Abstract
Genetically engineered (GE) animals that are meant for release in the wild could significantly impact ecosystems given the interwoven or entangled existence of species. Therefore, among other things, it is all too important that regulatory agencies conduct entity appropriate, rigorous risk assessments that can be used for informed decision-making at the local, national and global levels about the release of those animals in the wild. In the United States (US), certain GE animals that are intended for release in the wild may be regulated as new animal drugs by the Food and Drug Administration. This paper argues that the decision to treat them as new animal drugs is attributable to the influence of neoliberalism on the US biotechnology regulatory policy framework. The case is made that there should be public democratic deliberations and decision-making about the values and concerns that should guide the nation’s biotechnology regulatory policy paradigm, including the risk assessment process for GE animals meant for release in the wild.
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Notes
The term ‘genetically engineered’ (GE) is used to denote organisms that have been manipulated in the laboratory by modern biotechnology methods such as recombinant DNA technology and gene editing.
The FDA regulates food, drugs and cosmetics by virtue of the authority vested in it by Congress. The agency’s regulatory function is essentially protective in the sense that it is responsible for protecting public health. For instance, it has a duty to ascertain that foods (except those regulated by the U.S. Department of Agriculture) “are safe, wholesome, sanitary and properly labeled” (US FDA 2017b). Among other things, it is also required to ensure “that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective” (US FDA 2017b).
This paper does not engage with the issue of the regulation of GE insects as NADs, but the arguments presented in it may have relevance for those cases. In October 2017, the FDA issued Guidance #236 that GE mosquitos meant to control the population of mosquitos would be regulated by the Environmental Protection Agency (EPA) as a pesticide. The FDA also stated that it would continue to regulate “mosquito related products” as a drug that are meant to “cure, mitigate, treat or prevent a disease (including [those intended] … to reduce the level, replication or transmissibility of a pathogen in mosquitoes)” (US FDA 2017a).
In January 2017, the FDA issued a revised Guidance #187. It is meant to apply to animals with intentionally altered genomic DNA developed by means of genome editing technologies, as well as techniques such as rDNA in genetic engineering. The former category of technologies included “the use of ‘nucleases’ or ‘genome editing technologies’ including engineered nuclease/nucleotide complexes such as zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs), and the clustered regulatory interspersed short palindromic repeats (CRISPR) associated systems. These nucleases are intended to introduce alterations at specific sites in the genome, rather than the more random changes associated with rDNA technology. The process of producing these targeted DNA sequence alterations is often referred to as ‘genome editing’” (US FDA 2017c, p. 4).
Aldrich has made the point that since GE animals cannot be separated from their “underlying genetic material” (2015, p. 313) regulatory agencies should receive authorization to regulate the GE animal as that would clarify the regulatory process.
See section titled, “A. Adequacy and…”.
Ibid.
In common parlance, ‘drug’ also refers to chemicals that are designated illegal substances.
Guidance documents are meant to provide the industries whose products the agency regulates with its current thinking about various issues. Some guidance documents describe the agency’s interpretation of policy, including the design, production, labeling, promotion, manufacturing, and testing of regulated articles. Guidance documents may also address the inspection and enforcement policies (US FDA 2016b). Guidance documents are legally non-binding for the agency and the party to whose products they are applicable. (See Noah (1997) for a history of the changes in the legal status of guidance documents.).
At a 2010 FDA meeting about the AquaBounty GE salmon, the Regulatory Counsel to FDA Office of Chief Counsel, L. Epstein, provided an account of the process by which the agency arrived at the decision to construe the rDNA construct introduced in the fish as a drug (it should be clear that the agency staff is under a mandate to "fit" new "biotechnologies" into pre-existing categories) (also see Mandel (2017) about this problem):
Well, why is this construct (i.e., the rDNA construct introduced into the salmon) a drug? It doesn’t seem to make intuitive sense, but in fact, the definition of a drug in the Federal Food, Drug and Cosmetic Act includes - it is sort of a long definition, so I won’t read the whole thing, but the relevant part is that it includes an ‘article intended to affect the structure or any function of the body of animals.’ And we have just learned that that is exactly what the rDNA construct in that animal is intended to do; it is intended to impart new traits. So, therefore, that rDNA construct meets the definition of a drug and is subject to FDA regulation under the drug laws and rules (US FDA 2010, pp. 36–37).
Rose, an anthropologist and ethologist, borrowed this concept of species from the worldview of the Australian Aboriginal people in the Victoria River area of the Northern Territory of Australia. That worldview is a radically different one than the neoliberal one that conceptualizes non-human species and even many groups of humans as mere means.
The notion of “interspecies association” is borrowed from Tsing’s work (2012, p. 143).
See, for instance, Odling-Smee et al. (2003).
Even the submission of an application for a new drug to the FDA is considered confidential business information.
In part three, it is argued that the agency has asserted regulatory authority over GE animals because of the US biotechnology regulatory policy framework.
Cosmetics fall within the purview of the agency too.
This analysis mirrors the argument constructed by Mandel and Marchant (2014) about the statutory warrant for the EPA’s attempt to regulate living microorganisms and the justified legal challenges to the agency’s regulatory authority (see below).
As drugs require regulatory approval prior to market introduction, sponsors must fulfill the FDA’s premarket approval conditions and consider possible environmental significance (as required by NEPA) as part of their application to the FDA (OSTP 2017, p. 18) (more on this later). The exception would be if the sponsor claims a categorical exemption for investigational new drug.
In general, the FDA’s attempts to satisfy its NEPA obligations leave much to be desired. For instance, the agency’s guidance recommends that sponsors of new drugs evaluate their accumulation in the environment, but it does not require that they collect data about the possible complex interactions between the new drug and other drugs that have accumulated in the environment (see US FDA 2000, 2004). Needless, to say, the significant accumulation of various kinds of medications in water ways from overuse in humans for medical purposes and in livestock for growth promotion is a substantial environmental issue, which the FDA does not address as it attempts to discharge its NEPA obligations.
In the case of a GE salmon and a GE mosquito, the agency chose to ask the sponsors of the GE animals to prepare an environmental assessment report.
In the case of the AquaBounty salmon, the company consulted with the agency over a period of more than 10 years.
Presumably, it is acting under a Congressional mandate to conduct science-based risk evaluations.
It is also unclear if the environmental assessment will necessarily draw on the knowledge of informal epistemic communities comprising of local laypersons who by virtue of their proximity to the designated area of release have firsthand, long term knowledge of that ecosystem that is different from scientific knowledge or a bureacratic understanding of it (see, for instance, Wynne 1989). Also, environmental risks would be better evalauted using an ecological risk assessment paradgim, which entail the “use of probabilistic decision-making tools to evaluate the likely benefits and potential harms of a proposed activity on the well being of humans and the environment, often under conditions of uncertainty” (NASEM 2016). That approach would permit a more nuanced and rigorous evaluation than the standard environmental (risk) assessment employed by the FDA under NEPA (I owe this point to J. Kuzma). However, even ecological risk assessments are normative endeavors, and thus, the question of the values and concerns that should shape them ought to be the subject of public deliberations and decision-making.
This question takes on particular importance in the case of animals with gene drives, based on CRISPR/Cas9. (CRISPR refers to Clustered Regularly Interspaced Short Palindromic Repeats and Cas9 is a nuclease that makes cuts in DNA next to CRISPR sequences.) Theoretically speaking, depending on the species, the release of a relatively few such animals could result in the trait affecting the entire wild-type population within a fairly short timespan (Burt 2003). Ideally, the use of the GE animals would have the intended effect on its wild-type counterpart only and be limited to the target area. But depending on the species, the introduced trait, and the relationship of the target species to other species in an ecosystem or in the larger complex of inter-connected ecosystems, multiple species could be affected whose "ways of life’" are mutually interwoven or entangled (the latter notion is borrowed from Tsing (2012)). Therefore, it is arguable if GE animals with gene drives should be released in the wild without the consent of the global community.
Neoliberalism supports disclosure of risks to consumers provided it does not impinge on the right of commercial endeavors to protect their proprietary interests or stifle innovation.
It is generally assumed that neoliberalism is averse to regulations, but that is not the case. It opposes regulations that do not serve the interests of corporations and the elite managerial and financial class (Harvey 2005).
The economics Nobel prize is unrelated to the other Noble prizes; the former was created by the Swedish banking elite (Harvey 2005, p. 22).
For a careful and detailed account of the implementation of neoliberal policies, see Harvey (2005).
Neoliberalism takes on local hues and is affected by them.
The US is not the only nation that has succumbed to this appeal. Patel-Campillo (2014, pp. 210–211) notes that this feature of neoliberalism appeals to all nations.
“Embedded” should not be read to mean “located for tax purposes.”
The Council also asserted that federal regulations that aimed to reduce health or safety risks ought to be “based upon scientific risk-assessment procedures and should address risks that are real and significant rather than hypothetical or remote” (OSTP 1992, p. 6762). This recommendation divided risks into two types; risks that were legitimate because they were based on what it construed to be “real and significant” as opposed to risks that it considered to be lacking merit, i.e., risks that were “hypothetical or remote.” The Council’s attempt to distinguish between “real and significant risks” that are amenable to scientific risk assessment and “other” kinds of risks could be read as an attempt to discredit normative opposition to biotechnologies.
This was a new policy that was instituted in response to the sponsors of the FLAVR SAVR tomatoes seeking guidance from the FDA regarding their regulatory requirements for their food product (FR 57, May 29, p. 22985).
During the Reagan era, the FDA was identified as in ‘need’ of neoliberalization because it was “quite good at confronting businesses and reigning in their profit-seeking behavior if their interests conflicted with the public interest” (Markel 2005, p. 2490). As a result the agency’s ability to serve as the public health watch dog was undermined, with its budget for food contamination prevention significantly cut, and its legal investigations cancelled (Hilts 2003, pp. 215–216). The FDA employees were flooded with paperwork, compromising their ability to investigate companies that violated the agency’s regulations (Hilts 2003, p. 215).
At least, from a public relations perspective, it would appear unseemly if the state presented its self as concerned with the profit margins of biotechnology corporations that spanned the globe and held virtual monopolies over the products that they sold.
See, for instance, Hartsock (1998) on standpoint epistemology.
According to the Pew Center article, the US Census Bureau has noted that voter turnout for the presidential election in 1980 was 64%, in 1984 64.9%, in 1988 62.2%, in 1992 67.7, in 1996 58.4%, in 2000 59.5%, in 2004 63.8%, in 2008 63.6%, in 2012 61.8% and in 2016 61.4%. Thus, if voter turnout in presidential elections is indicative of the population’s willing to participate in political decision-making, the picture is bleak.
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The author would like to thank Jeff Burkhardt for his careful editorial guidance and review.
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Meghani, Z. Genetically Engineered Animals, Drugs, and Neoliberalism: The Need for a New Biotechnology Regulatory Policy Framework. J Agric Environ Ethics 30, 715–743 (2017). https://doi.org/10.1007/s10806-017-9696-1
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DOI: https://doi.org/10.1007/s10806-017-9696-1