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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Page 11
... concern ourselves with the cancer risk esti- mated for the test animals . However , aren't the clarifications , in essence , saying that the estimated cancer risk to animals is insig- nificant ? Dr. ALBERT . Yes , they are saying that ...
... concern ourselves with the cancer risk esti- mated for the test animals . However , aren't the clarifications , in essence , saying that the estimated cancer risk to animals is insig- nificant ? Dr. ALBERT . Yes , they are saying that ...
Page 12
... concern , it is equally inconsequen- tial at comparably low levels in the laboratory animals . Is that cor- rect ... concerned with in human populations . Human expo- sure in an issue such as this would presumably - would hopefully , and ...
... concern , it is equally inconsequen- tial at comparably low levels in the laboratory animals . Is that cor- rect ... concerned with in human populations . Human expo- sure in an issue such as this would presumably - would hopefully , and ...
Page 20
... concern ? [ The testimony appears in app . 1 , p . 123. ] Mr. COOPER . Yes , although I would say as to the scientific credi- bility that that is a matter on which I am not competent to have an opinion . There was debate at the time the ...
... concern ? [ The testimony appears in app . 1 , p . 123. ] Mr. COOPER . Yes , although I would say as to the scientific credi- bility that that is a matter on which I am not competent to have an opinion . There was debate at the time the ...
Page 24
... concern goes beyond the immediate public health concerns at issue here . We are not really passing judgment on the wisdom of reviewing the merits of the Delaney clause . Rather , we are concerned that whatever changes might take place ...
... concern goes beyond the immediate public health concerns at issue here . We are not really passing judgment on the wisdom of reviewing the merits of the Delaney clause . Rather , we are concerned that whatever changes might take place ...
Page 26
... concerned in the actions that were taken . And I would like to introduce for the record , sir , his complete chronology in the article that was published in Regulation , which I consider a very scholarly article , and my rebuttal to it ...
... concerned in the actions that were taken . And I would like to introduce for the record , sir , his complete chronology in the article that was published in Regulation , which I consider a very scholarly article , and my rebuttal to it ...
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Expressions et termes fréquents
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...