Cloned Meat Q&A

FDA Issues Draft Documents on the Safety of Animal Clones

On December 28 2006, the United States Food & Drug Administration (FDA) gave preliminary approval for meat and dairy products from cloned animals to be sold as food for human use with the exception of sheep, due to limited data on sheep cloning. They also stated that labeling of cloned food would not be required.

Formal adoption of this policy is expected in early 2007. In the meantime, a voluntary ban, as agreed by cloning companies for the past three years, will remain in place on sales of cloned-derived food.

What is cloning?

Cloning is an assisted reproductive technology that enables the production of offspring that are genetically identical to the single donor animal.

In a process called "somatic cell nuclear transfer", scientists replace all the genetic material in an egg with a mature cell containing the complete genetic code from the donor. This process results in an embryo, which is implanted into a surrogate mother, who carries the pregnancy into full term. A clone is that animal resulting directly from this process.

Why is cloning of animals being done?

The aim behind cloning is to create exact genetic duplicates of animals considered to be superior in one way or another to consistently produce offspring just as superior to pass on naturally-occurring, desirable traits such as disease resistance and higher quality meat to production herds. In contrast to the normal elements of chance that still occurs within classic breeding and genetic development, cloning provides the opportunity for more rapid distribution of genetics and targeted consistency of outcome.

Why does the FDA not require labeling of food derived from cloned animals?

Based on their report, the FDA concluded there is no difference between food produced from animals bred conventionally or those who were cloned and, therefore, decided no labeling was needed.

Their "no-labeling required" stance is identical to their stance on genetically engineered foods. For example, any food labels that claim that the food has not been genetically engineered must also include a statement that no difference has been found between non-genetically engineered food or from that which has been genetically engineered. A similar qualifying statement is expected to be required for any product that makes a "not cloned" claim.

What is the impact of cloning on the animal itself and its progeny?

The concept of cloning is more focused on efficiency and the economic benefits of the producer or the specific flavor, texture, or nutritional benefits rather than the overall effect of cloning on an animal's physical and mental welfare, and general well-being. Unlike mass production of objects, it is hard to justify mass production of identical living creatures in the interests of efficiency. Besides the increased chance that cloning may result in more deaths, adverse health outcomes including deformities than other reproductive technologies, nuclear transfer cloning of animals that normally reproduce sexually is a wholly artificial act with no correspondence in nature.

Does the FDA note any health risks for clones and their progeny?

Yes, within their summary of the draft assessment findings revealed in the December 28, 2006 document Animal Cloning: Proposed Risk Management Plan for Clones and their Progeny (Docket No. 2003N-0572) they report:

"Surrogate dams bearing cattle and sheep clones show an increased frequency of adverse outcomes compared to dams bearing non-clone pregnancies. This increase is not seen in swine and goat surrogate dams bearing clone pregnancies. Early reports of cloning in cattle and sheep indicated that most clone pregnancies failed to result in live births. As the technology improves, however, the proportion of live, normal births appears to be increasing. Animal cloning, particularly in cattle and sheep, is associated with an increased risk of adverse health outcomes in the surrogate dams carrying late-term clone fetuses, as well as very young clones. Specific health issues of concern for the surrogate dams include the increased incidence of prenatal hydroallantois and/or hydrops in the surrogate dams carrying clone pregnancies to term. Health issues of concern for the clones themselves include perinatal symptoms related to LOS [large offspring syndrome] including, but not limited to, pulmonary and/or renal insufficiency, difficulty maintaining body temperature, and umbilical hernias."

"Increased risks of adverse health outcomes have been observed in surrogate dams and very young clones. Working with professional societies dedicated to animal health and the care of food-producing animals, such as those associated with veterinary medicine or the practice of embryo transfer, FDA will encourage the development of standards of care for animals involved in the cloning process (i.e., clones and their surrogate dams)."

"The scientific community's understanding of the epigenetic processes involved in early embryonic development is still imperfect, however, knowledge about the molecular mechanisms involved is growing. There currently appears to be general agreement that epigenetic dysregulation is responsible for the anomalies observed in clones. The exact mechanism(s) by which dysregulation occurs (or correct regulation persists) is not yet well understood. Because of this biological uncertainty, we will carefully monitor this expanding field to ensure that the positions commonly held on epigenetic mechanisms, especially as they apply to clones, will continue to be supported."

What is Whole Foods Market's stance on food derived from cloned animals?

Whole Foods Market does not intend to sell meat or milk from cloned animals. We require producers who sell to us only use natural breeding or artificial insemination as acceptable breeding methods. In the meantime, we are waiting for the USDA to officially confirm that organic meat does not permit the use of cloned animals for breeders or the sale of meat or milk from cloned animals.

Whole Foods Market also believes any food derived from cloned animals should be required to be labeled as such to allow consumers to make informed decisions on the meat and milk they buy.

Is cloning an animal the same as genetically engineering an animal?

No, while cloning is the transfer of the same genetic material to a host cell to create identical genetic duplicates of an animal, genetic engineering is the deliberate modification of the genetic material itself which involves altering, adding or deleting DNA; cloning does not change the gene sequence In other words, cloning starts with an animal considered superior whose genetics are transferred to another egg, but the specific gene sequence is not changed in the process.

On the other hand, using a process called transgenesis, genetic engineering of animals involves the manipulation of genetic material. This can be done by moving one or more specific genes from the same species or another species into the genome of an animal in order to have a desirable trait expressed. For example, genetic engineering could be used to develop an animal that had lactose-free milk or specific levels of fat, animals with very different traits originating from another species, or to create animals specific human health needs, such as providing the medium to develop a drug or to use more compatible animal parts in transplants.

What is the difference between cloning and artificial insemination?

Cloning involves the insertion of an embryo into a surrogate mother. In contrast, artificial insemination involves the insertion of semen extracted from a bull or male animal to impregnate a female animal of the same species rather than by natural physical act of mating. Artificial insemination increase the chances that the genetic traits contributed from the bull that had been considered desirable will be exhibited, in some measure, by the progeny. Even so, as it is a manipulation in the normal process of reproduction, an animal unique to the parents will be developed rather than identical as occurs in cloning.

Will cloned meat and milk soon be on the market?

Since it is so expensive to clone an animal, meat or milk products would most likely come from the offspring of the cloned animal (the progeny) of cloned animals rather than the cloned animal itself. Although the progeny themselves are not called clones, they are derived from sexual reproduction that has at least one parent as a clone.

Even so, some animals created during cloning experiments would be allowed to be sold as meat or their milk for human consumption.