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# 4301 North Fairfax Drive \* Suite 425 \* Arlington, VA 22203-1616 (703) 236-2300 \* FAX (703) 236-2301

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March 29, 2007

Via eDocket

Docket No. APHIS-2007-0006

Regulatory Analysis and Development, PPD APHIS

Station 3A-03.8, 4700 River Road, Unit 118

Riverdale, MD 20737-1238.

> Re: Docket No. APHIS-2007-0006 - *Ventria Bioscience; Availability of
> an Environmental Assessment for Field Tests of Rice Genetically
> Engineered To Express Lactoferrin, Lysozyme, or Serum Albumin.*

The USA Rice Federation (USA Rice), located at 4301 N. Fairfax Drive,
Suite 425, Arlington, VA 22203 is the national advocate for all segments
of the rice industry. The USA Rice Producers' Group, the USA Rice
Millers' Association, the USA Rice Merchant's Group and the USA Rice
Council form the membership of the Federation. Through our charter
members we represent the industry in Arkansas, California, Florida,
Louisiana, Mississippi, Missouri, and Texas.

The purpose of this letter is to provide comment on the February 28,
2007, Federal Register notice (72 FR 8959) concerning the environmental
assessment for a permit for Ventria Bioscience (Ventria) to grow
pharmaceutical rice in Kansas. The USA Rice Federation respectfully
requests that the permit be denied based on several outstanding factors.
Our policy on the issue of introducing genetically modified (GM) rice in
the U.S., as established by our Board of Directors states in part:

> "We support the development of genetically modified rice varieties,
> but do not support their commercial release prior to scientific-based
> regulatory approval and consumer acceptance (i.e., no negative impact
> on commercial sales of U.S. rice)."

Prior to August 18, 2006, our foreign markets made it clear that they
would not risk adverse public reaction by even the appearance that U.S.
non-GM food and feed rice [could]{.underline} be commingled with any
type of GM rice, be it food and feed, pharmaceutical or plant
industrial. Since August 18 the U.S. rice industry has been hit hard by
the loss of foreign markets and required destination testing as a result
of the accidental introduction of Liberty Link Rice 601 (LL601) and
Liberty Link Rice 62 (LL62). The legal and financial repercussions of
those accidental releases are still ongoing. To resolve the domestic
crisis LL601 was given expedited approval here in the U.S. however it
remains a regulated genetic event everywhere else in the world and will
do so because Bayer CropScience is not willing to pursue foreign
deregulation.

LL62 on the other hand is deregulated here in the U.S. and in a very few
foreign countries, but its deregulation is being held up in major
markets like the European Union.

As a result of the market repercussions, the U.S. rice industry took the
unprecedented action of banning Cheniere, a popular variety of rice that
was infiltrated by the LL traits, and initiating seed testing to ensure
the world a clean U.S. rice supply.

Now, APHIS is requesting comment on allowing the planting, harvesting
and milling of a pharmaceutical rice with human genes/proteins, albeit
in a traditionally non-rice state. However, immediately after the
publication of this proposed permit, the agency announced that
Clearfield 131, the popular replacement variety for Cheniere, has been
infiltrated by an unknown GM trait and the agency took the unprecedented
action of issuing an Emergency Action Notification detaining all
Clearfield 131 seed. The GM trait has only recently been identified as
yet another Liberty Link event -- Liberty Link Rice 604 (LL604).

Taken together, the announcements and actions of the last seven months
are unfortunate but certain evidence that the U.S. regulatory regime for
biotech research is unable to achieve its goal of protecting the
environment and the public's food and feed supply from unwanted
intrusions of genetically engineered material. If Ventria's
pharmaceutical rice were to escape into the commercial rice supply, the
financial devastation to the U.S. rice industry would likely be
absolute. There is no tolerance, either regulatory or in public
perception, for a human gene-based pharmaceutical to end up in the
world's food supply.

While APHIS may base its decision on the stringency of its permit
controls and not on market and financial considerations, it is still
negligent for the agency to risk an entire industry for the sake of
profit for one company. Already, the USA Rice Federation is receiving
complaints from the public that are confusing the Ventria permit with
the latest Liberty Link rice issue and assuming the worst. Markets are
already questioning the same thing. Also, as previously stated, the
agency has shown that existing controls approved for genetic events in
rice (and other crops such as corn) have failed repeatedly.

A review of the APHIS Environmental Assessment (EA) in response to the
three permit applications from Ventria Bioscience raises several
concerns.

1.  On page 3, APHIS states that "the **majority** of harvested seeds
    will be milled to flour and will not be shipped to any outside
    milling facilities." On page 9, APHIS states that "**some viable
    seed** may be stored ...and/or shipped to other locations for
    analysis or planting..." The next sentence refers to controls on
    "interstate shipping". [^1] This infers that the seeds will be
    shipped out of state while at the same time seemingly abrogates any
    control of *intrastate* shipping. Taken together these statements
    appear to infer that some seed will be saved and shipped to other
    unknown, out of state locations that are not covered in this
    Environmental Assessment. (emphasis added)

2.  Ventria will extract lysozyme and lactoferrin, commonly found in
    milk and saliva, to be used in various commercial food and drinks as
    well as medical foods. However the company will also extract
    recombinant human serum albumin (HSA) protein, which according to
    APHIS, is produced in the liver and has no "oral or dermal
    activities."[^2] Also, past NEPA Decision Worksheets, while listing
    FDA GRAS (Generally Recognized As Safe) decisions for lysozyme[^3]
    and lactoferrin[^4], note no such GRAS decision for HSA.[^5] These
    facts would appear to indicate that HSA has no possibility of being
    declared safe should it accidentally enter the food supply.

3.  APHIS repeatedly[^6] states that it requires a ¼ mile (1320 ft)
    isolation from other rice, basing this figure on going one hundred
    thirty-two times beyond the Association of Official Seed Certifying
    Agencies (AOSCA) standard of 10 feet of separation for "foundation
    certified rice seed".[^7] Using the AOSCA figure as the basis of
    their minimum isolation distance, by definition, makes the ¼ mile
    distance meaningless and arbitrary. The reason is that the AOSCA
    distance, while unarguably being a benchmark in terms of seed
    isolation standards, was designated for issues of non-GM, varietal
    purity. It was not created to be used to ensure genetic purity. This
    is a blatant case of comparing apples to oranges and APHIS would
    have done just as well using apple standards to set their isolation
    standards for pharmaceutical rice. Furthermore, the agency goes on
    to state, "In practice, there is no known commercial rice grown in
    the state of Kansas."[^8] In other words, since APHIS knows of no
    other rice being grown in the state, it opted for an arbitrary
    isolation distance without utilizing the scientific process to
    determine a distance appropriate for the crop and the GM event. This
    begs the question of what will happen should someone start growing
    conventional rice in Kansas, possibly near the fields of
    pharmaceutical rice?

4.  In the 2004 EA for Ventria's pharmaceutical rice project in
    Missouri, the equipment was all dedicated, including onsite storage
    and milling.[^9] For the Kansas project, the EA states that storage
    and milling is approximately 10 miles away. The EA allows for other
    uses of the equipment, storage and milling facilities after
    cleaning.[^10] Since the rice is being grown next to other crops
    (listed as corn, soybeans and winter wheat) [^11] it is possible
    that human error coupled with the multiple use of the equipment and
    facilities may lead to an infiltration of the pharmaceutical rice in
    other harvested food supplies.

5.  APHIS also states there are post harvest land use restrictions on
    planting non-pharmaceutical rice food and feed crops in the fallow
    zone or the field test perimeter during the monitoring period,
    however the agency allows that permission can be obtained.[^12] For
    purposes of environmental safety, it should be plainly stated that
    no food or feed crops will be allowed. After all, while it might be
    easy to see volunteer rice in a soybean crop, it won't be too easy
    to see rice in a wheat field.

6.  We also note certain static language carried over with little or no
    modifications from past supporting documents and EAs year after
    year. One phrase we could not find in this EA is as follows:
    "Hundreds of field trials have been performed with transgenic rice
    plants under APHIS authority, and APHIS is familiar with rice
    biology and methods to manage confined rice field trials. Ventria
    previously grew rice in these same locations in North Carolina in
    2005 and satisfactorily maintained confined plantings."[^13] First,
    as we now know not all of the "hundreds" of the rice field trials
    under APHIS authority resulted in no adverse impact to the
    commercial rice crop since we now are dealing with three escaped
    genetically engineered events. Second, noticing the time delay
    between when the industry reasonably believes the aforementioned
    events escaped and their subsequent discovery, APHIS cannot be
    assured that Ventria's past field trials were "satisfactorily
    maintained."

**Therefore the USA Rice Federation has no choice but to request in the
strongest possible terms that the permit for Ventria's pharmaceutical
rice be denied. A denial by APHIS would be in accordance with
Alternative #1 in Section IV, page 6 of the Draft Environmental
Assessment for Ventria's permits.**

In addition, because of no assurance or confidence that Ventria
pharmaceutical rice can be kept separate from commercial food and feed
rice, we believe that USDA must engage FDA in a risk analysis and risk
assessment of the potential health affects that could occur when genetic
material from the pharmaceutical rice is eventually found in commercial
rice. In addition, APHIS should conduct a full Environmental Impact
Statement concurrent with FDA's analysis. Further production of
Ventria's pharmaceutical rice should not occur in the U.S. until, at a
minimum, the FDA and APHIS have concluded the studies, assuming the
agencies determine that there are no potential health effects. At that
time, if Ventria still seeks a permit, the issue can again be reviewed
through the public notice and comment process of USDA.

Thank you for your consideration of this request. Please contact me if I
can be of further service at 703-236-1445.

Regards,

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Steven Hensley

Director Regulatory Affairs

USA Rice Federation

[^1]: USDA/APHIS Draft Environmental Assessment In response to Permit
    applications 06-278-01r, 06-278-02r and 06-285-02r received from
    Ventria Bioscience to conduct field planting of rice (Oryza sativa)
    genetically engineered to express human lysozyme, lactoferrin and
    serum albumin

[^2]: EA appendix 2, pg. 14.

[^3]: NEPA Decision Worksheet and Summary for Permit 05-332-02r

[^4]: NEPA Decision Worksheet and Summary for Permit 05-332-01r

[^5]: NEPA Decision Worksheet and Summary for Permit 06-285-01r

[^6]: EA. pp 7 & 8.

[^7]: EA. pg 7.

[^8]: EA. pg 7.

[^9]: USDA/APHIS Environmental Assessment In response to permit
    application (04-302-01r) received from Ventria Bioscience for
    field-testing of rice, *Oryza sativa,* genetically engineered to
    express human lactoferrin, pg 4.

[^10]: EA. Appendix 4, Section IV, pg 18.

[^11]: EA. pp 8 & 10.

[^12]: EA. Appendix 4 Section VIII, pg 19.

[^13]: NEPA Decision Summary for Permit 05-332-01r. January 19, 2006