What Industry Veterans Should Know About FSMA

Extensive experience has been gained in USDA- and FDA-regulated further processing industries. Completion of the FSPCA Preventive Controls for Human Food Blended Course has enhanced understanding of FSMA regulations and terminology, and met the qualifications required for designation as a Preventive Controls Qualified Individual (PCQI).

Although the FSMA final rule was issued in 2015 and widely adopted by most facilities, smaller operations and those subject to alternative sections—such as the Produce Safety Rule—may still be working through its complexities and provisions. Under FSMA, every facility must have a PCQI responsible for preparing or overseeing the Food Safety Plan, validating preventive controls, reviewing records, and conducting plan reanalysis. Enrollment in the course provided insight into the distinctions and overlaps between the FSMA Food Safety Plan and previously implemented food safety programs.

FSMA requires a comprehensive risk assessment or hazard analysis to identify hazards requiring preventive controls. This includes controls related to processing, sanitation, allergens, supply chains, and recall procedures. The structure of the FSMA Food Safety Plan aligns closely with established food safety systems, such as HACCP, Sanitation Standard Operating Procedures (SSOPs), environmental microbiological monitoring, supplier approval programs, allergen management, and recall readiness. While the FSMA framework expands the scope of risk assessment beyond traditional process controls, it remains grounded in HACCP methodology. The updated approach incorporates additional categories—such as allergen, sanitation, and supplier controls—that are consistent with sound food safety practices.

Key distinctions between FSMA and previous USDA/FDA regulations were emphasized during the course, including:

• Requirements for supplier verification, particularly the Foreign Supplier Verification Program (FSVP)
• Introduction of radiological hazards as a category of operational concern
• Broader application of "parameters and values" instead of the more rigid "maximum and minimum values" traditionally associated with Critical Control Points (CCPs), allowing for greater flexibility in defining preventive measures

Comprehensive food safety support is available through a team of certified experts. This group includes professionals in microbiology, chemistry, equipment engineering, and food safety, with certifications in HACCP, SQF, BRC, and other programs. Services include direct, in-plant assistance to address a wide range of regulatory and operational challenges.