[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42704-42705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15615]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2016-0310; FRL-9947-25]
Plant-Incorporated Protectants: Proposed Modification of
Registration Procedures for Plant-Incorporated Protectants in Breeding
Line Intermediates; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is making available for comment a White Paper describing
how the Agency is proposing to modify its current approach to plant-
incorporated protectants (PIPs) in breeding line intermediates (BLIs)
under Section 3, Registration of Pesticides, of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). A PIP is a type of
pesticide intended to be produced and used in a living plant, or the
produce thereof. A BLI is an intermediate used in plant breeding to
bring together, or ``stack,'' two or more PIPs that have each been
individually engineered into different lines of a seed propagated
plant. These proposed changes are intended to bring efficiencies to the
Agency's approach to PIPs in BLIs while not reducing EPA's ability to
ensure that PIPs in BLIs meet the requirements of FIFRA.
DATES: Comments must be received on or before August 15, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0310, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are a person
or company involved with agricultural biotechnology that may develop
and market plant-incorporated protectants. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 32532) e.g., establishments primarily engaged in the
formulation and
[[Page 42705]]
preparation of agricultural and household pest control chemicals;
Food Processing (NAICS code 311) transforming agricultural
products into products for immediate or final consumption;
Crop Production (NAICS code 111) e.g., establishments
primarily engaged in growing crops, plants, vines or trees and their
seeds;
Colleges, Universities and Professional Schools (NAICS
code 611310) e.g., establishments of higher learning which are engaged
in development and marketing of virus-resistant plants;
Research and Development in the Physical, Engineering and
Life Sciences (NAICS code 54171) e.g., establishments primarily engaged
in conducting research in the physical, engineering or life sciences,
such as agriculture and biotechnology.
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 email. 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 preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
C. How can I get copies of this document and other related information?
A copy of the White Paper Concerning Registration of Plant-
Incorporated Protectants for Use in Breeding Line Intermediates to
Produce Stacked Products is available in the docket under docket
identification (ID) number EPA-HQ-OPP-2016-0310.
II. What action is the Agency taking?
EPA is making available for comment a White Paper describing a
proposed modification of its approach to regulation of plant-
incorporated protectants (PIPs) in breeding line intermediates (BLIs)
under Section 3, Registration of Pesticides, of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). This modification
is proposed in light of the increasing use of BLIs to stack together
several different PIPs during seed production.
A plant-incorporated protectant (PIP) is a type of pesticide
defined at Title 40 of the Code of Federal Regulations as ``intended to
be produced and used in a living plant, or the produce thereof, and the
genetic material necessary for production of such a pesticidal
substance. It also includes any inert ingredient contained in the
plant, or the produce thereof.'' BLIs are an integral part of the
process used to bring together, using conventional breeding in seed
production, two or more PIPs that have each been individually
engineered into different lines of a seed propagated plant. EPA's
proposed modification of its approach to regulation of PIPs in BLIs is
a refocusing of the Agency's use of its authority to regulate
pesticides, and maintains EPA's ability to ensure that PIPs in BLIs
meet the requirements of FIFRA.
The White Paper describes how the Agency proposes to refocus its
authority to regulate PIPs in BLIs. Currently, each combination of PIPs
in BLIs must have a unique registration before it can be sold or
distributed in commerce. Under the proposal described in the White
Paper, rather than requiring a unique registration for each BLI
combination, EPA would regulate PIPs in BLIs through the terms and
conditions imposed on the registrations issued for each PIP to be
combined through the use of BLIs in the stacked commercial PIP product.
Such registrations would control which PIPs can be used in which BLIs
and how the PIPs in BLIs can be used. Under the proposed approach, EPA
would continue to assess PIPs in BLIs for potential risk and continue
to use its FIFRA authorities to ensure safe use of PIPs in BLIs.
EPA's proposed modifications would introduce changes into its
approach to PIPs in BLIs that are intended to reduce administrative
costs for both the Agency and for companies using BLIs to stack several
PIPs together in a single product. The proposed modification is
directed solely at PIPs in BLIs used for the purpose of producing seed
and is not intended to change EPA's approach to issuance of unique
registrations for PIPs intended for full commercial sale and
distribution. A full copy of the White Paper is available in docket
EPA-HQ-OPP-2016-0310.
EPA requests comment on the proposal as a whole and on the various
aspects of the proposal from both the public and industry, including
seed companies, farmers, grain dealers, food processors and grocery
manufacturers. EPA is specifically seeking comment from state
regulatory officials on how this proposed approach might affect their
approach to pesticide regulation. EPA asks comment on the extent to
which this type of approach to PIPs in BLIs relieves administrative
burden and cost for the regulated community, and how frequently
registrants are likely to use such an approach. EPA also requests
comment on how the proposed approach would affect efficiency and cost
savings, in light of the commercial seed production landscape created
by the licensing of intellectual property in the form of PIPs. EPA also
asks farmers, grain dealers, food processors and grocery manufacturers
whether this proposed change in approach could affect their activities,
including possible effects on trade, and if yes, how.
Authority: 7 U.S.C. 136 et seq.
Dated: June 14, 2016.
Mark A. Hartman,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2016-15615 Filed 6-29-16; 8:45 am]
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