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Notice

Pesticide Reregistration Performance Measures and Goals

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AGENCY:

Environmental Protection Agency (EPA).

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ACTION:

Notice.

SUMMARY:

This notice announces EPA's progress in meeting its performance measures and goals for pesticide reregistration during fiscal year 2006. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA to publish information about EPA's annual achievements in this area. This notice discusses the integration of tolerance reassessment with the reregistration process, and describes the status of various regulatory activities associated with reregistration and tolerance reassessment. The notice gives total numbers of chemicals and products reregistered, tolerances reassessed, Data Call-Ins issued, and products registered under the “fast-track” provisions of FIFRA. This notice also contains the schedule for completion of activities for specific chemicals during fiscal years 2007 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 [EPA-HQ-OPP-2006-1005], should be received on or before October 22, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-1005, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov/​. Follow the on-line instructions for submitting comments.
  • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
  • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2006-1005. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://www.regulations.gov/​, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov, your e-mail address will be captured automatically and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​docket.htm/​.

Docket: All documents in the docket are listed in the index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.

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FOR FURTHER INFORMATION CONTACT:

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

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to persons who are interested in the progress and status of EPA's pesticide reregistration and tolerance reassessment programs, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date, and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns, and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity, obscene language, or personal threats.

viii. Make sure to submit your comments by the comment period deadline.

II. Background

EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide Start Printed Page 46998reregistration, 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) (which provides for expedited processing and review of similar applications), that were approved or disapproved.
  • The future schedule for reregistrations in the current and succeeding fiscal year.
  • The projected year of completion of the reregistrations under section 4.

FIFRA, 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 required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law. EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health, 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).The Agency met the first two statutory deadlines and substantially met the third, completing over 99% of all required tolerance reassessment decisions by August 3, 2006. These decisions represent significant enhancements in public health and environmental protection. By successfully implementing FQPA, EPA is ensuring that all pesticides used on food in the United States meet the law's new, more stringent safety standard. EPA's approach to tolerance reassessment under FFDCA 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). The Agency's accomplishments under FQPA during the past 10 years are discussed at http://www.epa.gov/​pesticides/​regulating/​laws/​fqpa/​fqpa_​accomplishments.htm.

The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004. Among other things, PRIA directed EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use pesticide REDs by October 3, 2008. The Agency completed 99% of the REDs due by August 3, 2006, and plans to complete all remaining REDs by October 3, 2008. EPA's schedule for meeting these deadlines is available on the Agency's website at http://www.epa.gov/​pesticides/​reregistration/​decision_​schedule.htm.

III. 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) 2006 (from October 1, 2005, through September 30, 2006), EPA made significant progress in completing risk assessments and risk management decisions for pesticide reregistration (See Table 1).

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).Start Printed Page 46999

Table 1.—Reregistration/Risk Management Decisions Completed: In FY 2006 and FY 1991 through FY 2006

FY 2006 DecisionsTotal, FY 1991 through FY 2006
59 FY 2006 REDs (37 REDs + 22 OP IREDs became REDs) ADBAC Aliphatic alkyl quarternaries (DDAC) Aliphatic solvents Alkyl benzene sulfonates Atrazine (2003 IRED became a RED, 4-6-06) Cacodylic acid Chlorine dioxide Copper and oxides Copper compounds II Copper salts Copper sulfate Cypermethrin Dicamba Dichloran (DCNA) Imazapyr Inorganic chlorates (sodium chlorate) Inorganic sulfites Iodine Malathion (OP RED) MCPB Metaldehyde Methanearsonic acid, salts (DSMA, MSMA, CAMA) MGK-264 Mineral bases, weak (sodium carbonate) PCNB Permethrin 2-Phenylphenol and salts Phytophthora palmivora Piperonyl butoxide Propiconazole Propylene oxide Pyrethrins Resmethrin Salicylic acid Simazine (triazine RED) TCMTB Triadimefon330 REDs
22 OP IREDs became REDs on 7-31-06 Acephate Azinphos-methyl Bensulide Chlorpyrifos Diazinon Dichlorvos or DDVP Dicrotophos Dimethoate Disulfoton Ethoprop Methamidophos Methidathion Methyl Parathion Naled Oxydemeton-methyl (ODM) Phorate Phosmet Pirimiphos-methyl Profenofos Propetamphos Terbufos Tribufos (DEF)
4 IREDs Carbofuran (N-methyl carbamate) Dichlorvos (DDVP) (OP IRED, became a RED on 7-31-06) Dimethoate (OP IRED, became a RED on 7-31-06) Formetanate HCl (N-methyl carbamate)4 IREDs
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19 TREDs Acetochlor Amitraz Azadirachitin Bitertanol Boric acid group CP enolpyruvylshikimate-3-phosphate Ethephon Ethylene oxide (ETO) (RED in FY 2007) Inert ingredients of semichemical dispensers Imazaquin Methyl bromide (commodity uses RED & TRED in FY 2006; soil fumigant uses RED in FY 2007) Neomycinphosphotransferase II Oxytetracycline Propazine Rotenone (RED in FY 2007) Sodium Cyanide Streptomycin Triadimenol Tridemorph95 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 2006 in completing Reregistration Eligibility Decisions (REDs) for groups of related pesticide active ingredients or cases is summarized in Table 2.

Table 2.—Overall RED Progress, FY 1991 through FY 2006

REDs completed330 (54%)
Cases canceled229 (37%)
REDs to be completed54 (9%)
Total reregistration cases613 (100%)

ii. Profile of completed REDs. A profile of the REDs completed by the end of FY 2006 is presented in Table 3.

Table 3.—Profile of 330 REDs Completed, FY 1991 through FY 2006

Pesticide active ingredients527
Pesticide productsover 20,000

iii. Risk reduction in REDs. Through the reregistration program, EPA seeks to reduce risks associated with the use of older pesticides. In developing REDs, EPA works with stakeholders including pesticide registrants, growers and other pesticide users, and environmental and public health interests groups, as well as the States, USDA, and other Federal agencies and others to develop measures 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 interim risk management decision. An IRED may include measures to reduce risks from food, drinking water, residential, occupational, and/or ecological exposure while the cumulative risk assessment is pending. For example, EPA generally did not consider individual organophosphate (OP) pesticide decisions made in advance of the cumulative risk assessment to be completed REDs or tolerance reassessments. Instead, the Agency issued IREDs for these chemicals. EPA completed the risk assessments and reregistration eligibility decisions for those OP pesticides with IREDs, once the Agency completed the OP cumulative risk assessment on July 31, 2006.See http://www.epa.gov/​pesticides/​cumulative/​.

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;Start Printed Page 47001
  • EPA completed a RED for the pesticide before FQPA was enacted; 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.

As with IREDs, EPA does 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.

During FY 2006, EPA completed 19 TREDs. By August 3, 2006, EPA also completed tolerance assessment decisions for food use pesticide inert ingredients that are exempted from the tolerance requirement. Almost 900 of the 9,721 tolerance reassessment decisions required by the amended FFDCA were for such inert ingredient tolerance exemptions.

As a result of the FQPA, food-contact surface sanitizing solutions previously regulated by both EPA and the Food and Drug Administration were transferred to EPA's sole jurisdiction. Consequently, the approximately 107 ingredients that made up these sanitizer solutions in 21 CFR 178.1010 were transferred to 40 CFR 180.940. In addition to reassessing the 9,721 tolerances and exemptions for food and feed commodities, EPA also was required to reassess these sanitizer tolerance exemptions by August 3, 2006. The Antimicrobials Division (AD) in EPA's Office of Pesticide Programs is responsible for reassessing exemptions from the requirement of a tolerance for the food-contact surface sanitizing solutions requiring reassessment. AD completed the reassessment of 120 tolerance exemptions in FY 2006, resulting in a total of 174 tolerance exemptions reassessed for the food-contact surface sanitizing solutions.

4. Goals for FY 2007 and future years. EPA's major pesticide reregistration and tolerance reassessment goals for FY 2007 and future years are as follows.

i. Complete individual pesticide risk management decisions. EPA's goal in conducting the reregistration program is to complete 6 remaining Reregistration Eligibility Decisions (REDs) and Interim REDs (IREDs) for pesticides with food uses and 19 REDs for pesticides with no food uses during FY 2007. The Agency plans to complete the remaining 29 non-food use REDs in FY 2008. EPA's schedule for completing these decisions appears near the end of this document, and also is available on the Agency's website at http://www.epa.gov/​pesticides/​reregistration/​decision_​schedule.htm.

ii. Complete tolerance reassessment decisions. EPA completed over 99% of all required tolerance reassessment decisions by August 3, 2006, the 10-year anniversary of FQPA. EPA expects to complete the N-methyl carbamate cumulative risk assessment and the Agency's final 84 tolerance reassessment decisions, thereby completing the FQPA tolerance reassessment program.

iii. Evaluate cumulative risks. EPA completed cumulative risk assessments for the organophosphate (OP), triazine, and chloroacetanilide pesticides during FY 2006. Once EPA completes an individual decision for aldicarb, the Agency will make a cumulative risk finding for the N-methyl carbamate common mechanism group of pesticides. No other groups are scheduled at present for cumulative risk assessments. For further information, see EPA's Assessing Pesticide Cumulative Risk web page, http//www.epa.gov/​pesticides/​cumulative/​index.htm.

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

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

In issuing a completed RED document, EPA sends registrants a 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 2006. 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 2006, EPA completed the product reregistration actions detailed in Table 4.

Table 4.—Product Reregistration Actions Completed during FY 2006

Product reregistration actions169
Product amendment actions40
Product cancellation actions297
Product suspension actions0
Total actions506

2. Status of the product reregistration universe. The status of the universe of pesticide products subject to reregistration at the end of FY 2006 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 2006 (as of September 30, 2006)

Products reregistered2,063
Products amended554
Start Printed Page 47002
Products canceled4,672
Products sent for suspension30
Total products with actions completed7,319
Products with actions pending12,932
Total products in product reregistration universe20,251

The universe of 20,251 products in product reregistration at the end of FY 2006 represented an increase of 8,638 products from the FY 2005 universe of 11,613 products. The increase consists of 8,613 products associated with FY 2006 REDs, IREDs, and TREDs, and 25 products that were added as a result of DCI activities and processing for several previously issued REDs and IREDs.

At the end of FY 2006, 12,932 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, but they are associated with more recently completed REDs. Their product-specific data are not yet due to be submitted to or reviewed by the Agency. EPA's goal is to complete 545 product reregistration actions during fiscal year 2007.

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

1. DCIs for REDs and IREDs. 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 2006 REDs and IREDs are shown in Table 6.

Table 6.—DCIs Issued to Support Product Reregistration for FY 2006 REDs and IREDs

Case NameCase No.Number of Products Covered by the RED1Number of Product Chemistry Studies Required2Number of Acute Toxicology Studies Required3Number of Efficacy Studies Required
ADBAC03501,047PDCI has not been completed yetAntimicrobial RED - Acute toxicity batching not completed yetPDCI has not been completed yet
Aliphatic Alkyl Quarternaries (DDAC)3003382PDCI has not been completed yetAntimicrobial RED - Acute toxicity batching not completed yetPDCI has not been completed yet
Aliphatic Solvents300415831Acute toxicity batching not completed yetPDCI has not been completed yet
Alkylbenzene Sulfonates4006200Antimicrobial RED - Acute toxicity batching not completed yet5
Cacodylic Acid20803631See footnote 4 below0
Chlorine Dioxide402395PDCI has not been completed yetAntimicrobial RED - Acute toxicity batching not completed yetPDCI has not been completed yet
Copper Compounds II064917331Needs batching0
Copper and Oxides4025237PDCI has not been completed yetAcute toxicity batching not completed yetPDCI has not been completed yet
Copper Salts40263831Acute toxicity batching not completed yet0
Copper Sulfate063612731Acute toxicity batching not completed yet0
Cypermethrin21306931Acute toxicity batching not completed yetPDCI has not been completed yet
Start Printed Page 47003
Dicamba006544831Acute toxicity batching not completed yet0
Dichloran (DCNA)0113253154 (1 batch/8 not batched)0
Dichlorvos (DDVP)031010031258 (20 batches/23 not batched)PDCI has not been completed yet
Dimethoate0088543196 (7 batches/9 not batched)0
Formetantate HCL (IRED)009163136 (6 products not batched)0
Imazapyr30781931Acute toxicity batching not completed yet0
Inorganic Chlorates (Sodium Chlorate)40495831156 (9 batches/17 not batched)PDCI has not been completed yet
Inorganic Sulfites4056931Acute toxicity batching not completed yet1
Iodine and Iodophor Complexes3080670126 (12 batches/9 not batched)9
Malathion024815331Acute toxicity batching not completed yetPDCI has not been completed yet
MCPB and Salts236553124 (1 batch/3 not batched)0
Metaldehyde05765231102 (7 batches/10 not batched)0
Methanearsonic acid, salts (Organic Arsenicals) (MSMA/DSMA/CAMA)2395129See footnote 4 belowSee footnote 4 belowSee footnote 4 below
Methyl Bromide (RED/TRED)03351431Not Applicable1
MGK 264243065331Acute toxicity batching not completed yetPDCI has not been completed yet
Mineral Bases, Weak (Sodium Carbonate)40664PDCI has not been completed yetAntimicrobial RED - Acute toxicity batching not completed yetPDCI has not been completed yet
2-Phenylphenol and Salts (Orthophenyl Phenol)2575118PDCI has not been completed yet450 (22 batches/53 not batched)PDCI has not been completed yet
PCNB01288231270 (14 batches/31 not batched)0
Start Printed Page 47004
Permethrin251095731Acute toxicity batching not completed yetPDCI has not been completed yet
Piperonyl Butoxide (PBO)25251,45131Acute toxicity batching not completed yetPDCI has not been completed yet
Propiconazole312517231264 (14 batches/30 not batched)0
Propylene Oxide (PPO)256033118 (3 not batched)0
Pyrethrins25801,28631Acute toxicity batching not completed yetPDCI has not been completed yet
Resmethrin042123231Acute toxicity batching not completed yetPDCI has not been completed yet
Simazine0070443184 (8 batches/6 not batched)0
TCMTB262527PDCI has not been completed yetAntimicrobial RED - Acute toxicity batching not completed yetPDCI has not been completed yet
Triadimefon27005631102 (7 batches/10 not batched)0
Total No. of Products---8,606---------
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.)
4 Ineligible for reregistration; public comments under consideration. Depending on the Agency's formal response to the public comments, PDCIs may or may not be required for these chemicals.

2. DCIs for TREDs. There are cases in which product-specific DCIs may be required for TREDs, particularly if the Agency believes that adequate product chemistry or acute toxicity data are not currently on file to support the reregistration of the products associated with the TREDs. The Agency is requiring product-specific DCIs for the following TRED:

Table 7.—DCIs Issued to Support Product Reregistration for FY 2006 TRED

Case NameCase No.Number of Products Covered by the TRED1Number of Product Chemistry Studies Required2Number of Acute Toxicology Studies Required3Number of Efficacy Studies Required
TriadimenolNA73142 (7 products not batched)0
Start Printed Page 47005
Total No. of Products---7---------
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.)

D. Progress in Reducing the Number of Unreviewed, Required Reregistration Studies

EPA has made progress in reviewing scientific studies submitted by pesticide registrants in support of pesticides undergoing reregistration (See Table 8). The percent of studies reviewed by EPA remained constant in FY 2006.

Table 8.—Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2006

Pesticide Reregistration List, per FIFRA Section 4(c)(2)Studies Reviewed + Extraneous1Studies Awaiting ReviewTotal Studies Received
List A11,262 + 588 = 11,850 (87%)1,788 (13%)13,638
List B6,585 + 1,041 = 7,626 (81%)1,748 (19%)9,374
List C2,097 + 334 = 2,431 (84%)463 (16%)2,894
List D1,266 + 133 = 1,399 (86%)228 (14%)1,627
Total Lists A - D21,210 + 2,096 = 23,306 (84.65%)4,227 (15.35%)27,533 (100%)
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.

E. Aggregate Status of Tolerances Reassessed

During FY 2006, EPA completed 1,820 tolerance reassessments and ended the fiscal year with a total of 9,637 tolerance reassessment decisions to date, addressing over 99% of the 9,721 tolerances that require reassessment (See Table 9).

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, the Agency's highest priority group for reassessment.

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 2006*

Tolerances Reassessed Through...Late FY 96FY 1997FY 1998FY 1999FY 2000FY 2001FY 2002FY 2003FY 2004FY 2005FY 2006Total, End of FY 2006
Reregistration/REDs25339277359444623179874131,0372,937
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Tolerance Reassessments/TREDs00000077614119693061,284
Registration022430834055216200071011,415
Tolerance revocations3081251322355450172751852,362
Other decisions including inerts0102330090526181652911,639
Total tolerances reassessed285641,3971,4451212972,6571194677221,8209.637
*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 to reregistration, and for pesticides with import tolerances only. Tolerance reassessments for the OPs, triazines, and chloroacetanilides (groups with completed cumulative risk assessments) and for pesticides that are not part of a cumulative group may be counted at present and are included in the FY 2006 accomplishments.Tolerance reassessments for pesticides that are part of the N-methyl carbamate cumulative group are not included in the Agency's lists of accomplishments. The reassessment of these 84 tolerances will be completed after EPA completes a cumulative risk evaluation for the group in FY 2007.

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 1,639 additional tolerance reassessment decisions have been made. Some have been made for inert ingredient tolerance exemptions through actions not directly related to registration or reregistration.

2. Accomplishments for priority pesticides. During FY 2006, EPA completed tolerance reassessment decisions for many high priority pesticides in review, including OPs, carbamates, and carcinogens (See Table 10).

Table 10.—Tolerance Reassessments Completed for Priority Pesticides

Pesticide ClassTolerances to be ReassessedReassessed by End of FY 2006
Carbamates545461 (84.6%)
Carcinogens2,0082,008 (100%)
Inert ingredient tolerance exemptions844844 (100%)
Organochlorines253253 (100%)
Organophosphates (OPs)1,6911,691 (100%)
Other4,3804,380 (100%)
Total9,7219,637 (99.1%)
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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, and completed an OP Cumulative Risk Assessment; 2006 Update in August 2006, available on EPA's website at http://www.epa.gov/​pesticides/​cumulative.

EPA completed IREDs and REDs for the three remaining individual OP pesticides (DDVP, dimethoate, and malathion) in FY 2006.With the mitigation measures identified for the individual OP pesticides in the pertinent IREDs completed during the past several years, EPA determined that the cumulative risks associated with the OPs do not exceed the FFDCA safety standard. The individual OP pesticides are indeed eligible for reregistration provided that they met the interim reregistration eligibility criteria of the pertinent IREDs.

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 2006, 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 2006

Me-too product registrations/Fast track308
Amendments/Fast track3,332
Total applications processed by fast track means3,640

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 2006.

On a financial accounting basis, EPA devoted 26.8 full-time equivalents (FTEs) in FY 2006 to reviewing and processing applications for fast track me-too product registrations and label amendments. The Agency spent approximately $3.35 million in FY 2006 in direct costs (i.e., time on task, not including administrative expenses, computer systems, management overhead, and other indirect costs) on expedited processing and reviews.

G. Future Schedule for Reregistrations

EPA plans to complete the remaining 7 REDs for pesticides with food uses in FY 2007, as well as 18 of the remaining non-food use REDs. The remaining 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 is available on EPA's website at http://www.epa.gov/​pesticides/​reregistration/​decision_​schedule.htm.

1. RED and IRED Schedule for FY 2007. List 1 contains pesticides scheduled for Reregistration Eligibility Decisions (REDs) and Interim REDs (IREDs) in FY 2007.

List 1.—FY 2007 RED and IRED Schedule

2,4 DP

Aldicarb (N-methyl carbamate IRED and RED)

Aliphatic alcohols

Aliphatic esters

Alkyl trimethylenediamines

Allethrin stereoisomers

4-Aminopyridine

Antimycin A

Benzoic acid

Bioban-p-1487

Bromonitrostyrene

Chlorflurenol

Dikegulac sodium

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

Glutaraldehyde

MCPP

Mefluidide

Naphthenate salts

Octhilinone

Rotenone (TRED completed in FY 2006)

Trimethoxysilyl quats

The following N-methyl carbamate IREDs will become REDs when EPA completes the cumulative risk assessment for this common mechanism group.

Carbaryl

Carbofuran

Formetanate HCl

Oxamyl

List 2.—FY 2008 REDs Schedule

Acrolein

Amical 48

Busan 77

Chloropicrin

Chromated arsenicals (CCA)

Coal tar/creosote

Dazomet

Flumetralin

Formaldehyde

Grotan

Inorganic thiosulfates (ammonium and calcium thiosulfate)

Methyl bromide (soil fumigant uses RED; commodity uses TRED & RED completed FY 2006)

Methyldithiocarbamate salts (metam sodium/metam potassium)

MITC

Naphthalene

Nicotine

Organic esters of phosphoric acid

p-Dichlorobenzene

Pentachlorophenol

Polypropylene glycol

Prometon

Siduron

Sodium fluoride

Sulfometuron methyl

Sumithrin

TBT-containing compounds

Tetramethrin

Triforine

Triclosan (Ingasan)

H. Projected Year of Completion of Reregistrations

EPA expects to complete seven remaining reregistration eligibility decisions for N-methyl carbamate pesticides and others with food uses in FY 2007, and to complete decisions for the remaining 47 pesticides with no food uses or tolerances during FY 2007 and FY 2008 (by October 3, 2008).Product reregistration, which takes place only after the reregistration eligibility decisions have been completed for the active ingredients, will not likely be completed before 2012.

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List of Subjects

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Dated: August 15, 2007.

James B. Gulliford,

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

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[FR Doc. E7-16560 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-S