Delaney Clause, prohibiting

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. 

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. 

Delaney Clause prohibited any carcinogenic additive in food, regardless of its potency, and was an early example of the application of a precautionary measure, even though the implications of the clause have been downplayed since then. 

As virtually everyone knows, the Delaney Clause prohibits the addition to food of any additive that has been found to induce cancer upon ingestion by test animals. As very few people realize, however, that general proposition is riddled with statutory exemptions, has been subjected to constant administrative exceptions created by FDA to avoid absurd results, and thus has been invoked only twice in its 24-year existence.(25) It simply is not an important factor in FDA s decision-making on food safety. If it were repealed tomorrow, and the other food safety statutory provisions remained unchanged, not a single FDA decision during the past 24 years would be changed. 

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. 

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. 

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. 

These studies persuaded the Canadian and American authorities to suspend use of the sweetener in 1977. In the USA it was banned under the Delaney Clause of the Food, Drug, and Cosmetic Act which prohibits the use of any food additive that has been shown to produce cancer in laboratory animals. There was a public outcry against the ban, as saccharin was the only general purpose artificial sweetener approved for use and available to diabetics and those with an obesity problem as well as to people who wished to reduce their consumption of sugar. The result was a moratorium on the ban in the USA to allow the evidence to be examined. Further studies were carried out and, while they confirmed the findings, it proved possible to rationalize the results in relation to human safety, as we shall see in the next chapter. In 1991 the FDA eventually withdrew its proposal to ban the sweetener.The cloud hanging over it was finally removed in 2000 when official concerns were dropped. 

As noted above, the FFDCA tasks FDA with determining whether a food contact notification has demonstrated the safety of the proposed use. The food additive Delaney clause of the FFDCA states 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... . Therefore, demonstration of carcinogenicity in any animal species is deemed sufficient to prohibit approval as a food additive. 

If the RAC, which has been treated with a pesticide, is processed, and if the concentrations of the pesticide in the final form of the processed food are greater than the concentrations found in the RAC, then a food additive tolerance must be established under Section 409 of the FFDCA. Like the 408 RAC tolerance, a Section 409 food additive tolerance must be set at a level that is not unsafe. But over and above the basic requirement of safety. Section 409 prohibits establishing a food additive tolerance when the compound has been shown to induce cancer in man or animals. This prohibition is the Delaney clause. 

The ability to detect environmental contaminants at very low levels had important regulatory implications under the 1958 Delaney Clause of the Federal Food, Drug and Cosmetic Act (FFDCA), which prohibited the presence of carcinogenic substances as additives in processed foods (47), Pesticide residues were included under this rule. The Delaney Clause, based upon the theory that no risk threshold exists for chemical carcinogens, did not permit balancing benefits of food additives with potentially low carcinogenic risk when ingested... 

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