By Tom Still
MADISON – Without technology innovators, would regulators have anything to do?
Four events in the past week or so are a reminder that for every breakthrough in fields such as biotechnology and nanotechnology, another regulatory hurdle pops up to slow the sprint toward progress.
That wouldn’t be surprising or even unwelcome if the skepticism was always based on scientific inquiry, but sometimes the barriers are erected by politics or a “just-say-no” agenda rooted in cultural and social opposition. Here are four examples that demonstrate the range of regulatory review confronting technologists:
The governor of Vermont has signed a bill requiring seed manufacturers to label genetically modified seed starting in October. All sales must be reported to Vermont’s agriculture secretary, as well. One anti-biotech group trumpeted the labeling law as “an important first step toward enacting more stringent regulation later.” That’s despite the latest United Nations report clearly stating that biotechnology is an important tool in fighting world hunger and solving environmental problems.
A report issued by the National Academy of Sciences said there’s no evidence that milk or meat from cloned animals will make anyone sick, but it also said researchers need better testing methods and more data. In the meantime, the Food and Drug Administration is asking companies not to market food from cloned animals.
While acknowledging there are no documented cases of health problems caused by biotech food, a report released by the National Research Council and the Institutes of Medicine advised the federal government to take a harder look at the safety of genetically altered food. The report recommended shifting emphasis from how the food was altered to the end result – essentially, product over process.
A panel of British scientists has concluded that most products of nanotechnology, including atom-scale electronic components and super-strong materials, will probably prove harmless and ultimately beneficial. But it warned that some popular nanoparticle-laden cosmetics be kept off the market until proven safe for use on skin – a policy more restrictive than current FDA policy.
The Vermont labeling law shows how politics and competing agricultural interests combined to produce regulation that simply isn’t supported by the science. Supporters of Vermont’s organic food industry, rather than relying on old-fashioned competition, decided that anti-biotech politics would enhance the image they’re trying to sell. The tactics are much the same in Iowa and California, other places where anti-biotech laws have passed or are pending.
“There is a grand strategy at work here,” wrote Bill Horan, an Iowa farmer who serves on the board of Truth About Trade and Technology. “The activists are trying to win enough small-bore victories to put a crimp in the production of genetically enhanced food everywhere” by using regulation to price them out of the market.
The National Academy of Sciences report on cloned meat at least set goals for further research. It concluded the technologies available are not sufficient for determining what parameters, such as DNA or the presence of certain amino acids, are relevant for predicting the effect on human health. However, those who work with cloned animals say they’re providing the FDA with everything they have asked for – and would welcome definitive “end points” for determining whether cloned animals are exactly the same as other animals. Otherwise, researchers will be stuck in an endless search for data to satisfy regulators who may not really know what they want.
The NRC and Institute of Medicine report seemed to provide more specific guidance. Scrutiny of biotech food should be done on a case-by-case basis, the report urged, not driven by a sense that the very process of genetic modification is flawed. If the composition of the new product is similar to the conventional version, little further testing would be needed. But if the modified food differed greatly, researchers should pay much closer attention to unintended health effects.
The nanotech report by Britain’s Royal Society and Royal Academy of Engineering, by and large, echoed the enthusiasm of those who contend the emerging business will power the next industrial revolution. Hundreds of tons of nanomaterials were manufactured last year in the United States and the U.S. market is expected to top $1 trillion within a decade.
However, the report warned that atomic and molecular devices can behave in unpredictable ways. Because of their sometimes extreme chemical reactivity – and because they are just the right size to integrate themselves into living cells – nanoparticles can prove dangerous in some situations. For example, not enough is known about nanomaterials used in some cosmetics, although others have been adequately tested.
There is a huge difference between technology regulation driven by science and that provoked by political causes. Public acceptance of biotech and nanotech products may depend on policymakers and journalists being able to tell the difference.
Still is president of the Wisconsin Technology Council. He is the former associate editor of the Wisconsin State Journal in Madison.
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