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Notice

Pesticide Reregistration Performance Measures and Goals

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Information about this document as published in the Federal Register.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's progress in meeting its performance measures and goals for pesticide reregistration during fiscal year 2003. 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 2004 through 2008.

DATES:

This notice is not subject to a formal comment period. Nevertheless, EPA welcomes input from stakeholders and the general public. Written comments, identified by the docket ID number [OPP-2003-0390], should be received on or before July 6, 2004.

ADDRESSES:

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.

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FOR FURTHER INFORMATION CONTACT:

Carol P. Stangel, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, telephone: (703) 308-8007, e-mail: stangel.carol@epa.gov.

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SUPPLEMENTARY 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. Docket. EPA has established an official public docket for this action under docket ID number OPP-2003-0390. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the “Federal Register” listings at http://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 “Regulating Pesticides,” or go directly to www.epa.gov/​pesticides/​reregistration/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or Start Printed Page 25083delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment, and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

2. EPA Dockets—i. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2003-0390. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0390. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

3. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP- 2003-0390.

4. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0390. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. Background

EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 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. Start Printed Page 25084346a, 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, which is helping us meet 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% by August 3, 2002. EPA has focused 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), carbamate, organochlorine, and B2 (probable human) carcinogen pesticides, the Agency's highest priority for review. Although EPA has directed most of its resources toward this group, a number of Group 1 pesticides are nevertheless being 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). In conducting the pesticide reregistration and tolerance reassessment programs at present, EPA is developing measures that show results in terms of outcomes, as well as traditional outputs, as directed by the Office of Management and Budget (OMB).

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 the past year in each of the program areas included in FIFRA section 4(l).

A. Status of Reregistration

During fiscal year (FY) 2003 (from October 1, 2002, through September 30, 2003), EPA made significant progress in completing risk assessments and risk management decisions for pesticide reregistration (See Table 1).

Table 1.—Reregistration/Risk Management Decisions Completed: FY 2003 and Total

FY 2003: 42 DecisionsTotal, End of FY 2003
13 REDs Dinocap (Voluntary Cancellation) Diuron Fenthion (Voluntary Cancellation)2 Fenvalerate (Voluntary Cancellation) Imazalil MGK Repellent 326 (Dipropyl isocinchomeronate) Molinate (Voluntary Cancellation) Oxadiazon Propanil Sodium acifluorfen Thiophanate-methyl Triethylene glycol Ziram (part of Dimethyldithiocarbamate salts)227 REDs
3 IREDs Atrazine1,3 Carbaryl1,4 Methyl Parathion223 IREDs
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13 TREDs Bacillus popilliae and Bacillus lentimorbus Biochemical volatile attractants Chitin 4-CPA CRYAC 1,4-Dimethyl-naphthalene Farnesol Fenridazone potassium (Voluntary Cancellation and Tolerance Revocation) Lactofen Mustard oil Neem oil Potassium salts of fatty acids Promalin58 TREDs and Inert Tolerance Exemption Reassessment Decisions
13 Inert Tolerance Exemption Reassessment Decisions Aluminum hydroxide Aluminum sulfate Ascorbic acid Barium sulfate Beeswax Benzoic acid Carnauba wax Fatty acids (some) Manganese carbonate Potassium sorbate Sodium benzoate Sorbic acid Sorbitol
1 Subject to NRDC consent decree
2 Organophosphate (OP) pesticide
3 Triazine pesticide
4 Carbamate pesticide

The Agency's decisions are embodied in Reregistration Eligibility Decision (RED) documents, Interim Reregistration Eligibility Decisions (IREDs), and 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 2003 in completing Reregistration Eligibility Decisions (REDs) is summarized in Table 2.

Table 2.—Overall RED Progress, End of FY 2003

REDs completed227 (37%)
Cases canceled231 (38%)
REDs to be completed154 (25%)
Total reregistration cases612 (100%)

ii. Profile of completed REDs. A profile of the 227 REDs completed by the end of FY 2003 is presented in Table 3.

Table 3.—Profile of 227 REDs Completed, End of FY 2003

Pesticide active ingredients326
Pesticide products9,650+
REDs with food uses117
Post-FQPA REDs86
Post-FQPA REDs with food uses*64
*EPA is revisiting 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, and environmental and public health interests, as well as 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.Start Printed Page 25086

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 interim 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 has not considered individual OP pesticide decisions to be completed REDs or tolerance reassessments. Instead, the Agency is issuing IREDs for these chemicals at this time. EPA will complete the risk assessments and may issue REDs for 23 OP pesticides with IREDs, once the Agency completes a cumulative assessment of the OPs.

3. Tolerance reassessment “TREDs.” EPA 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 1, 1984, and is considered a “new” active ingredient, not subject to reregistration (most FY 2003 TREDs are in this category);
  • EPA completed a RED for the pesticide before FQPA was enacted (FY 2003 TREDs Bacillus popilliae and 4-CPA are in this post-RED category); 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 (e.g., mevinphos).

During FY 2003, in addition to completing 13 TREDs, EPA also completed tolerance reassessment decisions for 13 pesticide inert ingredients that are exempted from the tolerance requirement. Almost 1,000 of the 9,721 tolerance reassessment decisions required by the amended FFDCA are for such inert ingredient tolerance exemptions. EPA has reassessed 377 of these inert ingredient tolerance exemptions to date, and plans to complete the reassessment of all the inert ingredient tolerance exemptions by August 2006.

As with IREDs, EPA will not complete risk assessment and risk management for pesticides subject to TREDs that are part of a cumulative group until cumulative risks have been considered for the group.

4. Goals for FY 2004 and future years. EPA's major pesticide reregistration and tolerance reassessment goals for FY 2004 and future years are as follows. In addition to achieving these traditional output-oriented goals, EPA also is working to develop measures that show results in terms of outcomes, as directed by OMB.

i. Complete individual pesticide risk management decisions. EPA's goal in conducting the reregistration and tolerance reassessment program is to complete about 20-40 Reregistration Eligibility Decisions (REDs) and Interim REDs each year during fiscal years 2004 through 2006, giving priority to pesticides with associated tolerances, and to complete about 20 REDs in FY 2007 and in FY 2008 for pesticides with no food uses or tolerances. EPA's schedule for completing these decisions appears near the end of this document.

ii. Complete 100% of tolerance reassessment decisions. EPA is continuing to reassess tolerances within time frames set forth in FFDCA as amended by FQPA, giving priority to those food use pesticides that appear to pose the greatest risk. Integration of the reregistration and tolerance reassessment programs has added complexity to the reregistration process for food use pesticides. The Agency successfully reached its first two tolerance reassessment milestones by completing over 33% of all tolerance reassessment decisions by August 3, 1999, and over 66% by August 3, 2002. EPA is working toward meeting the final FQPA tolerance reassessment goal: To complete 100% of all required tolerance reassessment decisions by August 3, 2006.

iii. Evaluate cumulative risks. Once EPA completes individual risk assessments for the OPs, carbamates and others, the Agency will make cumulative risk findings for each of these common mechanism groups of pesticides. For further information, see EPA's cumulative risk website, http://www.epa.gov/​pesticides/​cumulative/​.

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

At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered. This concluding part of the reregistration process is called “product reregistration.”

In issuing a completed RED document, EPA sends registrants a Data Call-In (DCI) notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED. Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered.

A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process. Ideally, in response to the DCI notice 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 2003. 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 2003, EPA completed the product reregistration actions detailed in Table 4.

Table 4.—Product Reregistration Actions Completed during FY 2003

Product reregistration actions53
Product amendment actions40
Product cancellation actions213
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Product suspension actions5
Total actions311

2. Status of the product reregistration universe. The status of the universe of pesticide products subject to reregistration at the end of FY 2003 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.

Table 5.—Status of the Universe of Products Subject to Product Reregistration, for FY 2003 (as of September 30, 2003)

Products reregistered1,690
Products amended385
Products canceled4,019
Products sent for suspension17
Total products with actions completed6,111
Products with actions pending3,545
Total products in product reregistration universe9,656

The universe of 9,656 products in product reregistration at the end of FY 2003 represented an increase of 1,039 products from the FY 2002 universe of 8,617 products. The increase consists of 493 products associated with FY 2003 REDs, and 516 products associated with IREDs, plus 30 products that were added as a result of DCI activities and processing for several previously issued REDs and IREDs.

At the end of FY 2003, 3,545 products had product reregistration decisions pending. Some pending products await science reviews, label reviews, or reregistration decisions by EPA. Others are 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 is to complete 450 product reregistration actions during fiscal year 2004.

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

1. DCIs for REDs. The number and type of Data Call-In requests or DCIs that EPA is preparing to issue under FIFRA section 3(c)(2)(B) to support product reregistration for pesticide active ingredients included in FY 2003 REDs are shown in Table 6. OMB clearance under the Paperwork Reduction Act is required to issue the DCIs in REDs and IREDs.

Table 6.—DCIs Prepared to Support Product Reregistration for FY 2003 REDs

Case NameCase NumberNumber of Products Covered by the RED1Number of Product Chemistry Studies Required2Number of Acute Toxicology Studies Required3Number of Efficacy Studies Required
Dinocap (Voluntary Cancellation)22000N/AN/AN/A
Diuron004610131Acute toxicity batching has not been finalized.0
Fenthion (Voluntary Cancellation)02906N/AN/AN/A
Fenvalerate (Voluntary Cancellation)228054N/AN/AN/A
Imazalil2325163172 (1 batch/11 products not batched)0
MGK-326 (Dipropyl isocinchomeronate)22159231Acute toxicity batching has not been finalized.0
Molinate (Voluntary Cancellation)243513N/AN/AN/A
Oxadiazon24855331216 (5 batches/31 products not batched)0
Propanil02264231162 (9 batches/18 products not batched)0
Sodium acifluorfen2605103154 (1 batch/8 products not batched)0
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Thiophanate-methyl26806731162 (6 batches/21 products not batched)0
Triethylene glycol3146183472 (4 batches/8 products not batched)0
Ziram2180213148 (4 batches/4 products not batched)0
1 The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the RED document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when the RED is issued). This table reflects the 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.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)

2. DCIs for IREDs. The number and type of data requests or DCIs that EPA is preparing to issue to support product reregistration for pesticide active ingredients included in FY 2003 Interim REDs (IREDs) are shown in Table 7.

Table 7.—DCIs Prepared to Support Product Reregistration for FY 2003 IREDs

Case NameCase NumberNumber of Products Covered by the IRED1Number of Product Chemistry Studies Required2Number of Acute Toxicology Studies Required3Number of Efficacy Studies Required
Atrazine006217422294 (14 batches/35 products not batched)0
Carbaryl008031431852 (37 batches/105 products not batched)5
Methyl parathion0153283136 (3 batches/3 products not batched)0
1 The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the RED document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when the RED is issued). This table reflects the 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.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)

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).Start Printed Page 25089

Table 8.—Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2003

Pesticide Reregistration Group or List, per FIFRA Section 4(c)(2)Studies Reviewed + Extraneous1Studies Awaiting ReviewTotal Studies Received
List A11,190 + 583 = 11,773 (86.8%)1,784 (13.2%)13,557
List B6,500 + 1,028 = 7,528 (81.2%)1,738 (18.8%)9,266
List C2,059 + 334 = 2,393 (83.8%)462 (16.2%)2,855
List D1,221 + 133 = 1,354 (85.6%)228 (14.4%)1,582
Total Lists A - D20,970 + 2,078 = 23,048 (84.55%)4,212 (15.45%)27,260
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 appear to have increased (or the study “backlog” appears to have decreased) significantly during FY 2003. At the end of the fiscal year, nearly 85% of all studies received by the Agency in support of reregistration had been reviewed, compared to 80% at the end of FY 2002. This improvement may have been partly a result of EPA's transition to a new information system, OPPIN. In converting to OPPIN, the Agency cleaned up records used to prepare the annual status of studies report. Duplicates as well as bad and/or erroneous data were removed from the data base, resulting in a lower total number of studies received and a greater percent of studies reviewed. EPA has a high degree of confidence in the new OPPIN data base, which will be used from now on to generate the annual status of studies reports.

E. Aggregate Status of Tolerances Reassessed

During FY 2003, EPA completed 119 tolerance reassessments and ended the fiscal year with a total of 6,626 tolerance reassessment decisions to date, addressing over 68% of the 9,721 tolerances that require reassessment (See Table 9). Sixty percent of all tolerance reassessment decisions completed so far are for pesticides in priority Group 1.

EPA reassessed over 33% of all food tolerances by August 3, 1999, and completed over 66% of all required tolerance reassessment decisions by August 3, 2002, meeting two important statutory deadlines established by the FQPA. EPA's general schedule for tolerance reassessment (62 FR 42020, August 4, 1997) identified three groups of pesticides to be reviewed; this grouping continues to reflect the Agency's overall scheduling priorities. In completing tolerance reassessment, EPA continues to give priority to pesticides in Group 1.

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); by reevaluating pesticides with pre-FQPA REDs, 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).

Table 9.—Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2003*

Tolerances Reassessed Through...During Late FY 96During FY 1997During FY 1998During FY 1999During FY 2000During FY 2001During FY 2002During FY 2003Total, End of FY 2003
Reregistration/REDs253392783594446231791,401
Tolerance Reassessments/TREDs00000077614790
Registration02243083405521620001,343
Tolerance revocations30810513223554501,928
Other decisions01023300904261,164
Total tolerances reassessed285641,3961,4451212972,6561196,626
*Includes corrected counts for some previous years.

i. Reregistration/REDs. EPA is using the reregistration program to accomplish much of tolerance reassessment. For each of the tolerance reassessment decisions made through REDs since enactment of the FQPA, the Agency has made the finding as to whether there is a reasonable certainty of no harm, as required by FFDCA. Many tolerances reassessed through reregistration remain the same while others may be raised, lowered, or revoked.

ii. Tolerance reassessments/TREDs. Tolerances initially evaluated through REDs that were completed before FQPA was enacted in August 1996 now are being reassessed to ensure that they meet the new FFDCA safety standard. EPA issues these post-RED tolerance reassessment decisions as TREDs. The Agency also issues TREDs summarizing tolerance reassessment decisions for some developing REDs, for new pesticide active ingredients not subject Start Printed Page 25090to reregistration, and for pesticides with import tolerances only. Tolerance reassessments for pesticides that are not part of a cumulative group may be counted at present and are included in the FY 2003 accomplishments.Tolerance reassessments for pesticides that are part of a cumulative group are not included in the Agency's lists of accomplishments. These tolerances will be considered again and their reassessment will be completed after EPA completes a cumulative risk evaluation for the group.

iii. Registration. Like older pesticides, all new pesticide registrations must meet the safety standard of FFDCA. Many of the registration applications EPA receives are for new uses of pesticides already registered for other uses. To reach a decision on a proposed new food use of an already registered pesticide, EPA must reassess the aggregate risk of the the existing tolerances, as well as the proposed new tolerances, to make sure there is reasonable certainty that no harm will result to the public from aggregate exposure from all uses.

iv. Tolerance revocations. 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.

v. Other reassessment decisions. In addition to the types of reassessment actions described above, a total of 1,164 additional tolerance reassessment decisions have been made, some for inert ingredient tolerance exemptions, through actions not directly related to registration or reregistration. A list of these other tolerance reassessment decisions with their Federal Register citations is available in the docket for this Federal Register notice.

2. Accomplishments for priority pesticides. During FY 2003, EPA completed tolerance reassessment decisions for many high priority pesticides in review, including OPs, carbamates, organochlorines, and carcinogens (See Table 10).

Table 10.—Tolerance Reassessments Completed for Priority Pesticides

Pesticide ClassTolerances to be ReassessedReassessed by End of FY 2003
Carbamates545303 (55.6%)
Carcinogens2,0081,301 (64.79%)
High hazard inerts53 (60%)
Organochlorines253253 (100%)
Organophosphates1,6911,127 (66.65%)
Other5,2193,639 (69.73%)
Total9,7216,626 (68.16%)

3. Tolerance reassessment and the organophosphates. EPA developed an approach for assessing cumulative risk for the OP pesticides as a group, as required by FFDCA, and applied this methodology in conducting an OP cumulative risk assessment. The Agency issued preliminary and revised OP cumulative risk assessment documents in December 2001 and June 2002, available on EPA's website at http://www.epa.gov/​pesticides/​cumulative.

Through this assessment of the OP pesticides, EPA has evaluated several hundred OP tolerances and found that most require no modification to meet the new FFDCA safety standard. The Agency's regulatory actions on individual OP pesticides during the past few years have substantially reduced the risks of these pesticides. EPA completed a methyl parathion IRED in FY 2003 and plans to complete IREDs for the three remaining individual OP pesticides (DDVP, dimethoate, and malathion) in FY 2005.

Most of the reregistration and tolerance reassessment decisions that EPA has made for the OP pesticides will not be considered complete until after the Agency concludes its cumulative evaluation of the OPs. The results of individual OP assessments (IRED and TRED documents) include significant risk mitigation measures, however, and any resulting tolerance revocations are counted as completed tolerance reassessments. In addition, some OP tolerances that make at most a minimal or negligible contribution to the cumulative risk from OP pesticides were counted as reassessed during FY 2002. Once EPA completes a cumulative evaluation of the OPs, the Agency will reconsider individual OP IREDs and TREDs, and may issue final REDs and tolerance reassessments for these pesticides.

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

By law, EPA must expedite its processing of certain types of applications for pesticide product registration, i.e., applications for end use products that would be identical or substantially similar to a currently registered product; amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses. During FY 2003, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as “fast track” applications) shown in Table 11.

Table 11.—Fast Track Applications Approved in FY 2003

Me-too product registrations/Fast track417
Start Printed Page 25091
Amendments/Fast track5,193
Total applications processed by expedited means5,610

For those applications not approved, the Agency generally notifies the registrant of any deficiencies in the application that need to be corrected or addressed before the application can be approved. Applications may have been withdrawn after discussions with the Agency, but none were formally “disapproved” during FY 2003.

On a financial accounting basis, EPA devoted over 28 full-time equivalents (FTEs) in FY 2003 to reviewing and processing applications for fast track me-too product registrations and label amendments. The Agency spent approximately $3 million in FY 2003 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.

G. Future Schedule for Reregistrations

EPA plans to complete tolerance reassessment by August 3, 2006, as required by FFDCA, and also to complete reregistration eligibility decisions for pesticides with food uses by that date. REDs for pesticides that have no food uses or tolerances will be completed by October 3, 2008. The Agency's schedule for completing these decisions is as follows. This schedule also will be available on EPA's website at http://www.epa.gov/​pesticides/​reregistration.

1. RED, IRED, and TRED Schedules for FY 2004, FY 2005, and FY 2006. Lists 1, 2, and 3 contain pesticides scheduled for Reregistration Eligibility Decisions (REDs), Interim REDs (IREDs), and Reports on FQPA Tolerance Reassessment Progress and Risk Management Decisions (TREDs) in FY 2004, FY 2005, and FY 2006. Although these lists may change due to the dynamic nature of the review process, EPA is committed to meeting the reregistration and tolerance reassessment deadlines. Any pesticides for which decisions are not completed during the current fiscal year will be rescheduled for decisions the following year.

List 1.—FY 2004 RED, IRED, and TRED Schedule

REDs

Benfluralin

Benzisothiazolin-3-one (BIT)

Carboxin

Cycloate

Dihalodialkyldantoins

Ethoxyquin

MCPA

Naphthalene acetic acid

Naptalam

Omadine salts

Phenol and salts

PHMB

Pine oils

Propylene/dipropylene glycol

Sabadilla alkaloids

Sulfonated oleic acid

Thiram

IREDs

Atrazine revised IRED (due and completed 10-31-03)

Formetanate HCl

TREDs

Amitraz

Bacillus thuringiensis var. San Diego (completed)

Boric Acid Group

Carbon dioxide (completed)

Chlorimuron ethyl

DCPA or dacthal

Desmedipham

Dimethenamid

Flumetsulam

Fluridone

Limonene

Nitrogen (completed)

Oil of lemon

Oil of orange

Oryzalin

Putrescent whole egg solids

Thifensulfuron methyl

Tribenuron methyl

Trifluralin

List 2—FY 2005 RED, IRED, and TRED Schedule

REDs

2 Phenylphenol and salts

2,4-D

2,4-DB

Ametryn

Aquashade

Azadioxabicyclo-octane

Benzoic acid

Cacodylic acid

Chlorine dioxide

Chloroneb

Chlorsulfuron

Chromated arsenicals (CCA)

Coal tar/creosote

Dimethipin

Dimethyldithiocarbamate salts (rest of case) (Ferbam)

Endothall

Ethofumesate

Fluometuron

Inorganic chlorates

Iodine

Mancozeb

Maneb

Metam sodium/metam potassium

Methanearsonic acid, salts (MSMA, DSMA, CAMA)

Methyl bromide

Methyl isothiocyanate (MITC)

Metiram

Napropamide

Nitrapyrin

PCNB

Pentachlorophenol

Phenmedipham

Phytophtora palmivora

Pyrazon

Sodium fluoride

Thidiazuron

IREDs

Dichlorvos (DDVP)

Dimethoate

Malathion

TREDs

Burkholderia cepacia

Cyhexatin

Ethephon

Fluazifop-p-butyl

Flumiclorac-pentyl

Imazethebenz

Maleic hydrazide

Methyl eugenol

Nicosulfuron

Sulfuric acid monourea

Tanol derivatives

List 3.—FY 2006 RED, IRED, and TRED Schedule

REDs

Aliphatic solvents

Aromatic solvents

Chloropicrin

Copper and oxides

Copper compounds

Copper sulfate

Cypermethrin

Dicamba

Dichloran (DCNA)

Dodine

Ethylene oxide

Fluvalinate

Formaldehyde

Imazapyr

Inorganic polysulfides

Inorganic sulfites

MCPB

Metaldehyde

MGK-264

Naphthenate salts

Permethrin

Piperonyl butoxide

Propiconazole

Propylene oxide

Pyrethrins

Resmethrin

Rotenone

Salicylic acid

Sethoxydim

TCMB

Triadimefon

IREDs

Aldicarb

Carbofuran

Simazine

TREDs

Acetochlor

AmmoniaStart Printed Page 25092

Azadirachitin

Benzaldehyde

Bitertanol

Bromine

Ethalfluralin

Fomesafen

Imazaquin

Menthol

Oxytetracycline

Procymidone

Propazine

Sodium cyanide

Streptomycin

Tetradifon

Triadimenol

Tridemorph

2. Post-2006 REDs. REDs for pesticides with no associated tolerances will be completed in FY 2007 and FY 2008, unless decisions for these pesticides can be completed sooner. Lists 4 and 5 contain pesticides scheduled for REDs in FY 2007 and FY 2008.

List 4.—FY 2007 RED Schedule

2,4-DP

4-t-Amylphenol

Acrolein

Aliphatic alcohols

Aliphatic esters

Allethrins

Amical 48

Antimycin A

Bioban-p-1487

Busan 77

Chlorflurenol

Copper salts

Dazomet

Dikegulac sodium

Glutaraldehyde

Groton

Irgasan

MCPP

Octhilinone

TBT-containing compounds

Trichloromelamine

List 5.—FY 2008 RED Schedule

4-Amionpyradine

ADBAC

Aliphatic alkyl quaternaries

Alkyl trimethylenediamines

Alkylbenzene sulfonates

Bromonitrostyrene

Flumetralin

Mefluidide

Methoxychlor

Naphthalene

Nicotine

p-Dichlorobenzene

Polypropylene glycol

Prometon

Siduron

Sulfometuron methyl

Sumithrin

Tetramethrin

Triforine

Trimethoxysilyl quats

H. Projected Year of Completion of Reregistrations

EPA generally is conducting reregistration in conjunction with tolerance reassessment, which FFDCA mandates be completed by August 2006. EPA plans to meet the statutory deadline for completing tolerance reassessment, and in so doing, to complete reregistration eligibility decisions for pesticides with tolerances. The Agency expects to complete remaining reregistration eligibility decisions for pesticides with no food uses or tolerances during FY 2007 and FY 2008.

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List of Subjects

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Dated: April 22, 2004.

Margaret Schneider,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

End Signature End Supplemental Information

[FR Doc. 04-10213 Filed 5-4-04; 8:45 am]

BILLING CODE 6560-50-S