2012-15604. Final Test Guidelines; 810 Series 2000 Product Performance; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing the availability of the final test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically OCSPP 810.2400—Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations; OSCPP 810.2500—Air Sanitizers—Efficacy Data Recommendations; and OSCPP 810.2600—Disinfectants and Sanitizers for Use in Water—Efficacy Data Recommendations. These test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). As guidance documents, the final test guidelines are not binding on either EPA or any outside parties. These test guidelines are final and effective 90 days after publication of this notice.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

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

SUPPLEMENTARY INFORMATION:

I. Introduction

These test guidelines are part of a series of test guidelines established by OCSPP for use in testing pesticides and chemical substances to develop data for submission to the Agency under TSCA (15 U.S.C. 2601 et seq.), FIFRA (7 U.S.C. 136 et seq.), and FFDCA section 408 (21 U.S.C. 346a).

The 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 companies that are subject to data submission requirements under TSCA, FIFRA and/or FFDCA.

As guidance documents, the test guidelines are not binding on either EPA or any outside parties, and EPA may depart from the test guidelines where circumstances warrant and without prior notice. At places in these guidance documents, the Agency uses the word “should.” In these guidance documents, use of “should” with regard to an action means that the action is recommended rather than mandatory. The procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guidelines, 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 TSCA, 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. How can I get copies of this document and other related information?

1. Docket for this document. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0681, is available either electronically through http://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW. Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPP Docket is [phone]. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.

2. Electronic access to the OCSPP Test Guidelines. To access OCSPP test guidelines electronically, please go to http://www.epa.gov/​ocspp/​pubs/​frs/​home/​testmeth.htm. You may also access the test guidelines in http://www.regulations.gov,, grouped by series under docket ID numbers: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-2009-0576.

III. Overview

A. What action is EPA taking?

EPA is announcing the availability of final test guidelines under Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents:

1. OCSPP 810.2400—Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations .

2. OSCPP 810.2500—Air Sanitizers—Efficacy Data Recommendations.

3. OSCPP 810.2600—Disinfectants and Sanitizers for Use in Water—Efficacy Data Recommendations.

These final test guidelines address efficacy testing for antimicrobial agents intended to be used as disinfectants and sanitizers for use on fabrics, on textiles, in the air and in water.

B. How were these final test guidelines developed?

The product performance 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 FIFRA Scientific Advisory Panel (SAP) related to the conduct of studies for antimicrobial agents (the first meeting September 9-10, 1997, announced in the Federal Register issue of July 14, 1997 (62 FR 37584) (FRL-5731-4) and the second meeting July 17-19, 2007, announced in the Federal Register issue of March 14, 2007 (72 FR 11867) (FRL-8118-7). Information and recommendations regarding these two SAPs can be found at the Office of Science and Coordination and Policy's Web site: http://www.epa.gov/​scipoly/​sap/​index.htm. The test guidelines described in Unit III were also made available for public comment on September 15, 2011 (76 FR 57031) (FRL 8879-1) and revised based on comments received from industry. In addition, formatting changes to incorporate the test guidelines into the OCSPP test guideline 810 series were made.

List of Subjects

• Environmental protection
• Chemical testing
• Test guidelines

Dated: June 19, 2012.

James Jones,

Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention.