FSMA FOR SMALL MANUFACTURERS

"Do I have to register my food facility with the FDA?"

Food manufacturing facilities (of any size) must register with FDA unless exempt. There are exemptions for farms, retail food establishments, restaurants, and non-profit food establishments. All of these exemptions are defined in the applicable regulations, so if you think you might qualify under one of these exemptions you should evaluate this FDA-issued guidance document.   

The registration obligation falls to the "owner, operator or agent in charge” of a facility that is engaged in the manufacturing/processing, packaging, or holding of food for human or animal consumption in the United States.

If required to register with FDA, you must do so before the facility begins manufacturing/processing, packing, or holding operations.

Registrations must be renewed with the FDA every other year, during the period beginning on October 1 and ending on December 31 of every even-numbered year. 

FDA has issued a small entity compliance guide for completing the food facility registration process.       


"If I own or operate a small business, do FSMA's requirements apply to me?"

If your operations meet the definition of a "qualified facility,” then modified requirements do apply to your facility and the full requirements in 21 CFR Part 117, including the hazard analysis and risk-based preventive controls, do not apply.  However, even if your operations meet the definition of a "qualified facility,” there are several requirements that must be met.

In general, a "qualified facility” is a facility that meets the definition of a "very small business":

A business, 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, packaged, or held without sale (i.e. held in a warehouse for a fee).

You must make the calculation to determine your status as a "qualified facility” on an annual basis, no later than July 1 of each calendar year. FDA has a guidance document that gives very specific examples of how to calculate your eligibility as a "qualified facility,” including how to determine your annual sales of human food and what to do if you do not have 3 years of sales data.  

If you manufacture animal food, the threshold for a "very small business” is :

A business that averages less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food.

 "I've confirmed that I'm a 'qualified facility.' Now what do I have to do?"

You must file a Qualified Facility Attestation, Form FDA 3942a. This form requires you to attest to your status as a "qualified facility” and to your food safety practices/compliance. You do the second part by attesting that either 1) you have identified potential hazards associated with the food being produced, are implementing preventive controls, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or 2) your facility is in compliance with state, local or other non-Federal food safety laws. You must keep records that support either attestation option.

You should also keep the records that you use for your calculations of annual sales, as well as a record of the actual calculations that you make. While FDA does not typically ask to review these records during routine inspections, they may be reviewed if doing an inspection "for cause” (e.g. an inspection associated with an outbreak of a foodborne illness) or if FDA has reason to believe the facility does not meet the requirements of a "qualified facility.”

You must submit your first attestation (Form FDA 3942a) before beginning operations if your facility begins manufacturing, processing, packing or holding food after 9/17/18. If you began manufacturing, processing, packing, or holding food before 9/17/18, then the deadline was 12/17/18 for the first attestation to FDA. 

Beginning in 2020, you must re-submit the Form FDA 3942a to FDA every 2 years during the same time frame that you would need to renew your facility registration.        

Determine your status as a "qualified facility” on an annual basis, not later than July 1 of each calendar year. If your facility’s status changes from "qualified facility” to no longer a "qualified facility,” then you must submit Form FDA 3942a notifying FDA of that change in status by July 31 of the applicable calendar year. More information, including the forms, can be found here.

Remember, even if you are a "qualified facility,” you must certify that the facility is conducting hazard analysis/preventive control/monitoring efforts or that the facility is in compliance with any applicable state and local laws. Being a "qualified facility” under Federal laws does not give the facility an exemption from local or state laws.

 

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