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Who is “qualified” under FDA’s final rule on preventive controls for human food? Why would someone want to be “qualified?” What is the role of someone who is “qualified?” How much of a role does a “qualified” person play to ensure a safe and wholesome food supply?

The Preventative Controls for Human Foods (PCHS) Rule under the Food Safety Modernization Act has several definitions such as Qualified Auditor, Qualified Individual, and Preventive Controls Qualified Individual. I will discuss the definitions and responsibilities for the Preventive Controls Qualified Individual and the Qualified Individual only. As implementation of the PCHS rule begins for some, these individuals will play a vital role in the safety of our food supply.

The PCHS Rule was adopted on September 15, 2015 and applies to facilities that manufacture, process, pack, or hold human food. In general, facilities required to register with FDA under section 415 of the Food, Drug and Cosmetic Act are regulated. The rule sets standards for most wholesale food establishments and updates Good Manufacturing Practices. Most noteworthy is that it requires a food safety plan that identities known or reasonably foreseeable hazards; initiates, monitors, and verifies preventative controls; takes corrective action when needed; and requires documentation to demonstrate that the plan is working. It excludes farms, retail establishments, and those facilities under juice and seafood HACCP. Several other exemptions and limited exemptions within the Rule exist, but are beyond the discussion of this article.

There is some similarity between the definitions of the Qualified Individual and the Preventive Controls Qualified Individual, and thereby, some confusion. However, very distinct responsibilities and background qualifications separate the roles. The regulatory definitions of these two positions appear in bold type below.

Qualified Individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.

This definition casts a broad net that will include many wholesale food facility employees that have at least some food safety responsibilities. The Qualified Individual is expected to be able to demonstrate competence for their assigned job activities as it relates to food safety. Training in the principles of food hygiene and food safety, as appropriate to the food, the facility, and the individual’s assigned duties, must be provided and documented. There are no defined minimum training requirements within the rule for the Qualified Individual.

Preventive Controls Qualified Individual (PCQI) means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

The “standardized curriculum” is offered through the Food Safety Preventive Controls Alliance (FSPCA). The courses, found on the FSPCA website, are 2.5 days in length. The FSPCA also provides a train-the-trainer course for instructors. Courses are being scheduled throughout the nation by the FSPCA and others including food facilities, academia, consultants, and private food safety trainers. Individuals can also meet the PCQI requirements through job experience in lieu of the training requirement.

The rule is very clear in defining tasks that only a PCQI can do. The responsibilities of a PCQI include preparation of the food safety plan, validation of preventive controls, records review, and reanalysis of the plan. The PCQI may be a facility employee, but they can also use outside assistance in developing the plan and for other tasks that must be performed by the PCQI. In many situations, more than one PCQI may be needed to effectively develop and implement the food safety plan.

The mandates under the PCHF Rule establish set requirements and standards for the two positions that are vital for proper implementation. The rule places great responsibilities on the regulated community, so competent and knowledgeable food safety staff are essential. Food safety continues to become more complex and demanding as new and emerging challenges arise. Competent Qualified Individuals and Preventive Controls Qualified Individuals will go a very long way towards ensuring a safe and wholesome food supply.

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