[*PG619]HUMAN-NONHUMAN CHIMERAS:
A REGULATORY PROPOSAL ON THE
BLURRING OF SPECIES LINES
Abstract: The chimera of modern biotechnology is defined broadly as a single organism composed of a mixture of materials from two or more organisms possessing distinct genetic backgrounds. Unlike the United States, which does not regulate chimeras directly, Canada has responded to the unregulated pursuit of chimera technology by banning certain chimeras as part of comprehensive legislation designed to regulate human reproductive technologies. In 2004, the Canadian Parliament passed the Assisted Human Reproduction Act despite criticism urging greater legislative justification for the Act’s provisions and modification to its statutory definitions. Because current regulatory mechanisms in the United States, including patent law and administrative oversight, fail to regulate chimera technology, the United States should enact new legislation, using Canada’s legislation as a model, to prohibit embryonic chimeras and to regulate other human-nonhuman combinations. Unregulated biotechnology threatens to disrupt legal and social institutions; therefore, the United States must make a balanced effort now to protect the public interest.
The Chimera of ancient Greek mythology was a fire-breathing beast with a lion’s head, goat’s body, and dragon’s tail that ravaged the kingdom of Lycia until the hero, Bellerophon, destroyed it.1 The chimera of modern biotechnology is defined broadly as a single organism composed of a mixture of materials from two or more organisms possessing distinct genetic backgrounds.2 The mythological origin of the term reflects not only the multispecies composition of chimeras, but also their potential, as products of unbridled technological innovation, to generate disruption and confusion in society.3
[*PG620] Chimeras were once merely the fantastic creations of science fiction; however, rapid advances in genetics, cloning, and embryology have resulted in the blurring of species lines, including our own species, Homo sapiens.4 In particular, recent advances in the development of chimeras have led to the creation of a variety of organisms with both human and animal components.5
Despite these scientific developments and the expanding discussion of chimeras among bioethicists, legal discourse has not explored thoroughly the implications of this emerging technology.6 In the United States, there is no regulatory body prepared to address the specific legal and ethical issues that chimeras present.7 The Food and Drug Administration (the “FDA”) has not extended its regulatory reach to embryonic chimeras,8 although it has made a controversial claim of jurisdiction over human cloning.9 Furthermore, present efforts to regulate federally funded research, such as President George W. Bush’s limitation on the creation of new stem cell lines, do not encompass chimera technology directly, or private biotechnology research generally.10 Likewise, internal methods of biotechnology regulation, including self-policing organizations and institutional review boards, have proven to be insufficient regulators of biotechnology.11
Unlike the United States, Canada responded to the unregulated pursuit of chimera technology by banning certain human-nonhuman [*PG621]combinations as part of comprehensive legislation designed to regulate human reproductive technologies.12 The Canadian Parliament passed the Assisted Human Reproduction Act (the “AHR Act”) in 2004,13 despite criticism urging greater legislative justification for the Act’s provisions and modification to the statutory definitions.14 In contrast, legislators in the United States have struggled to reach a consensus on embryo research and human cloning, but have yet to address chimeras specifically.15 The United States, therefore, should confront the pressing issues arising from the creation of novel beings by implementing legislation modeled after Canada’s AHR Act.16
This Note weighs the arguments for and against regulating the creation of various types of chimeras,17 evaluates opportunities to regulate chimeras within existing institutions,18 and examines Canada’s AHR Act as a possible model for legislation in the United States.19 Part I of this Note explains the science behind chimera creation as it pertains to the complex definitional issues inherent in regulation.20 Part II of this Note sets forth some of the ethical and legal arguments in support of and in opposition to the regulation of chimeras.21 Part III examines the potential use of existing legal mechanisms to regulate chimeras, including patent law, the FDA, and existing laws.22 Part IV analyzes [*PG622]Canada’s AHR Act and describes the critical debate surrounding this legislation.23 Part V addresses the constitutional and legal implications of modeling legislation in the United States after the AHR Act including scientific expression under the First Amendment, the concept of personhood, and protection for chimeras under the Thirteenth Amendment.24 Finally, Part VI argues that because current mechanisms fail to regulate chimera technology, the United States should enact legislation, using Canada’s AHR Act as a model, to prohibit the use of human gametes and embryos to make chimeras.25
Regulators must understand and reference the underlying biotechnology to develop coherent and useful definitions of chimeras.26 Moreover, scientific understanding reveals how rapid advances in biotechnological techniques shape the ethical and legal discourse regarding chimera regulation.27 For example, complex biotechnology enables scientists to increase the human composition of chimeras dramatically, thus dismantling traditional concepts of species and personhood.28 As a result, biotechnological differences suggest that certain technology may contravene the public welfare and human dignity, whereas other technology generates less concern.29
Scientists have been crossing species boundaries for decades by transferring specific genes30 and other materials from one species to [*PG623]another.31 Conventional technologies include animal breeding to produce hybrids, such as mules;32 interspecies organ donation;33 and genetic recombination techniques.34 Interspecies organ donation, or xenotransplantation, emerged several decades ago as an attempt to remedy the insufficient number of human organ donors.35 Researchers hope that, in the future, specially bred animals will provide an abundant supply of organs for human recipients.36
Scientists modify donor animals using genetic engineering techniques such as genetic recombination, which involves the transfer of genes from one species to another.37 Scientists have used recombinant DNA techniques to express human proteins in lower life forms, including bacteria.38 Subsequent innovations have allowed scientists to [*PG624]engineer uniquely human susceptibilities into mammals.39 For example, by the late 1980s, scientists refined recombinant DNA technology to create mice that expressed human proteins40 and mice that contained entire human immune systems.41
Recent advances in biotechnology have expanded the potential to blend species beyond the limits of traditional transplantation and genetic recombination techniques.42 Innovations in stem cell research, embryology, and cloning enable scientists to create modern chimeras, which increasingly blur the line between human and animal.43
The narrow scientific definition of chimera is an organism that has at least two different populations of cells, which are genetically distinct and originated from different fertilized eggs.44 Scientists typically create chimeras by mixing stem cells45 (or embryos) from one [*PG625]species with early embryos of another species.46 Each type of cell retains its own character, such that the resulting chimera is a combination of mismatched parts.47 Because the DNA from each species ordinarily does not combine in this process, any offspring of the chimera will contain DNA from just one of the original species.48
An indeterminate number of people are born as natural human-human chimeras.49 These chimeric people possess two types of cells containing different sets of DNA as a result of a rare genetic anomaly that is seldom detected.50 Scientists have manipulated this process in animals to produce unnatural yet viable transgenic chimeras, beginning with a goat-sheep chimera, or “geep,” in 1984.51 Based on this success, scientists proposed injecting human stem cells into mouse embryos to test their pluripotency, or potential to develop into various types of tissues.52 The researchers hypothesized that if the cells survived and became pluripotent, they then would contribute to the formation of all of the chimera’s tissues, including germ line cells, which produce eggs and sperm.53 Developmental biologists, however, were divided on whether it was ethical to add human cells to developing animal embryos.54 Nevertheless, this theory was tested in 2004, when researchers [*PG626]produced human-pig chimeras by injecting human stem cells into developing pig embryos.55 The developing pigs contained both human and porcine cells, and surprisingly, some cells fused spontaneously to incorporate both human and pig DNA.56
Policymakers and ethicists often reference other interspecies combinations, such as hybrids, when discussing chimeras.57 Hybrids are created when an egg and a sperm from different but closely-related species join to form a single zygote.58 Although scientists create hybrids in the laboratory, they also combine material from different species into a single cell using cloning59 techniques.60 These human-nonhuman em[*PG627]bryos raise some of the same profound ethical questions as traditional chimeras.61 For example, following the first human-nonhuman nuclear transfer62 in 1998, President Bill Clinton indicated that he was “‘deeply troubled’” by the human-nonhuman nuclear transfer and asked the National Bioethics Advisory Board to investigate the research.63 In the procedure at issue, scientists at a private biotechnology company fused the nuclei of human body cells with cow eggs from which the nuclei had been removed.64 Only one of the resulting embryos, which contained 99% human DNA from the transferred human nucleus and 1% cow DNA from the egg’s mitochondria,65 developed past the sixteen-cell stage.66
In 2003, scientists in China removed the DNA from the nuclei of rabbit eggs and replaced it with DNA from human body cells.67 The scientists then allowed the embryos to develop for several days before [*PG628]they destroyed them.68 Researchers claim that these techniques may yield embryonic stem cells, from which they hope to produce cells and tissues for human transplantation.69 This research raises additional concerns, however, because if the experiments were continued, they might lead to the development of human-nonhuman beings.70
Notwithstanding concerns about the void of legal authority controlling the development of chimera technology in the United States, there is also no consensus about which, if any, chimeras should be regulated.71 The arguments for and against the regulation of chimeras involve two traditions of Western philosophy.72 The first philosophy, the deontological approach, evaluates the inherent rightness or wrongness of an action without regard to the consequences.73 The second philosophy, the utilitarian approach, weighs the benefits and harms of an action without judging its morality.74 Arguments for and against chimera regulation implicate both philosophies.75
The primary ethical objections to making human chimeras are deontological.76 Deontological arguments include, for example, emphasis on the dignity of humanity or stewardship over other beings.77 In light of the special dignity afforded to the human embryo, deontologists might advocate a ban on chimeras made using human embryos.78 Also, deontologists might object to some future uses of chimeras, which although purely speculative, indicate the type of unrestrained scientific experimentation that the government might intervene to prevent.79 For example, researchers may create future human-nonhuman chimeras for nonmedical, elective purposes such as to delay aging and to enhance human capabilities.80 These efforts to create chimeras for nontherapeutic purposes might raise deontological objections based on assertions of their intrinsic wrongness.81
Utilitarians might find that the benefits of creating human-nonhuman chimeras for medical and pharmaceutical research outweigh any harmful results.82 Human-nonhuman chimeras are increasingly valuable to pharmaceutical companies for studying the benefits of new drugs.83 Currently, FDA regulations require pharmaceutical companies to test new drugs extensively on animals before they may be tested on humans; however, drugs that produce a beneficial effect [*PG630]for animals may not produce the same effect in humans.84 The creation of human-nonhuman chimeras would make this process more efficient, because researchers could evaluate the direct effect of new drugs on the human cells of chimeras.85
Human-nonhuman chimeras also offer promise in organ transplantation.86 Humans are less likely to reject organs harvested from chimeras than from animal donors, because animal hearts and kidneys grown partly from human cells in chimeras would resemble the recipient’s organs more closely.87 Chimeras are also useful in studies of human development.88 Given that scientists have already produced human-rabbit chimeras as sources of stem cells,89 utilitarians might support adding pluripotent animal stem cells to developing human embryos to test for immunological resistance to disease.90 Similarly, utilitarians might urge the isolation of gene sequences from animals resistant to diseases such as HIV for introduction into the human genome to confer HIV resistance.91
A more radical utilitarian approach might support creating chimeras for human genetic enhancement.92 Researchers could add animal genes to the human genome to confer new traits or to delay aging; for example, increasing human night vision by adding genes from nocturnal animals or combating human telomere93 degradation by adding genes from long-living creatures.94 At the same time, the utilitarian approach necessitates acknowledging the risk that the pro[*PG631]posed experiments would introduce unpredictable and harmful animal genes into the human germ line.95
Although scientists have been creating human-nonhuman chimeras for several decades, advances in embryology and cloning have pushed this technology in new directions.96 These unprecedented developments in biotechnology have generated public debate; however, most research involving early human life is unregulated,97 aside from limitations on federal funding for stem cell research.98 For example, there are no federal laws regulating privately funded embryo research99 and no significant restrictions on human cloning or the pursuit of inheritable genetic modifications.100
Particularly in the area of intellectual property law, practitioners have urged Congress to resolve the debate over which forms of life are patentable.101 The issue arose in the 1980 decision of the United States Supreme Court in Diamond v. Chakrabarty, which established [*PG632]that a genetically engineered bacterium was a patentable invention.102 The Court stated that Congress intended for patentable subject matter to “include anything under the sun that is made by man,” but for it to exclude ideas as well as laws and processes of nature.103 Despite arguments that this holding might lead to the patenting of a “gruesome parade of horribles,” the Court indicated that Congress could make the determination of which lifeforms are not patentable.104 The current debate involves those who believe that no one should possess the exclusive rights to living organisms,105 including chimeras, and those who hope to secure patents on humans and nonhuman combinations for the generation of stem cells and tissues.106
In the years since Chakrabarty, the U.S. patent system has become a maelstrom of controversy regarding human-nonhuman chimeras.107 In 1997, cellular biologist Stuart Newman,108 with support from biotechnology activist, Jeremy Rifkin,109 filed an enterprising patent application to force the U.S. Patent and Trademark Office (the “USPTO”) to decide whether chimeras containing up to fifty percent human DNA are patentable subject matter (the “Newman patent”).110 The application provoked immediate public debate over what it means to be human and whether the USPTO should be an arbiter of morality in biotechnology.111 Rifkin and Newman’s objective was not to create the chimeras, but rather to secure the exclusive right to the technology for twenty [*PG633]years after the patent was granted, or, if the patent was denied, to reduce the economic incentive for others to develop chimeras.112 The USPTO denied the patent application in 1999;113 however, Newman and Rifkin have continued to appeal.114
Originally, the USPTO denied the Newman patent because it claimed that the invention “embrace[d] a human being.”115 When Newman and Rifkin asked the USPTO to identify the legal basis for banning their patent, the USPTO stated that the Newman patent would violate the Thirteenth Amendment, which forbids slavery and the ownership of human beings.116 The USPTO has maintained that it will not grant patents on human life nor for the processes to create human life; however, it no longer relies on the Thirteenth Amendment as its reason.117 Instead, the USPTO has revived the beneficial-utility doctrine, originally set forth by Justice Joseph Story, which was used to deny patents on gambling devices and early medical frauds.118 In denying the Newman patent, the USPTO interpreted the utility requirement to exclude inventions deemed to be “injurious to the well being, good policy, or good morals of society.”119 Accordingly, [*PG634]by declaring certain human-nonhuman chimeras unpatentable, the USPTO appears willing to set normative standards for biotechnology.120
The moral utility doctrine, as implemented by the USPTO, differs from European patent laws, which explicitly address the moral status of the human embryo in biotechnology.121 In 1998, the European Parliament and the Council of the European Union issued a directive that forbids patents on inventions that contravene the “ordre public,” or public morality.122 The Preamble to the Directive sets forth that “processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability.”123 In contrast, the role of the embryo in U.S. abortion law124 and the lack of public consensus on the moral status of the embryo125 would complicate any attempt to model chimera regulation after the European patent system.126
In addition to policy decisions by the USPTO, Congress may use its statutory authority to withhold the issue of patents for certain dan[*PG635]gerous technologies.127 For example, under the Atomic Energy Act of 1954, the Department of Defense must review all patent applications regarding atomic energy to determine whether an invention has weapon potential.128 If the invention only has defense-related potential, then the Department of Defense may assert a monopoly over the technology and may take the rights to the invention in exchange for compensation.129 Congress has not considered chimeras to be of equal danger to atomic weaponry at this time.130
Nevertheless, in 2004, Congress passed a provision of the federal budget that prohibited the USPTO from issuing patents on human organisms.131 The provision codifies the USPTO’s current position against granting patents for genetically engineered human beings, fetuses, and embryos.132 The provision, however, will not affect the patenting and marketing of DNA sequences, cell lines, stem cells, tissues, and other biological products of human origin.133 In addition, the provision does not prevent scientists from seeking patents for processes to create biological products.134
[*PG636] As a result, this provisionary ban allows the USPTO to continue to address new or borderline issues, including chimeras.135 The USPTO already grants patents on animals that have been modified to include a few human genes for the production of a human protein or antibody; however, it remains unclear under the provision which chimeras are so humanlike that they cannot be patented, such as the human-chimpanzee chimera described in the Newman patent application.136 The USPTO Director stated that the provision gives “unequivocal congressional backing” for the USPTO’s refusal “to grant any patent containing a claim that encompasses any member of the species Homo sapiens at any stage of development,” which suggests that chimeras created from human embryos may not qualify for patent protection.137 Nevertheless, in denying the Newman patent, the USPTO did not explain its determination that chimeras containing less than fifty percent human DNA encompass a human being and therefore are unpatentable.138 Hence, the interpretive question remains: How many human gene sequences are needed for the USPTO to decide that a chimera is human?139
Current administrative regulations, as applied to animal and human subject research, provide a starting point to determine whether biotechnology regulation in the United States may be expanded adequately to encompass chimeras.140 Multiple federal agencies regulate the experimental and commercial uses of genetically modified animals.141 In 1986, the Coordinated Framework for Regulation of Biotechnology (the “Framework”) formalized this decentralized approach.142 The agencies listed in the Framework are governed by almost a dozen federal statutes, regulations, and guidelines.143 No single agency, however, provides for the comprehensive regulation of genetically modified or[*PG638]ganisms, and none of the agencies address modern chimera technology directly.144
Under the Framework, the FDA, the Environmental Protection Agency, and the U.S. Department of Agriculture regulate the research, development, and approval of biotechnology products.145 The Framework regulates these products according to their composition and proposed uses, rather than by their method of production.146 As a result, cutting-edge biotechnology is subject to the same fragmented laws and policies that govern conventional products.147
The FDA has claimed authority over various forms of assisted reproductive technology,148 although it has not added human-nonhuman chimeras specifically to its jurisdiction.149 The FDA’s legal mandate, as conferred by Congress under the Commerce Clause,150 authorizes it to regulate the distribution of products linked to interstate commerce.151 Although this mandate technically does not cover the direct regulation of biotechnology, the FDA may regulate a broad range of activities surrounding the distribution of biotechnology products.152
The Federal Food, Drug, and Cosmetic Act of 1938 (the “FFDC Act”) and the Public Health Services Act (the “PHS Act”) set forth the FDA’s regulatory authority.153 As an administrative agency, the FDA may interpret these enabling statutes to accommodate circumstances that Congress could not have predicted when originally drafting the statutes.154 In general, by working within its charters, an agency has [*PG639]latitude to adapt to new challenges without requiring congressional authority or instruction for each situation.155 As a consequence, an agency may respond to new technology without risking that additional legislation will disrupt existing policies.156 Congress’s deference to agencies, however, makes it difficult to predict which modernizing efforts a reviewing court will permit and which it will nullify.157
The FDA’s jurisdiction includes one quarter of all consumer products and encompasses modern biotechnologies, such as tissue transplants, stem cell research, and human cloning.158 Despite the limited expertise of FDA regulators in dealing with these emerging areas of technology, the FDA has not sought congressional assistance for an expansion of its statutory jurisdiction or for stronger administrative tools.159
The FFDC and PHS Acts provide three possible mechanisms for the FDA to assert jurisdiction over human-nonhuman chimeras and other forms of emerging biotechnology.160 Chimeras may be “biological products” pursuant to the PHS Act.161 Alternatively, chimeras may be “drugs,”162 or the procedures used to create chimeras may be medical “devices” under the FFDC Act.163 If the FDA has jurisdiction under these statutes and their implementing regulations, then it must approve an investigative new drug application before research may proceed.164 Unauthorized research may be subject to criminal or civil sanctions.165
Despite its broad discretion to interpret its charter, the FDA was reluctant to extend its jurisdiction to human tissues.166 Although in the 1970s the FDA declared jurisdiction over porcine heart valves used in xenotransplantation as biological materials, the FDA did not extend its jurisdiction to human heart valves until many years later.167 The FDA acknowledged that tissues could be regulated as drugs, medical devices, or biotechnology products; however, it did not commence regulation of human tissues until concerns about the transmission of infectious diseases, such as HIV, from donors to transplant recipients compelled it to assert its regulatory authority.168
The FDA was less hesitant to declare its jurisdiction over human cloning, which it claimed through a series of informal expressions made over several years, beginning with a remark in 1999 regarding cloning as a form of gene therapy.169 Cloning, the FDA asserted, fell under its biologics regulations, which primarily involve human gene therapy and the medical manipulation and reinsertion of human cells.170 The FDA suggested that it would regulate cloning for reproductive purposes but not necessarily cloning for biomedical research.171 The FDA further stated that cloning to produce children [*PG641]would require filing an investigational new drug application,172 but it was not prepared to grant such applications for cloning.173
In addition to regulation through patent law and agency oversight, governments traditionally regulate reproductive biotechnology using six general frameworks.174 None of these regulatory mechanisms explicitly addresses chimeras; they serve as starting points for the regulation of novel biotechnology, however.175 The first framework avoids broad legislation in favor of case by case judicial precedent, as exemplified by legal decisions regarding the disposition of frozen embryos.176 This form of regulation, which often incorporates oversight by institutional review boards, is not comprehensive and varies by region.177 Presently, the only case law applicable to chimeras pertains to the USPTO’s denial of patents on human life.178
The second framework involves specific legislation for isolated issues, such as legislation to prohibit or restrict a particular technology.179 The third scheme involves broader legislation directed at assisted reproductive technology and typically encompasses the treatment of embryos in research.180 Canada’s AHR Act is an example of broad assisted reproductive technology legislation that also encompasses chimeras.181 The fourth regulatory scheme involves human sub[*PG642]ject research legislation, which includes the use of embryos, fetal tissue, and human beings.182 This framework includes institutional review boards and a group of regulatory statutes for research on human subjects, known as the Common Rule.183 The fifth scheme involves the formation of an advisory panel or commission which typically develops a regulatory scheme.184 The AHR Act provides for such an advisory panel in regard to stem cell technology.185 Finally, the most common regulatory framework currently being applied to biotechnology is a combination of schemes.186
Like Canada, the President’s Council on Bioethics (the “President’s Council”) incorporated chimeras into its discussions of assisted reproductive technologies in the United States.187 Beginning in 2002, the President’s Council devoted considerable resources to examining the governance of biotechnologies that “touch the beginnings of human life.”188 Suggesting the need to overhaul existing regulatory institutions and create new regulatory authorities, the President’s Council admitted that it was far from able to offer clear recommendations regarding major institutional reforms.189
In 2003, the President’s Council examined assisted human reproduction and explored whether legislation could be tailored to include new technology such as chimeras.190 The only federal law cur[*PG643]rently in place to regulate assisted human reproduction is the Fertility Clinic Success Rate and Certification Act of 1992, which does not encompass chimeras directly.191 The President’s Council recognized the need to “flesh out what these [terms] mean . . . and [the] disagreement about chimera.”192 The President’s Council’s commitment to formulating clear definitions of chimeras reflects the debate over the definitions contained in Canada’s AHR Act, which is discussed further in Part IV.193
In its deliberations, the President’s Council discussed the need to respect the humanity of procreation by preserving a reasonable boundary between humans and nonhumans during the early stages of life.194 Because no public institutions are responsible for setting appropriate limits for these rapidly advancing technologies, the President’s Council urged Congress to adopt targeted restrictions on several well-defined activities.195 The Council recommended collecting these measures in a “Reproduction and Responsibility Act,” which would acknowledge the need for a moratorium on certain practices until the public [*PG644]and legislators have had an opportunity to debate the appropriate governance of these technologies.196
In 2004, following its review and analysis, the President’s Council concluded that the creation of human-nonhuman chimeras raises unique challenges to the character of human procreation.197 The President’s Council distinguished various contexts in which scientists create chimeras, opining that there is nothing inherently objectionable about mixing human and animal tissues.198 In the context of therapy and preventative medicine, the President’s Council endorsed xenotransplantation, animal-derived pharmaceuticals, and the insertion of animal genes into humans or human fetuses to prevent disease.199
In the context of procreation, the President’s Council recommended two prohibitive rules to establish boundaries where it deemed the ethical concerns most acute and the need for bright-line rules most reasonable.200 First, it recommended that Congress “[p]rohibit the production of a hybrid human-animal embryo by fertilization of human egg by animal sperm or of animal egg by human sperm.”201 The President’s Council explained that it did not want to judge the humanity or moral worth of a hybrid entity, and it did not want this ambiguously human life to have nonhuman ancestors.202 Second, the President’s Council recommended that Congress “[p]roscribe the transfer, for any purpose, of any human embryo into the body of any member of a non-human species,” explaining that humans should be placed only in human wombs.203
The President’s Council initially discussed three provisions;204 however, it omitted a recommendation prohibiting the combination of human and nonhuman embryos.205 Some members suggested that this prohibition was premature because the President’s Council had not [*PG645]considered sufficiently the potential scientific benefits of embryonic chimeras.206
In 2002, the President’s Council examined Canada’s efforts to regulate reproductive technologies.207 Canada’s AHR Act reflects a decade-long effort to address the moral and ethical issues surrounding assisted reproductive technology, while promoting scientific and medical research.208 To satisfy the dual goals of resolving ethical concerns and developing useful science, the AHR Act covers activities that are completely prohibited209 and those that are subject to regulatory control.210 The creation of various forms of chimeras and hybrids is prohibited under the AHR Act.211
The communitarian Canadian approach to assisted reproductive technology is unlike the rights-based approach to biotechnology in the United States.212 Differences between the two ideological frameworks originate from the United States’ heritage of rugged individualism and regulatory suspicion, in contrast with Canada’s historical and geographic reliance on ordered control and governmental guidance.213
These historical differences influence the Canadian and United States’ approaches to the regulation of novel biotechnology.214 For [*PG646]example, Canada has developed a stronger concept of public interest than the United States.215 As a result, Canadian society is more accepting than the United States of a broad and active role for the government in promoting its public interest.216 Consequently, the assumption that the government should change social conditions for the better has characterized policies regulating reproductive technology in Canada.217 The United States, in contrast, has been less receptive to governmental interference in science and the marketplace, which has led to an absence of biotechnology regulation.218
The legislative history of the AHR Act explains its emphasis on the regulation of chimeras created from human embryological materials and its exclusion of other types of chimeras.219 Bill C-6 originated from guidelines issued in March 2002 by the Canadian Institutes of Health Research (the “CIHR”), Canada’s main federal funding agency for health research.220 The CIHR guidelines addressed cloning and human embryo experimentation as well as the creation of embryological chimeras.221
Subsequent to the passage of the CIHR guidelines, the Canadian Parliament released the AHR Act to regulate various forms of fertility [*PG647]treatment.222 Although the AHR Act was designed to regulate in vitro manipulation of human embryos, it also encompassed some of the embryo and stem cell research guidelines propounded by the CIHR.223 Notably, the AHR Act established a licensing system for embryo experimentation,224 an area of research that continues to be heavily debated in the United States.225 Under the AHR Act, the CIHR will grant licenses to researchers allowing them to utilize in vitro embryos, if the CIHR is convinced that the research could not be completed using stem cells or cells from other sources.226 These controversial licensing and research provisions require that Canada form an oversight committee to provide a national ethics review of all stem cell research.227
According to the legislation’s objective to regulate assisted human reproduction,228 the AHR Act addresses only embryonic combinations of both chimeras229 and hybrids.230 Section 5(1)(i) of the AHR [*PG648]Act prohibits creating chimeras or transplanting chimeras into either human beings or nonhuman life forms.231 Section 5(1)(j) prohibits creating hybrids for the purpose of reproduction or transplanting a hybrid into either a human being or a nonhuman life form.232 Sections 5(2) and 5(3) prohibit anyone from offering or advertising the performance of any of the prohibited activities, or paying, or offering to pay, someone else to do so.233
The AHR Act generated considerable controversy in Canada, because the government provided few formal documents or statements to justify the statutory ban.234 Furthermore, the AHR Act generated confusion over the scope and purpose of the definitions of chimera and hybrid.235 The AHR Act takes a broad position in regard to human-nonhuman hybrids, prohibiting both traditional hybrid combinations of eggs and sperm as well as transgenic organisms created using nuclear transfer techniques.236 Additionally, the definition of hybrid contains a catch-all provision to encompass variations of hybrids not presently contemplated.237 The prohibition, however, applies only to hybrids created for reproductive purposes.238 Presumably, scientists may create hybrids for research or any other purposes.239
In contrast, the AHR Act adopts a narrow position on the prohibition of human-nonhuman chimeras, describing only two possibilities: (1) the insertion of nonhuman cells into human embryos, and [*PG649](2) the insertion of cells from another human (at any stage of development including other embryos)240 into human embryos.241 Notably, the AHR Act does not encompass the transfer of human stem cells into nonhuman embryos in its definition of chimera.242 In addition, the AHR Act does not address the movement of tissues or organs between humans and animals.243 Although the Canadian government did not offer detailed explanations for its chosen definitions, the narrow definition of chimera likely resulted from the limited objective of the legislation: to regulate human reproductive technology.244
Critics of the AHR Act find its criminal sanctions, which carry maximum penalties of $500,000 or ten years in prison, to be unduly harsh.245 The original CIHR guidelines never inflicted financial penalties on researchers for noncompliance, but instead simply withheld research funding.246 Moreover, critics claim that researchers should not face large fines and jail terms in their efforts to further scientific knowledge.247 Conversely, supporters of the AHR Act argue that sanctions would encourage researchers to act ethically and carefully when engaging in stem cell research and related experiments.248
A legislative prohibition on biotechnology similar to Canada’s AHR Act might raise constitutional issues in the United States.249 For [*PG650]example, prohibiting the creation of certain human-nonhuman chimeras might implicate the First Amendment and the Thirteenth Amendment.250 Nevertheless, given the rapid progression of biotechnology, legislation would permit public deliberation about the role of scientific research, the concept of personhood, the moral status of the embryo, and the future of human-nonhuman chimeras.251
Opponents to the regulation of chimeras may assert that there is a First Amendment free speech right and a Fourteenth Amendment right to engage in scientific inquiry.252 In 1923, the U.S. Supreme Court stated in dicta in Meyers v. Nebraska that the Fourteenth Amendment grants the right “to acquire useful knowledge.”253 Nevertheless, courts subsequently have not found a deeply rooted constitutional interest in scientific inquiry.254
Scientific research, however, is a foundation for the exchange of ideas, and might be entitled to the same constitutional protection as the distribution of scientific information.255 Although disseminating scientific information is inherently communicative, scientists would need to show that scientific research is likewise expressive as symbolic conduct.256 The First Amendment protects expressive conduct if the [*PG651]conduct is intended to convey a particularized message, and if it is likely that those who view the message will understand it.257
Chimera creation, in particular, may straddle the line between scientific inquiry and artistic expression.258 For example, images of mice with artificial human ears growing on their backs have been described as “the most symbolically-charged recent depictions of biomedical experimentation and its challenge to the category ‘human.’”259 In addition, artists have recognized the potential for creative expression through transgenics.260 For example, one artist produced a green-fluorescent-protein rabbit with DNA derived from a jellyfish.261 The artist has announced his plans to produce a glowing dog by the same technique and, likewise, to create human-nonhuman chimeras as potential art.262 The artist explained that his work is defined not only by the scientific creations themselves, but also by their roles in society.263 Given the expressive aspects of creating chimeras, courts may be forced to make decisions about emerging biotechnology on the basis of the First Amendment.264
Despite arguments that species are constantly changing and that human beings have been crossing species lines for years in agriculture and selective breeding, critics assert that scientists should not create chimeras because biotechnology should not disrupt individual species.265 Regardless of whether the concept of species is simply a biological construct,266 animals often suffer for the advancement of science.267 Researchers will continue to employ genetic engineering and other biotechnology techniques on animals to study human disease, to develop pharmaceuticals, and to improve food and organ sources.268 Notwithstanding these beneficial opportunities, some animal rights organizations continue to oppose biotechnology developments, including the patenting of life forms.269
The exploitation of human-nonhuman chimeras raises unique concerns, because unlike other animal research subjects, these chimeras are partially human.270 Human beings are no longer defined solely by genetic composition.271 The Human Genome Project, which sequenced the DNA of a small number of individuals, revealed the genetic similarity of human beings to one another and to other species.272 Consequently, the ethical debate regarding how to regulate chimera requires characterizing personhood.273
Legal and regulatory issues in modern biotechnology often depend on determining the “moral status”274 of the embryo.275 The embryo in utero is not a “person” under the Fourteenth Amendment according to the 1973 U.S. Supreme Court decision in Roe v. Wade; however, that decision may not bear on the status of a living human embryo ex utero, where there is no imperative to consider fetal and maternal rights together.276 Courts have held that living human embryos occupy an interim position between person and property that entitles them to “special respect” because of their potential to become human life.277
In regard to human cloning, President George W. Bush has declared his support for legislative proposals to ban all human cloning.278 Congress, however, has not been able to reach a consensus.279 The debate involves the process of nuclear transfer, which may be [*PG654]used to create cloned human embryos as well as human-nonhuman embryos.280 Opponents of a complete ban on human cloning generally approve of using nuclear transfer to create embryos, provided the embryos are not used for reproductive purposes.281 Those in favor of a ban on human cloning generally believe that a partial ban, prohibiting only cloning to produce children, would be impossible to enforce; therefore, pragmatic and ethical concerns require a complete ban on human cloning.282
Embryos, unlike chimeras, are entirely human, yet the United States has not prohibited their manufacture or destruction in human cloning and embryo research.283 Therefore, until legislators reach a consensus on the moral status of the living human embryo, which contains the potential to become a human being and from which all human beings develop, any attempt to define and regulate human-nonhuman chimeras will remain complicated.284
In the absence of legislation or as a result of renegade science, human-nonhuman chimeras may be inevitable.285 In response, the courts and legislatures will need to decide the status of transgenic creatures and determine how to classify them on a scale between person and property.286 The classification of chimeras as human would restrict their legal use in scientific research.287 In fact, the prospective treatment of human-nonhuman chimeras may resemble the history of racial classification in the United States.288 Indeed, if chimeras are human, then committing them to scientific experimentation [*PG655]would be a form of servitude in violation of the Thirteenth Amendment289 and also would violate their First Amendment right of freedom of association.290
The question remains whether chimeras would be treated as animals even if they consist almost entirely of human DNA.291 The constitutional difficulties arise not only in patent law, but in terms of what types of research would infringe on personhood.292 Due to the imprecise definition of human being supplied by the courts, legislators, and agencies, the rights afforded to human-nonhuman chimeras will depend on a determination of their humanity.293 These questions are admittedly esoteric,294 but the law must consider now the legal ramifications of the creation of new “species” of chimera.295
To prevent the unrestricted development of human-animal chimeras, the United States should pass legislation similar to Canada’s AHR Act.296 Existing institutions are not equipped to regulate this emerging biotechnology.297 By enacting clearly defined legislation, Congress may address the legal and ethical complexities presented by human-nonhuman chimeras, while continuing to promote medical and scientific advances.298
The President’s Council suggested that existing institutions cannot regulate sufficiently the creation of various types of human-[*PG656]nonhuman chimeras.299 Patent law, agency regulation by the FDA, and other regulatory mechanisms are not equipped to deal adequately with human-nonhuman chimera technology.300
In the area of patent law, Congress recently affirmed the USPTO’s authority to deny patents pertaining to human life; however, it remains unclear whether the USPTO will deny patents on certain human-nonhuman chimeras.301 Patent law cannot completely regulate biotechnology because scientists may decide to pursue certain technologies regardless of whether the products or processes are patentable.302 Also, patent protection is limited to twenty years, after which technology enters the public domain.303 Furthermore, patent law should be morally neutral, because it was designed to reward inventors of desirable inventions rather than to regulate or prohibit undesirable technology.304 Therefore, the USPTO may lack authority and resources to limit patents on technology to develop human-nonhuman chimeras.305
Nevertheless, there is an underlying concern about the commodification of human life306 in biotechnology patents in the United States.307 Patent law could be used to declare some biotechnology to be unpatentable subject matter because these technologies pose significant risks to human dignity.308 Some threats to human dignity have benefits to technology, science, and medicine that outweigh any [*PG657]harms.309 In these instances, such patents should be permitted if careful attention is paid to the laws and policies that apply to the practices involved, with a goal of minimizing threats to human dignity.310
Then again, a policy of allowing patents with the goal of minimizing threats to human dignity should not apply to close cases involving human-nonhuman chimeras.311 For example, it is difficult to distinguish a human embryo from a human embryo with a few animal genes.312 In this case, by asserting a compelling interest in protecting human dignity, the government may eliminate the need to decide whether these chimeras are human because they are close enough to raise concerns.313 This analysis still poses the difficult question of deciding when a chimera is “humanlike” enough to be unpatentable, but this is less difficult than deciding whether a chimera is “human” at all.314 In comparison, the moral utility test in patent law is not particularly useful in a patent application for human-nonhuman chimeras, because the utilitarian arguments would inevitably outweigh the deontological arguments in the patent forum.315 Therefore, the debate over the patentability of chimeras will continue in the USPTO until either Congress or the U.S. Supreme Court intervenes to set clear boundaries on the patentability of humanlike life forms.316
The USPTO’s refusal to issue patents for chimeras that are less than fifty percent human does not eliminate the ability of researchers to pursue this controversial technology.317 Therefore, legislators should intervene with regulations to prohibit certain human-nonhuman chimeras in order to protect and promote the public interest.318 Any effort by the FDA to declare jurisdiction over chimeras would route this technology into a regulatory system without the benefit of a public debate [*PG658]in Congress.319 Furthermore, it is likely that those planning to produce human-nonhuman chimeras would support FDA jurisdiction as a less restrictive alternative to legislation, because FDA oversight might not foreclose controversial chimera research regardless of public opposition.320 Consequently, FDA jurisdiction would absolve Congress of its role in resolving the unprecedented ethical issues raised by chimeras.321
An additional limitation to FDA jurisdiction is the FFDC Act’s requirement that information about the process of product design and the results of clinical trials must remain confidential during the approval process.322 This process, which takes place in secrecy, does not permit a public discussion about the safety and significance of the relevant biotechnology.323 Moreover, FDA jurisdiction inhibits the creative resolution of broad public questions involving ethics and human values.324 Therefore, although the FDA has not stated explicitly whether the creation of chimeras falls within its jurisdiction, the FDA should not assert its regulatory authority over chimera technology.325
Notwithstanding these disadvantages, if chimera technology may be classified as a drug, medical device, or biological product, then the FDA legally could assert its regulatory authority over the research and development of chimeras.326 Already, the FDA has declared its jurisdiction over xenotransplantation, primarily under its biologics authority.327 In 2003, the FDA issued comprehensive guidelines for the transfer of [*PG659]cells, tissues, and organs from nonhuman organisms, or from living nonhuman biological materials, into humans.328 Although the FDA recognized the benefits of this technology for transplant recipients, it expressed concern about the spread of infectious disease and the formation of new viruses in the general human population.329 The potential for disease transmission or genetic abnormalities could prompt the FDA to regulate human-nonhuman chimeras similarly to its regulation of porcine heart valves or human heart valves used in transplantation.330
It is unlikely, however, that Congress intended for the FDA to have jurisdiction over chimera creation, because this might exceed the FDA’s authority under its enabling statutes.331 In light of FDA v. Brown & Williamson Tobacco Corp., in which the U.S. Supreme Court, in 2000, rejected the FDA’s interpretation of its enabling statute to encompass tobacco, other courts may take a similar stance on the FDA’s assertion of jurisdiction over human embryos and biotechnology.332
Nevertheless, the FDA maintains that existing laws provide both jurisdiction and sufficient means of control over certain biotechnologies.333 The courts, in accord, have not voided any FDA initiatives in biotechnology.334 Given the tendency of courts to yield to FDA control in biotechnology, judicial decisions may not provide an accurate measure of whether the FDA has exceeded its regulatory reach or failed to extend its reach far enough.335 More specifically, the judiciary may not evaluate whether the FDA moved too hesitantly toward emerging technologies and whether the impact of the FDA’s regulations lagged behind developing technology.336 Therefore, even if the FDA or another regulatory body had the authority to regulate chimeras, legislation would still be appropriate.337
Unlike regulation by federal agencies, patent law, and federal funding, legislation directly regulating the creation of human-nonhuman chimeras would apply to all research in the private and public sectors.338 Research would be governed by one set of rules rather than by separate standards for federal or private funding.339 This would eliminate any encouragement to move research to the private sector.340
In adopting legislation similar to Canada’s AHR Act, the United States must resolve complex definitional issues that have led to criticism of the AHR Act.341 Congress must determine which chimeras to prohibit and then frame the terminology to include only the chimeras being targeted.342 Legislation modeled after the AHR Act should refine the Act’s comprehensive definition of hybrid and develop a more inclusive definition of chimera that incorporates all chimeras made using human embryos.343 Interspecies organisms that do not fall within the statutory language should be evaluated using several factors, including, but not limited to (1) the types of biological materials combined, (2) the relationship between the combined organisms, (3) whether the combination occurs naturally or through human intervention, and (4) at which point in development the combination occurs.344 This evaluation could be accomplished by a new regulatory body.345
Despite ethical concerns about designing new creatures solely for human exploitation, animal-animal chimeras may be excluded from a reasonable legislative definition of chimeras.346 The President’s Council discussed the creation of animal-animal chimeras in detail, but these chimeras pose no significant ethical issues because they contain no human components and do not impinge on the concept of personhood.347 Consequently, any regulatory definition of chimera including animal-animal chimeras would be accurate scientifically but would be overinclusive if the focus of legislation is biotechnology involving nascent human life.348
In contrast to animal-animal, the scientific community has shunned the creation of human-human chimeras in the laboratory.349 For example, researchers criticized a 2003 experiment that combined male and female human embryos into a single hermaphroditic human-human chimera.350 These artificial chimeras raise moral concerns because of their minimal utility, their unnaturalness, and their adverse effect on human dignity.351 Both the AHR Act and the President’s Council’s interim recommendations contain provisions banning the creation of some human-human embryos.352 Therefore, [*PG662]chimera regulation should prohibit explicitly the creation of all human-human chimeras at the embryonic level.353
The AHR Act also prohibits the transfer of nonhuman cells to human embryos to form chimeras.354 These nonhuman-human combinations raise strong ethical considerations because they utilize developing human embryos.355 Although the President’s Council decided not to recommend a ban on the combination of human and nonhuman embryos, Congress nevertheless should prohibit the creation of these nonhuman-human chimeras.356 This is because they violate human dignity and the doctrine of special respect for human embryos and they could lead to the development of new humanlike species for scientific exploitation.357
The AHR Act does not address non-embryonic transfers from nonhumans to humans; however, these transfers should be considered by a regulatory body that can balance the various factors.358 Although many of these transfers are widely accepted, some pose unique ethical concerns.359 In the area of xenotransplantation, the placing of pig heart valves in human beings caused some initial concern among recipients; however, this transplant procedure is now regulated and accepted.360 The public is not likely to object to the development of other single organ transplants from animals into human beings.361 Yet, if a human were to receive many organs from a nonhuman, or if it were possible to transfer a single vital organ from a [*PG663]similar species (such as a primate brain) into a human, then concern might arise as to whether the resulting organism was really human.362 Thus, chimeras made by moving nonhuman parts into human beings raise concerns when the transfer is significant enough to cast doubts on the humanity of the recipient.363 The AHR Act, by definition, does not cover this mode of chimera creation; nevertheless, the United States should consider creating a new regulatory body to evaluate these transfers.364
Neither the AHR Act nor the recommendations of the President’s Council prohibit the transfer of human stem cells to nonhuman embryos.365 Generally, medical and scientific uses of chimeras are less objectionable than the creation of chimeras for art or curiosity;366 however, any transfer of human embryonic cells to developing nonhumans presents the same ethical concerns as nonhuman-to-human chimeras and should be restricted.367
On a non-embryonic level, the public generally accepts scientific and medical practices involving the transfer of human material to animals, such as in the creation of transgenic mice.368 A research proposal to create a mouse with human neurons in its brain received publicity, but did not generate much disapproval.369 A research proposal transferring human brain tissue into a primate, however, would cause more serious ethical concerns because of the similarities between the two species.370 Thus, chimeras made by moving human parts into nonhuman beings raise concerns when the transfer is significant enough to cast doubts on the humanity of the recipient.371 This research should also be reviewed by a new regulatory body.372
The United States should adopt Canada’s approach to regulating chimera technology, particularly because the strong consideration of individual rights in the United States would mitigate any rigidity in the Canadian collectivist view.373 Any legislative attempt to regulate chimera technology, however, must articulate recognition of the opposing views on this issue.374 In Canada, the government’s insufficient justification for the AHR Act disappointed even its supporters.375 Therefore, the United States should acknowledge the mechanical differences between various chimeras and the unique ethical issues they pose in framing legislation.376
In adopting legislation similar to the AHR Act, policymakers must decide whether to create an administrative body for oversight of chimera technology and whether to utilize criminal law to limit potentially harmful technology.377 Proposed bills to ban human cloning have included criminal sanctions; therefore, the criminalization of scientific activity is not without precedent.378 The inadequacy of the patchwork regulations under the Consolidated Framework strongly suggests the need for a single overseeing body to address novel biotechnology.379 Ultimately, the success of legislation to regulate chimera technology will depend on effective enforcement through criminal sanctions, a regulatory agency, or both.380
The regulation of the creation of human-nonhuman embryonic chimeras would not violate the First Amendment, because biotech[*PG665]nology regulation does not hamper freedom of speech or religion, as there is no fundamental right to scientific inquiry.381 Accordingly, general viewpoint-neutral regulation of expression in biotechnology is permissible under rational basis review.382
To the extent chimera creation is expressive conduct and regulation is not viewpoint neutral, regulation must satisfy strict scrutiny if it is not narrowly tailored.383 In this regard, a law prohibiting the creation of chimeras would have to serve a compelling state interest and must not suppress free expression;384 however, to the extent that chimera research is expressive, it may be commercial speech, subject to intermediate scrutiny.385 Although the U.S. Supreme Court has held that scientific investigations are not generally commercial, recent efforts to showcase transgenic art suggest commercial, non-scientific reasons to create chimeras.386
With rapid developments in biotechnology blurring the lines between species and calling into question what it means to be a human person, human-nonhuman chimeras are no longer products of science fiction. Congress has been unable to reach a consensus on the regulation of biotechnology involving completely human subjects, such as human cloning and embryo research. As a result, scientists continue to create chimeras with increasing quantities of human tissues and genetic materials without limitation. The debate has found an audience in the patent system, but resolution of complex moral and scientific issues is better left to a public forum. Furthermore, chimera regulation cannot be accomplished effectively through existing legislation or regulatory agencies such as the FDA.
Consequently, the United States should consider legislation to regulate the production of certain types of chimeras, particularly human-nonhuman embryonic chimeras. Legislation would not raise any [*PG666]insurmountable constitutional issues with regard to scientific expression and would avoid the constitutional issues that will arise if scientists develop new species of humanlike chimeras. The United States should follow Canada’s approach in preparing legislation to regulate chimera production. In adopting legislation modeled after Canada’s AHR Act, the United States should reexamine its individualist approach to biotechnology and consider the critical definitional and ethical issues in regulating chimeras. Unregulated biotechnology, like the Chimera of Lycia, threatens to disrupt legal and social institutions; therefore, the United States must make a balanced effort now to protect the public interest.