Document ID: EPA-HQ-OPP-2009-0207-0193
Agency: epa
Document Type: Notice
Title: Product Cancellation Order for Certain Pesticide Registrations
Posted Date: 2014-03-26T04:00Z

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Pages 16793-16795]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06687]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0207; FRL-9907-35]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

DATES: The cancellations are effective April 1, 2015.

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: keller.kaitlin@epa.gov.

SUPPLEMENTARY 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.

                     Table 1--Product Cancellations
------------------------------------------------------------------------
    EPA  Registration  number        Product name        Chemical name
------------------------------------------------------------------------
2517-61.........................  Sergeant's Dual     Propoxur, MGK 264,
                                   Action Flea &       Phenothrin.
                                   Tick Collar (With
                                   D-Phenothrin).

[[Page 16794]]

 
2517-78.........................  Sergeant's Sendran  Propoxur.
                                   Flea & Tick
                                   Collar.
2517-144........................  Sergeant's 933      Propoxur, MGK 264,
                                   Plus Flea & Tick    Phenothrin,
                                   Collar (With D-     Pyriproxy- fen.
                                   Phenothrin and
                                   Pyriproxy- fen).
2724-254........................  Dog Collar for      Propoxur.
                                   Flea Control.
2724-275........................  Propoxur Flea       Propoxur.
                                   Collar for Cats
                                   RF-101.
2724-491........................  RF 9907 Flea        Propoxur, S-
                                   Collar for Cats     Methoprene.
                                   and Kittens.
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.

               Table 2.--Registrants of Canceled Products
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            EPA company  number               Company name and  address
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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 Assessments, 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.

[[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.

List of Subjects

    Environmental protection, Pesticides and pests, Propoxur.

    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]
BILLING CODE 6560-50-P