HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. VII. Influential Scientific, Financial and Statistical Information

10/01/2002

CDC considers the information disseminated in the MMWR Recommendations and Reports, the Hazardous Substance Release/Health Effects Database, Toxicological Profiles, ATSDR Public Health Assessments, and Federal Register publications related to science as influential scientific information.

Risk Assessment

Some of the influential information that we disseminate is based on an analysis of the risks to the public of certain actions or exposures to hazardous substances. For purposes of this guidance, we are defining risk as the likelihood that injury or damage is or can be caused by a substance, technology, or activity. We use risk analysis (the integration of risk assessment with risk management and risk communication) as a tool to enhance the scientific basis for all of our regulatory decisions.

The OMB Guidelines provide special considerations that must be taken into account in certain risk assessments, those that provide the basis for the dissemination of influential information. The guidelines state that "With regard to analysis of risks to human health, safety, and the environment maintained or disseminated by the agencies, agencies shall either adopt or adapt the quality principles applied by Congress to risk information used and disseminated pursuant to the Safe Drinking Water Act Amendments of 1996 (SDWA) (42 U.S.C. 300g-1(b)(3)(A) and (B))."

The SDWA risk assessment principles are as follows:

  1. To the degree that the agency action is based on science, the agency shall use
    1. the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices
    2. data collected by accepted methods (if reliability of the method and the nature of the decision justify use of the data)
  2. In the dissemination of public information about risks, the agency shall ensure that the presentation of information about risk effects is comprehensive, informative, and understandable.
  3. In a document made available to the public in support of a regulation, the agency shall specify, to the extent practicable
    1. Each population addressed by any estimate of applicable risk effects
    2. The expected risk or central estimate of risk for the specific populations affected
    3. Each appropriate upper-bound or lower-bound estimate of risk
    4. Each significant uncertainty identified in the process of the assessment of risk effects and the studies that would assist in resolving the uncertainty and
    5. Peer-reviewed studies known to the agency that support, are directly relevant to, or fail to support any estimate of risk effects and the methodology used to reconcile the inconsistencies in the scientific data

Many of our actions are based on scientific experts' judgments using available data, are essentially qualitative and do not lend themselves to the types of quantitative risk assessments contemplated by the SDWA principles. As a result, we have adapted the general principles for risk assessments from the SDWA to fit these situations.

  1. The agency will use
    1. the best available science and supporting studies conducted in accordance with sound and objective scientific practices, including peer-reviewed science and supporting studies when available
    2. data collected by accepted methods (if reliability of the method and the nature of the decision justify use of the data)
  2. In the dissemination of public information about risks, the agency will ensure that the presentation of information about risk effects is comprehensive, informative, and understandable.

In situations where a quantitative risk assessment is conducted, we generally follow basic risk assessment principles in the NAS paradigm of 1983. Our needs for quantitative risk assessments range over a wide variety of hazards including physical hazards encountered during exposure to toxic substances and antimicrobial resistance to antibiotic therapy. Thus, we also ascribe to the statement from NAS when it revisited the risk assessment process in 1994 (Science and Judgment in Risk Assessment, NAS 1994): "Risk assessment is not a single process, but a systematic approach to organizing and analyzing scientific knowledge and information." In each of the areas we regulate, we apply risk assessment practices to the specific task that are widely accepted among relevant domestic and international public health agencies.

For quantitative risk assessments in support of the dissemination of influential information, CDC intends to apply the following principles:

  1. The agency will use
    1. the best available science and supporting studies conducted in accordance with sound and objective scientific practices, including peer-reviewed science and supporting studies when available.
    2. data collected by accepted methods (if reliability of the method and the nature of the decision justifies use of the data).
  2. In the dissemination of public information about health risks, the agency shall ensure that the presentation of information is comprehensive, informative, and understandable, within the context of its intended purpose.
  3. In a document made available to the public, the agency shall specify, to the extent practicable-
    1. Each population addressed by any estimate of applicable effects;
    2. The expected or central estimate of risk for the specific populations affected;
    3. Each appropriate upper-bound and/or lower-bound risk estimates;
    4. Data gaps and other significant uncertainties identified in the process of the risk assessment and the studies that would assist in reducing the uncertaintaies; and
    5. Additional studies not used in the risk assessment that support or fail to support the findings of the assessment and the rationale of why they were not used.