Many in the agri-food industry are concerned about the “outcome-based” approach the Canadian Food Inspection Agency (CFIA) is promoting as a better and more enlightened way of achieving regulatory compliance. One of the main concerns is about what needs to be done to “validate” and subsequently “verify” that a process is achieving the intended outcome, to produce a safe product.
The CFIA employs three regulatory schemes: prescriptive, system-based and outcome-based. Most of the agency’s regulations today are based on a prescriptive approach in that technical requirements for compliance are defined in regulatory text that outlines processors or actions that must be taken by the processor. This approach lacks flexibility to adopt developments that could be more effective and less costly.
The system-based approach mandates that some processors must have a preventative control plan such as HACCP for meat or QMP for fish. These programs are well entrenched and highly refined within the vast majority of agri-food companies in the developed world.
The outcome-based approach basically allows the processor to do what can be proven to be effective in achieving a desired outcome defined by the CFIA. To add clarity, the agency specifies what it looks for to see if the desired outcome is reached. The agency’s Food Inspection Modernization plans call for making this the preferred regulatory scheme in the future.
Outcome-based regulations won’t be the dramatic shift from the agency’s current regulations as many fear it will be. Instead, much of the information in the prescriptive regulations will appear as guidelines and as model systems for achieving a regulatory outcome. Thus those currently in compliance with a prescribed process will not have to perform revalidation tests. In other words, the process is grandfathered.
Any modifications to grandfathered processes, as well as new processes and interventions, must be validated in a manner judged to be acceptable to the CFIA. One of the promises being made by the agency is to provide resources and guidance to assist food processors in developing appropriate validation programs.
Validation and verification
Validating that a modification to a grandfathered process is compliant should be a relatively inexpensive and uncomplicated process. There should be enough data around from verification tests on the original system to benchmark against. This still needs to be done with diligence. It is also prudent to keep the CFIA abreast of what you are doing.
Validating that new technology such as equipment and interventions achieve the prescribed CFIA outcomes can be very expensive and time consuming. It helps if the process has been validated elsewhere for similar products. Emerging technology will require careful collaboration with the CFIA to ensure that the right things are done. Fortunately, there have been advances in computer modelling of a number of food safety interventions, and some of these could be useful to explore as part of a validation plan:
• Pathogen modelling program (PMP). This 20-year-old program, which is available free of charge at http://portal.arserrc.gov/, is believed to be the most widely used predictive microbiological software. It is regularly updated and is a tool more suitable for the seasoned microbiologist.
• ComBase (Combined database on predictive microbiology information) is a user-friendly database (www.combase.cc) that includes more than 40,000 data curves on growth, survival or inactivation of microorganisms in foods.
• Other helpful sites include: Sym’previus (www.symprevius.org), an extensive French system.; Foodrisk.org (www.foodrisk.org); Forecast Bureau Service (www.campden.co.uk); Refrigerated Index Calculator (www.foodsafetycentre.com); AMI’s freeware (www.amif.org), which calculates heat inactivation for time-temperature profiles; and the University of Wisconsin’s THERM (temperature history evaluation for raw meat) at http://meathaccp.wisc.edu/
Moving to an outcome-based scheme will provide food processors with more flexibility in the long run. There will be some growing pains in the transition process so a little patience from all will go a long way. Critical to the program’s success will be for the CFIA to ensure that the outcomes they set are reasonable and risk-based. Processors need to be cautioned that compliance in no way ensures zero risk, so extra due diligence in validating new processes is advised.
Dr. R.J. (Ron) Wasik, PhD, MBA, CFS, is president of RJW Consulting Canada Ltd. in Delta, B.C. Contact him at firstname.lastname@example.org