Environmental Protection Agency (EPA).
This notice announces EPA's progress in meeting its performance measures and goals for pesticide reregistration during fiscal years 2000 and 2001. 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. Finally, this notice contains the schedule for completion of activities for specific chemicals during fiscal years 2002 and 2003.
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 ID number [OPP-2002-0121], should be received on or before November 12, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION section of this notice.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Carol P. Stangel, Special Review and Registration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone: (703) 308-8007, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
I. Important Information
A. Does this 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. How Can I Get Additional Information or Copies of Support Documents?
1. Electronically. You may obtain electronic copies of this document and various support documents from the EPA Internet website, www.epa.gov. On EPA's home page, select “Laws and Regulations,” and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at www.epa.gov/fedrgstr. To access information about pesticide reregistration, go to the home page for the Office of Pesticide Programs at www.epa.gov/pesticides and select “Reregistration” under “Topics,” at the top of the screen, or go directly to www.epa.gov/pesticides/reregistration/.
2. In person. The official record for this notice, as well as the public version, has been established under docket ID number [OPP-2002-0121] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of any electronic comments, which does not include any information claimed as Confidential Business Information (CBI), is available for inspection in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Public Information and Records Integrity Branch telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically:
1. By mail. Submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
2. In person. Deliver written comments to Public Information and Records Integrity Branch, in Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
3. Electronically. Submit your comments and/or data electronically to firstname.lastname@example.org. Please note that you should not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on disks in Wordperfect 6.1/8.0/9.0 or ASCII file format. All comments and data in Start Printed Page 58042electronic form must be identified by the docket ID number [OPP-20002-0121]. Electronic comments on this notice may also be filed online at many Federal Depository Libraries.
D. How Should I Handle Information that I Believe is Confidential?
You may claim information that you submit in response to this document as confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed, except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice.
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, as amended by the Food Quality Protection Act of 1996 (FQPA). 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 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), 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, as amended in 1988, 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, as amended by the Food Quality Protection Act (FQPA) of 1996. 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 perform a more 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; and
- Possible endocrine or estrogenic effects.
As amended by FQPA, FFDCA requires the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they meet the safety standard of the law. EPA was directed to give priority to the review of those pesticides that appear to pose the greatest risk to public health, and to reassess 33% of the 9,721 existing tolerances and exemptions within 3 years (by August 3, 1999), 66% within 6 years (by August 3, 2002), and 100% in 10 years (by August 3, 2006). (Note: Although the total number of tolerances existing on August 3, 1996, and subject to FQPA reassessment was initially reported as 9,728, that number has been corrected to 9,721, based on the Agency's Tolerance Reassessment Tracking System.)
EPA is meeting the FFDCA's tolerance reassessment requirements through reregistration and several other program activities. In making reregistration eligibility decisions, the Agency also is completing much of tolerance reassessment, within the time frames mandated by the new law. EPA reassessed the first 33% of all food tolerances by August 3, 1999, and the second 33% of all food tolerances by August 3, 2002. EPA is focusing particularly on priority Group 1 pesticides, those identified as posing the greatest potential risks. Over half of the universe of tolerances to be reassessed are included in this category, including tolerances for the organophosphate (OP) pesticides, the Agency's highest priority for review. Carbamate, organochlorine, and B2 (probable human) carcinogen pesticides also are included in priority Group 1. Although EPA is directing most of its resources toward this group, a number of Group 1 pesticides will nevertheless be reassessed in the third 33% owing to the challenging issues they present. EPA's approach to tolerance reassessment under FFDCA, including the three priority Groups, is 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).
III. FQPA and Program Accountability
One of the hallmarks of the FQPA amendments to the FFDCA is enhanced accountability. Through this summary of performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, EPA describes progress made during each of the past 2 years in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal years (FYs) 2000 and 2001 (from October 1, 1999, through September 30, 2001), EPA made significant progress in completing risk assessments and risk management decisions for the OP pesticides, the Agency's highest priority chemicals for reregistration and tolerance reassessment, and for other pesticides. See Table 1. Start Printed Page 58043
|FY 2000: 19 Decisions||FY 2001: 14 Decisions||Total, End of FY 2001|
|6 REDs Diclofop-methyl Ethyl parathion (voluntary cancellation)* Etridiazole (Terrazole) Temephos* Triallate** Vinclozolin||3 REDs Benomyl (voluntary cancellation) Ethion (voluntary cancellation)* Propargite||207 REDs|
|7 IREDs Bensulide* Fenthion* **Oxamyl** Phorate* Profenofos* Propetamphos* Tribufos*||6 IREDs Acephate* Chlorpyrifos* Ethoprop* Methidathion* Pirimiphos-methyl* Terbufos*||12 OP IREDs 1 carbamate IRED|
|6 TREDs Cadusafos* Chlorethoxyfos* Coumaphos* Fenitrothion* Mevinphos* Phostebupirim*||5 TREDs Butylate** Chlorpyrifos-methyl (voluntary cancellation)* Oxadixyl (voluntary cancellation) Phosalone* Trichlorfon*||9 OP TREDs 1 thiocarbamate TRED 1 other TRED (Oxadixyl)|
|*Organophosphate (OP) pesticide.|
|**Carbamate or thiocarbamate pesticide.|
The Agency's decisions are embodied in Reregistration Eligibility Decision (RED) documents, Interim Reregistration Eligibility Decisions (IREDs), or Reports on FQPA Tolerance Reassessment Progress and Interim Risk Management Decisions (TREDs).
1. REDs. Through the reregistration program, EPA is reviewing current scientific data for older pesticides (those initially registered before November 1984), reassessing their effects on human health and the environment, and requiring risk mitigation measures as necessary. Pesticides that have sufficient supporting data and whose risks can be successfully mitigated may be declared “eligible” for reregistration. EPA presents these pesticide findings in a RED document.
i. Overall RED progress. EPA's overall progress at the end of FY 2000 and FY 2001 in completing Reregistration Eligibility Decisions (REDs) is summarized in Table 2.
|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 profile of the 204 REDs completed by the end of FY 2000 and 207 REDs completed by the end of FY 2001 is presented in Table 3.
|FY 2000/204 REDs Include||FY 2001/207 REDs Include|
|Pesticide active ingredients||302||305|
|REDs with food uses||99||102|
|Post-FQPA REDs with food uses||46||49|
|Start Printed Page 58044|
|Tolerance reassessments completed for post-FQPA REDs*||1,045||1,091|
|*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 pesticide risks is an important aspect of the reregistration program. In developing REDs, EPA works with stakeholders including pesticide registrants, growers, and other pesticide users, environmental and public health interests, the States, USDA and other Federal agencies, and others to develop voluntary measures or regulatory controls needed to effectively reduce risks of concern. Almost every RED includes some measures or modifications 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; adding more protective clothing and equipment requirements; 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.
2. Interim REDs or IREDs. EPA issues IREDs for pesticides that are undergoing reregistration, require a reregistration eligibility decision, and also must be included in a cumulative assessment under FQPA because they are part of a group of pesticides that share a common mechanism of toxicity. An IRED is issued for each individual pesticide in the cumulative group when EPA completes the pesticide's risk assessment and risk management decision. An IRED may include measures to reduce food, drinking water, residential, occupational, and/or ecological risks, to gain the benefit of these changes before the final RED can be issued following the Agency's consideration of cumulative risks. For example, EPA generally will not consider individual OP or N-methyl carbamate pesticide decisions to be completed REDs or tolerance reassessments, but instead will issue IREDs for these chemicals until the cumulative risks of the OPs or carbamates have been considered.
3. Tolerance reassessment “TREDs.” EPA also issues Reports on FFDCA Tolerance Reassessment Progress and Interim Risk Management Decisions, known as TREDs, for pesticides that require tolerance reassessment decisions under FFDCA, but do not require a reregistration eligibility decision at present because:
- The pesticide was first registered after November 1984 and is considered a “new” active ingredient, not subject to reregistration (e.g., oxadixyl in FY 2001);
- EPA completed a RED for the pesticide before FQPA was enacted (e.g., trichlorfon); or
- The pesticide is not registered for use in the U.S. but tolerances are established that allow crops treated with the pesticide to be imported from other countries (for example, mevinphos).
As with IREDs, EPA will not take final action on pesticides subject to TREDs that are part of a cumulative group until cumulative risks have been considered for the group.
5. Goals for FY 2002 and FY 2003. EPA's major pesticide reregistration and tolerance reassessment goals for FY 2002 and FY 2003 are as follows.
i. Complete individual pesticide risk management decisions. EPA's goal in conducting the reregistration and tolerance reassessment program was to complete about 30 Reregistration Eligibility Decisions (REDs) in FY 2002, and about 17 REDs in FY 2003. Candidate pesticides for these and other individual pesticide decisions are listed near the end of this document.
ii. Consider OP and other cumulative risks. EPA began developing methods for cumulative risk assessment several years ago and components of a cumulative risk assessment for the OP pesticides in FY 2001. This effort continued through FY 2002. In addition to completing risk assessments and risk management decisions for most individual OP pesticides, the Agency issued the preliminary OP cumulative risk assessment in December 2001 (see http://www.epa.gov/pesticides/cumulative/pra-op/ ). After considering public comment, stakeholder input, and the results of additional scientific review, EPA issued a revised OP cumulative risk assessment in June 2002, and expects to consider OP cumulative risks during 2002. The Agency then may issue final reregistration eligibility and tolerance reassessment decisions for individual OP pesticides with IREDs and TREDs. Consideration of the cumulative risks of N-methylcarbamates, chloroacetanilides, and perhaps other common mechanism groups of pesticides will follow. For further information, see EPA's cumulative risk website, http://www.epa.gov/pesticides/cumulative.htm.
iii. Complete 66% of tolerance reassessment decisions. EPA is continuing to reassess tolerances within time frames set forth in FFDCA as amended by FQPA, building on the reassessment of 33% of existing tolerances by August 3, 1999, and giving priority to those food use pesticides that appear to pose the greatest risk. The Agency successfully reached its next tolerance reassessment milestone by completing 66% of all tolerance reassessment decisions by August 3, 2002. Integration of the reregistration and tolerance reassessment programs has added complexity to the reregistration process for food use pesticides.
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 calls in any product-specific data and revised labeling needed to make final reregistration decisions 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. Start Printed Page 58045
A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process. Ideally, in response to the DCI notice accompanying the RED document, 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 issues an amendment to the product's registration, incorporating the labeling changes specified in the RED; 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.
1. Product reregistration actions in FY 2000 and FY 2001. 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, and later the product may be voluntarily canceled, all within the same year. During FY 2000 and FY 2001, EPA completed the product reregistration actions detailed in Table 4. The program's goal has been to complete 750 product reregistration actions each fiscal year.
|FY 2000||FY 2001|
|Product reregistration actions||139||180|
|Product amendment actions||53||63|
|Product cancellation actions||360||613*|
|*Includes 387 product cancellations resulting from chlorpyrifos regulatory action.|
2. Status of the product reregistration universe. The status of the universe of pesticide products subject to reregistration at the end of FY 2000 and FY 2001 is shown in Table 5 below. This overall status information is not “cumulative”--it is not derived from summing up a series of annual actions. Adding annual actions would result in a larger overall number since each individual product is subject to multiple actions--it can be amended, reregistered, and/or canceled, over time. Instead, the “big picture” status information in Table 5 should be considered a snapshot in time. As registrants and EPA make marketing and regulatory decisions in the future, the status of individual products may change, and numbers in this table are expected to fluctuate.
|FY 2000||FY 2001|
|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 universe||7,255||7,872|
The universe of 7,255 products in product reregistration at the end of FY 2000 represented an increase of 210 products from the FY 1999 universe of 7,045 products. The increase consists of 108 products associated with FY 2000 REDs, and 96 products associated with IREDs, plus 6 products that were added as a result of DCI activities and processing for two previously issued REDs.
The universe of 7,872 products in product reregistration at the end of FY 2001 represents an increase of 617 products from the FY 2000 universe of 7,255 products. The increase consists of 75 products associated with FY 2001 REDs, and 523 products associated with IREDs, plus 19 products that were added as a result of DCI activities and processing for a previously-issued RED (thiobencarb).
At the end of FY 2000, 2,652 products had product reregistration decisions pending. At the end of FY 2001, this number had been reduced to 2,405 products. Some pending products await science reviews, label reviews, or reregistration decisions by EPA. Others Start Printed Page 58046are not yet ready for product reregistration actions; they are associated with more recently completed REDs, and their product-specific data are not yet due to be submitted to or reviewed by the Agency. EPA's goal again is to complete 750 product reregistration actions during fiscal year 2002.
3. Pre-RED product-specific actions for chlorpyrifos. During FY 2000 and FY 2001, EPA devoted considerable resources to implementing the June 2000 agreement with registrants to phase out and cancel many uses of the OP pesticide, chlorpyrifos. Although the Agency had not yet completed an IRED or RED for chlorpyrifos when the agreement was signed, approximately 840 individual chlorpyrifos products required cancellation, replacement, and/or amendment within specific time frames. Timely completion of these actions was essential to successfully implementing the chlorpyrifos agreement and achieving the desired risk mitigation measures. Devoting staff time and resources to the chlorpyrifos project reduced the Agency's ability to complete routine product reregistration actions during FY 2000 and FY 2001. EPA succeeded, however, in completing all necessary chlopyrifos product-specific actions and decisions by early in 2002.
C. Number and Type of DCIs to Support Product Reregistration by Active Ingredient
1. DCIs for REDs. The number and type of data requests or DCIs that EPA issued under FIFRA section 3(c)(2)(B) to support product reregistration for pesticide active ingredients included in FY 2000 and FY 2001 REDs are shown in Table 6. For the first time, OMB clearance was required and obtained in issuing the FY 2001 REDs and IREDs. Since the Ethyl Parathion, Benomyl, and Ethion REDs consisted of voluntary cancellations, products containing these pesticides will not be reregistered and therefore do not require DCIs.
|Case Number||Case Name||Number of Products Covered by the RED1||Number of Product Chemistry Studies Required2||Number of Acute Toxicology Studies Required3||Number of Efficacy Studies Required|
|DCIs Issued to Support FY 2000 REDs|
|2160||Diclofop-methyl||16||22||96 (16 not batched)||0|
|0009||Etridiazole (Terrazole)||31||22||102 (6 batches/11 not batched)||0|
|0155||Ethyl Parathion (voluntary cancellation)||19||--||--||--|
|0006||Temephos||27||22||48 (7 batches/1 not batched)||2|
|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 cancellation)||2||--||--||--|
|0090||Ethion (voluntary cancellation)||10||--||--||--|
|0234||Propargite||63||22||36 (1 batch/5 not batched)||--|
|1 The 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.|
|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, 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 considered 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, 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.|
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. Start Printed Page 58047
|Case Number||Case Name||Number of Products Covered by the IRED||Number of Product Chemistry Studies Required||Number of Acute Toxicology Studies Required||Number of Efficacy Studies Required|
|DCIs Issued to Support FY 2000 IREDs|
|2035||Bensulide||47||21||84 (7 batches/7 not batched)||0|
|0290||Fenthion||11||22||36 (2 batches/4 not batched)||2|
|0253||Oxamyl||6||22||12 (1 batch/1 not batched)||0|
|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 not batched)||4|
|0100||Chlorpyrifos||326||22||546 (34 batches/57 not batched)||2|
|0106||Ethoprop||15||22||36 (4 batches/2 not batched)||0|
|0034||Methidathion||31||22||30 (3 batches/2 not batched)||0|
|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 Agency does not issue product-specific data requests or DCIs for pesticides included in tolerance reassessment decisions or TREDs because, at present, these pesticides do not require product reregistration decisions; they are subject to tolerance reassessment only.
D. Progress in Reducing the Number of Unreviewed, Required Reregistration Studies
EPA is making progress in reviewing scientific studies submitted by pesticide registrants in support of pesticides undergoing reregistration. See Table 8.
|Pesticide Reregistration Group or List, per FIFRA Section 4(c)(2)||Studies Reviewed + Extraneous1||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 (76.02%)||6,753 (23.98%)||28,160|
|Start Printed Page 58048|
|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|
|1 Extraneous studies is a term used to classify those studies that are not needed because the guideline or data requirement has been satisfied by other studies or has changed.|
Studies reviewed by EPA increased by 3% (or the study review “backlog” decreased by 3%) during FY 2001. At the end of the fiscal year, over 79% of all studies received by the Agency in support of reregistration had been reviewed, compared to only 76% at the end of FY 2000, and less than 75% at the end of 1997. During FY 2001, the Agency made a special effort to clean up the data base used to track the review status of studies submitted for reregistration. Cases with completed REDs, for example, should no longer have studies “awaiting review”; all studies received should have been reviewed or found extraneous by the time a reregistration eligibility decision is made. The increase in the percent of studies reviewed that was reported during FY 2001 may continue in future years as improved, more thorough recordkeeping practices are followed.
E. Aggregate Status of Tolerances Reassessed
During FY 2000, EPA completed 121 tolerance reassessments and ended the fiscal year with a total of 3,554 tolerance reassessment decisions to date, addressing 36.6% of the 9,721 tolerances that require reassessment. During FY 2001, the Agency completed 288 tolerance reassessments and ended the fiscal year with a total of 3,842 tolerance reassessment decisions, addressing nearly 40% of the 9,721 tolerances that require reassessment (See Table 9). Over 63% of the tolerance reassessment decisions completed were for pesticides in priority Group 1.
Just as EPA reassessed 33% of all food tolerances by August 3, 1999, including many tolerances for pesticides identified as posing the greatest potential risks, the Agency also met the next FFDCA goal and completed 66% of all required tolerance reassessment decisions by August 3, 2002. EPA's general schedule for tolerance reassessment (Federal Register, August 4, 1997) identified three groups of pesticides to be reviewed; this grouping continues to reflect the Agency's overall scheduling priorities for tolerance reassessment. EPA continues to give priority to pesticides in Group 1, particularly the OP pesticides.
1. Aggregate accomplishments through reregistration and other programs. EPA is accomplishing tolerance reassessment through the registration and reregistration programs; by revoking tolerances for pesticides that have been canceled (many as a result of reregistration); and through other decisions not directly related to registration or reregistration, described further below. EPA is using the Tolerance Reassessment Tracking System (TORTS) to compile this updated information and report on the status of tolerance reassessment (See Table 9).
|Tolerances Reassessed Through...||During Late FY 96||During FY 1997||During FY 1998||During FY 1999||During FY 2000||Total, End of FY 2000||During FY 2001||Total, End of FY 2001|
|Total tolerances reassessed||28||561||1,398||1,446||121||3,554||288||3,842|
i. Reregistration/REDs. EPA is using the reregistration program to accomplish much of tolerance reassessment. For each of the tolerance reassessment decisions made to date, the Agency has made the finding that there is a reasonable certainty of no harm, as required by FFDCA. Many tolerances reassessed through reregistration remain the same while others may be raised, lowered, or revoked. In completing OP IREDs and TREDs during FY 2000 and FY 2001, the Agency also completed tolerance reassessment decisions for these pesticides. Many of these tolerance reassessments will not become final, however, until the cumulative risks of the OPs have been considered.
ii. Registration. Like older pesticides, all new pesticide registrations must meet the safety standard of FFDCA. Start Printed Page 58049 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 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. During FY 2000 and FY 2001, the Agency has specifically discouraged submission of applications and petitions for any new uses of the OP pesticides, given the need to consider cumulative risks from OP's as a group before any new uses can be fully evaluated.
iii. Tolerance revocations. Revoked tolerances represent uses of many different pesticide active ingredients that have been canceled in the past. Some pesticides were canceled due to the Agency's risk concerns. Others were canceled voluntarily by their manufacturers, based on lack of support for 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.
iv. Other reassessment decisions. In addition to the types of reassessment actions described above, a total of 234 additional tolerance reassessment decisions have been made, not directly related to registration or reregistration. These include 65 tolerances reassessed through the Plant Growth Regulator Rule which were scientifically reviewed and the exemption was retained (64 FR 31501; June 11, 1999) (FRL-6076-5); 80 organophosphate meat, milk, poultry, and egg tolerances that were determined to have no reasonable expectation of finite residue on July 7, 1999; 73 inert polymer tolerances that were determined on July 20, 1999, to meet the terms and criteria of the Toxic Substances Control Act Polymer Exemption Rule; 13 tolerance exemptions for Trichoderma harzianum KRL-AG2 (64 FR 16856; April 7, 1999); 1 tolerance exemption for Bacillus thuringiensis subspecies Kurstake CryIA(c) (62 FR 17722; April 11, 1997); 1 tolerance exemption for red pepper (63 FR 66999; December 4, 1998); and 1 tolerance exemption for cinnamaldehyde (64 FR 7801; February 17, 1999).
2. Accomplishments for priority pesticides. During FY 2000 and FY 2001, EPA completed tolerance reassessment decisions for many high priority pesticides in review, including OPs, carbamates, organochlorines, and carcinogens. (See Table 10.)
|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 organophosphates. EPA has developed an approach for assessing cumulative risk for the OPs as a group, as required by FFDCA. The Agency presented a comprehensive guidance document on cumulative risk assessment to the Scientific Advisory Panel in December 1999, issued draft guidance in 2000 for review and comment, and presented a case study on cumulative risk assessment to the SAP in December 2000. During FY 2001, EPA refined the methodology and began developing components of the OP cumulative preliminary risk assessment. With input from a Committee to Advise on Reassessment and Transition (CARAT) workgroup, the Agency began developing a process to inform stakeholders and the public and encourage their participation during the assessment of OP cumulative risks. At CARAT's recommendation, EPA initiated a series of technical briefings (which continued during early FY 2002) to explain and answer questions about the Agency's methods for assessing OP cumulative hazard, as well as exposure through drinking water, food, and in residential settings. An EPA website has been established to share updated information on pesticide cumulative risk assessment with the public (http://www.epa.gov/pesticides/cumulative.htm). The Agency issued a preliminary OP cumulative risk assessment on December 3, 2001, and issued a revised OP cumulative risk assessment for public comment in June 2002.
Most of the reregistration and tolerance reassessment decisions that EPA is making for the OP pesticides at present will not be considered final until after the Agency considers OP cumulative risks. The results of individual OP assessments (IRED and TRED documents) include risk mitigation measures, however, and any resulting tolerance revocations are counted as completed tolerance reassessments. Once EPA has considered the cumulative risks of the OPs, the Agency will reevaluate individual OP IREDs and TREDs and may issue final REDs for these pesticides.
4. Status of individual OP decisions. The status of each of the 49 known OP pesticides at the end of FY 2001 is reflected in this discussion.
i. OP decisions completed. During FY 2000, through the public participation process, EPA completed risk assessments and made individual risk management decisions for 14 OP pesticides. In addition, a decision reached in FY 1999 concluded EPA's review of another OP pesticide, sulfotepp. During FY 2001, EPA completed risk assessments and made risk management decisions for 10 more OP pesticides, bringing the number of OPs with individual decisions Start Printed Page 58050completed to 25 as of the end of FY 2001. A 26th OP, phosmet, had a partial interim decision completed. (See List 1.) Many OP pesticides not voluntarily canceled will be considered by the Agency in assessing OP cumulative risks.
List 1.—OP Pesticides with Individual Decisions Completed, End of FY 2001
Chlorpyrifos methyl TRED
Ethyl parathion RED
Phosmet Partial IRED
Pirimiphos methyl IRED
Tribufos (DEF) IRED
ii. OP decisions pending. Fourteen other OP pesticides had completed earlier phases of the public participation process and were in final Phase 6, awaiting individual decisions, at the end of FY 2001. EPA is working to complete individual risk management decisions for these 14 pesticides during 2002. See List 2.
List 2.—OP Pesticides with Individual Decisions Pending, End of FY 2001
Phosmet (full IRED)*
*Completed as of August 15, 2002.
iii. Early OP cancellations. Ten OP pesticides were canceled prior to or early in the pilot public participation process. See List 3.
List 3.—OPs Canceled Prior to/Early in the Pilot Public Participation Process
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 2000 and FY 2001, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as “fast track” applications) shown in Table 11.
|FY 2000||FY 2001|
|Me-too product registrations/Fast track||420||391|
|Total applications processed by expedited means||2,680||3,167|
Regarding numbers of applications disapproved, instead 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 2001.
On a financial accounting basis, EPA devoted approximately 29 full-time equivalents (FTEs) in both FY 2000 and FY 2001 to reviewing and processing applications for fast track me-too product registrations and label amendments. The Agency spent approximately $2.6 million in FY 2000 and $2.7 million in FY 2001 in direct costs (not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.
G. Future Schedule for Reregistrations
During the past several years, EPA has been conducting reregistration in conjunction with tolerance reassessment under FFDCA. That law requires the Agency to reassess all existing tolerances over a 10-year period to ensure consistency with the new safety standard, and to consider pesticides that appear to pose the greatest risk first. In prioritizing pesticides for reregistration eligibility review and tolerance reassessment, EPA is continuing to consider their potential risks, as reflected in the Agency's tolerance reassessment schedule published in the Federal Register on August 4, 1997 . EPA is giving highest priority to pesticides in Group 1, including the OP pesticides, and the carbamates, organochlorines, and B2 (probable human) carcinogens.
1. RED, IRED, and TRED Candidate Pesticides for FY 2002. List 4 contains the candidate pesticides for Reregistration Eligibility Decisions (REDs), Interim REDs (IREDs), and Reports on FQPA Tolerance Reassessment Progress and Interim Risk Management Decisions (TREDs) in FY 2002. As in previous years, any pesticides for which decisions are not completed during FY 2002 will automatically become candidates for decisions in FY 2003.
List 4.—FY 2002 RED, IRED, and TRED Candidate Pesticides
Thiabendazole* Start Printed Page 58051
[+ 25 OP IREDs may be counted as REDs once OP cumulative risks are considered]
Voluntary Cancellations that Will Count as REDs
Fenamiphos* (initially prepared as an OP IRED)
OP IRED and TRED Candidates
Phosmet (full IRED)*
Other IRED Candidates
Atrazine (being rescheduled for FY 2003)
Other TRED Candidates
Inorganic bromides from methyl bromide
*Completed as of August 15, 2002.
**TRED completed as of August 15, 2002; RED still to be completed.
2. RED, IRED, and TRED Candidate Pesticides for FY 2003. The candidate pesticides for FY 2003 RED, IRED, and TRED decisions are included in List 5.
List 5.—FY 2003 RED, IRED, and TRED Candidate Pesticides
RED and IRED Candidates
Methanearsonic acid, salts (CAMA, DSMA, and MSMA)
*May be completed as interim decisions if EPA decides that these pesticides belong to the triazoles group and that a common mechanism of toxicity exists.
**May be incorporated into the Fenvalerate RED.
H. Projected Year of Completion of Reregistrations
EPA is now conducting reregistration in conjunction with tolerance reassessment, which FFDCA mandates be completed by 2006. EPA plans to complete reregistration of pesticide active ingredients prior to the statutory deadline for completing tolerance reassessment.Start List of Subjects
List of Subjects
- Environmental protection
- Pesticides and pests
Dated: August 29, 2002.
Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. 02-23265 Filed 9-12-02; 8:45 am]
BILLING CODE 6560-50-S