What is a Hazard Analysis?

A Hazard Analysis is a written analysis in which you must identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control.

Hazard analysis factors can include the following:

1. The formulation of the food;
2. The condition, function, and design of the foreign supplier’s establishment and equipment;
3. Raw materials and ingredients;
4. Transportation practices;
5. Harvesting, raising, manufacturing, processing, and packing procedures;
6. Packaging and labeling activities;
7. Storage and distribution;
8. Intended or reasonably foreseeable use;
9. Sanitation, including employee hygiene; and
10. Any other relevant factors.

Sources:

• Federal Register Volume 80, Number 228, Page 74268, Section 2
• Federal Register Volume 80, Number 228, Page 74270, Section 4, Part C