April 26, 2014

New Stem Cell Research Revives Legal Debates Over Human Cloning

Stem cell scientists report the successful use of somatic cell nuclear transfer (SCNT) to create human embryonic stem cells (hESC) from an adult donor, effectively creating a population of therapeutically available cells to treat disease. This general technique, called therapeutic cloning, affords an opportunity to treat patients with genetically identical stem cells for any number conditions where new cells or replacement cells are needed (e.g., diabetes, Parkinson’s, spinal cord injuries). The investigators were able to generate of embryonic stem cells from a 35-year old and a 75-year old donors. Earlier research had demonstrated the generation of hESC if fetal or infant cells were the donors. Because human embryos were created and used to derive the hESC, the new research revives debates over the potential for advances in therapeutic stem cell research to simultaneously open the door to the misuse of these techniques for reproductive cloning, the generation of a cloned embryo that could be implanted and brought to term (a dual-use characterization). 

This debate is not new – these questions emerged at the first publication and use of somatic cell nuclear transfer (SCNT) to create the cloned sheep, Dolly, in 1997. In that period, with the recognition that advancing technical achievements might result in attempts to try human reproductive cloning, legislative efforts to ban both therapeutic and reproductive cloning or only reproductive cloning emerged at the state and national level in the U.S., as well as internationally. Subsequent research since 1997 revealed that cloning (using somatic cell nuclear transfer, SCNT) was easier to achieve with animals than with humans, until now, which is why this new research puts human cloning back into debate. The flash points in the legal debate are several: whether embryos can be  created for the sole purpose of producing genetically optimal stem cells, whether embryos can be destroyed during the derivation of human embryonic stem cells – and then the dual-use dilemma where the creation of an embryo could be a predicate to stem cell derivation or to reproduction. The Bush administration imposed a ban on federal funding for the derivation of hESC, and only allowed funds to be used on existing cell lines. In 2009, the Obama administration reversed that course and issued guidelines which allowed federal funds to be used to derive new embryonic stem cell lines from already-existing embryos (from fertility clinics). NIH maintains a hESC registry that catalogues cell lines that can be studied with federal funds. In 2011, a legal challenge to the Obama policy emerged from several adult stem cell researchers who alleged that allowing federal funds for hESC research violated the federal Dickey-Wicker amendment, which prohibits the creation of embryos for research or the destruction of embryos during research (see earlier post). In Sherley v. Sebelius (D.C. Cir. 2012), the D.C. Circuit upheld the Obama policy, finding that destruction of embryos that occurs in the ESC derivation process was not a part of individual ESC research projects using already derived ESCs:
Therefore, ESC research is no more “research in which...embryos are...subjected to risk” than it was “research in which...embryos are...destroyed.”  
With the demonstration that hESC can be derived from older human donors, human therapeutic cloning appears more viable and commercially attractive (older patients with degenerative conditions are a prime target). Will this lead to a demand for new cloning-related laws to avoid the dual-use potential? It’s unlikely right now, as the new research is an expansion of already existing technologies, rather than a paradigm-shifting breakthrough. Yet, making human embryo cloning technically possible revives the concerns that animated late-1990s legislative activity. For example, recently introduced legislation, H.R. 2433, distinguishes federal support for embryonic stem cell research from any endorsement of "human cloning:"
Defines "human cloning" to mean the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus. 
Yet, another bill, H.R. 2164, would prohibit both therapeutic and reproductive cloning with its more expansive definition of human cloning:
(1) Human cloning.--The term `human cloning' means human asexual reproduction, accomplished by introducing the nuclear  material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism (at any stage of development) with a human or predominantly human genetic constitution. 
A patchwork of state laws address cloning: several states maintain bans on all human cloning (prohibit conduct per se, or disallow use of state funds), while other states allow therapeutic, but not reproductive cloning (including authorizing use of state funds). The stem cell field is more scientifically complex now than it was in 1998, with techniques using adult stem cells and induced pluripotent stem cells (neither of which are derived from human embryos) also competing for therapeutic supremacy, and avoiding the legal and moral questions attaching to the derivation and use of hESC.

April 19, 2014

Vermont Prepared to Install First Mandatory State Labeling Law for Genetically Engineered Foods

The Vermont legislature has passed what could be the nation’s first state law requiring the labeling of foods with genetically engineered (GE) ingredients (at the federal level, the FDA does not mandate the labeling of GE-derived foods). The Vermont Senate has now cleared H. 112, which sets labeling standards for raw agricultural commodities and processed food that contain genetically engineered ingredients. In the last several years, a mechanism has emerged for states who want to implement labeling in concert with other states - they passed conditional labeling requirements for foods with GE ingredients that would only take effect if other states were adopting the same standards. Most notably, in 2013, Connecticut and Maine took this approach (see earlier post) and as of now, their laws have not taken effect as they await the required trigger conditions. The new Vermont law also adopts a similar conditional trigger, if that were to accrue before July 1, 2015, but if not – the Vermont law will go into effect on that date, whether other states do so or not. So Vermont is prepared to go it alone. Already, advocates of labeling in Vermont are anticipating the legal consequences of the law, sketching out responses to likely constitutional challenges – on First Amendment grounds (compelled speech) and the dormant Commerce Clause (improper state overreach into a federal sphere of action). Vermont has already experienced a defeat over a labeling law enacted in 1994 that required the labeling of dairy products from cows that were treated with recombinant bovine somatotropin (“rBST”); dairy farmers challenged the law under the First Amendment. In that case, the trial court had characterized the state motivation for the law: 
The State does not claim that health or safety concerns prompted the passage of the Vermont Labeling Law. Instead, it bases its justification for mandatory labeling not otherwise required by the FDA on strong consumer interest and the public's "right to know" whether a particular dairy product contains milk produced by cows given rBST. 
The 2nd Circuit ruled for the farmers, noting the government’s asserted interest in in satisfying the consumers’ right to know was “insufficient” to justify the speech-related injury claimed by the farmers: 
[W]e hold that consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement in a commercial context (citations omitted).
With that characterization in mind, the new Vermont labeling law includes the following statement of objectives: 
Because both the FDA and the U.S. Congress do not require the labeling of food produced with genetic engineering, the State should require food produced with genetic engineering to be labeled as such in order to serve the interests of the State, notwithstanding limited exceptions, to prevent inadvertent consumer deception, prevent potential risks to human health, promote food safety, protect cultural and religious practices, protect the environment, and promote economic development. 
This clause explicitly expands the state rationale to include matters of health and safety, likely elevating the significance of the government interests at stake, and refuting any charge that the state is only satisfying consumer curiosity, a seemingly trivial government interest to the courts that doomed the 1994 dairy labeling law. There is a flurry of state labeling efforts now underway -  there are 33 new GE food labeling bills pending in 19 states, as well as an Oregon ballot initiative on the November 2014 ballot.  At the federal level, opponents of mandatory labeling of GE food have introduced a federal bill, H.R. 4432, that would override any state legislation that would amend the Federal Food, Drug, and Cosmetic Act to declare that any labeling with respect to "bioengineering" would constitute “misbranding” and thus violate the federal statute. This bill would explicitly override state labeling laws: 
No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering. 
This bill competes with the previously-introduced H.R. 1699, a federal bill that would mandate nationwide GE food labeling. Both federal bills are unlikely to pass, leaving the state patchwork of labeling efforts and mandates in place.