On Jan. 4, 2011 the United States launched the development of the FDA Food Safety Modernization Act (FSMA), “the most sweeping reform of U.S. food safety laws in more than 70 years.” Recognizing the need for information regarding these new regulatory requirements, the Food Processors of Canada (FPC) recently held a technical information session for its members on the impacts of the Preventive Control Rule. The session was well attended by more than 50 participants representing a wide variety of Canadian food manufacturers.
The FPC invited Dr. David Acheson (former assistant commissioner for Food at the USFDA) and Cameron Prince (former vice-president of the Canadian Food Inspection Agency) of The Acheson Group, to provide background on FSMA and highlight the main impacts of the Preventive Control Rule on Canadian food producers exporting to the U.S. Here are some key points that came out of the session.
FSMA requirements focus on preventing, rather than reacting to problems that can cause foodborne illness. The new requirements will apply to firms that manufacture, process, pack or hold human food. These firms will be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions will be taken to correct problems that arise.
Although these requirements appear to very similar to HACCP and GFSI programs, there are differences in the new FSMA Preventive Controls Rule that will require companies to re-evaluate and adjust their programs. Under the Preventive Control approach, hazards related to the process and to the plant operation are controlled under a prerequisite program will now require the same level of documentation, monitoring, record keeping and corrective actions as a CCP under HACCP. The Preventive Control approach is portrayed as “HACCP+” in which Prerequisite Programs such as “Cleaning and Sanitation,” “Allergen Control” and “Recall” could be identified as Preventive Controls and require the same level of control as a CCP. Existing HACCP plans will remain in effect.
Processors of Ready-to-Eat (RTE) products exporting to the U.S. may also be required to implement an environmental pathogen monitoring program. If the RTE product is open to the environment after processing and before packaging and a kill step does not follow the packaging step, an environmental pathogen monitoring program will be required.
The Preventive Control Rule requires that a qualified individual develop, implement, and monitor the Preventive Controls Program. This individual is known as a Preventive Controls Qualified Individual (PCQI). Although the Rule recognizes that experienced food safety managers may qualify for this position, it is strongly recommended that companies have a certified PCQI on staff. In most cases this will mean that a QA manager will be required to take a two-and-a-half day certified training program.
Foreign suppliers verification
U.S. importers must also comply with the Foreign Suppliers Verification Rule, which will mean that U.S. importers will need to verify that Canadian Suppliers are in compliance with all U.S. Rules for FDA commodities. The verification could include an audit by the U.S. importer or a third party representing the U.S. importer.
The date for implementation is September 2016 for large companies with more than 500 employees, and September 2017 for medium and smaller companies. Certain commodities are exempt, including fish/seafood and produce (already covered by existing FDA rules), and USDA commodities (meat, catfish).
Start getting ready
FPC is now working with The Acheson Group (TAG) to set up a series of in-depth FSMA workshops and training in Canada. The training will be based on the FDA Preventive Controls training but will also be customized to Canadian food processors and exporters. Details on locations and costs are now being evaluated. I encourage food processors to contact the FPC at [email protected] to enroll in this great training opportunity.
All Canadian food processors are advised to take advantage of this training opportunity whether exporting to the U.S. or not. Don’t be surprised if the Safe Foods for Canadians Act will have similar requirements as FSMA when finally enacted.
Dr. R.J. (Ron) Wasik PhD, MBA, CFS, is president of RJW Consulting Canada Ltd. Contact him at [email protected]