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FSMA Key Requirements: Food Safety Plans and Preventive Controls Qualified Individuals

In case you were not already overwhelmed with the acronyms used in the food industry and associated regulations, the Food Safety Modernization Act (FSMA) of 2011 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR 117)1 sparked a whole new set of alphabet soup, including FSMA, FSS, FSP, PCQI, PC, PRP, TAN and many more. Learning the acronyms, some of which are defined herein, will likely be fairly easy in comparison to understanding the regulations. The compliance dates for 21 CFR 117 have arrived with more approaching, depending on your company.2 A key requirement of 21 CFR 117 includes the preparation and implementation of a Food Safety Plan (FSP) for a facility,3 the outcome of implementing the FSP is defined as a Food Safety System (FSS). The regulation specifically states that certain tasks and responsibilities, such as building the FSP, validating preventive controls (PC),4 reviewing records, and reanalyzing the FSP, be completed or overseen by one or more Preventive Controls Qualified Individuals (PCQIs).

What is an FSP? The FSP largely focuses on assessing hazards during the manufacturing, processing, packing, and holding of food products and establishing risk-based PCs to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level (21 CFR 117.3). Written documents which include a hazard analysis, PCs, supply-chain programs, recall plan, and implementation, corrective action, and verification procedures make up the FSP. The FSP specifically addresses food safety hazards (biological, chemical (including radiological), or physical) with the potential to cause illness or injury. It is important to understand that by no means does the FSP replace current Good Manufacturing Practices (cGMPs) or other procedures, which are considered prerequisite programs (PRPs), and make up the foundation of the FSS.

Who builds and oversees the FSP? One or more PCQIs must prepare or oversee the preparation of the FSP (21 CFR 117.126), as well as perform or oversee any required “reanalysis” of the FSP (21 CFR 117.170). A PCQI is, “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” (21 CFR 117.3). So, there are two ways to qualify as a PCQI, whichever route is elected, “records that document applicable training of the preventive controls qualified individual…” must be maintained. The PCQI may be an individual employed by the company or an independent consultant from outside the company.

PCQIs at Burdock Group To stay abreast on regulations applicable to the food industry and better serve our clients, two members of Burdock Group attended the “Food Safety Preventive Controls Alliance – Preventive Controls for Human Food” course, which is recognized by FDA as “standardized curriculum”, hosted by D.L. Newslow & Associates, Inc. in Orlando, FL.5 The course consisted of exceptional instruction and lively group discussions, as the class consisted of a diverse group of representatives from chemical, spice, juice, and botanical raw ingredient manufacturing companies; warehouse storage facilities; and even an accreditation body. Upon completion of the course, everyone received the PCQI Certification. Now well-equipped, Burdock Group is looking forward to supporting our clients in complying with 21 CFR 117 Subpart C – Hazard Analysis and Risk-Based Preventive Controls.

During the course, it quickly became clear how different every facility’s FSP must be in order to address biological, chemical (including radiological), and/or physical food safety hazards with the potential to cause illness or injury. If you and/or your company are in need of additional resources related to FSMA, FSSs, or FSPs, the U.S. FDA has provided many resources for companies to understand and comply with the new regulations,6 including a FSMA Technical Assistance Network (TAN) that allows for the submittal of questions related to FSMA directly to the U.S. FDA.7 Burdock Group is always a reliable resource for information, as well. Be sure to watch for additional newsletters that dive deeper into the requirements for FSPs as related to hazard analysis and PCs for human food in the coming months!


  1. Published in the Federal Register on September 17, 2015.

  2. FSMA Compliance Dates. Site visited on January 31, 2018.

  3. “A domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of this chapter [21 CFR part 1, subpart H]” (21 CFR 177.3).

  4.  “Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packaging, or holding at the time of the analysis” (21 CFR 117.3).

  5. D. L. Newslow & Associates Workshops. Site visited on February 2, 2018.

  6. FDA Food Safety Modernization Act (FSMA). Site visited on February 1, 2018.

  7. FSMA Technical Assistance Network (TAN). Site visited on February 1, 2018.

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