Delaney Clause

To further improve the general safety standards, the Delaney Clause was included in the Pood Additives Amendment of 1958. The Delaney Clause states that no food additive or color additive can be deemed safe if it has been found to induce cancer when ingested by humans or animals (23). The Clause acts as an absolute prohibition on the use of any additive found to cause cancer without any regard for whether, or to what extent, the substance is hazardous to human health. As scientific advances continue, both in the realm of food technology and analysis of previously undetected contaminants, the... 

The food additive and GRAS rules appHcable to human foods generally apply to animal food ingredients. However, the Delaney clause s prohibition against carcinogenic substances in food additives was amended to permit carcinogenic chemicals to be fed to animals if the animals are not adversely affected and no residue can be found after slaughter. 

D. Blumenthal, FDA Consumer, 18—21 (May 1990). An example of the confusion that can be caused by the strict enforcement of the Delaney Clause. 

Since it does not appear that a lower limit was set as to what constitutes OOS, a similarly legalistic situation holds as when the infamous Delaney clause was on the books What today still passes as < 105% (105.005. .. 105.049, assuming an instrumental resolution equivalent to 0.1), will become OOS if instrumental resolution improves by a factor of 10. 

The Delaney Clause was introduced to protect the American consumer from dangerous substances. By the if proven toxic, X is forbidden logic that did not include any reference to medical risk, the inexorable progress of instrumental analysis naturally lead to the situation where, in a few years, apple pie would have been declared off limits had the clause not been struck from the books, because it is certain to contain a one part per trillion of some X that is toxic at the kg-per-day level. 

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... 

The FDA also regulates food additives - substances, such as antioxidants, emulsifiers and non-nutritive sweeteners, that are intentionally and directly added to food to achieve some desired technical quality in the food. As noted, the Delaney clause prohibits the deliberate addition to food of any amount of a carcinogen. These additives, if they are threshold agents (not carcinogenic), can be allowed as long as the human intake does not exceed a well-documented ADI. Those who would seek approval for an additive need to supply the FDA with all of the toxicity information needed to establish a reliable ADI, and all of the product-use data that would permit the agency to assure itself that the ADI will not be exceeded when the additive is used. 

Until 1994 the EPA regulated pesticides proposed for use on food crops under certain sections of the Food, Drug, and Cosmetics Act. Carcinogenic pesticides were subject to the Delaney clause, and were thus prohibited. The use of a non-carcinogenic pesticide was allowed if its manufacturer provided data sufficient to establish an RfD, and information on expected food residue levels sufficient to document that the RfD would not be exceeded when people consumed food containing residues of the pesticide. The tool for determining compliance with this criterion is called a tolerance, and it is expressed as the maximum amount of a pesticide that can be present in a given amount of food, if the RfD is not to be exceeded. 

In 1958, in response to the increased awareness that chemicals can cause cancer, the US Congress passed the Delaney clause, which prohibited the addition to the food supply of any substance known to cause cancer in animals or humans. Compared with today s standards, the analytical methods to detect a potentially harmful substance were very poor. As the analytical methods improved, it became apparent that the food supply had low levels of substances that were known to cause cancer in either animals or humans. The obvious question was Is a small amount of a substance safe to consume. This question in turn raised many others about how to interpret data or extrapolate data to very low doses. The 1970s saw a flourishing of activity to develop and refine risk assessment methodologies. 

Food Additives Act (1958) - This act included the infamous "Delaney Clause" which in effect says that substances used as food additives must be classified as human carcinogens if they lead to cancer when ingested by man or animals at any level of exposure. The additives used prior to 1958 were placed on a list and called Generally... 

Finally it should be noted that prior to the FQPA in 1996, the Delaney clause prohibited the establishment of tolerances or maximum allowable levels for food additives if it has been shown to induce cancer in human or animal. This is an important change in regulations because pesticide residues were considered as food additives. Because of the FQPA, pesticide residues are no longer regarded as food additives, and there is no prohibition against setting tolerances for carcinogens. 

Amitrole is a nonselective systemic triazole herbicide. It is used for control of annual grasses and perennial and annual broadleaf weeds, for poison ivy control, and for control of aquatic weeds in marshes and drainage ditches. This compound is compatible with many other herbicides. It is available as wettable powders, soluble concentrates, and water-dispersible granules. Amitrole was involved in the Delaney Clause s first enforcement.1213... 

Since its adoption, the 1938 law has been amended repeatedly, eventually extending the FDA s regulatory powers to pesticides and food additives. In 1958, the Delaney clause was incorporated into the law. This now controversial provision prohibits the approval of any food additive found to induce cancer in humans or animals. 

Minutes, EMS Council Meeting (October 17,1972), EMS, Mailing Papers. The Delaney Clause, passed in 1958 as part of an amendment to the Food and Drug Act, banned food additives that tested positive in human or animal carcinogenicity tests. Chu to de Serres (October 24,1975), RRS, MS 1261, Box 1, Folder 18. 

An important aspect of the act is the so-called Delaney clause, which specifies that no additive shall be deemed safe if it is found to induce cancer in man or animal. Such special consideration in the case of cancer-producing compounds is not incorporated in the food laws of many other countries. 

A peculiar aspect of the federal act of 1958 is the so-called Delaney clause, which stipulates that any substance that is found to cause... 

In the United States, safety is often expressed as the principle of reasonable certainty of no harm. This principle has replaced the earlier idea of zero tolerance for toxic substances. The idea of zero tolerance is incorporated in the Delaney clause of the Food Additives Amendment. 

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