Delaney-clause (1).docx

Questions for Research 1. Identify the poison and its overall toxicological characteristics. Delaney Clause of the FD&C Act prohibits the approval of regulated food additives “found to induce when ingested by man or animal”

Food additives promoting carcinogenicity at high exposure doses. Acrylamide Ovarian Cancer Breast Cancer Endometrial Cancer Malignant melanoma Allura Red AC Colon tumor Aspartame Urinary track tumor Lymphoma, Leukemia and Breast tumor BHA Breast tumor BHT Bladder tumor Lung tumor Cyclamic acid and Colon and Hepatocellular tumors, its Na and Ca Salts Prostate adenocarcinoma, Thyroid and Uterus adenomas Nitrates, Nitrites Colorectal cancer Bladder tumor Non-hodgkin lymphoma Thyroid tumor Brain Hepatocellular tumor Advanced prostate cancer Saccharin and its salts Bladder tumor ; Thyroid tumor Talc Adrenal gland and lung adenoma/carcinoma Endometrial cancer (in genital usage of women as talcum powder Xylitol Adrenal medulla tumor Reference/s: Kumar, J., Das, S., Teoh, S. L. (2017 October) Frontiers in Nutrition: Dietary Acrylamide and the risks of Developing Cancer: Facts to Ponder. DOI:www.ncbi.nlm.nih.gov/pmc/articles/PMC5835509 Gultekin F, Yasar S, Gurbuz N, Ceyhan BM (2015) Food Additives of Public Concern for their Carcinogenicity. J Nutrition Health Food Sci 3(4): 1-6. DOI: http://dx.doi.org/10.15226/jnhfs.2015.00149

2. What important Toxicology Principle/s is/are supported by the topic? Enumerate and Rationalize. Delaney clause is the provision in the amendment which said that if a substance were found to cause cancer in man or animal, it could not be used as a food additive. Delaney clause uses toxicological principle called Dose-Response Principle. Dose-Response Principle evaluates the clinical effects of toxic substance based on the amount of exposure. The dose is the total amount of chemical and duration of the exposure. Chemicals cause predictable toxic effects based on the dose. It states that the patient who have higher concentration and large durations of exposure result to greater doses to the living organisms. Those receiving larger doses need more urgent attention and possibly life- saving interventions. According to Takayama, et.al (2000), Sodium cyclamate which is used as artificial sweetener are tested to monkeys and rats giving different amount of dose. Monkey’s daily intake is 100mg/kg while in rats, their daily intake is 34 mg/kg in a duration of 4 weeks resulting to testicular cancer. According to Kumar, et.al. (2018), Acrylamide, a water soluble white crystalline solid commonly used in industries, is used as a food additive in the form of acrylic acid that can develop cancer. In this study, they tested rats administering more than 17.1 mcg/day causes ovarian, breast, endometrial, pancreatic, prostate cancer and malignant melanomas. Clinical studies in rodents show carcinogenic result upon the administration of the additive. Yet, the evidence is still limited due to lack of human studies.

Reference/s: 

Kirk MA, Deaton ML. Bringing order out of chaos: effective strategies for medical response to mass chemical exposure. Emerg Med Clin North Am. 2007 May;25(2):527-48.

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Kumar, J., Das, S., & Teoh, S. L. (2018). Dietary Acrylamide and the Risks of Developing Cancer: Facts to Ponder. Frontiers in nutrition, 5, 14.

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Takayama, S., Renwick, A. G., Johansson, S. L., Thorgeirsson, U. P., Tsutsumi, M., Dalgard, D. W., & Sieber, S. M. (2000). Long-term toxicity and carcinogenicity study of cyclamate in nonhuman primates. Toxicological Sciences, 53(1), 33-39.

3. Delaney Clause, also known as the 1958 Delaney Amendment to the Federal Food Drug and Cosmetic Act created an absolute prohibition against the deliberate introduction of any level of carcinogen into the food supply. There is however, an emerging scientific controversy over its application, and many now question the merits of the clause as it is written. This amendment

was very narrowly drawn. It was about processed foods, it was about cancer, but not the full picture. Therefore, We think that it is important with all public health and environmental laws to constantly take advantage of the new science, to address emerging problems, to prevent problems. There have been many controversies on this policy. Scientists who are rethinking the significance of the "zero risk" requirement of the Delaney Clause do not believe the public should be unconcerned about chemicals added to food. They simply believe the clause is no longer consistent with current scientific knowledge, and they argue that chemicals added in trace quantities, for worthwhile reasons, should be considered from a different perspective. No one can doubt that this is, in principle, good public health policy. The clause addresses the safety of food intended for human consumption. Since the policy also addresses the use of pesticides in raw foods, especially synthetic or chemical pesticides, it's use in agriculture was also regulated. This, in effect, reduces contamination of the environment, including plants and animals, preventing dangerous effects on them as well. Some manufacturers have actually supported this policy. They have been able to develop safer alternatives, and are very interested in the fact that this law will allow them to sort of get a bump up in the registration process. There' s a preference created in terms of how we manage things in the process for what we refer to as safer alternatives. For those who are still making the basic 1950s chemical or pesticide, they may not be as happy. In conclusion, this law has protected the public on the dangers of food additives. However, the sole criterion for approval of these additives was safety; FDA was not permitted to take into account any “benefits” associated with an additive's use, not even the capacity to reduce other dietary risks. It is argued that the Delaney approach to safety regulation is not only misguided, but that relaxation of the law - for example, to permit substances that pose 'insignificant' cancer risks - would produce only marginal improvement in regulation. As a result, appeals on the law and reform proposals have been introduced. One have addressed the Delaney Clause directly and modified its terms to permit FDA (or, since under this variant pesticides would stilll be subject to the standards for food additives, EPA) to “exempt” from banning any carcinogenic additive whose use would pose at most negligible or trivial risk. Reference: Corliss, J. "The Delaney Clause: Too Much of a Good Thing?" Journal of the National Cancer Institute 85 (1993): 600-603. Gold, L. S., et al. "Rodent Carcinogens: Setting Priorities." Science 258 (9 October 1992): 261-265 4.Relate the Delaney Clause in the present society The traditional interpretation of the Delaney Clause of the Food, Drug and Cosmetics Act is it prohibits the addition to the human food supply of any chemical that had caused cancer in humans or animals. The aim of this law was to prevent cancer in humans.

It introduced a zero-tolerance approach which requires an absolute ban on any compound found to induce cancer. Zero-tolerance for every recognized compound that can be shown to give rise to cancer is no longer conceded as the best method to minimize overall cancer risks in society. This approach is said to be impractical to regulating carcinogens in present-day society because nearly everything causes cancer. In fact, it has been suggested that zero-tolerance may actually be counterproductive to the policy goals of the FDC Act, because banning weak rodent carcinogens that are beneficial to our nation’s food supply (e.g., pesticides, preservatives) could alter the diet resulting in increased cancer rates. Reference : Merrill, R.A. (1997). FOOD SAFETY REGULATION: Reforming the Delaney Clause. Annual Reviews Inc.: Virginia