Building a Better Risk Assessment Process

One of many areas in which the Bush Administration has sought to throw sand in the gears of the regulatory process is by tampering with the methods of risk assessment used by regulatory agencies as part of their process of gauging how much regulation, if any, is needed in a certain area.

More specifically, risk assessment in this context is the process by which scientists try to evaluate and quantify risks associated with human or environmental exposure to chemicals and pollutants in the air, water, food, or consumer products.  The goal is to summarize, based on the weight of all available scientific evidence, the risks posed by particular chemicals or pollutants.  Policymakers then decide, based on statutory directives and the available science (as characterized through the risk assessment process), whether and how to regulate the particular chemical or pollutant.

When done correctly, risk assessments bridge between the quite divergent worlds of science and policymaking.  Policymakers understandably want to make decisions based on complete and certain information.  Available science, however, is never complete or absolutely certain, leaving policymakers with sometimes significant gaps in knowledge.  As a result, risk assessors must develop a set of “default options” or make assumptions to bridge these gaps in knowledge.  These bridges involve questions of both science and policy, so scientists and policymakers both play a legitimate role in choosing default options, often leading to disputes.  Not purely science, and not purely policymaking, the risk assessment process thus serves as the awkward transitional phase between these often irreconcilable worlds.

Unfortunately, the foes of regulation have become rather adept at manipulating the risk assessment process in recent years, often smuggling their policy preferences into the process under the cloak of “sound science.”

Along the way, these advocates have taken every opportunity to saddle the risk assessment process with additional and unnecessary requirements, “innocently” claiming that such requirements are intended to improve the science on which risk assessment is in part based.  Carl Cranor, Ph.D., a University of California, Riverside, philosophy professor and CPR Member Scholar, explains, “There’s every incentive to complicate the risks assessment, to make it as detailed, as data-heavy and as data-obscured as possible, because that just delays doing anything about the product that may be causing harm.”  And every day of regulatory delay is literally money in the bank for the potentially affected industry.

The manipulation of the risk assessment process has generated a lot of collateral damage as well.  Lengthy delays have resulted in a severe backlog in new and emerging chemicals and pollutants that need to be evaluated.  This backlog in turn has left policymakers unable to address the new chemicals and pollutants, placing people and the environment in unnecessary and unacceptable risk.  Worst of all, perhaps, the pattern of flagrant manipulation has severely damaged the credibility of the whole enterprise.  For most observers, risk assessment has become a tool for protecting the narrow interests of regulated industries rather than a process intended to protect the public interest.

With all that in mind, the National Academy of Sciences convened a panel of scientists to evaluate the current risk assessment process and make suggestions for its improvement.  Last week, the panel released its final report summarizing its evaluation and its recommendations for improving the risk assessment process.

Many of the panel’s recommendations are intended to expedite the risk assessment process.  One recommendation is to narrow the scope of inquiry for risk assessments, so that they do not become too bogged down in matters of only tangential importance.  Another recommendation is to establish a transparent process for developing a risk assessment agenda.  This process would bring together key stakeholders, identify the objectives for the risk assessment process to be undertaken, and establish a firm deadline for completing the risk assessment process.

Other recommendations contained in the panel’s report seek to revise the risk assessment process so that it better accounts for vulnerable populations, such as children.  This recommendation dovetails with a recommendation included in CPR’s recent report, Protecting Public Health and the Environment by the Stroke of a Presidential Pen, which calls on President-elect Barack Obama to issue an Executive Order requiring federal agencies to develop an affirmative agenda for protecting children from toxics and pollutants.  The current risk assessment process does not account for the fact that children eat more in comparison to their bodyweight, breathe faster, and are in the process of developing fragile neurological systems.  As a result, the risk assessment process tends systematically to underestimate the risks posed by toxics and pollutants for children—a shortcoming that must be rectified in order to protect children properly.

For all its strengths, however, the recommendations in the panel’s report do little to address the problem of lack of data concerning harmful toxics and pollutants.  Those “data gaps” are largely an artifact of the weak laws by which toxic substances are presently regulated in this country.  In particular, current law does not compel chemical companies to provide regulators with information about the chemicals they produce.  Instead, regulators must rely on “backend” approaches for protecting the environment and public health—such as the use of risk assessments—that seek to address the risks posed by toxics and pollutants only after they have been released into the environment or the marketplace.  In a recent post on CPRBlog, Matt Shudtz discussed the idea of reforming the Toxic Substances Control Act (TSCA) to follow the European Union’s REACH program.  The REACH program requires chemical manufacturers to perform certain kinds of testing and to provide certain kinds of information to regulators in order for the chemical to become registered, and thus legally sold in commerce.

Building TSCA on the same precautionary approach embraced by the REACH program would provide regulators with more information about the potential risks posed by the toxics and pollutants that are being released into the environment and the marketplace.  This, along with a better risk assessment process, would go a long way toward protecting public health and the environment.

(Thanks are due to Matt Shudtz for his insights on the risk assessment process discussion in this post.)