Document ID: EPA-HQ-OPP-2006-0291-0001
Agency: epa
Document Type: Notice
Title: Pesticides; Draft Guidance for Pesticide Registrants on Small- Scale Field Testing and Low-level Intermittent Presence in Food of Plant-Incorporated Protectants (PIPs)
Posted Date: 2006-09-29T12:46:22Z

[Federal Register: September 29, 2006 (Volume 71, Number 189)]
[Notices]               
[Page 57509-57510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se06-80]                         

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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Pesticides; Draft Guidance for Pesticide Registrants on Small-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: moe.patricia@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 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