Document ID: EPA-HQ-OPP-2009-0499-0007
Agency: epa
Document Type: Notice
Title: Data Requirements for Plant-Incorporated Protectants (PIPs) and Certain Exemptions for PIPs; Pesticides
Posted Date: 2011-03-16T04:00Z

[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Proposed Rules]
[Pages 14358-14359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5997]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 158, and 174

[EPA-HQ-OPP-2009-0499; FRL-8863-5]
RIN 2070-AJ27

Pesticides; Data Requirements for Plant-Incorporated Protectants 
(PIPs) and Certain Exemptions for PIPs; Notification to the Secretaries 
of Agriculture and Health and Human Services

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification to the Secretaries of Agriculture and Health and 
Human Services.

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SUMMARY: This document notifies the public that the Administrator of 
EPA has forwarded to the Secretaries of Agriculture and Health and 
Human Services a draft proposed rule under sections 21 and 25(a) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The draft 
proposed rule will propose codifying data requirements that 
specifically address the registration data needs of plant-incorporated 
protectants (PIPs). These data requirements are intended to provide EPA 
with data and other information necessary for the registration of a PIP 
or the issuance of an experimental use permit for a PIP. Also, EPA will 
propose to exempt cisgenic PIPs from registration to encourage research 
and development of useful biotechnology and reduce the number of PIPs 
seeking registration. Cisgenic PIPs are formed when genetic material is 
transferred, using bioengineering technology, between plants that could 
transfer the genetic material naturally.

DATES: Comments must be received on or before April 15, 2011.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0499. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP

[[Page 14359]]

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5354; e-mail address: 
kyprianou.rose@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    This action is directed to the public in general. It simply 
announces the submission of a draft proposed rule to the United States 
Department of Agriculture (USDA) and does not otherwise affect any 
specific entities. This action may, however, be of particular interest 
to those persons who produce or register plant-incorporated protectants 
(PIPs) under FIFRA or may seek a tolerance or tolerance exemption for a 
PIP under the Federal Food, Drug, and Cosmetic Act (FFDCA). This action 
may also be of interest to those persons involved in biotechnology 
research or development of PIPs. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be interested in this action. If you have any 
questions regarding this action, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

II. What action is EPA taking?

    Section 25(a)(2) of FIFRA provides that the Administrator must 
provide the Secretary of Agriculture with a copy of any draft proposed 
rule at least 60 days before signing it for publication in the Federal 
Register. Similarly, section 21(b) of FIFRA provides that the 
Administrator must provide the Secretary of Health and Human Services 
with a copy of any draft proposed rule pertaining to a public health 
pesticide at least 60 days before signing it for publication in the 
Federal Register. The draft proposed rule is not available to the 
public until after it has been signed by EPA. If either Secretary 
comments in writing regarding the draft proposed rule within 30 days 
after receiving it, the Administrator shall include in the proposed 
rule when published in the Federal Register the comments of the 
Secretary and the Administrator's response to those comments. If 
neither Secretary comments in writing within 30 days after receiving 
the draft proposed rule, the Administrator may sign the proposed 
regulation for publication in the Federal Register anytime after the 
30-day period.

III. Do any Statutory and Executive Order reviews apply to this 
notification?

    No. This document is not a proposed rule, it is merely a 
notification of submission to the Secretaries of Agriculture and Health 
and Human Services. As such, none of the regulatory assessment 
requirements apply to this document.

List of Subjects

40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements.

40 CFR Part 158

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

40 CFR Part 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Plant-incorporated 
protectants, Reporting and recordkeeping requirements.

    Dated: March 4, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2011-5997 Filed 3-15-11; 8:45 am]
BILLING CODE 6560-50-P