[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:
[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-
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 [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 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:
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
[[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 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).
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
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Product Reregistration Actions............................. 167
Product Amendment Actions.................................. 70
Product Cancellation Actions............................... 511
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TOTAL Actions in FY '99.................................... 748
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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.
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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
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TOTAL Products in Product Reregistration Universe.......... 7,045
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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
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Total
List Studies Reviewed + Extraneous Studies Awaiting Studies
Review Received
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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
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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):
Me-too product registrations/fast track: 513
Amendments/fast track: 3,141
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