Environmental Protection Agency (EPA).
This notice announces EPA's progress in meeting its performance measures and goals for pesticide reregistration during fiscal year 2008. 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, Data Call-Ins issued, and products registered under the “fast-track” provisions of FIFRA.
This notice is not subject to a formal comment period. Nevertheless, EPA welcomes input from stakeholders and the general public. Written comments, identified by the docket identification (ID) number EPA-HQ-OPP-2008-0897, should be received on or before July 13, 2009.
Submit your comments, identified by docket ID number EPA-HQ-OPP-2008-0897, 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2008-0897. 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 regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be captured automatically and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at 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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. Although this action may be of particular interest to persons who are interested in the progress and status of EPA's pesticide reregistration and tolerance reassessment programs, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked Start Printed Page 22542will 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.
EPA must establish and publish in the Federal Register its annual performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, under section 4(l) of FIFRA, 7 U.S.C. 136a-1(l). Specifically, such measures and goals are to include:
- The status of reregistration.
- The number of products reregistered, canceled, or amended.
- The number and type of data requests or Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) issued to support product reregistration by active ingredient.
- Progress in reducing the number of unreviewed, required reregistration studies.
- The aggregate status of tolerances reassessed.
- The number of applications for registration submitted under subsection (4)(k)(3) (which provides for expedited processing and review of certain 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 authorized 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 could be declared “eligible” for reregistration. To be eligible, an older pesticide must have a substantially complete data base, and must not cause unreasonable adverse effects to human health or the environment when used according to Agency approved label directions and precautions.
In addition, all pesticides with food uses must meet the safety standard of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a. Under FFDCA, EPA must make a determination that pesticide residues remaining in or on food are “safe”; that is, “that there is reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue” from dietary and other sources. In determining allowable levels of pesticide residues in food, EPA must, among other requirements, perform a comprehensive assessment of each pesticide's risks, considering:
- Aggregate exposure (from food, drinking water, and residential uses).
- Cumulative effects from all pesticides sharing a common mechanism of toxicity.
- Possible increased susceptibility of infants and children.
- Possible endocrine or estrogenic effects.
The 1996 FFDCA amendments also required the reassessment of all existing tolerances (pesticide residue limits in food) and tolerance exemptions within 10 years, to ensure that they met the safety standard of the law. EPA was directed to give priority to the review of those pesticides that appeared to pose the greatest risk to public health. The Agency completed the last of 9,721 required tolerance reassessment decisions in September 2007, ensuring that all pesticides used on food in the United States meet the law's safety standard. EPA's approach to tolerance reassessment under FFDCA was described fully in the Agency's document, “Raw and Processed Food Schedule for Pesticide Tolerance Reassessment” (62 FR 42020, August 4, 1997) (FRL-5734-6).
The Pesticide Registration Improvement Act (PRIA) of 2003 became effective on March 23, 2004 (7 U.S.C. 136w-8). Among other things, PRIA directed EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use pesticide REDs by October 3, 2008. The Agency completed decisions for the last of 613 reregistration pesticide cases in September 2008, meeting the PRIA deadline. REDs are available on the Agency's Pesticide Reregistration Status Web page, http://www.epa.gov/pesticides/reregistration/status.htm.
III. Program Accountability
Through this summary of performance measures and goals for pesticide reregistration, tolerance reassessment, and expedited registration, EPA describes progress made during the past year in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2008 (from October 1, 2007, through September 30, 2008), EPA completed risk assessments and risk management decisions for the last 27 of 613 pesticide cases that were subject to reregistration. The Agency's decisions are embodied in RED documents (see Table 1).
|FY 2008 Decisions||Total, FY 1991 through FY 2008|
|27 FY 2008 REDs:||384 REDS|
|Chromated arsenicals (CCA)|
|Diiodomethyl p-tolyl sulfone (Amical 48)|
|Ethylene oxide (ETO)|
|Inorganic thiosulfates (ammonium thiosulfate)|
|Methyl bromide (soil fumigant uses RED; commodity uses TRED & RED completed FY 2006)|
|Methyl isothiocyanate (MITC)|
|Methyldithiocarbamate salts (metam sodium/metam potassium)|
|Organic esters of phosphoric acid|
|Start Printed Page 22543|
Through the reregistration program, EPA reviewed current scientific data for older pesticides (those initially registered before November 1984), reassessed their effects on human health and the environment, and required risk mitigation measures as necessary. Pesticides that had sufficient supporting data and whose risks could be successfully mitigated were declared “eligible” for reregistration.
1. Overall RED progress. In FY 2008, EPA completed the last of 613 required reregistration eligibility decisions (see Table 2).
|REDs completed||384 (63%)|
|Cases canceled||229 (37%)|
|REDs to be completed||0 (0%)|
|Total reregistration cases||613 (100%)|
2. Risk reduction in REDs. Through the reregistration program, EPA has reduced risks associated with the use of older pesticides. In developing REDs, EPA worked with stakeholders including pesticide registrants, growers and other pesticide users, and environmental and public health interests groups, as well as the States and Tribes, USDA and other Federal agencies, and other entities to develop measures to effectively reduce risks of concern. Almost every RED includes some measures or modifications in how a pesticide can be legally used to reduce risks. The options for such risk reduction were extensive and included voluntary cancellation of pesticide products or deletion of uses; declaring certain uses ineligible or not yet eligible (and then proceeding with follow-up action to cancel the uses or require additional supporting data); restricting use of products to certified applicators; limiting the amount or frequency of use; improving use directions and precautions; requiring more protective clothing and equipment; requiring special packaging or engineering controls; requiring no-treatment buffer zones; employing ground water, surface water, or other environmental and ecological safeguards; and other measures.
B. Product Reregistration; Numbers of Products Reregistered, Canceled, and Amended
At the end of the reregistration process, after EPA has issued a RED and declared a pesticide reregistration case eligible for reregistration, individual end-use products that contain pesticide active ingredients included in the case still must be reregistered. This concluding part of the reregistration process is called “product reregistration.”
In issuing a completed RED document, EPA sends registrants a DCI notice requesting any product-specific data and specific revised labeling needed to complete reregistration for each of the individual pesticide products covered by the RED. Based on the results of EPA's review of these data and labeling, products found to meet FIFRA and FFDCA standards may be reregistered.
A variety of outcomes are possible for pesticide products completing this final phase of the reregistration process. Ideally, in response to the DCI notice, the pesticide producer, or registrant, will submit the required product-specific data and revised labeling, which EPA will review and find acceptable. At that point, the Agency may reregister the pesticide product. If, however, the product contains multiple active ingredients, the Agency instead would first require the registrant to amend the product's registration, incorporating the labeling changes specified in the RED as interim measures. A product with multiple active ingredients could not be fully reregistered until the last active ingredient in its formulation was 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 2007. EPA counts each of the post-RED product outcomes described above as a product reregistration action. A single pesticide product may be the subject of several product reregistration actions within the same year. For example, a product's registration initially may be amended, then the product may be reregistered, or the product may first be suspended and later it may be voluntarily canceled. During FY 2007, EPA completed the product reregistration actions detailed in Table 3.
|Product reregistration actions||538|
|Product amendment actions||70|
|Product cancellation actions||370|
|Product suspension actions||0|
2. Status of the product reregistration universe for FY 2007. EPA also keeps track of the status of the universe of products subject to reregistration, that is, the overall number of products reregistered, amended, canceled, and sent for suspension, as well as the number of products with actions pending, as of the end of the fiscal year. 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 4 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 fluxuate.
|Products sent for suspension||6|
|Total products with actions completed||8,285|
|Products with actions pending||13,066|
|Start Printed Page 22544|
|Total products in product reregistration universe||21,351|
The universe of products in product reregistration at the end of FY 2007 represented an increase of 1,100 products from the FY 2006 universe of 20,251 products. The increase consists of 1,099 products associated with FY 2007 REDs, and one product that was added as a result of DCI activities and processing for previously issued REDs.
At the end of FY 2007, 13,066 products had product reregistration decisions pending. Some pending products awaited science reviews, label reviews, or reregistration decisions by EPA. Others were not yet ready for product reregistration actions, but were associated with more recently completed REDs. Their product-specific data were not yet due to be submitted to or reviewed by the Agency.
3. Product reregistration actions and universe in FY 2008.In response to 2009 findings by EPA's Office of the Inspector General resulting from the annual FIFRA Financial Statements Audit, the EPA Office of Pesticide Programs (OPP) is reviewing product reregistration actions completed in FY 2008 and will make any needed corrections. OPP expects to complete this review by December 31, 2009. In next year's Performance Measures and Goals Federal Register notice reporting on actions completed in FY 2009, the Agency plans to provide numbers of product reregistration actions completed in FY 2008 and in FY 2009.
4. Product reregistration goal in FY 2009. EPA's goal is to complete 1,275 product reregistration actions during FY 2009. Additional information is available on EPA's Product Reregistration Web page, http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.
C. Number and Type of DCIs to Support Product Reregistration by Active Ingredient
The number and type of product-specific Data Call-In (PDCI) requests that EPA intends to issue under FIFRA section 3(c)(2)(B) to support product reregistration for pesticide active ingredients included in FY 2008 REDs are shown in Table 5.
|Case Name||Case No.||Number of Products Covered by the RED1||Number of Product Chemistry Studies Required2||Number of Acute Toxicology Studies Required3||Number of Efficacy Studies Required|
|Acrolein||2005||8||31||6 (1 batch)||0|
|Busan 77||3034||149||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Chromated Arsenicals (CCA)||0132||21||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Creosote/Coal Tar||0139||14||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Dazomet||2135||22||31||42 (2 batches/5 products not batched)||0|
|Diiodomethyl-p-tolyl sulfone (Amical 48)||4009||9||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Ethylene Oxide||2275||26||31||Not Applicable4||0|
|Formaldehyde||0556||9||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|HHT (Grotan)||3074||17||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Inorganic Thiosulfates (Ammonium Thiosulfate)||4057||1||31||6 (1 product not batched)||0|
|Methyl Bromide (soil fumigant uses)||0335||73||31||Not Applicable4||2|
|Start Printed Page 22545|
|Methyl Isothiocyanate (MITC)||2405||2||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Methyldithiocarbamate Salts (Metam Sodium/Metam Potassium)||2390||55||31||66 (6 batches/5 products not batched)||0|
|Naphthalene||0022||9||31||12 (1 batch/1 product not batched)||0|
|Nicotine (Cancellation)||2460||1||Not Applicable||Not Applicable5||Not Applicable|
|Organic Esters of Phosphoric Acid||4122||2||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Pentachlorophenol||2505||6||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|d-Phenothrin (Sumithrin)||0426||195||31||Acute toxicity batching has not been completed||PDCI has not been completed|
|Prometon||2545||52||31||90 (10 batches/5 products not batched)||0|
|Siduron||3130||19||31||54 (3 batches/6 products not batched)||0|
|Sodium Fluoride||3132||7||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Sulfometuron Methyl||3136||28||31||84 (7 batches/7 products not batched)||0|
|TBT-Containing Compounds||2620||29||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Tetramethrin||2660||292||31||276 (17 batches/29 products not batched) 6||6|
|Triclosan (Irgasan)||2340||20||31||Antimicrobial RED--Acute toxicity batching has not been completed||PDCI has not been completed|
|Triforine||2720||3||31||Acute toxicity batching has not been completed||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 current number of products associated with each RED, as they are being tracked for product reregistration.~|
|2 This column shows the number of product chemistry studies that are required for each product covered by the RED.Start Printed Page 22546|
|3 In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA batches products that can be considered similar from an acute toxicity standpoint. For example, 1 batch could contain 5 products. In this instance, if 6 acute toxicology studies usually were required per product, only 6 studies (rather than 30 studies) would be required for the entire batch. Factors considered in the sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and bioIogica~l 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 Acute toxicity data are not required for the chloropicrin, ethylene oxide, and methyl bromide PDCIs; these chemicals are highly toxic and toxicity categories are already established for all products.|
|5 The Nicotine RED is a cancellation; therefore, neither a PDCI nor acute toxicity data are required.|
|6 A majority of the tetramethrin products also contain MGK-264, PBO, and pyrethrins as active ingredients. These products were included in the acute toxicity batching for the MGK-264, PBO, and Pyrethrins REDs, issued in FY 2006. The registrants of these products would either submit or cite acute toxicity data according to the acute toxicity batchings in those REDs. If the acute toxicity data are acceptable, the data will support the product for all of the active ingredients (MGK-264, PBO, pyrethrins and tetramethrin). Therefore, only 138 products that contain tetramethrin as an active ingredient are included in the acute toxicity batching for FY 2008.|
D. Progress in Reducing the Number of Unreviewed, Required Reregistration Studies
EPA made progress during FY 2008 in reducing the number of studies still categorized as “unreviewed” that were submitted by registrants in support of pesticides undergoing reregistration. During 2008, the Agency reduced by 5% the number of studies for List A pesticides categorized as unreviewed, and reduced by almost 3% the number of such studies for all pesticides. The Agency is exploring options for further categorizing reregistration studies more precisely (see Table 6).
|Pesticide Reregistration List, per FIFRA Section 4(c)(2)||Studies Reviewed (including cited1) + Extraneous2||Studies Awaiting Review||Total Studies Received|
|List A||12,095 reviewed (includes 779 cited) + 663 extraneous = 12,758 (92%)||1,071 (8%)||13,829|
|List B||6,748 reviewed (includes 88 cited) + 1,081 extraneous = 7,829 (82%)||1,738 (18%)||9,567|
|List C||2,131 reviewed (includes 29 cited) + 351 extraneous = 2,482 (84%)||461 (16%)||2,943|
|List D||1,280 reviewed (includes 3 cited) + 136 extraneous = 1,416 (86%)||228 (14%)||1,644|
|Total Lists A - D||22,254 reviewed (includes 899 cited) + 2,231 extraneous = 24,485 (87.5%)||3,498 (12.5%)||27,983 (100%)|
|1 Cited studies is a term used to classify those studies that are referenced in REDs, RED bibliographies, or related science support documents.|
|2 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. 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 (me too products); amendments to current product registrations that do not require review of scientific data; and products for public health pesticide uses. During FY 2008, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as “fast track” applications) shown in Table 7.
|Me-too product registrations/Fast track||411|
|Total applications processed by fast track means||2,968|
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 2008.
On a financial accounting basis, EPA devoted 25.6 full-time equivalents (FTEs) in FY 2008 to reviewing and processing applications for fast track me-too product registrations and label amendments. The Agency spent approximately $3.3 million in FY 2008 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.
F. Projected Year of Completion of Reregistrations
EPA completed the 27 remaining reregistration eligibility decisions in FY 2008. Product reregistration, which takes place only after the reregistration eligibility decisions have been Start Printed Page 22547completed for the active ingredients, will not likely be completed before 2014.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: May 1, 2009.
Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. E9-10758 Filed 5-12-09; 8:45 am]
BILLING CODE 6560-50-S