February 5, 2008
On January 15th, FDA issued its final risk assessment on the safety of meat
and milk from healthy cloned animals and their offspring. Consistent with FDA’s
12/06 draft guidance, it concluded that there is no incremental risk to humans
from consumption of these foods. See, "Cloned
Foods." FDA does not currently plan to impose a requirement that foods from
cloned animals be labeled as such. A voluntary moratorium on products from the
offspring of cloned animals is lifted. FDA nevertheless asked that the voluntary
moratorium on using milk from cloned animals remain in place, pending further
inquiries as requested by certain Senators. Some food companies have promised
that they will not use cloned milk or meat in their products. Organic producers
say that meat, milk and other products from cloned animals will not be sold as
“organic” in the United States. Some critics have suggested that FDA’s analysis
is faulty because it focused on the total number of animals that appear to be
adversely affected, not the frequency or severity of the health problems.
In most other countries, milk and food from cloned animals have not been
approved for consumption. The EU has no laws regulating animal cloning and food
derived from cloned animals. The European Food Safety Authority (“EFSA”),
commissioned last February by the European Commission, issued a draft opinion on
January 11th that meat and dairy products from cloned animals are probably safe
for human consumption. The EFSA report says that milk and meat from healthy
cattle and pig clones and their offspring are “within the normal range with
respect to the composition and nutritional value of similar products obtained
from conventionally bred animals.” The report acknowledged that the data
available on safety are “limited.” Study size has so far been small; few animals
have been followed for extended periods of time. EFSA is soliciting opinions
from experts and the general public.
The European Group on Ethics, 15 experts appointed by the European
Commission, issued a statement claiming that using cloned animals for production
of food such as meat or milk is not justified. The group asserted that cloned
animals experience a higher rate of disease than animals produced
conventionally, including malformations, respiratory problems, enlarged livers,
hemorrhage, and kidney abnormalities. The Center for Food Safety praised the
Group’s statement. Others have suggested that cloning will diminish genetic
diversity.
California is now considering a bill introduced in that state’s Senate
calling for labeling of bills from cloned animals. Consumers Union and the
Center for Food Safety have issued statements of support. Legislation such as
this, of course, creates the risk that producers could be faced with differing
requirements in different states. Last year, Governor Schwarzenegger vetoed a
similar bill that was passed by the legislature because he concluded that the
bill was preempted by federal law.
Thus, the controversy over food from cloned animals continues. At present,
the cost of raising a cloned animal is considered too high to be cost-effective.
Clones of high-quality animals will likely be used for breeding, and their
offspring and products from their offspring will be sold as food. The economic
model is that clones of the best breeding stock will produce high-quality
offspring for human consumption or for production of milk. Proponents argue that
cloning may permit better quality meat to be marketed, from animals with
increased disease resistance.
Interestingly, CSPI seems to be maintaining a relatively low profile.
Although it points to unanswered questions on animal welfare, ethical and
environmental implications of cloning and so forth, its biotechnology director
has been quoted as saying that “while the safety of any food cannot be proven
with absolute certainty, consumers should have confidence that meat and milk
from cloned animals and their offspring will be safe.”
It is too early to predict the outcome of this debate. The odds are good that
if cloned animals do become regular sources of food, many will continue to raise
safety questions, and studies will probably be needed to determine the long-term
health effects of widespread consumption.