Preserving human potential as freedom: a framework for regulating epigenetic harms.

Author:Khan, Fazal


Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between "nature" and "nurture" as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents' generation might affect our health now, even if we have not experienced the same exposures. In the same vein, current exposures could affect the health of not only individuals currently living but also future generations. Given the relative novelty of epigenetics research and the multifactorial nature of human development and disease causation, it is unlikely that conclusive proof can be established showing that particular exposures lead to epigenetic risks that manifest into specific conditions. Using the Capabilities Approach ("CA") developed by Amartya Sen and Martha Nussbaum, this article argues that epigenetic risk is not merely a medical issue, but that it more generally implicates the underlying fairness and justice of our social contract. For instance, how we develop mentally or physically has a tremendous impact upon our inherent capabilities and our set of life options. The CA prompts us to ask questions such as: (1) what impact do particular epigenetic risks have on our ability to exercise free choices; (2) are these risks avoidable; and (3) how are these risks distributed across society? Due to the complex nature of epigenetic risk, tort law is predictably incapable of addressing this harm. Further, while regulatory agencies possess the statutory authority to begin addressing epigenetic harms, currently these agencies are not attuned to measure or to respond to this type of harm. This article argues that it is imperative to initiate a regulatory framework to address epigenetic risk from specific substances even if conclusive proof of disease causation cannot be established. Shifting the burden of generating epigenetic risk data to producers of suspected harmful substances serves as a start. As information concerning epigenetic risks accrues, the regulatory response should evolve concurrently. As part of a dynamic policy-making approach our goals need to encompass the following: (i) promotion of knowledge in the scientific, legal, and public domains; (ii) assessment and modification of current regulations to address preventable risk; and (iii) an overarching commitment to protect human capabilities in an equitable manner.

TABLE OF CONTENTS INTRODUCTION I. SCIENCE OF EPIGENETICS: OUT WITH THE NEW, IN WITH THE OLD? A. Proof of Concept: Evidence of Epigenetic Mechanisms B. Evidence of Epigenetic Mechanisms in Human Studies II. TORT LAW'S 1NABILITY TO ADDRESS EPIGENETIC HARM A. Latency Problem 1. Statutes of Limitations / Repose 2. Product Identification B. Multifactorial Nature of Disease Causation C. Tort Claims for Increased Risk D. Weak Deterrent Signal from Torts E. Minimal Tort Incentive for Long-Term Safety Precautions F. The Justice Problem: Being Punished for Wrongs Committed by Others III. INADEQUACY OF CURRENT REGULATORY REGIME TO ADDRESS EPIGENETIC HARM A. Legal Authority for Public Safety Regulation B. Phthalates: A Case Study of Regulatory Inaction IV. THE CAPABILITIES APPROACH: THE NORMATIVE CASE TO ADDRESS EPIGENETIC HARM A. Rawls and the Capabilities Approach B. Basic Elements of the Capabilities Approach V. REGULATING EPIGENETIC RISK IN THE FACE OF UNCERTAINTY A. Cost-Benefit Analysis B. Precautionary Principle C. Optimal Search D. Applying the Three Decision Making Models to Ireland's Folic Acid Debate VI. ADAPTIVE KNOWLEDGE FORCING REGULATORY FRAMEWORK A. Level 1: Disclosure Standard B. Level 2: Labeling Standard C. Level 3: Epigenetic Tax and Permit System to Protect Human Capabilities D. Level 4: Restricted Uses and Outright Ban CONCLUSION INTRODUCTION

Do our ancestors' experiences from several generations ago play a role in our current health? Could a famine or a period of food abundance experienced by our grandfathers influence whether some of us are currently obese or likely to develop diabetes? Can being the grandchildren of those who suffered through the threat of genocide or intense racial discrimination affect levels of certain chemicals in our brains even if we are not exposed to the same social stresses? In other words, are we biologically fettered to the "memories" of past generations independent of changes to our ancestors' DNA--that is, our human genome?

Surprisingly, according to rapidly growing research in the area of epigenetics, the answer to all of the questions above is converging on yes. (1) Therefore, an individual's diet, environmental exposures, and social interactions could influence the health and behavior of that individual's offspring. The implications of epigenetics are far-ranging and can alter the way we think about policies as widely divergent as product safety, environmental regulation, and even affirmative action. In a profound way, epigenetics challenges the notion that genetics predominantly determine a person's fate and will make many of us reconsider what we think we know about human capabilities and predispositions. (2)

As explained below, although epigenetics may predict baffling hereditary effects, the science behind epigenetics is not incomprehensible. Ultimately the greater challenge to policymakers will be to decide whether regulations designed to avoid such harms should even be attempted? In the face of any potential health risks, harms may arise from inaction as well as from regulatory inaction. (3)

Given that our understanding of the science behind epigenetics is still relatively new, the conservative approach might be to advocate a "hands-off" regulatory attitude until scientific data conclusively demonstrates disease causation through this process. However, in the face of initial compelling evidence that the repercussions of serious harm to human health could span several generations, we cannot afford to take a laissez-faire approach. Further complicating our calculus is the likelihood, supported by recent research, that some epigenetic modifications may be reversible. (4) So how do we proceed in the face of uncertain, but grave, harms that may or may not be reversible? (5)

Currently, the two dominant paradigms for shaping governmental response to public safety threats are cost-benefit analysis and the precautionary principle. (6) Cost-benefit analysis requires that the quantified benefits of a proposed regulation exceed or "justify" the quantified costs. (7) However, if the risk of a threat is uncertain and therefore unquantifiable, cost-benefit analysis provides little guidance, except perhaps to do nothing in the absence of quantifiable justification. In contrast, the precautionary principle holds that when an activity raises threats to human health, precautionary steps should be taken even if cause and effect has not been fully established. These two paradigms are often pitted against one another and perceived in cultural and political terms. (8) Cost-benefit analysis is often seen as more libertarian and as representing an "American way" of thinking about risk, while the precautionary principle is cast as more paternalistic and "European." (9) Of course, these are general characterizations of the decisionmaking models, and they are not mutually exclusive, as many models in actual use combine elements of both cost-benefit analysis and the precautionary approach. (10)

Regarding the causation of human diseases from substance exposures in particular, our knowledge of epigenetics is likely to be very fluid over the next several decades. Further, in speaking with researchers in the field and reviewing the scientific literature, it is evident that the medical and scientific community generally believes that epigenetic theory is valid and that research in this area will likely shed much light on disease causation. (11) However, the status quo of current legal rules and regulatory policies do not seem to provide adequate protection to the public from epigenetic harms. The tort system in theory can regulate harmful substances in the stream of commerce by imposing liability on products that cause too much harm. However, for a variety of reasons explained below, tort law appears incapable of limiting epigenetic risk. In addition, while the Food and Drug Administration and Environmental Protection Agency possess adequate statutory authority, their historical and current regulatory postures are not attuned to regulating epigenetic harms.

This article proposes a dynamic regulatory framework allowing for decisive actions against epigenetic threats without conclusive proof of harm, but requiring continual adaptation as new learning becomes available. My initial claim is that available evidence regarding epigenetic pathways of disease is sufficient to justify significant government funding of basic scientific research in this area. However, implementing societal protections from epigenetic harms cannot wait until research provides "conclusive" findings. The rationale for such action comes from applying the Capabilities Approach ("CA") normative framework, as developed by Amartya Sen and Martha Nussbaum. Namely, it is government's responsibility to address preventable harms that potentially limit a person's innate capabilities and life options. (12) Therefore, I assert that for certain suspect classes of substances, regulation should shift the burden to producers to force acknowledgement of the epigenetic effects of their products and activities. Going forward, in response to new learning about general epigenetics and specific substances, an epigenetic...

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