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September 13, 2002. EPA status of reregistration and tolerance reassessments for 7 organofluorine pesticides. Federal Register.

Sodium acifluorfen


[Federal Register: September 13, 2002 (Volume 67, Number 178)]
[Page 58041-58051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]


[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 

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: 


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 

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-
(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 
    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:
The status of reregistration.
The number of products reregistered, canceled, or amended.
The number and type of data requests or Data Call-In (DCI) 
notices under section 3(c)(2)(B) issued to support product 
reregistration by active ingredient.
Progress in reducing the number of unreviewed, required 
reregistration studies.
The aggregate status of tolerances reassessed.
The number of applications for registration submitted under 
subsection (k)(3), expedited processing and review of similar 
applications, that were approved or disapproved.
The future schedule for reregistrations in the current and 
succeeding fiscal year.
The projected year of completion of the reregistrations 
under section 4.
    FIFRA, as amended in 1988, authorizes EPA to conduct a 
comprehensive pesticide reregistration program--a complete review of 
the human health and environmental effects of older pesticides 
originally registered before November 1, 1984. Pesticides meeting 
today's scientific and regulatory standards may be declared 
``eligible'' for reregistration. To be eligible, an older pesticide 
must have a substantially complete data base, and must not cause 
unreasonable adverse effects to human health or the environment when 
used according to Agency approved label directions and precautions.
    In addition, all pesticides with food uses must meet the safety 
standard of section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) 21 U.S.C. 346a, as amended by the Food Quality Protection Act 
(FQPA) of 1996. Under FFDCA, EPA must make a determination that 
pesticide residues remaining in or on food are ``safe''; that is, 
``that there is reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue'' from dietary and 
other sources. In determining allowable levels of pesticide residues in 
food, EPA must perform a more comprehensive assessment of each 
pesticide's risks, considering:
Aggregate exposure (from food, drinking water, and 
residential uses).
Cumulative effects from all pesticides sharing a common 
mechanism of toxicity.
Possible increased susceptibility of infants and children; 
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 

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........
7 IREDs                           6 IREDs             12 OP IREDs
Bensulide*......................  Acephate*.........  1 carbamate IRED
Fenthion*.......................  Chlorpyrifos*.....
**Oxamyl**......................  Ethoprop*.........
Phorate*........................  Methidathion*.....
Profenofos*.....................  Pirimiphos-methyl*
Propetamphos*...................  Terbufos*.........
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
*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 
    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:
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);
EPA completed a RED for the pesticide before FQPA was 
enacted (e.g., trichlorfon); 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 (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/
    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 
    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
                                        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
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 

    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                      --                     --                     --
0006                                 Temephos                27                      22                     48 (7 batches/1 not    2
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                       --                     --                     --
0090                                 Ethion (voluntary       10                      --                     --                     --
0234                                 Propargite              63                      22                     36 (1 batch/5 not      --
\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
\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
0290                                 Fenthion                11                      22                     36 (2 batches/4 not    2
0253                                 Oxamyl                  6                       22                     12 (1 batch/1 not      0
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
0100                                 Chlorpyrifos            326                     22                     546 (34 batches/57     2
                                                                                                             not batched)
0106                                 Ethoprop                15                      22                     36 (4 batches/2 not    0
0034                                 Methidathion            31                      22                     30 (3 batches/2 not    0
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
List B                                 5,951 + 654 = 6,605      2,815 (30%)              9,420
List C                                 2,149 + 228 = 2,377      1,013 (30%)              3,390
List D                                 1,307 + 94 = 1,401       333 (19%)                1,734
Total Lists A - D                      20,112 + 1,295 = 21,407  6,753 (23.98%)           28,160

[[Page 58048]]

                                 Review Status of Studies Received, October 2001
List A                                 11,109 + 471 = 11,580    2,204 (16%)              13,784
List B                                 5,357 + 744 = 7,101      2,447 (26%)              9,548
List C                                 2,264 + 239 = 2,503      943 (27%)                3,446
List D                                 1,342 + 94 = 1,436       306 (18%)                1,742
Total Lists A - D                      21,072 + 1,548 = 22,620  5,900 (20.7%)            28,520
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 
    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 
    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 
    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 
    Dichlorvos (DDVP)
    Methyl parathion
    Phosmet (full IRED)*
*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 

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) 
    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
    Sodium acifluorfen

[[Page 58051]]

[+ 25 OP IREDs may be counted as REDs once OP cumulative risks are 
Voluntary Cancellations that Will Count as REDs
    Fenamiphos* (initially prepared as an OP IRED)
OP IRED and TRED Candidates
    Dichlorvos (DDVP)
    Methyl parathion
    Phosmet (full IRED)*
    Tetrachlorvinphos (TRED)*
Other IRED Candidates
    Atrazine (being rescheduled for FY 2003)
Other TRED Candidates
    Diquat dibromide*
    Fenbutatin oxide*
    Inorganic bromides from methyl bromide
    Propionic acid
    Sodium hypochlorite
*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
    Cacodylic acid
    Dipropyl isocinchomeronate
    Formetanate HCl
    Methanearsonic acid, salts (CAMA, DSMA, and MSMA)
TRED Candidates
    Chlorophenoxyacetic acid
*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 
[FR Doc. 02-23265 Filed 9-12-02; 8:45 am]