Document ID: EPA-HQ-OPP-2007-0086-0001
Agency: epa
Document Type: Notice
Title: Implementation of the Emerging Pathogens and Disinfection Hierarchy for Antimicrobial Products; Notice of Availability
Posted Date: 2007-07-25T04:00Z

[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Notices]               
[Page 40879-40880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-71]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0086; FRL-8134-2]

 
Implementation of the Emerging Pathogens and Disinfection 
Hierarchy for Antimicrobial Products; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: To assure that EPA's practices related to implementing the 
Food Quality Protection Act of 1996 (FQPA) are transparent and open to 
public participation, EPA is soliciting comments on the pesticide draft 
science guidance document entitled ``Implementation of the Emerging 
Pathogens and Disinfection Hierarchy for Antimicrobial Products.''

DATES: Comments must be received on or before August 24, 2007.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-0086, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

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'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-
2007-0086. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, 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 regulations.gov or e-
mail. The Federal regulations.gov 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 
regulations.gov, 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

[[Page 40880]]

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 in regulations.gov. To access the electronic docket, go to: 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. 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 http://www.regulations.gov, or, if only available 

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.

FOR FURTHER INFORMATION CONTACT: Laura Bailey, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-6212; fax number: (703) 308-6467; e-mail address: 
bailey.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you formulate or 
market pesticide products. Potentially affected entities may include, 
but are not limited to:
    Antimicrobial pesticides (NAICS 325612)
    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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended by the 
Food Quality Protection Act (FQPA) of August 3, 1996 Section 2(u). 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov 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 as 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 your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest 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 the Agency Taking?

    There is a growing need for the public health community to 
recognize and respond to unique threats from newly-identified microbial 
pathogens (e.g., severe acute respiratory syndrome (SARS Co-V) and re-
emerging infectious disease agents of importance (e.g., Vancomycin-
Resistant Staphylococcus aureus (VRSA)). Based upon contemporary 
understanding of the physiochemical structure of microorganisms and 
their respective inactivation kinetics, microorganisms can be ranked 
with respect to their susceptibility to hard surface disinfectants.
    The guidance proposes to utilize an organism hierarchy to identify 
products for use with emerging pathogens and to permit registrants, in 
accordance with EPA regulations, to make limited label statements. The 
guidance applies only to emerging enveloped and non-enveloped viruses 
and may be implemented after the Centers for Disease Control and 
Prevention has identified the taxonomic genera of the emerging virus. 
Limitations, label recommendations and the process for implementation 
are discussed in detail in the supporting guidance document. The 
supporting implementation guidance is available in the docket at EPA-
HQ-OPP-2007-0086.

List of Subjects

    Environmental protection, Pesticides and pests, Disinfection 
hierarchy, Emerging pathogens, Antimicrobial products.

    Dated: July 13, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E7-14292 Filed 7-24-07; 8:45 am]

BILLING CODE 6560-50-S