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Stop Biopharm Rice: Consumers Union, OCA, and Allies' Letter to California Officials

April 1, 2004

A.G. Kawamura, Secretary
California Department of Food and Agriculture
1220 N Street
Sacramento, CA 95814

Dear Secretary Kawamura ,

We strongly urge you to reject the request by Ventria BioScience for
emergency approval to commercially grow rice genetically engineered with
artificial human genes to produce two pharmaceutical compounds, recombinant
human lactoferrin and lysozyme.

Your approval of this proposal would trigger the first commercial use of a
food plant to produce drugs in the nation, and the first commercialization
of a plant product engineered to contain human genes. The request raises
very serious issues of human and environmental safety and potential economic
impact
This application deserves a full public hearing, allowing comment from
consumer groups, farmers, scientists, physicians, businesses, and
environmental groups, prior to permitting this drug-producing rice to be
grown on large acreage.

There are significant public health issues associated with this entirely
novel crop. If the crop is grown in the open air, inadvertent and
uncontrollable public exposure to the drugs in the rice is likely. The
National Academy of Sciences/National Research Council released a report in
January 2004 (Biological Confinement of Genetically Engineered Organisms)
that said that, given present technology, containment of transgenes is not
feasible: ³It is unlikely that any single bioconfinement technique will be
completely effective² (NRC. 2004: 10). In fact, in November, 2002, the
United States Department of Agriculture (USDA) revealed that another
experimental pharmaceutical crop--corn engineered by ProdiGene to produce a
pig vaccine--had contaminated two sites, in Nebraska and Iowa. In the
Nebraska incident, a full silo of soybeans had to be condemned at a cost of
$2.7 million.

To avoid contamination problems, the NRC recommended an increase in public
participation in the process of regulating these crops:

The public¹s right to information participate in decision making are fundamental to the practice of democracy.
Each right complements the other. Appropriate transparency and public
participation can improve the effectiveness of confinement by informing
decision makers about otherwise unknown facts about the environments in
which confinement would be implemented and by increasing the acceptance of
bioconfinement measures (and of the GEOs being confined) by building trust
in the decision-making process. Transparency and public participation
should be important components in developing and implementing the most
appropriate bioconfinement techniques and approaches (NRC. 2004: pg. 8).

The health impacts of the drugs designed into this rice on people who might
inadvertently be exposed to it have not been properly evaluated, but could
be serious. Noted food allergy specialist Stephen Taylor of the University
of Nebraska has warned that it is important to evaluate lactoferrin and
lysozyme as produced in Ventria¹s rice as to whether they may cause serious
food allergies (see article at
http://www.nature.com/nsu/020422/020422-19.html). The human body produces
lactoferrin and lysozyme in breast milk, but the version produced in rice is
slightly different, and thus may trigger a potentially dangerous allergic
response. A related concern is the unexplained presence of antibodies to
human lactoferrin in the blood of people suffering from autoimmune disorders
such as rheumatoid arthritis and Crohn¹s Disease (Roozendaal et al., 1998,
abstract at :
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Ab
stract&list_uids=9781375&itool=iconabstr
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&amp;db=pubmed&am
p;dopt=Abstract&amp;list_uids=97811375&amp;itool=iconabstr> ).

Potential environmental impact is also of concern. These two proteins,
lactoferrin and lysozyme, are of interest to Ventria because of their
bacteria-killing and fungi-killing properties. Such a product could have
impacts on beneficial microbes in the environment and on wildlife via
disruption of their gut flora. If transferred to weedy rice through
pollination, the proven antibacterial and antifungal properties of lysozyme
could make the weed rice better able to resist rice diseases, possibly
creating a superweed. The USDA does not currently evaluate such potential
effects in any detail.

In the regulatory arena, federal policy is not yet fully established for
pharmaceutical crops. Just last month, the USDA asked for comments, and has
held stakeholder meetings, on a proposed Environmental Impact Statement
(EIS). USDA asked for comment on whether its requirements for testing of
Plant Made Pharmaceuticals (PMPs) should be strengthened. The fact that
USDA is asking for comments in this area suggests that there is serious
ongoing debate as to whether the agency¹s present regulations are stringent
enough.

The North American Millers Association, in comments to the USDA about their
EIS proposal, asked the agency to develop more stringent rules in this area,
stating that
³the risk of adulteration from genetic material² modified for pharmaceutical
or industrial uses entering the food chain was, in its view, "unacceptable"
(LA Times, 3/30/04 at:
http://www.latimes.com/business/la-fi-rice30mar30,1,2657028.story?coll=la-he
adlines-business). The National Food Processors Association has stated
that:

If the food industry had complete control of this promising technology from
the beginning, we would never have supported the use of food or feed crops
for the production of PMPs. The risk of contamination of the food or feed
supply is just too great (NFPA press release, February 6, 2003).

Just last month, an editorial in Nature Biotechnology entitled, ³Drugs in
Crops well:

The problem is of drugs or drug intermediates in food or feed crop species bears the
potential danger that pharmaceutical substances could find their way into
the food chain through grain admixture, or pollen-borne gene flow (in maize,
at least) or some other accidental mix-up because of the excusably human
inability to distinguish between crops for food and crops for drugsSIs this
really so different from a conventional pharmaceutical or biopharmaceutical
manufacturer packaging its pills in candy wrappers or flour bags or storing
its compounds or production batches untended outside the perimeter fence?
(Nature Biotechnology, Feb. 2004, pg. 133, at
http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v22/n2/full/nbt
0204-133.htm).
<http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v22/n2/full/nb
t0204-133.htm).>

The planting of this Ventria rice could also have a negative impact on
California¹s rice industry. Any contamination of food rice would lead to a
decline or an end to rice exports to Japan and South Korea (a letter sent by
Consumers Union Japan[1] <#_ftn1> to the California Rice Commission on March
27, 2004 stated: ³We wish to inform you that if you approve Ventria¹s
request, California¹s rice market in Japan will be seriously threatened.²).
In addition, any contamination of food rice with genes for lactoferrin and
lysozyme would result in rice recalls, as this would violate FDA rules.

A decision to allow commercial planting of pharmaceutical rice
is too important and far reaching a decision to be left solely to a slim
majority (6-5) of a panel of the California Rice Commission. This
critically important decision requires input from the public and careful
consideration and analysis by the California Department of Food and
Agriculture¹s (CDFA¹s) own experts as well as the expertise of those at
California Environmental Protection Agency and Department of Health.

From a public health or public good perspective, this decision
should not be rushed. Despite Ventria¹s request for an ³emergency
exemption,² there is no emergency that precludes, from a public health
perspective, a thorough vetting of the complicated issues involved. In
fact, public health could be seriously undermined by a rushed approval. An
important opportunity to gather needed data should not be set aside simply
to accommodate Ventria Bioscience¹s desired planting schedule.

We urge CDFA to deny Ventria Bioscience¹s request for an
emergency exemption and, instead, to conduct a full scientific and public
policy review of this broad and far-reaching question.

Sincerely,

Michael Hansen, Ph.D, Senior Research Associate
Elisa Odabashian, Senior Policy Analyst
Consumers Union of United States

Dan Jacobson, Legislative Director
Environment California

Bill Allayaud, State Director
Sierra Club California

Ronnie Cummins, National Director
Organic Consumers Association

Lisa Archer, Grassroots Coordinator
Friends of the Earth

[1] <#_ftnref1> Consumers Union Japan is a separate, independent consumer
organization, not connected in any way to Consumers Union of United States,
one of the signers of this letter.