[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: 
[email protected].
 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:


 
------------------------------------------------------------------------
                                        Examples of potentially affected
               Category                             entities
------------------------------------------------------------------------
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
------------------------------------------------------------------------


     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: [email protected]. 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