Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act; Reopening of Comment Period

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]

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