1. AFLATOXIN REGULATORY ISSUES Garnett E. Wood, Ph.D. Food and Drug Administration Center for Food Safety and Applied Nutrition Center for Food Safety and Applied Nutrition

2. AFLATOXINS Naturally occurring fungal metabolites Naturally occurring fungal metabolites Produced byAspergillus flavus & Produced byAspergillus flavus & Aspergillus parasiticus Aflatoxin B 1, B 2, G 1, G 2 & M 1 Aflatoxin B 1, B 2, G 1, G 2 & M 1 Pre-harvest and post-harvest occurrence Pre-harvest and post-harvest occurrence Primarily associated with corn, peanuts, Primarily associated with corn, peanuts, tree nuts, cottonseed, dairy products tree nuts, cottonseed, dairy products Stable to heat and processing procedures Stable to heat and processing procedures Associated with human liver cancer Associated with human liver cancer

3. 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.”

4. Strategies Used by FDA to Enforce the Act Setting of regulatory limits (action levels) Setting of regulatory limits (action levels) Monitoring to ensure compliance with limits Monitoring to ensure compliance with limits Taking appropriate enforcement action Taking appropriate enforcement action Providing guidance to the food industry Providing guidance to the food industry Cooperating with other agencies on food safety Cooperating with other agencies on food safety

5. Factors to Consider in Setting Regulatory Limits Availability of data on incidence and occurrence Availability of data on incidence and occurrence Availability of toxicological data Availability of toxicological data Availability of analytical methodology Availability of analytical methodology The need to maintain an adequate food supply at reasonable cost The need to maintain an adequate food supply at reasonable cost Knowledge of legislation in other countries involved in international trade Knowledge of legislation in other countries involved in international trade

6. FDA Regulatory Levels for Total Aflatoxins (ppb) All products for humans, except milk 20 All products for humans, except milk 20 Corn for immature animals and dairy cattle 20 Corn for immature animals and dairy cattle 20 Corn or peanut pdts. for breeding beef Corn or peanut pdts. for breeding beef cattle, swine, mature poultry100 Corn or peanuts pdts. for finishing swine200 Corn or peanuts pdts. for finishing swine200 Corn or peanut pdts. for finishing beef cattle300 Corn or peanut pdts. for finishing beef cattle300 Cottonseed meal (as feed ingredient)300 Cottonseed meal (as feed ingredient)300 All other feedstuffs 20 All other feedstuffs 20 Milk (Aflatoxin M 1 ) 0.5 Milk (Aflatoxin M 1 ) 0.5

7. 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 76 Countries:total aflatoxins 0-35 ppb 61 Countries:aflatoxin B 1 only 1-20 ppb 61 Countries:aflatoxin B 1 only 1-20 ppb EU (corn for further treatment): EU (corn for further treatment): aflatoxin B 1 5 ppb total aflatoxins 10 ppb

8. Compliance Programs for Mycotoxins Mycotoxins in Domestic Foods (CFSAN) Mycotoxins in Domestic Foods (CFSAN) Mycotoxins in Imported Foods (CFSAN) Mycotoxins in Imported Foods (CFSAN) Feed Contaminants Program (CVM) Feed Contaminants Program (CVM) These programs are updated and reissued periodically because of changes in methodology, and number of products to be collected.

9. FDA Compliance Programs Objectives Collect and analyze samples of food and feed to determine compliance with FDA action levels 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 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 Determine awareness of potential problems and control measures employed

10. Prevention of Aflatoxin Formation Pre-harvest Pre-harvest Resistant varieties (if practicable) Crop rotation, irrigation Insect management Minimize kernel damage during harvesting Post-harvest Post-harvest Clean and dry corn to <15% moisture Facility with temperature-moisture control Insect and pest management

11. Decontamination Strategies Physical separation Physical separation Food processing Food processing - Fermentation - Nixtamalization - Thermal Diverting contaminated grain to industrial uses Diverting contaminated grain to industrial uses Chemical inactivation, ammonia Chemical inactivation, ammonia