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Tributyltin Methacrylate and Bis(tributyltin) Oxide; Product Cancellation Order

Note: EPA no longer updates this information, but it may be useful as a reference or resource.


 
[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Notices]
[Page 12655-12658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr04-65]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0012; FRL-7346-8]

Tributyltin Methacrylate and Bis(tributyltin) Oxide; Product
Cancellation Order

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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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

[[Page 12656]]

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: (703)
308-8019; fax number: (703) 308-8041; e-mail address: 
Bloom.Jill@epa.gov; 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 (703) 305-
5805.
    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
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       Company Name and Address       EPA Registration #        Product Name             Chemical Name
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Atofina Chemicals, Inc.                5204-63                  Biomet 300 Antifouling   Tributyltin
2000 Market Street...................                            Agent                    methacrylate
Philadelphia, PA 19103-3222..........
                                      -----------------------------------------------------------------
                                       5204-65                  Biomet 302 Antifouling   Tributyltin
                                                                 Agent                    methacrylate
                                      -----------------------------------------------------------------
                                       5204-67                  Biomet 304 Antifouling   Tributyltin
                                                                 Agent                    methacrylate
                                      -----------------------------------------------------------------
                                       5204-80                  Biomet 303/60            Tributyltin
                                                                 Antifouling Agent        methacrylate
                                      -----------------------------------------------------------------
                                       5204-81                  Biomet 304/60            Tributyltin
                                                                 Antifouling Agent        methacrylate
                                      -----------------------------------------------------------------
                                       5204-83                  Polyflo 4024             Tributyltin
                                                                                          methacrylate
                                      -----------------------------------------------------------------
                                       5204-87                  Biomet 305               Tributyltin
                                                                                          methacrylate
                                      -----------------------------------------------------------------
                                       5204-88                  Biomet 309               Tributyltin
                                                                                          methacrylate
                                      -----------------------------------------------------------------
                                       5204-90                  Biomet 300/60            Tributyltin
                                                                 Antifouling Agent        methacrylate
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[[Page 12657]]

    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
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Atofina Chemicals, Inc.           5204-1              Biomet TBTO
2000 Market Street..............
Philadelphia, PA 19103-3222.....
------------------------------------------------------------------------
Crompton Corporation              8898-17             Eurotin TBTO
1 American Way..................
Greenwich, CT 06831.............
------------------------------------------------------------------------

    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

[[Page 12658]]

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.
[FR Doc. E4-557 Filed 3-16-04; 8:45 am]
BILLING CODE 6560-50-S 

 
 


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