Bridges Trade BioRes • Volume 8 • Number 1 • 25th January 2008

US FOOD AND DRUG ADMINISTRATION: CLONES ARE ‘SAFE’ TO EAT

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US FOOD AND DRUG ADMINISTRATION: CLONES ARE ‘SAFE’ TO EAT

After six years of research, the US Food and Drug Administration (FDA) announced on 15 January that food products from cloned pigs, cows, goats and their offspring are as safe as food produced from traditionally-bred animals. Due to inadequate data, a decision on food products from other animals was not yet made.

As WTO Members around the world begin to assess and implement strategies regarding food products based on clones, they may be going down different paths — meaning trade in cloned products could become a complicated and contentious issue in the future.

FDA ushers in cloned meat and dairy

Dr. Stephen Sundlof, the FDA food safety chief said, "We found nothing in the food that could potentially be hazardous" and that "it is beyond our imagination to even find a theory that would cause the food to be unsafe." The US National Academy of Sciences came to the same conclusion.

The FDA conclusion is not unchallenged, however. The US Congress recently passed legislation requesting that the FDA further study the safety of food products from cloned animals. A large number of consumer and animal rights groups are opposed to cloning, and even producers have acknowledged concerns over the marketability of cloned food products in export markets.

Clones are very expensive to produce, ranging from US$10,000 to US$20,000 per cloned cow, compared to just US$1,000 for an ordinary cow.

Bruce Knight, the USDA undersecretary for marketing and regulatory programs, emphasised that because there were so few cloned animals, it was "unlikely many consumers will encounter products made from clones." Agricultural companies would more likely use the clones for breeding purposes, only introducing their offspring into the food chain. The USDA has requested that companies voluntarily keep milk and food products from cloned animals from distribution, especially to give time to government officials to disseminate their findings to foreign trade partners and food companies. This voluntary moratorium is not applicable to the cloned animals’ offspring.

The FDA is not planning to require the meat or milk products from cloned animals or their offspring to be labelled, as they say there is no material difference between them and food produced by conventional methods.

Consumer and animal rights groups react

Consumer groups claim that the data used by the FDA does not sufficiently establish that foods from cloned animals and their offspring are safe for consumption. Andrew Kimbrell of the Center for Food Safety said the decision was based on an "incomplete and flawed review that relies on studies supplied by the cloning companies that want to force cloning technology on American consumers." Tom Buis, President of the National Farmers Union added that "there is no data to suggest any consumer demand for such products."

Animal rights groups strongly opposed cloning, arguing that the process itself is "stressful to the animals involved." Wayne Pacelle from the Humane Society of the US did not think that the FDA gave sufficient consideration to the welfare of the animals or of their surrogates. Animal protection groups also called for a discussion on the ethical implications of cloning animals.

Biotechnology industry supports cloning

Support for the FDA announcement came primarily from the biotechnology industry. Mark Walton, President of ViaGen, a genetic biotechnology company, announced that "ViaGen applauds the release of the [FDA's] rigorous scientific analysis of the safety of food from cloned animals and their offspring." David Faber, President of Trans Ova, another genetics company specialising in reproductive technologies, stated that their "farmer and rancher clients are pleased [with the decision] because it provide[s] them with another reproductive tool." Faber also "pledged" that Trans Ova would be a "good steward of the technology." The company, in conjunction with ViaGen, announced that they would track the food products through a Supply Chain Management Program to aid "food processors wishing to identify food products from [cloned] animals."

The Biotechnology Industry Organisation supported the fact that the FDA would not require cloned food products to be labelled, arguing that "cloning is simply a way to make offspring." Because other forms of "animal procreation" do not have labelling requirements, cloning should not either.

The European Food Safety Authority seeks comments on clones

The European Food Safety Authority (EFSA) published a draft scientific report on 11 January, reaching a conclusion similar to that of the FDA: food products from cloned cows and pigs are the same as those from traditionally bred cows and pigs. However, the EFSA cautioned that there was ‘only limited data available’ and has opened the draft scientific opinion to public comment until 25 February this year.

The European Commission’s Group on Ethics for science and new technologies (EGE) opposed cloning animals, finding no argument to justify cloning animals for food. The group stated that "considering the current level of suffering and health problems of surrogates and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified" and that more research was needed on their offspring. The EGE also recommended that more studies be conducted on the long-term health impacts of cloned animals and their offspring and called for public debate on "the impact of…cloning on agriculture and the environment, on the society impact of increasing meat consumption…[and] the fair distribution of food resources."

The EFSA plans on issuing its final report in May. If the EFSA authorises the sale of food products from cloned animals, "the EU has indicated [they would have to be labelled]." It remains unclear to what extent food products from offspring would be labelled.

Like in the US, the announcement was met with great resistance by various groups. According to a survey conducted by the International Food Information Council, less than half of all consumers were likely to buy food products made from cloned animals.

Australia, New Zealand, Japan and Canada are also evaluating the safety, health and environmental issues associated with animal cloning.

What are the trade implications?

Although the EU EFSA has tentatively reached the same conclusion as the US FDA, they may take different final decisions, complicating trade in meat and dairy between the two trade blocs. Potential differences with regard to labelling requirements could also complicate trade. The EU has previously rejected hormone-treated beef imports from the US, and takes a much stricter approach to genetically-modified foods than the US. These differences between the trade partners have already led to two major dispute cases at the WTO.

Taking into account public sentiment and the EGE’s position, the EU may decide not approve the to approve importation of cloned food products and their offspring. This could potentially lead to another trade dispute between the US and EU. This scenario is tempered, however, by the similar uneasiness of American consumers toward food products produced from cloned animals. It could also be tempered by the voluntary withholding of food products from cloned animals and their offspring by US producers, at least in the short to medium term. The International Dairy Foods Association (IDFA) has stated that "it would be prudent to wait until all major foreign trading partners have reviewed and approved the same cloning technology."

Background

Cloning is the process by which biological material is duplicated. Reproductive cloning is the cloning process associated with animal cloning, which gained widespread attention after the successful cloning of Dolly the sheep in 1997. It is the process by which scientists "transfer genetic material from the nucleus of a donor adult cell to an egg whose nucleus, and thus its genetic material, has been removed." Scientists then stimulate cell division and transfer the resulting embryo into the uterus of a surrogate until birth.

Although reproductive cloning is viewed by some as a way to provide a steady food supply, according to the US Department of Energy’s Human Genome Project, there are risks associated with animal cloning. First, cloning is expensive and inefficient, with "more than 90 percent of cloning attempts [failing] to produce viable offspring." Second, cloned animals "tend to have more compromised immune function and higher rates of infection, tumour growth, and other disorders." Lastly, "defects in the genetic imprint of DNA…may lead to [development] abnormalities [in] cloned embryos."

"FDA Issues Documents on the Safety of Food from Animal Clones," FDA Press Release, 15 January 2008; "FDA to Back Food From Cloned Animals: Move Would Defy Congress’s Wish for Delay," Washington Post, 5 January 2008; "FDA OKs Meat from Most Cloned Animals,: CNN.com, 15 January 2008; "EFSA Launches its Draft Opinion on Animal Cloning for Public Consultation," EFSA Press Room, 11 January 2008; "Will You Eat Meat from Cloned Animals?" Reuters, 17 January 2008; "Foes Decry Clone Ruling," USA Today, 16 January 2008; "US Approves Animal Clones as Food," BBC News, 15 January 2008; "FDA Says Cloned Animals Safe for Food," Associated Press, 15 January 2008; "Industry Responds to FDA Cloning Decision," Dairy Herd, 16 January 2008; "USDA Recommends that Food from Clones Stay Off the Market," Washington post, 16 January 2008; "Fierce Responses to FDA Cloning Safety Report," Truth about Trade and Technology News Clippings, 21 January 2008; "Cloned Meat and Dairy Products Step Closer to EU Supermarkets," Reuters, 11 January 2008; "EU Report Says Cloned Food Probably Safe," Associated Press, 12 January 2008; "EU Ethics Group Advises Against Cloning Animals for Food," EurActiv.com, 18 January 2008; "Cloning Fact Sheet," US Department of Energy, Office of Science, Office of Biological and Environmental Research, Human Genome Project; "International Markets: Europe" and "Statistics," US Meat Export Federation; "Dairy and Products Annual: 2007," USDA Foreign Agricultural Service, 19 October 2007; "Biotech Food Tears Rifts in Europe," NY Times, 6 June 2006.