Letter from Congress Member Bliley to OMB Director

May 20, 1999

The Honorable Jacob Lew
Director
Office of Management and Budget
Old Executive Office Building, Room 252
17th Street & Pennsylvania Avenue, NW
Washington, D.C. 20503

Dear Director Lew:

As you know, the Committee on Commerce has long been interested in improving the scientific basis for Federal decision making, including regulatory decisions and decisions about allocation of Federal resources. We continue to seek to improve the quality of data and information used and disseminated by Federal agencies and by non-Federal entities with financial support from the Federal government.

Accordingly, we have undertaken a number of related actions, including establishment of the Risk Assessment and Management Commission and enactment of legislative provisions designed to enhance data quality, such as those in the Safe Drinking Water Act Amendments of 1996.

I am writing today in regard to one of Congress' recent actions to improve the quality of data and information used in Federal government decisions. Specifically, the Conference Report accompanying the FY 1999 Omnibus Appropriations Act (Pub.L. 105-277) includes provisions that call upon OMB to issue regulations to ensure and maximize the quality, objectivity, utility, and integrity of data and information used, generated, or disseminated by Federal agencies and by non-Federal entities with financial support from the Federal government.

The Risk Commission's 1997 report, the language of the Safe Drinking Water Act Amendments and the legislative and oversight record of Congress make clear that improving quality, objectivity, utility, and integrity of many federal risk information systems requires a change from intentionally-biased risk assessment and characterization practices to scientifically objective and unbiased processes. I have attached some quotations which outline the proper standard. Among other items, the Committee hopes that OMB regulations will help move Federal practice in this direction.

The Committee urges you to issue the necessary OMB regulations by September 30, 1999. We also urge you to assure that OMB requires Federal agencies to develop, within one year and with public participation, conforming rules consistent with the OMB rule. Finally, it is important that the OMB and conforming agency rules contain administrative mechanisms to allow affected persons to petition for correction of information which does not comply with such rules.

I am unaware of what activities OMB has underway to develop and implement the data quality regulations. I am concerned about OMB's performance in this matter, because the Paperwork Reduction Act of 1995 required OMB to issue such regulations on data quality, and OMB seems to have accomplished little over the last nearly four years to comply.

Please be assured that I am committed to improving the quality of the data used by the Federal government. Accordingly, please provide me, within the next two weeks, with a status report on what activities OMB has underway and/or planned to issue data quality regulations and how I might provide input into this process. If you have questions concerning this request feel free to contact Nandan Kenkeremath of the Committee staff at 226-2424.

Sincerely,

Tom Bliley
Chairman

TJB:nk

cc:

The Honorable C.W. Bill Young
Chairman, Committee on Appropriations
The Honorable Jim Kolbe
Chairman, Subcommittee on Treasury, Postal Service, and General Government

Statements Supporting Scientifically Objective Risk Assessment and Characterization

Commission on Risk Assessment and Risk Management Recommendations

" A good risk management decision ...."

"Is based on a careful analysis of the weight of scientific evidence that supports conclusions about a problem's potential risks to human health and the environment." Vol. I, p. 4

"Reduce or eliminate risks in ways that:
-- Are based on the best available scientific, economic, and other technical information." Vol I, p.4.

"[T]he Commission's Risk Management Framework is intended to:

...Ensure that decisions about the use of risk assessment and economic analysis rely on the best scientific evidence and are made in the context of risk management alternatives." Vol. I, p.5.

"Making judgements about risk on the basis of scientific information is called 'evaluating the weight of the evidence.' .... It is important that risk assessors respect the objective scientific basis of risk and procedures for making inferences in the absence of adequate data. " Vol. I, p.23.

"Because so many judgements must be made based on limited information, it is critical that all reliable information be considered. Risk assessors and economists are responsible for providing decision-makers with the best technical information available or reasonably attainable, including evaluations of the weight of the evidence that supports different assumptions and conclusions." Vol. I, p.38.

"Risk comparisons should help to convey the nature and magnitude of a particular risk estimate. Such comparisons should systematically address risks associated with different options, with chemically related agents, with the same agent from different exposure sources, with different kinds of agents with the same exposure pathway, or with different agents that produce similar effects." Vol. II, p.3.

From 1997 Final Report, Vols. 1 & 2 of the Commission on Risk Assessment and Risk Management

Memorandum from Commission on Risk Assessment and Risk Management
(Addressing 7/11/97 Superfund Discussion Draft Generally Incorporating Scientifically Objective Risk Assessment Principles)

"The Risk Commission appreciates having had the opportunity to work with you on the proposed remedy selection and community participation provisions of CERCLA in your discussion draft. The provisions provide useful direction ...for performing objective, science-based assessments and characterizations of health and environmental risks."

From Memorandum to Commerce Committee majority staff dated August 29, 1997.

Letter from John Graham, Director, Harvard Center for Risk Analysis
(Addressing 7/11/97 Superfund Discussion Draft Generally Incorporating Objective Risk Assessment Principles)

"The first and most important strength of the draft is the requirement that scientific information about risk play a central role in remedial decisions as well as communication with the public. I am particularly enthusiastic about the call for OBJECTIVE risk assessments that are based on THE WEIGHT OF THE EVIDENCE, with an emphasis on the BEST, RELEVANT AND CURRENT INFORMATION (section 127). These are the kinds of authorizing language that will stimulate use of sound risk assessment practices and promote quality control in such practices. The preference given to SITE-SPECIFIC information is necessary to discourage the agency from continuing its reliance on default assumptions when informative, site-specific information is available. The science-based approach to risk assessment will enhance public health by shifting remedial resources away from 'unrealistic and insignificant' risk toward important public health problems. It is precisely this change in orientation that is necessary to enhance the effectiveness and credibility of the Superfund program."

From Letter to Chairmen Bliley and Oxley dated October 1, 1997.

Twenty Scientist Letter

"Dear Congressmen Oxley and Bilirakis: We Fellows and former presidents of the Society for Risk Analysis support the basic thrust of Title III of H.R. 9 which imposes requirements on risk analysis for prospective regulations....

...Congress should press regulators to use the best available scientific knowledge in formulating estimates.

Risk estimates should include not only upper bound estimates but also estimates based on the best scientific understanding.... the point is that risk estimators should be pushed to use the best scientific understanding of the issues, not some arbitrarily conservative estimate based on assumptions rather than knowledge. Presenting only 'conservative' estimates leave decisionmakers with no scientific basis for distinguishing which risks are real; they can lead to unnecessarily costly regulation of trivial risks, diverting attention from important public health risks."

From Letter from 20 fellows and former presidents of the Society for Risk Analysis, reprinted in Joint Hearing before the Subcommittee on Commerce, Trade, and Hazardous Materials and the Subcommittee on Health and Environment, February 1 and 2, 1995.

Safe Drinking Water Act Amendments of 1996

Section 103 amending section 1412 (b)

"....the Administrator shall use --- (1) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; "

"the Administrator shall, in a document made available to the public in support of a regulation promulgated under this section, specify, to the extent practicable --

(ii) the expected risk or central estimate of risk for the specific populations;

(v) peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data."

Enterprise for the Environment Panel Report

"E4E participants believe the environmental protection system should:
.... generate, disseminate and rely on the best-available scientific and economic information;"

From the Environmental Protection System in Transition: Toward a More Desirable Future, Center for Strategic and International Studies, January 1998.

National Academy of Public Administration Recommendations

" Congress should: .... Request 'best estimates' as well as protective 'upper-bound' point estimate"

From National Academy of Public Administration, Setting Priorities, Getting Results: a New Direction for the Environmental Protection Agency, 1995.

American Bar Association Recommendations

"1. Risk assessment considers an important and useful subset of information relevant to regulatory decisions. It should provide scientific estimates and characterizations of the nature and magnitude of risks posed to human health, human safety and the integrity and quality of the environment, and should be based on careful analysis of the weight of all available evidence. The process should be constructed to avoid bias and political pressure. Other relevant information, such as economic, social and political factors that do not relate to risk assessment may also be important to a risk manager and, if so, should be considered by him or her."

From 1999 Recommendations of the American Bar Association Section of Administrative Law and Regulatory Practice

1992 EPA "Habicht" Memorandum on Risk Characterization

"[I]nformed EPA risk assessors and managers need to be completely candid about confidence and uncertainties in describing risks and in explaining the regulator decisions. Specifically, the Agency's risk assessment guidelines call for full and open discussion of uncertainties in the body of each EPA risk assessment, including prominent display of critical uncertainties. Numerical risk estimates should always be accompanied by descriptive information carefully selected to ensure an objective and balanced characterization of risk in risk assessment reports and regulatory documents."

"Regarding the interface between risk assessment and risk management, risk assessment information must be clearly presented, separate from any non-scientific risk management considerations. Discussion of risk management options should follow, based on consideration of all relevant factors, scientific and non-scientific."

"For the generators of the assessment, distinguishing between risk assessment and risk management means that scientific information is selected, evaluated, and presented without considering non-scientific factors including how the scientific analysis might influence the regulatory decision. Assessors are charged with (1) generating a credible, objective, realistic and balanced analysis ..."

"For the users of the assessment and for decisionmakers who integrate these assessments into regulatory decisions, the distinction between risk assessment, and risk management means refraining from influencing the risk description through consideration of non-scientific factors --e.g., the regulatory outcome -- and from attempting to shape the risk assessment to avoid statutory constraints, meet regulatory objectives, or serve political purposes...Matters such as risk assessment priorities, degree of conservatism, and acceptability of particular risk levels are reserved for decisionmakers who are charged with making decisions regarding protection of public health."

From 1992 EPA Guidance Memorandum