Skip to Content


Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Environmental Protection Agency (EPA).




EPA is announcing the availability of the draft test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water.


Comments must be received on or before December 14, 2011.


Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0681, by one of the following methods:

  • Federal eRulemaking Portal: 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 (703) 305-5805.

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, 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 or e-mail. The Web site 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, 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 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, or, if only Start Printed Page 57032available 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 (703) 305-5805.

Electronic access to the harmonized test guidelines. To access the harmonized test guidelines electronically, please go to​ocspp and select “Test Methods and Guidelines.” You may also access the harmonized test guidelines in grouped by series under docket ID numbers: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

Start Further Info


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: (703) 308-6349; e-mail address:

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address:

FIFRA 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: (703) 305-5017 and TDD: (202) 554-0551; fax number: (703) 305-5558.

End Further Info End Preamble Start Supplemental Information


I. 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 chemical substances under TSCA, FFDCA, or FIFRA, 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 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.

II. What action is EPA taking?

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

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

2. Air Sanitizers—Efficacy Data Recommendations (OCSPP Guideline 810.2500).

3. Disinfectants for Use in Water—Efficacy Data Recommendations (OCSPP Guideline 810.2600).

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

As a guidance document, the test guidelines are not binding on either EPA or any outside parties. At places in this guidance, the Agency uses the word “should.” In this guidance, 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 guideline, but EPA recognizes that departures may be appropriate in specific situations. EPA will consider alternatives to the recommendations described in the test guidelines on a case-by-case basis, after assessing whether the alternative will provide the data necessary to inform the regulatory decision that must be made.

III. How were these draft 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 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's Web site:​scipoly/​sap/​index.htm. In addition to formatting changes to incorporate the guidelines into the OCSPP test guideline 810 series, EPA has added sections that incorporate new guidelines and clarifications from other guidance documents, and comments from the regulated industry. In particular, the waiver for the submission of efficacy data for air sanitizers that contain at least 5% glycol has been rescinded. Altogether, these draft test 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 40 CFR 158.2220 contains a table entitled “Antimicrobial Product Performance Data Start Printed Page 57033Requirements,” which referenced under the “Guideline Number” column the 91 series of test guidelines. EPA's intention is to replace the 91 series test guideline designations with the appropriate 810 series test guideline designations. Therefore, at the time of the publication of the final rule, appropriate references to the 810 series test guideline numbers and names will be incorporated into the final rule.

IV. Are there any applicable voluntary consensus standards that EPA should consider?

This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA requires EPA to provide an explanation to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards when NTTAA directs the Agency to do so.

These test guidelines represent an Agency effort to harmonize the test guidelines within OCSPP, as well as to harmonize the OCSPP test guidelines with those of OECD. The process for developing and amending these test guidelines, which began in 1991, includes public participation and the extensive involvement of the scientific community, including peer review by SAP and the SAB and other expert scientific organizations.

In the future, these test guidelines could be incorporated into regulatory actions taken by EPA under TSCA, i.e., with regard to the TSCA section 4 testing program. Although, NTTAA requirements do not specifically apply to the issuance of these particular test guidelines, EPA invites your comment on whether or not there are any voluntary consensus standards that should be considered during the development of the final test guidelines or any future regulatory action that may be taken under TSCA. Future regulatory actions under TSCA section 4 may involve notice and comment rulemaking or negotiated voluntary testing enforcement consent agreements/orders/decrees. Nevertheless, However, the Agency is interested in whether or not there are any voluntary consensus standards that EPA should consider either as part of the development of the final test guidelines themselves or in lieu of these final test guidelines when the Agency develops any future regulatory action that incorporates these test guidelines. Any comments provided will assist the Agency in complying with NTTAA by facilitating the Agency's identification of voluntary consensus standards that should be addressed in the test guideline or considered during the development of a proposed regulatory action that incorporates any standards included in the final test guidelines. Please submit your comments as directed under ADDRESSES.

Start List of Subjects

List of Subjects

End List of Subjects Start Signature

Dated: September 7, 2011.

Stephen A. Owens,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

End Signature End Supplemental Information

[FR Doc. 2011-23666 Filed 9-14-11; 8:45 am]