
[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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acrolein                             2005                    8                       31                     6 (1 batch)            0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Busan 77                             3034                    149                     31                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloropicrin                         0040                    74                      31                     Not Applicable\4\      0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chromated Arsenicals (CCA)           0132                    21                      31                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Creosote/Coal Tar                    0139                    14                      31                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dazomet                              2135                    22                      31                     42 (2 batches/5        0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methyl Bromide (soil fumigant uses)  0335                    73                      31                     Not Applicable\4\      2
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naphthalene                          0022                    9                       31                     12 (1 batch/1 product  0
                                                                                                             not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
