FDA Issues Guidance for Small Businesses to Comply with Preventive Controls Under FSMA

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The U.S. Food and Drug Administration (FDA) issued draft guidance to assist qualified facilities, such as very small businesses, in complying with the Preventive Controls for Human Food Rule or the Preventive Controls for Animal Food Rule under the FDA Food Safety Modernization Act (FSMA).

A business that meets the definition of a “qualified facility” is subject to modified requirements of the preventive controls rules. These modified requirements can be met by submitting a form to FDA, attesting to the business’s status as a qualified facility and attesting that the facility is implementing preventive controls to address hazards associated with its food or is in compliance with non-Federal food safety laws and regulations. This draft guidance, “Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) ” explains how to determine whether a business meets the definition of “qualified facility” and how to submit the FDA form attesting to its status as a qualified facility.

A “qualified facility” is

  • A very small business (less than $1 million is “sales”); or
  • A facility to which both of the following apply:
    • During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
    • The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

What you may find of interest is the recommended process for a 3PL warehouse to calculate the annual monetary value of food “sold”. The recommended calculation looks at the amount of insurance that a warehouse holds for its products. (See beginning page 13 of the guidance.) This draft guidance will be available for public comment for 180 days starting on May 16, 2016.

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