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CLONING update060709

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Foals of the Future: Legal Ramifications of Cloning and Other Breeding Technologies

by: Milt Toby, JD

July 01 2007 Article # 9917

Two-time Thoroughbred Horse of the Year John Henry enjoys the life of Riley at the Kentucky Horse Park, munching grass and making occasional appearances for park visitors. It's a well-deserved retirement of one of the best horses ever to set foot on a racetrack. A durable campaigner who won 39 races during an eight-year career, John Henry was retired in 1984 with career earnings of more than $6.5 million, the highest ever for a Thoroughbred gelding.

Notwithstanding his record as a racehorse, John Henry always will be plagued by a few "What ifs." What if he hadn't been gelded as a 2-year-old? What if he had raced successfully without being gelded? What if he had been retired to stud and had been bred to the books of mares that a Horse of the Year usually attracts? Such speculation is fodder for endless debate and accompanies the careers of all the great Thoroughbred geldings, from Exterminator, to Kelso, to Forego, to classic winner Funny Cide.

But it's all speculation. John Henry lost his chance for a career in the breeding shed when an unfashionable pedigree and an intractable nature led to the unkindest cut of all--or did it?

Cloning, et al.

When John Henry was racing, cloning was in its infancy and faced an uncertain future. Years earlier, in a 1938 research paper, pioneering embryologist Hans Spemann, PhD, called cloning an adult a "fantastical experiment," and during the next few decades the consensus among most research scientists grew to be that cloning an adult mammal was impossible. Twenty-five years later, though, a handful of cloned horses are on the ground, and more are on the way. A commercially viable, albeit very expensive, technology now exists to create an exact genetic duplicate of John Henry, or of any other horse.

The clone would not be John Henry, of course, but it would be the next best thing--a genetically identical copy. The clone might not look exactly like John Henry, or have the same temperament or ability as the original. Appearance depends in some part on development in the womb, and training and environment both affect how an animal acts and performs. A clone would be able to do one thing which John Henry undeniably cannot--pass along the champion's genes to a new generation.

The question no longer is: Can a horse be cloned? Instead, the relevant question has become: Should horses be cloned?

For that matter, should embryo transfer be allowed, in effect giving multiple full or half siblings a chance of being born in the same year?

If the answer is "yes," then should the technology be regulated? If so, how and by whom? The possibilities are endless and, depending on your point of view, either wonderful or terrifying.

Cloned champion horses and mules are on the ground, and two of the three cloned mules have already competed in races. Some of the horse clones are now of breeding age. There have already been plans to breed Prometea, the world's first cloned horse (born in Italy in 2003), and owners planned to breed Paris Texas (clone of champion show jumper Quidam de Revel) this year as a 2-year-old to some mares. So what does this mean to the horse industry?

Setting aside the technical and ethical issues related to cloning, two related legal questions emerge. The first relates to registration and identification of cloned horses, the second to competition.

Registration

The issue of whether a cloned horse can, or should be, eligible for registration changed from an interesting theoretical question to a thorny practical problem for many breed registries during the last four years.

Scientists at the University of Idaho produced the first cloned equid, a mule, in 2003, the same year that an Italian research project produced Prometea. The mare and her Haflinger dam are identical twins because the mare that carried the foal also provided the genetic material used in the cloning process.

Two years later, using a cell line provided by Paris-based Cryozootech, the Italian research team created a second clone, an identical copy of champion endurance horse Pieraz. The colt was given the unwieldy name "Pieraz- Cryozootech-Stallion." Cryozootech also provided the cell line used for the first successful cloning of a horse in the United States, a colt named "Paris Texas" produced by scientists at Texas A&M University and foaled in 2005.

Pieraz-Cryozootech-Stallion and Paris Texas apparently are the first cloned horses to be accepted for registration anywhere. (The three cloned mules were registered with The American Mule Racing Registry, which is part of The American Donkey and Mule Society.) In September 2005 at the Fédération Equestre Internationale (FEI) World Breeding Championships for Young Horses in Belgium, Studbook Zangersheide, a sport horse registry, issued passports for the two horses. Earlier in the year registry officials had determined that a clone could be registered if the DNA profile of the donor horse was recorded in the registry and if the clone's DNA profile was identical to the donor's. The registry planned to issue registration documents for the clones that were identical to the donors' papers, with the additional notation "CL" indicating a clone.

Other breed registries have been less accepting of clones. The Jockey Club, which maintains the American Stud Book as the official registry for every Thoroughbred foaled in the United States, Canada, and Puerto Rico, lists cloning (along with artificial insemination and embryo transfer) as an unapproved breeding practice. Section V(1)(d) specifically prohibits registration of any foal produced "by the processes of artificial insemination, embryo transfer or transplant, cloning, or any other form of genetic manipulation."

The British Jockey Club has similar restrictions on registration of clones, as do the American Quarter Horse Association (AQHA), the United States Trotting Association, the American Saddlebred Horse Association, the Morgan Horse Association, and every other breed registry that has considered the question. Whether these restrictions will survive a serious legal challenge is unclear.

The AQHA, for example, traditionally limited the registration of foals produced using another technology, embryo transfer, to one foal per mare per year. As embryo transfer became more reliable and somewhat more affordable, some Quarter Horse breeders began to view the registration restriction as economically harmful.

A number of prominent breeders sued the AQHA in 2000, claiming that a good broodmare could produce several foals each year through embryo transfer and that the registration restrictions reduced the value of most of those foals because only one could be registered each year. The breeders claimed losses totaling more than $10 million.

A Texas judge determined that the rule violated state antitrust laws, and during a trial to determine damages, the AQHA and the breeders settled the dispute. The AQHA agreed to eliminate the restriction on the number of foals from a mare that could be registered in a single year and to make the change retroactive. This allowed all foals produced using embryo transfer since 1980 (the year the AQHA first accepted such foals) eligible for registration. Lead counsel for the breeders estimated the number of horses made eligible for registration by the rule change at around 3,000.

Among the expert witnesses for the breeders was economist Christopher C. Pflaum, PhD. In an affidavit, he gave an opinion that the AQHA rule restricting registration of foals produced from a single mare to one per year amounted to a "naked restraint as that term is generally construed in antitrust economics." He stated that the rule artificially restricted the supply of high-quality Quarter Horses, and that as a result, consumers thus paid an inflated price for inferior animals. He added that the owners of quality mares earned lower profits than they would without the restrictions of the rule, that the overall quality of horses offered for sale was reduced, and that the quality of competition in events limited to registered Quarter Horses was diminished.

Similar arguments could be made about most other restrictions on the use of new breeding technologies. Whether those arguments actually will be made remains to be seen. Private organizations such as breed registries and equestrian groups generally have been accorded wide latitude by courts in formulating and administering rules, generally on the related theories that no government action is involved and that participating in an equine activity is a privilege and not a right.

The United States Equestrian Federation (USEF) has survived numerous legal challenges to its right to discipline its members. Courts likewise have concluded that registration of horses by The Jockey Club is a private rather than a state activity, an important legal distinction.

In a recent case, a Kentucky breeder sued The Jockey Club in federal court arguing in part that the registry's refusal to accept the name "Sally Hemings" for a filly sired by Jefferson's Secret and produced from a mare sired by Colonial Affair was a violation of the owner's rights. The Court ruled against the owner on the ground that his rights were not infringed by the action of a private organization. (Sally Hemings was a slave of Thomas Jefferson and reputed to have mothered several of his children.)

A more radical approach than a legal challenge to existing rules would be establishment of a new breed registry that would accept cloned horses for registration. While The Jockey Club is recognized as the exclusive registry for Thoroughbred horses in the United States, Canada, and Puerto Rico, it is far from clear that the organization has a proprietary interest in the raw pedigree information catalogued in The American Stud Book. Even if a new registry were established, however, a more difficult question is whether horses registered there would be accepted by the public agencies and private organizations that organize competitions.

Regulations governing Thoroughbred racing in Kentucky, for example, require in part that "no horse shall be entered or raced in this state unless duly registered and named in the registry office of the Jockey Club in New York..." The rules also give track stewards the discretion to waive that requirement "if the horse is otherwise correctly identified to the stewards' satisfaction," whatever that means.

Whether satisfactory identification under current rules would include registration by a group in competition with The Jockey Club will be decided in court if the question ever arises.

A related legal problem apart from registration is regulation of cloning to protect the consumer. Consider a champion performance gelding that is cloned to produce a stallion for breeding. If one clone of the horse has a certain value as a stud prospect, what happens if additional clones are produced? Do additional clones of the same horse increase or decrease the value of the first clone? Or foals sired by, or produced from, the first clone?

Until now there have been physical limitations on overproduction of a successful bloodline. A stallion could cover only a limited number of mares during a stud career; a broodmare could produce only a limited number of foals. The laws of supply and demand offered some protection to buyers of horses from the best families.

Today, at least in a theoretical sense, new technology can virtually eliminate the upper limit on the supply side of the equation. Should investors in a cloned horse try and protect their investments by requiring a limitation on production of future clones of the same horse?

Competition

Essential to the commercial viability of cloning are opportunities for an owner to do something with the cloned animal to earn back the investment, which can be substantial. ViaGen, based in Austin, Texas, for example, will clone a horse for $150,000, with a reduced price of $90,000 each for additional clones of the same animal. That's a lot of money for a horse that cannot be registered and, therefore, will be barred from any competition limited to registered horses. But the big money in Quarter Horses is not in the AQHA competitions; rather, it is in NRHA, NCHA, etc., which only require identification, not registration.

Racing for Thoroughbreds, Quarter Horses, and Arabians currently is off limits to clones, as are breed-specific horse shows that require registration as a prerequisite for entry. Under current rules, for example, a cloned American Saddlebred cannot compete for a world championship at the Kentucky State Fair.

Although agencies and organizations conducting competitions might require breed registration, they typically are entities separate from the registries. Legal challenges to the registration requirements of individual competitions might stand a better chance of success than attacks on the registries.

In any event, not all competitions are limited to registered horses. Show jumping, three-day eventing, most hunter shows, polo, driving, dressage, reining, and cutting are examples of competitions that generally are open to nonregistered horses, and by implication, clones. It is not surprising, then, that the first commercially cloned equines in the United States were cutting horses Royal Blue Boon and Tap O Lena.

Royal Blue Boon won more than $381,764 in cutting events, and her foals have earned more than $2.5 million. The 26-year-old mare is too old for breeding and has been pensioned, but thanks to the combined efforts of ViaGen and Encore Genetics (a performance horse breeding and marketing business), the mare's clone, Royal Blue Boon Too, can carry on the genes of her famous dam.

A clone of Tap O Lena, a winner of more than a half-million dollars and another prominent producer of cutting horses, was foaled a few weeks after Royal Blue Boon Too. Initially, at least, there is no reason to think that foals produced from clones of Royal Blue Boon and Tap O Lena will sell for anything other than top dollar. The National Cutting Horse Association intends to allow cloned horses to compete.

Champion show jumper E.T., a Hanoverian gelding, also has been cloned. Born in 2006, the foal E.T. Cryozootech-Stallion reportedly will not compete and will be used exclusively for stud duty. It is far too early in the game to know whether horses produced from cloned mares or sired by clones of geldings will compete as successfully as expected. What if they do not? Are the buyers of a cloned horse entitled to any sort of special warranty? Cloned mules Idaho Gem and Idaho Star made their racing debuts on June 3 and 4, 2006, in Winnemucca, Nev., each winning a qualifying heat before placing third and sixth, respectively, in the final 350-yard dash. This was the first time clones competed in athletic events. According to Dirk Vanderwall, DVM, MS, PhD, Dipl. ACT, and Gordon Woods, DVM, MS, PhD, Dipl. ACT, professors of animal and veterinary science at the University of Idaho, the mules are exceeding their expectations.

Neither a general warranty of merchantability nor a warranty of fitness for a particular purpose specifically guarantee competitive success. It would be nonsensical for the buyer of a well-bred yearling to sue the breeders or sellers if the horse does not develop into a champion. There is no guarantee that the offspring of two champions ever will inherit championship genes. The uncertainty of breeding is the lifeblood of horse sports.

But if a buyer purchases a clone of a champion horse, the guesswork about inheritance has been eliminated. The buyer can look at the donor horse and know exactly what he or she is getting. Should the sale of a clone be accompanied by a guarantee that an exact duplicate of the champion will perform as well as the original?

Take-Home Message

Recent advances in reproductive technology have generated far more questions than answers in the last few years. Until issues relating to registration, identification, and competition have been resolved, caveat emptor--let the buyer beware--takes on added significance.

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