[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
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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
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Total Products Completed.................................... 3,928
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Products with Decisions Pending................................. 2,868
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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
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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
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Total............................................... 1,395
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Numbers of Reassessments by Priority Group..............
Group 1............................................... 1,023 (73% )
Group 2............................................... 202 (15% )
Group 3............................................... 170 (12% )
===============
Total............................................... 1,395 (100% )
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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
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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
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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
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Total Tolerances Reassessed......... 28 558 1,395 1,981 1,309 3,290
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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