NEPA Decision Summary for Permit #12-180-112r
Ventria Bioscience (Nathan Fortner) has requested a permit (#12-180-112r) to plant a
five acre site in St. Croix, Virgin Islands, no more than two times with rice (Oryza sativa)
plants genetically engineered to produce
Information - CBI) in rice seeds.
Based on a review of Permit #12-180-112r, the following determinations were made:
performed with transgenic rice plants under APHIS authority, and APHIS is familiar
with rice biology and methods to manage confined field trials of rice. Ventria has
previously grown genetically engineered (GE) rice containing plant-made
pharmaceuticals (PMP) in this location in St. Croix annually since winter 2008-2009
and also in other locations in Kansas annually since 2007, and they have satisfactorily
managed those plantings.
Ventria has monitored for the presence of three of its engineered proteins (lactoferrin,
found. All of Ventria’s engineered genes including their newly developed ones (CBI)
are codon optimized and designed with regulatory promoters such that expression
occurs only in the rice endosperm, thus limiting the possibility that the engineered
proteins could be exuded through the root systems. Furthermore, because all viable
transgenic plant material will be removed from the test site and/or destroyed, there
will be no foreseeable cumulative impacts resulting from field trials of these
Lactoferrin from cow’s milk and related products have been granted GRAS status by
the FDA. Lactoferrin is used as a food additive and is sold as a nutritional
supplement. Egg white lysozyme and related gene products have been granted GRAS
status by the FDA. Lysozyme is used as a food additive and is sold as a nutritional
supplement. Serum albumin (HSA) is a soluble, monomeric protein which
comprises about one-half of the blood serum protein. The protein is encoded by the
steroids, fatty acids, and thyroid hormones and plays a role in stabilizing extracellular
fluid volume. It is used in medical practice to replace blood volume in burn victims,
patients suffering acute traumatic shock, and those undergoing certain types of
surgery. It has no reported oral or dermal activities. Transferrin is an iron binding
glycoprotein similar in form, function and use to lactoferrin except that it is mainly
found in blood plasma instead of milk. Transferrin is found in many organisms and
provides a broad range of protective functions through controlling iron uptake. The
other thirteen gene product combinations being developed (claimed as CBI) also have
expected pharmaceutical uses and most have been previously field tested in VI and
KS by Ventria. None of these other thirteen gene product combinations are
commonly characterized as allergens, nor do they share any amino acid homology
with known toxic peptides in a database search (Swiss-PROT). The target molecules
claimed as CBI are antigenic, membrane-binding- and glyco-proteins, a growth factor
enzyme. Selectable marker genes with a safe history of use, either phosphinothricin
acetyltransferase, hygromycin phosphotransferase or phosphomannose isomerase,
were also used in each of the seventeen constructs.
Environmental assessment (EA) documents have been prepared for some of these
of the current application submitted by Ventria Bioscience, given the small size of
this planting (no more than two releases on five acres) raised no new issues, so
previous EAs are applicable.
method except for one genotype which was transformed with disarmed
seventeen introduced gene combinations originate from rice, corn and/or A.
endosperm and are free of potential contaminants from either human or transgenic
animal or plant systems. No other plant tissue/part expresses any of the target
molecules at detectable levels. The constructs and their transgenic lines have been
grown for several years under at least greenhouse conditions, if not also in the field,
and have demonstrated gene expression and yield stability. There has been no
observable phenotypic difference between these transgenic lines and either their
untransformed antecedent rice lines or conventional cultivars other than expression of
the desired genes of interest and selectable markers. Also, Southern analysis has
shown stable chromosomal integration/inheritance of the codon optimized synthetic
target genes within the rice genome.
germplasm evaluation and selection in Ventria's Breeding Nursery. The following
activities will be conducted:
line and transgenic line.
Evaluation and selection of breeding lines.
Production of breeders seed.
Development of breeder seed from new breeding lines.
Development of pure line seed stocks.
Production of seed for laboratory analysis of the proteins of interest.
Assessment of gene stability.
Characterization of the plant (e.g. tissue specific expression, Southern analysis
None of this rice is used as food or feed. Ventria does not distribute or offer any of
pollen is heavy) and is not generally pollinated by insects. The Association of Official
Seed Certifying Agencies (AOSCA) certified seed regulations for foundation rice
seed require a minimum isolation distance from other rice varieties of at least ten feet
when hand- or machine-planted.
There are no commercial rice fields in St. Croix. There is no weedy red rice in the
for weedy rice in this area since 2008 and none was found. Any non-GE rice lines
used as controls or grown for any other reason within the regulated field trial will be
treated as regulated material.
The proposed confinement protocols are adequate to ensure that the field test is
surrounding each release site and a separation distance of 1320 feet from any other
rice (one hundred thirty two times the AOSCA standard) as proposed by the applicant
should be more than adequate to prevent gene flow.
The 50 foot fallow zone is bermed by natural topography in the St. Croix site and has
irrigation water or rain events will settle within this zone. Measures are in place to
keep water from leaving the fields during managed flood periods. Movement of seed
off-field by waterfowl and establishment in other fields is unlikely because: (1)
Ventria manages its rice fields to discourage waterfowl from landing during seed set
and maturation; and (2) studies as summarized in the permit have shown that viable
rice does not pass through the gut of waterfowl. In previous field tests, seed
dormancy in rice has not been observed. Following harvest, the fields will be
mowed, burned, and disked, and off-season flushing may be used to accelerate
germination of any remaining seed. After harvest the field will be fallowed through
the summer season until the following winter cropping season. Monthly scouting for
one year from the date of harvest and removal of any weedy or volunteer rice before
it flowers within the field plot and the 1320 isolation zone, particularly the 50 ft.
fallow zone, will ensure that there are no issues related to volunteer rice plants.
The rice seed will be ground seeded (not aerially seeded) with a drill seeder or a
closed-loop growing system using dedicated equipment for all planting, harvesting,
seed cleaning, seed handling, drying and storage exclusively for its proprietary rice
lines. Cleanout and storage of this equipment is described in their Standard Operating
Procedures which have been reviewed by APHIS. A non-dedicated, off-site seed
dryer and temporary storage area may also be used. In this case the seed will be
dryed inside envelopes or sacks, so there will be no direct contact of the seed with the
dryer. APHIS has reviewed and approved protocols for their use and believes that
they are sufficient to prevent commingling of Ventria’s rice with other seed. An
APHIS inspection will be required before such equipment can be returned to general
use. All production personnel are trained in these methods.
considered “hurricane season” (June 1- November 30), so dispersal of plant materials
outside the trial site is unlikely. Even if plant material were dispersed beyond the trial
site by extreme weather events, given the requirement of highly managed fields for
growth and persistence of rice plants, it is unlikely that seed or plants would grow or
area. Federally listed threatened or endangered animal species in the Virgin Islands
include three species of sea turtles (green , hawksbill and leatherback), two species of
whales (finback and sperm), two species of coral (elkhorn and staghorn), two species
of birds (the roseate Western Hemisphere tern and the piping plover) and two species
of reptiles (the St. Croix ground lizard and the Virgin Islands tree boa). Plant species
in St. Croix include Vahl’s boxwood (Buxus vahlii), the evergreen shrub
Calyptranthes thomasiana, the small spiny shrub Catesbaea melanocarpa and the St.
Thomas prickly ash (Zanthoxylum thomasianum). Individual FWS recovery plans for
these species indicate that C. thomasiana and Z. thomasianum do not occur on St.
Croix and that B. vahlii is assumed to have been extirpated from St. Croix. The
nearest critical habitat to the trial site in St. Croix is over 1 mile away in the ocean.
None of the species listed grow in or inhabit agricultural pasture in the planting
location or in rice fields in general, or consume rice, so would not be expected to be
impacted by this planting. Ventria’s primary products have not shown toxicity in their
testing work. Some of the new products in development have not been assessed for
food safety. Ventria assessed all for similarity to known toxins and found no protein
sequence similarity that would indicate toxicity of any of these proteins. The lack of
exposure of these TES to Ventria’s rice provides further assurance that there should
be no effect on TES from growing these rice lines. Therefore, these field trials will
not harm or have adverse or other significant effects on threatened or endangered
species and no consultation with Fish and Wildlife Service is required prior to issuing
when added to other past, present, and reasonably foreseeable future actions
(regardless of which agency or person undertakes such actions) is not expected to
have a potential for significant environmental impacts. The only past, present, and
reasonably foreseeable actions specifically associated with the locations for the
proposed releases are those related to agricultural production. The proposed release
site has been used for pasture for cattle, sheep and goats for the past 30 years, and the
proposed release will not result in a change in agricultural status of this land.
Although the specific agricultural practices used in rice cultivation are different than
pasture management, the surrounding land is already used for agricultural production.
The size of the present environmental release comprises up to two plantings of up to
seventeen genotypes planted on up to five acres in St. Croix for a period not to exceed
one year without issuance of a new permit or deregulation, both of which would
involve a separate NEPA assessment. The introduced traits, with their lack of
toxicity, should not impact biological or physical resources. The location of the trial,
to confine the regulated article to the release sites and areas being monitored, should
prevent its persistence in the environment, and should prevent gene flow that could
impact sensitive markets. APHIS has determined that there are no past, present, or
reasonably foreseeable actions that would aggregate with effects of the proposed
action to create cumulative impacts or reduce the long-term productivity or
sustainability of any of the resources (soil, water, ecosystem quality, biodiversity,
etc.) associated with the release sites or the ecosystem in which they are situated. No
resources will be significantly impacted due to cumulative impacts resulting from the
For the above reasons, and those documented on the NEPA/ESA decision worksheet,
engineered organisms or products that do not involve a new species or organism or novel
modification that raises new issues. Issuance of this permit qualifies for categorical
exclusion status under 7 CFR § 372.5(c)(3)(ii), and none of the exceptions for
categorically excluded actions under 7 CFR § 372.5(d) apply to this action because
APHIS has determined that all environmental impacts resulting from the issuance of this
permit will be insignificant. APHIS has determined that this action does not have the
potential to significantly affect the quality of the human environment, and neither an
environmental assessment nor an environmental impact statement is required.
U.S. Fish and Wildlife Service Species Reports
U.S. Fish and Wildlife Services Critical Habitat Portal
Susan M. Koehler, Ph.D.
Chief, Plant Branch
Environmental Risk Analysis Division
Biotechnology Regulatory Services
Prepared by CMCV