Biotech to bring home the bacon?
Author: Henry I. Miller
Publication:
Date: Wednesday, October 01, 2008
Via: AgBios
A Food and Drug Administration policy published for public
comment Sept. 18 threatens the health of a promising new field, the production
of animals with novel and valuable traits.
After more than 20 years of deliberation, the FDA's Center
for Veterinary Medicine has proposed that every "transgenic" animal
crafted with gene-splicing technology will be subject to the procedures and
regulations for drugs used to treat animal diseases, such as pain relievers or
anti-flea medicines.
But the introduction of a gene is not the same as the
administration of a drug. Moreover, the FDA's approach represents a major shift
in the regulation of biotechnology that will be hugely expensive to animal
breeders and detrimental to consumers.
What kinds of animals? One that has awaited an FDA policy
for almost a decade is an Atlantic salmon that contains a newly introduced
Chinook salmon growth hormone gene that remains turned on all year round (instead
of during only the warmer months, as in nature). This cuts the time to
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.
There are numerous other applications in various stages of R&D,
including livestock with leaner muscle mass, enhanced resistance to disease or
improved use of dietary phosphorous to lessen the environmental impacts of
animal manure.
Until now, the FDA has not regulated new lines of farm
animals or, for that matter, animals used for what might be termed "medical
purposes." For example, they do not regulate German shepherds or golden
retrievers bred to enhance traits that make them better seeing-eye or companion
dogs. The FDA has not even asserted its jurisdiction over animals that are "transgenic,"
or genetically engineered, for research, which include hundreds of lines of
rodents.
The "new drug" paradigm doesn't fit transgenic
animals well. A better model is the approach taken by another FDA component, the
Center for Food Safety and Nutrition, which places the burden of ensuring the
safety of foods and food ingredients on those who produce them.
The rules prohibit the adulteration (contamination) or
misbranding (mislabeling) of food, but the agency does not inspect or evaluate
food prior to its sale in shops, supermarkets or restaurants. Rather, federal
oversight relies on market surveillance, or post-marketing regulation, and the
FDA takes action if there is an apparent problem. This approach has worked
quite well over many years.
The law does require a pre-marketing safety review for
certain food-related products. These include most food additives - a class of
ingredients that includes preservatives, emulsifiers, spices, sweeteners and
natural and synthetic flavors or colors, among others. In general, a food
additive must be pre-approved if it becomes a component of or otherwise affects
the characteristics of a food and if it is "not generally recognized as
safe (GRAS) by qualified experts for its intended use."
GRAS is an important concept: Before a new food additive is
marketed, it is the responsibility of the producer to determine whether or not
the substance is GRAS. The agency routinely reviews food additive applications
for safety only when the substance in question has been determined not to be
GRAS by the producer. If the producer determines that a substance is GRAS, only
a notification of that decision to the FDA is necessary (which is then subject
to agency review).
The FDA's existing approach to biotechnology and to foods in
general could be adapted easily to transgenic animals. Traditionally, the
combination of two GRAS substances is still GRAS. Similarly, because adding a
GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an FDA pre-marketing
review would not be necessary for genetic constructions like the fast-growing
salmon. But instead the FDA intends to treat every new animal as though it
contains a "new drug," the evaluation of which can take many years
even if there is virtually no likelihood of harm.
The FDA's approach to "novel" foods, published in 1992,
is compatible with the GRAS/food additive paradigm. It emphasizes that the
Center for Food Safety and Nutrition does not impose discriminatory regulation
based on the use of one technique or another, but that greater scrutiny is
applied only when certain safety issues are raised. These include the presence
of a completely new substance in the food supply, increase in levels of a
natural toxin, or the presence of an allergen where a consumer would not expect
it.
Officials at the FDA's Center for Veterinary Medicine say a
newly introduced gene expressed in an animal is analogous to the injection of a
new drug, that the genetic modification mediates the introduction of the
substance synthesized under the direction of the new gene - a hormone or enzyme,
for example. But this view ignores that neither the FDA nor any other
government agency routinely conducts pre-market review of new genetic
constructions that occur "naturally." (We call these "mutants.")
An example is the Zucker rat, a
naturally occurring mutant more than 4 times the size of its normal siblings, and
which is available from commercial breeders for research. Another more familiar
example is the mule, a horse-donkey genetic hybrid which, by any reasonable
definition, is certainly transgenic, although it doesn't involve the use of
newfangled genetic techniques.
Why would the FDA adopt such a dubious policy? Whenever they
can, bureaucrats exhibit a tendency to arrogate new responsibilities and expand.
"Dogs bark, cows moo, and regulators regulate," FDA Commissioner
Frank E. Young once quipped. And the "new drug" paradigm is the only
vehicle available to the Center for Veterinary Medicine. (Recall the old adage,
"When the only tool you have is a hammer, more and more problems begin to
look like nails.")
If animal biotech companies are to bring home the bacon, the
FDA will need to get its act together. When genetically engineered pigs can fly ... .
SOURCE:
agbios.com