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Controversial Gene-Altered Pharm Rice Put on Hold in California

Genetically modified rice crop blocked

By Paul Jacobs
Mercury News
Sat, Apr. 10, 2004

The state's top agriculture official Friday blocked a proposal to plant the
nation's first commercial crop of a grain genetically modified to produce a
medicine.

The decision leaves open the possibility the proposal could return, however,
for next year's growing season in California.

Ventria Bioscience, a Sacramento biotechnology company, was hoping to plant
up to 120 acres of rice, engineered to produce two proteins found in human
breast milk, tears and saliva. The proteins are natural antibiotics that
help fight off certain infections.

The company's precedent-setting proposal was opposed by environmental and
consumer groups as well as some rice growers, who feared the modified rice
crop might contaminate standard table-rice varieties and threaten a thriving
rice export business.

Rejecting the recommendation of an advisory committee, California Food and
Agriculture Secretary A.G. Kawamura concluded there was no reason to do a
hurried review of the proposal by treating it as an emergency under state
law. That effectively ends any chance Ventria could obtain approval to plant
modified rice in time to harvest a crop this year, at least in California.

Late last month, a California Rice Commission advisory committee -- made up
of rice experts, growers and traders -- recommended that Kawamura move
quickly to approve Ventria's plan as long as crops were planted in any of 10
counties south of the state's Central Valley rice belt. The closest
table-rice crop would probably be 100 miles or more away, minimizing any
chance of field contamination.

But state Department of Food and Agriculture chief counsel John C. Dyer,
writing on behalf of Kawamura, argued that it was unlikely that the small
company would get the federal permit it needed in time to plant its crop
this year, even if the state moved ahead quickly.

The company needs both state and federal permits before it can plant its
pharmaceutical rice.

To declare an emergency and eliminate a lengthy public comment period is
allowed under state law, but only in response to ``demonstrated imminent
threats,'' Dyer wrote in a letter to the California Rice Commission. ``On
the other hand, it is clear that the public wants an opportunity to comment
prior to any authorization to plant.''

The company proposal now goes back to the rice commission for further
action.

Ventria Chief Executive Scott Deeter said he was surprised by the decision
and said his small company is still considering its options. He said he was
puzzled because the company had met 13 times with the California Rice
Commission's advisory committee, ``five of which were open to public
comment.''

Deeter conceded that Kawamura's decision meant that there would be no
planting in California this year. But one option is to ``expand to other
locations outside of California, which have a more streamlined approach to
regulatory issues.''

Opponents of the Ventria plan argued that there was no need to move ahead
without a full public discussion.

``We didn't think it was an emergency,'' said Elisa Odabashian, a policy
analyst for Consumers Union, one of several groups that asked Kawamura to
proceed cautiously with a precedent-setting decision.

``We're glad it's been opened up to public comment because it's a very new
technology. Once that's opened up, it is hard to pull back,'' Odabashian
said. ``We advocate growing these crops in very tight greenhouses so there
is no possibility for drift and contamination of the food supply.''

But Ventria and its backers argue that the genetically modified rice is no
hazard to consumers and would provide real benefits to people, not only in
the United States but throughout the world.

The company is able to splice genetic instructions for human proteins into
the rice in such a way that relatively large amounts are produced in the
harvested grain. The two proteins -- lysozyme and lactoferrin -- are natural
antibiotics that appear to help nursing children ward off intestinal
infections. Lactoferrin also plays a key role in absorbing iron in the human
gut.

If Ventria can grow large amounts of the proteins cheaply, the proteins
could be added to infant formulas and to inexpensive remedies for treating
diarrhea, a condition that kills an estimated 3 million infants each year
worldwide.

The Biotechnology Industry Organization argues that there are huge benefits
from pharmaceutical crops and that the risks are best managed by federal
regulators.

***************************************************************

Modified rice won't be planted -- for now State halts planting of rice for
pharmaceutical use Public to have say before state rules on bioengineered crop

Charlie Goodyear, Chronicle Staff Writer
San Francisco Chronicle
Saturday, April 10, 2004

State agricultural officials have blocked efforts to plant genetically
engineered rice in Southern California for what would have been the nation's
first crop bioengineered for use in the pharmaceutical industry.

The California Department of Food and Agriculture said Friday that there
appears to be no urgent need to plant the rice. A company called Ventria
Bioscience was hoping to plant by May 1 after narrowly winning approval from
the California Rice Commission.

In a letter to the commission, John Dyer, chief counsel to the department,
said it was unclear whether the proper federal permits had been obtained to
plant the engineered rice.

At the same time, Dyer wrote, "it is clear that the public wants an
opportunity to comment prior to any authorization to plant."

The department said Ventria's May 1 deadline to plant in time for the
state's rice-growing seasons did not qualify as an emergency.

Ventria wants to plant the rice because it contains a human protein that
could be used to produce medicine to combat anemia and diarrhea, which are
among the leading causes of death for children under 5 in underdeveloped
countries.

The company contends that using the rice is many times cheaper than
developing the proteins in a laboratory and therefore can create affordable
medicines. A Ventria spokesman could not be reached for comment Friday.

Greg Massa, a Colusa County rice grower, had opposed the Ventria plan and
was pleased by the department's action.

"I'm very happy,'' he said. "I think this is the best outcome that we could
have hoped for here. The rice commission passed this onto the (department)
without adequate input from growers and without any input from the public.
All of those people need to comment. Obviously, there is no emergency.''

Many of California's 2,200 rice farmers have worried that an engineered crop
could taint the state's harvest of conventionally grown rice, much of which
is exported to Japan. The Japanese government issued a statement this week
saying the rice planting sought by Ventria raised food-safety concerns.
Japanese rice retailers and consumer groups are seeking to give their
opinion on the plan.

Charley Matthews, a member of the advisory panel that approved of the so-
called pharm rice proposal, said it was unclear whether a public hearing
could be held in time for the crop to be planted.

"The problem is a late planting date,'' Matthews said. "It creates a lot of
risk for actual production. It's agronomic risk, but we're used to that.
It's kind of inconvenient.''

Matthews said he wasn't surprised that state officials ultimately decided to
delay planting given all the controversy surrounding the issue of
genetically engineered crops.

Simon Harris, a spokesman for Californians for Genetically Engineered Free
Agriculture, said Ventria's plan did not eliminate risk to contamination of
the state's rice crop.

"We think that there's no hurry,'' Harris said. "There should be plenty of
time for public input.''

***************************************************************

California regulators derail biotech company's rice plans

By: PAUL ELIAS - Associated Press
Saturday, April 10, 2004

SAN FRANCISCO -- State regulators on Friday derailed a small biotechnology
company's ambitious plans to begin immediately growing commercial quantities
of rice engineered with human genetic material.

The California Department of Food and Agriculture denied Ventria
Bioscience's application to grow more than 120 acres of rice in Southern
California because federal regulators haven't issued a permit. The
Sacramento-based company said it has not yet applied for federal regulatory
approval.

State officials also said the public needs more time to comment on an issue
that has roiled the $500 million-a-year California rice industry. Many rice
farmers fear consumer perception will turn against their crops and cost them
customers in biotechnology-adverse Europe and Japan if Ventria's permit was
granted.

Now Ventria, which already has permission to grow experimentally on small
plots, will have to wait at least until next year to expand production.

Despite the regulatory setback and continued vocal opposition, Ventria chief
executive Scott Deeter said Friday the company would reapply in California.

The company would explore options in Hawaii and the South, Deeter said,
adding that Ventria intends to apply next year for a federal permit to
expand its operations.

The human genes that Ventria inserts into its rice produce proteins which
are found in mother's milk, tears and saliva and can combat diarrhea and
anemia, Deeter said.

"This will enhance and save human life," Deeter said.

Company scientists spliced the human genes into the rice genome. The
resulting proteins show up in rice seeds, which are then milled into powder
for bottling. The company hopes to sell its products over the counter,
perhaps by 2006.

Ventria has been growing genetically engineered rice on 120 acres in
Northern California on an experimental basis since it received U.S.
Department of Agricultural permits in 1997.

On Monday, the USDA refused to renew that permit for this year, saying the
company planned to grow its experimental rice too close to crops intended
for human consumption.

Deeter said the company would address the USDA's concern and still expected
to receive approval to continue growing the genetically engineered rice on
its current plot.

The California Rice Commission, a lobbying group which supported Ventria's
application, declined comment Friday.

Company critics, however, seized on the USDA concerns as an indication
Ventria can't be trusted to expand. They are concerned the biotech rice
hasn't been studied enough to ensure its safety if it accidentally found its
way into the food supply.

"This pharmaceutical rice crop raises a raft of serious public health,
environmental and economic concerns," said Michael Hansen of the Consumers
Union's Consumer Policy Institute. The Consumer's Union, along with several
other environmental and food safety groups typically skeptical of
biotechnology, urged California regulators last week to deny the permit.

Many rice farmers fear that even absent any accidental mixing of their crops
with Ventria's rice, customers in Europe and Japan could boycott their
product.

***************************************************************

Permit for biotech rice is denied

By Judy Silber
CONTRA COSTA TIMES
Posted on Fri, Apr. 09, 2004

In a decision that could affect a growing debate over the planting of
genetically engineered rice in California, a federal agency has ruled
against a company's bid to grow its crops in this state.

Citing concerns about the potential for mix-ups between the biotech rice and
commercial varieties, the U.S. Department of Agriculture denied a permit
that would have allowed Sacramento-based Ventria BioScience to plant rice
genetically engineered for the production of pharmaceuticals.

But Ventria said the denial is likely to be only a small setback for its
quest to plant in California up to 120 acres of rice.

"We're working with the USDA on all of our issues," Deeter said. "This is
fairly standard that they ask a lot of questions. Our job is to go back and
answer them."

A representative from the USDA could not be reached for comment.

Ventria received its first permit in 1997 from the federal agency to plant
rice containing two human proteins. With the rice serving as a
mini-pharmaceutical factory, Ventria intends to extract the proteins to
produce pills for the treatment of diarrhea and anemia.

But unlike other planting seasons, Ventria's activities have been closely
watched this year. It wants to expand the number of acres planted in
California to move toward commercial production and so must receive state
approval.

The application has ignited fierce protests from both farmers and
environmentalists.

Farmers fear the introduction of genetically engineered rice will destroy a
$500 million industry because of the threat of contamination and potential
boycotts from Europe and Asia. Environmentalists say not enough is known
about the crops' effects on wildlife.

Despite those objections, the company received approval on March 29 from the
California Rice Commission, a group of marketers and growers that sets
guidelines for planting and production. The approval restricted growth of
the crops in counties where rice is not grown. Ventria now awaits a final
decision by the secretary of the California Department of Food and
Agriculture on whether it can plant this spring.

However, the USDA's denial will trump any decisions made by the California
agencies.

In its letter to Ventria, the USDA said growth of the biotech crops should
be in isolated areas, away from commercial rice crops. The agency said it
was concerned that Ventria's rice is growing within 100 feet of rice
intended for human and animal food.

But Deeter said this discussion is less relevant to California than it is
for Ventria's activities in other states. That's because if the state
approves the company's request to plant in 2004, it will be restricted on
where it can grow the biotech rice.

"We have an unblemished record," Deeter said. "We don't see this as a major
hurdle, but it is something that we need to go through."