AFLATOXINAFLATOXIN REGULATORY ISSUESREGULATORY ISSUES

Garnett E. Wood, Ph.D.Garnett E. Wood, Ph.D.

Food and Drug AdministrationFood and Drug Administration

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

AFLATOXINSAFLATOXINS

Naturally occurring fungal metabolitesNaturally occurring fungal metabolites Produced byProduced by Aspergillus flavus & Aspergillus flavus &

Aspergillus parasiticusAspergillus parasiticus Aflatoxin BAflatoxin B11, B, B22, G, G11, G, G22 & M & M11

Pre-harvest and post-harvest occurrencePre-harvest and post-harvest occurrence Primarily associated with corn, peanuts,Primarily associated with corn, peanuts, tree nuts, cottonseed, dairy productstree nuts, cottonseed, dairy products Stable to heat and processing proceduresStable to heat and processing procedures Associated with human liver cancerAssociated with human liver cancer

Food Drug & Cosmetic Act-402(a) 1Food Drug & Cosmetic Act-402(a) 1

“ “ A food shall be deemed A food shall be deemed adulterated if it bears or contains adulterated if it bears or contains any poisonous or deleterious any poisonous or deleterious substance which may render it substance which may render it injurious to health.”injurious to health.”

Strategies Used by FDA Strategies Used by FDA to Enforce the Actto Enforce the Act

Setting of regulatory limits (action levels)Setting of regulatory limits (action levels) Monitoring to ensure compliance with limitsMonitoring to ensure compliance with limits Taking appropriate enforcement actionTaking appropriate enforcement action Providing guidance to the food industryProviding guidance to the food industry Cooperating with other agencies on food Cooperating with other agencies on food

safetysafety

Factors to Consider in Setting Factors to Consider in Setting Regulatory LimitsRegulatory Limits

Availability of data on incidence and Availability of data on incidence and occurrenceoccurrence

Availability of toxicological dataAvailability of toxicological data

Availability of analytical methodologyAvailability of analytical methodology

The need to maintain an adequate food The need to maintain an adequate food supply at reasonable costsupply at reasonable cost

Knowledge of legislation in other Knowledge of legislation in other countries involved in international trade countries involved in international trade

FDA Regulatory Levels for FDA Regulatory Levels for Total Aflatoxins (ppb)Total Aflatoxins (ppb)

All products for humans, except milkAll products for humans, except milk 20 20 Corn for immature animals and dairy cattleCorn for immature animals and dairy cattle 20 20

Corn or peanut pdts. for breeding beef Corn or peanut pdts. for breeding beef

cattle, swine, mature poultrycattle, swine, mature poultry 100100 Corn or peanuts pdts. for finishing swineCorn or peanuts pdts. for finishing swine 200200 Corn or peanut pdts. for finishing beef cattleCorn or peanut pdts. for finishing beef cattle 300300 Cottonseed meal (as feed ingredient)Cottonseed meal (as feed ingredient) 300300 All other feedstuffsAll other feedstuffs 20 20 Milk (Aflatoxin MMilk (Aflatoxin M11)) 0.5 0.5

Current Worldwide Regulations Current Worldwide Regulations for Aflatoxinsfor Aflatoxins

Regulations vary depending on whether country Regulations vary depending on whether country setting limits is an importer or exportersetting limits is an importer or exporter

76 Countries:76 Countries: total aflatoxinstotal aflatoxins 0-35 ppb 0-35 ppb 61 Countries:61 Countries: aflatoxin Baflatoxin B11 only 1-20 ppb only 1-20 ppb EU (corn for further treatment): EU (corn for further treatment):

aflatoxin Baflatoxin B11 5 ppb 5 ppbtotal aflatoxinstotal aflatoxins 10 ppb 10 ppb

Compliance Programs for Compliance Programs for MycotoxinsMycotoxins

Mycotoxins in Domestic Foods (CFSAN)Mycotoxins in Domestic Foods (CFSAN) Mycotoxins in Imported Foods (CFSAN)Mycotoxins in Imported Foods (CFSAN) Feed Contaminants Program (CVM)Feed Contaminants Program (CVM)

These programs are updated and reissued These programs are updated and reissued periodically because of changes in periodically because of changes in methodology, and number of products to be methodology, and number of products to be collected.collected.

FDA Compliance Programs FDA Compliance Programs ObjectivesObjectives

Collect and analyze samples of food and Collect and analyze samples of food and feed to determine compliance with FDA feed to determine compliance with FDA action levelsaction levels

Remove from interstate commerce those Remove from interstate commerce those products which contain aflatoxins at levels products which contain aflatoxins at levels judged to be of regulatory significancejudged to be of regulatory significance

Determine awareness of potential problems Determine awareness of potential problems and control measures employedand control measures employed

Prevention of Aflatoxin Prevention of Aflatoxin FormationFormation

Pre-harvestPre-harvestResistant varieties (if practicable)Resistant varieties (if practicable)Crop rotation , irrigationCrop rotation , irrigationInsect managementInsect managementMinimize kernel damage during harvestingMinimize kernel damage during harvesting

Post-harvest Post-harvest Clean and dry corn to <15% moistureClean and dry corn to <15% moistureFacility with temperature-moisture controlFacility with temperature-moisture controlInsect and pest managementInsect and pest management

Decontamination StrategiesDecontamination Strategies

Physical separationPhysical separation Food processingFood processing

- - FermentationFermentation- Nixtamalization- Nixtamalization- Thermal- Thermal

Diverting contaminated grain to Diverting contaminated grain to industrial usesindustrial uses

Chemical inactivation, ammoniaChemical inactivation, ammonia