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

2. 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

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)
Monitoring to ensure compliance with limits
Taking appropriate enforcement action
Providing guidance to the food industry
Cooperating with other agencies on food safety

5. 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

6. 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
Milk (Aflatoxin M1)

7. Current Worldwide Regulations for Aflatoxins
Regulations vary depending on whether country setting limits is an importer or exporter
76 Countries: total aflatoxins ppb
61 Countries: aflatoxin B1 only ppb
EU (corn for further treatment):
aflatoxin B ppb
total aflatoxins ppb

8. 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.

9. 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

10. 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

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