News article: Risk Science and Law Panel Weighs Bipartisan Regulatory Reform Bill

Risk Science and Law Panel Weighs Regulatory Reform Bill

Part I of a RiskWorld special report on the proposed Regulatory Improvement Act of 1997 (see also Part II)

Story posted September 16, 1997.

By guest writer Wayne Roth-Nelson, founder and interim chair of the Risk Science and Law Specialty Group of the Society for Risk Analysis and principal of Roth-Nelson Risk Science in Lafayette, Colorado
E-mail to: roth_nelson@compuserve.com

September 16, 1997 -- A panel of experts from the Risk Science and Law Specialty Group of the Society for Risk Analysis has closely followed the bipartisan Regulatory Improvement Act of 1997 (S. 981), which would require risk assessment and cost-benefit analysis of major new regulations. The bill, which is sponsored by U.S. Senator Carl Levin (D-MI) and U.S. Senator Fred Thompson (R-TN), has been introduced in the Governmental Affairs Committee.

Members of the Risk Science and Law Specialty Group are scientists and lawyers interested in the interface between risk assessment and laws, regulations, and courtroom proceedings. Founded in December 1996, the group strives to provide leadership in conducting collaborative research on the application of science and law and in identifying and illuminating issues that arise from risk-related legislative bills, statutes, regulatory rules, and judicial proceedings.

The differing viewpoints of the SRA specialty group panelists on the Levin-Thompson bill presented in this report underscore the range and diversity of science and policy opinion held among the group's members. The opinions expressed here are those of the panelists and not of their affiliated organizations.

Separating Science and Policy in Risk Assessment

The Levin-Thompson bill is inexplicit on the key issue of segregating policy and science in the practice of regulatory risk assessment. There is, however, a call for identifying the scientific and policy basis for choosing among conflicting analytical assumptions that underlie a risk assessment. How the risks would be altered if alternative assumptions were adopted must be disclosed by the risk analyst. This approach is similar to that taken by the earlier bipartisan Roth-Glenn bill of 1995. That proposed legislation indirectly served to separate science and policy in risk assessment by directing regulatory agencies to make the process more transparent to the public.

One of the panelists, associate law professor Wendy Wagner of Case Western Reserve University in Cleveland, Ohio, said that the courts currently cause agencies to exaggerate the scientific grounding of their risk assessments. This bias occurs at the expense of making the policy choices more identifiable.

"Judicial overemphasis on scientific evidence and legislative mandates that make science the basis for standard setting can cause agencies to place unwarranted high priority on certain chemical exposures and health risks just so they can survive judicial review," Wagner said. In consequence, those toxic substances presenting greater potential risk but for which strong evidence is lacking may be neglected. The Levin-Thompson bill again seems to avoid such controversy and does little to resolve these difficulties, she feels.

Clearly many policy decisions are embedded in the "scientific" risk analysis that underlies the regulation of toxins. As to how those decisions are viewed by the judiciary, Wagner believes that courts seem to think risk assessment is predominantly a scientific enterprise, thus promoting its presentation by government agencies as if it is highly scientific. She recommends instead that courts should defer to the apparent policy choices of the regulatory agencies, provided the choices fall within their bounds of statutory discretion. Of course, drawing out the regulators’ policy judgments may cause the public to refute an agency’s policy preferences. Conversely, continuing to pretend that risk assessment is firmly grounded in science may mislead the public into believing that it must be trusted even though only scientists may comprehend it.

When the public and the courts are ever more inclined to defer to agency scientists, Wagner believes the public is disenfranchised from playing a democratic role in choosing policy options and shaping the uses of risk assessment. Considering that regulatory risk analysis has sought to adopt uncertain principles near the cutting edge of science, and that little scientific consensus is available, the public cannot be expected to simply trust in science. Any regulatory reform bill might be expected to guide the courts toward the separation of science and policy in risk-based regulation.

Wagner suggests that perhaps a limited grasp of science itself among judges may be at fault. "Skepticism about the limited scientific capabilities of the judiciary is supported by a pattern of inconsistent and often ill-advised rulings in both the review of agency regulations involving risk assessment and in adjudicating toxic tort cases," she stated, adding that instead of linking the public to the regulatory process, the courts are driving a larger wedge between agencies and the public.

She maintains strong concerns about whether the Levin-Thompson bill could succeed in counteracting the tendency of agencies to overstate the scientific basis of their risk assessments.

Making Risk Science Realistic and Accountable

Panelist Steven Lewis, a toxicologist with Exxon Biomedical Sciences in East Millstone, New Jersey, observed that scientists have seen an intrusion of law and policy into risk science, particularly with the greater democratic involvement of nonexpert stakeholders and increased public participation. "Many scientists as well as the public doubt that lawyers and policy makers can be trusted to participate constructively," he said. "Scientists and policy makers alike are concerned with whether citizens can understand risk science well enough to take a constructive role."

Instead, he added, the public just wants to know if a chemical is safe, not how many parts per million can be allowed, and how many in the scientific community agree. If scientists can’t agree, or don’t know for sure, then why are they to be trusted any more than politicians? The public seems as disillusioned with science as with politics, Lewis believes. If scientists reach a consensus that a chemical is harmful, the public wants to know what will be done, clearly a concern for politics rather than science.

Scientists may be skeptical about calls for greater stakeholder engagement in regulatory risk assessments. Once involved, stakeholders may not comprehend the scientific basis for regulatory risk assessment and may seek to oversimplify complex problems, such as the natural variability of human response to specified chemical doses and the scientific uncertainty of health risks.

The new regulatory reform bill makes a strong statement supporting comparative risk assessment as a means of placing relative risks in a common framework understandable to all. Comparative risk assessment also is useful in setting budget and regulatory priorities "to assist in allocating resources within and across agencies to set priorities for the reduction of risks...," the bill states. It calls for developing methods to compare the magnitude of dissimilar risks to health, safety and the environment by writing into a risk assessment the comparable risks "familiar to and routinely encountered by the general public." For example, the risk from lead isolated in groundwater at a Superfund industrial site might be compared to the more familiar risk of ingesting lead in peeling paint or curbside lead deposited by auto exhaust, both of which expose many children.

The distinction between voluntary risks (e.g., diet and smoking) and involuntary risks (e.g., radiation and smog) must be made, according to the Levin-Thompson bill. It also declares the rights of stakeholders to know how risks would be reduced with each alternative regulatory action and what the substitution risks would be: risks that are created as a result of reducing or eliminating other risks. One example is the removal of asbestos from schools and office buildings.

Lewis said that many scientists agree with efforts to reformulate regulatory risk assessments to make them more realistic, better grounded in science, and less distorted by policy considerations. Thus, the bill serves indirectly to separate science and policy in risk assessment by directing regulatory agencies to make the process more transparent to the public. It raises the importance of disclosing policy-based risk factors, and it recognizes social costs that offset risk reduction.

For example, in the past risk scientists may have deferred to policy makers regarding whether to count all the tumors or just the malignant ones when a health risk is calculated. After counting all the tumors as a matter of policy, they may have asked which among a number of different dose-response relationships, all similarly credible, should be assumed in order to extrapolate risks from laboratory animals, mostly rodents, to humans. Lewis noted that under the Levin-Thompson bill a new analytical paradigm would call for the risk assessor to present all the plausible alternatives with their respective rationales, assumptions, and information gaps. Choosing among scientific alternatives that are driven by policy preferences would be separated from issues of science itself.

Regarding the 1995 Roth-Glenn bipartisan reform bill reported previous to the Levin-Thompson bill, Lewis said, "Among those provisions that could have most affected scientific practices were requirements to expand risk assessments and characterizations to include ranges of estimated risks, extensive discussions of uncertainty, and formal peer review of the results."

Indeed, the new bipartisan reform bill does call for reasonable ranges of risks or a probability distribution of risk in place of traditional point values, as well as a clearcut analysis of risk uncertainty and variability. The use of peer-review panels to improve the quality of risk science is prescribed in the bill, and risk calculations that conflict with empirical data must be reconciled.

Regarding more realistic risk assessments, the size of a population at risk must be reported, and risks from the exposure of sensitive subpopulations must be detailed. The real likelihood of a worst-case exposure scenario must be estimated, such as when residential re-use often is assumed for a site presently in nonresidential use.

To reduce policy distortions, the most plausible estimates of risks must be favored over risks deliberately biased conservatively. However, the new bill is less explicit than previous unpassed reform bills which admonished the use of worst-case exposure scenarios, point values instead of risk distributions, and conservatively biased default assumptions. The bill does appear to be responsive to the need for scaling risk assessment efforts to the size of population at risk and placing highest priorities on human resources at greatest risk.

Lewis has predicted a substantial change in the way science is used in regulation and the way regulatory policy uses science. He anticipates greater flexibility in risk modeling as reflected in the U.S. Environmental Protection Agency's new cancer risk assessment guidelines, wider use of Monte Carlo simulation, and greater efforts to communicate uncertain risks. Because the compromise Levin-Thompson bipartisan reform bill takes many meaningful steps in the directions foreseen by Lewis and other scientists, Lewis is in strong support of this bill.

Making Judicial Review Serve Stakeholders

Panelist Katy Kunzer, who is assistant general counsel at the Chemical Manufacturers Association in Arlington, Virginia, described judicial review as the rock upon which risk and related cost-benefit legislation introduced in 1995 has floundered. That legislation set requirements for conducting risk assessments and cost-benefit analyses and their use in making regulatory decisions. Judicial review is the process which the affected public can rely upon to hold agencies accountable for compliance with these requirements.

To preclude the courts from being overly intrusive where aspects of risk science are at issue, the 1995 legislation placed limitations on the "normal" scope of judicial review where these requirements are concerned. Many, however, argued for even greater limitations or no review at all.

"The issue of the appropriate power and scope of judicial review was very controversial because it went to the heart of the diligence which an agency would exercise to implement the legislation," Kunzer stated. That legislation, of course, never passed, leaving unresolved the proper role of the courts in reviewing the requirements for risk assessment and cost-benefit analysis. [For a concise primer on judicial review, see "What Risk Analysts Should Know About Judicial Review."]

Kunzer observed that courts currently lack specific criteria for evaluating risk assessments, which causes them to defer to an agency’s expertise in most cases; invalidated risk assessments are few and far between. She noted that a statutory mandate of criteria for risk assessment could aid the court in its review, and mandatory, rigorous peer review could serve well to screen for problems in the risk assessment, upon which courts could rely.

She agreed that courts sometimes defer inappropriately to agency risk assessments when assuming they reflect only the agency’s scientific expertise; risk assessments usually conceal various policy judgments as well. At the very least, those policy judgments should be tested against the discretion granted the agency by the statute authorizing the regulation in which the risk assessment is used. Risk legislation could make the court’s job easier by forcing the agency to separate science from policy and by requiring peer review.

"If the requirements of a legislative bill for conducting risk assessments (and cost-benefit analyses) are clearly written and give the agencies the appropriate discretion, no special type of judicial review -- that is, limitations on normal review -- is necessary," Kunzer said.

How then does the new bipartisan reform bill affect the process and approach of judicial review? The bill does provide some criteria by which to evaluate a risk assessment, although not very explicitly. It also requires peer review for risk assessments. Kunzer agreed that the bill indirectly separates science and policy by making the process more transparent. This language, if adopted by the U.S. Congress, should help to inform the arguments made in court among experts asserting whether or not and how a risk assessment that is tied to a final regulatory rule may be arbitrary and capricious under the Administrative Procedures Act.

The new bill appears to keep tight reins on judicial review; only the absence of any risk assessment supporting a "major" rule can clearly invalidate the rule. The bill seems strict in limiting judicial review when an agency deems that a rule is or is not "major." That determination cannot be set aside by a reviewing court except where it is shown to be "erroneous in light of the information available to the agency at the time the agency made the determination."

The bill strictly confines the scope of judicial review concerning risk assessment to the limited uses made allowable in the bill. These appear to be limited to (1) the possible erroneous designation of a "major" rule; (2) making judicially reviewable only those risk assessments linked to final rules; and (3) mandating a risk assessment in support of any "major" final rule. A risk assessment clearly tied to a major and final rule must be placed in the rulemaking record for review by the court to determine if the rule is arbitrary and capricious.

Conclusions

Kunzer is cautiously optimistic that the new bipartisan reform bill offers worthwhile, modest gains, although she would much prefer to preserve the traditional scope and power of judicial review as it applies to risk assessment and cost-benefit analysis.

Wagner, however, is more skeptical and believes the bill’s guidance on judicial review should be more exact. "Reforming judicial review by clearly instructing the courts to give considerable deference to agency judgments is, in my opinion, the best and perhaps the only way to curb the agencies’ inclination to overstate the technical grounding of their risk assessments," she said.

Many adjudicated science-policy issues may arise from failure of the courts to identify the limits of science. Drawing the line between science and value judgments by taking into account the current capabilities of scientific experimentation should help to focus judicial review on scientific controversies.

Lewis agrees that most often when the courts deferred to agency expertise, they actually deferred to the policy assumptions hidden within the scientific framework of risk assessment. "If those assumptions had been more transparent, courts might have found some of them arbitrary and capricious under the Administrative Procedures Act, and, therefore, beyond the allowable limits of agency discretion," he said. That outcome of judicial review could have the effect of removing issues of science such as uncertainty from intertwined science-policy disputes.

Lewis would limit judicially reviewable issues pertaining to risk assessment rules to just the policy choices, while Wagner would instruct the courts to give greater deference to an agency’s policy judgments. Limited judicial review of an agency’s accuracy in scientific factfinding that authenticates a risk assessment would be continued.

Go to:

RiskWorld News Department

RiskWorld Home Page