ANALYSIS - US Oversight of Biotech Crops Seen Lacking

KANSAS CITY, Mo. - Criticism is mounting over the US government's efforts to control experimental genetically modified crops in the wake of admissions that a discarded biotech rice has contaminated US commercial supplies.

The disclosure of the contamination of experimental biotech rice owned by Bayer CropScience, a unit of Bayer AG, coupled with statements by USDA officials that they have no idea how the contamination occurred or how extensive it may be, has outraged players up and down the food chain.

Farmers, food and beverage makers and exporters all are positioning themselves for a long, and likely costly, ordeal.

Already, Japan has suspended imports of US long grain rice because of the contamination, and Europe, a major export market for US rice, has insisted rice imports be tested and any contaminated rice excluded from shipments to the 25-member European Union.

Other US rice customers are also reportedly reviewing their planned purchases even as US rice prices have dropped sharply.

Meanwhile, with much of the US rice industry in turmoil because the extent of the contamination is unknown, an official with the USDA's Animal Health and Plant Health Inspection Service said it would likely take two to three months before the agency had many answers.

"This is real money that farmers are losing," said Arkansas Rice Growers Association executive director Greg Yielding, who said he has fielded dozens of calls from frantic rice farmers. "It is a big deal. We do not feel that USDA and APHIS have adequate funds or staff to do this job. They can't tell you where anything is even though they get permits for it."


HOLES IN OVERSIGHT

Over the last decade, the USDA has approved applications for more than 49,000 field site tests of GMO crops and APHIS has deregulated more than 70 GMO crop lines, many of which have been embraced by farmers because they are easier and/or more profitable to grow.

USDA and APHIS have touted the government's ability to oversee the growth of biotechnology in agriculture and repeatedly assured consumer groups and foreign governments that safety was a foremost concern for regulators.

But an Office of Inspector General audit of APHIS' and its biotechnology regulatory services unit found numerous holes in oversight efforts and issued a stern warning in its December 2005 report.

It said APHIS lacks "basic information about the field test sites it approves and is responsible for monitoring, including where and how the crops are being grown and what becomes of them at the end of the field test."

The OIG said that even though APHIS was supposed to inspect experimental fields, it was not even requiring companies to provide site location information. The government did not require companies to document efforts to make sure GMO crops were segregated, and it didn't test neighboring fields to look for contamination during or after field trials.

The OIG also said it found widespread violations of a rule requiring experimental crops to be shipped in metal containers, instead allowing them to be shipped in boxes or bags.

Overall, the OIG audit found the APHIS regulatory system so weak that it increased the risk that experimental GMO crops would "persist in the environment."

The contaminated rice is only one example of unapproved GMO's slipping into the mainstream. Last year, Swiss agrochemicals firm Syngenta revealed that its unapproved, experimental strain of corn known as Bt10, was found to have contaminated corn supplies from 2001-2004.

Also, a biotech grass resistant to weedkiller developed in part by Monsanto Co. has been found growing in the wild, while ProdiGene Inc. had to buy back and destroy millions of dollars of grain after tainting crops with an experimental corn plant used to produce medicine.

And earlier this month, a US district judge ruled that APHIS broke environmental rules when it allowed the planting of certain biotech corn and sugarcane between 2001 and 2003 in Hawaii.


MORATORIUM SOUGHT

Because of the government oversight concerns, Greenpeace International has called for a ban on US GMO rice and the Center for Food Safety has said it wants a moratorium on all field tests of genetically modified crops until government oversight improves.

"There is all this stuff in writing to give you a sense of security but when you look at what they're actually doing, it's nothing," said Center for Food Safety scientist policy analyst Bill Freese.

Cindy Smith, deputy administrator for APHIS' biotechnology regulatory services acknowledged in an interview some issues with oversight, but said those problems were largely in the past and had been corrected or would be soon.

"You will likely continue to see the program evolve in different ways. As long as we're regulating this technology, we're going to have to continue to grow and expand and respond based on the nature of the technology," Smith said.

Original Story at PlanetArk

Section 18 Emergency Exemptions from Pesticide Registration

Under the authority of §18 of Federal Insecticide, Fungicide & Rodenticide Act, EPA can allow State and Federal agencies to permit the unregistered use of a pesticide in a specific geographic area for a limited time if emergency pest conditions exist. EPA's background document, Section 18s Program and Proposed Reforms, details proposed changes to the Section 18 process.

Typically, a need for an emergency exemption arises when growers and others encounter a pest problem on a site (in most cases, a crop) for which there is either no registered pesticide available, or for which there is a registered pesticide that would be effective but is not yet approved for use on that particular site. Also, exemptions can be approved for public health and quarantine reasons.

Most requests for emergency exemptions are made by state lead agricultural agencies, although the United States Department of Agriculture and United States Department of Interior also request exemptions.

In New Jersey, the state lead agency is the New Jersey Department of Environmental Protection (NJDEP). Typically, a request for the emergency exemption will be accompanied by a description of the pest problem and why a particular control is warranted. EPA then issues the NJDEP a letter of specific exemption from registration (also known as a 'Section 18') for the pesticide product to deal with the emergency pest condition for a prescribed time period.

If a need is immediate, a state agency may issue a crisis exemption under Section 18 of FIFRA which allows the unregistered use for 15 days. Crisis exemptions are typically requested following a specific exemption that has not been processed in accord within the sometimes limited window of a pest outbreak.

In cooperation with the NJDEP, NJinPAS posts notices of these Section 18 specific or crisis exemptions to the appropriate topical NJinPAS listservs. If you would like to receive notice of Section 18's issued, you may enroll in the individual NJinPAS listservs for fruit, vegetables, or field and forage crops.

Section 18 Emergency Exemptions (both 'crisis' and 'specific') from pesticide registration granted in New Jersey are listed below. Each exemption listing includes: the emergency exemption number assigned by EPA, the date issued; date of expiration; the registrant (company that manufactures the pesticide product); the common and brand names with the EPA Registration Number of the pesticide product; and the prescribed use of the pesticide product. Additionally, the exemption listing includes the date and responsible party for a required report to the NJDEP on the exemption; the persons listed are typically those who requested the exemption form the NJDEP initially. You may view a selection of corresponding labels to these Emergency Exemptions on the Rutgers Cooperative Extension website. When available, these labels are provided as hyperlinks at the individual brand listing (see the 'Brand & Label' column of the table below).

Original Article

Biotech Firm, Govt. Hid Rice Contamination from Public

Aug. 24 – Last week, the US Department of Agriculture announced that US commercial long-grain rice supplies are contaminated with "trace amounts" of genetically engineered rice unapproved for human consumption.

The genetically engineered (GE) rice is known as Liberty Link (LL) 601. Its genetic code has been modified to provide resistance to herbicides and is illegal for marketing to humans because it has not undergone environmental and health impact reviews by the USDA and the Food and Drug Administration (FDA). LL601 was field-tested from 1998 to 2001 under permits granted by the USDA, but Bayer Corp Science, the developer of the experimental rice, did not seek commercial approval for it.

The contamination was only disclosed after Bayer notified the USDA itself. Currently, the government relies on self-reporting from food companies to determine genetically engineered (GE) contamination, rather than a federal testing system. The USDA dismissed concerns that companies may not always "self-report" or even be aware of their mistakes, which would lead to further undetected contamination of unapproved GE food.

It appears a separate company first detected the contamination in January of this year and that Bayer may have known about the contamination since May. But the government was not notified until July 31. It took another 18 days for the USDA to tell the public.
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At a press conference, Secretary of Agriculture Mike Johanns would not divulge how the contamination had happened, or how far it had spread. It was unclear whether he even knew. Jim Rogers, a USDA spokesperson, told The NewStandard the contaminated rice was detected in barrels sent to Missouri and Arizona.

"But the rice could have come from anywhere [in the US]," Rogers said.

Riceland, a farmer-owned cooperative that markets rice produced by Southern farmers, issued a press release on August 18, saying it first discovered the contamination in January. Riceland conducted its own tests from several grain-storage locations and found: "A significant number tested positive for the Bayer trait. The positive results were geographically dispersed and random throughout the rice-growing area."
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Riceland notified Bayer of the contamination in May, but did not notify the public or the government.

Johanns indicated that an economic motive was behind the government’s delay of nearly three weeks before informing the public about the contamination, as the government anticipated foreign rice importers might reject the product. The Secretary said the USDA spent the time preparing tests for rice importers to check the product for contamination. The US constitutes about 12 percent of the world’s rice trade.

There are currently no plans to destroy or recall the rice, and Rogers is unsure if Bayer will be fined. While the government "validates" its tests for the rice, Johanns directed people to Bayer’s website, saying the company "has made arrangements with private laboratories to run tests" on the rice.
“We see this as an opportunity to get out the message that this is a radically new technology. These foods have not been tested and we don’t know if they’re safe.”

Although the field tests for LL601 ended in 2001, the contamination appeared in a 2005 harvest, leaving some food-safety advocates to worry that the contamination has been present for several years and suggesting that genetically modified strains can persist in the environment well after they have been discontinued in experiments.

Two other varieties of rice with the same gene and from the same company have already been approved for human consumption, though never marketed. There is currently no known, intentional commercial US production of genetically engineered rice.

Johanns said that based on "available scientific data" provided by Bayer, the USDA and the FDA have concluded "that there are no human-health, food-safety or environmental concerns associated with this GE rice."

When pressed about the health implications of the contaminated rice, Rogers noted that foods from pesticide- and herbicide-resistant crops are already on the market. In fact, according to the USDA, 70 percent of processed foods on grocery store shelves contain genetically engineered ingredients.

Rogers dismissed concern that, because the government relies on companies’ self-reporting, there could be widespread contamination of unapproved GE ingredients in the US food supply. He said the government did not have plans to begin testing food itself.

But this is not the first time unapproved genetic material has escaped detection in the food supply. In 2004, the company Syngenta admitted that for four years, it had sold unapproved GE maize in the US.

In response to the Bayer revelation, Greenpeace has called for a worldwide ban on imports of US rice. Already, Japan has suspended US rice imports.

The Center for Food Safety, a public-interest organization, is also calling for a moratorium on all new permits for open-air field testing of GE crops. The Center is concerned that open-air testing allows GE crops to cross pollinate with neighboring non-GE crops.

"We see this as an opportunity to get out the message that this is a radically new technology," said Bill Freese, science policy analyst for the Center. "These foods have not been tested, and we don’t know if they’re safe."

Original Story

FDA approves viruses for treating food

A mix of bacteria-killing viruses can be safely sprayed on cold cuts, hot dogs and sausages to combat common microbes that kill hundreds of people a year, federal health officials said Friday in granting the first-ever approval of viruses as a food additive.

The combination of six viruses is designed to be sprayed on ready-to-eat meat and poultry products, including sliced ham and turkey, said John Vazzana, president and chief executive officer of manufacturer Intralytix Inc.

The special viruses called bacteriophages are meant to kill strains of the Listeria monocytogenes bacterium, the Food and Drug Administration said in declaring it safe to use on ready-to-eat meats prior to their packaging.

The viruses are the first to win FDA approval for use as a food additive, said Andrew Zajac, of the regulatory agency's office of food additive safety.

The bacterium the viruses target can cause a serious infection called listeriosis, primarily in pregnant women, newborns and adults with weakened immune systems. In the United States, an estimated 2,500 people become seriously ill with listeriosis each year, according to the Centers for Disease Control and Prevention. Of those, 500 die.

Luncheon meats are particularly vulnerable to Listeria since once purchased, they typically aren't cooked or reheated, which can kill harmful bacteria like Listeria, Zajac said.

The preparation of bacteriophages — the name is Greek for "bacteria-eater" — attacks only strains of the Listeria bacterium and not human or plant cells, the FDA said.

"As long as it used in accordance with the regulations, we have concluded it's safe," Zajac said. People normally come into contact with phages through food, water and the environment, and they are found in our digestive tracts, the FDA said.

Consumers won't be aware that meat and poultry products have been treated with the spray, Zajac added. The Department of Agriculture will regulate the actual use of the product.

The viruses are grown in a preparation of the very bacteria they kill, and then purified. The FDA had concerns that the virus preparation potentially could contain toxic residues associated with the bacteria. However, testing did not reveal the presence of such residues, which in small quantities likely wouldn't cause health problems anyway, the FDA said.

"The FDA is applying one of the toughest food-safety standards which they have to find this is safe," said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a consumer advocacy group. "They couldn't approve this product if they had questions about its safety."

Intralytix, based in Baltimore, first petitioned the FDA in 2002 to allow the viruses to be used as a food additive. It has since licensed the product to a multinational company, which intends to market it worldwide, said Intralytix president Vazzana. He declined to name the company but said he expected it to announce its plans within weeks or months.

Intralytix also plans to seek FDA approval for another bacteriophage product to kill E. coli bacteria on beef before it is ground, Vazzana said.

Scientists have long studied bacteriophages as a bacteria-fighting alternative to antibiotics.

Original Story