0155.13_ss_Attachment-D_PR Notice 2008-2

EPA ICR No. 0155.13

OMB Control No. 2070-0029
ATTACHMENT D

Pesticide Registration (PR) Notice 2008-2 –
Guidance for Antimicrobial Pesticide Products With Anthrax-Related Claims

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES

August 26, 2008
PESTICIDE REGISTRATION (PR) NOTICE 2008-2
NOTICE TO:

Manufacturers, Producers, Formulators and Registrants of Pesticides

ATTENTION:

Persons Responsible for Federal Registration and Registration of
Pesticide Products

SUBJECT:

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 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 employing
terms and conditions of registration that limit the use of anthrax-related products to those who
are properly trained and determined to be competent in their use.
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 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 the spores of 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 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, as described below. 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
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military personnel who respond to incidents involving anthrax spores.
II.

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

Currently, no published EPA guidance is available concerning test methods to
demonstrate the efficacy of anthrax-related products. However, in July, 2007, EPA/OPP
presented its draft efficacy test method guidance to the FIFRA Scientific Advisory Panel (SAP)
for review and comment, and the SAP provided comments supportive of EPA’s proposal.
EPA/OPP expects to issue a draft of Product Performance Test Guidelines for Public Health
Uses of Antimicrobial Agents (OPPTS 810.2100 Sterilant—Efficacy Data Recommendations) in
2008 that will recommend efficacy test methods for demonstrating the efficacy of sterilants and
sporicides. EPA expects to issue a final version of this efficacy guidance document in 2009. This
guidance document will include the efficacy test methods that are recommended for products
with anthrax-related claims.
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 anthrax spores in the absence of published efficacy
test method guidance, EPA will evaluate such data for consistency with the draft guidance that
has already been reviewed by the FIFRA SAP.
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 and determined to be competent. 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;

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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.
The registrant commits to verify, prior to sale or distribution, that the recipient falls
within one of the above user categories. For the first two user categories listed above (i.e.,
FOSCs, U.S. Military personnel, their contractors, and other persons under their supervision),
such verification may be accomplished through a critical review of documents, such as a letter on
government letterhead, a government purchase order, or a government-issued identification
badge.
2. Training and Determination of Competency of Applicators
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
the supervision of FOSCs or trained U.S. Military personnel, the registrant commits to providing
training for such persons and to determining their competency through written examination. The
registrant may itself perform the training and competency determination, or enter into a contract
with a qualified third party to conduct the training and competency determination on the
registrant’s behalf. The registrant further commits that the training curriculum will provide for
refresher training and competency determination 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 B. anthracis
spores and while using the pesticide product;
Detailed instructions for safe and effective use of the registered pesticide product and any
associated equipment;
Detailed review of the steps involved in the remediation and restoration 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 examination.
As part of the application for registration, the registrant will develop and submit training
materials and a competency examination. EPA intends to review such materials at the same time
as it reviews the efficacy data, other data, and labeling submitted with the application for
registration. To assist applicants or registrants in developing their written examinations and
training materials, EPA intends to pursue the development of a generic competency examination
and generic training materials that could be used by any registrant. EPA will likely seek the
services of a professional organization/company that has experience in developing competency
examinations and training materials to accomplish this task. EPA will also seek the assistance of
experts who have experience with remediating sites contaminated with biological materials.
Once the exam and training materials are developed to EPA’s satisfaction, registrants may add
their own product-specific information and submit their examination and training materials in
support of registration, as specified in this PR Notice. It should be noted that the Agency may
not be able to complete development of the generic competency exam and other training
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materials for another year or more. Meanwhile, any registrant who wants to obtain registration of
a product bearing anthrax-related claims for sale or distribution to or use by persons whom the
registrant must train (e.g., persons other than Federal OSCS, the U.S. Military, and contractors or
persons under their supervision as noted above) would have to develop its own training module
(including a competency examination and other training materials) and obtain approval of it by
the Agency.
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 two 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
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:

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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 (anthrax) 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, (d) a draft competency examination
and training materials, and (e) a signed copy of the 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, (e) a draft competency
examination and training materials, and (f) 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
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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

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
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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 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 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 is available under Docket ID No. EPA-HQ-OPP-2004-0419. Both dockets
may be accessed at www.regulations.gov.
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.
VI.

For Further Information

If you have questions or need further information about this notice, you may contact Jeff
Kempter, Senior Advisor, Antimicrobials Division, 703-305-4448 or [email protected].

Debra Edwards, Ph.D., Director
Office of Pesticide Programs

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