What is Food Safety Modernization Act Compliance? Although it has a more formal, legal name, the short title is, “FDA Food Safety Modernization Act” – otherwise known as FSMA. It is Public Law 111-353 dated January 4, 2011. Although the law itself, is composed of 88 pages in the Federal Register, it required promulgation of many rules by FDA, and with all the rules and associated guidance documents, it totals many thousands of pages. Its purpose is to shift the focus from responding to food-borne illnesses to preventing them. Thus, any selling “food,” including feed for livestock as a co-product of biofuels production, must comply with FSMA. See Food Safety Modernization Act in Biofuels Industry. See also 5 Signs Your Current GMP is Ready for FSMA.
A Food Safety Modernization Act Compliance consultant should have formal training and be certified as a Preventive Controls Qualified Individual (PCQI). Unlike GFSI, the FDA does not require a facility’s PCQI to be your employee. You can hire an outside consultant. And, although formal training and certification is not required by FDA, it is best practice to use a PCQI. A good PCQI consultant will have practical experience in developing and executing compliant food (feed) safety programs along with experience using food safety software tools.
FDA is currently pursuing inspection of all food (feed) producing facilities. Non-compliance with FSMA can now result in severe repercussions for the facility and will have a very real impact on the business. If you have any question about your FSMA compliance or food defense, it is always best to seek professional assistance early.
Large renewable energy and biochemical consulting firms have experts in FSMA, as well as in the common areas like bio and renewable fuels, biomaterials, biomass and biomass power, biomaterials, biochemicals and biotechnologies. But, they also have an expertise in a wide variety of specialty services like expert witness testimony, techno-economic analysis, due diligence, feasibility studies, budgeting, project management, technology assessment, insurance, due diligence, risk management, benchmarking, intellectual property, HAZOP, financial modeling, competitor analysis, and assistance with RIN and Low Carbon Fuel Standards (LCFS) matters. These firms should also be able to assist with other things like Aspen plus, logistics, bioreactor design, municipal solid waste remediation, syngas and bio-based product development, carbon credits, climate change analysis, environmental permitting, equipment sales, experimental validations, grant writing, IP strategy, life cycle analysis (LCA), plant operations, plant sales and auctions, and risk analysis (FMEA).
Lee Enterprises Consulting is the world’s premier bioeconomy consulting group, with over 100 highly qualified experts serving in all these areas. Take a look at our experts and the services we provide. 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.