E8-3112. Azinphos-methyl; Product Cancellation Order and Amendments to Terminate Uses

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice publishes EPA's order for the cancellations and amendments to terminate uses, voluntarily requested by the registrants and accepted by the Agency, of products containing the pesticide azinphos-methyl (AZM), pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows an August 8, 2007 Federal Register Notice of Receipt of Requests from the AZM registrants to voluntarily cancel and amend to terminate uses of all their AZM product registrations by September 30, 2012. Subject to the terms and conditions described in Unit II below and except as provided in the existing stocks provisions of the cancellation order, the order terminates distribution, sale and use of AZM products labeled for use on Brussels sprouts and nursery stock effective as of today's date; and prohibits use of such products on Brussels spouts and nursery stock effective September 30, 2008; terminates AZM use on walnuts, almonds, and pistachios effective October 30, 2009; and cancels all AZM products effective September 30, 2012. The cancellation of AZM products serves to terminate the six remaining uses of AZM (apples, pears, cherries, blueberries, alkali bee beds, and parsley) on September 30, 2012. All distribution, sale and use of such products will be prohibited as of that date except as provided in the existing stocks order of the notice. While the alkali bee bed use was not specifically identified in the registrants' voluntary cancellation requests, the registrants requested cancellation of all AZM products, which includes products labeled for the bee bed use. These are the last AZM products registered for use in the United States. In the August 8, 2007 notice, EPA indicated that it would issue an order implementing the cancellations and amendments to terminate uses, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests. The Agency did not receive any comments on the notice. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellations and amendments to terminate uses. Any distribution, sale, or use of the AZM products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.

DATES:

This order is February 20, 2008.

FOR FURTHER INFORMATION CONTACT:

Tom Myers, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

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. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0061. 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 Office of Pesticide Programs (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 [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/​fedrgstr.

II. What Action is the Agency Taking?

This notice announces the cancellation and amendments to terminate uses, as requested by registrants, of all end-use and manufacturing-use AZM products registered under section 3 and 24(c) of FIFRA. At the request of EPA, the AZM registrants requested that EPA terminate certain uses in 2007 and 2009 and cancel all remaining AZM product registrations in 2012 (identified in Table 1 of this notice), subject to certain terms and conditions. Specifically they requested the deletion of the Brussels sprouts and nursery stock uses from their registrations not sooner than the later of September 30, 2007 or 90 days from the date EPA approves draft labeling submitted by the registrants (draft labeling was approved on August 14, 2007); deletion of the walnut, almond, and pistachio uses not sooner than October 30, 2009; and the cancellation of all AZM registrations (thereby ending AZM use on apples, pears, cherries, blueberries, alkali bee beds, and parsley) not sooner than September 30, 2012. Other terms and conditions include:

1. A condition that the requests for termination of use and voluntary cancellation shall not be made effective until EPA conducts an independent scientific review of a submission from the registrants requesting reconsideration of EPA's decision to maintain an inter-species uncertainty factor in its risk assessment of AZM for agricultural workers. EPA has conducted this review and provided its response to the registrants.

2. A condition that the requests for voluntary cancellation of all AZM products shall not become effective unless:

i. EPA holds at least one public meeting to obtain views regarding the continued need for access to AZM prior to July 1, 2011 (EPA has thus far held a series of public meetings under the auspices of the Pesticide Program Dialogue Committee regarding the need for AZM and issues related to the transition to alternatives); and

ii. EPA makes a determination not later than November 1, 2011 for the remaining uses of AZM whether to conduct a risk-benefit analysis for AZM prior to the cancellation of these uses, and, if it so determines, conducts such analysis not later than July 1, 2012.

If the actions described above result in the retention of any AZM use beyond the stop-use date (as provided in the existing stock provisions below and in appendix A of the November 16, 2006 Final Decisions for the Remaining Uses for Azinphos-methyl), the registrants may request that product labeling be amended consistent with the terms of such actions and EPA shall grant any amendment that is consistent with such actions and the provisions of 40 CFR part 156.

Affected registrations are listed in sequence by registration number in Table 1 of this unit. EPA believes this is the complete list of all such products; however, because the registrants requested cancellation of all AZM products, the cancellation order and amendment to terminate uses extend to all AZM products held by these registrants irrespective of whether the products are specifically listed in the tables below.

Table 1.—AZM Product Cancellations

EPA Registration Number	Product Name
264-722	Guthion Solupak 50% Wettable Powder in Water Soluble Packets
264-733	Guthion Solupak 50% Wettable Powder Insecticide
10163-78	Gowan Azinphos-M 50 WSB
10163-95	Azinphos-methyl Technical
11678-53	Cotnion-Methyl
66222-11	Cotnion-Methyl Azinphos-methyl 50W
66330-233	Azinphos-methyl 50W
ID000006	Guthion Solupak 50% Wettable Powder Insecticide
NJ990010	Guthion Solupak 50% Wettable Powder Insecticide
OH020005	Guthion Solupak 50% Wettable Powder Insecticide
OR040020	Guthion Solupak 50% Wettable Powder Insecticide
TX030011	Guthion Solupak 50% Wettable Powder Insecticide
WA000001	Guthion Solupak 50% Wettable Powder Insecticide
WA030035	Guthion Solupak 50% Wettable Powder Insecticide

Table 2 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. Please note, Guthion Technical Insecticide (264-722) was transferred to Makhteshim Chemical Works LTD (11678-70) in October 2007, and Guthion Solupak 50% Wettable Powder Insecticide (264-733) was transferred to Makteshim-Agan of North America (66222-162) in October 2007. In addition, the following Special Local Need registrations will be cancelled immediately upon publication of this notice: ID000006, NJ990010, OH020005, TX030011, and WA000001. Special Local Need registrations OR040020 and WA030035 (both registered only for alkali bee bed use) are subject to existing stocks provisions as listed in Unit IV.2. of this notice.

Table 2.—Registrants of Cancelled and/or Amended AZM Products

EPA Company Number	Company Name and Address
264	Bayer Crop Science P.O. Box 12014 2 T.W. Alexander Drive Research Triangle Park, NC 27709
11678	Makteshim Chemical Works LTD c/o Makteshim Agan of North America 4515 Falls of Neuse RD STE 300 Raleigh, NC 27609
66222	Makteshim-Agan of North America 4515 Falls of Neuse RD STE 300 Raleigh, NC 27609
10163	Gowan Company PO Box 5569 Yuma, AZ 85366-5569
66330	Arysta Lifescience North America Corporation 15401 Weston Parkway, Suite 150 Cary, NC 27513

III. Summary of Public Comments Received and Agency Response to Comments

During the public comment period provided, EPA received no comments in response to the August 8, 2007 Federal Register notice (72 FR 44511) (FRL-8134-7) announcing the Agency's receipt of the requests for voluntary cancellations and amendments to terminate uses of AZM.

IV. Cancellation Order

1. Cancellation and amendment. Pursuant to FIFRA section 6(f), EPA hereby approves the requested cancellations and amendments to terminate uses of AZM registrations identified in Table 1 of Unit II. and any other AZM product that may be held by the registrants listed in Table 2 of Unit II. Accordingly, subject to the terms and conditions described in Unit II. of this notice, the Agency orders that these AZM product registrations are hereby canceled and amended as follows:

i. Use of AZM products on Brussels sprouts and nursery stock is prohibted as of September 30, 2008.

ii. Use of AZM products on walnuts, almonds, and pistachios is prohibited effective October 30, 2009

iii. All AZM products currently held by any of the registrants listed in Table 2 of Unit II are canceled effective September 30, 2012. Any distribution, sale, or use of these products in a manner inconsistent with this order, including the provisions in Unit IV.2 regarding the disposition of existing stocks, will be considered a violation of section 12(a)(2)(K) and/or 12(a)(1)(A) of FIFRA.

2. Existing Stocks. For purposes of this order, the term “existing stocks” is defined, pursuant to EPA's existing stocks policy (56 FR 29362, June 26, 1991) as those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the amendment or cancellation action. This cancellation order includes the following existing stocks provisions.

a. Distribution or sale. i. Distribution or sale of products bearing the Brussels sprouts and nursery stock uses is prohibited effective as of February 20, 2008, except for the purposes of proper disposal, reformulation, relabeling, or export consistent with section 17 of FIFRA, which activities may continue until such stocks are depleted.

ii. Distribution or sale of Special Local Need registrations OR040020 and WA030035 bearing the alkali bee beds use is prohibited after December 31, 2010 except the sale or distribution of such products for the purposes of proper disposal, reformulation, relabeling, or export consistent with section 17 of FIFRA, which activities may continue until such stocks are depleted.

iii. For products bearing all other uses, distribution or sale of such products is prohibited after September 30, 2012 except the sale or distribution of such products for the purposes of proper disposal, reformulation, relabeling, or export consistent with section 17 of FIFRA, which activities may continue until such stocks are depleted.

b. Use. i. Use of products on Brussels sprouts and nursery stock is prohibited as of February 20, 2008. Labels prohibit use on almonds, walnuts, and pistachios after October 30, 2009.

ii. Use of all azinphos methyl products subject to this notice for any use is prohibited after September 30, 2012.

Note that the stop use dates for the uses are also reflected on amended product labeling. Any use of existing stocks must be consistent with the directions for use on product labeling.

V. 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 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 Administrator may approve such a request.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated:February 12, 2008.

Steven Bradbury,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.