ViaGen, a company providing gene banking and cloning services, gave the following description of the cloning process [often referred to by its specific name, Somatic Cell Nuclear Transfer (SCNT)] on its website (accessed Jan. 28, 2008):
"The nucleus from a mature, unfertilized egg, containing a single set of genes from the female, is removed and discarded. It is replaced with an adult somatic (body) cell from the donor animal, containing two sets of genes (one from each of the donor's parents). Following the application of an electrochemical stimulus, the egg/cell 'couplet' fuses, and the resulting clone embryo begins to divide like a naturally conceived embryo. After a brief period of growth in culture, the embryo is transferred into a recipient (a female of the same species, generally in estrus or hormonally-stimulated) as in conventional embryo transfer. In a matter of months — whatever the natural gestation period is for that species — she will give birth to an animal that is genetically identical to the donor animal."
Should the FDA Have Approved Milk Produced by Cloned Cows for Human Consumption?
The United States Food and Drug Administration (FDA) wrote in its Jan 8, 2008 report titled "Animal Cloning: A Risk Assessment," published on its website:
"[T]here is no a priori reason to expect that SCNT [Somatic Cell Nuclear Transfer cloning procedure] will introduce any new, potentially toxic substances into the milk or meat of otherwise healthy animals, the remaining food safety concerns addressed whether subtle changes have occurred that would alter the presence of important nutrients...
The complexity of milk itself is one of the primary difficulties in determining whether residual non-PMO [FDA Pasteurized Milk Ordinance] managed hazards exist in the milk of animal clones. Milk from cows, sheep, and goats are mixtures that are estimated to be composed of more than 100,000 molecules, whose presence and proportion is a function of both the genetics of the animal and its environment. Not every component in milk has been identified and characterized; thus determining whether animal clones are producing a hazardous substance in their milk although theoretically possible, is highly impractical.
[I]t is unlikely that the cloning process would trigger expression of a novel substance that would not have independently arisen through random mutations in cow populations. In addition, it seems unlikely that a reprogramming error would lead to expression of an excess of a metabolically active protein with no adverse effects on the producing animal itself...
Several peer-reviewed studies describe the composition of milk from bovine clones. In addition to gross composition (percent solids, fat, protein, and lactose), some reports include a detailed analysis of fatty acids, vitamins, minerals, and amino acids, and in some cases, comparisons are made with previously published reference values for milk composition. These studies indicate that milk from cow clones is not significantly different in composition from milk from non-clones. Some minor differences have been identified in the composition of milk from clones compared to non-clones or reference values, but in each of these reports, the authors attribute the minor differences to diet, environmental conditions, small numbers of animals, and limited numbers of genotypes, rather than to cloning per se. None of these differences, however, indicate the presence of hazards that could pose food consumption risks, as they all fall within published historical values for milk."
Mark Walton, PhD, ViaGen President, wrote in his Jan. 15, 2008 press release titled "Statement on FDA Final Risk Assessment on Food from Cloned Animals," published on the Clone Safety website:
"ViaGen applauds the release of the U.S. Food and Drug Administration's (FDA) rigorous scientific analysis of the safety of food from cloned animals and their offspring. FDA's determination that meat and milk from animal clones is safe to eat concludes the most extensive food safety review in FDA's history, and complements two earlier reports from the National Academy of Sciences that reached the same conclusion.
Cloning companies will continue to work out an orderly marketing transition with the food industry and relevant government agencies - including FDA and USDA - as we move toward commercialization."
Marie K. Walsh, PhD, Associate Professor in the Nutrition and Food Sciences Department at Utah State University, et al, wrote in their 2003 article "Comparison of Milk Produced by Cows Cloned by Nuclear Transfer with Milk from Non-Cloned Cows," published in the journal Cloning and Stem Cells:
"Milk from cloned Holstein cows was directly compared to milk from non-cloned Holstein cows. Gross compositions of milk from cloned and non-cloned cows were not significantly different with respect to the main effect of cow type (i.e., cloned or non-cloned) or the interaction of cow type and time (i.e., stage of lactation)...
There were no significant differences between milk samplings taken from cloned and non-cloned cows with respect to concentrations of individual milk proteins...No significant differences were observed for 12 of the 14 fatty acids measured...
The current study provides the first evidence that there appear to be few food safety concerns with milk from cloned animals that would suggest a scientific based concern about the use of this technology for replicating animals for use in a commercial farming operation."
Götz Laible, PhD, Senior Scientist at AgResearch, et al., wrote in their 2007 article "Compositional Analysis of Dairy Products Derived from Clones and Cloned Transgenic Cattle," published in Theriogenology:
"Although it appears that SCNT can produce physiologically normal cloned animals, results accumulated over the past 10 years have revealed that even surviving clones could be stricken with epigenetic errors resulting from incomplete reprogramming of the donor cell nucleus. The potential for epigenetic errors and the uncertainty surrounding their effects on the composition and thus safety of food products derived from cloned livestock animals has been a major obstacle in gaining regulatory approval for entry of cloned products into the food chain.
Accumulating data on clone-derived milk and meat suggest that any remaining epigenetic anomalies in apparently healthy clones do not affect the composition of these foods; they appeared to be essentially identical and thus as safe as products derived from conventional animals."
The Center for Food Safety (CFS) wrote in a Jan. 15, 2008 press release titled "FDA Opens 'Pandora's Box' by Approving Food from Clones for Sale," published on its website:
"Today, the Center for Food Safety (CFS) condemned the Food and Drug Administration's (FDA) irresponsible determination that milk and meat from cloned animals are safe for sale to the public. In addition, the FDA is requiring no tracking system for clones or labeling of products produced from clones or their offspring. This action comes at a time when the U.S. Senate has voted twice to delay FDA's decision on cloned animals until additional safety and economic studies can be completed by the National Academy of Sciences and the United States Department of Agriculture (USDA)...
In its risk assessment of cloned food, the FDA claims to have evaluated extensive peer reviewed safety studies to support its conclusion, yet a recent report issued by CFS, Not Ready for Prime Time, shows the assessment only references three peer-reviewed food safety studies, all of which focus on the narrow issue of milk from cloned cows. What is even more disturbing is that these studies were partially funded by the same biotech firms that produce clones for profit."
Michael Hansen, PhD, Senior Scientist for the Consumers Union, was quoted as stating the following in Jan. 17, 2008 article titled "Consumers Union Calls on Congress to Require Tracking and Labeling of Clones for Milk and Meat," published on the Consumers Union website:
"The FDA's own data show that a large proportion of cloned animals do not make it to their first birthday. Many fail to survive gestation, and others have birth defects such as squashed faces, deformed limbs, and immune deficiencies. Consumers have a right to choose whether they eat milk and meat from clones...
It should be mandatory for clones and their offspring to be tracked and their products labeled in the supermarket...If cloning were a new animal drug, its use would be prohibited, since animal drugs must be safe for animals as well as humans. But because cloning is a new reproductive technology, there is no law requiring it to be safe for animals. Having our food come from healthy animals helps the food to be safe...
There is simply too little data for consumers to be completely confident that eating cloned food is safe."
Barbara A. Mikulski, MSW, U.S. Senator (Dem.) from Maryland, was quoted in a Jan. 15, 2008 press release issued by her office titled "Mikulski Condemns FDA Endorsement of Cloned Food," published on the Senator's website:
"Just because something has been created in a lab, doesn't mean we should have to eat it. If we discover a problem with cloned food after it is in our food supply and it's not labeled, the FDA won't be able to recall it like they did Vioxx - the food will already be tainted. We have been down this road before with product safety - the FDA has a credibility crisis...
The FDA received thousands of comments when it released its initial decision that food from cloned animals is safe. Many of these comments said more information is needed. We must listen to the public. Consumers should have confidence in what they are putting into their mouths...We should stop the FDA from putting this into our food supply without more information and informed consent."
The American Anti-Vivisection Society wrote in its action alert titled "Support Amendment to Prevent Animal Cloning in Farm Bill," published on the End Animal Cloning website (accessed Jan. 24, 2008):
"An average of 95 percent of cloning attempts fail, resulting in disease, deformity, and premature death for the overwhelming majority of animals involved. Scientific studies consistently demonstrate that clones, as well as the surrogate mothers who carry the pregnancies, suffer greatly. What's more, the dairy industry has stated that there is no consumer benefit to animal cloning, and is worried that the use of cloned animals will hurt small farmers and U.S. trade...
Given that cloning poses such a serious threat to animal welfare and jeopardizes the safety of our food supply, it is not surprising that two-thirds of Americans are opposed to animal cloning. Please support Senator Mikulski and Specter's Amendment #3524 to stop the FDA from allowing cloned animals into the food supply. Once cloned animals taint the food supply, undetected, we cannot go back."
Heather Whitehead, True Food Network Director, wrote in her article "Something's Scary in the Dairy," published on the Environmental Magazine website (accessed Jan. 24, 2008):
"Leading cloning scientists say that even seemingly healthy clones are likely to carry genetic abnormalities. These abnormalities could have food safety consequences, but almost no studies have looked at this problem. The National Academy of Sciences found, 'There is currently no data to indicate whether abnormalities in patterns of gene expression persist in adult clones and are associated with food safety risks'...
To manage the high pregnancy failure rate in cloning, scientists often inject surrogate cows with massive doses of hormones. To live with immune deficiencies, cloned offspring may be given high doses of antibiotics and other veterinary drugs. Commercialization of cloning would almost certainly increase levels of veterinary hormones and antibiotics in the human food supply, yet the FDA has failed to assess the food safety issues of such an increase."