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By Charles Breen

The Food Safety Modernization Act (FSMA) Preventive Control for Human Foods (PCHF) regulation (21 CFR 117) signed into law in 2011 offers a wealth of opportunity (and a requirement) for companies to improve their food safety procedures and protocols through the implementation of a preventive strategy against foodborne risks. As part of this regulation, food manufacturers must require that employees are qualified to perform their assigned tasks in a manner that protects food safety and prevents against adulteration. In addition, each company must have at least one employee, preferably located at the food manufacturing facility, who functions as a Preventive Controls Qualified Individual (PCQI). The PCQI functions as the responsible party overseeing the development and execution of all food safety programs and must have the knowledge, skills and abilities to perform these tasks based on their education, on the job experience or a combination.

Also, as part of FSMA, the Foreign Supplier Verification Program (FSVP) Final Rule for importers of human and animal food requires in Part 1 Subpart L that food manufacturers enlist a “Qualified Individual” who has responsibility for ensuring that all foreign suppliers of foods or food ingredients imported for consumption or further manufacturing in the U.S. produce their products in a manner consistent with FSMA requirements. This FSVP Qualified Individual (QI) must also have the knowledge, skills and abilities (KSAs) appropriate to evaluate foreign supplier compliance through their education OTJ experience or a combination of both. 

The FSMA PCHF regulation calls for a PCQI while the FSVP regulation calls for a QI. Though the terms are nearly the same and the regulations are related, they have different meanings. What exactly is the difference, in FDA’s view, of a PCQI and a QI, and how can companies determine that they are meeting FDA’s intent?

PCHF’s PCQI

PCHF’s big focus is on preventive controls for all food manufacturing facilities producing foods or food ingredients that will be consumed in the US. FDA requires that risk be assessed and mitigated so the risk no longer has public health significance, and that specific controls or mitigations steps be evaluated for effectiveness by a PCQI. A new term in the PCHF Final Rule, the requirement for a PCQI applies to covered domestic and foreign facilities producing human and animal food, generally those that need to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (though there are, as expected, some exemptions). Though one PCQI can develop food safety plans for multiple facilities, it is important to note that each plan must be specific to the facility and address the unique processes and hazards within.

As a PCQI, considerations for biological, chemical and physical hazards must be thoroughly understood and assessed. Biological hazards include parasites and disease-causing bacteria; chemical hazards include radiological exposure, pesticides, drug residues, natural toxins, food decomposition, unapproved additives and food allergens; and physical hazards include items such as glass, rocks, metal parts or other foreign objects. FSMA requires that a food safety plan that specifically controls each of them must be developed by the PCQI. 

FDA accepts that either training or education (or a combination thereof) can provide the knowledge and skills required to perform PCQI duties as long as they equal a standardized curriculum recognized as adequate by FDA, such as that designed by the Food Safety and Preventive Controls Alliance (FSPCA) and instructed by FSPCA “Lead Instructors”. EAS offers the FDA-recognized FSPCA PCQI training curriculum, taught by Lead Instructors, as part of our comprehensive suite of in-house seminars and workshops.

Many who have already received training in HACCP, SQF, , BRC, IFS or FSSC22000 may still need additional training due to additional requirements for Good Manufacturing Practices requirements and Preventive Controls specified under PCHF in Part 117. FDA does not require, but it does recognize a formal FSPCA certificate verifying competency in Preventive Controls, for participants who successfully complete FSPCA PCQI workshop. 

FSVP’s QI

Companies importing finished food and food ingredients for further processing into the U.S. must have an FSVP QI to develop their FSVP food safety assessment program. An FSVP QI may be employed by the FSVP “Importer” or the Importer can contract with a private individual or consulting company like EAS Consulting Group to perform the FSVP QI responsibilities. A FSVP QI must evaluate the overall food safety risk of a food or food ingredient provided by a foreign supplier utilizing various documents originating from the foreign supplier and determine whether the foods or food ingredients meet FDA’s strict food safety requirements found in the PCHF and FSVP regulations. Much like PCHF’s PCQI, the FSVP QI will use the foreign supplier’s documents and the nature of the imported food or food ingredient to assess whether adequate controls are in place for potential biological, chemical and physical hazards. In addition, the FSVP QI will assess food safety risk by looking at whether their foreign supplier has been the subject of an FDA warning letter or import alert, their food safety performance history, results from testing, private or government audit results, and the supplier’s record of correcting problems. 

Once the QI has determined that a foreign supplier’s risks have appropriate controls, they will continue to monitor their performance by conducting appropriate supplier verification activities including some combination of onsite audits, reviewing supplier relevant food safety activities and sampling and testing of a food.  By regulation, these evaluation activities must be performed no less than every three years, or sooner if the FSVP importer becomes aware of new information concerning food safety or the foreign supplier’s performance.  It is our recommendation that these evaluation activities be updated annually as the food manufacturing environment is constantly changing and performing food safety risk assessments of a foreign manufacturer once every three (3) years may result in a significant food safety issue being allowed to continue for too long.

In addition to a QI’s assessment duties for a food importer, the FSVP Importer must also make sure their US Customs Broker identifies them for each incoming food or food ingredient shipment on the US Customs and Border Protection “ACE” electronic database as the FSVP Importer. The information must include the FSVP importer’s name, mailing address, and a unique facility identifier (UFI) recognized as acceptable to FDA. At present, FDA recognizes only DUNS numbers as an acceptable UFI.

Everyone with a role in importing foreign sourced foods should be familiar with applicable FSVP requirements including US Customs Brokers,foreign exporters, foreign food manufacturers, and US importers. This comprehensive approach is required under FSMA’s PCHF and FSVP regulations, intended to improve the nation’s level of protect food safety protection. FSPCA has developed an FDA-recognized FSVP training curriculum and EAS offers this in a workshop format in addition that of FSPCA’s Preventive Controls training curriculum. 

The microscope under which food safety assessments are evaluated has never been as detailed and is being scrutinized by FDA as now. With the possibility for potentially damaging regulatory enforcement consequences, many firms need to review, upgrade and have an outside, objective assessment of their food safety plans, whether they are domestic food manufacturers that have to comply with FSMA’s PCHF regulation or foreign food manufacturers that have to comply with both FSMA’s PCHF and FSVP regulations. An objective outside compliance assessment of a food manufacturer’s food safety plan needs to evaluate both the written plan and the effectiveness of its implementation. Third parties, such as EAS, can perform this objective outside assessment using a team approach to bring the correct level of expertise for development of an in-depth understanding of food manufacturer’s existing food safety system. The use of outside objective and qualified third-party private organizations such as EAS to evaluate and test the food manufacturer’s food safety program is part of any food manufacturer’s due diligence effort and can also offer a greater peace of mind to senior management of the facility and company owning the food manufacturing facility. Murphy’s Law says that if something can go wrong, it will. With a detailed food safety strategy in place, those risks can be identified and minimized before they become a problem.

More Like This?

EAS offers a wealth of additional learning opportunities on FSMA and FSVP. Check out the On-Demand Webinars page under Resources of our website for more topics like this including:

  • FSVP – What Does it Mean for your Business? – Presented by Charles Breen and Susan Moyers, Ph.D.
  • FSVP – What Does it Mean for your Business? – Presented in Spanish, Gustavo Gonzales, Ph.D.

Also, look for EAS in the News for articles such as:

FDLI Update: “FSMA After One Year: Advancing and Building Food Safety Systems for the 21st Century”, Steve Armstrong, EAS Independent Advisor, Food Law and Regulation


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