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Exploring the E-Suite with Elizabeth Anderson, Ph.D., Fellow ATS, Chief Science Officer and Senior Fellow, Exponent, Inc.; formerly, Carcinogen Assessment Group and Office of Health and Environmental Assessment, U.S. EPA
I led the health sciences assessment work for the first 14 years after U.S. EPA was formed in December 1970. At the time, U.S. EPA was a very small agency. I was the only health scientist in an eight-person Office of Technical Analysis, reporting directly to U.S. EPA’s first Administrator, Bill Ruckelshaus. He is an extraordinary person—a terrific and committed leader, who also knew how to make hard work fun. The Administrator asked me to lead an intra-agency committee to write a cancer policy to address the zero risk tolerance expectation for substances with some evidence, often conflicting, of carcinogenicity, as indicated by tumors in animals or humans. Another challenge was that substances could be ubiquitous or important to our society. We knew a “zero tolerance” policy for all possible carcinogens would be unworkable, so my committee reported out a process rather than a cancer policy. That process was the first use of risk assessment to organize what is known and unknown about the likelihood that exposure to a particular agent might cause illness. On the assumption the agent might cause illness, the next step is to define what levels of risk and exposure would be acceptable and protective of public health. The concept of risk acceptance was novel at the time and was introduced in a social and political climate aimed at seeking the ideal, i.e., zero risk.
My office at U.S. EPA conducted and I co-authored more than 150 risk assessments between 1976 and 1983 as a basis for defining major regulatory policy. The National Academy of Sciences published its endorsement of this risk assessment process in 1983. The Academy’s report, referred to as “The Red Book,” inspired national and international adoption of the U.S. EPA’s approach to risk assessment started by my intra-agency committee. I led the effort to expand the health assessment program, which resulted in establishing the central risk assessment office for the Agency—the Office of Health and Environmental Assessment. This office reported directly to the Administrator, who granted us wide latitude to expeditiously conduct our assessments.
My academic background is in synthetic organic chemistry, the chemistry of making organic molecules, amongst other applications, to be biologically active. I was pre-med at the College of William and Mary, but I was strongly discouraged from pursuing medical school “because I would be taking the place of a man” (a quote from the Chairman of the Chemistry Department). Instead, I was granted a fellowship at the University of Virginia to pursue a master’s degree in synthetic organic chemistry. Next, I applied for a unique fellowship being granted by the U.S. Department of Defense and completed my Ph.D. work in synthetic organic chemistry. During those early years of U.S. EPA, my degree and training best fit the Agency’s needs. There were no degrees in toxicology, relevant applications in epidemiology were just emerging, and mechanism of action had received little attention. I was fortunate to be in the right place at the right time.
Most of all, it was challenging. Following the civil rights movement, the anti-Vietnam war movement, and 20 million people marching on the first Earth Day, the spirit of the time was that significant change can happen; every move at EPA was front-page news. We all felt a sense of urgency to make a difference and establish scientific credibility for all decisions that the Agency had to make. U.S. EPA inherited a rapidly cascading series of enabling legislation starting with the Clean Air Act in December of 1970, followed by amendments to the Federal Water Pollution Control Act; the Federal Insecticide, Fungicide, and Rodenticide Act; Radiation Authorities; the Drinking Water Act; “Superfund” (CERCLA); and the Resource Conservation and Recovery Act (RCRA). All compelled the Agency to be protective of public health. Implementing this Congressional directive was left to the Agency and, for our part, this meant meeting strict deadlines and establishing scientific foundations that defined protection and that could survive challenges from Congress and the scientific, private, public, and legal communities.
At a very young age, many of us at U.S. EPA inherited a great deal of responsibility. New areas of complexity seemed to develop on a daily basis. Looking back, a culture of committed, young professionals worked hard and achieved a great deal. We were inspired by the excitement and challenge of those times. Many of us have remained friends and colleagues until the present day. Some of us are still involved, as board members of the U.S. EPA Alumni Association.
I am proud of many things, but I am most proud of my role in co-authoring the first guidelines to establish risk assessment and risk management as the basis for setting public policy to protect public health and having the opportunity to found and direct U.S. EPA’s first health assessment offices, the Carcinogen Assessment Group, and the expanded Office of Health Environmental Assessment. In addition, I had the opportunity to found and direct the Agency’s expansion of health topics to include reproductive risk assessment, mutagen risk assessment, and exposure assessment groups; these offices conducted all risk assessments for the Agency’s program offices for many years.
I was fortunate to be a part of establishing the scholarship in this rapidly developing and complex field of health risk assessment. A small number of us founded the Society for Risk Analysis, a focal point for sharing scientific developments from all sectors, including engineering and the social sciences. I served as one of the early Presidents and, for 10 years, was Editor-in-Chief of the Society’s flagship journal, Risk Analysis: An International Journal. In addition, as U.S. EPA’s representative, I had the privilege of participating in the worldwide application of risk assessment first in Europe through the World Health Organization and subsequently through the Pan American Health Organization and other organizations.
After spending 14 years being a part of U.S. EPA’s founding, I entered the private sector, initially as President and CEO of the first private health and environmental assessment consulting firm, Clement Associates. In addition to work for private clients, U.S. EPA contracted with me to oversee and direct the first risk assessments for all of its Superfund sites, as did the Agency for Toxic Substances and Disease Registry to direct and write the first Toxicity Profiles. Later, I founded my own company, Sciences International, and directed it for 13 years, during which we addressed a wide variety of interesting and challenging issues. Subsequently, Exponent asked me to serve as Vice President for Health Sciences, a post I served in for 10 years, then as Chief Science Officer. More recently, I am honored to accept the Exponent designation of Senior Fellow, a rare recognition by the Company. Presently, I continue my work in the field of health risk assessment. I know that the framework and process we created in the early years made it possible to identify gaps in knowledge and point to ways for improving the foundations for health risk assessment.
Without a doubt, the need to sensibly apply the science we know to separate the important from the unimportant issues. Often, I feel that we lose sight of the fact that health risk assessment has achieved endorsement worldwide as the premier way to address the complexity of issues involved in defining public health protection. Also, the outcomes of risk assessment now have challenging new applications, e.g., in toxic tort litigation or world trade decisions.
In the policy area, one important emerging issue is the use of health risk assessment to “prove safety.” Adopting ever-diminishing levels of possible protection to achieve this goal effectively creates a “zero tolerance” policy, the very policy that would have defeated U.S. EPA at its inception. I believe that little is gained by these controversial policies that create debate for years; under these approaches we can lose sight of what is important. For example, important EPA risk assessment documents may now take years to become final because of endless debates in areas of scientific uncertainty where societal impacts can be enormous but risk reduction uncertain and marginal. We accept risk in every other part of our society, so it is unrealistic to apply a zero-risk policy to our environmental decisions.
Secondly, I feel that it is most unfortunate that the sciences so essential to public health understanding are often caught in agendas that constrain even the most objective review and use of our public health documents. There is no question that science has become politicized. I contend that U.S. EPA would have been lost without access to all scientists of importance to our decisions, regardless of who had funded their work.
Finally, I see an increasing lack of understanding of the difference between science as applied to public health protection—to preempt and prevent disease—and the science of establishing causality. It is critical to use honest science, regardless of the setting, to avoid mistakes. Distortion of scientific foundations and fact to achieve economic or political gain is deplorable and should be rejected.
The endless challenges. Risk assessment demands that we honestly express what is known and unknown. Exploring the unknowns and narrowing our knowledge gaps are endlessly rewarding endeavors.
It is very difficult to find a single answer to this question. Exploring new science will always be at the top of the list. The greatest non-scientific challenge is the fact that not all are in engaged in finding the truth. Trying to explain the known scientific facts in situations involving exploitation of scientific unknowns or distortion, whether in the courtroom or as a part of political debate, is challenging. The climate created by the spirit of the ’60s was to seek the truth. We were all essentially on the same page; we shared common goals even as we debated the best methods of scientific approach. Today, goals often do not converge; science in the age of polarization is challenging.
I have been surrounded by thought leaders and gifted people throughout my career. The environmental movement attracted so many to the new U.S. EPA. One who contributed so much to my understanding was Dr. Roy Albert, the Deputy Director of the School of Environmental Medicine at NYU. He was blessed with an extraordinary intellect and excellent sense of balance. He was the outside Chair of our Carcinogen Assessment Group in the early years, a role that would not be possible in the bureaucracy today. And I must continue to give credit to U.S. EPA Administrator Ruckelshaus.
Follow your dreams. Work is never work if you feel passionate about what you are doing. Achieve the best education you can get and keep your options open. You may need to help create your own opportunity. Have confidence in your capabilities to achieve your goals and set high ones.