Considerations in Estimating Social and Economic Impacts of Immunotoxic Agents

ABSTRACT

To make appropriate regulatory policy decisions, the potential social and economic impacts of the policy must first be established. For environmental and occupational agents, social and economic impacts are derived from animal toxicology and, when available, human studies that serve as the base for risk-benefit analysis (RBA). Because immune function is associated with resistance to infectious disease, developing RBA for data derived from immunotoxicology studies will require determining the changes in the frequency or severity of infectious disease resulting from an exposure. Fortunately, considerable information is readily available for identifying the frequency of infectious diseases in the general population and its social and economic impacts and to assist the risk assessor when conducting RBA for immunotoxicology endpoints. The following is a brief review describing some issues in using immunotoxicity data when conducting RBA. It presents an economic methodology to determine the economic impacts of infectious diseases to society, sources where these types of information are available, and an example using a specific infectious disease, otitis media.

Key Words:

• risk assessment
• immunotoxicology
• economic impact
• risk factors
• immune system disorders
• cost of illness

Notes

¹Circular A-4 refines OMB's “best practices” document of 1996 (http://www.whitehouse.gov/omb/inforeg/riaguide.html), which was issued as a guidance in 2000; (http://www.whitehouse.gov/omb/memoranda/m00-08.pdf), and reaffirmed in 2001; (http://www.whitehouse.gov/omb/memoranda/m01-23.html). It replaces both the 1996 “best practices” and the 2000 “guidance for regulatory agencies.” US Office of Management and Budget. 2003. Circular A-4; September 17, 2003. Available at http://www.whitehouse.gov/omb/inforeg/circular_a4.pdf

²ICD-10-CM was sent out for public comment in June 2003 and should be available soon.

∗ Source for individual diseases USDHHS and NIH (2000).