FDA's Regulation of Carcinogenic Additives: Hearing Before a Subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, First Session, June 24, 1987U.S. Government Printing Office, 1987 - 252 pages |
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17 and Red acrylonitrile agency agency's animal carcinogens animal tests anticancer clause approved argument brief cancer in animals cancer risk cause cancer clarification Color Additive Amendments Commissioner Committee Cong Congress COOPER Cosmetic Act CTFA D.C. Cir D&C Orange D&C Red Delaney Clause document Drug Administration drugs and cosmetics evaluation exposure externally applied drugs FD&C FDA concluded February February 19 Federal Food Federal Register final rules Flamm Food and Drug Food Safety Fragrance Association furazolidone induce cancer ingested interpretation issue Justice Department laboratory animals lead acetate legislative history LIGHTFOOT maximum tolerated dose methylene chloride minimis doctrine minimis policy minimis risk Orange 17 panel permanent listing Petitioners posed provisional listing provisions Public Citizen public health quantitative risk assessment regulation regulatory risk of cancer risk to humans safe SCARLETT scientific judgment scientists Secretary statute statutory subcommittee substance Ted Weiss tion toxicity tumors YOUNG
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Page 225 - All laws should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression, or an absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language, which would avoid results of this character. The reason of the law in such cases should prevail over its letter.
Page 80 - Secretary (A) fails to establish that the proposed use of the food additive under the conditions of use to be specified in the regulation will be safe: provided that no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 242 - Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently.
Page 80 - Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii...
Page 239 - ... (2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section. While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f...
Page 89 - When a court reviews an agency's construction of the statute which it administers, it is confronted with two questions. First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.
Page 91 - No such regulation shall issue if a fair evaluation of the data before the Secretary — (A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe...
Page 244 - ... to an advisory committee, be issued within ninety days after the date of such filing, except that the Secretary may (prior to such ninetieth day) by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition...
Page 89 - Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.
Page 240 - Secretary shall consider among other relevant factors— (A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive; (B) the cumulative effect of such additive in the diet of man or animals, taking into account...