In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of request by registrants to voluntarily cancel certain pesticide registrations. EPA intends to grant this request at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the request, or unless the registrants withdraw their request. The cancellation for the allethrins technical products will be effective September 30, 2015, and the cancellation for the allethrins end-use products will be effective December 31, 2016, as described in Unit II. below. If any of these cancellation requests are granted, the Agency will issue a cancellation order that will prescribe conditions pertaining to the sale, distribution, and use of existing stocks of canceled products.
Comments must be received on or before January 17, 2013.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0844, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Molly Clayton, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 603-0522; email address: firstname.lastname@example.org.
I. General Information
A. Does this action apply to me?
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. 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 email. 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.
II. What action is the Agency taking?
This notice announces receipt by the Agency of a request from the technical registrants Valent Biosciences Corporation and Sumitomo Chemical Company Limited to cancel all their allethrins pesticide products registered under FIFRA section 3 or 24(c). These registrations are listed in sequence by registration number in Table 1 of this unit.
The allethrin series of pyrethroid insecticides includes bioallethrin (PC code 004003), esbiol (004004), esbiothrin (004007, formerly 004003/004004), and pynamin forte (004005). The allethrins are members of the pyrethroid class of insecticides. They are used to control flying and crawling insects in a number of commercial, horticultural and residential applications. Common product forms include wasp and hornet aerosols; yard and patio foggers; flying insect killer aerosols; total release aerosols (indoor foggers); mosquito repellants (mats and coils); space sprays; and crawling insect killer aerosols. The allethrins are not registered for use on food, and they have no U.S. tolerances associated with their use; therefore, they are not subject to the Food Quality Protection Act (FQPA). There are currently two technical registrants for the allethrins, with one (Valent BioSciences Corporation) being a subsidiary of the second (Sumitomo Chemical Company).
The allethrins were the subjects of a reregistration eligibility decision (RED), which was completed on June 30, 2007, and amended on May 27, 2009. In reregistration, EPA completed human health and environmental risk assessments for the allethrins. During reregistration, to reduce potential ecological exposure, the registrants voluntarily canceled pet shampoos and dips and large-scale outdoor uses, such as uncultivated agricultural areas and golf courses. Since outdoor uses were thereby limited to localized spot treatments, no ecological mitigation measures were specified in the RED.
On March 31, 2010, the public phase of registration review for the allethrins began with the opening of the initial docket (EPA-HQ-OPP-2010-0022). The comment period for the allethrins registration review docket was open for 60 days, from March 31, 2010, to June 1, 2010. The Final Work Plan (FWP) for the allethrins was completed on August 11, 2010. The Agency's projected registration review timeline described in the FWP established that the preliminary risk assessments would be completed by December 2018, and the final registration decision would be completed in 2020.
The technical registrants subsequently requested cancellation of their allethrins technical products effective September 30, 2015, and cancellation of their end use products effective December 31, 2016.
Table 1—Technical Product Registrations With Pending Requests for Cancellation
|Registration No.||Product name|
|10308-3||Pynamin Forte Technical.|
|73049-394||VBC Bioallethrin 90% Concentrate.|
|73049-395||VBC Esbiol Concentrate.|
Table 2—End-Use Product Registrations With Pending Requests for Cancellation
|Registration No.||Product name|
|73049-157||Cypermethrin/Esbiothrin/Piperonyl Butoxide 0.05%/0.1%/0.4% A.|
|73049-177||DS 205 Insecticide.|
|73049-178||UltraTec DS 215 Insecticide.|
|73049-180||DS 530 Insecticide.|
|73049-183||ULTRATEC DS 210 Insecticide.|
|73049-184||Ultratec KD AC.|
|73049-210||DSP 0.25-2.5-25 AC.|
|73049-354||UltraTec DS OB AC.|
|73049-389||UltraTec DSP 515 Insecticide.|
|73049-390||UltraTec DS 105 OB Insecticide.|
Table 3 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.
Table 3—Registrants Requesting Voluntary Cancellation
|EPA Company No.||Company name and address|
|10308||Sumitomo Chemical Company, Ltd., 1330 Dillon Heights Avenue, Baltimore, MD 21228-1199.|
|73049||Valent BioSciences Corporation, 870 Technology Way, Suite 100, Libertyville, IL 60048-6316.|
III. What is the Agency's authority for taking this action?
Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register.
Section 6(f)(1)(B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) provides for the possibility of a 180-day comment period where the voluntary cancellation involves a pesticide registered for at least one minor agricultural use. Because the allethrins are not registered for any minor agricultural uses, this 180-day comment provision does not apply, and EPA is providing a 30-day comment period on the proposed voluntary cancellation of allethrins registrations.
IV. Procedures for Withdrawal of Request
Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT. If the products have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. Any request for withdrawal should be submitted before the end of the comment period but, as a practical matter, must be received before EPA issues a final order.
V. Existing Stocks
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Because these allethrins products are reregistered pesticides, and there are no known risks of concern, the cancellation date for the technical products will occur five years prior to the time of the planned registration review decision for the allethrins, the Agency expects to grant this request unless the Agency receives substantive comments that warrant further review of the request or the registrants withdraw their request. In 2013, EPA intends to issue an order in the Federal Register canceling all of the technical registrations as of September 30, 2015 and end use product registrations as of December 31, 2016. It is the Agency's current intention to include in that order the following terms and conditions applicable to existing stocks:
- No sale or distribution of allethrins technical products by any person, other than for purposes of disposal or export, will be permitted after September 30, 2015.
- No use of technical allethrins products to formulate end-use products will be permitted after December 31, 2015.
- As of January 1, 2017, persons other than registrants will be allowed to sell, distribute, or use existing stocks of cancelled end use products until such stocks are exhausted. Use of existing stocks will be permitted only to the extent that the use is consistent with the terms of the previously-approved labeling accompanying the product used.
List of Subjects
Environmental protection, Pesticides and pests, Allethrins.
Dated: December 3, 2012.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide Programs.
[FR Doc. 2012-30357 Filed 12-18-12; 8:45 am]
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