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FDA Guidance on Facilities Subject to Modified Requirements Under Preventive Control Rules

Tuesday, May 17, 2016
Sandler, Travis & Rosenberg Trade Report

The preventive control rules for human and animal food that the Food and Drug Administration issued last fall under the Food Safety Modernization Act require domestic and foreign facilities required to register with the FDA as a food facility to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps they would take to prevent or significantly minimize the likelihood of those problems occurring. The rules also contain modified requirements for facilities that meet the definition of a “qualified facility” (e.g., very small businesses), which are required to submit a form to the FDA attesting to their status as a qualified facility and that they are implementing preventive controls to address hazards associated with their food or are in compliance with non-federal food safety laws and regulations.

The FDA has now issued a draft guidance document explaining how to determine whether a business is a qualified facility and how to submit forms FDA 3942a (human food) or 3942b (animal food) attesting to that status. Comments on this draft guidance will be accepted for 180 days after May 16.

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