OMB and the politicization of risk assessment.

• Author: Shapiro, Sidney A.
• Position: Office of Management and Budget - Symposium

1. INTRODUCTION II. THE EXPLOITATION OF SCIENTIFIC UNCERTAINTY A. The Interaction of Law, Science, and Policy B. Uncertainty and Politization 1. Scientifically Inappropriate Default Rules 2. Ossification III. OMB'S RISK ASSESSMENT BULLETIN IV. OMB's LACK OF SCIENTIFIC EXPERTISE V. OMB's POLITICAL MOTIVES A. Ossification 1. No Assessment of Potential Problems 2. Industry-Generated Risk Assessments B. The Bending of Risk Assessment 1. Anomalous Definition of Adverse Effects 2. Central Estimate 3. Inappropriate Risk Communication C. Consulting the NRC VI. OMB's APPROPRIATE ROLE VII. CONCLUSION I. INTRODUCTION

   In 2004, sixty of the nation's most eminent scientists signed a declaration objecting to the politicization of science in the Bush Administration. (1) The administration's efforts to politicize science are documented in recent books and reports. (2) According to one author, "[t]he degree of lying, deception, and manipulation of information reported across so many federal agencies would seem to have required in the administration of George W. Bush a combination of callousness, mendacity, and hubris that is rare even in the messy history of American politics." (3)

   In January 2006, the Office of Management and Budget (OMB) proposed a draft Risk Assessment Bulletin (Bulletin) containing guidelines for the conduct of all risk assessments by government agencies. (4) The Bulletin covered any scientific or technical document that assessed possible risks to human health, safety, or the environment. (5) OMB sought comments on the proposed Bulletin from the public and from regulatory agencies, (6) and it asked the National Research Council (NRC) of the National Academy of Sciences (NAS) to conduct an independent "scientific and technical review of the proposed [B]ulletin." (7) The NRC empanelled a committee of experts on risk assessment to undertake the review, (8) and the committee sought review of its draft report from additional experts. (9)

   The committee began its work anticipating that "its role would be to recommend modifications [to the Bulletin], if necessary. [However,] [a]fter digging deeply into the bulletin and after extensive discussion, the committee reluctantly came to its conclusion that the bulletin could not be rescued." (10) The report indicates the scope of the problems found by the committee. (11) The appendix lists each OMB requirement in the proposed Bulletin line by line. (12) The committee has an objection or problem with nearly every line. (13) In January 2007, the NRC panel advised OMB that it should withdraw the proposed Bulletin, (14) which OMB did. (15) In September 2007, OMB issued a memorandum on "Updated Principles for Risk Analysis," which restates and updates an earlier OMB memorandum on risk assessment. (16) The memorandum, however, leaves open the issue for the next administration of what role OMB should play regarding agency risk assessment. (17)

   OMB's lack of scientific expertise played a role in the failure of the Bulletin, but there is also abundant evidence that OMB saw the Bulletin as an opportunity to politicize risk assessment. It is therefore worthwhile to analyze OMB's initial effort and to consider what role OMB should play in superintending the risk assessment process in the federal government. This Article proposes that OMB should restrict its role to performing an agenda-setting and coordination role.

   The argument for this conclusion proceeds in five steps. Section II explains how the relationship of science, law, and policy in regulation opens the door for politicization of science. Section III offers a description of OMB's draft Risk Assessment Bulletin. Section IV considers whether the many problems with the Bulletin identified by the NRC committee can be explained by OMB's lack of scientific expertise. This Section argues that OMB's lack of expertise is a reason for the failure of the draft Bulletin, but OMB also saw the Guidelines as an opportunity to politicize the risk assessment process in the government. Section V explains how the NRC committee's evaluation of the Bulletin reveals OMB's political motives in proposing the Bulletin. Section VI discusses an appropriate role for OMB in superintending science. It explains why OMB should restrict its role to performing an agenda setting and coordination role.

2. THE EXPLOITATION OF SCIENTIFIC UNCERTAINTY

   One of the primary ways the Bush Administration has politicized science has been to change scientific results or to repress them. The most well-known example involves Phillip Cooney, former chief of staff of the White House Council on Environmental Quality until 2005, who edited government climate reports to overemphasize the uncertainty of a human role in global climate change and deemphasize the scientific evidence of such a role. (18) Administration officials at other agencies, however, have also asked or demanded that scientists change risk assessments because the results did not support policy outcomes preferred by the Administration. (19) In other instances, administration officials have refused to permit agency scientists to publish scientific papers or make presentations at scientific meetings in order to suppress inconvenient scientific information. (20)

   The Administration has also engaged in science denial. Its obsessive refusal to acknowledge or act on the overwhelming scientific evidence of global climate change is the most obvious example of this type of politicization, (21) but it is not the only type of such activity in the Bush Administration. The Food and Drug Administration (FDA), for example, refused to approve the emergency Contraceptive Plan B, despite the fact that two scientific advisory committees had overwhelmingly found that the drug was safe and effective. In light of the advisory committee recommendations, FDA's weak efforts to justify the outcome strongly suggest the Administration was supporting the reproductive agenda of its religious supporters. (22)

   OMB's efforts to politicize risk assessment involve a more subtle form of politicization--the exploitation of scientific uncertainty. This section explains this form of politicization.

   1. The Interaction of Law, Science, and Policy

      Congress passed most of the legislation used in this country to regulate the risks that technologies pose for people and the environment in the 1960s and 1970s. (23) A common feature of this legislation is the authorization to act on the basis of anticipated harm. (24) Specifically, Congress specified "risk triggers" that establish the evidentiary burden that an agency has to meet in order to regulate. (25) Under a "risk-based threshold," for example, an agency must prove that the public or the environment is exposed to a substance or hazard at a potentially dangerous level. (26) A regulatory agency will marshal scientific evidence to determine whether a regulatory trigger has been met.

      Whether an agency has sufficient scientific evidence to satisfy a statutory risk trigger is a legal issue and not a scientific one. It is a legal issue because Congress intended agencies to make regulatory decisions on the basis of imperfect scientific knowledge. (27) Congress adopted this policy so that agencies could act in anticipation of harm to individuals and the environment. This means agencies are not required to conform to scientific standards of certainty. As Judge Skelly Wright once explained, "[a]gencies are not limited to scientific fact, to 95% certainties." (28) A determination that there is sufficient evidence to satisfy a risk trigger is therefore legally valid even if the scientific community does not universally agree about the degree of risk that exists. (29)

      Although an agency does not have to wait for universal scientific agreement in order to act, it still must have sufficient scientific evidence to satisfy a statutory trigger. An agency, for example, could not regulate a chemical to protect individuals from cancer ff there is no reasonable scientific support in the rulemaking record that the chemical presents a "risk" of Cancer. A decision to regulate without sufficient evidence would be arbitrary and capricious under the Administrative Procedure Act (APA). (30)

      The Supreme Court's recent decision in Massachusetts v. Environmental Protection Agency (Massachusetts v. EPA) (31) illustrates this interaction of law, policy, and science. The state of Massachusetts and other parties sued the Environmental Protection Agency (EPA) after it rejected a petition from the parties to regulate greenhouse emissions from new motor vehicles under section 202 of the Clean Air Act (CAA). (32) The Court held that EPA's rejection of the petition was "arbitrary and capricious." (33) EPA defended its rejection of the petition in part on the ground that NAS said a causal link between greenhouse gases and global warming could not be "unequivocally" established. (34) The Court concluded that the absence of scientific certainty was "irrelevant" because the question under the statute was whether the scientific evidence was sufficient to make an endangerment finding. (35) Section 202 mandates that the EPA "Administrator shall by regulation prescribe ... standards applicable to the emission of any air pollutant from any class ... of new motor vehicles ... which may reasonably be anticipated to endanger the public health or welfare." (36) Since Congress ordered EPA to act on less than definitive scientific evidence, the Court held the CAA required EPA to regulate unless "scientific uncertainty is so profound that it precludes EPA from making a reasoned judgment as to whether greenhouse gases contribute to global warming." (37)

      The mandate of agencies to act on the basis of anticipated harm makes scientific uncertainty an unavoidable aspect of regulatory science. An NRC report explained this problem in the context of assessing risks to human health:

      [D]ata may be incomplete, and there is often great uncertainty in...