The Two Critical Questions For Your Food Compliance

Is my business a ‘Qualified Facility’?

The new Food and Drug Administration (FDA) food regulations are now in place (21 CFR Part 117). Though many of the new requirements are similar to the old regulations, the emphasis is now on having a Food Safety Management System rather than a checklist of activities to assure compliance. “Food gas” includes any gas used in foods and beverages.

Among other important regulations, there are two significant provisions in the new regulations that could seem challenging to implement:

  • Hazard Analysis and Risk-Based Preventive Controls (HARPC)
  • Supply-Chain Program

Fortunately, the new regulations contain some small business exemptions and alternatives for these requirements. In summary, if you can be considered a “Qualified Facility” under the FDA rules, your compliance burden is reduced.

Is my business a “Qualified Facility”?

Answer these two questions to determine if your company is a Qualified Facility and exempt from a formal HARPC and a Supply-Chain Program:

  1. For the previous three years, did your company’s food sales average less than $500,000 per year (adjusted for inflation?)
  2. Was the majority of your food gas sales to a consumer, restaurant or retail food establishment within your state or within 275 miles of your plant?

If you answered “Yes” to both questions, you can claim FDA’s “qualified facility exemption.”

How does the qualified facility exemption affect me?

If you are a qualified facility, you can avoid conducting a formal HARPC and Supply-Chain Program. Instead, you need to send the FDA an “attestation” (by December 2018) that you:

  • Have identified the potential hazards associated with the food gas being produced
  • Are implementing preventive controls to address the hazards
  • And are monitoring the performance of the preventive controls to ensure that such controls are effective
  • Or are subject to food safety laws of other jurisdictions along with licenses, permits, inspections, etc.

The attestation would be resubmitted every two years (during re-registration) and anytime a change is needed.

Hazard Analysis and Risk-Based Preventive Controls (HARPC)

Even if you are qualified for the exemption, you might decide to conduct the HARPC anyway. We have prepared free HARPC templates for GAWDA distributor members’ use. If you qualify for the exemption, you do not need to make this decision until 2018. This will give you ample time to see how the HARPC templates fit into your compliance program.

If you decide to implement the HARPC templates, we have included the required Food Safety Plan elements: written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, written corrective action procedures, and verification procedures.

Supply-Chain Program

If your company can claim the “qualified facility exemption” above, you can also be exempt from the formal Supply-Chain Program. However, the new sample food gas procedures already include the necessary provisions for the Supply-Chain Program. The Compressed Gas Association is presently developing a food gas supplier qualification publication. We will harmonize with this CGA publication when it is available.

Your risk analysis for food gases will consider if a “supply-chain-applied control” is necessary. A supply-chain-applied control is required if a food safety hazard exists for your raw material and you are relying on your supplier (or their suppliers) to control the hazard. If the supply-chain-applied control is not applied directly by your supplier, you must verify/review the control.

Will you need to audit your supplier? The answer is “maybe.” If there is a food safety hazard in your raw material that will be controlled by your supplier, and there is a reasonable probability that exposure to the hazard will
result in serious adverse health consequences or death to humans, then you must either:

Conduct an onsite audit yourself or by a third-party, or

Obtain a written determination that other verification activities of the supplier provide adequate assurance that the hazards are controlled.

If an onsite audit must be conducted, the auditor must be qualified and may not have a financial conflict of interest in the results of the audit. In some cases, an inspection by federal, state or local authorities may be used instead of conducting your own audit.

Contact for:

  • An annotated copy of the new regulations
  • Sample food/beverage gas procedures
  • Sample HARPC templates
  • Invitations to the monthly GAWDA Food Gas
  • Roundtables.
Gases and Welding Distributors Association
Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Lewisville, Texas. Members can reach him at 508-883-0927 and