Has FDA Vascillation Effectively Killed Market for Cloned Farm Animals?

The Associated Press ran a story this month outlining fears by the dairy industyr that the U.S. Food and Drug Administration’s inability to come to a decision about the safety of food from cloned animals may have already doomed that market. It has already led to the failure of one company that was prepared to sell cloned farm animals.

In 2003, the FDA issued a draft safety assessment that found food from cloned animals was probably as safe as food from non-cloned animals. But it also effectively banned the sale of food from non-cloned animals until it makes a final determination.

Several additional studies have been published in the interim confirming the FDA’s draft assessment that food from cloned animals is safe and indistinguishable from that produced by non-cloned animals, but the FDA’s final determination of safety is still nowhere in sight.

One company, Infigen, has already went out of business thanks to the FDA waffling. In 2002 and 2003, Infigen made headlines for advances it made in cloning pigs that allowed it to produce cloned pigs with just one round of embryo implantation in a single pig compared to earlier methods which required multiple rounds of embryo implantation in multiple animals to produce viable clones. Infigen co-founder Michael Bishop told the Associated Press that the FDA’s delay in approving food from cloned animals was the straw that broke his company’s back,

It’s hard to find people who want to do business with you when a government agency could possibly regulate against the food products entering the food chain.

According to the Associated Press, Bishop believes that cloned farm animals will never be economically viable.

This sentiment is apparently shared by many dairy farmers whom would otherwise benefit the most from cloned animals. As the Associated Press notes, because cloned animals are so expensive its unlikely they would ever be used for slaughter. Instead they would be beneficial in things like a dairy operation where a farmers could clone particularly productive dairy cows.

But the FDA lack of a decision and the current ban clearly creates the impression that milk from cloned cows may not be safe. Susan Ruland, a spokeswoman from the International Dairy Foods Association, told the Associated Press,

There’s a strong general feeling among our members that consumers are not receptive to milk from cloned cows. This seems to be one of the things where technology seems to drop something in the lap of the food companies. It’s not driven by the market or any benefit to the consumer.

There are currently farmers in the United States who have cloned dairy cows, but they feed the milk to family and employees rather than sell it for the moment. Wisconsin dairy farmer Bob Schauff, for example, tells the Associated Press that he had four clones of a prize-winning Holstein dairy cow made four years ago. Schauff calls the ban,

. . . ridiculous. It’s a phobia more than anything scientific. We need to get FDA to come along and say it’s fine. They’re as normal as any other animal. Common sense has to take over soon.

So when will the FDA finally resolve the matter one way or another? That’s anybody’s guess. According to the Associated Press, an FDA official said that the agency has no timetable for making a final decision.

The full text of the FDA’s draft assessment can be read here.


Dairy industry skeptical about cloned cows. Frederic J. Frommer, Associated Press, August 11, 2005.

More Animal Rights Reactions to Dog Cloning

As was mentioned a few days ago, South Korean researchers recently managed to clone a dog. Animal rights activists quickly reacted to this announcement by denouncing it as immoral.

Physicians Committee for Responsible Medicine’s Neal Barnard complained that the whole process was immoral and pointless. In an op-ed for the Ft. Worth Telegram, Barnard wrote,

First, one basic moral issue: The cloning process often means operating on
hundreds of animals to extract their eggs in order to try to produce an infant.
About 90 percent of cloning attempts fail to produce viable offspring. Those
born alive often have compromised immune systems and higher rates of infection
and tumor growth. A dismaying number — perhaps about 30 percent — suffer
from “large offspring syndrome,” a debilitating condition marked by an enlarged
heart, immature lungs and other health problems.

Even if cloning were more efficient, it still would not be the scientific
path we need to pursue. Answers to the most pressing human health problems —
heart disease, cancer, diabetes, hypertension and others — lie in understanding
human cells, human genes and, in some cases, human habits.

Profound physiological differences make it very difficult to extrapolate
experimental results from any animal to a human. Trying to use animals as
“models” for humans has produced catastrophic results: The anti-inflammatory drug
Vioxx, which tested as safe in mice and rats, turned out to double the risk of
heart attack and stroke in humans.

Well, at least no one will ever accuse Barnard of letting evidence get in his way. It is interesting that Barnard mentions heart disease, cancer and diabetes — all diseases that animal research has played a key role in understanding and treating — before falsely claiming that animal models are useless.

And, of course, Barnard cannot be bothered to note that the side effects of Vioxx also did not show up in human clinical trials either for a very good reason — the increase in heart and stroke risk appears to only occur after long-term use of the drug. The real issue raised by the Vioxx problem is how to balance the tradeoffs between getting a potentially lifesaving drug to market and having thorough clinical data of the long term effects of using a drug. Perhaps Barnard would favor requiring that companies do more animal testing that lasts for longer periods of time, as that is one clear way of discovering side effects like that seen with Vioxx.

Besides, the South Korean researchers made clear that their ultimate goal was creating embryonic stem cell lines with their technology, not the production of a line of cloned dogs. Unique aspects of the canine reproductive system mean that dog cloning is unlikely to become common.

Jennifer Fearing of United Animal Nations wrote an op-ed in the San Francisco Chronicle expressing similar views to Barnard’s,

And while some see animal cloning as an opportunity — albeit grotesquely
inefficient and arguably immoral — to advance animal or human health, others
are engaged in the effort strictly as a for-profit venture to reproduce
people’s pets. The wholly unregulated company that sold the cat Little Nicky as a
clone for $50,000 in December is aggressively marketing its gene-banking
services to veterinarians and to pet lovers across the country through direct mail
and ambitious public-relations strategies. Despite having produced only a
handful of cat clones and no dogs, this company, based in Sausalito, will
happily take your $1,395 (plus $150 a year in storage fees) along with Fido’s or
Fluffy’s DNA, on the off chance you can one day afford to pay the remaining
$30,000 to order up your clone. All this while, millions of healthy and
adoptable cats and dogs die every year only because there are not enough homes.

I’ll admit to being especially fond of animals, but I don’t know any pet
lover who would willingly comply with a process that caused the pain and
suffering of hundreds of animals to clone his or her favorite pet. Once people
really understand that the odds are better than not that the clone will not act
and possibly not even look like the animal they hope to replace, most are
turned off. They’re among more than 80 percent of the American public who are
opposed to pet cloning, according to a poll commissioned by the American Anti-
Vivisection Society. Those who fall for cloning’s false promise are being
misled, blinded by the grief of losing their beloved companion, or are more
interested in vanity and novelty than they are in what it means to be a companion
in the first place.

. . .

Don’t be fooled by the cute photos. For every one of those kittens and
puppies that they bring out into the light, there are hundreds more who suffered
to make that photo op possible. The “promise” of pet cloning isn’t humane —
to either the animals or the humans involved. It is a consumer fraud and an
animal welfare atrocity.

An atrocity!

The American Anti-Vivisection Society, which failed in its efforts to get the U.S. Department of Agriculture to regulate pet cloning firms, issued a press release that said, in part,

This experiment strongly reinforces the scientific consensus that animal cloning is consistently inefficient and results in traumatic animal suffering. According to the dog cloning study to be published in Nature August 4, 2005, multiple cloned embryos were transplanted into each of 123 dogs resulting in only three pregnancies and two live births. Of the two cloned Afghan hound male puppies, one survived; the other suffered respiratory distress and succumbed to aspiration pneumonia at three weeks of age.

In broader terms, this extremely inefficient pet cloning methodology may lead to misuse of pet cloning for profit and could seriously compromise the welfare of countless dogs. The American Anti-Vivisection Society is particularly concerned about the situation in the U.S. where pet cloning is unregulated, and the industry has been aggressively marketing pet cloning to veterinarians and potential consumers. AAVS, anticipating this event, has led a series of efforts to prohibit pet cloning and educate the public, including producing a report detailing the dangers of pet cloning, co-sponsored legislation in California to prohibit the sale of cloned pets, filing a petition with the U.S. Department of Agriculture (USDA) requesting regulation, continuing to meet with USDA, and keeping the media and consumers informed about the issue.

That legislation, also endorsed by United Animal Nations, has so far failed to make it out of committee in the California legislature.


Good grief, Snuppy. Jennifer Fearing, San Francisco Chronicle, August 10, 2005.

Is the tail wagging the dog? Neal Barnard, Ft. Worth Star Telegram, August 12, 2005.

South Korean Researchers Clone Dog

South Korean researchers in August reported that they have succeeded in cloning a dog — the first time that species has been successfully cloned.

Veteinarian Woo-Suk Hwang led the team that cloned the Afghan hound. Hwang had previously cloned cows, pigs, and a variety of cows that are resistant to mad cow disease.

Unlike those animals, however, cloning dogs is a bigger challenge since dogs don’t respond ot the hormons used to stimulate ovulation. Cloning dogs required monitoring more than 100 female dogs. In all, 1,095 embryos were transferred to 123 surrogate dogs resulting in just 3 pregnancies. Only two of those were carried to term, and one of those dogs died from aspiration pneumonia at 22 days old.

The puppy that did survive, however, appears to be a completely normal Afghan puppy and is now 3 years old.

Hwang is also an expert at stem cell production, and in 2004 successfully derived stem cells from a cloned human embryo. His research on dog cloning will soon shift to developing a line of embryonic dog stem cells which could potentially be used in understanding and treating human diseases.

Animal rights groups weren’t exactly happy about the announcement. Despite the enormous difficulty in cloning dogs, Humane Society of the United States’ Wayne Pacelle told the Associated Press,

This technology could lead to a brave new world of puppy production if it were hijacked by profiteers seeking to use cloning to supply the pet trade.


South Korean scientists clone dog. Peter Gorner, Chicago Tribune, August 3, 2005.

Snappy response to Snuppy’s birth. Joseph Verrengia, Associated Press, August 5, 2005.

Dog cloned in South Korea. Bryn Nelson, Newsdady, August 2005.

USDA Rejects Call to Regulate Pet Cloning

In July, the U.S. Department of Agriculture rejected a petition by the American Anti-Vivisection Society asking the agency to regulate pet cloning companies as research facilities under the Animal Welfare Act.

In a letter to the AAVS, the USDA’s Chester Gipson wrote that,

GSC [Genetic Savings & Clone] is providing a production service, using in vitro technology combined with standard veterinary medical practice. Furthermore, we have determined that GSC is not a dog or cat dealer under the AWA, because the retail sales of dogs and cats are specifically exempted from the AWA.

Genetic Savings & Clone CEO Lou Hawthorne said that his company had also requested that pet cloning firms be regulated by the USDA — preferring one federal regulating body instead of having to deal with a patchwork of state regulations — but received the same response as the AAVS. Hawthorne told The Scientist,

However, the USDA/APHIS responded to our request in the same way that they responded to the AAVS petition: GSC does not require AWA oversight, because we outsource our animal care and only work with embryos at our facility. If/when we change our production model and maintain animals at our main facility — something we’re seriously considering — then we’ll again petition the USDA/APHIS to oversee our work under the terms of the AWA.

The USDA did say that in order to show its animals at animal shows, Genetic Savings & Clone would have to obtain an animal exhibitor’s license. Hawthorne told The Scientist that the company is in the process of finishing the license application and expects to receive approval from the USDA.


USDA: no pet cloning regulation. Ivan Oranksy, The Scientist, July 19, 2005.

Meat, Milk from Cloned Animals Nearly Identical to Non-Cloned Meat, Milk

In a finding that must be a real surprise, the Center for Regenerative Biology at the University of Connecticut has concluded that milk and meat from cloned animals is nearly identical to meat and milk from animals produced the old fashioned way.

Currently the U.S. Food and Drug Administration has asked the food industry not to sell meat or milk from cloned animals until it can analyze the safety considerations.

The University of Connecticut research found that the meat from cloned cows contained higher levels of fat and fatty acids but at levels that were still within accepted ranges by the beef industry.

Analysis of milk from cloned animals had similar findings. Researcher Jerry Yang said the results indicated that the genes of cloned animals function as they do in non-cloned animals. Yang told the BBC,

The production of each milk protein constituent involves the elaborate regulatory function of many proteins and enzymes, and any abnormal gene expression would likely be reflected by imbalances in the constituents of milk.

These findings are consistent with two other studies published in the journal Cloning & Stem Cells in 2004 which also found that milk and meat from cloned animals were nearly identical to that from non-cloned animals.

Still, skeptics abound. Compassion in World farming director Joyce D’Silva told the BBC,

We don’t know what this technology will result in in the future; we know so far that it is unsustainable. Huge numbers of animals die. They are born with deformed lungs, hearts and kidneys which don’t function. They die slow and lingering deaths. Is this the technology that we need or want? I don’t think so.

Well, of course we don’t know what the future will bring, so we should simply ignore any technology that we lack perfect information about. That’s the animal rights way. If you don’t know something, then the last thing you want to do is emerge from ignorance.


Produce from cloned cattle ‘safe’. The BBC, April 12, 2005.

Study: Cloned Meat, Milk Nearly the Same. Associated Press, April 11, 2005.

Great Britain Approves Horse Cloning Plan

After denying proposals to clone horses in 2004 (see this article for more background), Great Britain approved a plan by Professor Twink Allen of Cambridge University to clone horses.

Allen wants to clone horses, in part, to better understand and improve the genetic selection process in creating racing horses. The government had previously denied his requests on the grounds that the benefits outweighed the possible harm done to the cloned animals. Allen, in turn, accuse the government of caving to animal rights activists.

The government approved his latest request, but the approval stipulates that Allen cannot clone champion race horses.

Allen had mixed feelings about the government finally approving his research, telling Cambridge News,

I’m very pleased, but disappointed they haven’t gone the whole hog and allowed us sensibly to clone for commercial reasons, where there is a real need for it.

Allen will carry out tests in which he hopes to mitigate the problem associated with cloning other animals. He told Cambridge News,

If by doing these we can show that we don’t turn out a bunch of abnormal, suffering animals, my opponents might be able to have their minds changed.

If by opponents he’s talking about animal rights activists, Allen should save his breath. As Andrew Tyler of Animal Aid told Cambridge News, activists consider any such cloning to be an abomination,

This [research] is grotesque and the start of a slippery slope. Prof. Allen has already conducted experiments that turn the stomach. The Home Office originally rejected this application and for good reason.


Scientist gets go-ahead for horse cloning ban. Cambridge news, March 31, 2005.