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GMO experiments receive questionable oversight
Bill
Lambrecht
Updated 7:57 am, Monday, September 8, 2014
Worker
Javier Alcantar tends to corn crops at the Monsanto Co. test field in Woodland,
California, U.S., on Friday, Aug. 10, 2012. Monsanto Co., an American multinational
agricultural biotechnology corporation, is the world's leading producer of the
herbicide glyphosate and the largest producer of genetically engineered (GE)
seed. Photo: Noah Berger, Bloomberg
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Washington -- At a secret location among the vineyards of California's
Central Coast, a plot of genetically engineered corn is producing proteins for
industrial and pharmaceutical uses, including an experimental vaccine for
hepatitis B.
The altered corn is growing with
federal approval 100 feet from a steelhead stream in San Luis Obispo County, in
designated critical habitat for the threatened California red-legged frog. Agriculture Department inspectors have reported
two "incidents" at the site, including conventional corn sprouting in
a 50-foot fallow zone, but the findings did not rise to the level of a fine or
even to a formal notice of noncompliance for the company that planted it, Applied Biotechnology Institute Inc.
Details of Applied Biotechnology's
inspections and hundreds of other field trials with genetically modified plants
were obtained by Hearst Newspapers under Freedom of Information
laws. The inspection reports and other Agriculture Department records present a
picture of vast, swiftly expanding outdoor experimentation and
industry-friendly oversight of those experiments.
The founder and president of Applied
Biotechnology, John A. Howard, previously founded another
company that was permanently banned from trials of genetically modified
organisms - GMOs - after creating such contaminated messes in the Midwest that
a half-million bushels of soybeans and more than 150 acres of corn had to
be destroyed.
Yet since 2009, the U.S. Department
of Agriculture has approved the Applied Biotechnology Institute's little-known
plantings, albeit with limits so strict that ears of corn must be locked up and
plant remains must be buried 3 feet deep. Indeed, things are proceeding so well
for Applied Biotechnology that Howard is seeking land to expand the 5-acre
"pharming" operation.
The outdoor tests are at the leading
edge of a technological revolution based on reordering the building blocks of
life. The advent of GMOs has spawned global debate and protest over issues of
consumer safety and the uncertain effects of altered genes on
the environment.
Industry-friendly approach
The documents show how the obscure Animal and Plant Health Inspection Service
(APHIS), part of the Agriculture Department, takes an industry-friendly
approach in seeking to prevent contamination or economic harm from
field trials.
Among the findings of a Hearst
Newspapers investigation:
-- Minimal penalties. The
Agriculture Department issued just two civil penalties for field trials since
2010 despite sending out nearly 200 notices of noncompliance - incidents from paperwork
violations to lost seeds to modified plants sprouting where they shouldn't.
-- Monsanto mistakes. The Missouri
biotech giant received at least 35 notices of noncompliance from 2010 through
2013, more than any other company. In 2010, the company paid a civil penalty
for accidentally ginning experimental cotton in Texas two years earlier, an
error that led to unapproved cottonseed meal and hulls being consumed by Texas
livestock and exported to Mexico for animal feed. Monsanto blamed
human error.
-- Natural perils. Dozens of times,
heavy rains washed out or otherwise damaged test plots, raising the specter of
unwanted dispersal of GMOs. Animals pose other threats. Birds, insects and
larger animals don't distinguish between gene-altered crops and conventional varieties.
APHIS says it has approved nearly
20,000 field-trial permits, covering an estimated 100,000 plantings of
gene-altered crops. The agency says it has no firm count.
Once genetically engineered crops
become commercialized, no government agency tracks them. That underscores the
importance of monitoring field trials, particularly with crops like alfalfa and
canola, and grasses with sexually compatible wild relatives.
Economic risks
Besides threatening the environment,
escaped or unapproved crops can generate economic problems, as did last year's
discovery of wheat engineered to resist Monsanto's Roundup weed-killer.
The herbicide-tolerant wheat, found
on an Oregon farm, had been tested by Monsanto in 16 states from 1998 to 2005
before the company suspended its trials. Monsanto has since resumed research
into genetically modified wheat.
Within days after the discovery,
Japan, Korea and Taiwan suspended imports of certain wheat varieties from the
Pacific Northwest out of fear of contamination. The European Union demanded new testing of imports
from the United States, and wheat futures dropped sharply. Nowhere in the world
is genetically modified wheat legal.
APHIS investigated but has yet to
report its findings. Monsanto has said the rogue wheat might have resulted
from sabotage.
Since winning APHIS approval in 1996
for herbicide-tolerant soybeans - the first genetically engineered crop
commercialized in the United States - Monsanto has become the unrivaled global
leader in the business.
The company, which reported $14
billion in revenue last year, says it has conducted roughly 26,000 field trials
in the United States since 1990, more than one-fourth of the 100,000 that APHIS
estimates have taken place.
Breaches
of standards
Monsanto says it relies on training
and audits to strengthen field trial procedures and has self-reported some 300
potential violations. But, as the company observes on its website, "We do
experience occasional deviations from internal and APHIS standards." Among
those deviations, an inspection report in North Carolina in 2007 noted that
Monsanto had planted modified soybeans "entirely in the wrong county"
- one of several such incidents.
APHIS sent Monsanto a notice of
noncompliance in July after the company divulged that it had "unintended
constructs" of genes at 39 corn trial locations across five states.
APHIS' handling of field trials has
drawn criticism from scientists and from other federal agencies. The
Agriculture Department's inspector general in 2005 identified "weaknesses
in inspections and enforcement" as basic as being unaware of the locations
of field trials.
In 2008, the Government Accountability Office, citing
"controversy and financial harm" from a half-dozen unauthorized
releases, recommended more robust monitoring of field trials. The GAO also said
government agencies should work together after engineered products hit the
market to determine unintended consequences to the environment, conventional
farming and food safety.
APHIS officials said they have
bolstered the agency's science capacity and increased its inspection staff
to 130.
Nonetheless, APHIS is drawing heat
from farmers worried about the potential effects of so many field trials. Last
year, more than 150 farm groups and businesses, many in the organic trade,
asked the Agriculture Department to strengthen oversight of field trials.
In San Luis Obispo County, Applied
Biotechnology's Howard hopes the company can avoid the public uneasiness with
genetically modified food.
In May, APHIS granted Applied
Biotechnology's request for a confined release of genetically engineered corn
designed to produce 22 pharmaceutical and industrial molecules. The government
is allowing the company to keep some of them confidential.
APHIS' decision summary minimizes
potential impacts. It notes that the hepatitis B protein - derived from the
hepatitis B virus - has no "toxic activity."
The ruling asserts that corn, a
wind-pollinated crop, lacks sexually compatible relatives in the wild and
therefore does not threaten surrounding plant life.
Some restrictions
As for the steelhead trout, APHIS
acknowledged "potential for a small amount of genetically engineered
pollen to drift into the stream" but concluded that because of the minimal
exposure and lack of toxicity, it would have no effect.
Nonetheless, the federal agency
ordered that the engineered corn not be grown within a mile of commercial corn
and its seed must be maintained with what are called
chain-of-custody documents.
Before starting Applied
Biotechnology Institute in California, Howard set up ProdiGene Inc. of College Station, Texas, in the
late 1990s and carried the title of chief scientific officer.
But that company encountered such
contamination problems with its APHIS-approved field trials that the Agriculture
Department eventually forced it out of the business of growing
pharmaceutical plants.
In 2002 - the year Howard says he
parted ways with ProdiGene - APHIS disclosed that corn plants from ProdiGene's
field test a year earlier in Nebraska were sprouting in a field of soybeans
planted at the site. But before the corn could be removed, the potentially
contaminated soybeans were harvested. All 500,000 bushels had to
be destroyed.
Also in 2002, ProdiGene was forced
to burn 155 acres of corn near the site of a field trial in Iowa after
pharmaceutical plants were found growing illegally. ProdiGene was fined
$250,000.
In addition, the Agriculture
Department purchased, hauled and destroyed the adulterated soybeans at a cost
of $3.5 million, and gave ProdiGene two years interest-free to pay the
government back.
ProdiGene's problems persisted. In
2004, an inspector found that oats growing alongside one of the company's test
corn sites in Nebraska had been baled for animal feed. In addition, engineered
corn was sprouting in a nearby sorghum field.
It took three years, but this time,
APHIS came down hard. In 2007, ProdiGene received a modest $3,500 fine but
agreed that neither it nor "its successors in interest" would ever
again apply to the Agriculture Department for permission to introduce GMOs into
the environment.
Departure
date in question
Despite his claim that he left his
executive position with the company in 2002, Howard remained a director of
ProdiGene until 2007, according to the Texas secretary of state's records.
Howard still owns "lots of shares" in the company, he said.
In an interview, Howard said he was
not involved in practices that led to the contamination incidents before his
departure in September 2002 after what he described as "a difference of
opinion with management."
APHIS skirted the question of
whether the California company's GMO releases should be allowed given the 2007
agreement, responding by e-mail that it has issued permits to Applied
Biotechnology Institute "for a variety of genetically engineered
organisms, including products developed by ProdiGene."
But Greg Jaffe, a lawyer with the
Center for Science in the Public Interest, a Washington, D.C., advocacy group,
suggests that the agreement has been "technically violated given that Applied
Biotechnology Institute is selling ProdiGene's main product and ProdiGene
personnel are doing the same thing in the new company."
Howard, 63, of Cayucos (San Luis
Obispo County), received a doctorate in biochemistry from UC Riverside.
Howard said his company has security
measures even beyond those imposed by the Agriculture Department.
He believes that his quest to
produce a hepatitis B vaccine insulates him from some of the opposition to
genetically modified foods.
"It's harder to make up some
Frankenstein scenario where this is terrible when the outcome of not doing it
is that people die," he said.
Bill Lambrecht is an investigative
reporter for Hearst Newspapers. E-mail: bill.lambrecht@hearstdc.com
