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Executive Summary

FD&C BLUE No. 2: FDA, HRG ARGUE "BURDEN OF PROOF" QUESTION in separate briefs filed Nov. 13 in the ongoing administrative law proceedings concerning the agency's approval of the color additive. The Health Research Group (HRG) had requested the hearing to air its objections to the decision. A central issue in the documents was whether the burden of proving that the dye is safe or unsafe rests with the agency or HRG. In a "critique of HRG's proposed findings of fact and conclusions of law," FDA's Center for Food Safety & Applied Nutrition (CFSAN) said that "HRG has failed to recognize that as the hearing requester it has the burden in this proceeding of going forward with a prima facie case based on credible and credited evidence to show that the brain glioma occurrences [found in high-dose male rats in studies] preclude FDA from finding Blue No. 2 to be safe." If "HRG had met its burden," in proving the safety of FD&C Blue No. 2 is questionable, "then CFSAN and [industry petitioner Certified Color Mfrs. Assn.] CCMA would have the burden of persuasion on the safety of Blue No. 2," FDA maintained. "However, even assuming that the burden of persuasion has fallen to them, CFSAN and CCMA have met that burden," the agency continued. "The evidence presented in this proceeding clearly shows that the glioma results in the Bio-dynamics rat study do not preclude a finding of safety." FDA and CCMA "have presented convincing evidence that establishes with reasonable certainty that no harm will result from the use of Blue No. 2," the agency maintained. HRG's "response to the center's and CCMA's proposed findings of fact and conclusions of law" argued that, "contrary to the center's construction of the burden of proof in this proceeding, HRG does not have to demonstrate that FD&C Blue No. 2 is a carcinogen or that it is unsafe in order to prevail. Rather, the Food & Drug Act places the burden of proof of safety squarely on the CCMA and the Center . . . Thus, if the data do not establish safety, but instead are equivocal, the additive cannot be approved." TXHowever, "not only does HRG not have this burden, but it has more than met any responsibility to demonstrate that there are significant doubts about the safety of the additive," the consumer group contended. "In this regard, HRG fails to see how the center can seriously contest that such doubts exist, in light of the Natl. Toxicology Program's [NTP] Board of Scientific Counselors' . . . conclusion that the data on brain carcinogenicity are 'equivocal,' and in light of the FDA's own Cancer Assessment Cmte.'s . . . initial determination that the carcinogenicity of Blue No. 2 cannot be ruled out." The NTP board reviewed the data on FD&C Blue No. 2 at FDA's request.

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