19 November 2008

7 minute read

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Image: FDA

The US Food and Drugs Administration (FDA) recently released a draft guidance on animals being genetically engineered for the food sector entitled: Guidance for Industry Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs. They say that when this draft is finalized, it will reflect the FDA’s current thoughts on this topic.

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. Ever since the idea was first conceived it has been the bone of contention among the media. Science fiction literature has portrayed it in a whole spectrum of colours, but the issue is no longer confined to fiction. It has entered the world around us almost unforeseen and now it beckons on the door of animal farming, but do we yet understand its real implications?

According to Randall Lutter, "Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation." Dr Lutter, the deputy commissioner of policy for the FDA, in a press item released shortly after the draft report, commented that the FDA guidance "provides a framework for both GE animals and products made from them to reach the market".

According to the FDA, genetically engineered organisms currently being developed are being used to improve animal health or enhance agronomic traits and food quality. For instance, we may start seeing fish that grow faster and more efficiently, or goats being engineered with spider genes to produce silk in their milk. Some GE pigs could have less environmentally deleterious wastes, whilst others may be engineered with mouse and bacterial DNA to improve digestion.

An FDA Fact Sheet says that GE food animals could also produce "highly specific antimicrobials that target disease-causing bacteria such as E. coli 0157:H7 or Salmonella".

There are also implications for these animals to have increased drought and heat tolerance, which may allow for high quality food to be produced in parts of the world where disease, climate, or accessibility of forage material have previously limited the ability to raise food animals. Animals can be engineered to be resistant to painful diseases, have less environmental impact, grow more quickly, require less feed, and produce healthier food.

The draft makes clear the opinion portrayed by the Food and Drugs Administration, but the issue is more complex than simply that of improving efficiency and meat quality. For instance, when does a genetically modified animal cease to be an animal at all? How safe is it to unleash these animals on nature? And what effects will this have on farmers and the industry as a whole?

A Glance Through European Eyes

Conspiracy theorists dream up scenarios involving giant chickens and headless cattle, but are these visions as radical as they seem? A lot of the fears involved with genetically engineered food animals are not based merely around farming, or even modern day experiments, but rather they are concerned with what the next step after that will entail and whether or not this is a future that we will be stepping into with our eyes fully open.

There is undoubtedly a question of ethics at stake among many people, as this would be a genetically unnatural step. An FDA Consumer Q and A, says that the issue of ethics is an extremely complicated one. However, "On the one hand", it says, "the standard for approval does not explicitly include ethics...many people would consider animal health and safety to be a subcategory of the broader term 'ethics'".

A quick look at European perceptions on genetic tampering of food animals shows evident concerns. In a survey conducted by the European Commission, entitled Europeans’ Attitudes Towards Animal Cloning Analytical Report, released in October 2008, three-quarters of interviewees agreed that there could be ethical grounds for rejecting animal cloning, whilst 69% agreed that animal cloning would risk treating animals as commodities rather than creatures with feelings.

Significantly, a large majority of EU citizens were unwilling to accept animal cloning for food production purposes and 58 per cent said that such cloning should never be justified. The question is: would these people vote the same way if the topic concerned genetically engineered animals, rather than cloned animals?

A majority of EU citizens said that it was unlikely that they would buy meat or milk from cloned animals, even if a trusted source stated that such products were safe to eat, whilst eight out of ten EU citizens (83 per cent) said that special labelling should be required if food products from the offspring of cloned animals become available in the shops. Would it be a breach of rights if this option was refused?

The Fearful Glare of the Media

The main aspects of the FDA's draft guidance that has drawn concern amongst consumer groups is food labelling and transparency. "While the new guidance would require a long-overdue review process, the proposed FDA rules are seriously flawed," says TheTrueFoodNetwork.

"Under this draft, the public cannot know if the review of a product has met the highest scientific standards until after its approval, and then they cannot avoid the product in the marketplace because it is not labeled. The FDA feels it deserves the public’s trust, but refuses to give us the tools to verify that it is doing its job fairly and adequately."

But, genetically engineered organisms are nothing novel. Since its first demonstration as proof of principle by Cohen and Boyer in 1973, recombinant DNA (rDNA) technology has been applied to microorganisms, plants, and animals. Now, more than two decades later, many different species, including those traditionally consumed as food, have been genetically engineered with various rDNA constructs.

However, according to NaturalNews, ever since the beginning of Genetically Engineered grains, controversy has surrounded their safety. The Organic Consumers organization is equally against genetically engineered grains stating "Campaign activists are also demanding that corporations and governments heed the concerns of consumers, North and South, and remove genetically engineered corn and other foods and crops from the market, unless they can be proven to be safe for human health and the environment."

NaturalNews claims that hundreds of US consumers have reported allergic reactions after consuming FDA-approved products such as Kraft and other brand name products likely to contain genetically engineered corn.

The FDA says that under the draft guidance, in those cases where the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. However, at a time when the FDA has inadequate resources to protect the food system and is reeling under allegations of conflicts of interest has the issue of food safety been fully considered?

The Centre for Food Safety, a non-profit organisation, has spotted an area of concern. "This new proposal uses a secret approval process wherein no one other than FDA reviewers can see the data submitted before final approval," said Jaydee Hanson, Policy Analyst on cloning and genetics for the Center for Food Safety. "And, unlike drugs which can be recalled because they are labeled, FDA maintains that genetically engineered animals should not be labeled."

After all is said and done, the fact remains that any move towards genetically engineered food animals will most probably proceed a monumental shift in what we now know as farming and what we perceive as meat. If it is for anyone to decide whether it is the right, or wrong move then we ask "who should it be?" Is it the American government, corporate leaders, or the everyday citizen that has to produce, or consume these products? What is there to be really gained, and parallel to these gains, what is there to be lost?

The comment period for the FDA's Draft Guidance ended on the 18^th November.

Further Reading

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You can view the Food and Drug Administration Draft Guidance by clicking here.

November 2008