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Draft Test Guidelines; Series 810-Product Performance Test Guidelines; Notice of Availability and Request for Comments

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Environmental Protection Agency (EPA).




This notice announces the availability for comment of several 810 series, non-binding, draft test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP). The test guidelines provide guidance on conducting testing by the public and companies that are subject to EPA data submission requirements under OCSPP's major statutory mandates.


Comments must be received on or before August 17, 2015.


Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0276, by one of the following methods:

  • Federal eRulemaking Portal: Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
  • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
  • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at​dockets.

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For general information contact: Melissa Start Printed Page 34639Chun, Regulatory Coordination Staff (7101M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-1605; email address:

For technical information contact: Stephen Tomasino, Biological and Economic Analysis Division (7503P), Office of Pesticide Programs, Environmental Protection Agency, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number: (410) 305-2976; email address:

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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 pesticides and other chemical substances for submission of data to EPA 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/or the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, 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 email. 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 preparing and submitting your comments, see the commenting tips at​dockets/​comments.html.

3. Electronic access to the OCSPP Test Guidelines. You may access the guidelines in at, grouped by series under docket ID numbers: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

II. Background

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.

III. What action is EPA taking?

EPA is making available for comment the following 810 Series draft test guidelines: OCSPP Test Guideline 810.2000—General Considerations for Testing Antimicrobial Agents, OCSPP Test Guideline 810.2100—Sterilants & Sporicides Recommendations for Efficacy Testing, and OCSPP Test Guideline 810.2200—Disinfectants for Use on Hard Surfaces—Efficacy Data Recommendations.

The Agency published the notice announcing the final test guidelines for these product performance testing guidelines for antimicrobial agents in the Federal Register of March 16, 2012 (77 FR 15750) (FRL-9332-4). Since then, the Agency has received information from the users that these test guidelines are confusing and in some cases, inaccurate. The test guidelines have been re-formatted to be more user friendly, correct technical information, and include updates from policy documents published after 2012. As noted in section I.B.3 of this notice, the public can access the guidelines in at, grouped by series under docket ID numbers: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

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Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 U.S.C. 301 et seq.

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Dated: June 4, 2015.

James Jones,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

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[FR Doc. 2015-14955 Filed 6-16-15; 8:45 am]