AFLATOXIN REGULATORY 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