FDA issues draft guidance for small firms to comply with FSMA
Compliance dates for some businesses begin in September 2016 for the Preventive Controls for Human Food or the Preventive Controls for Animal Food Rule.
A “very small business” is defined as one including any subsidiaries and affiliates, averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale
A “qualified facility” is subject to modified requirements of the rules and includes a very small business, which has three years to comply from when the final rule was published.
Small businesses (with fewer than 500 full-time equivalent employees) have two years and all other businesses have one year.
An alternative approach can be used if it satisfies the requirements of the regulation.
The draft guidance explains how to determine whether a business meets the definition of “qualified facility” and how to submit the associated FDA form.
It is available for public comment for 180 days starting today (May 16).
