FUTURE POTENTIAL CONFLICTS
Concerns over legal vacuum with food from clones
By Brian Beary | Thursday 25 June 2009
In addition to the many food safety-related trade disputes have dragged on for years and decades, the potential for new ones breaking out is strong. Nowhere is this more striking than with food from cloned animals or their offspring. In January 2008, the US Food and Drug Administration (FDA) concluded “it had no further concerns about the safety of food from cattle, swine or goat clones, or from the progeny of cattle, swine, goat or sheep clones”. The FDA finding paves the way for products from cloned animals and their offspring to be sold in supermarkets. EU officials were taken aback by the decision - not so much by the substance as by the process. One said it was strange that a decision with such significant implications would be taken by a regulatory agency, without having first been debated and enshrined in law by the US Congress.
While the first cloned animal was produced in 1996 for research purposes, it is only more recently the issue of marketing food from cloned animals has come up. The EU still has no legal framework for dealing with food from clones. The European Parliament has asked for a ban to be introduced in a resolution MEPs adopted in September 2008. The European Commission is assessing the implications of such a ban. The Liaison Centre for the Meat Processing Industry in the EU (CLITRAVI) has called for authorisation to market food from clones to be delayed until the EU carries out more research, in particular into the offspring of cloned animals. In a February 2008 letter to the European Food Safety Authority (EFSA), CLITRAVI noted how the US and New Zealand appeared to be ahead of the EU in cloning techniques, which risked putting European industry at a competitive disadvantage.
EFSA has carried out a risk assessment for cloning in cattle and pigs and their offspring. In its July 2008 opinion, EFSA concluded that food from such animals are as safe for humans to eat as conventionally-bred animals, and did not pose additional risks to the environment. But it also found that cloning techniques posed risks for the health of the animal bearing the clone and the clone itself, although not the offspring. The agency stressed that these animals had not yet been studied in their whole life cycle. This assessment highlights an important difference between EU and US regulatory cultures because unlike EFSA, the US FDA did not assess the impact cloning has on animal welfare.
“I am keeping my fingers crossed that this will not be a problem for transatlantic trade,” said one EU official, who warned, however, that “if the EU decides to prohibit products from the offspring of clones we will have a problem”. This is because the US, unlike the EU, has no mandatory system for identifying and labelling cattle. Instead, about 30% of US cattle take part in a voluntary animal identification programme whereas with the other 70%, there is no record of where they were born, how old they are or where they came from. Given this, an EU ban on products from clones or their offspring could in theory affect a wide range of US meat exports to the EU because there is no system enabling them to be certified as ‘clone-free’.
On the US side, there is awareness of the danger of this turning into another trade dispute. “There is a potential for our approaches to diverge in the future and that is why we are very interested in engaging in discussions on regulation,” said one US trade official. The official said that there had been “some technical discussions” with international trading partners, but mainly within the context of animal cloning for research purposes.
In practice, food products from the offspring of cloned bulls are already on the market in Europe and the US, according to one food safety official. That is because although US food producers, prodded by the US Department of Agriculture, imposed a voluntary moratorium on marketing food from clones, aware of the potential backlash from consumers, they imposed no such restrictions on food from the
offspringof clones. In reality, this is where any future trade will be because it costs about US$20,000 to clone an individual animal so it is not commercially interesting for industry to sell the clones themselves.
Rather, there can be a lucrative trade in the semen
and offspring of clones because, given that only the most productive animals are typically cloned, their offspring - effectively a half clone - will be genetically predisposed to being highly productive too. Semen from cloned animals can already be legally sold in Europe and does not even need to be labelled because the EU’s novel foods regulation (1997/258/EC), which requires new foods to be authorised and labelled, does not cover clones’ semen or offspring. The EU is in the midst of debating whether to extend the regulation to clones and their offspring. The Council of Ministers is inclined to do so, but the Commission is opposed because it feels it will be impossible to enforce this as there is no international system for identifying and tracing such foods.
“The number of descendents of cloned animals on the EU market may be small but it is still greater than zero,” said one EU official. A closely related area where trade obstacles may arise, depending how the EU and US legal frameworks develop, is with genetically engineered animals. For example in the fisheries sector, salmon is likely to be an early test case, as scientists are already manipulating the salmon’s hormones to enable it to grow faster.
NEW US FOOD SAFETY LAW
European officials also have concerns about plans to create a new regime for inspecting food imports the US Congress is putting together. US lawmakers are overhauling the entire US food safety legal framework. Legislation is likely to be enacted in 2009 that greatly increases the US FDA’s powers to inspect foods imports. The initial draft had EU officials worried because it required every food exported to the US to be certified as safe to eat by a third party, such as a private agency that the FDA would authorise to do the job. This legislation has been drafted in response to a spate of recent food scares in the US, including outbreaks of e coli in spinach and peppers, and incidences of salmonella in peanut butter. It is being pushed hardest by the Democrats, who have a commanding majority of both the House of Representatives and Senate - and who of course occupy the White House too.
Congressman John Dingell (Democrat, Michigan) introduced a bill, on 28 January 2009 (HR 759), that sent alarm bells ringing in the European Commission by requiring all foods exported to the US to be certified as complying with US food safety rules. That draft has since been superseded by a draft adopted on 17 June by the House Energy and Commerce Committee, which is more palatable from a European exporters’ perspective.
The most recent version ditches the third-party certification requirement and reduces the annual registration fee EU exporters to the US would have to pay to the FDA from the US$10,000 originally proposed to US$500. With the full House due to vote on the bill in July, EU officials are hopeful that the final version agreed by the House and Senate will contain a clause exempts trading partners with high food safety standards such as the EU from having to undergo additional inspections from the FDA. According to one EU official, “the problem we would have with a blanket third-party inspection requirement is that it does not distinguish between high-risk and low-risk exporting countries. We are pushing for language that will enable the US administration to conclude mutual recognition agreements with low-risk trading partners, such as the EU and New Zealand”.
A vote on the House floor is due in July, after which the Senate will adopt its bill and then the two versions will have to be reconciled before President Barack Obama can sign it into law. n
US legislation potentially subjecting food imports from the EU to more inspections is expected to be enacted in 2009
Dolly the sheep made history in 1996 by becoming the world’s first cloned animal. To date, mice, rabbits, cattle, swine, sheep, goats, deer, horses, mules, cats and dogs have been cloned.