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Executive Summary

FDA MAY APPLY DE MINIMIS CONCEPT TO REVIEW TEN COLOR ADDITIVES currently on the provisional list, Com. Young told Public Citizen's Health Research Group June 21. In a letter denying the group's petition for the ban of the ten dyes, Young stated: "I conclude that the agency has the discretion to utilize the de minimis concept in appropriate circumstances to approve for permanent listing the color additives that are the subject of your petition." The de minimis approach could exempt compounds which have been shown to cause cancer in animals from regulatory action under the Delaney anti-cancer clause. It would allow for approval of the substances on the basis that they present an insignificant risk. The colors involved are: D&C Red Nos. 8, 9, 19, 33, 36, 37, D&C Orange No. 17, FD&C Yellow Nos. 5 and 6 and FD&C Red No. 3. In a June 26 Federal Register notice, FDA said it will extend the provisional listing of all the colors, except Yellow No. 5, from Sept. 3 to dates ranging from 90 days to five years. In the letter to the consumer group, Young said FDA intends to approve Yellow 5. Use of de minimis would set a precedent in FDA's regulation of color additives, although the agency has previously applied the concept in approving unrelated compounds such as lead acetate. Young pointed out that de minimis may be appropriate in this circumstance because "it is possible to calculate, based on the capabilities of modern science, the upper bounds of risk from carcinogens such that one can determine that, in some cases, any 'gain' from removing the carcinogen from the market would be trivial or of no value." The risk analysis will have to be done separately for each color additive, Young noted. The process would involve the calculation of the lifetime exposure, a determination of the potency of the carcinogen, and a computation of risk based on exposure and potency. The agency adopts a "conservative" method of analysis in making risk computations, Young said. He explained that analyses produce answers in terms of the "proportion of people who might, in a worst case scenario, be expected to develop cancer if the assumption that the product is a carcinogen is accepted and if the conservative assumption used in the risk assessment acutally occur." The approach would not conflict with Congress' intent in enacting the Delaney Clause because "Congress has not been extraordinarily rigid in the legislation at issue; in fact, the legislative history supports the contrary conclusion," the commissioner maintained. The agency has, however, received recent Capitol Hill pressure to ban the dyes. The House Govt. Operations Cmte. recently issued a report criticizing FDA's and HHS' "failure to enforce the FD&C Act" by not banning the dyes. Rep. Feighan (D-Ohio) introduced a bill on June 26 that would delist D&C Red Nos. 8, 9, 19, 37, D&C Orange No. 17 and FD&C Red No. 3

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