81 FR 42704 - Plant-Incorporated Protectants: Proposed Modification of Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates; Notice of Availability
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 126 (June 30, 2016)
Federal Register Volume 81, Issue 126 (June 30, 2016)
| Page Range | 42704-42705 | |
| FR Document | 2016-15615 |
[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)] [Notices] [Pages 42704-42705] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15615] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![42704 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices
Federal Register. Thereafter, following consistent with the terms of the breeding to bring together, or ‘‘stack,’’
the public comment period, the EPA previously approved labeling on, or that two or more PIPs that have each been
Administrator may approve such a accompanied, the canceled products. individually engineered into different
request. The notice of receipt for this lines of a seed propagated plant. These
C. For All Products Identified in Table
action was published for comment in proposed changes are intended to bring
2 of Unit II
the Federal Register of January 5, 2016 efficiencies to the Agency’s approach to
(81 FR 236) (FRL–9937–07). The Now that EPA has approved product PIPs in BLIs while not reducing EPA’s
comment period closed on February 4, labels reflecting the requested ability to ensure that PIPs in BLIs meet
2016. amendments to delete uses, registrants the requirements of FIFRA.
are permitted to sell or distribute DATES: Comments must be received on
VI. Provisions for Disposition of
products listed in Table 2 of Unit II. or before August 15, 2016.
Existing Stocks
under the previously approved labeling
Existing stocks are those stocks of until January 2, 2018, a period of 18 ADDRESSES: Submit your comments,
registered pesticide products which are months after publication of the identified by docket identification (ID)
currently in the United States and cancellation order in this Federal number EPA–HQ–OPP–2016–0310, by
which were packaged, labeled, and Register, unless other restrictions have one of the following methods:
released for shipment prior to the been imposed. Thereafter, registrants • Federal eRulemaking Portal: http://
effective date of the action. The existing will be prohibited from selling or www.regulations.gov. Follow the online
stocks provision for the products subject distributing the products whose labels instructions for submitting comments.
to this order is as follows. include the deleted uses identified in Do not submit electronically any
Table 2 of Unit II., except for export information you consider to be
A. For Products 524–523, 10163–291, Confidential Business Information (CBI)
10163–292, and 100–1249 in Table 1 of consistent with FIFRA section 17 (7
U.S.C. 136o) or for purposes of proper or other information whose disclosure is
Unit II restricted by statute.
disposal.
The registrants have indicated to the Persons other than the registrant may • Mail: OPP Docket, Environmental
Agency via written response that there sell, distribute, or use existing stocks of Protection Agency Docket Center (EPA/
are no existing stocks of these specific the products whose labels include the DC), (28221T), 1200 Pennsylvania Ave.
products. Therefore, no existing stocks terminated uses until supplies are NW., Washington, DC 20460–0001.
date is necessary. Registrants are exhausted, provided that such sale, • Hand Delivery: To make special
prohibited from selling or distributing distribution, or use is consistent with arrangements for hand delivery or
these specific products listed in Table 1 the terms of the previously approved delivery of boxed information, please
of Unit II., except for export consistent labeling on, or that accompanied, the follow the instructions at http://
with FIFRA section 17 (7 U.S.C. 136o) products with the terminated uses. www.epa.gov/dockets/contacts.html.
or for proper disposal. Because products
Authority: 7 U.S.C. 136 et seq. Additional instructions on commenting
524–523 and 100–1249 were not sold or
or visiting the docket, along with more
marketed into the channels of trade, Dated: June 13, 2016.
information about dockets generally, is
persons other than the registrant do not Michael Goodis,
available at http://www.epa.gov/
need an existing stocks period. Acting Director, Pesticide Re-Evaluation dockets.
Regarding products 10163–291 and Division, Office of Pesticide Programs.
10163–292, while the registrant no [FR Doc. 2016–15616 Filed 6–29–16; 8:45 am] FOR FURTHER INFORMATION CONTACT:
longer has any inventory, persons other BILLING CODE 6560–50–P
Robert McNally, Biopesticides and
than the registrants may sell, distribute, Pollution Prevention Division (7511P),
or use existing stocks of the affected Office of Pesticide Programs,
canceled products until existing stocks ENVIRONMENTAL PROTECTION Environmental Protection Agency, 1200
are exhausted, provided that such sale, AGENCY Pennsylvania Ave. NW., Washington,
distribution, or use is consistent with DC 20460–0001; main telephone
[EPA–HQ–OPP–2016–0310; FRL–9947–25]
the terms of the previously approved number: (703) 305–7090; email address:
labeling on, or that accompanied, the Plant-Incorporated Protectants: BPPDFRNotices@epa.gov.
canceled products. Proposed Modification of Registration SUPPLEMENTARY INFORMATION:
B. For All Other Products Identified in Procedures for Plant-Incorporated I. General Information
Table 1 of Unit II Protectants in Breeding Line
Intermediates; Notice of Availability A. Does this action apply to me?
The registrants may continue to sell
and distribute existing stocks of all AGENCY: Environmental Protection You may be potentially affected by
other products listed in Table 1 of Unit Agency (EPA). this action if you are a person or
II. until June 30, 2017, which is 1-year ACTION: Notice. company involved with agricultural
after the publication of the Cancellation biotechnology that may develop and
Order in the Federal Register. SUMMARY: EPA is making available for market plant-incorporated protectants.
Thereafter, the registrants are prohibited comment a White Paper describing how The following list of North American
from selling or distributing products the Agency is proposing to modify its Industrial Classification System
listed in Table 1 of Unit II., except for current approach to plant-incorporated (NAICS) codes is not intended to be
export in accordance with FIFRA protectants (PIPs) in breeding line exhaustive, but rather provides a guide
mstockstill on DSK3G9T082PROD with NOTICES
section 17 (7 U.S.C. 136o) or for intermediates (BLIs) under Section 3, to help readers determine whether this
purposes of proper disposal. Registration of Pesticides, of the Federal document applies to them. Potentially
Persons other than the registrants may Insecticide, Fungicide and Rodenticide affected entities may include:
sell, distribute, or use existing stocks of Act (FIFRA). A PIP is a type of pesticide • Pesticide and Other Agricultural
the affected canceled products until intended to be produced and used in a Chemical Manufacturing (NAICS code
existing stocks are exhausted, provided living plant, or the produce thereof. A 32532) e.g., establishments primarily
that such sale, distribution, or use is BLI is an intermediate used in plant engaged in the formulation and
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![Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices 42705
preparation of agricultural and intermediates (BLIs) under Section 3, public and industry, including seed
household pest control chemicals; Registration of Pesticides, of the Federal companies, farmers, grain dealers, food
• Food Processing (NAICS code 311) Insecticide, Fungicide and Rodenticide processors and grocery manufacturers.
transforming agricultural products into Act (FIFRA). This modification is EPA is specifically seeking comment
products for immediate or final proposed in light of the increasing use from state regulatory officials on how
consumption; of BLIs to stack together several this proposed approach might affect
• Crop Production (NAICS code 111) different PIPs during seed production. their approach to pesticide regulation.
e.g., establishments primarily engaged A plant-incorporated protectant (PIP) EPA asks comment on the extent to
in growing crops, plants, vines or trees is a type of pesticide defined at Title 40 which this type of approach to PIPs in
and their seeds; of the Code of Federal Regulations as BLIs relieves administrative burden and
• Colleges, Universities and ‘‘intended to be produced and used in cost for the regulated community, and
Professional Schools (NAICS code a living plant, or the produce thereof, how frequently registrants are likely to
611310) e.g., establishments of higher and the genetic material necessary for use such an approach. EPA also requests
learning which are engaged in production of such a pesticidal comment on how the proposed
development and marketing of virus- substance. It also includes any inert approach would affect efficiency and
resistant plants; ingredient contained in the plant, or the cost savings, in light of the commercial
• Research and Development in the produce thereof.’’ BLIs are an integral seed production landscape created by
Physical, Engineering and Life Sciences part of the process used to bring the licensing of intellectual property in
(NAICS code 54171) e.g., establishments together, using conventional breeding in the form of PIPs. EPA also asks farmers,
primarily engaged in conducting seed production, two or more PIPs that grain dealers, food processors and
research in the physical, engineering or have each been individually engineered grocery manufacturers whether this
life sciences, such as agriculture and into different lines of a seed propagated proposed change in approach could
biotechnology. plant. EPA’s proposed modification of affect their activities, including possible
its approach to regulation of PIPs in effects on trade, and if yes, how.
B. What should I consider as I prepare BLIs is a refocusing of the Agency’s use
my comments for EPA? of its authority to regulate pesticides, Authority: 7 U.S.C. 136 et seq.
1. Submitting CBI. Do not submit this and maintains EPA’s ability to ensure Dated: June 14, 2016.
information to EPA through that PIPs in BLIs meet the requirements Mark A. Hartman,
regulations.gov or email. Clearly mark of FIFRA. Acting Director, Biopesticides and Pollution
the part or all of the information that The White Paper describes how the Prevention Division, Office of Pesticide
you claim to be CBI. For CBI Agency proposes to refocus its authority Programs.
information in a disk or CD–ROM that to regulate PIPs in BLIs. Currently, each [FR Doc. 2016–15615 Filed 6–29–16; 8:45 am]
you mail to EPA, mark the outside of the combination of PIPs in BLIs must have BILLING CODE 6560–50–P
disk or CD–ROM as CBI and then a unique registration before it can be
identify electronically within the disk or sold or distributed in commerce. Under
CD–ROM the specific information that the proposal described in the White ENVIRONMENTAL PROTECTION
is claimed as CBI. In addition to one Paper, rather than requiring a unique AGENCY
complete version of the comment that registration for each BLI combination,
[EPA–HQ–OECA–2012–0657; FRL–9946–
includes information claimed as CBI, a EPA would regulate PIPs in BLIs
31–OEI]
copy of the comment that does not through the terms and conditions
contain the information claimed as CBI imposed on the registrations issued for Information Collection Request
must be submitted for inclusion in the each PIP to be combined through the Submitted to OMB for Review and
public docket. Information so marked use of BLIs in the stacked commercial Approval; Comment Request; NSPS
will not be disclosed except in PIP product. Such registrations would for Flexible Vinyl and Urethane Coating
accordance with procedures set forth in control which PIPs can be used in and Printing (Renewal)
40 CFR part 2. which BLIs and how the PIPs in BLIs
2. Tips for preparing your comments. can be used. Under the proposed AGENCY: Environmental Protection
When preparing and submitting your approach, EPA would continue to assess Agency (EPA).
comments, see the commenting tips at PIPs in BLIs for potential risk and ACTION: Notice.
http://www.epa.gov/dockets/ continue to use its FIFRA authorities to
comments.html. ensure safe use of PIPs in BLIs. SUMMARY: The Environmental Protection
EPA’s proposed modifications would Agency has submitted an information
C. How can I get copies of this introduce changes into its approach to collection request (ICR), ‘‘NSPS for
document and other related PIPs in BLIs that are intended to reduce Flexible Vinyl and Urethane Coating
information? administrative costs for both the Agency and Printing (40 CFR part 60, subpart
A copy of the White Paper Concerning and for companies using BLIs to stack FFF) (Renewal)’’ (EPA ICR No. 1157.11,
Registration of Plant-Incorporated several PIPs together in a single product. OMB Control No. 2060–0073), to the
Protectants for Use in Breeding Line The proposed modification is directed Office of Management and Budget
Intermediates to Produce Stacked solely at PIPs in BLIs used for the (OMB) for review and approval in
Products is available in the docket purpose of producing seed and is not accordance with the Paperwork
under docket identification (ID) number intended to change EPA’s approach to Reduction Act (44 U.S.C. 3501 et seq.).
issuance of unique registrations for PIPs This is a proposed extension of the ICR,
mstockstill on DSK3G9T082PROD with NOTICES
EPA–HQ–OPP–2016–0310.
intended for full commercial sale and which is currently approved through
II. What action is the Agency taking? distribution. A full copy of the White June 30, 2016. Public comments were
EPA is making available for comment Paper is available in docket EPA–HQ– previously requested via the Federal
a White Paper describing a proposed OPP–2016–0310. Register (80 FR 32116) on June 5, 2015,
modification of its approach to EPA requests comment on the during a 60-day comment period. This
regulation of plant-incorporated proposal as a whole and on the various notice allows for an additional 30 days
protectants (PIPs) in breeding line aspects of the proposal from both the for public comments. A fuller
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Document Created: 2018-02-08 07:45:04
Document Modified: 2018-02-08 07:45:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received on or before August 15, 2016. | |
| 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 | |
| FR Citation | 81 FR 42704 |
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