published information on the biology of this protein indicate that this
PIP inert ingredient is not known to be toxic and/or pathogenic to
plant or animal species. In 1996, the Agency granted a tolerance
exemption for this PIP inert ingredient in all plants due to the low
human health risks associated with this protein (40 CFR 180.1174; 61 FR
40338, August 2, 1996). Based on all of its assessments, EPA has
determined that this inert ingredient will pose low ecological and
occupational risk.
    EPA has conducted an environmental risk assessment of the PIP inert
ingredient glyphosate oxidoreductase (GOX) and the genetic material
necessary for its production. Topics covered in this assessment include
mode of action, ecological effects, endangered species considerations,
and gene flow from a modified crop to wild or weedy relatives. Data
cited in this assessment were submitted to the Agency in support of
Monsanto's MON 810 Bt Corn registration. Ecological data and published
information on the biology of this protein indicate that this PIP inert
ingredient is not known to be toxic and/or pathogenic to plant or
animal species. In 1997, the Agency granted a tolerance exemption for
this PIP inert ingredient in all plants due to the low human health
risks associated with this protein (40 CFR 180.1190; 62 FR 52505,
October 8, 1997). Based on all of its assessments, EPA has determined
that this inert ingredient will pose low ecological and occupational
risk.
    EPA has conducted an environmental risk assessment of the PIP inert
ingredient neomycin phosphotransferase II (NPTII) and the genetic
material necessary for its production. Topics covered in this
assessment include mode of action, ecological effects, endangered
species considerations, and gene flow from a modified crop to wild or
weedy relatives. Data cited in this assessment were submitted to the
Agency in support of Monsanto's NewLeaf Potato and YieldGard Plus Corn
registrations and is discussed in more detail in the Bacillus
thuringiensis Plant-Incorporated Protectant and MON 863 Biopesticide
Registration Action Documents (Ref. 123). Ecological data and published
information on the biology of this protein indicate that this PIP inert
ingredient is not known to be toxic and/or pathogenic to plant or
animal species. In 1994, the Agency granted a tolerance exemption for
this PIP inert ingredient in all plants due to the low human health
risks associated with this protein (40 CFR 180.1134; 59 FR 49351,
September 28, 1994). Based on all of its assessments, EPA has
determined that this inert ingredient will pose low ecological and
occupational risk.
    EPA has conducted an environmental risk assessment of the
Escherichia coli-derived PIP inert ingredient beta-D-glucuronidase
(GUS) and the genetic material necessary for its production. Topics
covered in this assessment include mode of action, ecological effects,
endangered species considerations, and gene flow from a modified crop
to wild or weedy relatives. Data cited in this assessment were
submitted to the Agency in support of Monsanto's Bollgard II Bt cotton
registration and are discussed in the Bollgard II Biopesticide
Registration Action Document (Ref. 124). Ecological data and published
information on the biology of this protein indicate that this PIP inert
ingredient is not known to be toxic and/or pathogenic to plant or
animal species. In 2001, the Agency granted a tolerance exemption for
this PIP inert ingredient in all plants due to the low human health
risks associated with this protein (40 CFR 180.1216; 66 FR 42957,
August 16, 2001). Based on all of its assessments, EPA has determined
that this inert ingredient will pose low ecological and occupational
risk.
    EPA has conducted an environmental risk assessment of the
Escherichia coli-derived PIP inert ingredient phosphomannose isomerase
(PMI) and the genetic material necessary for its production. Topics
covered in this assessment include mode of action, ecological effects,
endangered species considerations, and gene flow from a modified crop
to wild or weedy relatives. Data cited in this assessment were
submitted to the Agency in support of Syngenta's MIR604 Bt corn
registration. Ecological data and published information on the biology
of this protein indicate that this PIP inert ingredient is not known to
be toxic and/or pathogenic to plant or animal species. In 2004, the
Agency granted a tolerance exemption for this PIP inert ingredient in
all plants due to the low human health risks associated with this
protein (40 CFR 180.1252; 69 FR 26770, May 14, 2004). Based on all of
its assessments, EPA has determined that this inert ingredient will
pose low ecological and occupational risk.
    EPA believes the partial tetracycline resistance gene as present in
papaya line 55-1 presents low risk to human health and the environment
and could also be added to 40 CFR part 174 subpart X. No protein is
expected to be produced from the gene because it is under the control
of a prokaryotic promoter and is only a partial gene that is not
expected to function in plants (Ref. 125). Therefore, no ecological or
human health effects would be associated with this inert ingredient as
found in papaya line 55-1 because it consists of only DNA. Transfer of
an antibiotic resistance marker gene from plants to microorganisms in
the gut or in the environment may theoretically be possible, but it is
extremely unlikely (Refs. 126 and 127). In addition, because only a
portion of the tetracycline resistance gene is present in papaya line
55-1, if any horizontal gene transfer of this genetic material were to
occur, it would be unlikely to confer antibiotic resistance to any
organism that acquired it (Ref. 125).
    EPA asked the 2005 SAP to comment on the Agency's environmental
risk assessment for the first six of these selectable markers. The
Panel concluded that the ``antibiotic resistance marker (NPTII) and
other markers (GUS and PMI) should be exempt provided they were in the
plant species determined to be of low risk using criteria'' the SAP
proposed as discussed in Unit III.C.2.i. (Ref. 11) and EPA relied on,
as appropriate, in developing the list comprising Sec.  174.27(a)(1).
In addition, the Panel concluded that the ``herbicide markers (CP4
EPSPS, GOX/GOXv247 and PAT) should not be exempted, but rather should
be considered on a case-by-case basis taking into consideration the
potential that the crop plant has to become feral'' (Ref. 11). EPA
notes, however, that the only crop plants that will be included on the
list comprising Sec.  174.27(a)(1) are those whose potential to become
feral has been considered. Thus, EPA's inclusion of these six
selectable markers in 40 CFR part 174 subpart X - List of Approved
Inert Ingredients when they are used in PIPs as inert ingredients in a
plant that satisfies Sec.  174.27(a) is consistent with the 2005 SAP's
recommendations regarding these inert ingredients.
    EPA is also considering an alternative under which NPTII, GUS, and
PMI would be exempt from FIFRA when used as inert ingredients with any
exempt PIP, regardless of the plant in which they are expressed.
Although the SAP recommended that they only be exempt provided they
were used in a plant species determined to be of low risk based on the
considerations encompassed in Sec.  174.27(a), the Panel did not
provide a rationale as to why the markers would not be considered low
risk in other plants as well. Given that these markers are widespread
in the environment and would be expected to confer no particular
selective advantage

on any plant in the environment that might express them, the Agency
knows of no rationale why this limitation would be necessary. The
Agency believes that its risk assessment would support such an
exemption for these inert ingredients.
    EPA is also proposing a technical correction to Sec.  174.480 to
make the language consistent with the general requirements for
exemption, which recognize that for some PIPs no FFDCA tolerance may be
required. In such cases, it is not necessary that the inert ingredients
have been exempted from FFDCA section 408 requirements.

V. Economic Analysis

    Virus infection is a serious problem in agricultural production.
Virtually every plant species is susceptible to infection by at least
one of more than 500 known plant viruses (Ref. 6). Particular crop or
weed hosts are nearly always infected by certain plant viruses under
natural conditions (Ref. 103). Plant viruses create economic losses for
a vast variety of crops by reducing yields and negatively affecting the
quality of the crop, damaging fruits, leaves, seeds, flowers, stems,
and/or roots (Refs. 103 and 128). Symptom development and vector
transmission rates are affected by the environment and so can vary
across locations or seasons (Ref. 103).
    Virus diseases have often resulted in devastating agricultural
losses, at times destroying entire plantings of crops in certain
locations (Ref. 103). For example, more than 100 million citrus trees
had been destroyed by citrus tristeza virus (CTV) by 1991 in citrus
growing regions around the world, including California (Ref. 129). CTV
is one of the most economically important viruses because of its
widespread distribution, the severity of damage caused by infection,
and the long life span of individual trees (Ref. 130).
    Growers may need to use several control methods during a crop
season in an attempt to prevent viral infection and dissemination,
primarily by planting virus-free material for mechanically transmitted
viruses. For vector-transmitted viruses, control measures have often
focused on chemical insecticides, fungicides, and nematicides to reduce
the population of vectors that transmit viruses from plant to plant.
However, control of vectors is not always feasible or effective as a
way to control virus transmission (Ref. 103). In another common control
strategy, crops are grown in rotation with crops that the virus does
not infect to reduce the virus load in the field. This method has
serious limitations as well. In some cases, the development of
resistant cultivars can be the only viable means of virus control.
Plants developed through conventional breeding techniques offer some
degree of virus resistance. However, breeding for resistance has not
been successful for the majority of field crops that are severely
affected by viruses (Ref. 128). In some agricultural regions, some crop
species cannot be grown effectively because of the persistent presence
of infected plant populations and/or potential virus vectors (Ref.
103). Contrary to traditional control measures, transgenic virus-
resistant crops offer an effective means of virus protection.
    This proposed rule would benefit the public by ensuring protection
of human health and the environment while also reducing the cost of and
time needed for regulatory review of transgenic virus-resistant crops.
This proposal would also help to appropriately allocate Federal
resources for risk evaluation by focusing Agency attention on those
PVCP-PIPs that warrant review. This proposed rule would also benefit
the industry by removing regulatory uncertainty for this class of
products.
    This economic analysis (EA) prepared for this proposed rule
estimates the projected compliance cost for the industry under the
baseline of full registration for all PVCP-PIPs and compares that to
the compliance cost for the potentially affected industry under the
proposed rule in order to estimate the expected savings from the
regulation relief. The steps used to obtain a cost estimate for the
proposed rule are summarized below.
    Since the nature and timing of future development of PVCP-PIPs are
unknown, the EA begins by identifying nine case studies that represent
the broadest range of PVCP-PIPs that the Agency anticipates could be
developed in the future. After considering the characteristics of the
products that have already been marketed, characteristics of the crop
plants that have been the subject of field trials for PVCP-PIPs, and
knowledge of the field of genetically engineered virus-resistant crops,
EPA estimated the percentage of products projected to be characterized
by each case study, i.e., the ``prevalence'' of the case study. The
stated prevalence represents the best estimate of the expectation of a
PVCP-PIP product like the one in a specific case study being developed
in the future.
    For each case study, a set of data would be required of a developer
in order to register the PVCP-PIP. The cost and burden of potential
data requirements for each case study under the baseline are compared
with the potential data requirement costs and burden under the proposed
option. Using the prevalence for each case study, EPA estimated the
probability of developing a PVCP-PIP product like that examined in any
of the case studies in any year, given that the Agency anticipates 1.5-
2.5 PVCP-PIPs being developed each year over a 10-year period. These
probabilities determine the frequency and timing of development and
registration of PVCP-PIPs in a model EPA designed to compute compliance
cost savings.
    To estimate compliance cost savings in any year, the number of
PVCP-PIPs like the one developed in a given case study was multiplied
by the difference between cost and burden under the proposed rule and
baseline. Since the model made use of probabilities, the average of
5,000 simulations was computed for each year to represent the annual
compliance cost savings for the proposed rule. Using this procedure,
the estimated annual impact, based on average cost estimates per data
requirement, is expected to result in a regulatory compliance cost
reduction approximately within the range of $340,000 and $360,000 a
year. Over a 10-year period, the annual average regulatory compliance
cost reduction is expected to be approximately $350,000.
    The potential exemptions under the proposed rule, as compared to
the baseline under which no PVCP-PIPs are exempted, would reduce
regulatory costs for the potentially affected industry and the EPA,
remove regulatory uncertainty for industry, and provide important
information to the public regarding the safety of exempted PVCP-PIPs.
Entities that may benefit from the proposed rule and alternative
options are the public, companies that develop and market PVCP-PIPs
(applicants and/or registrants), farmers, and the environment. However,
potential future benefits to these entities are difficult to quantify
due to data limitations and uncertain market conditions. In addition,
considerable difficulty exists in quantitatively evaluating non-market
benefits, such as reduced environmental and human health risks,
consistency of regulation, reduced regulatory uncertainty, and
improvements in public perception of biotechnology products.

VI. Preliminary Statutory Finding

A. What Risk Assessment Methodology did EPA use for this Proposed Rule?

    Generally, when EPA assesses the risks caused by the use of a
pesticide, it considers both the potential hazard that the pesticide
poses to the environment and the potential for

exposure to the pesticide due to its use. For most pesticides (e.g.,
chemical pesticides), EPA relies on data generated by laboratory
testing using representative animal models to estimate hazard
endpoints. To develop exposure estimates the Agency evaluates other
information including product characterization data, proposed use
patterns, and information generated from mathematical models. Exposure
and hazard estimates are combined to quantify the potential risk
associated with the pesticide's use. The data requirements describing
the types of information to be generated and other guidance for
assessing risk are detailed in 40 CFR part 158.
    The questions posed as part of the risk assessment in evaluating
most pesticides (e.g., biological or chemical pesticides) can also be
posed for the PVCP-PIPs that are exempted in this proposed action, and
40 CFR part 158 can be used as guidance. EPA adopted an approach for
evaluating the potential risks of PVCP-PIPs that is consistent with the
unique characteristics of pesticides produced and used in a living
plant and the scientific knowledge and experience accumulated on these
substances.
    To address the hazard endpoints described in 40 CFR part 158 for
the PVCP-PIPs that qualify for this proposed exemption, EPA relied on a
very large body of information in the public literature that was
developed through many decades of testing and observation. EPA thus did
not need to rely on animal model testing for assessing risk as it would
for most other pesticides (e.g., chemical pesticides) where specific
hazard data are lacking. In addition, PIPs are produced within the
living plant, and the pesticidal substance is used in situ in the
plant. Exposure to PVCP-PIPs is therefore limited relative to exposure
to chemical pesticides that are applied broadly in the environment,
e.g., through aerial application.
    1. Large body of knowledge and experience exists. Typically, in
assessing a pesticide for environmental risk, EPA considers data
fulfilling the information requirements posed in 40 CFR part 158 to
evaluate the potential effect of the pesticide on birds, mammals,
freshwater fish and invertebrates, estuarine and marine animals, and
nontarget plants and insects (e.g., predators, parasites, and
pollinators). For most pesticides, this information must be generated
using animal models. To address these same questions for the PVCP-PIPs
that are the subject of this proposed exemption, EPA was able to rely
on a long history of hundreds, if not thousands of years of natural
exposure to plant virus coat proteins by nontarget organisms. EPA
relies on these experiences and the scientific literature generated by
a century of food safety studies (Refs. 131 and 132) to assess the
PVCP-PIPs that are the subject of these exemptions.
    EPA also took into account the large and varied information base
available in the public scientific literature from a number of
disciplines including plant genetics, plant physiology, plant virology,
weed science, molecular biology, biochemistry, ecology, and plant
breeding. For example, the Agency used experimental data derived from
the science of plant pathology to characterize the pest resistance
mechanisms in plants (Ref. 56) and relied on the scientific knowledge
base of plant virology and virus ecology to evaluate how plant viruses
interact with each other and with the plant during infection (Ref. 60).
    2. PVCP-PIPs are produced within the living plant, and the
pesticidal substance is used in situ in the plant, affecting the
exposure paradigm. EPA used information from the fields of plant
pathology, biochemistry, microbial ecology, and ecology in considering
all aspects of risk, including exposure. PVCP-PIPs are produced within
the living plant itself, and the pesticidal substance is used in situ
in the plant to protect against pests, in contrast to most other
pesticides, which must be applied to or near the plant. Because a PVCP-
PIP is produced and used within the plant, physiological constraints
limit the amount of pesticidal substance produced by the plant.
Regardless of the tissues containing the PVCP-PIP or the level at which
PVC-protein is expressed, the PVCP-PIP, including any PVC-protein, is
contained within the plant parts. Therefore, the routes by which other
organisms may be exposed to the PVCP-PIP may be more limited, e.g.,
dietary exposure is likely to be the predominant route of exposure, and
physical contact with the plant or plant parts will generally be
necessary for exposure to occur.
    The PVCP-PIPs exempted by this proposed rule are biotic and are
subject to the processes of biodegradation and decay that all such
materials undergo (Ref. 133). Biotic materials are broken down to
constituent parts through the enzymatic processes of living organisms,
and these constituent parts are used as building blocks during growth
of other biotic substances. In addition, PVCP-PIPs are biodegradable to
their constituent elements through catabolism by living organisms.
Because of their biodegradable nature, PVCP-PIPs do not bioaccumulate
(i.e., build up in tissues because the body is unable to either break
the substance down or eliminate it) or biomagnify (i.e., progressively
build up in successive trophic levels because it bioaccumulates in the
bodies of organisms lower in the food chain). Because of these
characteristics, the potential for new exposures to occur beyond direct
physical exposures to the plant or plant parts is limited.
    A question directly affecting the exposure component of the risk
assessment that has no equivalent in the assessment of more traditional
pesticides (e.g., chemical pesticides) must be posed for PIPs. Because
PIPs are produced and used in the living plant, the possibility that
the ability to produce a PIP may be transferred by outcrossing and
hybridization from the crop plant to a wild or weedy relative was
considered. A large volume of information is available in the public
literature to assess the risks of gene flow generally (Refs. 19 and
134) and for PVCP-PIPs in particular (Refs. 12, 32, 36, 135, 136, 137,
138, 139, and 140).

B. Exemption Determination for PVCP-PIPs, Including Certain Inert
Ingredients

    EPA preliminarily concludes that PVCP-PIPs that meet the criteria
specified in this proposed action warrant exemption under FIFRA section
25(b)(2). The use of PVCP-PIPs that meet the criteria in 40 CFR 174.21,
including the criteria proposed in this Federal Register to be inserted
at 40 CFR 174.27 poses a low probability of risk to the environment and
is not likely to cause unreasonable adverse effects in the absence of
regulatory oversight. EPA bases this preliminary conclusion upon an
evaluation of the potential risks that use of PVCP-PIPs qualifying for
this exemption would reasonably pose to man and the environment, and
upon an evaluation of whether their use causes unreasonable adverse
effects. EPA preliminarily concludes that PVCP-PIPs qualifying for this
exemption pose a low probability of risk to the environment as
demonstrated by information from the fields of plant genetics, plant
physiology, plant virology, weed science, molecular biology,
biochemistry, ecology, and plant breeding; from many years of
experience growing and consuming plants that contain coat proteins from
plant viruses; and from Agency knowledge about horticultural and
agricultural practices. EPA also believes that use of these plant-
incorporated protectants in food is safe under the FFDCA section 408
standard as explained in the preamble

to this document and the companion document published elsewhere in this
issue of the Federal Register exempting residues of the PVC-protein
portion of a PVCP-PIP.
    EPA believes that PVCP-PIPs that meet the criteria in 40 CFR
174.21, including the criteria proposed in this Federal Register to be
added at 40 CFR Sec.  174.27, are also not likely to cause unreasonable
adverse effects, even in the absence of regulatory oversight. As a
result, EPA concludes that PVCP-PIPs qualifying for this exemption do
not cause any unreasonable adverse effects with respect to human
dietary risk. Taking into account the economic, social, and
environmental costs and benefits of the use of such products, as
discussed in the preamble and associated Economic Analysis (found in
the docket for this rulemaking), EPA believes that the low levels of
risks that such products present do not justify the cost of regulating
such products. Note that products that qualify for this exemption would
remain subject to the requirement for submission of information
regarding adverse effects under 40 CFR 174.71. Even though EPA believes
the probability is very low that risks would arise with the PVCP-PIPs
qualifying for this exemption, the adverse effects reporting
requirement will alert the Agency should any such rare circumstances
occur. EPA could then address such instances, as appropriate, under
FIFRA.

VII. Request for Comment

    EPA requests comment on whether the Agency has appropriately
identified in this proposed exemption those PVCP-PIPs that are of a
nature not requiring regulation under FIFRA. In particular, the Agency
requests comment on the following specific issues:
    1. EPA requests comment on whether additional plants could be
appropriately included in the list of plants comprising proposed Sec.
174.27(a)(1) because they would present low risk with respect to
concerns associated with weediness of the plant itself and any wild or
weedy relatives of the plant if it were to contain any PVCP-PIP. For
example, the 2004 SAP identified the following plants that are not
included in proposed Sec.  174.27(a)(1): almond (Prunus communis),
apricot (Prunus armeniaca), cape daisy (Osteospermum spp.),
chrysanthemum (Dendranthema spp.), celery (Apium graveolens), eggplant
(Solanum melongena), geranium (Pelargonium spp.), hyacinth (Hyacinthus
spp.), guava (Psidium guajava), kiwi (Actinidia spp.), nectarine and
peach (Prunus persica), okra (Abelmoschus esculentus), olive (Olea
europaea), parsley (Petroselinum crispum), petunia (Petunia spp.),
pistachio (Pistacia vera), plum (Prunus domestica), spinach (Spinacia
oleracea), taro (Colocasia esculenta), tomato (Solanum lycopersicum),
watermelon (Citrullus lanatus), and wishbone flower (Torenia spp.).
    EPA would be particularly interested in information about these
plants or others that addresses the questions in Unit III.C.2.i. that
EPA posed to crop experts as part of its evaluation as to whether
specific species should be included on the list. In some cases, EPA has
already consulted with one or more experts for these plants, but the
Agency does not believe it has the information necessary to draw a
conclusion for these plants. Given the reliance on expert opinion to
make these determinations, EPA would like to have responses from at
least three experts for any given crop before including it on the list
at Sec.  174.27(a)(1). In other cases, EPA completed at least three
consultations, but the Agency received information from at least one
expert suggesting that the plant may not meet the low risk standard for
inclusion in the Sec.  174.27(a)(1) list, e.g., because of questions
about the formation of viable hybrids in nature with wild or weedy
relatives or questions about the propensity of the crop to naturalize.
EPA describes its analyses in the following paragraphs and requests
assistance from the public on the issues raised.
    EPA is inclined to include almond (Prunus communis) on the list in
Sec.  174.27(a)(1) on the basis of information received from expert
consultations. However, EPA is seeking any information from the public
that would enable the Agency to complete its assessment of the
potential for a PVCP-PIP to introgress into a population of a wild or
weedy relative or a naturalized population of the species and what
effect such introgression might have. Specifically, the experts
indicated that natural hybrids may be able to form with some other
stone fruit trees (Ref. 42). However, if such trees are likely to be
found in commercial cultivation, natural hybrids would not necessarily
be expected in areas outside of managed orchards. Regarding whether
almond is a weedy species, both experts mentioned that almond forms
feral populations. However, they have not usually required weed
management activity because ``the trees are infrequent and tend to be
seen as beneficial'' (Ref. 42). One expert said, ``Almond is not highly
susceptible to viruses affecting other Prunus tree crop species. Thus
virus resistance is not a major determinate of feral almond fitness in
current environments.... Thus, it is likely that transgenic resistance
would not greatly benefit either commercial or feral almonds'' (Ref.
42).
    EPA is inclined to include amaryllis (Hippeastrum spp.) on the list
in Sec.  174.27(a)(1) on the basis of information received from
consultations with amaryllis experts that EPA conducted upon
recommendation from other experts in flower breeding. However, EPA is
seeking any information from the public that would enable the Agency to
complete its assessment of the weedy characteristics of amaryllis and
the potential for gene exchange between feral and cultivated
populations. Two experts indicated that there are no wild or weedy
relatives in the United States with which amaryllis can form viable
hybrids in nature, although one expert said, ``Hippeastrum puniceum
(Lam.) Kuntze is naturalized in Puerto Rico, the Virgin Islands,
Louisiana and Hawaii. Hippeastrum puniceum is a diploid species that is
occasionally used in breeding programs. In controlled crosses, it will
breed with other diploid species, and is probably represented in modern
Hippeastrum cultivars. However, most modern Hippeastrum cultivars
available in the florist and greenhouse trade are complex, tetraploid
hybrids that are difficult to backcross to H. puniceum'' (Ref. 42). One
expert believed that no species in the genus are known to become feral
or easily spread into non-crop areas. However, the others noted that
this occasionally occurs without requiring weed management activity.
One said, ``Hippeastrum puniceum may have been introduced into Puerto
Rico, possibly during pre-Colombian times, and it has since sparingly
naturalized.... Spread is slow and minimal and has not required
management activity'' (Ref. 42). Another said, ``Plants generally
naturalize in disturbed areas along roadsides and irrigation ditches.
The species is self-incompatible, but can form seed in naturalized
settings. The plants also reproduce asexually via off-sets. Long
distance dispersal appears minimal. Hippeastrum puniceum is considered
a low-risk introduced plant in Hawaii and appears that it does not
require active weed-management'' (Ref. 42). All three experts agreed
that it was unlikely acquisition of virus resistance would cause
amaryllis to become feral or easily spread into non-crop areas in the
United States. For example, one expert said, ``Hippeastrum has been
grown commercial outdoors since the early 1900's in semi-tropical areas
of the US (Hippeastrum is not winter-hardy).

There has not been a single record of any plants escaping and becoming
feral. 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 is inclined to include apricot (Prunus armeniaca) on the list
in Sec.  174.27(a)(1) on the basis of information received from expert
consultations. However, EPA is seeking any information from the public
that would enable the Agency to complete its assessment of the
potential for a PVCP-PIP to introgress into a population of a wild or
weedy relative or a naturalized population of the species.
Specifically, two experts indicated that apricot may be able to cross
with plum species because ``[i]f planted in close proximity apricot can
be crossed by bees to Japanese plums. That suggests the same could
happen with native US plum species, of which there are many in the
eastern US'' (Ref. 42). However, both experts suggested that the
frequency of hybrid production would be extremely low. Two experts
indicated that apricot is not known to become feral or easily spread
into non-crop areas, while the third expert said that he has ``seen
rare plants in [Michigan] that are feral or left-over homeowner trees.
They did not appear to spread as the big seeds mostly drop under the
trees and seem not very competitive compared to the weeds'' (Ref. 42).
All of the experts agreed that acquisition of virus resistance would be
unlikely to change apricot's propensity to become feral. According to
one expert, ``It is not likely that this would occur because climatic
conditions and the occurrence of fungal and bacterial diseases are more
limiting than the viruses'' (Ref. 42).
    EPA believes that more information about cape daisy (Osteospermum
spp.) is needed to address issues raised by expert consultation. EPA is
seeking any information from the public that would enable the Agency to
complete its assessment of the potential for a PVCP-PIP to enhance the
potential of species in this genus to naturalize. One expert indicated,
``Osteospermum fruticosum is a low-risk naturalized plant in Hawaii,
and is also found, along with O. ecklonis, in California. Other
Osteospermum species have naturalized in Australia and New Zealand. The
genus is endemic to the Cape Floristic Region of southern Africa which
has a Mediterranean climate. Thus, there is potential for more species
of Osteospermum to naturalize in California which, like Australia and
New Zealand, has a Mediterranean climate.... Transgenic or not,
Osteosperum [sic] has potential to further naturalize in Mediterranean
climates and needs further monitoring for invasive potential in these
areas'' (Ref. 42). However, the other two experts indicated that it was
unlikely that virus resistance would cause cape daisy to become feral
or easily spread into non-crop areas. One said, ``Other factors are
much more likely to limit its invasive potential, such as available
moisture, presence of competing vegetation, and predation by insects
and vertebrates. Viruses do not appear to be limiting its spread''
(Ref. 42). The other expert said, ``Viral resistance could conceivably
increase fecundity and spread, but there is no data to confirm or
refute the possibility'' (Ref. 42).
    EPA is inclined to include chrysanthemum (Dendranthema spp.) on the
list in Sec.  174.27(a)(1) on the basis of information received from
consultations with two chrysanthemum experts. These experts indicated
that there are no wild or weedy relatives in the United States with
which commercial chrysanthemum can form viable hybrids in nature. One
expert believed that no species in the genus are known to become feral
or easily spread into non-crop areas, while the other noted that this
has occurred rarely in California, Ohio, Pennsylvania, and
Massachusetts. Nevertheless, these populations have not required weed
management activity because they ``have remained small consisting of
only a few plants'' (Ref. 42). Both experts believed it unlikely that
acquired virus resistance could lead to commercial chrysanthemum
becoming feral or easily spreading into non-crop areas. One expert
said, ``Plants in the genus Dendranthema are generally not easily
propagated by seed, and are vegatatively [sic] propagated by cuttings
or division. They do not compete well with other plants and do not
persist in untended garden situations, and would certainly not do so in
non-crop areas'' (Ref. 42).
    EPA has received one response from an eggplant expert suggesting
that eggplant (Solanum melongena) meets the requirements for inclusion
on the list in Sec.  174.27(a)(1). This consultation indicates that
eggplant 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 eggplant weedy or invasive. The expert
said, ``Similar to other species where wild relatives have been
utilized to enhance the cultivated form of the crop, genes for improved
fitness are derived from the wild relative. Neither the disease
resistant wild relative nor the improved cultivars have shown a
propensity to become feral'' (Ref. 42). EPA is seeking public comment
on this determination because the Agency desires a more robust response
base.
    EPA believes that more information about geranium (Pelargonium
spp.) is needed to address issues raised by expert consultation. EPA is
seeking any information from the public that would enable the Agency to
complete its assessment of the potential for a PVCP-PIP to spread to a
wild or weedy population in the United States or enhance the potential
of species in this genus to naturalize. Regarding the potential for
spread to a wild or weedy population, two experts indicated that
species within this genus do not form viable hybrids in nature with
wild or weedy relatives in the United States, but a third expert said,
``In the wild, P. cucullatum will hybridize with P. betulinum (L.)
L'Her. and P. patulum Jacq. Pelargonium grandiflorum forms natural
hybrids with P. sublignosum Knuth. The extent to which these
hybridizations and other hybridizations occur is not well known'' (Ref.
42). Regarding the weedy tendencies of this genus, one expert indicated
that ``nine species are reported as naturalized or persistent in
California... but most occupy disturbed sites near cultivated or
urbanized areas'' (Ref. 42). Another expert said, ``It seems possible
that in Mediterranean climates Pelargonium could become a weed
problem'' (Ref. 42). Two other experts thought that acquisition of
virus resistance would not affect the weedy tendencies of this genus.
One said, ``Pelargonium species are notoriously poor seed producers and
are all also native to Africa, particularly South Africa. They have
specialized ecological niches that would not easily be available
anywhere in the U.S. or its territories. California is the most likely
place where this could happen, and no incidence of an adventive
Pelargonium has ever been reported. Viral resistance would not mitigate
these factors that prevent adventive establishment'' (Ref. 42).
    EPA is inclined to include hyacinth (Hyacinthus spp.) on the list
in Sec.  174.27(a)(1) on the basis of information received from
consultations with hyacinth experts. However, EPA is seeking any
information from the public that would enable the Agency to complete
its assessment of the potential for hyacinth to naturalize. Three
experts consulted indicated that this genus does not form viable
hybrids in nature with

wild or weedy relatives in the United States. Two experts indicated
that there are no naturalized species of Hyacinthus in the United
States, although a third said, ``Hyacinthus orientalis has been
reported as naturalized in the Blackland Prairies of Texas,'' but
details were not available (Ref. 42). All three experts agreed that
acquired virus resistance is unlikely to make hyacinth become feral or
spread into non-crop areas.
    On the basis of expert consultation, EPA has concluded that guava
(Psidium guajava) does not meet the low risk standard needed for
inclusion on the Sec.  174.27(a)(1) list. Two experts indicated that
more research is needed to establish the potential for outcrossing with
wild or weedy relatives. All three experts reported that guava is known
to become feral or easily spread into non-crop areas in the United
States. One expert stated, ``Guava is a vigorous, common, weed in both
warm to cool climates. It would likely give this plant additional
competitive advantage with transgenic resistance to viruses'' (Ref.
42). However, another expert believed that ``[g]uava is easily spread
without having transgenic resistance. It does not appear that
containing resistance to one or more virus [sic] would enhance its
ability to become feral'' (Ref. 42). EPA requests commenters who
believe guava would be appropriate to include on the list in Sec.
174.27(a)(1) specifically to address whether there are wild or weedy
relatives with which guava could form viable hybrids in nature in the
United States (including Puerto Rico, the Virgin Islands, Guam, the
Trust Territory of the Pacific Islands, and American Samoa) and to
address the concern that guava is a weedy species and acquisition of
virus resistance could exacerbate these tendencies. Please provide
literature citations or other evidence to support any claims contrary
to EPA's expert consultations.
    EPA believes that more information about lily (Lilium spp.) is
needed to address issues raised by expert consultation conducted after
recommendation from other flower experts. EPA is seeking any
information from the public that would enable the Agency to complete
its assessment of the potential for lily to become feral or spread into
non-crop areas and the impact that acquired virus resistance might have
on this potential. The experts agreed that in the United States the
likelihood of a species in the genus Lilium forming viable hybrids in
nature with a wild or weedy relative was very small given that lilies
do not cross readily. ``This is especially true for the hybrids that
are adapted or selected for the intensive greenhouse or irrigated
gardens' environment. These lilies do not form successful colonies
outside these specific environments. The chance that genes will be
transferred from gardens to wild populations is negligible'' (Ref. 42).
However, regarding the weedy tendencies of this genus, one expert said
``Several species of Asian or European origin are sporadically
naturalized following escape from cultivation, but none strays far or
is widespread or common enough to be considered a pest.... Lilium
longiflorum (Easter lily; Japan) has been recorded from Utah and
Florida'' (Ref. 42). Another expert said, ``Lilium [formosanum] (Taiwan
lily) has been known to invade natural habitats in Northern and Eastern
Australia.... Caution would be advised in introducing L. [formosanum]
into... the US'' (Ref. 42). Two experts believed it unlikely that
acquired virus resistance would affect the likelihood of lilies
becoming feral, although a third said, ``Virus resistance might
increase the speed and degree with which these exotic species might
naturalize'' (Ref. 42).
    EPA is inclined to include nectarine and peach (Prunus persica) on
the list in Sec.  174.27(a)(1) on the basis of information received
from expert consultations. However, EPA is seeking any information from
the public that would enable the Agency to complete its assessment of
the potential for a PVCP-PIP to introgress into a population of a wild
or weedy relative or a naturalized population of the species and what
effect such introgression might have. Specifically, the experts
indicated that natural hybrids may be able to form with some other
stone fruit trees (Ref. 42). However, if such trees are likely to be
found in commercial cultivation, natural hybrids would not necessarily
be expected in areas outside of managed orchards. Regarding whether
Prunus persica is a weedy species, three of the four experts mentioned
that nectarines and peaches are able to form feral populations (Ref.
42). Nevertheless, three of the four experts indicated that they
believed it would be unlikely that Prunus persica's weedy tendencies,
if any, would be exacerbated if it acquired transgenic resistance to
one or more viruses. One expert said, ``Generally the viruses are not
the limiting factor to the establishment of feral peaches. The limiting
factors are fungal and bacterial diseases that kill the plants before
they can reproduce'' (Ref. 42). The fourth expert said, ``I would
expect that the acquisition of virus resistance would enhance the
spread of feral populations but would suggest that other causes of
death, such as peach tree short life, bacterial canker and Armillaria
Root Rot, are likely to be a more significant limitation to the spread
and longevity of a feral nectarine tree'' (Ref. 42).
    EPA believes that more information about olive (Olea europaea) is
needed to address issues raised during expert consultation. Two experts
indicated that hybridization with a wild or weedy relative has not been
documented in the United States (Ref. 42). Both of these experts
indicated that olive can naturalize. However, they disagreed about the
frequency with which this is likely to occur. One expert suggested
olive frequently forms reproducing and sustaining populations in non-
crop areas and that it was ``highly likely'' that olive would become
feral or easily spread into non-crop areas if it acquired transgenic
resistance to one or more viruses because ``O. europaea seeds are very
viable and dispersed by rodents'' (Ref. 42). However, another said,
``It is highly unlikely that olives would become strongly feral or
widely spread because the seeds are infrequently spread far from the
tree, have a low reproduction rate due to poor seed germination and
have a high rate of feral seedling mortality. Further, as a slow
growing tree olives do not spread rapidly'' (Ref. 42). The 2005 SAP
also commented on including olives in the list of plants in Sec.
174.27(a)(1). They noted olives have reportedly formed ``feral olive
infestations in the Channel Islands National Park, and in oak woodlands
and forest on Sonoma Valley and Davis, CA. In California, olive is
`considered an invasive exotic' that `compete[s] with native flora'
(personal communication)'' (Ref. 42). EPA believes that before olive
could be added to the list of plants in Sec.  174.27(a)(1), the Agency
would need information to resolve the question of how weedy olive is in
the United States and the effect virus resistance would have on any
feral populations of olive that could acquire a PVCP-PIP from
cultivated olive.
    EPA has received one response from a parsley expert suggesting that
parsley (Petroselinum crispum) meets the requirements for inclusion on
the list in Sec.  174.27(a)(1). This consultation indicates that
parsley 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 parsley weedy or invasive. The breeder
noted that parsley

could form viable hybrids with feral populations of parsley, but
``parsley populations are generally quite short-lived away from
cultivation and typically are not self-sustaining'' (Ref. 42). He also
noted, ``I would not expect parsley to become more easily spread with
the acquisition of virus resistance. Although I'm aware that parsley is
a host to celery mosaic virus and carrot motley dwarf, I have not known
these viruses to be common limiting factors in parsley growth or
reproduction, at least not here at our genebank in Iowa. Fungal
diseases and insects are much more important'' (Ref. 42). EPA is
seeking public comment on this determination because the Agency desires
a more robust response base.
    EPA is inclined to include petunia (Petunia spp.) on the list in
Sec.  174.27(a)(1) on the basis of information received from
consultations with petunia experts. However, EPA is seeking any
information from the public that would enable the Agency to complete
its assessment of the weedy characteristics of petunia and the
likelihood that acquired virus resistance could cause petunia to become
feral or easily spread into non-crop areas. The experts indicated that
this genus does not form viable hybrids in nature with wild or weedy
relatives in the United States. However, two of the three experts
indicated that petunia has formed reproducing and sustaining
populations in non-crop areas while noting that such populations have
not required weed management activity. All three experts indicated that
acquired virus resistance is unlikely to change the status quo.
However, one noted that, ``as viruses affect petunia vigor, resistance
might conceivably increase the odds'' (Ref. 42).
    EPA is inclined to include pistachio (Pistacia vera) on the list in
174.27(a)(1) on the basis of information received from two expert
consultations. However, EPA is seeking any information from the public
that would enable the Agency to complete its assessment of the
potential for a PVCP-PIP to introgress into a population of a wild or
weedy relative or a naturalized population of the species and what the
impact of acquired virus resistance is likely to be. Specifically, the
experts indicated several crosses have been reported in the literature,
suggesting ``that potentially P. vera genes can eventually be
transmitted to other species in the form of gene flow.'' However,
hybrids are only rarely formed as ``they are isolated
phenologically....'' Nevertheless, one expert also indicated, ``There
are a lot of unknowns in the phenology and cross-compatibility of
different species of pistachio'' (Ref. 42). Both experts indicated that
ferality in pistachio is rare. One suggested it was not possible to say
what the likelihood would be that pistachio would become feral or
easily spread into non-crop areas if it acquired transgenic virus
resistance. However the other said, ``It is very unlikely pistachio
would be widely feral as the primary method of spread, drop from the
tree, results in a large percentage (>95%) of the nuts degrading, so
they do not sprout. Further, the nuts do not go a long distance when
they drop, localizing spread if sprouting does occur. Finally, if birds
do remove a nut with a viable embryo from the tree they generally
destroy it by eating...'' (Ref. 42).
    EPA is inclined to include plum (Prunus domestica) on the list in
Sec.  174.27(a)(1) on the basis of information received from expert
consultations. However, EPA is seeking any information from the public
that would enable the Agency to complete its assessment of the
potential for a PVCP-PIP to introgress into a population of a wild or
weedy relative or a naturalized population of the species.
Specifically, the experts indicated that several native plum species
occur in the United States. However, one indicated that because ``P.
domestica is a hexaploid, it would not cross with native Prunus plum
species, which are all diploid'' (Ref. 42). In addition, if any hybrids
between cultivated plum and wild American plum species did occur, they
``would not be fertile because of the chromosome number difference.''
EPA thus believes that the risk of introgressing a PVCP-PIP into a wild
or weedy population through gene transfer in the United States is very
low. Regarding whether plum is a weedy species, one expert mentioned
that although he had not personally observed it, he ``heard from others
that domestica... [is] found naturalized particularly in New England
and Oregon. Some of these species tend to be easily spread by root
suckers, and are better able to compete as weeds. Likely they only
survive on roadsides and unmanaged areas, and could be easily killed if
desired'' (Ref. 42). Nevertheless, all three of the experts indicated
that they believed it would be unlikely that plum's weedy tendencies,
if any, would be exacerbated if it acquired transgenic resistance to
one or more viruses. According to one expert, ``I doubt viruses are the
only thing which restricts domestica from spreading more than it
already has'' (Ref. 42). According to another, ``Currently virus
diseases are not the most important limiting diseases for plum in the
U.S. Other fungal and bacterial diseases are the limiting factors and
cause death of uncared for commercial plums. Therefore transgenic plums
with virus resistance would still be very susceptible to these limiting
fungal and bacterial diseases'' (Ref. 42).
    EPA has received one response from a spinach expert suggesting that
spinach (Spinacia oleracea) meets the requirements for inclusion on the
list in Sec.  174.27(a)(1). This consultation indicated that spinach
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 spinach weedy or invasive. The expert
noted, ``Transgenic viral resistance alone probably would not make
spinach survive wild conditions, because there are other fungus (e.g.
downy mildew, Stemphylium leaf spot) diseases and bacterial diseases
(e.g. bacterial leaf spot), as well as drought resistance and competing
ability issues'' (Ref. 42). EPA is seeking public comment on this
determination because the Agency desires a more robust response base.
    EPA believes that more information about taro (Colocasia esculenta)
is needed to address issues raised by expert consultation. For example,
although experts knew of no weedy relatives with which taro might
cross, ``crossing is theoretically possible among all of the taros''
(Ref. 42). One expert indicated that ``taro can flower naturally in
places such as Kula in Maui, Hawaii. The climate there allows taro to
flower naturally, whereas in other places it is often necessary to
induce flowering with hormone applications. Furthermore, hybrids made
by cross-fertilization are viable. It is entirely possible for taro to
survive in the wild in tropical and subtropical climates. Most taros
would succumb because taro has been cultivated for so long that it is
mostly dependent on humans to compete with many weeds. By itself it is
almost always out-competed by weeds and dies out. But theoretically it
can survive, it can cross-pollinate and form viable progeny'' (Ref.
42). Regarding whether taro is known to become feral or easily spread
in non-crop areas, one expert said, ``YES, but only in favorable
conditions of adequate warmth and moisture.'' Another expert indicated
that ``taro is considered an invasive species in certain places
(Florida)'' (Ref. 42). Regarding whether acquired transgenic resistance
to one or more viruses could change taro in this

respect, the experts disagreed. One expert said, ``It is highly
unlikely that taro 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 intervention just as
non-transgenic plants.'' Another expert said, ``Taro has many pests,
including viruses, that restricts [sic] its ability to compete with
more weedy plant species. Resistance to any of these pests would
increase its competitiveness but this is not likely to turn taro into a
weed problem.'' However, the third expert said, ``With resistance to
one or more virus diseases, taro would become hardier. That is the
reason for breeders to go to the trouble of developing disease-
resistant plants. A hardier taro is more likely to be successful and
survive as an escaped cultivated species. It has already been seen that
taro has become feral in certain parts of Florida. With added
resistance, it would be more likely to survive in the wild, provided
that resistance gives it some advantage. In other words, if the virus
disease is important, resistance is valuable. In Thailand, the taro
plants that one can find along roadsides (feral) possess a high degree
of resistance to taro leaf blight, the most destructive disease of
cultivated taro there. Those that don't possess resistance don't stand
much of a chance to survive on their own'' (Ref. 42). EPA believes that
before taro could be added to the list of plants in Sec.  174.27(a)(1),
the Agency would need information to evaluate the likelihood that feral
populations of taro could acquire a PVCP-PIP from cultivated taro and
to evaluate whether acquisition of virus resistance is likely to
increase taro's likelihood of forming feral populations.
    EPA believes that more information about tomato (Solanum
lycopersicum) is needed to address issues raised by several experts
that EPA consulted. For example, three of four experts indicated that
tomato is able to form viable hybrids in nature in the United States
with its putative progenitor Solanum lycopersicum var. cerasiforme.
These experts indicated the hybrids formed are fertile, self-
compatible, and freely intercross due to highly compatible phenology.
However, a third expert indicated that ``[a]lthough crosses can occur
between wild species and cultivated tomato, usually with human
intervention, the direction of the cross is such that the wild species
has to be the male parent.... If the cultivated tomato has the
transgene, transfer to wild species via pollen will not happen'' (Ref.
42). EPA is not however interested solely in whether transfer occurs
via pollen, but whether a transgene could introgress into a wild
population through a hybrid intermediate. Three of four experts also
indicated that tomato is able to form feral populations in the United
States (including Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa), although one
expert pointed out that neither virus-resistant cultivars nor resistant
wild relatives have demonstrated a greater propensity to become feral,
suggesting that acquisition of a PVCP-PIP may not exacerbate whatever
weedy tendencies exist in tomato. However, another expert suggested
that this question would have to be tested in the field under
controlled conditions. EPA believes that before tomato could be added
to the list of plants in Sec.  174.27(a)(1), the Agency would need
information to evaluate the effect of virus resistance on any wild or
weedy populations of tomato that could acquire a PVCP-PIP from
cultivated tomato and to evaluate whether acquisition of virus
resistance is likely to exacerbate tomato's weedy tendencies.
    EPA believes that more information about watermelon (Citrullus
lanatus) is needed to address issues raised by expert consultation. For
example, experts indicated that watermelon is able to cross with C.
lanatus var. citroides. Moreover, one expert indicated hybrids made by
cross-fertilization are sexually fertile and demonstrate ``[m]ore vigor
compared with cultivated watermelon (C. lanatus var. lanatus)'' (Ref.
42). Regarding whether watermelon is known to become feral or easily
spread in non-crop areas, one expert indicated that escaped plants are
able to form reproducing and sustaining populations in non-crop areas,
although this occurs rarely and has not required weed management
activity outside of crop areas (Ref. 42). Regarding whether acquired
transgenic resistance to one or more viruses could change watermelon in
this respect, one expert indicated this was ``[u]nlikely. Watermelons
have few viruses that kill the plant or decrease its reproductive
activity. Therefore, gaining virus resistance will not likely increase
it's [sic] reproductive success in feral populations'' (Ref. 42).
Another expert said, ``Virus pressure would likely be far less in feral
populations than in cultivated fields due to differences in time of
germination, rate of growth, population density, [and] reduced numbers
of aphid vectors'' (Ref. 42). EPA believes that before watermelon could
be added to the list of plants in Sec.  174.27(a)(1), the Agency would
need information to evaluate the likelihood that wild populations of C.
lanatus var. citroides or feral populations of C. lanatus var. lanatus
could acquire a PVCP-PIP from cultivated watermelon and what effect
this acquisition might have.
    EPA believes that more information about wishbone flower (Torenia
spp.) is needed to address issues raised by expert consultation. EPA is
seeking any information from the public that would enable the Agency to
complete its assessment of the potential for a PVCP-PIP to enhance the
potential of species in this genus to naturalize. All three experts
consulted indicated that Torenia species do not form viable hybrids in
nature with wild or weedy relatives in the United States. However, all
indicated that Torenia has naturalized in certain areas of the United
States. One expert said, ``Torenia fournieri has been reported to
naturalize by seed in Florida and Louisiana, but it is not clear to
what extent. I personally have observed re-seeding in garden settings.
Given the rising popularity of Torenia in American horticulture, there
is probable cause for concern in the deep south, California and Hawaii.
However, the species in cultivation are heat sensitive and moisture-
demanding, which would probably limit the extent to which they can
naturalize'' (Ref. 42). Expert consultations also suggest that not
enough information is known about the potential of virus resistance to
affect the plant's weedy tendencies. One expert said, ``I do not know
to what extent viruses impact Torenia fournieri. It is conceivable that
viral resistance could increase fecundity'' (Ref. 42).
    EPA is not proposing to include celery (Apium graveolens), kiwi
(Actinidia spp.), or okra (Abelmoschus esculentus) on the list in Sec.
174.27(a) because the Agency was unable to complete any expert
consultations on these crops. EPA is therefore seeking information from
the public to address whether such crops could qualify for inclusion on
the list.
    EPA also requests comment on the weediness potential of squash
(Cucurbita pepo) and any wild or weedy relatives in the United States
that could acquire a PVCP-PIP from cultivated squash through gene flow.
    2. EPA requests comment on the Agency's options for the weediness
criterion in Sec.  174.27(a)(2) discussed in Unit III.C.2.iii.
Specifically, the Agency is considering whether it is more appropriate
to evaluate the potential for a crop to form ``viable hybrids'' or

``viable, fertile hybrids'' in nature with a wild or weedy relative.
    In addition, EPA is considering whether it is necessary to evaluate
whether the plant containing the PIP is unlikely to establish weedy or
invasive populations outside of agricultural fields in the United
States even if the plant contains a PVCP-PIP, assuming that the plant
has no wild or weedy relatives in the United States with which it can
form viable hybrids in nature and it is not a weedy or invasive species
outside of agricultural fields in the United States.
    EPA also requests comment on language for the criterion in Sec.
174.27(a)(2) (e.g., such as under option four) that would allow EPA to
broadly consider the effect that virus resistance might have on wild or
weedy plant populations that could acquire the PVCP-PIP. Under such an
approach, the individual determinations that the Agency would make
would likely require data to be generated that would not normally occur
as a routine part of product development (but may be developed for a
review by USDA/APHIS). Such determinations are likely to involve
similar amounts of effort as registration reviews, but they would
provide a means whereby a PVCP-PIP could be exempted even if used in a
plant that has wild or weedy relatives in the United States. The Agency
requests commenters to indicate how controversial individual
determinations using such language as under option 4 are likely to be,
as the Agency would like to have an exemption procedure that requires
only one public notice (see Unit III.A.2.).
    3. EPA requests comment on the merits of incorporating the use of
biocontainment and/or bioconfinement techniques into Sec.  174.27(a),
such that PVCP-PIPs deployed in tandem with such technology could be
determined to meet the weediness criterion. Please see the discussion
of this option in Unit III.C.3., which articulates several issues
associated with such an option and suggests regulatory language that
might be used.
    4. EPA requests comment on the Agency's use of the term ``weedy.''
EPA uses the term in two different contexts: in ``wild or weedy
relatives'' and in ``weedy or invasive species.'' However, the Agency
notes that the term has a different meaning in each context. When
discussing a ``wild or weedy relative,'' 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. However, when discussing ``weedy or
invasive species,'' EPA considers a weedy species to be a species that
is an aggressive competitor in natural ecosystems. EPA recognizes that
it would be better to have a single definition of the term ``weedy,''
but the Agency believes both meanings of the term ``weedy'' are in
common, scientific usage. In addition, the Agency is not aware of a
term other than ``wild or weedy relative'' that would encompass all
plants that grow outside of agricultural fields, or a term other than
``weedy or invasive species'' that would encompass all of the plants
that are problematic from a management perspective. EPA would be
particularly interested in alternative suggestions to describe each of
these situations and thus enable the Agency to avoid using two
different meanings for the word ``weedy.''
    5. EPA requests comment on whether the viral interactions criterion
in Sec.  174.27(b)(1)(i) could be expanded to read ``the viral
pathotype used to create the PVCP-PIP has naturally infected plants in
the United States or other parts of North America and naturally infects
plants of the same species as those containing the PVCP-PIP.'' EPA
recognizes that viruses are likely to move freely across political
boundaries. Thus, limiting this criterion to viruses that have
naturally infected plants ``in the United States or other parts of
North America'' may be most appropriate limitation for avoiding the
introduction of sequences from an exotic virus into the United States
through creation of a PVCP-PIP.
    6. EPA requests comment on whether it is necessary for the Agency
to address viral interactions, i.e., recombination, as articulated in
Sec.  174.27(b), in order for the Agency to conclude that a PVCP-PIP is
low risk. EPA requests commenters to indicate whether their comments
apply to RNA viruses, DNA viruses, or both. The Agency notes that a
large number of PVCP-PIPs are likely to meet Sec.  174.27(b) as
proposed. EPA therefore requests commenters who believe Sec.  174.27(b)
is unnecessary to focus their remarks on why those PVCP-PIPs that do
not meet the conditions of proposed Sec.  174.27(b) would pose low risk
with respect to recombination rather than addressing the average risk
associated with PVCP-PIPs as a whole.
    For the PVCP-PIPs that would only qualify for an exemption without
the limitations provided by Sec.  174.27(b), EPA does not believe the
Agency can conclude low risk with respect to recombination (as the
Agency must do in order to remove Sec.  174.27(b) entirely) because the
2004 and 2005 SAPs have identified specific instances where this
general conclusion may not hold. Nevertheless, EPA is considering
removing this criterion in whole or in part if the Agency receives
information suggesting that such factors as articulated and as
incorporated into Sec.  174.27(b) are unnecessary for concluding a
particular PVCP-PIP is low risk. For example, the Agency notes that the
current global movement of goods and people likely results in the at
least occasional transport of plant viruses great distances from their
original geographic distribution in spite of governmental efforts to
limit their movement. In such a context, the Agency questions the
relevance of requiring as a condition of exemption that the viral
pathotype used to create the PVCP-PIP has naturally infected plants in
the United States.
    7. EPA requests comment on whether the protein production criterion
in Sec.  174.27(c)(1)(i) could be modified to encompass other types of
PVCP-PIP constructs that mediate resistance based on PTGS. According to
today's proposal, any such constructs other than those inserted only in
an inverted repeat orientation or lacking a start codon would be
reviewed by the Agency for lack of protein production under Sec.
174.27(c)(2). However, if the Agency could identify additional types of
constructs that would present reasonable assurance that no protein
would be produced in any plant tissues at any point in the plant's
developmental cycle, including if PTGS were to be suppressed, such
constructs could be included under Sec.  174.27(c)(1)(i) and would not
require Agency review to verify that no protein would be produced.
    8. EPA requests comment on whether the Agency could extend the
proposed exemption (including regulatory text and rationale as written)
to other PIPs that are based on any plant virus gene that confers virus
resistance when no protein is produced from the inserted virus sequence
because it is inserted only in an inverted repeat orientation and/or it
lacks an initiation codon for protein synthesis. The 2005 SAP noted
that ``[o]ther PIPs conferring virus resistance should be evaluated
similarly as are the PVCP-PIPs, if the PIPs mode of action is via
PTGS'' (Ref. 11). However, the Panel also mentioned several risk
concerns associated with specific virus proteins. The Agency therefore
concluded that PTGS was a necessary but not sufficient condition for
expanding the exemption to other types of virus gene-based PIPs given
that protein can be produced under certain circumstances from many
constructs

that employ PTGS, and the Agency does not currently have sufficient
information to conclude that such protein would pose low risk to the
environment. In the case of the two types of inserts described above,
the 2005 SAP indicated that it could be ``safely determined'' that no
protein would ever be produced from such constructs (Ref. 11), and they
would meet Sec.  174.27(b) and (c). Section 174.27(a) would be
evaluated as it is evaluated for PVCP-PIPs given that the relevant
consideration would be the virus-resistant phenotype of the plant
rather than the means by which the trait is conferred. EPA thus
believes that the criteria in today's proposed exemption address all
relevant risk considerations for PIPs based on any plant virus gene
when no protein is produced from the inserted virus sequence. EPA is
therefore inclined to expand the exemption to include PIPs based on any
viral gene that confers virus resistance if the PIP meets Sec.
174.27(a) and no protein is produced from the inserted virus sequence
because it is inserted only in an inverted repeat orientation and/or it
lacks an initiation codon for protein synthesis.
    9. EPA requests comment on the alternative approach the Agency is
considering for exempting marker genes that are used as inert
ingredients with PIPs under which NPTII, GUS, and PMI would be exempt
from FIFRA when used as inert ingredients with any exempt PIP,
regardless of the plant in which they are expressed (as discussed in
Unit IV).
    10. EPA requests comment on the possibility of developing an
Agency-determined approach for exempting inert ingredients under FIFRA.
Under this approach, EPA would propose new language at 40 CFR 174.21(c)
that would enable the Agency to review inert ingredients on a case-by-
case basis to determine whether they meet the standard established for
inert ingredients in 40 CFR part 174 subpart X-List of Approved Inert
Ingredients. EPA is considering such a procedure to ensure that a low-
risk PVCP-PIP that otherwise meets the conditions for exemption at
Sec.  174.21 would not require a FIFRA registration solely due to the
presence of an inert ingredient that may prove to be low risk upon
review. The only alternative to registration for such a PVCP-PIP would
be to add the inert ingredient to the list through rulemaking under
FIFRA section 25(b), such that the PVCP-PIP could be exempted.
Rulemaking would take considerably longer than an Agency determination
procedure like that described in today's proposal for other exemption
criteria.
    The criteria that EPA is considering for determining whether an
inert ingredient would be exempt under an Agency determination are:
    i. The inert ingredient is non-toxic to humans and animals and does
not produce a toxic substance,
    ii. The inert ingredient is non-allergenic, and
    iii. If the inert ingredient is an antibiotic resistance gene or
marker protein, therapy with antibiotics would not be compromised even
if the gene were to be transferred from plants to microorganisms in the
gut of man or animal, or in the environment.
    11. EPA requests comment on the Agency's assumption in the economic
analysis for this proposed rule that the estimated number of PVCP-PIPs
submitted for regulatory review will be the same per year over the next
10 years. EPA assumed a uniform distribution given that the Agency
lacks reliable information on which to base a more complex distribution
pattern. EPA is particularly interested in any data or information
supporting a different assumption for the economic analysis.
    12. EPA requests comment on the usefulness of a guidance document
that would provide a simplified description of the final rule. EPA
intends to develop such a document and is interested to know what
specific content the public would find most helpful.

VIII. References

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Cucumber mosaic virus. Journal of General Virology 2003; 84:249-58.
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recombination in transgenic grapevines expressing the coat protein gene
of Grapevine fanleaf virus. Transgenic Research 2004; 13:165-79.
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plants expressing viral transgenes. Seminars in Virology 1996; 7:417-
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    112. Rovere, C.V., del Vas, M., Hopp, H.E. RNA-mediated virus
resistance. Current Opinion in Biotechnology 2002; 13:167-72.
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virus resistant transgenic plants. In: Schiemann, J. The Biosafety
Results of Field Tests of Genetically Modified Plants and
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Forstwirtschaft, 2000:186-8.
    114. Dinant, S., Blaise, F., Kusiak, C., Astier-Manifacier, S.,
Albouy, J. Heterologous resistance to potato virus Y in transgenic
tobacco plants expressing the coat protein gene of lettuce mosaic
potyvirus. Phytopathology 1993; 83:819-24.
    115. Teycheney, P.Y., Aaziz, R., Dinant, S., Sal[aacute]nki, K.,
Tourneur, C., Bal[aacute]zs, E. et al. Synthesis of (-)-strand RNA from
the 3' untranslated region of plant viral genomes expressed in
transgenic plants upon infection with related viruses. Journal of
General Virology 2000; 81:1121-6.
    116. AIBS. Transgenic virus-resistant plants and new plant viruses.
http://www.aphis.usda.gov/ppq/biotech/virus/95_virusrept.pdf. 1995.

    117. Greene, A.E., Allison, R.F. Deletions in the 3' untranslated
region of cowpea chlorotic mottle virus transgene reduce recovery of
recombinant viruses in transgenic plants. Virology 1996; 225:231-4.
    118. Nagy, P.D., Ogiela, C., Bujarski, J.J. Mapping sequences
active in homologous RNA recombination in brome mosaic virus:
prediction of recombination hot spots. Virology 1999; 254:92-104.
    119. Miller, W.A., Koev, G., Beckett, R. Issues surrounding
transgenic resistance to the Luteoviridae. In: Schiemann, J. The
Biosafety Results of Field Tests of Genetically Modified Plants and
Microorganisms. Berlin: Biologische Bundesanstalt f[uuml]r Land- und
Forstwirtschaft, 2000:203-9.
    120. Nagy, P.D., Zhang, C., Simon, A.E. Dissecting RNA
recombination in vitro: role of RNA sequences and the viral replicase.
The EMBO Journal 1998; 17:2392-403.
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264:1650-1.
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264:1649-50.
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(Vector ZMIR13L) in Event MON863 Corn (006484) Biopesticide
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J.D., Nielsen, K. Horizontal transfer of antibiotic resistance genes
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UK: CABI International, 1997.
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Regulatory Toxicology and Pharmacology 1990; 12(3).
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OECD Workshop on Food: Provisional Proceedings of the Safety
Evaluation. Paris: OECD, 1994:71-9.
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5th ed. New York: W. H. Freeman and Company, 2002.
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introgression from genetically modified crops to their wild relatives.
Nature Reviews Genetics 2003; 4:806-17.
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Ellstrand, N. Biosafety of hybrids between transgenic virus-resistant
sugar beet and swiss chard. Ecological Applications 2001; 11:142-7.
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hybrids of Cucurbita pepo (Cucurbitaceae): implications for crop-to-
wild gene flow. Heredity 2001; 86:694-702.
    137. Ilardi, V., Barba, M. Assessment of functional transgene flow
in tomato fields. Molecular Breeding 2001; 8:311-5.
    138. Fuchs, M., Chirco, E.M., Gonsalves, D. Movement of coat
protein genes from a commercial virus-resistant transgenic squash into
a wild relative. Environmental Biosafety Research 2004; 3:5-16.
    139. Bartsch, D. Ecological impact of transgenic virus-resistance
in crop, weed, and wild plant populations (due to potential alterations
of plant invasiveness). In: Tepfer, M., Bal[aacute]zs, E. Virus-
resistant Transgenic Plants: Potential Ecological Impact. Berlin:
Springer, 1997:107-13.
    140. Tepfer, M. Risk assessment of virus-resistant transgenic
plants. Annual Review of Phytopathology 2002; 40:467-91.

IX. Content of Official Record

    EPA has established an official record for this rulemaking. The
official record includes all information considered by EPA in
developing this proposed rule including documents specifically
referenced in this action, any public comments received during an
applicable comment period, and any other information related to this
action, including any information claimed as CBI and any information
received in any of the related dockets mentioned below. This official
record includes all information physically located in the dockets
described in the following paragraph, as well as any documents that are
referenced in the documents in the dockets. The public version of the
official record does not include any information claimed as CBI.
    The complete official record for this rulemaking includes:
    The docket identified by the docket control number OPP-300370 for
the document entitled ``Proposed Policy: Plant-Pesticides Subject to
the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal
Food, Drug, and Cosmetic Act'' (59 FR 60496, November 23, 1994)(FRL-
4755-2).
    The docket identified by the docket control number OPP-300369 for
the document entitled ``Plant-Pesticides Subject to the Federal
Insecticide, Fungicide and Rodenticide Act; Proposed Rule'' (59 FR
60519, November 23, 1994)(FRL-4755-3).
    The docket identified by the docket control number OPP-300368 for
the document entitled ``Plant-Pesticides; Proposed Exemption From the
Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic
Act'' (59 FR 60535, November 23, 1994)(FRL-4758-8).
    The docket identified by the docket control number OPP-300371 for
the document entitled ``Plant-Pesticides; Proposed Exemption From the
Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic
Act for Nucleic Acids Produced in Plants'' (59 FR 60542, November 23,
1994)(FRL-4755-5).
    The docket identified by the docket control number OPP-300367 for
the document entitled ``Plant-Pesticides; Proposed Exemption From the
Requirement of a Tolerance Under the Federal Food, Drug, and Cosmetic
Act for Viral Coat Proteins Produced in Plants'' (59 FR 60545, November
23, 1994)(FRL-4755-4).
    The docket identified by the docket control number OPP-300370A for
the document entitled ``Plant-Pesticide Subject to the Federal
Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug,
and Cosmetic Act; Reopening of Comment Period'' (61 FR 37891, July 22,
1996)(FRL-5387-4).
    The docket identified by the docket control number OPP-300368A for
the document entitled ``Plant-Pesticides; Supplemental Notice of
Proposed Rulemaking'' (62 FR 27132, May 16, 1997)(FRL-5717-2).
    The docket identified by the docket control number OPP-300371A for
the document entitled ``Plant-Pesticides; Nucleic Acids; Supplemental
Notice of Proposed Rulemaking'' (62 FR 27142, May 16, 1997)(FRL-5716-
7).
    The docket identified by the docket control number OPP-300367A for
the document entitled ``Plant-Pesticides; Viral Coat Proteins;
Supplemental Notice of Proposed Rulemaking'' (62 FR 27149, May 16,
1997)(FRL-5716-6).
    The docket identified by the docket control number OPP-300369A for
the document entitled ``Plant-Pesticides, Supplemental Notice of
Availability of Information'' (64 FR 19958, April 23, 1999)(FRL-6077-
6).
    The docket identified by the docket control number OPP-300369B for
the document entitled ``Regulations Under the Federal Insecticide,
Fungicide, and Rodenticide Act for Plant-Incorporated Protectants
(Formerly Plant-Pesticides)'' (66 FR 37772, July 19, 2001)(FRL-6057-7).
    The docket identified by the docket control number OPP-300368 for
the document entitled ``Exemption From

the Requirement of a Tolerance Under the Federal Food, Drug, and
Cosmetic Act for Residues Derived through Conventional Breeding From
Sexually Compatible Plants of Plant-Incorporated Protectants (Formerly
Plant-Pesticides)'' (66 FR 37830, July 19, 2001)(FRL-6057-6).
    The docket identified by the docket control number OPP-300371 for
the document entitled ``Exemption From the Requirement of a Tolerance
Under the Federal Food, Drug, and Cosmetic Act for Residues of Nucleic
Acids that are Part of Plant-Incorporated Protectants (Formerly Plant-
Pesticides)'' (66 FR 37817, July 19, 2001)(FRL-6057-5).
    The docket identified by the docket control number OPP-300370B for
the document entitled ``Plant-Incorporated Protectants (Formerly Plant-
Pesticides), Supplemental Proposal'' (66 FR 37855, July 19, 2001)(FRL-
6760-4).
    The docket identified by the docket control number EPA-HQ-OPP-2006-
0643 for the companion document entitled ``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 (PVC-Proteins)'' (FRL-8100-5) published
elsewhere in this issue of the Federal Register.
    The docket identified by the docket control number EPA-HQ-OPP-2006-
0642 for this document (FRL-8100-7).
    Also included in the complete official record are:
    1. Public comments submitted in response to the proposals and
supplemental documents cited in the above paragraph.
    2. Reports of all meetings of the Biotechnology Science Advisory
Committee and the FIFRA Scientific Advisory Panel pertaining to the
development of this proposed rule.
    3. The Economic Analysis for this proposed rule and supporting
documents.
    4. Support documents and reports.
    5. Records of all communications between EPA personnel and persons
outside EPA pertaining to the proposed rule. (This does not include any
inter- and intra-agency memoranda, unless specifically noted in the
indices of the dockets).
    6. Published literature that is cited in this document.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this is a ``significant regulatory
action'' because it may raise potentially novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in the Executive Order. Therefore, this action was
submitted to OMBfor review, and changes made during that review have
been documented in the docket.
    In addition, EPA has prepared an economic analysis of the impacts
related to this proposed action. The economic analysis evaluates the
quantifiablebenefits of exempting PVCP-PIPs from FIFRA requirements (40
CFR part174) and discusses the non-quantifiable benefits of this
action. Thiseconomic analysis is contained in a document entitled
``EconomicAnalysis for Proposed Exemption Under the Federal
Insecticide,Fungicide, and Rodenticide Act for Certain Plant-
IncorporatedProtectants Derived from a Plant Viral Coat Protein Gene
(PVCP-PIPs)''(called here ``the EA''). This document is available in
thedocket and is briefly summarized in Unit V.

B. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et
seq., an Agency may not conduct or sponsor, and a person is notrequired
to respond to a collection of information unless it displays acurrently
valid OMB control number, or is otherwise required to submitthe
specific information by a statute. The OMB control numbers for EPA's
regulations codified in Title 40 of the CFR, after appearing in the
preamble of the final rule, are further displayed either by publication
in the Federal Register or by other appropriate means, such as on the
related collection instrument or form, if applicable. The display of
OMB control numbers in certain EPA regulations is consolidated in a
list at 40 CFR 9.1.
    The information collection requirements contained in thisproposed
rule have been submitted to OMB for review and approvalunder the PRA in
accordance with the procedures at 5 CFR 1320.11.The burden and costs
related to the information collection requirementscontained in this
rule are described in an addendum to a currently approved Information
Collection Request (ICR) identified as EPA ICR No. 1693.04 (OMB number
2070-0142). As defined in the PRA, ``burden'' means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes ofcollecting, validating, and verifying information,
processing andmaintaining information, and disclosing and providing
information;adjust the existing ways to comply with any previously
applicableinstructions and requirements; train personnel to be able to
respond toa collection of information; search data sources; complete
and reviewthe collection of information; and transmit or otherwise
disclose theinformation.
    This proposed rule includes information collection requirements
ofdevelopers who wish to exempt PVCP-PIPs under the provisions of
theproposed rule. Developers self-determining their exemption status
willhave to develop and maintain records supporting their
determinationand report their determination to EPA. Developers relying
on Agencydetermination of exemption status will have to develop the
informationneeded for the Agency determination and submit it to EPA.
The Agencyhas estimated that this information collection has an
estimated burdenof 21.5 hours per response for developer-determined
exemptions and23.5 hours per response for Agency-determined exemptions.
EPAestimates that there will be one submission of each type per year
fora total annual respondent burden of 45 hours.
    Direct your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, to EPA using the public docket that has been
established for this proposed rule (Docket ID No. EPA-HQ-OPP-2006-
0642). In addition, send a copy of your comments about the ICR to OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th St., NW., Washington, DC 20503, Attention: Desk
Office for EPA ICR No. 2070-0142. Since OMB is required to complete its
review of the ICR between 30 and 60 days after April 18, 2007, please
submit your ICR comments for OMB consideration to OMB by May 18, 2007.
    The Agency will consider and address comments received on
theinformation collection requirements contained in this proposal
whenit develops the final rule.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 USC 601 et seq., the Agency hereby certifies

that this rule will not have a significant adverse economic impact on a
substantial number of small entities.
    For purposes of assessing the impacts of today's rule on
smallentities, small entity is defined as: (1) a small business
according tothe small business size standards established by the U.S.
Small BusinessAdministration (SBA), which in this case is a pesticides
and agriculturalchemical producer (NAICS code 325320) with fewer than
500employees; a crop producer (NAICS code 111) with less than
$750,000in revenues; a college, university, or professional school
(NAICS code611310) with annual revenues less than $6.5 million; or an
entity inresearch and development in the physical, engineering, and
lifesciences (NAICS code 54171) with fewer than 500 employees; (2)
asmall governmental jurisdiction that is a government of a city,
county,town, school district or special district with a population of
less than50,000; and (3) a small organization that is any not-for-
profit enterprisewhich is independently owned and operated and is not
dominant inits field.
    In determining whether a rule has a significant economic impacton a
substantial number of small entities, the impact of concern is
anysignificant adverse economic impact on small entities, since the
primarypurpose of the regulatory flexibility analyses is to identify
and addressregulatory alternatives ``which minimize any significant
economicimpact of the proposed rule on small entities'' (5 U.S.C. 603
and 604). Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden or otherwise has a positive
economic effect on all of the small entities subject to the rule. This
proposed rule will generate savings by exempting PVCP-PIPs with a low
probability of risk from FIFRA requirements. Given the overall
potential savings attributed to this rule, the Agency concludes that
this proposed action will not result in adverse economic impacts,
regardless of the size of the firm currently developing and testing
PVCP-PIPs or planning to develop and test PVCP-PIPs. Today's action
relieves a regulatory burden. Nevertheless, the Agency continues to be
interestedin the potential impacts of the proposed rule on small
entities andwelcomes comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA),Public Law 104-4, EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more forState, local or tribal governments, in the
aggregate, or on the privatesector in any one year. The analysis of the
cost savings associated withthis action are described in Unit V of this
preamble. The requirementsof sections 202, 203, 204 or 205 of UMRA
which relate to regulatoryrequirements that might significantly or
uniquely affect smallgovernments and to regulatory proposals that
contain a significantFederal intergovernmental mandate, respectively,
do not apply totoday's rule because the rule affects only the private
sector, i.e., personsfield testing such as universities, multinational
companies,biotechnology companies, chemical companies, seed
companies;persons selling and distributing such as multinational
companies,biotechnology companies, chemical companies, seed companies;
andpersons using PVCP-PIPs such as farmers.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) EPA has determined that this proposed rule does
not have federalism implications, because it will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132. The primary result of this action is to
exempt certain PVCP-PIPs from most FIFRA requirements. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175

    Pursuant to Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), EPA has concluded that this rule does not have tribal
implications because it will not have any affect on tribal governments,
on the relationship between the Federal government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes, as specified in the Executive
Order. EPA is proposing to exempt certain PVCP-PIPs from most FIFRA
requirements. This is only expected to affect the private sector, not
tribes or tribal governments. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866, nor is it likely to have any
significant adverse effect on the supply, distribution, or use of
energy.

H. Executive Order 13045

    This rule is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because because it is not designated as
an ``economically significant'' regulatory action as defined in
Executive Order 12866 and because the Agency does not have reason to
believe that the environmental health or safety risks addressed by this
action presentdisproportionate risks to children. The Agency has
determined that thePVCP-PIPs that would be exempted by this rule pose
only a lowprobability of risk to human health, including the health of
infants andchildren, and that there is a reasonable certainty no harm
will resultto infants and children from aggregate exposure to residues
of thesePVCP-PIPs in food. Existing information suggests there are
nodisproportionate effects on infants or children from dietary or
otherexposures. EPA's assessment and the results of its assessment
arecontained in Unit VIII of the companion document publishedelsewhere
in this issue of the Federal Register exempting from the FFDCA section
408 requirement of a tolerance, residues of the plantvirus coat protein
portion of a PVCP-PIP.

I. National Technology Transfer Advancement Act

    This rule does not involve a regulatory action that would
requirethe Agency to consider voluntary consensus standards pursuant
tosection 12(d) of the National Technology Transfer and AdvancementAct
of 1995 (NTTAA), (15 U.S.C. 272 note). Section 12(d) directs EPA to use
voluntary consensus standards in its regulatory activities unless to do
so would be inconsistent with applicable law or otherwise impractical.
Voluntaryconsensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus

standards bodies. The NTTAA requires EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards when the NTTAA directs the
Agency to do so.

J. Executive Order 12898

    Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-
IncomePopulations (59 FR 7629, February 16, 1994), EPA has
consideredenvironmental justice related issues with regard to the
potential impactsof this action on the environmental and health
conditions in low incomeand minority communities. The Agency is
required to considerthe potential for differential impacts on sensitive
sub-populations. EPAconsidered available information on the
sensitivities of subgroups aspertains to the exemptions. EPA concluded
that no subgroup would bedifferentially affected. See also the
companion document ``Exemptionfrom the Requirement of a Tolerance under
the Federal Food, Drug, andCosmetic Act for Residues of Plant Virus
Coat Proteins that are Partof a Plant-Incorporated Protectant (PVC-
Proteins)'' published elsewherein this issue of the Federal Register.

XI. FIFRA Review Requirements

    In accordance with FIFRA section 25(d), EPA submitted a draft of
thisproposed rule to the FIFRA Scientific Advisory Panel, the Secretary
of Agriculture, and to the Committee of Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate.

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedures,
Pesticides and pests.

    Dated: April 9, 2007.
Stephen L. Johnson,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 174--[AMENDED]

    1. The authority citation for part 174 would continue to read as
follows:

    Authority: 7 U.S.C. 136-136y and 21 U.S.C. 346a and 371.
    2. By alphabetically adding to Sec.  174.3 new definitions to read
as follows:

Sec.  174.3  Definitions.

* * * * *
    Naturally infect means to infect by transmission to a plant through
direct plant-to-plant contact (e.g., pollen or seed), an inanimate
object (e.g., farm machinery), or vector (e.g., arthropod, nematode, or
fungus). It does not include infection by transmission that occurs only
through intentional human intervention, e.g., manual infection in a
laboratory or greenhouse setting.
* * * * *
    PVCP-PIP is 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.
    PVC-protein is the plant virus coat protein portion of a PVCP-PIP.
* * * * *
    United States means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the PacificIslands, and American Samoa.
    Unmodified means having or coding for an amino acid sequence that
is identical to an entire coat protein of a naturally occurring plant
virus.
* * * * *
    Virtually unmodified means having or coding for an amino acid
sequence that is identical to an entire coat protein of a naturally
occurring plant virus, except for the addition of one or two amino
acids at the N- and/or C-terminus other than cysteine, asparagines,
serine, and threonine and/or the deletion of one or two amino acids at
the N- and/or C-terminus.
    Weedy species means a species that is an aggressive competitor in
natural ecosystems.
* * * * *
    3. In Sec.  174.21 by revising the introductory text and paragraph
(c) to read as follows:

Sec.  174.21  General qualifications for exemptions.

    A plant-incorporated protectant is exempt from the requirements of
FIFRA, other than the requirements of Sec.  174.71, if it meets all of
the following criteria. Plant-incorporated protectants that are not
exempt from the requirements of FIFRA under this subpart are subject to
all the requirements of FIFRA.
* * * * *
    (c) Any inert ingredient that is part of the plant-incorporated
protectant is on the list codified at Sec. Sec.  174.485 through
174.486.
    4. By adding Sec.  174.27 to subpart B to read as follows:

Sec.  174.27  Plant-incorporated protectant derived from a coat protein
gene(s) from a virus(es) that naturally infects plants (PVCP-PIP).

    In order for a plant-incorporated protectant derived from one or
more genes that encode a coat protein of a virus that naturally infects
plants (PVCP-PIP) to be exempt, the criteria in paragraphs (a), (b),
and (c) and the requirements in paragraph (d) of this section must all
be satisfied.
    (a) The criterion in paragraph (a) of this section is satisfied if
either paragraph (a)(1) or paragraph (a)(2) of this section applies:
    (1) 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.).
    (2) The Agency determines after review that the plant containing
the PIP meets paragraphs (a)(2)(i), (a)(2)(ii), and (a)(2)(iii) of this
section:
    (i) Has no wild or weedy relatives in the United States with which
it can form viable hybrids in nature.
    (ii) Is not a weedy or invasive species outside of agricultural
fields in the United States.
    (iii) Is unlikely to establish weedy or invasive populations
outside of agricultural fields in the United States even if the plant
contains a PVCP-PIP.
    (b) The criterion in paragraph (b) of this section is satisfied if
either paragraph (b)(1)(i), paragraph (b)(1)(ii), or paragraph (b)(2)
of this section applies:
    (1)(i) The viral pathotype used to create the PVCP-PIP has
naturally infected plants in the United States and naturally infects
plants of the same species as those containing the PVCP-PIP, or
    (ii) The genetic material that encodes the pesticidal substance or
leads to the production of the pesticidal substance is

inserted only in an inverted repeat orientation or lacking an
initiation codon for protein synthesis such that no PVC-protein is
produced in the plant.
    (2) The Agency determines after review that viruses that naturally
infect the plant containing the PVCP-PIP are unlikely to acquire the
coat protein sequence through recombination and produce a viable virus
with significantly different properties than either parent virus.
    (c) The criterion in paragraph (c) of this section is satisfied if
either paragraph (c)(1) or paragraph (c)(2) of this section applies:
    (1) The genetic material that encodes the pesticidal substance or
leads to the production of the pesticidal substance:
    (i) Is inserted only in an inverted repeat orientation or lacking
an initiation codon for protein synthesis such that no PVC-protein is
produced in the plant, or
    (ii) Encodes only a single virtually unmodified viral coat protein.
Multiple PVC-proteins could each separately meet this criterion.
Chimeric PVC-proteins do not qualify.