[Federal Register: April 18, 2007 (Volume 72, Number 74)]
[Proposed Rules]
[Page 19589-19640]
[DOCID:fr18ap07-18]

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Part II

Environmental Protection Agency

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40 CFR Part 174

 Exemption Under the Federal Insecticide, Fungicide, and Rodenticide
Act for Certain Plant-Incorporated Protectants Derived From Plant Viral
Coat Protein (PVCP-PIPs) Gene(s); Supplemental Proposal; Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0642; FRL-8100-7]
RIN 2070-AD49

Exemption Under the Federal Insecticide, Fungicide, and
Rodenticide Act for Certain Plant-Incorporated Protectants Derived From
Plant Viral Coat Protein Gene(s) (PVCP-PIPs); Supplemental Proposal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to exempt from Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) requirements plant-incorporated
protectants derived from plant viral coat protein genes (PVCP-PIPs)
when the PVCP-PIP meets specified criteria. EPA is proposing this
exemption because the Agency believes that the PVCP-PIPs covered by
this exemption would be of a character which is unnecessary to be
subject to FIFRA in order to carry out the purposes of the Act.

DATES: Comments must be received on or before July 17, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0642, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0642. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Melissa Kramer, Hazard Assessment
Coordination and Policy Division (7202M), Office of Science
Coordination and Policy, 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001; telephone number:<PHONE_NUMBER>; fax number: (202) 564-
8502; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Notice Apply to Me?

    You may be potentially affected by this action if you are a person
or company involved with agricultural biotechnology that may develop
and market plant-incorporated protectants. Potentially affected
entities may include, but are not limited to:
     Pesticide and Other Agricultural Chemical Manufacturing
(NAICS code 32532), e.g., establishments primarily engaged in the
formulation and preparation of agricultural and household pest control
chemicals;
     Crop Production (NAICS code 111), e.g., establishments
primarily engaged in growing crops, plants, vines, or trees and their
seeds;
     Colleges, Universities, and Professional Schools (NAICS
code 611310), e.g., establishments of higher learning which are engaged
in development and marketing of virus-resistant plants;
     Research and Development in the Physical, Engineering, and
Life Sciences (NAICS code 54171), e.g., establishment primarily engaged
in conducting research in the physical, engineering, or life sciences,
such as agriculture and biotechnology.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR part 174. If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2006-0642. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.

    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Proposing?

    EPA is proposing an exemption from FIFRA for certain plant virus
coat protein plant-incorporated protectants or ``PVCP-PIPs.'' EPA is
proposing to define a PVCP-PIP as ``a plant-incorporated protectant
derived from one or more genes that encode a coat protein of a virus
that naturally infects plants. This includes plant-incorporated
protectants derived from one or more plant viral coat protein genes
that produce only RNA and no virus-related protein.'' PVCP-PIPs
introduced into plants with the intention of preventing or mitigating
viral disease meet the FIFRA section 2(u) definition of ``pesticide''
because they are introduced into plants with the intention of
``preventing, destroying, repelling, or mitigating any pest...'' (7
U.S.C. 136(u)) and plant viruses meet the FIFRA section 2 definition of
``pest'' (7 U.S.C. 136(t)). EPA is proposing this exemption because the
Agency believes that the PVCP-PIPs covered by this exemption would be
of a character which is unnecessary to be subject to FIFRA in order to
carry out the purposes of the Act.
    A PIP can be exempt from the requirements of FIFRA, other than the
adverse effects reporting requirements of 40 CFR 174.71, if it meets
all three of the requirements listed in 40 CFR 174.21. Section
174.21(a) requires that the PIP meet the criteria listed in at least
one of the sections in Sec. Sec.  174.25 through 174.50. Section
174.21(b) requires that when the PIP is intended to be produced and
used in a crop used as food, the residues of the PIP are either
exempted from the requirement of a tolerance under FFDCA or no
tolerance would otherwise be required for the PIP. Section 174.21(c)
requires that an exempt PIP must contain only those inert ingredient(s)
included on the list codified at Sec. Sec.  174.485 through 174.490.
(Reference to Sec. Sec.  174.485 through 174.490 in Sec.  174.21(c) is
proposed to be changed to refer to Sec. Sec.  174.485 through 174.486
in today's Proposed Rule.) See Unit II.F. for further discussion of
these Sec.  174.21 criteria.
    The rule proposed in today's Federal Register would establish 40
CFR 174.27, which would contain three criteria that, when met, would
allow PVCP-PIPs to meet the general requirement for exemption for all
PIPs listed at 40 CFR 174.21(a). Today's Federal Register also proposes
to add several substances known to be used as inert ingredients in PIPs
to 40 CFR part 174 subpart X, thereby potentially expanding the PVCP-
PIPs that could meet the conditions of Sec.  174.21(c). A companion
document published elsewhere in today's Federal Register also proposes
a tolerance exemption for certain PVCP-PIP residues, thereby
potentially expanding the PVCP-PIPs that could meet the conditions of
Sec.  174.21(b).
    The three criteria that EPA is proposing to insert at 40 CFR 174.27
are intended to address three issues that may be associated with a
PVCP-PIP. These issues are:
     The potential for increased weediness or invasiveness of
the crop plant containing the PVCP-PIP or any wild or weedy relatives
that could acquire the PVCP-PIP through gene flow thereby causing
negative effects on either the agro-ecosystem or natural environments.
This issue is addressed in proposed Sec.  174.27(a).
     The potential that viruses with novel properties could
develop through novel viral interactions. This issue is addressed in
proposed Sec.  174.27(b).
     The potential for human or nontarget organism exposure to
proteins that have not previously existed in nature and thus should be
examined to determine whether they have potentially toxic or allergenic
properties. This issue is addressed in proposed Sec.  174.27(c).
    In order to satisfy 40 CFR 174.21(a), a PVCP-PIP would have to
satisfy proposed Sec.  174.27(a), (b), and (c). The requirements at
Sec.  174.27(d) would also have to be met to qualify for exemption.
Proposed Sec.  174.27(a), (b), and (c) each can be met in one of two
ways: a product developer may self-determine that paragraph (1) of the
criterion applies (i.e., Sec.  174.27(a)(1), (b)(1), or (c)(1)) or the
Agency may determine that paragraph (2) of the criterion applies (i.e.,
Sec.  174.27(a)(2), (b)(2), or (c)(2), respectively). Paragraph (1) of
each proposed criterion (i.e., Sec.  174.27(a)(1), (b)(1), and (c)(1))
describes an objective, well-defined characteristic. Therefore, the
developer may determine whether the PVCP-PIP meets the requirement.
Paragraph (2) of each proposed criterion (i.e., Sec.  174.27(a)(2),
(b)(2), and (c)(2)) is conditioned on an Agency determination because
it may involve analysis of several types of information. Each criterion
may be satisfied either by self determination under paragraph (1) or
Agency determination under paragraph (2) irrespective of how the other
two criteria are satisfied; there is no requirement that all three
criteria must be satisfied under either paragraph (1) or paragraph (2)
in order to qualify for the exemption.

B. What is the Agency's Authority for Taking this Action?

    This rule is promulgated under the authority of FIFRA sections
3(a), 25(a), and 25(b) (7 U.S.C. 136a(a), 136w(a), and 136w(b)).
    FIFRA section 3(a) states that, except as provided by the Act, no
person may distribute or sell in the United States any pesticide that
is not registered under the Act (7 U.S.C. 136(a)). FIFRA section 2(u)
defines ``pesticide'' as: ``(1) any substance or mixture of substances
intended for preventing, destroying, repelling, or mitigating any pest,
(2) any substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant, and (3) any nitrogen
stabilizer...'' (7 U.S.C. 136(u)). Under FIFRA section 2(t), the term
``pest'' includes ``(1) any insect, rodent, nematode, fungus, weed, or
(2) any other form of terrestrial or aquatic plant or animal life or
virus, bacteria, or other microorganism... which the Administrator
declares to be a pest...'' subject to certain exceptions (7 U.S.C.
136(t)).
    Before EPA may register a pesticide under FIFRA, the applicant must
show that the pesticide ``when used in accordance with widespread and
commonly recognized practice... will not generally cause unreasonable
adversese effects on the environment'' (7 U.S.C. 136a(c)(5)(D)). The
term ``environment'' includes ``water, air, land, and all plants and
man and other

animals living therein, and the interrelationships which exist among
these'' (7 U.S.C. 136(j)). FIFRA section 2(bb) defines the term
``unreasonable adverse effects on the environment'' to mean: ``(1) any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 408 of the Federal Food, Drug, and Cosmetic
Act'' (7 U.S.C. 136(bb)).
    Although FIFRA requires the registration of most pesticides, it
also authorizes the regulation of unregistered pesticides. FIFRA
section 3(a) provides that, to the extent necessary to prevent
unreasonable adverse effects on the environment, the Administrator may
limit the distribution, sale, or use of any pesticide that is not
registered under section 3 of FIFRA, subject to an experimental use
permit under section 5 of FIFRA, or subject to an emergency exemption
under section 18 of FIFRA. Pesticides that are ``not registered''
include pesticides that are exempt from FIFRA requirements under
section 25(b).
    An unregistered pesticide may be distributed or sold if it is
exempted by regulation under FIFRA section 25(b). Under FIFRA section
25(b)(2), the Agency can exempt pesticides from some or all of the
requirements of FIFRA when the Agency determines that the pesticide is
``of a character which is unnecessary to be subject to [FIFRA] in order
to carry out the purposes of this Act'' (7 U.S.C. 136w(b)(2)). EPA
interprets section 25(b)(2) to authorize the Agency to exempt a
pesticide or category of pesticides that EPA determines (1) poses a low
probability of risk to the environment and (2) is not likely to cause
unreasonable adverse effects to the environment even in the absence of
regulatory oversight under FIFRA. This standard differs from the
standard for registration which considers only whether the pesticide
``when used in accordance with widespread and commonly recognized
practice... will not generally cause unreasonable adverse effects on
the environment'' (7 U.S.C. 136a(c)(5)(D)).
    In evaluating the first condition that must be met for the Agency
to exempt a pesticide, i.e., whether use of the pesticide poses a low
probability of risk to the environment, EPA considers the extent of the
potential risks caused by use of the pesticide to the environment,
including humans and other animals, plants, water, air and land.
Potential risks to humans include dietary risks as well as non-dietary
risks such as those resulting from occupational or residential exposure
to the pesticide. EPA uses the FFDCA section 408 standard in evaluating
dietary risks as discussed in Unit II.C. of this preamble. EPA will not
exempt pesticides unless they pose a low probability of risk to the
environment.
    In evaluating the second condition that must be met for the Agency
to exempt a pesticide, i.e., whether the use of the pesticide is
unlikely to cause unreasonable adverse effects on the environment even
in the absence of regulatory oversight under FIFRA, EPA balances all
the potential risks to human health, including dietary risks (see Unit
II.C. of this preamble for discussion of the FFDCA standard), and risks
to the remainder of the environment from use of the pesticide against
the potential benefits associated with its use. In balancing risks and
benefits, EPA considers the economic, social, and environmental costs
and benefits of the use of the pesticide. If the pesticide poses a low
probability of risk to the environment and is not likely to cause
unreasonable adverse effects to the environment even in the absence of
regulatory oversight under FIFRA, EPA may exempt the pesticide from
regulation under FIFRA.

C. What is the Relationship of FIFRA Exemptions to the FFDCA Section
408 Standard?

    Under FFDCA section 408(a), a pesticide chemical residue in or on a
food (hereafter simply ``in food'') is not considered safe unless EPA
has issued a tolerance for the residue and the residue is within the
established tolerance limit or EPA has issued an exemption from the
requirement of a tolerance for the residue (21 U.S.C. 346a(a)(1)).
FFDCA section 408 authorizes EPA to determine a residue is safe and
therefore exempt from the requirement of a tolerance if the
Administrator ``has determined that there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information'' (21 U.S.C.
346a(c)(2)(A)(ii)). Section 408 of the FFDCA also directs EPA to
specifically consider harm that may result to infants and children as a
result of pesticide chemical residues. For additional discussion of
this standard, see the Exemption from the Requirement of a Tolerance
under the Federal Food, Drug, and Cosmetic Act for Residues of Plant
Virus Coat Proteins that are Part of a Plant-Incorporated Protectant
published concurrently in today's Federal Register.
    EPA uses the FFDCA section 408 safety standard in evaluating
whether a pesticide used in food meets the FIFRA section 25(b)(2)
exemption standard with respect to human dietary risk. A pesticide in
food poses a low probability of human dietary risk if it meets the
FFDCA section 408 standard for an exemption from the requirement of a
tolerance. Such a pesticide also is not likely to cause unreasonable
adverse effects to the environment, with respect to human dietary risk
only, if the dietary risks resulting from use of that pesticide are
consistent with the FFDCA section 408 exemption standard, and the
potential benefits of use outweigh any dietary risk even in the absence
of regulatory oversight.
    FIFRA, however, does not provide for exemption of a pesticide in
food based solely upon human dietary risk and consistency with the
FFDCA section 408 exemption standard; an exemption from the
requirements of FFDCA does not exempt a product from regulation under
FIFRA. For an exemption under FIFRA, EPA must also evaluate non-dietary
risks to humans and the remainder of the environment from the pesticide
and determine both that the pesticide poses only a low probability of
non-dietary risks and that use of the pesticide is not likely to cause
any unreasonable adverse effects to the environment from such
nondietary risks in the absence of regulation.

D. What is the Role of Other Federal Agencies?

    EPA is the Federal agency responsible for the regulation of
pesticides. Under the Coordinated Framework for Regulation of
Biotechnology (51 FR 23302, June 26, 1986), EPA works closely with the
U.S. Department of Agriculture (USDA), which has responsibilities under
the Plant Protection Act (PPA), and the U.S. Food and Drug
Administration (FDA), which has responsibilities under FFDCA. EPA,
USDA, and FDA consult and exchange information when such consultation
is helpful in resolving safety questions. The three agencies also
strive for consistency between programs following one of the basic
tenets of the Coordinated Framework, i.e., that the agencies composing
the Framework adopt consistent approaches to the extent permitted by
the respective statutory authorities. A consistent approach between
agencies is easier for the regulated community to understand, and it
likely conserves resources

because data developed for one agency may meet at least some of the
requirements posed by another agency for the same or similar products.
    1. USDA. USDA has the responsibility of preventing the introduction
and dissemination of plant pests under the PPA. Before a genetically
engineered plant that is subject to the PPA may be introduced into the
environment, approval must be obtained from the USDA/Animal Plant
Health Inspection Service (APHIS) unless such a plant has been reviewed
and granted Nonregulated Status. The USDA regulations use genetic
engineering and potential plant pest risk as criteria for determining
the scope of its regulations (62 FR 23945, May 2, 1997). Any
genetically engineered plant that contains genetic material from a
plant pest is subject to the regulations. Thus, all plants containing
PVCP-PIPs are subject to USDA/APHIS requirements under the PPA.
    EPA therefore recognizes that there is a potential for duplicative
oversight with respect to certain issues that may arise in decisions
about PVCP-PIPs that require any review by EPA. For example, in its
reviews of Petitions for Determination of Nonregulated Status under
regulations at 7 CFR part 340, the potential for weediness, for
displacement of native species, and potential consequences of gene
transfer are evaluated by USDA/APHIS. EPA and USDA/APHIS will continue
to consult and collaborate on reviews of PVCP-PIPs. EPA and USDA/APHIS
will work together to avoid potential duplication and inconsistencies
and to coordinate their analyses in accordance with their respective
expertise and jurisdiction.
    2. FDA. FDA is the primary U.S. agency responsible for ensuring the
safety of commercial food and food additives. FDA's authority under
FFDCA extends to any nonpesticidal substance that may be introduced
into a new plant variety and that is expected to become a component of
food. Pursuant to sections 201 and 408 of FFDCA and the creation of
EPA, pesticide chemical residues are subject to EPA's regulatory
authority under FFDCA.

E. What is a PVCP-PIP?

    EPA is proposing to define a PVCP-PIP as ``a plant-incorporated
protectant derived from one or more genes that encode a coat protein of
a virus that naturally infects plants. This includes plant-incorporated
protectants derived from one or more plant viral coat protein genes
that produce only RNA and no virus-related protein.''
    Coat proteins are those substances that viruses produce to
encapsulate and protect the viral nucleic acid and to perform other
important tasks for the virus, e.g., assistance in viral replication,
movement within the plant, and transmission of the virus from plant to
plant by insects (Ref. 1). In many cases, when the genetic material
encoding a plant virus coat protein is engineered into a plant's
genome, the plant displays resistance to infection by that virus as
well as other viruses having similar coat protein sequences (Ref. 2).
    Current scientific information suggests that prevention or
mitigation of disease by PVCP-PIPs may occur by two different
mechanisms. For some PVCP-PIPs, resistance is believed to be protein-
mediated because efficacy is correlated with the concentration of coat
protein produced by the transgene (Ref. 3). In protein-mediated
resistance, the coat protein is thought to impede the infection cycle
by interfering with the disassembly of infecting viruses (Ref. 4).
    In transgenic plants, a second mechanism of resistance, post-
transcriptional gene silencing (PTGS) may be activated. In PTGS,
prevention or mitigation of viral disease is not correlated with the
level of coat protein expression. Indeed, virus resistance can occur
even when a coat protein gene expresses untranslatable RNA sequences
and no coat protein is detected (Ref. 4). PTGS is a defense mechanism
in plants against foreign RNA (e.g., viruses) in which sequence-
specific RNA degradation is initiated by the plant in response to the
foreign RNA itself. Evidence suggests that PTGS is initiated once there
is a threshold accumulation of double-stranded (ds) RNA in the cell
cytoplasm (Ref. 5). Over 90% of plant viruses have single-stranded RNA
genomes, but viral replication transiently produces dsRNA in quantities
sufficient to trigger PTGS (Ref. 6). PTGS is also known to occur with
transgenes that are transcribed at a low level but that likely produce
dsRNA (Ref. 7). Once the plant recognizes the dsRNA, it is thought to
be cleaved by a dsRNA-specific nuclease to produce small 21- to 25-
nucleotide short interfering RNA sequences (siRNAs; Ref. 8). The siRNAs
are thought to serve as guides for the cleavage of single-stranded RNA
with a sequence similar to the dsRNAs (Ref. 9). Thus once PTGS is
initiated, it targets all RNA with high sequence similarity to the
sequence that initiated the process, regardless of whether it was
transcribed from the transgene, an endogenous gene, or viral RNA.
    A plant virus coat protein transgene that confers virus resistance
through either a protein- or RNA-mediated mechanism would fall within
EPA's proposed definition of a PVCP-PIP. The substances involved in
either mechanism of resistance would meet the FIFRA definition of a
pesticide because the transgene and any material expressed from the
transgene are introduced into a plant for the purpose of preventing or
mitigating viral disease (see Unit II.A.).
    The proposed definition of a PVCP-PIP contains the phrase
``naturally infects plants.'' Including this phrase in the definition
would specifically limit the proposed exemption by requiring that the
virus coat protein gene sequence used in the PVCP-PIP be based
exclusively on a plant virus sequence. This limitation is proposed in
order to exclude from the definition any coat proteins of plant viruses
that have been modified with sequences from animal or human viruses.
EPA includes this concept in today's proposal in response to comment
received from the public in earlier Federal Register documents
pertaining to PVCP-PIPs.

F. What Conditions Must be Met for a PVCP-PIP to Qualify for a FIFRA
Exemption?

    As noted above, a PIP is exempt from the requirements of FIFRA,
other than the adverse effects reporting requirements of 40 CFR 174.71,
if the PIP meets the requirements in 40 CFR 174.21(a), (b), and (c).
Therefore, the following factors need to be considered to determine the
FIFRA status of a PVCP-PIP. First, does the PVCP-PIP meet the
requirement at 40 CFR 174.21(a)? Second, do the residues of the PVCP-
PIP meet the requirement at 40 CFR 174.21(b)? Third, do the inert
ingredients that are part of the PVCP-PIP meet the requirement at 40
CFR 174.21(c)?
    1. Does the PVCP-PIP meet the requirement at 40 CFR 174.21(a)?
Section 174.21(a) requires that the PIP meet the criteria listed in at
least one of the sections in Sec. Sec.  174.25 through 174.50. Today's
action proposes to establish Sec.  174.27, which would contain criteria
allowing certain PVCP-PIPs to meet the Sec.  174.21(a) requirement for
exemption. These criteria identify those PVCP-PIPs that EPA has been
able to determine meet the standard under FIFRA section 25(b)(2), i.e.,
that pose a low probability of risk to the environment and that are not
likely to cause unreasonable adverse effects to the environment even in
the absence of regulatory oversight under FIFRA. EPA is proposing
criteria that address the

relevant potential risks associated with these products:
    i. The potential for increased weediness or invasiveness of the
crop plant containing the PVCP-PIP or any wild or weedy relatives that
could acquire the PVCP-PIP through gene flow thereby causing negative
effects on either the agro-ecosystem or natural environments. This
issue is addressed at Sec.  174.27(a) and is referred to as
``weediness'' for the purposes of this document.
    ii. The potential for viruses with novel properties developing
through novel viral interactions. This issue is addressed at Sec.
174.27(b) and is referred to as ``viral interactions'' for the purposes
of this document.
    iii. The potential for human or nontarget organism exposure to
proteins that may not have previously existed in nature and thus should
be examined to determine whether they have potentially toxic or
allergenic properties. This issue is addressed at Sec.  174.27(c) and
is referred to as ``protein production'' for the purposes of this
document.
    Proposed Sec. Sec.  174.27(a), (b), and (c) are discussed in
greater detail in Unit III of this Federal Register document. In
addition, a graphical depiction of what this rule is proposing is
available in the docket for this proposed rule.
    2. Do the residues of the PVCP-PIP meet the requirement at 40 CFR
174.21(b)? Section 174.21(b) requires that in order to qualify for a
FIFRA exemption, the residues of a PVCP-PIP that is intended to be
produced and used in a crop used as food must either be exempted from
the requirement of a tolerance under FFDCA or no tolerance would
otherwise be required for the PVCP-PIP. Therefore, if a PVCP-PIP is
used in a food plant (e.g., the PVCP-PIP is produced and used in a corn
plant) or residues of the PVCP-PIP might reasonably be expected in food
(e.g., the PVCP-PIP is produced and used in an ornamental plant but
could move through gene flow to a sexually compatible food plant), the
FFDCA section 408 requirements must be considered when determining
whether the PVCP-PIP can be exempted under FIFRA. If a PVCP-PIP would
not be used in and would not reasonably be expected in a crop used as
food (e.g., the PVCP-PIP is produced and used in an ornamental plant
with no sexually compatible relatives that are food plants), the FFDCA
section 408 requirements do not need to be considered.
    EPA anticipates that in most cases the PVCP-PIP residues will
consist of residues of nucleic acids, residues of inert ingredients,
and residues of the plant virus coat protein portion of the PVCP-PIP
(the ``PVC-protein''). Residues of nucleic acids are exempt from the
requirement of a tolerance at 40 CFR 174.475. As of the time this
proposed rule is being issued, residues of those inert ingredients that
are exempt from the requirement of a tolerance are listed at 40 CFR
part 180 and 40 CFR part 174 subpart W. In a companion piece appearing
in today's Federal Register, EPA is proposing a tolerance exemption for
residues of certain PVC-proteins that meet specified criteria. Due to
different statutory requirements, the proposed FFDCA exemption criteria
differ from the criteria proposed in this Federal Register for 40 CFR
174.27 under FIFRA.
    3. Do the inert ingredients that are part of the PVCP-PIP meet the
requirement at 40 CFR 174.21(c)? Section 174.21(c) requires that in
order for a PIP to qualify for exemption any inert ingredient contained
in the PIP must be codified at subpart X of 40 CFR part 174 - List of
Approved Inert Ingredients. Subpart X lists the inert ingredients (i)
that may be used in a plant-incorporated protectant listed in subpart B
(Exemptions) of part 174 and (ii) whose residues are either exempted
from the requirement of a tolerance under FFDCA or no tolerance would
otherwise be required. EPA is proposing to add several substances known
to be used commonly as inert ingredients in PIPs to 40 CFR part 174
subpart X. These substances already have tolerance exemptions under
FFDCA. EPA proposes in today's Federal Register that these substances,
when used in exempt PIPs as inert ingredients under specified
conditions, should also be exempt from FIFRA because they are of a
character which is unnecessary to be subject to FIFRA in order to carry
out the purposes of the Act.

G. What if a PVCP-PIP Does Not Qualify for Exemption?

    If EPA is unable to conclude that a PVCP-PIP meets the standard for
exemption, an applicant may still apply to register the PVCP-PIP under
section 3 of FIFRA. EPA may be able to conclude that the PVCP-PIP meets
the standard for registration (i.e., when it is used in accordance with
widespread and commonly recognized practice, it will not generally
cause unreasonable adverse effects on the environment). EPA recognizes
that the proposed exemption criteria may not identify all low risk
PVCP-PIPs. A case-by-case review for registration would allow the
Agency to evaluate factors not readily incorporated into clear,
unambiguous exemption criteria. As part of registration, the Agency
could also impose conditions of use as appropriate. As is EPA's general
practice regarding registration of PIPs, the Agency will consult with
USDA in evaluating PVCP-PIPs for registration.

H. What is the History of this Proposal?

    1. Scientific input. EPA sponsored or cosponsored with other
Federal agencies, six conferences relevant to development of this
proposed rule: on October 19-21, 1987, a meeting on ``Regulatory
Considerations: Genetically Engineered Plants'' at Cornell University
in Ithaca, New York; on September 8-9, 1988, a ``Transgenic Plant
Conference'' in Annapolis, Maryland; on November 6-7, 1990, a
conference on ``Pesticidal Transgenic Plants: Product Development, Risk
Assessment, and Data Needs'' in Annapolis, Maryland; on April 18-19,
1994, a ``Conference on Scientific Issues Related to Potential
Allergenicity in Transgenic Food Crops'' in Annapolis, Maryland; on
July 17-18, 1997, a ``Plant Pesticide Workshop'' in Washington, DC; and
on December 10-12, 2001 a conference on ``Assessment of the Allergenic
Potential of Genetically Modified Foods'' in Chapel Hill, North
Carolina. EPA incorporated information from these conferences in
development of this proposed rule as appropriate.
    EPA has requested the advice of two scientific advisory bodies at
five meetings while developing its approach to plant-incorporated
protectants. On December 18, 1992, EPA convened a FIFRA Scientific
Advisory Panel (SAP) to review a draft policy on PIPs (then called
plant-pesticides) and to respond to a series of related questions posed
by the Agency dealing primarily with EPA's approach under FIFRA. On
July 13, 1993, EPA requested the advice of a Subcommittee of the EPA
Biotechnology Science Advisory Committee (BSAC) on a series of
scientific questions dealing with EPA's approach to PIPs under FFDCA.
On January 21, 1994, EPA asked for advice on the Agency's approach to
PIPs under both statutes at a joint meeting of the SAP and the BSAC. To
evaluate more recent scientific advances, EPA again brought these
issues to a FIFRA SAP meeting on October 13-14, 2004. On December 6-8,
2005, EPA convened a SAP meeting to address a series of scientific
questions related to this proposal. EPA incorporated advice from all
five meetings in development of this proposed rule as appropriate.
    2. Federal Register documents. The history of this proposal
consists of the original proposed exemption from

FIFRA requirements that appeared in the November 23, 1994 Federal
Register (59 FR 60519); the original proposed exemption from FFDCA
tolerance requirements in the November 23, 1994 Federal Register (59 FR
60545); and several supplemental documents appearing in the May 16,
1997 Federal Register (59 FR 27149), the July 22, 1996 Federal Register
(61 FR 37891), the April 23, 1999 Federal Register (64 FR 19958), and
the July 19, 2001 Federal Register (66 FR 37772 and 37855).
    i. November 23, 1994. In a document that appeared in the November
23, 1994 Federal Register (59 FR 60519) (FRL-4755-3), EPA proposed two
alternatives under FIFRA section 25(b)(2) to exempt PVCP-PIPs from
FIFRA requirements. Option 1 proposed to categorically exempt plant-
pesticides derived from coat proteins from plant viruses (now called
PVCP-PIPs). Option 2 proposed a more limited exemption covering only
those PVCP-PIPs that would have the least potential to confer selective
advantage on free-living wild relatives of the plants that could
acquire the PVCP-PIP through gene flow (discussed in detail in Unit
III.C.3.).
    Elsewhere in the November 23, 1994, Federal Register (59 FR 60545)
(FRL-4755-4), EPA proposed to exempt from the FFDCA requirement of a
tolerance, residues of plant virus coat proteins produced and used in
living plants as a plant-incorporated protectant (then called a plant-
pesticide). The proposed exemption from the requirement of a tolerance
read, ``Residues of coat proteins from plant viruses, or segments of
the coat proteins, produced in living plants as plant-pesticides are
exempt from the requirement of a tolerance'' (59 FR 60547).
    ii. May 16, 1997. In August of 1996, Congress enacted the Food
Quality Protection Act (FQPA), which amended FFDCA and FIFRA. On May
16, 1997, EPA published a supplemental document in the Federal Register
(62 FR 27149) (FRL-5716-6) to provide the public with an opportunity to
comment on EPA's analysis of how certain FQPA amendments to FFDCA and
FIFRA applied to the 1994 proposed exemption from the requirement of a
tolerance for residues of viral coat proteins produced in plants as
part of a PIP. (Today's Federal Register terms such entities ``PVC-
proteins.'')
    In the 1997 supplemental document, EPA explained how most of the
substantive factors that the amended FFDCA requires EPA to consider in
evaluating pesticide chemical residues had been considered in the
Agency's 1994 proposed tolerance exemption. Even though the Agency may
not have used the terminology specified in the FQPA, EPA did take into
account most of the factors (e.g., toxicity and consumption patterns)
in issuing its 1994 proposal to exempt residues of PVC-proteins, or
residues of segments of such proteins, from FFDCA tolerance
requirements. EPA therefore sought comment on the requirements imposed
by FQPA that the Agency had not addressed in its 1994 proposal,
specifically:
    a. EPA's conclusion that there are no substances outside of the
food supply that may have a cumulative toxic effect with residues of
PVC-proteins,
    b. EPA's conclusion that there are no substances outside of the
food supply to which humans might be exposed through non-occupational
routes of exposure that are related via a common mechanism of toxicity
to residues of PVC-proteins,
    c. Any available information on PVC-proteins causing estrogenic
effects,
    d. EPA's rationale, described in greater detail, for concluding
that PIPs are likely to present a limited exposure of pesticidal
substances to humans in which the predominant route of exposure will be
dietary, and
    e. EPA's rationale, described in greater detail, for concluding
that the Agency's analysis concerning the dietary safety of food
containing PVC-proteins applies to infants and children as well as
adults.
    Because of the 1996 FQPA, EPA's final determination under FIFRA for
PVCP-PIPs in food plants could also be affected by comments on the
companion document in today's Federal Register that proposes a
tolerance exemption for certain PVCP-PIP residues.
    iii. July 22, 1996. On July 22, 1996, EPA issued a supplemental
document (61 FR 37891) (FRL-5387-4) requesting comment on one aspect of
its November 23, 1994 Federal Register document: how the concept of
inert ingredient related to plant-incorporated protectants.
    iv. April 23, 1999. On April 23, 1999, EPA published a supplemental
document in the Federal Register (64 FR 19958) (FRL-6077-6) soliciting
comment on whether to change the name of pesticides produced and used
in living plants.
    v. July 19, 2001. In July of 2001, EPA published a package of
notices related to PIPs in the Federal Register, including a
supplemental document (66 FR 37855) (FRL-6760-4) that provided the
public with additional opportunity to comment on the FIFRA and FFDCA
exemptions for PIPs that the Agency proposed in 1994 but had not yet
finalized by 2001. EPA also requested comment on the information,
analyses, and conclusions pertaining to these PIPs (including PVCP-
PIPs) contained in the NRC report entitled ``Genetically Modified Pest-
Protected Plants: Science and Regulation'' (Ref. 10). The public was
given an opportunity to comment on a proposal to clarify the language
of the original 1994 proposals EPA was considering in response to
public comment received on the 1994 proposal. In addition, the Agency
requested additional public comment on several scientific issues. Also
in the July 19, 2001 Federal Register (66 FR 37772) (FRL-6057-7), EPA
changed the name of these pesticides from ``plant-pesticides'' to
``plant-incorporated protectants'' or ``PIPs.''
    The documents and reports of the meetings described above,
including associated public comments, are available in the public
dockets established for the associated rulemakings as described in Unit
IX of this preamble.
    Today's proposed rule completely supersedes these previous
proposals. EPA does not intend to respond to comments submitted on
those proposals. Thus, individuals who believe that any comments
submitted on any of the earlier proposals remain germane to today's
proposal, should submit them (or relevant portions) again during this
comment period.

III. Proposed Exemption Criteria under Sec.  174.27

A. Structure of the Proposed Exemption Criteria under Sec.  174.27

    In order to satisfy the general requirement for a FIFRA exemption
listed at 40 CFR 174.21(a), EPA is proposing to add three criteria at
40 CFR 174.27. As discussed in Unit II.F.1., the three criteria that
EPA is proposing to adopt at 40 CFR 174.27 are intended to address
three issues that are associated with potential risks of PVCP-PIPs.
    The PVCP-PIP would have to meet proposed Sec. Sec.  174.27(a), (b),
and (c) to satisfy 40 CFR 174.21(a). Proposed Sec. Sec.  174.27(a),
(b), and (c) each can be met in one of two ways: a product developer
may self-determine that paragraph (1) of the criterion is met (i.e.,
Sec.  174.27(a)(1), (b)(1), or (c)(1)) or the Agency may determine that
paragraph (2) of the criterion is met (i.e., Sec.  174.27(a)(2),
(b)(2), or (c)(2), respectively). Paragraph (1) of each proposed
criterion (i.e., Sec.  174.27(a)(1), (b)(1), and (c)(1)) describes an
objective, well-defined characteristic. Therefore, the developer may
determine whether the PVCP-PIP meets the requirement. Paragraph (2) of

each proposed criterion (i.e., Sec.  174.27(a)(2), (b)(2), and (c)(2))
is conditioned on an Agency determination because several types of
information may need to be evaluated using a weight-of-evidence
approach to determine whether the PVCP-PIP meets the requirement and is
therefore of a nature warranting exemption.
    1. Exemption by self-determination. Each criterion may be satisfied
under either paragraph (1) or paragraph (2) irrespective of how the
other two criteria are satisfied; there is no requirement that all
three criteria must be satisfied under either paragraph (1) or
paragraph (2) in order for a PVCP-PIP to qualify for the exemption.
However, if a PVCP-PIP satisfies all three criteria under paragraph (1)
by developer self determination (i.e., it meets proposed Sec. Sec.
174.27(a)(1), (b)(1), and (c)(1)) and it satisfies Sec. Sec.  174.21(b)
and (c), EPA is proposing that the developer submit a notification to
the Agency of that determination and certify that the PVCP-PIP
qualifies for exemption under FIFRA, i.e., that the PVCP-PIP meets
Sec. Sec.  174.21(a), (b), and (c). In addition, EPA is proposing that
the developer maintain information adequate to support the
determination. Such records must be made available for EPA inspection
and copying or be otherwise submitted to the Agency for review upon
request for the duration of time that the PVCP-PIP is sold or
distributed. EPA is proposing that these records be kept so that EPA
could review a particular exemption determination if needed at a future
date.
    EPA is proposing to require that the notifications contain:
    i. The name of the crop (including genus and species) containing
the PVCP-PIP.
    ii. The name of the virus from which the coat protein gene was
derived.
    iii. The name of the virus(es) to which resistance is conferred.
    iv. When available, a unique identifier.
    EPA is proposing this notification requirement because it provides
a mechanism that allows the Agency to keep a record of all PVCP-PIPs
that may be sold or distributed. EPA expects that such a list would be
useful to developers whose products are moving in international trade
because it would enable EPA to post information on the United States
Regulatory Agencies Unified Biotechnology Website (found at http://usbiotechreg.nbii.gov/database_pub.asp
) indicating that the developer

has determined that the product satisfies the Agency's safety
requirements. Such information can facilitate acceptance by importing
countries. Absent such a posting, the field for EPA information would
be blank, and importers might question the regulatory status of the
product in the United States. In addition, EPA considers that such a
list may be useful to the Agency for ensuring enforcement and
compliance with FIFRA regulations because it will enable compliance
personnel to ascertain the exemption status of products encountered in
distribution and trade channels.
    2. Exemption by Agency determination. If a PVCP-PIP does not
satisfy a particular criterion under paragraph (1) (i.e., Sec.
174.27(a)(1), (b)(1), or (c)(1)), EPA proposes that as an alternative
route to exemption, the product developer would submit data or other
information to the Agency to demonstrate that a particular PVCP-PIP
meets paragraph (2) of that criterion (i.e., it meets Sec.
174.27(a)(2), (b)(2), or (c)(2), respectively). In addition, as part of
this submission, a developer would also include a certification as to
any determination that the product meets Sec.  174.27(a)(1), (b)(1),
and/or (c)(1), as appropriate. During its review under Sec.
174.27(a)(2), (b)(2), and/or (c)(2), EPA would not review the
developer's determination that the product met any criterion under
Sec.  174.27(a)(1), (b)(1), or (c)(1).
    EPA expects that in many instances developers would have most, if
not all the information that would need to be included in any exemption
submission under Sec. Sec.  174.27(a)(2), (b)(2), or (c)(2) because it
would have been gathered in the course of product development or for
submission to USDA/APHIS as part of a petition for determination for
non-regulated status. EPA will consult with USDA in evaluating whether
a PVCP-PIP meets the conditions for an Agency-determined exemption. EPA
is proposing that information supporting the submission be maintained
as records that will be available for EPA inspection as necessary for
the duration of time that the PVCP-PIP is sold or distributed.
    EPA will evaluate the information contained in the submission and
publish a notice allowing the public to comment on the Agency's
determination that a product meets Sec.  174.27(a)(2), (b)(2), and/or
(c)(2), as appropriate. EPA is providing such a public comment period
because even though the public will have had the opportunity to comment
through this proposal on the appropriateness of the criteria in Sec.
174.27(a)(2), (b)(2), and (c)(2), the public would not otherwise have
an opportunity to comment on whether a particular PVCP-PIP meets these
criteria, given that these determinations depend on a case-by-case
analysis of several types of information.
    The Agency plans to publish a Federal Register notice announcing
its determination that a PVCP-PIP meets Sec.  174.27(a)(2), (b)(2),
and/or (c)(2), and if no adverse comments are received during the
comment period, the Agency's decision will be considered final, and EPA
will publish no further notice. Based on its experience with EUP
notices, EPA expects that, in general, determinations that a PVCP-PIP
qualifies for exemption will be noncontroversial and generate no
adverse comments. However, in the case of adverse comments, EPA would
publish a subsequent Federal Register notice announcing its final
determination and address all public comments. EPA would prefer
criteria in Sec.  174.27(a)(2), (b)(2), and (c)(2) that would allow the
public and PVCP-PIP developers to readily predict the outcome of an
Agency review. Such criteria would reduce regulatory uncertainty in
PVCP-PIP development and decrease the time EPA would need to evaluate
the data/information necessary to make a determination that a PVCP-PIP
meets a given criterion. However, using criteria for which
determinations can be readily predicted might reduce the number of
PVCP-PIPs that would qualify for exemption. EPA tried to balance these
concerns and proposed multiple options when the Agency was unsure how
to resolve this dilemma.
    However, EPA does not believe that the considerations underlying
its decisions to grant the public a further opportunity to comment on
the Agency's decision apply in cases where the Agency rejects a
submission for an exemption. Accordingly, if EPA determines that the
product fails to meet one or more of the exemption criteria, EPA will
provide notice to the applicant of its decision on the submission and
that a registration would be required for the PVCP-PIP before the PVCP-
PIP could be sold or distributed. The product developer may then submit
an application for registration to the Agency. EPA would evaluate such
PVCP-PIPs under the existing registration process and could implement
conditions of use as appropriate.

B. Key Scientific Issues Associated with the Proposed Exemption
Criteria under Sec.  174.27

    Several scientific questions concerning risk issues associated with
PVCP-PIPs have been identified:
     What is the potential for a PVCP-PIP to endow plants with
characteristics

that could disrupt the existing network of ecological relationships in
managed, semi-managed, or natural ecosystems, e.g., through gene
transfer to wild or weedy\1\ relatives? This issue is addressed at
proposed Sec.  174.27(a) and is referred to as ``weediness'' for the
purposes of this discussion.
---------------------------------------------------------------------------

    \1\ In the context of the phrase ``wild and weedy'' relatives/
plants used throughout this preamble, EPA considers weedy plants to
be those with the characteristics of weeds, i.e., those that are
considered undesirable, unattractive, or troublesome, especially
when growing where they are not wanted. Wild plants are those that
occur, grow, and live in a natural state and are not domesticated,
cultivated, or tamed. EPA considers a naturalized population to be
an enduring population of domesticated plants that grows in wild
(non-cultivated) areas. EPA considers a native plant population to
be one that originates in a particular region or ecosystem.
---------------------------------------------------------------------------

     What is the potential for interactions between a PVCP-PIP
and an infecting virus to affect plant virus epidemiology or
pathogenicity? This issue is addressed at proposed Sec.  174.27(b) and
is referred to as ``viral interactions'' for the purposes of this
discussion.
     What is the potential for exposure of humans or nontarget
organisms to PVC-proteins with novel toxic or allergenic properties?
This issue is addressed at proposed Sec.  174.27(c) and is referred to
as ``protein production'' for the purposes of this discussion.
    These three questions are addressed below under the headings of
weediness, viral interactions, and protein production, respectively.

C. Weediness

    1. Scientific issues. In evaluating whether a PVCP-PIP could alter
ecological relationships among plants, EPA considered two primary
issues: (1) whether the PVCP-PIP could endow a transgenic plant itself
with an increased ability to spread into natural or semi-managed
habitats and (2) whether the transfer of a PVCP-PIP from a transgenic
plant into wild or weedy relatives could endow the wild or weedy
relative with increased competitive ability and thus disrupt ecological
relationships. Gene transfer among sexually compatible plants is a
natural phenomenon that EPA does not consider to be an environmental
risk per se. Whether the transfer of a PVCP-PIP could significantly
disrupt ecological relationships in specific instances depends on all
of the following considerations: First, does the crop plant containing
the PVCP-PIP have wild relatives with which it is able to hybridize in
nature? If it does not, there can be no gene transfer. Second, if there
are sexually compatible relatives, is the gene conferring virus
resistance likely to become stable in the population? Third, is the
stable introduction of a PVCP-PIP into the plant population (i.e.,
introgression) likely to cause the population to become more weedy/
invasive or otherwise alter its competitive ability, thereby
significantly changing the population dynamics of the plant community?
The 2005 SAP concurred that these are important considerations for
PVCP-PIPs by noting that an ``important ecological risk associated with
gene flow from crop plants into their wild relatives is that the
acquisition of crop genes might substantially alter the population
dynamics of the wild plant. In particular, a transgene introgressed
from the crop relative into a wild population might allow the wild
species to persist in larger populations across a larger geographic
range, or in a wider range of habitats. Collectively these changes in
population dynamics can be considered `increased weediness'. The
probability that a particular transgene will lead to increased
weediness depends on the phenotype conferred by the transgene and on
the ecological factor(s) currently limiting the size or distribution of
the wild species. In particular, if the transgene alters plant response
to the ecological factor limiting population size, then population
dynamics may be affected. For PVCP-PIPs, the relevant consideration is
whether virus resistance (conferred by the PVCP-PIP) leads to changes
in the size or distribution of wild plant species with the PVCP-PIP''
(Ref. 11).
    i. Likelihood that a crop plant containing a PVCP-PIP could itself
disrupt ecological relationships. In considering whether a PVCP-PIP
could affect the ability of a plant to spread into natural or semi-
managed habitat at the margins of cultivated fields, i.e., to form
feral or naturalized populations, the key consideration is whether
viral infection is currently limiting the ability of agricultural crops
to do so. The 2005 SAP pointed out that PVCP-PIPs ``are developed when
virus infection of a crop reduces the crop yield, suggesting that virus
infection is quite likely in naturalized populations of the crop as
well'' (Ref. 11). However, virus infection in crop plants does not
necessarily limit the spread of the crop into natural or semi-managed
areas. As the 2005 Panel also noted, ``little is known about factors
controlling population size in plant populations in general, including
those that are currently stable, as well as those that are currently
weedy or invasive'' (Ref. 11). Few published studies are available that
evaluate this question directly, perhaps due to the general rarity of
negative results in scientific literature. However, one study did find
virus infection to have little effect on an agricultural crop. Field
experiments with transgenic virus-resistant sugar beets revealed no
competitive advantage (measured as seedling emergence and biomass
production) between the transgenic and susceptible control lines (Ref.
12).
    Although virus infection has been shown to negatively impact growth
and/or reproduction of some natural plant communities (discussed below
in Unit III.C.1.ii.), EPA recognizes that there is reason to question
whether the situation would be different for crop plants. The National
Research Council (NRC) noted in 1989 that most naturalized,
domesticated crops generally are unable to effectively compete with
wild species in natural ecosystems and have not been known to acquire
this ability with the type of single-gene traits commonly introduced
through genetic modification (Ref. 13). The 1989 NRC report went on to
note that plant breeders have capitalized for decades on the fact that
relatively minor genetic changes can produce plants with altered
ecological properties, but the addition of pest resistant traits has
not been known to result in increased weediness of widely used crops
(Ref. 13). A 1989 survey of the weedy characteristics of crop versus
weed species showed that weeds possess significantly more weedy
characteristics on average than do crop plants (Ref. 14). For
domesticated crops, the traits that make them useful to humans also
reduce their competitive ability in nonagricultural habitats. Crops
that have been subjected to long-term breeding (e.g., corn and
soybeans) are unlikely to possess characteristics that would allow the
plant to compete effectively outside of managed ecosystems. Domesticity
arises because intensive breeding efforts seek to eliminate many
characteristics of the crop plant that would enhance weediness (e.g.,
seed shattering, thorns, seed dormancy, and bitterness). For example,
lack of seed shattering and seed dormancy greatly reduces the ability
of an annual crop to persist without human intervention. Highly
domesticated crops such as corn are thus unlikely to survive for
multiple generations outside agricultural fields no matter what
transgenic trait they contain, including virus resistance (Ref. 15).
    However, some crop species, e.g., cranberry and blackberry may have
more similarities to their wild relatives than highly domesticated
crops such as corn or soybean. As noted by the 2005

SAP, ``Determining whether a particular crop can naturalize and then
spread as a weedy species is difficult to ascertain from the literature
and determining the probability that a crop will be more weedy or
invasive if it contains a PVCP-PIP is even more difficult'' (Ref. 11).
Such determinations may therefore need to rely on information not
available in public literature as part of a risk assessment for a
particular plant. Plants, such as forest trees, that may grow for many
years in natural environments or in very close proximity to natural
environments present additional difficulty in evaluating and managing
risks (Ref. 16). The period of time over which such plants would
persist is significantly longer than for annual, short-lived species.
Individual plants will therefore experience a much wider range and
variety of stress conditions, enemy attacks, and climate change, making
predictions about naturalization potential with acquired virus
resistance particularly challenging.
    Thus, although EPA believes that many crop species are unlikely to
disrupt ecological relationships through acquisition of a PVCP-PIP, the
available information is insufficient to support the general
conclusions that EPA would need to make for a categorical exemption of
PVCP-PIPs. EPA would need to conclude that there is a low risk that
acquisition of a PVCP-PIP would significantly affect the
competitiveness of any of the plants currently grown as crops and that
none of these crop species would significantly disrupt ecological
relationships when modified to contain a PVCP-PIP. Therefore, the
Agency believes that it is necessary to evaluate each plant species
independently to consider whether it is likely to establish weedy or
invasive populations outside of agricultural fields in the United
States and thereby potentially significantly disrupt ecological
relationships if it becomes virus resistant due to a PVCP-PIP. Factors
likely to influence this determination cannot be readily distilled into
a straightforward criterion suitable for a categorical exemption.
    ii. Likelihood that a crop plant containing a PVCP-PIP could
significantly disrupt ecological relationships through gene transfer.
The question of whether gene transfer from a crop to a wild or weedy
relative could significantly disrupt ecological relationships is a more
complicated question because a much broader range of potential plants
may be involved when wild or weedy relatives are considered in addition
to the crops themselves. The answer to this question depends first on
the question of whether the transgenic crop plants could transfer a
PVCP-PIP to other plant populations. This potential for transfer
depends in part on the frequency of hybridization between domesticated
species and their wild relatives. Hybridization is affected by the
ability of plants to cross-pollinate which in turn is affected by their
timing of reproductive viability and the proximity of the plants.
Hybridization is also affected by the ability of pollen to fertilize
recipient plants, the recipient plants to develop viable seeds, these
seeds to germinate, and the seedlings to grow into viable adults (Ref.
17). In spite of these potential constraints, a survey of the world's
most important crops suggests that spontaneous hybridization of
domesticated plants with wild relatives appears to be a general feature
across at least a portion of the worldwide geographic area over which
each is cultivated (Refs. 18 and 19). The ability to cross crops with
wild relatives (which may not necessarily occur where the crop is
grown) is also the basis of many traditional breeding techniques that
are used for virtually all crops (Ref. 20).
    Whether virus infection limits the growth and/or reproductive
ability of wild or weedy plant populations is more difficult to answer
generically for all plants in all ecosystems. Viruses are pervasive in
many natural plant populations (Refs. 21, 22, 23, and 24), although a
comprehensive body of literature on the effect of viruses in weed
species is lacking. According to the 2004 SAP, ``Our knowledge about
the effect of virus infection on non-crop plants is quite limited''
(Ref. 25). Some published studies report that virus infection can have
little or no effect on the plants. For example, a survey of Plantago
species in England showed that although 92 of 144 plants were infected
with one or more viruses, most of the plants showed no obvious disease
symptoms (Ref. 23). A literature review of the role of weeds in the
occurrence and spread of plant virus diseases describes several cases
where viruses significantly damage certain crops but have little effect
on their weed hosts (Ref. 26).
    Other published studies have reported that infection reduces plant
growth and/or fecundity. For example, naturally occurring tobacco leaf
curl virus infection increases mortality and has negative effects on
growth and seed output in plants from wild populations of the flowering
perennial plant Eupatorium chinense (Ref. 27). Greenhouse experiments
with this same plant under two irradiance levels showed that virus
infection did not affect survivorship under high-light conditions but
caused severe damage under low-light conditions (Ref. 28). Vegetative
growth and flower production of purslane (Portulaca oleracea) was also
reduced when plants were inoculated with cucumber mosaic virus (Ref.
29). Field experiments showed that wild cabbage plants (Brassica
oleracea) inoculated with turnip mosaic virus or turnip yellow mosaic
virus have reduced survival, growth, and reproduction (Ref. 30). Such
experiments suggest that viruses can sometimes reduce individual plant
growth and/or fecundity when infection occurs. However, individual-
level effects are insufficient to understand population-level
processes. For example, even if virus disease significantly affected
individual plant fitness, a decline in individual-plant fitness might
reduce competition such that uninfected plants could increase
reproductive output, thereby mitigating any population-level effects
(Ref. 31).
    It can be difficult to predict the actual impact on overall plant
population dynamics that would result from acquisition of virus
resistance by plants that are in some way negatively affected by virus
infection. EPA is not aware of any published study that has directly
examined this question by, for example, purposefully freeing a plant
species from virus infection and investigating the resulting population
dynamics of infected versus uninfected plants. The 2004 SAP was also
unaware of any such study, but offered that ``[b]ased on knowledge
obtained from observation of cultivated crops in the agroecosystem, the
majority of the Panel concluded that it would be unlikely that a plant
population freed from viral pressure would give a plant species a
competitive advantage'' (Ref. 25). Some members of the 2005 SAP agreed
with the 2004 SAP, while ``[o]ther members of the current [2005] SAP
believed, based on new information (Fuchs et al. 2004; Sukopp et al.,
2005) not available to the 2004 Panel, as well as EPA indicating a lack
of data on this topic, that concluding that viruses typically have no
effect on their wild plant hosts is not accurate. Because of the
differing opinions among the current [2005] Panelists, and the general
paucity of data, the Panel cautioned that further research is needed to
provide stronger support to this particular issue'' (Refs. 11, 32, and
33). EPA also notes that evaluating impacts on plant population
dynamics is further complicated because in certain cases gene transfer
of a PVCP-PIP to wild or weedy relatives might potentially be
desirable. For example, an invasive virus species might be

effectively controlled through broad acquisition of resistance by plant
species susceptible to the virus. Controlling disease outbreaks in
perennial agricultural plants and trees could be significantly aided by
reducing viral load in the environment through such approaches.
    A few studies are available that are relevant to the question of
whether acquisition of virus resistance could affect plant population
dynamics. These studies show that in some cases virus infection can
have such effects, suggesting that acquired virus resistance might as
well. For example, infection with alfalfa mosaic virus substantially
diminished the ability of certain medic cultivars to compete with other
species such as capeweed in grazed pasture swards, both directly by
decreasing the competitive ability of infected plants, and indirectly
by altering the proportions in which the species germinated (Ref. 34).
In another example of virus infection affecting plant population
dynamics, growth analysis of Eupatorium makinoi revealed that plants
naturally infected with a geminivirus had significantly reduced stem
growth and plant height, along with decreased flowering and
survivorship. This study suggests that in spite of the long-term
coexistence of the virus and Eupatorium makinoi, such negative fitness
attributes have a significant impact on at least some local plant
populations in this species (Ref. 35).
    Although relatively little research has been published regarding
how plant population dynamics are directly influenced by virus
infection, such results as described in the previous paragraph provide
some support for the premise that virus resistance might be an
important ecological fitness characteristic. At least some plant
populations acquiring virus resistance might in some instances be able
to better compete against other species (Ref. 36) and/or spread to
habitats previously unsuitable because of the presence of the virus
(Ref. 37). For example, a broad survey of geographic data on plant
associations with viruses from published compendia and governmental or
academic databases showed that plants were infected by 24% fewer
viruses in their naturalized ranges than in their native ranges,
supporting the hypothesis that the impact of invasive plants results in
part from reduced natural enemy (e.g., virus) attack (Ref. 38). On the
other hand, enemy release is only one of many hypotheses that could
explain the abundance and/or impact of an invasive plant (Ref. 39). In
addition, a few published studies have reported that in certain
instances virus infection can increase plant fitness, suggesting that
acquisition of virus resistance might decrease plant fitness. For
example, infection by barley yellow dwarf virus was found in at least 1
year to increase the fitness of the host plant green foxtail (Setaria
viridis) by approximately 25% (Ref. 40). In some cases, plants might be
more attractive to herbivores when not infected by viruses, as was
found to be the case for dusky coral pea (Kennedya rubicunda; Ref. 41).
In this experiment, caged rabbits presented with a mixture of carrots
and powdered plant extract grazed the mixture made from virus-free
plant material at twice the rate as plant material infected with
Kennedya yellow dwarf virus due presumably to greater palatability. In
general, negative fitness attributes would be expected to be selected
against in populations. Nevertheless, such considerations might be
important in certain instances, e.g., when evaluating possible effects
on endangered species.
    EPA believes it likely that many of the potential PVCP-PIP/plant
combinations pose a low risk of disrupting the existing network of
ecological relationships in semi-managed or natural ecosystems.
Multiple conditions must be met to pose a higher level of risk, i.e.,
hybridization with a wild relative must occur, introgression of the
gene must occur, and acquired virus resistance must confer an advantage
(or disadvantage) to the recipient plant sufficient to alter plant
population dynamics. Nevertheless, the research discussed above showing
that in some cases viruses can affect plant population dynamics for at
least some plants highlights the difficulty in drawing a general
conclusion as to whether all PVCP-PIP/plant combinations are likely to
pose a low risk of significantly disrupting existing ecological
networks. Virtually any crop could be modified to contain a PVCP-PIP,
including less domesticated forage crops and trees, and such a wide
range of plants will be associated with a concomitantly wide range of
characteristics and behaviors. Ecosystems are highly complex and
variable, and some of the factors that limit fitness of a given plant
species can be subtle and are not well understood (Ref. 15).
Consequently, EPA does not believe that the available body of evidence
would currently support a definitive conclusion for all PVCP-PIPs that
the potential transfer to wild or weedy relatives presents a low risk
of significantly altering the network of ecological relationships in
semi-managed or natural ecosystems.
    Information may be available to evaluate the likelihood of acquired
virus resistance impacting a particular plant species or population.
However, the existing body of literature currently does not appear
sufficient to describe any set of circumstances that would predict for
the wide variety of possible PVCP-PIP/plant combinations whether
introgression of the PVCP-PIP into a wild or weedy relative could
change the population dynamics of the recipient plant and through this
route potentially affect ecological relationships with other plants and
other organisms in the community. For example, it is not possible to
predict a priori whether a possible fitness advantage that individual
plants might acquire with a PVCP-PIP would make the plant population
better able to compete against other species. Whether population
dynamics would be affected and ecological relationships could be
disrupted in a given circumstance is dependent on multiple, interacting
factors. In some instances, a weight-of-evidence, case-by-case review
of information such as experimental data might allow such a
determination; however, general knowledge of factors likely to
influence population dynamics cannot be readily distilled into a
straightforward criterion suitable for a categorical exemption.
    2. Proposed exemption criterion. EPA is proposing Sec.  174.27(a)
based on a set of considerations articulated by the 2005 SAP to
identify plants that would not pose concerns associated with increased
weediness of either the crop plant itself or any sexually-compatible
wild relatives, if the crop plant were to contain a PVCP-PIP. Section
174.27(a)(1) is a categorical exemption criterion for a subset of PVCP-
PIPs, i.e., a list of plants that have already been determined by the
Agency to be low risk with respect to concerns associated with
weediness irrespective of the particular PVCP-PIP the plants might
contain. Section 174.27(a)(2) is a conditional exemption criterion
based on Agency review of whether a particular plant/PVCP-PIP
combination poses low risk with respect to concerns associated with
weediness. Both parts of Sec.  174.27(a) are discussed in more detail
in Units III.E.1.iii. and III.E.1.iv. below. Note that a PVCP-PIP
qualifies for exemption based in part on its presence in a particular
crop species. The record on which this proposed exemption is based is
not currently broad enough to support an exemption for a PVCP-PIP in
another species if that species has not been evaluated for concerns
associated with weediness when it contains a particular

virus-resistant trait. A PVCP-PIP that has been moved into another
species does not qualify for the exemption unless the recipient plant
appears on the list in Sec.  174.27(a)(1). Such a PVCP-PIP would either
need an individual exemption determination under Sec.  174.27(a)(2) or
a registration in order to be sold or distributed.
    i. Proposed categorical exemption criterion in Sec.  174.27(a)(1).
As articulated above, EPA does not believe it can propose a categorical
exemption based on whether a PVCP-PIP/plant combination is likely to
result in changes in plant population dynamics because this endpoint
cannot easily be predicted based on straightforward characteristics of
the PVCP-PIP and/or plant. However, EPA believes that a criterion for a
categorical exemption could be developed based on evaluation of
individual crop species for their potential to naturalize and invade
natural ecosystems, including with acquisition of a PVCP-PIP and for
the existence of wild or weedy relatives that could acquire a PVCP-PIP
through gene flow. Certain plants are expected to pose low risk with
respect to concerns associated with weediness regardless of any
particular PVCP-PIP that the species contained. However, for the
categorical exemption, the Agency is attempting to identify those
situations where no case-by-case review is necessary to conclude that a
PVCP-PIP would present a low risk of causing adverse effects. In such
situations, a product developer could use a clearly defined criterion
to make a determination of status. Based on these considerations, EPA
has developed a list of plants that the Agency proposes a developer
could use to self-determine whether Sec.  174.27(a) is met.
    A PVCP-PIP would meet proposed Sec.  174.27(a) under Sec.
174.27(a)(1) if the plant containing the PIP is one of the following:
Anthurium (Anthurium spp.), asparagus (Asparagus officinale), avocado
(Persea americana), banana (Musa acuminata), barley (Hordeum vulgare),
bean (Phaseolus vulgaris), cacao (Theobroma cacao), carnation (Dianthus
caryophyllus), chickpea (Cicer arietinum), citrus (Citrus spp., e.g.,
Citrus aurantifolia, Citrus limon, Citrus paradisii, Citrus sinensis),
coffee (Coffea arabica and Coffea canephora), corn (Zea maize), cowpea
(Vigna unguiculata), cucumber (Cucumis sativus), gerbera (Gerbera
spp.), gladiolus (Gladiolus spp.), lentil (Lens culinaris), mango
(Mangifera indica), orchids (Orchidaceae), papaya (Carica papaya), pea
(Pisum sativum), peanut (Arachis hypogaea), pineapple (Ananas comosus),
potato (Solanum tuberosum), soybean (Glycine max), starfruit (Averrhoa
carambola), sugarcane (Saccharum officinarum), or tulips (Tulipa spp.).
    EPA developed this list of plants after consultations with both the
2004 and 2005 SAPs. The 2004 SAP recommended a longer list of plants,
chosen initially based on the presumption that they had no wild or
weedy relatives in the United States. However, the 2005 SAP noted that
the longer list of plants recommended by the 2004 SAP clearly contained
``some species that form viable crop-wild hybrids...'' (Ref. 11).
Recognizing that much of the most useful information is not likely to
be found in the literature, ``the Panel recommended consulting
agronomists, breeders, and/or ecologists with specialized expertise
before including any crop on a list of exempt species'' (Ref. 11). The
2005 Panel also recommended a specific set of conditions that each
species would have to meet based on the advice of such experts (i.e.,
agronomists, breeders, and/or ecologists with specialized expertise) if
it were to be placed on the list:
    1. A crop should be included on the exempt list if it forms no
viable hybrids with wild or weedy relatives anywhere in the US...
    2. A crop should...be included on the exempt list only if it is
[not] currently weedy or invasive...
    3. A crop should be included on the exempt list if... it will
not establish weedy or invasive populations if it becomes virus
resistant (due to a PVCP-PIP)...
    4. If a PVCP-PIP crop has the potential to naturalize, but the
PVCP-PIP transgene is in biocontainment and/or biomitigation
constructs that are stacked such that escapes from cultivation are
too unfit to compete with the wild type, a consensus of breeders,
agronomists, and ecologists, or others with experience with the
species could advise addition to the list (Ref. 11).

    EPA believes that the first three conditions proposed by the 2005
SAP are useful factors in evaluating whether a plant warrants inclusion
on the list in Sec.  174.27(a)(1). EPA considered each of these factors
when evaluating each of the plants currently on the list in proposed
Sec.  174.27(a)(1). However, EPA also recognizes that plants that do
not strictly meet condition 1 as laid out by the SAP may nevertheless
be determined to pose low risk with respect to weediness concerns after
a case-by-case review of the plants' traits and consideration of the
whole range of factors that affect weediness. For example, corn may not
meet the first condition above as articulated by the SAP if it proves
to in fact have wild relatives in some region of the United States with
which it can form viable hybrids. However, as discussed below, EPA does
not believe that the characteristics of the wild relatives or the
hybrids that could be formed suggest any reason to suspect acquired
virus resistance would change the weediness potential of corn, the
hybrid, or the wild relative, and EPA therefore proposes to include
corn on the list. Thus, in practice EPA considers the 2005 SAP's first
three conditions as a useful guide of the factors that should be taken
into account in evaluating whether to include a plant on the list.
However, EPA believes that relying on a strict interpretation of these
conditions would exclude many plants containing PVCP-PIPs that meet
FIFRA's low risk standard. The 2005 SAP itself suggested that some
flexibility of interpretation might be appropriate. Although the Panel
used the phrase ``no viable hybrids'' in condition 1, the Panel
elsewhere recommended against granting exemption to crops with
``sexually compatible wild relatives'' where ``sexually compatible
refers to the possibility of having crop transgenes backcross and
introgress into the relative; it does not refer to sterile hybrids''
(Ref. 11).
    Although EPA considered the first three conditions proposed by the
2005 SAP in deciding whether to include a particular plant species on
the list in Sec.  174.27(a)(1), EPA believes that the fourth condition
as articulated would be inappropriate for these purposes. A
biocontainment and/or biomitigation construct would be associated with
a particular PVCP-PIP, not a particular plant species. The intent of
Sec.  174.27(a)(1) is to list species that would not present concerns
related to weediness regardless of the particular PVCP-PIP that the
species contained. EPA believes that construct-specific considerations
could be taken into account under an Agency review procedure such as
that described below in Unit III.C.2.iii.
    The Panel recommended ``consulting agronomists, breeders, and/or
ecologists with specialized (taxon-specific) expertise on weedy
populations before including any crop on a list of exempt species''
because this information ``is difficult to ascertain from the
literature and determining the probability that a crop will be more
weedy or invasive if it contains a PVCP-PIP is even more difficult.''
Likewise, the Panel indicated ``[i]t is very difficult to identify
crops that have no sexually compatible wild or weedy relatives in the
US or its possessions and that do not become weedy or invasive
themselves. This information is unique to each crop, is often not
published, and is often known only by the agronomists, breeders, and

ecologists working with the specific taxa in question'' (Ref. 11). EPA
agrees that such information is difficult to obtain from the literature
and therefore relied on written consultation with such experts in
evaluating whether the three conditions proposed by the 2005 SAP had
been met for a particular crop species.
    In consulting with experts for a particular crop, EPA asked at
least three individuals a series of questions designed to address the
issues identified by the 2005 SAP as relevant for evaluating whether a
PVCP-PIP would be low risk with respect to concerns associated with
weediness if it were to be found in the particular species.
Specifically, EPA wanted to know:
     Does this crop form viable hybrids in nature (i.e.,
without human intervention) with wild or weedy relatives in the United
States (including Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa)?
    If yes, what species are they? Which of these species are
themselves commercially grown crops? What is the frequency of hybrid
production? Have hybrids demonstrated enhanced fitness (vigor) relative
to parental varieties? Can the hybrids reproduce asexually? Are the
hybrids sexually fertile?
    If hybrids are sexually fertile, will they outcross or only
backcross with the crop parent? How does the phenology of the crop
species compare with the phenology of plant(s) with which it is
sexually compatible? Are there any other attributes of these species
that may enhance or inhibit sexual reproduction and species out-
crossing?
     Is this crop known to become feral or easily spread into
non-crop areas in the United States (including Puerto Rico, the Virgin
Islands, Guam, the Trust Territory of the Pacific Islands, and American
Samoa)? If yes, have escaped plants formed reproducing and sustaining
populations in non-crop areas? Where has this been known to happen?
With what frequency is this likely to occur? Have feral populations
required weed management activity?
     How likely is it that this crop would become feral or
easily spread into non-crop areas if it acquired transgenic resistance
to one or more viruses? What is the basis for your answer?
    EPA focused these questions on ``non-crop areas'' to emphasize that
the key consideration is a crop's behavior in natural settings. EPA
recognizes that most crops within agricultural fields form volunteer
populations, where propagules of the crop from the previous rotation
grow in the subsequent crop rotation. The Agency did not consider
behavior in crop areas when evaluating the crops for inclusion on the
list at proposed Sec.  174.27(a)(1).
    The responses to specific Agency-posed questions received from
these expert consultations are available in the docket for this
proposed rule (Ref. 42). EPA considered the experts' responses in
conjunction with other information when determining whether to list a
crop at proposed Sec.  174.27(a)(1), as discussed below. Crops that EPA
evaluated but did not include in the proposed list for one reason or
another are discussed in Unit VII where comment on these crops is
specifically requested.
    EPA notes that the 2005 SAP also suggested the Agency ``consider
the geographic distribution of crops and their wild relatives when
considering potential exemptions'' (Ref. 11). Although this is a
potential option the Agency could pursue, a number of considerations
limit the utility of using the potential for geographic isolation in
determining whether a plant could be included on the list in Sec.
174.27(a)(1). For example, EPA would need to consider carefully whether
such isolation is likely to remain throughout the commercial life of
the PVCP-PIP. Such isolation could occur if the crop containing the
PVCP-PIP would not be commercially viable in the areas where wild
relatives occur given biological considerations that are unlikely to
change. However, geographic isolation could also be due to factors that
may change throughout the commercial life of a PVCP-PIP, e.g.,
individual farmer choices of which crops to plant. Because of such
considerations, EPA anticipates that it would only be able to support
an exemption dependant on geographic restrictions where biological or
similar factors provide assurance that the geographic isolation will
remain constant during the entire commercial life of the PVCP-PIP.
    The next several Subunits summarize EPA's conclusions to include
the crops listed at proposed Sec.  174.27(a)(1) based on consideration
of the conditions suggested by the 2005 SAP and their recommendation
that evaluation of these conditions be done in consultation with
breeders, agronomists, and ecologists familiar with the particular
species. The analyses below indicate that there is an extremely low
probability that virus resistance conferred through a PVCP-PIP in any
of these plants would significantly alter existing plant population
dynamics or existing ecological relationships. The list is
straightforward, providing an easy-to-understand criterion.
Accordingly, EPA is proposing that a developer may self-determine
whether a PVCP-PIP meets this criterion, i.e., whether the plant
containing the PVCP-PIP is on the proposed list, because no further
data or information would be needed to evaluate whether ecological
relationships could be disrupted through increased weediness when the
plant modified to contain the PVCP-PIP is on the list.
    a. Anthurium. EPA proposes that anthurium (Anthurium spp.) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with anthurium experts. These consultations indicate that anthurium
meets the three conditions outlined above by the SAP: It does not have
wild or weedy relatives in the United States with which it can form
viable hybrids in nature, it is not currently weedy or invasive in the
United States, and there is no reason to believe that acquisition of
virus resistance would make anthurium weedy or invasive. All three
experts contacted by EPA indicated agreement with these statements. For
example, one expert stated, ``The commercial species [of] Anthurium
(Anthurium schezerianum and Anthurium andraenum) have been grown
outdoors since the early 1900's in semi-tropical and tropical areas of
the US and there are no records of any commercial species escaping and
becoming feral into non-crop areas. There is no reason to believe that
acquiring transgenic resistance to one or more viruses would increase
the ability of plants to become feral or easily spread into non-crop
areas'' (Ref. 42). EPA therefore believes that anthurium meets the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    b. Asparagus. EPA proposes that asparagus (Asparagus officinale) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with asparagus experts. These consultations indicate that asparagus
meets the three conditions outlined above by the SAP. One, it does not
have wild or weedy relatives in the United States with which it can
form viable hybrids in nature. One expert said, ``Although volunteer
asparagus plants may grow ``wild'' (i.e., not intentionally
cultivated), they are not typically considered to be weeds. There are
several horticultural varieties of asparagus, which could potentially
be cross-pollinated. However, considering that asparagus is insect
pollinated, this is likely to occur only in the rare situation where an
asparagus grower also is growing horticultural varieties'' (Ref. 42).
Second, the experts agreed that asparagus is not currently weedy or
invasive outside of agricultural fields in

the United States. Two of the three experts indicated that asparagus
can infrequently become feral. However, ``[a]sparagus is not typically
considered to be a weedy species. In addition, since asparagus has
separate male and female plants, it is considerably more difficult for
``wild'' populations to become established. Asparagus is also a
relatively slow growing plant such that eradication (if necessary)
would not be particularly onerous'' (Ref. 42). Third, these experts
agreed that it is unlikely that acquisition of virus resistance would
make asparagus weedy or invasive. For example, one expert stated, ``I
have worked with this crop since 1978 and in all those years, I have
not observed asparagus to become easily spread at all in non-crop or
crop areas. Although asparagus does rarely grow wild in some areas
(usually the temperate zones) asparagus is a very poor competitor with
weeds and other plants and asparagus requires much attention and
cultural care to thrive. I have only viewed a very rare occassionaly
[sic] plant along fence rows and they usually are very weak and non-
vigorous. Acquired transgenic resistance would do nothing to affect
asparagus to become feral'' (Ref. 42). EPA therefore believes that
asparagus meets the conditions recommended by the 2005 SAP for
inclusion on the list and will present low risk with respect to
weediness.
    c. Avocado. EPA proposes that avocado (Persea americana) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with avocado experts. These consultations indicate that avocado meets
the three conditions outlined above by the SAP: It does not have wild
or weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make avocado weedy or invasive. All three experts
contacted by EPA indicated agreement with these statements. For
example, one expert stated ``Transgenic resistance should not affect
the likelihood of spread. Viral susceptibility is not an important
factor limiting the plant's ability to become feral'' (Ref. 42). EPA
therefore believes that avocado meets the conditions recommended by the
2005 SAP for inclusion on the list and will present low risk with
respect to weediness.
    d. Banana. EPA proposes that banana (Musa acuminata) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with banana
experts. These consultations indicate that banana meets the three
conditions outlined above by the SAP: It does not have wild or weedy
relatives in the United States with which it can form viable hybrids in
nature, it is not currently weedy or invasive in the United States, and
there is no reason to believe that acquisition of virus resistance
would make banana weedy or invasive. All three experts contacted by EPA
indicated agreement with these statements. For example, one expert
stated ``[i]t is highly unlikely that banana with acquired transgenic
resistance would spread to non-crop areas because the probability of
crossing is extremely small. Through vegetative propagation it will
require man [sic] intervention just as non-transgenic plants'' (Ref.
42). EPA therefore believes that banana meets the conditions
recommended by the 2005 SAP for inclusion on the list and will present
low risk with respect to weediness.
    e. Barley. EPA proposes that barley (Hordeum vulgare) be included
on the list in Sec.  174.27(a)(1) based on EPA consultations with
barley experts. These consultations indicate that barley meets the
three conditions outlined above by the SAP: It does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make barley weedy or invasive, as viruses are not
consistently associated with failure of barley to show any evidence of
being weedy or invasive. Three experts contacted by EPA indicated
agreement with these statements. For example, one expert stated that he
believes the likelihood that barley would become feral or easily spread
into non-crop areas if it acquired transgenic virus resistance is
``negligible. Barley has been cultivated for decades in many U.S.
environments, including environments that impose relatively mild
disease pressure, particularly for viral diseases, such as the upper
midwest and western states, and barley has not been able to establish
itself in those regions as a feral species'' (Ref. 42). EPA notes that
the 2005 SAP indicated that ``barley can hybridize with Hordeum
jubatum, which is a weed in the USA'' (Ref. 11). However, three barley
breeders consulted about this specific issue did not agree that
hybridization was likely to occur. One stated, ``In relation to Hordeum
vulgare subsp. Vulgare (cultivated barley) Hordeum jubatum is in the
tertiary genepool. This means crossability is extremely difficult event
under laboratory conditions'' (Ref. 42). A study that attempted to
cross barley with two wild relatives, H. murinum L. and H. jubatum L.,
found that no hybridization occurred, even under favorable greenhouse
conditions with forced pollination (Ref. 43). EPA therefore believes
that barley meets the conditions recommended by the 2005 SAP for
inclusion on the list and will present low risk with respect to
weediness.
    f. Bean. EPA proposes that bean (Phaseolus vulgaris) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with bean
experts. These consultations indicate that bean meets the three
conditions outlined above by the SAP. One, it does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature. One expert mentioned that ``[h]ybrids between
Phaseolus vulgaris and Phaseolus acutifolius (tepary bean) are only
achieved through extensive crossing and embryo rescue and thus is
highly unlikely to occur in nature'' (Ref. 42). Another expert said
bean would ``only - but rarely - hybridize with wild vulgaris (only
where wild vulgaris occur, generally not in [the United States] & there
are often biological barriers to such occurring'' (Ref. 42). Second,
these experts agreed that bean is not currently weedy or invasive in
the United States. Third, these experts agreed that it is unlikely that
acquisition of virus resistance would make bean weedy or invasive. For
example, one expert stated, ``Viruses generally do not prevent
susceptible beans from making a crop (just the yield and quality of the
crop is greatly reduced'' (Ref. 42). EPA therefore believes that bean
meets the conditions recommended by the 2005 SAP for inclusion on the
list and will present low risk with respect to weediness.
    g. Cacao. EPA proposes that cacao (Theobroma cacao) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with cacao
experts. These consultations indicate that cacao meets the three
conditions outlined above by the SAP: It does not have wild or weedy
relatives in the United States with which it can form viable hybrids in
nature, it is not currently weedy or invasive in the United States, and
there is no reason to believe that acquisition of virus resistance
would make cacao weedy or invasive. All three experts contacted by EPA
indicated agreement with these statements. For example, one expert
stated that ``cacao is difficult to cultivate, the seeds are very
susceptible to desiccation, and germination must occur within a few
days or the seed die [sic]'' (Ref. 42). EPA therefore believes that
cacao meets the conditions

recommended by the 2005 SAP for inclusion on the list and will present
low risk with respect to weediness.
    h. Carnation. EPA proposes that carnation (Dianthus caryophyllus)
be included on the list in Sec.  174.27(a)(1) based on EPA
consultations with carnation experts. These consultations indicate that
carnation meets the three conditions outlined above by the SAP. One, it
does not have wild or weedy relatives in the United States with which
it can form viable hybrids in nature. Two, it is not currently weedy or
invasive in the United States. One expert indicated that Arkansas and
Massachusetts have populations of feral Dianthus caryophyllus. However
these have not required management activity because ``populations have
remained small consisting of only a few plants'' (Ref. 42). Three,
there is no reason to believe that acquisition of virus resistance
would make carnation weedy or invasive. One expert stated, ``Most
species of Dianthus are self-incompatible, and commercial selections of
carnation require hand pollination, and set little viable seed. There
is no record of carnation, D. caryophyllus, being naturalized or
invasive in any part of the world'' (Ref. 42). EPA therefore believes
that carnation meets the conditions recommended by the 2005 SAP for
inclusion on the list and will present low risk with respect to
weediness.
    i. Chickpea. EPA proposes that chickpea (Cicer arietinum) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with chickpea experts. These consultations indicate that chickpea meets
the three conditions outlined above by the SAP: It does not have wild
or weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make chickpea weedy or invasive. All three experts
contacted by EPA indicated agreement with these statements. For
example, one expert stated that ``there is no chance that chickpea
would become feral with or without virus resistance. The susceptibility
of the seeds to rotting without seed treatment would prevent any spread
to non-crop areas. Resistance to viruses would not affect this
outcome'' (Ref. 42). EPA therefore believes that chickpea meets the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    j. Citrus. EPA proposes that citrus (Citrus spp.) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with citrus
experts. These consultations indicate that citrus meets the three
conditions outlined above by the SAP. One, it does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature. One expert mentioned that citrus can hybridize with
other Citrus species and certain other closely related species in the
sub-family Aurantioidea. However, this expert also noted that it was
unlikely to hybridize naturally with any of these species that are
found in the United States because they are not closely related and
``would only be in the tertiary genepool for citrus'' (Ref. 42).
Another expert pointed out that Rangpur lime is sometimes mentioned as
native to Florida, but he did not think this was true; as far as he
knew, there are no wild or weedy relatives of citrus found in the
United States. Second, these experts agreed that citrus is not
currently weedy or invasive in the United States. One expert mentioned
that there are ``small feral populations of citrus found in Florida,
mostly on the borders of the Everglades area and in some old
forests.... However, these populations have not expanded their range. I
know of no weed management efforts'' (Ref. 42). Third, these experts
agreed that it is unlikely that acquisition of virus resistance would
make citrus weedy or invasive. For example, one expert stated that
``citrus is simply not an aggressive grower with or without a virus''
(Ref. 42). EPA therefore believes that Citrus species meet the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    k. Coffee. EPA proposes that coffee (Coffea arabica and Coffea
canephora) be included on the list in Sec.  174.27(a)(1) based on EPA
consultations with coffee experts. These consultations indicate that
both species of coffee meet the three conditions outlined above by the
SAP: They do not have wild or weedy relatives in the United States with
which they can form viable hybrids in nature, they are not currently
weedy or invasive in the United States, and there is no reason to
believe that acquisition of virus resistance would make coffee weedy or
invasive. All three experts contacted by EPA indicated agreement with
these statements. For example, one expert stated, ``Coffee plantations
that are abandoned usually decay and are not overtaken by coffee
plants. The crop needs maintenance to grow properly. It is not a weedy
species'' (Ref. 42). EPA therefore believes that coffee meets the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    l. Corn. EPA proposes that corn (maize; Zea mays) be included on
the list in Sec.  174.27(a)(1) based on EPA's extensive experience
regulating PIPs in corn (Ref. 44), literature that is available on corn
biology, the OECD Consensus Document on the Biology of Zea mays subsp.
mays (Maize) (Ref. 45), and EPA consultations with corn experts (Ref.
42). OECD consensus documents are written by national experts who
freely consult with breeders, agronomists, and ecologists who are
specialists in the field. Each document must be reviewed and approved
by experts in the 30 OECD member countries, and often by experts from
non-OECD member countries. This body of information indicates that corn
is low risk with respect to concerns associated with weediness.
    EPA's 2001 risk assessment for Bt PIPs evaluated the potential for
corn to form viable hybrids with wild or weedy relatives in the United
States (Ref. 44). EPA's summary conclusion was that while wild
relatives of corn (i.e., Eastern Gama Grass and teosintes) may exist in
the United States, there is no significant risk of gene capture and
expression of a PIP in any of these relatives. The potential for
pollen-directed gene flow from corn to Eastern Gama Grass is extremely
remote. This is evidenced by the difficulty with which Tripsacum
dactyloides x Zea mays hybrids are produced in structured breeding
programs. Additionally, the genus does not represent any species
considered as serious or pernicious weeds in the United States or its
territories. Any introgression of genes into this species as a result
of cross fertilization with genetically modified corn is not expected
to result in a species that is weedy or difficult to control. In many
instances where hybridization has been directed between these two
species, the resultant genome is lacking in most or all of the corn
chromosomal complement in subsequent generations. Many of the Zea
species loosely referred to as ``teosintes'' will produce viable
offspring when crossed with Zea mays ssp. mays. None of these plants
are known to harbor weedy characteristics, and none of the native
teosinte species, subspecies, or races are considered to be aggressive
weeds in their native or introduced habitats. In fact, many are on the
brink of extinction where they are indigenous and will be lost without
human intervention (i.e., conservation measures). Two of the three
experts EPA consulted indicated that corn will not form viable hybrids
with any wild or weedy relatives in the United States.

The third indicated that hybrids could be formed with teosintes, but
that a hybrid ``would lose its seed dispersal ability, so would have
highly diminished ability to propagate in the wild. In regions where
teosinte is a weed (mostly in Mexico), the teosintes have been
naturally selected to have `gametophyte factors' (e.g., Ga1-s, Tcb1),
that essentially block corn pollen from fertilizing teosinte'' (Ref.
42).
    Further, the body of information and the experts that EPA consulted
on corn indicate that it is not currently weedy or invasive in the
United States. None of the landraces or cultivated lines of Zea mays
are considered to have weedy potential, and all are generally
considered to be incapable of survival in the wild as a result of
breeding practices (i.e., selection) during domestication of the crop.
According to the OECD consensus document, ``[m]aize has lost the
ability to survive in the wild due to its long process of
domestication, and needs human intervention to disseminate its seed.
Although corn from the previous crop year can overwinter and germinate
the following year, it cannot persist as a weed'' (Ref. 45). One expert
EPA consulted stated, ``Maize does not become feral or spread easily
into non-crop areas in the United States or its territories. During its
domestication many centuries ago, maize lost many of the attributes
necessary to sustain itself in nature'' (Ref. 42).
    Finally, there is no reason to believe that acquisition of virus
resistance would make corn weedy or invasive, as viruses are not
consistently associated with failure of corn to show any evidence of
being weedy or invasive. The experts EPA consulted agree that corn's
becoming weedy with acquisition of a PVCP-PIP is unlikely. For example,
one expert indicated, ``Domesticated maize has no seed dispersal
mechanism. Humans are required to remove kernels from the cob (a
typical cob holds 500-1,000 kernels, which would essentially try to all
grow in the same spot, this would starve the resulting plants for
nutrients and water and result in there being no progeny). Maize would
essentially die out within a year or two, without human intervention''
(Ref. 42). EPA therefore believes that corn meets the conditions
recommended by the 2005 SAP for inclusion on the Sec.  174.27(a)(1)
list and will present low risk with respect to weediness.
    m. Cowpea. EPA proposes that cowpea (black-eyed pea; Vigna
unguiculata) be included on the list in Sec.  174.27(a)(1) based on EPA
consultations with cowpea experts. These consultations indicate that
cowpea meets the three conditions outlined above by the SAP. One, it
does not have wild or weedy relatives in the United States with which
it can form viable hybrids in nature. One expert indicated, ``the
cowpea is a highly self-pollinating crop that rarely outcrosses with
other cowpeas. I expect that it might be possible for cowpea to rarely
outcross with a `wild' V. unguiculata, but it is probably safe to
assume that the `wild' cowpea genotypes don't exist in the United
States'' (Ref. 42). Second, the experts agreed that cowpea is not
currently weedy or invasive outside of agricultural fields in the
United States. One expert said, ``I am not aware of any instance where
the cowpea has become feral or easily spread into non-crop areas in the
United States. HOWEVER, I am aware of instances where cultivated cowpea
varieties have become weed pests in cultivated areas in the United
States where OTHER CROPS are grown. For example, cowpea varieties with
hard seeds can be a weed problem in soybean crops. The hard cowpea
seeds over-winter in the soil and can produce plants in subsequent
years; these cowpea plants often can't be easily killed by soybean
herbicides (closely related plant) and the seeds are often so close in
size to soybean seeds that [they] can be difficult to remove from the
harvested soybean product'' (Ref. 42). However, EPA considers that the
key consideration is the plant's behavior in natural settings,
including semi-managed habitat surrounding agricultural fields, as
opposed to its behavior within the fields themselves. Third, these
experts agreed that it is unlikely that acquisition of virus resistance
would make cowpea weedy or invasive. For example, one expert stated ``I
am not aware of any virus problem in cowpea, if resolved via transgenic
means, would result in the crop becoming feral'' (Ref. 42). EPA
therefore believes that cowpea meets the conditions recommended by the
2005 SAP for inclusion on the list and will present low risk with
respect to weediness.
    n. Cucumber. EPA proposes that cucumber (Cucumis sativus) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with cucumber experts. These consultations indicate that cucumber meets
the three conditions outlined above by the SAP: It does not have wild
or weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make cucumber weedy or invasive. The experts contacted
by EPA indicated agreement with these statements. For example, one
expert stated that ``cucumber could not become feral due to acquired
transgenic virus resistance. The failure for [cucumber] to survive
without human intervention is not due to disease attack, but rather due
to [its] ability to compete with native plants and weeds, and to
withstand the stresses they are exposed to outside of cultivation,
particularly drought'' (Ref. 42). EPA therefore believes that cucumber
meets the conditions recommended by the 2005 SAP for inclusion on the
list and will present low risk with respect to weediness.
    o. Gerbera. EPA proposes that gerbera (Gerbera spp.) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with gerbera
experts. Two experts indicated that there are no wild or weedy
relatives in the United States with which gerbera can form viable
hybrids in nature. A third said, ``Gerbera jamesonii Bolus ex Adlam has
been recorded as naturalized in Florida. However, it is most likely
Gerbera hybrida (Gerbera jamesonii x G. viridiflora Schultz-Bip) which
is the designation for the commercially available Gerberas'' (Ref. 42).
Regarding the ferality of gerbera species, two experts believed feral
populations were not known to occur, while a third noted, ``Although G.
jamesonii (or G. hybrida) is attributed to Florida, it is most likely a
low risk for forming feral populations'' (Ref. 42). All three experts
believed it unlikely that acquired virus resistance could lead to
gerbera becoming feral or easily spreading into non-crop areas. One
expert said, ``Gerbera, in general, is a short-lived perennial in the
United States. It suffers from a number of fungal and bacteria
pathogens. A transgenic virus-resistant Gerbera offers little in terms
of [increased] fitness and increased invasive potential'' (Ref. 42).
    p. Gladiolus. EPA proposes that gladiolus (Gladiolus spp.) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with gladiolus experts. These consultations indicate that gladiolus
meets the three conditions outlined above by the SAP: It does not have
wild or weedy relatives in the United States with which it can form
viable hybrids in nature, it is not currently weedy or invasive in the
United States, and there is no reason to believe that acquisition of
virus resistance would make gladiolus weedy or invasive. The experts
contacted by EPA indicated agreement with these statements. For
example, one expert said, ``No gladiolus species or hybrid has ever
been documented as having successfully naturalized in the United

States. Virus resistance is not likely to make this any more likely''
(Ref. 42). EPA therefore believes that gladiolus meets the conditions
recommended by the 2005 SAP for inclusion on the list and will present
low risk with respect to weediness.
    q. Lentil. EPA proposes that lentil (Lens culinaris) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with lentil
experts. Although lentil was not on the list of plants recommended by
the 2004 SAP, several experts consulted about other crops mentioned
that lentil also appeared to meet the criteria that EPA was
investigating. Consultations about lentil indicate that it meets the
three conditions outlined above by the SAP: It does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make lentil weedy or invasive. The experts contacted
by EPA indicated agreement with these statements. For example, one
expert stated, ``Lentil could not possibly survive in the wild on its
own. [Lentils are] rather delicate plants, small in stature and very
weak in competition for space or water. It needs great care from grower
[sic] to produce seeds in cultivation. Its seed could not possibly
survive in the wild due to rotting by soil-born microorganisms.
Resistance to one or more viruses will not increase the survivability
of lentil seeds in the wild'' (Ref. 42). EPA therefore believes that
lentil meets the conditions recommended by the 2005 SAP for inclusion
on the list and will present low risk with respect to weediness.
    r. Mango. EPA proposes that mango (Mangifera indica) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with mango
experts. These consultations indicate that mango meets the three
conditions outlined above by the SAP: It does not have wild or weedy
relatives in the United States with which it can form viable hybrids in
nature, it is not currently weedy or invasive in the United States, and
there is no reason to believe that acquisition of virus resistance
would make mango weedy or invasive. All three experts contacted by EPA
indicated agreement with these statements. For example, one expert
stated, ``spread of mango seed by humans or animals into non-crop areas
is rare and suitable environments are few. Transgenic resistance should
not affect the likelihood of spread. Viral susceptibility is not an
important factor limiting the plant's ability to become feral'' (Ref.
42). EPA therefore believes that mango meets the conditions recommended
by the 2005 SAP for inclusion on the list and will present low risk
with respect to weediness.
    s. Orchids. EPA proposes that all genera of orchids in the family
Orchidaceae be included on the list in Sec.  174.27(a)(1) based on EPA
consultations with orchid experts. These consultations indicate that
orchids meet the three conditions outlined above by the SAP: They do
not have wild or weedy relatives in the United States with which they
can form viable hybrids in nature, they are not currently weedy or
invasive in the United States, and there is no reason to believe that
acquisition of virus resistance would make orchids weedy or invasive.
All three experts contacted by EPA indicated agreement with these
statements. For example, one expert stated, ``Species within these
genera have specific insect pollinators and those insects are unlikely
[to] be present for pollination in United States. In addition, species
within these genera are very difficult to grow from seed without human
intervention, requiring a symbiotic relationship with a specific fungal
species. Acquiring transgenic resistance to one or more viruses would
not affect pollination or seed germination'' (Ref. 42). EPA therefore
believes that species in the orchid family meet the conditions
recommended by the 2005 SAP for inclusion on the list and will present
low risk with respect to weediness.
    t. Papaya. EPA proposes that papaya (Carica papaya) be included on
the list in Sec.  174.27(a)(1) based on EPA consultations with papaya
experts. These consultations indicate that papaya meets the three
conditions outlined above by the SAP. First, it does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature. Although Carica papaya has been successfully crossed
with Vasconellea species using laboratory-based embryo rescue
techniques, such hybrids do not form in nature (Ref. 42). Second,
although all three breeding experts agreed that papaya is known to
establish outside of agricultural areas through human- and animal-
mediated seed dispersal, the species is not considered to be weedy or
invasive. For example, one expert stated, ``I have observed small feral
[papaya] populations in Guam, Hawaii and Puerto Rico... in areas close
to human dwellings and activities.... The feral papayas are not weedy
and are nonaggressive, they can easily be removed by cutting down.''
Further, as stated in USDA-APHIS' response to a petition for
determination of nonregulated status for transgenic virus-resistant
papaya, ``Papaya is not listed as a weed in the Federal Noxious Weed
Act (7 U.S.C. 2801-2813) and is not reported by the Weed Society of
America to be a common or troublesome weed anywhere in the United
States (Bridges and Bauman, 1992; Holm et al. 1979; Muenscher, 1980)''
(Ref. 46). Third, two of three experts indicate there is no reason to
believe that acquisition of virus resistance would make papaya weedy or
invasive. The third expert said that it was ``[v]ery likely'' papaya
would become feral or easily spread into non-crop areas if it acquired
transgenic resistance to one or more viruses because ``[a]necdotal and
informal reports at papaya conferences gave evidence that the virus
resistance transgene was found in feral populations'' (Ref. 42).
However, this comment seems to reflect the fact, as noted above, that
papaya does occasionally form feral populations in spite of not being
weedy or aggressive, and this characteristic would be expected whether
the papaya is transgenic or not. In his comments to EPA, another expert
concludes by saying that territorial records show papaya was not a weed
in Hawaii prior to the discovery of papaya viruses in the 1940s. If
papaya was not considered a weed prior to exposure to viruses, then
there is no reason to believe that a virus resistant papaya would
become a weed. Another expert corroborates this conclusion by stating,
``I see no competitive advantage of [virus-resistant] transgenic
papayas over nontransgenic papayas.... Papaya requires high levels of
human inputs to thrive or survive, including fertilizers, chemicals and
care'' (Ref. 42). EPA therefore believes that papaya meets the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    u. Pea. EPA proposes that pea (Pisum sativum) be included on the
list in Sec.  174.27(a)(1) based on EPA consultations with pea experts.
These consultations indicate that pea meets the three conditions
outlined above by the SAP: It does not have wild or weedy relatives in
the United States with which it can form viable hybrids in nature, it
is not currently weedy or invasive in the United States, and there is
no reason to believe that acquisition of virus resistance would make
pea weedy or invasive. All three experts contacted by EPA indicated
agreement with these statements. For example, one expert stated, ``pea
is not likely to become feral or easily spread into non-

crop areas due to acquired resistance to one or more viruses.
Acquisition of transgenic viral resistance would not provide any
adaptive advantage for survival of the transgenic crop plants. Peas
have been produced in the US for more than 75 years with infrequent
viral epidemics (5-9 year cycles) and no feral populations of pea have
been recorded; therefore environmental and cultural conditions are the
more likely agent preventing establishment of feral populations'' (Ref.
42). EPA therefore believes that pea meets the conditions recommended
by the 2005 SAP for inclusion on the list and will present low risk
with respect to weediness.
    v. Peanut. EPA proposes that peanut (Arachis hypogaea) be included
on the list in Sec.  174.27(a)(1) based on EPA consultations with
peanut experts. These consultations indicate that peanut meets the
three conditions outlined above by the SAP: It does not have wild or
weedy relatives in the United States with which it can form viable
hybrids in nature, it is not currently weedy or invasive in the United
States, and there is no reason to believe that acquisition of virus
resistance would make peanut weedy or invasive. All three experts
contacted by EPA indicated agreement with these statements. For
example, one expert stated, ``virus pressure is not the limiting
factor. Even without virus pressure peanut (Arachis hypogaea) are not
able to become feral or easily spread into non-crop areas. Peanut are
not able to sustain long term natural populations without cultivation
by man'' (Ref. 42). EPA therefore believes that peanut meets the
conditions recommended by the 2005 SAP for inclusion on the list and
will present low risk with respect to weediness.
    w. Pineapple. EPA proposes that pineapple (Ananas comosus) be
included on the list in Sec.  174.27(a)(1) based on EPA consultations
with pineapple experts. These consultations indicate that pineapple
meets the three conditions outlined above by the SAP. One, it does not
have wild or weedy relatives in the United States with which it can
form viable hybrids in nature. One expert indicated, ``The taxonomy of
the genus Ananas was recently critically reviewed and revised (Chan et
al., 2003) and all of the wild relatives of pineapple are classified in
the same genus and species as the cultivated pineapple but are
different botanical varieties. These are Ananas comosus var.
ananassoides and A. comosus var. parguazensis (Chan et al., 2003). If
these wild relatives are found in the United States and its territories
they would be in cultivated gardens or in pots. There are no reports
that A. comosus var comosus or its wild relatives survive naturally in
the wild or pose a potential threat as weed species. If natural crosses
between Ananas species occur in nature, it is highly unlikely that seed
produced from them would survive to produce a mature plant'' (Refs. 42
and 47). Second, the experts agreed that pineapple is not currently
weedy or invasive in the United States. Third, these experts agreed
that it is unlikely that acquisition of virus resistance would make
pineapple weedy or invasive. For example, one expert stated, ``Assuming
transgenic plants were resistant to all known pests, pineapple still
cannot compete with weeds, which quickly overtop slower growing
pineapple plants. Pineapple lacks any natural mechanism for vegetative
propagation and does not propagate naturally by seeds because seedlings
are delicate and require special care to survive to maturity'' (Ref.
42). EPA therefore believes that pineapple meets the conditions
recommended by the 2005 SAP for inclusion on the list and will present
low risk with respect to weediness.
    x. Potato. EPA proposes that potato (Solanum tuberosum) be included
on the list in Sec.  174.27(a)(1) based on the Agency's experience
regulating PIPs in potato (Ref. 44), literature that is available on
potato biology, the OECD Consensus Document on the Biology of Solanum
tuberosum subsp. tuberosum (Potato) (Ref. 48), and EPA consultations
with potato experts (Ref. 42). This body of information indicates that
potato is low risk with respect to concerns associated with weediness.
    EPA's 2001 risk assessment for Bt PIPs evaluated the potential for
potato to form viable hybrids with wild or weedy relatives in the
United States (Ref. 44). EPA's conclusion was that there is no
foreseeable risk of gene capture and PIP expression in wild relatives
of Solanum tuberosum in the United States. Successful gene