Of Fish, Milk, and Beets: Biotech Heats Up (Again)

By Ricardo Carvajal –

No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval.  In addition to signing on to letters of protest to the Commissioner (here and here), some have opted to sponsor legislation (here, here, and here) that would amend the FDC Act to require genetically engineered fish to be labeled as such or to ban them altogether.  As we noted in a prior posting, this is the first time FDA is considering a NADA for a genetically engineered animal intended for food use.  The level of controversy and opposition engendered thus far provides a strong disincentive to those developers waiting in line.

To appreciate just how protracted a battle the folks at AquAdvantage face, one need look no further than the dairy shelf, where the slugfest over labeling of milk derived from cows not treated with rbST continues more than 15 years after that drug’s approval (rbST stands for “recombinant bovine somatotropin,” a bioengineered hormone that increases milk production).  For years, marketers of milk derived from cows not treated with rbST have sought to advertise that fact so as to tap into the desire on the part of some consumers to avoid all things biotech.  Some labeling and advertising claims (e.g., “rbST free”) have provoked trade complaints from rbST advocates, who allege that the claims are false or misleading because they imply that milk derived from cows treated with rbST  contains rbST and is somehow inferior.  Having failed to get satisfaction from FDA and FTC in response to their trade complaints, rbST advocates turned to state legislatures to challenge the claims.  Ohio obliged by banning certain types of claims (including “rbST free”) on the ground that they were false or misleading.  A First Amendment challenge to Ohio’s ban was initially turned aside by a federal district court, which found the claims to be inherently misleading - but that victory was short lived.  The 6th Circuit Court of Appeals recently reversed and remanded the case for further proceedings, noting that milk derived from cows treated with rbST might yet be found to contain rbST, and that there is “evidence that [such milk] contains increased levels of IGF-1 and might be compositionally of a lesser quality.”  If so, then the claim “rbST free” in the labeling of milk derived from cows not treated with rbST would be truthful and not misleading.  These arguments are eerily similar to those raised against AquAdvantage – arguments that FDA presumed it had put to rest, at least in the case of rbST (a more in-depth article over the rbST controversy is available here).

The biotech headaches of late have not been FDA’s alone.  USDA/APHIS has been embroiled in litigation over its attempt to deregulate bioengineered alfalfa, and has now provoked the ire of a district court by issuing permits for the production of bioengineered Roundup Ready sugar beet seedlings – less than a month after being found in violation of the National Environmental Policy Act for deregulating the beets without preparing an Environmental Impact Statement.  The court has ordered APHIS to “state under penalty of perjury exactly when and where it made the information public that the permits had been granted.”  Ouch.

All in all, it would appear that a powerful alliance has emerged between consumer groups that generally oppose biotech and producers who have staked their livelihoods on the burgeoning consumer demand for “natural” and “organic” products.