Abstract
There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at least three ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions.
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Notes
Due to space constraints, we consider the phenomenon of the revolving door in the US only.
We recognize that not all businesses that form a particular industry will necessarily have the same interests in every regards. For instance, in certain respects the interests of small scale farms that produce organic vegetables are very different from those of the companies that engage in large scale farming using pesticides. We are also aware that trade groups and associations with considerable lobbying clout tend to represent the concerns of the powerful members of industries. In the fourth section of the paper, we address the conflicts of interests that might exist between different subgroups comprising a particular industry and we offer a way of addressing them.
We use the terms “genetically engineered” and “genetically modified” interchangeably to denote the process of manipulating a gene using recombinant DNA methods. That method allows for the insertion of a gene or a gene sequence in the DNA of the new host, generating a targeted result.
At that time, biotechnology had been identified as a promising new scientific and trade frontier.
Ceccoli has argued that the Prescription Drug Users Fee Act marked a change in the FDA’s understanding of consumer protection to take into account the “perils of delay in approving new drugs” and it was an attempt on the part of the agency to align its regulatory process with that of various other Western, industrialized nations (2004, 16).
Unfortunately, the latter possibility has not received much attention. We acknowledge, however, that with the recent change in administration and the banking and mortgage crises (that many feel were precipitated from a lack of regulation (Calmes 2008)) this orientation might be shifting.
At the time of writing this paper, the new Obama Administration posted a notice in the Federal Register for comments on formulating a new Executive Order on Federal Regulatory Review, calling for recommendations on: disclosure and transparency; encouraging public participation in agency regulatory processes; the role of cost-benefit analysis; the role of distributional considerations, fairness, and concern for the interests of future generations; methods of ensuring that regulatory review does not produce undue delay; the role of the behavioral sciences in formulating regulatory policy; and the best tools for achieving public goals through the regulatory process (OMB 2009). There seems to be a shift in the willingness on the part of the administration to consider, along with science-based risk assessment and cost-benefit analysis, other normative factors in formulation of regulations, and the arguments in this paper would support such revisions to federal regulatory review.
In 1986, the Coordinated Framework established as a formal policy by the federal government. It describes “the federal system for evaluating products developed using modern biotechnology” (United States Regulatory Agencies Unified Biotechnology Website).
The comments from experts and stakeholders were gathered anonymously and cannot be attributed to individuals, according to Institutional Review Board protocol.
To demonstrate that background assumptions mediate the relationship between hypotheses and data, Longino uses an example from neuroscience. Behavioral endocrinologists Ehrhardt and Meyer-Bahlburg (1981) have theorized that differences in gender role behavior are significantly determined by fetuses’ exposure to sex hormones (Longino 1990, 119). This theory is anchored in their research on girls with Congenital Adrenocortical Hyperplasis (CAH). CAH is a condition marked by higher than statistically normal production of androgen during female fetal development (Longino 1990, 114). Ehrhardt and Meyer-Bahlburg hypothesized that greater than normal exposure to androgen as fetuses causes these females to exhibit “tomboyish” behavior. As evidence they cited the correlation between girls with CAH and “tomboyish” behavior. On the basis of their research on CAH girls and drawing on cases in other mammalian species, for examples, rats, where behavior is hormonally determined, Erhardt and Meyer-Bahlburg theorize that prenatal exposure to sex hormones “importantly influences” gender role behavior in the human species (Longino 1990, 119).
Longino criticizes Erhardt and Meyer-Bahlburg for using loaded language (such as “tomboyish”) in their study and for not taking into account that their evidence (i.e., the reports about the “tomboyish” behavior of CAH girls by the girls themselves and their parents and teachers) might be problematically influenced by the observers’ expectations. She also contends that the relationship between their hypothesis (about CAH girls) and the evidence that they cite in support of it is mediated by a background assumption of which Ehrhardt and Meyer-Bahlburg appear to be unaware. The crucial bridging background assumption in question is a model of the brain that assumes that there is an uni-directional, causal relationship between brain structure and chemistry and behavior. Longino argues that if Erhardt and Meyer-Bahlburg had worked with an alternative model of the brain that recognized both agent intentionality and interaction between agents and their environment (along with brain structure and physiology) as determinants of human behavior, it is unlikely that they would draw as strong a causal connection between prenatal exposure to sex hormones and gender role behavior as they have done (This account is taken from Meghani’s unpublished dissertation, Can Medical Theories Be Objective? (2006)).
For instance, the two models of the brain rely on different "metaphysical assumptions about causality and human action," which have different attendant social, ethical, and political commitments and entailments (Longino 1990, 161). The model that draws a strong uni-directional relationship between brain structure and physiology is committed to a form of biological determinism. Such a model does not recognize the possibility of agency, including intentionality, thus, it limits our sense of ourselves as autonomous entities. Alternatively, the model that allows for agency, interaction between agents and their environment, and biology as determinates of behaviors confirms our sense of ourselves as capable of acting autonomously (Meghani’s unpublished dissertation (2006)).
It is worth noting that this, like other knowledge building enterprises, is a communal endeavor.
Thus, it would be a mistake to assume that all members of marginalized group will automatically have this kind of critical understanding of the culturally dominant worldview.
This claim is based on research by Muir and Howard (1999).
This issue deserves extended treatment. However, given the limited scope of this paper, we are only able to acknowledge it. Achieving a balance between transparency and democracy which relies on it and allowing businesses to recoup investment on technology development through intellectual property protection might be difficult. But it must be done as the current practice of privileging business interests undermines citizen autonomy.
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Acknowledgments
Kuzma’s work on this article was supported in part by National Science Foundation NIRT Grant SES-0608791 (Wolf, PI; Kokkoli, Kuzma, Paradise, Ramachandran, Co-PIs). Any opinions, findings, and conclusions or recommendations expressed in this article are those of the authors and do not necessarily reflect the views of the National Science Foundation. The authors would also like to thank Laura Yerhot, Research Assistant, Humphrey Institute, University of MN, for her initial literature review on the subject. We would also like to thank the anonymous reviewers who made helpful comments on an earlier version of this paper.
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Meghani, Z., Kuzma, J. The “Revolving Door” between Regulatory Agencies and Industry: A Problem That Requires Reconceptualizing Objectivity. J Agric Environ Ethics 24, 575–599 (2011). https://doi.org/10.1007/s10806-010-9287-x
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DOI: https://doi.org/10.1007/s10806-010-9287-x