[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: [email protected]. 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: 
[email protected].
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:

    [email protected]

    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