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207:" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a
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The
Delaney prohibition appears in three separate parts of the FFDCA: Section 409 on food additives; Section 512, relating to animal drugs in meat and poultry; and Section 721 on color additives. The Section 409 prohibition applied to many pesticide residues until enactment of the Food Quality
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than in the raw tomatoes used to make it. (It never applied to pesticides in raw foods.) When the law was passed, "neither advocates nor opponents of the policy, including FDA officials, believed it would have broad application, for only a handful of chemicals had then been shown to be animal
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became more powerful and able to detect smaller quantities of chemicals, and as chemicals became more widely used, regulatory agencies had an increasingly difficult time administering the
Delaney Clause as it "recognizes no distinctions based on carcinogenic
233:(FFDCA) food additive tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.
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340:, declaring that if a carcinogenic food additive creates an excess lifetime cancer risk of less than 1 additional cancer case in every 1,000,000 exposed individuals, the risk is negligible. This standard became known as the "
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and, at least in theory, it applies equally to additives used in large amounts and to those present at barely detectable levels. It thus takes no account of the actual risk a carcinogenic additive might pose."
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An Act to protect the public health by amending the
Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety.
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203:. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "
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269:, but only when the concentration of a residue of a cancer-causing pesticide increased during processing; for example when more of a pesticide was present in
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by declaring their intention to eat cranberries anyway. This episode is regarded as one of the first modern food scares based on a chemical additive.
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to promote the growth of livestock used in meat production, which remained present in the meat. It addressed the issue by using quantitative
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shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals.
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500:"Reaffirming the Delaney Anticancer Clause: The Legal and Policy Implications of an Administratively Created "De Minimis" Exception"
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229:(FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual
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eased restrictions on several pesticides which posed a "de minimis" risk to humans. This change was challenged by the
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issued a statement advising the public about the possible contamination of substantial quantities of cranberries in
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Protection Act of 1996. This legislation removed pesticide residue tolerances from
Delaney Clause constraints.
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Pesticide use was removed from the
Delaney Clause in 1996 by an amendment to Title IV of the
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The FDA was the first agency to have to confront this problem, with respect to the use of
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344:" exception to the Delaney Rule and was used throughout the FDA and other agencies.
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This source includes a useful historical survey of prior food safety regulation.
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Merrill, Richard A. "Food Safety
Regulation: Reforming the Delaney Clause" in
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Many foods contain natural substances which are carcinogenic, for example
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473:. New York, N.Y: Marcel Dekker. p. 827.
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510:(3). Food and Drug Law Institute: 393–428.
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419:"Generally Recognized as Safe (GRAS)"
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172:in the House as H.R. 13254
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261:The Delaney Clause applied to
215:"Generally recognized as safe"
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750:Food and Drug Administration
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221:Generally recognized as safe
205:generally recognized as safe
63:85th United States Congress
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399:Precautionary principle
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186:) on September 6, 1958
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321:analytical chemistry
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381:and sweet
342:de minimis
295:Washington
263:pesticides
170:Introduced
82:Public law
42:Long title
421:. Fda.gov
387:root beer
379:sassafras
299:herbicide
297:with the
243:provision
147:21 U.S.C.
137:21 U.S.C.
77:Citations
69:Effective
50:Nicknames
740:Oncology
658:Programs
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453:Archived
393:See also
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561:History
375:safrole
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271:ketchup
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512:JSTOR
383:basil
314:scare
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