[SANET-MG] Draft Documents on the Safety of Animal Clones

[jcummins <jcummins@UWO.CA>]

The FDA seems to be ignoring the clear evidence of epigenetic changes in 
clones that are passed on through the post cloning breeding generation.
FDA News
FOR IMMEDIATE RELEASE
P06-215
December 28, 2006
Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Issues Draft Documents on the Safety of Animal Clones
Agency Continues to Ask Producers and Breeders Not to Introduce Food 
from Clones into Food Supply
The U.S. Food and Drug Administration (FDA) today issued three documents 
on the safety of animal cloning -- a draft risk assessment; a proposed 
risk management plan; and a draft guidance for industry.

Draft risk assessment
The draft risk assessment finds that meat and milk from clones of adult 
cattle, pigs and goats, and their offspring, are as safe to eat as food 
from conventionally bred animals. The assessment was peer-reviewed by a 
group of independent scientific experts in cloning and animal health. 
They agreed with the methods FDA used to evaluate the data and the 
conclusions set out in the document.

The draft risk assessment presents an overview of assisted reproductive 
methods widely used in animal agriculture, the extensive scientific 
information available on animal health and food consumption risks, and 
draws science-based conclusions. These conclusions agree with those of 
the National Academies of Sciences, released in a 2002 report. Due to 
limited data on sheep clones, in the draft guidance FDA recommends that 
sheep clones not be used for human food.

"Based on FDA's analysis of hundreds of peer-reviewed publications and 
other studies on the health and food composition of clones and their 
offspring, the draft risk assessment has determined that meat and milk 
from clones and their offspring are as safe as food we eat every day," 
said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for 
Veterinary Medicine. "Cloning poses no unique risks to animal health 
when compared to other assisted reproductive technologies currently in 
use in U.S. agriculture."

An animal clone is a genetic copy of a donor animal, similar to 
identical twins but born at different times. Cloning is not the same as 
genetic engineering, which involves altering, adding or deleting DNA; 
cloning does not change the gene sequence.

Proposed risk management plan
The proposed risk management plan addresses risks to animal health and 
potential remaining uncertainties associated with feed and food from 
animal clones and their offspring.

The proposed plan outlines measures that FDA might take 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 in use in common agricultural practices.

One such measure could be that the agency would work with scientific and 
professional societies with expertise in animal health and reproduction 
to develop a set of care standards for animals involved in the cloning 
process. Although the agency does not have authority to address the 
ethics of animal cloning, the proposed risk management plan does state 
that FDA plans to continue to provide scientific expertise to interested 
parties working on these issues.

"Because the release of the draft risk assessment and proposed risk 
management plan marks the beginning of our interaction with the public 
on these issues, we are continuing to ask producers of clones and 
livestock breeders to voluntarily refrain from introducing food products 
from these animals into commerce so that we will have the opportunity to 
consider the public's comments and to issue any final documents as 
warranted," said Sundlof.

Draft guidance for industry
The draft guidance for industry addresses the use of food and feed 
products derived from clones and their offspring. The guidance is 
directed at clone producers, livestock breeders, and farmers and 
ranchers purchasing clones. It provides the agency's current thinking on 
use of clones and their offspring in human food or animal feed.

In the draft guidance, FDA does not recommend any special measures 
relating to human food use of offspring of clones of any species. 
Because of their cost and rarity, clones will be used as are any other 
elite breeding stock -- to pass on naturally-occurring, desirable traits 
such as disease resistance and higher quality meat to production herds. 
Because clones will be used primarily for breeding, almost all of the 
food that comes from the cloning process is expected to be from 
sexually-reproduced offspring and descendents of clones, and not the 
clones themselves.

FDA is seeking comments from the public on the three documents for the 
next 90 days. To submit electronic comments on the three documents, 
visit 
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. 
Written comments may be sent to: Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD, 20852. Comments must be received by Apr. 2, 2007 and 
should include the docket number 2003N-0573.

For more information, visit http://www.fda.gov/cvm/CloneRiskAssessment.htm.

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