Pesticide Reregistration Performance Measures and Goals, 36075-36085 [E6-9956]
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Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Notices
EIS No. 20060218, Draft EIS, FHW, NY,
Williamsville Toll Barrier
Improvement Project, Improvements
from New York Thruway, Interstate
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Funding, Erie and Genesee Counties,
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Comment Period from 7/17/2006 to
7/24/2006.
Dated: June 20, 2006.
Robert W. Hargrove,
Director, NEPA Compliance Division, Office
of Federal Activities.
[FR Doc. E6–9951 Filed 6–22–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2005–0484; FRL–8068–1]
Pesticide Reregistration Performance
Measures and Goals
Environmental Protection
Agency (EPA).
ACTION: Notice.
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AGENCY:
SUMMARY: This notice announces EPA’s
progress in meeting its performance
measures and goals for pesticide
reregistration during fiscal year 2005.
The Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) requires EPA
to publish information about EPA’s
annual achievements in this area. This
notice discusses the integration of
tolerance reassessment with the
reregistration process, and describes the
status of various regulatory activities
associated with reregistration and
tolerance reassessment. The notice gives
total numbers of chemicals and
products reregistered, tolerances
reassessed, Data Call-Ins issued, and
products registered under the ‘‘fasttrack’’ provisions of FIFRA. Finally, this
notice contains the schedule for
completion of activities for specific
chemicals during fiscal years 2006
through 2008.
DATES: This notice is not subject to a
formal comment period. Nevertheless,
EPA welcomes input from stakeholders
and the general public. Written
comments, identified by the docket ID
number [EPA–HQ–OPP–2005–0484],
should be received on or before August
22, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2005–0484, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov/. Follow the on-
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line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2005–0484. EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available on-line at https://
www.regulations.gov/, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov
Web site is an ‘‘anonymous access’’
system, which means EPA will not
know your identity or contact
information unless you provide it in the
body of your comment. If you send an
e-mail comment directly to EPA without
going through www.regulations.gov,
your e-mail address will be captured
automatically and included as part of
the comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket
are listed in the index. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
restricted by statute. Certain other
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material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Carol P. Stangel, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone: (703) 308–8007; e-mail:
stangel.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action 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 under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through EDOCKET,
regulations.gov, or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
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information (subject heading, Federal
Register date, and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns, and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity,
obscene language, or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline.
II. Background
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EPA must establish and publish in the
Federal Register its annual performance
measures and goals for pesticide
reregistration, tolerance reassessment,
and expedited registration, under
section 4(l) of FIFRA, as amended by the
Food Quality Protection Act of 1996
(FQPA). Specifically, such measures
and goals are to include:
• The status of reregistration.
• The number of products
reregistered, canceled, or amended.
• The number and type of data
requests or Data Call-In (DCI) notices
under section 3(c)(2)(B) issued to
support product reregistration by active
ingredient.
• Progress in reducing the number of
unreviewed, required reregistration
studies.
• The aggregate status of tolerances
reassessed.
• The number of applications for
registration submitted under subsection
(k)(3), expedited processing and review
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of similar applications, that were
approved or disapproved.
• The future schedule for
reregistrations in the current and
succeeding fiscal year.
• The projected year of completion
of the reregistrations under section 4.
FIFRA, as amended in 1988,
authorizes EPA to conduct a
comprehensive pesticide reregistration
program--a complete review of the
human health and environmental effects
of older pesticides originally registered
before November 1, 1984. Pesticides
meeting today’s scientific and regulatory
standards may be declared ‘‘eligible’’ for
reregistration. To be eligible, an older
pesticide must have a substantially
complete data base, and must not cause
unreasonable adverse effects to human
health or the environment when used
according to Agency approved label
directions and precautions.
In addition, all pesticides with food
uses must meet the safety standard of
section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA) 21 U.S.C.
346a, as amended by the Food Quality
Protection Act (FQPA) of 1996. Under
FFDCA, EPA must make a
determination that pesticide residues
remaining in or on food are ‘‘safe’’; that
is, ‘‘that there is reasonable certainty
that no harm will result from aggregate
exposure to the pesticide chemical
residue’’ from dietary and other sources.
In determining allowable levels of
pesticide residues in food, EPA must
perform a more comprehensive
assessment of each pesticide’s risks,
considering:
• Aggregate exposure (from food,
drinking water, and residential uses).
• Cumulative effects from all
pesticides sharing a common
mechanism of toxicity.
• Possible increased susceptibility of
infants and children; and
• Possible endocrine or estrogenic
effects.
As amended by FQPA, FFDCA
requires the reassessment of all existing
tolerances (pesticide residue limits in
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food) and tolerance exemptions within
10 years, to ensure that they meet the
safety standard of the law. EPA was
directed to give priority to the review of
those pesticides that appear to pose the
greatest risk to public health, and to
reassess 33% of the 9,721 existing
tolerances and exemptions within 3
years (by August 3, 1999), 66% within
6 years (by August 3, 2002), and 100%
in 10 years (by August 3, 2006).The
Agency met the first two statutory
deadlines and is on schedule to meet
the third. EPA’s approach to tolerance
reassessment under FFDCA is described
fully in the Agency’s document, ‘‘Raw
and Processed Food Schedule for
Pesticide Tolerance Reassessment’’ (62
FR 42020, August 4, 1997) (FRL–5734–
6).
The Pesticide Registration
Improvement Act (PRIA) of 2003
became effective on March 23, 2004.
Among other things, PRIA directs EPA
to complete Reregistration Eligibility
Decisions (REDs) for pesticides with
food uses/tolerances by August 3, 2006,
and to complete all non-food use
pesticide REDs by October 3, 2008.
EPA’s schedule for meeting these
deadlines is available on the Agency’s
website at www.epa.gov/pesticides/
reregistration/decision_schedule.htm.
III. FQPA and Program Accountability
One of the hallmarks of the FQPA
amendments to the FFDCA is enhanced
accountability. Through this summary
of performance measures and goals for
pesticide reregistration, tolerance
reassessment, and expedited
registration, EPA describes progress
made during the past year in each of the
program areas included in FIFRA
section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2005 (from
October 1, 2004, through September 30,
2005), EPA made significant progress in
completing risk assessments and risk
management decisions for pesticide
reregistration (See Table 1).
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TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: IN FY 2005 AND FY 1991 THROUGH FY 2005
FY 2005 Decisions
Total, FY 1991 through FY 2005
271 REDs
0 IREDs
23 IREDs
13 TREDs
Ammonia
Bromine
Cyhexatin
Fluazifop-p-butyl
Flumiclorac-pentyl
Imazamethabenz-methyl
Maleic hydrazide
Methyl eugenol
Nicosulfuron
Procymidone
Putrescent whole egg solids
Sulfuric acid monourea
Tanol derivatives
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28 REDs (27 countable)
2,4-D
2,4-DB
Ametryn
4-Amylphenol
Aquashade
Azadioxabicyclooctane
Benzisothiazolin-3-one
Chloroneb
Chlorsulfuron
Dimethipin
Dodine
Endothall
Ethofumesate
Ferbam (case 2180 already counted with Ziram)
Fluometuron
Inorganic polysulfides
Maneb
Mancozeb
Metiram
Napropamide
Nitrapyrin
Phenmedipham
Pyrazon
Sethoxydim
Tau-fluvalinate
Thidiazuron
Trichloromelamine
Xylene (Aromatic solvents)
83 TREDs
The Agency’s decisions are embodied
in Reregistration Eligibility Decision
(RED) documents, Interim Reregistration
Eligibility Decisions (IREDs), and
Reports on FQPA Tolerance
Reassessment Progress and [Interim]
Risk Management Decisions (TREDs).
1. REDs. Through the reregistration
program, EPA is reviewing current
scientific data for older pesticides (those
initially registered before November
1984), reassessing their effects on
human health and the environment, and
requiring risk mitigation measures as
necessary. Pesticides that have
sufficient supporting data and whose
risks can be successfully mitigated may
be declared ‘‘eligible’’ for reregistration.
EPA presents these pesticide findings in
a RED document.
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i. Overall RED progress. EPA’s overall
progress at the end of FY 2005 in
completing Reregistration Eligibility
Decisions (REDs) for groups of related
pesticide active ingredients or cases is
summarized in Table 2.
TABLE 2.—OVERALL RED PROGRESS,
FY 1991 THROUGH FY 2005
the end of FY 2005 is presented in Table
3.
TABLE 3.—PROFILE OF 271 REDS
COMPLETED, FY 1991 THROUGH FY
2005
Pesticide active ingredients
45
Pesticide products
about
11,600
REDs completed
271 (44%)
Cases canceled
231 (38%)
REDs with food uses
155
REDs to be completed
110 (18%)
Post-FQPA REDs
130
Total reregistration cases
612
(100%)
ii. Profile of completed REDs. A
profile of the 271 REDs completed by
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either as free-standing decisions or
Agency has issued IREDs for these
TABLE 3.—PROFILE OF 271 REDS
through REDs. During FY 2005, AD
COMPLETED, FY 1991 THROUGH FY chemicals. EPA will complete the risk
assessments and reregistration eligibility completed 35 tolerance exemption
2005—Continued
Post-FQPA REDs with food
uses*
102
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*EPA is revisiting tolerances associated with
the 53 food use REDs that were completed
before FQPA was enacted to ensure that they
meet the safety standard of the new law, as
set forth in the Agency’s August 4, 1997,
Schedule
for
Pesticide
Tolerance
Reassessment.
iii. Risk reduction in REDs. Through
the reregistration program, EPA seeks to
reduce risks associated with the use of
older pesticides. In developing REDs,
EPA works with stakeholders including
pesticide registrants, growers and other
pesticide users, and environmental and
public health interests, as well as the
States, USDA, and other Federal
agencies and others to develop measures
to effectively reduce risks of concern.
Almost every RED includes some
measures or modifications to reduce
risks. The options for such risk
reduction are extensive and include
voluntary cancellation of pesticide
products or deletion of uses; declaring
certain uses ineligible or not yet eligible
(and then proceeding with follow-up
action to cancel the uses or require
additional supporting data); restricting
use of products to certified applicators;
limiting the amount or frequency of use;
improving use directions and
precautions; adding more protective
clothing and equipment requirements;
requiring special packaging or
engineering controls; requiring notreatment buffer zones; employing
ground water, surface water, or other
environmental and ecological
safeguards; and other measures.
2. Interim REDs or IREDs. EPA issues
IREDs for pesticides that are undergoing
reregistration, require a reregistration
eligibility decision, and also must be
included in a cumulative assessment
under FQPA because they are part of a
group of pesticides that share a common
mechanism of toxicity. An IRED is
issued for each individual pesticide in
the cumulative group when EPA
completes the pesticide’s risk
assessment and interim risk
management decision. An IRED may
include measures to reduce food,
drinking water, residential,
occupational, and/or ecological risks, to
gain the benefit of these changes before
the final RED can be issued following
the Agency’s consideration of
cumulative risks. For example, EPA
generally has not considered individual
organophosphate (OP) pesticide
decisions to be completed REDs or
tolerance reassessments. Instead, the
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decisions for OP pesticides with IREDs,
once the Agency completes a
cumulative assessment of the OPs.
3. Tolerance reassessment ‘‘TREDs.’’
EPA issues Reports on FFDCA
Tolerance Reassessment Progress and
[Interim] Risk Management Decisions,
known as TREDs, for pesticides that
require tolerance reassessment decisions
under FFDCA, but do not require a
reregistration eligibility decision at
present because:
• The pesticide was first registered
after November 1, 1984, and is
considered a ‘‘new’’ active ingredient,
not subject to reregistration;
• EPA completed a RED for the
pesticide before FQPA was enacted; or
• The pesticide is not registered for
use in the U.S. but tolerances are
established that allow crops treated with
the pesticide to be imported from other
countries.
As with IREDs, EPA will not complete
risk assessment and risk management
for pesticides subject to TREDs that are
part of a cumulative group until
cumulative risks have been considered
for the group.
During FY 2005, in addition to
completing 13 TREDs, EPA also
completed 168 tolerance assessment
decisions for pesticide inert ingredients
that are exempted from the tolerance
requirement. Almost 900 of the 9,721
tolerance reassessment decisions
required by the amended FFDCA are for
such inert ingredient tolerance
exemptions. EPA has reassessed 573 of
these inert ingredient tolerance
exemptions to date, and plans to
complete the reassessment of all the
inert ingredient tolerance exemptions by
August 2006.
As a result of the Food Quality
Protection Act of 1996, food-contact
surface sanitizers previously regulated
by both EPA and the Food and Drug
Administration were transferred to
EPA’s sole jurisdiction. Consequently,
the approximately 107 ingredients that
made up these sanitizer solutions in 21
CFR 178.1010 were transferred to 40
CFR part 180, subpart D. In addition to
reassessing the 9,721 tolerances and
exemptions for food and feed
commodities, EPA also must reassess
these sanitizer tolerance exemptions by
August 3, 2006. The Antimicrobials
Division (AD) in EPA’s Office of
Pesticide Programs is responsible for
reassessing exemptions from the
requirement of a tolerance for the foodcontact surface sanitizing solutions
requiring reassessment. AD is
reassessing 60 of the 107 exemptions,
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reassessments decisions for 22 of these
60 food-contact surface sanitizing
solution ingredients. EPA is reassessing
tolerance exemptions for the other foodcontact surface sanitizing solutions
through other REDs and inert exemption
decisions.
4. Goals for FY 2006 and future years.
EPA’s major pesticide reregistration and
tolerance reassessment goals for FY
2006 and future years are as follows.
i. Complete individual pesticide risk
management decisions. EPA’s goal in
conducting the reregistration and
tolerance reassessment program is to
complete about 45 Reregistration
Eligibility Decisions (REDs) and Interim
REDs (IREDs) during FY 2006, for
pesticides with associated tolerances,
and to complete a total of about 45 REDs
in FY 2007 and FY 2008, for pesticides
with no food uses or tolerances. This
will satisfy PRIA requirements and
support the Agency’s tolerance
reassessment goal. EPA’s schedule for
completing these decisions appears near
the end of this document, and also is
available on the Agency’s Web site at
https://www.epa.gov/pesticides/
reregistration/decision_schedule.htm.
ii. Complete tolerance reassessment
decisions. EPA is continuing to reassess
tolerances within time frames set forth
in FFDCA as amended by FQPA, giving
priority to those food use pesticides that
appear to pose the greatest risk.
Integration of the reregistration and
tolerance reassessment programs has
added complexity to the reregistration
process for food use pesticides. The
Agency successfully reached its first
two tolerance reassessment milestones
by completing over 33% of all tolerance
reassessment decisions by August 3,
1999, and over 66% by August 3, 2002.
EPA plans to meet the final FQPA
tolerance reassessment goal.
iii. Evaluate cumulative risks. Once
EPA completes individual risk
assessments for the OPs, carbamates and
others, the Agency will make
cumulative risk findings for each of
these common mechanism groups of
pesticides. For further information, see
EPA’s cumulative risk website, https://
www.epa.gov/pesticides/cumulative/.
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
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still must be reregistered. This
concluding part of the reregistration
process is called ‘‘product
reregistration.’’
In issuing a completed RED
document, EPA sends registrants a Data
Call-In (DCI) notice requesting any
product-specific data and specific
revised labeling needed to complete
reregistration for each of the individual
pesticide products covered by the RED.
Based on the results of EPA’s review of
these data and labeling, products found
to meet FIFRA and FFDCA standards
may be reregistered.
A variety of outcomes are possible for
pesticide products completing this final
phase of the reregistration process.
Ideally, in response to the DCI notice
accompanying the RED document, the
pesticide producer, or registrant, will
submit the required product-specific
data and revised labeling, which EPA
will review and find acceptable. At that
point, the Agency may reregister the
pesticide product. If, however, the
product contains multiple active
ingredients, the Agency instead issues
an amendment to the product’s
registration, incorporating the labeling
changes specified in the RED; a product
with multiple active ingredients may
not be fully reregistered until the last
active ingredient in its formulation is
eligible for reregistration. In other
situations, the Agency may temporarily
suspend a product’s registration if the
registrant has not submitted required
product-specific studies within the time
frame specified. The Agency may cancel
a product’s registration because the
registrant did not pay the required
registration maintenance fee.
Alternatively, the registrant may request
a voluntary cancellation of their end-use
product registration.
1. Product reregistration actions in FY
2005. EPA counts each of the post-RED
product outcomes described above as a
product reregistration action. A single
pesticide product may be the subject of
several product reregistration actions
within the same year. For example, a
product’s registration initially may be
amended, then the product may be
reregistered, and later the product may
be voluntarily canceled, all within the
same year. During FY 2005, EPA
completed the product reregistration
actions detailed in Table 4.
TABLE 5.—STATUS OF THE UNIVERSE
OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2005
(AS OF SEPTEMBER 30, 2005)—
Continued
Products sent for suspension
Total products with actions
completed
Product reregistration actions
Product amendment actions
63
Product cancellation actions
342
Product suspension actions
0
Total actions
504
2. Status of the product reregistration
universe. The status of the universe of
pesticide products subject to
reregistration at the end of FY 2005 is
shown in Table 5 below. This overall
status information is not ‘‘cumulative’’-it is not derived from summing up a
series of annual actions. Adding annual
actions would result in a larger overall
number since each individual product is
subject to multipleactions--it can be
amended, reregistered, and/or canceled,
over time. Instead, the ‘‘big picture’’
status information in Table 5 should be
considered a snapshot in time. As
registrants and EPA make marketing and
regulatory decisions in the future, the
status of individual products may
change, and numbers in this table are
expected to fluctuate.
4,828
Total products in product reregistration universe
99
6,785
Products with actions pending
TABLE 4.—PRODUCT REREGISTRATION
ACTIONS COMPLETED DURING FY 2005
30
11,613
The universe of 11,613 products in
product reregistration at the end of FY
2005 represented an increase of 1,210
products from the FY 2004 universe of
10,403 products. The increase consists
of 1,150 products associated with FY
2005 REDs, 35 products associated with
TREDs, and 25 products that were
added as a result of DCI activities and
processing for several previously issued
REDs and IREDs.
At the end of FY 2005, 4,828 products
had product reregistration decisions
pending. Some pending products await
science reviews, label reviews, or
reregistration decisions by EPA. Others
are not yet ready for product
reregistration actions; they are
associated with more recently
completed REDs, and their productspecific data are not yet due to be
submitted to or reviewed by the Agency.
EPA’s goal is to complete 450 product
reregistration actions during fiscal year
2006.
TABLE 5.—STATUS OF THE UNIVERSE C. Number and Type of DCIs to Support
OF PRODUCTS SUBJECT TO PROD- Product Reregistration by Active
UCT REREGISTRATION, FOR FY 2005 Ingredient
(AS OF SEPTEMBER 30, 2005)
1. DCIs for REDs. The number and
Products reregistered
1,875
Products amended
505
Products canceled
4,375
type of Data Call-In requests or DCIs that
EPA is preparing to issue under FIFRA
section 3(c)(2)(B) to support product
reregistration for pesticide active
ingredients included in FY 2005 REDs
are shown in Table 6.
TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2005 REDS
Case Name
Case Number
Number of Products Covered by
the RED1
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
0073
696
31
Not Completed
Yet
0
2,4-DB
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2,4-D
0196
22
31
48 (6 batches/2
products not
batched)
0
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TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2005 REDS—Continued
Case Name
Number of Products Covered by
the RED1
Case Number
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
3016
37
PDCI has not
been completed yet
Antimicrobial
RED—Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Ametryn
2010
4
31
24 (4 products
not batched)
0
Aquashade
4010
4
31
24 (4 products
not batched)
0
Azadioxabicylclooctane
3023
2
PDCI has not
been completed yet
Antimicrobial
RED—Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Benzisothiazolin-3-one
3026
47
PDCI has not
been completed yet
108 (5 batches/
13 not
batched)
PDCI has not
been completed yet
Chloroneb
0007
12
31
60 (2 batches/8
not batched)
0
Chlorsulfuron
0631
16
31
72 (2 batches/10
products not
batched)
0
Dimethipin
3063
5
31
24 (4 products
not batched)
0
Dodine
0161
5
31
24 (4 products
not batched)
0
Endothall
2245
30
31
36 (2 batches/4
products not
batched)
0
Ethofumesate
2265
18
31
66 (3 batches/8
products not
batched)
0
Ferbam
2180
7
31
24 (4 products
not batched)
0
Fluometuron
0049
19
31
36 (5 batches/1
product not
batched)
0
Inorganic Polysulfides
4054
17
31
96 (16 products
not batched)
0
Mancozeb
0643
100
31
144 (5 batches/
19 products
not batched)
0
Maneb
0642
21
31
60 (3 batches/7
products not
batched)
0
Metiram
0644
4
31
18 (3 products
not batched)
0
Napropamide
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4-t Amylphenol and Salts
2450
15
31
48 (5 batches/3
not batched)
0
Nitrapyrin
0213
4
31
12 (1 batch/1
product not
batched)
0
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TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2005 REDS—Continued
Case Name
Number of Products Covered by
the RED1
Case Number
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
Phenmedipham
0277
16
31
96 (16 products
not batched)
0
Pyrazon
2570
3
31
18 (3 products
not batched)
0
Sethoxydim
2600
10
31
48 (1 batch/7 not
batched)
0
Tau-Fluvalinate
2295
5
31
18 (3 products
not batched)
5
Thidiazuron
4092
18
31
42 (4 batches/3
products not
batched
0
Trichloromelamine
3144
8
PDCI has not
been completed yet
36 (1 batch/5 not
batched)
PDCI has not
been completed yet
Xylene
3020
5
31
18 (3 products
not batched)
0
Total No. of Products
1,150
1The number of registered products containing a pesticide active ingredient can change over time. The product total 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.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.
3In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ‘‘batches’’ products
that can be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six
acute toxicology studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors considered in the sorting process include each product’s active and inert ingredients (e.g., identity, percent composition, and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification,
precautionary labeling). The Agency does not describe batched products as ‘‘substantially similar,’’ because all products within a batch may not
be considered chemically similar or have identical use patterns.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not
included in the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)
2. DCIs for IREDs. EPA completed no
IREDs during FY 2004.
3. DCIs for TREDs. There are special
cases where product-specific DCIs may
be required for TREDs, particularly if
the Agency believes that adequate
product chemistry or acute toxicity data
are not currently on file to support the
reregistration of the products associated
with the TREDs. The Agency is
requiring a product-specific DCI for the
following TRED:
TABLE 7.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2005 TRED
Case Name
Fluazifop-p-butyl
Case Number
2285
35
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Total No. of Products
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
31
Number of Products Covered by
the TRED1
84 (4 batches/10
not batched)
0
35
1The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the
TRED document (counted when the TRED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when the TRED is issued). This table reflects the final number of products associated with each TRED, as they are being
tracked for product reregistration.
2This column shows the number of product chemistry studies that are required for each product covered by the TRED.
3In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ‘‘batches’’ products
that can be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six
acute toxicology studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors considered in the sorting process include each product’s active and inert ingredients (e.g., identity, percent composition, and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification,
precautionary labeling). The Agency does not describe batched products as ‘‘substantially similar,’’ because all products within a batch may not
be considered chemically similar or have identical use patterns.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not
included in the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)
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registrants in support of pesticides
undergoing reregistration (See Table 8).
The percent of studies reviewed by EPA
remained constant in FY 2005.
D. Progress in Reducing the Number of
Unreviewed, Required Reregistration
Studies
EPA has made progress in reviewing
scientific studies submitted by pesticide
TABLE 8.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2005
Pesticide Reregistration List, per
FIFRA Section 4(c)(2)
Studies Reviewed + Extraneous1
List A
11,238 + 589 = 11,827 (87%)
1,788 (13%)
13,615
List B
6,542 + 1,033 = 7,575 (81%)
1,748 (19%)
9,323
List C
2,096 + 334 = 2,430 (84%)
464 (16%)
2,894
List D
1,248 + 133 = 1,381 (86%)
229 (14%)
1,610
Total Lists A–D
21,124 + 2,089 = 23,213
(84.6%)
4,229 (15.4%)
27,442 (100%)
Studies Awaiting Review
Total Studies Received
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data requirement has been satisfied by other studies or has changed.
E. Aggregate Status of Tolerances
Reassessed
During FY 2005, EPA completed 772
tolerance reassessments and ended the
fiscal year with a total of 7,817 tolerance
reassessment decisions to date,
addressing over 80% of the 9,721
tolerances that require reassessment
(See Table 9).
EPA reassessed over 33% of all food
tolerances by August 3, 1999, and
completed over 66% of all required
tolerance reassessment decisions by
August 3, 2002, meeting two important
statutory deadlines established by the
FQPA. EPA’s general schedule for
tolerance reassessment (62 FR 42020,
August 4, 1997) identified three groups
of pesticides to be reviewed; this
grouping continues to reflect the
Agency’s overall scheduling priorities.
In completing tolerance reassessment,
EPA continues to give priority to
pesticides in Group 1, the Agency’s
highest priority group for reassessment.
1. Aggregate accomplishments
through reregistration and other
programs. EPA is accomplishing
tolerance reassessment through the
registration and reregistration programs;
by revoking tolerances for pesticides
that have been canceled (many as a
result of reregistration); by reevaluating
pesticides with pre-FQPA REDs, and
through other decisions not directly
related to registration or reregistration,
described further below. EPA is using
the Tolerance Reassessment Tracking
System (TORTS) to compile this
updated information and report on the
status of tolerance reassessment (See
Table 9).
TABLE 9.—TOLERANCE REASSESSMENTS COMPLETED POST-FQPA BY FISCAL YEAR, THROUGH FY 2005*
During
Late FY
96
During
FY 1997
During
FY 1998
During
FY 1999
During
FY 2000
During
FY 2001
During
FY 2002
During
FY 2003
During
FY 2004
During
FY 2005
Total,
End of
FY 2005
25
339
277
359
44
46
231
79
87
413
1,897
Tolerance Reassessments/
TREDs
0
0
0
0
0
0
776
14
119
69
970
Registration
0
224
308
340
55
216
200
0
71
--
1,412
Tolerance revocations
3
0
812
513
22
35
545
0
172
75
2,239
Other decisions
0
1
0
233
0
0
905
26
18
165
1,299
28
564
1,397
1,445
121
297
2,657
119
467
722
7,817
Tolerances Reassessed Through...
Reregistration/REDs
Total tolerances reassessed
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*Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA is using
the reregistration program to accomplish
much of tolerance reassessment. For
each of the tolerance reassessment
decisions made through REDs since
enactment of the FQPA, the Agency has
made the finding as to whether there is
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a reasonable certainty of no harm, as
required by FFDCA. Many tolerances
reassessed through reregistration remain
the same while others may be raised,
lowered, or revoked.
ii. Tolerance reassessments/TREDs.
Tolerances initially evaluated through
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REDs that were completed before FQPA
was enacted in August 1996 now are
being reassessed to ensure that they
meet the new FFDCA safety standard.
EPA issues these post-RED tolerance
reassessment decisions as TREDs. The
Agency also issues TREDs summarizing
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tolerance reassessment decisions for
some developing REDs, for new
pesticide active ingredients not subject
to reregistration, and for pesticides with
import tolerances only. Tolerance
reassessments for pesticides that are not
part of a cumulative group may be
counted at present and are included in
the FY 2005
accomplishments.Tolerance
reassessments for pesticides that are
part of a cumulative group are not
included in the Agency’s lists of
accomplishments. These tolerances will
be considered again and their
reassessment will be completed after
EPA completes a cumulative risk
evaluation for the group.
iii. Registration. Like older pesticides,
all new pesticide registrations must
meet the safety standard of FFDCA.
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
aggregate risk of the 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.
iv. Tolerance revocations. Revoked
tolerances represent uses of many
different pesticide active ingredients
that have been canceled in the past.
Some pesticides were canceled due to
the Agency’s risk concerns. Others were
canceled voluntarily by their
manufacturers, based on lack of support
for reregistration. Tolerance revocations
are important even if there are no
domestic uses of a pesticide because
residues in or on imported commodities
treated with the chemical could still
present dietary risks that may exceed
the FFDCA ‘‘reasonable certainty of no
harm’’ standard, either individually or
36083
cumulatively with other substances that
share a common mechanism of toxicity.
v. Other reassessment decisions. In
addition to the types of reassessment
actions described above, a total of 1,299
additional tolerance reassessment
decisions have been made, some for
inert ingredient tolerance exemptions,
through actions not directly related to
registration or reregistration. A list of
these other tolerance reassessment
decisions with their Federal Register
citations is available in the docket for
this Federal Register notice. Other
support documents are available in
docket ID number EPA–HQ–OPP–2002–
0162.
2. Accomplishments for priority
pesticides. During FY 2005, EPA
completed tolerance reassessment
decisions for many high priority
pesticides in review, including OPs,
carbamates, organochlorines, and
carcinogens (See Table 10).
TABLE 10.—TOLERANCE REASSESSMENTS COMPLETED FOR PRIORITY PESTICIDES
Pesticide Class
Tolerances to be Reassessed
Reassessed by End of FY 2005
545
317 (58.17%)
Carcinogens
2,008
1,530 (76.20%)
High hazard inerts
5
5 (100%)
Organochlorines
253
253 (100%)
Organophosphates (OPs)
1,691
1,147 (67.83%)
Other
5,219
4,565 (87.47%)
Total
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Carbamates
9,721
7,817 (80.41%)
3. Tolerance reassessment and the
organophosphates. EPA developed an
approach for assessing cumulative risk
for the OP pesticides as a group, as
required by FFDCA, and applied this
methodology in conducting an OP
cumulative risk assessment. The Agency
issued preliminary and revised OP
cumulative risk assessment documents
in December 2001 and June 2002,
available on EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
Through this assessment of the OP
pesticides, EPA has evaluated several
hundred OP tolerances and found that
most require no modification to meet
the new FFDCA safety standard. The
Agency’s regulatory actions on
individual OP pesticides during the past
few years have substantially reduced the
risks of these pesticides. EPA plans to
complete IREDs and REDs for the three
remaining individual OP pesticides
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17:22 Jun 22, 2006
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(DDVP, dimethoate, and malathion) in
FY 2006.
Most of the reregistration and
tolerance reassessment decisions that
EPA has made for the OP pesticides will
not be considered complete until after
the Agency concludes its cumulative
evaluation of the OPs. The results of
individual OP assessments (IRED and
TRED documents) include significant
risk mitigation measures, however, and
any resulting tolerance revocations are
counted as completed tolerance
reassessments. In addition, some OP
tolerances that make at most a minimal
or negligible contribution to the
cumulative risk from OP pesticides were
counted as reassessed during FY 2002.
Once EPA completes a cumulative
evaluation of the OPs, the Agency will
reconsider individual OP IREDs and
TREDs, and complete reregistration
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eligibility and tolerance reassessment
decisions for these pesticides.
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 2005, EPA considered
and approved the numbers of
applications for registration requiring
expedited processing (also known as
‘‘fast track’’ applications) shown in
Table 11.
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Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Notices
TABLE 11.—FAST TRACK APPLICATIONS APPROVED IN FY 2005
Me-too product registrations/Fast track
340
Amendments/Fast track
2,639
Total applications processed by fast track means
2,979
jlentini on PROD1PC65 with NOTICES
For those applications not approved,
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 2005.
On a financial accounting basis, EPA
devoted 31.7 full-time equivalents
(FTEs) in FY 2005 to reviewing and
processing applications for fast track
me-too product registrations and label
amendments. The Agency spent
approximately $3.56 million in FY 2005
in direct costs (i.e., time on task, not
including administrative expenses,
computer systems, management
overhead, and other indirect costs) on
expedited processing and reviews.
G. Future Schedule for Reregistrations
EPA plans to complete tolerance
reassessment by August 3, 2006, as
required by FFDCA, and also to
complete reregistration eligibility
decisions for pesticides with food uses
by that date. REDs for pesticides that
have no food uses or tolerances will be
completed by October 3, 2008. The
Agency’s schedule for completing these
decisions is as follows. This schedule
also is available on EPA’s website at
https://www.epa.gov/pesticides/
reregistration/decision_schedule.htm.
1. RED, IRED, and TRED Schedules
for FY 2006. List 1 contains pesticides
scheduled for Reregistration Eligibility
Decisions (REDs), Interim REDs (IREDs),
and Reports on FQPA Tolerance
Reassessment Progress and Risk
Management Decisions (TREDs) in FY
2006. Although this list may change due
to the dynamic nature of the review
process, EPA is committed to meeting
the reregistration and tolerance
reassessment deadlines. Any pesticides
for which decisions are not completed
during the current fiscal year will be
rescheduled for decisions the following
year.
List 1.—FY 2006 RED, IRED, and TRED
Schedule
REDs
ADBAC
Aliphatic alkyl quarternaries
Aliphatic solvents
Alkylbenzene sulfonates
Cacodylic acid
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Chlorine dioxide
Copper compounds II
Copper salts
Copper sulfate
Cypermethrin
Dicamba
Dichloran (DCNA)
Ethylene oxide
Glutaraldehyde
Imazapyr
Inorganic chlorates
Inorganic sulfites
Iodine
MCPB
Metaldehyde
Methanearsonic acid, salts (DSMA,
MSMA, CAMA)
MGK-264
Mineral acids, weak (sodium
carbonate)
PCNB
Permethrin
2-Phenylphenol and salts
Phytophtora palmivora
Piperonyl butoxide
Propiconazole
Propylene oxide
Pyrethrins
Resmethrin
Rotenone
Salicylic acid
TCMB
Triadimefon
IREDs
Aldicarb
Carbofuran
Dichlorvos (DDVP)
Dimethoate
Formetanate HCl
Malathion
Simazine
TREDs
Acetochlor
Amitraz
Azadirachtin
Benzaldehyde
Bitertanol
Boric acid group
CP enolpyruvylshikimate-3-phosphate
Ethephon
Fomesafen
Imazaquin
Methyl bromide
Neomycinphosphotransferase II
Oxytetracycline
Propazine
Sodium cyanide
Streptomycin
Triadimenol
Tridemorph
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2. Post-2006 REDs. REDs for
pesticides with no associated tolerances
will be completed in FY 2007 and FY
2008, unless decisions for these
pesticides can be completed sooner.
Lists 2 and 3 contain pesticides
scheduled for REDs in FY 2007 and FY
2008.
List 2.—FY 2007 RED Schedule
2,4-DP
Acrolein
Aliphatic alcohols
Aliphatic esters
Alkyl trimethylenediamine
Allethrin stereoisomers
Amical 48
Antimycin A
Benzoic acid
Bioban-p-1487
Bromonitrostyrene
Chlorflurenol
Chloropicrin
Chromated arsenicals (CCA)
Coal tar/creosote
Copper and oxides
Dazomet
Dikegulac sodium
Formaldehyde
Grotan
Irgasan
MCPP
Methyl bromide
Methyldithiocarbamate salts (metam
sodium/metam potassium)
MITC
Octhilinone
Pentachlorophenol
List 3.—FY 2008 RED Schedule
4-Aminopyradine
Busan 77
Flumetralin
Mefluidide
Naphthalene
Naphthalene salts
Nicotine
Organic esters of phosphoric acid
(new case)
p-Dichlorobenzene
Polypropylene glycol
Prometon
Siduron
Sodium fluoride
Sodium/potassium
dimethyldithiocarbamate salts (case
2180 already counted with ziram)
Sulfometuron methyl
Sumithrin
TBT-containing compounds
Tetramethrin
Triforine
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Trimethoxysilyl quats
H. Projected Year of Completion of
Reregistrations
EPA generally is conducting
reregistration in conjunction with
tolerance reassessment, which FFDCA
mandates be completed by August 2006.
EPA plans to meet the statutory
deadline for completing tolerance
reassessment, and in so doing, to
complete reregistration eligibility
decisions for pesticides with tolerances,
as required by PRIA. The Agency
expects to complete remaining
reregistration eligibility decisions for
pesticides with no food uses or
tolerances during FY 2007 and FY 2008
(by October 3, 2008).Product
reregistration, which takes place only
after the reregistration eligibility
decisions have been completed for the
active ingredients, will not likely be
completed before 2012.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: June 16, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances.
[FR Doc. E6–9956 Filed 6–22–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2006–0516; FRL–8073–8]
Certain New Chemicals; Receipt and
Status Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: Section 5 of the Toxic
Substances Control Act (TSCA) requires
any person who intends to manufacture
(defined by statute to include import) a
new chemical (i.e., a chemical not on
the TSCA Inventory) to notify EPA and
comply with the statutory provisions
pertaining to the manufacture of new
chemicals. Under sections 5(d)(2) and
5(d)(3) of TSCA, EPA is required to
publish a notice of receipt of a
premanufacture notice (PMN) or an
application for a test marketing
exemption (TME), and to publish
periodic status reports on the chemicals
under review and the receipt of notices
of commencement to manufacture those
chemicals. This status report, which
covers the period from May 22, 2006 to
June 2, 2006, consists of the PMNs
pending or expired, and the notices of
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17:22 Jun 22, 2006
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commencement to manufacture a new
chemical that the Agency has received
under TSCA section 5 during this time
period.
DATES: Comments identified by the
specific PMN number or TME number,
must be received on or before July 24,
2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
no. EPA–HQ–OPPT–2006–0516, by one
of the following methods.
• https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO, EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
number EPA–HQ–OPPT–2006–0516.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
• Instructions: Direct your comments
to docket ID number EPA–HQ–OPPT–
2006–0516. EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ systems, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov your e-mail address will
be automatically captured and included
as part of the comment that is placed in
the public docket and made available on
the Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
36085
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the regulations.gov index.
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through
regulations.gov or in hard copy at the
OPPT Docket, EPA Docket Center (EPA/
DC), EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280.
FOR FURTHER INFORMATION CONTACT:
Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division,
Office of Pollution Prevention and
Toxics (7408M), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. As such, the Agency has not
attempted to describe the specific
entities that this action may apply to.
Although others may be affected, this
action applies directly to the submitter
of the premanufacture notices addressed
in the action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36075-36085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9956]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2005-0484; FRL-8068-1]
Pesticide Reregistration Performance Measures and Goals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal year 2005. The Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) requires EPA to publish information about EPA's annual
achievements in this area. This notice discusses the integration of
tolerance reassessment with the reregistration process, and describes
the status of various regulatory activities associated with
reregistration and tolerance reassessment. The notice gives total
numbers of chemicals and products reregistered, tolerances reassessed,
Data Call-Ins issued, and products registered under the ``fast-track''
provisions of FIFRA. Finally, this notice contains the schedule for
completion of activities for specific chemicals during fiscal years
2006 through 2008.
DATES: This notice is not subject to a formal comment period.
Nevertheless, EPA welcomes input from stakeholders and the general
public. Written comments, identified by the docket ID number [EPA-HQ-
OPP-2005-0484], should be received on or before August 22, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0484, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2005-0484. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at https://www.regulations.gov/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or e-mail. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be captured automatically
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at https://www.epa.gov/epahome/
docket.htm/.
Docket: All documents in the docket are listed in the index.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone: (703) 308-8007; e-mail:
stangel.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action 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 under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
[[Page 36076]]
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity, obscene language, or personal threats.
viii. Make sure to submit your comments by the comment period
deadline.
II. Background
EPA must establish and publish in the Federal Register its annual
performance measures and goals for pesticide reregistration, tolerance
reassessment, and expedited registration, under section 4(l) of FIFRA,
as amended by the Food Quality Protection Act of 1996 (FQPA).
Specifically, such measures and goals are to include:
The status of reregistration.
The number of products reregistered, canceled, or amended.
The number and type of data requests or Data Call-In (DCI)
notices under section 3(c)(2)(B) issued to support product
reregistration by active ingredient.
Progress in reducing the number of unreviewed, required
reregistration studies.
The aggregate status of tolerances reassessed.
The number of applications for registration submitted
under subsection (k)(3), expedited processing and review of similar
applications, that were approved or disapproved.
The future schedule for reregistrations in the current and
succeeding fiscal year.
The projected year of completion of the reregistrations
under section 4.
FIFRA, as amended in 1988, authorizes EPA to conduct a
comprehensive pesticide reregistration program--a complete review of
the human health and environmental effects of older pesticides
originally registered before November 1, 1984. Pesticides meeting
today's scientific and regulatory standards may be declared
``eligible'' for reregistration. To be eligible, an older pesticide
must have a substantially complete data base, and must not cause
unreasonable adverse effects to human health or the environment when
used according to Agency approved label directions and precautions.
In addition, all pesticides with food uses must meet the safety
standard of section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21 U.S.C. 346a, as amended by the Food Quality Protection Act
(FQPA) of 1996. Under FFDCA, EPA must make a determination that
pesticide residues remaining in or on food are ``safe''; that is,
``that there is reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue'' from dietary and
other sources. In determining allowable levels of pesticide residues in
food, EPA must perform a more comprehensive assessment of each
pesticide's risks, considering:
Aggregate exposure (from food, drinking water, and
residential uses).
Cumulative effects from all pesticides sharing a common
mechanism of toxicity.
Possible increased susceptibility of infants and children;
and
Possible endocrine or estrogenic effects.
As amended by FQPA, FFDCA requires the reassessment of all existing
tolerances (pesticide residue limits in food) and tolerance exemptions
within 10 years, to ensure that they meet the safety standard of the
law. EPA was directed to give priority to the review of those
pesticides that appear to pose the greatest risk to public health, and
to reassess 33% of the 9,721 existing tolerances and exemptions within
3 years (by August 3, 1999), 66% within 6 years (by August 3, 2002),
and 100% in 10 years (by August 3, 2006).The Agency met the first two
statutory deadlines and is on schedule to meet the third. EPA's
approach to tolerance reassessment under FFDCA is described fully in
the Agency's document, ``Raw and Processed Food Schedule for Pesticide
Tolerance Reassessment'' (62 FR 42020, August 4, 1997) (FRL-5734-6).
The Pesticide Registration Improvement Act (PRIA) of 2003 became
effective on March 23, 2004. Among other things, PRIA directs EPA to
complete Reregistration Eligibility Decisions (REDs) for pesticides
with food uses/tolerances by August 3, 2006, and to complete all non-
food use pesticide REDs by October 3, 2008. EPA's schedule for meeting
these deadlines is available on the Agency's website at www.epa.gov/
pesticides/reregistration/decision_schedule.htm.
III. FQPA and Program Accountability
One of the hallmarks of the FQPA amendments to the FFDCA is
enhanced accountability. Through this summary of performance measures
and goals for pesticide reregistration, tolerance reassessment, and
expedited registration, EPA describes progress made during the past
year in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2005 (from October 1, 2004, through
September 30, 2005), EPA made significant progress in completing risk
assessments and risk management decisions for pesticide reregistration
(See Table 1).
[[Page 36077]]
Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2005
and FY 1991 through FY 2005
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2005 Decisions 2005
------------------------------------------------------------------------
28 REDs (27 countable) 271 REDs
2,4-D.....................................
2,4-DB....................................
Ametryn...................................
4-Amylphenol..............................
Aquashade.................................
Azadioxabicyclooctane.....................
Benzisothiazolin-3-one....................
Chloroneb.................................
Chlorsulfuron.............................
Dimethipin................................
Dodine....................................
Endothall.................................
Ethofumesate..............................
Ferbam (case 2180 already counted with
Ziram).
Fluometuron...............................
Inorganic polysulfides....................
Maneb.....................................
Mancozeb..................................
Metiram...................................
Napropamide...............................
Nitrapyrin................................
Phenmedipham..............................
Pyrazon...................................
Sethoxydim................................
Tau-fluvalinate...........................
Thidiazuron...............................
Trichloromelamine.........................
Xylene (Aromatic solvents)................
------------------------------------------------------------------------
0 IREDs 23 IREDs
------------------------------------------------------------------------
13 TREDs 83 TREDs
Ammonia...................................
Bromine...................................
Cyhexatin.................................
Fluazifop-p-butyl.........................
Flumiclorac-pentyl........................
Imazamethabenz-methyl.....................
Maleic hydrazide..........................
Methyl eugenol............................
Nicosulfuron..............................
Procymidone...............................
Putrescent whole egg solids...............
Sulfuric acid monourea....................
Tanol derivatives.........................
------------------------------------------------------------------------
The Agency's decisions are embodied in Reregistration Eligibility
Decision (RED) documents, Interim Reregistration Eligibility Decisions
(IREDs), and Reports on FQPA Tolerance Reassessment Progress and
[Interim] Risk Management Decisions (TREDs).
1. REDs. Through the reregistration program, EPA is reviewing
current scientific data for older pesticides (those initially
registered before November 1984), reassessing their effects on human
health and the environment, and requiring risk mitigation measures as
necessary. Pesticides that have sufficient supporting data and whose
risks can be successfully mitigated may be declared ``eligible'' for
reregistration. EPA presents these pesticide findings in a RED
document.
i. Overall RED progress. EPA's overall progress at the end of FY
2005 in completing Reregistration Eligibility Decisions (REDs) for
groups of related pesticide active ingredients or cases is summarized
in Table 2.
Table 2.--Overall RED Progress, FY 1991 through FY 2005
------------------------------------------------------------------------
------------------------------------------------------------------------
REDs completed 271 (44%)
------------------------------------------------------------------------
Cases canceled 231 (38%)
------------------------------------------------------------------------
REDs to be completed 110 (18%)
------------------------------------------------------------------------
Total reregistration cases 612 (100%)
------------------------------------------------------------------------
ii. Profile of completed REDs. A profile of the 271 REDs completed
by the end of FY 2005 is presented in Table 3.
Table 3.--Profile of 271 REDs Completed, FY 1991 through FY 2005
------------------------------------------------------------------------
------------------------------------------------------------------------
Pesticide active ingredients 45
------------------------------------------------------------------------
Pesticide products about 11,600
------------------------------------------------------------------------
REDs with food uses 155
------------------------------------------------------------------------
Post-FQPA REDs 130
------------------------------------------------------------------------
[[Page 36078]]
Post-FQPA REDs with food uses* 102
------------------------------------------------------------------------
*EPA is revisiting tolerances associated with the 53 food use REDs that
were completed before FQPA was enacted to ensure that they meet the
safety standard of the new law, as set forth in the Agency's August 4,
1997, Schedule for Pesticide Tolerance Reassessment.
iii. Risk reduction in REDs. Through the reregistration program,
EPA seeks to reduce risks associated with the use of older pesticides.
In developing REDs, EPA works with stakeholders including pesticide
registrants, growers and other pesticide users, and environmental and
public health interests, as well as the States, USDA, and other Federal
agencies and others to develop measures to effectively reduce risks of
concern. Almost every RED includes some measures or modifications to
reduce risks. The options for such risk reduction are extensive and
include voluntary cancellation of pesticide products or deletion of
uses; declaring certain uses ineligible or not yet eligible (and then
proceeding with follow-up action to cancel the uses or require
additional supporting data); restricting use of products to certified
applicators; limiting the amount or frequency of use; improving use
directions and precautions; adding more protective clothing and
equipment requirements; requiring special packaging or engineering
controls; requiring no-treatment buffer zones; employing ground water,
surface water, or other environmental and ecological safeguards; and
other measures.
2. Interim REDs or IREDs. EPA issues IREDs for pesticides that are
undergoing reregistration, require a reregistration eligibility
decision, and also must be included in a cumulative assessment under
FQPA because they are part of a group of pesticides that share a common
mechanism of toxicity. An IRED is issued for each individual pesticide
in the cumulative group when EPA completes the pesticide's risk
assessment and interim risk management decision. An IRED may include
measures to reduce food, drinking water, residential, occupational,
and/or ecological risks, to gain the benefit of these changes before
the final RED can be issued following the Agency's consideration of
cumulative risks. For example, EPA generally has not considered
individual organophosphate (OP) pesticide decisions to be completed
REDs or tolerance reassessments. Instead, the Agency has issued IREDs
for these chemicals. EPA will complete the risk assessments and
reregistration eligibility decisions for OP pesticides with IREDs, once
the Agency completes a cumulative assessment of the OPs.
3. Tolerance reassessment ``TREDs.'' EPA issues Reports on FFDCA
Tolerance Reassessment Progress and [Interim] Risk Management
Decisions, known as TREDs, for pesticides that require tolerance
reassessment decisions under FFDCA, but do not require a reregistration
eligibility decision at present because:
The pesticide was first registered after November 1, 1984,
and is considered a ``new'' active ingredient, not subject to
reregistration;
EPA completed a RED for the pesticide before FQPA was
enacted; or
The pesticide is not registered for use in the U.S. but
tolerances are established that allow crops treated with the pesticide
to be imported from other countries.
As with IREDs, EPA will not complete risk assessment and risk
management for pesticides subject to TREDs that are part of a
cumulative group until cumulative risks have been considered for the
group.
During FY 2005, in addition to completing 13 TREDs, EPA also
completed 168 tolerance assessment decisions for pesticide inert
ingredients that are exempted from the tolerance requirement. Almost
900 of the 9,721 tolerance reassessment decisions required by the
amended FFDCA are for such inert ingredient tolerance exemptions. EPA
has reassessed 573 of these inert ingredient tolerance exemptions to
date, and plans to complete the reassessment of all the inert
ingredient tolerance exemptions by August 2006.
As a result of the Food Quality Protection Act of 1996, food-
contact surface sanitizers previously regulated by both EPA and the
Food and Drug Administration were transferred to EPA's sole
jurisdiction. Consequently, the approximately 107 ingredients that made
up these sanitizer solutions in 21 CFR 178.1010 were transferred to 40
CFR part 180, subpart D. In addition to reassessing the 9,721
tolerances and exemptions for food and feed commodities, EPA also must
reassess these sanitizer tolerance exemptions by August 3, 2006. The
Antimicrobials Division (AD) in EPA's Office of Pesticide Programs is
responsible for reassessing exemptions from the requirement of a
tolerance for the food-contact surface sanitizing solutions requiring
reassessment. AD is reassessing 60 of the 107 exemptions, either as
free-standing decisions or through REDs. During FY 2005, AD completed
35 tolerance exemption reassessments decisions for 22 of these 60 food-
contact surface sanitizing solution ingredients. EPA is reassessing
tolerance exemptions for the other food-contact surface sanitizing
solutions through other REDs and inert exemption decisions.
4. Goals for FY 2006 and future years. EPA's major pesticide
reregistration and tolerance reassessment goals for FY 2006 and future
years are as follows.
i. Complete individual pesticide risk management decisions. EPA's
goal in conducting the reregistration and tolerance reassessment
program is to complete about 45 Reregistration Eligibility Decisions
(REDs) and Interim REDs (IREDs) during FY 2006, for pesticides with
associated tolerances, and to complete a total of about 45 REDs in FY
2007 and FY 2008, for pesticides with no food uses or tolerances. This
will satisfy PRIA requirements and support the Agency's tolerance
reassessment goal. EPA's schedule for completing these decisions
appears near the end of this document, and also is available on the
Agency's Web site at https://www.epa.gov/pesticides/reregistration/
decision_schedule.htm.
ii. Complete tolerance reassessment decisions. EPA is continuing to
reassess tolerances within time frames set forth in FFDCA as amended by
FQPA, giving priority to those food use pesticides that appear to pose
the greatest risk. Integration of the reregistration and tolerance
reassessment programs has added complexity to the reregistration
process for food use pesticides. The Agency successfully reached its
first two tolerance reassessment milestones by completing over 33% of
all tolerance reassessment decisions by August 3, 1999, and over 66% by
August 3, 2002. EPA plans to meet the final FQPA tolerance reassessment
goal.
iii. Evaluate cumulative risks. Once EPA completes individual risk
assessments for the OPs, carbamates and others, the Agency will make
cumulative risk findings for each of these common mechanism groups of
pesticides. For further information, see EPA's cumulative risk website,
https://www.epa.gov/pesticides/cumulative/.
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
[[Page 36079]]
still must be reregistered. This concluding part of the reregistration
process is called ``product reregistration.''
In issuing a completed RED document, EPA sends registrants a Data
Call-In (DCI) notice requesting any product-specific data and specific
revised labeling needed to complete reregistration for each of the
individual pesticide products covered by the RED. Based on the results
of EPA's review of these data and labeling, products found to meet
FIFRA and FFDCA standards may be reregistered.
A variety of outcomes are possible for pesticide products
completing this final phase of the reregistration process. Ideally, in
response to the DCI notice accompanying the RED document, the pesticide
producer, or registrant, will submit the required product-specific data
and revised labeling, which EPA will review and find acceptable. At
that point, the Agency may reregister the pesticide product. If,
however, the product contains multiple active ingredients, the Agency
instead issues an amendment to the product's registration,
incorporating the labeling changes specified in the RED; a product with
multiple active ingredients may not be fully reregistered until the
last active ingredient in its formulation is eligible for
reregistration. In other situations, the Agency may temporarily suspend
a product's registration if the registrant has not submitted required
product-specific studies within the time frame specified. The Agency
may cancel a product's registration because the registrant did not pay
the required registration maintenance fee. Alternatively, the
registrant may request a voluntary cancellation of their end-use
product registration.
1. Product reregistration actions in FY 2005. EPA counts each of
the post-RED product outcomes described above as a product
reregistration action. A single pesticide product may be the subject of
several product reregistration actions within the same year. For
example, a product's registration initially may be amended, then the
product may be reregistered, and later the product may be voluntarily
canceled, all within the same year. During FY 2005, EPA completed the
product reregistration actions detailed in Table 4.
Table 4.--Product Reregistration Actions Completed during FY 2005
------------------------------------------------------------------------
------------------------------------------------------------------------
Product reregistration actions 99
------------------------------------------------------------------------
Product amendment actions 63
------------------------------------------------------------------------
Product cancellation actions 342
------------------------------------------------------------------------
Product suspension actions 0
------------------------------------------------------------------------
Total actions 504
------------------------------------------------------------------------
2. Status of the product reregistration universe. The status of the
universe of pesticide products subject to reregistration at the end of
FY 2005 is shown in Table 5 below. This overall status information is
not ``cumulative''--it is not derived from summing up a series of
annual actions. Adding annual actions would result in a larger overall
number since each individual product is subject to multipleactions--it
can be amended, reregistered, and/or canceled, over time. Instead, the
``big picture'' status information in Table 5 should be considered a
snapshot in time. As registrants and EPA make marketing and regulatory
decisions in the future, the status of individual products may change,
and numbers in this table are expected to fluctuate.
Table 5.--Status of the Universe of Products Subject to Product
Reregistration, for FY 2005 (as of September 30, 2005)
------------------------------------------------------------------------
------------------------------------------------------------------------
Products reregistered 1,875
------------------------------------------------------------------------
Products amended 505
------------------------------------------------------------------------
Products canceled 4,375
------------------------------------------------------------------------
Products sent for suspension 30
------------------------------------------------------------------------
Total products with actions completed 6,785
------------------------------------------------------------------------
Products with actions pending 4,828
------------------------------------------------------------------------
Total products in product reregistration 11,613
universe
------------------------------------------------------------------------
The universe of 11,613 products in product reregistration at the
end of FY 2005 represented an increase of 1,210 products from the FY
2004 universe of 10,403 products. The increase consists of 1,150
products associated with FY 2005 REDs, 35 products associated with
TREDs, and 25 products that were added as a result of DCI activities
and processing for several previously issued REDs and IREDs.
At the end of FY 2005, 4,828 products had product reregistration
decisions pending. Some pending products await science reviews, label
reviews, or reregistration decisions by EPA. Others 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 450 product reregistration actions during fiscal year 2006.
C. Number and Type of DCIs to Support Product Reregistration by Active
Ingredient
1. DCIs for REDs. The number and type of Data Call-In requests or
DCIs that EPA is preparing to issue under FIFRA section 3(c)(2)(B) to
support product reregistration for pesticide active ingredients
included in FY 2005 REDs are shown in Table 6.
Table 6.--DCIs Issued to Support Product Reregistration for FY 2005 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case Number Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the RED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,4-D 0073 696 31 Not Completed Yet 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,4-DB 0196 22 31 48 (6 batches/2 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36080]]
4-t Amylphenol and Salts 3016 37 PDCI has not been Antimicrobial RED-- PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ametryn 2010 4 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aquashade 4010 4 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Azadioxabicylclooctane 3023 2 PDCI has not been Antimicrobial RED-- PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzisothiazolin-3-one 3026 47 PDCI has not been 108 (5 batches/13 not PDCI has not been
completed yet batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloroneb 0007 12 31 60 (2 batches/8 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorsulfuron 0631 16 31 72 (2 batches/10 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dimethipin 3063 5 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dodine 0161 5 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endothall 2245 30 31 36 (2 batches/4 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethofumesate 2265 18 31 66 (3 batches/8 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ferbam 2180 7 31 24 (4 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluometuron 0049 19 31 36 (5 batches/1 0
product not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Polysulfides 4054 17 31 96 (16 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mancozeb 0643 100 31 144 (5 batches/19 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maneb 0642 21 31 60 (3 batches/7 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metiram 0644 4 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Napropamide 2450 15 31 48 (5 batches/3 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nitrapyrin 0213 4 31 12 (1 batch/1 product 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36081]]
Phenmedipham 0277 16 31 96 (16 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyrazon 2570 3 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sethoxydim 2600 10 31 48 (1 batch/7 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tau-Fluvalinate 2295 5 31 18 (3 products not 5
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thidiazuron 4092 18 31 42 (4 batches/3 0
products not batched
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trichloromelamine 3144 8 PDCI has not been 36 (1 batch/5 not PDCI has not been
completed yet batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Xylene 3020 5 31 18 (3 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products 1,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The number of registered products containing a pesticide active ingredient can change over time. The product total 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.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.
3In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ``batches'' products that can
be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six acute toxicology
studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors considered in the
sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary
labeling). The Agency does not describe batched products as ``substantially similar,'' because all products within a batch may not be considered
chemically similar or have identical use patterns.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the acute
toxicity batchings because they are supported by a valid parent product (section 3) registration.)
2. DCIs for IREDs. EPA completed no IREDs during FY 2004.
3. DCIs for TREDs. There are special cases where product-specific
DCIs may be required for TREDs, particularly if the Agency believes
that adequate product chemistry or acute toxicity data are not
currently on file to support the reregistration of the products
associated with the TREDs. The Agency is requiring a product-specific
DCI for the following TRED:
Table 7.--DCIs Issued to Support Product Reregistration for FY 2005 TRED
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case Number Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the TRED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluazifop-p-butyl 2285 35 31 84 (4 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the TRED document
(counted when the TRED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when
the TRED is issued). This table reflects the final number of products associated with each TRED, as they are being tracked for product reregistration.
2This column shows the number of product chemistry studies that are required for each product covered by the TRED.
3In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ``batches'' products that can
be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six acute toxicology
studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors considered in the
sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary
labeling). The Agency does not describe batched products as ``substantially similar,'' because all products within a batch may not be considered
chemically similar or have identical use patterns.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the acute
toxicity batchings because they are supported by a valid parent product (section 3) registration.)
[[Page 36082]]
D. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
EPA has made progress in reviewing scientific studies submitted by
pesticide registrants in support of pesticides undergoing
reregistration (See Table 8). The percent of studies reviewed by EPA
remained constant in FY 2005.
Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2005
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration List, per Studies Reviewed +
FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A 11,238 + 589 = 11,827 1,788 (13%) 13,615
(87%)
----------------------------------------------------------------------------------------------------------------
List B 6,542 + 1,033 = 7,575 1,748 (19%) 9,323
(81%)
----------------------------------------------------------------------------------------------------------------
List C 2,096 + 334 = 2,430 464 (16%) 2,894
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,248 + 133 = 1,381 229 (14%) 1,610
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A-D 21,124 + 2,089 = 23,213 4,229 (15.4%) 27,442 (100%)
(84.6%)
----------------------------------------------------------------------------------------------------------------
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data
requirement has been satisfied by other studies or has changed.
E. Aggregate Status of Tolerances Reassessed
During FY 2005, EPA completed 772 tolerance reassessments and ended
the fiscal year with a total of 7,817 tolerance reassessment decisions
to date, addressing over 80% of the 9,721 tolerances that require
reassessment (See Table 9).
EPA reassessed over 33% of all food tolerances by August 3, 1999,
and completed over 66% of all required tolerance reassessment decisions
by August 3, 2002, meeting two important statutory deadlines
established by the FQPA. EPA's general schedule for tolerance
reassessment (62 FR 42020, August 4, 1997) identified three groups of
pesticides to be reviewed; this grouping continues to reflect the
Agency's overall scheduling priorities. In completing tolerance
reassessment, EPA continues to give priority to pesticides in Group 1,
the Agency's highest priority group for reassessment.
1. Aggregate accomplishments through reregistration and other
programs. EPA is accomplishing tolerance reassessment through the
registration and reregistration programs; by revoking tolerances for
pesticides that have been canceled (many as a result of
reregistration); by reevaluating pesticides with pre-FQPA REDs, and
through other decisions not directly related to registration or
reregistration, described further below. EPA is using the Tolerance
Reassessment Tracking System (TORTS) to compile this updated
information and report on the status of tolerance reassessment (See
Table 9).
Table 9.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2005*
--------------------------------------------------------------------------------------------------------------------------------------------------------
During Total,
Tolerances Reassessed Through... Late FY During During During During During During During During During End of
96 FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2005
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 277 359 44 46 231 79 87 413 1,897
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance Reassessments/TREDs 0 0 0 0 0 0 776 14 119 69 970
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration 0 224 308 340 55 216 200 0 71 -- 1,412
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 35 545 0 172 75 2,239
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions 0 1 0 233 0 0 905 26 18 165 1,299
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 119 467 722 7,817
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA is using the reregistration program to
accomplish much of tolerance reassessment. For each of the tolerance
reassessment decisions made through REDs since enactment of the FQPA,
the Agency has made the finding as to whether there is a reasonable
certainty of no harm, as required by FFDCA. Many tolerances reassessed
through reregistration remain the same while others may be raised,
lowered, or revoked.
ii. Tolerance reassessments/TREDs. Tolerances initially evaluated
through REDs that were completed before FQPA was enacted in August 1996
now are being reassessed to ensure that they meet the new FFDCA safety
standard. EPA issues these post-RED tolerance reassessment decisions as
TREDs. The Agency also issues TREDs summarizing
[[Page 36083]]
tolerance reassessment decisions for some developing REDs, for new
pesticide active ingredients not subject to reregistration, and for
pesticides with import tolerances only. Tolerance reassessments for
pesticides that are not part of a cumulative group may be counted at
present and are included in the FY 2005 accomplishments.Tolerance
reassessments for pesticides that are part of a cumulative group are
not included in the Agency's lists of accomplishments. These tolerances
will be considered again and their reassessment will be completed after
EPA completes a cumulative risk evaluation for the group.
iii. Registration. Like older pesticides, all new pesticide
registrations must meet the safety standard of FFDCA. 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
aggregate risk of the 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.
iv. Tolerance revocations. Revoked tolerances represent uses of
many different pesticide active ingredients that have been canceled in
the past. Some pesticides were canceled due to the Agency's risk
concerns. Others were canceled voluntarily by their manufacturers,
based on lack of support for reregistration. Tolerance revocations are
important even if there are no domestic uses of a pesticide because
residues in or on imported commodities treated with the chemical could
still present dietary risks that may exceed the FFDCA ``reasonable
certainty of no harm'' standard, either individually or cumulatively
with other substances that share a common mechanism of toxicity.
v. Other reassessment decisions. In addition to the types of
reassessment actions described above, a total of 1,299 additional
tolerance reassessment decisions have been made, some for inert
ingredient tolerance exemptions, through actions not directly related
to registration or reregistration. A list of these other tolerance
reassessment decisions with their Federal Register citations is
available in the docket for this Federal Register notice. Other support
documents are available in docket ID number EPA-HQ-OPP-2002-0162.
2. Accomplishments for priority pesticides. During FY 2005, EPA
completed tolerance reassessment decisions for many high priority
pesticides in review, including OPs, carbamates, organochlorines, and
carcinogens (See Table 10).
Table 10.--Tolerance Reassessments Completed for Priority Pesticides
------------------------------------------------------------------------
Tolerances to be Reassessed by End
Pesticide Class Reassessed of FY 2005
------------------------------------------------------------------------
Carbamates 545 317 (58.17%)
------------------------------------------------------------------------
Carcinogens 2,008 1,530 (76.20%)
------------------------------------------------------------------------
High hazard inerts 5 5 (100%)
------------------------------------------------------------------------
Organochlorines 253 253 (100%)
------------------------------------------------------------------------
Organophosphates (OPs) 1,691 1,147 (67.83%)
------------------------------------------------------------------------
Other 5,219 4,565 (87.47%)
------------------------------------------------------------------------
Total 9,721 7,817 (80.41%)
------------------------------------------------------------------------
3. Tolerance reassessment and the organophosphates. EPA developed
an approach for assessing cumulative risk for the OP pesticides as a
group, as required by FFDCA, and applied this methodology in conducting
an OP cumulative risk assessment. The Agency issued preliminary and
revised OP cumulative risk assessment documents in December 2001 and
June 2002, available on EPA's Web site at https://www.epa.gov/
pesticides/cumulative.
Through this assessment of the OP pesticides, EPA has evaluated
several hundred OP tolerances and found that most require no
modification to meet the new FFDCA safety standard. The Agency's
regulatory actions on individual OP pesticides during the past few
years have substantially reduced the risks of these pesticides. EPA
plans to complete IREDs and REDs for the three remaining individual OP
pesticides (DDVP, dimethoate, and malathion) in FY 2006.
Most of the reregistration and tolerance reassessment decisions
that EPA has made for the OP pesticides will not be considered complete
until after the Agency concludes its cumulative evaluation of the OPs.
The results of individual OP assessments (IRED and TRED documents)
include significant risk mitigation measures, however, and any
resulting tolerance revocations are counted as completed tolerance
reassessments. In addition, some OP tolerances that make at most a
minimal or negligible contribution to the cumulative risk from OP
pesticides were counted as reassessed during FY 2002. Once EPA
completes a cumulative evaluation of the OPs, the Agency will
reconsider individual OP IREDs and TREDs, and complete reregistration
eligibility and tolerance reassessment decisions for these pesticides.
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 2005, EPA
considered and approved the numbers of applications for registration
requiring expedited processing (also known as ``fast track''
applications) shown in Table 11.
[[Page 36084]]
Table 11.--Fast Track Applications Approved in FY 2005
------------------------------------------------------------------------
------------------------------------------------------------------------
Me-too product registrations/Fast track 340
------------------------------------------------------------------------
Amendments/Fast track 2,639
------------------------------------------------------------------------
Total applications processed by fast track 2,979
means
------------------------------------------------------------------------
For those applications not approved, 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.
A
