Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Anthrax-Related Claims, 31325-31326 [E7-10694]

Download as PDF Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Notices symptoms in patients with either spinal cord injury or multiple sclerosis. 4aminopyridine is an active ingredient used in bird repellents that is currently undergoing reregistration. • Extensive background materials concerning research to quantify the level of exposure received by people who mix, load, and apply pesticides. These materials, which were prepared by the Agricultural Handlers Exposure Task Force and by the Antimicrobial Exposure Assessment Task Force, generally explain the scope of the research programs being proposed by the Task Forces and describe the general scientific framework for conducting the research. In addition, each Task Force has provided Standard Operating Procedures which will guide the conduct of the studies. The Board may also be reviewing draft HSRB reports for subsequent Board approval. Finally, the Board may also discuss planning for future HSRB meetings. b. Meeting Minutes and Reports. Minutes of the meeting, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matters will be released within 90 calendar days of the meeting. Such minutes will be available at https:// www.epa.gov/osa/hsrb/ and https:// www.regulations.gov. In addition, information concerning a Board meeting report, if applicable, can be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION CONTACT. Dated: May 31, 2007. Kevin Teichman, Acting EPA Science Advisor. [FR Doc. E7–10859 Filed 6–5–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2006–1004; FRL–8113–5] Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With AnthraxRelated Claims Environmental Protection Agency (EPA). ACTION: Notice of availability. jlentini on PROD1PC65 with NOTICES AGENCY: SUMMARY: The Agency is announcing the availability of, and seeking public comment on, a draft Pesticide Registration Notice entitled, ‘‘Guidance for Antimicrobial Pesticide Products With Anthrax-Related Claims.’’ PR notices are issued by the Office of VerDate Aug<31>2005 16:59 Jun 05, 2007 Jkt 211001 Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions. This particular notice would, once final, provide guidance to prospective applicants of antimicrobial products that make labeling claims to inactivate Bacillus anthracis (anthrax) spores (hereafter referred to as ‘‘anthraxrelated products’’). DATES: Comments must be received on or before September 4, 2007. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2006–1004, by one of the following methods: • Federal eRulemaking Portal: https:// 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–2006– 1004. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// 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 email. The Federal regulations.gov website 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 email 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. If PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 31325 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. 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 https:// 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: Jeff Kempter, Antimicrobials Division, 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: kempter.carlton@epa.gov. 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 biodecontamination 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. 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 E:\FR\FM\06JNN1.SGM 06JNN1 31326 Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Notices 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. jlentini on PROD1PC65 with NOTICES 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– OPPT–2006–1004. Publicly available docket materials are available either in the electronic docket at https:// 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 (703) 305–5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet VerDate Aug<31>2005 16:59 Jun 05, 2007 Jkt 211001 under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. II. What Guidance Does this PR Notice Provide? This draft PR Notice provides guidance to the registrant concerning antimicrobial products that make labeling claims to ‘‘inactivate Bacillus anthracis (anthrax) spores’’ (hereafter referred to as ‘‘anthrax-related products’’). In summary, this notice specifies that in order for a product to qualify for a claim of inactivating anthrax spores, an anthrax-related product should be: 1. Supported by specific sporicidal efficacy studies that are acceptable to EPA; and 2. Subject to specific terms and conditions of registration that limit the use of these products to certain trained 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. This guidance should help the United States be better prepared to respond to the intentional, accidental or natural introduction of anthrax spores by helping to assure that anthrax-related products bear appropriate labeling and are effective when used as directed. In October 2001, when several letters containing Bacillus anthracis (anthrax) spores were introduced into the U.S. Postal Service mail system causing extensive contamination to dozens of buildings, no antimicrobial products were specifically registered for inactivating this particular pathogen. Since that time, the EPA has conducted extensive research and coordinated across the federal government to determine which efficacy test methods would be appropriate for demonstrating the effectiveness of antimicrobial products for inactivating B. anthracis spores. Guidance on acceptable efficacy test methods will be made available in a separate document. EPA’s Office of Pesticide Programs has also developed guidance on the terms and conditions of registration for the labeling of these products. EPA intends to limit the use of these products to certain groups of trained persons. This notice is aimed primarily at applicants and registrants, but may also be of interest to other federal, state, and local government agencies, academic institutions, and other interested parties. III. Do PR Notices Contain Binding Requirements? The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and to pesticide PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR Notice is not binding on pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Decontamination. Dated: May 21, 2007. Debra Edwards, Director, Office of Pesticide Programs. [FR Doc. E7–10694 Filed 6–5–07; 8:45 am] BILLING CODE 6560–50–S OFFICE OF SCIENCE AND TECHNOLOGY POLICY Meeting of the President’s Council of Advisors on Science and Technology ACTION: Notice of meeting. SUMMARY: This notice sets forth the schedule and summary agenda for a meeting of the President’s Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. Notice of this meeting is required under the Federal Advisory Committee Act (FACA). Dates and Place: June 25, 2007, Arlington, VA. The meeting will be held in Room 1235 of the National Science Foundation at 4201 Wilson Boulevard, Arlington, Virginia 22230. Note that due to security requirements at the National Science Foundation, anyone planning to attend must pre-register no later than close of business on Thursday, June 21, 2007 by going to the PCAST Web site at: https://www.ostp.gov/PCAST/pcast.html or by calling 703–536–4996. Type of Meeting: Open. Further details on the meeting agenda will be posted on the PCAST web site given above. Proposed Schedule and Agenda: The President’s Council of Advisors on Science and Technology (PCAST) is scheduled to meet in open session on Monday, June 25, 2007, at approximately 9 a.m. The PCAST subcommittee on nanotechnology has convened a group of experts from academia, industry, and nongovernmental organizations to provide an overview of nanotechnology applications and implications. The E:\FR\FM\06JNN1.SGM 06JNN1

Agencies

[Federal Register Volume 72, Number 108 (Wednesday, June 6, 2007)]
[Notices]
[Pages 31325-31326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10694]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-1004; FRL-8113-5]


Pesticides; Draft 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, and seeking 
public comment on, a draft Pesticide Registration Notice entitled, 
``Guidance for Antimicrobial Pesticide Products With Anthrax-Related 
Claims.'' PR notices are issued by the Office of Pesticide Programs 
(OPP) to inform pesticide registrants and other interested persons 
about important policies, procedures, and registration related 
decisions. This particular notice would, once final, provide guidance 
to prospective applicants of antimicrobial products that make labeling 
claims to inactivate Bacillus anthracis (anthrax) spores (hereafter 
referred to as ``anthrax-related products'').

DATES: Comments must be received on or before September 4, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-1004, by one of the following methods:
     Federal eRulemaking Portal: https://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-
2006-1004. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://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 website 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. 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. 
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 https://
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: Jeff Kempter, Antimicrobials Division, 
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: 
kempter.carlton@epa.gov.

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. 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

[[Page 31326]]

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.

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-OPPT-2006-1004. Publicly 
available docket materials are available either in the electronic 
docket at https://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 (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr.

II. What Guidance Does this PR Notice Provide?

    This draft PR Notice provides guidance to the registrant concerning 
antimicrobial products that make labeling claims to ``inactivate 
Bacillus anthracis (anthrax) spores'' (hereafter referred to as 
``anthrax-related products''). In summary, this notice specifies that 
in order for a product to qualify for a claim of inactivating anthrax 
spores, an anthrax-related product should be:
    1. Supported by specific sporicidal efficacy studies that are 
acceptable to EPA; and
    2. Subject to specific terms and conditions of registration that 
limit the use of these products to certain trained 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. This guidance should help the United 
States be better prepared to respond to the intentional, accidental or 
natural introduction of anthrax spores by helping to assure that 
anthrax-related products bear appropriate labeling and are effective 
when used as directed.
    In October 2001, when several letters containing Bacillus anthracis 
(anthrax) spores were introduced into the U.S. Postal Service mail 
system causing extensive contamination to dozens of buildings, no 
antimicrobial products were specifically registered for inactivating 
this particular pathogen. Since that time, the EPA has conducted 
extensive research and coordinated across the federal government to 
determine which efficacy test methods would be appropriate for 
demonstrating the effectiveness of antimicrobial products for 
inactivating B. anthracis spores. Guidance on acceptable efficacy test 
methods will be made available in a separate document. EPA's Office of 
Pesticide Programs has also developed guidance on the terms and 
conditions of registration for the labeling of these products. EPA 
intends to limit the use of these products to certain groups of trained 
persons. This notice is aimed primarily at applicants and registrants, 
but may also be of interest to other federal, state, and local 
government agencies, academic institutions, and other interested 
parties.

III. Do PR Notices Contain Binding Requirements?

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and to pesticide registrants. While the 
requirements in the statutes and Agency regulations are binding on EPA 
and the applicants, this PR Notice is not binding on pesticide 
registrants, and EPA may depart from the guidance where circumstances 
warrant and without prior notice. Likewise, pesticide registrants may 
assert that the guidance is not appropriate generally or not applicable 
to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Decontamination.

    Dated: May 21, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-10694 Filed 6-5-07; 8:45 am]
BILLING CODE 6560-50-S
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