06-2711. 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.

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.

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/​. 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 [phone]. 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/​, 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/​ 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 [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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

1. Submitting CBI. Do not submit this information to EPA through www.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 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 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.”

List of Subjects

• Environmental protection, pesticides and pests

Dated: March 9, 2006.

Frank Sanders,

Director, Antimicrobials Division, Office of Pesticide Programs.