The FDA Defect Levels Handbook

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Defect Levels Handbook

FDA determines “Allowable Filth” in the Defect Levels Handbook

What is the “Defects Levels Handbook”?

FDA determines the maximum about filth in the Defect Levels Handbook. Within the Code of Federal Regulations, Title 21 Part 110.110 gives the Food Drug and Administration Act the authority to establish the maximum levels of acceptable food defects in food that present no hazards to human health.

The “Food Defect Action Levels” in the booklet are determined on the premise that the maximum levels pose no threat to human health.

Why Are Defect Levels Necessary?

According to the FDA, it is “economically impractical to grow, harvest, or process raw products that are totally free of non-hazardous, naturally occurring, unavoidable defects” (FDA.gov).

These natural defects include small amounts of insect filth in spices, mold on pears, and rot on potato chips. A list of Commodities and Defect Action Levels can be found on the FDA’s website or here: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/SanitationTransportation/ucm056174.htmhttps://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm056174.htm#chemical

The maximum defect levels are necessary because there needs to be a set limit for what the FDA will regard as “adulterated”. Under the Food, Drug, and Cosmetic Act, food is considered adulterated if it “bears or contains any poisonous or deleterious substance which may render it injurious to health” (U.S.C. 21 U.S. Code § 342(a)). Concealing damaged or inferior products is also a form of adulteration.

Take for example the wheat flour. During the growing season, the sun shines, field mice run, and bugs buzz. During the harvest of wheat, the combines also harvest some rodent filth and insect-damaged kernels. The FDA sets maximum levels for how many kernels can be defected. For example, there can be no more than an “average of 32 or more insect-damaged kernels per 100 grams” (MPM-V15) of insect damaged kernels. Once the kernels have been properly processed into flour, this number will drastically be reduced, for there are many refining techniques millers use to sort out damaged kernels prior to milling the wheat into flour.

These maximum levels are not levels manufactures try to stay just below, for most industries provide products far below the maximum levels of contaminants.

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