73 FR 51472 E8-20236. Pesticide Reregistration Performance Measures and Goals  

  • 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.

    Table of Contents


    DATES: Back to Top

    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: Back to Top

    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.


    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.


    I. General Information Back to Top

    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 Back to Top

    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 Back to Top

    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) 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 Back to Top
    FY 2007 Decisions Total, FY 1991 through FY 2007
    27 FY 2007 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 357 REDS

    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 Back to Top
    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 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 Back to Top
    Case Name Case No. Number of Products Covered by the RED 1 Number of Product Chemistry Studies Required 2 Number of Acute Toxicology Studies Required 3 Number of Efficacy Studies Required
    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.
    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 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.)
    4These 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.
    5Two additional active ingredients were significantly similar to Trimethoxysiyl Quats (Case 3148) and were included in the Trimethoxysiyl Quats case before the RED was completed.
    Aldicarb 0140 39 31 12 (2 batches) 0
    Aliphatic Alcohols, C6-C16 4004 22 31 54 (5 batches/4 products not batched) 0
    Aliphatic Esters 4005 1 31 6 (1 product not batched) 0
    Alkyl Trimethylenediames 3014 13 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    Allethrin Stereoisomers 0437 251 31 Acute toxicity batching has not been completed 0
    4-Aminopyridine 0015 10 31 PDCI and Acute toxicity batching have not been completed PDCI has not been completed
    Antimycin-A 4121 1 31 6 (1 product not batched) 0
    Benzoic Acid 4013 11 31 Acute toxicity batching has not been completed 0
    Bioban-p-1487 3028 5 34 Antimicrobial RED -- Acute toxicity batching has not been completed PDCI has not been completed
    Bromonitrostyrene (Voluntary Cancellation) 2065 6 NA NA NA
    Carbaryl4 0080 101 NA NA NA
    Carbofuran4 0101 88 NA NA NA
    Chlorflurenol 2095 5 31 30 (5 products not batched) 0
    Chlormequat Chloride 3003 4 31 24 (4 products not batched) 0
    Copper-8-Quinolate 4026 28 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    2,4-DP-p (dichorprop-p) 0294 63 31 Acute toxicity batching has not been completed 0
    Dikegulac Sodium 3061 2 31 12 (2 products not batched) 0
    Flumetralin 4119 6 31 Acute toxicity batching has not been completed PDCI has not been completed
    Formetanate HCl4 0091 6 NA NA NA
    Glutaraldehyde 2315 59 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    Mecoprop-p (MCPP-p) 0377 314 31 Acute toxicity batching has not been completed 0
    Mefluidide 2370 12 31 48 (2 batches/6 products not batched) 0
    Naphthenate Salts 3099 49 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    Octhilinone 2475 37 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    Oxamyl4 0253 12 NA NA NA
    Para-Dichlorbenzene 3058 28 31 Acute toxicity batching has not been completed 0
    Polypropylene Glycol (Butoxypolypropylene Glycol) 3123 53 31 PDCI and Acute toxicity batching have not been completed PDCI has not been completed
    Rotenone 0255 50 31 Acute toxicity batching has not been completed PDCI has not been completed
    Trimethoxysilyl Quats 31485 30 34 Antimicrobial RED--Acute toxicity batching has not been completed PDCI has not been completed
    Total No. of Products --- 1,306 --- --- ---

    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 Back to Top
    Pesticide Reregistration List, per FIFRA Section 4(c)(2) Studies Reviewed + Extraneous 1 Studies Awaiting Review Total Studies Received
    1 Extraneous 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.
    List A 11,283 + 603 = 11,886 (87%) 1,788 (13%) 13,674
    List B 6,630 + 1,061 = 7,691 (81.5%) 1,748 (18.5%) 9,439
    List C 2,098 + 334 = 2,432 (84%) 463 (16%) 2,895
    List D 1,275 + 134 = 1,409 (86%) 228 (14%) 1,637
    Total Lists A - D 21,286 + 2,132 = 23,418 (84.7%) 4,227 (15.3%) 27,645 (100%)

    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 20071 Back to Top
    Tolerances Reassessed Through... Late FY 96 FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 Total, End of FY 2007
    1Includes corrected counts for some previous years.
    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

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

    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


    Busan 77


    Chromated arsenicals (CCA)

    Coal tar/creosote


    Diiodomethyl p-tolyl sulfone (Amical 48)

    Ethylene oxide (ETO) (TRED completed in FY 2006)



    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)



    Organic esters of phosphoric acid




    Sodium fluoride

    Sulfometuron methyl



    Tributyltin-containing compounds

    Triclosan (Irgasan)


    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 Back to Top

    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

Document Information

Comments Received:
Document Number:
Document Citation:
73 FR 51472
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.
51472-51478 (7 pages)