2011-26532. Environmental Science Center Microbiology Laboratory; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The U.S. EPA invites interested stakeholders to participate in a laboratory-based technical workshop that will focus on the conduct of the Association of Official Analytical Chemists (AOAC) Use-dilution method (UDM) and the status and implementation of a new test method, the Organization for Economic Cooperation and Development (OECD) Quantitative Method for Evaluating Bactericidal Activity of Microbicides Used on Hard, Non-Porous Surfaces. The workshop is being held to discuss current and proposed revisions mainly associated with the Staphyloccocus aureus and Pseudomonas aeruginosa methodologies. The goals of the workshop are to provide a comprehensive review and discussion period on the status of the UDM and OEDC methods integrated with hands-on laboratory demonstrations. An overview of various data sets and collaborative studies will be used to supplement the discussions which will be held at the EPA Environmental Science Center Microbiology Laboratory.

DATES:

The meeting will be held on November 15 and 16, 2011 from 8:30 a.m. to 4 p.m. Requests to participate in the meeting must be received on or before November 4, 2011. To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

ADDRESSES:

The meeting will be held at the Environmental Protection Agency's Environmental Science Center, 701 Mapes Road, Ft. Meade, Maryland 20755-5350. Requests to participate in the meeting, identified by docket identification (ID) number EPA-HQ-OPP-2011-0842, may be submitted to the person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Michele Cottrill, 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?

You may be potentially affected by this action if you represent antimicrobials product registrants, healthcare facilities who use antimicrobial products, Professional associations for healthcare officials. Potentially affected entities may include, but are not limited to those persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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. How can I get copies of this document and other related information?

EPA has established a docket for this action under docket ID number EPA-HQ-OPP-2011-0842. 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 Office of Pesticide Programs (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].

II. Background

The AOAC Use-dilution method (UDM), is currently accepted by EPA for regulatory purposes to measure the efficacy of liquid hospital disinfectants against Staphyloccocus aureus, Pseudomonas aeruginosa and Salmonella enterica on hard non-porous surfaces. In addition to using the method for registration purposes, the method is currently in use as part of the post market Antimicrobials Testing Program. The workshop is being held to discuss current and proposed revisions mainly associated with the S. aureus and P. aeruginosa methodologies, which are designed to further optimize and standardize the UDM, and to discuss the data associated with these revisions. At the workshop, the UDM method will be discussed along with the status and implementation of a new test method, the OECD Quantitative Method for Evaluating Bactericidal Activity of Microbicides Used on Hard, Non-Porous Surfaces (OECD method), will be discussed. The OECD Method recently underwent a multi-laboratory ring trial and the EPA is interested in adopting the OECD method for regulatory purposes. The method is based on test guidelines from the (OECD), an intergovernmental organization consisting of 30 industrialized countries in Europe, North America, Asia and the Pacific. Through its Environment Program, OECD works to help countries manage the risks of chemicals as efficiently and effectively as possible.

This is a technical meeting for individuals with laboratory expertise in conducting the UDM and OECD procedures or who plan to conduct these methods in the future. Participants must be knowledgeable of the safety practices and procedures for working in a Biosafety Level II laboratory environment in order to participate in the laboratory demonstrations. The detailed agenda for the workshop is available in the docket. The Agency is encouraging participation from a cross-section of affected parties including industry, state and federal partners, and testing laboratories. Due to space constraints in the laboratory, attendance will be limited to 30 total participants, with a maximum of 20 participating in the laboratory exercises.

III. How can I request to participate in this meeting?

You may submit a request to participate in this meeting to the person listed under FOR FURTHER INFORMATION CONTACT. Do not submit any information in your request that is considered CBI. Requests to participate in the meeting, identified by docket ID number EPA-HQ-OPP-2011-0842, must be received on or before November 4, 2011.

List of Subjects

Environmental protection, Association of Official Analytical Chemists (AOAC), Public health claims, Use-dilution method.

Dated: October 6, 2011.

Joan Harrigan-Farrelly,

Director, Antimicrobials Division, Office of Pesticide Programs.