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, 1987, Volume 4
United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee
U.S. Government Printing Office, 1987 - 252 pages
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action Administration agency agency's Amendments animal carcinogens animals applied appropriate approved argument asked authority basis believe brief carcinogenic cause clarification color additives Commissioner Committee concern concluded Congress considered Cooper cosmetics court D&C Orange D&C Red decision Delaney Clause Department determine discussed document dose effect establish estimates evaluation exposure fact FDA's February Federal Register final food additive Food and Drug Government Group hearing House human important induce cancer intended interpretation involved issue judgment Justice legislative matter meaning minimis Office permit posed position possible present proposed provisional listing provisions public health quantitative risk assessment question reason referred regulation regulatory represent require respect response result rule safe safety ScARLETT scientific scientists Secretary standard statement statute statutory studies substance tion understanding WEISS Young
Page 244 - 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 165 - Safe" means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.
Page 95 - 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 248 - Secretary by notice to the applicant in writing postpones the effective date of the application to such time (not more than one hundred and eighty days after the filing thereof) as the Secretary deems necessary to enable him to study and investigate the application.
Page 93 - 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. If, however, the court determines Congress has not directly addressed the precise question at issue...
Page 93 - 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 244 - 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...
Page 244 - ... (iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive.
Page 251 - The regulations published under paragraph (2) or (3) of this subsection will be effective upon publication. (5) Within thirty days after publication, any person adversely affected by a regulation published pursuant to paragraph (2) or (3) of this subsection, or pursuant to subsection (e), may file objections thereto with the Secretary, specifying with particularity the provisions of the regulation deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such...