On July 15, 2008, The European Food Safety Authority (EFSA) announced its final scientific opinion that food from cloned cattle and pigs is safe, and there are no implications of animal cloning on the environment.

The findings of the EFSA Report concur with those presented in the Risk Assessment (RA) released on December 28, 2006, by the Food and Drug Administration (FDA).

As previously discussed in the Terry Etherton Blog on Biotechnology, the FDA RA (“A Risk-Based Approach to Evaluate Animal Clones and Their Progeny – DRAFT”) concluded that “….the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats. Thus, edible products from healthy clones that meet existing requirements for meat and milk in commerce pose no increased food consumption risk(s) relative to comparable products from sexually-derived animals.”

Key findings of the EFSA Scientific Committee Report are:

- There is no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals.

- Somatic cell nuclear transfer, or SCNT (the most common technique used to clone animals) results in the production of healthy cattle and pig clones, and healthy offspring that are similar to their conventional counterparts based on parameters such as physiological characteristics, demeanor and clinical status.

- From the data collected, no environmental impact is foreseen.

In February 2007, EFSA was asked by the European Commission to provide a scientific opinion on the food safety, animal health, animal welfare and environmental implications of animal clones, obtained through the SCNT technique, of their progeny and of the products obtained from those animals. The final opinion also follows public consultation on a draft opinion issued earlier this year.

As I have discussed previously, cloned animals will be of value because of their increased genetic merit to provide healthy and nutritious meat and milk. Cloned animals also will increase food production, improve disease resistance, and enhance reproductive efficiency. An additional benefit is that cloning can be used to protect endangered species.

In previous blogs, I have written about the fact that the more consumers know about biotechnology, the more they accept it. Thus, educational programs/strategies are important to accurately inform the public. This is widely recognized…but comes with the reality that large scale programs to educate the public about science and ag biotechnology are challenging and costly.

Animal scientists at the University of California-Davis have just released a wonderful and educational movie on Animal Biotechnology. The documentary is narrated and co-authored by Cooperative Extension Specialist Alison Van Eenennaam and graduate student William Pohlmeier. My encouragement is to clink on the above link, and watch the movie!

It begins with a brief historical description about the development of various animal biotechnologies. Biomedical and agricultural applications of animal biotechnology are discussed. In addition, some of the science-based and ethical issues engendered in the “public discussion” are addressed.

Excerpts from interviews of leading academic and industry scientists in the field are interspersed throughout the movie.

Enjoy watching Animal Biotechnology – The Movie … it is a terrific resource for those who wish to learn more about the wonderful world of animal biotechnology.

For Immediate Release

Wednesday, May 2, 2007

Contact:
Cassandra Benz
217.356.2426 Ext. 33

Hundreds of Scientists Endorse FDA Risk Assessment on Livestock Cloning

Over 200 scientists have signed a public statement in support of the U.S. Food and Drug Administration’s draft risk assessment on the safety of food from cloned animals and their conventionally-bred offspring. The sign-on letter was distributed by the Federation of Animal Science Societies (FASS). The full text and list of signers can be found at www.fass.org/DefendScience.

“FASS is proud to give scientists an opportunity to congratulate the U.S. FDA on a thorough and excellent job,” said Dr. Jerome Baker, CEO of FASS. “This is one of the most rigorous food safety reviews ever conducted. The American people should be absolutely confident in the FDA’s good work.”

The document states that “We support and agree with the FDA’s conclusion as stated in the science-based draft risk assessment that edible products from healthy cloned animals and progeny of cloned animals pose no additional food consumption risks relative to corresponding products from other animals.” It is signed by some of the world’s leading researchers. Signers include Dr. Terry Etherton, who was on the National Academy of Sciences panel that evaluated the safety of food from clones and their offspring, as well as one of the “fathers” of Dolly the Sheep — Dr. Ian Wilmut.

In addition to coordinating the sign-on letter, FASS also ran an advertisement in the Wednesday, May 2^nd Washington Post. In that ad, Etherton says “The scientific evidence is absolutely, robustly clear. There is no food safety risk from the meat or milk from clones, or from their conventionally bred offspring.” In addition to serving on the NAS panel that evaluated this issue, Etherton is a former President of FASS and the Head of the Department of Dairy and Animal Science at Penn State University.

“FASS will continue to take an active role in helping educate the public about the scientific community’s support for the FDA on this issue,” said Baker.

About FASS: The chief public voice for animal science in the United States, the Federation of Animal Science Societies represents 13 scientific societies and more than 10,000 individual animal scientists.

Federation of Animal Science Societies
111 N. Dunlap Avenue
Savoy, Illinois 61874
phone: 217/356-3132
E-mail: fass@assochq.org
Web site: www.fass.org

On December 28, 2006, the Food and Drug Administration (FDA) released a draft risk assessment (RA) on whether cloning affects food safety or animal health, and whether food products from livestock should be sold for consumption. The draft, “A Risk-Based Approach to Evaluate Animal Clones and Their Progeny – DRAFT” presents the FDA’s position. The risk assessment concludes that “….the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats. Thus, edible products from healthy clones that meet existing requirements for meat and milk in commerce pose no increased food consumption risk(s) relative to comparable products from sexually-derived animals.”

The risk assessment employed a “weight of evidence” approach for drawing conclusions regarding risks to animal health and for consumption of food products from clones and their progeny. This approach consisted of four steps:

1. Evaluation of the empirical evidence (i.e., data on molecular mechanisms, physiological measurements, veterinary records, and observations of general health and behavior) for the species being considered;
2. Consideration of biological assumptions predicated on our growing understanding of the molecular mechanisms involved in mammalian development;
3. Evaluation of the coherence of the observations with predictions based on biological mechanisms; and
4. Evaluation of the consistency of observations across all of the species considered, including the mouse model system.

There is a long and distinguished history in the U.S. of assessing the safety of foods introduced into the marketplace. FDA’s Center for Veterinary Medicine (CVM) has the regulatory responsibility for considering the safety of animals and their progeny that are produced as a result of cloning. In addition, CVM is responsible for the regulatory review conducted to determine the safety of food products (e.g., meat, milk, eggs) from animals developed through cloning.

Assessment of food safety involves an integrated multi-disciplinary approach that incorporates molecular biology, protein chemistry and biochemistry, food chemistry, nutritional sciences and toxicology. Consumers should understand and appreciate that absolute safety is not the objective with respect to any approach used to evaluate complex substances such as food. The standard that has been adopted by FDA is that the food under evaluation should be as safe as an appropriate counterpart that has a long history of safe use. It must be emphasized that it is the food product itself, rather the biotechnology process used to generate cloned animals, that is the focus of the evaluation.

Despite the impressive scientific evidence that food from cloned animals is safe, opponents of cloning and animal biotechnology have again “cranked up” their campaign to scare consumers as a strategy to encourage consumers to avoid food from cloned animals. Arthur Caplan, Ph.D, in an MSNBC piece, put this campaign in perspective: “All of this nonsense took a toll. It made Americans forget that cloning is nothing more than artificially creating twins. It made us forget that every drop of wine we drink comes from cloned grapes. It made us ignore the fact that if you want to worry about what you are eating you would be better off fretting over whether the FDA has enough inspectors on the job at meat plants looking for salmonella and E. coli than whether your dinner started off as a clone.”

The release of the draft RA by the FDA is a long-awaited step in the process FDA will follow to formally release regulatory guidance about the entry of edible products from cloned farm animals in the food system. I believe that cloning will benefit animal agriculture (see my previous Blog on cloning at http://blogs.das.psu.edu/tetherton/?p=31). I am hopeful that the regulatory review process will move ahead in a timely manner to enable livestock producers and biotechnology companies to sell cloned animals in the marketplace. Cloned animals will be of value because of their increased genetic merit to provide healthy and nutritious meat and milk. Cloned animals will also increase food production, improve disease resistance, and enhance reproductive efficiency. An additional benefit is that cloning can be used to protect endangered species.

The next step in the ongoing review process is for the FDA to seek comments from the public about the draft risk assessment. Draft Risk Assessment documents will be available for public comment for 90 days (due by Wednesday, March 28, 2007). I encourage readers to provide your comments on these documents. Comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with Docket number 2003N-0573. Comments may also be submitted electronically via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

Animal cloning has generated much public discussion about the need for, and safety of this scientific method. In this Blog I present information that the biotechnology is safe for both animals and consumers. In addition, it provides many benefits which is why so many scientists and livestock producers are excited about the technology being approved by the Food and Drug Administration (FDA). The discovery and development of techniques to propagate animals by nuclear transfer (cloning) offers many important applications to animal agriculture, including reproducing highly desired elite sires and dams. Animals selected for cloning will be of great value because of their increased genetic merit for increased food production, disease resistance, reproductive efficiency, or will be valued because they have been genetically modified to produce organs that can be used for transplantation into humans. Cloned animals (or twins) are often more efficient in their use of feed, and consequently, will produce less waste which will reduce the impact of animal agriculture on the environemtn. In addition, there is great potential to develop cloned animals that produce bioproducts that have important biomedical applications.

What is Cloning?

Cloning, a term originally used primarily in horticulture to describe asexually produced progeny, means to make a copy of an individual or, in cellular and molecular biology, groups of identical cells, and replicas of DNA and other molecules. For example, monozygotic twins are clones. Animal cloning in the late 1980s resulted from the transfer of nuclei from blastomeres of early cleavage-stage embryos into enucleated oocytes. The cloning of the sheep, Dolly, was the result of somatic cell nuclear transfer (SCNT) by Wilmut and colleagues (Wilmut et al., 1997). This was a landmark scientific discovery because it demonstrated that it was possible to clone an animal by removing the nucleus (which contains the genetic information in the form of DNA) from a cell of an adult animal, inserting this into an enucleated oocyte (an egg from which the nucleus has been removed), and then activating the “reconstructed” embryo. The resulting cloned embryos are cultured for a period of time to reach the optimal stage for embryo transfer where they are transplanted into a “mother” animal. Cloning by SCNT transfer requires that the introduced nucleus be reprogrammed by the cytoplasm of the egg and direct development of a new embryo, which is then transferred to a recipient mother for development to term. The resulting offspring will be identical to their siblings and to the original donor animal in terms of their nuclear DNA.

Are There Compositional Changes and Adverse Health Effects of Foods Derived From Cloned Animals?

Historically, equivalence of tissue (food) composition has been an important component of the regulatory process to evaluate food safety. For genetically modified plants and the animal biotechnologies reviewed by the Food and Drug Administration, the evaluation has included comprehensive compositional analyses of plants, tissues, and milk (when appropriate). A committee convened by the National Academies (2004) (of which I was a member) found that a comparable approach for animal products, primarily meat and milk, from cloned animals would be an appropriate, scientifically-based approach to assess compositional equivalence. Implicit to assessing compositional equivalence is that no increased health risk would be expected if the compositional analyses of animal products from cloned and non-cloned animals were substantially equivalent.

There is a long history of assessing the safety of foods introduced into the marketplace. The approach involves an integrated multi-disciplinary approach that incorporates molecular biology, protein chemistry and biochemistry, food chemistry, nutritional sciences, and toxicology. It is important to appreciate that absolute safety is not the objective with respect to any methodology or combination of methodologies used to evaluate complex substances such as food. The standard that has been applied is that the food under evaluation should be as safe as an appropriate counterpart that has a long history of safe use. This comparative evaluation process is the foundation of establishing substantial equivalence of the food being evaluated. It also is important to emphasize that it is the food product itself, rather the biotechnology process used to generate genetically modified animals and cloned animals, that should be the focal point of the evaluation. The primary objective of the safety review is to assess food safety; embedded in this is whether the process might affect the food. In addition, it is important to recognize that a statistically significant difference in one or more compounds in the food evaluated and the appropriate comparator does not necessarily imply an outcome with respect to human health. This must be evaluated on a case-by-case basis as part of the regulatory framework. The National Academies Report found that there is no scientific evidence that cloning is associated with any unintended compositional change(s) that results in an unintended health consequence in humans. Since there is no evidence that food from cloned animals poses any increased health risk to the consumer it can be concluded that food from cloned animals should be approved for consumption.

Summary

It is important to appreciate that animal cloning is another example of an assisted breeding technology. Farmers have long used artificial insemination and split embryos to improve the health and quality of their herds. A cloned animal is a genetic twin of the donor animal. Cloning is not a transgenic procedure because there is no change in the orginal genome (genetic information stored as DNA in the nucleus) through addition, deletion or movement of the genes. Decades of research have demonstrated that cloned animals are just as healthy and normal as non-cloned animals.

References

Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. Institute of Medicine and National Research Council of The National Academies. The National Academies Press, Washington, DC. 2004.

Wilmut I, Schnieke AE, McWhir J, Kind AJ, Campbell KH. 1997. Viable offspring, derived from fetal and adult mammalian cells. Nature 385:810-813.