SARA’Stoxicological profile requirements
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Richard M. Dowd
On Apr. 17, 1987, the EPA and the Agency for Toxic Substances Disease Registry (ATSDR), an independent body within the US. Department of Health and Human Services headquartered with the Center for Communicable Diseases in Atlanta, jointly published two notices in the Federal Regisrer, as required by the 1986 Superfund Amendments and Reauthorization Act (SARA). The first is a priority listing of the top 100 chemicals found at Superfund and at Resource Conservation and Recovery Act (RCRA) sites for which the agencies must prepare toxicological profiles. The second contains guidelines for the profiles, the first 25 of which must be published in October. Although ATSDR has statutory responlibility for producing the profiles, the two agencies are cooperating to prepare them quickly. The notices are important for two reasons: They establish a method for ranking hazardous chemicals that differs from methods used in the past, and they provide a basis for research programs on specific chemicals, the cost for which will be borne by industry. F’riority listing The I 0 0 priority chemicals were ranked according to degree of hazard to human beings. To determine the degree of hazard, EPA and ATSDR jointly decided tohse three criteria: the toxicity of a chemical, its frequency and amounts at sites, and levels of exposure to humans. The agencies then turned to two available sets of information: the “reportable quantities” (RQ) compilations for Superfund/RCRA chemicals, including EPA’s March 1987 final ranking for carcinogenic potentials, and in621)
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Environ. Sci. Technol.. Vol. 21. No. 7. 1987
The profile development process The top 25 chemicals consist of six metals and such organic compounds as benzo[a]pyrene, cyanide, benzene, vinyl chloride, methylene chloride, dioxins, and PCBs. Because these profiles must be published this Oct. 17, the development schedule allows little time for peer review by EPA, ATSDR, or the National Toxicology Program, not to mention scientists outside those organizations. Therefore, although the Federal Register requests comments, it is highly unlikely that revisions will be made prior to the publication deadline. The profiles will contain sections on the toxicology of each chemical compound (similar to existing information) as well as a new category that attempts to define significant human effects levels when sufficient data are available. Another new category required by SARA will identify gaps in data and consequent toxicological research needed, especially on acute, subacute, and chronic human effects levels.
the National Toxicology Program and existing research under the Toxic Substances Control Act and Federal Insecticide, Fungicide and Rodenticide Act. Congress also has stated its intention for industry to bear the costs of SARA research and has directed EPA to promulgate regulations to ensure industry compliance. These notices raise several areas of concern both to the federal agencies involved and to the chemical industry. One is the relationship between research needed to aid understanding of the broad biochemical bases of toxic effects and research directed to the Same end for a specific chemical. Without such basic research, there is great potential for replicative research that incurs significant costs without the corresponding benefit of information. But given the law’s chemical-specific thrust, should such basic research be conducted under S A M s mantle? Another issue is the extent to which chemical-specific information should be weighed in ranking individual compounds. For example, should chemical speciation of metals be explicitly considered in developing toxicological profiles or in identifying gaps in data for future research? Developing an effective SARA research program and assuring the necessary funding levels will depend in part on maximizing the use of existing governmental and industrial research and encouraging additional voluntary work. How can all the parties to this enterprise communicate more effectively than they do through the Federal Register and formal comments? Is there a need for a new advisory research program or should the role of the National Academy of Sciences, for example, be expanded or redefined? Answers to such questions are not immediately obvious, but the issues need to be resolved expeditiously to avoid redundant efforts and unnecessary costs.
The research program SARA also requires ATSDR (with EPA’s assistance) to design a research program to fill identified gaps in data. This program is to be coordinated with
Richard M. Dowd, Ph.D., is president of R. M. Dowd & Company, scientific and environmentalpolicy consultants in Washington, D. C.
formation from EPA’s Contract Laboratory Program (CLP) for chemical measurements from Superfund/RCRA sites. The CLP provided data both on occurrences of chemicals in specific media (air, water, soil) and on individual media concentrations; the mediaspecific values were then ranked for all the chemicals. The agencies next developed an algorithm by which the RQ rankings were combined with occurrence-concentration rankings to form a final SARA hazard ranking. Obviously, the validity of this system’s hazard rankings depends greatly on the accuracy with which the RQs represent true hazard and the CLP data reflect actual occurrences and concentrations. Unfortunately, because of SARA’S requirement for rapid action, there was little opportunity to scrub either data source, and errors are likely to be present.
0013938)(1871092106265J1.5010 0 1987American Chemical Society
