E8-20384. Final Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The Agency is announcing the availability of a Pesticide Registration Notice (PR Notice) entitled “Antimicrobial Pesticide Products With Anthrax-Related Claims.” This PR Notice was issued by the Agency on [insert date PR Notice is signed by the OD] and is identified as PR Notice 2008-2. PR Notices are issued by the EPA's Office of Pesticide Programs (EPA/OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This particular PR Notice provides guidance pertaining to applications of registration for antimicrobial products that would make labeling claims to inactivate Bacillus anthracis (anthrax) spores (hereafter referred to as “anthrax-related products”).

FOR FURTHER INFORMATION CONTACT:

Jeff Kempter, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-305-5448; fax number: 703-308-6467; e-mail address: [e-mail].

SUPPLEMENTARY 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 required to register pesticides and federal, state, and local government agencies and private institutions or organizations who are interested in bio-decontamination chemicals. Since other entities may also be interested, 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 information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-1004. 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].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. What Guidance Does this PR Notice Provide?

This final PR Notice provides guidance pertaining to applications for registration of antimicrobial products that would make labeling claims to “inactivate Bacillus anthracis (anthrax) spores” (hereafter referred to as “anthrax-related products”). This guidance should help the United States be prepared to respond to incidents involving anthrax spores by assuring that anthrax-related products are registered, that they bear appropriate labeling, and that they are effective when used as directed. In addition, this guidance will help protect public health from the potential risks of anthrax spores by limiting the use of anthrax-related products to those who are properly trained and determined to be competent in their use.

In summary, this PR notice specifies that in order for a product to qualify for a claim of inactivating anthrax spores, an anthrax-related product should be: (a) supported by specific sporicidal efficacy studies that are acceptable to EPA and (b) subject to specific terms and conditions of registration that limit the use of these products to certain persons. Prospective applicants are encouraged to follow the guidance in this notice and consult with EPA prior to applying for registration or amendment of a product when seeking such a claim.

In October 2001, when several letters containing Bacillus anthracis (anthrax) spores were introduced into the U.S. Postal Service mail system, no antimicrobial products were specifically registered for inactivating the spores of this particular pathogen. Since that time, EPA/OPP has developed guidance on the terms and conditions of registration for the labeling of these products that will limit their use to certain persons, as described below. In addition, the EPA/OPP has developed guidance on laboratory efficacy test methods for demonstrating the effectiveness of antimicrobial products for inactivating anthrax spores on inanimate surfaces. Such efficacy testing guidance will be issued separately from this PR Notice. It is EPA's intent that registrants will follow the efficacy testing guidance and this PR Notice when applying for registration of anthrax-related products, and that such products, when registered, will be made available to trained and competent civilian and military personnel who respond to incidents involving anthrax spores.

The information collection activities associated with the activities described in this PR Notice are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The corresponding Information Collection Request (ICR) document for the training of pesticide applicators has been assigned EPA ICR number 0155.09 and is approved under OMB control number 2070-0029. The ICR document for the pesticide application process has been assigned EPA ICR number 0277.13, and is approved under OMB control number 2070-0060. The total estimated respondent paperwork burden associated with the training and certification of a pesticide applicator is an annual average of 3.1 burden hours. The annual average reporting and recordkeeping burden for a registration applicant respondent is estimated to range from 14 hours to 646 hours, depending upon the type of activity. For “Type A” activities, which include new active ingredients and new uses, the estimated annual applicant burden average is 194 hours per application. For “Type B” activities, which include amendments and notifications, the estimated annual applicant burden average is 14 hours per application. The respondent burden estimate for “Type C” reduced risk products is an average of 646 hours per product. A copy of the most recent version of EPA ICR #0155.09 is available under Docket ID No. EPA-HQ-OPP-2003-0357, and a copy of the most recent version of EPA ICR #0277.13 is available under Docket ID No. EPA-HQ-OPP-2004-0419. Both dockets may be accessed at www.regulations.gov.

III. Do PR Notices Contain Binding Requirements?

The PR Notice discussed in this notice is intended to provide general guidance to pesticide applicants and registrants. While the requirements in the statutes and Agency regulations are binding on EPA, registrants, and applicants, this PR Notice is not binding on either EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide applicants and registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation. Pesticide applicants and registrants may propose alternatives to the recommendations described in the PR Notice, and the Agency will assess them for appropriateness on a case-by-case basis and will respond in writing.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Anthrax
• Decontamination
• Pesticides and pests

Dated: August 26, 2008.

Debra Edwards,

Director, Office of Pesticide Programs.