
[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5012-5013]
From the Federal Register Online via the Government Printing 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,mario@epa.gov.

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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