Expert-reviewed exposures

Exposure Matrices Using Job or Crop to Infer Exposure 261 Self-Reported Exposures 261 Expert-Reviewed Exposures 262 Determinants of Exposure Studies 264 Exposure Databases 264 Exposure Measurements 265 CONCLUSIONS AND RECOMMENDATIONS 266 REFERENCES 268... 

Additionally, problems may arise if the preclinical data on which the assessment is made are old and unreliable and raise specific toxicological concerns. Considering all these factors, it is probable that a robust expert review of available preclinical and human exposure data for a food additive may satisfy a regulatory body. As noted above, there is an indication in Europe that new pharmaceutical excipients already used in food for orally administered products or for topical cosmetics may not have to be considered new chemical entities, and therefore full evaluation may be bypassed. ... 

These experts collectively have knowledge of methyl parathion s physical and chemical properties, toxicokinetics, key health end points, mechanisms of action, human and animal exposure, and quantification of risk to humans. All reviewers were selected in conformity with the conditions for peer review specified in Section 104(I)(13) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended. 

Fourteen formulations of chemical alternatives were submitted to EPA under confidentiality and they were assessed based on numerous human health and ecotoxicity endpoints in addition to bioaccumulation potential and environmental persistence. They were also screened for potential exposure to workers, users and the aquatic environment. Where data gaps existed, EPA experts used models and chemical analogs to estimate the hazard for a particular endpoint. The literature and test data reviews were published in the final report, Environmentally Preferable Options for Furniture Fire Safety Low Density Furniture Foam . In addition, each hazard endpoint was ranked with a concern level (High, Moderate or Low) based on the criteria used by the EPA s New Chemicals Program to rate the concern level of new chemicals submitted under the Toxic Substance Control Act (TSCA). As seen in Figure 8.2, where the hazard endpoint rankings are bold, the value is based on experimental data. Where the hazard endpoints are presented in italic font, the value is estimated based on models or chemical analogs. In this way, detailed hazard information was summarized and presented in a clear and concise format. 

Peter Lacouture, Associate Director, Clinical Research, The Purdue Frederick Company, Norwalk, Connecticut Dr. Fumio Matsumura, Associate Director, Toxic Substances Program, Institute of Toxicology and Environmental Health, University of California, Davis, California Dr. Frederick Oehme, Director, Comparative Toxicology Laboratories, Kansas State University, Manhattan, Kansas and Dr. Jack Radomski, Private Consultant, Jonesport, Maine. These experts collectively have knowledge of heptachlor and heptachlor epoxide s physical and chemical properties, toxicokinetics, key health end points, mechanisms of action, human and animal exposure, and quantification of risk to humans. All reviewers were selected in conformity with the conditions for peer review specified in Section 104(i)(13) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended. 

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