Buckle up for FSMA
The threat of getting a ticket isn’t the only reason I take my safety seriously; I wore a seatbelt long before the advent of primary seatbelt laws. That’s why I often feel frustrated with the proliferation of laws designed to protect me from myself, like “Click it or Ticket.”
Likewise, I’m certain you have been taking the safety of your ethanol plant’s distillers’ grains seriously long before Congress started talking about the Food Safety Modernization Act (FSMA). Your commitment to produce safe and nutritious animal feed products, regardless of what the government prescribes as a consequence for doing otherwise, is part of why your ethanol plant is still in the business of selling them.
Despite that reality, you’re soon going to be spending substantial time and money proving it to the Food and Drug Administration (FDA).
FSMA is like a marriage arranged by Congress that weds the regulatory oversight of the FDA to the ongoing operations of your ethanol plant. It gives them expansive authority over the entire supply chain of animal feed and feed ingredients, including your ethanol plant’s production of distillers’ grains. And because of it you are about to become well acquainted with another agency of government oversight and its brand of formal food safety.
These regulations will prohibit manufacturing, processing, packing, or holding animal feed for sale at a facility not using Current Good Manufacturing Practices (cGMP) for Food for Animals, and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Food for Animals.
You will implement process controls requiring testing and preventive controls requiring capital modification, commit to ongoing employee training, and create paperwork to tie it all together.
The document trail will be as important as the substance of the rules themselves. In fact, any animal feed ingredients produced will be rendered adulterated and unfit for consumption unless documentation demonstrates the proper use of cGMPs and HARPC.
So while your plant’s existing practices might already incorporate a majority of these forthcoming expectations, demonstrating compliance involves documenting, formalizing, and institutionalizing the processes required by the FDA under FSMA. This requires your facility to develop and implement a Written Food Safety Program.
Bureaucratizing measures you already take, or altering those processes to reflect the desires of the FDA, can be a frustrating burden. So it may be tempting to search for workarounds and loopholes, to help you avoid FSMA’s grasp in the short run. However, in the long run it will be advantageous to leverage this period for implementing updated manufacturing practices and new preventive controls now.
FSMA is an imperfect solution to a problem that doesn’t particularly plague the ethanol industry to begin with. But you can’t afford to ignore the impact significant regulatory changes will have on your margins and your operations when as much as a quarter of an ethanol plant’s revenue comes from co-product sales, including distillers’ grains.
Proactive management of this new relationship with the FDA is essential to minimize the cost and burden of the transition.
FSMA is an opportunity to renew your existing commitment to producing safe and nutritious animal feed products. You already take safety seriously (that’s part of why you’re still in business). So why not do everything you can to bring FSMA to your plant on your own terms and in your own way? That way, you’re fully compliant and ready before the FDA’s final rollout of government auditors (who will charge you $221 per hour per inspector during a re-inspection).
You can use the pressure of FSMA to find ways to improve existing practices, and focus on evaluating absent or overlooked internal controls you might not have previously identified. Take the time to work through issues now. Familiarize yourself with FSMA today. Assess your internal resources and capabilities tomorrow. Assign key staff next week. Determine your overall approach to compliance before the pressure builds to have your comprehensive written food safety plan correctly documented, formalized, and implemented.
FSMA Assistance Available
If time, resources, or expertise are holding you back from “getting buckled up for FSMA,” the team of Certified Public Accountants and consultants at Christianson and Associates is positioned to help you make a successful transition into FSMA-Readiness and FSMA-Compliance.
This article was also published in Ethanol Today.