State's Ban On Gene-Altered Fish A First
But aquaculture firm says FDA will approve 'transgene' farms

By Robert McClure
Seattle Post-Intelligencer Reporter
Monday, December 23, 2002

Washington this month became the first state in the nation to ban cultivation of genetically engineered fish.

"Transgenic" salmon carrying growth genes from another fish can grow twice as fast as normal, significantly cutting costs for aquaculture operations that raise fish in net pens. Eight such fish farms operate in Washington's inland saltwaters.

But the Washington Fish and Wildlife Commission was convinced by environmentalists that the risk is too great that altered fish could escape and interbreed with wild fish, ruining a genetic pool shaped by eons of evolution.

"This isn't the genie we want to take out of the bottle," said Shawn Cantrell, Northwest regional director for Friends of the Earth. "There are too many unknowns and possible downsides."

The ban by the Washington Fish and Wildlife Commission is largely symbolic. The fish can't be grown anywhere in the nation yet, pending approval of the altered salmon by the U.S. Food and Drug Administration.

Proponents say concern about the fish should be allayed by the time a Waltham, Mass.-based company, Aqua Bounty, wins FDA approval for the altered fish.

"We're confident we can bring forth sufficient scientific information to show these are both safe to eat and safe to use in the environment," said Joe McGonigle, Aqua Bounty vice president.

Opponents, who call the altered salmon "Frankenfish," point to a study by Purdue University animal scientist William Muir and biologist Richard Howard.

The Purdue scientists reported that transgenic fish that mate with wild fish produce fewer eggs that hatch.

However, the transgenic-wild-crossed fish that did hatch were more likely to find mates when they grew to adulthood.

Muir and Howard termed it the "Trojan gene effect," because genetic material slipped into the population confers a mating advantage to fish whose eggs are least likely to hatch and survive to adulthood.

Over the course of 40 generations, this combined effect could lead to the extinction of the wild and transgenic fish, the Purdue researchers said, because the fish most likely to find a mate are also least likely to produce large numbers of viable offspring.

The Purdue research involved Japanese medaka, a small and fast-maturing fish. It remains unclear whether similar effects would occur in Pacific Northwest salmon, and the researchers said their conclusions about extinction should "be interpreted cautiously."

But proponents of the ban said the Purdue study is the best evidence available.

"Short of taking genetically engineered fish and releasing them into Puget Sound and seeing what is the result, you're going to have to depend on other species, or computer models or some other extrapolation," said Friends of the Earth's Cantrell.

The Fish and Wildlife Commission's decision to ban the altered fish came with approval of the state's first comprehensive rules for aquaculture. Fish and Wildlife staffers recommended a two-year moratorium on altered fish, but environmentalists asked for and won the permanent ban.

"It's important to go pretty slow, to do more experiments and gather more data," said commission member Bob Tuck, a fish biologist. "We are in the early stages of understanding these things, and with the responsibility of protection of the public resources, that should be kept in mind. You can always go back and reconsider."

Washington's ban, enacted Dec. 9, is the first permanent prohibition. California last summer rejected a ban. Maryland has a five-year moratorium on genetically altered fish in all waters connected to Chesapeake Bay.

Atlantic salmon grown in Washington and in British Columbia's much-larger salmon aquaculture industry have escaped on numerous occasions, sometimes by the thousands. The genetically altered Atlantic salmon developed by Aqua Bounty are supposed to be sterile, but critics point out that the sterilization process is not foolproof.

"It's very hard to do anything 100 percent in fish and wildlife or in farming operations," said Tuck, the commission member.

Critics are also unhappy that some of the scientific research conducted by Aqua Bounty to support its application to the FDA has not yet been made public.

McGonigle said some of Aqua Bounty's research has been published in science journals, and all of it will be made public once his company receives FDA approval.

He said the cost advantage of faster-growing fish could provide enough economic leeway for fish farmers to move operations from the open sea to land-based fish pens -- which would end many of the environmentalists' criticisms of aquaculture.

Also, McGonigle said, faster-growing fish would allow fish farm managers to allow any given net pen to go unused, or fallow, twice as often. Letting a pen go fallow is a key way fish farmers fight sea lice, bacteria and other fish health problems, he said.

In a report for the FDA earlier this year, the National Academy of Sciences, which is chartered by Congress to advise the federal government on scientific matters, said skeptics of genetically engineered organisms may have a point.

A panel of scientists assembled by the academy concluded that effects of genetically engineered animals on the environment are "of high concern . . . in large part due to the uncertainty inherent in identifying environmental problems early on and the difficulty of remediation once a problem has been identified."

An FDA spokeswoman said the agency had no comment on the Aqua Bounty matter.

"The problem is that the FDA knows nothing about biology," said Glen Spain, northwest representative of the Pacific Coast Federation of Fishermen's Associations.

British Study Uncovers GM Contamination In Oilseed Rape

(Thursday, Jan. 2, 2003 -- CropChoice news) -- Financial Times: Genes from GM crops are interbreeding on a large scale with other crops and weeds, according to the results of a government report which examined official trials, it emerged yesterday.

Evidence from the six-year research programme shows that for the first time in Britain contamination between engineered oilseed rape and non-GM plants does exist.

The research, which has given the first results from official farm-scale trials will prove a major embarrassment to the government, which has gone on record as saying the results would settle the debate on whether GM crops were a danger to the environment.

Nicola Sturgeon, SNP shadow health minister, said the findings had uncovered one of the greatest fears about GM crops and called for a halt to the experiments.

"Cross-pollination has always been a very frightening development. Given that we have insufficient information about growing GM crops we should not be doing it. The health hazards are enormous."

Earlier this month doctors from the British Medical Association suggested a GM ban to the Scottish Parliament. The move followed an investigation prompted by a 6000-signature petition collected by protesters from the Munlochy GM trial site in Ross-shire. Munlochy was among 60 GM trial sites in the UK studied in the report.

Jo Hunt, director of the lobby group Highlands and Islands GM Concern, said that the findings were only the "tip of the iceberg" and also called for GM trials to be stopped.

"If one part of the science of GM has been shown to be flawed we need to examine the rest of it," she said. "What we have here is a 'trickle down' potential of other unwanted traits. Horizontal gene transfer means in effect that the genie is out of the bottle and can never be recaptured.

"The government has always tried to reassure people this would never occur. Ross Finnie, the rural affairs minister, ignored the vote of the transport and environment committee in April which called for GM trials to be stopped. He said there was no proof of GM transfer in Scotland. This research has shown the truth of the matter."

It is believed the government sought to curtail publicity by publishing an abridged version of its findings on the the web site of the Department of the Environment, Food and Rural Affairs(Defra) on Christmas Eve, knowing that no newspapers would be printed the following day.

Friends of the Earth, the environmental campaigning group, warned last night the results highlight the potential threat of "super weeds" in the British countryside.

The research found that the weed wild turnip was affected by gene flow when planted next to GM oilseed rape, prompting fears that it could become resistant to herbicides.

Current isolation requirements for GM crops could be reviewed following the publication of the results.

Peter Riley, spokesman for Friends of the Earth, said: "These results should cause the government to think again about the long-term implications on the commercial growing of oilseed rape. Contamination of crops and seeds is inevitable once commercial growing begins.

"The prospect of super weeds causing problems for farmers is a step nearer."

Mr Riley accused the advisory committee on releases to the environment (ACRE) of complacency over contamination levels and called on the government to review ACRE's role.

He also criticised Defra for not publishing the full report on its website.

He added: "It's unusual because the department is usually open. It seems to me to be moving backwards rather than forwards."

Last night Dr Dan Barlow, director of Friends of the Earth Scotland, said: "Oil seed rape has been the main oil seed crop grown in Scotland. If GM crops are allowed to be grown then organic and conventional farmers can kiss their 'GM-free' status goodbye, which will be a major commercial blow.

"These results show that the protesters at Munlochy and Newport on Tayport and elsewhere in Scotland were absolutely right."

The work, which was reviewed by ACRE, focused on GM oilseed rape crops at sites including official farm-scale trials. In some samples, the GM oilseed rape contaminated normal crops 200 metres away.

The report summary published on the Defra website stated that commercial scale releases of GM oilseed rape in the future could pollinate other crops and Brassica rapa (wild turnip).

It added: "There may be a need to review isolation requirements in keeping with current legislation on contamination thresholds in crops, in light of this research."

A spokesman for DEFRA said: "There's been no decision on the future of GM. If a decision is made discussions on separation distances will be part of that."

He said the results, which included research on a pilot farm-scale trial, were as expected, showing low levels of contamination. He said publishing the report on Christmas Eve was not the "ideal time", but said: "There has been no attempt to mislead."

FDA Policies for Gene-Altered Foods Faulted in Report

by Justin Gillis
Washington Post
Tuesday, January 7, 2003

Excessive levels of harmful compounds could show up in genetically engineered foods because the government has failed to put strong safeguards in place to catch them, a consumer group says in a report scheduled for release today.

The Center for Science in the Public Interest (CSPI), a Washington group known for a moderate stance on the use of genetic engineering to alter food plants, contends that the Food and Drug Administration, the primary federal agency responsible for food safety, missed "obvious errors" in reviewing some gene-altered crops. Although crops now on the market appear to be safe to eat, the group said the FDA's procedures are so full of holes that continued safety cannot be ensured as companies press to bring many more genetically engineered plants to market.

"The companies don't provide enough data to prove these foods are safe," said Gregory A. Jaffe, director of biotechnology issues at the center. "And FDA's review process doesn't give you a lot of comfort that they've looked at it closely and challenged the companies."

Laura Tarantino, deputy director of food-additive safety at the FDA, rejected the group's contentions, saying companies have provided all the data on their crops that the agency deemed important. She said FDA staffers were well aware of the possibility that genetic engineering could increase levels of harmful compounds in food. She called this a "very hypothetical risk" and said she did not believe it had happened with any crop now on the market. She added, however, that the FDA was studying whether it should make changes in the way it reviews such foods as more move toward commercialization.

The food-processing industry also rejected the report's conclusions, saying the current regulatory setup gives the FDA maximum "flexibility" to ensure that foods are safe.

The center's report is designed to influence an unfolding public debate about the way the nation regulates genetically altered crops. At the request of the FDA and other federal agencies, a panel of the National Academy of Sciences, meeting today in Washington, is studying whether such crops could have unintended consequences for human nutrition.

Much of the concern centers on "anti-nutrients," or harmful compounds common in many food crops. Typically such compounds are present only at minuscule levels. But when crops are genetically altered there is at least a theoretical risk that the level of anti-nutrients could increase, making consumption of that plant more harmful. The FDA has failed to establish firm procedures requiring companies to test for such harmful changes, the report said.

The center said the FDA's review process is an outgrowth of the nation's lax approach to dealing with genetically altered crops. Congress has never passed a law to regulate plants or animals created through genetic engineering, and, as a result, federal agencies have had to stretch old laws, written for other purposes, to create a patchwork system of rules.

Some gene-altered food plants, particularly if they contain foreign genes to help them fight bugs, fall under regulations requiring their creators to get mandatory approval from the Environmental Protection Agency before going to market. But others fall solely under the FDA's food-safety jurisdiction, and that agency has adopted only voluntary procedures for companies to follow in assuring the public their products are safe.

The food industry likes this voluntary system. Environmental groups, suspicious of all genetic manipulation of plants or animals, have long decried it. CSPI is one of the few consumer-oriented groups that supports genetic manipulation in principle but argues that the voluntary system must be scrapped.

For the report, CSPI reviewers studied about a quarter of all the cases where gene-altered plants have come before the FDA for review. In many instances, the report said, the FDA requested information on the nutritional composition of a plant that industry failed to provide. In three of 14 cases, CSPI reviewers found "obvious errors" in FDA analyses of certain food crops. For instance, certain scientific papers -- cited to prove that human exposure to a particular foreign protein in gene-altered tomatoes and cantaloupes was safe -- don't actually prove anything of the sort, the center said. "Had FDA conducted thorough reviews, the errors would have been easily detected," the report said.

Tarantino of the FDA said she had not seen the CSPI report and could not respond to the claim. But there is routine give-and-take between the FDA and companies about the quality of scientific evidence, she added, and the agency will not bless crops for commercialization until it is satisfied.

CSPI called for a tighter system involving mandatory review of new products and a detailed statistical analysis of risks -- in essence, a version of the rigorous drug-approval process for which the FDA is widely respected.

Timothy Willard, a spokesman for the National Food Processors Association, said the food industry would support some changes, including making some type of FDA review mandatory. But he noted that no company has opted out of the current voluntary process, which has worked to date.

http://www.commondreams.org/headlines03/0107-05.htm

Wheat Industry Wrestles with GMO Issues

Carey Gillam
Reuters
January 28, 2003

ALBUQUERQUE, N.M. -- U.S. wheat industry meetings this week will be dominated by fierce debate over genetically modified wheat produced by Monsanto Co., a biotech crop pioneer.

The annual gathering of industry groups, including the National Association of Wheat Growers and U.S. Wheat Associates, the growers' marketing arm, opened in Albuquerque on Sunday.

Monsanto completed final regulatory submissions last month in the United States and Canada for what would be the world's first transgenic wheat, and now the company is primed to add "Roundup Ready" wheat to its stable of biotech crop offerings.

Some wheat farmers may be warming to the prospect of a new tool to help them grow more robust and profitable wheat, engineered to withstand Monsanto's popular glyphosate-based Roundup herbicide.

But widespread evidence of opposition to GMO wheat from overseas buyers, particularly in Europe, still makes it unclear when -- or if -- GMO wheat will make it to market.

"It is not a given," said NAWG chief executive Darren Coppock. "Our intent and the goal is to introduce it, but right now...customer acceptance is a big obstacle."

Genetically modified wheat dominates the schedule at this year's meeting.

The first general session, scheduled for Wednesday, is dedicated to the debate on genetically modified products. One panel discussion, "Lessons Learned on the Way to Commercializing a Biotech Product," includes leaders of the U.S. corn and soybean growers' groups, whose members have been growing genetically modified crops for several years. That panel is followed by "Assuring Customer Acceptance," led by the chairman of the groups' Joint Biotechnology Committee.

More than corn or soybeans, which are mostly used for livestock feeds, wheat goes straight to consumer products -- and to consumer fears. Anti-GMO groups in recent years have prompted many costly food product recalls based on consumer doubts about including GMO ingredients in foods.

Partners and Promises

Monsanto has spent the last few years pitching the benefits of its Roundup-resistant wheat, which is designed to allow farmers to control weeds by spraying the herbicide directly over entire fields, killing weeds without harming the crops.

Roundup Ready varieties of corn and soybeans became popular with farmers in the mid-1990s, and the company did not anticipate the outcry surrounding its GMO wheat research.

But U.S. states that grow spring wheat, the first type of wheat for which Monsanto has created a genetically modified version, threatened moratoriums, and farmers fretted that even if they did not grow GMO wheat themselves, customers opposed to biotech would shun them for fear of getting contaminated grain.

To ease grower fears, Monsanto has pledged that it will not introduce GMO wheat until the industry is ready. The company promised to wait for regulatory approval in the United States, Canada and Japan as well as agreements for major export markets and for grain handling protocols.

"We think that there are a series of milestones that if we can achieve, we'll set up a responsible and successful introduction of biotech wheat," Michael Doane, Monsanto's head of wheat industry affairs, told Reuters.

Monsanto's apparent willingness to go slow has helped it win some support among farmers. In North Dakota, which grows nearly half of the United States hard red spring wheat crop, the state farm bureau in November said it was moving away from earlier stringent opposition to GMO wheat, adopting a policy to "support a cautious approach" instead.

Many farmers will be watching this week's meetings.

"There isn't a wheat producer out there who isn't affected by this," said Neal Fisher, North Dakota Wheat Commission administrator. "We know there are a lot of challenges ahead for us. Certainly, the debate goes on."

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