Delaney Amendment—

The government is charged by the Constitution with a responsibility for the public welfare, (a) Discuss the government s responsibility in controlling the risks in society, (b) Tobacco is not subject to the Delaney Amendment that bans material that can be demonstrated to cause cancci m animafs regardless of the quantity of material used in the tests. Why aren t all materials subject to the same ruk-s ... 

The Delaney Amendment to the Food and Drug Act addressed the control of food additives. 

The Delaney Amendment to the Food and Drug Act defined and controlled food additives any additives showing an increase in cancer tumors in rats, even if extremely large doses were used in the animal studies, had to be outlawed in foods recent debates have focused on a number of additives, including the artificial sweetener cyclamate. 

Some legal limits make no scientific sense. The Delaney Amendment to the U.S. Federal Food, Drug, and Cosmetic Act of... 

In the future new constituents may be analyzed for in an ecologically oriented society. Only a single paper on the presence of traces of urethane in diethylpyrocarbamate-treated wine was sufficient to ban its use. Under the Delaney amendment the zero-tolerance rule may require many new analytical procedures of very small amounts of certain components of wines derived directly or indirectly from additives. Obviously the future enologist will have to be as sophisticated in the chemical analytical laboratory as in sensory examination. 

A few other comments Ethanol is listed by OSHA as a suspect but unproved carcinogen, but OSHA does not have jurisdiction over beverage alcohol, nor, since it is a natural product, does the Delaney Amendment apply. This could lead to paradoxical situations. Ethanol will continue to grow explosively in volume in the next few years as a motor fuel indeed, this has happened in Brazil. The field is extremely volatile, and new developments occur every week, particularly with respect to fermentation and gasohol. Things should be clearer in about five years, and we should remind ourselves to take a similar look at ethanol then. 

Delaney amendment Amendment to the Food, Drug, and Cosmetic Act of the Food and Drug Administration of the United States. The amendment states that food additives that cause cancer in humans or animals at any level shall not be considered safe and are, therefore, prohibited. 

The ADI is usually set one hundred times lower than the no observable effect level (NOEL). A much greater safety factor is required if there is evidence that the pesticide causes cancer in test animals. Although the Delaney Amendment to the Federal Food, Drug, and Cosmetic Act prevents the addition of an animal carcinogen to foods, it does not apply to pesticide residues that occur inadvertently in the production of the crop. 

Color Additive Amendment required manufacturers to establish safety of color additives in foods, drugs, and cosmetics and prohibited the use of any color additive shown to induce cancer as per the Delaney Amendment noted above. 

Food Quality Protection Act amended the Food, Drug, and Cosmetic Act to eliminate the application of the 1958 Delaney amendment to pesticides. 

In the 1950s, the Delaney Amendment to the FD C Act authorized an investigation into the new dyes, flavorings and preservatives that were... 

Predicting regulations is not an easy forecast to make, but the zones of uncertainty are decreasing. Some statutory guidance applies. For example, the Delaney Amendment requires a simplistic risk assessment, centering solely on the questions of... 

Origin of No Residue. The 1958 amendments also had another important food safety concept, the anticancer proviso or the Delaney Amendment as it is often referred to. This provision is incorporated in Section 409 (c)(3)(A) and states "That no additive shall be deemed 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."... 

The Delaney amendment to the Food and Drug Act prohibits the use in food production of materials that exhibit any evidence of carcinogeniciry. Therefore, evea though great efforts are made to reduce solvent... 

Fig. 2. Regulatory Levels [1 ] and Detection Limits (Lj,). The upper portion of the figure traces a presumed relation between earthquake magnitude [abscissa] and cost to society [ordinate). The "Delaney amendment" viewpoint (not defined for earthquakes) might be interpreted as requiring zero societal risk and a corresponding Ij magnitude of zero, which of course is scientifically unattainable. Rather, an acceptable cost to society for undetected earthquakes, here imagined to be 0.1 M, is used to establish the requisite "regulatory" level. The lower part of the figure...

The Delaney Amendment overrides the HEW Department and absolutely prohibits use at any concentration of an additive which induces cancer in man or animal. 

In the USA, therefore, the use of plastics in contact with food is under the direct jurisdiction of the FDA who issue detailed positive lists of permitted plastics and additives. The whole cost of test and evaluation is put on the plastics and additive manufacturers. The Delaney Amendment has caused great difficulty but has not yet affected plastics. 

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