[Federal Register Volume 64, Number 222 (Thursday, November 18, 1999)]
[Notices]
[Pages 63036-63045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30157]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34191; FRL-6092-3]


Pesticide Reregistration Performance Measures and Goals

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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[[Page 63037]]

SUMMARY: This notice announces EPA's progress in meeting its 
performance measures and goals for pesticide reregistration during 
1998. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
requires EPA to publish this information annually. The 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 high priority 
chemicals.
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 number [OPP-34191], 
should be received on or before January 18, 2000.
ADDRESSES: Comments may be submitted by regular 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, Environmental 
Protection Agency (7508C), 401 M St., SW., Washington, DC 20460, 
telephone: (703) 308-8007, e-mail: [email protected].
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 in the ``FOR FURTHER INFORMATION CONTACT'' section.

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 Home page 
at www.epa.gov. On the 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 directly 
to the Home Page for the Office of Pesticide Programs at www.epa.gov/
pesticides and select ``Pesticide Reregistration'' under ``Select Topic 
From List,'' the pull-down menu at the top of the screen.
     2. In person. The official record for this notice, as well as the 
public version, has been established under docket control number [OPP-
34191] (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 Rm. 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 To? 

     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, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460.
     2. In person. Deliver written comments to Public Information and 
Records Integrity Branch, in Rm. 119, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
     3.  Electronically. Submit your comments and/or data 
electronically to [email protected] . 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 5.1/6.1 or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket control number [OPP-36191]. 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 annually in the Federal Register 
its 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:
    a. The status of reregistration;
    b. The number of products reregistered, canceled, or amended;
    c. The number and type of data requests or Data Call-In notices 
(DCIs) under section3(c)(2)(B) issued to support product reregistration 
by active ingredient;
    d. Progress in reducing the number of unreviewed, required 
reregistration studies;
    e. The aggregate status of tolerances reassessed;
    f. The number of applications for registration submitted under 
subsection (k)(3),expedited processing and review of similar 
applications, that were approved or disapproved;
    g. The future schedule for reregistrations; and
    h. 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 prior to November 1, 1984. Those pesticides 
meeting today's scientific and regulatory standards may be declared 
``eligible'' for reregistration. In order to be so designated, an older 
pesticide must have a substantially complete data base, and must be 
found not to cause unreasonable risks to human health or the 
environment when used in accordance with Agency approved label 
directions and precautions.
     In addition, all pesticides with food uses must meet the safety 
standard of the Food Quality Protection Act (FQPA) of 1996. Under FQPA, 
EPA must make a determination that pesticide residues remaining in or 
on food are ``safe''; that is, ``that there is reasonable certainty

[[Page 63038]]

that no harm will result from aggregate exposure to the pesticide 
chemical residue'' from dietary and other sources. In determining 
allowable levels of pesticide residues in food, EPA must perform a more 
comprehensive assessment of each pesticide's risks, considering:
     Aggregate exposure (from food, drinking water, and 
residential uses);
     Cumulative effects from all pesticides sharing a common 
mechanism of toxicity;
     Possible increased susceptibility of infants and children; 
and
     Possible endocrine or estrogenic effects.
    FQPA 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 
9,7211 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).
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    1 Although the total number of tolerances existing on August 3, 
1996, and subject to FQPA reassessment was initially reported as 
9,728, the correct number based on the Agency's recently completed 
Tolerance Tracking System is 9,721.
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     EPA is meeting FQPA's tolerance reassessment requirements through 
reregistration and several other key program activities. Schedules have 
been coordinated and integrated so that, in the course of making 
reregistration eligibility decisions, the Agency also is completing 
much of tolerance reassessment within the time frames mandated by the 
new law. EPA has met the FQPA goal of reassessing the first 33% of all 
food tolerances by August 3, 1999. Among these first completed 
tolerance reassessments, over 66% are for pesticides identified as 
posing the greatest potential risks. EPA is focusing attention 
particularly on priority Group 1 pesticides; over half of the universe 
of tolerances to be reassessed are included in this category, including 
tolerances for the organophosphate pesticides (the Agency's highest 
priority for review), as well as the carbamates, organochlorines, and 
B2(probable human) carcinogens. EPA's approach to tolerance 
reassessment under FQPA, including the three priority Groups, is 
described fully in the Agency's document entitled, ``Raw and Processed 
Food Schedule for Pesticide Tolerance Reassessment'' (62 FR 42020, 
August 4, 1997)(FRL-5734-6).
    FQPA has added considerably more complexity to the process of 
reregistering pesticides. New statutory requirements to consider 
aggregate exposure and cumulative risk, along with implementing new 
processes to increase stakeholder involvement and ensure a reasonable 
period for transition to new pest control tools and practices, have 
made risk assessment more complex and have lengthened the ''front end'' 
portion of reregistration. Over the longer run, these changes will 
enhance protection of human health and the environment and should speed 
risk reductions. EPA is now conducting reregistration in conjunction 
with tolerance reassessment, which FQPA mandates be completed by 2006. 
Reregistration of pesticide active ingredients and products will be 
completed prior to the statutory deadline for completing tolerance 
reassessment. However, there are increasing indications that all 
elements of reregistration, especially those elements also necessary to 
complete tolerance reassessment, will not be completed for all active 
ingredients by 2002.
     When the ongoing pesticide reregistration program is completed by 
the year 2006, registration review as mandated by section 3(g) of FIFRA 
(a new provision adopted as part of the FQPA) will be underway. EPA's 
goal under the new program is to review every pesticide registration on 
a 15-year cycle.

 III. FQPA and Program Accountability

     One of the hallmarks of FQPA is enhanced accountability. EPA has 
incurred several additional obligations under this law, including the 
requirement to publish annually a summary of the program's performance 
measures and goals for reregistration, tolerance reassessment, and 
expedited registration. The following sections describe EPA's progress 
in the areas specifically identified by FIFRA section 4(l).

A. Status of Reregistration 

     Through the reregistration program, EPA is reviewing current 
scientific data for older pesticides and requiring changes to improve 
their safety. Pesticides that have sufficient supporting human health 
and environmental effects data and do not pose unreasonable risks may 
be declared ``eligible'' for reregistration. EPA presents these 
findings in Reregistration Eligibility Decision (RED) documents. At the 
end of fiscal year 1998 (FY `98) (that is, as of September 30, 1998), 
the Agency had completed 184 REDs out of a universe of 612 cases, or 
groups of related pesticide active ingredients subject to 
reregistration. Eight of the 184 decisions were voluntary cancellations 
that were counted as REDs because significant progress had been made in 
developing RED documents for these pesticides by the time the requests 
for their cancellation were received. An additional 231 reregistration 
cases were voluntarily canceled before EPA invested significant 
resources in developing their REDs. A total of 415 reregistration cases 
(68%), therefore, had completed the reregistration eligibility decision 
making process by the end of the fiscal year, leaving 197 cases (32%) 
awaiting such decisions.
     The 184 REDs completed by the end of FY `98 include 281 active 
ingredients and encompass almost 6,800 pesticide products. Eighty-two 
(82) of these REDs have food uses. Between August 3, 1996, the date 
when FQPA was enacted, and September 30, 1998, EPA completed 43 REDs, 
29 with food uses. The Agency reassessed 6382 tolerances for 
these post-FQPA REDs. [Note: Tolerances associated with the 53 food use 
REDs that were completed before FQPA was enacted will be revisited 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.]
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    2 Numbers of tolerance reassessments in this report are obtained 
from EPA's recently completed Tolerance Reassessment Tracking System 
(TORTS). The Agency has increased confidence in numbers derived from 
this new system, after completing an intensive quality control check 
of the entire data base. Where discrepancies are found between old 
and new tolerance reassessment numbers, those from the new system 
should take precedence. EPA plans to use these numbers as the 
baseline for all future tolerance reassessment reports and analyses.
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     Reducing pesticide risks is an important aspect of the 
reregistration program. In developing REDs, EPA works with pesticide 
registrants to develop voluntary measures or regulatory controls needed 
to effectively reduce risks of concern. Every RED includes some risk 
reduction measures. The options for reducing risks 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

[[Page 63039]]

environmental and ecological safeguards; and other measures.
     EPA has previously projected its goal in conducting the 
reregistration program is to complete 34 REDs in FY `99, 20 in FY 2000, 
and 30 in FY 2001. EPA also intends to reassess tolerances within time 
frames set forth in FQPA, building on the reassessment of 33% of the 
existing tolerances by August 3, 1999, giving priority to those food 
use pesticides that appear to pose the greatest risk. As noted above, 
the integration of these two 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 a RED has been 
issued and a pesticide reregistration case has been declared eligible 
for reregistration, individual end-use pesticide products that contain 
pesticide active ingredients included in the case must still be 
reregistered. This concluding part of the reregistration process is 
called ``product reregistration.''
    A variety of outcomes are possible for pesticide products going 
through this final phase of the reregistration process. Ideally, the 
registrant submits the required product-specific data and revised 
labeling, which are reviewed and accepted by EPA. At that point, the 
Agency reregisters 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. 
Alternatively, the pesticide producer, or registrant, may request a 
voluntary cancellation of their end-use product registration. 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 frames specified, or may cancel a product's 
registration because the registrant did not pay the required 
registration maintenance fee. During FY `98, 746 pesticide products 
reached one of these outcomes, as shown in the following table 1.

Table 1.-- Product Reregistration Decisions and Actions Completed during
                            Fiscal Year 1998
 
 
 
Products Reregistered..............................................  221
Products Amended...................................................   53
Products Canceled..................................................  337
Products Sent for Suspension.......................................  135
 
                                                                    ====
    Total..........................................................  746
 

     The status of the universe of 6,796 pesticide products subject to 
product reregistration based on completed REDs as of August 1999, is 
shown in table 2 below. This product reregistration status information 
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 the following table 2 may 
fluctuate.

      Table 2.-- Status of Universe of Products Subject to Product
                    Reregistration, as of August 1999
 
 
 
Products Reregistered...........................................   1,204
Products Amended................................................     166
Products Canceled...............................................   2,408
Products Sent for Suspension....................................     150
 
                                                                 =======
    Total Products Completed....................................   3,928
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Products with Decisions Pending.................................   2,868
 
                                                                 =======
    Total Products in Universe..................................   6,796
 

     Currently, 2,868 products have product reregistration decisions 
pending. Some of these products are awaiting science reviews or 
decisions by EPA. Others are not yet ready for product reregistration 
decisions; they are associated with more recently completed REDs, and 
their product-specific data are not yet due to be submitted to, or 
reviewed by, the Agency. EPA's goal is to complete reregistration 
decisions for 750 products during fiscal year 1999, and to 
substantially reduce or eliminate the backlog of pending product 
reregistration decisions within the next several years.

C. Number and Type of DCIs Issued to Support Product Reregistration by 
Active Ingredient

     The number and type of data requests or Data Call-In notices 
(DCIs) issued by EPA under FIFRA section 3(c)(2)(B) to support product 
reregistration for pesticide active ingredients included in fiscal year 
1998 REDs are shown in the following table 3.

                                    Table 3.--Data Call Ins Issued to Support Product Reregistration for FY `98 REDs
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                                                                  Number of
                                                                   Products      Number of Product          Number of Acute         Number of Efficacy
               Case No.                        Case Name          Covered in     Chemistry Studies        Toxicology Studies         Studies Required
                                                                    RED\1\          Required\2\               Required\3\
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0063.................................  Alachlor                           13                       20  72 (12 not batched)                             0
0025.................................  Aluminum Phosphide                 23                       20  42(5 batches/2 not                              1
                                                                                                        batched)
0025.................................  Magnesium Phosphide                 4                       20  18 (1 batch/2 not                               1
                                                                                                        batched)
2070.................................  Bromoxynil                         23                       20  72 (5 batches/7 not                             0
                                                                                                        batched)
0097.................................  Chlorothalonil                    210                       20  828 (17 batches/121 not                         0
                                                                                                        batched)
0002.................................  DEET                              232                       20  300 (26 batches/24 not                          2
                                                                                                        batched)

[[Page 63040]]

 
0328.................................  1,3-Dichloropropene                17                       20  24 (4 batches)                                  0
0021.................................  Dicofol                            31                       20  66 (3 batches/8 not                            10
                                                                                                        batched)
2585.................................  Hydramethylnon                     30                       20  24 (3 batches/1 not                             0
                                                                                                        batched)
2335                                   Iprodione                          40                       17  72 (3 batches/9 not                             0
                                                                                                        batched)
0028.................................  Methomyl                           31                       20  54 (5 batches/4 not                             2
                                                                                                        batched)
0177.................................  Propachlor                          8                       20  30 (1 batch/4 not                               0
                                                                                                        batched)
2675.................................  Thiodicarb                         30                       20  60 (2 batches/8 not                             0
                                                                                                        batched)
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\1\ The number of registered products containing a pesticide active ingredient can change over time. The product count that appears in the RED document
  may not be the same as the final count, which is prepared just before the RED document is mailed to registrants. 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 were required, only six studies would be needed rather than 30 studies. 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, wet table powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). 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.

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

     EPA is making good progress in reviewing scientific studies 
submitted by registrants in support of pesticides undergoing 
reregistration. Nearly 28,000 studies (27,728) have been received by 
the Agency through the reregistration program. Over 75% (20,857) of 
these studies either have been reviewed (19,583 or over 70% ), or have 
been found to be extraneous (1,274 or almost 5% ). (Extraneous studies 
is a term used to classify those studies that are not needed because 
the guideline or data requirement has been satisfied by other studies 
or has changed.) Less than 25% (6,871) of all studies received are 
``awaiting review'' for future REDs, to complete the reregistration 
program. A more detailed account of the number and percent of studies 
received, reviewed, and awaiting review by reregistration list appears 
in table 4 below.
     The proportion of studies awaiting review by EPA decreased 
slightly during the past year. At the end of 1997, almost 75% of all 
studies received in support of reregistration had been reviewed, 
compared to over 75% at the end of 1998. Thus, the reregistration study 
``backlog'' remained fairly constant, but did decrease slightly during 
1998.

                   Table 4.-- Review Status of Studies Submitted for Pesticide Reregistration
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                                                                                                         Total
                  List                       Studies Reviewed + Extraneous    Studies Awaiting Review   Studies
                                                                                                        Received
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List A..................................     10,423 + 291 = 10,714 (81% )           2,571 (19% )         13,285
List B..................................      5,720 + 661 = 6,381 (68% )            2,956 (32% )         9,337
List C..................................      2,133 + 228 = 2,361 (70% )            1,013 (30% )         3,374
List D..................................       1,307 + 94 = 1,401 (81% )             331 (19% )          1,732
                                         =======================================================================
  TOTAL Lists A - D.....................    19,583 + 1,274 = 20,857 (75% )          6,871 (25% )         27,728
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E. Aggregate Status of Tolerances Reassessed

     EPA recently met the FQPA goal of reassessing 33% of all food 
tolerances by August 3, 1999, including many tolerances for pesticides 
identified as posing the greatest potential risks. As required by FQPA, 
the Agency announced its general schedule for tolerance reassessment in 
the Federal Register on August 4, 1997. This document identified three 
groups of pesticides to be reviewed; the grouping reflects EPA's 
overall scheduling priorities for tolerance reassessment. The Agency 
has given priority to Group 1 pesticides, particularly to the 
organophosphate pesticides (OPs).
     1.  Tolerance reassessment and the organophosphates. Because of 
the intense public interest in tolerance reassessment for the OPs, EPA 
and USDA created the Tolerance Reassessment Advisory Committee (TRAC) 
in 1998, to give advice on the best way to conduct the process, 
beginning with this class of pesticides. With guidance from TRAC, EPA 
is piloting an approach to tolerance reassessment that allows for much 
greater transparency and public involvement in developing both risk 
assessments and risk management decisions. Scientific analyses and risk 
assessments for the OPs have been made far more accessible to the 
public through a systematic notice and comment process, complemented by 
an Agency website (www.epa.gov/pesticides/op/), and supplemented by 
public meetings and technical briefings.
     Through the ongoing public participation process for the OPs, EPA 
is obtaining additional health and environmental effects data, use 
data, and other information that is valuable in revising and completing 
our risk assessments. EPA expects to present its risk management 
proposals for the first several OPs, inviting public examination, 
discussion, and comment on both risk mitigation measures and possible 
transition strategies to alternative pest control approaches,

[[Page 63041]]

during FY `99. The Agency also is developing a method for calculating 
cumulative risk for the OPs as a group, and expects to issue its draft 
guidance on aggregating exposure by this fall for review and comment. A 
comprehensive guidance document on combining common mechanism of 
toxicity and aggregate exposure will be presented to the Scientific 
Advisory Panel by the end of the calendar year. Although all individual 
OP tolerances will not be reassessed in the first one-third, EPA is 
making significant progress with this group of chemicals and expects to 
complete the reassessments for all OP pesticides by the end of 2000.
     2.  Fiscal Year 1998 accomplishments. During FY `98, EPA 
reassessed 1,395 tolerances through the reregistration and registration 
programs and in conducting follow-up activities to revoke tolerances 
for pesticides that had been canceled previously, many as a result of 
reregistration. By the end of FY `98, the Agency was well on its way to 
meeting the first statutory tolerance reassessment deadline, as a 
cumulative total of 1,981 tolerances had been reassessed under FQPA 
since August 1996.
     Many (809 or 58% ) of EPA's 1,395 tolerance reassessment actions 
during FY `98 were tolerance revocation decisions, implemented through 
rule making. (Although the Agency made decisions to revoke these 
tolerances and signed final rule making to effect these decisions 
during FY `98, some of the rules were not published in the Federal 
Register until after the end of the fiscal year.) Other FY `98 
reassessments occurred through reregistration/REDs (276) and through 
registration (310). Over 73 % of the FY `98 tolerance reassessments 
were for pesticides in priority Group 1 (1,023); others were for 
pesticides in Group 2 (202) and Group 3 (170). EPA reassessed 303 OP 
tolerances, 92 carbamate tolerances, and 350 carcinogen tolerances 
during FY `98. The Agency completed 224 tolerance reassessments for 
children's foods (i.e., foods among the top 20 raw agricultural 
commodities eaten by children age 1 to 6 years old, and among the top 
20 commodities consumed by infants, according to a 1989-1991 survey.) 
902 of the tolerances reassessed were for pesticide minor uses. Please 
see the following table 5 for a summary of these FY `98 
accomplishments.

    Table 5.--Fiscal Year 1998 Tolerance Reassessment Accomplishments
 
 
 
Sources of FY `98 Tolerance Reassessments...............
  Reregistration/REDs...................................             276
  Registration..........................................             310
  Tolerance Revocations.................................             809
 
                                                         ===============
    Total...............................................           1,395
------------------------------------------------------------------------
Numbers of Reassessments by Priority Group..............
  Group 1...............................................    1,023 (73% )
  Group 2...............................................      202 (15% )
  Group 3...............................................      170 (12% )
 
                                                         ===============
    Total...............................................   1,395 (100% )
------------------------------------------------------------------------
Special Types of Tolerances Reassessed..................
  Organophosphates......................................             303
  Carbamates............................................              92
  Carcinogens...........................................             350
  Kids Foods............................................             224
  Minor Uses............................................             902
 
                                                         ===============
    total...............................................           1,871
 

     3.  Cumulative accomplishments. EPA is conducting a variety of 
tolerance reassessment activities throughout the pesticide program that 
recently enabled the Agency to meet the FQPA goal of reassessing 33% of 
all food tolerances by August 3, 1999. As mentioned earlier, EPA's 
Tolerance Reassessment Tracking System (TORTS) is enabling the Agency 
to compile and consistently report on these tolerance reassessment 
accomplishments. The Agency has a high degree of confidence in this new 
data base, which was designed, created, and quality controlled 
internally, and is being operated in-house. Based on records regarding 
all 9,721 permanent tolerances subject to reassessment under FQPA, 
TORTS provides timely, detailed, and accurate reports highlighting many 
important aspects of the Agency's completed tolerance reassessments. 
Where discrepancies between old and new tolerance reassessment numbers 
are found, information from TORTS should take precedence. This system 
provides a solid baseline for all future Agency tolerance reassessment 
reports and analyses.
     As of August 1999, of the 9,721 tolerances subject to 
reassessment, EPA has reassessed a net total of 3,290 tolerances. The 
Agency is accomplishing tolerance reassessment through the 
reregistration program, the registration program, and by revoking 
tolerances for pesticides that have been canceled (many as a result of 
reregistration). (Please see table 6).

            Table 6.-- Tolerance Reassessments Completed Post-FQPA by Fiscal Year, as of August 1999
----------------------------------------------------------------------------------------------------------------
                                          During                           Total,   During FY
     Tolerances Reassessed Through       Late FY   During FY  During FY  End of FY    `99,So    Total, August FY
                                           `96        `97        `98        `98        Far            `99
----------------------------------------------------------------------------------------------------------------
Reregistration/REDs...................         25        337        276        638        253                891
Registration..........................          0        221        310        531        324                855
Tolerance Revocations.................          3          0        809        812        513              1,325
Other Decisions.......................          0          0          0          0        219                219
 
                                       =========================================================================
  Total Tolerances Reassessed.........         28        558      1,395      1,981      1,309              3,290
----------------------------------------------------------------------------------------------------------------

    i. Reregistration/REDs. EPA is using the reregistration program to 
accomplish much of the tolerance reassessment. As of August 1999, 891 
tolerance reassessment decisions have been completed through 
reregistration. EPA has reviewed each of these existing tolerances and 
made the finding that there is a reasonable certainty of no harm, as 
required by FQPA. Many of the tolerances reassessed through REDs will 
remain the same while others are subject to modification, i.e., they 
may be raised, lowered, or revoked. Those that are being revoked are 
discussed further below. Although the Agency has reassessed all of 
these tolerances as part of reregistration consistent with FQPA, 
reached reassessment decisions, and issued formal REDs to document and 
announce its decisions, the rulemaking that will finally modify or 
revoke these tolerances has not yet been completed for all chemical 
cases.

[[Page 63042]]

     ii. Registration. Like older pesticides, all new pesticide 
registrations must meet the safety standard of FQPA. 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. As of August 1999, 855 
tolerances have been reassessed as a result of the registration 
process. The Agency has specifically discouraged submission of 
applications and petitions for any new uses of the organophosphate 
pesticides, given the associated risk concerns.
     iii.  Tolerance revocations. EPA also has made decisions and has 
formally revoked, through rule making, a total of 1,325 tolerances. 
These revoked tolerances represent uses of many different pesticide 
active ingredients that were canceled in recent years, some due to the 
Agency's risk concerns; and many others voluntarily, based on lack of 
support for reregistration. By requiring the systematic updating of 
scientific data bases for older chemicals, EPA's reregistration program 
elicited registrant decisions to support or not support their 
chemicals. Registrants may have chosen not to support a specific use or 
an entire chemical for economic reasons, or in reaction to the Agency's 
risk concerns. Now that most unsupported pesticides and uses have been 
canceled, tolerances for residues also can be revoked; existing stocks 
of the chemicals are presumed to have been exhausted, and sufficient 
time will have elapsed for any treated food to clear channels of trade. 
These tolerance revocation actions are important; although many of the 
pesticides are no longer used in the United States, commodities treated 
with them could still have been imported before the revocations became 
effective.
     iv. Other reassessment decisions. In addition to those described 
above, a total of 219 additional tolerance reassessment decisions have 
been made. These include 65 tolerances reassessed through the Plant 
Growth Regulator Rule (64 FR 31501, June 11, 1999) (FRL-6076-5); 80 
organophosphate meat, milk, poultry, and egg tolerances determined to 
have no reasonable expectation of finite residue and therefore revoked 
on July 7, 1999; and 74 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 (and so they also meet 
the FQPA safety standard).

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 `98, EPA 
considered and approved the following numbers of applications for 
registration requiring expedited processing (also known as ``fast 
track'' applications):
     Me-too product registrations/fast track: 496
     Amendments/fast track: 3,054
     Total: 3,550 applications processed by expedited means


     Regarding numbers of applications disapproved, 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 `98.
     On a financial accounting basis, EPA devoted approximately 30 
full-time equivalents (FTEs) to reviewing and processing applications 
for me-too product registrations and fast-track label amendments. The 
Agency spent $2.4 million in direct costs (not including administrative 
expenses, computer systems, management overhead, and other indirect 
costs) during FY `98 on expedited processing and reviews.

G. Future Schedule for Reregistrations

     EPA is now conducting its reregistration in conjunction with 
tolerance reassessment under FQPA. 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. The OP pesticides thus are 
the focal point of EPA's reregistration and tolerance reassessment 
programs at present (see List 1).

List 1.--The Organophosphate Pesticides
    Acephate
    Azinphos-methyl
    Bensulide
    Cadusafos*++
    Chlorethoxyfos++
    Chlorpyrifos
    Chlorpyrifos-methyl++
    Chlorthiophos**
    Coumaphos+
    Dialifor**
    Diazinon
    Dichlorvos (DDVP)
    Dicrotophos
    Dimethoate
    Dioxathion**
    Disulfoton
    Ethion
    Ethoprop
    Ethyl parathion
    Fenamiphos
    Fenitrothion+
    Fenthion
    Fonofos**+
    Isazophos**++
    Isofenphos**+
    Malathion
    Methamidophos
    Methidathion
    Methyl parathion
    Mevinphos**+
    Monocrotophos**
    Naled
    Oxydemeton-methyl
    Phorate
    Phosalone**
    Phosmet
    Phosphamidon**+
    Phostebupirim++
    Pirimiphos-methyl
    Profenofos
    Propetamphos
    Sulfotepp
    Sulprofos**+
    Temephos
    Terbufos
    Tetrachlorvinphos+
    Tribufos (DEF)
    Trichlorfon+

     * Import tolerances only; no U.S. registrations.
    ** Canceled or proposed for cancellation; will be included in 
the organophosphate risk assessment if import tolerances remain 
after other tolerances are revoked.
    + Reregistration Eligibility Decision has been completed.
    ++ Registered post-'84 (not subject to reregistration).


    EPA currently is reviewing each of the OP pesticides individually, 
and will conduct a cumulative assessment of all these pesticides 
together when the necessary methodology is complete. The Agency's pilot 
public participation process for the OPs features unprecedented 
pesticide information-sharing through the creation of public dockets 
(both electronic and in printed form), and several opportunities for 
public comment on each OP. Meanwhile, REDs for other types of 
pesticides are also in preparation. EPA expects to complete 8 to 10 
REDs for the primarily non-OP RED candidates in List 2 below during the 
remainder of FY `99. In addition, several reregistration cases are in 
the process of being voluntarily canceled by their registrants.

[[Page 63043]]

 These voluntary cancellations (and possibly others) will also count as 
FY `99 REDs (see List 3).

List 2.--Fiscal Year 1999 RED Candidates
    Bendiocarb
    Captan
    EPTC
    Folpet
    Formetanate HCl
    Lamprecide
    Niclosamide
    Pebulate
    Sulfotepp (OP)*
    TPTH
    * EPA plans to complete a RED for the OP sulfotepp in FY `99, 
and will consider the pesticide again later in preparing a 
cumulative assessment for all the OP pesticides.


List 3.-- Fiscal Year 1999 Voluntary Cancellations that Count as REDs, 
as of August 1999
    Fonofos (OP)
    Isofenphos (OP)
    Oxythioquinox
    Ryanodine
    Vernolate


     In prioritizing pesticides for reregistration eligibility review 
and tolerance reassessment, EPA continues to consider their potential 
risks, as reflected in the Agency's tolerance reassessment schedule 
published in the Federal Register on August 4, 1997. The Agency is 
giving highest priority to pesticides in Group 1 and is continuing to 
follow the schedule for reviewing clusters or waves of priority Group 1 
pesticides, published in table 3 of our October 7, 1998, Federal 
Register Notice on Pesticide Reregistration Performance Measures and 
Goals for 1997 (63 FR 53895-53902) (FRL-6016-5). While focusing 
intensively on the organophosphates, the Agency also is making good 
progress in reviewing tolerances for other classes of pesticides in 
priority Group 1, including the carbamates, organochlorines, and 
probable B2 carcinogens. EPA's current schedules for 
completing reregistration eligibility decisions (REDs) and tolerance 
reassessments for the carbamates, organochlorines, and carcinogens in 
Group 1 are presented in tables 7, 8, and 9 below.

 Table 7.--Schedule (Estimated Dates by Fiscal Year) for Completing REDs
         and Tolerance Reassessments for Carbamate Pesticides\1\
------------------------------------------------------------------------
                                                           Tolerance
             Chemical                      RED            Reassessment
------------------------------------------------------------------------
                               Carbamates
Asulam**..........................         Completed*              2002*
Bendiocarb........................               1999               1999
Benomyl**.........................               2000               2000
Carbaryl**........................               2000               2000
Carbofuran........................               2000               2000
Chlorpropham (CIPC)...............         Completed*              2002*
Desmedipham.......................         Completed*              2002*
Formetanate HCl...................               1999               1999
Isopropyl Carbanilate (IPC or              (Canceled)          Completed
 Propham).........................
Methiocarb........................         Completed*         Completed*
Phenmedipham......................               2000               2000
Thiophanate methyl................               2000               2000
Trimethacarb......................         (Canceled)               2001
                            Oxime Carbamates
Aldicarb..........................               2000               2000
Methomyl..........................          Completed          Completed
Oxamyl............................               2000               2000
Thiodicarb**......................          Completed          Completed
                             Thiocarbamates
 Butylate.........................         Completed*              2000*
Diallate..........................         (Canceled)          Completed
EPTC..............................               1999               1999
Molinate**........................               2000               2000
Pebulate..........................               1999               1999
Thiobencarb.......................          Completed          Completed
Vernolate.........................    1999 (Canceled)              1999
------------------------------------------------------------------------
\1\ Triallate, which is both a carbamate and a carcinogen, is included
  in Table 9 below to avoid duplicate counting.

    * RED completed before FQPA--needs FQPA reassessment.
    ** Is also a carcinogen.

[[Page 63044]]



 Table 8.--Schedule (Estimated Dates by Fiscal Year) for Completing REDs
        and Tolerance Reassessments for Organochlorine Pesticides
------------------------------------------------------------------------
                                                           Tolerance
            Chemical                      RED            Reassessment
------------------------------------------------------------------------
Dicofol *.......................           Completed           Completed
Endosulfan......................                2000                2000
Lindane *.......................                2000                2000
Methoxychlor....................                2001                2001
------------------------------------------------------------------------

    * Is also a carcinogen.

 Table 9.--Schedule (Estimated Dates by Fiscal Year) for Completing REDs
   and Tolerance Reassessments for Carcinogenic Pesticides in Group 1
------------------------------------------------------------------------
                                                           Tolerance
            Chemical                      RED            Reassessment
------------------------------------------------------------------------
Acetyldehyde....................           Completed           Completed
Acetochlor......................           (post-84)              2001**
Aciflourfen, Sodium salt........                2000                2000
Alachlor........................           Completed           Completed
Amitraz.........................         Completed *                2001
Amitrole........................           Completed     (no tolerances)
Atrazine........................                2000                2000
Cacodylic Acid..................                2000                2000
Captan..........................                1999                1999
Chlorothalonil..................           Completed           Completed
Creosote........................                1999     (no tolerances)
Cyanazine.......................           (Canceled                2002
                                    effective 12/31/
                                                 99)
Cypermethrin....................                2001           Completed
Dacthal (DCPA)..................         Completed *                2002
Daminozide (Alar)...............           Completed     (no tolerances)
Diclofop-methyl.................                2000                2000
Difenoconazole..................           (post-84)              2003**
Ethalfluralin...................         Completed *               2002*
Ethylene Oxide..................                2001                2001
Folpet..........................                1999                1999
Fomesafen.......................           (post-84)              2002**
Heptachlor (non-food)...........           Completed     (no tolerances)
Hexythiazox.....................           (post-84)              2002**
Imazalil........................                2000                2000
Iprodione.......................           Completed           Completed
Lactofen........................           (post-84)              2000**
MGK Repellent 326...............                2002     (no tolerances)
Mancozeb........................                2000                2000
Maneb...........................                2000                2000
Metam Sodium....................                2001     (no tolerances)
Metiram.........................                2000                2000
Metolachlor.....................         Completed *               2002*
Orthophenylphenol...............                2000                2000
Oryzalin........................         Completed *               2002*
Oxadiazon.......................                2001                2001
Oxadixyl........................           (post-84)              2001**
Oxyfluorfen.....................                2000                2000
Oxythioquinox...................     1999 (Canceled)                2000
Pentachloronitrobenzene (PCNB)..                2001                2001
Pentachlorophenol (non-food)....                1999     (no tolerances)
Permethrin......................                2001                2001
Procymidone.....................          (Canceled)        2001 (import
                                                         tolerance only)
Pronamide.......................          Completed*               2001*
Propargite......................                2000                2000
Propazine.......................          (Canceled)                2000
Propiconazole...................                2000                2000
Propylene Oxide.................                2000                2000
Simazine........................                2000                2000
Tebuconazole....................           (post-84)           Completed
Telone..........................           Completed     (no tolerances)
Terbutryn.......................          (Canceled)                2001
Terrazole.......................                2000                2000
TPTH............................                1999                1999
Triadimefon.....................                2001                2001

[[Page 63045]]

 
Triadimenol.....................           (post-84)              2001**
Triallate.......................                2000                2000
Trifluralin.....................         Completed *               2002*
Vinclozolin.....................                1999           Completed
------------------------------------------------------------------------

    * RED completed before FQPA--needs FQPA reassessment.
    ** Registered after 1984. No RED needed; however, tolerances 
must be reassessed.

H. Projected Year of Completion of Reregistrations

    EPA is now conducting reregistration in conjunction with tolerance 
reassessment, which FQPA mandates be completed by 2006. EPA plans to 
complete reregistration of pesticide active ingredients and products 
prior to the statutory deadline for completing tolerance reassessment.

List of Subjects

    Environmental protection.

    Dated: November 2, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides, and Toxic 
Substances.

[FR Doc. 99-30157 Filed 11-17-99; 8:45 am]
BILLING CODE 6560-50-F