Gene food escapes health tests
Date: 12/06/99
By MARK RAGG
There are no plans to test the safety of genetically modified foods for humans, either before or after their release. Neither are there plans to test the safety of the hundreds of genetically modified foods already on the market.
In a series of interviews this week, government food regulators and plant scientists developing the foods said such testing was neither necessary nor feasible. However, doctors and public health groups said they were both essential and practical.
Dr Lisa Kelly, head of the biotechnology section at the Australian and New Zealand Food Authority, which has the combined roles of food regulator and food industry promoter, said clinical trials were certainly not needed to establish safety.
"Traditionally, we operate on the basis of reasonable certainty of no harm," Dr Kelly said. "Foods are assumed to be safe until proven otherwise."
The authority asked industry to perform a series of studies, including animal studies at times, to show that genetically modified foods were similar to existing foods. With that evidence, testing in humans was not required, she said.
Professor Nancy Millis, chair of the Genetic Manipulation Advisory Committee, which regulates the use of genetically modified crops and organisms, said clinical trials were unnecessary.
"You'd have to expose enormous numbers of people who would be prepared to go on diets," Professor Millis said. "This wouldn't be appropriate unless you had good reason to believe genetically modified foods harmful. And you have to ask - what reasons are there to believe the
foods are harmful?"
Dr T.J. Higgins, senior scientist with the CSIRO's Division of Plant Industry, which is developing genetically modified crops for food, said: "We have never done clinical trials. I can not see any possible reason for doing clinical trials on food, and to add to the cost in that way. We go from the starting point that most food is safe and nutritious. With genetically modified food, we ask: 'What do we think might be different?' If there's nothing different, why do clinical trials?" Dr Geoffrey Annison, scientific and technical director of the Australian Food and Grocery Council, said: "There is absolutely no evidence that genetic technology represents any greater risks than traditional breeding methods." Mr Brian Arnst, a spokesman for Monsanto, the world's largest manufacturer of genetically modified organisms, laughed when asked whether human trials were needed. "By
inserting one gene, we're actually changing things less than in traditional breeding, where lots of genes are changed."
However, these views are not supported by groups working in human health. Professor Fran Baum, president of the Public Health Association of Australia, called for a moratorium on the sale of genetically modified foods until their safety for people was proved. "You see, you don't actually need genetically modified foods," Professor Baum said. "They're not necessary. We believe you should invoke the precautionary principle - why not wait and see until they're proved safe? And it's not just foods. It's about the side-effects of genetically modified crops and their effects on the
environment. We just don't know what it's going to be." The vice-present of the Australian Medical Association, Dr Sandra Hacker, said she wondered how scientists could be so certain.
"The arguments about safety aren't in yet," Dr Hacker said. "I'm surprised people are so confident that no scientific endeavour at all is thought necessary. Actually, I'm quite amazed.
"Philosophically, it's a strange stance. They're saying we don't need to look at this. Why not? One must ask whether or not there's any pressure on the scientists from big business."
Professor Stewart Truswell, emeritus professor of human nutrition at Sydney University, said the safety of genetically modified foods was unknown, and could not be known for a long time. "Everyone is saying, 'For God's sake, slow down'. I totally support that view," Professor Truswell said.
Regarding human trials, he believed they would be necessary in some cases, while not in others. "It all depends on what you've done. But if you've made something dangerous to insects, and to other animals, how do you know it's not dangerous to humans?" Dr John Coveney, a senior lecturer in public health at Flinders University, said short-term testing in humans was quite practical and totally necessary.
"What we're talking about is an entirely new method of producing food," he said. "We can't possibly predict the outcome on human health. I'm staggered to hear people say that testing on humans is not required."
Dr Coveney said more complete animal testing of all genetically modified products was the first step required. Then, if proved safe, human trials were needed. "There's a fairly well understood procedure that is used if you want to register a new drug. It could quite easily be followed with foods." Volunteers could be divided into three groups - one to eat a genetically modified food such as soybeans, one to eat normal soybeans and one to avoid soybeans altogether. Blood tests could check on the function of the liver, kidney and immune system, and for any allergic responses. General health could be monitored.
"That's fairly standard," Dr Coveney said. "I don't think it's too much to ask for, considering we're dealing with something that's very, very new."
Professor John Simes, director of the National Health and Medical Research Council's Clinical Trials Centre, said large-scale, long-term trials were difficult but possible, as long as labelling was comprehensive.
"I think it's a sufficiently important issue - we're drastically changing the way food is being produced. Assuming the human race is going to be around for millions of years, we really need to understand the implications."
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