AFLATOXIN REGULATORY ISSUES

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 20
• Milk (Aflatoxin M1) 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
• 61 Countries aflatoxin B1 only 1-20 ppb
• EU (corn for further treatment)
• aflatoxin B1 5 ppb
• total aflatoxins 10 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 lt15 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