E4-557. Tributyltin Methacrylate and Bis(tributyltin) Oxide; Product Cancellation Order

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, the Agency is issuing a Cancellation Order announcing its approval of the voluntary cancellations submitted by Atofina Chemicals, Inc., for certain manufacturing and end-use products containing tributyltin methacrylate. The Agency is also issuing a Cancellation Order announcing its approval of the amendments requested by Atofina and Crompton Corporation, to terminate the use for formulating antifouling paints from certain of their manufacturing-use products containing bis(tributyltin) oxide. These Orders follow a December 5, 2003 Notice of Receipt of requests by Atofina Chemicals, Inc. and Crompton Corporation to voluntarily cancel or amend to terminate uses of their product registrations as described above. As noted in the December 5, 2003 Notice of Receipt, Atofina and Crompton requested that they be allowed to sell the subject products only until November 30, 2003. Since that date has passed, no separate existing stocks orders are needed to permit continued sale. The Cancellation Orders set forth the applicable terms and conditions for the affected registrations. Under these Orders, no further distribution, sale or use of the affected products by Atofina and Crompton is permitted.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, 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 information in this notice, 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 an official public docket for this action under docket identification (ID) number OPP-2003-0291. The official public docket consists of the documents specifically referenced in this action, any public comments received and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202-4501. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket 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/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://cascade.epa.gov/​RightSite/​dk_​public_​home.htm to submit or view public comments, access the index listing of the contents of the official public docket and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

The Agency is approving the requested cancellations of one end-use and eight manufacturing-use products containing tributyltin methacrylate, and the amendments to terminate the use to formulate antifouling paints of two manufacturing-use products containing bis(tributyltin) oxide registered under section 3 of FIFRA. The subject registrations are specifically identified in Tables 1 and 2 below. These requests were made by Atofina Chemicals, Inc. and Crompton Corporation, and were announced in the Federal Register on December 5, 2003 (68 FR 68039) (FRL-7331-1). Atofina and Crompton requested that the Administrator waive the 180-day comment period provided under FIFRA section 6(f)(1)(C) for their requests. In light of this requested waiver, EPA provided a 30-day public comment period on the voluntary cancellation and use termination requests.

As part of the December 5, 2003 Notice, the Agency indicated that it would issue Orders granting the registration amendments and cancellations unless the Agency received any substantive comment within the 30-day public comment period that would merit its further review of these requests. EPA received two comments in response to the Notice. These comments are discussed in Unit III. of this Notice. The Agency has made note of the concerns expressed in the comments, but does not believe the commenters' intent is to delay the Agency's granting of the subject requests. Likewise, the Agency does not believe the comments provide a basis for rejecting the requests. Accordingly, EPA is issuing Orders in this Notice canceling the nine registrations identified in Table 1 and amending the two registrations listed in Table 2.

Table 1.—Manufacturing and End-Use Product Cancellations for Tributyltin Methacrylate

Company Name and Address	EPA Registration #	Product Name	Chemical Name
Atofina Chemicals, Inc. 2000 Market Street Philadelphia, PA 19103-3222	5204-63	Biomet 300 Antifouling Agent	Tributyltin methacrylate
	5204-65	Biomet 302 Antifouling Agent	Tributyltin methacrylate
	5204-67	Biomet 304 Antifouling Agent	Tributyltin methacrylate
	5204-80	Biomet 303/60 Antifouling Agent	Tributyltin methacrylate
	5204-81	Biomet 304/60 Antifouling Agent	Tributyltin methacrylate
	5204-83	Polyflo 4024	Tributyltin methacrylate
	5204-87	Biomet 305	Tributyltin methacrylate
	5204-88	Biomet 309	Tributyltin methacrylate
	5204-90	Biomet 300/60 Antifouling Agent	Tributyltin methacrylate

Of the registrations listed in Table 1, Registration number 5204-83 is an end-use product, and the remainder are manufacturing-use products.

Table 2.—Manufacturing-Use Product Registration Amendments for Bis(Tributyltin) Oxide

Company Name and Address	EPA Registration #	Product Name
Atofina Chemicals, Inc. 2000 Market Street Philadelphia, PA 19103-3222	5204-1	Biomet TBTO
Crompton Corporation 1 American Way Greenwich, CT 06831	8898-17	Eurotin TBTO

The registrations listed in Table 2 are amended to terminate the use for formulating antifouling paints. The cancellations and amendments to terminate a use are effective upon the date of publication of this document.

Any distribution, sale or use of products identified in Tables 1 and 2 in a manner inconsistent with the terms of the Cancellation Orders (including the provisions dealing with existing stocks described in Unit IV. of this Notice) will be considered a violation of section 12(a)(2)(K) of FIFRA and/or section 12(a)(1)(A) of FIFRA.

B. What is the Agency's Authority for Taking this Action?

Pursuant to section 6(f) of FIFRA, EPA hereby approves the requested cancellations and amendments to terminate a use of the affected registrations identified in Tables 1 and 2 of this Notice. Accordingly, the Agency orders that the end-use and manufacturing-use product registrations identified in Table 1 are hereby canceled. The Agency also orders that the use identified for deletion from the manufacturing-use product registrations identified in Table 2 is hereby terminated.

III. What Comments did the Agency Receive?

The Agency received two comments during the 30-day public comment period announced in the December 5, 2003 notice of receipt of requests to cancel or terminate a use of the subject registrations. Both commenters, Arch Chemicals, Inc. and Interlux, support the cancellation and use terminations requested by the registrants.

Arch Chemicals also comments that the existing stocks provisions discussed in the December 5, 2003, Notice, which proposed to allow the continued distribution, sale, and use by dealers and users of the Atofina and Crompton products until stocks are exhausted, are inconsistent with the Agency's interest in addressing the environmental risks associated with the use of such products. Arch Chemicals notes that the existing stocks provisions also are inconsistent with the January 1, 2003 target date for the tributyltin (TBT) ban in the International Convention on the Control of Harmful Anti-Fouling Systems on Ships. Based on the shelf-life of the TBT antifouling additives and paints, Arch concludes that the use of these paints could continue for another 3 years. Arch Chemicals also comments that because levels of TBT are already of concern in the aquatic environment, companies who continue to sell TBT antifouling paints in the United States should be required to provide continuous TBT-level monitoring data until sales cease.

Interlux similarly opposes the existing stocks provisions, and notes that it phased-out its TBT antifouling paint registrations in anticipation of the ban, while some other paint companies chose to continue sales. Interlux notes that vessels painted with TBT antifouling paints after January 1, 2003, may require repainting with non-TBT systems when the Convention is ratified or enters into force. Interlux asks the Agency to implement additional measures to prevent the continued sale and use of TBT antifouling paints for what it considers to be an indefinite period. Both Arch Chemicals and Interlux are concerned about the continued sale, distribution, and use of TBT antifouling paints formulated from the Atofina and Crompton products.

The Agency shares the concern that continued use of the TBT antifouling paints poses risks to the environment and potential problems for users, particularly when use could go on for an indefinite period. The Agency will continue its efforts to negotiate the cancellation of the remaining TBT antifouling paint registrations based on this concern. In the past year, negotiations have resulted in requests for voluntary cancellation of the majority of the TBT antifouling registrations. With the cancellations and use terminations of the manufacturing-use TBT antifoulant products (as subject to this Notice), the remaining TBT antifouling paint formulators have a finite source for the TBT they use to manufacture their products. The best information available to the Agency at this time indicates that existing stocks of the manufacturing-use products in the hands of formulators, and of the formulated products themselves, are limited. Cancellation of the remaining registrations for these formulated products will result in specific existing stocks provisions for each of them. Because the TBT manufacturing-use product registrations are canceled, registrants of the remaining TBT products have lost the generic data exemption afforded them when Atofina and Crompton were developing the long-term monitoring data required for continued registration of TBT antifouling products. As a result, the remaining TBT registrants are obligated to satisfy all outstanding TBT Data Call-In data requirements for which they previously had a generic data exemption. The Agency is addressing this issue separately from the Cancellation Orders for the Atofina and Crompton products.

For these reasons, the Agency does not believe that the comments submitted during the comment period merit further review or a denial of the requests for voluntary cancellation and use termination. Rather than undertake to modify the terms of the Cancellation Orders for the manufacturing-use products announced herein, the Agency will address the use of existing stocks of the formulated products at the time their cancellations are requested or proposed.

IV. Existing Stocks Provisions

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 a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation or amendment. Any distribution, sale or use of existing stocks in a manner inconsistent with the terms of the cancellation Order or the existing stocks provisions contained in the Order will be considered a violation of section 12(a)(2)(K) and/or section 12(a)(1)(A) of FIFRA. The following summarizes the effective dates of cancellation as well as the existing stocks provisions for each product subject to the cancellation Order.

1. Canceled registrations (Table 1 in Unit II.) The effective date of cancellation is the date of publication of this document. As of the date of publication of this document, Atofina may not sell, distribute, or use products listed in Table 1. Sale, distribution, or use by persons other than the registrant may continue until supplies are exhausted. Additionally, sale, distribution or use of the stocks by persons other than the registrant in the channels of trade may continue until depleted, provided any sale, distribution, or use is in accordance with the existing label of that product.

2. Registrations amended to delete terminated uses (Table 2 in Unit II.) The effective date of the cancellation effectuating the use terminations is the date of publication of this document. As of the date of publication of this document, Atofina and Crompton may not sell, distribute, or use the products listed in Table 2 bearing labels allowing the use which is the subject of the use termination request. Sale, distribution, or use of these products bearing labels allowing the use which is the subject of the use termination request by persons other than the registrants may continue until supplies are exhausted. Additionally, sale, distribution or use of the stocks with such labels in the channels of trade by persons other than the registrant may continue until depleted, provided any sale, distribution or use is in accordance with the existing label of that product.

List of Subjects

Environmental protection, Pesticides and pests.

Dated: March 2, 2004.

Debra Edwards,

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