Rules released for
engineered animals
By David Brown
Source: The
September 18, 2008
via CheckBiotech
The agency's
regulatory control of animals will be considerably stronger than its oversight
of genetically engineered plants and microorganisms.
The guidelines tell companies what the FDA wants to know
about their work at virtually every stage of creating an engineered animal.
For example, biotech firms will be asked to provide the
molecular identity of snippets of DNA inserted in an animal's genome and where
the genetic message lands and whether it descends unaltered through subsequent
generations. The FDA also wants to be told how the genetic alterations may
change an animal's health, behavior and nutritional value.
The companies also should inform the agency how they will
keep track of animals, prevent them from mingling with
nonengineered cousins and dispose of them when they
die.
Genetically engineered animals - salmon, pigs, cows and
goats - are all in development and are expected to have two main uses. Some
will be food animals whose new genetic endowment makes them disease-resistant,
faster-growing or more nutritious. Others will be engineered to produce
medically useful substances, such as hormones or antibodies.
Pigs able to more easily absorb phosphorus, and therefore
need less feed supplementation, are being developed in
Food produced from genetically engineered animals will not
have to be labeled as such. However, if the genetic manipulation changes the
nutritional content, that must be declared on the label.
The requests in the guidelines are not mandatory. However,
biotech companies seeking FDA approval to commercialize genetically engineered
animals must follow federal drug laws.
The FDA has been providing the advice informally for about
10 years, said Eric Flamm, a policy adviser at the agency.
The guidelines will be open for public comment for 60 days.
The new guidelines drew criticism from some groups worried
about possible hazards of bioengineered animals.
"The first time that the public will learn about a
genetically engineered animal will be the day it is approved," said
Margaret Mellon, of the Union of Concerned Scientists. "This requires that
you completely trust the FDA to do this right, and I don't think folks trust
FDA that much."
While companies will have to provide detailed information
about their work from the earliest stage, the FDA is forbidden by law from
revealing that information to the media or the public. That is because much of
the information is proprietary, competitive and valuable. The agency cannot
even acknowledge a company has a "new drug application" on file.
Source: The
greenbio.checkbiotech.org