[Federal Register Volume 64, Number 78 (Friday, April 23, 1999)]
[Proposed Rules]
[Pages 19958-19961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10237]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152, 174, and 180
[OPP-300369A; FRL-6077-6]
RIN 2070-AC02
Plant-Pesticides, Supplemental Notice of Availability of
Information
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; supplemental notice.
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SUMMARY: EPA is soliciting comment on a request to substitute an
alternative name for the term ``plant-pesticide.'' This document also
solicits suggestions for appropriate alternative names.
DATES: Comments and data must be received on or before May 24, 1999.
ADDRESSES: Comments and data may be submitted by mail, electronically,
or in person. Please follow the detailed instructions for each method
as provided in Units I.C. and D. of this document. To ensure proper
receipt by EPA, your comments and data must identify the docket control
number
[[Page 19959]]
OPP-300369A in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Philip Hutton, Biopesticides
and Pollution Prevention Division (7511C), Office of Pesticide
Programs, Environmental Protection Agency, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202; telephone: (703) 308-8260; e-mail address:
hutton.phil@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Document Apply To Me?
You may be potentially affected by this document, if you conduct
large scale field tests during the process of developing plant-
pesticides, or if you sell or distribute plant-pesticides. Potentially
affected entities may include, but are not limited to:
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Examples of potentially affected
Category entities
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Field testing Universities; domestic, foreign,
or multinational biotechnology
companies; chemical companies;
or seed companies
Selling and distributing Domestic, foreign, or
multinational biotechnology
companies; chemical companies;
or seed companies
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding the types of entities potentially affected
by this document. If you have any questions regarding the applicability
of this document to a particular entity, consult the technical person
listed in the ``FOR FURTHER INFORMATION CONTACT'' at the beginning of
this document.
B. How Can I Get Additional Information or Copies of This Document or
Other Documents?
1. Electronically. You may obtain electronic copies of this
document and other documents from the EPA Internet Home Page at http://
www.epa.gov/. On the Home Page, select ``Laws and Regulations'' and
then look up the entry for this document under the ``Federal Register--
Environmental Documents.'' You can also go directly to the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr/.
2. In person or by phone. If you have any questions or need
additional information about this document, you may contact the
technical person identified in the ``FOR FURTHER INFORMATION CONTACT''
section of this document. In addition, the official record for this
document, including the public version, has been established under
docket control number OPP-300369A, (including comments and data
submitted electronically as described in Unit I.C. of this document).
This record not only includes the documents that are physically located
in the docket, but also includes all the documents that are referenced
in those documents. A public version of this record, including printed,
paper versions of any electronic comments and data, which does not
include any information claimed as Confidential Business Information
(CBI) is available for inspection in Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Public Information and
Records Integrity Branch telephone number is (703) 305-5805.
C. How and To Whom Do I Submit Comments?
You may submit comments and data through the mail, in person, or
electronically. To ensure proper receipt by EPA, your comments and data
must identify the docket control number OPP-300369A in the subject line
on the first page of your response.
1. By mail. Submit written comments and data to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW. Washington, DC 20460.
2. In person or by courier. Deliver written comments and data to:
Public Information and Records Integrity Branch, Information Resources
and Services Division, Office of Pesticide Programs, Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA.
3. Electronically. Submit your comments and data electronically by
e-mail to: opp-docket@epa.gov. Do not submit any information
electronically that you consider to be CBI. Submit comments and data as
an ASCII file, avoiding the use of special characters and any form of
encryption. Comments and data will also be accepted on standard disks
in WordPerfect 5.1/6.1 or ASCII file format. All copies of electronic
comments and data must be identified by the docket control number OPP-
300369A. Electronic comments on this document may be filed online at
many Federal Depository Libraries.
D. How Should I Handle CBI Information That I Want To Submit To the
Agency?
You may claim information that you submit in response to the
document as CBI by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the comment and data
that does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential will be included in the
public docket by EPA without prior notice. If you have any questions
about CBI or the procedures for claiming CBI, please consult with the
technical person identified in the ``FOR FURTHER INFORMATION CONTACT''
section.
II. History
Section 2(u) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136(u)) defines pesticide as: ``(1)
any substance or mixture of substances intended for preventing,
destroying, repelling, or mitigating any pest, (2) any substance or
mixture of substances intended for use as a plant regulator, defoliant,
or desiccant, and (3) any nitrogen stabilizer . . . .'' The substances
plants produce for protection against pests are pesticides under the
FIFRA definition of pesticide, if humans intend to use these substances
for ``preventing, destroying, repelling, or mitigating any pest.''
EPA recognizes the unique use pattern of these pesticides, which
are produced and used in the living plant. Thus, in a November 23,
1994, Federal Register document (59 FR 60496), EPA suggested giving
these types of pesticides a unique name, ``plant-pesticides,'' in order
to distinguish them from chemical, microbial, or biochemical
pesticides. Since 1994, EPA has been using the term, ``plant-
[[Page 19960]]
pesticide,'' to refer to these unique pesticides. EPA believes a unique
name for this category of pesticides benefits the public by providing
the means to readily identify regulations specific to this type of
pesticide in the Code of Federal Regulations (CFR). A ``plant-
pesticide'' was described in the November 23, 1994, Federal Register
document (59 FR 60496) as ``a pesticidal substance that is produced in
a living plant and the genetic material necessary for production of the
substance, where the substance is intended for use in the living
plant.''
EPA received several letters during the official comment period
for the November 23, 1994, Federal Register document (59 FR 60496) that
expressed concern about the name, ``plant-pesticide.'' These comments
expressed the opinion that the term ``pesticide'' has a negative
connotation, and requested that EPA consider another name.
III. Request for Comment
EPA is requesting comment on the advisability of substituting
another name for the term, ``plant-pesticide.'' EPA also requests
suggestions for appropriate alternative names, as no alternative names
were suggested during the official comment period. Alternative names
may be names in common scientific use, e.g., ``plant defense
compounds,'' or names created specifically to describe this type of
pesticide, e.g., ``caedeflors'' or ``floragens.'' EPA, specifically,
requests comment on whether the alternative name, ``plant-expressed
protectants,'' would be an acceptable name for this category of
pesticides. EPA is only seeking comments on the advisability of
substituting another name for the term ``plant-pesticides'' and on
appropriate alternative names. The Agency is not reopening the comment
period on previously published Federal Register documents dealing with
plant-pesticides as described in Unit IV. of this document.
If EPA changes the name describing the pesticides currently
termed, ``plant-pesticides,'' the change will only affect the name. It
will not affect the status of the pesticidal substance or the genetic
material necessary to produce it. These will still be pesticides under
FIFRA section 2(u). Similarly, a change of name will not affect any
regulatory requirements.
IV. Sources of Additional Information
Commenters, who wish to obtain further information on plant-
pesticides and on EPA's approach to them, should consult the documents
listed in this unit, as well as the dockets for these documents. In the
November 23, 1994, Federal Register, EPA published a package of five
separate documents (59 FR 60496, 60519, 60535, 60542, and 60545) (FRL-
4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and FRL-4755-4) which
described EPA's policy and proposals for plant-pesticides. On July 22,
1996, EPA published a supplemental document in the Federal Register (61
FR 37891) (FRL-5387-4) on one aspect of its November 23, 1994, Federal
Register documents; i.e., how the concept of inert ingredient related
to plant-pesticides. On May 16, 1997, EPA published in the Federal
Register three supplemental documents (62 FR 27132, 27142, and 27149)
(FRL-5717-2, FRL-5716-7, and FRL-5715-6) to provide the public an
opportunity to comment on EPA's analysis of how certain amendments to
the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA by the Food
Quality Protection Act (FQPA) apply to EPA's proposed exemptions under
FFDCA section 408 for certain categories of residues of plant-
pesticides and proposed exemptions under FIFRA for certain categories
of plant-pesticides.
Included in the dockets cited in this unit are:
1. Relevant Federal Register documents, such as the June 26, 1986,
policy statement issued by the Office of Science and Technology Policy,
the ``Coordinated Framework for Regulation of Biotechnology'' (51 FR
23302).
2. All public comments received in response to all of the documents
cited in this unit, including comments received after the close of the
official public comment periods for the documents, such as the report
from 11 professional scientific societies entitled ``Appropriate
Oversight for Plants with Inherited Traits for Resistance to Pests.''
3. Reports of the scientific advisory committees on plant-
pesticides, such as the January 21, 1994, joint meeting of a Subpanel
of the FIFRA Scientific Advisory Panel and a Subcommittee of the EPA
Biotechnology Science Advisory Committee.
4. All support documents and reports.
5. Published literature cited in the documents.
V. Regulatory Assessment Requirements
A. Certains and Executive Orders
This supplemental document only seeks comment on an alternative
name for the term ``plant-pesticide.'' As such, this document does not
require review by the Office of Management and Budget (OMB) under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993), the Paperwork Reduction Act (PRA) (44 U.S.C.
3501 et seq.), or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). For the same reason, it does not require any action
under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Pub.L. 104-4), or Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). In addition, no action is
needed under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.).
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulations. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governements ``to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates.''
Today's supplemental document does not create an unfunded Federal
mandate on State, local, or tribal governments. This action does not
impose any enforceable duties on these entities. Accordingly, the
requirements of section 1(a) of Executive Order 12875 do not apply to
this supplemental document.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998), EPA may not issue a regulation that is not required by statute,
that significantly or uniquely affects the communities of Indian tribal
governments, and that imposes substantial direct compliance costs on
those communities, unless the Federal
[[Page 19961]]
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments. If the mandate is unfunded,
EPA must provide OMB, in a separately identified section of the
preamble to the rule, a description of the extent of EPA's prior
consultation with representatives of affected tribal governments, a
summary of the nature of their concerns, and a statement supporting the
need to issue the regulation. In addition, Executive Order 13084
requires EPA to develop an effective process permitting elected and
other representatives of Indian tribal governments ``to provide
meaningful and timely input in the development of regulatory policies
on matters that significantly or uniquely affect their communities.''
Today's supplemental document does not significantly or uniquely
affect the communities of Indian tribal governments. This action does
not involve or impose any requirements that affect Indian tribes.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this supplemental document.
List of Subjects in Parts 152, 174, and 180
Environmental protection, Agricultural commodities, Pesticides and
pests, Plants.
Dated: April 16, 1999.
Susan Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-10237 Filed 4-22-99; 8:45 am]
BILLING CODE 6560-50-F
