[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Notices]
[Pages 51472-51478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20236]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1072; FRL-8346-4]
Pesticide Reregistration Performance Measures and Goals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal year 2007. 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 year
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 identification (ID)
number [EPA-HQ-OPP-2007-1072], should be received on or before November
3, 2008.
ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2007-1072, by one of the following methods:
Federal eRulemaking Portal: http://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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-1072. 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 http://www.regulations.gov/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The 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 regulations.gov,
your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket are listed in the index.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either in the electronic
docket at http://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;
[[Page 51473]]
telephone: (703) 308-8007; e-mail: [email protected].
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
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 reregistration, tolerance
reassessment, and expedited registration, under section 4(l) of FIFRA,
7 U.S.C. 136a-1(l). 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 FIFRA 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 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. 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, among other requirements, perform a 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.
Possible endocrine or estrogenic effects.
The 1996 FFDCA amendments also 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.
The Agency completed over 99% of the required tolerance reassessment
decisions by August 3, 2006, and upon concluding the N-methyl carbamate
cumulative risk assessment, completed all 9,721 tolerance reassessment
decisions in September 2007. These decisions represent significant
enhancements in public health and environmental protection. By
successfully implementing this provision of FFDCA, EPA is ensuring that
all pesticides used on food in the United States meet the law's safety
standard. EPA's approach to tolerance reassessment under FFDCA was
described fully in the Agency's document, ``Raw and Processed Food
Schedule for Pesticide Tolerance Reassessment'' (62 FR 42020, August 4,
1997) (FRL-5734-6).
The Pesticide Registration Improvement Act (PRIA) of 2003 became
effective on March 23, 2004 (7 U.S.C. 136w-8). 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 for pesticides with food uses 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 at http://www.epa.gov/pesticides/reregistration/decision_schedule.htm.
III. Program 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
[[Page 51474]]
program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2007 (from October 1, 2006, through
September 30, 2007), EPA made significant progress in completing risk
assessments and risk management decisions for pesticide reregistration.
The Agency's decisions are embodied in RED documents. (See Table 1).
Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2007
and FY 1991 through FY 2007
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2007 Decisions 2007
------------------------------------------------------------------------
27 FY 2007 REDs 357 REDS
Aldicarb..................................
Aliphatic alcohols, C6-C16................
Aliphatic esters..........................
Alkyl trimethylenediamines................
Allethrin stereoisomers...................
4-Aminopyridine...........................
Antimycin A...............................
Benzoic acid..............................
Bioban-p-1487.............................
Bromonitrostyrene (Voluntary cancellation)
Carbaryl..................................
Carbofuran (2006 IRED became a RED).......
Chlorflurenol.............................
2,4-DP-p (dichlorprop-p)..................
Dikegulac sodium..........................
Flumetralin...............................
Formetanate hydrochloride (2006 IRED
became a RED).
Glutaraldehyde............................
MCPP-p (mecoprop-p).......................
Mefluidide................................
Naphthenate salts.........................
Octhilinone...............................
Oxamyl (2000 IRED became a RED)...........
p-Dichlorobenzene (paradichlorobenzene)...
Polypropylene glycol......................
Rotenone..................................
Trimethoxysilyl quats.....................
------------------------------------------------------------------------
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.
Three of the FY 2007 REDs were for the N-methyl carbamate
pesticides carbofuran, formetanate hydrochloride, and oxamyl. EPA
completed Interim REDs for these pesticides in earlier years. With
completion of the N-methyl carbamate cumulative risk assessment in
September 2007, these last Interim REDs became final REDs. Additional
information is available on EPA's Assessing Pesticide Cumulative Risk
web page, http://www.epa.gov/pesticides/cumulative/.
1. Overall RED progress. EPA's overall progress at the end of FY
2007 in completing REDs for groups of related pesticide active
ingredients or cases is summarized in Table 2.
Table 2.--Overall RED Progress, FY 1991 through FY 2007
------------------------------------------------------------------------
------------------------------------------------------------------------
REDs completed 357 (58%)
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Cases canceled 229 (37%)
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REDs to be completed 27 (5%)
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Total reregistration cases 613 (100%)
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2. 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 and Tribes, USDA
and other Federal agencies, and other entities to develop measures to
effectively reduce risks of concern. Almost every RED includes some
measures or modifications in how a pesticide can be legally used 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; requiring more protective clothing and
equipment; 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.
3. Goal for FY 2008. EPA's goal in conducting the reregistration
program is to complete the remaining 27 REDs during FY 2008. EPA's
schedule for completing these decisions appears in Unit III.G., and
also is available on the Agency's website at http://www.epa.gov/pesticides/reregistration/decision_schedule.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 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, 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 would first require the
registrant to amend the product's registration, incorporating the
labeling changes specified in the RED as interim measures. 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.
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, or the product may first be suspended
and later it may be
[[Page 51475]]
voluntarily canceled. EPA also keeps track of the status of the
universe of pesticide products subject to reregistration, that is, the
overall number of products reregistered, amended, canceled, and sent
for suspension, as well as the number of products with actions pending,
as of the end of each fiscal year.
In response to May 2008 draft findings and recommendations by EPA's
Office of the Inspector General resulting from the annual FIFRA
Financial Statements Audit, the EPA Office of Pesticide Programs (OPP)
is reviewing and strengthening its internal processes and controls for
handling and electronically managing information concerning product
reregistration actions and accomplishments. OPP expects to complete
this review by December 31, 2008. In next year's Performance Measures
and Goals Federal Register notice reporting on actions completed in FY
2008, the Agency plans to provide numbers of product reregistration
actions completed in FY 2007 and in FY 2008.
EPA's goal is to complete 1,000 product reregistration actions
during FY 2008.
C. Number and Type of DCIs to Support Product Reregistration by Active
Ingredient
The number and type of product-specific Data Call-In (PDCI)
requests that EPA is preparing to issue under FIFRA section 3(c)(2)(B)
to support product reregistration for pesticide active ingredients
included in FY 2007 REDs are shown in Table 3.
Table 3.--DCIs to Support Product Reregistration for FY 2007 REDs
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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
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Aldicarb 0140 39 31 12 (2 batches) 0
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Aliphatic Alcohols, C6-C16 4004 22 31 54 (5 batches/4 0
products not
batched)
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Aliphatic Esters 4005 1 31 6 (1 product not 0
batched)
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Alkyl Trimethylenediames 3014 13 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Allethrin Stereoisomers 0437 251 31 Acute toxicity 0
batching has not
been completed
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4-Aminopyridine 0015 10 31 PDCI and Acute PDCI has not been
toxicity batching completed
have not been
completed
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Antimycin-A 4121 1 31 6 (1 product not 0
batched)
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Benzoic Acid 4013 11 31 Acute toxicity 0
batching has not
been completed
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Bioban-p-1487 3028 5 34 Antimicrobial RED -- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Bromonitrostyrene (Voluntary 2065 6 NA NA NA
Cancellation)
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Carbaryl\4\ 0080 101 NA NA NA
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Carbofuran\4\ 0101 88 NA NA NA
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Chlorflurenol 2095 5 31 30 (5 products not 0
batched)
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Chlormequat Chloride 3003 4 31 24 (4 products not 0
batched)
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Copper-8-Quinolate 4026 28 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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[[Page 51476]]
2,4-DP-p (dichorprop-p) 0294 63 31 Acute toxicity 0
batching has not
been completed
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Dikegulac Sodium 3061 2 31 12 (2 products not 0
batched)
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Flumetralin 4119 6 31 Acute toxicity PDCI has not been
batching has not completed
been completed
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Formetanate HCl\4\ 0091 6 NA NA NA
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Glutaraldehyde 2315 59 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Mecoprop-p (MCPP-p) 0377 314 31 Acute toxicity 0
batching has not
been completed
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Mefluidide 2370 12 31 48 (2 batches/6 0
products not
batched)
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Naphthenate Salts 3099 49 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Octhilinone 2475 37 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Oxamyl\4\ 0253 12 NA NA NA
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Para-Dichlorbenzene 3058 28 31 Acute toxicity 0
batching has not
been completed
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Polypropylene Glycol 3123 53 31 PDCI and Acute PDCI has not been
(Butoxypolypropylene Glycol) toxicity batching completed
have not been
completed
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Rotenone 0255 50 31 Acute toxicity PDCI has not been
batching has not completed
been completed
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Trimethoxysilyl Quats 3148\5\ 30 34 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Total No. of Products --- 1,306 --- --- ---
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\1\ The 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 current number of products associated with each RED, as they are being tracked for product reregistration.
\2\ This column shows the number of product chemistry studies that are required for each product covered by the RED.
\3\ In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA batches products that can
be considered similar from an acute toxicity standpoint. For example, 1 batch could contain 5 products. In this instance, if 6 acute toxicology
studies usually were required per product, only 6 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 bioIogical 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.)
\4\ These 4 chemicals were addressed in IREDs issued in previous fiscal years. At that time, PDCIs were approved and/or issued for Carbaryl, Formetanate
HCl, and Oxamyl. A PDCI was not issued for Carbofuran because its products were declared ineligible for reregistration. These IREDs became REDs in
September 2007 when the N-Methyl Carbamate cumulative risk assessment was completed. Additional PDCIs will not be issued for these REDs.
[[Page 51477]]
\5\ Two additional active ingredients were significantly similar to Trimethoxysiyl Quats (Case 3148) and were included in the Trimethoxysiyl Quats case
before the RED was completed.
D. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
Although EPA made progress during FY 2007 in reviewing scientific
studies submitted by registrants in support of pesticides undergoing
reregistration, the percent of studies reviewed remained constant (See
Table 4). The Agency is considering options for categorizing
reregistration studies more precisely.
Table 4.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2007
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration List, per Studies Reviewed +
FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A 11,283 + 603 = 11,886 1,788 (13%) 13,674
(87%)
----------------------------------------------------------------------------------------------------------------
List B 6,630 + 1,061 = 7,691 1,748 (18.5%) 9,439
(81.5%)
----------------------------------------------------------------------------------------------------------------
List C 2,098 + 334 = 2,432 463 (16%) 2,895
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,275 + 134 = 1,409 228 (14%) 1,637
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A - D 21,286 + 2,132 = 23,418 4,227 (15.3%) 27,645 (100%)
(84.7%)
----------------------------------------------------------------------------------------------------------------
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 2007, EPA completed 84 tolerance reassessment decisions
for the N-methyl carbamate pesticides. With these reassessments, the
Agency addressed 100% of the 9,721 tolerances that required
reassessment (See Table 5).
EPA's general schedule for tolerance reassessment (62 FR 42020,
August 4, 1997) identified three groups of pesticides to be reviewed;
this grouping reflected the Agency's overall scheduling priorities. In
completing tolerance reassessment, EPA gave priority to pesticides in
Group 1, the Agency's highest priority group for reassessment.
1. Aggregate accomplishments through reregistration and other
programs. EPA accomplished tolerance reassessment through pesticide
registration and reregistration; by revoking tolerances for pesticides
that have been canceled (many as a result of reregistration); by
reevaluating pesticides with REDs issued prior to August 1996; and
through other decisions not directly related to registration or
reregistration, described further below. EPA used the Tolerance
Reassessment Tracking System (TORTS) to compile this updated
information and report on the status of tolerance reassessment (See
Table 5).
Table 5.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2007\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total,
Late FY FY FY FY FY FY FY FY FY FY FY End of
Tolerances Reassessed Through... FY 96 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 FY
2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 277 359 44 46 231 79 84 413 1,037 84 3,018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance Reassessments/TREDs 0 0 0 0 0 0 776 15 119 69 305 0 1,284
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration 0 224 308 340 55 216 200 0 69 0 1 0 1,413
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 35 545 0 174 112 185 0 2,401
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions including inerts 0 1 0 233 0 0 905 26 21 128 291 0 1,605
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 120 467 722 1,819 84 9,721
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA used the reregistration program to
accomplish much of tolerance reassessment. For each of the tolerance
reassessment decisions made through REDs since August 1996, 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 remained the same while others were raised, lowered, or
revoked.
ii. Tolerance reassessments/TREDs. Tolerances initially evaluated
through REDs that were completed before August 1996 were reassessed to
ensure that they met the new FFDCA safety standard. EPA issued these
post-RED tolerance reassessment decisions as TREDs. The Agency also
issued TREDs summarizing tolerance reassessment decisions for some REDs
under development, for new pesticide active ingredients not subject to
reregistration,
[[Page 51478]]
and for pesticides with import tolerances only.
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. When EPA has canceled use on a
particular crop or commodity of all products containing a pesticide
active ingredient, the Agency ordinarily will revoke the tolerance,
unless a party provides data to support it as an import tolerance. Some
pesticides were canceled due to the Agency's risk concerns. Others were
canceled voluntarily by their manufacturers, based on economic
decisions not to support 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 1,605 additional
tolerance reassessment decisions were made. Some were made for inert
ingredient tolerance exemptions through actions not directly related to
registration or reregistration.
2. Accomplishments for priority pesticides. During FY 2007, EPA
completed the remaining 84 tolerance reassessment decisions for the
high priority N-methyl carbamate pesticides. This completes the
reassessment of priority pesticides.
F. Applications for Registration Requiring Expedited Processing;
Numbers Approved and Disapproved
By law, EPA must expedite its processing of certain types of
applications for pesticide product registration, i.e., applications for
end-use products that would be identical or substantially similar to a
currently registered product; amendments to current product
registrations that do not require review of scientific data; and
products for public health pesticide uses. During FY 2007, EPA
considered and approved the numbers of applications for registration
requiring expedited processing (also known as ``fast track''
applications) shown in Table 6.
Table 6.--Fast Track Applications Approved in FY 2007
------------------------------------------------------------------------
------------------------------------------------------------------------
Me-too product registrations/Fast track 394
------------------------------------------------------------------------
Amendments/Fast track 3,441
------------------------------------------------------------------------
Total applications processed by fast track 3,835
means
------------------------------------------------------------------------
For those applications not approved, the Agency generally notifies
the registrant of any deficiencies in the application that need to be
corrected or addressed before the application can be approved.
Applications may have been withdrawn after discussions with the Agency,
but none were formally ``disapproved'' during FY 2007.
On a financial accounting basis, EPA devoted 25.4 full-time
equivalents (FTEs) in FY 2007 to reviewing and processing applications
for fast track me-too product registrations and label amendments. The
Agency spent approximately $3.15 million in FY 2007 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 27 REDs in FY 2008, meeting the
October 3, 2008 PRIA deadline. The Agency's schedule for completing
these decisions is as follows. This schedule also is available on EPA's
website at http://www.epa.gov/pesticides/reregistration/decision_schedule.htm.
List 1.--FY 2008 REDs Schedule
Acrolein
Busan 77
Chloropicrin
Chromated arsenicals (CCA)
Coal tar/creosote
Dazomet
Diiodomethyl p-tolyl sulfone (Amical 48)
Ethylene oxide (ETO) (TRED completed in FY 2006)
Formaldehyde
Grotan
Inorganic thiosulfates (ammonium thiosulfate)
Methyl bromide (soil fumigant uses; commodity uses TRED & RED
completed FY 2006)
Methyldithiocarbamate salts (metam sodium/metam potassium)
MITC (methyl isothiocyanate)
Naphthalene
Nicotine
Organic esters of phosphoric acid
Pentachlorophenol
Prometon
Siduron
Sodium fluoride
Sulfometuron methyl
Sumithrin
Tetramethrin
Tributyltin-containing compounds
Triclosan (Irgasan)
Triforine
H. Projected Year of Completion of Reregistrations
EPA expects to complete 27 remaining reregistration eligibility
decisions in FY 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 2014.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: August 22, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-20236 Filed 9-2-08; 8:45 am]
BILLING CODE 6560-50-S