Insect Fragments and Mold in Food: Understanding FDA’s Defect Action Levels

Under Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration, or FDA, to establish maximum levels of natural or inevitable defects in foods for human use that present no health risk. Insect fragments include legs, antennae, and other insect parts that can end up in the goods. These ‘food faults’ end up in food during the raw material harvesting and production processes. Because it is economically impracticable to cultivate, harvest, or process raw goods that are completely free of non-hazardous, naturally occurring, unpredictable shortcomings, the FDA established these action levels.

These defects are so little they do not cause adverse effects on consumers. Insects, while awful, do not usually cause food-borne diseases.

It is erroneous to believe that because the FDA has defined a defect action level for a food product, the food maker merely needs to keep slightly below that level. Whereas bacterial infections, such as sapovirus, which was recently discovered in oysters recalled by the FDA, can cause disease and death.

The amounts reflect the thresholds at which the FDA will consider a food product to be “adulterated” and susceptible to enforcement action under Section 402(a)(3) of the Food, Drug, and Cosmetics Act. The FDA may evaluate and adjust the defect action levels on this list as technology advances.

If a product has no defect action level, or when findings reveal levels or kinds of defects that do not appear to satisfy the action level requirements, FDA reviews the samples and makes a case-by-case decision. In establishing the relevance and regulatory effect of the findings, FDA’s technical and regulatory specialists in filth and extraneous materials apply a range of criteria, frequently in combination.

The FDA evaluates the findings based on scientific evidence and understanding of how a food is cultivated, harvested, and processed. The application of chemical agents to manage insects, rodents, and other natural pollutants has little to no effect on natural and inevitable food faults.

Pesticides are also used for cosmetic objectives, such as preventing some food products from becoming inedible due to bug damage.

According to the Food Defects Levels Handbook, the levels mentioned in the agency’s recommendations are the maximum, while the actual concentrations in foods are frequently lower.

Fruit and vegetables (fresh, canned, and frozen), spices, shellfish, and nuts are among the items that might have minor flaws. There are 111 goods listed in total.



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