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and health hazards using analog analysis, quantitative structure activity relationship models, and expert judgment. The structure activity team has identified 54 structural alert categories that may indicate a potential concern for chemicals that fall into these categories (Personal communication, L. Scarano, EPA, October 11, 2001).

The third step is to prioritize the results of the safety evaluations and to decide if further review is warranted. If it is required, the next step is a more detailed standard review. In this step, a risk assessment is conducted, human health hazard information is evaluated, and the chemical is assigned a qualitative determination of the hazard concern level. Evidence of adverse effects in human populations and conclusive evidence of severe effects in animal studies constitute a high hazard concern level. A moderate level of concern results from suggestive animal studies and analog data and knowledge that the chemical class has produced toxicity. The low concern level is for those chemicals for which no concern was identified. At this point, depending on the hazard concern level and considering the estimated exposures and releases, EPA will inform the manufacturer that the chemical presents potential risk issues and that more testing is needed. If EPA does not act to regulate the chemical, the manufacturer may commence production or importation.

REFERENCES

Bergfeld WF, Andersen FA. 2000. The cosmetic ingredient review. In: Estrin NF, Akerson JM, eds. Cosmetic Regulation in a Competitive Environment. New York: Marcel Dekker. Pp. 195–216.


CDER (Center for Drug Evaluation and Research). 2001. Milestone Status of OTC Drug Review Documents as of March 1, 2001. Online. Food and Drug Administration. Available at http://www.fda.gov/cder/otc/milestone/pdf. Accessed March 28, 2002.


Degnan FH. 2000. FDA’s Creative Application of the Law. Washington, DC: Food, Drug, and Law Institute. Pp. 19–26.


Hallagan JB, Hall RL. 1995. FEMA GRAS—A GRAS assessment program for flavor ingredients. Flavor and Extract Manufacturers Association. Regul Toxicol Pharmacol 21:422–430.


OFAS (Office of Food Additive Safety). 2003. Redbook 2000. Toxicological Principles for the Safety of Food Ingredients. Online. Available at http://www.cfsan.fda.gov/~redbook/red-toca.html. Accessed March 28, 2002.


Woods LA, Doull J. 1991. GRAS evaluation of flavoring substances by the Expert Panel of FEMA. Regul Toxicol Pharmacol 14:48–58.



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