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Poly(hexamethylenebiguanide) hydrochloride; Para Tertiary-Amylphenol and Salts; 1, 2-Benzisothiazolin-3-one; and Azadioxabicyclooctane Reregistration Eligibility Decisions; Notice of Availability

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

 
[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Notices]
[Page 14514-14517]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr06-65]

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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0161; FRL-7768-5]
 
Poly(hexamethylenebiguanide) hydrochloride; Para Tertiary-Amylphenol and 
Salts; 1, 2-Benzisothiazolin-3-one; and Azadioxabicyclooctane 
Reregistration Eligibility Decisions; Notice of Availability

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

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SUMMARY: This notice announces the availability of EPA's Reregistration 
Eligibility Decisions (REDs) for the pesticides 
poly(hexamethylenebiguanide) hydrochloride hereafter referred to as 
PHMB, para tertiary-amylphenol and salts hereafter referred to as 4-t, 
1, 2-benzisothiazolin-3-one hereafter referred to as BIT and 
azadioxabicyclooctane hereafter referred to as Aza. This notice opens a 
public comment period on these documents. The Agency's risk assessments 
and other related documents are also available in the Dockets for PHMB, 
4-t, BIT and Aza. EPA has reviewed PHMB, 4-t, BIT and Aza through the 
public participation process that the Agency uses to involve the public 
in developing pesticide reregistration and tolerance reassessment 
decisions. Through these programs, EPA is ensuring that all pesticides 
meet current health and safety standards.

[[Page 14515]]


DATES: Comments must be received on or before May 22, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number, by one of the following methods: For PHMB, docket 
identification (ID) number EPA-HQ-OPP-2004-0305; for 4-t, docket 
identification (ID) number EPA-HQ-OPP-2005 -0181; for BIT, docket 
identification (ID) number EPA-HQ-OPP-2005-0200; for Aza, docket 
identification (ID) number EPA-HQ-OPP-2005-0186.
    ? http://www.regulations.gov/. Exit Disclaimer Follow the on-line 
instructions for submitting comments.
    ? Mail: Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, 1200 Pennsylvania Ave., N.W., Washington, DC 20460-0001.
     Hand delivery. Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., 
Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2004-0305, for 
PHMB; Docket ID number EPA-HQ-OPP-2005-0181, for 4-t; Docket ID number 
EPA-HQ-OPP-2005-0200, for BIT; and Docket ID number EPA-HQ-OPP-2005-
0186, for Aza. The docket facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the docket facility is (703) 305-5805. Such deliveries are only 
accepted during the Docket's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
     Instructions. Direct your comments by the specific docket ID 
number- as listed above. EPA's policy is that all comments received 
will be included in the public docket without change and may be made 
available on-line at http://www.regulations.gov/, Exit Disclaimer 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 captured 
automatically and included as part of the comment that is placed in the 
public 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. For additional information about EPA's public docket, visit 
the EPA Docket Center homepage at http://www.epa.gov/epahome/docket.htm.
     Docket: All documents in the docket are listed in the 
regulation.gov index. Although, listed in the index, some information 
is not publicly available, i.e., CBI or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
at http://www.regulations.gov/ Exit Disclaimer or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB) (7502C), Office of 
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, 
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the docket facility 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: For PHMB, contact Jennifer Slotnick, 
Antimicrobials Division (7510C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., N.W., 
Washington, DC 20460-0001; telephone number: (703) 305-0601; fax 
number: (703) 308-8481; e-mail address: slotnick.jennifer@epa.gov.
    For 4-t, contact ShaRon Carlisle, Antimicrobials Division (7510C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., N.W., Washington, DC 20460-0001; telephone number: 
(703) 308-6427; fax number: (703) 308-8481; e-mail address: 
carlisle.shaRon@epa.gov.
     For BIT, contact Rebecca Miller, Antimicrobials Division (7510C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., N.W., Washington, DC 20460-0001; telephone number: 
(703) 305-0012; fax number: (703) 308-8481; e-mail address: 
miller.rebecca@epa.gov.
     For Aza, contact ShaRon Carlisle, Antimicrobials Division (7510C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., N.W., Washington, DC 20460-0001; telephone number: 
(703) 308-6427; fax number: (703) 308-8481; e-mail address: 
carlisle.shaRon@epa.gov.

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

    1. Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov Exit Disclaimer 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 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.
    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

[[Page 14516]]

your estimate in sufficient detail to allow for it to be reproduced.
    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?

     Under section 4 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to 
ensure that they meet current scientific and regulatory standards. EPA 
has completed a Reregistration Eligibility Decision (RED) for the 
pesticides PHMB, 4-t, BIT and Aza under section 4(g)(2)(A) of FIFRA.
     PHMB is used as a fungicide, algicide, and sanitizer in swimming 
pools; preservative for cut flowers; materials preservative; 
bacteriostat in industrial processes and water systems; and hard 
surface disinfectant (food and non-food contact surfaces). End-use 
products are formulated as soluble concentrates, as solids, as ready-
to-use solutions, and in water-soluble packaging.
     4-t is used in disinfectants, hard non-porous surface sanitizers 
and air deodorizing products used in agricultural premises, in food 
handling establishments, commercial, institutional and industrial 
premises, residential, public access premises and in medical settings. 
These products primarily are used on hard, non-porous surfaces (walls, 
floors, tables, fixtures) textiles (clothing, diapers, mattresses and 
bedding), carpets, medical instruments and agricultural equipment.
     BIT is an antimicrobial that is used as an industrial preservative 
for the protection of water-based adhesives, caulks, sealants, grouts, 
spackling, ready-mixed cements, ready-mixed wallboard compounds, 
aqueous compositions such as emulsion paints, aqueous slurries, home 
cleaning and car care products, laundry detergents, fabric softeners, 
stain removers, inks, photographic processing solutions, paints and 
stains, titanium dioxide slurries, oil in water emulsions, latices, 
metalworking fluids, casein/rosin dispersions, textile spin-finish 
solutions, pesticide formulations, tape joint compound, leather 
processing solutions, preservation of fresh animal hides and skins, and 
for offshore and terrestrial gas/oil drilling muds and packer fluids 
preservation. BIT is also used as an inert ingredient in a variety of 
products as a materials preservative. Exposures and risks from the use 
of products containing BIT as both the active and inert ingredients are 
assessed in this RED. End-use products are formulated as either a 
soluble, ready-to-use, or flowable concentrates (all of which are 
considered to be liquids). Aza consists of an equilibrium mixture of 
three chemicals (I: 5-hydroxymethoxymethyl-1-aza-3,7-
dioxabicyclo(3,3,0)octane; II: 5-hydroxymethyl-1-aza-3,7-
dioxabicyclo(3,3,0)octane; III: 5-hydroxypoly(methylene-oxy)methyl-1-
aza-3,7-dioxabicyclo(3,3,0)octane). These chemicals cannot be divided 
into components for individual testing and the three of them will be 
referred to as azadioxabicyclooctane in the Reregistration Eligibilty 
Decision. This mixture is registered as a preservative for 
antimicrobial control in the following use sites: Oil recovery drilling 
muds and flooding fluids; industrial adhesives and coatings (natural 
based and synthetic); latex and polymer emulsions; metalworking cutting 
fluids; latex paints; paper coatings; caulks and sealants; inks; 
pigment dispersion and pigment slurry; and textile fiber finishes that 
are not intended as clothing. Azadioxabicyclooctane has been cleared by 
the Food and Drug Administration (FDA) for use as an antibacterial 
preservative in paper and paperboard products that are limited to dry 
food contact only in 21 CFR 176.180 as well as a component in paper 
adhesives in 21 CFR 175.105.
     EPA has determined that the data base to support reregistration is 
substantially complete and that products containing PHMB, 4-t, BIT and 
Aza are eligible for reregistration provided the risks are mitigated 
either in the manner described in the RED or by another means that 
achieves equivalent risk reduction. Upon submission of any required 
product specific data under section 4(g)(2)(B) and any necessary 
changes to the registration and labeling (either to address concerns 
identified in the RED or as a result of product specific data), EPA 
will make a final reregistration decision under section 4(g)(2)(C) for 
products containing PHMB, 4-t, BIT and Aza.
     Although, the RED decisions were made in FY 04 (PHMB) and FY05 (4-
t, BIT and Aza), certain components of the documents, which did not 
affect the final regulatory decisions, were undergoing final editing at 
that time. None of these additions or changes alter the conclusions 
documented in the PHMB, 4-t, BIT and Aza REDs now available for comment.
     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, EPA is tailoring its public participation process to be 
commensurate with the level of risk, extent of use, complexity of 
issues, and degree of public concern associated with each pesticide. 
Due to its uses, risks, and other factors, PHMB, 4-t, BIT and Aza were 
reviewed through the modified 4-Phase process. Through this process, 
EPA worked extensively with stakeholders and the public to reach the 
regulatory decisions for PHMB, 4-t, BIT and Aza.
     The reregistration program is being conducted under 
Congressionally mandated time frames, and EPA recognizes the need both 
to make timely decisions and to involve the public. The Agency is 
issuing the PHMB, 4-t, BIT and Aza REDs for public comment. This 
comment period is intended to provide an additional opportunity for 
public input and a mechanism for initiating any necessary amendments to 
the RED. All comments should be submitted using the methods in 
ADDRESSES, and must be received by EPA on or before the closing date. 
These comments will become part of the Agency Dockets for PHMB, 4-t, 
BIT and Aza. Comments received after the close of the comment period 
will be marked ''late.'' EPA is not required to consider these late 
comments.
     The Agency will carefully consider all comments received by the 
closing date and will provide a Response to Comments Memorandum in the 
Docket and regulations.gov. If any comment significantly affects the 
document, EPA also will publish an amendment to the RED in the Federal 
Register. In the absence of substantive comments requiring changes, the 
PHMB, 4-t, BIT and Aza REDs will be implemented as they are now presented.

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 action.''

[[Page 14517]]

List of Subjects

    Environmental protection, pesticides and pests.

    Dated: March 9, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 06-2711 Filed 3-21-06; 8:45 am]
BILLING CODE 6560-50-S

 
 

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