The EPA and Epigenetics: Baby Steps or Going Nowhere?

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by Shea Robison (@EpigeneticsGuy)

Epigenetics research in both animal and human studies has identified a number of environmental factors – from maternal behavior to levels of physical exercise to food types and availability to the presence of certain endocrine disrupting chemicals – which can alter epigenetic patterns, sometimes in ways which can be effectively transmitted to subsequent generations without these future generations being physically exposed to the original trigger of the epigenetic change.

That there are specific environmental and behavioral factors which can produce such significant changes in gene expression in the present, and which can now be linked to such far-reaching transgenerational effects in the future,[1] presents a significant collective action problem similar to problems such as air and water pollution, or global climate change.  As resolving or mediating collective action problems is perceived as one of the primary functions of government, the collective action problem of transgenerational epigenetic inheritance recommends a significant role for government in the regulation of such factors.

There are a number of existing regulatory structures and statutes already in place that could be used to address these epigenetic effects.  At the federal level, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) are two of the more prominent entities that would have significant oversight of regulation for epigenetic purposes, but so also could the Department of Agriculture, the Department of the Interior – and really any agencies dealing with the food supply or the environment.  A very short list of federal regulatory vehicles which could be modified to account for these epigenetic effects would be the Clean Air Act (CAA), the Clean Water Act (CWA), the Toxic Substances Control Act (TCSA), and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). However, these existing acts of legislation as currently constituted require significant reworking to properly address these epigenetic effects.  The discussion of what are some of these issues with existing legislation, and what are potential ways to incorporate epigenetics into existing policy or for drafting all-new epigenetic-centered legislation is one of the main purposes of this blog.

In particular, in an extensive legal and ethical analysis of the implications of epigenetics, Rothestein et al. have identified the FIFRA as amended by the 1996 Food Quality Protection Act (FQPA) as the federal statute most likely to first incorporate epigenetic data into risk assessments and regulatory decisions.[2]  This is because the amended FIFRA is the only federal environmental statute that requires pre-market safety testing and approval of chemical products which must pass through a battery of approximately 100 toxicological assays conducted by the EPA (although it bears mentioning at this point, though, that none of these assays currently evaluates for epigenetic effects).  In addition, the FQPA amendments also require the EPA to develop a program for testing for endocrine disruptors in pesticides.  Given the importance of epigenetics in the functioning of the endocrine system, this aspect of the FIFRA is particularly a propos in the context of the policy emphasis of this blog.  Finally, the FQPA also requires the EPA to apply an extra ten-fold safety factor in regards to children which, given the importance of the critical epigenetic developmental windows, is also an especially applicable provision.

However, the EPA has yet to implement any of these provisions or to produce any formal recommendations for epigenetics-based policies.  A 2010 article in the New York Times discusses EPA efforts to address the growing evidence of the epigenetic effects of exposure to chemical pollutants common in contemporary society.[3] In this article, the senior research fellow in drug safety research and development at Pfizer Inc. observes that “the mix of chemicals a fetus is exposed to has exploded in the past 200 years, heralded by the Industrial Revolution,” and that “technology has outstripped evolution.” As a result of the growing body of research in epigenetics which demonstrates both immediate and transgenerational epigenetic effects of this modern cocktail of chemicals on humans, EPA regulators met with scientists to discuss how to design regulations based on these findings, but again no formal recommendations of policies have been produced.

In 2009 the EPA did begin an Epigenetics Project with the objective to closely study DNA methylation, which the official EPA documentation refers to as “the most common type of epigenetic modification [which] plays an important role in cancer, aging, neurodevelopment, and fertility.”[4]  As of 2014, this project has produced six journal articles and twelve publications on the impacts of DNA methylation, but as of yet no concrete policies based on epigenetics have resulted from this research. This project is also set to expire in October of 2014.

However, there are some very good logisitical reasons for this seeming lack of action. For one, the process for assessing the toxicity of chemicals and for recommending policies for legislation is a long and multi-faceted one which already faces a significant backlog of conventional analyses even before epigenetic concerns are taken into account. According to the article in the New York Times mentioned before, in 2010 the EPA already had a backlog of 478 chemicals in need of an environmental health assessment. The process for conducting such assessments involves the careful review both within and outside of EPA of the impact of the chemical, as well as assessments of the legal and political feasibility of any new restrictions that the agency might impose on industry as a result of this assessment, generating a thousand-page risk assessment document called IRIS which can take years to complete

Given all the administrative and scientific and legal and political strictures the agency is faced with, progress of these assessments is slow. During the George W. Bush administration, the EPA was able to assess two chemicals a year; this number increased to nine per year under the Obama administration, which still leaves a significant backlog of chemicals yet to be assessed – and these are just assessments of the environmental effects of chemicals according to conventional standards. These number do not include the requests for assessment of the epigenetic effects, of which the science is compelling but still in many cases far from providing enough justification for policy.

As observes the author of the New York Times article, “given such a backlog for toxins that are harmful as demonstrated using traditional science, regulating based on epigenetic research is perhaps many years away.”

Even so, given the rapid increase in the weight of the evidence from epigenetics as to the toxic effects of these chemicals, especially when so many of these effects are transgenerational, what is the appropriate balance between caution and action? Is the fact that the current assessment processes are so mired in bureaucratic procedures a valid justification for not taking action? What can be changed in the EPA processes to facilitate epigenetics-based assessments? Should the current backlog be dealt with before epigenetics are considered?  Finally, what about the state of the science of epigenetics? What is the appropriate threshold of scientific proof before political action is deemed necessary?

I am curious to hear what you think. Leave your comments below and I will respond.

Also, if you find these thoughts I’ve shared interesting and worthwhile, Like this post, Reblog it, or Tweet about it using the buttons below.

[1] Jirtle, R. and Skinner, M. 2007. Environmental epigenomics and Disease Sucsceptibility. Nature Reviews Genetics 8; 253-262; Watson, R. and Goodman, J. 2002. Epigenetics and DNA Methylation Come of Age in Toxicology. Toxicological Science 67(1): 11-16.

[2] Rothstein, M. A., Cai, Y., & Marchant, G. E. 2009. The ghost in our genes: legal and ethical implications of epigenetics. Health matrix 19(1):1-62.

[3] Epigenetics Project | Research Project Database | NCER | ORD | US EPA. 2009.Epigenetics Project | Research Project Database | NCER | ORD | US EPA. Retrieved July 29, 2014, from http://cfpub.epa.gov/ncer_abstracts/index.

[4] Vaidyanathan, G. (2010, November 15). Prenatal Exposures Prompt EPA to Re-examine Chemical Regulations. New York Times.

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