2010-7505. Malathion and Diquat Dibromide; Cancellation Order for Amendments to Terminate Uses

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA’s order for the amendments to terminate uses, voluntarily requested by the registrants and accepted by the Agency, of uses of the products listed in Table 1, pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows a February 10, 2010 Federal Register Notice of Receipt of Requests from the registrants listed in Table 2 to voluntarily amend to terminate certain uses of these product registrations. These are not the last products containing these pesticides registered for use in the United States. In the February 10, 2010 Notice, EPA indicated that it would issue an order implementing the 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, or unless the registrants withdrew their requests within this period. The Agency received one comment on the notice, but this comment did not merit the Agency’s further review of the requests. Further, the registrants did not withdraw their requests. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested amendments to terminate uses. 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 7, 2010.

FOR FURTHER INFORMATION CONTACT:

Eric Miederhoff, Pesticide Re-evaluation Division, 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?

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0979. 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].

II. What Action is the Agency Taking?

This notice announces the amendments to terminate uses, as requested by registrants, for products registered under section 3 of FIFRA. These registrations are listed in sequence by registration number in Table 1 of this unit.

Table 1.— Amended Product Registrations

EPA Registration No.	Product Name	Active Ingredient	Delete from Label
100-1061	Reglone Desiccant Herbicide	Diquat dibromide	Sorghum (seed crop only) Soybean (seed crop only)
4787-46	Atrapa® 8E	Malathion	Animal premise and barns used for dairy and livestock
67760-40	Fyfanon® 57% EC	Malathion	Animal premise and barns used for dairy and livestock

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.

Table 2.—Registrants of Amended Products

EPA Company Number	Company Name and Address
100	Syngenta Crop Protection, Inc. P.O. Box 18300 Greensboro, NC 27419-8300
4787	Cheminova, A/S P.O. Box 110566 One Park Drive, Suite 150 Research Triangle Park, NC 27709
67760	Cheminova, Inc. Washington Office 1600 Wilson Boulevard Suite 700 Arlington, VA 22209

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

During the public comment period provided, EPA received one comment in response to the February 10, 2010 Federal Register notice announcing the Agency's receipt of the requests for voluntary amendments to terminate uses of products listed in Table 1 of Unit II.

The commenter, Stephen A. McFadden, stated that organophosphate insecticides (OP) as a class are too neurotoxic to be used safely in high human exposure applications, such as indoor uses, urban aerial spray programs, and uses that result in high residual levels in foods. McFadden suggested that high levels of exposure to cholinesterase inhibitors such as OP insecticides - may cause a state of permanent hypersensitivity to cholinesterase inhibitors. Nonetheless, the commenter supported the Agency’s implementation of the voluntary use termination requests for malathion, an organophosphate insecticide.

The amendments to terminate uses that McFadden commented on were not risk-based actions resulting from an Agency risk assessment, but were voluntarily requested by the registrant. However, McFadden’s comment suggests that organophosphate insecticides such as malathion are too toxic for uses other than those included in this cancellation action. Malathion is currently undergoing Registration Review. During this process, the Agency intends to review and revise its existing risk assessments for malathion. The Agency will consider McFadden’s comment as the human health risk assessment for malathion is revised.

For these reasons, the Agency does not believe that the comment submitted during the comment period merit further review or a denial of the requests for voluntary use termination.

IV. Cancellation Order

Pursuant to FIFRA section 6(f), EPA hereby approves the requested amendments to terminate uses of malathion and diquat dibromide registrations identified in Table 1 of Unit II. Accordingly, the Agency orders that the product registrations identified in Table 1 of Unit II. are hereby amended to terminate the affected uses. 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 considered a violation of FIFRA.

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.

VI. Provisions for Disposition of Existing Stocks

Existing stocks are 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 cancellation action. The effective date of the amendments to terminate uses is April 7, 2010. The cancellation order that is the subject of this notice includes the following existing stock provisions:

The registrant may sell and distribute existing stocks of products listed in Table 1 of Unit II. under the previously approved labeling which includes the deleted uses until April 7, 2011. Persons other than the registrant may sell and distribute existing stocks of products listed in Table 1 of Unit II. whose labels include the deleted uses until exhausted. Use of the products whose labels include the deleted uses listed in Table 1 of Unit II. may continue until existing stocks are exhausted, provided that such use is consistent with the terms of the previously approved labeling on, or that accompanied, the products.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: March 26, 2010.

Richard P. Keigwin, Jr.,

Director, Pesticide Re-evaluation Division, Office of Pesticide Programs.