The FDA’s Center for Veterinary Medicine recently issued three documents related to cloned foods:
- “Animal Cloning: A Draft Risk Assessment”
- “Animal Cloning: Proposed Risk Management Plan for Clones and Their Progeny”
- “Guideline No. 179: Guidance for Industry Use of Edible Products from Animal Clones or Their Progeny for Human Food or Animal Feed”
These are drafts open for comment until April 2, 2007.
The FDA concluded that, while there were little data, the data available indicated that “SCNT [somatic cell nuclear transfer, i.e., 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 [Assisted Reproductive Technologies] or natural breeding.” Furthermore, “[e]xtensive evaluation of the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats.”
In short, unless the comments provided within the next three months indicate otherwise, food from cloned animals will be on the market in about a year and require no additional labeling to distinguish it from food products from non-cloned animals.
Keeping the Facts Straight Most objections to “cloned foods” stem from a misunderstanding of the technology and its ramifications:
- First, not the food, but the animal used to produce the food is what is cloned. Potentially, the actual clone could be used as food but, since it costs $15,000 to $20,000 to produce a clone, it is usually only the clone’s milk or offspring that are intended for the food market.
- Cloning is not a form of genetic engineering. The DNA provided by the animal being cloned is not altered. Cloning is a form of assisted reproduction that creates an identical twin at a later time. Any accidental alteration of the DNA results in death of the clone usually in the lab, but occasionally one survives through gestation and birth, but not beyond the perinatal period. Thus, all clones that have the potential of entering the food supply or of being bred are genetically identical to the animal that was cloned.
- Food from clones poses no more risk to the consumer than the animal being cloned. The susceptibility to disease or other conditions that may disqualify clones from food production is no greater than that of the original animal. Thus, the fact that an animal is a clone poses no unique risk to the food supply.
- The first sheep (Dolly) was cloned in 1996. The first cow was cloned in 1998 and the first pig in 2000.
- In 2001, the FDA decided to study the issue of food from cloned animals and asked the food industry not to introduce any food produced by clones or their progeny into the market. The FDA’s notice of publication that accompanies the afore-mentioned drafts requests that this “voluntary moratorium” continue.
- It is possible that some cloned animals or their progeny have already entered the food supply, but there is no definitive evidence that this has happened.
- The FDA has asked for a “voluntary” moratorium because, under current law, the agency probably doesn’t have the authority to ban foods made from clones. Unless Congress amends the Federal Food, Drug, and Cosmetic Act (FFDCA), this will continue to be the case regardless of what the FDA decides when it publishes its final rule.
- The milk and beef from cloned cows is indistinguishable from that produced by other cows. It’s not adulterated; there are no additives. The following is an oversimplified description of federal law, but should shed some light on why the FDA is proceeding as it is. Basically, federal law (the FFDCA) presumes that unadulterated food is safe. The FDA has the authority to regulate the use of additives and to require accuracy in labeling. Labeling may be regulated to assure that the identity of the food is correctly represented (margarine is not butter) and that potentially harmful additives or allergens are indicated on the label. Food from cloned animals simply does not differ from regular food in any manner that justifies regulation under the FFDCA.
- It is time to give some clarification regarding the phrase “genetic engineering.” Genetically engineered animals have been genetically altered, not just reproduced. Under a broad definition of “genetic engineering”, all animal husbandry that involves changing the genetic makeup from one generation to the next involves genetic engineering. In this sense, each time a breeder chooses a mate for an animal, he is engaged in genetic engineering. This type of genetic engineering actually takes place through selective reproduction. A newer type of genetic engineering, which is what most people mean when they use the term, refers to genetic alterations made by man not through selective breeding but through selecting the actual specific genes that will be combined. This can also involve taking out or adding genetic material, including the addition of genetic materials from different breeds, species, phyla, or even kingdoms. The resulting animal or plant is called “transgenic” if foreign DNA is integrated into the genome.
- There are over a billion acres of land, most of it in the United States, planted with strains of transgenic crops. These crops, for the most part, are corn, soybeans and cotton.
- At this time, there is only one transgenic fish approved for sale in the United States, and it is an aquarium fish, not for human consumption. There is, however, a petition pending with the FDA to approve a transgenic salmon, and it will be labeled as such if it is approved.
- The Center for Food Safety and several other consumer groups have filed a Citizen Petition with the FDA encouraging the agency to regulate cloned foods as new animal drugs. Under the FFDCA, drugs require pre-approval for safety and efficacy before being marketed. This is quite a stretch. The relevant part of the FFDCA definition of a “drug” according to the petition is “any articles (other than food) intended to affect the structure or any function of the body of man or other animals.” It is further worth noting that genetically modified foods, including transgenic animals, require pre-market approval by the FDA because they are considered as containing “food additives.” This actually makes some definitional sense since genetic material is added or changed to create a genetically modified plant or animal. But, this same logic does not hold for cloning.
The conclusion I draw from these facts is that the FDA should not be involved at all in regulating food from clones or their progeny. Under existing law, the FDA doesn’t have the authority to regulate food from clones even if there were a safety issue.
Regarding labeling — that issue will take care of itself without FDA interference. If there is enough public concern that food produced from clones or their progeny is unsafe, then producers of organic foods will start specifying "Not from cloned animals" on their labels in the same way they have advertised "Not from animals treated with hormones or antibiotics."
The Center for Food Safety claims that “63% of Americans would not buy cloned food, even if FDA deemed the products safe.” They present these data from a 2005 poll as an argument for regulation. I think such poll results only justify purchasing stock in organic food companies that promise not to sell products from cloned animals — but not government intervention.
Ethical Considerations The ethical concerns addressed here are primarily moral considerations that legitimately could influence actions taken by individual breeders, producers, and consumers, but not legitimately be used to argue for government intervention. Even the FDA agrees with this point. In its proposed risk management plan, the agency states: “The Draft Risk Assessment is strictly a science-based evaluation of animal health and food consumption risks, and the Proposed Risk Management Plan and Draft Guidance for Industry do not address any ethical or other non-science based concerns regarding animal cloning.”
Most ethical objections to cloning and genetic engineering in general come from a fear of the unknown consequences of such technology, a religious or moral objection to tampering with natural reproduction, and/or a concern for preventing cruelty to animals. While all these concerns hold legitimate moral sway with various portions of the population, they are not grounds for government action. We live in a pluralist society and those who disagree on religious or moral grounds with cloning should be free to speak out, boycott, or not participate in the objectionable activity, but those who do not object should be equally free to participate in producing food from clones and/or eating it.
The one legitimate concern I see with cloning is one almost as old as animal husbandry itself. By its very nature, manipulating a gene pool to create certain desired phenotypes creates a homogeneity that can put the whole group at risk. As a 25-year veteran breeder of rare breed dogs and cats, I know first-hand that breeders often attempt to ferment type at the expense of health. A lack of genetic diversity in purebred animals caused by too much inbreeding makes those animals more susceptible to disease, shorter-lived, and more prone to unhealthy offspring. Domestically bred animals loose their genetic resilience when intentional line-breeding or the overuse of certain choice animals makes it difficult to find animals that aren’t related.
To prevent such homogeneity, some breeders feel it is their moral obligation not to flood the gene pool with one particular genotype. They do this by not breeding two animals related more closely than five generations back or by not breeding their pride stud more than four times a year. Such ethical standards are usually set by individual breeders or private breed associations. Cloning itself is not inbreeding but it can result in flooding a gene pool; for example, there are reports of a farmer who has cloned his prize bull five times already. Now an animal whose genetic material would appear in X number of offspring, will in fact appear in X6 number of offspring. In this way, cloning can over-saturate a gene pool with a particular animal’s genes, making the group more susceptible to intentional or accidental inbreeding and, in turn, genetically weaken the group as a whole.
Like cloning, genetic engineering could be used to create consistency within a breed, but it also could be used to create diversity. Genetic engineering could help eliminate genetically linked diseases, even those in rather homogeneous groups. It could also be used to create more diversity in ways that help preserve the desired traits without creating too much homogeneity.
Also, while individual breeds within a species become more homogeneous, genetic engineering could help the number of breeds proliferate — just look at the number of dog, cat, and bovine breeds that exist today. It certainly would be disappointing for those who like the taste of a particular kind of beef to learn that the breed of cattle that produces that beef is failing in part because of too much cloning, but that would not mean the end of all beef or all bovines. It would simply mean regenerating the breed either from a survivor, hopefully genetically engineering out the flaw that caused problems, or altering another breed to have the characteristics that were prized in the breed that failed.
None of the ethical issues presented by cloning food-producing animals are new. Cloning and genetic engineering only provide new and more effective methods of doing what humans have been doing for millennia — that is, manipulating the genetic makeup of plants and animals to create better food. Put another way, humans have been tampering with nature, playing God with the creation of animals, and eating their creations for thousands of years. The only thing that has changed is the technology. The goals and the ethical problems inherent in those goals remain the same. And, as is usually the case, the very technology that poses potential problems, undoubtedly also holds the solution to those problems should they arise.