Conducting an FSVP hazard analysis

A hazard analysis is the foundation of every FSVP file. You must identify and evaluate the known or reasonably foreseeable hazards for each type of food you import, to decide whether any of them require a control. The analysis must be written, whatever it concludes (21 CFR 1.504(a)).

Hazard types to consider (21 CFR 1.504(b)(1)):

• Biological — including microbiological hazards such as parasites, environmental pathogens, and other pathogens
• Chemical — including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens
• Physical — such as stones, glass, and metal fragments

Consider hazards that occur naturally, that may be introduced unintentionally, and that may be introduced intentionally for economic gain (21 CFR 1.504(b)(2)).

For each hazard, the evaluation must assess (21 CFR 1.504(c)(1)):

1. The probability that the hazard will occur in the absence of controls
2. The severity of the illness or injury if it were to occur

The result tells you which hazards require a control, and who controls each one (your supplier, their supplier, or someone after import) shapes your supplier verification activities. See Choosing FSVP supplier verification activities.

Common pitfalls:

• Treating allergens as low-risk on an undocumented assumption, such as the supplier "not running other allergens"
• Reusing one generic analysis across different foods, when the rule asks for one for each type of food
• Leaving the analysis unchanged after the supplier changes processes, ingredients, or facilities

WARNING: A qualified individual must perform the hazard analysis (21 CFR 1.503(a)). Alternatively, if another entity, such as your foreign supplier, had a qualified individual analyze the hazards, you may review and assess that analysis instead. You must document your review, including that a qualified individual did the analysis (21 CFR 1.504(d)).