Transcript Aflatoxin Regulatory Issues

AFLATOXIN
REGULATORY ISSUES
Garnett E. Wood, Ph.D.
Food and Drug Administration
Center for Food Safety and Applied Nutrition
AFLATOXINS
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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
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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
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Availability of data on incidence and
occurrence
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Availability of toxicological data
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Availability of analytical methodology
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The need to maintain an adequate food
supply at reasonable cost
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Knowledge of legislation in other
countries involved in international trade
FDA Regulatory Levels for
Total Aflatoxins (ppb)
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All products for humans, except milk
20
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Corn for immature animals and dairy cattle
20
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Corn or peanut pdts. for breeding beef
cattle, swine, mature poultry
100
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Corn or peanuts pdts. for finishing swine
200
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Corn or peanut pdts. for finishing beef cattle
300
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Cottonseed meal (as feed ingredient)
300
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All other feedstuffs
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Milk (Aflatoxin M1)
20
0.5
Current Worldwide Regulations
for Aflatoxins
Regulations vary depending on whether country
setting limits is an importer or exporter
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76 Countries: total aflatoxins
0-35 ppb
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61 Countries: aflatoxin B1 only 1-20 ppb
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EU (corn for further treatment):
aflatoxin B1
total aflatoxins
5 ppb
10 ppb
Compliance Programs for
Mycotoxins
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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
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Collect and analyze samples of food and
feed to determine compliance with FDA
action levels
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Remove from interstate commerce those
products which contain aflatoxins at levels
judged to be of regulatory significance
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Determine awareness of potential problems
and control measures employed
Prevention of Aflatoxin
Formation
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Pre-harvest
Resistant varieties (if practicable)
Crop rotation , irrigation
Insect management
Minimize kernel damage during harvesting
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Post-harvest
Clean and dry corn to <15% moisture
Facility with temperature-moisture control
Insect and pest management
Decontamination Strategies
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Physical separation
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Food processing
- Fermentation
- Nixtamalization
- Thermal
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Diverting contaminated grain to
industrial uses
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Chemical inactivation, ammonia