[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5012-5013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2198]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2011-0038; FRL-9328-7]
Environmental Protection Agency, Department of Health and Human
Services and Department of Agriculture; Memorandum of Understanding
Regarding Genetically Engineered Plants
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces that pesticide-related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by submitters in accordance with 40 CFR 2.309(c) and 2.308(h)(2) will
be shared with the Department of Human Services (HHS) and the U.S.
Department of Agriculture (USDA). HHS's Centers for Disease Control and
Prevention and the Food and Drug Administration (FDA) will perform work
for OPP under a Memorandum of Understanding (MOU). The MOU will support
and encourage cooperation and communication between USDA, FDA, and EPA
in the regulatory oversight over
[[Page 5013]]
genetically engineered plants and the foods derived from such plants.
Under the MOU, USDA's office of Animal and Plant Health Inspection
Service/Biotechnology Regulatory Services (APHIS/BRS) and EPA agree to
share with each other information about genetically engineered plants
and the foods derived from such plants, including non-public
information exempt from public disclosure usually referred to as
``confidential business information'' and/or ``trade secrets.''
FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 305-8338: email
address: steadman,[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action applies to the public in general. As such, 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
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. How can I get copies of this document and other related information?
EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0038. 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 Bldg.), 2777 S. Crystal Dr., 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
Facility telephone number is (703) 305-5805. A copy of the MOU has been
placed in the docket.
II. Brief Summary of the Memorandum of Understanding (MOU)
EPA regulates pesticides in particular plant-incorporated
protectants (PIPs). PIPs are pesticidal substances (such as Bacillus
thuringiensis protein) produced in plants and the genetic material
necessary for their production in plants (such as cry genes). EPA
grants experimental use permits for field testing and registrations
that permit the sale and use of pesticides, including PIPs, in commerce
under FIFRA, 7 U.S.C. 136 et seq. EPA also issues tolerances or
tolerance exemptions that permit pesticide chemical residues in food
under section 408 of FFDCA.
The MOU will support and encourage cooperation and communication
between USDA, FDA, and EPA in the regulatory oversight over genetically
engineered plants and the foods derived from such plants. Under the
MOU, USDA/APHIS/BRS, FDA, and EPA agree to share with each other
information about genetically engineered plants and the foods derived
from such plants, including non-public information exempt from public
disclosure usually referred to as ``confidential business information''
and/or ``trade secrets'' (also referred to as ``non-public
information'' in the MOU).
Subject to Units A, B, and C defined in the MOU, an agency shall
not further disclose non-public information received under the MOU
except with the written permission of the agency from which the non-
public information originated.
Under the MOU, USDA/APHIS/BRS would share non-public information
including CBI that it receives from private entities pursuant to its
biotechnology regulations under 7 CFR part 340 only as described below.
Confidential information provided by USDA/APHIS/BRS may only be
shared with FDA and EPA personnel who have been granted access to non-
public information by the Director of USDA/APHIS/BRS' Regulatory
Operations Division or his/her designate via the APHIS Access
Authorization Agreement for Trade Secrets and Confidential Business
Information form.
List of Subjects
Environmental protection, Business and industry, Genetically
engineered plants, Government contracts, Government property,
Memorandum of Understanding, Security measures.
Dated: January 19, 2012.
Michael Hardy,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.
[FR Doc. 2012-2198 Filed 1-31-12; 8:45 am]
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