FSMA’s Human Food Rule Requirements
Updated: Nov 22, 2018
The recent changes and version updates of GFSI Benchmark Requirements and Scheme Standards are being driven primarily by FSMA, its food defense requirements, and the industry’s focus on and need to prevent food fraud. Thus, the GFSI schemes IFS, BRC, SQF and FSSC have adjusted their standards to better align with the human food PC rule, resulting in their similar food safety outcomes as FSMA.
Following are the key updates of each, as related to FSMA, food defense, and food fraud:
IFS V6.1 added food fraud, so is now very similar to FSMA.
BRC V7 added a FSMA module and mandatory training for auditors. Also BRC will bring out Issue 8 later this year, adding food fraud, food defense, and changes need to meet GFSI 7.1, and other FSMA requirements.
SQF V8 (for food processors) strengthened food fraud, food defense, and supply chain requirements along with other structural changes to the standard.
FSSC V4.1 included little change in relation to FSMA but remains similar to FSMA in outcomes.
There also is a foundational relationship between FSMA and GFSI because HACCP is the foundation of all modern food safety systems: FSMA and GFSI are both based on HACCP. But, in FSMA, the additional concepts of “hazard- and risk-based preventive control” has been brought in, resulting in more rigorous controls on areas proven to be problematic in food safety, such as sanitation and allergens.
Even with the foundational relationship and similarities, FSMA’s preventive control concepts are not fully mirrored in the scheme standards, with no PC-like requirements on allergens, sanitation, or supply chain management, or on having a preventive controls qualified individual (PCQI). However, they do require competent, trained food safety professionals.
Additionally, FSMA tends to be more detailed or rigorous in relation to corrective action documentation, supply chain PCs, environmental monitoring, and byproducts for animal feed. The Schemes tend to be more detailed in training, recall, traceability, allergen control validation, and management commitments.
Thus, while FSMA and GFSI do both provide similar food safety outcomes, complying with one does not mean a food facility is in complete compliance with the other. This is an area that many in the industry, including us at TAG, are looking to address; to determine if there a way to have a single system that covers FSMA and GFSI requirements, so facilities no longer need “two sets of books.”
All that said, it is important to remember that FSMA is a federal regulatory program, so its recordkeeping (and other) requirements are mandatory, while GFSI’s are voluntary. This also results in FSMA’s inclusion of exemptions and administrative burden-of-proof requirements to attain them that are not found, or needed, in GFSI.
Cameron Prince is Senior Director, Food Safety for The Acheson Group (TAG). Prince is a certified lead auditor for BRC and FSSC 2200, certified HACCP trainer (NSF), and a FSMA Preventive Controls certified lead instructor. Contact TAG to learn more about our FSMA and GFSI consulting services, including consultations, program design and gap assessments.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com