DID THE 9th CIRCUIT JUST ELIMINATE SUBSTANTIAL EQUIVALENCE?

It's been a while since we have been able to blog about the changing attitudes toward Geneticall Modified Organisms (GMOs) and their effect on the food supply, but this is the occasion to do so, for one of our regular article spotters and contributors, K.M., found this hugely significant summary of a recent decision by the U.S. Ninth Circuit Appellate Court, which has been in recent years manifesting a refreshing return to occasional sanity. The decision, in this case, is summarized by the Swampington, D.C., legal firm of Perkins Coie... yea, that Perkins Coie:

Ninth Circuit Issues Significant Ruling on Bioengineered Food Disclosure Standard

The decision was issued in regard to the case of National Grocer vs. Rollins, and concerns the National Bioengineered Food Standard (referred to in the Perkins Coie less-than-helpful summary where the abbreviation is never explained nor defined, nor clear English used. C'mon you folks at Perkins Coie: abbreviationism is NOT communication, it's merely Another Bad Habit of Americans. But I digress.)  Here is the central core of the Court's decision:

• Detectability of bioengineered genetic material. The panel held that USDA had acted contrary to the NBFDS statute by excluding from the definition of “bioengineered food” any item in which modified genetic material is merely “not detectable.” The appellate court noted that the NBFDS did not expressly define what it means for a food to “contain” modified genetic material. The Ninth Circuit evaluated the language of USDA’s regulations and concluded that the agency’s “non-detectability” rule was “not legally equivalent to a finding that the food does not ‘contain’ genetically modified material,” at least as currently worded. The panel directed the district court to enter summary judgment for plaintiffs on that claim and to remand the matter to USDA, while recognizing that USDA may address detectability issues on remand, including the agency’s consideration of the sensitivity of detection methods. The Ninth Circuit directed the district court to (1) enter summary judgment in plaintiffs’ favor on the issue of detectability, (2) remand the relevant regulations, 7 C.F.R. § 66.1 and § 66.9, to USDA, and (3) determine whether the regulations should be vacated in connection with that agency remand. (Emphases added)

Now, following K.M.'s suggestion in the email that accompanied the article link, I suggest that this decision may be a bold step in the direction of re-evaluation of the whole concept and doctrine of "substantial equivalence" behind the emergence of GMOs, and the whole regulatory and legal culture that emerged from that doctrine, which doctrine, let it be noted, subtly lurks between the lines of the above summary of the Court's finding. "Substantial equivalence" was the doctrine used and promoted by the Big Agri companies like Mon(ster)santo to argue that their genetically modified seeds were no different than ordinary versions of the same seed as far as human consumption was concerned. Genetically modified peas, or beans, or carrots, or potatoes, or whatever, were "substantially equivalent" to non-modified peas, beans, carrots, potatoes, or whatever, from the standpoint of nutrition (and hence, they also argued, from the standpoint of health, and so on.) It was, to put it simply, a version of the old argument that if it looks like a duck, and quacks like a duck, it's a duck. But here is precisely where the doctrine breaks down: ducks cannot be patented, and thus cannot be licensed, nor can anyone owning a duck be sued by a duck-growing corporation for owning a duck.  But a genetically modified organism possesses its modification only "by the hand of man," and thus a genetically modified duck, or pea, or corn, or carrot, can be patented and the patent-holder can charge a royalty or license fee for the use of his product.

In looking at the decision of the court it is in my opinion important to note that it is applying a very rigorous standard that goes beyond the "substantial equivalence" doctrine, because even though a genetic modification is "non-detectable" to the naked eye(the "if it looks like a duck and quacks like a duck, it's a duck" argument), or perhaps falls below some purely artificial "threshold percentage number" where the amount of modified material is said to be "non-detectable" for regulatory purposes, this does not mean the same thing as not containing any genetic material whatsoever, because that non-detectable threshold is merely regulatory, and the actual res or reality is otherwise.

And that, both to K.M.'s mind and mine as well, means that a very large swipe against the doctrine of substantial equivalence has just been made, and that doctrine, let it be noted enabled the whole GMO penetration of the food supply and the current regulatory culture; it means that whole culture is now open to legal challenge.

In this case, time, and litigation, will obviously tell if this implication of the decision is true, and will be upheld.  But interestingly enough, Perkins Coie seems to be thinking the same thing, for it ends its summary of the decision with this warning (and I have edited the quotation to replace the abbreviationism with standard English):

The National Grocers case represents a significant departure from current [Bio-engineered] disclosure standards as implemented by [United Stated Department of Agriculture]. Given the remand for further consideration by the district court and [United States Department of Agriculture], industry stakeholders should carefully monitor any changes that affect their [Bio-engineered] disclosure practices. (Emphasis added)

Time will tell, of course, but the warning is, in my estimation, sufficient to suggest that big changes are coming to the whole GMO "experiment".

It's about time.

See you on the flip side...

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