With the benchmarked standards for the Global Food Safety Initiative (GFSI) and the rules of the FSMA having the same goal in mind – safe food for consumers – there are many similarities between their requirements.
Each GFSI standard and FSMA rule has its own nuances, but it is estimated that compliance to one of the benchmarked standards will get you at least 80% of the way toward compliance with FSMA.
REQUIREMENTS. One of the most common challenges authors of standards and legislation have is how to write a set of requirements that is flexible enough for the variety of food and beverage products that exist. The GFSI-benchmarked standards and FSMA rules both found a similar solution to this. Both require site-specific and product-specific risk assessments which take into account known risks (based on science and history). Each organization must validate its unique strategies for achieving food safety based on its unique set of circumstances, including, but not limited, to raw material type, suppliers, facility conditions, personnel, geography, target consumer, and finished-product characteristics.
Each GFSI-benchmarked standard requires the food and beverage manufacturing facility to have a fully implemented and validated HACCP program. While FDA has HACCP requirements for juice and seafood, FSMA calls for a slightly modified version for other segments of the industry, namely Hazard Analysis and Risk-Based Preventive Controls (HARPC). Industry experts have described HARPC as a program that has leap-frogged over HACCP.
Another way of thinking of this is that HACCP is a sub-set of HARPC. Both require risk assessment, identification of controls, monitoring, corrective action, verification, validation, and recordkeeping. The key difference is that the criteria for identifying controls is different between the two. HACCP plans identify critical control points (CCPs), which have a narrower definition than the preventive controls of HARPC. The identification and management of preventive controls is arguably the largest gap between the GFSI-benchmarked standards and FSMA. The industry will need to escalate its monitoring and validation of non-CCP controls, including prerequisite programs and non-CCP process steps that contribute to food safety.
Other key areas of comparison between the FSMA and GFSI include:
- Protection against intentional alteration. The industry is required to take steps to prevent potential acts of intentional adulteration, whether that adulteration is intended to cause harm (food defense) or produce economic gain (food fraud). Food defense primarily focuses on strategies an organization can use to prevent adulteration while the product is under its control; food fraud focuses on dishonest suppliers. This is an area for which risk assessment is paramount, and for which FSMA is prescriptive. Based on the Proposed Rule for Mitigation Strategies to Prevent Intentional Adulteration, four activities have been flagged as requiring mitigation: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing. Each facility also must have a complete risk assessment to identify other actionable process steps and ensure that mitigation strategies are implemented, monitored, verified, and recorded.
- Raw materials. The importance of raw materials and suppliers in creating safe food is recognized across the industry and highlighted by both FSMA and GFSI. Both require rigorous supplier programs that include assessing the risk, not only of each raw material, but also of the specific supplying sites. A robust supplier-verification program will include multiple factors, including, but not limited to: geography, history, location of the hazard control in the supply chain, other products handled at the suppliers’ facility, verification of suppliers’ food safety, and food-defense programs.
- Recordkeeping. Good recordkeeping practices are required for GFSI certification and this will be useful in complying with FSMA, since additional records access has been awarded to FDA. The threshold for record-sharing with FDA has been lowered from credible evidence to reasonable belief. We have already seen FDA suspend registration due to inadequate records.
Many relevant skills and habits have been imbedded in facilities that are certified to a GFSI-benchmarked standard that facilitate compliance with FSMA. In addition to components of FSMA already in effect, the industry must continue to monitor the roll out of the final rules to identify the rules that will require modification to existing programs to ensure compliance.
The author is vice president, Food Safety Services, Americas, AIB International.