GMW:_Drucker_exposes_fraudulent_claims_of_Miller,_Conko_and_the_FDA

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GMW:_Drucker_exposes_fraudulent_claims_of_Miller,_Conko_and_the_FDA

" GM_WATCH "

Tue, 22 Jun 2004 19:37:52 +0100

 

GM WATCH daily

http://www.gmwatch.org

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The American lawyer Steven Drucker has once again exposed what he rightly terms

" the fraudulent and illegal nature of the FDA's policy " on GM foods.

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Steven Druker:

 

In response to my comment in the Financial Times, Henry Miller (who directed the

FDA Office of Biotechnology for many years) and Gregory Conko wrote a letter to

the editor attacking my key points. On June 4, the paper ran a letter from me

that explains why their allegations are false and exposes the fraudulent and

illegal nature of the FDA's policy in greater detail.

 

By attacking my comment, Miller and Conko did me a favor, because they provided

a vehicle for me to get important additional information into the FT that had to

be excluded from the comment due to space limitations.

 

Steven M. Druker

Executive Director

Alliance for Bio-Integrity

Home Office: (641) 472-8008

www.biointegrity.org

 

[steven Druker's original FT article " America's hypocrisy over modified produce "

(Financial Times

May 18, 2004), which sparked the controversy is at

http://www.biointegrity.org/american-hypocrisy.htm

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Copyright Steven M. Druker 2004

 

A slightly shortened version of this letter to the editor ran in the Financial

Times June 4, 2004 under the heading: " No Consensus on GM Food Safety. "

 

GENE-ALTERED FOODS ARE NOT GENERALLY RECOGNIZED AS SAFE

 

Sir, in their May 24 letter, Henry I. Miller and Gregory Conko contest my

assertions that US food safety law mandates the precautionary principle and that

genetically modified (GM) foods are on the US market illegally. (Comment:

" America's Hypocrisy Over Modified Produce, " May 18). But their arguments are

fallacious and rest on inaccurate allegations about the law.

 

While they rightly recognize that all new additives to food must undergo

rigorous government pre-market review unless they are " generally recognized as

safe " (GRAS), they wrongly imply that the manufacturer has unbridled discretion

to determine whether an additive is GRAS - and that such substances need not be

proven safe. Further, they falsely assert that GM foods satisfy the GRAS

requirements.

 

In reality, US law prescribes that to qualify as GRAS, an additive must fulfil

two criteria. First, there has to be overwhelming consensus about safety among

experts; and any significant disagreement counts as its lack. The internal files

of the Food and Drug Administration (FDA) reveal the requisite consensus has

never existed for GM foods. This was exposed when my organisation brought a

lawsuit against the FDA that forced it to divulge its files, which show the

predominant consensus among its own experts was that GM foods entail unique

risks and cannot be presumed safe. Further, in a letter to a Canadian health

official, FDA's biotechnology co-ordinator admitted there is not a consensus

about safety among experts outside the FDA either.

 

Second, even if there's unanimous consensus, the law prescribes it must be based

on evidence that clearly establishes safety. FDA regulations state such evidence

must be of " ...the same quantity and quality of scientific evidence as is

required to obtain approval of the substance as a food additive. " Thus, there is

no legal way around the requirement that GM foods be demonstrated safe. Again,

FDA files reveal this requirement has not been met either. One FDA scientist

noted " the paucity of data " about GM foods, and an official wrote a memo which

queried, " . . . (A)re we asking the scientific experts to generate the basis

for this policy statement in the absence of any data? " (Photocopies of key FDA

documents, along with fuller explanations of US law, are posted at

www.biointegrity.org)

 

However, FDA administrators, who admit they have been operating under a White

House directive " to foster " the biotech industry, circumvented the law and

allowed GM foods on the market without any testing under the fraudulent claim

there is an overwhelming consensus among experts they are safe.

 

Dr. Miller was director of the FDA Office of Biotechnology for many years.

Regardless of whether he is attempting to deceive, has himself been deceived, or

is merely mistaken, his incorrect allegations about US law and the status of GM

foods reveal the extreme extent to which the facts have been clouded. When they

are understood, it's clear the Bush administration's attempt to bar other

nations from applying the precautionary principle to these novel products is not

only ludicrous but unconscionable.

 

Steven M.Druker

Alliance for Bio-Integrity

Fairfield, IA 52556, US

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Financial Times (London, England)

May 24, 2004 Monday

USA Edition 1

LETTERS TO THE EDITOR

 

EU is out of step over regulation of modified products

 

From Dr Henry I. Miller and Mr Gregory Conko.

 

Sir, The premise of Steven Druker's rant that the US criticises Europe's

application of the precautionary principle yet uses it itself ( " America's

hypocrisy over modified produce, " May 18) is absurd. The example he invokes to

prove his case, the requirement in US law for the review of food additives

before they are sold, proves exactly the opposite.

 

Under American law, a new food or food ingredient is either " generally

recognised as safe " (GRAS) or it is a food additive and requires government

review and approval. The maker of the product gets to determine whether or not

the product is GRAS.

The objective of pre-marketing regulation generally is to circumscribe

potentially high-risk categories of products, such as food additives (which are,

by definition, not generally recognised as safe), pesticides, prescription drugs

and nuclear power plants. In contrast, all of the gene-spliced, or " genetically

modified " (GM) plants now on the market are widely recognised to be in a

negligible or very low risk category, as will be most future varieties.

 

The US National Research Council observed 15 years ago: " With classical

techniques of gene transfer, a variable number of genes can be transferred, the

number depending on the mechanism of transfer; but predicting the precise number

or the traits that have been transferred is difficult, and we cannot always

predict the (traits) that will result. With organisms modified by molecular

methods, we are in a better, if not perfect, position to predict the (traits). "

 

An analysis by the European Union that summarises the conclusions of 81

different EU-funded research projects spanning 15 years concluded that because

gene-spliced plants and foods are made with highly precise and predictable

scientific techniques, they are at least as safe, and often safer, than their

conventional counterparts. And David Byrne, EU commissioner for health and

consumer protection, has acknowledged that Europe's precautionary labelling and

traceability rules have nothing to do with protecting consumer health or the

natural environment.

 

Therein lies the fundamental difference between the US and European approaches

to the precautionary principle. Many, if not most, countries impose extra

scrutiny on higher risk categories of activities, technologies, and products.

But out of ignorance, caprice or protectionism, Europe has chosen vastly to

over-regulate a negligible-risk, proven, beneficial technology.

 

Henry I. Miller, The Hoover Institution, Stanford, CA, US

Gregory Conko, Director of Food Policy Safety, Competitive Enterprise Institute,

Washington, DC, USA