What biodiesel producers should know about FSMA

If your glycerin or free fatty acids may find their way into the food or feed supply, you must comply with the daunting Food Safety Modernization Act
By Ron Kotrba | January 27, 2016

If you’re a biodiesel producer and there is a reasonable probability that even some of your glycerin is going into the feed or food supply, then you will have to comply with the Food Safety Modernization Act, according to two attorneys with Faegre, Baker and Daniels LLP who spoke at the National Biodiesel Conference in Tampa this week.

Moreover, if you’re a grease collector and distributor, and you sell feedstock that goes to a biodiesel producer whose glycerin may end up in the feed or food supply, you may also have to comply, although Rachael Spiegel, an associate at FBD, says more on this will be known come spring when the sanitary transportation guidelines under FSMA are issued by the Food and Drug Administration.

Biodiesel producers whose glycerin may go into the food or feed supply must register with FDA, a free and easy process that can be completed online, Spiegel said. The rest of the work, however, promises to be neither free nor easy.

FBD was approached by Valero because the oil company with several ethanol refineries wanted to get ahead of the regulations. FBD has been working on developing a standard national plan for ethanol and now biodiesel facilities having to comply with FSMA. Jamey Cline with Christianson & Associates told me his firm is also working on getting biofuel facilities in compliance with the new regulations. But a difficult part of this is that not all of the guidelines have been released yet, and Spiegel said if someone tells you they know everything about this confusing and incomplete set of regulations, they are not to be believed.

The law was enacted in 2011, but it wasn’t until 2015 when the first of several guidelines (Current Good Manufacturing Processes and Foreign Supply Verification) under FSMA began rolling out. This spring, regulations for the sanitary transportation of food and feed are expected, and depending on what these are, this may encompass grease collectors and distributors.

Very small businesses, and small businesses have a few years to comply with the regulations, but the larger companies have less time. But if you are covered under this regulation—and if your glycerin goes into the feed or food supply, then you are covered—the time to act is now.

For starters, facilities that must comply need to conduct a thorough hazard analysis of any contamination risks, Spiegel said. Covered facilities must develop and implement a written (and printed out and readily accessible) Food Safety Plan that covers the hazard analysis, preventative controls, monitoring procedures, corrective action procedures, verification procedures, a supply chain program and a recall plan.

Each hazard must be assessed as well as the probability of its occurrence. If it’s a severe hazard with high probability the material that may end up in the feed or food supply can become adulterated, then preventative controls must be implemented to prevent or significantly minimize the hazard. Customers purchasing your glycerin could demand to see your testing results or audit you if the risk is high enough, according to Spiegel.

She says supply agreements will likely contain more indemnity agreements as a result of FSMA. Also, if you’re not sure whether your glycerin is going into the food or feed industry—and don’t want it to because you don’t want to comply with the daunting regulations—you can stipulate in your contracts that the material is not to be used for food or feed.

FSMA changes FDA’s inspection authority, and there’ll be a lot of give and take about inspections, she and FBD partner Andrew Anderson said. But if the FDA shows up and you have nothing, they may impose a plan, perhaps tougher than needed, on your facility at your expense.

I talked with Niki Teta, owner of Daytona Biodiesel, a small operation just getting off the ground, about the regulations. Niki sat in the session with me. “I’m definitely concerned about these regulations,” he told me afterwards. “How much overhead is it going to require? It could make the difference in whether I move forward with my plant or get out of the business and try to find another way to survive.”