[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11456-11460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4649]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0909; FRL-8859-4]
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 years 2009 and 2010. 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 the total
numbers of products reregistered and products registered under the
``fast-track'' provisions of FIFRA.
[[Page 11457]]
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-2009-0909, should be received on or before May 2,
2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0909, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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-OPP-
2009-0909. EPA's policy is that all comments received will be included
in the 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 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Pesticide Re-
evaluation Division (7509P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (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 or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
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(1). 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 of 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 section 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.
[[Page 11458]]
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 or 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 (Pub. L. 108-199, Div. G, Title V, Sec.
501, 118 Stat. 419). Among other things, PRIA amended FIFRA section
4(g)(2) to require EPA to complete Reregistration Eligibility Decisions
(REDs) for pesticides with food uses/tolerances by August 3, 2006, and
to complete all non-food use 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 each of the past 2
years in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
EPA had no remaining reregistration eligibility decisions to
complete in FY 2009 or FY 2010; the last decisions for 613
reregistration cases were completed in FY 2008.
During FY 2009 and FY 2010, the Agency focused on completing
product reregistration decisions.
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, 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 2008, FY 2009, and FY 2010.
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. As a result of 2009 findings
by EPA's Office of the Inspector General from the annual FIFRA
Financial Statements Audit, EPA's Office of Pesticide Programs has
reviewed product reregistration actions completed in FY 2008. Final
numbers of FY 2008 product reregistration actions as well as FY 2009
and FY 2010 actions are presented in Table 1.
Table 1--Product Reregistration Actions Completed in FY 2008, FY 2009, and FY 2010
[As of September 30, 2010]
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Actions FY 2008 FY 2009 FY 2010
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Product reregistration actions.................................. 697 603 484
Product amendment actions....................................... 205 292 40
Product cancellation actions.................................... 309 869 1,188
[[Page 11459]]
Product suspension actions...................................... 3 5 6
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Total actions............................................... 1,214 1,769 1,718
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2. Status of the product reregistration universe for FY 2008, FY
2009, and FY 2010. 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 2 should be considered a snapshot
in time. As registrants and EPA make marketing and regulatory decisions
in the future, the status of individual products may change, and
numbers in this table are expected to fluctuate.
Table 2--Status of the Universe of Products Subject to Product Reregistration, for FY 2008, FY 2009, and FY 2010
[As of September 30, 2010]
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Status FY 2008 FY 2009 FY 2010
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Products reregistered........................................... 3,282 3,885 4,369
Products amended................................................ 847 1,139 1,179
Products canceled............................................... 5,355 6,224 7,412
Products sent for suspension.................................... 9 14 20
Total products with actions completed........................... 9,493 11,262 12,980
Products with actions pending................................... 12,746 10,860 9,059
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Total products in product reregistration universe........... 22,239 22,122 22,039
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At the end of FY 2010, 9,059 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.
The universe of products in product reregistration has increased in
some years and decreased in other years. Generally, an increase
resulted from products associated with the most recently completed
REDs, while a decrease was due to fluctuations in numbers of products
associated with product-specific DCIs (PDCIs).
During FY 2010, EPA refined the number and status of products in
the product reregistration universe, and the Agency will use the
revised numbers in reporting on the status of the universe starting in
FY 2011. By identifying and including products that were canceled
between the time when REDs were signed and product-specific DCIs were
issued, the Agency has been able to more precisely define the universe
of products that are subject to product reregistration. This will
enable the Agency to more accurately track the status of products
undergoing product reregistration, describe progress in meeting program
goals, and carry out plans to complete remaining product reregistration
decisions during the next few years.
3. Product reregistration goal in FY 2011. EPA's goal is to
complete 1,500 product reregistration actions during FY 2011.
Additional information is available on EPA's Product Reregistration web
page, http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.
C. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
EPA completed the last REDs in 2008, so all necessary studies to
make reregistration eligibility decisions for all active ingredients
subject to reregistration have been reviewed. Some of the Agency's
records, however, still incorrectly depicted a number of reregistration
studies as ``in review.'' From August 2008 to August 2010, the Agency
conducted an internal examination and clean-up of these records in
order to more precisely categorize reregistration studies still
depicted as ``in review.'' As shown in Table 3, as a result of this
clean-up effort, the Agency succeeded in determining that most
reregistration studies (26,019 or more than 94% of the 27,645 studies
received) have been reviewed or found to be extraneous. Only 5.9%
(1,626) of these studies are still depicted in our data base as ``in
review.'' EPA believes the remaining studies to be duplicative,
unnecessary, or already reviewed, because the Agency has completed REDs
for all pesticides subject to reregistration and no registrant has
objected that the Agency failed to consider a submitted study. At this
time, the Agency does not plan to spend further resources examining
these records.
[[Page 11460]]
Table 3--Review Status of Studies Submitted for Pesticide Reregistration
[As of July 2010]
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Studies reviewed
Pesticide reregistration list, per FIFRA section (including cited Studies still ``in Total studies
4(c)(2) or extraneous) review'' received
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List A.............................................. 12,960 (95%) 714 (5%) 13,674
List B.............................................. 8,789 (93%) 650 (7%) 9,439
List C.............................................. 2,800 (97%) 95 (3%) 2,895
List D.............................................. 1,470 (90%) 167 (10%) 1,637
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Total Lists A--D................................ 26,019 (94.1%) 1,626 (5.9%) 27,645 (100%)
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D. 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 2009 and FY
2010, EPA considered and approved the numbers of applications for
registration requiring expedited processing (also known as ``fast
track'' applications) shown in Table 4.
Table 4--Fast Track Applications Approved in FY 2009 and 2010
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FY 2009 FY 2010
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Me-too product registrations/ 372 260
Fast track.....................
Amendments/Fast track........... 2,653 3,391
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Total applications processed 3,025 3,651
by fast track means........
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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 ``denied'' during FY 2009 or FY 2010.
On a financial accounting basis, EPA devoted 17.8 full-time
equivalents (FTEs) in FY 2009 and 16.6 FTEs in FY 2010 to reviewing and
processing applications for fast track me-too product registrations and
label amendments. The Agency spent approximately $2.4 million in FY
2009 and $2.35 million in FY 2010 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 last reregistration eligibility decisions in FY
2008. Product reregistration will not likely be completed before 2014.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: February 24, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-4649 Filed 3-1-11; 8:45 am]
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