What does FSMA Compliance entail? Though the Food Safety Modernization Act (or “FSMA”) was signed into law on January 04, 2011, it has taken many years for all the rules to be written and implemented. There are many reasons for this, but it mostly boils down to three: (1) this was a sweeping piece of legislation that required a great deal of time for developing the rules, (2) the FDA wisely sought input from industry – which, again, required considerable time, and (3) the roll-out for the rules was staggered over several years – mostly based on “size” of food-producing operations. As of now, all rules are completely in place and you must be complying. What does that mean?
For anyone operating in the Bio-Economy, the most important thing to remember is this: regardless of whether your products go directly into human food with your first down-stream customer, or if there just the possibility that they can be used indirectly several steps “down the chain” for food production, you MUST be in full compliance with the FSMA requirements. The days of “passing the buck” – making your down-stream customer responsible for food safety – are over. We now operate in a “cradle-to-grave” environment; that is, if you touch a product, you are responsible for its food safety.
One nice thing about the FSMA is that it allows for smaller companies to use outside consultants to assist with developing all the necessary programs and documentation necessary to fully comply with the requirements. You are not required to hire such an expert “in-house”. Further, even if you have an in-house expert, the FSMA allows for companies to engage outside consultants to come in and help with pre-audit gap analysis. Using an “outside set of eyes” is crucial in helping identify deficiencies that you might overlook on a day-to-day basis.
When choosing an outside consultant, you should hire one which has PCQI certification. PCQI stands for “Preventive Controls Qualified Individual”. Usually, these folks have been trained and certified by 3rd-party organizations. Although not required, another very desirable attribute of your outside consultant is training or certification in one of the GFSI schemes. GFSI stands for Global Food Safety Initiative; some of the common schemes employed in North America are SQF, BRC, and FSSC 22000. Although the FDA does not recognize these schemes as a substitute for FSMA compliance, there is a great deal of overlap with FSMA – especially regarding food-safety culture and actual operating parameters. Finally, your outside consultant should have direct experience with execution and maintenance of these programs in an actual food-production facility.
Large renewable energy and biochemical consulting firms certainly have experts in biofuels and renewable fuels, and the more common areas like biomaterials, biomass and biomass power, feedstocks, and biotechnologies. In these larger consulting groups, one may also find very specialized expertise like FSMA compliance, catalytic valorization, carbon intensity, polymer recycling, cogeneration, combined heat & power, formulation chemistry, cannabinoids, solvents, sludge, solid state fermentation, soil amendment, solid recovered fuels, RFS2, carbon fiber, GMPE, Polymer Pyrolysis, Polypropylene, fuel additives, biopharmaceuticals, renewable technology, oilseed processing or water treatment.
Lee Enterprises Consulting is the world’s premier bioeconomy consulting group, with over 100 highly qualified experts serving this and many other areas. Take a look at our experts and the services we provide and you will see that we have just the right expert for any clean energy project. Most of our experts are also available to advise and serve as expert witnesses in bioeconomy litigation matters. For the larger projects, we specialize in putting together full service, interdisciplinary teams with one point of contact. Call us at 1+ (501) 833-8511 or email us for more information. See also, Food Safety Modernization Act (FSMA) in the Biofuels Industry.