Document ID: EPA-HQ-OPP-2007-1072-0001
Agency: epa
Document Type: Notice
Title: Pesticide Reregistration Performance Measures and Goals
Posted Date: 2008-09-03T04:00Z

[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Notices]               
[Page 51472-51478]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-67]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1072; FRL-8346-4]

 
Pesticide Reregistration Performance Measures and Goals

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

SUMMARY:  This notice announces EPA's progress in meeting its 
performance measures and goals for pesticide reregistration during 
fiscal year 2007. The Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) requires EPA to publish information about EPA's annual 
achievements in this area. This notice discusses the integration of 
tolerance reassessment with the reregistration process, and describes 
the status of various regulatory activities associated with 
reregistration and tolerance reassessment. The notice gives total 
numbers of chemicals and products reregistered, tolerances reassessed, 
Data Call-Ins issued, and products registered under the ``fast-track'' 
provisions of FIFRA. This notice also contains the schedule for 
completion of activities for specific chemicals during fiscal year 
2008.

DATES:  This notice is not subject to a formal comment period. 
Nevertheless, EPA welcomes input from stakeholders and the general 
public. Written comments, identified by the docket identification (ID) 
number [EPA-HQ-OPP-2007-1072], should be received on or before November 
3, 2008.

ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2007-1072, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-1072. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at http://www.regulations.gov/, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be captured automatically and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/docket.htm/.
    Docket: All documents in the docket are listed in the index. 
Although listed in the index, some information is not publicly 
available, i.e., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours 
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Carol P. Stangel, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460;

[[Page 51473]]

telephone: (703) 308-8007; e-mail: 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, obscene language, or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline.

II. Background

    EPA must establish and publish in the Federal Register its annual 
performance measures and goals for pesticide reregistration, tolerance 
reassessment, and expedited registration, under section 4(l) of FIFRA, 
7 U.S.C. 136a-1(l). Specifically, such measures and goals are to 
include:
     The status of reregistration.
     The number of products reregistered, canceled, or amended.
     The number and type of data requests or Data Call-In (DCI) 
notices under FIFRA section 3(c)(2)(B) issued to support product 
reregistration by active ingredient.
     Progress in reducing the number of unreviewed, required 
reregistration studies.
     The aggregate status of tolerances reassessed.
     The number of applications for registration submitted 
under subsection (k)(3) (which provides for expedited processing and 
review of similar applications), that were approved or disapproved.
     The future schedule for reregistrations in the current and 
succeeding fiscal year.
     The projected year of completion of the reregistrations 
under section 4.
    FIFRA authorizes EPA to conduct a comprehensive pesticide 
reregistration program--a complete review of the human health and 
environmental effects of older pesticides originally registered before 
November 1, 1984. Pesticides meeting today's scientific and regulatory 
standards may be declared ``eligible'' for reregistration. To be 
eligible, an older pesticide must have a substantially complete data 
base, and must not cause unreasonable adverse effects to human health 
or the environment when used according to Agency approved label 
directions and precautions.
    In addition, all pesticides with food uses must meet the safety 
standard of section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) 21 U.S.C. 346a. Under FFDCA, EPA must make a determination that 
pesticide residues remaining in or on food are ``safe''; that is, 
``that there is reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue'' from dietary and 
other sources. In determining allowable levels of pesticide residues in 
food, EPA must, among other requirements, perform a comprehensive 
assessment of each pesticide's risks, considering:
     Aggregate exposure (from food, drinking water, and 
residential uses).
     Cumulative effects from all pesticides sharing a common 
mechanism of toxicity.
     Possible increased susceptibility of infants and children.
     Possible endocrine or estrogenic effects.
    The 1996 FFDCA amendments also required the reassessment of all 
existing tolerances (pesticide residue limits in food) and tolerance 
exemptions within 10 years, to ensure that they met the safety standard 
of the law. EPA was directed to give priority to the review of those 
pesticides that appeared to pose the greatest risk to public health. 
The Agency completed over 99% of the required tolerance reassessment 
decisions by August 3, 2006, and upon concluding the N-methyl carbamate 
cumulative risk assessment, completed all 9,721 tolerance reassessment 
decisions in September 2007. These decisions represent significant 
enhancements in public health and environmental protection. By 
successfully implementing this provision of FFDCA, EPA is ensuring that 
all pesticides used on food in the United States meet the law's safety 
standard. EPA's approach to tolerance reassessment under FFDCA was 
described fully in the Agency's document, ``Raw and Processed Food 
Schedule for Pesticide Tolerance Reassessment'' (62 FR 42020, August 4, 
1997) (FRL-5734-6).
    The Pesticide Registration Improvement Act (PRIA) of 2003 became 
effective on March 23, 2004 (7 U.S.C. 136w-8). Among other things, PRIA 
directed EPA to complete Reregistration Eligibility Decisions (REDs) 
for pesticides with food uses/tolerances by August 3, 2006, and to 
complete all non-food use pesticide REDs by October 3, 2008. The Agency 
completed 99% of the REDs for pesticides with food uses due by August 
3, 2006, and plans to complete all remaining REDs by October 3, 2008. 
EPA's schedule for meeting these deadlines is available on the Agency's 
website at http://www.epa.gov/pesticides/reregistration/decision_
schedule.htm.

III. Program Accountability

    Through this summary of performance measures and goals for 
pesticide reregistration, tolerance reassessment, and expedited 
registration, EPA describes progress made during the past year in each 
of the

[[Page 51474]]

program areas included in FIFRA section 4(l).

A. Status of Reregistration

    During fiscal year (FY) 2007 (from October 1, 2006, through 
September 30, 2007), EPA made significant progress in completing risk 
assessments and risk management decisions for pesticide reregistration. 
The Agency's decisions are embodied in RED documents. (See Table 1).

Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2007
                       and FY 1991 through FY 2007
------------------------------------------------------------------------
                                              Total, FY 1991 through FY
             FY 2007 Decisions                          2007
------------------------------------------------------------------------
27 FY 2007 REDs                             357 REDS
Aldicarb..................................
Aliphatic alcohols, C6-C16................
Aliphatic esters..........................
Alkyl trimethylenediamines................
Allethrin stereoisomers...................
4-Aminopyridine...........................
Antimycin A...............................
Benzoic acid..............................
Bioban-p-1487.............................
Bromonitrostyrene (Voluntary cancellation)
Carbaryl..................................
Carbofuran (2006 IRED became a RED).......
Chlorflurenol.............................
2,4-DP-p (dichlorprop-p)..................
Dikegulac sodium..........................
Flumetralin...............................
Formetanate hydrochloride (2006 IRED
 became a RED).
Glutaraldehyde............................
MCPP-p (mecoprop-p).......................
Mefluidide................................
Naphthenate salts.........................
Octhilinone...............................
Oxamyl (2000 IRED became a RED)...........
p-Dichlorobenzene (paradichlorobenzene)...
Polypropylene glycol......................
Rotenone..................................
Trimethoxysilyl quats.....................
------------------------------------------------------------------------

    Through the reregistration program, EPA is reviewing current 
scientific data for older pesticides (those initially registered before 
November 1984), reassessing their effects on human health and the 
environment, and requiring risk mitigation measures as necessary. 
Pesticides that have sufficient supporting data and whose risks can be 
successfully mitigated may be declared ``eligible'' for reregistration. 
EPA presents these pesticide findings in a RED document.
    Three of the FY 2007 REDs were for the N-methyl carbamate 
pesticides carbofuran, formetanate hydrochloride, and oxamyl. EPA 
completed Interim REDs for these pesticides in earlier years. With 
completion of the N-methyl carbamate cumulative risk assessment in 
September 2007, these last Interim REDs became final REDs. Additional 
information is available on EPA's Assessing Pesticide Cumulative Risk 
web page, http://www.epa.gov/pesticides/cumulative/.
    1. Overall RED progress. EPA's overall progress at the end of FY 
2007 in completing REDs for groups of related pesticide active 
ingredients or cases is summarized in Table 2.

         Table 2.--Overall RED Progress, FY 1991 through FY 2007
------------------------------------------------------------------------

------------------------------------------------------------------------
REDs completed                              357 (58%)
------------------------------------------------------------------------
Cases canceled                              229 (37%)
------------------------------------------------------------------------
REDs to be completed                        27 (5%)
------------------------------------------------------------------------
Total reregistration cases                  613 (100%)
------------------------------------------------------------------------

    2. Risk reduction in REDs. Through the reregistration program, EPA 
seeks to reduce risks associated with the use of older pesticides. In 
developing REDs, EPA works with stakeholders including pesticide 
registrants, growers and other pesticide users, and environmental and 
public health interests groups, as well as the States and Tribes, USDA 
and other Federal agencies, and other entities to develop measures to 
effectively reduce risks of concern. Almost every RED includes some 
measures or modifications in how a pesticide can be legally used to 
reduce risks. The options for such risk reduction are extensive and 
include voluntary cancellation of pesticide products or deletion of 
uses; declaring certain uses ineligible or not yet eligible (and then 
proceeding with follow-up action to cancel the uses or require 
additional supporting data); restricting use of products to certified 
applicators; limiting the amount or frequency of use; improving use 
directions and precautions; requiring more protective clothing and 
equipment; requiring special packaging or engineering controls; 
requiring no-treatment buffer zones; employing ground water, surface 
water, or other environmental and ecological safeguards; and other 
measures.
    3. Goal for FY 2008. EPA's goal in conducting the reregistration 
program is to complete the remaining 27 REDs during FY 2008. EPA's 
schedule for completing these decisions appears in Unit III.G., and 
also is available on the Agency's website at http://www.epa.gov/
pesticides/reregistration/decision_schedule.htm.

B. Product Reregistration; Numbers of Products Reregistered, Canceled, 
and Amended

    At the end of the reregistration process, after EPA has issued a 
RED and declared a pesticide reregistration case eligible for 
reregistration, individual end-use products that contain pesticide 
active ingredients included in the case still must be reregistered. 
This concluding part of the reregistration process is called ``product 
reregistration.''
    In issuing a completed RED document, EPA sends registrants a DCI 
notice requesting any product-specific data and specific revised 
labeling needed to complete reregistration for each of the individual 
pesticide products covered by the RED. Based on the results of EPA's 
review of these data and labeling, products found to meet FIFRA and 
FFDCA standards may be reregistered.
    A variety of outcomes are possible for pesticide products 
completing this final phase of the reregistration process. Ideally, in 
response to the DCI notice, the pesticide producer, or registrant, will 
submit the required product-specific data and revised labeling, which 
EPA will review and find acceptable. At that point, the Agency may 
reregister the pesticide product. If, however, the product contains 
multiple active ingredients, the Agency instead would first require the 
registrant to amend the product's registration, incorporating the 
labeling changes specified in the RED as interim measures. A product 
with multiple active ingredients may not be fully reregistered until 
the last active ingredient in its formulation is eligible for 
reregistration. In other situations, the Agency may temporarily suspend 
a product's registration if the registrant has not submitted required 
product-specific studies within the time frame specified. The Agency 
may cancel a product's registration because the registrant did not pay 
the required registration maintenance fee. Alternatively, the 
registrant may request a voluntary cancellation of their end-use 
product registration.
    EPA counts each of the post-RED product outcomes described above as 
a product reregistration action. A single pesticide product may be the 
subject of several product reregistration actions within the same year. 
For example, a product's registration initially may be amended, then 
the product may be reregistered, or the product may first be suspended 
and later it may be

[[Page 51475]]

voluntarily canceled. EPA also keeps track of the status of the 
universe of pesticide products subject to reregistration, that is, the 
overall number of products reregistered, amended, canceled, and sent 
for suspension, as well as the number of products with actions pending, 
as of the end of each fiscal year.
    In response to May 2008 draft findings and recommendations by EPA's 
Office of the Inspector General resulting from the annual FIFRA 
Financial Statements Audit, the EPA Office of Pesticide Programs (OPP) 
is reviewing and strengthening its internal processes and controls for 
handling and electronically managing information concerning product 
reregistration actions and accomplishments. OPP expects to complete 
this review by December 31, 2008. In next year's Performance Measures 
and Goals Federal Register notice reporting on actions completed in FY 
2008, the Agency plans to provide numbers of product reregistration 
actions completed in FY 2007 and in FY 2008.
    EPA's goal is to complete 1,000 product reregistration actions 
during FY 2008.

C. Number and Type of DCIs to Support Product Reregistration by Active 
Ingredient

    The number and type of product-specific Data Call-In (PDCI) 
requests that EPA is preparing to issue under FIFRA section 3(c)(2)(B) 
to support product reregistration for pesticide active ingredients 
included in FY 2007 REDs are shown in Table 3.

                                            Table 3.--DCIs to Support Product Reregistration for FY 2007 REDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aldicarb                             0140                    39                      31                     12 (2 batches)         0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Alcohols, C6-C16           4004                    22                      31                     54 (5 batches/4        0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Esters                     4005                    1                       31                     6 (1 product not       0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alkyl Trimethylenediames             3014                    13                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allethrin Stereoisomers              0437                    251                     31                     Acute toxicity         0
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-Aminopyridine                      0015                    10                      31                     PDCI and Acute         PDCI has not been
                                                                                                             toxicity batching      completed
                                                                                                             have not been
                                                                                                             completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimycin-A                          4121                    1                       31                     6 (1 product not       0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benzoic Acid                         4013                    11                      31                     Acute toxicity         0
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioban-p-1487                        3028                    5                       34                     Antimicrobial RED --   PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bromonitrostyrene (Voluntary         2065                    6                       NA                     NA                     NA
 Cancellation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbaryl\4\                          0080                    101                     NA                     NA                     NA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbofuran\4\                        0101                    88                      NA                     NA                     NA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorflurenol                        2095                    5                       31                     30 (5 products not     0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlormequat Chloride                 3003                    4                       31                     24 (4 products not     0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper-8-Quinolate                   4026                    28                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 51476]]

2,4-DP-p (dichorprop-p)              0294                    63                      31                     Acute toxicity         0
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dikegulac Sodium                     3061                    2                       31                     12 (2 products not     0
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Flumetralin                          4119                    6                       31                     Acute toxicity         PDCI has not been
                                                                                                             batching has not       completed
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formetanate HCl\4\                   0091                    6                       NA                     NA                     NA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glutaraldehyde                       2315                    59                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mecoprop-p (MCPP-p)                  0377                    314                     31                     Acute toxicity         0
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mefluidide                           2370                    12                      31                     48 (2 batches/6        0
                                                                                                             products not
                                                                                                             batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naphthenate Salts                    3099                    49                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Octhilinone                          2475                    37                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oxamyl\4\                            0253                    12                      NA                     NA                     NA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Para-Dichlorbenzene                  3058                    28                      31                     Acute toxicity         0
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Polypropylene Glycol                 3123                    53                      31                     PDCI and Acute         PDCI has not been
 (Butoxypolypropylene Glycol)                                                                                toxicity batching      completed
                                                                                                             have not been
                                                                                                             completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rotenone                             0255                    50                      31                     Acute toxicity         PDCI has not been
                                                                                                             batching has not       completed
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Trimethoxysilyl Quats                3148\5\                 30                      34                     Antimicrobial RED--    PDCI has not been
                                                                                                             Acute toxicity         completed
                                                                                                             batching has not
                                                                                                             been completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products                 ---                    1,306                    ---                    ---                    ---
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the RED document
  (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when the
  RED is issued). This table reflects the current number of products associated with each RED, as they are being tracked for product reregistration.
\2\ This column shows the number of product chemistry studies that are required for each product covered by the RED.
\3\ In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA batches products that can
  be considered similar from an acute toxicity standpoint. For example, 1 batch could contain 5 products. In this instance, if 6 acute toxicology
  studies usually were required per product, only 6 studies (rather than 30 studies) would be required for the entire batch. Factors considered in the
  sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and bioIogical activity), type of
  formulation (e.g., emulsifiable concentrate, aerosol wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary
  labeling). The Agency does not describe batched products as substantially similar, because all products within a batch may not be considered
  chemically similar or have identical use patterns. (Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the acute
  toxicity batchings because they are supported by a valid parent product (section 3) registration.)
\4\ These 4 chemicals were addressed in IREDs issued in previous fiscal years. At that time, PDCIs were approved and/or issued for Carbaryl, Formetanate
  HCl, and Oxamyl. A PDCI was not issued for Carbofuran because its products were declared ineligible for reregistration. These IREDs became REDs in
  September 2007 when the N-Methyl Carbamate cumulative risk assessment was completed. Additional PDCIs will not be issued for these REDs.

[[Page 51477]]

\5\ Two additional active ingredients were significantly similar to Trimethoxysiyl Quats (Case 3148) and were included in the Trimethoxysiyl Quats case
  before the RED was completed.

D. Progress in Reducing the Number of Unreviewed, Required 
Reregistration Studies

    Although EPA made progress during FY 2007 in reviewing scientific 
studies submitted by registrants in support of pesticides undergoing 
reregistration, the percent of studies reviewed remained constant (See 
Table 4). The Agency is considering options for categorizing 
reregistration studies more precisely.

            Table 4.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2007
----------------------------------------------------------------------------------------------------------------
  Pesticide Reregistration List, per      Studies Reviewed +
        FIFRA Section 4(c)(2)                Extraneous1        Studies Awaiting Review   Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A                                 11,283 + 603 = 11,886    1,788 (13%)              13,674
                                        (87%)
----------------------------------------------------------------------------------------------------------------
List B                                 6,630 + 1,061 = 7,691    1,748 (18.5%)            9,439
                                        (81.5%)
----------------------------------------------------------------------------------------------------------------
List C                                 2,098 + 334 = 2,432      463 (16%)                2,895
                                        (84%)
----------------------------------------------------------------------------------------------------------------
List D                                 1,275 + 134 = 1,409      228 (14%)                1,637
                                        (86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A - D                      21,286 + 2,132 = 23,418  4,227 (15.3%)            27,645 (100%)
                                        (84.7%)
----------------------------------------------------------------------------------------------------------------
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data
  requirement has been satisfied by other studies or has changed.

E. Aggregate Status of Tolerances Reassessed

    During FY 2007, EPA completed 84 tolerance reassessment decisions 
for the N-methyl carbamate pesticides. With these reassessments, the 
Agency addressed 100% of the 9,721 tolerances that required 
reassessment (See Table 5).
    EPA's general schedule for tolerance reassessment (62 FR 42020, 
August 4, 1997) identified three groups of pesticides to be reviewed; 
this grouping reflected the Agency's overall scheduling priorities. In 
completing tolerance reassessment, EPA gave priority to pesticides in 
Group 1, the Agency's highest priority group for reassessment.
    1. Aggregate accomplishments through reregistration and other 
programs. EPA accomplished tolerance reassessment through pesticide 
registration and reregistration; by revoking tolerances for pesticides 
that have been canceled (many as a result of reregistration); by 
reevaluating pesticides with REDs issued prior to August 1996; and 
through other decisions not directly related to registration or 
reregistration, described further below. EPA used the Tolerance 
Reassessment Tracking System (TORTS) to compile this updated 
information and report on the status of tolerance reassessment (See 
Table 5).

                                Table 5.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2007\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                  Total,
                                                   Late     FY      FY      FY      FY      FY      FY      FY      FY      FY      FY      FY    End of
        Tolerances Reassessed Through...           FY 96   1997    1998    1999    2000    2001    2002    2003    2004    2005    2006    2007     FY
                                                                                                                                                   2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs                                   25     339     277     359      44      46     231      79      84     413   1,037      84   3,018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance Reassessments/TREDs                          0       0       0       0       0       0     776      15     119      69     305       0   1,284
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration                                           0     224     308     340      55     216     200       0      69       0       1       0   1,413
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations                                  3       0     812     513      22      35     545       0     174     112     185       0   2,401
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions including inerts                       0       1       0     233       0       0     905      26      21     128     291       0   1,605
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed                           28     564   1,397   1,445     121     297   2,657     120     467     722   1,819      84  9,721
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Includes corrected counts for some previous years.

    i. Reregistration/REDs. EPA used the reregistration program to 
accomplish much of tolerance reassessment. For each of the tolerance 
reassessment decisions made through REDs since August 1996, the Agency 
has made the finding as to whether there is a reasonable certainty of 
no harm, as required by FFDCA. Many tolerances reassessed through 
reregistration remained the same while others were raised, lowered, or 
revoked.
    ii. Tolerance reassessments/TREDs. Tolerances initially evaluated 
through REDs that were completed before August 1996 were reassessed to 
ensure that they met the new FFDCA safety standard. EPA issued these 
post-RED tolerance reassessment decisions as TREDs. The Agency also 
issued TREDs summarizing tolerance reassessment decisions for some REDs 
under development, for new pesticide active ingredients not subject to 
reregistration,

[[Page 51478]]

and for pesticides with import tolerances only.
    iii. Registration. Like older pesticides, all new pesticide 
registrations must meet the safety standard of FFDCA. Many of the 
registration applications EPA receives are for new uses of pesticides 
already registered for other uses. To reach a decision on a proposed 
new food use of an already registered pesticide, EPA must reassess the 
aggregate risk of the the existing tolerances, as well as the proposed 
new tolerances, to make sure there is reasonable certainty that no harm 
will result to the public from aggregate exposure from all uses.
    iv. Tolerance revocations. When EPA has canceled use on a 
particular crop or commodity of all products containing a pesticide 
active ingredient, the Agency ordinarily will revoke the tolerance, 
unless a party provides data to support it as an import tolerance. Some 
pesticides were canceled due to the Agency's risk concerns. Others were 
canceled voluntarily by their manufacturers, based on economic 
decisions not to support reregistration. Tolerance revocations are 
important even if there are no domestic uses of a pesticide because 
residues in or on imported commodities treated with the chemical could 
still present dietary risks that may exceed the FFDCA ``reasonable 
certainty of no harm'' standard, either individually or cumulatively 
with other substances that share a common mechanism of toxicity.
    v. Other reassessment decisions. In addition to the types of 
reassessment actions described above, a total of 1,605 additional 
tolerance reassessment decisions were made. Some were made for inert 
ingredient tolerance exemptions through actions not directly related to 
registration or reregistration.
    2. Accomplishments for priority pesticides. During FY 2007, EPA 
completed the remaining 84 tolerance reassessment decisions for the 
high priority N-methyl carbamate pesticides. This completes the 
reassessment of priority pesticides.

F. Applications for Registration Requiring Expedited Processing; 
Numbers Approved and Disapproved

    By law, EPA must expedite its processing of certain types of 
applications for pesticide product registration, i.e., applications for 
end-use products that would be identical or substantially similar to a 
currently registered product; amendments to current product 
registrations that do not require review of scientific data; and 
products for public health pesticide uses. During FY 2007, EPA 
considered and approved the numbers of applications for registration 
requiring expedited processing (also known as ``fast track'' 
applications) shown in Table 6.

          Table 6.--Fast Track Applications Approved in FY 2007
------------------------------------------------------------------------

------------------------------------------------------------------------
Me-too product registrations/Fast track     394
------------------------------------------------------------------------
Amendments/Fast track                       3,441
------------------------------------------------------------------------
Total applications processed by fast track  3,835
 means
------------------------------------------------------------------------

    For those applications not approved, the Agency generally notifies 
the registrant of any deficiencies in the application that need to be 
corrected or addressed before the application can be approved. 
Applications may have been withdrawn after discussions with the Agency, 
but none were formally ``disapproved'' during FY 2007.
    On a financial accounting basis, EPA devoted 25.4 full-time 
equivalents (FTEs) in FY 2007 to reviewing and processing applications 
for fast track me-too product registrations and label amendments. The 
Agency spent approximately $3.15 million in FY 2007 in direct costs 
(i.e., time on task, not including administrative expenses, computer 
systems, management overhead, and other indirect costs) on expedited 
processing and reviews.

 G. Future Schedule for Reregistrations

    EPA plans to complete the remaining 27 REDs in FY 2008, meeting the 
October 3, 2008 PRIA deadline. The Agency's schedule for completing 
these decisions is as follows. This schedule also is available on EPA's 
website at http://www.epa.gov/pesticides/reregistration/decision_
schedule.htm.
List 1.--FY 2008 REDs Schedule
    Acrolein
    Busan 77
    Chloropicrin
    Chromated arsenicals (CCA)
    Coal tar/creosote
    Dazomet
    Diiodomethyl p-tolyl sulfone (Amical 48)
    Ethylene oxide (ETO) (TRED completed in FY 2006)
    Formaldehyde
    Grotan
    Inorganic thiosulfates (ammonium thiosulfate)
    Methyl bromide (soil fumigant uses; commodity uses TRED & RED 
completed FY 2006)
    Methyldithiocarbamate salts (metam sodium/metam potassium)
    MITC (methyl isothiocyanate)
    Naphthalene
    Nicotine
    Organic esters of phosphoric acid
    Pentachlorophenol
    Prometon
    Siduron
    Sodium fluoride
    Sulfometuron methyl
    Sumithrin
    Tetramethrin
    Tributyltin-containing compounds
    Triclosan (Irgasan)
    Triforine

H. Projected Year of Completion of Reregistrations

    EPA expects to complete 27 remaining reregistration eligibility 
decisions in FY 2008. Product reregistration, which takes place only 
after the reregistration eligibility decisions have been completed for 
the active ingredients, will not likely be completed before 2014.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 22, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-20236 Filed 9-2-08; 8:45 am]

BILLING CODE 6560-50-S