[Federal Register Volume 65, Number 115 (Wednesday, June 14, 2000)]
[Notices]
[Pages 37375-37383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15034]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34221; FRL-6556-5]


Pesticide Reregistration Performance Measures and Goals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's progress in meeting its 
performance measures and goals for pesticide reregistration during 
1999. 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 chemicals during the 
next two fiscal years.

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

[[Page 37376]]

number [OPP-34221], should be received on or before August 14, 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, U.S. Environmental 
Protection Agency (7508C), Ariel Rios Building, 1200 Pennsylvania 
Avenue, NW., Washington, DC 20460, telephone: (703) 308-8007, e-mail: 
<a href="/cdn-cgi/l/email-protection#abd8dfcac5cccec785c8cad9c4c7ebcedbca85ccc4dd"><span class="__cf_email__" data-cfemail="ccbfb8ada2aba9a0e2afadbea3a08ca9bcade2aba3ba">[email protected]</span></a>.

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-
34221] (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 (CM #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, U.S. Environmental Protection 
Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., 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 <a href="/cdn-cgi/l/email-protection#e48b9494c9808b878f8190a4819485ca838b92"><span class="__cf_email__" data-cfemail="402f30306d242f232b2534002530216e272f36">[email protected]</span></a>. 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 or ASCII file format. All 
comments and data in electronic form must be identified by the docket 
control number [OPP-34221]. 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 section 3(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 in the current and 
succeeding fiscal year; 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 
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:
    <bullet> Aggregate exposure (from food, drinking water, and 
residential uses);
    <bullet> Cumulative effects from all pesticides sharing a common 
mechanism of toxicity;
    <bullet> Possible increased susceptibility of infants and children; 
and
    <bullet> 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

[[Page 37377]]

review of those pesticides that appear to pose the greatest risk to 
public health, and to reassess 33% of the 9,721 \1\ existing tolerances 
and exemptions within three 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 more recently 
completed Tolerance Reassessment 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. Last summer, EPA met the FQPA goal of reassessing the first 
33% of all food tolerances by August 3, 1999. Over 66% of these first 
completed tolerance reassessments are for pesticides identified as 
posing the greatest potential risks--i.e., pesticides in priority Group 
1. 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 B<INF>2</INF> (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).

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 1999 (FY '99) (that is, as of September 30, 1999), 
the Agency had completed 198 REDs out of a universe of 612 cases, or 
groups of related pesticide active ingredients subject to 
reregistration. Fifteen of the 198 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 429 
reregistration cases (70%), therefore, had completed the reregistration 
eligibility decision-making process by the end of the fiscal year, 
leaving 183 cases (30%) awaiting such decisions.
    The 198 REDs completed by the end of FY '99 include 296 active 
ingredients and encompass over 7,000 pesticide products. Ninety-three 
(93) of these REDs have food uses. Between August 3, 1996, the date 
when FQPA was enacted, and September 30, 1999, EPA completed 57 REDs, 
40 with food uses. According to EPA's Tolerance Reassessment Tracking 
System (TORTS), which was completed and began operating during FY '99, 
the Agency has reassessed 999 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.]

    The 14 REDs completed during FY '99 include seven decisions in 
which some or all uses of the pesticides were found to be eligible for 
reregistration, and seven voluntary cancellations. The first 
organophosphate (OP) pesticide RED, for Sulfotepp, is among these 14 
decisions. The FY '99 REDs with their reregistration case numbers are 
listed below.
    List--Reregistration Eligibility Decisions (REDs) Completed in FY 
'99

1. Bendiocarb (case 0409)--Voluntary Cancellation
2. Captan (case 0120)
3. S-Ethyl dipropylthiocarbamate (EPTC) (case 0064)
4. Folpet (case 0630)
5. Fonofos (case 0105) Voluntary Cancellation (OP)
6. Isofenphos (case 2345)--Voluntary Cancellation (OP)
7. Niclosamide (case 2455)
8. Oxythioquinox (case 2495)--Voluntary Cancellation
9. Pebulate (case 2500)
10. Ryanodine (case 2595)--Voluntary Cancellation
11. Sulfotepp (case 0338)--Voluntary Cancellation (OP) with phase-out
12. 3-trifluoromethyl-4-nitrophenol (TFM or Lamprecide) (case 3082)
13. Triphenyltin Hydroxide (TPTH) (case 0099)
14. Vernolate (case 2735)--Voluntary Cancellation

    While not completed REDs, highlights of the reregistration program 
during FY '99 included EPA's actions in early August to increase 
protection for children and families by mitigating the risks posed by 
two OP pesticides, methyl parathion and azinphos-methyl. Agreements 
with the registrants resulted in voluntary cancellation of many of the 
most significant food crop uses of methyl parathion, one of the most 
toxic and widely used OPs. Removing all fruit and many vegetable crop 
uses considerably reduced risks to children from residues in food, as 
well as risks to workers and the environment. The Agency also accepted 
voluntary measures to reduce both food and worker risks of azinphos-
methyl, an OP used on a wide variety of fruits and vegetables. Both 
methyl parathion and azinphos-methyl currently are part of the Agency's 
ongoing review of all OP pesticides.
    EPA also intends to issue ``interim REDs'' for most OPs which will 
include risk management decisions to address occupational and 
ecological risks, as well as food/water/residential risks on an 
individual chemical basis. The first two of these, for profenofos and 
bensulide, will be issued shortly. Final regulatory decisions or final 
REDs cannot be made until a cumulative risk assessment is conducted for 
all OPs, which are being analyzed on the basis of a common mechanism of 
toxicity.
    At the end of FY '99, the Agency also had recently reached an 
agreement with the registrant to reduce dietary, worker, and ecological 
risks of the carbamate pesticide, formetanate hydrochloride.
    Reducing pesticide risks is an important aspect of the 
reregistration program. In developing REDs, EPA works with stakeholders 
including pesticide registrants, growers, USDA, and others to develop 
voluntary measures or regulatory controls needed to effectively reduce 
risks of concern. Every RED includes some measures or modifications to 
reduce risks. The options for such risk reduction are extensive and 
include voluntary

[[Page 37378]]

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.
    EPA's current goal in conducting the reregistration program is to 
complete 20 REDs in FY 2000 and 30 in FY 2001. EPA 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 EPA has issued a 
RED and declared a pesticide reregistration case eligible for 
reregistration, individual end-use products that contain pesticide 
active ingredients included in the case still must be reregistered. 
This concluding part of the reregistration process is called ``product 
reregistration.''
    In issuing a completed RED document, EPA calls in any product-
specific data and revised labeling needed to make final reregistration 
decisions for each of the individual pesticide products covered by the 
RED. Based on the results of EPA's review of this data and labeling, 
products that are found to meet FIFRA and FQPA standards may be 
reregistered.
    A variety of outcomes are possible for pesticide products 
completing this final phase of the reregistration process. Ideally, in 
response to the Data Call-In (DCI) 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 '99. EPA counts each of the 
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, through this process, 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 '99, EPA completed 748 product 
reregistration actions, as detailed in the following Table 1. The 
program nearly met its goal, to complete 750 product reregistration 
actions during the fiscal year.

    Table 1.--Product Reregistration Actions Completed during FY 1999
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Product Reregistration Actions.............................          167
Product Amendment Actions..................................           70
Product Cancellation Actions...............................          511
========================================================================
TOTAL Actions in FY '99....................................          748
------------------------------------------------------------------------

    2. Status of the product reregistration universe. At present, a 
universe of over 7,000 pesticide products is subject to product 
reregistration based on REDs completed as of September 30, 1999. The 
current status of these products is shown in Table 2 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 2 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 2.--Status of the Universe of Products Subject to Product
                Reregistration, as of September 30, 1999.
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Products Reregistered......................................        1,281
Products Amended...........................................          185
Products Canceled..........................................        2,671
Products Sent for Suspension...............................          144
TOTAL Products with Actions Completed......................        4,281
Products with Actions Pending..............................        2,764
========================================================================
TOTAL Products in Product Reregistration Universe..........        7,045
------------------------------------------------------------------------

    The universe of 7,045 products in product reregistration at the end 
of FY '99 represents an increase of 249 products from the FY '98 
universe of 6,796 products. The increase consists of 237 products 
associated with FY '99 REDs, plus 12 products that were added as a 
result of data call-in activities and processing for several previously 
issued REDs.
    At the end of FY '99, 2,764 products had product reregistration 
decisions pending. Some of these products are awaiting science reviews, 
label reviews, or reregistration decisions by EPA. Other products are 
not yet ready for product reregistration actions; they are associated 
with more recently completed REDs, and their product specific data are 
not yet due to be submitted to or reviewed by the Agency. EPA's goal is 
to complete 750 product reregistration actions during fiscal year 2000.

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 FY 1999 
REDs are shown in Table 3. The FY '99 REDs that consisted of voluntary 
cancellations are not included in this table because products 
containing these pesticides will not be reregistered and therefore do 
not require DCIs.

[[Page 37379]]



                                    Table 3.--Data Call-Ins Issued to Support Product Reregistration for FY 1999 REDs
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                                                                                             Number of
                                                                                Number of     Product                                         Number of
                         Case No.                               Case Name        Products    Chemistry   Number of Acute Toxicology Studies    Efficacy
                                                                                Covered by    Studies               Required \3\               Studies
                                                                               the RED \1\    Required                                         Required
------------------------------------------------------------------------------------------------\2\-----------------------------------------------------
0120......................................................             Captan          159           21     384 (17 batches/47 not batched)            0
0064......................................................               EPTC           31           21        30 (2 batches/3 not batched)            0
0630......................................................             Folpet           16           17       66 (2 batches/ 9 not batched)            0
2455......................................................        Niclosamide            7           21                      18 (3 batches)            0
2500......................................................           Pebulate            2           21                  12 (2 not batched)            0
3082......................................................                TFM            2           21                      12 (2 batches)            0
0099......................................................               TPTH          2 0           21       30 (3 batches/ 2 not batched)           0
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\1\ The number of registered products containing a pesticide active ingredient can change over time. The number of products that appears in the RED
  document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later,
  when the RED is issued). This table reflects the final number of products associated with each RED, as they are being tracked for product
  reregistration.
\2\ This column shows the number of product chemistry studies that are required for each product covered by the RED.
\3\ In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ``batches'' products that
  can be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if sixacute
  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, 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. As of October 1999, 27,926 studies have been received 
by the Agency through the reregistration program. Over 75% (21,001) of 
these studies either have been reviewed (19,732 or 70.7%), or have been 
found to be extraneous (1,269 or 4.5%). (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% (6,925) 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 overall universe of studies to be reviewed has increased during 
the past two years, while the proportion of studies reviewed by EPA has 
also increased somewhat. A number of studies have been submitted 
voluntarily by pesticide registrants, to address new FQPA provisions 
during reregistration and tolerance reassessment. At the end of 1999, 
over 75% of all studies received by the Agency in support of 
reregistration had been reviewed, compared to less than 75% at the end 
of 1997. Thus, the reregistration study review ``backlog'' decreased 
slightly during 1999 but remained fairly constant.

                    Table 4.--Review Status of Studies Submitted for Pesticide Reregistration
----------------------------------------------------------------------------------------------------------------
                                                                                                        Total
                    List                         Studies Reviewed + Extraneous     Studies Awaiting    Studies
                                                                                        Review         Received
----------------------------------------------------------------------------------------------------------------
List A......................................       10,490 + 292 = 10,782 (80.2%)      2,656 (19.8%)       13,438
List B......................................         5,795 + 655 = 6,450 (68.8%)      2,924 (31.2%)        9,374
List C......................................           2,140 + 228 = 2,368 (70%)        1,012 (30%)        3,380
List D......................................          1,307 + 94 = 1,401 (80.8%)        333 (19.2%)        1,734
================================================================================================================
TOTAL Lists A-D.............................                      21,001 (75.2%)      6,925 (24.8%)       27,926
----------------------------------------------------------------------------------------------------------------

E. Aggregate Status of Tolerances Reassessed

    Last summer, EPA met and surpassed 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. At the 
end of FY '99, EPA had completed 3,430 tolerance reassessment 
decisions, covering over 35% of the 9,721 tolerances that require 
reassessment. The Agency is well on its way to meeting the next FQPA 
goal to complete 66% of all tolerance reassessment decisions by August 
3, 2002.
    As required by FQPA, 2 years ago, 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 pesticides in 
Group 1, 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 advise us on the best way to enhance public participation in 
the tolerance reassessment process, beginning with this class of 
pesticides (see List 1). With guidance from TRAC, EPA piloted an 
approach to tolerance reassessment that allows for much greater 
transparency and public

[[Page 37380]]

involvement in developing both our risk assessments and risk management 
decisions. Scientific analyses, risk assessments and related 
information 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.

    List 1. The Organophosphate Pesticides

Acephate
Azinphos-methyl
Bensulide
*++Cadusafos
++Chlorethoxyfos
**Chlorfenvinphos
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).

    During FY '99, through the ongoing public participation process for 
the OPs, EPA obtained additional health and environmental effects data, 
use data, and other information that has been valuable in revising and 
completing many of our risk assessments. EPA initiated action in early 
August 1999 to reduce the risks associated with two OPs, methyl 
parathion and azinphos methyl, based partly on information developed 
through this process. Near the end of the fiscal year, EPA began 
examining the results of the pilot process, and considering ways to 
amend the process so that it will be most effective in the future. 
During FY 2000, the Agency proposed for comment (65 FR 14199, March 15, 
2000) and plans to establish a final public participation process for 
pesticides in tolerance reassessment and reregistration, encompassing 
both the OPs and other types of chemicals. Our goal is to develop a 
process that fully involves stakeholders, starting early and continuing 
throughout the development of risk assessments and risk mitigation 
options, for all pesticides still awaiting reregistration and tolerance 
reassessment decisions.
    EPA expects to present its risk management conclusions for the 
first several OP pesticides early in 2000, elucidating both risk 
mitigation measures and possible transition strategies to alternative 
pest control approaches. The Agency also is developing an approach for 
assessing cumulative risk for the OPs as a group as required by FQPA, 
and expects to issue draft guidance in 2000 for review and comment. EPA 
presented a comprehensive guidance document on cumulative risk 
assessment to the Scientific Advisory Panel in December 1999, and will 
revise its guidance as necessary based on the panel's recommendations.
    Although all individual OP tolerances were not reassessed in the 
first one-third, EPA is making significant progress with this group of 
chemicals. We expect to complete the risk assessments for each of the 
individual OP pesticides during calendar year 2000. The Agency will 
develop a cumulative assessment for all the OPs once the individual 
assessments are complete and a cumulative assessment methodology is 
available.
    2. Fiscal Year 1999 accomplishments. During FY '99, EPA reassessed 
1,445 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. EPA also completed the Tolerance Reassessment Tracking 
System (TORTS), which is making it possible for the Agency to compile 
and report, accurately and consistently, numbers of tolerance 
reassessment accomplishments. We have a high degree of confidence in 
TORTS, which was designed, created, and quality controlled internally 
and is being operated in-house. Based on records for all 9,721 
permanent tolerances subject to reassessment under FQPA, TORTS is 
providing timely, detailed, accurate reports highlighting many 
important aspects of completed tolerance reassessments.
    Of EPA's 1,445 tolerance reassessment actions during FY '99, 513 
were tolerance revocation decisions, implemented through rule-making. 
The Agency made decisions to revoke these tolerances, signed final 
rule-making to effect these decisions, and published the relevant rules 
in the Federal Register during the fiscal year. Other FY '99 
reassessments occurred through reregistration/REDs (359), through 
registration (340), and through other actions not directly related to 
either registration or reregistration (233). During FY '99, over 61% of 
the tolerance reassessment decisions completed were for pesticides in 
priority Group 1 (883); others were for pesticides in Group 2 (216) and 
Group 3 (346). EPA reassessed 180 OP tolerances, 77 carbamate 
tolerances, 50 organochlorine tolerances, and 266 carcinogen tolerances 
during FY '99. The Agency completed 243 tolerance reassessments for 
children's foods (i.e., foods among the top 20 raw agricultural 
commodities eaten by children age one to six years old, and among the 
top 20 commodities consumed by infants, according to a 1989-1991 
survey). Of the tolerances reassessed, 837 were for pesticide minor 
uses. Please see the following Table 5 for a summary of these FY '99 
accomplishments.

------------------------------------------------------------------------
 
------------------------------------------------------------------------
Sources of FY '99 Tolerance Reassessments............
  Reregistration/ REDs...............................                359
  Registration Actions...............................                340
  Tolerance Revocations..............................                513
  Other..............................................                233
========================================================================
------------------------------------------------------------------------
Numbers of Reassessments by Priority Group...........
  Group 1............................................          883 (61%)
  Group 2............................................          216 (15%)
  Group 3............................................          346 (24%)
========================================================================
TOTAL................................................       1,445 (100%)
------------------------------------------------------------------------

[[Page 37381]]

 
Tolerances Reassessed for Certain Types of Pesticides
 and Groups..........................................
  Organophosphates...................................                180
  Carbamates.........................................                 77
  Organochlorines....................................                 50
  Carcinogens........................................                266
  Kids Foods.........................................                243
  Minor Uses.........................................                837
------------------------------------------------------------------------

    3. Cumulative accomplishments. EPA is conducting a variety of 
tolerance reassessment activities throughout the pesticide program that 
are enabling the Agency to meet its FQPA goals. As of September 30, 
1999, of the 9,721 tolerances subject to reassessment, EPA had 
reassessed a net total of 3,430, over 35% of all tolerances requiring 
reassessment. The Agency 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). (Please see 
Table 6.)

         Table 6.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, as of September 30, 1999
----------------------------------------------------------------------------------------------------------------
                                                 During Late   During FY    During FY    During FY    Total, End
         Tolerances Reassessed Through              FY '96        '97          '98          '99       of FY '99
----------------------------------------------------------------------------------------------------------------
Reregistration/REDs............................           25          337          278          359          999
Registration...................................            0          221          311          340          872
Tolerance Revocations..........................            3            0          809          513        1,325
Other Decisions................................            0            1            0          233          234
================================================================================================================
    TOTAL Tolerances Reassessed................           28          559        1,398        1,445        3,430
----------------------------------------------------------------------------------------------------------------

    i. Reregistration/REDs. EPA is using the reregistration program to 
accomplish much of tolerance reassessment. As of September 30, 1999, a 
total of 999 tolerance reassessment decisions had 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 
reregistration will remain the same while others are subject to 
modification, i.e., they may be raised, lowered, or revoked.
    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 September 30, 1999, 
a total of 872 tolerances were 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 formally revoked,through 
rule-making, a total of 1,325 tolerances. These 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. In this 
situation, tolerances were revoked because there is no longer a need 
for them. No registered uses of the pesticides remain in the U.S., and 
tolerances are not required to cover residues in or on either domestic 
or imported food commodities. Tolerance revocations 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 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 (and so they also meet the FQPA safety standard); 13 
tolerance exemptions for Trichoderma harzianum KRL-AG2 (64 FR 16856; 
April 7, 1999) (FRL-6070-3); one tolerance exemption for Bacillus 
thuringiensis subspecies Kurstake CryIA(c) (62 FR 17722; April 11, 
1997) (FRL-5596-7); one tolerance exemption for Red Pepper (63 FR 
66999; December 4, 1998) (FRL-6039-5); and one tolerance exemption for 
Cinnamaldehyde (64 FR 7801; February 17, 1999) (FRL-6049-9).

F. Applications for Registration Requiring Expedited Processing; 
Numbers Approvedand 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 '99, EPA 
considered and approved the following numbers of applications for 
registration requiring expedited processing (also known as ``fast 
track'' applications):
    <bullet> Me-too product registrations/fast track: 513
    <bullet> Amendments/fast track: 3,141
    <bullet> Total applications processed by expedited means: 3,654
    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 '99.
    On a financial accounting basis, EPA devoted approximately 33.3 
full-time equivalents (FTEs) to reviewing and processing applications 
for me-too product registrations and fast-track label amendments. The 
Agency spent $2.8 million in direct costs (not including administrative 
expenses, computer systems, management overhead, and

[[Page 37382]]

other indirect costs) during FY '99 on expedited processing and 
reviews.

G. Future Schedule for Reregistrations

    EPA is now conducting 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. 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, 
particularly the organophosphates (OPs).
    1. OP REDs. The organophosphate pesticides are the focal point of 
EPA's reregistration and tolerance reassessment programs at present. 
EPA currently is reviewing the OP pesticides individually, and expects 
to complete individual risk assessments and risk management decisions 
for each of these pesticides during calendar year 2000 (see List 2). 
Although the Agency is not making final reregistration decisions for 
most of the OP pesticides now, the results of the individual OP 
assessments will include risk mitigation measures, and any resulting 
tolerance revocations will be counted as completed tolerance 
reassessments. EPA will conduct a cumulative assessment for the OP 
pesticides when the individual assessments and necessary methodology 
are complete, and will encourage the public to participate in this 
assessment. The Agency's final decisions for the OP pesticides will be 
made at the conclusion of the cumulative assessment process.
    EPA generally will not count individual OP decisions as completed 
REDs or tolerance reassessments until the Agency completes the 
cumulative risk assessment and risk management decision for all the OP 
pesticides. Decisions for individual OP pesticides with no FQPA-related 
uses (i.e., no uses resulting in food, drinking water, residential, or 
bystander exposure) may be counted as REDs prior to the cumulative 
decision. In addition, when the Agency accept requests for voluntary 
cancellation of individual OP pesticides, EPA will count these actions 
as REDs, and will count the associated tolerances as reassessed when 
they are revoked.

    List 2. OP RED Candidate Pesticides

1. Acephate
2. Azinphos-methyl
3. Bensulide
4. Chlorpyrifos
5. Diazinon
6. Dichlorvos (DDVP)
7. Dicrotophos
8. Dimethoate
9. Disulfoton
10. Ethion
11. Ethoprop
12. Ethyl Parathion
13. Fenamiphos
14. Fenthion
15. Malathion
16. Methamidophos
17. Methidathion
18. Methyl Parathion
19. Naled
20. Oxydemeton-methyl
21. Phorate
22. Phosmet
23. Pirimiphos-methyl
24. Profenofos
25. Propetamphos
26. Temephos
27. Terbufos
28. Tribufos (DEF)

    2. Non-OP RED candidates for FY 2000. REDs for pesticides other 
than the OPs also are in preparation. EPA expects to complete REDs for 
most or all of the non-OP RED candidate pesticides in List 3 below, and 
perhaps some other pesticides, during FY 2000.The Agency will be 
increasing opportunities for public involvement in the development of 
non-OP REDs during FY 2000 and beyond.

    List 3. Non-OP RED Candidate Pesticides for Fiscal Year 2000

1. Aldicarb
2. Atrazine
3. Benomyl
4. Bis (bromoacetoxy)-2-butene
5. Carbofuran
6. Diclofop methyl
7. Endosulfan
8. Etridiazole (Terrazole)
9. Imazalil
10. Molinate
11. Omadine Salts
12. Oxamyl
13. Propargite
14. Propylene oxide
15. Sodium acifluorfen
16. Thiabendazole
17. Thiophanate methyl
18. Thiram
19. Triallate
20. Vinclozolin

    3. Non-OP RED candidate pesticides for FY 2001. EPA's goal is to 
complete 30 REDs during FY 2001. Although it is based on many variables 
and can be expected to change, our tentative list of RED candidate 
pesticides for FY 2001 appears in List 4 below.

    List 4. RED Candidate Pesticides for Fiscal Year 2001

1. Amical 48
2. 4-t Amylphenol
3. Benfluralin
4. Benzisothiazolin-3-one
5. Cacodylic acid
6. Carbaryl
7. Chlorine dioxide
8. Chloropicrin
9. Chromated Arsenicals
10. Coal Tar/Creosote
11. Cycloate
12. Cypermethrin
13. Dazomet
14. Dimethipin
15. Dimethyldithiocarbamate salts including Ferbam, Ziram, and 
Sodium dimethyldithiocarbamate
16. Dinocap
17. Dipropyl isocinchomeronate or MGK 326
18. Ethylene oxide
19. Formetanate hydrochloride
20. Irgasan DP-300
21. Lindane
22. Mancozeb
23. Maneb
24. Methanearsonic acid, salts including CAMA, DSMA, MSMA
25. Methyl bromide
26. Methyl isothiocyanate
27. Methyldithiocarbamate salts including metam-sodium
28. Metiram
29. MGK-264
30. Napthaleneacetic acid
31. Oxadiazon
32. Oxyfluorfen
33. Pentachloronitrobenzene or PCNB
34. Pentachlorophenol
35. Permethrin
36. Phenol and salts
37. Phenylphenol
38. Piperonyl butoxide
39. Propiconazole
40. Pyrethrin
41. Simazine
42. TCMTB or 2-(Thiocyanomethylthio) benzothiazole
43. Triadimefon

    4.Voluntary cancellations as REDs. When for business or other 
reasons a pesticide registrant requests that the Agency cancel all 
remaining registered products containing a pesticide in reregistration, 
EPA stops work on the development of a reregistration eligibility 
decision document for the pesticide and counts the RED as completed. 
Voluntary cancellations are counted as REDs on the date when an Agency 
official signs and dates a decision memorandum documenting the Agency's 
intent to accept the registrant's request for cancellation. EPA then 
publishes in the Federal Register for public comment a FIFRA section 
6(f) notice of receipt of the request for voluntary cancellation. The 
cancellations requested do not become effective until a designated time 
after the public comment period closes.
    5. Tolerance reassessment decision documents. When EPA reassesses 
the tolerances for a pesticide that is not in the queue for 
reregistration (that is, a pesticide for which a RED was

[[Page 37383]]

completed prior to FQPA, or a pesticide initially registered after 1984 
and not subject to reregistration), the Agency will produce a document 
explaining the basis for these decisions. During FY 2000 and FY 2001, 
the Agency expects to complete tolerance reassessment decision 
documents for the pesticides in Lists 5 and 6 below.

    List 5. Tolerance Reassessment Decisions for Fiscal Year 2000

1. Butylate
2. Lactofen
3. Several OPs going through the pilot process, including Cadusafos 
and Chlorethoxyfos

    List 6. Tolerance Reassessment Decisions for Fiscal Year 2001

1. Acetochlor
2. Amitraz
3. Asulam
4. Bromine
5. Chlorpropham
6. Cyhexatin
7. Desmedipham
8. Diphenamid
9. Inorganic Bromide
10. Linuron
11. Norflurazon
12. Oxadixyl
13. Procymidone
14. Propamide
15. Triadimenol
16. Tribenuron methyl
17. Tridiphane

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: May 31, 2000.
Susan H. Wayland,
Acting Assistant Administrator, Office of Prevention, Pesticides, and 
Toxic Substances.
[FR Doc. 00-15034 Filed 6-13-00; 8:45 am]
BILLING CODE 6560-50-F


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