[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Notices]
[Page 22541-22547]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my09-50]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0897; FRL-8397-6]
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 2008. 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, Data Call-Ins issued,
and products registered under the ``fast-track'' provisions of FIFRA.
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-2008-0897, should be received on or before July 13,
2009.
ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2008-0897, 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-
2008-0897. 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 athttp://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; 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
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
[[Page 22542]]
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 (4)(k)(3) (which provides for expedited processing and
review of certain 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 authorized 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 could 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 the last of 9,721 required tolerance reassessment
decisions in September 2007, 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 decisions for the last of 613 reregistration pesticide cases
in September 2008, meeting the PRIA deadline. REDs are available on the
Agency's Pesticide Reregistration Status Web page, http://www.epa.gov/
pesticides/reregistration/status.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 program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2008 (from October 1, 2007, through
September 30, 2008), EPA completed risk assessments and risk management
decisions for the last 27 of 613 pesticide cases that were subject to
reregistration. The Agency's decisions are embodied in RED documents
(see Table 1).
Table 1--Reregistration/Risk Management Decisions Completed: In FY 2008
and FY 1991 through FY 2008
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2008 Decisions 2008
------------------------------------------------------------------------
27 FY 2008 REDs: 384 REDS
Acrolein
Busan 77
Chloropicrin
Chromated arsenicals (CCA)
Creosote/Coal tar
Dazomet
Diiodomethyl p-tolyl sulfone (Amical 48)
Ethylene oxide (ETO)
Formaldehyde
HHT (Grotan)
Inorganic thiosulfates (ammonium
thiosulfate)
Methyl bromide (soil fumigant uses RED;
commodity uses TRED & RED completed FY
2006)
Methyl isothiocyanate (MITC)
Methyldithiocarbamate salts (metam sodium/
metam potassium)
Naphthalene
Nicotine (cancellation)
Organic esters of phosphoric acid
Pentachlorophenol
d-Phenothrin (Sumithrin)
Prometon
Siduron
Sodium fluoride
Sulfometuron methyl
TBT-containing compounds
[[Page 22543]]
Tetramethrin
Triclosan (Irgasan)
Triforine
------------------------------------------------------------------------
Through the reregistration program, EPA reviewed current scientific
data for older pesticides (those initially registered before November
1984), reassessed their effects on human health and the environment,
and required risk mitigation measures as necessary. Pesticides that had
sufficient supporting data and whose risks could be successfully
mitigated were declared ``eligible'' for reregistration.
1. Overall RED progress. In FY 2008, EPA completed the last of 613
required reregistration eligibility decisions (see Table 2).
Table 2--Overall RED Progress, FY 1991 through FY 2008
------------------------------------------------------------------------
------------------------------------------------------------------------
REDs completed 384 (63%)
------------------------------------------------------------------------
Cases canceled 229 (37%)
------------------------------------------------------------------------
REDs to be completed 0 (0%)
------------------------------------------------------------------------
Total reregistration cases 613 (100%)
------------------------------------------------------------------------
2. Risk reduction in REDs. Through the reregistration program, EPA
has reduced risks associated with the use of older pesticides. In
developing REDs, EPA worked 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 were extensive and
included 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.
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 could not be fully reregistered until
the last active ingredient in its formulation was 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 2007. 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 voluntarily canceled. During FY 2007, EPA completed the
product reregistration actions detailed in Table 3.
TABLE 3--Product Reregistration Actions Completed in FY 2007
------------------------------------------------------------------------
FY
Actions FY 2007 2008
-------------------------------------------------------------------- ------
Product reregistration actions 538
------------------------------------------------------------------------
Product amendment actions 70
------------------------------------------------------------------------
Product cancellation actions 370
------------------------------------------------------------------------
Product suspension actions 0
------------------------------------------------------------------------
Total actions 978
------------------------------------------------------------------------
2. Status of the product reregistration universe for FY 2007. EPA
also keeps track of the status of the universe of 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 the fiscal year. This
overall status information is not ``cumulative''--it is not derived
from summing up a series of annual actions. Adding annual actions would
result in a larger overall number since each individual product is
subject to multiple actions--it can be amended, reregistered, and/or
canceled, over time. Instead, the ``big picture'' status information in
Table 4 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 fluxuate.
TABLE 4--Status of the Universe of Products Subject to Product
Reregistration, for FY 2007 (As of September 30, 2007)
------------------------------------------------------------------------
------------------------------------------------------------------------
Products reregistered 2,602
------------------------------------------------------------------------
Products amended 631
------------------------------------------------------------------------
Products canceled 5,046
------------------------------------------------------------------------
Products sent for suspension 6
------------------------------------------------------------------------
Total products with actions completed 8,285
------------------------------------------------------------------------
Products with actions pending 13,066
------------------------------------------------------------------------
[[Page 22544]]
Total products in product reregistration 21,351
universe
------------------------------------------------------------------------
The universe of products in product reregistration at the end of FY
2007 represented an increase of 1,100 products from the FY 2006
universe of 20,251 products. The increase consists of 1,099 products
associated with FY 2007 REDs, and one product that was added as a
result of DCI activities and processing for previously issued REDs.
At the end of FY 2007, 13,066 products had product reregistration
decisions pending. Some pending products awaited science reviews, label
reviews, or reregistration decisions by EPA. Others were not yet ready
for product reregistration actions, but were associated with more
recently completed REDs. Their product-specific data were not yet due
to be submitted to or reviewed by the Agency.
3. Product reregistration actions and universe in FY 2008.In
response to 2009 findings 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 product reregistration
actions completed in FY 2008 and will make any needed corrections. OPP
expects to complete this review by December 31, 2009. In next year's
Performance Measures and Goals Federal Register notice reporting on
actions completed in FY 2009, the Agency plans to provide numbers of
product reregistration actions completed in FY 2008 and in FY 2009.
4. Product reregistration goal in FY 2009. EPA's goal is to
complete 1,275 product reregistration actions during FY 2009.
Additional information is available on EPA's Product Reregistration Web
page, http://www.epa.gov/pesticides/reregistration/product-
reregistration.htm.
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 intends to issue under FIFRA section 3(c)(2)(B) to
support product reregistration for pesticide active ingredients
included in FY 2008 REDs are shown in Table 5.
Table 5--DCIs to Support Product Reregistration for FY 2008 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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Acrolein 2005 8 31 6 (1 batch) 0
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Busan 77 3034 149 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Chloropicrin 0040 74 31 Not Applicable\4\ 0
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Chromated Arsenicals (CCA) 0132 21 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Creosote/Coal Tar 0139 14 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
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Dazomet 2135 22 31 42 (2 batches/5 0
products not
batched)
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Diiodomethyl-p-tolyl sulfone 4009 9 31 Antimicrobial RED-- PDCI has not been
(Amical 48) Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethylene Oxide 2275 26 31 Not Applicable\4\ 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formaldehyde 0556 9 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
HHT (Grotan) 3074 17 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Thiosulfates (Ammonium 4057 1 31 6 (1 product not 0
Thiosulfate) batched)
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Methyl Bromide (soil fumigant uses) 0335 73 31 Not Applicable\4\ 2
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[[Page 22545]]
Methyl Isothiocyanate (MITC) 2405 2 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methyldithiocarbamate Salts (Metam 2390 55 31 66 (6 batches/5 0
Sodium/Metam Potassium) products not
batched)
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Naphthalene 0022 9 31 12 (1 batch/1 product 0
not batched)
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Nicotine (Cancellation) 2460 1 Not Applicable Not Applicable\5\ Not Applicable
--------------------------------------------------------------------------------------------------------------------------------------------------------
Organic Esters of Phosphoric Acid 4122 2 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pentachlorophenol 2505 6 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
d-Phenothrin (Sumithrin) 0426 195 31 Acute toxicity PDCI has not been
batching has not completed
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prometon 2545 52 31 90 (10 batches/5 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Siduron 3130 19 31 54 (3 batches/6 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sodium Fluoride 3132 7 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfometuron Methyl 3136 28 31 84 (7 batches/7 0
products not
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
TBT-Containing Compounds 2620 29 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tetramethrin 2660 292 31 276 (17 batches/29 6
products not
batched) \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triclosan (Irgasan) 2340 20 31 Antimicrobial RED-- PDCI has not been
Acute toxicity completed
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triforine 2720 3 31 Acute toxicity 0
batching has not
been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,143
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 current 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.
[[Page 22546]]
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, 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 inertingredients (e.g., identity, percent composition, and bioIogica~l 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.)
4Acute toxicity data are not required for the chloropicrin, ethylene oxide, and methyl bromide PDCIs; these chemicals are highly toxic and toxicity
categories are already established for all products.
5The Nicotine RED is a cancellation; therefore, neither a PDCI nor acute toxicity data are required.
6A majority of the tetramethrin products also contain MGK-264, PBO, and pyrethrins as active ingredients. These products were included in the acute
toxicity batching for the MGK-264, PBO, and Pyrethrins REDs, issued in FY 2006. The registrants of these products would either submit or cite acute
toxicity data according to the acute toxicity batchings in those REDs. If the acute toxicity data are acceptable, the data will support the product
for all of the active ingredients (MGK-264, PBO, pyrethrins and tetramethrin). Therefore, only 138 products that contain tetramethrin as an active
ingredient are included in the acute toxicity batching for FY 2008.
D. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
EPA made progress during FY 2008 in reducing the number of studies
still categorized as ``unreviewed'' that were submitted by registrants
in support of pesticides undergoing reregistration. During 2008, the
Agency reduced by 5% the number of studies for List A pesticides
categorized as unreviewed, and reduced by almost 3% the number of such
studies for all pesticides. The Agency is exploring options for further
categorizing reregistration studies more precisely (see Table 6).
Table 6--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2008
----------------------------------------------------------------------------------------------------------------
Studies Reviewed
Pesticide Reregistration List, per (including cited1) + Studies Awaiting Review Total Studies Received
FIFRA Section 4(c)(2) Extraneous2
----------------------------------------------------------------------------------------------------------------
List A 12,095 reviewed 1,071 (8%) 13,829
(includes 779 cited) +
663 extraneous =
12,758 (92%)
----------------------------------------------------------------------------------------------------------------
List B 6,748 reviewed 1,738 (18%) 9,567
(includes 88 cited) +
1,081 extraneous =
7,829 (82%)
----------------------------------------------------------------------------------------------------------------
List C 2,131 reviewed 461 (16%) 2,943
(includes 29 cited) +
351 extraneous = 2,482
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,280 reviewed 228 (14%) 1,644
(includes 3 cited) +
136 extraneous = 1,416
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A - D 22,254 reviewed 3,498 (12.5%) 27,983 (100%)
(includes 899 cited) +
2,231 extraneous =
24,485 (87.5%)
----------------------------------------------------------------------------------------------------------------
1Cited studies is a term used to classify those studies that are referenced in REDs, RED bibliographies, or
related science support documents.
2Extraneous 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. 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 (me too products); amendments to current
product registrations that do not require review of scientific data;
and products for public health pesticide uses. During FY 2008, EPA
considered and approved the numbers of applications for registration
requiring expedited processing (also known as ``fast track''
applications) shown in Table 7.
Table 7--Fast Track Applications Approved in FY 2008
------------------------------------------------------------------------
------------------------------------------------------------------------
Me-too product registrations/Fast track 411
------------------------------------------------------------------------
Amendments/Fast track 2,557
------------------------------------------------------------------------
Total applications processed by fast track 2,968
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 2008.
On a financial accounting basis, EPA devoted 25.6 full-time
equivalents (FTEs) in FY 2008 to reviewing and processing applications
for fast track me-too product registrations and label amendments. The
Agency spent approximately $3.3 million in FY 2008 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.
F. Projected Year of Completion of Reregistrations
EPA completed the 27 remaining reregistration eligibility decisions
in FY 2008. Product reregistration, which takes place only after the
reregistration eligibility decisions have been
[[Page 22547]]
completed for the active ingredients, will not likely be completed
before 2014.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: May 1, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E9-10758 Filed 5-12-09; 8:45 am]
BILLING CODE 6560-50-S