Environmental Protection Agency (EPA).
This notice announces EPA's progress in meeting its performance measures and goals for pesticide reregistration during fiscal years 2009 and 2010. 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 the total numbers of products reregistered and products registered under the “fast-track” provisions of FIFRA.Start Printed Page 11457
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-2009-0909, should be received on or before May 2, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0909, 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility'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-OPP-2009-0909. EPA's policy is that all comments received will be included in the 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 Web site 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 automatically captured and included as part of the comment that is placed in the 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.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Carol P. Stangel, Pesticide Re-evaluation Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (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 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 or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
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(1). 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 of 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 section 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.Start Printed Page 11458
- 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 or 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 (Pub. L. 108-199, Div. G, Title V, Sec. 501, 118 Stat. 419). Among other things, PRIA amended FIFRA section 4(g)(2) to require EPA to complete Reregistration Eligibility Decisions (REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete all non-food use 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 each of the past 2 years in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
EPA had no remaining reregistration eligibility decisions to complete in FY 2009 or FY 2010; the last decisions for 613 reregistration cases were completed in FY 2008.
During FY 2009 and FY 2010, the Agency focused on completing product reregistration decisions.
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, 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 2008, FY 2009, and FY 2010. 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. As a result of 2009 findings by EPA's Office of the Inspector General from the annual FIFRA Financial Statements Audit, EPA's Office of Pesticide Programs has reviewed product reregistration actions completed in FY 2008. Final numbers of FY 2008 product reregistration actions as well as FY 2009 and FY 2010 actions are presented in Table 1.
|Actions||FY 2008||FY 2009||FY 2010|
|Product reregistration actions||697||603||484|
|Product amendment actions||205||292||40|
|Product cancellation actions||309||869||1,188|
|Start Printed Page 11459|
|Product suspension actions||3||5||6|
2. Status of the product reregistration universe for FY 2008, FY 2009, and FY 2010. 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 2 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.
|Status||FY 2008||FY 2009||FY 2010|
|Products sent for suspension||9||14||20|
|Total products with actions completed||9,493||11,262||12,980|
|Products with actions pending||12,746||10,860||9,059|
|Total products in product reregistration universe||22,239||22,122||22,039|
At the end of FY 2010, 9,059 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.
The universe of products in product reregistration has increased in some years and decreased in other years. Generally, an increase resulted from products associated with the most recently completed REDs, while a decrease was due to fluctuations in numbers of products associated with product-specific DCIs (PDCIs).
During FY 2010, EPA refined the number and status of products in the product reregistration universe, and the Agency will use the revised numbers in reporting on the status of the universe starting in FY 2011. By identifying and including products that were canceled between the time when REDs were signed and product-specific DCIs were issued, the Agency has been able to more precisely define the universe of products that are subject to product reregistration. This will enable the Agency to more accurately track the status of products undergoing product reregistration, describe progress in meeting program goals, and carry out plans to complete remaining product reregistration decisions during the next few years.
3. Product reregistration goal in FY 2011. EPA's goal is to complete 1,500 product reregistration actions during FY 2011. Additional information is available on EPA's Product Reregistration web page, http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.
C. Progress in Reducing the Number of Unreviewed, Required Reregistration Studies
EPA completed the last REDs in 2008, so all necessary studies to make reregistration eligibility decisions for all active ingredients subject to reregistration have been reviewed. Some of the Agency's records, however, still incorrectly depicted a number of reregistration studies as “in review.” From August 2008 to August 2010, the Agency conducted an internal examination and clean-up of these records in order to more precisely categorize reregistration studies still depicted as “in review.” As shown in Table 3, as a result of this clean-up effort, the Agency succeeded in determining that most reregistration studies (26,019 or more than 94% of the 27,645 studies received) have been reviewed or found to be extraneous. Only 5.9% (1,626) of these studies are still depicted in our data base as “in review.” EPA believes the remaining studies to be duplicative, unnecessary, or already reviewed, because the Agency has completed REDs for all pesticides subject to reregistration and no registrant has objected that the Agency failed to consider a submitted study. At this time, the Agency does not plan to spend further resources examining these records.Start Printed Page 11460
|Pesticide reregistration list, per FIFRA section 4(c)(2)||Studies reviewed (including cited or extraneous)||Studies still “in review”||Total studies received|
|List A||12,960 (95%)||714 (5%)||13,674|
|List B||8,789 (93%)||650 (7%)||9,439|
|List C||2,800 (97%)||95 (3%)||2,895|
|List D||1,470 (90%)||167 (10%)||1,637|
|Total Lists A—D||26,019 (94.1%)||1,626 (5.9%)||27,645 (100%)|
D. 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 2009 and FY 2010, EPA considered and approved the numbers of applications for registration requiring expedited processing (also known as “fast track” applications) shown in Table 4.
|FY 2009||FY 2010|
|Me-too product registrations/Fast track||372||260|
|Total applications processed by fast track means||3,025||3,651|
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 “denied” during FY 2009 or FY 2010.
On a financial accounting basis, EPA devoted 17.8 full-time equivalents (FTEs) in FY 2009 and 16.6 FTEs in FY 2010 to reviewing and processing applications for fast track me-too product registrations and label amendments. The Agency spent approximately $2.4 million in FY 2009 and $2.35 million in FY 2010 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 last reregistration eligibility decisions in FY 2008. Product reregistration will not likely be completed before 2014.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: February 24, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
[FR Doc. 2011-4649 Filed 3-1-11; 8:45 am]
BILLING CODE 6560-50-P