Author

Fabiola Negron

Director of Food Safety

Do FCEs need a PCQI?

Nov 26, 2021

FDA requires most FDA-registered food establishments to create and implement a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Food Safety Plan. Companies subject to the Preventive Controls Rule (21 CFR 117) must designate a Preventive Controls Qualified Individual (PCQI) to develop the HARPC Plan.

Companies often ask Registrar Corp if their Food Canning Establishment (FCE) needs a PCQI. If your food products are subject to FCE requirements, they are likely also subject to the Preventive Controls Rule. FDA requires that a PCQI develop and implement a HARPC Plan for all products that the Rule covers.

Does your FCE require a PCQI? Registrar Corp Can Help.

Registrar Corp’s Food Safety Specialists are PCQIs and can assist your facility in developing a food safety plan. For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

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Want to know if your FCE needs a PCQI? Keep reading to learn what FDA might require from your FCE.

Low Acid Canned Foods and Acidified Foods

One of the ways FDA determines which requirements to enforce for an FCE, including Preventive Controls requirements, is by considering two categories of canned food products: Low Acid Canned Foods (LACF) and Acidified Foods (AF).

A food product is typically considered an LACF or AF if packaged in a hermetically sealed container, has a water activity greater than 0.85, and is not stored, distributed, and retailed under refrigerated conditions.. If the food has a final equilibrium pH greater than 4.6, the food is Low Acid. If a food has a final equilibrium pH of less than or equal to 4.6 due to the addition of acid ingredients to a low acid food, the food is then Acidified. If a food has a natural equilibrium pH below 4.6, it is considered a naturally acid food. Naturally acid foods like apple puree and vinegar are exempt from FCE requirements. Other categories (i.e. carbonated beverages, fermented foods) are also excluded.

Need help with FDA’s FCE regulations? Visit Registrar Corp’s FCE Wizard to identify your possible requirements.

FDA Requirements for FCE Products

Foods subject to FCE requirements, such as LACFs and AFs, are also subject to the Preventive Controls Rule and require a HARPC Plan unless an exemption applies to that particular food. For example, seafood and juice products are subject to Hazard Analysis Critical Control Point (HACCP), so those products don’t require a HARPC plan. Likewise, USDA-regulated foods are not subject to the Preventive Controls Rule.

LACF foods require a PCQI to develop and implement the HARPC Plan and Supply Chain Program for addressing chemical and physical hazards. For LACF products, microbiological hazards do not need to be addressed in a HARPC Plan if they comply with the LACF regulation (21 CFR 113).

Acidified Foods are fully subject to the HARPC Plan and Supply Chain Program requirements as well as those of the Acidified Foods regulation in (21 CFR 114). The PCQI must address acidification of the food and other preventive controls in the HARPC Plan.

Who Qualifies as a PCQI?

A PCQI is responsible for developing or overseeing the development of a HARPC Plan. To become a PCQI, an individual must successfully complete training to develop and apply risk-based preventive controls. The individual’s training must be at least equivalent to training received under a standardized curriculum the FDA recognizes. Job experience can also qualify a PCQI to develop and apply a food safety system. Get trained to become a PCQI with our 100% Online, Self-Paced PCQI Training.

Does your FCE require a PCQI? Registrar Corp Can Help.

Registrar Corp’s Food Safety Specialists are PCQIs and can assist your facility in developing a Food Safety Plan. For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

Get Assistance

Author


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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