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Federal Register / Vol. 67, No. 178 / Friday, September 13, 2002 / Notices 58041

How the Proposals Are Reviewed and SUMMARY: This notice announces EPA’s B. How Can I Get Additional Ranked progress in meeting its performance Information or Copies of Support The Selection Committee reviews measures and goals for pesticide Documents? each proposal with the following reregistration during fiscal years 2000 1. Electronically. You may obtain criteria in mind. Each area has a and 2001. The Federal , electronic copies of this document and numerical value, with an opportunity Fungicide, and Rodenticide Act (FIFRA) various support documents from the for a narrative response. The points of requires EPA to publish information EPA Internet website, www.epa.gov. On each reviewer for each proposal are about EPA’s annual achievements in EPA’s home page, select ‘‘Laws and totaled, comments are added, then each this area. This notice discusses the Regulations,’’ and then look up the proposal is given an average. The integration of tolerance reassessment entry for this document under ‘‘Federal Committee meets to discuss each with the reregistration process, and Register—Environmental Documents.’’ proposal and review the results of describes the status of various You can also go directly to the Federal scoring. The proposals with the highest regulatory activities associated with Register listings at www.epa.gov/ ranking, up to the estimated amount of reregistration and tolerance fedrgstr. To access information about funding, are selected. Upon approval of reassessment. The notice gives total pesticide reregistration, go to the home management, formal applications are numbers of chemicals and products page for the Office of Pesticide Programs then requested from the selected reregistered, tolerances reassessed, Data at www.epa.gov/pesticides and select applicants. Call-Ins issued, and products registered ‘‘Reregistration’’ under ‘‘Topics,’’ at the Proposal Evaluation Criteria under the ‘‘fast-track’’ provisions of top of the screen, or go directly to www.epa.gov/pesticides/reregistration/. • 1. Does the project meet one or FIFRA. Finally, this notice contains the schedule for completion of activities for 2. In person. The official record for more of the Regional priorities? If not, this notice, as well as the public specific chemicals during fiscal years has the applicant justified the need for version, has been established under the project? 2002 and 2003. • docket ID number [OPP–2002–0121] 2. Does the project have DATES: This notice is not subject to a (including comments and data transferability to other State/Tribes/ formal comment period. Nevertheless, submitted electronically as described Local governments? • EPA welcomes input from stakeholders below). A public version of this record, 3. Did applicant follow proposal including printed, paper versions of any guidelines? Did it address all and the general public. Written comments, identified by the docket ID electronic comments, which does not components? include any information claimed as • 4. What is the applicant’s past number [OPP–2002–0121], should be Confidential Business Information (CBI), performance, if applicable? received on or before November 12, • 5. Is the budget reasonable and 2002. is available for inspection in Room 119, appropriate? Crystal Mall #2, 1921 Jefferson Davis • 6. What are the potential ADDRESSES: Comments may be Highway, Arlington, VA, from 8:30 a.m. environmental results? Does it result in submitted by mail, electronically, or in to 4 p.m., Monday through Friday, physical, natural restoration? Are the person. Please follow the detailed excluding legal holidays. The Public environmental results immediate or instructions for each method as Information and Records Integrity long term? How many acres of wetlands provided in Unit I. of the Branch telephone number is (703) 305– are enhanced, restored, created? SUPPLEMENTARY INFORMATION section of 5805. • 7. What is the outreach/educational this notice. C. How and to Whom Do I Submit value of the project? Comments? • 8. What is the likelihood of success? FOR FURTHER INFORMATION CONTACT: Can the project be realistically Carol P. Stangel, Special Review and You may submit comments through accomplished? Registration Division (7508C), Office of the mail, in person, or electronically: • 9. Does the project have durable Pesticide Programs, Environmental 1. By mail. Submit written comments and sustainable characteristics; in other Protection Agency, 1200 Pennsylvania to: Public Information and Records words, will it outlive the project period? Ave., NW., Washington, DC 20460, Integrity Branch, Information Resources • 10. Is the project part of an telephone: (703) 308–8007, e-mail: and Services Division (7502C), Office of approved State Wetlands Conservation [email protected]. Pesticide Programs, U.S. Environmental Plan? Protection Agency, 1200 Pennsylvania SUPPLEMENTARY INFORMATION: Avenue, NW., Washington, DC 20460. Oscar Ramirez, Jr., 2. In person. Deliver written I. Important Information Acting Director, Water Quality Protection comments to Public Information and Division. A. Does this Apply to Me? Records Integrity Branch, in Rm. 119, [FR Doc. 02–23365 Filed 9–12–02; 8:45 am] Crystal Mall #2, 1921 Jefferson Davis BILLING CODE 6560–50–P This action is directed to the public Highway, Arlington, VA. in general. Although this action may be 3. Electronically. Submit your of particular interest to persons who are comments and/or data electronically to ENVIRONMENTAL PROTECTION interested in the progress and status of [email protected]. Please note that AGENCY EPA’s pesticide reregistration and you should not submit any information [OPP–2002–0121; FRL–6803-5] tolerance reassessment programs, the electronically that you consider to be Agency has not attempted to describe all CBI. Electronic comments must be Pesticide Reregistration Performance the specific entities that may be affected submitted as an ASCII file avoiding the Measures and Goals by this action. If you have any questions use of special characters and any form AGENCY: Environmental Protection regarding the information in this notice, of encryption. Comment and data will Agency (EPA). consult the person listed under FOR also be accepted on disks in Wordperfect 6.1/8.0/9.0 or ASCII file ACTION: Notice. FURTHER INFORMATION CONTACT. format. All comments and data in

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electronic form must be identified by of older pesticides originally registered EPA is meeting the FFDCA’s tolerance the docket ID number [OPP–20002– before November 1, 1984. Pesticides reassessment requirements through 0121]. Electronic comments on this meeting today’s scientific and regulatory reregistration and several other program notice may also be filed online at many standards may be declared ‘‘eligible’’ for activities. In making reregistration Federal Depository Libraries. reregistration. To be eligible, an older eligibility decisions, the Agency also is pesticide must have a substantially completing much of tolerance D. How Should I Handle Information complete data base, and must not cause reassessment, within the time frames that I Believe is Confidential? unreasonable adverse effects to human mandated by the new law. EPA You may claim information that you health or the environment when used reassessed the first 33% of all food submit in response to this document as according to Agency approved label tolerances by August 3, 1999, and the confidential by marking any part or all directions and precautions. second 33% of all food tolerances by of that information as CBI. Information In addition, all pesticides with food August 3, 2002. EPA is focusing so marked will not be disclosed, except uses must meet the safety standard of particularly on priority Group 1 in accordance with procedures set forth section 408 of the Federal Food, Drug, pesticides, those identified as posing the in 40 CFR part 2. A copy of the and Cosmetic Act (FFDCA) 21 U.S.C. greatest potential risks. Over half of the comment that does not contain CBI 346a, as amended by the Food Quality universe of tolerances to be reassessed must be submitted for inclusion in the Protection Act (FQPA) of 1996. Under are included in this category, including public record. Information not marked FFDCA, EPA must make a tolerances for the (OP) confidential will be included in the determination that pesticide residues pesticides, the Agency’s highest priority public docket by EPA without prior remaining in or on food are ‘‘safe’’; that for review. , organochlorine, notice. is, ‘‘that there is reasonable certainty and B2 (probable human) carcinogen II. Background that no harm will result from aggregate pesticides also are included in priority exposure to the pesticide chemical Group 1. Although EPA is directing EPA must establish and publish in the residue’’ from dietary and other sources. most of its resources toward this group, Federal Register its annual performance In determining allowable levels of a number of Group 1 pesticides will measures and goals for pesticide pesticide residues in food, EPA must nevertheless be reassessed in the third reregistration, tolerance reassessment, perform a more comprehensive 33% owing to the challenging issues and expedited registration, under assessment of each pesticide’s risks, they present. EPA’s approach to section 4(l) of FIFRA, as amended by the considering: tolerance reassessment under FFDCA, Food Quality Protection Act of 1996 • Aggregate exposure (from food, including the three priority Groups, is (FQPA). Specifically, such measures drinking water, and residential uses). described fully in the Agency’s and goals are to include: • Cumulative effects from all document, ‘‘Raw and Processed Food • The status of reregistration. pesticides sharing a common Schedule for Pesticide Tolerance • The number of products mechanism of toxicity. Reassessment’’ (62 FR 42020, August 4, reregistered, canceled, or amended. • 1997) (FRL–5734–6). • The number and type of data Possible increased susceptibility of infants and children; and requests or Data Call-In (DCI) notices • III. FQPA and Program Accountability under section 3(c)(2)(B) issued to Possible endocrine or estrogenic support product reregistration by active effects. One of the hallmarks of the FQPA ingredient. As amended by FQPA, FFDCA amendments to the FFDCA is enhanced • Progress in reducing the number of requires the reassessment of all existing accountability. Through this summary unreviewed, required reregistration tolerances (pesticide residue limits in of performance measures and goals for studies. food) and tolerance exemptions within pesticide reregistration, tolerance • The aggregate status of tolerances 10 years, to ensure that they meet the reassessment, and expedited reassessed. safety standard of the law. EPA was registration, EPA describes progress • The number of applications for directed to give priority to the review of made during each of the past 2 years in registration submitted under subsection those pesticides that appear to pose the each of the program areas included in (k)(3), expedited processing and review greatest risk to public health, and to FIFRA section 4(l). of similar applications, that were reassess 33% of the 9,721 existing A. Status of Reregistration approved or disapproved. tolerances and exemptions within 3 • The future schedule for years (by August 3, 1999), 66% within During fiscal years (FYs) 2000 and reregistrations in the current and 6 years (by August 3, 2002), and 100% 2001 (from October 1, 1999, through succeeding fiscal year. in 10 years (by August 3, 2006). (Note: September 30, 2001), EPA made • The projected year of completion Although the total number of tolerances significant progress in completing risk of the reregistrations under section 4. existing on August 3, 1996, and subject assessments and risk management FIFRA, as amended in 1988, to FQPA reassessment was initially decisions for the OP pesticides, the authorizes EPA to conduct a reported as 9,728, that number has been Agency’s highest priority chemicals for comprehensive pesticide reregistration corrected to 9,721, based on the reregistration and tolerance program--a complete review of the Agency’s Tolerance Reassessment reassessment, and for other pesticides. human health and environmental effects Tracking System.) See Table 1.

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TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: FY 2000, FY 2001, AND TOTAL

FY 2000: 19 Decisions FY 2001: 14 Decisions Total, End of FY 2001

6 REDs 3 REDs 207 REDs Diclofop-methyl Benomyl (voluntary cancellation) Ethyl (voluntary cancellation)* (voluntary cancellation)* Etridiazole (Terrazole) Propargite Temephos* Triallate** Vinclozolin

7 IREDs 6 IREDs 12 OP IREDs * * 1 carbamate IRED * * **** Ethoprop* * * * Pirimiphos-methyl* Propetamphos* * Tribufos*

6 TREDs 5 TREDs 9 OP TREDs Cadusafos* Butylate** 1 thiocarbamate TRED * Chlorpyrifos-methyl (voluntary cancellation)* 1 other TRED (Oxadixyl) * Oxadixyl (voluntary cancellation) * * * Trichlorfon* Phostebupirim* *Organophosphate (OP) pesticide. **Carbamate or thiocarbamate pesticide.

The Agency’s decisions are embodied scientific data for older pesticides (those be declared ‘‘eligible’’ for reregistration. in Reregistration Eligibility Decision initially registered before November EPA presents these pesticide findings in (RED) documents, Interim Reregistration 1984), reassessing their effects on a RED document. Eligibility Decisions (IREDs), or Reports human health and the environment, and i. Overall RED progress. EPA’s overall on FQPA Tolerance Reassessment requiring risk mitigation measures as progress at the end of FY 2000 and FY Progress and Interim Risk Management necessary. Pesticides that have 2001 in completing Reregistration Decisions (TREDs). sufficient supporting data and whose Eligibility Decisions (REDs) is 1. REDs. Through the reregistration risks can be successfully mitigated may program, EPA is reviewing current summarized in Table 2.

TABLE 2.—OVERALL RED PROGRESS, END OF FY 2000 AND FY 2001

End of FY 2000 End of FY 2001

REDs completed 204 (33%) 207 (34%)

Cases canceled 231 (38%) 231 (38%)

REDs to be completed 177 (29%) 174 (28%)

Total reregistration cases 612 (100%) 612 (100%)

ii. Profile of completed REDs. A completed by the end of FY 2001 is profile of the 204 REDs completed by presented in Table 3. the end of FY 2000 and 207 REDs

TABLE 3.—PROFILE OF REDS COMPLETED, END OF FY 2000 AND FY 2001

FY 2000/204 REDs Include FY 2001/207 REDs Include

Pesticide active ingredients 302 305

Pesticide products 7,200+ 7,800+

REDs with food uses 99 102

Post-FQPA REDs 63 66

Post-FQPA REDs with food uses 46 49

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TABLE 3.—PROFILE OF REDS COMPLETED, END OF FY 2000 AND FY 2001—Continued

FY 2000/204 REDs Include FY 2001/207 REDs Include

Tolerance reassessments completed for post- 1,045 1,091 FQPA REDs* *EPA will revisit tolerances associated with the 53 food use REDs that were completed before FQPA was enacted to ensure that they meet the safety standard of the new law, as set forth in the Agency’s August 4, 1997, Schedule for Pesticide Tolerance Reassessment.

iii. Risk reduction in REDs. Reducing cumulative risks of the OPs or review, EPA issued a revised OP pesticide risks is an important aspect of have been considered. cumulative risk assessment in June the reregistration program. In 3. Tolerance reassessment ‘‘TREDs.’’ 2002, and expects to consider OP developing REDs, EPA works with EPA also issues Reports on FFDCA cumulative risks during 2002. The stakeholders including pesticide Tolerance Reassessment Progress and Agency then may issue final registrants, growers, and other pesticide Interim Risk Management Decisions, reregistration eligibility and tolerance users, environmental and public health known as TREDs, for pesticides that reassessment decisions for individual interests, the States, USDA and other require tolerance reassessment decisions OP pesticides with IREDs and TREDs. Federal agencies, and others to develop under FFDCA, but do not require a Consideration of the cumulative risks of voluntary measures or regulatory reregistration eligibility decision at N-methylcarbamates, controls needed to effectively reduce present because: chloroacetanilides, and perhaps other • risks of concern. Almost every RED The pesticide was first registered common mechanism groups of includes some measures or after November 1984 and is considered pesticides will follow. For further modifications to reduce risks. The a ‘‘new’’ active ingredient, not subject to information, see EPA’s cumulative risk options for such risk reduction are reregistration (e.g., oxadixyl in FY website, http://www.epa.gov/pesticides/ 2001); cumulative.htm. extensive and include voluntary • cancellation of pesticide products or EPA completed a RED for the iii. Complete 66% of tolerance deletion of uses; declaring certain uses pesticide before FQPA was enacted (e.g., reassessment decisions. EPA is ineligible or not yet eligible (and then trichlorfon); or continuing to reassess tolerances within • The pesticide is not registered for proceeding with follow-up action to time frames set forth in FFDCA as use in the U.S. but tolerances are cancel the uses or require additional amended by FQPA, building on the established that allow crops treated with supporting data); restricting use of reassessment of 33% of existing the pesticide to be imported from other products to certified applicators; tolerances by August 3, 1999, and giving countries (for example, mevinphos). limiting the amount or frequency of use; priority to those food use pesticides that As with IREDs, EPA will not take final improving use directions and appear to pose the greatest risk. The action on pesticides subject to TREDs precautions; adding more protective Agency successfully reached its next that are part of a cumulative group until clothing and equipment requirements; tolerance reassessment milestone by cumulative risks have been considered requiring special packaging or completing 66% of all tolerance for the group. engineering controls; requiring no- 5. Goals for FY 2002 and FY 2003. reassessment decisions by August 3, treatment buffer zones; employing EPA’s major pesticide reregistration and 2002. Integration of the reregistration ground water, surface water, or other tolerance reassessment goals for FY and tolerance reassessment programs environmental and ecological 2002 and FY 2003 are as follows. has added complexity to the safeguards; and other measures. i. Complete individual pesticide risk reregistration process for food use 2. Interim REDs or IREDs. EPA issues management decisions. EPA’s goal in pesticides. IREDs for pesticides that are undergoing conducting the reregistration and B. Product Reregistration; Numbers of reregistration, require a reregistration tolerance reassessment program was to Products Reregistered, Canceled, and eligibility decision, and also must be complete about 30 Reregistration Amended included in a cumulative assessment Eligibility Decisions (REDs) in FY 2002, under FQPA because they are part of a and about 17 REDs in FY 2003. At the end of the reregistration group of pesticides that share a common Candidate pesticides for these and other process, after EPA has issued a RED and mechanism of toxicity. An IRED is individual pesticide decisions are listed declared a pesticide reregistration case issued for each individual pesticide in near the end of this document. eligible for reregistration, individual the cumulative group when EPA ii. Consider OP and other cumulative end-use products that contain pesticide completes the pesticide’s risk risks. EPA began developing methods active ingredients included in the case assessment and risk management for cumulative risk assessment several still must be reregistered. This decision. An IRED may include years ago and components of a concluding part of the reregistration measures to reduce food, drinking cumulative risk assessment for the OP process is called ‘‘product water, residential, occupational, and/or pesticides in FY 2001. This effort reregistration.’’ ecological risks, to gain the benefit of continued through FY 2002. In addition In issuing a completed RED these changes before the final RED can to completing risk assessments and risk document, EPA calls in any product- be issued following the Agency’s management decisions for most specific data and revised labeling consideration of cumulative risks. For individual OP pesticides, the Agency needed to make final reregistration example, EPA generally will not issued the preliminary OP cumulative decisions for each of the individual consider individual OP or N-methyl risk assessment in December 2001 (see pesticide products covered by the RED. carbamate pesticide decisions to be http://www.epa.gov/pesticides/ Based on the results of EPA’s review of completed REDs or tolerance cumulative/pra-op/ ). After considering these data and labeling, products found reassessments, but instead will issue public comment, stakeholder input, and to meet FIFRA and FFDCA standards IREDs for these chemicals until the the results of additional scientific may be reregistered.

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A variety of outcomes are possible for with multiple active ingredients may the post-RED product outcomes pesticide products completing this final not be fully reregistered until the last described above as a product phase of the reregistration process. active ingredient in its formulation is reregistration action. A single pesticide Ideally, in response to the DCI notice eligible for reregistration. In other product may be the subject of several accompanying the RED document, the situations, the Agency may temporarily product reregistration actions within the pesticide producer, or registrant, will suspend a product’s registration if the same year. For example, a product’s submit the required product-specific registrant has not submitted required registration initially may be amended, data and revised labeling, which EPA product-specific studies within the time then the product may be reregistered, will review and find acceptable. At that frame specified. The Agency may cancel and later the product may be voluntarily a product’s registration because the point, the Agency may reregister the canceled, all within the same year. registrant did not pay the required pesticide product. If, however, the During FY 2000 and FY 2001, EPA registration maintenance fee. product contains multiple active Alternatively, the registrant may request completed the product reregistration ingredients, the Agency instead issues a voluntary cancellation of their end-use actions detailed in Table 4. The an amendment to the product’s product registration. program’s goal has been to complete 750 registration, incorporating the labeling 1. Product reregistration actions in FY product reregistration actions each fiscal changes specified in the RED; a product 2000 and FY 2001. EPA counts each of year.

TABLE 4.—PRODUCT REREGISTRATION ACTIONS COMPLETED DURING FY 2000 AND FY 2001

FY 2000 FY 2001

Product reregistration actions 139 180

Product amendment actions 53 63

Product cancellation actions 360 613*

Total actions 552 856 *Includes 387 product cancellations resulting from chlorpyrifos regulatory action.

2. Status of the product reregistration summing up a series of annual actions. Table 5 should be considered a snapshot universe. The status of the universe of Adding annual actions would result in in time. As registrants and EPA make pesticide products subject to a larger overall number since each marketing and regulatory decisions in reregistration at the end of FY 2000 and individual product is subject to multiple the future, the status of individual FY 2001 is shown in Table 5 below. actions--it can be amended, reregistered, products may change, and numbers in This overall status information is not and/or canceled, over time. Instead, the this table are expected to fluctuate. ‘‘cumulative’’--it is not derived from ‘‘big picture’’ status information in

TABLE 5.—STATUS OF THE UNIVERSE OF PRODUCTS SUBJECT TO PRODUCT REREGISTRATION, FOR FY 2000 (AS OF SEPTEMBER 30, 2000) AND FY 2001 (AS OF SEPTEMBER 30, 2001)

FY 2000 FY 2001

Products reregistered 1,369 1,549

Products amended 227 290

Products canceled 3,007 3,620

Products sent for suspension -- 8

Total products with actions completed 4,603 5,467

Products with actions pending 2,652 2,405

Total products in product reregistration uni- 7,255 7,872 verse

The universe of 7,255 products in processing for two previously issued added as a result of DCI activities and product reregistration at the end of FY REDs. processing for a previously-issued RED 2000 represented an increase of 210 The universe of 7,872 products in (thiobencarb). products from the FY 1999 universe of product reregistration at the end of FY At the end of FY 2000, 2,652 products 7,045 products. The increase consists of 2001 represents an increase of 617 had product reregistration decisions 108 products associated with FY 2000 products from the FY 2000 universe of pending. At the end of FY 2001, this REDs, and 96 products associated with 7,255 products. The increase consists of number had been reduced to 2,405 IREDs, plus 6 products that were added 75 products associated with FY 2001 products. Some pending products await as a result of DCI activities and REDs, and 523 products associated with science reviews, label reviews, or IREDs, plus 19 products that were reregistration decisions by EPA. Others

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are not yet ready for product agreement was signed, approximately C. Number and Type of DCIs to Support reregistration actions; they are 840 individual chlorpyrifos products Product Reregistration by Active associated with more recently required cancellation, replacement, and/ Ingredient completed REDs, and their product- or amendment within specific time specific data are not yet due to be frames. Timely completion of these 1. DCIs for REDs. The number and type of data requests or DCIs that EPA submitted to or reviewed by the Agency. actions was essential to successfully issued under FIFRA section 3(c)(2)(B) to EPA’s goal again is to complete 750 implementing the chlorpyrifos support product reregistration for product reregistration actions during agreement and achieving the desired pesticide active ingredients included in fiscal year 2002. risk mitigation measures. Devoting staff 3. Pre-RED product-specific actions FY 2000 and FY 2001 REDs are shown time and resources to the chlorpyrifos for chlorpyrifos. During FY 2000 and FY in Table 6. For the first time, OMB 2001, EPA devoted considerable project reduced the Agency’s ability to clearance was required and obtained in resources to implementing the June complete routine product reregistration issuing the FY 2001 REDs and IREDs. 2000 agreement with registrants to actions during FY 2000 and FY 2001. Since the Ethyl Parathion, Benomyl, and phase out and cancel many uses of the EPA succeeded, however, in completing Ethion REDs consisted of voluntary OP pesticide, chlorpyrifos. Although the all necessary chlopyrifos product- cancellations, products containing these Agency had not yet completed an IRED specific actions and decisions by early pesticides will not be reregistered and or RED for chlorpyrifos when the in 2002. therefore do not require DCIs.

TABLE 6.—DCISTOSUPPORT PRODUCT REREGISTRATION FOR FY 2000 AND FY 2001 REDS

Number of Products Number of Product Number of Acute Number of Efficacy Case Number Case Name Covered by the Chemistry Studies Toxicology Studies Studies Required RED1 Required2 Required3

DCIs Issued to Support FY 2000 REDs

2160 Diclofop-methyl 16 22 96 (16 not batched) 0

0009 Etridiazole 31 22 102 (6 batches/11 0 (Terrazole) not batched)

0155 Ethyl Parathion (vol- 19 ------untary cancella- tion)

0006 Temephos 27 22 48 (7 batches/1 not 2 batched)

2695 Triallate 7 21 42 (7 not batched) 0

2740 Vinclozolin 8 22 30 (5 not batched) 0

DCIs Issued to Support FY 2001 REDs

0119 Benomyl (voluntary 2 ------cancellation)

0090 Ethion (voluntary 10 ------cancellation)

0234 Propargite 63 22 36 (1 batch/5 not -- batched)

1The number of registered products containing a pesticide active ingredient can change over time. The number of products 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 final 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, one batch could contain five products. In this instance, if six acute toxicology studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Factors con- sidered in the sorting process include each product’s active and inert ingredients (e.g., identity, percent composition, and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification, pre- cautionary 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. 2. DCIs for IREDs. The number and type of data requests or DCIs issued by EPA to support product reregistration for pesticide active ingredients included in FY 2000 and FY 2001 Interim REDs (IREDs) are shown in Table 7.

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TABLE 7.—DCISTOSUPPORT PRODUCT REREGISTRATION FOR FY 2000 AND FY 2001 IREDS

Number of Products Number of Product Number of Acute Case Number Case Name Covered by the Chemistry Studies Toxicology Studies Number of Efficacy IRED Required Required Studies Required

DCIs Issued to Support FY 2000 IREDs

2035 Bensulide 47 21 84 (7 batches/7 not 0 batched)

0290 Fenthion 11 22 36 (2 batches/4 not 2 batched)

0253 Oxamyl 6 22 12 (1 batch/1 not 0 batched)

0103 Phorate 22 22 21 (7 batches) 0

2540 Profenofos 2 22 12 (2 not batched) 0

2550 Propetamphos 2 22 12 (2 not batched) 2

2145 Tribufos (DEF) 6 22 12 (2 batches) 0

DCIs Prepared to Support FY 2001 IREDs

0042 Acephate 141 22 108 (7 batches/11 4 not batched)

0100 Chlorpyrifos 326 22 546 (34 batches/57 2 not batched)

0106 Ethoprop 15 22 36 (4 batches/2 not 0 batched)

0034 Methidathion 31 22 30 (3 batches/2 not 0 batched)

2535 Pirimiphos-methyl 5 22 24 (4 not batched) 0

0109 Terbufos 5 22 18 (3 batches) 0 Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in acute toxicity batchings when they are supported by a valid parent product (section 3) registration.

3. DCIs not needed for TREDs. The reregistration decisions; they are subject D. Progress in Reducing the Number of Agency does not issue product-specific to tolerance reassessment only. Unreviewed, Required Reregistration data requests or DCIs for pesticides Studies included in tolerance reassessment EPA is making progress in reviewing decisions or TREDs because, at present, scientific studies submitted by pesticide these pesticides do not require product registrants in support of pesticides undergoing reregistration. See Table 8.

TABLE 8.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2000 AND FY 2001

Pesticide Reregistration Group or 1 List, per FIFRA Section 4(c)(2) Studies Reviewed + Extraneous Studies Awaiting Review Total Studies Received

Review Status of Studies Received, October 2000

List A 10,705 + 319 = 11,024 (81%) 2,592 (19%) 13,616

List B 5,951 + 654 = 6,605 (70%) 2,815 (30%) 9,420

List C 2,149 + 228 = 2,377 (70%) 1,013 (30%) 3,390

List D 1,307 + 94 = 1,401 (81%) 333 (19%) 1,734

Total Lists A - D 20,112 + 1,295 = 21,407 6,753 (23.98%) 28,160 (76.02%)

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TABLE 8.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2000 AND FY 2001— Continued

Pesticide Reregistration Group or 1 List, per FIFRA Section 4(c)(2) Studies Reviewed + Extraneous Studies Awaiting Review Total Studies Received

Review Status of Studies Received, October 2001

List A 11,109 + 471 = 11,580 (84%) 2,204 (16%) 13,784

List B 5,357 + 744 = 7,101 (74%) 2,447 (26%) 9,548

List C 2,264 + 239 = 2,503 (73%) 943 (27%) 3,446

List D 1,342 + 94 = 1,436 (82%) 306 (18%) 1,742

Total Lists A - D 21,072 + 1,548 = 22,620 (79.3%) 5,900 (20.7%) 28,520 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.

Studies reviewed by EPA increased by E. Aggregate Status of Tolerances general schedule for tolerance 3% (or the study review ‘‘backlog’’ Reassessed reassessment (Federal Register, August decreased by 3%) during FY 2001. At During FY 2000, EPA completed 121 4, 1997) identified three groups of the end of the fiscal year, over 79% of tolerance reassessments and ended the pesticides to be reviewed; this grouping all studies received by the Agency in fiscal year with a total of 3,554 tolerance continues to reflect the Agency’s overall support of reregistration had been reassessment decisions to date, scheduling priorities for tolerance reviewed, compared to only 76% at the addressing 36.6% of the 9,721 reassessment. EPA continues to give end of FY 2000, and less than 75% at tolerances that require reassessment. priority to pesticides in Group 1, the end of 1997. During FY 2001, the During FY 2001, the Agency completed particularly the OP pesticides. Agency made a special effort to clean up 288 tolerance reassessments and ended 1. Aggregate accomplishments the data base used to track the review the fiscal year with a total of 3,842 through reregistration and other status of studies submitted for tolerance reassessment decisions, programs. EPA is accomplishing reregistration. Cases with completed addressing nearly 40% of the 9,721 tolerance reassessment through the registration and reregistration programs; REDs, for example, should no longer tolerances that require reassessment by revoking tolerances for pesticides have studies ‘‘awaiting review’’; all (See Table 9). Over 63% of the tolerance that have been canceled (many as a studies received should have been reassessment decisions completed were for pesticides in priority Group 1. result of reregistration); and through reviewed or found extraneous by the Just as EPA reassessed 33% of all food other decisions not directly related to time a reregistration eligibility decision tolerances by August 3, 1999, including registration or reregistration, described is made. The increase in the percent of many tolerances for pesticides further below. EPA is using the studies reviewed that was reported identified as posing the greatest Tolerance Reassessment Tracking during FY 2001 may continue in future potential risks, the Agency also met the System (TORTS) to compile this years as improved, more thorough next FFDCA goal and completed 66% of updated information and report on the recordkeeping practices are followed. all required tolerance reassessment status of tolerance reassessment (See decisions by August 3, 2002. EPA’s Table 9).

TABLE 9.—TOLERANCE REASSESSMENTS COMPLETED POST-FQPA BY FISCAL YEAR, THROUGH FY 2001

Tolerances Reassessed During Late During FY During FY During FY During FY Total, End During FY Total, End Through... FY 96 1997 1998 1999 2000 of FY 2000 2001 of FY 2001

Reregistration/REDs 25 339 278 359 44 1,045 46 1,091

Registration 0 221 308 341 55 925 215 1,140

Tolerance revocations 3 0 812 513 22 1,350 27 1,377

Other decisions 0 1 0 233 0 234 0 234

Total tolerances reas- sessed 28 561 1,398 1,446 121 3,554 288 3,842

i. Reregistration/REDs. EPA is using required by FFDCA. Many tolerances these pesticides. Many of these the reregistration program to accomplish reassessed through reregistration remain tolerance reassessments will not become much of tolerance reassessment. For the same while others may be raised, final, however, until the cumulative each of the tolerance reassessment lowered, or revoked. In completing OP risks of the OPs have been considered. decisions made to date, the Agency has IREDs and TREDs during FY 2000 and ii. Registration. Like older pesticides, made the finding that there is a FY 2001, the Agency also completed all new pesticide registrations must reasonable certainty of no harm, as tolerance reassessment decisions for meet the safety standard of FFDCA.

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Many of the registration applications manufacturers, based on lack of support finite residue on July 7, 1999; 73 inert EPA receives are for new uses of for reregistration. Tolerance revocations polymer tolerances that were pesticides already registered for other are important even if there are no determined on July 20, 1999, to meet the uses. To reach a decision on a proposed domestic uses of a pesticide because terms and criteria of the Toxic new food use of an already registered residues in or on imported commodities Substances Control Act Polymer pesticide, EPA must reassess the treated with the chemical could still Exemption Rule; 13 tolerance existing tolerances, as well as the present dietary risks that may exceed exemptions for Trichoderma harzianum proposed new tolerances, to make sure the FFDCA ‘‘reasonable certainty of no KRL-AG2 (64 FR 16856; April 7, 1999); there is reasonable certainty that no harm’’ standard, either individually or 1 tolerance exemption for Bacillus harm will result to the public from cumulatively with other substances that thuringiensis subspecies Kurstake aggregate exposure from all uses. During share a common mechanism of toxicity. CryIA(c) (62 FR 17722; April 11, 1997); FY 2000 and FY 2001, the Agency has iv. Other reassessment decisions. In specifically discouraged submission of addition to the types of reassessment 1 tolerance exemption for red pepper applications and petitions for any new actions described above, a total of 234 (63 FR 66999; December 4, 1998); and uses of the OP pesticides, given the additional tolerance reassessment 1 tolerance exemption for need to consider cumulative risks from decisions have been made, not directly cinnamaldehyde (64 FR 7801; February OP’s as a group before any new uses can related to registration or reregistration. 17, 1999). be fully evaluated. These include 65 tolerances reassessed 2. Accomplishments for priority iii. Tolerance revocations. Revoked through the Plant Growth Regulator pesticides. During FY 2000 and FY tolerances represent uses of many Rule which were scientifically reviewed 2001, EPA completed tolerance different pesticide active ingredients and the exemption was retained (64 FR reassessment decisions for many high that have been canceled in the past. 31501; June 11, 1999) (FRL–6076–5); 80 priority pesticides in review, including Some pesticides were canceled due to organophosphate meat, milk, poultry, OPs, carbamates, organochlorines, and the Agency’s risk concerns. Others were and egg tolerances that were determined carcinogens. (See Table 10.) canceled voluntarily by their to have no reasonable expectation of

TABLE 10.—TOLERANCE REASSESSMENTS COMPLETED FOR PRIORITY PESTICIDES

Pesticide Class Tolerances to be Reassessed Reassessed by End of FY 2000 Reassessed by End of FY 2001

Organophosphates 1,691 505 (29.86%) 529 (31.28 %)

Carbamates 545 169 (31.01%) 171 (31.38%)

Organochlorines 253 50 (19.76%) 50 (19.76%)

Carcinogens 2,009 708 (35.24%) 754 (37.53%)

High hazard inerts 5 0 0

Other 5,218 2,122 (40.67%) 2,338 (44.81%)

Total 9,721 3,554 (36.56%) 3,842 (39.52%)

3. Tolerance reassessment and the (which continued during early FY 2002) resulting tolerance revocations are . EPA has developed to explain and answer questions about counted as completed tolerance an approach for assessing cumulative the Agency’s methods for assessing OP reassessments. Once EPA has risk for the OPs as a group, as required cumulative hazard, as well as exposure considered the cumulative risks of the by FFDCA. The Agency presented a through drinking water, food, and in OPs, the Agency will reevaluate comprehensive guidance document on residential settings. An EPA website has individual OP IREDs and TREDs and cumulative risk assessment to the been established to share updated may issue final REDs for these Scientific Advisory Panel in December information on pesticide cumulative pesticides. 1999, issued draft guidance in 2000 for risk assessment with the public (http:/ 4. Status of individual OP decisions. review and comment, and presented a /www.epa.gov/pesticides/ The status of each of the 49 known OP case study on cumulative risk cumulative.htm). The Agency issued a pesticides at the end of FY 2001 is assessment to the SAP in December preliminary OP cumulative risk reflected in this discussion. 2000. During FY 2001, EPA refined the assessment on December 3, 2001, and i. OP decisions completed. During FY methodology and began developing issued a revised OP cumulative risk 2000, through the public participation components of the OP cumulative assessment for public comment in June process, EPA completed risk preliminary risk assessment. With input 2002. assessments and made individual risk from a Committee to Advise on Most of the reregistration and management decisions for 14 OP Reassessment and Transition (CARAT) tolerance reassessment decisions that pesticides. In addition, a decision workgroup, the Agency began EPA is making for the OP pesticides at reached in FY 1999 concluded EPA’s developing a process to inform present will not be considered final review of another OP pesticide, stakeholders and the public and until after the Agency considers OP sulfotepp. During FY 2001, EPA encourage their participation during the cumulative risks. The results of completed risk assessments and made assessment of OP cumulative risks. At individual OP assessments (IRED and risk management decisions for 10 more CARAT’s recommendation, EPA TRED documents) include risk OP pesticides, bringing the number of initiated a series of technical briefings mitigation measures, however, and any OPs with individual decisions

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completed to 25 as of the end of FY Tribufos (DEF) IRED 2001. A 26th OP, , had a partial Trichlorfon TRED Chlorthiophos interim decision completed. (See List 1.) ii. OP decisions pending. Fourteen Many OP pesticides not voluntarily other OP pesticides had completed canceled will be considered by the earlier phases of the public participation Agency in assessing OP cumulative process and were in final Phase 6, risks. awaiting individual decisions, at the Isazophos List 1.—OP Pesticides with Individual end of FY 2001. EPA is working to Isofenphos Decisions Completed, End of FY 2001 complete individual risk management Acephate IRED decisions for these 14 pesticides during Bensulide IRED 2002. See List 2. List 2.—OP Pesticides with Individual Cadusafos TRED Sulprofos Chlorethoxyfos TRED Decisions Pending, End of FY 2001 Chlorpyrifos IRED Azinphos-methyl* F. Applications for Registration Chlorpyrifos methyl TRED Requiring Expedited Processing; Coumaphos TRED (DDVP) Numbers Approved and Disapproved Ethion RED * Ethoprop IRED By law, EPA must expedite its * Ethyl parathion RED processing of certain types of * Fenitrothion TRED applications for pesticide product registration, i.e., applications for end Fenthion IRED * Methidathion IRED use products that would be identical or Methyl parathion substantially similar to a currently Mevinphos TRED * Phorate IRED Oxydemeton-methyl registered product; amendments to Phosalone TRED Phosmet (full IRED)* current product registrations that do not Phosmet Partial IRED * require review of scientific data; and Phostebupirim TRED *Completed as of August 15, 2002. products for public health pesticide Pirimiphos methyl IRED iii. Early OP cancellations. Ten OP uses. During FY 2000 and FY 2001, EPA Profenofos IRED pesticides were canceled prior to or considered and approved the numbers Propetamphos IRED early in the pilot public participation of applications for registration requiring Sulfotepp RED process. See List 3. expedited processing (also known as Temephos RED List 3.—OPs Canceled Prior to/Early in ‘‘fast track’’ applications) shown in Terbufos IRED the Pilot Public Participation Process Table 11.

TABLE 11.—FAST TRACK APPLICATIONS APPROVED IN FY 2000 AND FY 2001

FY 2000 FY 2001

Me-too product registrations/Fast track 420 391

Amendments/Fast track 2,260 2,776

Total applications processed by expedited 2,680 3,167 means

Regarding numbers of applications G. Future Schedule for Reregistrations 1. RED, IRED, and TRED Candidate disapproved, instead the Agency Pesticides for FY 2002. List 4 contains generally notifies the registrant of any During the past several years, EPA has the candidate pesticides for deficiencies in the application that need been conducting reregistration in Reregistration Eligibility Decisions to be corrected or addressed before the conjunction with tolerance reassessment (REDs), Interim REDs (IREDs), and application can be approved. under FFDCA. That law requires the Reports on FQPA Tolerance Applications may have been withdrawn Agency to reassess all existing Reassessment Progress and Interim Risk after discussions with the Agency, but tolerances over a 10–year period to Management Decisions (TREDs) in FY none were formally ‘‘disapproved’’ ensure consistency with the new safety 2002. As in previous years, any during FY 2001. standard, and to consider pesticides that pesticides for which decisions are not On a financial accounting basis, EPA appear to pose the greatest risk first. In completed during FY 2002 will devoted approximately 29 full-time prioritizing pesticides for reregistration automatically become candidates for equivalents (FTEs) in both FY 2000 and eligibility review and tolerance decisions in FY 2003. FY 2001 to reviewing and processing reassessment, EPA is continuing to List 4.—FY 2002 RED, IRED, and TRED applications for fast track me-too consider their potential risks, as Candidate Pesticides product registrations and label reflected in the Agency’s tolerance RED Candidates amendments. The Agency spent reassessment schedule published in the Diuron** approximately $2.6 million in FY 2000 Federal Register on August 4, 1997 . * and $2.7 million in FY 2001 in direct Imazalil** EPA is giving highest priority to costs (not including administrative * expenses, computer systems, pesticides in Group 1, including the OP Oxyfluorfen* management overhead, and other pesticides, and the carbamates, ** indirect costs) on expedited processing organochlorines, and B2 (probable Sodium and reviews. human) carcinogens. Thiabendazole*

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Thiophanate-methyl Fluvalinate consent for recovery of past and Ziram HCl projected future response costs [+ 25 OP IREDs may be counted as REDs Methanearsonic acid, salts (CAMA, concerning the Jasper County/Tri-State once OP cumulative risks are DSMA, and MSMA) Mining Area Site, Operable Unit No. 1, considered] Molinate Jasper County, Missouri, with the Voluntary Cancellations that Will Count PCNB following parties: E.I. DuPont de as REDs Nemours and Company, USX, Inc., and Fenamiphos* (initially prepared as an Thiram Kellogg Brown & Root, Inc. This OP IRED) Triadimefon* proposed settlement was approved by Oxadiazon TRED Candidates the United States Department of Justice OP IRED and TRED Candidates Bitertanol (DOJ) on July 28, 2002. Azinphos-methyl* Chlorophenoxyacetic acid DATES: EPA will receive written Diazinon* ** comments relating to the proposed Dichlorvos (DDVP) Oryzalin administrative order on consent by Dicrotophos* Triadimenol* October 15, 2002. In addition, a public Dimethoate *May be completed as interim decisions meeting may be requested pursuant to Disulfoton* if EPA decides that these pesticides Section 7003 of RCRA. Malathion belong to the triazoles group and that a ADDRESSES: Comments should be Methamidophos* common mechanism of toxicity exists. Methyl parathion addressed to E. Jane Kloeckner, Senior **May be incorporated into the Assistant Regional Counsel, United Naled* RED. Oxydemeton-methyl States Environmental Protection Phosmet (full IRED)* H. Projected Year of Completion of Agency, Region VII, 901 N. 5th Street, Tetrachlorvinphos (TRED)* Reregistrations Kansas City, Kansas 66101 and should refer to Jasper County/Tri-State Mining Other IRED Candidates EPA is now conducting reregistration Area Site Administrative Order on (being rescheduled for FY in conjunction with tolerance Consent, Docket No. CERCLA–07–2002– 2003) reassessment, which FFDCA mandates 0051. Other TRED Candidates be completed by 2006. EPA plans to * The proposed settlement may be complete reregistration of pesticide examined or obtained in person or by Chlorpropham* active ingredients prior to the statutory Difenzoquat* mail from Kathy Robinson, Regional deadline for completing tolerance Hearing Clerk, at the office of the United dibromide* reassessment. Fenarimol* States Environmental Protection Fenbutatin oxide* List of Subjects Agency, Region VII, 901 N. 5th Street, * Environmental protection, Pesticides Kansas City, KS 66101, (913) 551–7567. Inorganic bromides from methyl and pests. SUPPLEMENTARY INFORMATION: The bromide proposed agreement concerns the Jasper Dated: August 29, 2002. County Superfund Site (Site), Operable Stephen Johnson, Unit No.1, located in Jasper County, * Assistant Administrator, Office of Prevention, Missouri. The Site is an abandoned, * Pesticides and Toxic Substances. uncontrolled lead and zinc mining Norflurazon* [FR Doc. 02–23265 Filed 9–12–02; 8:45 am] mega-site that contains nine million Primisulfuron-methyl* BILLING CODE 6560–50–S tons of surface mining wastes on about Pronamide* 5,000 acres located with 270 square Propionic acid miles. Sodium hypochlorite ENVIRONMENTAL PROTECTION EPA has identified E.I. du Pont de AGENCY Nemours and Company; Kellogg Brown * & Root, Inc.; and USX, Inc. (Settling [FRL–7376–1] * Respondents) as three of ten viable *Completed as of August 15, 2002. Notice of Proposed Administrative potentially responsible parties (PRPs) at **TRED completed as of August 15, Order on Consent Pursuant to Section the Site. These parties are eligible for a 2002; RED still to be completed. 122(h) of the Comprehensive peripheral party settlement based on 2. RED, IRED, and TRED Candidate Environmental Response, their volume of mining wastes Pesticides for FY 2003. The candidate Compensation and Liability Act compared to the volume of site-wide pesticides for FY 2003 RED, IRED, and (CERCLA), Jasper County/Tri-State wastes and the small amount of TRED decisions are included in List 5. Mining Area Site, Operable Unit No. 1, contamination that their wastes List 5.—FY 2003 RED, IRED, and TRED Jasper County, MO, Docket No. contribute to the site-wide risks. Each Candidate Pesticides CERCLA 07–2002–0051 peripheral party produced less than two RED and IRED Candidates percent of the ore when compared to the AGENCY: Environmental Protection identified PRPs and operated on-site for Agency. less than four years. ACTION: Notice of proposed This settlement requires the Settling administrative order on consent, Jasper Respondents to pay $818,349 to EPA County/Tri-State Mining Area Site, and $88,396 to the State of Missouri. Cycloate Operable Unit No. 1, Jasper County, The money will be paid to the Jasper Dinocap Missouri. County Site Special Account and used Dipropyl isocinchomeronate to implement the selected remedial Ethoxyquin SUMMARY: Notice is hereby given of a action for the Jasper County Site, Fenvalerate proposed administrative order on Operable Unit No.1, which will address

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