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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... -29 Prepared statement ..... APPENDIXES Appendix 1. - Documents referred to in the record Appendix 2. - Correspondence and related documents . ( III ) 31-41 6999 166 Pub H * 094666-5 17/22/87 FDA'S REGULATION OF CARCINOGENIC ADDITIVES.
... -29 Prepared statement ..... APPENDIXES Appendix 1. - Documents referred to in the record Appendix 2. - Correspondence and related documents . ( III ) 31-41 6999 166 Pub H * 094666-5 17/22/87 FDA'S REGULATION OF CARCINOGENIC ADDITIVES.
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... referred to are in app . 1 , p . 71. ] Dr. ALBERT . That is right . Mr. WEISS . Don't the " clarifications , " then , involve an additional step that is not usually performed in risk assessment , whereby we return to the test animals ...
... referred to are in app . 1 , p . 71. ] Dr. ALBERT . That is right . Mr. WEISS . Don't the " clarifications , " then , involve an additional step that is not usually performed in risk assessment , whereby we return to the test animals ...
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... referred to is in app . 1 , p . 106. ] Mr. WEISS . And didn't high administration officials serving on the Working Group on Food Safety of the Cabinet Council on Human Resources come to the same conclusion in January 1983 ? [ The ...
... referred to is in app . 1 , p . 106. ] Mr. WEISS . And didn't high administration officials serving on the Working Group on Food Safety of the Cabinet Council on Human Resources come to the same conclusion in January 1983 ? [ The ...
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... referred to I noted that this latest decision with respect to color additives did not drop from the sky . There was a long history of interpretations of the scope of the De- laney clause and a growing use of risk assessment procedures ...
... referred to I noted that this latest decision with respect to color additives did not drop from the sky . There was a long history of interpretations of the scope of the De- laney clause and a growing use of risk assessment procedures ...
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... referred to today's headlines regarding alleged viola- tions of the Boland amendment . This represents exactly the same kind of thing in a different arena . I believe that we , as Americans , engage at our own peril when we denigrate ...
... referred to today's headlines regarding alleged viola- tions of the Boland amendment . This represents exactly the same kind of thing in a different arena . I believe that we , as Americans , engage at our own peril when we denigrate ...
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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 proposed 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 YOUNG
Fréquemment cités
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 84 - ... that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to...
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...