Toxicogenomics
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❖ Copyright © 2002, The Environmental Law Institute®, Washington, D.C. Reprinted by permission from The Environmental Forum®, November/December 2002 COVER Toxicogenomics STORY A scientific revolution is underway that is already affecting environmental, safety, and health regulatory policy and could dramatically change it within the next decade or so. It is not too soon for EPA as well as other affected agencies to begin the policy evolution necessary to keep up with the new technology LYNN L. BERGESON, LISA M. CAMPBELL, and RICHARD P. BOZOF oxicogenomics — an emerging ter screening of industrial chemicals and al- science that studies the interaction lowing safer drugs to get to market faster; between peoples’ genes, toxic • Individuals who have been exposed to chemicals in the environment, and chemicals, improving health intervention disease — has the potential to measures, improving epidemiological studies, Trevolutionize risk assessments and the regu- and affecting toxic tort litigation; and latory actions that rely on them, as well as • Individuals who may be unusually sus- to greatly advance the fields of toxicology ceptible to environmental stressors, including and environmental health. Its use for risk chemicals, enabling or requiring their expo- assessment could alter dramatically how sure to be reduced or that their health be moni- safety margins are calculated and how ex- tored more closely, particularly in a workplace posures are assessed, as well as premarket setting. safety testing of chemicals, evaluations of The Environmental Protection Agency and new drugs, and a host of other issues — all other regulatory agencies are considering of which in turn raise countless legal and toxicogenomics in various contexts. In No- ethical issues. vember, for example, representatives from the The legal issues range from the implica- Department of Energy, Occupational Safety tions of toxicogenomics information on ad- and Health Administration, National Institute verse information reporting requirements of Occupational Safety and Health, and EPA under the federal pesticide and chemical participated in a National Academy of Sci- substances laws, to their effect on workplace ences symposium entitled “Toxicogenomics: safety standards and the rights of individual The ‘New Biology’ Revolution in Environ- employees, to their use — and potential mis- mental Health Sciences.” Each federal agency use — in toxic tort actions. Toxicogenomics acknowledged the significance of genomic data and their use also raise a plethora of data. Given the significant issues and deep ethical issues — many of which involve core and wide-ranging impacts this technology privacy rights. The debate and resolution of may have, which they acknowledge — and these issues will affect regulation and liti- the fact that they are already using gation — and individuals — in fundamen- toxicogenomics data — the agencies are not tal ways for years to come. as aggressive as they should be in adopting These controversies should not obscure policies governing toxicogenomics and pre- the numerous potential benefits of paring to integrate it into their decisionmak- toxicogenomics, many of which are highly ing where warranted. significant. First and foremost, toxico- In particular, EPA’s Interim Policy on genomics can help explain the mechanisms Genomics does not go nearly far enough. Pre- by which chemicals cause toxicity, improv- pared last June by the agency’s Science Policy ing our understanding of disease. In a regu- Council, it appropriately acknowledges the latory setting, toxicogenomics can produce significance of toxicogenomics, but leaves a number of desirable results. For example, unexpressed the critical need for EPA to de- it can help identify: velop a comprehensive policy framework to •The toxic effects of pollutants and govern the use of this rapidly growing tech- manufactured chemicals and drugs in hu- nology and expedite its inclusion in risk as- mans, reducing exposure risks through bet- sessment and other agency science as appro- 28 ❖ THE ENVIRONMENTAL FORUM Copyright © 2002, The Environmental Law Institute®, Washington, D.C. Reprinted by permission from The Environmental Forum®, November/December 2002 ❖ priate. In the interim policy, EPA indeed states potentially be followed by other agencies — that toxicogenomics will “have an enormous ignores the crosscutting nature of these bur- impact on our ability to assess the risks from geoning applications and invites inconsis- exposures to stressors and ultimately to im- tency and potential confusion. EPA in particu- prove our risk assessments.” However, the lar should, given that risk assessment is its life- agency cautions that the technology is evolv- blood and the foundation for many of its regu- ing, that the relationships between gene ex- latory decisions, be in the forefront of devel- pression (the proteins the gene produces) and oping a framework to govern how this infor- adverse health effects are at present unclear, mation should be factored into its policies. and that for assessment purposes EPA will Lynn L. Bergeson and Lisa consider genomics information on a case-by- M. Campbell are founding case basis. Thus, the policy recognizes, but he sensitive and controversial shareholders of Bergeson does not address, the need to investigate how issues raised by the use of & Campbell, P.C., and information from this technology may be used toxicogenomics data — which are Richard P. Bozof is Of in risk assessments or the need to provide outlined below — require that guidance on the ethical, legal, and social im- such a framework be developed Counsel to the firm. plications of such use. early and, given the profound ethical and le- Located in Washington, T D.C., the firm Other agencies that will be much affected gal issues at stake, through a transparent, pub- by toxicogenomics — OSHA and the Food and lic process. As a practical matter, the horse is concentrates on chemical, Drug Administration in particular — appear already out of the barn — these data are being medical device, and also not to be moving forward as aggressively provided to EPA under the Voluntary diagnostic product as they should be. Neither Children’s Chemical Evalu- approval and regulation, OSHA nor FDA has adopted ation Program, its Endocrine and associated business a policy on toxicogenomics. EPA’s Interim Disrupter Screening Pro- issues. NIOSH, which is within gram, and other programs. OSHA, is using genomics in- Genomics Policy EPA will consider them, and formation, and FDA has ini- it should not do so without tiated toxicogenomics re- recognizes, but such a framework. The search projects that promise agency has convened pub- to improve the effectiveness does not address, lic advisory committees un- of therapeutic drugs and re- the need to der the Federal Advisory duce their risks. But neither Committee Act for issues of agency appears to have de- investigate how less significance, and it veloped a formal framework should do so here promptly. to anticipate and address this technology In short, with its revolu- many of the issues concern- may be used in tionary potential advan- ing toxico-genomics that are tages, toxicogenomics can- pertinent to its mission. risk assesments or not be relegated to a “wait Given the dramatic and and see” approach by EPA far-reaching benefits of the need to and other agencies who rely toxicogenomics informa- on risk assessments. More tion, the similarly dramatic provide guidance needs to be done now to en- effects that it can have on on other uses sure the expeditious and op- risk assessment and its con- timal use of this technology sequences, and the many in a manner that is scientifi- important legal and ethical issues its use cally, legally, and ethically sound. Given their raises, EPA’s interim policy — and the respective charges, EPA and other agencies backseat position taken by other agencies whose work will be most affected should take whose mandates also will be dramatically af- a strong lead in identifying and resolving the fected by these issues — needs to be much significant issues that toxicogenomics raises. bolder. A scientific revolution is underway EPA in particular is well-suited to assume a that is already affecting environmental, safety, leadership role in developing an interagency and health regulatory policy and could dra- framework, including, at a minimum, OSHA, matically change it within the next decade — FDA, the National Institute of Environmental and it is not too soon to begin the policy evo- Health Sciences, and the Centers for Disease lution necessary to keep up with the chang- Control and Prevention, for how, when, and in ing science. The cautious case-by-case ap- what circumstances toxicogenomics informa- proach stated in EPA’s policy — one that may tion will be considered for regulatory pur- NOVEMBER/DECEMBER 2002 ❖ 29 Copyright © 2002, The Environmental Law Institute®, Washington, D.C. Reprinted by permission from The Environmental Forum®, November/December 2002 ❖ ANOTHER VIEW A Powerful Tool With Great Promise For Risk Assessments s expressed in our recently minnows as an indicator of exposure genomics technology be applied to issued Interim Policy on to estrogen. This would help exam- decisions about the risk a chemical AGenomics, we at the Envi- ine the quality of water in streams may pose to humans and wildlife. ronmental Protection Agency believe and identify endocrine disrupters. We are concerned not only about “that genomics will have an enor- An important goal for