The FDA has initiated a recall of half a billion eggs, the most extensive in history, because of salmonella contamination that has already sickened 1,300. The head of the agency, Margaret Hamburg, said in interviews that regulators "need additional resources, we need additional authority [and] greater ability to trace back products to their source so that we can identify how the contamination occurred and what products are at risk."

A plea for more power and resources is bureaucrats' typical response to any crisis, but ironically, unwise FDA policies place obstacles in the way of technology to enhance disease resistance in eggs that could have prevented the outbreak in the first place.

The FDA's regulation of "genetically engineered" (GE) animals tortures the science and opts for the most stringent, stultifying regulatory approach among the possible choices. After more than 20 years of deliberation, last year the FDA's Centre for Veterinary Medicine chose to require that every genetically engineered animal would be subject to the same pre-market approval procedures and regulations for drugs, such as pain relievers and anti-flea medicines, that are used to treat animal diseases. The rationale is that a genetically engineered construct "that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug."

But this explanation conveniently ignores the science, the FDA's own precedents, and the availability of other, better regulatory options.

What kinds of animals are we talking about? One that has been awaiting an FDA policy for a decade is an Atlantic salmon that contains a Chinook salmon growth hormone gene that remains turned on all year (instead of during only the warmer months, as in nature). This cuts the salmon's time to reach a marketable adult weight from 30 months to 18. The extra gene confers no detectable differences in the salmon's appearance, taste or nutritional value; it just grows faster – a tremendous economic advantage to those farming the fish.

There are numerous other applications in various stages of research and development, including livestock with leaner muscle mass and improved use of dietary phosphorus to lessen the environmental impacts of animal manure.

The technology could also be used both to inhibit micro-organisms' ability to grow within chickens and their eggs and to block the synthesis and action of the bacterial toxins. This same technology can be employed to produce antibodies that can be administered to infected patients to neutralise the toxins.

Until last year, the FDA had not regulated new lines of farm animals or, for that matter, animals used for what might be termed "medical purposes". For example, they still do not regulate German shepherds or golden retrievers bred to enhance traits that make them better "seeing-eye" or companion dogs. Likewise, the FDA has not asserted its jurisdiction over GE animals crafted for research purposes, which includes hundreds of lines of rodents.

The lengthy, expensive pre-marketing approval requirement only applies if the animal is crafted with state-of-the-art recombinant DNA ("gene-splicing") techniques. So, for example, if the Atlantic-Chinook salmon described above were to be the result of some sort of artificial insemination instead of recombinant DNA techniques, it would be exempt from pre-approval evaluation.

In other words, the FDA's regulatory trigger is not the risk-related traits of an animal, but the use of a certain technology – and the most precise and predictable one, at that. That makes no sense.

The "new drug" paradigm does not fit GE animals well; the introduction of a gene that affects some characteristic is not the same as the administration of a drug. A more apposite model is the approach taken by FDA's food regulator, the Centre for Food Safety and Nutrition, which does not perform case by case reviews of every new product but limits them to products of non-negligible risk. This approach has worked quite well over many years.

The result of the FDA's risk-averse approach to genetically engineered animals is that yet another entire innovative business sector is burdened with an excessively regulatory policy that inflates research and development costs and inhibits innovation. Yet again, regulators on their faces.

Source:

Henry Miller (24.8.10). The FDA needs egging on. If we had a sensible and safe policy that permitted more genetic engineering in farming, this egg recall might have been avoided. The Guardian (http://www.guardian.co.uk/commentisfree/cifamerica/2010/aug/24/fda-egg-recall)

Reproduced by permission of the author.

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