Pesticide Reregistration Performance Measures and Goals, 46996-47007 [E7-16560]
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46996
Federal Register / Vol. 72, No. 162 / Wednesday, August 22, 2007 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2007–0484; FRL–8458–4]
Board of Scientific Counselors,
National Center for Environmental
Research (NCER) Standing
Subcommittee Meeting—2007
Environmental Protection
Agency (EPA).
ACTION: Notice of Meeting.
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AGENCY:
SUMMARY: Pursuant to the Federal
Advisory Committee Act, Public Law
92–463, the Environmental Protection
Agency, Office of Research and
Development (ORD), gives notice of a
meeting of the Board of Scientific
Counselors (BOSC) National Center for
Environmental Research (NCER)
Standing Subcommittee.
DATES: The meeting (a teleconference
call) will be held on Tuesday,
September 11, 2007 from 1 p.m. to 3
p.m. All times noted are eastern time.
The meeting may adjourn early if all
business is finished. Requests for the
draft agenda or for making oral
presentations at the conference call will
be accepted up to 1 business day before
the meeting.
ADDRESSES: Participation in the meeting
will be by teleconference only—meeting
rooms will not be used. Members of the
public may obtain the call-in number
and access code for the call from Susan
Peterson, whose contact information is
listed under the FOR FURTHER
INFORMATION CONTACT section of this
notice. Submit your comments,
identified by Docket ID No. EPA–HQ–
ORD–2007–0484, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: Send comments by
electronic mail (e-mail) to:
ORD.Docket@epa.gov, Attention Docket
ID No. EPA–HQ–ORD–2007–0484.
• Fax: Fax comments to: (202) 566–
0224, Attention Docket ID No. EPA–
HQ–ORD–2007–0484.
• Mail: Send comments by mail to:
Board of Scientific Counselors, National
Center for Environmental Research
(NCER) Standing Subcommittee—2007
Docket, Mailcode: 28221T, 1200
Pennsylvania Ave., NW., Washington,
DC 20460, Attention Docket ID No.
EPA–HQ–ORD–2007–0484.
• Hand Delivery or Courier: Deliver
comments to: EPA Docket Center (EPA/
DC), Room B102, EPA West Building,
1301 Constitution Avenue, NW.,
Washington, DC, Attention Docket ID
No. EPA–HQ–ORD–2007–0484. Note:
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this is not a mailing address. 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 No. EPA–HQ–ORD–2007–
0484. 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 https://
www.regulations.gov or e-mail. The
https://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 https://
www.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, 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/dockets.htm.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., 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
electronically in https://
www.regulations.gov or in hard copy at
the Board of Scientific Counselors,
National Center for Environmental
Research (NCER) Standing
Subcommittee—2007 Docket, EPA/DC,
EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
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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 ORD
Docket is (202) 566–1752.
FOR FURTHER INFORMATION CONTACT: The
Designated Federal Officer via mail at:
Susan Peterson, Mail Code 8104–R,
Office of Science Policy, Office of
Research and Development,
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; via phone/voice
mail at: (202) 564–1077; via fax at: (202)
565–2911; or via e-mail at:
peterson.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
General Information
Participation in the meeting will be by
teleconference only—meeting rooms
will not be used. Members of the public
who wish to obtain the call-in number
and access code to participate in the
conference call may contact Susan
Peterson, the Designated Federal
Officer, via any of the contact methods
listed in the FOR FURTHER INFORMATION
CONTACT section above, by 4 working
days prior to the conference call.
The purpose of the meeting is to
provide follow-up to the subcommittee
from the July 24–25, 2007 face-to-face
meeting. Proposed agenda items for the
conference call include, but are not
limited to: presentations on ORD
communications, and discussion of the
charge questions to subcommittee. The
conference call is open to the public.
Information on Services for
Individuals with Disabilities: For
information on access or services for
individuals with disabilities, please
contact Susan Peterson at (202) 564–
1077 or peterson.susan@epa.gov. To
request accommodation of a disability,
please contact Susan Peterson,
preferably at least 10 days prior to the
meeting, to give EPA as much time as
possible to process your request.
Dated: August 15, 2007.
Mary Ellen Radzikowski,
Acting Director, Office of Science Policy.
[FR Doc. E7–16608 Filed 8–21–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2006–1005; FRL–8149–5]
Pesticide Reregistration Performance
Measures and Goals
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Notice.
SUMMARY: This notice announces EPA’s
progress in meeting its performance
measures and goals for pesticide
reregistration during fiscal year 2006.
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. This notice
also contains the schedule for
completion of activities for specific
chemicals during fiscal years 2007
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–2006–1005],
should be received on or before October
22, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–1005, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov/. Follow the online 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–
2006–1005. 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
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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
website 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 athttps://
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 athttps://
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; email: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
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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
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
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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) (which provides for 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
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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
required the reassessment of all existing
tolerances (pesticide residue limits in
food) and tolerance exemptions within
10 years, to ensure that they met the
safety standard of the law. EPA was
directed to give priority to the review of
those pesticides that appeared 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 substantially met the
third, completing over 99% of all
required tolerance reassessment
decisions by August 3, 2006. These
decisions represent significant
enhancements in public health and
environmental protection. By
successfully implementing FQPA, EPA
is ensuring that all pesticides used on
food in the United States meet the law’s
new, more stringent safety standard.
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
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FR 42020, August 4, 1997) (FRL–5734–
6). The Agency’s accomplishments
under FQPA during the past 10 years
are discussed athttps://www.epa.gov/
pesticides/regulating/laws/fqpa/
fqpa_accomplishments.htm.
The Pesticide Registration
Improvement Act (PRIA) of 2003
became effective on March 23, 2004.
Among other things, PRIA directed 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. The
Agency completed 99% of the REDs due
by August 3, 2006, and plans to
complete all remaining REDs by October
3, 2008. EPA’s schedule for meeting
these deadlines is available on the
Agency’s website athttps://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) 2006 (from
October 1, 2005, through September 30,
2006), EPA made significant progress in
completing risk assessments and risk
management decisions for pesticide
reregistration (See Table 1).
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).
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TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: IN FY 2006 AND FY 1991 THROUGH FY 2006
FY 2006 Decisions
Total, FY 1991 through FY 2006
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59 FY 2006 REDs
(37 REDs + 22 OP IREDs became REDs)
ADBAC
Aliphatic alkyl quarternaries (DDAC)
Aliphatic solvents
Alkyl benzene sulfonates
Atrazine (2003 IRED became a RED, 4-6-06)
Cacodylic acid
Chlorine dioxide
Copper and oxides
Copper compounds II
Copper salts
Copper sulfate
Cypermethrin
Dicamba
Dichloran (DCNA)
Imazapyr
Inorganic chlorates (sodium chlorate)
Inorganic sulfites
Iodine
Malathion (OP RED)
MCPB
Metaldehyde
Methanearsonic acid, salts (DSMA, MSMA, CAMA)
MGK-264
Mineral bases, weak (sodium carbonate)
PCNB
Permethrin
2-Phenylphenol and salts
Phytophthora palmivora
Piperonyl butoxide
Propiconazole
Propylene oxide
Pyrethrins
Resmethrin
Salicylic acid
Simazine (triazine RED)
TCMTB
Triadimefon
22 OP IREDs became REDs on 7–31–06
Acephate
Azinphos-methyl
Bensulide
Chlorpyrifos
Diazinon
Dichlorvos or DDVP
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl (ODM)
Phorate
Phosmet
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tribufos (DEF)
330 REDs
4 IREDs
Carbofuran (N-methyl carbamate)
Dichlorvos (DDVP) (OP IRED, became a RED on 7–31–06)
Dimethoate (OP IRED, became a RED on 7–31–06)
Formetanate HCl (N-methyl carbamate)
4 IREDs
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TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: IN FY 2006 AND FY 1991 THROUGH FY
2006—Continued
FY 2006 Decisions
Total, FY 1991 through FY 2006
19 TREDs
Acetochlor
Amitraz
Azadirachitin
Bitertanol
Boric acid group
CP enolpyruvylshikimate-3-phosphate
Ethephon
Ethylene oxide (ETO) (RED in FY 2007)
Inert ingredients of semichemical dispensers
Imazaquin
Methyl bromide (commodity uses RED & TRED in FY 2006; soil fumigant
uses RED in FY 2007)
Neomycinphosphotransferase II
Oxytetracycline
Propazine
Rotenone (RED in FY 2007)
Sodium Cyanide
Streptomycin
Triadimenol
Tridemorph
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 2006 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 2006
REDs completed
330 (54%)
Cases canceled
229 (37%)
REDs to be completed
54 (9%)
Total reregistration cases
613
(100%)
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ii. Profile of completed REDs. A
profile of the REDs completed by the
end of FY 2006 is presented in Table 3.
TABLE 3.—PROFILE OF 330 REDS
COMPLETED, FY 1991 THROUGH FY
2006
Pesticide active ingredients
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95 TREDs
eligibility decision, and also must be
TABLE 3.—PROFILE OF 330 REDS
COMPLETED, FY 1991 THROUGH FY included in a cumulative assessment
under FQPA because they are part of a
2006—Continued
Pesticide products
over
20,000
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 groups, 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
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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 risks from
food, drinking water, residential,
occupational, and/or ecological
exposure while the cumulative risk
assessment is pending. For example,
EPA generally did not consider
individual organophosphate (OP)
pesticide decisions made in advance of
the cumulative risk assessment to be
completed REDs or tolerance
reassessments. Instead, the Agency
issued IREDs for these chemicals. EPA
completed the risk assessments and
reregistration eligibility decisions for
those OP pesticides with IREDs, once
the Agency completed the OP
cumulative risk assessment on July 31,
2006.See https://www.epa.gov/
pesticides/cumulative/.
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;
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• 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 does 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 2006, EPA completed 19
TREDs. By August 3, 2006, EPA also
completed tolerance assessment
decisions for food use pesticide inert
ingredients that are exempted from the
tolerance requirement. Almost 900 of
the 9,721 tolerance reassessment
decisions required by the amended
FFDCA were for such inert ingredient
tolerance exemptions.
As a result of the FQPA, food-contact
surface sanitizing solutions 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 180.940. In addition to reassessing
the 9,721 tolerances and exemptions for
food and feed commodities, EPA also
was required to 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
completed the reassessment of 120
tolerance exemptions in FY 2006,
resulting in a total of 174 tolerance
exemptions reassessed for the foodcontact surface sanitizing solutions.
4. Goals for FY 2007 and future years.
EPA’s major pesticide reregistration and
tolerance reassessment goals for FY
2007 and future years are as follows.
i. Complete individual pesticide risk
management decisions. EPA’s goal in
conducting the reregistration program is
to complete 6 remaining Reregistration
Eligibility Decisions (REDs) and Interim
REDs (IREDs) for pesticides with food
uses and 19 REDs for pesticides with no
food uses during FY 2007. The Agency
plans to complete the remaining 29 nonfood use REDs in FY 2008. EPA’s
schedule for completing these decisions
appears near the end of this document,
and also is available on the Agency’s
website at https://www.epa.gov/
pesticides/reregistration/
decision_schedule.htm.
ii. Complete tolerance reassessment
decisions. EPA completed over 99% of
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all required tolerance reassessment
decisions by August 3, 2006, the 10–
year anniversary of FQPA. EPA expects
to complete the N-methyl carbamate
cumulative risk assessment and the
Agency’s final 84 tolerance
reassessment decisions, thereby
completing theFQPA tolerance
reassessment program.
iii. Evaluate cumulative risks. EPA
completed cumulative risk assessments
for the organophosphate (OP), triazine,
and chloroacetanilide pesticides during
FY 2006. Once EPA completes an
individual decision for aldicarb, the
Agency will make a cumulative risk
finding for the N-methyl carbamate
common mechanism group of
pesticides. No other groups are
scheduled at present for cumulative risk
assessments. For further information,
see EPA’s Assessing Pesticide
Cumulative Risk web page,http//
www.epa.gov/pesticides/cumulative/
index.htm.
B. Product Reregistration; Numbers of
Products Reregistered, Canceled, and
Amended
At the end of the reregistration
process, after EPA has issued a RED and
declared a pesticide reregistration case
eligible for reregistration, individual
end-use products that contain pesticide
active ingredients included in the case
still must be reregistered. This
concluding part of the reregistration
process is called ‘‘product
reregistration.’’
In issuing a completed RED
document, EPA 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
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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
2006. 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 2006, EPA
completed the product reregistration
actions detailed in Table 4.
TABLE 4.—PRODUCT REREGISTRATION
ACTIONS COMPLETED DURING FY 2006
Product reregistration actions
169
Product amendment actions
40
Product cancellation actions
297
Product suspension actions
0
Total actions
506
2. Status of the product reregistration
universe. The status of the universe of
pesticide products subject to
reregistration at the end of FY 2006 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 2006
(AS OF SEPTEMBER 30, 2006)
Products reregistered
2,063
Products amended
554
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TABLE 5.—STATUS OF THE UNIVERSE
OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2006
(AS OF SEPTEMBER 30, 2006)—
Continued
Products canceled
4,672
Products sent for suspension
30
Total products with actions completed
7,319
Products with actions pending
12,932
Total products in product reregistration universe
20,251
The universe of 20,251 products in
product reregistration at the end of FY
2006 represented an increase of 8,638
products from the FY 2005 universe of
11,613 products. The increase consists
of 8,613 products associated with FY
2006 REDs, IREDs, and 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 2006, 12,932
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, but they
are associated with more recently
completed REDs. Their product-specific
data are not yet due to be submitted to
or reviewed by the Agency. EPA’s goal
is to complete 545 product reregistration
actions during fiscal year 2007.
C. Number and Type of DCIs to Support
Product Reregistration by Active
Ingredient
1. DCIs for REDs and IREDs. 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 2006 REDs and IREDs are shown in
Table 6.
TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2006 REDS AND IREDS
Case Name
Case No.
Number of Products Covered by
the RED1
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
0350
1,047
PDCI has not
been completed yet
Antimicrobial
RED – Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Aliphatic Alkyl
Quarternaries
(DDAC)
3003
382
PDCI has not
been completed yet
Antimicrobial
RED – Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Aliphatic Solvents
3004
158
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Alkylbenzene
Sulfonates
4006
20
0
Antimicrobial
RED – Acute
toxicity batching not completed yet
5
Cacodylic Acid
2080
36
31
See footnote 4
below
0
Chlorine Dioxide
4023
95
PDCI has not
been completed yet
Antimicrobial
RED – Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Copper Compounds II
0649
173
31
Needs batching
0
Copper and Oxides
4025
237
PDCI has not
been completed yet
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Copper Salts
4026
38
31
Acute toxicity
batching not
completed yet
0
Copper Sulfate
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ADBAC
0636
127
31
Acute toxicity
batching not
completed yet
0
Cypermethrin
2130
69
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
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TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2006 REDS AND IREDS—Continued
Case Name
Case No.
Number of Products Covered by
the RED1
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
0065
448
31
Acute toxicity
batching not
completed yet
0
Dichloran (DCNA)
0113
25
31
54 (1 batch/8
not batched)
0
Dichlorvos (DDVP)
0310
100
31
258 (20 batches/
23 not
batched)
PDCI has not
been completed yet
Dimethoate
0088
54
31
96 (7 batches/9
not batched)
0
Formetantate HCL
(IRED)
0091
6
31
36 (6 products
not batched)
0
Imazapyr
3078
19
31
Acute toxicity
batching not
completed yet
0
Inorganic Chlorates
(Sodium Chlorate)
4049
58
31
156 (9 batches/
17 not
batched)
PDCI has not
been completed yet
Inorganic Sulfites
4056
9
31
Acute toxicity
batching not
completed yet
1
Iodine and Iodophor
Complexes
3080
67
0
126 (12 batches/
9 not batched)
9
Malathion
0248
153
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
MCPB and Salts
2365
5
31
24 (1 batch/3
not batched)
0
Metaldehyde
0576
52
31
102 (7 batches/
10 not
batched)
0
Methanearsonic acid,
salts (Organic
Arsenicals) (MSMA/
DSMA/CAMA)
2395
129
See footnote 4
below
See footnote 4
below
See footnote 4
below
Methyl Bromide (RED/
TRED)
0335
14
31
Not Applicable
1
MGK 264
2430
653
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Mineral Bases, Weak
(Sodium Carbonate)
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Dicamba
4066
4
PDCI has not
been completed yet
Antimicrobial
RED – Acute
toxicity batching not completed yet
PDCI has not
been completed yet
2-Phenylphenol and
Salts (Orthophenyl
Phenol)
2575
118
PDCI has not
been completed yet
450 (22 batches/
53 not
batched)
PDCI has not
been completed yet
PCNB
0128
82
31
270 (14 batches/
31 not
batched)
0
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TABLE 6.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2006 REDS AND IREDS—Continued
Case Name
Number of Products Covered by
the RED1
Case No.
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
Permethrin
2510
957
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Piperonyl Butoxide
(PBO)
2525
1,451
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Propiconazole
3125
172
31
264 (14 batches/
30 not
batched)
0
Propylene Oxide (PPO)
2560
3
31
18 (3 not
batched)
0
Pyrethrins
2580
1,286
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Resmethrin
0421
232
31
Acute toxicity
batching not
completed yet
PDCI has not
been completed yet
Simazine
0070
44
31
84 (8 batches/6
not batched)
0
TCMTB
2625
27
PDCI has not
been completed yet
Antimicrobial
RED – Acute
toxicity batching not completed yet
PDCI has not
been completed yet
Triadimefon
2700
56
31
102 (7 batches/
10 not
batched)
0
Total No. of Products
---
8,606
---
---
---
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.)
4Ineligible for reregistration; public comments under consideration. Depending on the Agency’s formal response to the public comments,
PDCIs may or may not be required for these chemicals.
2. DCIs for TREDs. There are cases in
which 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 product-specific DCIs for the
following TRED:
TABLE 7.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2006 TRED
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Case Name
Triadimenol
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16:26 Aug 21, 2007
Number of Products Covered by
the TRED1
Case No.
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Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
31
7
Number of Product
Chemistry Studies
Required2
42 (7 products
not batched)
0
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TABLE 7.—DCIS ISSUED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2006 TRED—Continued
Case Name
Total No. of Products
---
7
Number of Product
Chemistry Studies
Required2
Number of Acute
Toxicology Studies
Required3
Number of Efficacy
Studies Required
---
Number of Products Covered by
the TRED1
Case No.
---
---
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.)
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 2006.
TABLE 8.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2006
Pesticide Reregistration List, per
FIFRA Section 4(c)(2)
Studies Reviewed + Extraneous1
List A
11,262 + 588 = 11,850 (87%)
1,788 (13%)
13,638
List B
6,585 + 1,041 = 7,626 (81%)
1,748 (19%)
9,374
List C
2,097 + 334 = 2,431 (84%)
463 (16%)
2,894
List D
1,266 + 133 = 1,399 (86%)
228 (14%)
1,627
Total Lists A - D
21,210 + 2,096 = 23,306
(84.65%)
4,227 (15.35%)
27,533 (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 2006, EPA completed
1,820 tolerance reassessments and
ended the fiscal year with a total of
9,637 tolerance reassessment decisions
to date, addressing over 99% 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 2006*
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Tolerances Reassessed
Through...
Late
FY 96
Reregistration/REDs
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25
FY
1997
339
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FY
1998
FY
1999
277
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2000
359
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FY
2001
44
FY
2002
46
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231
FY
2003
79
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2004
87
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FY
2005
413
FY
2006
1,037
Total,
End of
FY
2006
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TABLE 9.—TOLERANCE REASSESSMENTS COMPLETED POST-FQPA BY FISCAL YEAR, THROUGH FY 2006*—Continued
Tolerances Reassessed
Through...
Late
FY 96
FY
1997
FY
1998
FY
1999
FY
2000
FY
2001
FY
2002
FY
2003
FY
2004
FY
2005
Total,
End of
FY
2006
FY
2006
Tolerance Reassessments/TREDs
0
0
0
0
0
0
776
14
119
69
306
1,284
Registration
0
224
308
340
55
216
200
0
71
0
1
1,415
Tolerance revocations
3
0
812
513
22
35
545
0
172
75
185
2,362
Other decisions including inerts
0
1
0
233
0
0
905
26
18
165
291
1,639
Total tolerances reassessed
28
564
1,397
1,445
121
297
2,657
119
467
722
1,820
9.637
*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
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 the OPs, triazines, and
chloroacetanilides (groups with
completed cumulative risk assessments)
and for pesticides that are not part of a
cumulative group may be counted at
present and are included in the FY 2006
accomplishments.Tolerance
reassessments for pesticides that are
part of the N-methyl carbamate
cumulative group are not included in
the Agency’s lists of accomplishments.
The reassessment of these 84 tolerances
will be completed after EPA completes
a cumulative risk evaluation for the
group in FY 2007.
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 1,639
additional tolerance reassessment
decisions have been made. Some have
been made for inert ingredient tolerance
exemptions through actions not directly
related to registration or reregistration.
2. Accomplishments for priority
pesticides. During FY 2006, EPA
completed tolerance reassessment
decisions for many high priority
pesticides in review, including OPs,
carbamates, and carcinogens (See Table
10).
TABLE 10.—TOLERANCE REASSESSMENTS COMPLETED FOR PRIORITY PESTICIDES
Pesticide Class
Tolerances to be Reassessed
Reassessed by End of FY 2006
545
461 (84.6%)
Carcinogens
2,008
2,008 (100%)
Inert ingredient tolerance exemptions
844
844 (100%)
Organochlorines
253
253 (100%)
Organophosphates (OPs)
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1,691
1,691 (100%)
Other
4,380
4,380 (100%)
Total
9,721
9,637 (99.1%)
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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, and
completed an OP Cumulative Risk
Assessment; 2006 Update in August
2006, available on EPA’s website
athttps://www.epa.gov/pesticides/
cumulative.
EPA completed IREDs and REDs for
the three remaining individual OP
pesticides (DDVP, dimethoate, and
malathion) in FY 2006.With the
mitigation measures identified for the
individual OP pesticides in the
pertinent IREDs completed during the
past several years, EPA determined that
the cumulative risks associated with the
OPs do not exceed the FFDCA safety
standard. The individual OP pesticides
are indeed eligible for reregistration
provided that they met the interim
reregistration eligibility criteria of the
pertinent IREDs.
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 2006, EPA considered
and approved the numbers of
applications for registration requiring
expedited processing (also known as
‘‘fast track’’ applications) shown in
Table 11.
TABLE 11.—FAST TRACK
APPLICATIONS APPROVED IN FY 2006
308
Amendments/Fast track
3,332
Total applications processed by
fast track means
jlentini on PROD1PC65 with NOTICES
Me-too product registrations/Fast
track
3,640
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
VerDate Aug<31>2005
16:26 Aug 21, 2007
Jkt 211001
Agency, but none were formally
‘‘disapproved’’ during FY 2006.
On a financial accounting basis, EPA
devoted 26.8 full-time equivalents
(FTEs) in FY 2006 to reviewing and
processing applications for fast track
me-too product registrations and label
amendments. The Agency spent
approximately $3.35 million in FY 2006
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 the remaining
7 REDs for pesticides with food uses in
FY 2007, as well as 18 of the remaining
non-food use REDs. The remaining
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 athttps://www.epa.gov/
pesticides/reregistration/
decision_schedule.htm.
1. RED and IRED Schedule for FY
2007. List 1 contains pesticides
scheduled for Reregistration Eligibility
Decisions (REDs) and Interim REDs
(IREDs) in FY 2007.
List 1.—FY 2007 RED and IRED
Schedule
2,4 DP
Aldicarb (N-methyl carbamate IRED
and RED)
Aliphatic alcohols
Aliphatic esters
Alkyl trimethylenediamines
Allethrin stereoisomers
4-Aminopyridine
Antimycin A
Benzoic acid
Bioban-p-1487
Bromonitrostyrene
Chlorflurenol
Dikegulac sodium
Ethylene oxide (ETO) (TRED
completed in FY 2006)
Glutaraldehyde
MCPP
Mefluidide
Naphthenate salts
Octhilinone
Rotenone (TRED completed in FY
2006)
Trimethoxysilyl quats
The following N-methyl carbamate
IREDs will become REDs when EPA
completes the cumulative risk
assessment for this common mechanism
group.
Carbaryl
Carbofuran
Formetanate HCl
Oxamyl
List 2.—FY 2008 REDs Schedule
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
47007
Acrolein
Amical 48
Busan 77
Chloropicrin
Chromated arsenicals (CCA)
Coal tar/creosote
Dazomet
Flumetralin
Formaldehyde
Grotan
Inorganic thiosulfates (ammonium
and calcium thiosulfate)
Methyl bromide (soil fumigant uses
RED; commodity uses TRED & RED
completed FY 2006)
Methyldithiocarbamate salts (metam
sodium/metam potassium)
MITC
Naphthalene
Nicotine
Organic esters of phosphoric acid
p-Dichlorobenzene
Pentachlorophenol
Polypropylene glycol
Prometon
Siduron
Sodium fluoride
Sulfometuron methyl
Sumithrin
TBT-containing compounds
Tetramethrin
Triforine
Triclosan (Ingasan)
H. Projected Year of Completion of
Reregistrations
EPA expects to complete seven
remaining reregistration eligibility
decisions for N-methyl carbamate
pesticides and others with food uses in
FY 2007, and to complete decisions for
the remaining 47 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: August 15, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
[FR Doc. E7–16560 Filed 8–21–07; 8:45 am]
BILLING CODE 6560–50–S
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 72, Number 162 (Wednesday, August 22, 2007)]
[Notices]
[Pages 46996-47007]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16560]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-1005; FRL-8149-5]
Pesticide Reregistration Performance Measures and Goals
AGENCY: Environmental Protection Agency (EPA).
[[Page 46997]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal year 2006. 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. This notice also contains the schedule for
completion of activities for specific chemicals during fiscal years
2007 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-2006-1005], should be received on or before October 22, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-1005, 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-
2006-1005. 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 website 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 athttps://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 athttps://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
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
[[Page 46998]]
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) (which provides for 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 required the reassessment of all existing
tolerances (pesticide residue limits in food) and tolerance exemptions
within 10 years, to ensure that they met the safety standard of the
law. EPA was directed to give priority to the review of those
pesticides that appeared 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 substantially met the third,
completing over 99% of all required tolerance reassessment decisions by
August 3, 2006. These decisions represent significant enhancements in
public health and environmental protection. By successfully
implementing FQPA, EPA is ensuring that all pesticides used on food in
the United States meet the law's new, more stringent safety standard.
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 Agency's accomplishments under FQPA during the past 10
years are discussed athttps://www.epa.gov/pesticides/regulating/laws/
fqpa/fqpa_accomplishments.htm.
The Pesticide Registration Improvement Act (PRIA) of 2003 became
effective on March 23, 2004. Among other things, PRIA directed 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. The Agency completed 99% of
the REDs due by August 3, 2006, and plans to complete all remaining
REDs by October 3, 2008. EPA's schedule for meeting these deadlines is
available on the Agency's website athttps://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) 2006 (from October 1, 2005, through
September 30, 2006), EPA made significant progress in completing risk
assessments and risk management decisions for pesticide reregistration
(See Table 1).
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).
[[Page 46999]]
Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2006
and FY 1991 through FY 2006
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2006 Decisions 2006
------------------------------------------------------------------------
59 FY 2006 REDs 330 REDs
(37 REDs + 22 OP IREDs became REDs).......
ADBAC.....................................
Aliphatic alkyl quarternaries (DDAC)......
Aliphatic solvents........................
Alkyl benzene sulfonates..................
Atrazine (2003 IRED became a RED, 4-6-06).
Cacodylic acid............................
Chlorine dioxide..........................
Copper and oxides.........................
Copper compounds II.......................
Copper salts..............................
Copper sulfate............................
Cypermethrin..............................
Dicamba...................................
Dichloran (DCNA)..........................
Imazapyr..................................
Inorganic chlorates (sodium chlorate).....
Inorganic sulfites........................
Iodine....................................
Malathion (OP RED)........................
MCPB......................................
Metaldehyde...............................
Methanearsonic acid, salts (DSMA, MSMA,
CAMA).
MGK-264...................................
Mineral bases, weak (sodium carbonate)....
PCNB......................................
Permethrin................................
2-Phenylphenol and salts..................
Phytophthora palmivora....................
Piperonyl butoxide........................
Propiconazole.............................
Propylene oxide...........................
Pyrethrins................................
Resmethrin................................
Salicylic acid............................
Simazine (triazine RED)...................
TCMTB.....................................
Triadimefon...............................
22 OP IREDs became REDs on 7-31-06
Acephate..................................
Azinphos-methyl...........................
Bensulide.................................
Chlorpyrifos..............................
Diazinon..................................
Dichlorvos or DDVP........................
Dicrotophos...............................
Dimethoate................................
Disulfoton................................
Ethoprop..................................
Methamidophos.............................
Methidathion..............................
Methyl Parathion..........................
Naled.....................................
Oxydemeton-methyl (ODM)...................
Phorate...................................
Phosmet...................................
Pirimiphos-methyl.........................
Profenofos................................
Propetamphos..............................
Terbufos..................................
Tribufos (DEF)............................
------------------------------------------------------------------------
4 IREDs 4 IREDs
Carbofuran (N-methyl carbamate)...........
Dichlorvos (DDVP) (OP IRED, became a RED
on 7-31-06).
Dimethoate (OP IRED, became a RED on 7-31-
06).
Formetanate HCl (N-methyl carbamate)......
------------------------------------------------------------------------
[[Page 47000]]
19 TREDs 95 TREDs
Acetochlor................................
Amitraz...................................
Azadirachitin.............................
Bitertanol................................
Boric acid group..........................
CP enolpyruvylshikimate-3-phosphate.......
Ethephon..................................
Ethylene oxide (ETO) (RED in FY 2007).....
Inert ingredients of semichemical
dispensers.
Imazaquin.................................
Methyl bromide (commodity uses RED & TRED
in FY 2006; soil fumigant uses RED in FY
2007).
Neomycinphosphotransferase II.............
Oxytetracycline...........................
Propazine.................................
Rotenone (RED in FY 2007).................
Sodium Cyanide............................
Streptomycin..............................
Triadimenol...............................
Tridemorph................................
------------------------------------------------------------------------
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
2006 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 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
REDs completed 330 (54%)
------------------------------------------------------------------------
Cases canceled 229 (37%)
------------------------------------------------------------------------
REDs to be completed 54 (9%)
------------------------------------------------------------------------
Total reregistration cases 613 (100%)
------------------------------------------------------------------------
ii. Profile of completed REDs. A profile of the REDs completed by
the end of FY 2006 is presented in Table 3.
Table 3.--Profile of 330 REDs Completed, FY 1991 through FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
Pesticide active ingredients 527
------------------------------------------------------------------------
Pesticide products over 20,000
------------------------------------------------------------------------
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 groups, 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 risks from food, drinking water, residential,
occupational, and/or ecological exposure while the cumulative risk
assessment is pending. For example, EPA generally did not consider
individual organophosphate (OP) pesticide decisions made in advance of
the cumulative risk assessment to be completed REDs or tolerance
reassessments. Instead, the Agency issued IREDs for these chemicals.
EPA completed the risk assessments and reregistration eligibility
decisions for those OP pesticides with IREDs, once the Agency completed
the OP cumulative risk assessment on July 31, 2006.See https://
www.epa.gov/pesticides/cumulative/.
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;
[[Page 47001]]
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 does 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 2006, EPA completed 19 TREDs. By August 3, 2006, EPA also
completed tolerance assessment decisions for food use pesticide inert
ingredients that are exempted from the tolerance requirement. Almost
900 of the 9,721 tolerance reassessment decisions required by the
amended FFDCA were for such inert ingredient tolerance exemptions.
As a result of the FQPA, food-contact surface sanitizing solutions
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 180.940. In addition to
reassessing the 9,721 tolerances and exemptions for food and feed
commodities, EPA also was required to 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
completed the reassessment of 120 tolerance exemptions in FY 2006,
resulting in a total of 174 tolerance exemptions reassessed for the
food-contact surface sanitizing solutions.
4. Goals for FY 2007 and future years. EPA's major pesticide
reregistration and tolerance reassessment goals for FY 2007 and future
years are as follows.
i. Complete individual pesticide risk management decisions. EPA's
goal in conducting the reregistration program is to complete 6
remaining Reregistration Eligibility Decisions (REDs) and Interim REDs
(IREDs) for pesticides with food uses and 19 REDs for pesticides with
no food uses during FY 2007. The Agency plans to complete the remaining
29 non-food use REDs in FY 2008. EPA's schedule for completing these
decisions appears near the end of this document, and also is available
on the Agency's website at https://www.epa.gov/pesticides/
reregistration/decision_schedule.htm.
ii. Complete tolerance reassessment decisions. EPA completed over
99% of all required tolerance reassessment decisions by August 3, 2006,
the 10-year anniversary of FQPA. EPA expects to complete the N-methyl
carbamate cumulative risk assessment and the Agency's final 84
tolerance reassessment decisions, thereby completing theFQPA tolerance
reassessment program.
iii. Evaluate cumulative risks. EPA completed cumulative risk
assessments for the organophosphate (OP), triazine, and
chloroacetanilide pesticides during FY 2006. Once EPA completes an
individual decision for aldicarb, the Agency will make a cumulative
risk finding for the N-methyl carbamate common mechanism group of
pesticides. No other groups are scheduled at present for cumulative
risk assessments. For further information, see EPA's Assessing
Pesticide Cumulative Risk web page,http//www.epa.gov/pesticides/
cumulative/index.htm.
B. Product Reregistration; Numbers of Products Reregistered, Canceled,
and Amended
At the end of the reregistration process, after EPA has issued a
RED and declared a pesticide reregistration case eligible for
reregistration, individual end-use products that contain pesticide
active ingredients included in the case still must be reregistered.
This concluding part of the reregistration process is called ``product
reregistration.''
In issuing a completed RED document, EPA 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 2006. 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 2006, EPA completed the
product reregistration actions detailed in Table 4.
Table 4.--Product Reregistration Actions Completed during FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
Product reregistration actions 169
------------------------------------------------------------------------
Product amendment actions 40
------------------------------------------------------------------------
Product cancellation actions 297
------------------------------------------------------------------------
Product suspension actions 0
------------------------------------------------------------------------
Total actions 506
------------------------------------------------------------------------
2. Status of the product reregistration universe. The status of the
universe of pesticide products subject to reregistration at the end of
FY 2006 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 2006 (as of September 30, 2006)
------------------------------------------------------------------------
------------------------------------------------------------------------
Products reregistered 2,063
------------------------------------------------------------------------
Products amended 554
------------------------------------------------------------------------
[[Page 47002]]
Products canceled 4,672
------------------------------------------------------------------------
Products sent for suspension 30
------------------------------------------------------------------------
Total products with actions completed 7,319
------------------------------------------------------------------------
Products with actions pending 12,932
------------------------------------------------------------------------
Total products in product reregistration 20,251
universe
------------------------------------------------------------------------
The universe of 20,251 products in product reregistration at the
end of FY 2006 represented an increase of 8,638 products from the FY
2005 universe of 11,613 products. The increase consists of 8,613
products associated with FY 2006 REDs, IREDs, and 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 2006, 12,932 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, but they are associated with more
recently completed REDs. Their product-specific data are not yet due to
be submitted to or reviewed by the Agency. EPA's goal is to complete
545 product reregistration actions during fiscal year 2007.
C. Number and Type of DCIs to Support Product Reregistration by Active
Ingredient
1. DCIs for REDs and IREDs. 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 2006 REDs and IREDs are shown in Table 6.
Table 6.--DCIs Issued to Support Product Reregistration for FY 2006 REDs and IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case No. Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the RED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
ADBAC 0350 1,047 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Alkyl Quarternaries 3003 382 PDCI has not been Antimicrobial RED - PDCI has not been
(DDAC) completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Solvents 3004 158 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alkylbenzene Sulfonates 4006 20 0 Antimicrobial RED - 5
Acute toxicity
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cacodylic Acid 2080 36 31 See footnote 4 below 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorine Dioxide 4023 95 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Compounds II 0649 173 31 Needs batching 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper and Oxides 4025 237 PDCI has not been Acute toxicity PDCI has not been
completed yet batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Salts 4026 38 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Sulfate 0636 127 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cypermethrin 2130 69 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47003]]
Dicamba 0065 448 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dichloran (DCNA) 0113 25 31 54 (1 batch/8 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dichlorvos (DDVP) 0310 100 31 258 (20 batches/23 PDCI has not been
not batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dimethoate 0088 54 31 96 (7 batches/9 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formetantate HCL (IRED) 0091 6 31 36 (6 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Imazapyr 3078 19 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Chlorates (Sodium 4049 58 31 156 (9 batches/17 not PDCI has not been
Chlorate) batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Sulfites 4056 9 31 Acute toxicity 1
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Iodine and Iodophor Complexes 3080 67 0 126 (12 batches/9 not 9
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Malathion 0248 153 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
MCPB and Salts 2365 5 31 24 (1 batch/3 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaldehyde 0576 52 31 102 (7 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methanearsonic acid, salts (Organic 2395 129 See footnote 4 below See footnote 4 below See footnote 4 below
Arsenicals) (MSMA/DSMA/CAMA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methyl Bromide (RED/TRED) 0335 14 31 Not Applicable 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
MGK 264 2430 653 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mineral Bases, Weak (Sodium 4066 4 PDCI has not been Antimicrobial RED - PDCI has not been
Carbonate) completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-Phenylphenol and Salts 2575 118 PDCI has not been 450 (22 batches/53 PDCI has not been
(Orthophenyl Phenol) completed yet not batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
PCNB 0128 82 31 270 (14 batches/31 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47004]]
Permethrin 2510 957 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Piperonyl Butoxide (PBO) 2525 1,451 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propiconazole 3125 172 31 264 (14 batches/30 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propylene Oxide (PPO) 2560 3 31 18 (3 not batched) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyrethrins 2580 1,286 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Resmethrin 0421 232 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Simazine 0070 44 31 84 (8 batches/6 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
TCMTB 2625 27 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triadimefon 2700 56 31 102 (7 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products --- 8,606 --- --- ---
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.)
4Ineligible for reregistration; public comments under consideration. Depending on the Agency's formal response to the public comments, PDCIs may or may
not be required for these chemicals.
2. DCIs for TREDs. There are cases in which 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 product-specific DCIs for the following
TRED:
Table 7.--DCIs Issued to Support Product Reregistration for FY 2006 TRED
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case No. Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the TRED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triadimenol NA 7 31 42 (7 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47005]]
Total No. of Products --- 7 --- --- ---
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.)
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 2006.
Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2006
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration List, per Studies Reviewed +
FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A 11,262 + 588 = 11,850 1,788 (13%) 13,638
(87%)
----------------------------------------------------------------------------------------------------------------
List B 6,585 + 1,041 = 7,626 1,748 (19%) 9,374
(81%)
----------------------------------------------------------------------------------------------------------------
List C 2,097 + 334 = 2,431 463 (16%) 2,894
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,266 + 133 = 1,399 228 (14%) 1,627
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A - D 21,210 + 2,096 = 23,306 4,227 (15.35%) 27,533 (100%)
(84.65%)
----------------------------------------------------------------------------------------------------------------
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 2006, EPA completed 1,820 tolerance reassessments and
ended the fiscal year with a total of 9,637 tolerance reassessment
decisions to date, addressing over 99% 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 2006*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total,
Tolerances Reassessed Through... Late FY FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 End of
96 FY 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 277 359 44 46 231 79 87 413 1,037 2,937
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47006]]
Tolerance Reassessments/TREDs 0 0 0 0 0 0 776 14 119 69 306 1,284
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration 0 224 308 340 55 216 200 0 71 0 1 1,415
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 35 545 0 172 75 185 2,362
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions including inerts 0 1 0 233 0 0 905 26 18 165 291 1,639
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 119 467 722 1,820 9.637
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA is using the reregistration program to
a
