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Re: U.S. suppresses and falsifies science (20/2/2008)

EXTRACT: FDA has never provided any but the most broad, and therefore virtually useless, guidelines on safety testing for GMOs. When I was an official adviser to FDA from 2002-2005, our committee made several specific recommendations to the agency to improve its guidelines, but these were apparently ignored.

NOTE: European regulation of GM may be poor with the EU Environment Commissioner Stavros Dimas noting that the key regulatory body - EFSA 'cannot deliver a sound scientific opinion on GMOs' but when it come to the US...

The following comments on our earlier bulletion - 'U.S. suppresses and falsifies science' - come from Dr. Doug Gurian-Sherman - a Senior Scientist with the Union of Concerned Scientists. Amongst previous posts, Doug has worked for the U.S. Environmental Protection Agency (EPA) where he was responsible for assessing human health and environmental risks from transgenic plants and microorganisms and for developing biotechnology policy.

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Re: GMW: U.S. suppresses and falsifies science

One correction to your excerpt is that the FDA does not approve GMOs, but performs only a brief review of them (EPA has mandatory food safety testing for pesticidal crops (like Bt), but these are very cursory as well). This is not merely a matter of semantics. After its perfunctory review, FDA sends the company a form letter reminding the company that it has the responsibility to make sure that the GMO is safe (these letters, but not the safety data, are available to the public on the FDA/CFSAN website). This is very different from a safety approval, for example as is done for chemical food additives or drugs. In the latter case, the burden of proof is on the company to show that the drug or additive is safe. But under the legal provisions that regulate GMOs in the U.S. (so called Generally Recognized as Safe, or GRAS, provisions of the food safety law), there is a presumption of safety, and therefore no rigorous safety assessment or requirements. These GRAS provisions were set up long ago with the intention of allowing common substances like table salt to be sold without rigorous testing, or newer foods that have no obvious risks. Under GRAS, it is left to the company to decide what tests to perform and how to perform them. FDA has never provided any but the most broad, and therefore virtually useless, guidelines on safety testing for GMOs. When I was an official adviser to FDA from 2002-2005, our committee made several specific recommendations to the agency to improve its guidelines, but these were apparently ignored. If there is a clear red flag on safety, FDA can then remit the GMO to the more rigorous mandatory testing of food additives, but this (to the best of my knowledge) has never happened since the regulations were approved in 1992, with the possible exception of the FlavrSavr tomato, in the early 1990s, at the company's request.

It is important to keep in mind that data coming from the U.S. on food safety depends almost completely on the intentions and competence of the company performing the tests. The EU has mandatory approvals that are somewhat more rigorous than those of the U.S. But for U.S. citizens and possibly those in countries that rely on U.S. safety data, these safety reviews are often merely a figleaf compared to a real approval.

- Doug

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GMW: U.S. suppresses and falsifies science

1.Top Scientists Want Research Free From Politics

2.Government By the Industry, For the Industry

NOTE: Worth remembering that the approval of GMOs in the United States by the Food and Drug Administration (FDA), based on a misrepresentation of the facts and a massive cover up of FDA scientists' warnings (item 2), occurred well before the Bush Administration came to office, as did the equally controversial approval of Monsanto's GM hormone rBGH (aka rBST).

As Anthony Robbins, professor of medicine at Tufts University and former director of the National Institute for Occupational Safety and Health, notes in this article, 'Although surely the worst, the Bush Administration is not the first, nor will it be the last [U.S.] administration to mistreat and misuse science and scientists.' (item 1)

EXTRACTS: The [FDA's] policy boldly claimed that there was no information to indicate that GM foods were different or more risky than natural varieties. Since the American public generally trusts the FDA, people assumed that no such risks existed. But nearly a decade later, the agency's internal documents made public for the first time through a lawsuit told a different story. (item 2)

'At FDA morale stinks. Hundreds of people have either retired or quit in disgust. All the best people, who believed in working on behalf of public health, have gone.' - a congressional aide (item 2)

[the rest of this bulletin is available at http://www.lobbywatch.org/archive2.asp?arcid=8773 ]

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