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.
#30
