U.S. Food and Drug Administration action level

Data are scarce in mammals that link zinc concentrations in tissues with environmental zinc perturbations. In harbor porpoises, impaired homeostasis reportedly occurs when zinc exceeds 100 mg/kg FW liver however, livers of many species of marine mammals routinely exceed this value (Wood and Van Vleet 1996). Elevated zinc concentrations, in mg Zn/kg DW tissue, were >120 in cattle liver, >180 in sheep kidney, and >250 in sheep liver (Table 9.9), but their significance is unclear. No international regulations or guidelines applicable to zinc are available (USPHS 1989). No U.S. Food and Drug Administration action level or other maximum acceptable concentration exists for zinc, and therefore no Final Residue Value can be calculated (USEPA 1987). This seems to be a high priority research need. 

Past chlordane use, coupled with atmospheric transport as the major route of dissemination, produced global contamination of fish and wildlife resources and human populations. The chemical and its metabolites were frequently detected in all species examined, but usually at low concentrations. Residues in fish muscle sometimes exceeded the U.S. Food and Drug Administration action level of 0.3 mg/kg fresh weight recommended for human health protection. In general, chlordane in animals is highest near areas where the chemical has been applied to control termites concentrations are highest in fat and liver, especially in predatory species. 

This nonsystematic approach to monitoring has proven inadequate for protecting the U.S. food supply. In response, the FDA enacted the Hazard Analysis and Critical Control Points (HACCP) program of 1997 (U.S. Food and Drug Administration, 1995, 2001). In the U.S., the FDA has established action levels in suspect seafood for the toxins causing some of the shellfish poisonings (see Table 7.3). When an action level is reached, the HACCP plan must be followed to prevent unsafe product from reaching consumers. 

U.S. Food and Drug Administration (FDA) action levels in seafood for the toxins associated with shellfish poisonings. 

The threshold toxic dose for histamine in foods is not precisely known. Estimates are difficult to acquire from outbreaks of histamine poisoning because of the variability in histamine content in the fish (1,65). Simidu and Hibiki ( ) estimated the threshold toxic dose for histamine in fish to be approximately 60 mg/100 g, but their methods were not terribly precise. Based on experience acquired in the investigation of hundreds of scombroid poisoning incidents, the U.S. Food and Drug Administration recently established 50 mg/100 g as the hazard action level for histamine in tuna. They have not yet established regulatory limits for histamine in other fish or cheese. 

FDA (U.S. Food and Drug Administration). 1979. Action level for mercury in fish, shellfish, crustaceans and other aquatic animals. Withdrawal of proposed rulemaking. Dept of Health, Education and Welfare. Fed. Regist. 44(14) 3990-3993. Jan. 19. 

FDA. 1989a. Action levels for residues of heptachlor and heptachlor epoxide in food and feed. U.S. Department of Health and Human Services. Food and Drug Administration. Federal Register 54 50025- 50026. 

As a safeguard to our health, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the U.S. Public Health Service (USPHS) and the Federal Radiation Council (FRC), are among the groups that periodically monitor the level of radioactivity in the food supply. The FRC has stipulated the lower levels of radioactive contamination of foods. Should the level exceed these limits, the Agency will recommend actions which should be taken. 

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