The FDA announced today that it would give preliminary approval to lift a five year-old, informal ban on including the meat or milk of cloned cattle, pigs and goats in the US food chain. Sheep remain off-limits until more evidence is produced. Should this decision remain in place, the United States would become the first nation on Earth to allow artificially cloned meat and milk products for sale.

This is not the first time such regulations have been proposed. In 2003, tentative approval was granted but then withdrawn at the recommendation of the FDA’s own advisory panel for lack of scientific evidence. Not the first Bush-appointed federal agency to be found adjusting guidelines without compelling data, FDA was ordered to investigate the matter. Three years later, the Draft Risk Assessment released today is the follow up to the earlier fracas.

Today’s ruling, based upon the findings of a team of federally selected scientists, will now undergo a public comment phase. For at least three months, US citizens may give testimony regarding this decision, as well as suggestions regarding labeling guidelines. Any permanent decisions made will likely not be implemented until the latter half of 2007.

Stakeholders in this debate include large agribusiness firms, vertically integrated and invested in bioresearch as well as the family farmers that subcontract through them. Bioresearch firms and the universities that train them would benefit greatly from a federal seal of approval on their product. On the other side is an increasingly distrustful American consumer and, as always, a small farmer or rancher, trying to make ends meet. Those who trade agricultural commodities may find themselves under pressure to refuse shipments of US-produced animal products. Aid organizations may have trouble convincing disaster stricken countries to accept donations of milk products such as happened with GMO maize in some African nations in recent years.

Currently the FDA does not intend to label products containing cloned animals as the 700-page study judges them “virtually indistinguishable” after 6-18 months, depending on species. FDA guidelines for labeling changes pertain to foods that are demonstrably different unless other legislation requires it. Fallout from this change could include other countries banning unlabeled meat and dairy. It is likely that many smaller and local vendors in the US will advertise not using such animals in their products, such as milk now labeled “hormone-free.”

Many consumer advocacy groups are gearing up to give this comment period the same attention as the first draft of the National Organic Program that drew over 100,000 responses, sending the legislation back for several years of rewrites. The dairy industry itself reports 14% of women surveyed would stop drinking milk if cloned cows were allowed to contribute to the supply. There continues to be no evidence that there is anything inherently wrong with milk from such animals, but the process itself remains unprofitable and has demonstrated genetic degradation that is passed on to offspring as shortened life spans.

Further opposition has come from Capitol Hill. Mounting congressional pressure recently included a letter to the Secretary of Health and Human Services, the cabinet-level position responsible for the FDA, to request special and careful consideration of this issue is taken before declaring the ban lifted. It is likely that a legislated ban could be proposed should the rule-change go through. The signatory legislators have today reiterated their request for a careful and open comment period.

Despite an industry-wide acceptance of the ban, many thousands of clone offspring have already made their way into the food chain, as there has been no formal or informal ban on artificially inseminating with clone sperm. Exceptions such as this cause detractors to criticize the current administration’s policy of non-binding industry self-regulation.

Proponents of the still fledgling livestock cloning industry insist there is a need for standardized product in an increasingly industrialized agricultural setting. Though this still represents less than a single percent of the animals used for meat or milk in the US, many consumers worry not only how the products from these animals will impact their health, but also what sort of agriculture depends on such experimental creatures.

The numbers of cloned animals in the United States remains quite low – fewer than a thousand cows and pigs — in part, due to the cost and effort still required when producing a cloned animal. Abnormalities in cloned animals mean many clones and surrogate mothers die as a result, but when it works, it works well as a replacement for skilled animal husbandry. The skill of a specialized breeder can be replaced when a champion line becomes a champion clone. Farming operations with razor-thin per-animal margins will try to cut expensive labor costs wherever possible.

Because of this expense, most cloned animals are likely to be used as breeding stock with their offspring making it to your table. Very large agricultural companies or their farmer sub-contractors usually own these animals. Their expansive facilities are largely automated and run by technicians rather than farmers.

Once used breeding stock is past its prime, it will certainly end up on someone’s plate if there is no law preventing that. However, the comparative pittance the animal’s owner will receive for rendering does in no way offset the expense that will have to be made up from decreased labor costs, usually in the form of automated expansion. Farmers bemoan dumping out milk from such animals, but if there is no rule against it, I see no reason why they wouldn’t feed that milk to other animals, such as pigs or even sheep.

So, today’s ruling is symbolic only on several levels. This would affect a fraction of a percentage of the animals in our industrial food supply network. The farmers employing this method are spending incredible sums of loan money on these animals while the labs that create them are loosing millions in speculative money as well. In the face of such vehement opposition from consumer groups across the board and from their own commodity organizations, there must be a compelling reason to legalize this practice.

One can only imagine that since there is no currently economic-related reason to do so now, that those who set agricultural policy envision a future where cloned animals are the norm, rather than the exception. Precisely what form that would take is a matter of speculation, but it certainly is not an administrative endorsement of current trends towards decentralized production with a minimum of confinement. It is possible this is simply a rule change to minimize the paperwork required from the very few people who own such animals, though the approach would seem heavy-handed, if true. Since jobs in biotechnology are considered desirable, this may be an attempt to establish United States as a leader in what some believe to be the next phase of animal production.

Perhaps there is something to President Bush’s otherwise bizarre statements in his 2006 State of the Union speech where he said he supported a ban on “animal-human hybrids.” Any such transgenic creations would not covered by this proposal. Either way, it is clear the move to push this legislation through is not all it appears to be – it certainly sets the stage for other, perhaps even more controversial regulations.

Let your opinion be heard before 2 April 2007. Public comment may be sent to FDA via electronic form or by an old fashioned letter. Please send written comments to

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD, 20852.

If writing, be sure to include the docket number: 2003N-0573.

Marie Richie is a writer, scientist and photographer in Portland, Oregon. Visit her online at http://www.sillydogmedia.com/ . Email Marie directly: sillydog (at) sillydogmedia.com

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