Document ID: EPA-HQ-OPP-2007-0298-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-18T05:00Z

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-OPP-2006-1004 at   HYPERLINK "http://www.regulations.gov" 
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.

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
anthrax-related 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 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 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:  

 

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 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

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   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  Please submit any
comments on these ICRs as part of 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.

Draft of 05/11/2007

 PAGE   

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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.