[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28822]


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[Federal Register: November 23, 1994]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152 and 174

[OPP-300369; FRL-4755-3]
RIN 2070-AC02

 

Plant-Pesticides Subject to the Federal Insecticide, Fungicide, 
and Rodenticide Act; Proposed Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The substances plants produce to protect themselves against 
pests and disease are considered to be pesticides under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) definition of 
``pesticide'' (i.e., if they are ``. . . intended for preventing, 
destroying, repelling or mitigating any pest. . .''). These substances, 
along with the genetic material necessary to produce them, are 
designated ``plant-pesticides'' by EPA. EPA proposes to amend an 
existing regulation and to create a new regulation to clarify the 
relationship between plants and plant-pesticides and their regulatory 
status under FIFRA. EPA also proposes to exempt from FIFRA requirements 
classes of plant-pesticides that the Agency has determined pose low 
probability of risk and are not likely to cause unreasonable adverse 
affects on the environment. Recognizing the unique characteristics of 
plant-pesticides, the Agency proposes to create a new part in the CFR 
for regulations unique to plant-pesticides.

DATES: Comments identified by the docket control number [OPP-300369] 
must be received on or before January 23, 1995.

ADDRESSES: Submit written comments 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 20460. In person, bring comments to Rm. 1132, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (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 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, Telephone number: (202) 260-6900.

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA proposes to clarify the regulatory status, under FIFRA, of 
pesticidal substances produced in plants (plant-pesticides) and of 
plants that produce pesticidal substances and act as biological control 
agents. EPA defines a biological control agent as ``any living organism 
applied to or introduced into the environment that is intended to 
function as a pesticide against another organism declared to be a pest 
by the Administrator'' (40 CFR 152.3). EPA also proposes to exempt from 
FIFRA regulation certain types of pesticidal substances produced in 
plants that EPA believes do not warrant regulation.
    In the Federal Register of June 2, 1982 (47 FR 23928), EPA 
promulgated a final regulation under FIFRA section 25(b) that exempted 
all biological control agents, except for certain microorganisms, from 
the requirements of FIFRA. This exemption was promulgated because EPA 
found that the risks posed by biological control agents other than 
microorganisms were adequately addressed by other Federal agencies such 
as the U.S. Department of Agriculture's (USDA's) Animal and Plant 
Health and Inspection Service (APHIS) and the U.S. Department of the 
Interior. Although plants used as biological control agents were not 
specifically addressed in 40 CFR 152.20 or in the June 2, 1982, Federal 
Register document, EPA has considered these plants to be excluded from 
regulation under FIFRA through this exemption. EPA continues to believe 
that plants used as biological control agents are adequately regulated 
by other Federal agencies. However, EPA believes that the status of 
pesticidal substances produced in plants (i.e., plant-pesticides) 
requires regulatory clarification.
    Although plants used as biological control agents were exempted 
from FIFRA regulation under 40 CFR 152.20, substances that are 
extracted from plants and used as pesticides are not similarly 
exempted. For example, chrysanthemums produce pyrethrum, a substance 
that has insecticidal activity. Chrysanthemums that produce pyrethrum 
are exempt from regulation when used as biological control agents 
(i.e., living chrysanthemums), but pyrethrum itself, as the pesticide 
substance, is not exempt when it is extracted from chrysanthemum plants 
and applied to other plants as an insecticide.
    This distinction is reasonable in light of the potential for 
increased and unique exposures due to large-scale application of 
extracted pyrethrum to plants that do not naturally produce it. The use 
of extracted pyrethrum as an insecticide can involve exposure to the 
pesticide over large acreages, whereas the exposure associated with 
pyrethrum produced by living chrysanthemum plants would not be expected 
to reach such proportions. In addition, application of pyrethrum beyond 
the environment in which it is normally produced (i.e., beyond the 
living chrysanthemum plant) could result in new or unique exposures of 
nontarget organisms, including humans.
    Although it has been EPA's policy under FIFRA to regulate 
pesticidal substances that have been extracted from plants, to date the 
Agency has not clearly stated its policies for regulation of pesticidal 
substances that are produced in living plants and function in situ to 
protect the plant from pests or disease (i.e., not extracted from the 
plants). This proposed rule is designed to provide such clarification.
    FIFRA section 2(u) defines ``pesticide'' as: ``(1) any substance or 
mixture of substances intended for preventing, destroying, repelling, 
or mitigating any pest, and (2) any substance or mixture of substances 
intended for use as a plant regulator, defoliant, or desiccant. . . .'' 
The substances that are produced in plants to protect them against 
pests and disease are considered to be pesticides under the definition 
of FIFRA section 2, (i.e., if they are ``. . . .intended for 
preventing, destroying, repelling, or mitigating any pest. . .'') 
regardless of whether the pesticidal capabilities evolved in the plants 
or were introduced by traditional breeding or through the techniques of 
modern biotechnology. These substances, along with the genetic material 
necessary to produce them, are designated ``plant-pesticides'' by the 
Agency.
    There are a number of types of substances produced in plants that 
enable plants to resist pest attack and disease. These substances 
include both those pesticidal substances that would be considered 
normally a component of a plant and those that would be considered new 
to a plant. Examples of plant-pesticides that would be considered 
normally a component of a plant are phytoalexins (plant-produced 
substances that act against phytopathogenic microorganisms). An example 
of a plant-pesticide that would not be considered normally a component 
of a plant is the insecticidal delta endotoxin that is produced in the 
bacterium, Bacillus thuringiensis.
    This proposal would clarify the relationship between plants and 
plant-pesticides. It applies to all pesticidal substances produced in 
living plants, including bryophytes such as mosses, seedless vascular 
plants such as ferns, gymnosperms such as conifers, and angiosperms 
such as most major crop plants. This proposal would reaffirm that 
plants continue to be exempt under 40 CFR 152.20 and, under a new part 
174 (in the 40 CFR) would codify which categories of plant-pesticides 
would be exempt and which would be regulated by EPA under FIFRA. 
Recognizing the unique characteristics of plant-pesticides, the Agency 
will, in the future, include, in part 174, other regulations specific 
to plant-pesticides.
    As part of the effort to develop this proposal, EPA requested 
advice from two scientific advisory committees at three meetings. On 
December 18, 1992, a Subpanel of the FIFRA Scientific Advisory Panel 
(SAP) was convened to review a draft proposed policy statement and to 
answer a series of scientific questions concerned primarily with EPA's 
proposed approach for plant-pesticides under FIFRA. On July 13, 1993, a 
Subcommittee of the EPA Biotechnology Science Advisory Committee (BSAC) 
was convened to address a series of scientific questions concerned 
primarily with EPA's proposed approach for plant-pesticides under the 
Federal Food, Drug, and Cosmetic Act (FFDCA). On January 21, 1994, a 
joint BSAC/SAP Subpanel was convened to address a series of scientific 
questions concerned with the scope of regulation under both FIFRA and 
FFDCA and guidance for data needs for the evaluation of plant-
pesticides.
    This proposed rule is one of several documents published in today's 
issue of the Federal Register that address EPA's approach to regulating 
plant-pesticides. The other documents are: (1) A proposed policy 
statement that generally describes how EPA proposes to regulate plant-
pesticides under FIFRA and the FFDCA (``Plant-pesticides Subject to the 
Federal Insecticide, Fungicide, and Rodenticide Act and the Federal 
Food, Drug, and Cosmetic Act; Proposed Policy''; (2) a proposed 
exemption from the requirement of a tolerance for categories of plant-
pesticides that do not result in significantly different dietary 
exposures (``Plant-pesticides; Proposed Exemption from the Requirement 
of a Tolerance Under the Federal Food, Drug, and Cosmetic Act''; (3) a 
proposed exemption from the requirement of a tolerance for coat 
proteins from plant viruses (``Plant-pesticides; Proposed Exemption 
from the Requirement of a Tolerance Under the Federal Food, Drug, and 
Cosmetic Act for Viral Coat Proteins Produced in Plants'' and (4) a 
proposed exemption from the requirement of a tolerance for nucleic 
acids produced in plants as part of a plant-pesticide (``Plant-
pesticides; Proposed Exemption from the Requirement of a Tolerance 
Under the Federal Food, Drug, and Cosmetic Act for Nucleic Acids 
Produced in Plants'').

II. Statutory Authority

    This rule is being proposed under the authority of section 3 and 
section 25(a) and (b) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136 et. seq.). FIFRA section 2(u) defines 
``pesticide'' as: ``(1) any substance or mixture of substances intended 
for preventing, destroying, repelling, or mitigating any pest, and (2) 
any substance or mixture of substances intended for use as a plant 
regulator, defoliant, or desiccant . . . ''
    FIFRA section 3 provides that no person may distribute or sell in 
the United States any pesticide that is not registered under the Act. 
Before a product may be registered as a pesticide under FIFRA, it must 
be shown that when used in accordance with widespread and commonly 
recognized practice, it will not generally cause ``unreasonable adverse 
effects on the environment.'' FIFRA section 2(bb) defines the term 
``unreasonable adverse effects on the environment'' as any unreasonable 
risk to humans or the environment, taking into account the economic, 
social, and environmental costs and benefits of the use of any 
pesticide. Thus, FIFRA involves a balancing of the risks presented by 
the use of the pesticide against the benefits associated with the use 
of that pesticide.
    In addition, FIFRA section 3(a) provides that, to the extent 
necessary to prevent unreasonable adverse effects on the environment, 
the Administrator may by regulation limit the distribution, sale or use 
of any pesticide that is not registered under FIFRA or subject to an 
Experimental Use Permit under FIFRA section 5 or subject to an 
emergency exemption under FIFRA section 18.
    Under FIFRA section 25(b), EPA may exempt, by regulation, any 
pesticide determined to be adequately regulated by another Federal 
agency, or of a character which is unnecessary to be subject to the Act 
in order to carry out the purposes of the Act.

III. 40 CFR Part 174

    EPA is proposing to set forth, under FIFRA, a new part in 40 CFR 
specifically for plant-pesticides regulated under FIFRA. In proposed 
part 174, as well as at Sec. 152.20, EPA would clarify the regulatory 
relationship between plants and plant-pesticides and, at Sec. 174.5, 
EPA would define the scope of regulation for plant-pesticides under 
FIFRA. Although EPA is not proposing in today's issue of the Federal 
Register specific regulatory requirements for plant-pesticides in part 
174 (e.g., labeling and Experimental Use Permit requirements), EPA 
plans to propose such regulations in the future. In the interim period 
before these additional regulatory amendments are proposed and 
promulgated, EPA will use existing pesticide regulations (see 40 CFR 
parts 152 to 173 and 40 CFR parts 177 to 186) for plant-pesticides 
where applicable. However, these existing regulations were developed 
generally for traditional, chemical pesticides. Because of the unique 
characteristics of plant-pesticides, EPA recognizes that the existing 
regulations may not always be appropriate for these products. The 
characteristics of plant-pesticides such as both their production and 
use in plants; their biological properties; and their potential ability 
to spread and increase in quantity in the environment distinguishes 
them from traditional, chemical pesticides. The Agency therefore 
intends to apply the existing regulations to plant-pesticides in a 
manner that addresses the unique issues associated with plants. 
Producers are encouraged to consult with the Agency well in advance of 
any proposed activities involving plant-pesticides. (Refer to the 
Federal Register document entitled, ``Proposed Policy; Plant-pesticides 
Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and 
the Federal Food, Drug, and Cosmetic Act.'')

IV. Definitions

    Because of the unique nature of plant-pesticides, the Agency is 
proposing certain definitions that will apply to plant-pesticides only. 
These definitions are contained in the proposed regulatory text under 
40 CFR 152.3, and in 40 CFR 174.3. The following unit describes the key 
definitions for plant-pesticides under FIFRA and the rationales 
underlying these definitions.

A. Definition of Plant-pesticide

    EPA would define ``plant-pesticide'' under FIFRA as:

    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.

    EPA is including the genetic material necessary to produce the 
substance in the proposed definition of plant-pesticide for a number of 
reasons. First, it is the genetic material that is introduced into the 
plant with the intent that it will ultimately result in a pesticidal 
effect. Additionally, EPA's regulation of pesticides is based on an 
evaluation of the potential for unreasonable adverse effects associated 
with the pesticidal substance, in this case, the pesticidal substance 
produced in the plant. Regulation also includes risk management 
considerations. A focus on the genetic material would permit the Agency 
to address the potential for the spread of the pesticidal substance in 
the environment through the spread of the genetic material necessary 
for the production of the substance. Moreover, the amount of pesticidal 
substance likely to be produced by the plant is also an important 
consideration that the Agency may, in some circumstances, be able to 
address through the inclusion of genetic material in the definition of 
plant-pesticide. In addition, including the genetic material in the 
definition of plant-pesticide would permit the Agency to address plant-
pesticides during stages of the plant's life cycle or in plant parts 
where the pesticidal substance itself is not produced or is produced in 
very small amounts (e.g., in pollen or seed). In these cases it is 
technically easier to verify the presence of the genetic material than 
the pesticidal substance.

B. Definition of Active and Inert Ingredients

     The regulation of pesticides under FIFRA entails the 
identification of ``active ingredients'' and ``inert ingredients.'' 
Under FIFRA section 2, the term active ingredient means ``. . . an 
ingredient which will prevent, destroy, repel, or mitigate any pest. . 
. [or acts as a plant regulator, defoliant or desiccant].'' The term 
inert ingredient means ``. . . an ingredient which is not active.'' EPA 
recognizes that plant-pesticides have certain characteristics that are 
different from those of more traditional chemical pesticides. EPA 
believes that the overall characteristics of plant-pesticides require 
specifically tailored active and inert ingredient definitions.
    In light of this consideration, EPA proposes to use the following 
definitions for plant-pesticides.

    Active ingredient, when referring to plant-pesticides only, 
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.
    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.

    Note that the plant-pesticide active ingredient is the plant-
pesticide and therefore the proposed definition of active ingredient 
for plant-pesticides is the same as the definition of plant-pesticide. 
The plant-pesticide product includes both the active and inert 
ingredients.
    The definition of plant-pesticide and the active and inert 
ingredient definitions would include all of the genetic material 
``necessary for the production'' of the pesticidal and inert substance. 
The following genetic regions are considered ``necessary for the 
production'' of the plant-pesticide active and inert substances: (1) 
The genetic material that encodes for the pesticidal substance or leads 
to the production of the pesticidal substance, and (2) regulatory 
regions such as promoters, enhancers, and terminators.
    The genetic material can either directly encode for the pesticidal 
substance or may encode for enzymes that lead to the production of a 
pesticidal substance (e.g., phenylalanine ammonia-lyase (PAL) catalyzes 
the first reaction in the synthesis of such phytoalexins as 
pterocarpans in Leguminosae and furanocoumarins in Solanaceae and 
Umbelliferae; Ref. 4). It might also include genetic regions encoding 
for RNA that acts as the pesticidal substance or leads to the 
production of the pesticidal substance (e.g., antisense mRNA). The 
active and inert ingredients would also include any regulatory regions, 
such as promoters, that control the expression of the genetic material 
encoding for the pesticidal or inert substance or leading to the 
production of the pesticidal or inert substance and are introduced into 
the plant along with that gene. For example, a different regulatory 
element could lead to the production of the pesticidal substance in new 
plant parts or for new durations, resulting in new exposure scenarios.
    The genetic material ``necessary for the production'' of the plant-
pesticide active and inert substances does not include genetic regions 
that are not involved in DNA expression (i.e., noncoding, nonexpressed 
sequences such as linkers, adapters, homopolymers, and sequences of 
restriction enzyme recognition sites). However, the Agency would 
require information concerning these sequences if it determines that 
such information is necessary for the evaluation of the active or inert 
ingredient.
    There may be genetic material encoding other functions (e.g., 
genetic material intended to alter the amount of carbohydrate in the 
plant) that are introduced into the plant along with the active and 
inert ingredients. These activities would be subject to the Food and 
Drug Administration (FDA) authorities.

V. Proposed Exemptions for Plant-pesticides

    EPA has attempted to identify those types of plant-pesticides that 
have greater potential for environmental and/or human health risks and 
to focus its regulatory scrutiny on these plant-pesticides. To exempt 
from regulation those plant-pesticides having low potential for risk, 
EPA is proposing to employ its exemption authority under FIFRA section 
25(b). FIFRA section 25(b)(2) allows the Agency to exempt a pesticide 
from the requirements of FIFRA if it is of a character unnecessary to 
be subject to the Act in order to carry out the purposes of the Act. 
Through FIFRA section 25(b)(2), EPA proposes to exempt certain 
categories of plant-pesticides that EPA believes pose low probability 
of risk and are not likely to cause unreasonable adverse effects even 
in the absence of any regulatory oversight under FIFRA and, thus, are 
of a character unnecessary to be subject to the Act. Those plant-
pesticides not exempted would form the scope of EPA's regulatory 
scrutiny under FIFRA.
    EPA finds that the plant-pesticides it is proposing to exempt have 
a low probability of risk and have potential benefits associated with 
them (e.g., economic benefits to farmers and reducing the need for 
chemical pesticides) that outweigh any potential risks associated with 
them, and that the low probability of risk does not justify the cost of 
regulation. Therefore, the Agency proposes under 40 CFR 174.5 to 
exempt, from FIFRA regulation, the categories of plant-pesticides that 
EPA has identified as those that are likely to pose little risk and are 
not likely to cause unreasonable adverse effects on the environment 
even in the absence of regulatory oversight.
    While EPA's analysis of the potential risks and benefits of plant-
pesticides has led the Agency to the conclusion that some categories of 
plant-pesticides warrant regulation while others do not, the Agency 
cannot foresee all potential adverse effects to human health or the 
environment which may potentially arise for testing and use of specific 
plant-pesticides. Thus, in Sec. 174.7 EPA is proposing to require 
reporting of information on adverse effects from the testing and use of 
plant-pesticides that EPA is proposing to exempt in Sec. 174.5. 
Proposed Sec. 174.7 is meant to address unforeseeable events resulting 
from use of such pesticides. EPA believes that such events are likely 
to be extremely rare; however, Sec. 174.7 is a means of ensuring that 
any potential risk is addressed and that the Agency's data base is as 
complete as possible. Information on potential unreasonable adverse 
effects would be required to be reported if such information is 
obtained, from any source, by any person who sells or distributes a 
plant-pesticide. Failure to comply with Sec. 174.7 would be an unlawful 
act under FIFRA section 12(a)(2)(S) and could result in an enforcement 
action (for penalties) under FIFRA section 14. In addition, FIFRA 
section 6(a)(2) applies to plant-pesticides that would not be exempt 
under this proposed rule.
    As with traditional pesticides, the underlying considerations in 
analyzing risks posed by plant-pesticides are the potential for 
exposure to the pesticidal substance and hazards of the pesticidal 
substance to humans, other nontarget organisms, and the environment. 
For plant-pesticides, exposure and hazard will be determined by the 
chemical and toxicological properties of the pesticidal substance and 
the biological characteristics of the plant that is producing the 
substance.
    The properties of the plant-pesticide, including the mechanism by 
which it affects the target pest, will determine the potential for 
hazards to nontarget organisms, including humans. The type of organism 
exposed to the plant-pesticide will be determined by the characteristic 
of the plants that produce the substance and the environment where the 
plants are grown; e.g., whether the production of the substance is 
limited to particular plant parts, the organisms that normally 
associate with the plant, and the acreage and location planted. An 
important consideration not seen with traditional pesticides is the 
potential for spread of the plant's genetic material. Because plants 
can reproduce sexually and/or asexually, the ability to produce the 
plant-pesticide could spread through the agro- or natural ecosystems, 
particularly if wild relatives acquire the ability to produce the 
plant-pesticide through successful hybridization.
    Such hazard and exposure considerations form the bases of the three 
exemptions, discussed in Units V.A., V.B., and V.C. of this preamble, 
that the Agency is proposing for plant-pesticides under FIFRA.
    The benefits associated with use of some categories of plant-
pesticides include the economic benefit to farmers for use of plant-
pesticides in circumstances where traditional pesticides may not be as 
effective (e.g., for some systemic plant pests) or may be more 
expensive, thus increasing crop yield and/or reducing farmers' costs. 
An additional benefit is the environmental benefit associated with 
potential reduced use of pesticides that may be less environmentally 
benign than these plant-pesticides.

A. Exemption of Plant-pesticides Derived from Closely Related Plants

    A primary consideration in evaluating plant-pesticides is the 
potential for new exposures of nontarget organisms to the pesticide. If 
a plant normally produces a pesticidal substance, organisms that come 
in contact with the plant have likely been exposed to that substance in 
the past, perhaps over long periods of time. The potential for new 
exposures to occur would be very low.
    In contrast, if a plant-pesticide is not normally produced by a 
plant, the organisms that come in contact with the plant may never have 
been exposed to the substance. For instance, certain spiders produce a 
toxin that is targeted for their insect prey. Plants are not known to 
produce this toxin in nature or in cultivation. If this toxin were to 
enter the gene pool of specific plants, organisms that had never 
previously been exposed to the toxin could now be exposed. Prior to the 
introduction of the toxin into these plants, only the insect prey of 
the spider would potentially be exposed to the toxin. If plants could 
now express the toxin, a different or larger group of organisms could 
be exposed to it, possibly resulting in adverse effects to these 
organisms. For instance, insects that feed on the plant could be 
exposed to the toxin. If the toxin is found in pollen, pollinators 
could also be exposed.
    EPA is proposing to concentrate its regulatory efforts under FIFRA 
on those plant-pesticides that are new to the plant and, thus, have the 
greatest potential for exposing nontarget organisms to a new pesticidal 
substance. The Agency is proposing to exempt from FIFRA regulation 
those plant-pesticides that are normally a component of (not new to) a 
plant. In defining, for regulatory purposes, those substances it 
considers to be normally a component of a plant, the Agency is 
presenting three approaches to the proposed exemption for public 
comment. In selecting among these three options, the Agency will 
consider how well each of the options: (1) Distinguishes, on a risk 
basis, those plant-pesticides that would result in new environmental 
exposures from those that would not; (2) provides a standard of 
sufficient regulatory clarity so that the public, industry, and the 
Agency can easily identify those plant-pesticides that would be subject 
to regulation; (3) does not place an undo burden on producers/
developers; and (4) creates as similar a scope of regulation as 
possible for this exemption under FIFRA as EPA is proposing under 
FFDCA, given the differences in mandate and structure of the two 
statutes. The three options are described below followed by a 
description of terms used in the options in Unit V.A.4. of this 
preamble and an analysis of the options in Unit V.A.5. of this 
preamble. For the reasons discussed in Unit V.A.5. of this preamble, 
EPA prefers Option 1 over Options 2 or 3.
    1. Option 1: Plant-pesticides derived from sexually compatible 
plants. This approach is based on the concept of sexual compatibility. 
The Agency believes this concept describes a measure of relatedness 
between plants and views plant-pesticides moved between sexually 
compatible plants as not new to the plant. The use of the standard of 
sexual compatibility is embodied in the following language from the 
proposed regulatory text: [Plant-pesticides are exempt from FIFRA 
requirements if:]

    . . .The genetic material that encodes for a pesticidal 
substance or leads to the production of a pesticidal substance is 
derived from plants that are sexually compatible with the recipient 
plant and has never been derived from a source that is not sexually 
compatible with the recipient plant;. . .

    2. Option 2: Plant-pesticides derived from plants within the same 
genus. A second approach that EPA is considering for defining when a 
plant-pesticide is new to the plant is a standard based on taxonomy. 
Under this approach, the standard would rely on the taxonomic grouping 
of genus; plant-pesticides moved between plants in the same genus would 
be exempt. The assumption under this approach is that the genus 
grouping correlates with a relatively high degree of relatedness among 
plants even though not all plants in a genus are sexually compatible. 
Similarity in traits ranging from flower morphology to the presence of 
particular alkaloids and flavonoids, for example, have been used to 
determine whether to classify a plant species in a particular genus and 
these traits likely bespeak a high degree of relatedness. The language 
defining this option would be as follows: [Plant-pesticides are exempt 
from FIFRA requirements if:]

    The genetic material that encodes for a pesticidal substance or 
leads to the production of a pesticidal substance is derived from 
plants that are within the same genus as the recipient plant 
[regardless of sexual compatibility] and has never been derived from 
a source outside of that genus;

    3. Option 3: Plant-pesticides derived from plants within the same 
genus or from sexually compatible plants. The third approach EPA is 
considering combines the above two standards of taxonomy and sexual 
compatibility. The standard under this option would rely primarily on 
the taxonomic grouping of genus as a measure of relatedness. 
Recognizing that some plants that are sexually compatible are 
classified in different genera and assuming that sexual compatibility 
bespeaks a high degree of relatedness, EPA also includes a provision 
extending the exemption to include sexually compatible plants from any 
genera. The language defining this option would be as follows: [Plant-
pesticides are exempt from FIFRA requirements if:]

    The genetic material that encodes for a pesticidal substance or 
leads to the production of a pesticidal substance:
    (1) Is derived from plants that are within the same genus as the 
recipient plant [regardless of sexual compatibility] or, is derived 
from plants that are sexually compatible with the recipient plant; 
and
    (2) Has never been derived from a source outside the same genus 
that is not sexually compatible with the recipient plant.

    4. Terms used in the options. The phrase ``genetic material that 
encodes for the pesticidal substance or leads to the production of the 
pesticidal substance'' refers to genetic material that: (1) Directly 
encodes for the pesticidal substance; (2) encodes for enzymes that lead 
to the production of a pesticidal substance (as in the example of the 
PAL gene discussed in Unit IV. of this preamble); or (3) encodes for 
RNA that acts as a pesticide or leads to the production of a pesticidal 
substance (e.g., antisense RNA).
    For the purposes of the options for this exemption under FIFRA, 
this phrase is not intended to include regulatory regions or noncoding, 
nonexpressed nucleotide sequences when the genetic material encoding 
for or leading to the production of the pesticidal substance would 
otherwise be exempt. For this specific exemption, these regulatory 
regions and noncoding, nonexpressed nucleotide sequences may be derived 
from any source. For example, if a viral promoter attached to a corn 
structural gene encoding a pesticidal substance is introduced into 
another corn variety, the structural gene and the viral promotor 
genetic construct would meet the criteria of the options for this 
exemption.
    Note that whereas regulatory elements are not, for the purposes of 
the proposed exemptions, considered part of the genetic material ``that 
encodes for a pesticidal substance or leads to the production'' of a 
pesticidal substance, regulatory elements are considered part of the 
genetic material ``necessary for the production'' of a pesticidal 
substance under the definitions of the plant-pesticide active and inert 
ingredients (see Unit IV. of this preamble).
    The definition for ``sexually compatible'' means being capable of 
forming a viable zygote through the fusion of two gametes and can 
include the use of bridging crosses and wide cross breeding techniques 
such as surgical alteration of the plant pistil, bud pollination, 
mentor pollen, immunosuppressants, in vitro fertilization, pre- and 
post-pollination hormone treatments, manipulation of chromosome 
numbers, and embryo culture. It can also include, for the purposes of 
this exemption, ovary and ovule cultures. EPA believes that the 
production of viable zygotes through these techniques indicates a 
sufficient level of relatedness between the parental plants involved to 
be included under the rubric of ``sexually compatible.''
    The phrase ``. . . has never been derived from a source that is not 
sexually compatible with the recipient plant . . .'' is meant to 
indicate in the proposed regulatory text that the genetic material 
would not qualify for the exemption if it is introduced into a plant 
from a sexually incompatible source and subsequently introduced into 
other sexually compatible plants. An example of such a situation would 
be if the Bacillus thuringiensis delta endotoxin is introduced into 
wheat and the endotoxin producing wheat subsequently hybridized with 
rye using wide cross techniques to produce triticale. The endotoxin 
produced in the triticale would not be eligible for the exemption.
    5. Analysis of options. EPA's goal in developing these options for 
defining an exemption under FIFRA is to identify those plant-pesticides 
with a higher potential for new environmental exposures to nontarget 
organisms. Under Option 1, the Agency would consider plant-pesticides 
produced in sexually compatible plants to be least likely to result in 
these new exposures. Since traits can be passed through a plant 
population by sexual recombination, it is reasonable to predict that, 
in a sexually compatible population, new exposures of organisms that 
associate with plants in the population to the pesticidal substance are 
unlikely.
    Sexually compatible plants are more apt to share traits than are 
unrelated plants. It is a common expectation that similarity is 
associated with the degree of relatedness. Natural hybridization and 
selection have produced groups of plants which have a common gene pool. 
Generations of artificial hybridization practiced to produce improved 
crops for cultivation have tended to increase the extent of relatedness 
among elements of a broader segment of agricultural plants.
    The practice of saving seed from desirable plants has been going on 
for thousands of years and controlled crosses to produce plant hybrids 
have been documented since the eighteenth century. Since the 
rediscovery of Mendel's work on the inheritance of traits, there is a 
base of experience of 50 to 100 years of breeding for most major crops. 
During that time, it has been common agricultural practice to cross 
sexually compatible wild relatives with crop plants to develop crop 
varieties with better pest resistance. Techniques such as genetic 
mapping reveal the presence of genetic loci in cultivated plants that 
previously were considered to be present only in the wild species. 
Sexually compatible crop varieties are also crossed with each other to 
achieve better pest resistance in their progeny. Because of these 
common practices, the potential for significantly different 
environmental exposures from current crop plants is likely to be low.
    EPA proposes to extend the concept of sexual compatibility to 
include wide crosses because wide crosses are commonly used to expand 
the plant gene pool for varietal improvement, and EPA believes that a 
fairly high degree of relatedness between the parental plants is 
indicated when a wide cross produces a viable zygote. However, for 
regulatory purposes it is somewhat difficult to define what constitutes 
a wide cross since techniques may change over time. EPA is thus 
proposing, for the purposes of this proposed rulemaking, a definition 
of wide crosses that is based on existing techniques with a provision 
to add new techniques if they meet the definition.
    Options 2 and 3 both rely on taxonomy, and this standard may also 
represent an acceptable degree of relatedness. Plant species within the 
same genus may have become separated by geography, timing of 
pollination, or other factors to form two distinct populations no 
longer sexually compatible. Events such as mutation and environmental 
selection can reinforce the isolation and uniqueness of the gene pools. 
However, the ability to overcome these incompatibility barriers between 
species in the same genera through human intervention (e.g., bridging 
crosses and wide crosses) is evidence that such plants are fairly 
closely related. The majority of successful wide crosses to date have 
occurred between species within the same genus.
    The second option is based solely on the taxonomic standard of 
genus. Sexual compatibility (including the use of bridging crosses and 
wide crosses) with the recipient plant would not be a criterion. The 
third option relies primarily on taxonomy but also includes the 
standard of sexual compatibility. Unlike Option 2, under this option, 
plant-pesticides derived from a plant outside of the same genus as the 
recipient plant could still be eligible for the exemption if sexual 
compatibility between the source and the recipient plant is 
demonstrated.
    The use of a taxonomic standard may, from a regulatory perspective, 
be somewhat clearer than a standard based solely on sexual 
compatibility (including bridging and wide crosses). However, taxonomy 
may be a more artificial standard than sexual compatibility as a 
predictor of different environmental exposures of a plant-pesticide, 
particularly for unmanaged or semi-managed plants. Isolation, 
adaptation to unique environments, and low natural rates of gene flow 
even between populations of the same species characterize many natural 
populations. For these types of plants, the taxonomic standard used in 
Options 2 and 3 may not be as appropriate as the sexual compatibility 
standard used in Option 1 with regard to novel exposures to plant-
pesticides produced in unmanaged or semi-managed plants. In addition, 
classification of plants in different genera is not fixed and could 
change over time and between scientific authorities.
    Option 1 is more compatible than either Option 2 or 3 with EPA's 
preferred approach to plant-pesticides under FFDCA. Under FFDCA, EPA 
sets tolerances for pesticide residues in foods. EPA may also exempt 
pesticides from the requirement of a tolerance when such tolerance is 
not needed to protect the public health. EPA is proposing to exempt 
from FFDCA requirements certain plant-pesticides that would not result 
in significantly new dietary exposures as it is proposing to exempt 
plant-pesticides that would not result in new environmental exposures 
from FIFRA requirements. Under both statutes, EPA's preferred approach 
uses the standard of sexual compatibility presented in Option 1 in this 
document. In addition, using a taxonomic standard alone (Option 2) is 
not considered a viable option under FFDCA (see Federal Register 
document entitled, ``Plant-pesticides; Proposed Exemption from the 
Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic 
Act.''
    For some crop plant varieties, e.g., potatoes, vegetative 
propagation is commonly used in addition to breeding. Since 
vegetatively propagated plants have the same genetic makeup, EPA 
intends that a plant-pesticide produced in a vegetatively propagated 
plant would meet the criteria of Option 1 as long as the plant-
pesticide is either produced during vegetative propagation or, during 
breeding, the original genetic source of the plant-pesticide is 
sexually compatible with the recipient plant, as defined in the 
proposed regulatory text. A plant-pesticide produced in vegetative 
plants would meet the criteria of Option 2 and 3 as long as the plant-
pesticide is produced during vegetative propagation or the original 
genetic source of the plant-pesticide is in the same genus as or, in 
the case of Option 3, is sexually compatible with the recipient plant.
    None of the options presented in this unit are intended to exempt 
plant-pesticides which are significantly different in structure or 
function from the plant-pesticide as it occurs in the source plant. 
Such significantly modified plant-pesticides would not be eligible for 
exemption under any of the options. Rearrangements or modifications of 
the sequence encoding a plant-pesticide, for example, could result in 
plant-pesticides with significantly different structures and/or 
functions from those in the source plant and these would not be exempt. 
If this type of modification were to occur, the potential for new and 
different exposures in the environment could be significant.
    Under all of the approaches discussed in this unit, the Agency has 
evaluated whether changes in the levels of plant-pesticides that plants 
normally produce would warrant regulation under FIFRA. (Ref. 1) The 
Agency's analysis indicates that changes in the levels of such plant-
pesticides expressed by a plant could result in increased or decreased 
exposures of nontarget organisms to a plant-pesticide. However, EPA 
believes, for the reasons outlined below, that the potential for 
unreasonable adverse effects from these exposures is low and these 
types of plant-pesticides do not warrant regulation under FIFRA.
    In deciding whether and how to regulate such plant-pesticides, EPA 
first considered whether an increase in the levels of these plant-
pesticides is likely to exceed the ranges normally found within and 
between plant varieties (both cultivated and uncultivated). EPA 
believes that increases in the levels of such plant-pesticides are not 
likely to result in overall significantly different exposures of 
nontarget organisms to the pesticide. The level of production of such 
pesticidal substances normally varies among related plants because of 
differences in genetic makeup and environmental conditions. This 
variation, in turn, results in natural variations in the levels of 
exposure to the pesticide. Nontarget organisms that associate with the 
plants, such as birds and insect pollinators, are exposed to a range of 
such plant-pesticide levels in nature.
    EPA also considered the extent to which any substance can be 
increased in cultivated plants without unwanted effects on other, 
desirable characteristics of the plant (e.g., yield or palatability of 
fruit). In general, breeders balance all of these characteristics in 
developing marketable plant varieties. Considerations of 
characteristics such as yield could serve to mitigate against exceeding 
certain ranges of pesticide levels. Agricultural crop plants, those 
most likely to be grown in large acreages with concomitant large 
exposures, are not likely to be in the higher portion of the expression 
range because of these constraints and are not likely to produce as 
broad a range of levels of plant-pesticides that plants normally 
produce. EPA anticipates that the majority of agricultural crop plants 
with modified levels of plant-pesticide expression will fall within 
existing ranges of pesticide levels and does not anticipate that 
increasing the level of a plant-pesticide that is normally a component 
of a plant would lead to a signficantly different spectrum of exposure 
to the plant-pesticide.
    There are also difficulties in establishing what constitutes 
``significantly higher levels'' for regulatory purposes. At the July 
13, 1992 meeting, the BSAC Subcommittee was specifically asked and the 
subcommittee extensively discussed approaches to determining what 
constitutes significantly higher levels of a plant pesticide. During 
discussion at the meeting, the BSAC Subcommittee indicated it would be 
very difficult to establish standards for ``significantly higher 
levels'' since no formal complete data base of plant constituents and 
their concentration ranges exists. Because of these difficulties, the 
BSAC Subcommittee final report did not suggest a scope criterion based 
on ``significantly higher levels.'' For these reasons, EPA is not 
proposing, under FIFRA, to regulate using a criterion based on 
``significantly higher levels'' of a plant-pesticide.
    Consistent with the Agency's proposed statement of policy on plant-
pesticides, EPA recognizes that plant defense compounds found in plants 
that are not sexually compatible, or in other organisms such as 
microorganisms, can be structurally and functionally equivalent to 
compounds found in the recipient plant or in a plant sexually 
compatible with the recipient plant. EPA is willing to consider, in the 
future, exemptions for plant-pesticides (as are proposed for viral coat 
proteins) if a producer can provide evidence that the plant-pesticide 
is structurally and functionally equivalent to a plant-pesticide found 
in the recipient plant or in a plant sexually compatible with the 
recipient plant. Specifically, the Agency is willing to consider 
development of procedures and criteria for these plant-pesticides. 
Please see Request for Comment unit, Unit VII., of this preamble for a 
fuller discussion of how such exemptions might be granted in future 
rulemakings.

B. Exemption of Plant-pesticides That Act Primarily by Affecting the 
Plant

    One of EPA's primary goals in regulating pesticides is to control 
the potential for adverse effects of pesticides on nontarget organisms. 
An important component in the evaluation of this potential is the way 
in which the pesticidal substance acts on the target pest since it 
would also likely affect nontarget organisms through the same 
mechanism. A pesticidal substance that acts directly on the target pest 
through a toxic mechanism of action might also exert a similar effect 
on other organisms. For example, a substance that acts by inhibiting 
DNA synthesis of the pest could inhibit DNA synthesis in other 
nontarget organisms.Toxic mechanisms of action include, but are not 
limited to, those that affect: (i) Membrane permeability, (ii) cell 
division, (iii) gene expression, (iv) DNA replication, or (v) other 
metabolic functions (Ref. 3).
    Pesticidal substances can also act through mechanisms that are less 
likely to be directly toxic. Although it is possible for these 
substances to adversely affect nontarget organisms, the Agency believes 
that, in most cases, they pose significantly lower levels of 
environmental risk than plant-pesticides with a generalized toxic 
mechanism of action. Plant-pesticides that are less directly toxic 
generally act primarily by affecting the plant so that the pest is 
inhibited from attaching to the plant, penetrating the plant's surface 
or invading the plant's tissue. For example, if a plant is modified so 
that it can counter specific disease-producing compounds by 
inactivating them, it is less likely that organisms that interact with 
the plant in other, more beneficial ways will be affected. Similarly, a 
plant may be modified to produce defense structures such as layers of 
cork cells in response to infection by fungi or bacteria. These 
structures form a barrier to further penetration by the pests and may 
block the spread of any toxins. Other, nontarget organisms that do not 
stimulate this response are not likely to be adversely affected. The 
Agency believes that it would be appropriate to exempt from regulation, 
under FIFRA, plant-pesticides that act through mechanisms such as 
these. EPA believes that by focusing its regulatory attention on plant-
pesticides that act through toxic mechanisms, it will be able to focus 
on those plant-pesticides presenting higher levels of risk potential. 
The proposed regulatory text presents criteria to define mechanisms of 
action that are not directly toxic to the target pest.
    EPA proposes that producers would assess whether they meet the 
criteria presented in the proposed regulatory text. Proving eligibility 
would rest with the producer claiming the exemption and the producer 
could meet this responsibility by producing documentation of their 
determination should a question arise concerning their claim for 
exemption. If the producer's assessment is incorrect and the plant-
pesticide does not qualify for the exemption, anyone selling or 
distributing the plant-pesticide would be subject to enforcement 
actions for selling or distributing an unregistered pesticide. 
Producers would be encouraged to consult with the Agency with regard to 
specific cases.
    EPA is also considering whether to extend this exemption to include 
substances such as plant hormones because they act by ``primarily 
affecting the plant'' and do not act directly on a target pest (see 
Unit VII.B. of this preamble and the proposed statement of policy 
published elsewhere in today's issue of the Federal Register entitled 
``Proposed Policy; Plant-pesticides Subject to the Federal Insecticide, 
Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic 
Act'').

C. Exemption of Coat Proteins from Plant Viruses

    Coat proteins are those substances that encapsulate and protect the 
genetic material of certain viruses. In some cases, when the genetic 
material encoding for the coat protein is introduced into a plant's 
genome, the plant is able to resist subsequent infections by the same 
virus or related strains (termed viral coat protein mediated resistance 
or vcp-mediated resistance). The Agency is proposing to exempt the 
genetic material encoding for the coat protein and the coat protein 
itself when these are introduced into a plant to effectuate viral coat 
protein mediated resistance.
    The Agency's proposal is based on a number of considerations which, 
when taken together, bring EPA to the conclusion that coat proteins 
used in vcp-mediated resistance pose low probability of risk and would 
not cause unreasonable adverse effects. These considerations include 
the low potential for adverse affects to nontarget organisms and the 
potential benefits (environmental and economic) of utilizing vcp-
mediated resistance.
    To promote the fullest discussion of the issue possible, however, 
the Agency is also offering for discussion an alternative, more limited 
exemption. The two options are described below followed by an analysis 
of the options in Unit V.C.3. of this document.
    1. Option 1: Exemption of all coat proteins from plant viruses. 
Under EPA's preferred option, all coat proteins from plant viruses 
(vcp-mediated resistance coat protein) and the genetic material 
encoding for the coat protein would be exempt from FIFRA requirements 
when produced in plants for viral coat protein mediated resistance. 
This exemption would include the regulatory regions and noncoding, 
nonexpressed sequences needed to introduce the genetic material 
encoding for the viral coat protein into the plant. This exemption is 
embodied in the proposed regulatory text.
    2. Option 2: Exemption of coat proteins from plant viruses produced 
in plants with low potential for outcrossing to wild relatives. Under 
this exemption, the Agency would limit its exemption of vcp-mediated 
resistance coat proteins to those viral coat protein/plant combinations 
that would have the least potential to confer selective advantage on 
free-living wild relatives. The regulatory language defining these 
viral coat protein/plant combinations would be as follows:

    The pesticidal substance is a coat protein from a plant virus 
and the genetic material necessary to produce the coat protein has 
been introduced into a plant's genome, and the plant has at least 
one of the following characteristics:
    (1) The plant has no wild relatives in the United States with 
which it can successfully exchange genetic material, i.e., corn, 
tomato, potato, soybean, or any other plant species that EPA has 
determined has no sexually compatible wild relatives in the United 
States.
    (2) It has been demonstrated to EPA that the plant is incapable 
of successful genetic exchange with any existing wild relatives 
(e.g., through male sterility, self-pollination).
    (3) If the plant can successfully exchange genetic material with 
wild relatives, it has been empirically demonstrated to EPA that 
existing wild relatives are resistant or tolerant to the virus from 
which the coat protein is derived or that no selective pressure is 
exerted by the virus in natural populations.

    For the purposes of this option, ``introduced into the plant's 
genome'' would mean movement of nucleotide sequences into the genetic 
material in a plant cell's nucleus, mitochondria, chloroplasts, and any 
other plastids. ``Successfully exchange genetic material'' would mean 
capable of forming zygotes viable in the laboratory and/or field 
through the fusion of two gametes.
    Under this option, if a plant is not on the list of plants with no 
wild relatives in criterion (1), a producer would be required to submit 
a written request for a determination by EPA as to whether their viral 
coat protein/plant combination meets criterion (1), i.e., the Agency 
would have to determine that this particular plant species has no wild 
relatives in the United States. If criterion (1) could not be met, the 
producer would have to submit information to the Agency to show that 
criterion (2) is met or submit empirical evidence that criterion (3) is 
met.
    3. Analysis of options. The Agency's preferred option of exempting 
all vcp-mediated resistance coat proteins is based on the limited 
potential for adverse effects to nontarget organisms and/or new 
exposures to the coat protein and the potential environmental and 
economic benefits from using vcp-mediated resistance.
    Environmental benefits associated with the use of viral coat 
proteins include the reduction of the use of chemical pesticides for 
viruses that are spread by vectors (usually insects). Chemical 
pesticides are used for those crop plants where the most effective 
method of protection against viral attack is by controlling the vector. 
These pesticides may not be environmentally benign. The expression of 
viral coat proteins by plants for protection from viral infection would 
likely reduce the amount of chemical pesticide used to control the 
vectors.
    In addition to environmental benefits associated with the use of 
viral coat proteins, an effective method for controlling virus 
infection will have economic benefits. Plant viruses create economic 
losses for a vast variety of crops by reducing yields and negatively 
affecting the quality of the crop. Yield losses and quality effects for 
a specific crop may vary depending on the host plant and strains of the 
virus present, the incidence and activity of vectors, timing of the 
infection, health and nutritional state of the plant, and weather (Ref. 
5).
    Presently, growers may need to use several control methods during a 
crop season in an attempt to prevent viral infection and dissemination, 
primarily by planting virus free material (for mechanically transmitted 
viruses) and by controlling plant virus vectors, such as insect 
populations (for vector transmitted viruses). Insecticides, 
nematicides, and fungicides are all used for vector control with 
varying success, depending upon the virus/vector relationship and 
vector efficiency. Plants developed through conventional breeding 
techniques offer some degree of virus resistance. Such resistance may 
not be uniform or the virus may develop new strains. However, breeding 
for resistance has not been successful for the majority of field crops 
and, in particular, vegetable crops that are severely affected by 
viruses (Ref. 6).
    In enabling plants to resist viral attack, viral coat proteins act 
in a very specific fashion, apparently adversely affecting only viruses 
by blocking or limiting their ability to infect, replicate, and/or 
translocate within the plant. This specificity minimizes the potential 
for viral coat proteins produced in plants to adversely affect nonviral 
organisms. In addition, plants in nature and in the agro-ecosystem 
frequently exhibit viral infections; nontarget organisms, including 
humans, have been and continue to be exposed to the viral coat proteins 
with no observed adverse effects.
    The possibility that environmental risk might be associated with 
the use of vcp-mediated resistance was discussed at the December 18, 
1992 FIFRA Scientific Advisory Panel (SAP) Subpanel meeting (see Unit 
VI. of this preamble for a more thorough discussion of the issues 
discussed by EPA's science advisory committees). EPA agrees with the 
conclusions of the SAP Subpanel and in developing its proposal has 
utilized the advice of the Subpanel to supplement EPA's own evaluation 
of the scientific literature (Ref. 2). The considerations discussed by 
the Subpanel included: (1) The potential for new viruses to be formed 
through transcapsidation (also called heterologous encapsidation) and 
recombination, (2) the potential for synergistic infections, (3) the 
potential for seed transmission, and (4) the potential for the 
development of selective advantage in wild relatives through successful 
hybridization with the plant producing the viral coat protein. The SAP 
Subpanel report offered advice on these potential risk considerations 
and this advice is incorporated into the discussion below.
    Most plant viruses are composed of genetic material enclosed in a 
protein coat. For these viruses, the coat protein is the site of 
interaction with the host plant at several stages of the viral cycle 
(e.g., virus replication and movement within the plant). The coat 
protein also plays an essential role in transmission by vectors such as 
insects.
    The issue of transcapsidation revolves around the question: if a 
plant that produces a vcp-mediated resistance viral coat protein from 
Virus A is infected by Virus B, can the Virus B genome be encapsidated 
by the Virus A derived vcp-mediated resistance coat protein synthesized 
by the plant? The consequence of such transcapsidation is the possible 
extension of the host range of the virus through the possible 
transmission of the Virus B genetic material by vectors that would not 
normally transmit Virus B and possible infection of plants that would 
not normally be exposed to and/or infected by virus B.
    Heterologous encapsidation or transencapsidation has been observed 
both in vitro and in vivo between coinfecting whole viruses. However, 
transencapsidation between coinfecting viruses occurs more frequently 
between related viruses than unrelated viruses. Although some 
researchers have examined this question, there is no evidence that 
transencapsidation involving vcp-mediated resistance coat proteins 
produced in plants would occur at a higher frequency than has been 
observed with coinfecting whole viruses.
    With regard to transencapsidation involving vcp-mediated resistance 
coat proteins and horizontal transmission, the SAP Subpanel concluded 
that transencapsidation and transmission to other plants would most 
likely occur at low levels or would not occur, depending on: (1) The 
level of vcp-mediated resistance coat protein being produced by the 
plant (larger concentrations of vcp-mediated resistance coat protein 
would increase the probability of transcapsidation); (2) the efficiency 
of transencapsidation (this varies for transencapsidation of whole 
viruses); and (3) the efficiency of virus acquisition by the virus 
vector. For viruses in which a specific protein-RNA-helper factor 
complex is essential for transencapsidation or transmission to occur, 
transmission is virtually impossible.
    With regard to the potential for recombination between the plant-
encoded coat protein and coat protein from an infecting virus different 
from the virus contributing the coat protein gene, the consequence of 
such recombination is the potential for the formation of a new virus. 
The December 18, 1992, SAP Subpanel concluded that recombination is not 
a risk consideration meriting regulatory oversight. Most recombination 
events demonstrated to date involve either a debilitated virus under 
strong selection pressure for restoration of the wildtype virus, or the 
exchange of terminal regulatory sequences. In both conditions, 
recombination was only demonstrated between very similar or identical 
viruses. New viruses are thus unlikely to arise through a 
recombinational event involving substitution of the vcp-mediated 
resistance coat protein genetic material for the coat protein genetic 
material of the infecting virus. Should variants of a virus arise 
through recombination, these variants would be subject to selection/
competitive pressures throughout the infection cycle as are variants 
that arise from recombination between replicating viruses. In addition, 
there is no evidence that recombination between plant-produced coat 
proteins and an infecting virus would occur at greater frequencies than 
currently occur in nature between replicating viruses.
    Synergistic-infection occurs when two viruses infect the same 
plant, causing more severe damage than would occur if either virus 
alone infected the plant. With regard to the potential for synergistic-
infection, the SAP Subpanel stated that plants expressing Virus A vcp-
mediated resistance coat proteins do not express a synergistic response 
when the plant is inoculated with Virus B that potentially could act 
synergistically with Virus A, either because coat proteins are not 
involved in synergy, or because the level of expression of the protein 
is too low to potentiate the interaction.
    In some species of plants, infecting viruses can be transmitted 
vertically to progeny plants through seed. The question posed with vcp-
mediated coat proteins is whether their presence in the plant might 
affect seed transmission of infecting viruses. With regard to the 
possibility of coat protein modifications affecting the ability of seed 
to transmit viruses, the SAP Subpanel report states that in two cases 
where the viral genetics of seed transmission of viruses has been 
analyzed, genes other than those encoding the coat protein genes are 
involved in potentiating the transmission. There is no reason a priori 
to believe that introduction into the plant of viral coat protein genes 
would affect the level of vertical transmission of viruses through 
seed.
    The possibility that transfer of the vcp-mediated resistance coat 
protein gene to a wild relative of the modified crop plant might bestow 
a selective advantage on the wild relative has also been examined by 
the SAP Subpanel and the Agency. The SAP Subpanel report indicates that 
even if the low probability events of transfer and expression of the 
coat protein gene from crop plant to wild relative occur, the wild 
plant may not acquire a selective advantage. The Subpanel report noted, 
however, that while the series of events that must occur for the wild 
plant to acquire a selective advantage is rather improbable, such a 
series of events is not impossible.
    To address this possibility, the Agency is offering an alternative 
option that is a more limited exemption of vcp-mediated resistance coat 
proteins. For this alternative option, the Agency has defined a set of 
criteria and a process that would be used to identify those viral coat 
protein/plant combinations that have the greatest potential to outcross 
to wild, free-living relatives and thus have the possibility to endow 
these wild relatives with a competitive advantage. Viral coat proteins 
that potentially could be outcrossed would be subject to regulation. 
Those viral coat protein/plant combinations with a lesser or no 
probability of outcrossing and thus having a lesser or no probability 
of resulting in selective advantage would be exempt from regulation. An 
example of the latter situation would occur when a plant has no wild 
relatives in the United States or, if it has such relatives, cannot 
exchange genetic material with any of them. Under such circumstances, 
there is no opportunity for selective advantage through acquisition of 
the gene encoding the viral coat protein to occur in the wild relative 
since successful genetic exchange would not occur.
    It should be noted that neither of the exemptions described by 
Option 1 nor Option 2 for viral coat proteins extends to other methods 
used to create viral resistance in plants, such as the introduction of 
the gene encoding for RNA replicase or the introduction of genes 
encoding for satellite RNA (supernumary RNA with essentially no 
sequence similarity with the host virus) into plants. EPA does not 
believe it should exempt satellite RNA since single nucleotide base 
changes have been shown to significantly alter the characteristics of 
satellite RNAs including turning a nonnecrogenic satellite into a 
necrogenic satellite. At this point, the Agency is only proposing an 
exemption for vcp-mediated resistance coat proteins from plant viruses.
    EPA prefers Option 1 for a number of reasons. EPA believes that the 
use of vcp-mediated resistance represents little potential for 
adversely affecting nontarget organisms and has a low potential for 
other environmental risks even in the absence of any regulatory 
oversight under FIFRA. In addition, vcp-mediated resistance is 
associated with potential environmental benefits such as decreased use 
of chemical pesticides and economic benefits to farmers and society 
because it represents a means of controlling losses to viral disease in 
the absence of effective alternative methods to control viral 
infection. Option 1 represents a clearer regulatory line than Option 2 
in terms of which plant-pesticides will be regulated under FIFRA. 
Option 1 is more consistent with the approach taken for plant-
pesticides under FFDCA. Option 1 allows the Agency to focus on plant-
pesticides posing higher potential risks. In addition, under the Plant 
Pest Act, USDA/APHIS addresses the potential for selective advantage 
among wild plants in its review of plants genetically engineered to 
produce viral coat proteins.
    At the January 21, 1994 joint SAP/Biotechnology Science Advisory 
Committee (BSAC) meeting (see Unit VI of this preamble), the 
alternative option (Option 2) for the exemption of viral coat proteins 
was discussed. The joint Subpanel agreed that Option 2 created a 
process to address the possibility of selective advantage being 
acquired by a wild relative through outcrossing of the vcp-mediated 
resistance coat protein gene from the modified crop plant. However, the 
joint Subpanel did not believe that there was a high enough level of 
concern to warrant the inclusion of this option.
    The report of the January 21, 1994 meeting summarizes that: (1) 
Wild relatives are not found growing near many of the important crop 
plants grown in the United States; (2) criteria 2 and 3 of the 
alternative option address extremely rare situations, the existence of 
which would be very difficult to completely disprove; (3) the potential 
for increasing the ability of wild relatives to resist viral infection 
is likely to be beneficial because it could lead to a reduction of the 
reservoir for plant viruses; and (4) the use of vcp-mediated resistance 
is more ``environmentally friendly'' than the application of chemical 
pesticides to control virus vectors.
    The Agency's preferred option would be to completely exempt vcp-
mediated coat proteins from FIFRA regulation. Because of the potential 
benefits and the low probability of risks from the use of vcp-mediated 
resistance coat proteins in plants, EPA believes they warrant exemption 
under FIFRA 25(b) as being ``of a character that is not necessary to be 
subject to the Act.'' In addition, USDA/APHIS's review of field testing 
of plants genetically engineered to produce vcp-mediated resistance 
proteins addresses the possibility that the use of vcp-mediated coat 
proteins may create some potential for a selective advantage to be 
acquired by wild plants as well as the possibility of creating new 
viruses through recombination and/or transencapsidation.
    EPA is aware that, in addition to viral coat proteins, there are 
viral components such as viral movement proteins and viral replicase 
that are being tested for virus resistance strategies in plants. Many 
of the risk issues considered by EPA for viral coat proteins may be 
similar to those most likely to be addressed when examining the risks 
that could potentially be associated with the use of other viral 
components. USDA/APHIS's review of plants genetically engineered to 
produce viral coat proteins addresses such potential risks. EPA is 
committed to minimizing duplicative review of products between Federal 
agencies and is also committed to developing an appropriate regulatory 
approach for biologically-based pesticides in general, potentially 
including pesticides based on viral components produced in plants. EPA 
would tailor its regulatory procedures according to the biological 
characteristics of these products. These procedures could, for example, 
include expedited procedures for registration, the development of 
performance-based criteria for exemptions, and specific product 
exemptions. For example, the exemption of plant-pesticides that 
``primarily affect the plant'' could be extended in the future, through 
the inclusion of an additional criterion, to include viral components 
that are used in viral resistance strategies in plants when they affect 
the plant so that the viral pest cannot invade the plant.

VI. External Review

    In developing its approach to regulating plant-pesticides, EPA has 
requested the advice of two scientific advisory committees at three 
meetings. On December 19, 1992, pursuant to section 25 of FIFRA, a 
Subpanel of the FIFRA SAP was convened to review a draft policy 
statement on plant-pesticides and respond to a series of scientific 
questions posed by the Agency primarily on EPA's approach under FIFRA. 
On July 13, 1993, a Subcommittee of the EPA BSAC was convened to 
address a series of scientific questions primarily on EPA's approach 
under FFDCA. On January 21, 1994, a joint meeting of a SAP/BSAC 
Subpanel on plant-pesticides was held. The issues raised at these 
meetings are discussed below, together with the Agency's response. 
(Full reports from these meetings are available in the public docket.)

A. Substances New to the Plant

    Questions on how best to describe ``substances that are new to the 
plant'' were posed at all three science advisory meetings. At its 
December 1992 meeting, the FIFRA SAP Subpanel was asked whether the 
taxonomic demarcation of ``genus'' was appropriate, or whether some 
other demarcation would be more appropriate. The Subpanel expressed 
concern over an exemption based on a taxonomic definition and suggested 
the Agency evaluate a series of considerations involving the potential 
for quantitative and qualitative differences in exposure to a plant-
pesticide.
    The SAP Subpanel suggested that the Agency would ``need to create a 
workable balance between effective regulatory oversight and 
encouragement of the development of plant-produced pesticides.''
    At its July 13, 1993 meeting, the BSAC Subcommittee addressed a 
related issue with regard to the regulation of plant-pesticides under 
the FFDCA and human dietary exposures to plant pesticides.
    Included in questions to the Subcommittee were queries on the 
availability of information on current levels of exposure in the diet 
to plant-pesticides in raw agricultural commodities and on which plant-
pesticides might be of concern should their levels be significantly 
increased.
    The BSAC Subcommittee in their report stated that no formal, 
complete data base for such information exists. Rather most of this 
knowledge is part of breeders' experience, with breeders depending 
primarily on familiarity with food crops (e.g., knowledge of which crop 
plants have the ability to produce which toxicants) to ensure consumers 
are not exposed to deleterious levels of such substances. In general, 
little information exists on the range of levels of plant-pesticides in 
plants, including ranges within the most studied grouping, food plants. 
The mechanisms through which plants display resistance to pests, 
moreover, have not been well worked out. Based on experience, however, 
the BSAC Subcommittee suggested EPA consider a scheme based on sexual 
compatibility to identify those groupings wherein plant-pesticides 
might present new and novel dietary exposures and those that would not.
    The use of sexual compatibility and/or taxonomy as a standard for 
the potential for significantly different environmental exposures was 
discussed at the January 21, 1994, joint SAP/BSAC Subpanel meeting. The 
panel members were supplied with the reports of the previous meetings 
and drafts of proposals analyzing the strengths and weaknesses of 
approaches based on sexual compatibility and/or taxonomy. In response 
to the question of whether plants in a sexually compatible population 
are likely to share substances or traits, the joint Subpanel agreed 
that sexually compatible plants are more likely to have a common 
constitution than unrelated plants and thus movement of genetic 
material between sexually compatible plants is less likely to lead to 
novel exposures. Natural hybridization and selection have produced 
groups of plants which have a common gene pool. Generations of 
artificial hybridization to produce improved cultivated plants have 
tended to increase the extent of relatedness among elements of a 
broader segment of the natural diversity. In addition, modern 
techniques of genetic mapping have revealed the presence of genetic 
loci in cultivated plants that previously were considered to be present 
only in the wild species.
    In regard to the correlation of the concept of ``genus'' with 
significantly different environmental exposures, the panel noted that 
the taxonomic classification of a genus and the measure of sexual 
compatibility are closely interrelated. Sexual compatibility tends to 
promote genetic interchange and this interchange leads to populations 
of plants more like each other than like groups that have been sexually 
isolated. Because plants in the same genus likely have common ancestors 
that at some period in their evolution were sexually compatible, plants 
in the same genus are more apt to be sexually compatible with each 
other than with plants from other genera. Some barriers to sexual 
compatibility exist between species in the same genus even though the 
species are similar taxonomically. However, many of these sexual 
barriers can be overcome through the use of wide cross techniques by 
breeders.
    The report of the January 21, 1994, joint SAP/BSAC Subpanel 
meeting, indicates that the joint Subpanel agrees that basing an 
exemption on both the concept of sexual compatibility and the concept 
of taxonomy should restrict the occurrence of significantly different 
exposures and finds that Option 3 is a reasonable approach for 
agricultural plants. However, the joint Subpanel questioned whether an 
assumption of low probability of novel exposures can be extended to 
wild or semi-wild plants. For these types of plants, the genus standard 
``in particular,'' may result in the exemption from regulation of 
plant-pesticides that may present novel exposures.
    The Agency also included a question, at the January 21, 1994, joint 
BSAC/SAP meeting, concerning an approach using a criterion based on the 
process used to modify the plant, e.g., recombinant DNA methodologies. 
As described in the report of the joint BSAC/SAP Subpanel meeting, if 
the Agency were to use this approach, it would first exempt plant-
pesticides developed through techniques other than those of modern 
biotechnology from its regulatory scope. For those plant-pesticides 
that are not exempted because they were developed through techniques of 
modern biotechnology, the exemptions proposed by the Agency would apply 
(i.e., the exemption based on plants' relatedness and the exemption of 
plant-pesticides that act by ``primarily affecting the plant''; see 
Units V.A. and V.B. of this preamble).
    The joint Subpanel supported the inclusion of an option using a 
criterion based on methodologies such as rDNA as a rational approach to 
making the first cut as to which plant-pesticides would be regulated. 
However, the joint Subpanel cautioned that further exemptions such as 
those proposed by EPA should be used in conjunction with the criterion 
based on methodology. In addition, the joint Subpanel recommended that 
the Agency define methodologies in a way that clearly delineates to the 
scientific community and the public what is and is not included in the 
regulatory scope, based on current state-of-the science.
    EPA Response: The Agency has chosen to propose to use under both 
statutes, an approach based on sexual compatibility. First, this 
approach would exempt under both FIFRA and FFDCA, plant-pesticides 
having a high probability of being derived from plants having high 
numbers of genes in common. Under such circumstances, the likelihood of 
new or novel exposures both to the environment and in terms of human 
consumption is low.
    Second, use of the standard of sexual compatibility is the 
preferred option under both FIFRA and FFDCA and would allow EPA to use 
its authorities under FIFRA and FFDCA in concert to regulate plant-
pesticides, and thus to utilize, to the extent possible in light of the 
different statutory standards, similar approaches to oversight under 
each of the two statutes.
    Third, the Agency believes that its proposed approach would be 
consistent with the December 1992 SAP Supbanel's concern that EPA ``. . 
. create a workable balance between effective regulatory oversight and 
encouragement of the development of plant-produced pesticides.'' Under 
the preferred approach, novel exposures are not likely to occur with 
plant-pesticides exchanged between plants that are sexually compatible 
(See also Unit V. of this preamble for additional discussion).
    With regard to the advice of the January 21, 1994, joint SAP/BSAC 
Subpanel concerning the use of a process-based criterion in the scope, 
if the Agency were to use this approach, plant-pesticides developed 
through techniques other than those involving in vitro manipulation of 
genetic material would be exempt. In order to meet the recommendations 
of the joint Subpanel, the Agency would define this category of plant-
pesticides in the following way: The genetic material that encodes for 
the pesticidal substance or leads to the production of the pesticidal 
substance is extracted from an organism and introduced into the genome 
of the recipient plant or is synthesized in vitro and introduced into 
the genome of the recipient plant. The exemptions proposed by the 
Agency in Unit V. of this preamble would be used in concert with this 
criterion. The Agency believes this approach would meet the 
recommendations of the SAP/BSAC joint Subpanel. The Agency is 
soliciting comment on this approach (see Unit VII.A. of this preamble).

B. Plant-pesticides That Act Primarily by Affecting the Plant

    The SAP Subpanel at its December 1992 meeting considered whether 
EPA's language clearly and sufficiently identified plant resistance 
mechanisms that do not involve substances whose mode of action produces 
a direct toxic effect on the pest. The SAP Subpanel stated that for the 
most part the language EPA was proposing was clear and appropriately 
identified plant resistance mechanisms whose mode of action was not 
directly toxic. The Subpanel noted, however, that the issue of 
resistance to toxins produced by the pests was not addressed by that 
language. The Subpanel recommended insertion of the following statement 
into EPA's proposed language: ``Acts in the host plant to produce 
target(s) of the toxin that are resistant to the toxin's deleterious 
action.''
    EPA Response: EPA accepted this recommendation and modified the 
language of its approach to incorporate the issue of resistance to 
toxins.

C. Viral Coat Proteins

    The December 18, 1992, SAP Subpanel meeting and the January 21, 
1994, joint SAP/BSAC Subpanel meeting addressed the use of viral coat 
protein genes to modify plants to protect the plant from damage from 
viral infection. In the discussion at the December 18, 1992, SAP 
Subpanel meeting, several risk considerations were identified and the 
probability of occurrence of each addressed in the SAP Subpanel report. 
The SAP Subpanel report stated that the probability of occurrence of 
the risks examined is very low. The January 21, 1994, joint SAP/BSAC 
Subpanel meeting discussed the alternative option for the exemption of 
viral coat proteins from FIFRA regulation. The joint Subpanel did not 
believe that the potential risks associated with the use of vcp-
mediated resistance coat proteins warranted inclusion of the 
alternative option. Unit IV.C.3. of this document describes how the SAP 
and joint SAP/BSAC discussion of vcp-mediated resistance viral coat 
proteins supplements and influences EPA's analysis.
    EPA Response: EPA agrees that the probability of risks from the 
introduction of viral coat protein genes into plant genomes is low, and 
as its preferred option proposes to exempt these plant-pesticides from 
FIFRA oversight. Because of public comments received at the December 
18, 1992, SAP Subpanel meeting and the January 21, 1994, joint SAP/BSAC 
meeting, however, concerning viral coat protein and selective advantage 
to wild relatives of managed plants, EPA is offering for comment in 
this proposal the alternative approach to viral coat proteins to allow 
the fullest discussion possible.

D. U.S. Congress and U.S. Department of Agriculture

    In accordance with FIFRA section 25, a draft of this proposed 
regulation and a draft of the statement of policy published elsewhere 
in today's issue of the Federal Register entitled ``Proposed Policy; 
Plant-pesticides Subject to the Federal Insecticide, Fungicide, and 
Rodenticide Act and the Federal Food, Drug, and Cosmetic Act'' 
(proposed policy statement) was submitted in June 1994, to the U.S. 
Congress and USDA. USDA provided written comments on these two drafts 
on August 18, 1994. These comments are discussed below together with 
EPA's response.
    1. USDA suggests that the exemption EPA is proposing under FIFRA 
for viral coat proteins should be extended to include all plant viral 
proteins used in viral resistance strategies and the viral genetic 
sequences that encode them (including antisense constructs).
    EPA response: While EPA does not believe that, at this time, it can 
exempt all viral components from regulation under FIFRA it has 
requested comment on such an exemption. EPA is committed to minimizing 
duplicative review and would develop a coordinated approach with USDA 
for viral-based products other than viral coat proteins. As the 
experience base grows for these products, the two agencies can develop 
a regulatory course that is mutually acceptable. These procedures 
could, for example, include expedited procedures for registration, the 
development of performance-based criteria for exemptions, and specific 
product exemptions.
    2. USDA suggested that ambiguity exists in the use of the term 
``user'' in the discussion on informational labeling for plant-
pesticides in the proposed policy statement.
    EPA Response: EPA agrees that this discussion in the proposed 
policy statement may be ambiguous and proposes to replace the term 
``user'' with the term ``farmer and grower.''
    3. USDA noted that EPA's exemption based on the premise that plant-
pesticides derived from sexually compatible plants would not result in 
new environmental exposures does not take into account that similar or 
equivalent genes can be found in plants that are not sexually 
compatible.
    EPA's Response: EPA recognizes that plant defense compounds found 
in plants that are not sexually compatible, or in other organisms such 
as microorganisms, can be structurally and functionally equivalent to 
compounds found in the recipient plant or in a plant sexually 
compatible with the recipient plant. The Agency is willing to consider 
development of procedures and criteria for these plant-pesticides. A 
discussion of these procedures and criteria can be found in the Request 
for Comment unit, Unit VII., of this preamble.
    4. Although not included in USDA's written comments, USDA 
suggested, in a discussion at an August 18, 1994 meeting between USDA 
and EPA representatives, some clarifications in the discussion on plant 
regulators and plant hormones in the proposed policy statement. USDA 
indicated that there was some ambiguity as to how EPA would regulate 
plant hormones under FIFRA.
    EPA Response: EPA agrees that the plant regulator discussion may 
lead to some confusion as to how EPA would regulate plant hormones. EPA 
has agreed to include a discussion in the section on plant regulators 
in the proposed policy statement that would more fully describe the 
status of these plant-pesticides in relation to the proposed exemption 
of plant-pesticides derived from sexually compatible plants or under 
the proposed exemption of plant-pesticides that ``. . .primarily affect 
the plant. . .'' (see Unit IV.D.in the proposal published elsewhere in 
today's issue of the Federal Register entitled ``Plant-pesticides 
Subject to the Federal Insecticide, Fungicide, and Rodenticide Act; 
Proposed Rule'').

VII. Request for Comment

    The Agency requests comments on the proposed exemptions of plant-
pesticides under FIFRA.

A. Exemption of Plant-pesticides Derived from Closely Related Plants

    1. Three options. EPA requests comment on whether the Agency has 
appropriately identified in this proposed exemption (see Unit V.A. of 
this preamble) those plant-pesticides that are not likely to result in 
significantly different environmental exposures. EPA requests comment 
on its three options, specifically as to whether the options 
appropriately identify plant-pesticides that would not result in 
significantly different exposures to nontarget organisms and whether 
the language the Agency uses in the options clearly circumscribes the 
appropriate groupings. EPA requests comments on which option is most 
appropriate and why.
    2. Criterion based on process. With regard to an exemption 
criterion based on the process used to modify the plant, the Agency is 
soliciting comment on the joint BSAC/SAP Subpanel advice and the 
utility of an approach based on that advice (see Unit VI. of this 
preamble). EPA also requests comment on whether the group of plant-
pesticides that would be regulated under this approach would be 
equivalent to the group of plant-pesticides that would be regulated 
under Options 1, 2, or 3.
    3. Equivalent plant-pesticides. As described in Unit V.A.6. of this 
preamble, EPA is considering the development of procedures and criteria 
for how EPA can exempt a plant-pesticide if a producer can provide 
evidence that the plant-pesticide is structurally and functionally 
equivalent to a plant-pesticide found in a recipient plant or in a 
plant sexually compatible with the recipient plant. To effect such 
rulemaking, the Agency would need to meet statutory standards under 
FIFRA. In the instance of plant-pesticides, EPA would need, for 
example, to determine whether a plant-pesticide is indeed structurally 
and functionally equivalent to a plant-pesticide that has been 
exempted.
    Under such a rulemaking effort, a producer would provide 
information to the Agency showing that a plant-pesticide meets the 
standard for exemption under FIFRA. The Agency would respond, within a 
limited period of time, to the producer as to whether the plant-
pesticide meets that standard. The Agency envisions that producers 
would have a fairly high degree of latitude in types of specific data 
that could be used to demonstrate that a plant-pesticide meets the 
standard for exemption.
    The Agency is requesting comment on this framework for the 
exemption rulemakings. In particular, the Agency is soliciting comment 
and information on whether to incorporate specific data requirements/
methodologies into exemption criteria and on appropriate time-frames 
for the Agency determinations.
    The main challenge for EPA in engaging in such future rulemakings 
will be to develop criteria that can be used to create a standard for 
what constitutes equivalency. There are a number of different 
approaches that EPA believes it could utilize. The following discussion 
describes these approaches and some of the strengths and weaknesses of 
these options. The Agency requests comment on these approaches and 
solicits suggestions on additional factors that the Agency should weigh 
in the development of criteria for equivalency.
    In developing criteria for exempting a plant-pesticide from FIFRA, 
the first consideration for EPA is what parameters, in general, are 
good measurements for equivalency of function. The next consideration 
for the Agency in the development of criteria for creating exemptions 
is to examine these parameters in light of what is known concerning the 
characteristics of plant defense mechanisms.
    Turning first to the general parameters, some examples of the types 
of parameters that the Agency could use in developing criteria for 
proteinaceous substances are amino acid sequence homology, 
posttranslational processing, structure, stability, receptor/ligand 
specificity, and substrate specificity. For nonproteinaceous 
substances, equivalence in chemical composition and structure are 
additional examples of parameters that could be used as the basis for 
developing criteria.
    Any measures of equivalence that the Agency chooses to adopt should 
be applicable to particular plant-pesticides that may operate by a 
variety of mechanisms. The Agency requests comment on how evidence of 
structurally homology for proteinaceous defense compounds could be used 
in the future as reliable predictors of functional homology. Would it 
be more appropriate to develop an approach that does not rely soley on 
percent amino acid sequence homology but also incorporates the 
identification of conserved and variable amino acid sequences? For 
example, it is postulated that some disease resistance genes encode 
transmembrane receptors. Might sequences such as those involved in 
transmembrane interactions then be identified to provide additional 
assessment of equivalent function?
    A number of enzymes such as glucanase, chitinase, and proteinase 
inhibitors are also thought to be involved in plant defense responses. 
The question then arises as to whether a chitinase from, for example, 
tobacco or a microorganism is equivalent to a chitinase found in a 
plant sexually compatible with the recipient plant. As in the previous 
example, amino acid sequence homology could also assist in establishing 
equivalency for these enzymes. However, as with the previous example, 
the question of how much homology is sufficient remains. Would a better 
measurement be to use stability, substrate specificity, Km, and 
Vmax? Should these parameters be used in conjunction with 
homology?
    Nonproteinaceous compounds such as phenolics and phytoalexins are 
another class of plant defense compounds. For nonproteinaceous 
compounds structure/activity comparisons can be used to determine 
functional equivalence. For example, the presence of specific side 
chains could be used to establish equivalence. Other parameters such as 
stability could also be used. The question for the Agency is what 
amount/combinations of information would be necessary to use as a 
measure of equivalence..

B. Exemption of Plant-pesticides that Act Primarily by Affecting the 
Plant

    With regard to its exemption from FIFRA requirements of ``plant-
pesticides that act primarily by affecting the plant,'' EPA requests 
comment on whether this exemption appropriately focuses the Agency's 
regulatory attention on the plant-pesticides likely to present higher 
levels of hazard. The Agency also requests comment on whether the 
language defining this exemption is sufficiently clear and inclusive to 
identify plant-pesticides that act through nontoxic modes of action.
    The Agency is considering whether to extend this exemption to 
include substances such as plant hormones because they primarily affect 
the plant and do not have a directly toxic mechanism of action toward 
the target pest. The Agency is requesting comment as to whether it 
would be more appropriate to specifically exempt plant hormones as a 
category or to include in this exemption a performance-based criterion 
based on a description of the characteristics and/or mechanism of 
action of hormones (see Unit V.B. of this preamble).

C. Exemption of Coat Proteins from Plant Viruses

    EPA is also proposing to exempt from FIFRA regulation, coat 
proteins from plant viruses when the coat proteins are produced in 
plants. EPA has proposed two options for this exemption with Option 1 
presented in the proposed regulatory text. EPA is requesting comment on 
the appropriateness and clarity of the two options presented in this 
proposal. EPA is also requesting comment on: (1) The potential for the 
recipient crop plant producing the viral coat protein to become a weed; 
(2) the potential for increased competitive advantage of wild relatives 
in their native habitat after cross hybridization with a crop plant 
producing a viral coat protein; and (3) the potential for a viral coat 
protein gene to recombine with infecting viruses to extend host range 
or create new virus diseases.
    EPA is considering whether to propose in the future, an exemption 
of viral components, other than viral coat proteins, used in viral 
resistance strategies in plants. This exemption would include 
performance-based criteria that would be used by EPA to determine if a 
viral component would be exempt from regulation. EPA is requesting 
comment on whether such an exemption would be appropriate and is 
requesting comment on criteria that could be used to construct this 
exemption.

D. Substantiation of Claims for Confidential Information

    EPA requests comment on the proposed requirement (Sec. 174.9 of the 
regulatory text) that any claim of confidentiality must be 
substantiated at the time the claim is made. Specifically, EPA seeks 
comment on how to achieve the best balance between the burden on 
industry to provide substantiation before public disclosure becomes an 
active issue (e.g., in preparation for FIFRA Science Advisory Panel 
meetings) and the regulated community's desire to receive timely 
responses on submissions. This balance must take into consideration the 
needs of pesticide developers to protect information they believe to be 
critical to maintaining their competitiveness and the public's need for 
access to information related to potential environmental or human 
health effects early enough in the review process to provide informed 
comment before EPA makes a decision. EPA encourages the development of 
reduced risk pesticides and believes that, given the Agency's 
procedural requirements for CBI determinations, without up front 
substantiation, timely responses to subsmissions would be difficult 
when it becomes necessary to resolve the issue of CBI before a decision 
can be made.

VIII. Economic Analysis

    The regulatory impact analysis (RIA) evaluates the costs and 
benefits of amending EPA's regulations to allow for the regulation or 
exemption of specific types of plant-pesticides under FIFRA (40 CFR 
152.20 and 40 CFR part 174) and is intended to meet the requirements 
for a RIA as established by Executive Order No. 12866, the Regulatory 
Flexibility Act, and section 25 of FIFRA.
    The RIA presents the alternative regulatory options and the costs 
that were considered by the Agency including two options that were 
considered by the Agency but not included in this proposal. Four 
possible approaches to the regulation of plant-pesticides under FIFRA 
were evaluated in the RIA that allowed for varying degrees of 
regulatory coverage. RIA Option 1 is the most limited alternative in 
regulatory scope. RIA Option 2 represents EPA's proposed, and 
preferred, regulatory scope and is broader in coverage than RIA Option 
1. In addition to those plant-pesticides regulated under RIA Option 2, 
RIA Option 3's scope would include viral coat proteins used as plant-
pesticides. Finally, under RIA Option 4, all plant-pesticides, 
including those that result from traditional plant breeding, would be 
subject to the requirements of FIFRA. The costs of implementing the 
four options presented in Unit IV.A. of this preamble are comparable to 
each other and correspond to RIA Option 2. The costs for any of the 
four options presented in Unit IV.A. are substantially lower than RIA 
Option 4.
    Generally, costs will depend on whether the Agency exempts a plant-
pesticide or whether it requires a registration. The costs of 
regulating plant-pesticides are dependent upon the data needed for the 
registration of the particular types of plant-pesticides. Data needs 
are irrelevant for exempted plant-pesticides. For regulated plant-
pesticides, data needs will vary according to the gene product of the 
plant-pesticide and the recipient crop.
    Aggregate incremental compliance costs to the industry over a 10-
year period under regulatory (RIA) Option 1 are estimated to range from 
$53,700 in the first year of implementation to $2.6 million in the 10th 
year of implementation, with an average annual revenue requirement 
(ARR) of $1.2 million. Under EPA's proposed scope (RIA Option 2), 
aggregate incremental compliance costs are predicted to range from 
$53,700 in year 1 to $3.1 million in year 10, with an ARR of $1.6 
million. Aggregate incremental compliance costs for RIA Option 3 are 
estimated at nearly $741,100 in the first year of implementation and 
$5.1 million in the 10th year, with an ARR of $2.9 million. Finally, 
under RIA Option 4's broad regulatory scope, aggregate incremental 
compliance costs are projected to range from $76.6 million in year 1 to 
$81 million in year 10, with an ARR of $79 million.
    Costs were also estimated for the labor burden that would result 
from EPA staff preforming various activities associated with the 
registration of plant-pesticides. Some of these activities may include 
the establishment of the docket, internal reviews, requests for 
additional information, and consultations with applicants. The cost for 
the Agency to perform these activities under RIA Option 1 is estimated 
to range from nearly $40,000 in year 1 to approximately $259,000 in 
year 10. Under EPA's proposed regulatory scope, RIA Option 2, annual 
labor burden costs range from approximately $40,000 in the first year 
to $391,000 10 years after a final rule is promulgated. For RIA Option 
3, EPA costs are estimated to range between $123,000 in year 1 to 
$640,000 in year 10. Under the broad regulatory scope of RIA Option 4, 
EPA's labor costs are predicted to range between $14.7 million in year 
1 to $15.2 million in year 10. Labor burden cost estimates vary by 
year, due to the number and type of plant-pesticide submissions the 
Agency is predicted to receive.
    The aggregate cost to society of the proposed plant-pesticide 
regulation is the sum of the total costs to industry, plus the total 
costs to the Agency to implement the proposed rule. After calculating 
aggregate societal costs, they were discounted to allow for the time 
value of money and to determine a constant level annual cost. The 
annual societal revenue requirement over the 10-year period of analysis 
was estimated at nearly $1.4 million under RIA Option 1, $1.8 million 
under RIA Option 2, $3.3 million under RIA Option 3, and $93.7 million 
under RIA Option 4.
    Primarily affected by this proposed regulation will be those 
companies involved with agricultural biotechnology that have been 
identified as presently developing and testing plant-pesticides. While 
agricultural biotechnology is currently in its infancy with 1993 sales 
estimated at less than 2 percent of total biotechnology sales, future 
sales are forecasted to grow at an average annual rate of 33 percent to 
the year 2003. Firms developing biotechnology products are quite 
diverse and include large, multinational corporations, biotechnology 
companies (both large and very small), chemical companies, and seed 
companies. The impacts of EPA regulation of plant-pesticides to this 
growing market sector will not be all negative. Companies involved with 
agricultural biotechnology have asked for plant-pesticide regulations 
and they stand to benefit tremendously from this proposed regulation.
    The proposed rule will generate a wide range of benefits for the 
public, the firms involved with agricultural biotechnology, the 
environment, nontarget organisms, and states. Registrants of plant-
pesticides should benefit from the resolution of uncertainty regarding 
regulatory issues. With the promulgation of the proposed regulation, 
firms developing and testing plant-pesticides can plan ahead for timely 
product development and commercialization which should, in turn, 
attract investors to the agricultural biotechnology sector. The 
environment will benefit from safety measures that will protect against 
unintended environmental effects of accidental and deliberate releases 
of genetically engineered organisms. Nontarget organisms, including 
endangered species, will benefit from a registration process that will 
carefully consider the potential effects that certain plant-pesticides 
may have upon them. Finally, states will benefit by having a set of 
standardized Federal regulations that will be more easily conveyed, 
interpreted, and enforced. Many states may also benefit by not having 
to establish their own set of agricultural biotechnology regulations.
    Adverse economic impacts from the implementation of the proposed 
plant-pesticide regulation are not expected under EPA's proposed scope 
(RIA Option 2). Due to the lack of detailed financial information on 
those firms that are currently developing and testing plant-pesticides, 
the conclusion of ``no adverse economic impacts'' was based on public 
and proprietary information provided to EPA by industry financial 
advisory groups, biotechnology associations, university biotechnology 
specialists, and small biotechnology firms.

IX. Public Record

    EPA has established a public record for this rulemaking (docket 
control number OPP-300369). The record includes all information 
considered by EPA in developing this proposed rule. The record now 
includes the following items:
    1. Reports of all SAP and BSAC meeting pertaining to this proposed 
rule.
    2. Support documents and reports, including:
    (a) EPA issue paper. FIFRA: Benefit and environmental risk 
considerations for inherent plant-pesticides.
    (b) EPA issue paper. Issues associated with the regulation of viral 
coat proteins under FIFRA and FFDCA.
    3. Published literature that is cited in this document.
    4. The Regulatory Impact Analysis for this rule.
    5. Records of communications between EPA personnel and persons 
outside EPA pertaining to the development of this proposed rule. (This 
does not include any inter- or intra-agency memoranda, unless 
specifically noted in the Index of this docket.)

X. References

    (1) EPA issue paper. FIFRA: Benefit and environmental risk 
considerations for inherent plant-pesticides.
    (2) EPA issue paper. Issues associated with the regulation of viral 
coat proteins under FIFRA and FFDCA.
    (3) Klaasen, C.D., M.O. Amdur, and J.D. Doull. 1986. Casarett and 
Doull's Toxicology: The Basic Science of Poisons. Chapter 2. Third 
Edition. Macmillan Publishing Company, New York.
    (4) Lamb, C.J., J.A. Ryals, E.R. Ward, and R.A. Dixon. 1992. 
Emerging strategies for enhancing crop resistance to microbial 
pathogens. Bio/Technology. 10:1436-1445.
    (5) Matthews, R.E.F. 1981. Plant Virology. Chap. 17. Second 
edition, Academic Press, New York.
    (6) Tolin, S.A. 1991. Persistence, establishment, and mitigation of 
phytopathogenic viruses. In: Risk Assessment in Genetic Engineering. 
Edited by M.A. Levin and H.S. Strauss. McGraw Hill, Inc., New York. pp. 
140-161.

XI. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the proposed regulatory action is 
``significant'' and therefore subject to review by the Office of 
Management and Budget (OMB) and the requirements of the Executive 
Order. Under section 3(f), the Order defines a ``significant regulatory 
action'' as an action that is likely to result in a rule (1) Having an 
annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, or tribal governments or communities (also referred to as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising novel legal or policy issues arising 
out of legal mandates, the President's priorities, or the principles 
set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this proposed rule is a ``significant regulatory action'' because 
it raises novel policy issues arising out of FIFRA legal mandates. 
Thus, this proposal will be submitted to OMB for review, and any 
comments or changes made in response to OMB suggestions or 
recommendations, are documented in the public record.

B. Regulatory Flexibility Act

    This proposed rule was reviewed under the provisions of section 
3(a) Regulatory Flexibility Act (RFA) [5 U.S.C. 605(b)]. The RFA 
requires that agencies take special note of the impact of proposed 
regulations on small entities. Analysis requirements under the RFA can 
and should be combined with the analysis required under Executive Order 
12866.
    The regulatory flexibility analysis of this proposed regulation for 
plant-pesticides on small entities is demonstrated within the 
structuring of the four regulatory options proposed. These options were 
considered after extensive evaluations of the benefit/risk tradeoffs 
between option cost and risk reduction provided. The Agency has 
structured the resulting options from a narrow regulatory scope (RIA 
Option 1) to a broad regulatory scope (RIA Option 4) and, as such, has 
conducted an ``inherent'' sensitivity analysis for small firms likely 
to be affected by this proposed regulation. The Agency has determined 
that the tradeoffs between the benefits and risks of the proposed 
regulation are optimized under RIA Option 2, EPA's proposed scope.

C. Paperwork Reduction Act Paperwork Reduction Act

    The information collection requirements in this proposed rule have 
been submitted for approval to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An 
Information Collection Request document has been prepared by EPA (ICR 
No. 1693.01) and a copy may be obtained from Sandy Farmer, Information 
Policy Branch, (Mail Code 2136), Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460, or by calling (202) 260-2740.
    This collection of information has an estimated reporting burden 
averaging 1,143 hours per response and an estimated annual 
recordkeeping burden averaging 74 hours per respondent. These estimates 
include time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden to Chief, Information Policy Branch, (Mail Code 2136), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
and to the Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20503, marked ``Attention: Desk 
Officer for EPA.'' The final rule will respond to any OMB or public 
comments on the information collection requirements contained in this 
proposal.

List of Subjects in Parts 152 and 174

    Environmental protection, Biotechnology pesticides, Pesticides and 
pests, Plants, Plant-pesticides, Reporting and recordkeeping 
requirements.

    Dated: November 15, 1994.
Carol M. Browner,
Administrator.
    Therefore, it is proposed that 40 CFR Chapter I be amended as 
follows:

PART 152--[AMENDED]

    1. In part 152:
    a. The authority citation for part 152 would continue to read as 
follows:

    Authority: 7 U.S.C. 136-136y; subpart U is also issued under 31 
U.S.C. 9701.

    b. In Sec. 152.1, by designating existing text as introductory text 
and adding paragraphs (a) and (b) to read as follows:


Sec. 152.1  Scope.

    *  *  *  *  *
    (a) For procedures, requirements and criteria applicable to plant-
pesticides, refer to part 174 of this chapter.
    (b) [Reserved]
    c. In Sec. 152.3, by removing all alphabetic paragraph designations 
and alphabetically inserting the following definitions to read as 
follows:


Sec. 152.3  Definitions.

    *  *  *  *  *
    Genetic material necessary for the production means:
    (1) Genetic material that encodes for a pesticidal substance or 
leads to the production of a pesticidal substance.
    (2) Regulatory regions.
    It does not include noncoding, nonexpressed nucleotide sequences.
    *  *  *  *  *
    Living plant means a plant that is alive, including periods of 
dormancy, and all viable plant parts/organs involved in the plant's 
life cycle.
    *  *  *  *  *
    Noncoding, nonexpressed nucleotide sequences means the nucleotide 
sequences are not transcribed and are not involved in gene expression. 
Examples of noncoding, nonexpressed nucleotide sequences include 
linkers, adapters, homopolymers, and sequences of restriction enzyme 
recognition sites.
    *  *  *  *  *
    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.
    Regulatory region means genetic material that controls the 
expression of the genetic material that encodes for a pesticidal 
substance or leads to the production of a pesticidal substance. 
Examples of regulatory regions include promoters, enhancers, and 
terminators.
    *  *  *  *  *
    d. In Sec. 152.20, by revising paragraph (a)(1) and adding 
paragraph (a)(4) to read as follows:


Sec. 152.20   Exemptions for pesticides regulated by another Federal 
agency.

    *  *  *  *  *
    (a)  *  *  *  
    (1) Except as provided by paragraphs (a)(3) and (a)(4) of this 
section, all biological control agents are exempt from FIFRA 
requirements.
    *  *  *  *  *
    (4) All plants intended for use as biological control agents and 
any portion thereof, except plant-pesticides, are exempt from the 
requirements of FIFRA. Plant-pesticides are addressed in part 174, 
subpart A, of this chapter.
    *  *  *  *  *
    2. By adding part 174 to read as follows:

PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-PESTICIDES

Subpart A--General Provisions

Sec.

174.1    Scope and purpose.
174.3    Definitions.
174.5    Scope of coverage.
174.7    Submission of information regarding potential unreasonable 
adverse effects.
174.9    Confidential business information claims for plant-
pesticide submissions.
Subpart B--[Reserved]

    Authority: 7 U.S.C. 136-136y and 21 U.S.C. 346a and 371.

Subpart A--General Provisions


Sec. 174.1  Scope and purpose.

    Pesticidal substances produced in plants are pesticides as defined 
in FIFRA section 2. The characteristics of these pesticides such as 
their production and use in plants, their biological properties, and 
their ability to spread and increase in quantity in the environment 
distinguishes them from traditional, chemical pesticides. Therefore, 
plant-pesticides are subject to different regulatory requirements and 
procedures than traditional, chemical pesticides. This part 174 sets 
forth regulatory requirements, criteria, and procedures applicable to 
plant-pesticides under FIFRA and FFDCA. Unless otherwise provided by 
this part, the regulations in parts 152 through 173 and parts 177 
through 186 of this chapter, where applicable, apply to plant-
pesticides. EPA recognizes the unique nature of plant-pesticides 
necessitates flexibility in the application of regulations designed for 
traditional pesticides to plant-pesticides.


Sec. 174.3   Definitions.

    Terms used in this part have the same meaning as in FIFRA. In 
addition, the following terms have the meaning set forth in this 
section.
    Active ingredient, when referring to plant-pesticides only, 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.
    Administrator means the Administrator of the United States 
Environmental Protection Agency or his/her delegate.
    Biological control agent means any living organism applied to or 
introduced into the environment that is intended to function as a 
pesticide against another organism declared to be a pest by the 
Administrator.
    Bridging crosses between plants means the utilization of an 
intermediate plant in a cross to produce a viable zygote between the 
intermediate plant and a first plant, in order to cross the plant 
resulting from that zygote with a third plant that would not otherwise 
be able to produce viable zygotes from the fusion of its gametes with 
those of the first plant. The result of the bridging cross is the 
mixing of genetic material of the first and third plant through the 
formation of an intermediate zygote.
    EPA means the United States Environmental Protection Agency unless 
otherwise specified.
    FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
et seq.)
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide 
Act, as amended (7 U.S.C. 136-136y).
    Genetic material necessary for the production means:
    (1) Genetic material that encodes for a pesticidal substance or 
leads to the production of a pesticidal substance.
    (2) Regulatory regions.
    It does not include noncoding, nonexpressed nucleotide sequences.
    Genetic material that encodes for a pesticidal substance or leads 
to the production of a pesticidal substance does not include regulatory 
regions or noncoding, nonexpressed nucleotide sequences.
    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.
    Living plant means a plant that is alive, including periods of 
dormancy, and all viable plant parts/organs involved in the plant's 
life cycle.
    Noncoding, nonexpressed nucleotide sequences means the nucleotide 
sequences are not transcribed and are not involved in gene expression. 
Examples of noncoding, nonexpressed nucleotide sequences include 
linkers, adapters, homopolymers, and sequences of restriction enzyme 
recognition sites.
    Pesticide means any substance or mixture of substances intended for 
preventing, destroying, repelling, or mitigating any pest, or intended 
for use as a plant regulator, defoliant, or desiccant, other than any 
article that:
    (1) Is a new animal drug under FFDCA section 201 (w); or
    (2) Is an animal drug that has been determined by regulation of the 
Secretary of Health and Human Services not to be a new animal drug; or
    (3) Is an animal feed under FFDCA section 201(x) that bears or 
contains any substances described by Sec. 152.3(s)(1) or (2) of this 
chapter.
    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.
    Recipient plant means the plant into which the plant-pesticide is 
introduced and in which the plant-pesticide is produced.
    Regulatory region means genetic material that controls the 
expression of the genetic material that encodes for a pesticidal 
substance or leads to the production of a pesticidal substance. 
Examples of regulatory regions include promoters, enhancers, and 
terminators.
    Sexually compatible, when referring to plants, means capable of 
forming a viable zygote through the fusion of two gametes, including 
the use of bridging crosses or wide crosses between plants.
    Source means the donor of the genetic material that encodes for a 
pesticidal substance or leads to the production of a pesticidal 
substance.
    Wide crosses between plants means to facilitate the formation of 
viable zygotes through the use of surgical alteration of the plant 
pistil, bud pollination, mentor pollen, immunosuppressants, in vitro 
fertilization, pre- and post-pollination hormone treatments, 
manipulation of chromosome numbers, embryo culture, or ovary and ovule 
cultures or any other technique that the Administrator determines meets 
this definition.


Sec. 174.5   Scope of coverage.

    (a) Plant-pesticides not exempt from the requirements of FIFRA 
under paragraph (b) of this section are subject to the requirements of 
FIFRA.
    (b) All plant-pesticides (both the pesticidal substance and the 
genetic material necessary for its production) meeting at least one of 
the following criteria are exempt from the requirements of FIFRA:
    (1) The genetic material that encodes for a pesticidal substance or 
leads to the production of a pesticidal substance is derived from 
plants that are sexually compatible with the recipient plant and has 
never been derived from a source that is not sexually compatible with 
the recipient plant.
    (2) The pesticidal substance acts primarily by affecting the plant 
so that the target pest is inhibited from attaching to the plant, 
penetrating the plant, or invading the plant's tissue in at least one 
of the following ways:
    (i) The pesticidal substance acts as a structural barrier to 
attachment of the pest to the host plant, a structural barrier to 
penetration of the pest into the host plant, or a structural barrier to 
spread of the pest in the host plant, for example, through the 
production of wax or lignin, or length of trichomes (plant hairs).
    (ii) The pesticidal substance acts in the host plant to inactivate 
or resist toxins or other disease-causing substances produced by the 
target pest.
    (iii) The pesticidal substance acts by creating a deficiency of a 
plant nutrient or chemical component essential for pest growth on/in 
the host plant.
    (3) The pesticidal substance is a coat protein from a plant virus.


Sec. 174.7   Submission of information regarding potential unreasonable 
adverse effects.

    Any person who sells or distributes any plant-pesticide exempt 
under Sec. 174.5 who obtains any information regarding potential 
unreasonable adverse effects on human health or the environment must 
within 30 days of receipt of such information submit the information to 
EPA, unless the person has actual knowledge that EPA has been 
adequately informed of such information.

Sec. 174.9  Confidential business information claims for plant-
pesticide submissions.

    Although it is strongly recommended that the submitter minimize the 
amount of data and other information claimed as CBI, a submitter may 
assert a claim of confidentiality for all or part of the information 
submitted to EPA in a submission for a plant-pesticide. (See part 2, 
subpart B, of this chapter.) To assert such a claim, the submitter must 
comply with the following procedures:
    (a) Any claim of confidentiality must accompany the information at 
the time the information is submitted to EPA. Failure to assert a claim 
at that time will be considered a waiver of confidentiality for the 
information submitted, and the information may be made available to the 
public, subject to section 10(g) of FIFRA, with no further notice to 
the submitter.
    (b) Any claim of confidentiality must be accompanied, at the time 
the claim is made, by comments substantiating the claim and explaining 
why the submitter believes that the information should not be 
disclosed. The submitter should refer to Sec. 2.205(e)(4) of this 
chapter for points to address in the substantiation. If such comments 
are marked confidential when submitted to EPA, they will be treated as 
such in accordance with Sec. 2.205(c) of this chapter. EPA will 
consider incomplete all plant-pesticide submissions containing 
information claimed as CBI that are not accompanied by substantiation, 
and will suspend the review period of such submissions until the 
required substantiation is provided.

Subpart B--[Reserved]

[FR Doc. 94-28822 Filed 11-22-94; 8:45 am]
BILLING CODE 6560-50-F