On May 25, Health Canada closed consultations on a proposed policy change for cloned animal products; those from animals conceived through somatic cell nuclear transfer (SCNT) and their offspring.

The transfer involves replacing the nucleus of an unfertilized egg with the nucleus of a non-reproductive cell from another animal to form an embryo. That embryo is then transferred to a surrogate.

One proposed change would eliminate requirements to report whether hog or cattle products came from cloned animals or to have risk assessments beyond what is expected of other, established hog or cattle products.

Health Canada says meat from healthy cloned animals is no different than that from sexually reproduced animals and there are no health concerns with consuming meat from a cloned animal. It also says a main aspect of cloning animals is to “enhance the propagation of unique, high-value animals.”

The agency further noted cloned animals would primarily be used for breeding.

Under current rules, animal clones and their offspring are considered new living organisms and are subject to pre-manufacture and import assessment requirements. Should the proposed policy change proceed, they would be considered novel foods, which do not have those requirements.

Scrutiny

The consultation was recently highlighted by CBC. That report stated the Quebec agricultural trade union, L’Union des producteurs agricoles, released a letter noting regret that it was not invited to consult with Health Canada on the matter, and that it believes it is premature to remove monitoring and traceability of clone-derived meat.

The Quebec Food Processing Council also told CBC it was not consulted, but was not worried about the change.

Sylvain Charlebois, a professor and researcher of food distribution and policy from Dalhousie University, said he is concerned with the proposed update because it could affect consumer trust in the food industry.

“There is no plan to label the product and when you don’t necessarily have any transparency out there, you won’t help consumers understand the value of certain products. And that’s really kind of the situation we’re in right now,” said Charlebois.

According to the National Human Genome Research Institute, many cloned embryos don’t develop into healthy individuals. In the past, researchers have noticed other issues, such as birth size, birth defects and shorter lifespans.

Health Canada’s scientific report notes that cloned animals are at higher risk of birth defects and pregnancy-related complications, and that “considerably less information is known about the long-term effects on health and fertility of SCNT animal clones, mainly because cloning in livestock animals is a relatively new technology, so few clones have reached the advanced stages of their normal life expectancy.”

In the global sphere, the European Union has banned the cloning of farm animals since 2015. Other regions have more leniency. Health Canada says its proposal matches that of the United States, Japan and New Zealand.

Charlebois said he is concerned that proposed changes will affect Canadian exports to the EU.

“Would that compromise our ability to trade with the EU, which is a very important partner of ours? That’s something that we need to consider here. There are probably some risks related to Canada’s global influence.”

He said there is potential benefit in implementing this type of technology, but it should be done in a way that is transparent to consumers.

“When it comes to assessing that one technology’s ability to make any sort of social economic changes, the bottom line is consumer trust. How can consumers benefit from these advancements when there is no labelling required?”

The Canadian Cattle Association participated in the consultation. In an emailed statement, it confirmed support for Health Canada’s science-based approach on the proposed policy update. It said a reliable, science- and risk-based food safety system is crucial to the Canadian beef product.

“It is important to note cloning is not a viable production practice in Canada for many reasons, including unrealistic economic feasibility,” CCA said. “We do not see this becoming relevant in the marketplace as a production practice.

“CCA will continue to keep open lines of communication with the federal government to ensure that the best interests of Canadian beef producers are well represented and that consumers can continue to rely on a safe and nutritious Canadian beef product.”

After Charlebois posted about the proposed change on X (formerly known as Twitter), ensuing comments were divided. Many commenters said Canadians should know where their meat comes from and conveyed a desire to obtain meat from local ranchers. Others said they saw no harm in the update.

In an email, Health Canada said it is reviewing comments submitted by stakeholders during the consultation period. According to its website, it plans to implement the proposed update by fall if no new scientific evidence warrants review.

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Dolly, cloning’s poster child, was born in Scotland in 1996. She died prematurely in 2003, aged six, after developing osteoarthritis and a lung infection, raising concerns that cloned animals may age more quickly than normal offspring.

Now researchers have allayed those fears by reporting that 13 cloned sheep, including four genomic copies of Dolly, are still in good shape at between seven and nine years of age, or the equivalent of 60 to 70 in human years.

“Overall, the results are suggesting that these animals are remarkably healthy,” said Kevin Sinclair of the University of Nottingham, whose team reported their findings in the journal Nature Communications on Tuesday.

It is the first time experts have made such a detailed age-related health assessment of cloned animals, looking at factors such as blood pressure, diabetes risk and joint damage.

While no animals were lame, there were signs of mild osteoarthritis in some sheep and one had moderate disease, which scientists said was to be expected at their age.

Dolly was the first mammal to be cloned from an adult cell, using a process called somatic cell nuclear transfer (SCNT).

This involved taking a sheep egg, removing its DNA and replacing it with DNA from a frozen udder cell of a sheep that died years before. The egg was then zapped with electricity to make it grow like a fertilized embryo. No sperm were involved.

Dolly’s creation triggered fears of human reproductive cloning, or producing genetic copies of living or dead people, but mainstream scientists have ruled this out as far too dangerous.

Instead, the hope is to develop “therapeutic cloning,” in which cloned cells could be used to regenerate faulty tissue.

Dolly’s healthy heirs offer encouragement for regenerative medicine, although the SCNT process remains tricky and many would-be clones still fail to develop properly, despite technical advances since Dolly’s birth.

“This shows cells can undergo complete reprogramming and it’s reassuring to know that cells can be perfectly normal,” Sinclair said. “The challenge going forward is to increase the proportion of cells that undergo this complete reprogramming or better select for that.”

Parkinson’s disease

The four sheep cloned using the same genetic material as for Dolly — called Debbie, Denise, Dianna and Daisy — have just had their ninth birthdays and, together with nine other clones, are part of a unique flock based in Nottingham.

Unlike Dolly, who was housed indoors for security reasons, today’s clones live mainly outside, which may be one factor behind their relative health, since sheep kept in barns can be susceptible to infections.

Cloning is already used in some U.S. food production, although not in Europe. But the big hope is to produce human stem cells that could replace damaged tissue in devastating conditions like Parkinson’s disease or spinal cord injuries.

Work on stem cell medicine has been hobbled in the past by technical challenges as well as ethical issues but it received a boost three years ago when biologists finally created human stem cells using the same process that produced Dolly.

Until then, the most natural source of human stem cells was human embryos left over from IVF treatment, whose use in research is controversial.

Another approach involves adding genes to adult cells to turn back their biological clocks, creating so-called induced pluripotent stem cells that behave like embryonic ones. The long-term safety of these cells has still to be established.

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EU sources said the remaining sticking point was a demand by lawmakers in the European Parliament for a full EU ban on the sale of food derived from cloned animals and, crucially, their offspring.

EU governments and the bloc’s executive support an EU ban on the use of cloning for food production, and on the import and sale of food from clones.

But banning the sale of food derived from the offspring of cloned animals would be impractical and disrupt global trade, as meat, milk and processed products from such animals cannot be distinguished from those produced traditionally, they argued.

The Parliament’s representatives in the negotiations accused EU governments and the European Commission of intransigence, saying they had turned a blind eye to the ethical and animal welfare concerns raised by the use of cloning for food.

“It is … incredible that the council is willing to turn a blind eye to public opinion, as well as the ethical and animal welfare problems associated with cloning,” EU lawmakers Gianni Pittella and Kartika Liotard said in a joint statement.

Under EU procedures, governments and the Parliament have until the end of March to reach an agreement on the draft legislation, which regulates the approval and sale of “novel foods” not widely consumed in the EU before 1997.

A final round of negotiations is scheduled for March 28.

MARKET FOR CLONES

Animal cloning – which uses DNA transfer to create an exact genetic copy of an animal – currently has a success rate of below 20 per cent, with most cloned animals dying during or shortly after birth.

The technique is complex and costly, ensuring that cloned animals are unlikely to be used directly as food, but they can be bred traditionally to produce offspring that share similar traits, such as high milk production or rapid growth.

The United States is the most advanced country in terms of animal cloning for food production, with estimates provided by companies suggesting that “thousands of cattle” and “hundreds of pigs” have been cloned there so far.

The United States currently has a voluntary moratorium on the marketing of food from cloned animals, but not from their offspring.

In August, it emerged that meat from the offspring of a cloned cow was placed on the market by a dairy farm in Scotland, leading some British supermarkets to pledge not to sell any meat from clones or their young.

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Britain’s Food Standards Agency (FSA) is investigating allegations of unauthorized sales of meat, processed from Holsteins alleged to be born from embryos taken from a U. S. clone.

Meat and products from clones’ offspring are considered “novel” foods and can’t be sold without authorization, the FSA said.

The Canadian Food Inspection Agency said it will review any “credible” concerns raised in the U. K. investigation.

Canada’s interest stems from the international edition of theNew York Times,which on July 29 quoted an unnamed British dairy farmer as saying he’d sold milk from a cow bred from a clone and sold that cow’s embryos to unnamed “breeders in Canada.”

According to the Canadian Cattlemen’s Association, animal clones can be made in Canada but must be kept under quarantine and out of the food and feed chains.

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European Union lawmakers have rejected a proposal to allow the sale in Europe of food derived from cloned animals or their offspring, citing ethical concerns over the industrial production of cloned meat.

The European Parliament was voting on legislation to regulate the sale of “novel foods” – defined as food made with new production processes or that had not been widely consumed in the 27-nation bloc before 1997.

“Cloned animals suffer disproportionately highly from illnesses, malformations and premature death,” said Kartika Liotard, a Dutch lawmaker.

Lawmakers called on the EU’s executive arm to propose additional legislation explicitly banning the sale of meat from cloned animals.

The parliament said it also had concerns over the safety of food products developed using nanotechnology, and demanded a moratorium on their sale until they have undergone specific safety assessments.

If agreed, this could have an impact on nanotechnology products already on sale in the EU. In future, any approved foods containing nano-ingredients should be clearly labelled as such, the lawmakers said.

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The lawmakers rejected a proposal by the European Commission, and backed by member states, to include food produced from cloned animals in a list of approved food stuffs marketed and consumed in the bloc.

A final parliamentary vote is scheduled for July.

“MEPs (members of European parliament) voted in favour of entirely excluding food derived from cloned animals and their offspring from the scope of this legislation,” the members said in a statement.

European authorities must approve all “novel foods” – defined as food produced using new production processes, such as nanotechnology, or which have not been widely consumed in the 27-nation bloc before 1997.

Advancements in cloning technology, particularly of farm animals had raised the potential for it to be used on industrial scale to boost livestock herds for dairy and meat products.

Lawmakers said they were also concerned by the risks and the possible health effects of products developed using nanotechnology.

“Foods produced by nanotechnology processes must remain excluded from the (European) Community list until they have undergone specific and adequate risk assessments, and the possible health effects of materials at nano scale are better understood,” the lawmakers said.

The MEPs voted 42 votes in favour of rejecting the proposal, with two against and three abstentions.

The committee requested that the commission, the EU’s executive arm, present a separate legislative proposal banning food derived from cloned animals and their offspring.

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In 1996 a sheep named Dolly, the world’s first cloned mammal, was born in Edinburgh, Scotland. Since then cloning technology has been adopted by some in the equine community. So far there are fewer than 100 cloned horses in the world. Many are genetic twins of historical champions and as such are of extremely high profile and interest.

Prometea, the world’s first cloned horse, was created in 2003. In 2005 Texas A&M University cloned a European jumping stallion and named the colt Paris Texas. They then followed up with 12 more clones, including five Smart Little Lena clones that were foaled before the end of 2006 season.

This was before ViaGen Inc. patented the cloning process. ViaGen is the commercial cloning and gene-banking company that controls the international patent for equine cloning.

A major turn of events came in 2007 with the end of equine slaughterhouses in the United States. Slaughterhouse mares are the primary source of ovaries used in cloning. Healthy ovar ies and the harvested oocytes/eggs are key to a successful outcome.

Cloning involves taking a small tissue biopsy from the donor horse’s neck or underneath the tail. These tissue cells are then grown in a culture to produce millions of viable cells genetically identical to the donor. Then through nuclear transfer, DNA from the donor’s cells are injected into an enucleated oocyte.

There are various methods scientists use to get the egg and donor cell to develop into an embryo. A viable embryo is then transferred into a recipient mare and after a normal gestation the cloned foal is delivered.

The shortage of available ovar ies in 2007 prompted ViaGen Inc. to build another equine-cloning laboratory in Lethbridge, Alberta. This enabled easy access to the horse-processing plant in Fort Macleod and an ample supply of equine ovaries.

In the United States mostly cutting horses and rodeo horses are being cloned. In 2006 ViaGen Inc. produced the world’s first commercially cloned horse, a clone of the all-time leading National Cutting Horse Association dam Royal Blue Boon. In 2009 Scamper, the legendary barrel horse’s clone, Clayton, begins his career as the world’s first cloned stallion to stand for commercial breeding. As the number of clones continues to rise, breed registries will be asked to address their policies. Clones can be included in the equine registry in Belgium. Despite popularity of the cutting horses and rodeo horses in the United States it is primarily the European sport horses that dominate the equestrian-cloning percentage.

The dollar value for a clone? $150,000 American. This is certainly not beyond bookkeeping rationale for the repeat appearance of a champion. While genetics play a primary role in determining whether a horse will be an outstanding performer, so do several other factors including environment, training, and nutrition.

Can the cloned performer clone the performance? Horse fanciers remain curious to see how it will all play out.

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Synthetic bovine somatotropin, which is also called rbST, is already injected into cows to boost milk production, but Argentine researchers say their method is cheaper and produces a natural bovine hormone.

Andres Bercovich, head of research and development at biotechnology firm Bio Sidus, said that if a cow would normally produce 5.3 gallons (20 litres) of milk per day, it could produce more than six gallons (24 to 25 litres) when it is injected with the hormone.

“It’s going to be a cheaper method because it requires far less equipment and the only costs are what the animal needs,” he told Reuters on Wednesday.

Bio Sidus started cloning cows in 2002 and since then it has developed animals capable of producing human growth hormone and insulin in their milk.

The hormones can be extracted from the cows’ milk and used in the same way as synthetic hormones produced in laboratories from genetically engineered bacteria in tanks.

Bovine somatotropin has been approved for sale in the United States since 1993, but it has been banned in Japan, Australia, Canada and parts of Europe.

Opponents say it can have harmful effects on cows and humans and recently there has been a backlash against the synthetic hormone by food retailers and dairy manufacturers in the United States.

Bio Sidus aims to export the dairy hormone technology to the United States, Mexico, Brazil and Peru, but no date has yet been set and the company’s cloned bovine hormone technology has not been approved for sale in Argentina.

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