These trials should be confined in greenhouses, not outdoors.--Tom
 
-----Original Message-----
From: Laurel Hopwood <[log in to unmask]>
To: CONS-SPST-BIOTECH-FORUM <[log in to unmask]>
Sent: Mon, Sep 8, 2014 6:35 am
Subject: Investigation: GMO experiments receive questionable oversight

Excellent investigative piece about "pharm" crops and government oversight.

http://m.sfgate.com/science/article/GMO-experiments-receive-questionable-oversight-5740478.php
GMO experiments receive questionable oversight
9/7/2014
(edited)

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 GM 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 Howard, previously founded another company that was permanently banned from trials of 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.

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.

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.

Once GMO 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.

Monsanto, which reported $14 billion in revenue last year, says it has conducted roughly 26,000 field trials in the U.S. since 1990. As the company observes on its website, "We do experience occasional deviations from internal and APHIS standards."

APHIS' handling of field trials has drawn criticism from scientists and from other federal agencies. In 2008, the Government Accountability Office, citing "controversy and financial harm" from a half-dozen unauthorized releases, recommended more robust monitoring of field trials.

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.

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.

Applied Biotechnology Institute set up ProdiGene and Howard carried the title of chief scientific officer.
In 2002, the USDA 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.
In 2004, the USDA 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.
In 2007, ProdiGene received a modest $3,500 fine and agreed that neither it nor "its successors in interest" would ever again apply to the USDA for permission to introduce GMOs into the environment.

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.
APHIS skirted the question of whether the California company's GMO releases should be allowed given the 2007 agreement, responding 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."
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