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.
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.
Genetic counseling services have proliferated in the age of molecular medicine, as health care practitioners increasingly make use of genetic information as a basis for determining risk, diagnosis, treatment and prognosis. The professional field of genetic counseling now encounters the trend of state licensure standards for professional practice. To date, about 15 states mandate licensing for genetic counselors. Licensing is endorsed by the National Society of Genetic Counselors, which publishes model licensing standards and practice guidelines. Virginia has now passed a genetic counselor licensing statute, defining genetic counseling:
"Practice of genetic counseling" means (i) obtaining and evaluating individual and family medical histories to assess the risk of genetic medical conditions and diseases in a patient, his offspring, and other family members; (ii) discussing the features, history, diagnosis, environmental factors, and risk management of genetic medical conditions and diseases; (iii) ordering genetic laboratory tests and other diagnostic studies necessary for genetic assessment; (iv) integrating the results with personal and family medical history to assess and communicate risk factors for genetic medical conditions and diseases; (v) evaluating the patient's and family's responses to the medical condition or risk of recurrence and providing client-centered counseling and anticipatory guidance; (vi) identifying and utilizing community resources that provide medical, educational, financial, and psychosocial support and advocacy; and (vii) providing written documentation of medical, genetic, and counseling information for families and health care professionals.
Virginia is now the first state to incorporate a conscience clause into the licensure of genetic counselors:
Nothing in this chapter shall be construed to require any genetic counselor to participate in counseling that conflicts with their deeply-held moral or religious beliefs, nor shall licensing of any genetic counselor be contingent upon participation in such counseling. Refusal to participate in counseling that conflicts with the counselor's deeply-held moral or religious beliefs shall not form the basis for any claim of damages or for any disciplinary or recriminatory action against the genetic counselor, provided the genetic counselor informs the patient that he will not participate in such counseling and offers to direct the patient to the online directory of licensed genetic counselors maintained by the Board.
Conscience clauses have been added into licensing or accreditation laws since the Roe v. Wade decision in 1973. Such clauses were initially written so that health care professionals or institutions with moral or religious objections to the offering of abortion services were not compelled to do so. In the decades since Roe, conscience clauses have proliferated in both federal and state laws, largely aimed at the delivery of reproductive-related services, including abortion, contraception and sterilization (thus affecting not only direct health care professionals, but pharmacists as well).The rationale for the inclusion of the Virginia statutory provision has not been made explicit, but commentary suggests that the intent is to allow genetic counselors to refuse services to same-sex couples or unmarried persons who seek genetic counseling for reproductive purposes, or to clients who may consider abortion if genetic testing reveals serious genetic disease. It’s not clear when in the sequence of service delivery the counselor may decide to withdraw from the provision of services. The clause includes a provision that removes liability for the counselor for any consequences of denying service or withdrawing from services. What is clear, however, is that this clause would authorize the denying of particular services (the more typical conscience clause) but it would also allow denial of all services to particular individuals or groups, effectively discriminating against certain individuals who seek professional care. That possibility potentially raises the specter of an equal protection challenge as services are denied to classes of individuals based on their identity or status (similar to the recent Arizona legislation that would have allowed frank discrimination by business owners against gay people; it was vetoed by Gov. Brewer). Virginia has already opened the door to denial of professional services to classes of individuals, as it enacted a conscience clause limitation for adoption agencies in 2012 (North Dakota has also done so).Thus, claims of the exercise of religious liberty in the delivery of professional services potentially conflict with established anti-discrimination laws and guarantees of reproductive autonomy. Similar overtones of the clash between claims of religious liberty and legal guarantees of equal access have surfaced in the recent Affordable Care Act litigation over mandates for the coverage of contraception, Sebelius v. Hobby Lobby Stores, Inc. (argued last week at the Supreme Court).
The movement to place a referendum on the ballot in Colorado this year that would authorize the labeling of foods with genetically engineered (GE) ingredients has survived a legal challenge by opponents. Initiative 48 has been submitted by Right to Know Colorado GMO, which must now collect 86,105 signatures needed for the measure to appear on the 2014 Colorado ballot. A challenge to the proposed referendum was filed by an association of retail grocers, alleging that the measure was “misleading.” That petition recited various misleading aspects of the ballot measure, including this allegation:
The titles do not inform voters that the essence of the Proposed Initiative is that the failure to label genetically modified food is treated as "misbranding" of food.
In an order issued by the Colorado Supreme Court, the court affirmed an earlier decision of the Title Board, which characterized the initiative in its brief to the court:
The meat of the initiative is not misbranding. It is the creation of new labeling responsibilities to inform consumers.
If Right to Know Colorado can submit enough signatures for the ballot, it will appear later this year. In general, state-level developments in the labeling of genetically engineered food or ingredients emerge through direct legislative enactments (see here) or by ballot measures (see here). Many state-level legislative attempts to require GE labeling have failed (such as this effort in Colorado last year), so the direct ballot route becomes an alternative. That, however, is no guarantee of electoral success (a mandatory GE food labeling referendum, Proposition 37, appeared on the California 2012 ballot, and was defeated). In fact, defeat of that referendum has swung the pendulum back to a direct legislative effort in California this year (supporters note that “SB 1381 is a simpler, clearer version of Prop. 37).”
In a long-awaited opinion issued yesterday in Haskell v. Harris, the en banc 9th Circuit has upheld the constitutionality of the California law that authorizes the collection and testing of DNA samples from all persons arrested for or charged with any felony or attempted felony (profiles are entered into the national CODIS database). The practice of collecting DNA from arrestees began in Louisiana in 1997. The recent trend in state DNA collection practices for law enforcement has been to expand DNA profiling from those convicted of crimes to those arrested for various crimes. The Supreme Court upheld the constitutionality of arrestee DNA collection against a 4th Amendment challenge in Maryland v. King (2013) (see earlier post). California’s expansion of its DNA database was initiated with the passage of Proposition 69 in 2004, and expanded to include arrestees in 2009. An earlier 9th Circuit panel upheld the practice in 2012, while a state court disagreed and found the practice unconstitutional. In yesterday's ruling, Judge M. Smith filed a concurrence that accompanied the terse per curiam opinion from the full panel, acknowledged the impact of King:
The Supreme Court’s decision in King is fatal to Plaintiffs’ claims.
The court did note some of the safeguards in California’s policy (and which are found in most state policies):
Only law enforcement officials may access a DNA profile, and they may only use the DNA for identification purposes. Id. §§ 295.1(a), 299.5(f). Unauthorized access or disclosure is punishable under state law by imprisonment and a criminal fine. Id. § 299.5(i). Federal law imposes similar penalties for unauthorized use of, or access to, CODIS. See 4 2 U.S.C. §§ 14133(c), 14135e(c). An arrestee who is not ultimately convicted may ask the trial court to order the sample destroyed and the DNA profile expunged. Cal. Penal Code § 299(b).
This case took an interesting twist in 2012, when scientists in the ENCODE project published more annotation of the human genome and the development invited an analysis that the genetic markers used in forensic DNA science were more informative (and thus the collection was more invasive) than law enforcement claimed (see submission to the court by the Electronic Frontier Foundation and earlier post). There is no mention of the ENCODE-based arguments in the opinion just released. In its amicus brief, the Obama administration sided with California in arguing for the constitutionality of the law.The 9th Circuit opinion signals that 4th Amendment challenges to arrestee DNA collection are unlikely to succeed in view of King. It's possible that more detailed annotation of the human genome might provide a basis for future arguments that the CODIS markers are more informationally revealing than is currently believed (thus altering the privacy calculus), but the 9th Circuit's ruling ignored the opportunity to opine on the relevance of evolving science, leaving that to future cases.
