ICR Attachment D - Draft Guidance for Antimicrobial Pesticide Products With Anthrax-Related Claims

OMB Control Number 2070-0029; EPA ICR Number 0155.09
ICR ATTACHMENT D
“Guidance for Antimicrobial Pesticide Products With Anthrax-Related Claims”
Federal Register Notice of Availability (72 FR 31325)
and Draft Pesticide Registration (PR) Notice 2007-X

NOTE: The public comment period for the draft PR Notice closed on September 4, 2007. EPA
is no longer accepting public comments on that document.

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 http://
www.epa.gov/osa/hsrb/ and http://
www.regulations.gov. In addition,
information concerning a Board meeting
report, if applicable, can be found at
http://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Pesticides; Draft Guidance for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

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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: 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–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 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 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

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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 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: 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:
[email protected].
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

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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 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 (703) 305–5805.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet

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under the ‘‘Federal Register’’ listings at
http://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

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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:
http://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

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Draft of 05/11/2007
Draft Document for Public Review - EPA is releasing this draft document solely for the
purpose of public review and comment. This draft document is not now, and has not yet been,
formally disseminated by EPA. It does not represent and should not be construed to represent
any Agency policy or determination. Please submit comments to Docket ID # EPA-HQ-OPP2006-1004 at www.regulations.gov.

PESTICIDE REGISTRATION (PR) NOTICE 2007-X [DRAFT]
NOTICE TO MANUFACTURERS, PRODUCERS,
FORMULATORS AND REGISTRANTS OF PESTICIDES
ATTENTION:

Persons Responsible for Registration of Pesticide Products

SUBJECT:

Guidance for Antimicrobial Pesticide Products With Anthrax-Related
Claims

This notice provides guidance to prospective applicants of antimicrobial products that
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 made
available as registered products, 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 qualified in their use and who can safely and effectively remediate
contaminated facilities and their contents.
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: (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 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.
I.

Why This Notice is Being Issued

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 this particular pathogen. Since that time, EPA’s Office of Pesticide
Programs (EPA/OPP) has developed guidance on the terms and conditions of registration for the
labeling of these products, which will limit their use to certain groups of trained persons, as
described below. In addition, the EPA/OPP has developed guidance on efficacy test methods for
demonstrating the effectiveness of antimicrobial products for inactivating B. anthracis spores on
inanimate surfaces. Such efficacy testing guidance will be issued separately from this PR
Notice, as described below. It is EPA’s intent that registrants will follow these guidance
documents when applying for registration of anthrax-related products, and that such products,
when registered, will be made available to trained civilian and military personnel responsible for
preparing for and responding to incidents involving anthrax spores.
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Draft of 05/11/2007

II.

Registration Guidance for Anthrax-related Products
A. Efficacy Test Methods

Currently, no EPA guidance is available concerning test methods to demonstrate the
efficacy of anthrax-related products. EPA/OPP intends to add this guidance to Section 810.2100
of OPPTS’ Pesticide Assessment Guidelines (PAG), which currently describes efficacy test
methods that are recommended to demonstrate the efficacy of sterilants and sporicides.
EPA/OPP also plans to present the draft efficacy test method guidance to the FIFRA Scientific
Advisory Panel (SAP) for review and comment, and then issue the guidance in final form at
about the same time that this PR Notice is issued. Until EPA issues such efficacy test method
guidance, registrants are encouraged to submit their proposed efficacy test protocols to EPA for
review prior to conducting such testing. If an application for registration is received with
efficacy data to support a claim to inactivate B. anthracis spores in the absence of efficacy test
method guidance, EPA will evaluate such data on a case-by-case basis.
B. Terms and Conditions of Registration
Due to the high potential risk to human health posed by B. anthracis spores (especially
spores processed in a manner designed to enhance the potential for inhalation exposure), the
Agency intends to establish terms and conditions of registration that limit the use of anthraxrelated products to persons who are trained in their use. These limitations will help assure that
the registered antimicrobial products are used safely and effectively. To implement such
limitations, the registrant should agree in writing to specific Terms and Conditions of
Registration that include items 1-5 below. Once the registrant has agreed to the terms and
conditions, and once the Agency has issued a registration, the registrant would need to meet the
terms and conditions. The consequences of not meeting the terms and conditions are described
in section II.B.5. below. Further, the terms and conditions will be inserted into the Notice of
Registration and will apply to all uses on the product’s labeling. Accordingly, EPA strongly
recommends a separate product registration for the uses that fall within the scope of this PR
Notice.
1. Sale and Distribution Limitations
The registrant commits not to sell or distribute the product except to:
•
•
•

Federal On-Scene Coordinators (FOSC), and contractors and other trained
federal/state/local response personnel under the FOSC’s supervision;
Trained U.S. Military personnel and contractors under their supervision;
Persons who, within the preceding 24 months, have been trained and determined to be
competent by the registrant (or its contractor) in each of the topics described under item 2
below.
2. Training

Where a registrant proposes to sell or distribute anthrax-related products to persons other
than FOSCs, trained U.S. Military personnel, and contractors and other response personnel under
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Draft of 05/11/2007
the supervision of FOSCs or trained U.S. Military personnel, the registrant commits to providing
training for such persons and to determining their competency. The registrant may itself
perform the training or enter into a contract with a qualified third party to conduct the training on
the registrant’s behalf. The registrant further commits that the training curriculum will provide
for refresher training at least every two years and, at a minimum, include instruction concerning:
•
•
•
•

•

Characteristics of and human health hazards posed by B. anthracis spores;
Personal Protective Equipment (PPE) appropriate for protection against both B. anthracis
spores and the use of the pesticide product itself;
Detailed instructions for safe and effective use of the pesticide product and any
associated equipment;
Detailed review of all steps involved in the decontamination process as provided in
guidance from federal agencies (e.g., National Response Team Technical Assistance for
Anthrax Response, Interim Final Draft, July 2005) as well as review of applicable federal
statutory and regulatory requirements and guidance; and
An assessment of the trained applicator's competency on the above issues through a
written exam to be developed by the registrant.

EPA intends to review and approve any training program proposed in an application for
registration or amended registration before determining the product’s eligibility for registration.
3. Records and Reporting
The registrant commits to the following, commencing upon the effective date of
registration or, if the anthrax-related claim is added to an existing registration by amendment,
upon the effective date of that amendment:
•

•
•

Maintain accurate, up-to-date records of its required activities under these Terms and
Conditions, including:
--Names of trainers, a listing of their qualifications, and copies of all
training materials used.
--Names and addresses of persons who have been trained and the dates and
locations of such training.
--Names and addresses of persons to whom the pesticide has been sold or
distributed as well as the date and location of such sale or distribution and the
product and quantity sold or distributed.
Agree to maintain such records for three years, and to provide copies upon request of any
authorized employee of the EPA, or of any State or political subdivision, duly designated
by the Administrator.
Agree that records and reports made or maintained in connection with these Terms and
Conditions will not be claimed as confidential business information or trade secrets.
4. Labeling and Sale/Distribution/Use Limitations

The labeling of the affected anthrax-related product will include both a primary label on
the container of the product and supplemental labeling that is similar to a technical manual. All
primary and supplemental product labeling will be submitted to and reviewed by EPA as part of
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Draft of 05/11/2007
the application for registration.
•

The primary label and the technical manual will bear the following statements on the
front panel:
a.
Directly above the product name, within a black outline, and in a font size no
smaller than 12 points:

For use only by:
• Federal On-Scene Coordinators and contractors and other trained
federal/state/local response personnel under the FOSC’s supervision;
• Trained U.S. Military personnel and contractors under their supervision;
• Persons who, within the preceding 24 months, have been trained and
determined to be competent by the registrant (or its contractor) following
completion of the required training.
Under the terms and conditions of this product's registration, this product may
only be sold or distributed by the registrant directly to the persons identified
above.
b.
Directly under the Directions for Use heading, in a font size no smaller than the
heading, a statement that refers to the supplemental labeling, such as: “See the
accompanying technical manual for this product for complete use directions and
safety precautions for inactivating Bacillus anthracis spores.” The technical manual
is supplemental labeling under FIFRA and must comply with all pesticide product
labeling requirements and bear the same boxed statement as specified above.
5. Consequence of Non-Compliance with The Terms and Conditions of Registration
The registrant agrees that failure to comply with any terms and conditions of registration
specified above, may, at the sole discretion of EPA, result in the issuance of an order canceling
the affected registration(s) without a hearing. Before issuing any such order, the Agency will
notify the registrant in writing its intention to cancel the registration(s) and specify in such
notification the basis for its conclusion that the registrant has failed to comply with the terms and
conditions of registration. EPA will allow the registrant ten business days from the receipt of
such notification to submit in writing a request to meet with the Director of the Office of
Pesticide Programs (“Office Director”) before a cancellation order is issued. The Agency will
not issue a cancellation order before providing the registrant an opportunity to meet with the
Office Director to discuss whether cancellation is appropriate. The registrant agrees that the
decision of the Office Director will be final.
III.

Implementation

To amend the registration of a currently registered product, the registrant will need to
submit: (a) an Application for Registration form (EPA Form 8570-1) marked “Amendment” (for
currently registered sterilants/sporicides), (b) appropriate efficacy data in proper format, (c) three
copies of the revised labeling with changes clearly circled, and (d) a signed copy of the
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Draft of 05/11/2007
agreement to the Terms and Conditions of Registration described in section II.B. to be effective
in the event the registration is approved.
For new products, the registrant will submit: (a) an Application for Registration form
marked “Registration” (EPA Form 8570-1), (b) appropriate efficacy data, (c) three copies of the
draft labeling, (d) other forms and data required for a new product, and (e) a signed copy of the
agreement to Terms and Conditions of registration described in section II.B. to be effective in
the event the amendment is granted.
Registrants should note that the Terms and Conditions of registration will be inserted into
the Notice of Registration and will apply to all uses on the product’s labeling. Accordingly, EPA
strongly recommends a separate product registration for the uses that fall within the scope of this
PR Notice.
All applications for registration are subject to the Pesticide Registration Improvement
Act of 2003 with regard to fees charged for applications for registration of pesticide products.
Further information can be found at http://www.epa.gov/pesticides/fees/.
Submissions via the U.S. Postal Service: Use the official mailing address below for all
submissions directed to the OPP regulatory divisions by mail:
Document Processing Desk (AMEND or REG)
Office of Pesticide Programs (7504PY)
U. S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
PLEASE NOTE: Do not address mail to be sent through the U.S. Postal Service (USPS) to the
Arlington, Virginia address below. USPS will return it to you causing delay in processing your
actions. There is no U.S. Postal Service delivery at the Virginia address.
Submissions via Personal/Courier Delivery: Deliveries in person or by a commercial
courier for the regulatory divisions will be accepted at OPP’s Document Processing Desk
(7504C). Couriers and delivery personnel must present a valid picture identification card to gain
access to the building. Hours of operation for the Document Processing Desk are 8:00 A.M. to
4:30 P.M., Monday through Friday, excluding Federal holidays. Personal and courier deliveries
should be directed to:
Document Processing Desk (AMEND or REG)
Office of Pesticide Programs (7504PY)
U. S. Environmental Protection Agency
2777 S. Crystal Drive
Arlington, VA 22202

IV.

Scope of This Notice

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This PR Notice provides general guidance to EPA and to pesticide registrants and
applicants, and the public. This guidance is not binding on either EPA or any outside parties,
and the EPA may depart from the guidance where circumstances warrant and without prior
notice. In their submissions, registrants and applicants may propose alternatives to the
recommendations described in this notice, and the Agency will assess them for appropriateness
on a case-by-case basis and will respond in writing.
V.

Paperwork Reduction Act Notice

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 and is approved OMB control number 2070-0029. The ICR document
for the pesticide application process has been assigned EPA ICR number 0277, and is approved
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 are 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.
Under the PRA, “burden” means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide information to or for a Federal
agency. For this collection, it is the time reading the regulations, planning the necessary data
collection activities, conducting tests, analyzing data, generating reports and completing other
required paperwork, and storing, filing, and maintaining the data.
Under the PRA, an agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations codified in Chapter 40 of the CFR, after
appearing in the preamble of the final rule, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB control numbers in certain
EPA regulations is consolidated in 40 CFR part 9. For the ICR activity contained in this PR
Notice, EPA is displaying the applicable OMB control number in the PR Notice above, and the
applicable OMB control number also appears on the pesticide application.
In addition to commenting on the substance of this PR Notice, EPA welcomes your
comments on the information collected related activities and the provided burden estimates, as
well as any suggested methods for minimizing respondent burden, including the use of
automated collection techniques. A copy of the most recent version of EPA ICR # 0155 is
available under Docket ID No. EPA-HQ-OPP-2003-0357, and a copy of the most recent version
of EPA ICR #0277 is available under Docket ID No. EPA-HQ-OPP-2004-0419. Both dockets
may be accessed at www.regulations.gov. Please submit any comments on these ICRs as part of
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Draft of 05/11/2007
your comments on the PR Notice, using the docket established for the PR Notice and following
the instructions for submitting comments that are provided in the Federal Register document
accompanying the draft PR Notice.
VI.

For Further Information

If you have questions or need further information about this notice, you may contact the
Antimicrobials Division, (703) 308-6411.

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