RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MANAGING THE PROCESS -- PREFACE -- Contents -- FORMALDEHYDE The Consumer Product Safety Commission's Risk Assessment for Formaldehyde -- A. BACKGROUND AND CONTEXT -- 1. Describe the chemical and its uses. -- Production and Uses -- Release of Formaldehyde from Urea-Formaldehyde Foam Insulation (UFFI). -- 2. Describe how the question of risk was elevated to the agency agenda*. -- Irritation and Sensitization -- Carcinogenic Risk -- 3. Under what statutes and agency jurisdiction does the chemical fall? What statutory tests governed the decision? -- 4. What was the decision schedule? Note any statutory or other action deadlines. -- October 1976 -- June 10, 1980 -- November 20, 1980 -- February 5, 1981 -- April 10, 1981 -- October 26, 1981 -- April 2, 1982 -- B. IDENTIFICATION OF HAZARD (determining the presence or absence of potential toxic effects) -- 1. What health endpoints were evaluated? -- 2. What were the key data available for review? (What additional data were sought?) -- 3. Who performed the initial analysis? (What was their background? Available analytic resources?) -- Irritation and Sensitivity -- Carcinogenic Effects -- 4. How was uncertainty described in reaching final interpretations? Were crucial assumptions made explicit? -- Irritation and Sensitivity -- Carcinogenicity -- 5. What qualitative factors affected the weighting of data? -- 6. What inference options were used in the Hazard Identification step? Were they explicit and in accord with any general guidelines? -- Explicitness and Accordance with General Guidelines -- 7. Describe any internal, internal-advisory (e.g., EPA's SAB) and external (e.g., NAS) scientific review of the initial analysis. What, if any, criticism was incurred? -- 8. How were issues raised in the review(s) accommodated?.

9. What other issues arose concerning scientific data and their use? Briefly describe dissenting opinion (as pertaining to hazard identification only). -- Irritation and Sensitization -- Carcinogenicity -- 10. Is the substance subject to past or possible future regulatory actions in other programs? If so, did the program office coordinate with other agencies or programs? -- C. QUANTIFICATION AND CHARACTERIZATION OF RISK TO HUMANS -- 1. What health points were evaluated? -- 2. What were the key data available for review? (What additional data were sought?) -- Animal Data -- Human Exposure -- 3. Who performed the initial analysis? (What was their background? Available analytic resources?) -- 4. To what extent were results presented quantitatively? What factors influenced the degree of quantification? -- 5. How was uncertainty described in reaching final interpretations? Were crucial assumptions made explicit? -- 6. How were qualitative factors dealt with? -- Mechanisms of Action -- 7. What qualitative factors affected the weighting of data? -- 8. What inference options were used in the quantification of risk? Were they explicit and in accordwith any general guidelines? -- Inference Options Used in Dose-Response Assessment -- Explicitness and Accordance with General Guidelines -- 9. Describe any internal, internal-advisory (e.g., EPA's SAB), and external (e.g., NAS) scientific review of the initial analysis. What, if any, criticism was incurred? -- 10. How were issues raised in the review(s) accommodated? -- 11. What other issues arose concerning scientific data and their use? Describe dissenting opinion. -- 12. Is the substance subject to past or possible future regulatory actions in other programs? If so, did the program office coordinate with other agencies or programs? (See Question B.10). -- D. INTERPRETATION.

1. What role did risk assessment have in the final agency document where standards were established to control the chemical? -- 2. Were there variations--over time or across agency programs-in the assumptions used? Were these variations significant to the final risk assessment? -- Variations Over Time -- Variations Across Agencies -- 3. To the extent there were issues/concerns about questions of science, would the outcome have been improved by -- E. PERFORMANCE CONSIDERATIONS -- 1. Ability to obtain scientific information. -- 2. Credibility of assessments, likelihood that interested parties would accept them as definitive. -- Hazard Identification -- Quantification and Characterization of Risk to Humans -- 3. What was the extent of diversity of policy orientations represented within the assessment group itself. What was the degree to which interest pressures would be exerted from outside the assessment group? What was the responsiveness of the assessment to these diverse interests? -- 4. What were the time and resources necessary to complete the risk assessment? -- Hazard Identification Assessment -- Characterization of Risk to Humans -- 5. Responsiveness of assessment agenda to public concerns, interest group concerns, professional concerns, and emergence of new scientific data. -- 6. Ability of the risk assessment to identify research needs. -- 7. Extent to which risk assessment impeded or facilitated regulation. -- 8. Were related risk assessments consistent? -- 9. Extent to which there is an explicit distinction between weights accorded to scientific factors and policy factors. -- 10. Mode and frequency of communication between assessors and regulators. -- Hazard Identification -- Characterization of Risk -- SOME IMPORTANT REFERENCES CITED IN FORMALDEHYDE CASE STUDY -- NITRITE -- A. BACKGROUND AND CONTEXT -- 1. Describe the chemical and its uses.

2. Describe how the question of risk was elevated to the agency level. -- 3. Under what statutes and agency jurisdiction does the chemical fall? What statutory tests governed the decision? -- 4. What was the decision schedule? -- B. CHARACTERIZATION OF RISK TO HUMANS (Sections B & C were combined) -- 1. What health endpoints were evaluated? -- 2. What were the key data available for review? -- 3. Who performed the initial analysis? -- 4. To what extent were the results presented quantitatively? What factors influenced the degree of quantification? -- 5. How was uncertainty described in reaching the final interpretations? Were crucial assumptions made explicit? -- 6. How were qualitative factors dealt with? -- 7. What qualitative factors affected the weighting of data? Were such criteria explicit and in accord with any general guidelines? -- 8. Describe any internal, internal advisory, and external scientific review of the initial analysis. What if any, criticism was incurred? -- 9. How were the issues raised in the review(s) accommodated? -- 10. What other issues arose concerning scientific data and their use? Briefly describe dissenting opinion. -- 11. Is the substance subject to past or possible future regulatory actions in other programs? If so, did the program office coordinate with other agencies or programs? -- C. INTERPRETATION -- 1. What role did risk assessment have in the final agency document where standards were established (proposed) to control the chemical? -- 2. Were there variations in the assumptions used? Were these variations significant? -- 3. To the extent that there were issues/concerns about questions of science, would the outcome have been improved by coherent federal guidelines on carcinogenic risk assessment? -- D. PERFORMANCE CONSIDERATIONS -- 1. Ability to obtain relevant scientific information.

2. Credibility of assessments. -- 3. What was the extent of diversity of policy orientations within the assessment group? Outside pressures? Impact of pressures? -- 4. What were the time and resources necessary to complete the risk assessment? -- 5. Responsiveness of the assessment agenda to public concerns, interest group concerns, professional concerns, and emergence of new scientific information. -- 6. Ability of the risk assessment to identify research needs. -- 7. Extent to which risk assessment impeded or facilitated regulation. -- 8. Were related risk assessments consistent? -- 9. Was there a distinction between the weights given to science and policy considerations? -- 10. Mode and frequency of communication between assessors and regulators. -- ASBESTOS -- PART I: ENVIRONMENTAL PROTECTION AGENCY'S ASSESSMENT OF ASBESTOS-CONTAINING MATERIAL IN SCHOOLS -- A. BACKGROUND AND CONTEXT -- 1. Describe the chemical and its uses. -- 2. Describe how the question of risk was elevated to the agency agenda. -- 3. Under what statutes and agency jurisdiction does the chemical fall? What statutory tests governed the decision? -- 4. What was the decision schedule? Note any statutory or other action deadlines. -- C. QUANTIFICATION AND CHARACTERIZATION OF RISK TO HUMANS (Sections B and C have been combined.) -- 1. What health endpoints were evaluated? -- 2. What were the key data available for review? (What additional data were sought?) -- Human Data -- Data on Exposed School Population -- Exposure Assessment -- 3. Who performed the initial analysis? (What was their background? Available analytic resources?) -- 4. To what extent were results presented quantitatively? What factors influenced the degree of quantification? -- 5. How was uncertainty described in reaching final interpretations? Were crucial assumptions made explicit?.

6. How were qualitative factors dealt with?.