News
June 13
Denver Post editorial
The state agriculture department's
endorsement of a federal permit allowing
researchers to plant genetically engineered
"pharmaceutical" corn in Colorado
propels the state into the ongoing debate
over biotech crops.
The goal is to produce quicker, cheaper
medicine. Opponents believe the risks
to human and animal health and the state's
economy outweigh the benefits if the
altered corn contaminates other crops
or gets into the food supply. Both sides
have compelling arguments, and we urge
extreme caution as the federal government
moves ahead with the program.
Biopharmaceuticals are medicines not
yet approved for human use. A large
part of our concern stems from the fact
there has been little research by the
U.S. Department of Agriculture and Food
and Drug Administration, which sponsor
the program, on the impact of accidentally
eating altered crops. Some experts speculate
they could cause severe allergic reactions.
In addition, there was no organized
program of public notification and hearings
for this plan, such as those commonly
done by government agencies for many
environmental matters. This is Colorado's
first biopharmaceutical project, and
state and federal officials should have
made a greater effort to notify the
public, even though doing so wasn't
bureaucratically required.
Iowa-based researchers planted the
experimental corn recently on a 40-foot-by-90-foot
plot of prairie in Logan County, leaving
a five-mile buffer between the patch
and the closest farm. Federal regulations
require a one-mile safety zone. California,
which is considering a pharmaceutical
rice program, requires a minimum 100-mile
barrier.
The biopharmaceutical corn that will
sprout in Colorado will look like regular
corn, but the seeds have been injected
with a gene from the E. coli bacillus.
Researchers hope the gene will produce
a protein that can be processed to produce
a vaccine to treat severe diarrhea that
kills thousands of children in developing
counties.
Some of the concerns of opponents stem
from problems in other states. Two years
ago, 500,000 bushels of soybeans in
Nebraska had to be destroyed after they
were contaminated by pharmaceutical
corn. In Iowa, the USDA ordered 155
acres of regular corn incinerated in
2002 because pollen from genetically
altered corn may have drifted into nearby
fields.
State agriculture department officials
say the likelihood of something similar
happening in Colorado is remote. Researchers
planted their corn 30 days after regular
corn was planted in the area. And they
plan to harvest it early, after which
the corn stalks will be destroyed.
The state role in the biopharm program
seems unclear, and that's worrisome.
The federal government issues the permit
for such a project, and a private farmer
gives permission to use the land, leaving
the state as a bystander. Perhaps the
state needs to take a more hands-on
role by being given the power to issue
its own permits, as has been proposed
- and rejected - in the past. That would
give state officials a greater say on
safeguards rather than leaving them
in only a possible clean-up role.
For now, the researchers are focusing
on the process of production, trying
to perfect the injection of the E. ecoli
gene into the corn seed. There will
not be enough corn to actually produce
any vaccine. But if the process proves
successful, larger biopharm cornfields
could be sprouting in Colorado in the
future.
June 2
Reuters
The U.S. Agriculture Department's process
for approving permits to grow biopharmaceutical
crops is "shrouded in secrecy,"
making it difficult to know if the crops
pose a risk to humans or the environment,
a study said on Wednesday.
The activist group Center for Science
in the Public Interest, CPSI, said the
USDA's failure to disclose more details,
such as the drug or chemical being produced,
could lead to problems.
"It is impossible to know whether
these biopharmed crops present any food-safety
or environmental risk, since the whole
process is shrouded in secrecy,"
said Greg Jaffe, a director of biotech
projects at CSPI who authored the study.
Biopharming, which uses plants to generate
proteins that now cost millions of dollars
to make in large fermentation facilities,
has drawn the interest of several biotech
companies.
Developers believe that plants engineered
to produce specific proteins or compounds
to treat illnesses like diabetes could
cut the costs of producing some drugs.
Biopharming has shown signs of recovering
from a 2002 incident when experimental
corn plants grown by ProdiGene Inc.
were mixed with soybeans.
Cindy Smith, deputy administrator of
biotech regulations at the USDA's Animal
and Plant Health Inspection Service,
said the agency had already planned
to issue a report this month that addressed
many of the changes recommended by CSPI.
Smith said the USDA would begin releasing
the size of the field test and the risk
assessment on the environment for each
application. In addition, the public
would have 30 days to comment when the
agency does a more in-depth report on
the crop's impact on the environment
before a permit is issued.
"Our regulatory system now offers
those safeguards" to protect human
health and the environment, said Smith.
"I think the difference is the
safeguards we have in place will soon
be more transparent to the public and
that will allow the public greater confidence
in our regulatory system."
OVERHAUL PERMIT PROCESS
The CSPI report called for an overhaul
of the USDA permit process that would
center on allowing the public to review
the application and the permit after
it is issued.
It also recommended the USDA determine
each crop's impact on the environment,
with the Food and Drug Administration
assessing if the biopharm crop would
have any adverse effects if it entered
the food supply.
Smith said the USDA already determined
the crop's impact on the environment
before deciding whether to issue a permit.
In the past 12 months, the USDA has
received 16 applications to grow biopharm
crops, with half of those in the past
three months.
Six applications proposed growing corn,
according to CSPI. ProdiGene submitted
four of the applications to produce
pharmaceuticals with corn in Nebraska
and Texas.
"What we worry about is the potential
for more ProdiGene incidents or a contamination
of the food supply or for some other
detrimental effect," said Jaffe.
After ProdiGene, the USDA imposed tougher
rules on planting industrial and pharmaceutical
crops. Biotech companies must obtain
a USDA permit that sets strict planting
requirements to minimize environmental
risks. That includes planting experimental
crops at certain distances from other
crops and cleaning farm equipment.
Environmentalists, consumer advocates
and food industry groups have said the
USDA must impose stricter regulations
on pharmaceutical crops to prevent unapproved
plants from entering the food supply.
Many of the groups oppose using crops
such as corn that are consumed by humans
to generate pharmaceuticals without
a stronger regulatory process.
USDA sees resurgence in
permit applications
June 2
Washington Post
A small biotechnology company that
mishandled gene-altered corn 1 1/2 years
ago by allowing it to possibly mix with
food crops has applied for four new
permits to grow experimental plants
that could one day yield medicine, according
to a new report by a consumer group.
The company, ProdiGene Inc. of College
Station, Tex., has already received
approval from the U.S. Department of
Agriculture for one permit, which involves
growing gene-altered corn in Nebraska.
The company's applications are among
the 16 that have been filed in the past
year, marking the resurgence of an industry
attempting to turn ordinary plants such
as corn and rice into factories for
drugs and industrial chemicals, says
the report by the Center for Science
in the Public Interest.
The center supports the new technology,
called "biopharming," in principle,
but has called for stricter regulatory
oversight by the USDA. With the technique,
crops used for food can be bred instead
to produce special proteins for pharmaceuticals
or other compounds. Biotechnology companies
say the cutting-edge approach could
prove less expensive than conventional
means, and that could make certain drugs
more accessible to the public.
But the strategy has come under intense
scrutiny since November 2002, when the
USDA alleged that ProdiGene had failed
to take the necessary steps to keep
gene-altered corn separate from nearby
food crops in Nebraska and Iowa. The
company was later fined, and it agreed
to pay to destroy about 500,000 bushels
of soybeans that may have been contaminated
with the pharmaceutical corn.
Company officials said they have since
put in place stringent safeguards to
ensure a similar mishap does not occur.
The 2002 episode led to a drop-off
in applications to the USDA for permits
to grow the special crops. But according
to today's report, the hiatus has recently
ended and applications are once again
on the rise.
The center's new report, "Sowing
Secrecy: The Biotech Industry, USDA
and America's Secret Pharm Belt,"
says the USDA has approved seven of
the 16 applications received for permits
to conduct biopharming within the past
year. The other nine are pending.
During the year that included the growing
season immediately after the ProdiGene
incident, only four applications were
approved. In the year before the incident,
the USDA issued 25 permits.
The report also shows that of the 16
applications from the past year, about
two-thirds involved a food crop such
as corn, rice or barley. Many of the
gene-altered crops will be grown in
states where those kinds of crops are
cultivated for food.
"The food industry and consumer
groups said after ProdiGene that we
shouldn't be using food crops and if
we do use food crops, we should do it
very far away from where food crops
are grown for food purposes," said
Gregory Jaffe, the report's author and
the Center for Science in the Public
Interest's biotechnology project director.
"But if you look at the applications,
the companies don't seem to be listening."
Lisa Dry, spokeswoman for the Biotechnology
Industry Organization, said companies
are working with regulators to do all
they can to make sure biopharming remains
safe. The new report, she said, ignores
the potential benefits of biopharming
and the reason why new techniques are
needed to develop drugs. "The conventional
methods just don't meet the demand,"
she said.
Jaffe's organizations has long pushed
for more transparency in what it sees
as an opaque process for approving permits.
Yesterday, the USDA said it will announce
revised rules later this month that
will give the public greater access
to information about exactly what crops
biotechnology companies are planting
and how great a risk they pose.
"We believe in being transparent,
and that's why we are working on our
rules," said Cindy Smith, the USDA
administrator who oversees regulation
of biopharming.
Smith said the USDA hopes to address
one of Jaffe's central criticisms by
working with the Food and Drug Administration
to assess the effects on humans if a
gene-altered plant were to slip into
the food supply. That new policy has
not been finalized, however, and she
said it could take several years to
implement.
Scientists believe that most pharmaceutical
and industrial proteins are easily digestible
and are not likely to harm people, even
if they're eaten in large quantities.
Still, because the exact impact of any
individual protein is not known, if
gene-altered plants were to become mingled
with ordinary crops, it could spur a
massive recall.
That possibility concerns the Grocery
Manufacturers of America, which represents
the food and beverage industry.
"We need a comprehensive regulatory
system that ensures everyone knows who
is responsible for what when the products
are being developed. Right now we have
a piecemeal system," said Stephanie
Childs, a Grocery Manufacturers of America
spokeswoman.
But ProdiGene chief executive John
Reiher said the USDA has already enacted
a robust set of rules that allow for
no margin for error. The USDA tightened
its rules in March 2003, just four months
after ProdiGene's mishandling of its
gene-altered corn became public.
Under the revised rules, the USDA mandated
extended buffer zones between ordinary
crops and their gene-altered cousins,
more stringent harvesting procedures
and better training for farmers and
biotechnology company employees involved
in growing the crops. The USDA also
said that biopharm companies could expect
seven times more inspections by federal
regulators.
"USDA has expanded its regulatory
requirements since the ProdiGene incident.
. . . [The new rules] would prevent
a similar situation from happening again,"
said Reiher, whose company has three
applications pending to grow gene-altered
corn in Texas.
Reiher said ProdiGene is in full compliance
with the new regulations, and in some
cases exceeds the requirements. For
instance, the new rules dictate that
gene-altered corn can't be grown within
a mile of ordinary corn. Reiher said
his company's corn is kept two or three
miles away from any corn that winds
up on consumers' plates.
Scott E. Deeter, president and chief
executive of California-based Ventria
Bioscience, said technology and economics
often don't allow for the use of crops
other than food when it comes to biopharming.
His company, he said, has applied to
use rice and barley to develop products
that could improve human health.
"We wouldn't be able to bring
these benefits to society if we were
relegated to a non-food system,"
he said.
June 1
AP
San Francisco -- Biotechnology companies
are quietly pushing to splice more human
genes into growing numbers of food crops
after the practice was nearly left for
dead last year, a Washington-based advocacy
group will report Wednesday.
The spike comes a little more than
a year after a Texas company caused
such uproar with its accidental mixing
of its ``pharma'' crops with conventionally
grown plants that giant food manufacturers
called for tighter regulation of such
experiments and biotech titan Monsanto
Co. announced it was abandoning the
field.
The number of federal regulatory approvals
and applications of these outdoor plantings
-- often called ``biopharming'' -- have
nearly doubled in the last 12 months,
compared to the previous year, according
to a study to be released by the Washington
D.C.-based Center for Science in the
Public Interest.
``The biopharming industry seems to
be back in business,'' concluded the
report, which is based on publicly available
U.S. Department of Agriculture data.
The USDA has approved seven of the
16 applications it received between
May 2003 and April. The nine applications
pending were all submitted in the last
four months, and the report's author
Greg Jaffe expects those to be approved
in the coming weeks. That's because
the USDA has denied only two such applications
since 2000, Jaffe said.
The USDA has approved slightly more
than 300 biopharming plantings throughout
the country since 1995. As late as June
2002, it approved about 25 annually
before approvals fell to just four a
year 12 months later.
No human drug made from genetically
engineered crops has been approved for
commercial use and most applications
are for small outdoor plots of less
than acre each, the USDA said.
Still, Jaffe and other critics complain
that current USDA regulations are too
lax and not open enough to the public.
Most applications, for instance, don't
specify how many acres are to be cultivated
and exactly where the pharmaceutical
crops are to be grown, making it impossible
for nervous conventional farmers to
know whether biotech varieties that
could cross-pollinated with their harvest
are growing nearby.
Several small biotechnology companies
and university researchers are attempting
to make inexpensive human medicines
such as insulin and vaccines by splicing
protein-producing human genes into crops
that include corn, rice and even tobacco.
The human genes coax the crops to produce
proteins, which can be extracted from
the plants and turned into medicines.
At Stanford University, 16 lymphoma
patients last year were treated with
an experimental cancer drug extracted
from a genetically engineered tobacco
created by Large Scale Biology Corp.
-- the first human use of a pharmaceutical
derived from a plant.
This biotechnology niche had been growing
steadily for a decade despite continued
attacks from genetic engineering foes
who fear such work has not been studied
enough to ensure the safety of the nation's
food supply if accidental mixing occurs.
Pharming suffered a dramatic setback
in late 2002 when the USDA fined College
Station, Texas-based Prodigene Inc.
$500,000 and ordered it to pay another
$3 million to buy and destroy conventionally
grown soy contaminated with its corn,
which was genetically engineered to
produce a pig vaccine.
Since then, Large Scale Biology has
fallen on hard financial times and hasn't
continued with expanded lymphoma experiments.
The Grocery Manufactures of America,
which supports biotech crops approved
for consumption and represents the Coca
Cola Co., Nestle and dozens of others
in the $500 billion food industry, has
called on the USDA to tighten regulation
of pharma crops and biotech companies
to experiment exclusively with non-food
crops.
Last year, Monsanto Co., the world's
largest biotech farming company, announced
it was abandoning the pharmaceutical
field.
And in April, California regulators
denied Sacramento-based Ventria BioScience's
application to grow rice with human
genes after California rice growers
said they feared international customers
would refuse to buy their conventionally
grown crops out of contamination fears.
In response to the growing concern,
the USDA plans to unveil a revised review
process in the next three weeks that
would make public more information on
pharma applications and, for the first
time since 1998, require detailed environmental
assessments on large-scale projects
near commercialization, said Cindy Smith,
the deputy administrator of biotech
regulation for the department.
Smith said Prodigene will be the first
company to undergo the more stringent
environmental review on the two applications
it has pending to grow pharmaceutical
corn in Texas this year.
A Prodigene spokeswoman didn't return
a telephone call.
June 1
USA Today
The U.S. Department of Agriculture
plans a major shift in its biotechnology
policies to give the public more information
about the pros and cons of crops genetically
engineered to produce drugs.
Cindy Smith, USDA's deputy administrator
for biotechnology regulatory services,
says new procedures are needed because
larger field studies of such crops are
planned in the next five years.
Smith says that when the USDA issues
a permit to grow drug-producing plants,
the agency will publish online its reports
on the spectrum of risks and environmental
impact associated with that plant.
Previously, those reports had been
unavailable to the public.
USDA also plans to post the number
of acres requested for each crop, as
well as the number actually planted.
The lack of this information makes it
very difficult for the public to gauge
the potential impact of any test, Smith
says.
The only biotech seeds now used by
U.S. farmers are in cotton, soybean,
corn, canola and papaya that are pesticide,
herbicide and disease resistant. No
commercial crops now include plants
that have been engineered to produce
drugs.
Such plants are the holy grail of the
biotech industry because of their potential
for making expensive drugs cheaply.
There has been considerable concern
from the food industry that such plants,
which would look the same as their non-biotech
counterparts, might somehow get into
the food supply, where they could be
a health hazard.
The USDA plans to announce the changes
formally within a month, Smith says,
adding that it is not clear when they
will go into effect.
Smith announced the plans in response
to a report to be issued today indicating
that applications for the planting of
biotech crops that produce drugs and
industrial chemicals are again on the
rise.
Applications plummeted after an incident
in 2002 in which a corn-produced vaccine
to prevent diarrhea in pigs was nearly
released into the food supply.
The Center for Science in the Public
Interest report found that while the
USDA received only four applications
for growing so-called pharma crops from
July 2002 and June 2003, from May 2003
to April 2004 the agency received 16
such applications, half of those in
the past three months.
By comparison, USDA issued 25 permits
for such crops from July 2001 to June
2002.
While the biotech industry takes this
as a good sign, the food industry is
adamant that such crops post an "unacceptable
risk to the integrity of the food supply,"
according to the National Food Processors
Association.
The news comes as 17,000 biotech professionals
prepare to meet in San Francisco beginning
Sunday for the 10th annual Biotechnology
Industry Organization conference, with
hundreds and perhaps thousands of biotech
protesters close on their heels.
