[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]
 BILLING CODE 6560-50-P