Delaney clause
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| Long title | 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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| Nicknames | Delaney clause (referring to part of the amendment) |
| Enacted by | the 85th United States Congress |
| Effective | September 6, 1958 |
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| Public law | 85-929 |
| Statutes at Large | 72 Stat. 1784 aka 72 Stat. 1786 |
| Codification | |
| Titles amended | 21 U.S.C.: Food and Drugs |
| U.S.C. sections amended |
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| Legislative history | |
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The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. 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 "generally recognized as safe" 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 food additive.
Generally recognized as safe (GRAS) is a Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (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.
The Delaney Clause is a provision in the amendment named after Congressman James Delaney of New York. It said:
The Delaney Clause applied to pesticides in processed foods, 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 ketchup 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 carcinogens."
The Delaney Clause was invoked in 1959 when Arthur Sherwood Flemming, the Secretary of the Department of Health, Education and Welfare issued a statement advising the public about the possible contamination of substantial quantities of cranberries in Oregon and Washington with the herbicide aminotriazole, which the FDA had recently determined was a carcinogen (see Cranberry scare of 1959). Taking place the week of Thanksgiving, the announcement was referred to by many in the cranberry industry as "Black Monday" − sales plummeted, even though many government officials attempted to defuse the scare 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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