WASHINGTON, Feb. 3, 2016 - It’s not just food manufacturers who are having to deal with FDA’s major food safety overhaul. Nearly every biodiesel plant in the U.S. is on a tight deadline to rework its protocols to meet new industry regulations under the Food Safety Modernization Act (FSMA), and the National Biodiesel Board is working overtime to get the word out.

Raw glycerol is a major byproduct in the biodiesel business and because it goes into the animal and human food supply – it’s used as everything from a solvent to a sweetener to a thickening agent – the FDA will be monitoring its production closely, said Rachael Spiegel, a specialist in food litigation and regulatory practice at the Faegre Baker Daniels law firm.

“It’s just that FSMA hasn’t been on their radar,” Spiegel said about biodiesel producers. “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.’”

But that’s far from the case. Biodiesel producers could lose customers for their glycerol and risk steep fines from the FDA if the fuel makers don’t put in procedures that meet the agency’s demands under the FSMA Final Rule for Preventive Controls for Animal Food.

Not all of the glycerol that comes out of biodiesel plants is used in food or feed – some of it goes into pharmaceuticals, makeup and even antifreeze. But the industry produces roughly 140 million gallons per year, and the biodiesel refiners should put the new FSMA procedures in place so long as there is a possibility that what it makes ends up being eaten by humans or animals, 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.

And that’s exactly the kind of situation that the National Biodiesel Board wants to help its members avoid, said Scott Fenwick, NBB’s technical director. He said it was why he asked Spiegel to speak at the group’s annual convention in Tampa, Florida, last week and it’s why she’s helping the biofuel industry draft a unified approach to meeting FSMA requirements.

Of course, every facility is different and will have unique needs, but the general blueprint that will be published and distributed “shortly” by NBB should be a major aid for the industry, Fenwick said.

“Each of your facilities needs to go through a hazard analysis to understand what hazards will affect your facilities,” Spiegel told industry leaders at the NBB convention. But that’s just the first step. The next is installing what FDA calls “current good manufacturing practices,” or CGMPs. These are practices that need to be put in place to ensure that any byproduct that could potentially go into food or feed won’t become adulterated.

“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.

It’s a lot to do and time is getting short. The FDA published its Final Rule for Preventive Controls for Animal Food in September 2015, and most biodiesel plants will have to be compliant by this September – just eight months from now.

The FDA has promised to publish several “guidance documents” to help the industry be ready, but it may be several months before they are available, Fenwick said. That’s why the NBB is hurrying to get out its own instructional blueprint for members.

If producers set up their own safety procedures at their plants, they will likely be able to get away with doing far less than if they wait until FDA arrives and then demands to do the job, Fenwick said.


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