Food Safety Modernization Act (FSMA) in the Biofuels Industry

Food Safety Modernization Act (FSMA) in the Biofuels Industry? Every producing biofuels plant selling feed co-products to any animal species should be aware of, and in full compliance with, the rules laid out in the Food Safety Modernization Act – otherwise known as “FSMA”.

There are two main parts of FSMA that bio-fuels facilities should prepare for:  (1) Animal Food CGMP compliance, and (2) Animal Food PC compliance.  The acronym “CGMP” stands for Current Good Manufacturing Practices, and “PC” stands for Preventive Controls.  The CGMP rules apply to items such as pest management and handling of animal food (or raw materials) so as to prevent contamination.  The PC rules apply to items such as food safety plans and hazard analysis and prevention.  There are some other rules under the FDA’s jurisdiction that may impact your facility, as well – in particular:  sanitary transportation of food.  All areas will be scrutinized during an FDA inspection.

Some smaller plants may have become complacent about finalizing their compliance program for several reasons:  (1) the roll-out period for different rules took a while for all to be completed, and (2) there have been different compliance dates based on business size.  However, beginning in October of 2019, the delay period for will be over for all but the “very small businesses”.  Essentially, all bio-fuels plants will be required to be in full compliance.

What is the take-home message here? Given the severe consequences of non-compliance during an FDA inspection, on both your operations and bottom line, making certain that your FSMA compliance plan is completely reviewed and up to date before an FDA inspection is not a luxury.  It is a necessity.

Lee Enterprises Consulting is the world’s premier bioeconomy consulting group, with over 150 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.