Document ID: EPA-HQ-OPP-2009-0909-0001
Agency: epa
Document Type: Notice
Title: Pesticide Reregistration Performance Measures and Goals
Posted Date: 2011-03-02T05:00Z

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11456-11460]
From the Federal Register Online via the Government Printing 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: 
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 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
                                                                 -----------------------------------------------
    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
                                                                 -----------------------------------------------
    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
                                                     -----------------------------------------------------------
    Total Lists A--D................................      26,019 (94.1%)        1,626 (5.9%)       27,645 (100%)
----------------------------------------------------------------------------------------------------------------

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
                                 ---------------------------------------
    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]
BILLING CODE 6560-50-P