E6-16072. Pesticides; Draft Guidance for Pesticide Registrants on Small-Scale Field Testing and Low-level Intermittent Presence in Food of Plant-Incorporated Protectants (PIPs)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.

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 [phone].

-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 [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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.

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 [phone].

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.