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FDA COLOR ADDITIVE CLOSING DATA EXTENSIONS

Executive Summary

FDA COLOR ADDITIVE CLOSING DATA EXTENSIONS violate the transitional provisions of the Color Additive Amendments and the Administrative Procedure Act which prohibits "unreasonably delayed" agency action, the Health Research Group (HRG) declared in a Dec. 17 petition to FDA requesting that the agency ban 10 color additives. HRG's petition followed FDA's extension of the closing dates for 10 provisionally listed additives -- D&C Red No. 3, Yellow No. 5, Yellow No. 6, Orange No. 17, Red No. 8, Red No. 19, Red No. 9, Red No. 33, Red No. 37 and Red No. 36 -- from Dec. 1, 1984 to Feb. 1, 1985. "The 1960 Color Additive Amendments, requiring all permanently listed dyes to be proven safe, provided for a provisional list of dyes already on the market which could be marketed for 2-1/2 years or longer pending the completion of scientific studies to prove safety." HRG stated. "These 10 dyes have been on the provisional list for more than 20 years because FDA has repeatedly extended their provisional status." FDA explained in a Dec. 14 "Talk Paper" that although the agency has "previously extended the closing dates for these color additives on several occasions to study scientific and legal aspects of the safety of their uses . . . more time was required to do this than was anticipated." The consumer group cited a Nov. 23 agency memo from Center for Food Safety and Applied Nutrition Director Sanford Miller, in which Miller told Com. Young that "the only effect that we can realistically see from additional peer review [of the color additives] is a further delay that would risk a lawsuit asserting that FDA is not adhering to its responsibilities under the law." Miller said the agency has "already extended the provisional list so many times for such tenuous reasons that we are in danger of losing both a lawsuit and our credibility as a regulatory agency." HRG has previously taken FDA to court over extensions to provisional listings of color additives. In September 1977 the D.C. Federal Court turned down the group's motion for a court-ordered ban of 32 color additives.

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