[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Proposed Rules]
[Page 16312-16315]
[DOCID:fr04ap07-26]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 156, 167, 168, 169, 172, and 174

[EPA-HQ-OPP-2006-1003; FRL-8118-2]
RIN 2070-AJ32

Plant-Incorporated Protectants; Potential Revisions to Current
Production Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance Notice of Proposed Rulemaking (ANPRM).

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SUMMARY:  In light of the differences between plant-incorporated
protectants (PIPs) and other types of pesticides, EPA is considering
amendments to the current pesticide establishment and production
regulations promulgated under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and to other related FIFRA regulations as
needed for producers of PIPs. PIPs are pesticidal substances that are
intended to be produced and used in a living plant, or the produce
thereof, and the genetic material necessary for the production of such
a pesticidal substance, and also include any inert ingredient contained
in the plant, or the produce thereof. Given these characteristics, it
is possible that PIPs may not be produced in the manner contemplated
when the current establishment and production regulations were
promulgated for other types of pesticide. In this ANPRM, the Agency
provides a list of the general regulatory provisions applicable to PIPs
that EPA is considering amending and solicits public comment on the
completeness of the list and the scope of any potential changes to
these regulations. EPA also is soliciting information that may be
useful to EPA as it reviews these regulations and developing the
proposed rules. In addition to soliciting comments through this ANPRM,
EPA intends to solicit stakeholder input through two public meetings
during the comment period of this ANPRM.

DATES: Comments must be received on or before June 13, 2007.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-1003, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-1003. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
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 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Stephen Howie, Hazard Assessment
Coordination and Policy Division (7202M), Office of Science
Coordination and Policy, 1200 Pennsylvania Ave., NW., Washington, DC
20460-0001; telephone number:<PHONE_NUMBER>; fax number: (202) 564-
8502; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
import, process, or use PIPs. In order to identify potentially impacted
industries the analysis relies on North American Industrial
Classification System (NAICS) codes. Potentially affected entities may
include, but are not limited to:
     Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 325320). This industry comprises establishments that are
producing PIPs intended for distribution and sale as pesticides.
     Crop Production (NAICS code 111). These are establishments
such as farms, orchards, groves, greenhouses, and nurseries, primarily
engaged in growing crops, plants, vines, or trees and their seeds.
     Colleges, Universities, and Professional Schools (NAICS
code 611310). This industry comprises establishments primarily engaged
in furnishing academic courses and granting degrees at baccalaureate or
graduate levels. Furthermore, they may comprise establishments where
research on PIPs occurs and where PIPs may be grown.
     Research and Development in the Physical, Engineering, and
Life Sciences (NAICS code 54171). This industry comprises
establishments primarily engaged in conducting research and
experimental development in the physical, engineering, or life
sciences, such as agriculture, environmental,

biology, botany, biotechnology, forests, and other allied subjects.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Docket. EPA has established a docket for this action under
docket ID number EPA-HQ-OPP-2006-1003. 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<PHONE_NUMBER>.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    PIPs are ``pesticidal substances that are intended to be produced
and used in a living plant, or the produce thereof, and the genetic
material necessary for the production of such a pesticidal substance.
PIPs also include any inert ingredient contained in the plant, or the
produce thereof.'' (40 CFR 174.3) By definition, PIPs are primarily
distinguished from other types of pesticides because they are intended
to be produced and used in the living plant. Other types of pesticides
are primarily produced in a facility and used through physical
application, e.g., spraying or dusting of the plant. Since PIPs were
not defined when the existing regulations associated with pesticide
establishments and pesticide production were promulgated, the existing
regulations may not adequately address this distinction.
    The Agency is therefore considering amending the current FIFRA
regulations associated with pesticide establishments and pesticide
production to better address PIPs and PIP production given the unique
characteristics of PIPs compared to other types of pesticides.
    EPA is soliciting comments from interested stakeholders on the
issues and questions identified in this ANPRM. EPA intends to use this
information in reviewing these regulations and developing its proposed
rules.

B. What is the Agency's Authority for Taking this Action?

    EPA has regulatory authority to promulgate regulations under FIFRA
sections 3(a), 8(a), 25(a), and 25(b) (7 U.S.C. 136a(a), 136f(a),
136w(a), and 136w(b)).
    PIPs are pesticides under FIFRA section 2 because they are
introduced into plants with the intention of ``preventing, destroying,
repelling, or mitigating any pest...'' (7 U.S.C. 136(u)).
    Under FIFRA section 7, any person who manufactures, prepares,
compounds, propagates, or processes any pesticide is a ``producer.''
``Produce,'' as further described in in 40 CFR 167.3, also means to
package, repackage, label, relabel, or otherwise change the container
of any pesticide. FIFRA section 7 requires that producers of pesticides
register the establishments where production occurs and requires that
producers report their annual production (7 U. S. C. 136e). In
addition, producers of pesticides are required under FIFRA section 8(a)
to maintain records with respect to their operations, and to make such
records available for inspection (7 U.S.C. 136f(a)). Under FIFRA
section 9 appropriately credentialed inspectors have the authority to
conduct inspections at pesticide producing establishments or other
places where pesticides are being held for distribution or sale for the
purpose of inspecting and obtaining samples (7 U.S.C. 136g).

C. Why is the Agency Considering Amending the Regulations?

    EPA believes that the existing regulations need to be amended to
better address apparent differences between PIPs and other types of
pesticides in the application of FIFRA's production and production-
related requirements. The existing regulations were written for
pesticides that are generally produced and used in a more traditional
manner, e.g., spraying or dusting onto the plants. PIPs are produced
and used in a living plant, which raises questions regarding how that
``production'' should be regulated under the existing authorities of
FIFRA. In general, EPA's experience with PIPs is that they present
different and potentially lower risk situations compared to chemical
pesticides. However, EPA needs to ensure that appropriate PIP
production data are available to manage any potential risk a PIP might
pose.
    The United States Government published in the Federal Register
issue of June 26, 1986 (51 FR 23302) a document entitled, Coordinated
Framework for Regulation of Biotechnology (``Coordinated Framework''),
which describes in broad terms the Federal Government's approach to
regulating biotechnology products. In that document, the Federal
Government concluded that it could appropriately regulate the products
of biotechnology under existing laws, but recognized that, in some
cases, new regulations might be needed. Consistent with the Coordinated
Framework, EPA regulates PIPs under its pesticide authorities. In the
Federal Register issue of July 19, 2001 (66 FR 37771) (FRL-6057-7), EPA
published a rule that established a regulatory framework for PIPs. That
rule clarified the relationship between plants and PIPs under FIFRA,
exempted from FIFRA requirements PIPs derived entirely through
conventional breeding between sexually compatible plants, established a
new part in the Code of Federal Regulations specifically for PIPs (40
CFR part 174), provided requirements for reporting of adverse effects,
and set forth certain procedures for CBI. In that Federal Register
document, EPA also anticipated the future need for proposing
regulations tailored

specifically to PIPs so that the regulatory framework would better fit
their unique characteristics (66 FR 37807). EPA indicated that it would
continue to apply existing regulations to PIPs, except where superseded
by the regulations in the July 19, 2001 Final Rule, until the Agency
could develop additional regulations specifically tailored to PIPs.
    Since the mid-1990s, EPA has approved a number of PIP experimental
use permits (EUPs) under FIFRA section 5, as well as seed increase and
commercial use registrations under FIFRA section 3. During this time,
EPA has registered facilities involved in the production of PIPs as
pesticide producing establishments under FIFRA section 7. These have
included, for example, sites of the original transformation (where
plant tissue was transformed by the insertion of PIP genetic material)
and seed processing facilities.
    FIFRA section 7 requires that producers of pesticides register the
establishments where the pesticide is produced and report the amount of
pesticide produced. EPA's experience to date has demonstrated,
particularly in the area of pesticide production, that the existing
regulations (e.g., 40 CFR part 167) may need to be better tailored to
address PIPs. For example, existing regulations require pesticide
production quantities to be reported in terms of volume or weight
(gallons or pounds), measurements that are not useful when considering
a pesticidal substance produced within a plant. Other questions concern
the manner in which PIPs are increased within a living plant. Such
increase occurs at many stages from product development through use,
which raises questions concerning where pesticide production occurs,
and what establishments must register and report their production.
Clarification of this matter would help to ensure that appropriate
persons comply with production related requirements, and that other
persons do not face unnecessary regulatory burden. To that end, EPA is
reviewing the existing regulations in 40 CFR chapter I, subchapter E
and considering potential regulatory changes to address the apparent
differences between PIPs and other types of pesticides.

III. Current Regulations Under Review

    EPA is considering amending the following existing regulations
related to pesticide establishment and production to better address
PIPs and PIP production:
    1. Registration of establishments where PIPs are produced (FIFRA
section 7 and 40 CFR 167.20). Current regulations require any producer
of a pesticide to register the ``production'' site with EPA. The
statutory and regulatory definitions of ``produce'' include several
activities, including manufacturing, preparing, compounding,
propagating, or processing any pesticide or packaging, repackaging,
labeling, and relabeling the container of any pesticide.
    2. Reporting by registered production establishments (FIFRA section
7 and 40 CFR 167.85). Current regulations require a producer operating
a producing establishment to report annually the types and amount of
each pesticidal product that was produced, sold, or distributed the
previous year and to estimate the amount that will be produced during
the current year.
    3. Recordkeeping and inspection authority (FIFRA sections 8 and 9
and 40 CFR 169.2 and 169.3). EPA's statutory authority under FIFRA
section 8, and the regulations promulgated thereunder, require
pesticide producers, registrants, and applicants for registration to
maintain certain records related to pesticide production (i.e.,
including information regarding the production, receipt, and shipment
of pesticides) and to provide these records upon request to
appropriately credentialed inspectors. FIFRA section 8 also provides
authority for appropriately credentialed inspectors to conduct
inspections to access such information. Furthermore, under FIFRA
section 9 appropriately credentialed inspectors have the authority to
conduct inspections at pesticide producing establishments or other
places where pesticides are being held for distribution or sale for the
purpose of inspecting and obtaining samples.
    4. Labeling on PIP containers (FIFRA section 2 and 40 CFR 156.10).
The statute and current regulations provide requirements for labeling
of pesticides, including name of the product, identity of the producer,
net content, product registration number, establishment registration
number, ingredient statement, hazard and precautionary statements,
directions for use, and use classification. Currently, PIPs are labeled
for FIFRA section 5 EUPs and FIFRA section 3 seed increase
registrations only.
    5. EUPs for field testing of unregistered PIPs (FIFRA section 5 and
40 CFR part 172). FIFRA allows for field testing of unregistered
pesticides under an EUP. Any pesticide production activity related to
an EUP, either the production of a pesticide for use in an EUP or by
being produced as a result of an EUP, is subject to FIFRA production
establishment and recordkeeping requirements.
    6. Production of unregistered PIPs for export (FIFRA section 17 and
40 CFR 168.65-168.85). FIFRA exempts pesticides intended solely for
export from certain FIFRA requirements, including product registration
requirements. Products intended for export only are therefore not
subject to the product safety evaluation required of products intended
for domestic distribution and sale. However, they must still comply
with the producer establishment registration, reporting and
recordkeeping requirements of FIFRA sections 7 and 8 and are subject to
certain labeling requirements, e.g., their label must include the
statement: ``Not Registered for Use in the United States of America.''

IV. Request for Comments

    EPA is seeking public comment on the completeness of the list of
current regulations that need to be reviewed for applicability to PIPs
and PIP producers (see Unit III.), and is soliciting related
information to use in reviewing these regulations and developing its
proposed rules. These issues are especially challenging for PIPs, since
based on statutory and regulatory definitions, the borders between
production and use are unclear. EPA is seeking public input to help
inform decisions on how best to ensure appropriate compliance without
imposing unnecessarily burdensome reporting or labeling requirements on
PIP registrants, producers, distributors, and users.
    1. EPA would like comments in response to the following questions
with respect to the regulations referenced in Unit III.:
    a. Registration of establishments (Unit III.1.). Given that PIPs by
definition are intended to be produced and used in a living plant, what
activities should the Agency consider to be part of ``production'' as
that term is defined in FIFRA (which includes manufacturing, preparing,
compounding, propagating, or processing any pesticide or packaging,
repackaging, labeling, and relabeling the container), and what
establishments should be registered to help EPA manage any potential
risks associated with PIPs? What other types of facilities, if any
(e.g., growers involved in seed production), involved in the
development of PIP-containing varieties should be subject to these
requirements? Please explain the reason for your response.
    b. Production reporting (Unit III.2.). What production reporting,
by whom and in what units (e.g., volume, weight, number of seeds, etc.)
would be

appropriate? Should reporting units be dependent on the reproductive
methodology of the crop (e.g., seeds, bulbs, or tubers)? Given your
response to Unit IV.1.a., what types of production reporting would
provide the Agency with information valuable for compliance assurance
purposes and for managing any potential risks associated with a
violation?
    c. Recordkeeping and inspection (Unit III.3.). What establishments
or other locations are appropriate to be inspected for records and
samples, and what records would be appropriate for producers of PIPs to
maintain?
    d. Labeling (Unit III.4.). Please comment on current labeling
practices for PIPs. Are current labeling practices sufficient? For
example, do grower agreements offer sufficient information and
compliance assurance to ensure registered PIPs are used in a manner
that protects human health and the environment? Are there circumstances
where labeling different from that currently in practice for PIPs may
be appropriate?
    e. Experimental use permits (Unit III.5.). Are there aspects of
production in association with PIP EUPs that are different from
production associated with other types of pesticides used in EUPs? If
there are differences, how should they be addressed for PIP EUPs?
    f. Production for export (Unit III.6.). What conditions would
ensure that a PIP is intended for export only, and what would be
necessary for such a PIP to meet the requirements of FIFRA?
    2. Are there other characteristics not described in this document
unique to PIPs that may affect the application of the existing
regulations associated with pesticide establishments and pesticide
production to PIP producers?
    3. Are there additional sections of FIFRA implementing regulations
related to pesticide establishment and production regulations that
should be modified to more effectively address the unique
characteristics of PIPs?

V. Do Any Statutory or Executive Order Reviews Apply to this Action?

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that ANPRMs are considered ``significant
regulatory actions'' under section 3(f) of the Executive Order. The
Agency therefore submitted this document to OMB for the 10-day review
period afforded under this Executive order. Any changes made in
response to OMB comments during that review have been documented in the
docket as required by the Executive order.
    Since this ANPRM does not impose or propose any requirements, and
instead seeks comments and suggestions for the Agency to consider in
possibly developing a subsequent proposed rule, the various other
review requirements that apply when an agency imposes requirements do
not apply to this action.
    As part of your comments on this ANPRM, you may include any
comments or information that you have regarding this action. In
particular, any comments or information that would help the Agency to
assess the potential impact of a rule on small entities pursuant to the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.); to consider
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note); to consider environmental
health or safety effects on children pursuant to Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997); or to consider human health
or environmental effects on minority or low-income populations pursuant
to Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). The Agency will consider
such comments during the development of any subsequent notice of
proposed rulemaking as it takes appropriate steps to address any
applicable requirements.

List of Subjects in 40 CFR Parts 152, 156, 167, 168, 169, 172, 174

    Environmental protection, Pesticides and pests, Plant-incorporated
protectants, Reporting and recordkeeping requirements.

    Dated: March 22, 2007.
Stephen L. Johnson,
Administrator.
[FR Doc. E7-6151 Filed 4-3-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Page 34380]
[FR Doc No: 2012-14052]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR12-10-000]

Explorer Pipeline Company; Notice of Amendment to Petition for
Declaratory Order

    Take notice that on May 17, 2012, pursuant to Rule 215 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.215 (2011),
Explorer Pipeline Company (Explorer) filed an amendment to its March
23, 2012 Petition to the Federal Energy Regulatory Commission for a
declaratory order approving (1) priority capacity and (2) the overall
rate structure for Explorer's proposed diluent pipeline extension
project (Diluent Extension Project). In its Petition, Explorer
described the Diluent Extension Project as involving the construction
of a new pipeline segment from Peotone, Illinois to Manhattan,
Illinois, where Explorer's pipeline system will interconnect with
Enbridge's Southern Lights pipeline. In light of recent industry
developments, Explorer states in its amendment that it seeks to make
the priority capacity and overall rate structure it requests in its
Petition available to shippers who commit to a different
interconnection project. Accordingly, Explorer requests that the
Commission grant the Petition, subject to this amendment.
    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Anyone filing a motion to intervene or protest must
serve a copy of that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on Thursday, June 14, 2012.

    Dated: June 5, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-14052 Filed 6-8-12; 8:45 am]
BILLING CODE 6717-01-P