This PDF is the current document as it appeared on Public Inspection on 03/25/2014 at 08:45 am.
Environmental Protection Agency (EPA).
This notice announces EPA's order for the cancellations, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1 of Unit II., pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows a January 22, 2014 Federal Register notice of receipt of requests from the registrants listed in Table 2 of Unit II. to voluntarily cancel these product registrations. In the January 22, 2014 Federal Register notice, EPA indicated that it would issue an order implementing the cancellations, if appropriate according to the terms of the requests, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests, or unless the registrants withdrew their requests. The Agency received one comment on the January 22, 2014 Federal Register notice which is addressed in Unit III., the registrants did not withdraw their requests, and cancellation is appropriate according to the terms of the requests. Accordingly, EPA hereby issues this cancellation order granting the requested cancellations. Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.
The cancellations are effective April 1, 2015.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Kaitlin Keller, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8172; email address: 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, 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. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0207 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
II. What action is the Agency taking?
This notice announces the cancellation, as requested by registrants, of products registered under FIFRA section 3. These registrations are listed in sequence by registration number in Table 1.
|EPA Registration number||Product name||Chemical name|
|2517-61||Sergeant's Dual Action Flea & Tick Collar (With D-Phenothrin)||Propoxur, MGK 264, Phenothrin.|
|Start Printed Page 16794|
|2517-78||Sergeant's Sendran Flea & Tick Collar||Propoxur.|
|2517-144||Sergeant's 933 Plus Flea & Tick Collar (With D-Phenothrin and Pyriproxy- fen)||Propoxur, MGK 264, Phenothrin, Pyriproxy- fen.|
|2724-254||Dog Collar for Flea Control||Propoxur.|
|2724-275||Propoxur Flea Collar for Cats RF-101||Propoxur.|
|2724-491||RF 9907 Flea Collar for Cats and Kittens||Propoxur, S-Methoprene.|
|2724-493||RF-2007 Collar||Propoxur, S-Methoprene.|
Table 2 includes the names and addresses of record for all registrants of the products in Table 1, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1.
|EPA company number||Company name and address|
|2517||Sergeant's Pet Care Products, Inc., 10077 South 134th Street, Omaha, NE 68138|
|2724||Wellmark International, 1501 E. Woodfield Road, Suite 200 West, Schaumburg, IL 60173|
III. Summary of Public Comments Received and Agency Response to Comments
During the public comment period provided, EPA received one comment from the Natural Resources Defense Council (NRDC), in response to the January 22, 2014 Federal Register notice announcing the Agency's receipt of the requests for voluntary cancellations of products listed in Table 1 of Unit II. In its comments, NRDC raises concerns that the proposed cancellation will not adequately protect children from the risks of exposure to propoxur pet collars because it would allow the registrants to increase production prior to cancellation, potentially allow the registrants to substitute their registrations with different formulations of propoxur pet collars, and permit unsafe products to remain on the market indefinitely. NRDC also claims that the methodologies utilized in EPA's most recent September 2013 risk assessment, Propoxur Occupational and Residential Exposure (ORE) Assessment in Response to the Natural Resources Deference Council Petition for Pet Collars, underestimate the risk of propoxur pet collar exposure to children. EPA risk assessment methodology uses the procedures reviewed and endorsed by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panels (SAPs). EPA believes the use of FIFRA SAP-reviewed 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment s, as well as the refinements based on propoxur-specific data, appropriately characterize the risks of concern for propoxur pet collars in the September 2013 propoxur ORE assessment.
Wellmark International's (Wellmark's) voluntary cancellation request, dated September 9, 2013, also contained a request that the current Wellmark registrations for propoxur pet collars listed in Table 1 of Unit II. be amended such that Wellmark shall not produce more volume of each product under the terms of the current registrations during the remaining manufacturing period (i.e., from September 9, 2013 when the request for amendment was submitted until April 1, 2015, the effective date of cancellation—a period just over 1.5 years) than 1.5 times the average annual production level of each product for the calendar years 2010 through 2012. EPA granted this amendment request on December 6, 2013. This amendment does not allow for an increased level of production. Sergeant's Pet Care Products, Inc. (Sergeant's) provided an expression of intent on November 1, 2013, that states that until April 1, 2015 (the effective date of cancellation), Sergeant's intends to produce no more of the products listed in Table 1 of Unit II. than it sold during the 2-year timeframe of 2011 and 2012. Based on the voluntary cancellation requests, the Agency believes the registrants will remain at or below their average annual production of propoxur pet collars until the effective cancellation date of April 1, 2015. Thus, EPA disagrees with NRDC's claim that the proposed cancellation will allow registrants to increase production prior to cancellation.
In addition, NRDC claims that the proposed cancellation will allow products to remain on the market indefinitely. Specially, NRDC states that based on a typical shelf life of 5 years, consumers may be able to purchase propoxur pet collars in April 2020 or later. However, based on available information provided by the registrants, propoxur pet collars generally clear the channels of trade within 12 to 18 months. Therefore, EPA does not expect propoxur pet collars to remain on the market indefinitely, but rather, the Agency expects existing stocks of propoxur pet collars to move through the channels of trade faster than could be accomplished through a cancellation hearing.
Wellmark's voluntary cancellation request was conditioned upon the opportunity to submit a “concept package” for reformulation of the propoxur pet collars listed in Table 1 of Unit II. to address potential risks of concern. Wellmark did not provide sufficient information to address the potential risks of concern, and EPA thus notified Wellmark that the Agency intended to proceed with a final cancellation order. Therefore, all pet collars currently formulated with propoxur will be canceled effective April 1, 2015.
In addition, the Agency's existing stocks policy of June 26, 1991 (56 FR 29362), provides that where EPA has identified a particular risk issue, the Agency will generally weigh the risk against the benefits of allowing any continued sale, distribution, or use on a case-by-case basis. In doing so, one of the factors that the Agency may take into consideration is the degree to which the registrant's actions accelerated the removal of the pesticide from the market, and whether the cancellation would have occurred at all without the existing stocks provision (see 56 FR 29365).
EPA considered these factors and determined that the conditional voluntary requests for cancellation, including the existing stocks provisions upon which those voluntary requests were conditioned, will result in the removal of propoxur pet collar products from the market sooner (and with the expenditure of far fewer resources) than if EPA were to initiate and pursue cancellation proceedings. For these reasons, the Agency does not believe that the comments submitted during the comment period merit the denial of the requests for voluntary cancellation.Start Printed Page 16795
IV. Cancellation Order
Pursuant to FIFRA section 6(f), EPA hereby approves the requested cancellations of the registrations identified in Table 1 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 of Unit II. are canceled. The effective date of the cancellations that are the subject of this cancellation order is April 1, 2015. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit II. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA.
V. What is the Agency's authority for taking this action?
Section 6(f)(1) of FIFRA, 7 U.S.C. 136d(f), provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, following the public comment period, the EPA Administrator may approve such a request. The notice of receipt for this action was published for comment in the Federal Register of January 22, 2014 (79 FR 3586) (FRL-9904-26). The comment period closed on February 21, 2014.
VI. Provisions for Disposition of 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. The existing stocks provisions for the products subject to this order are as follows.
The registrants, Sergeant's Pet Care Products, Inc. (Sergeant's) and Wellmark International (Wellmark), may not “release for shipment,” as that term is defined by 40 CFR 152.3, any additional products listed in Table 1 of Unit II., after April 1, 2015, and may not sell or distribute existing stocks of such product after April 1, 2016. All sale or distribution of such existing stocks by Sergeant's and Wellmark is prohibited after April 1, 2016, unless that sale or distribution is solely for the purpose of facilitating disposal or export of the product consistent with FIFRA section 17.
After April 1, 2016, persons other than registrants will be allowed to sell, distribute, or use existing stocks until such stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.Start List of Subjects
List of Subjects
- Environmental protection
- Pesticides and pests
Dated: March 14, 2014.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
[FR Doc. 2014-06687 Filed 3-25-14; 8:45 am]
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