,436 306 (18%) 1,742
(82%)
-----------------------------------------------------------------------------------------
Total Lists A - D 21,072 + 1,548 = 22,620 5,900 (20.7%) 28,520
(79.3%)
----------------------------------------------------------------------------------------------------------------
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data
requirement has been satisfied by other studies or has changed.
Studies reviewed by EPA increased by 3% (or the study review
``backlog'' decreased by 3%) during FY 2001. At the end of the fiscal
year, over 79% of all studies received by the Agency in support of
reregistration had been reviewed, compared to only 76% at the end of FY
2000, and less than 75% at the end of 1997. During FY 2001, the Agency
made a special effort to clean up the data base used to track the
review status of studies submitted for reregistration. Cases with
completed REDs, for example, should no longer have studies ``awaiting
review''; all studies received should have been reviewed or found
extraneous by the time a reregistration eligibility decision is made.
The increase in the percent of studies reviewed that was reported
during FY 2001 may continue in future years as improved, more thorough
recordkeeping practices are followed.
E. Aggregate Status of Tolerances Reassessed
During FY 2000, EPA completed 121 tolerance reassessments and ended
the fiscal year with a total of 3,554 tolerance reassessment decisions
to date, addressing 36.6% of the 9,721 tolerances that require
reassessment. During FY 2001, the Agency completed 288 tolerance
reassessments and ended the fiscal year with a total of 3,842 tolerance
reassessment decisions, addressing nearly 40% of the 9,721 tolerances
that require reassessment (See Table 9). Over 63% of the tolerance
reassessment decisions completed were for pesticides in priority Group
1.
Just as EPA reassessed 33% of all food tolerances by August 3,
1999, including many tolerances for pesticides identified as posing the
greatest potential risks, the Agency also met the next FFDCA goal and
completed 66% of all required tolerance reassessment decisions by
August 3, 2002. EPA's general schedule for tolerance reassessment
(Federal Register, August 4, 1997) identified three groups of
pesticides to be reviewed; this grouping continues to reflect the
Agency's overall scheduling priorities for tolerance reassessment. EPA
continues to give priority to pesticides in Group 1, particularly the
OP pesticides.
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); 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 2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
During Late During FY During FY During FY During FY Total, End During FY Total, End
Tolerances Reassessed Through... FY 96 1997 1998 1999 2000 of FY 2000 2001 of FY 2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 278 359 44 1,045 46 1,091
----------------------------------------------------------------------------
Registration 0 221 308 341 55 925 215 1,140
----------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 1,350 27 1,377
----------------------------------------------------------------------------
Other decisions 0 1 0 233 0 234 0 234
----------------------------------------------------------------------------
Total tolerances reassessed 28 561 1,398 1,446 121 3,554 288 3,842
--------------------------------------------------------------------------------------------------------------------------------------------------------
i. Reregistration/REDs. EPA is using the reregistration program to
accomplish much of tolerance reassessment. For each of the tolerance
reassessment decisions made to date, the Agency has made the finding
that 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. In completing OP IREDs and
TREDs during FY 2000 and FY 2001, the Agency also completed tolerance
reassessment decisions for these pesticides. Many of these tolerance
reassessments will not become final, however, until the cumulative
risks of the OPs have been considered.
ii. Registration. Like older pesticides, all new pesticide
registrations must meet the safety standard of FFDCA.
[[Page 58049]]
Many of the registration applications EPA receives are for new uses of
pesticides already registered for other uses. To reach a decision on a
proposed new food use of an already registered pesticide, EPA must
reassess the existing tolerances, as well as the proposed new
tolerances, to make sure there is reasonable certainty that no harm
will result to the public from aggregate exposure from all uses. During
FY 2000 and FY 2001, the Agency has specifically discouraged submission
of applications and petitions for any new uses of the OP pesticides,
given the need to consider cumulative risks from OP's as a group before
any new uses can be fully evaluated.
iii. 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.
iv. Other reassessment decisions. In addition to the types of
reassessment actions described above, a total of 234 additional
tolerance reassessment decisions have been made, not directly related
to registration or reregistration. These include 65 tolerances
reassessed through the Plant Growth Regulator Rule which were
scientifically reviewed and the exemption was retained (64 FR 31501;
June 11, 1999) (FRL-6076-5); 80 organophosphate meat, milk, poultry,
and egg tolerances that were determined to have no reasonable
expectation of finite residue on July 7, 1999; 73 inert polymer
tolerances that were determined on July 20, 1999, to meet the terms and
criteria of the Toxic Substances Control Act Polymer Exemption Rule; 13
tolerance exemptions for Trichoderma harzianum KRL-AG2 (64 FR 16856;
April 7, 1999); 1 tolerance exemption for Bacillus thuringiensis
subspecies Kurstake CryIA(c) (62 FR 17722; April 11, 1997); 1 tolerance
exemption for red pepper (63 FR 66999; December 4, 1998); and 1
tolerance exemption for cinnamaldehyde (64 FR 7801; February 17, 1999).
2. Accomplishments for priority pesticides. During FY 2000 and FY
2001, 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 of FY Reassessed by End of FY
Pesticide Class Reassessed 2000 2001
----------------------------------------------------------------------------------------------------------------
Organophosphates 1,691 505 (29.86%) 529 (31.28 %)
----------------------------------------------------------------------------------------------------------------
Carbamates 545 169 (31.01%) 171 (31.38%)
----------------------------------------------------------------------------------------------------------------
Organochlorines 253 50 (19.76%) 50 (19.76%)
----------------------------------------------------------------------------------------------------------------
Carcinogens 2,009 708 (35.24%) 754 (37.53%)
----------------------------------------------------------------------------------------------------------------
High hazard inerts 5 0 0
----------------------------------------------------------------------------------------------------------------
Other 5,218 2,122 (40.67%) 2,338 (44.81%)
----------------------------------------------------------------------------------------------------------------
Total 9,721 3,554 (36.56%) 3,842 (39.52%)
----------------------------------------------------------------------------------------------------------------
3. Tolerance reassessment and the organophosphates. EPA has
developed an approach for assessing cumulative risk for the OPs as a
group, as required by FFDCA. The Agency presented a comprehensive
guidance document on cumulative risk assessment to the Scientific
Advisory Panel in December 1999, issued draft guidance in 2000 for
review and comment, and presented a case study on cumulative risk
assessment to the SAP in December 2000. During FY 2001, EPA refined the
methodology and began developing components of the OP cumulative
preliminary risk assessment. With input from a Committee to Advise on
Reassessment and Transition (CARAT) workgroup, the Agency began
developing a process to inform stakeholders and the public and
encourage their participation during the assessment of OP cumulative
risks. At CARAT's recommendation, EPA initiated a series of technical
briefings (which continued during early FY 2002) to explain and answer
questions about the Agency's methods for assessing OP cumulative
hazard, as well as exposure through drinking water, food, and in
residential settings. An EPA website has been established to share
updated information on pesticide cumulative risk assessment with the
public (http://www.epa.gov/pesticides/cumulative.htm). The Agency
issued a preliminary OP cumulative risk assessment on December 3, 2001,
and issued a revised OP cumulative risk assessment for public comment
in June 2002.
Most of the reregistration and tolerance reassessment decisions
that EPA is making for the OP pesticides at present will not be
considered final until after the Agency considers OP cumulative risks.
The results of individual OP assessments (IRED and TRED documents)
include risk mitigation measures, however, and any resulting tolerance
revocations are counted as completed tolerance reassessments. Once EPA
has considered the cumulative risks of the OPs, the Agency will
reevaluate individual OP IREDs and TREDs and may issue final REDs for
these pesticides.
4. Status of individual OP decisions. The status of each of the 49
known OP pesticides at the end of FY 2001 is reflected in this
discussion.
i. OP decisions completed. During FY 2000, through the public
participation process, EPA completed risk assessments and made
individual risk management decisions for 14 OP pesticides. In addition,
a decision reached in FY 1999 concluded EPA's review of another OP
pesticide, sulfotepp. During FY 2001, EPA completed risk assessments
and made risk management decisions for 10 more OP pesticides, bringing
the number of OPs with individual decisions
[[Page 58050]]
completed to 25 as of the end of FY 2001. A 26th OP, phosmet, had a
partial interim decision completed. (See List 1.) Many OP pesticides
not voluntarily canceled will be considered by the Agency in assessing
OP cumulative risks.
List 1.--OP Pesticides with Individual Decisions Completed, End of FY
2001
Acephate IRED
Bensulide IRED
Cadusafos TRED
Chlorethoxyfos TRED
Chlorpyrifos IRED
Chlorpyrifos methyl TRED
Coumaphos TRED
Ethion RED
Ethoprop IRED
Ethyl parathion RED
Fenitrothion TRED
Fenthion IRED
Methidathion IRED
Mevinphos TRED
Phorate IRED
Phosalone TRED
Phosmet Partial IRED
Phostebupirim TRED
Pirimiphos methyl IRED
Profenofos IRED
Propetamphos IRED
Sulfotepp RED
Temephos RED
Terbufos IRED
Tribufos (DEF) IRED
Trichlorfon TRED
ii. OP decisions pending. Fourteen other OP pesticides had
completed earlier phases of the public participation process and were
in final Phase 6, awaiting individual decisions, at the end of FY 2001.
EPA is working to complete individual risk management decisions for
these 14 pesticides during 2002. See List 2.
List 2.--OP Pesticides with Individual Decisions Pending, End of FY
2001
Azinphos-methyl*
Diazinon
Dichlorvos (DDVP)
Dicrotophos*
Dimethoate
Disulfoton*
Fenamiphos*
Malathion
Methamidophos*
Methyl parathion
Naled*
Oxydemeton-methyl
Phosmet (full IRED)*
Tetrachlorvinphos*
*Completed as of August 15, 2002.
iii. Early OP cancellations. Ten OP pesticides were canceled prior
to or early in the pilot public participation process. See List 3.
List 3.--OPs Canceled Prior to/Early in the Pilot Public Participation
Process
Chlorfenvinphos
Chlorthiophos
Dialifor
Dioxathion
Fonofos
Isazophos
Isofenphos
Monocrotophos
Phosphamidon
Sulprofos
F. Applications for Registration Requiring Expedited Processing;
Numbers Approved and Disapproved
By law, EPA must expedite its processing of certain types of
applications for pesticide product registration, i.e., applications for
end use products that would be identical or substantially similar to a
currently registered product; amendments to current product
registrations that do not require review of scientific data; and
products for public health pesticide uses. During FY 2000 and FY 2001,
EPA considered and approved the numbers of applications for
registration requiring expedited processing (also known as ``fast
track'' applications) shown in Table 11.
Table 11.--Fast Track Applications Approved in FY 2000 and FY 2001
------------------------------------------------------------------------
FY 2000 FY 2001
------------------------------------------------------------------------
Me-too product registrations/ 420 391
Fast track
------------------------------------------------------------------------
Amendments/Fast track 2,260 2,776
------------------------------------------------------------------------
Total applications processed by 2,680 3,167
expedited means
------------------------------------------------------------------------
Regarding numbers of applications disapproved, instead the Agency
generally notifies the registrant of any deficiencies in the
application that need to be corrected or addressed before the
application can be approved. Applications may have been withdrawn after
discussions with the Agency, but none were formally ``disapproved''
during FY 2001.
On a financial accounting basis, EPA devoted approximately 29 full-
time equivalents (FTEs) in both FY 2000 and FY 2001 to reviewing and
processing applications for fast track me-too product registrations and
label amendments. The Agency spent approximately $2.6 million in FY
2000 and $2.7 million in FY 2001 in direct costs (not including
administrative expenses, computer systems, management overhead, and
other indirect costs) on expedited processing and reviews.
G. Future Schedule for Reregistrations
During the past several years, EPA has been conducting
reregistration in conjunction with tolerance reassessment under FFDCA.
That law requires the Agency to reassess all existing tolerances over a
10-year period to ensure consistency with the new safety standard, and
to consider pesticides that appear to pose the greatest risk first. In
prioritizing pesticides for reregistration eligibility review and
tolerance reassessment, EPA is continuing to consider their potential
risks, as reflected in the Agency's tolerance reassessment schedule
published in the Federal Register on August 4, 1997 . EPA is giving
highest priority to pesticides in Group 1, including the OP pesticides,
and the carbamates, organochlorines, and B2 (probable human)
carcinogens.
1. RED, IRED, and TRED Candidate Pesticides for FY 2002. List 4
contains the candidate pesticides for Reregistration Eligibility
Decisions (REDs), Interim REDs (IREDs), and Reports on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decisions (TREDs) in
FY 2002. As in previous years, any pesticides for which decisions are
not completed during FY 2002 will automatically become candidates for
decisions in FY 2003.
List 4.--FY 2002 RED, IRED, and TRED Candidate Pesticides
RED Candidates
Diuron**
Endosulfan*
Imazalil**
Lindane*
Oxyfluorfen*
Propanil**
Sodium acifluorfen
Thiabendazole*
[[Page 58051]]
Thiophanate-methyl
Ziram
[+ 25 OP IREDs may be counted as REDs once OP cumulative risks are
considered]
Voluntary Cancellations that Will Count as REDs
Fenamiphos* (initially prepared as an OP IRED)
Oxadiazon
OP IRED and TRED Candidates
Azinphos-methyl*
Diazinon*
Dichlorvos (DDVP)
Dicrotophos*
Dimethoate
Disulfoton*
Malathion
Methamidophos*
Methyl parathion
Naled*
Oxydemeton-methyl
Phosmet (full IRED)*
Tetrachlorvinphos (TRED)*
Other IRED Candidates
Atrazine (being rescheduled for FY 2003)
Other TRED Candidates
Asulam*
Chlorpropham*
Difenzoquat*
Diquat dibromide*
Fenarimol*
Fenbutatin oxide*
Hexazinone*
Inorganic bromides from methyl bromide
Lactofen
Limonene
Linuron*
Metolachlor*
Norflurazon*
Primisulfuron-methyl*
Pronamide*
Propionic acid
Sodium hypochlorite
Sulfur
Tebuthiuron*
Urea*
*Completed as of August 15, 2002.
**TRED completed as of August 15, 2002; RED still to be completed.
2. RED, IRED, and TRED Candidate Pesticides for FY 2003. The
candidate pesticides for FY 2003 RED, IRED, and TRED decisions are
included in List 5.
List 5.--FY 2003 RED, IRED, and TRED Candidate Pesticides
RED and IRED Candidates
Aldicarb
Benfluralin
Cacodylic acid
Carbaryl
Carbofuran
Cycloate
Dinocap
Dipropyl isocinchomeronate
Ethoxyquin
Fenvalerate
Fluvalinate
Formetanate HCl
Methanearsonic acid, salts (CAMA, DSMA, and MSMA)
Molinate
PCNB
Permethrin
Thiram
Triadimefon*
TRED Candidates
Bitertanol
Chlorophenoxyacetic acid
Esfenvalerate**
Oryzalin
Triadimenol*
*May be completed as interim decisions if EPA decides that these
pesticides belong to the triazoles group and that a common mechanism of
toxicity exists.
**May be incorporated into the Fenvalerate RED.
H. Projected Year of Completion of Reregistrations
EPA is now conducting reregistration in conjunction with tolerance
reassessment, which FFDCA mandates be completed by 2006. EPA plans to
complete reregistration of pesticide active ingredients prior to the
statutory deadline for completing tolerance reassessment.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: August 29, 2002.
Stephen Johnson,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. 02-23265 Filed 9-12-02; 8:45 am]
BILLING CODE 6560-50-S