[Federal Register Volume 61, Number 141 (Monday, July 22, 1996)]
[Notices]
[Pages 37891-37893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18394]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300370A; FRL-5387-4]
Plant-Pesticides Subject to the Federal Insecticide, Fungicide,
and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act;
Reopening of Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; reopening of comment period.
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SUMMARY: This supplemental notice provides the public additional
opportunity to comment on one aspect of EPA's approach to plant-
pesticides under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
Specifically, EPA requests comment on additional information it is
considering regarding the treatment, as inert ingredients, of
``substances introduced into the plant along with the active ingredient
to confirm or ensure the presence of the active ingredient.'' Based
upon this new information, EPA may decide not to treat these substances
as inert ingredients or as pesticide components.
DATES: Comments identified by the docket control number [OPP-300370A]
must be received on or before August 21, 1996.
ADDRESSES: Submit written comments in triplicate by mail to: Program
Resources Section, Public Response and Program Resources Branch, Field
Operations Division (7506C), Environmental Protection Agency, 401 M
St., SW., Washington, DC. In person, bring comments to: Rm. 1132,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number ``OPP-300370A'' No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit
III. of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI.
[[Page 37892]]
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential may be disclosed publicly by EPA
without prior notice. All written comments will be available for public
inspection in Rm. 1132 at the Virginia address given above from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Bernice Slutsky, Science and
Policy Staff, Office of Prevention, Pesticides and Toxic Substances
(7101), Environmental Protection Agency, 401 M St., SW., Washington, DC
20460. Office location, telephone number, and e-mail address: Rm. E-
627, 401 M St., SW., Washington, DC, Telephone: (202-260-6900), e-mail:
slutsky.bernice@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Regulatory Background
In the Federal Register of November 23, 1994 (59 FR 60496) (FRL-
4755-2) EPA issued proposed policies and regulations addressing
substances that plants use to protect themselves against pests. EPA
termed these substances ``plant-pesticides.'' The proposed regulations
were issued under FIFRA, 7 U.S.C. 136w(b) (see 59 FR 60519) (FRL-4755-
3) and FFDCA, 21 U.S.C. 346a (see 59 FR 60535, 60542, and 60545) (FRL-
4758-8, FRL-4755-5, and FRL-4755-4).
Because of the unique nature of plant-pesticides, EPA proposed to
create a new part in the Code of Federal Regulations at 40 CFR part
174, specifically for plant-pesticides. The new part 174 would set
forth the scope of regulation, regulatory requirements, criteria, and
procedures applicable to plant-pesticides under FIFRA and FFDCA. In the
FIFRA and FFDCA proposed rules, EPA proposed to define plant-pesticides
as follows:
Plant-pesticide means a pesticidal substance that is produced in
a living plant and the genetic material necessary for the production
of the substance, where the substance is intended for use in the
living plant (59 FR 60534, 60542, 60544, and 60545).
EPA also proposed to define inert ingredients in the context of plant-
pesticides as follows:
Inert ingredient, when referring to plant-pesticides only, means
any substance, such as a selectable marker, other than the active
ingredient, and the genetic material necessary for the production of
the substance, that is intentionally introduced into a living plant
along with the active ingredient, where the substance is used to
confirm or ensure the presence of the active ingredient (59 FR 60534
and 60545).
II. Rationale
Since it published the proposed policy and regulations in November
1994, EPA has acquired additional information that has caused it to
reevaluate its treatment of substances ``intentionally introduced into
a living plant along with the active ingredient, where the substance is
used to confirm or ensure the presence of the active ingredient.''
Based upon this information, EPA is reconsidering whether to treat such
substances and the genetic material necessary to produce them as a
pesticide component (such as an inert ingredient).
FIFRA and FFDCA contain only general definitions of the relevant
terms. FIFRA section 2(m) defines a ``pesticide'' as any substance or
mixture of substances intended ``for preventing, destroying, repelling,
or mitigating any pest'' or ``for use as a plant regulator, defoliant,
or desiccant . . .'' (7 U.S.C. 136(u)). An ``active ingredient'' is
defined as an ``ingredient which will prevent, destroy, repel, or
mitigate any pest'' (7 U.S.C. 136(a)). FIFRA defines ``inert
ingredient'' to mean ``an ingredient which is not active'' (7 U.S.C.
136(m)). Under the FFDCA, a substance is a ``pesticide chemical'' if it
is a pesticide within the meaning of FIFRA (21 U.S.C. 321(q)).
Although these definitions provide some guidance, they do not
clearly address whether substances added with the active ingredient to
confirm or ensure the presence of the active ingredient (e.g.,
selectable markers) should be considered inert ingredients. When
Congress created the FIFRA definitions of pesticide and inert
ingredients, it did not consider how the statute would be applied to
such substances since the technology that could utilize these
substances as selectable markers had not yet been invented. Where a
statute is ambiguous, EPA as the administering agency is entitled to
make a reasonable policy choice in interpreting the statute (Chevron,
U.S.A. Inc. v. Natural Resources Defense Council, 467 U.S. 837, 843 n.
9, 845).
In this instance the difficulties associated with interpreting
ambiguous statutory terms are compounded by the unique nature of plant-
pesticides and the substances introduced to confirm or ensure their
presence in the plant. Substances used to confirm or ensure the
presence of a plant-pesticide in a plant are generally termed
``selectable markers'' and will hereafter be referred to by the term,
``selectable markers.'' Selectable markers are introduced into the
plant or plant cells by the process of transformation at the same time
as the genetic material that confers the desired trait (e.g., a
pesticidal trait). A selectable marker's purpose is to provide a
mechanism to distinguish cells that have successfully incorporated the
genetic material for the desired trait during the transformation from
the vast majority of cells that have not incorporated the trait. For
example, the selection process may depend upon the cells, after they
have been transformed, being resistant to an agent that is lethal to
non-transformed cells. Alternatively, cells, after they have been
transformed, may acquire the ability to produce a unique substance that
allows them to be distinguished from cells that have not been
transformed and therefore do not produce the unique substance. Usually
this selection process occurs only once in the very early stages of
product development.
Beyond its use for eliminating the large number of non-transformed
cells, a selectable marker is generally not necessary for expression of
the desired trait; i.e., selectable markers are not necessary for the
pesticidal function of the plant-pesticide in the plant nor do they
modify or enhance the pesticidal activity of the active ingredient.
Selectable markers may even be lost from the plant during subsequent
breeding with no effect on the plant-pesticidal active ingredient.
Existing regulations do not shed much light on how to treat
substances introduced with the plant-pesticide active ingredient (see,
e.g., 40 CFR 152.3(s), 153.2(m), 158.153(f), 177.3, and 180.1(k)).
Although EPA has had extensive experience with inert ingredients in the
context of traditional chemical pesticides, the unique nature of plant-
pesticides makes it difficult to apply the regulatory framework that
has been used with chemical pesticides.
Because of the ambiguous nature of the controlling statutory
provisions and the unique nature of plant-pesticides and substances
such as selectable markers, EPA believes it is reasonable to conclude
that a substance used to confirm or ensure the presence of the active
ingredient, and the genetic material necessary to produce that
substance, are not components of a pesticide. EPA weighed a number of
factors in reaching this conclusion, including the function of these
substances in plants, the effects of these substances on the
performance of the plant-pesticide, and the duration of that effect.
Substances such as selectable markers are intentionally introduced
[[Page 37893]]
into plants to aid in the selection of plants or plant cells that
contain the desired genetic material for the plant-pesticide. They do
not have pesticidal properties themselves and are not necessary to the
function of the plant-pesticide in the plant. Generally they are of no
use in modifying or enhancing the pesticidal activity of the plant-
pesticide and may even be lost later in the product development stage
with no effect upon pesticidal activity. Substances used to confirm or
ensure the presence of a plant-pesticide are frequently used only on a
one-time basis very early in the development of a new plant variety,
for example during the introduction of genetic material in the initial
genetic transformation of plant cells or tissue. Although a substance
such as a selectable marker is introduced at the same time as the
active ingredient, that concomitant event does not necessarily convert
selectable markers into pesticide ingredients.
The comments received in response to the 1994 proposal also helped
to focus EPA's concern about the classification of selectable markers
as inert ingredients. The comments addressing treatment of selectable
markers as inert ingredients raised a range of issues. These issues
included minimizing the potential for duplication of reviews with FDA;
inappropriateness of the Agency's inert policy for chemical pesticides
for substances such as selectable markers; and reservation about
whether risks associated with selectable markers would be adequately
addressed should they be considered inert ingredients. EPA will respond
to these comments together with comments received in response to this
Notice in the preamble of the final rule.
Should EPA decide that substances such as selectable markers are
not inert ingredients or pesticide components, FDA rather than EPA
would have direct jurisdiction over the presence of those substances in
food products. This would result in a more consistent approach to the
regulatory oversight of substances used to confirm or ensure the
presence of a plant-pesticide, e.g., selectable markers.
Should EPA decide that substances, and related genetic material,
used to confirm and ensure the presence of the plant-pesticide should
not be classified as part of a pesticide, the regulatory text in the
final rules under FIFRA and FFDCA would be modified to reflect this
decision, including defining the plant-pesticide product as the plant-
pesticide active ingredient.
III. Public Docket
A record has been established for this document under docket
number ``OPP-300370A'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Rm. 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this document, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
List of Subjects
Environmental protection, Biotechnology, Plant-pesticides, Plants.
Dated: July 15, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 96-18394 Filed 7-19-96; 8:45 am]
BILLING CODE 6560-50-F
