Daily News Update, Jan. 15, 2008
FDA concludes cloning food animals is
safe
After years of detailed study and
analysis, the Food and Drug Administration has concluded that meat and
milk from clones of cattle, swine, and goats, and the offspring of
clones from any species traditionally consumed as food, are as safe to
eat as food from conventionally bred animals. There was insufficient
information for the agency to reach a conclusion on the safety of food
from clones of other animal species, such as sheep.
FDA today issued three documents on animal
cloning outlining the agency's regulatory approach – a risk assessment;
a risk management plan; and guidance for industry.
The documents were originally released in
draft form in December 2006. Since that time, the risk assessment has
been updated to include new scientific information. That new information
reinforces the food safety conclusions of the drafts.
In 2001, U.S. producers agreed to refrain
from introducing meat or milk from clones or their progeny into the food
supply until FDA could further evaluate the issue. The U.S. Department
of Agriculture will convene stakeholders to discuss efforts to provide a
smooth and orderly market transition, as industry determines next steps
with respect to the existing voluntary moratorium.
The agency is not requiring labeling or
any other additional measures for food from cattle, swine, and goat
clones, or their offspring because food derived from these sources is no
different from food derived from conventionally bred animals. Should a
producer express a desire for voluntary labeling (e.g., "this product is
clone-free"), it will be considered on a case-by-case basis to ensure
compliance with statutory requirements that labeling be truthful and not
misleading.
Because clones would be used for breeding,
they would not be expected to enter the food supply in any significant
number. Instead, their sexually reproduced offspring would be used for
producing meat and milk for the marketplace. At this time, the agency
continues to recommend that food from clones of species other than
cattle, swine and goat (e.g., sheep) not be introduced into the food
supply.
An animal clone is a genetic copy of a
donor animal, similar to an identical twin, but born at a different
time. Cloning is not the same as genetic engineering, which involves
altering, adding or deleting DNA; cloning does not change the gene
sequence. Due to their cost and rarity, clones are intended to be used
as elite breeding animals to introduce desirable traits into herds more
rapidly than would be possible using conventional breeding.
Risk assessment
The risk assessment finds that
meat and milk from clones of cattle, swine, and goats, and food from the
sexually reproduced offspring of clones, are as safe to eat as food from
conventionally bred animals. The science-based conclusions agree with
those of the National Academy of Sciences, released in a 2002 report.
The assessment was peer-reviewed by a group of independent scientific
experts in cloning and animal health. They found the methods FDA used to
evaluate the data were adequate and agreed with the conclusions set out
in the document.
The risk assessment
presents an overview of assisted reproductive technologies widely used
in animal agriculture, the extensive scientific information available on
the health of animal clones and their sexually reproduced offspring, and
an assessment of whether food from clones or their sexually reproduced
offspring could pose food consumption risks different from the risks
posed by food from conventionally bred animals.
These conclusions were
first presented in draft documents over a year ago. Since then, the
agency has updated the risk assessment with data that became available,
as well as taking into account comments from the public comment period.
"After reviewing additional data and the
public comments in the intervening year since the release of our draft
documents on cloning, we conclude that meat and milk from cattle, swine,
and goat clones are as safe as food we eat every day," said Stephen F.
Sundlof, D.V.M., Ph.D., director of FDA's Center for Food Safety and
Applied Nutrition. "Our additional review strengthens our conclusions on
food safety."
Risk management plan
The risk management plan
outlines measures that FDA has taken to address the risks that cloning
poses to animals involved in the cloning process. These risks all have
been observed in other assisted reproductive technologies currently used
in common agricultural practices in the United States.
FDA is currently working
with scientific and professional societies with expertise in animal
health and reproduction to develop standards of care for animals
involved in the cloning process. Although the agency is not charged with
addressing ethical issues related to animal cloning for agricultural
purposes, FDA plans to continue to provide scientific expertise to
interested parties working on these issues.
Guidance for industry
The guidance for industry addresses the
use of food and feed products derived from clones and their offspring.
It is directed at clone producers, livestock breeders, and farmers and
ranchers purchasing clones, and provides the agency's current thinking
on use of clones and their offspring in human food or animal feed.
In the guidance, FDA does not recommend
any special measures relating to the use of products from cattle, swine,
or goat clones as human food or animal feed. Because insufficient
information was available on clones from other species, e.g., sheep
clones, to make a decision on the food consumption risks, the guidance
recommends that food products from clones of other species continue to
be excluded from the human food supply.
The guidance states that food products
from the offspring of clones from any species traditionally consumed for
food are suitable to enter the food and feed supply.
For more information, visit
http://www.fda.gov/cvm/cloning.htm.
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