The FDA’s Current Good Manufacturing Practices (or cGMPs) haven’t been updated since 1986 (that’s before I was born). This regulation, known by many of us in the industry as 21 CFR 110, covers the manufacturing, processing, packing and holding of food. While foods such as juice, seafood and canned products are covered under their own regulations, 110 covers everything else. It includes regulations for things such as the use of food grade equipment, sanitary operations and health requirements for personnel.
The Food Safety Modernization Act (FSMA) that was signed into law in 2011 aims to update the cGMPs as we currently know them. I think it’s about time we update the regulations that cover pretty much everything we eat. Our food supply is global, us millennials are hungrier than ever and we demand high quality, cheap, nutritious, organic, safe and locally sourced food. We also want it to taste good, stay fresh and be convenient. This is an incredible challenge on the part of the farmers, food producers and regulators alike. How do we keep the consumers happy while making a safe, wholesome product?
This is part of what FDA is trying to address with their new FSMA law. The law will update 21 CFR 110 from being just GMPs to include Hazard Analysis and Risk Based Preventive Controls (HARPC). Much like the Hazard Analysis and Critical Control Point (HACCP) system did for juice and seafood, HARPC will require companies to evaluate their process, ingredients, suppliers, equipment and finished products for hazards which may be likely to occur. The three types of known hazards we control for in food are physical, chemical and biological hazards. The new regulation will be written under 21 CFR Part 117 in the Code of Federal Regulations.
But how will regulators assess whether a company is in compliance with the new law? If we look at how juice and seafood is regulated under HACCP, companies are required to implement monitoring procedures for steps in their process they determine are critical control points (CCPs). This is all proven to an inspector by record keeping, one of the most important aspects of a food safety system. As we say in the industry, “if it isn’t written down, then it never happened”. Luckily for our tech-savvy generation, we don’t have to keep records by hand. Need to monitor your cooler temperature? There’s an “app” for that.
If you are a company engaged in any of these aspects of manufacturing, processing, packing or holding potentially hazardous foods for human consumption, you are likely monitoring temperatures at some point in your process. Whether it be during storage, cooking or cooling. The combination of time/temperature control is critical to keeping pathogenic bacteria from proliferating. And now with FSMA rules starting to be implemented, the FDA will have access by law to inspect records related to your monitoring of preventive controls.
As published in the Federal Register, section 117.145 of the proposed regulations includes access to records. FDA states, “We proposed that all monitoring of preventive controls must be documented in records that are subject to verification and records review.” So basically the regulations require food processors to look at their system, identify hazards, monitor those hazards and then be able to prove it with documentation. As you would imagine, this can generate a lot of records. But those who choose to use electronic monitoring and record keeping will likely be more efficient and accurate while saving time and money.
This not only makes inspections easier, it allows you to closely monitor your system so you can protect your consumers, your business and your brand’s reputation. There is nothing worse than causing your customers pain and discomfort in the form of foodborne illness. While these new laws aim to keep everyone safer, the principles for food safety are still the same: keep hot food hot, keep cold food cold; cook food thoroughly; clean and sanitize your food contact surfaces; eliminate any hazards that may be present.
These new regulations may require changes in your organization, but we will all be better off if you make a safer product. And I highly suggest that companies take advantage of the incredible technologies on the market that allow for things such as continuous temperature monitoring, electronic record keeping and cloud based platforms that store all of this information. We have the technological means to keep food safe and we must use it in any way possible because I firmly believe that no one should ever get sick from eating food.