[Federal Register Volume 71, Number 189 (Friday, September 29, 2006)]
[Notices]
[Pages 57509-57510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16072]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0291; FRL-8097-2]
Pesticides; Draft Guidance for Pesticide Registrants on Small-
Scale Field Testing and Low-level Intermittent Presence in Food of
Plant-Incorporated Protectants (PIPs)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PRN) entitled
``Guidance on Small-Scale Field Testing and Low-level Intermittent
Presence in Food of Plant-Incorporated Protectants (PIPs).'' PRNs 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, and serve to provide
guidance to pesticide registrants and OPP personnel. This particular
draft PRN provides guidance to the registrant concerning clarification
on the process by which EPA reviews and ensures the safety of low-level
intermittently-present residues of plant-incorporated protectants
(PIPs) in food or feed, and the conditions under which a tolerance or
exemption from the requirement of a tolerance would be required for
field tests for biotechnology-derived food and feed crop plants
containing plant-incorporated protectants.
DATES: Comments must be received on or before November 28, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0291, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0291. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
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
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Patricia Moe, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-0744; fax
number: (703) 308-7026; 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 involved
in plant breeding using plant-incorporated protectants including but
not limited to academic researchers, seed companies, and PIP
registrants. 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.
[[Page 57510]]
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI.. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
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-OPP-2006-0291. 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 Building), 2777 S.
Crystal Drive 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 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 http://www.epa.gov/fedrgstr.
II. What Guidance Does this PRN Provide?
This draft PRN provides guidance to the registrant concerning the
policies described in the August 2, 2002 Federal Register (67 FR 50578)
Notice on ``Proposed Federal Actions to Update Field Test Requirements
for Biotechnology Derived Plants and to Establish Early Food Safety
Assessments for New Proteins Produced by Such Plants'' issued under the
auspices of the Office of Science and Technology Policy (OSTP). The
OSTP notice was issued to outline what measures federal agencies would
take to prevent low levels of biotechnology derived genes and gene
products from being found in commercial food and feed. The OSTP notice
stated that EPA would rely on existing processes and publish guidance
for individuals and organizations conducting field testing of Plant-
Incorporated Protectants (PIPs). The proposed PRN describes those
existing rules along with the existing procedures related to them.
Additionally, the PRN provides guidance on residue containment in
small-scale field testing and the kinds of information that EPA has
received to support the PIP tolerances issued thus far.
No actions are required of registrants or other individuals
involved in small scale field testing of PIPs as a result of this PRN.
The PRN provides guidance and helps explain the existing rules and
regulations pertinent to this topic and provides a point of contact for
those wishing to discuss the issue or ask questions related to specific
test parameters. The PRN is also intended to reinforce coordination of
EPA regulatory efforts related to biotechnology products with those of
the Food and Drug Administration (FDA) and of the U.S. Department of
Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS),
as outlined under the Coordinated Framework for the Regulation of the
Products of Biotechnology.
III. Do PRNs Contain Binding Requirements?
The PRN discussed in this document is intended to provide guidance
to EPA personnel and decision makers and to pesticide registrants.
While the requirements in the statutes and Agency regulations are
binding on EPA and the applicants, this PRN is not binding on either
EPA or 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.
Dated: September 22, 2006.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. E6-16072 Filed 9-28-06; 8:45 am]
BILLING CODE 6560-50-S