06-2710. Trichloromelamine, Sulfonated Oleic Acid-Sodium Salt, and Triethylene Glycol; Reregistration Eligibility Decision for Low Risk Pesticides; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Reregistration Eligibility Decisions (RED) for the pesticides trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol, and opens a public comment period on these documents, related risk assessments, and other support documents. EPA has reviewed the low risk pesticides trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol through a modified, streamlined version of 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 trichloromelamine, docket identification (ID) number EPA-HQ-OPP-2005-0262.

For sulfonated oleic acid-sodium salt, docket ID number EPA-HQ-OPP-2005-0261.

For triethylene glycol, docket ID number EPA-HQ-OPP-2005-0250 by one of the following methods:

• 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., NW., 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-2005-0262 for trichloromelamine; docket ID number EPA-HQ-OPP-2005-0261 for sulfonated oleic acid-sodium salt and docket ID number EPA-HQ-OPP-2005-0250 for triethylene glycol. 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 to the chemical specific docket ID number (listed in ADDRESSES section). 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 trichloromelamine, contact Jennifer Slotnick, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

For sulfonated oleic acid-sodium salt, contact Kathryn Jakob, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

For triethylene glycol, contact Heather Garvie, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 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. Using a modified, streamlined version of its public participation process, EPA has completed a Registration Eligibility Decision (RED) for the low risk pesticides, trichloromelamine, sulfonated oleic acid and triethylene glycol under section 4(g)(2)(A) of FIFRA.

Trichloromelamine is a sanitizer and disinfectant with direct and indirect food uses, as well as non-food uses. It is used on hard surfaces and as a fruit and vegetable wash. End-use products are formulated as a soluble concentrate (in powder form). Trichloromelamine currently has a tolerance exemption as an antimicrobial pesticide when, ready for use, the end-use concentration does not exceed 200 parts per million (40 CFR 180.940(c)) when applied to food processing equipment and utensils.

As an active ingredient, sulfonated oleic acid-sodium salt is used as a bactericide and sanitizer for non-porous dairy, beverage, brewery and food processing equipment. Sulfonated oleic acid-sodium salt is formulated as a liquid concentrate. The RED reassesses the exemption from the requirement for a tolerance for sulfonated oleic acid-sodium salt. The tolerance exemption for sulfonated oleic acid-sodium salt is listed in 40 CFR 180.940 (c) (69 FR 23136, April 28, 2004) (FRL-7335-4).

Triethylene glycol is used as a bacteriostat (against odor-causing bacteria) for air sanitization and deodorization. In combination with other active ingredients, it is used as a fungicide, virucide and miticide for disinfection of hard, non-porous surfaces and as an insecticide (against lice) by direct application to caged birds and to the cage. For these uses, triethylene glycol is formulated primarily as a pressurized liquid. This document also addresses the exposures from the use of this pesticide as an inert ingredient. As an inert ingredient, triethylene glycol facilitates delivery of formulated pesticide chemical products that are used as herbicides, fungicides, insecticides, growth regulators and attractants on a wide variety of agricultural commodities. In addition to the above, triethylene glycol is approved by the Food and Drug Administration (FDA) as a preservative for food packaging adhesives as listed in 21 CFR 175.105. Currently, however, there are no EPA registered products for this use. Triethylene glycol also has an indirect food additive regulation 21 CFR 177.1200 (April 1, 2004) for its use as a plasticizer in cellophane. This use is regulated by the FDA.

EPA has determined that the data base to support reregistration is substantially complete and that products containing trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol will be 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 any 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 trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol.

EPA must review tolerances and tolerance exemptions that were in effect when the Food Quality Protection Act was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. EPA has reviewed and made the requisite safety finding for the trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol tolerances included in this notice.

Although the RED decisions were made in FY03 (for triethylene glycol) and FY05 (for trichloromelamine and sulfonated oleic acid-sodium salt), certain components of the documents which did not affect the final regulatory decision, were undergoing final editing at that time. None of these additions or changes alter the conclusions documented in the FY03 or FY05 REDs.

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 issues, and degree of public concern associated with each pesticide. EPA can expeditiously reach decisions for pesticides like trichloromelamine, sulfonated oleic acid-sodium salt and triethylene glycol, which pose few or no risk concerns, affect few if any stakeholders, and require little or no risk mitigation. Once EPA assesses uses and risks for such low risk pesticides, the Agency may go directly to a decision and prepare a document summarizing its findings, such as the REDs.

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 in finding ways to effectively mitigate pesticide risks. These three cases, however, poses few or no risks that require mitigation. The Agency therefore is issuing the trichloromelamine RED, the sulfonated oleic acid-sodium salt RED as well as the triethylene glycol RED, its risk assessments, and related support materials simultaneously for public comment. The comment period is intended to provide an 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 Docket for the specific active ingredient. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

EPA 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 RED will be implemented as it is 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.”

Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

• Environmental Protection
• Pesticides and Pests

Dated: March 9, 2006.

Frank Sanders,

Director, Antimicrobials Division, Office of Pesticide Programs.