February 16, 2016

Downstream Uses for Glycerin Place Biodiesel Producers Under FSMA Scrutiny

A natural byproduct of biodiesel production, glycerin is a simple compound used in a number of applications in the food industry. Because of these downstream uses, biodiesel producers are facing an unexpected hurdle: complying with Food and Drug Administration (FDA) regulations under the new Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Animal Food. As part of an effort to get its members up to speed, the National Biodiesel Board asked Rachael Dettmann Spiegel, an associate in Faegre Baker Daniels’ nationally ranked food litigation and regulatory practice, to present on compliance protocols at the National Biodiesel Conference, held in Tampa at the end of January. Her presentation was covered in Agri-Pulse.com and Biodiesel Magazine. 

“It’s just that the FSMA hasn’t been on [biodiesel producers] radar,” Spiegel said. “A lot of these companies probably just thought, ‘We’re selling it to a third-party refiner and we don’t need to worry about it.’”

While they may be surprised at the new responsibilities, biodiesel producers could suffer costly consequences if they fail to comply, Spiegel said.

“If the FDA … shows up at one of these facilities and inspects them for a food safety plan and the plant manager gives them a blank stare and has no clue what they are talking about, then the FDA can come back and say, ‘We’re going to charge you around $220 per hour for the re-inspection until you bring your plant into conformance,” Spiegel said.

According to Spiegel, the first step for producers is to undergo a hazard analysis “to understand what hazards will affect [their facilities].” Next, they will need to install “current good manufacturing practices.”

“There are standard plans that you can use, but each one will need to be tweaked to your individual facilities, especially depending on which inputs you’re using for biodiesel production, whether it’s rendered product, whether it’s oils, or whether you’ve got a consolidated crush facility,” she said.

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