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2-Plants: Update on GE pharma rice



                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  Grain of Doubt
SOURCE: Winston-Salem Journal, USA, by David Rice
        http://www.timesdispatch.com/servlet/Satellite?pagename=WSJ/
MGArticle/WSJ_BasicArticle&c=MGArticle&cid=1031783753130
DATE:   10 Jul 2005

------------------- archive: http://www.genet-info.org/ -------------------


Grain of Doubt
Genetically modified rice in Eastern North Carolina is setting off a
whirlwind of criticism and concern

PLYMOUTH - North Carolina farmers haven't grown rice in many years, so
they welcome the green sprigs now poking out of a flooded field near an
agricultural-research station here.

But this is not your Uncle Ben's rice.

Last month, with approval of two permits from the U.S. Department of
Agriculture, Ventria Bioscience, a biotechnology company in California,
planted 75 acres of rice that has been genetically engineered to produce
proteins found in human milk, saliva and tears.

The company says that the proteins it will extract from the rice
eventually could be used in granola bars, sports drinks or rehydration
formula to help infants in the Third World avoid death from diarrhea.

Environmentalists say that the rice poses a significant threat to other
crops and to the human food chain.

The planting is on private land near the state-owned Tidewater Research
Station in Washington County. On the way to North Carolina, Ventria
encountered opposition from rice growers, food vendors and
environmentalists in California and Missouri.

When the company tried to grow its rice in Missouri this spring, beer-
maker Anheuser-Busch threatened not to buy any rice grown in Missouri.
The two companies eventually reached a truce in which Ventria agreed not
to grow genetically modified rice within 120 miles of commercial rice crops.

Environmentalists and others say that the recent planting of Ventria's
rice crop near Plymouth brings the international debate over genetically
modified foods to North Carolina.

It also tests the state's considerable efforts to throw out a welcome mat
for the biotech industry.

"If it wasn't a food crop, I think it would be a lot less controversial.
But they've chosen to introduce a genetically modified, pharmaceutical-
producing food crop in North Carolina," said Hope Shand, the research
director at the Action Group on Erosion, Technology and Concentration in
Carrboro.

"They were run out of California, run out of Missouri, and then welcomed
with open arms in Eastern North Carolina," Shand said. "I just can't see
this as a viable rural-development strategy for North Carolina.

"Many scientists have concluded that it's virtually impossible to contain
these pharmaceutical crops," Shand said. "It's not just a bunch of wild-
eyed environmentalists who are concerned about this. We have the Grocery
Manufacturers Association, the Food Products Association who are
concerned about this experiment."

Researchers also use a nursery at the research station, less than a mile
from Ventria's test site, to grow seed stock for new rice varieties.
Scientists involved in those tests say that Plymouth was chosen for the
tests because it is 650 miles east of any commercial rice crop.

At least two scientists wrote to the USDA to say that there is a remote
possibility that pollen or disease from Ventria's rice could contaminate
rice grown at the nearby nursery and be distributed to rice growers
nationwide.

"It's not smart to introduce this pharmaceutical rice so close to
germplasm rice," said Jane Rissler, a senior scientist with the Union of
Concerned Scientists in Washington.

"That's the fundamental mistake - pharmaceuticals should not be grown in
food crops," Rissler said. "With human error, with the vagaries of
weather, it's going to be practically impossible to keep this out of the
food supply."

Company officials say that the risks are overstated, and that they take
every precaution to isolate Ventria's rice.

They point out that, unlike corn, rice is self-pollinating. The plant's
male and female organs are contained within the same flower, so its
pollen rarely travels farther than a few feet.

"There is a .001 percent chance of cross-pollination within 10 or 15
feet," said Somen Nandi, the director of molecular breeding for Ventria,
who is evaluating which of the company's rice varieties grow best in
North Carolina.

At the test site, an 18-inch dike borders the rice plots to keep water in
the field. A dedicated ditch provides water only to the rice field, and
water is screened before it leaves the field to keep rice from traveling.

Company officials say they will use equipment that is used only to grow
and harvest Ventria's rice. After harvest, they will drain the field and
burn the remnants to destroy plant matter.

And they say that adequate buffers are in place to protect other crops
from any crop migration. Nandi pointed to a field of cotton 200 feet
away, across a dirt road and a ditch.

"Not a single plant of rice will grow there. Not a single plant," he
said. "It (the rice plot) is a completely unique ecological niche."

Like much of the cotton grown in Eastern North Carolina, the cotton
across the road has been genetically modified for resistance to the
herbicide Roundup so that farmers can overspray young plants and make
fewer applications overall.

"This (cotton) is 100 percent GMO," Nandi said. "What's the problem with
rice?"

Scott Deeter, Ventria's president, says that human proteins for use in
rehydration formulas such as Pedialyte could help prevent the deaths of
1.9 million children that the World Health Organization estimates are
killed by diarrhea each year.

"Breast-fed babies are healthier than babies who are fed with infant
formula. These two proteins are part of the reason for that," Deeter said.

"It's a significant human-health problem," he said. "The challenge, of
course, is we've got to have a cost-effective, affordable therapy. That's
the advantage of using the rice."

Once harvested, Ventria's rice would not enter the food supply as grain,
he said. It would be pulverized into a powder. "We're not directly
feeding the rice. We're using the rice sort of as a factory, and we're
extracting the proteins," he said. Though it won USDA approval to grow
its rice here, Ventria is still waiting for the U.S. Food and Drug
Administration to approve its two human proteins - lactoferrin and
lysozyme - for use in foods. The proteins are being tested in Peru for
use in treating acute diarrhea, Deeter said.

"Putting proteins that are in saliva in a plant - every time we swallow,
we're swallowing these proteins," Deeter said. "The only difference here
that I can see is that it's new."

If Ventria wins FDA approval of its products, he said, the company will
try to expand production, depending on demand.

"At peak, 20,000 to 30,000 acres is a possibility if we're very
successful. How much of that is in North America, and ultimately in North
Carolina, is an open question," he said.

Researchers at N.C. State University who are monitoring the project say
they are investigating many of the claims from environmentalists and the
food industry that Ventria's rice crop could migrate, cross-pollinate
with other plants and contaminate the human food supply.

"Our interest is in monitoring these very sorts of issues," said Ron
Heiniger, an associate professor of crop science who works at the
Plymouth research station.

"That's what we're concerned about - do we get rice where we didn't get
rice before?" he said. "I'd like the opportunity to know scientifically
what the risks are."

Because no rice is grown commercially in North Carolina, researchers will
know exactly where it came from if it shows up outside the test plots,
Heiniger said.

"We'd have the environment to isolate the crop ... and prevent the crop
movement," he said. "If it is a worst-case scenario, if we get a lot of
movement of rice, then what better place to know that?"

Washington County lies along a major bird-migratory route. Bald eagles
soar over the research station and the rice field in summer, occasionally
plucking catfish from ponds at the research station. Rather than pollen
migration, Heiniger said, the possibility of movement of the rice crop
through waterfowl and other birds that feed on rice seed is researchers'
biggest concern.

They also want to study how to keep rice seed from washing away during
major floods like those caused by Hurricane Floyd in 1999.

"It'd be a miracle, frankly, to get the pollen to cross-pollinate," he
said. "There are unknowns, as with anything.... You expect the unexpected
- such as birds."

Deeter and Nandi, though, point to studies that found that once birds eat
rice seeds, they digest them completely.

"Once they're digested, they're not viable," Deeter said. "It seems
plausible, but it's not really supported by the science.... You've got to
use the science, because if you don't use the science, you're just using
emotion."

And despite his own questions about birds, Heiniger sees enormous
potential for farmers who grow Ventria's rice.

"They think they could have a huge impact on the health of children in
the Third World," he said. "These proteins right now come out of
mammalian tissue.... We're talking hundreds of dollars per ounce. If they
can grow them in rice that can be readily harvested, we're talking cents
per pound."

Genetically modified crops such as Roundup-ready cotton and soybeans, as
well as corn that has been genetically altered for insect resistance, are
already common in North Carolina.

So in rural Washington County, residents appear far more worried about
the U.S. Navy's plans to build an outlying landing field (OLF) than about
genetically modified organisms.

Local farmers who are accustomed to growing genetically modified corn,
cotton and soybeans appear to welcome Ventria's overtures as a new
opportunity for value-added agriculture.

"Several of them have offered - 'You can use my land,'" Heiniger said.

Joe Landino, the president of the Blackland Farm Managers Association, a
group of about 50 large-scale farmers in several eastern counties, says
that farmers are excited about growing pharmaceutical rice and think that
Ventria's effort will be a tightly controlled experiment.

Organic farmers, in particular, are often wary of genetically modified
crops that could creep into their fields. But the closest organic farmer
to Ventria's test site says he isn't worried.

"It's a virtual impossibility," said Wade Hubers, who grows organic corn
and soybeans in Hyde County, roughly 12 miles from the research station.

Hubers said that the organic corn and soybeans he grows fetch twice the
price of conventional crops, more than making up for the lower yield on
organic crops.

But the potential benefits from Ventria's rice far outweigh the risks, he
said.

"They're going to have a good buffer around it," he said. Though there
are some risks, Hubers said, "I look at this rice kind of like a
pharmaceutical company growing it in a greenhouse. It's that kind of risk."

When rice growers in Missouri opposed Ventria's plans there, "I think
they totally overreacted to it, but that's to North Carolina's benefit,"
Hubers said.

Landino said that despite environmentalists' worries, economic forces
will continue to drive demand for drugs and other products that can be
grown in plants.

"There's opposition to this biotechnology worldwide. But it's all in
vain, because people are going to be begging for these biotech products,"
he said. "You don't want to shut down something that can be so productive
in the future."

He also noted that although there is no commercial rice grown in North
Carolina, there are a few small plantings for ducks and other waterfowl.

"We've grown rice before down here," he said. "We know we can grow rice.
This is just a special project that needs a little more intensive
management."



                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  Using biotechnology to improve the yield and quality of rice
SOURCE: Western Farm Press, USA, by Daryll E. Ray
        http://westernfarmpress.com/news/7-20-05-using-biotechnology-in-rice/
DATE:   20 Jul 2005

------------------- archive: http://www.genet-info.org/ -------------------


Using biotechnology to improve the yield and quality of rice

Demographers project that the World's population will increase over the
next 30 years, increasing the demand for all crops, but particularly rice
because it is a significant source of calories for half of the world. As
a result, rice is receiving considerable attention by plant breeders who
are using both conventional and transgenic techniques. The goal of these
breeders is to increase rice's yield and quality.

APAC researcher Kelly Tiller has been a part of a consortium of research
institutions that has undertaken a "Participatory Assessment of Social
and Economic Impacts of Biotechnology" focusing on rice and tobacco. In a
recent column, we looked at the use of tobacco in the production of
pharmaceutical compounds. This week's column looks at the work that is
being done in rice and consumer attitudes toward biotechnology.

A full series of fact sheets can be obtained on the Internet from http://
www.agecon.vt.edu/biotechimpact. The institutions participating in this
research include Virginia Tech, The University of Tennessee, North
Carolina State University, Virginia State University, and the
International Rice Research Institute.

Rice is grown under a wide range of conditions from fertile, irrigated
lowland plots to saline or drought-prone fields that are deficient in
essential plant nutrients like zinc. Centuries of selective breeding by
peasant agriculturalists has resulted in a wide number of varieties that
are adapted to the local growing conditions and the cooking preferences
of each area. The traits that are bred into rice by plant breeders can
then be transferred to these local varieties.


Traits sought

The traits that geneticists want to breed into rice fall into several
distinct categories. One of the primary traits is increased
photosynthesis. By enabling plants to more efficiently use sunlight,
breeders hope to increase rice's yield, producing more rice on the same
amount of land.

A second set of traits of interest to breeders are those that protect the
plants against insects and disease. Some of the genetic work would help
the plant ward off infection by bacteria and fungi that are particularly
prevalent in irrigated rice paddies. The Bt technology that is so
familiar to U.S. farmers could be bred into rice to reduce the impact of
insect infestation, particularly by the stem borer that is endemic in
most rice growing countries of Asia.

Another trait that should be of no surprise to U.S. growers is herbicide
resistance. Similar to soybeans, herbicide resistant varieties could be
sprayed with a herbicide to reduce or eliminate weed pressure on the rice
crop, increasing the effective yield.

Because approximately half of the area on which rice is grown is less
than optimal, plant breeders are seeking to introduce genes into rice
that would increase its tolerance to drought, salinity, excess water, and
nutrient deficient soils. More than half of Asia's poor receive at least
50 percent of their calories from rice grown in these fragile
environments. Improving rice's stress tolerance would be aimed at
reducing malnutrition among the world's most vulnerable populations.

A fifth set of traits that are being bred into the rice genome are those
that would improve its nutritional content. The one that has garnered
most of the publicity is "Golden Rice" which has been bred to increase
the vitamin A content of rice, which is traditionally low in this
nutrient. Other breeders are working on increasing the iron and zinc
content of rice to increase the availability of these nutrients among the
poor for whom rice is the major component of their diet.


Consumer sentiment

Breeding these and other traits into the rice genome is only one part of
the story. The other crucial issue is consumer sentiment. Will consumers
be willing to eat rice with these traits bred into it? To help assess
consumer sentiment, several surveys of attitudes towards genetically
modified organisms (GMOs) were conducted in Bangladesh and the Philippines.

Several conclusions can be drawn from these surveys.

First, there is the need to assess GMO rice varieties for both
environmental impact and health impact with the latter being the most
important to consumers and agricultural leaders. Second, the survey
respondents indicated a preference for rice GMO research that is
conducted by public sector researchers. The results of such research were
seen by the survey respondents as more trustworthy than that done by
commercial firms.

Not surprisingly, the consumer surveys documented that attitudes toward
GMO rice was polarized. In such a climate, the trustworthiness and
objectivity of the research will be paramount in shaping consumer attitudes.

Daryll E. Ray holds the Blasingame Chair of Excellence in Agricultural
Policy, Institute of Agriculture, University of Tennessee, and is the
director of UT's Agricultural Policy Analysis Center (APAC). (865) 974-
7407; Fax: (865) 974-7298; dray@utk.edu; http://www.agpolicy.org. This
week's column is written with the research and assistance of Kelly
Tiller, assistant professor with APAC, and Harwood D. Schaffer, research
associate with APAC.


-------------------------------- GENET-news -------------------------------

TITLE:  What's So Scary About Rice?
        Biotech crops can make drugs -- but they must be kept out of the
food chain
SOURCE: BusinessWeek, USA, by Arlene Weintraub
        http://www.businessweek.com/magazine/content/05_31/b3945089_mz018.htm
DATE:   1 Aug 2005

------------------- archive: http://www.genet-info.org/ -------------------


What's So Scary About Rice?
Biotech crops can make drugs -- but they must be kept out of the food chain

In the heart of America's rice industry, a fight has broken out between
the King of Beers and a tiny biotech company. On one side is Anheuser-
Busch, which uses Missouri-grown rice as an ingredient in beer. On the
other side is Ventria Biosciences, which is moving to Missouri with plans
to cultivate transgenic rice containing human genes. The genes prompt the
plant to make two proteins normally found in breast milk, tears, and
saliva. The biotech company intends to turn the substances into
therapeutic food products to treat stomach disorders.

Anheuser-Busch executives seem to have been struck with indigestion at
the thought that human proteins might conceivably crop up in bottles of
Bud. Although highly unlikely, such a scenario isn't unheard of:
Bioengineered seeds have often turned up in places they don't belong. So
Busch vowed to boycott all Missouri rice last April, prompting Ventria to
temporarily shelve its plans in the state. "We want to make sure rice
growers in Missouri have a good relationship" with one of their biggest
customers, concedes Ventria CEO Scott Deeter. Meanwhile, on June 28 the
U.S. Agriculture Dept. approved Ventria's application to plant in North
Carolina instead.

The strange saga of Ventria and its alien rice casts a pall on a
potentially promising area in biotech. Stretched by unprecedented demand
for new drugs, biotech companies have been searching for alternatives to
traditional manufacturing methods -- an expensive process of growing
drugs in delicate hosts, such as cells from Chinese hamster ovaries.
Plants such as rice and corn may be ideal substitutes because they
naturally churn out proteins by the bushel. Getting them to make human
varieties is simply a matter of replacing pieces of their genetic code
with human genes -- just as technicians get hamster cells to produce
protein drugs. Then, to ratchet up production, you just plant more acres.

The economic benefits are enticing, too. A traditional biotech factory
might cost Ventria CEO Deeter $125 million. With rice, he can get the
same output for $4 million -- and he intends to pass the savings to
consumers. Several other biotech startups are experimenting with drugs
grown in plants, and giant Dow Chemical Co. is mulling the idea as well.
Consulting firm Frost & Sullivan Inc. predicts the first plant-
manufactured drugs will hit the market next year and sprout into a $2.2
billion-per-year industry by 2011.

That's if fears about food safety don't cause plant-grown pharmaceuticals
to die on the vine. Consumer and environmental advocates worry that
pollen from genetically engineered plants could drift into fields
containing food crops and produce contaminated hybrids. But that's not a
worry with rice, Deeter insists, because the plant is self-pollinating --
each seed contains everything it needs to produce another plant, so there
is no risk of transplanted genes leaking to other plants. Still,
environmentalists say, there's nothing to prevent a bird from gobbling up
the bioengineered seeds and then depositing them, intact, in a field
hundreds of miles away. "It's virtually certain this stuff will make it
into food-grade rice," says Margaret Mellon, director of the food and
environment program for the Union of Concerned Scientists in Washington.


OVERSEAS QUEASINESS

Such certainty is backed up by one particularly horrifying breach that
still haunts the food industry. In 2002 drug-producing corn made by
ProdiGene Inc. somehow began sprouting in soybean fields near its
Nebraska and Iowa sites. The USDA seized 500,000 bushels of soybeans and
charged ProdiGene nearly $3 million in fines and disposal costs. Any
further gaffes could threaten some $1.3 billion in annual U.S. rice sales
to foreign countries, many of which are still queasy about biotech crops
-- even those tweaked to produce tastier food.

What's needed, Ventria's critics argue, is a tighter regulatory framework
to ensure pharma crops stay out of the food supply. As it stands, the
USDA is the only federal agency that tightly regulates drug-producing
plants grown in outdoor test sites. The Food & Drug Administration
generally steps in later, when it's time to decide if the drugs
themselves are suitable for human consumption.

Since part of the FDA's mandate is to protect food, critics blast the
agency for failing to get involved in biotech plantings from the very
beginning. "It's a convoluted process," says Joseph Mendelson, legal
director for the Center for Food Safety in Washington, one of many groups
calling for the FDA to provide additional oversight on drugs made in
plants. An FDA policy adviser says several agencies are looking at
whether the system should be changed.

Some biotech outfits have dodged the protesters by avoiding food crops
altogether. St. Louis-based Chlorogen Inc. is developing a way to make
drugs in tobacco, which grows well in greenhouses, adding an extra
barrier against genetic leaks. CEO David N. Duncan says he's not
surprised that ProdiGene's mistake continues to reverberate, as Ventria
and others manipulate crops that form the very staples of the human diet.
"When you start messing with corn flakes and beer, you're going to get in
trouble," Duncan says.

Ventria can't seem to escape the controversy. Founded in 1997 in
Sacramento, the company planted several small fields of pharma-rice in
California. Despite an endorsement from California regulators, some
environmentalists and traditional rice farmers cried foul. Earlier this
year, Ventria decided to uproot itself and move to the plant-science
incubator at Northwest Missouri State University. Deeter says he isn't
being chased out of California, but rather he feels Missouri offers more
favorable economics for large-scale production.

It may be a while before Deeter can realize his dreams of amber waves of
humanized grain. In April, Anheuser-Busch lifted its boycott threat after
Ventria agreed to move its planned 200 acres from the southeast corner of
Missouri to the northwest region of the state -- 120 miles away from
food-grade rice. "We believe Ventria is now sufficiently away from
commercial rice producers," says Francine I. Katz, spokesperson for the
beer giant. But by the time the compromise was reached, Ventria had
missed prime planting season, forcing the company to wait until next year
to apply for a USDA permit to plant there. Meanwhile, Ventria planted 75
acres of rice in North Carolina in June, despite threats from the Center
for Food Safety, which is considering a lawsuit to curb the company.

Deeter is undeterred. "We fed the world with American agriculture, and
now we want to improve the world's health with it," he says. As for those
trying to stop him: "They have yet to find a single stomachache as a
result of biotech." Perhaps, but unless companies like Ventria and the
agencies that regulate them work harder to allay the world's food-safety
fears, farmlands won't be fertile ground for drugs.


-------------------------------- GENET-news -------------------------------

TITLE:  Online Extra: The Side Effects of Drugged Crops
SOURCE: BusinessWeek, USA, interview by Arlene Weintraub
        http://www.businessweek.com/magazine/content/05_31/b3945092_mz018.htm
DATE:   1 Aug 2005

------------------- archive: http://www.genet-info.org/ -------------------


Online Extra: The Side Effects of Drugged Crops
The Union of Concerned Scientists' Margaret Mellon explains the group's
concerns about the dangers genetically altered food poses

The Union of Concerned Scientists, founded in 1969 at the Massachusetts
Institute of Technology, has since grown into one of the most influential
voices on Capitol Hill. Now based in Washington, D.C., the group
frequently weighs in on issues related to the environment, energy, and
biotechnology.

Margaret Mellon, director of the food and environment program for the
group, specializes in studying how biotech is used in agriculture and how
it might affect food safety. In a recent interview with BusinessWeek's
Arlene Weintraub, Mellon outlined her views on the mission of Ventria
Biosciences and other biotech companies that are genetically altering
food crops to produce human drugs. Edited excerpts from their
conversation follow:

Q: Is the Union of Concerned Scientists opposed to genetically
engineering plants to produce human drugs? A: We're not opposed across
the board. It's a technology that should be examined. And we're
enthusiastic about using genetic engineering for drug production. We're
not so enthusiastic about outdoor applications of genetic engineering to
crops.

Q: What exactly is your concern? A: When you're genetically engineering
bioactive molecules -- drugs -- into crops and they're growing outdoors,
you must be able to assure those [engineered traits] don't move to food
crops. Otherwise you're imposing health and environmental risks.

Q: How might this affect trade with foreign countries? A: Genetically
engineered crops have uneven acceptance around the world. Some people
don't want any genetic engineering in their food. If they found drugs in
commodity crops, there would be a huge international brouhaha. People
around the world have choices -- they don't have to buy from the U.S.

Q: Right now, the U.S. Agriculture Dept. oversees the growing of plants
for pharmaceutical production. What are some of the questions that you
think need to be answered when it comes to regulatory oversight? A: We
need to look at the ways both the USDA and the Food & Drug Administration
are involved. The FDA has authority to oversee drug production. The
question is: When does drug production begin here? Is it when the
genetically engineered crop is delivered to the biotech manufacturing
facility? Or should the FDA's authority extend into the field?

The FDA needs to get new authority from Congress to allow them to
regulate genetically engineered organisms. There needs to be a pre-
commercial review of the risks inherent in this type of production.

Q: Some companies are developing animals -- such as goats and cows --
that might be able to produce human drugs in their milk. Why hasn't that
stirred up the same amount of controversy as drug-producing plants have?
A: The chances of a [captive] goat passing along a drug-producing gene to
a wild goat aren't very high. But even there, there are concerns.

We have to make sure the drugs don't carry viruses or other infectious
agents. We have to make sure we're not impeding the health and well-being
of the animals. And there could be problems with human error -- someone
selling one of these animals into the food supply, for example.

Q: It sounds like you're calling for big changes at the federal level. A:
The process we have now just isn't going to do it. People are nervous
about genetic engineering. This is not a trivial issue.





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