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



Hi Terry,
You asked a great question, however, a simple answer is not at hand.Genetic makeup has been determined to be a significant factor in a sheep’s susceptibility to infection with scrapie. Current experimental evidence indicates that there are different forms of the sheep prion proteins. Some forms are highly susceptible to the structural transformation to the abnormal form associated with scrapie while others demonstrate resistance to this change.As in all mammals, sheep are diploid organisms, so that all cells contain two copies of each chromosome and thus two copies of the gene that codes for the prion protein.. The prion protein is composed of 256 amino acids. Gene knock outs for the prion proteins seem to prevent infecting prions being made.Efforts have been made to make prion knock outs in cattle that could be cloned. Could the somatic cell used to make clones contain active prions? That is a possibility but natural embryos from prion infected mothers seem to be free of prions. However, it may be a case of live and learn. Hope this helped a little. sincerely, joe cummins
Terry S. Singeltary Sr. wrote:
CAN YOU CLONE A PRION ??? IF a TSE was unknowingly there, i suppose one
could clone that as well, couldn't they??? honest question, no tricks
attached. ...


http://www.fda.gov/cvm/CloneRiskAssessment.htm

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01541.html


TSS


----- Original Message ----- From: "Cricket Rakita" <cricket@SAVINGOURSEED.ORG>
To: <SANET-MG@LISTS.IFAS.UFL.EDU>
Sent: Thursday, December 28, 2006 3:59 PM
Subject: Re: [SANET-MG] Draft Documents on the Safety of Animal Clones


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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