GMO experiments receive questionable oversight, writes Bill Lambrecht

Read another article on a similar theme by Bill Lambrecht, "Gene-altered apple tested in Washington state":
http://gmwatch.org/index.php/news/archive/2014/15633

EXCERPT: 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.

GMO experiments receive questionable oversight: Central Coast corn used for varied experiments

Bill Lambrecht

SFGate, September 7, 2014
http://m.sfgate.com/science/article/GMO-experiments-receive-questionable-oversight-5740478.php

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's 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's 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: This email address is being protected from spambots. You need JavaScript enabled to view it.