2010-1323. Draft Test Guidelines; Notice of Availability and Request for Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing the availability of four draft test guidelines for Product Performance of Public Health Uses of Antimicrobial Agents for public review and comment.

DATES:

Comments must be received on or before March 29, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0681, 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 Facility’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 [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2009-0681. 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 at http://www.regulations.gov. 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 [phone].

Electronic access to the OPPTS Test Guidelines: To access the OPPTS harmonized test guidelines electronically, please go to http://www.epa.gov/​oppts and select “Test Methods & Guidelines” on the left side navigation menu. You may also access the guidelines in http://www.regulations.gov grouped by series under dockets ID numbers EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Communications Services Branch (7506P), Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone numbers: [phone] and TDD: [phone]; fax number: [phone].

For technical information contact: Michele Wingfield, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: wingfield.michele @epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

These draft guidelines are part of a series of test guidelines established by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).

The OPPTS test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. The test guidelines provide guidance for conducting the test, and are also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.

As a guidance document, the test guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the test guidelines where circumstances warrant and without prior notice. The procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in the test guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.

II. 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 those persons who are or may be required to conduct testing of pesticides and chemical substances for submission to EPA under FIFRA and/or FFDCA, 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 technical 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 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 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.

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 the estimate.

vi. Provide specific examples to illustrate your concerns and suggested 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.

III. Overview

A. What Action is EPA Taking?

EPA is announcing the availability for public review and comment of the following four draft test guidelines under Series 810-Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents:

• OPPTS 810.2000 - General Considerations for Public Health Uses of Antimicrobial Agents.
• OPPTS 810.2100 - Sterilants - Efficacy Data Recommendations.
• OPPTS 810.2200 - Disinfectants for Use on Hard Surfaces—Efficacy Data Recommendations.
• OPPTS 810.2300 - Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations.

These guidelines address efficacy testing for antimicrobial agents intended to be used on hard, inanimate, environmental surfaces, and which bear label claims as sterilants, disinfectants, and/or sanitizers. Data from these studies are used to support the labeling claims for public health related antimicrobial agents.

B. How Were These Test Guidelines Developed?

The product performance use guidelines for antimicrobial agents were last updated in 1982 under the “Pesticide Assessment Guidelines - Subdivision G, Product Performance.” Since then, the Agency has presented several issues at two separate meetings of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) (one in September 1997 and the other in July 2007) related to the conduct of studies for antimicrobial agents. In addition to formatting changes to incorporate the guidelines into the OPPTS guidelines series 810, EPA has added sections that incorporate the recommendations from the two SAPs, new guidelines and clarifications from other guidance documents, and comments from the regulated industry. In particular, a new section has been added that describes the data to be submitted to support labeling claims against two spore forming bacteria, Bacillus anthracis and Clostridium difficile. Altogether, these revised guidelines, once final, will represent the Agency’s current recommendations for conducting studies to support antimicrobial pesticide label claims.

On October 8, 2008, EPA published in the Federal Register a proposed rule entitled “Data Requirements for Antimicrobial Pesticides” (73 FR 59382). Proposed § 158.2220 (40 CFR part 158) contains a table entitled “Antimicrobial Product Performance Data Requirements,” which referenced under the Guidelines Number column the 91 series of guidelines. EPA’s intention is to replace the 91 series designations with the appropriate reference to the 810 series designations under 810.2000. Therefore, at the time of the publication of the final rule, appropriate references to the OPPTS test guideline numbers and names will be incorporated into the final data requirement regulations.

List of Subjects

• Environmental protection
• Chemical testing
• Test guidelines

Dated: January 15, 2010.

Stephen A. Owens,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.