Gene-Altered Crops Denounced - Washington Post (16/8/2006)

1.Gene-Altered Crops Denounced - Washington Post
2.Ruling hailed by opponents of genetically altered crops - Star Bulletin (Hawaii)

1.Gene-Altered Crops Denounced
Environmental Groups Seek Moratorium on Open-Air Tests
By Rick Weiss
Washington Post, August 16 2006; Page A03

Environmental groups yesterday called for a moratorium on open-air tests of crops genetically engineered to produce medicines and vaccines, citing a federal court's conclusion last week that the Agriculture Department repeatedly broke the law by allowing companies to plant such crops on hundreds of acres in Hawaii.

In a toughly worded 52-page decision released without fanfare late last week, a U.S. District judge in Hawaii concluded that USDA's Animal and Plant Health Inspection Service (APHIS), which grants permits for the planting of genetically engineered crops, should have first investigated whether the plants posed a threat to any of that state's hundreds of endangered species.

The corn and sugar cane plants, already harvested because the experiments involving them were completed before the case was decided, had been modified to produce human hormones, drugs and ingredients for vaccines against AIDS and hepatitis B.

"APHIS's utter disregard for this simple investigation requirement, especially given the extraordinary number of endangered and threatened plants and animals in Hawaii, constitutes an unequivocal violation of a clear congressional mandate," wrote Judge J. Michael Seabright in his Aug. 10 decision.

The ruling is the first by a federal court on the controversial practice of "bio-pharming," in which crops are engineered to produce potentially therapeutic human proteins. But it is not the first damning federal critique of APHIS's oversight. A December 2005 audit by the Agriculture Department's Office of Inspector General found multiple failings in the agency's enforcement of research rules for gene-altered plants.

APHIS spokeswoman Rachel Iadicicco said yesterday that the agency had already corrected the major problems cited in the 2005 report and had recently made policy changes to satisfy the court's concerns, as well. In addition, she said, APHIS is crafting a sweeping "programmatic" environmental impact statement addressing larger, long-standing concerns about its oversight of biotech crops.

But opponents said they have heard such assurances before.

"We are asking the judge to enjoin the issuance of any biopharma permits anywhere in the country unless and until APHIS completes a programmatic analysis of their regulatory program," said Paul H. Achitoff, managing attorney for Earthjustice in Honolulu, which litigated the case with the Washington-based Center for Food Safety.

The judge has scheduled a hearing for Tuesday to decide what remedies to impose.

The court ruling is the latest in a decade-long struggle that has pitted biotech companies against an uneasy coalition of environmentalists and conventional food producers and distributors.

Advocates believe that some drugs and vaccines may be produced more economically in crops than in the laboratory cultures that are commonly used today. Some even envision "edible vaccines," such as bananas laden with proteins that would boost blood levels of protective antibodies -- an attractive strategy for developing countries, where the refrigeration needed for many conventional vaccines is often not available.

But opponents fear that ordinary crops may become contaminated with drug-spiked versions grown in open fields, and that unwanted drug exposures from foods could trigger allergic reactions or other problems in people or animals.

2.Ruling hailed by opponents of genetically altered crops
By Tom Finnegan
Star Bulletin (Hawaii), August 13 2006

A Honolulu federal court ruling will make it harder to win permits to grow genetically engineered crops across the country, environmental watchdogs said yesterday.

The ruling, by Judge J. Michael Seabright in a 2003 case pitting three environmental groups against the U.S. Department of Agriculture, found that permits filed in 2001 by four Hawaii seed companies violated federal law.

Seabright said in last week's decision that the USDA should have at least considered the impact on endangered species and the human environment, as required by federal law, before issuing the four permits.

The permits to field-test corn and sugar cane engineered to produce experimental vaccines, proteins, hormones or drugs for diseases such as HIV, hepatitis B and cancer expired in 2003. The permits gave the companies the ability to plant more than 800 acres on controlled sites on Kauai, Oahu, Molokai and Maui. This type of farming is generally known as biopharming.

Currently, no one is biopharming or growing crops to produce drugs in Hawaii. Companies produce seeds here only for human and animal consumption.

Still, last week's decision will be far-reaching, said Honolulu Earthjustice Managing Attorney Paul Achitoff, whose office is handling the case for the environmental nonprofits.

"The days of rubber-stamping these (genetically engineered crop permits) are over," Achitoff said yesterday. "Whenever (the USDA) proposes to issue permits, they're going to have to examine their impact."

Achitoff said he believes the decision will force the USDA to hold public hearings on each permit as part of the National Environmental Policy Act, one of the federal laws the USDA violated.

That would be a huge win for opponents of genetic engineering, since more than 6,000 negative comments were received when the USDA asked the public to comment on field-testing these biopharming products in 2003, according to Seabright's ruling.

Seabright reserved judgment on the permitting process. A separate hearing on that issue is scheduled for next Tuesday.

Hawaii biotech advocates say they are not worried by the decision and that their products are safe.

Before biotech products are marketed, they undergo seven to 10 years of safety testing, said Rick Klemm, executive director of Hawaii Alliance for Responsible Technology, an agricultural trade alliance.

Some 31 regulatory agencies in 17 countries, as well as prominent international scientific authorities, have stated that biotech crops are as safe as conventional crops, he said.

Besides, Klemm said, the violations outlined in the decision "were procedural" and did not involve "any harm to human health and safety or the environment."

The USDA still issues permits to biopharm across the country, he said, and in his view Seabright said it was "quite reasonable" to do so.

According to the Web site for the USDA Animal Health and Inspection Service -- the branch entrusted to regulate genetically engineered crops -- there is a rigorous process to regulate biopharming, including inspections, audits and oversight, and its task is to make sure the products do not contaminate surrounding areas.

Between 1991 and July 2005, more than 90 permits for biopharming, or "pharmaceutical and industrial crops," have been issued across the country, according to the USDA site.

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