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AFLATOXINREGULATORY ISSUES Garnett E. Wood, Ph.D. Food and Drug Administration Center for Food Safety and Applied Nutrition
AFLATOXINS • Naturally occurring fungal metabolites • Produced by Aspergillus flavus & Aspergillus parasiticus • Aflatoxin B1, B2, G1, G2 & M1 • Pre-harvest and post-harvest occurrence • Primarily associated with corn, peanuts, tree nuts, cottonseed, dairy products • Stable to heat and processing procedures • Associated with human liver cancer
Food Drug & Cosmetic Act-402(a) 1 “ A food shall be deemed adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health.”
Strategies Used by FDA to Enforce the Act • Setting of regulatory limits (action levels) • Monitoring to ensure compliance with limits • Taking appropriate enforcement action • Providing guidance to the food industry • Cooperating with other agencies on food safety
Factors to Consider in Setting Regulatory Limits • Availability of data on incidence and occurrence • Availability of toxicological data • Availability of analytical methodology • The need to maintain an adequate food supply at reasonable cost • Knowledge of legislation in other countries involved in international trade
FDA Regulatory Levels for Total Aflatoxins (ppb) • All products for humans, except milk 20 • Corn for immature animals and dairy cattle 20 • Corn or peanut pdts. for breeding beef cattle, swine, mature poultry 100 • Corn or peanuts pdts. for finishing swine 200 • Corn or peanut pdts. for finishing beef cattle 300 • Cottonseed meal (as feed ingredient) 300 • All other feedstuffs 20 • Milk (Aflatoxin M1) 0.5
Current Worldwide Regulations for Aflatoxins Regulations vary depending on whether country setting limits is an importer or exporter • 76 Countries: total aflatoxins 0-35 ppb • 61 Countries: aflatoxin B1 only 1-20 ppb • EU (corn for further treatment): aflatoxin B1 5 ppb total aflatoxins 10 ppb
Compliance Programs for Mycotoxins • Mycotoxins in Domestic Foods (CFSAN) • Mycotoxins in Imported Foods (CFSAN) • Feed Contaminants Program (CVM) These programs are updated and reissued periodically because of changes in methodology, and number of products to be collected.
FDA Compliance Programs Objectives • Collect and analyze samples of food and feed to determine compliance with FDA action levels • Remove from interstate commerce those products which contain aflatoxins at levels judged to be of regulatory significance • Determine awareness of potential problems and control measures employed
Prevention of Aflatoxin Formation • Pre-harvest Resistant varieties (if practicable) Crop rotation , irrigation Insect management Minimize kernel damage during harvesting • Post-harvest Clean and dry corn to <15% moisture Facility with temperature-moisture control Insect and pest management
Decontamination Strategies • Physical separation • Food processing - Fermentation - Nixtamalization - Thermal • Diverting contaminated grain to industrial uses • Chemical inactivation, ammonia