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FDA Draft Risk Assessment on Cloning

FASS Scientific Advisory Committee on Biotechnology Position Statement on FDA Draft Risk Assessment on Cloning

FASS Scientific Advisory Committee on Food Safety, Animal Drugs, and Animal Health Position Statement on FDA Draft Risk Assessment on Cloning

On April 3, 2007, the FDA extended the comment period deadline to May 3, 2007. The FDA Prepublication Federal Register Notice is posted at http://www.fda.gov/OHRMS/DOCKETS/98fr/2003n-0573-nec0001.pdf .
For further information regarding animal cloning, visit http://www.fda.gov/fdac/207_toc.html

On December 28, 2006, the FDA published a draft risk assessment that found that the meat and milk products from cloned animals and their offspring are safe for human consumption. Two other documents – a draft guidance to industry and a proposed risk management plan for animal clones and their offspring – were also published. The draft risk assessment and the draft guidance to industry will be open for public comment for a 90-day period. These materials are all available on the FDA Web site at http://www.fda.gov/cvm/CloneRiskAssessment.htm.

In response to FDA’s announcement, BIO president and CEO Jim Greenwood issued a statement in support of FDA’s findings. This statement can be found on BIO’s Web site at http://www.bio.org/news/newsitem.asp?id=2006_1228_01. In addition, on the BIO Web site (http://www.bio.org/foodag/animals/), you will find other animal cloning materials, such as fact sheets, clips of recent media coverage on the issue, and other background materials.

BIO hosted a live Webcast on December 28, 2006, for allies, affiliates, and stakeholder groups to give an overview of the FDA announcement. Attendees had an opportunity to submit questions via e-mail to Dr. Barbara Glenn, managing director for animal biotechnology at BIO, who hosted the event. The Webcast is available at http://members.bio.org/biovideos/200612.asp, and will be archived on the BIO Website for repeat viewings.

Please visit www.CloneSafety.org for background information on cloning technology, research, and consumer opinion.

Additional Technology Updates
12/20/2006
As many may know, the scientific journal Theriogenology has published online a paper that will be presented in a pre-conference symposium to the meeting of the International Embryo Transfer Society in Kyoto, Japan on Jan. 4-9, 2007. The paper, "The US FDA and Animal Cloning: Risk and Regulatory Approach", can be found online at http://www.theriojournal.com/article/PIIS0093691X06005279/abstract and provides an overview of FDA’s assessment of the safety of milk and meat products from cloned animals and their offspring.

Additionally, in the last few weeks, Rutgers University published a consumer research report on livestock. Dr. William Hallman’s paper (from Rutgers University) is available online at http://www.foodpolicyinstitute.org/docs/summary/Animal%20Cloning%20Summary.pdf.