FDA Approves Use of Cloned Animals for Food

>Update January 18, 2007: Despite a finding by the Senate in the Farm bill that more study is needed, the Food and Drug Administration decided this week to allow production and marketing of food from cloned animals except sheep.

The FDA explained, "Extensive evaluation of the available data has not identified any subtle hazards that might indicate food consumption risks in healthy clones of cattle, swine or goats". The FDA said there was not enough information to confirm food from cloned sheep would be safe.

There are now approximately 570 cloned animals in the United States. The livestock industry has followed a voluntary ban on marketing food from cloned animals. In fact,  despite the FDA ruling, the USDA requested food producers to continue to follow the ban except for meat and milk from a clone’s offspring.  

The USDA hopes to give the public time to accept the idea of consuming food from cloned animals.

Let’s hope the public does not accept this. For more on the Senate findings and the FDA’s studies on this, read Animal Law Coalition’s report below.

Original report: Earlier this year the Food & Drug Administration’s Center for Veterinary Medicine completed a study of available data on the risk to livestock from cloning and to the public from consumption of milk and meat from these clones and their progeny.

The FDA relied primarily on data supplied by clone producers and a study completed by the National Academy of Sciences. The FDA’s draft report of this study suggested it "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 animals produced naturally.

Nonetheless, over 150,000 public comments received by the FDA opposed the use of cloned animals in food products.

Now the Senate has passed as part of the 2007 Farm bill (Farm, Nutrition and Bioenergy Act of 2007) a requirement the USDA and the National Academy of Sciences conduct further studies. Click here for a copy of the Senate’s amendment to the Farm bill that concerns the FDA study.

The initial study was based on the assumption the food products would not be obtained from the clone which would be used for breeding but rather from the clone’s progeny.  All food products, whether from cloned or naturally occurring animals, were assumed to be subject to the same regulatory standards.  It was assumed that any risks would be the result of factors associated with the cloning process such as incomplete reprogramming of the donor cell nucleus, selection of donor cells, cell cycle state and in vitro factors. It was further assumed if the animal food products from cloned and naturally produced animals are not materially different, there was no additional risk from the former. 

The FDA acknowledged "uncertainties associated with this judgment". The FDA warned the conclusion depended on the quality of the data that was evaluated. Also, cloning or Somatic Cell Nuclear Transfer (SCNT) is a very new process. There is uncertainty about the effect of this procedure on the production of the clones. The FDA noted, "There is less uncertainty about the health of clones as they age and have more time to exhibit the full range of functionality expected of breeding stock."

Also, it should be noted the FDA determined there is "some very limited risk" in the use of products from cloned perinatal cattle. The FDA further announced there is insufficient data to determine whether or not there is risk in the consumption of any products from sheep clones or their progeny.

As for the animals, according to the FDA, cloning "results in an increased frequency of health risks to animals involved in the cloning process, but these do not differ qualitatively from those observed in other ARTs or natural breeding." ART means assisted reproductive technology and refers to artificial insemination, embryo transfer, in vitro fertilization, embryo splitting, and blastomere nuclear transfer as well as cloning or SCNT.

The draft report also stated "some animals involved in the cloning process (i.e., cattle and sheep surrogate dams, and some clones) are at increased risk of adverse health outcomes relative to conventional animals. None of these adverse outcomes, however, are unique to cloning."

Regardless, the study concluded there is an increased risk of death and disease "in perinatal calf and lamb clones compared with calves and lambs produced using other ARTs".

Unlike other forms of ART, the loss of clone pregnancies in cattle has occurred at all stages of gestation. These lost or aborted pregnancies have been accompanied by hydrops (edema or swelling in the placenta or fetus itself), enlarged umbilicus, and abnormal placentae.

"The frequency of live normal births [of clones] appears to be low, although the situation appears to be improving as the technology matures." In cattle and sheep, this is attributable to a higher incidence of dystocia or difficult labor associated with clone pregnancies.

Large Offspring Syndrome or LOS is also found in an unusually high percentage in cattle and sheep clone pregnancies. LOS cows and sheep have a high mortality rate. The signs of LOS found in the offspring include 20% above average in size for species/breed, slow to stand, inability to thermoregulate, weak or absent suckle reflex, large umbilicus with patent blood vessels, deformities of limbs (tendon contracture) and /or head disproportionate or immature organ development, increased susceptibility to infection, respiratory signs: insufficient lung surfactant, failure of lungs to inflate, cardiovascular signs: patent ductus arteriosis, enlarged heart /ventricle, septal defects, and hydrops (edema or swelling)

Also, "weak or non-existent uterine contractions, poor mammary development and failure to lactate" have been observed in cattle carrying fetal clones.

It was reported in some studies "[e]wes carrying clone embryos did not show common signs of labor (increased activity, bleating, contractions), and delayed licking neonatal lambs (to bond with lambs, and to stimulate lambs to breathe, stand and nurse). One study "reported a lack of expected prepartum changes such as cervical dilation and swelling of the vulva in ewes carrying clone pregnancies. In such cases, delivery was assisted by administering hormones to induce more typical labor, or by C-section."

One study found a high mortality rate in swine clones. Swine clones appear to have lower birth weights. "Swine clones grew more slowly and weighed less at slaughter than sexually-derived comparators". Three swine clones in one study were described as "’poor doers’ with periodic or chronic scouring and other health problems that resulted in poor growth. One clone was diagnosed with a lung adhesion at slaughter."

Respiratory ailments have been observed in perinatal cloned goats.

It is important to emphasize some of these findings may not be attributable to cloning. Also, because of the limited data available, there may be other ill effects on animals from cloning that are not yet known.

The FDA report declined to state there is evidence of premature aging in clones though there is some anecdotal information suggesting as much.

One thing is certain. The experimentation on animals to advance and improve cloning technology is sure to continue.

For a complete copy of the FDA’s draft report, visit this site.