On the website listed, the docket 2003N-0573 does not appear to
exist. Furthermore, there appears to be no docket with a comment
period ending on 4/2/07. Is there a correction available for this
information, or perhaps is it just not posted on their website yet?
Be well,
Cricket Rakita
Saving Our Seed Project Coordinator
Carolina Farm Stewardship Association
286 Dixie Hollow
Louisa, VA 23093
phone: (540) 894-8865 fax: (540) 894-8060
cell: (706) 614-1451
web: http://www.savingourseed.org
email: cricket@savingourseed.org
jcummins wrote:
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assessment; a proposed risk management plan; and a draft guidance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the draft guidance FDA recommends that sheep clones not be used for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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