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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 B 1 , B 2 , G 1 , G 2 & M 1

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aflatoxin regulatory issues


Garnett E. Wood, Ph.D.

Food and Drug Administration

Center for Food Safety and Applied Nutrition

  • 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
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
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
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
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
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
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
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
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
Decontamination Strategies
  • Physical separation
  • Food processing

- Fermentation

- Nixtamalization

- Thermal

  • Diverting contaminated grain to industrial uses
  • Chemical inactivation, ammonia