By Greg Jaffe

Milk from cows treated with hormones, irradiated ground beef, cloned
animals - what's next on our technological wheel of progress involving food
animals?
GTC Therapeutics is one of a growing number of biotechnology firms that is
planning on using animals - including animals commonly eaten as food - as
miniature pharmaceutical factories. In this case, the company transplants
genes from a human into goats, which then produce milk that contains
anticoagulants and other human drugs. The company hopes this approach will
be much cheaper and easier than producing the drugs in the factory, yielding
a real benefit.

Before you look askance at your next helping of chevre or curried goat,
consider some of the other possible environmental or health benefits that
genetically engineered (GE) animals may provide.

AquaBounty has engineered a salmon by adding a gene from another fish
species so that it reaches market size in half the time. That may reduce
producer costs and generate an environmental benefit by cutting down on the
feed that fish-farming operations use and on the waste that the fish
produce. Other companies are seeking to engineer pigs to produce less
polluting waste, and engineer cows to be resistant to mad cow disease.

And scientists are engineering pigs so that their meat contains healthy
omega-3 fatty acids.

Companies have been experimenting with GE animals for over 20 years. Last
month, after spending five years studying the issue, the federal government
finally acknowledged that these engineered animals are trotting (and
swimming) toward the marketplace and that regulation is required.

The Food and Drug Administration announced that it will regulate GE animals
as ''new animal drugs,'' which requires FDA approval before companies could
market any products made from those animals. The upside of that approach is
that companies must demonstrate that milk or meat from these animals is safe
to eat. The downside is that new animal drug applications and the approval
process are shrouded in secrecy, with limited opportunity for public
participation. Such a closed process is unlikely to instill consumer
confidence that AquaBounty's salmon is safe to eat.

The FDA has had a hard enough time ensuring that conventionally grown
tomatoes, spinach, and other foods are free of bacterial pathogens. After
all the recent outbreaks, should consumers trust the FDA if companies'
safety data are not made public and its decisions cannot be reviewed? Should
supermarkets, restaurateurs, or other players in the food business?

While the FDA does have the expertise to deal with food safety questions, it
has much less expertise and authority to deal with the environmental
concerns presented by GE animals. A National Academy of Science report
described environmental issues as the ''greatest science-based concerns''
associated with GE animals due to the inability to identify all potential
problems early on and the difficulty of solving problems after they arise.
For instance, might the fast-growing salmon escape from their pens and
disrupt native fish populations?

Other federal government agencies that have greater expertise on
environmental issues, however, have remained silent on whether they, too,
will regulate GE animals.

Clearly, technology has outpaced our laws. The FDA announcement provided a
welcome framework for regulating GE animals, but that framework by itself
won't ensure safety or consumer acceptance. Congress should step in and
provide the FDA with adequate authority to address the full range of
environmental concerns that engineered animals might pose, including the
power to ''recall'' such animals if problems arise after commercialization.
Congress should also eliminate the current confidentiality requirements so
that safety data submitted to FDA and the agency's analysis of that data can
be reviewed by outside experts before GE animals are approved. And the FDA
should be directed to consult with other agencies, such as the Environmental
Protection Agency and the U.S. Fish and Wildlife Service, about potential
risks.

Senator Richard Durbin's Genetically Engineered Foods Act, first introduced
in 2004, would do all that, and Congress should take it up next year.
Developers, the food and farming industry, environmentalists, and consumers
alike should support it. Without a regulatory process that is thorough and
transparent, there is no chance that American consumers will - or should -
have confidence in the safety or environmental-harmlessness of these
animals.

Greg Jaffe is the director of the biotechnology project at the Center for
Science in the Public Interest.
www.checkbiotech.org