[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Pages 17977-17978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6811]



[EPA-HQ-OPP-2008-0171; FRL-8357-7]

Certain Tributyltin Compounds, Risk Assessments; Notice of 

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: This notice announces the availability of EPA's risk 
assessments, and related documents for the pesticides tributyltin 
oxide, tributyltin benzoate, and tributyltin maleate, and opens a 
public comment period on these documents (Phase 3 of 4-Phase Process). 
The public is encouraged to suggest risk management ideas or proposals 
to address the risks identified. EPA is developing a Reregistration 
Eligibility Decision (RED) for tributyltin oxide, tributyltin benzoate, 
and tributyltin maleate through a modified, 4-Phase public 
participation process that the Agency uses to involve the public in 
developing pesticide reregistration decisions. Through this program, 
EPA is ensuring that all pesticides meet current health and safety 

DATES: Comments must be received on or before June 2, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0171, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0171. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. 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 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 (703) 

FOR FURTHER INFORMATION CONTACT: Jill Bloom, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8019; fax 
number: (703) 308-7070; e-mail address: [email protected].


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 

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.

[[Page 17978]]

     iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is releasing for public comment its human health and 
environmental fate and effects risk assessments and related documents 
for tributyltin oxide, tributyltin benzoate, and tributyltin maleate, 
and soliciting public comment on risk management ideas or proposals. 
These three pesticide active ingredients are registered for a wide 
variety of uses, including antifoulants in specific, limited 
applications, and to control microbial growth in water cooling towers, 
construction materials, coatings, textiles, and animal housing 
facilities and hatchery applications. EPA developed the risk 
assessments and risk characterization for tributyltin oxide, 
tributyltin benzoate, and tributyltin maleate through a modified 
version of its public process for making pesticide reregistration 
eligibility and tolerance reassessment decisions. Through these 
programs, EPA is ensuring that pesticides meet current standards under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).
    The three tributyltin (TBT) compounds are formulated for 
application both in manufacturing processes and as end-use products 
applied directly by consumers. TBT oxide is registered for use in sites 
including antifoulant-impregnated rubber shaped for sonar domes, 
antifoulant components of oceanographic instruments, wood 
preservatives, construction materials including drywall, sterilants for 
nonfood processing equipment used in materials manufacture, hard 
surface disinfectants for hatchery and poultry/swine farm premises, and 
textiles. TBT benzoate is registered for use in sites including 
construction materials such as spackling compound and in adhesives for 
non-food contact surfaces. TBT maleate is registered for use as a 
materials preservative in sites including foam, textiles, carpet 
backing, and adhesives.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessments for tributyltin oxide, tributyltin benzoate, and 
tributyltin maleate. Such comments and input could address, for 
example, the availability of additional data to further refine the risk 
assessments, including information on residues of TBT in livestock and 
eggs from treated facilities, dermal and inhalation unit exposure 
values, leaching from treated wood, immunotoxicity, bioaccumulation, 
the availability of cost-effective alternatives to TBT, and unique 
benefits for the use of TBT could address the Agency's risk assessment 
methodologies and assumptions as applied to this specific pesticide.
    Through this notice, EPA also is providing an opportunity for 
interested parties to provide risk management proposals or otherwise 
comment on risk management for tributyltin oxide, tributyltin benzoate, 
and tributyltin maleate. Risks of concern associated with the use of 
these active ingredients are: Those associated with immunotoxicity, 
endocrine disruption, and bioaccumulation; application of wood 
preservative formulations; wearing treated clothing; using a treated 
mattress cover; worker application and post-application tasks for TBT 
treatments of agricultural premises; re-entry into treated agricultural 
premises; liquid pouring for manufacture of construction materials, and 
oilfield uses. In targeting these risks of concern, the Agency solicits 
information on effective and practical risk reduction measures.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development, implementation, and 
enforcement of environmental laws, regulations, and policies. To help 
address potential environmental justice issues, the Agency seeks 
information on any groups or segments of the population who, as a 
result of their location, cultural practices, or other factors, may 
have atypical, unusually high exposure to tributyltin oxide, 
tributyltin benzoate, and tributyltin maleate, compared to the general 
    EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004 (69 FR 26819) (FRL-7357-9), explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
the issues, and degree of public concern associated with each 
pesticide. For tributyltin oxide, tributyltin benzoate, and tributyltin 
maleate, a modified, 4-Phase process with one comment period for public 
consultation seems appropriate in view of its limited use. However, if 
as a result of comments received during this comment period EPA finds 
that additional issues warranting further discussion are raised, the 
Agency may lengthen the process and include a second comment period, as 
    All comments should be submitted using the methods in ADDRESSES, 
and must be received by EPA on or before the closing date. Comments 
will become part of the Agency Docket for tributyltin oxide, 
tributyltin benzoate, and tributyltin maleate. Comments received after 
the close of the comment period will be marked ``late.'' EPA is not 
required to consider these late comments.

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

    Section 4(g)(2) of FIFRA, as amended, directs that, after 
submission of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in 
product-specific data on individual end-use products and either 
reregistering products or taking other ``appropriate regulatory 

List of Subjects

    Environmental protection, Pesticides and pests, antimicrobials.

    Dated: March 26, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E8-6811 Filed 4-1-08; 8:45 am]