October 31, 2012

Biotech on the Ballot: Labeling of Genetically Engineered Food and Funding of Stem Cell Research

A preview of the biotechnology-related election issues on the November 6 ballot illustrates both direct and indirect implications of the upcoming vote. Two areas of biotechnology and the law will be clearly impacted by the results of state and national elections - the partial regulation of genetically engineered food through labeling, and the federal funding of embryonic stem cell research. The most directly consequential measure (yes/no) is in California. There is a state ballot initiative to require the labeling of genetically engineered (GE) foods in California, Prop 37; if adopted, it would be the first such state mandate to be imposed (see here). Thus, on November 7th, California could be looking at implementing a regime of mandatory labeling for GE foods, and we could expect legal challenges to follow with likely First Amendment challenges to the labeling, where the contours of the commercial speech doctrine would be at issue (e.g., somewhat analogous to International Dairy Foods Association v. Amestoy (2nd. Cir. 1996), where the 2nd Circuit invalidated a Vermont measure requiring hormone-related labeling of dairy products). 

It is also foreseeable that the outcome of the Presidential election will indirectly (but seriously) affect the status of stem cell research in the U.S. – specifically the ongoing controversy over the federal funding of embryonic stem cell research (see here). In 2009, President Obama reversed the Bush-era policy of disallowing the use of federal funds for the derivation of new embryonic stem cell lines; as a result, the National Institutes of Health (NIH) is allowed to award grants for such research. The Romney website contains a policy on stem cell research; while not directly addressing the use of federal funds for embryonic stem cell research, the statement is written to focus on alternatives: “Adult stem cell research and alternative methods to derive pluripotent stem cells, such as altered nuclear transfer and direct reprogramming, are scientific paths that carry much promise and avoid raising ethical concerns.” Governor Romney vetoed a Massachusetts bill in 2005 that would have allowed “therapeutic cloning” – the creation of a cloned embryo to derive genetically compatible embryonic stem cells (this debate was extant in federal legislative battles at that time, with Democrats and Republicans having opposing positions). The 2012 campaign site contains this statement: “When confronted with the issue of stem cell research as governor of Massachusetts, Mitt Romney chose to support life by vetoing a bill that would have allowed the cloning of human embryos.”  Actually, this is a veto more grounded in a rejection of deliberate embryo creation rather than the stem cell research itself. Thus, this statement does not address whether Romney would allow the funding to derive embryonic stem cells from leftover or discarded embryos that were created not for research, but in the process of assisted reproductive technologies (e.g., at fertility clinics). However, from all available evidence, it can be inferred that the Romney position will be to undo the Obama policy of federal funding for new stem cell lines from unused embryos.  Thus, on November 7th, the stem cell community wil either encounter the status quo (Obama) or the possible elimination of federal funds for embryonic stem cell research (Romney); a Romney win would also obviate the current legal challenges to the Obama policy. On a final note, the larger specter of federal support for scientific research is implicated in the national race, particularly as questions of government scope and resources have factored in so highly. A group of 68 Nobel Prize winners endorsed President Obama recently, largely based on their view that Obama “delivered on his promise to renew our faith in science-based decision making and has championed investment in science and technology,” while concluding that Romney would “devastate a long tradition of support for public research and investment in science.”

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