Pesticide Reregistration Performance Measures and Goals, 51472-51478 [E8-20236]
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[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)] [Notices] [Pages 51472-51478] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: E8-20236] ----------------------------------------------------------------------- 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: https://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 https://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 https://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 https://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 https://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, https://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 https://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 https://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
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