5 Signs Your Current Good Manufacturing Processes are Ready for the Food Safety Modernization Act

By Phil Cleary, Christianson & Associates, PLLP

Special to The Digest

The Food Safety Modernization Act covers the operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States.

Renewable fuels facilities producing feed co-products are no exception. In fact, if you are a biofuels producer that sells co-products later used as an ingredient in animal feed (ex. distillers grains, corn oil, glycerin), FSMA is a multi-faceted regulatory program with which you will soon become quite familiar.

The first phase of FSMA compliance requires implementation of “Current Good Manufacturing Processes” listed in Subpart B of the Code of Federal Regulations (21 CFR 507).

cGMPs help establish the basic environmental and operating conditions necessary to support the forthcoming “Hazard Analysis and Risk-Based Preventive Controls” (HARPC) and Written Food Safety Plan requirements. You might find it helpful to think of these cGMPs as a pre-requisite, phase-1 program that takes place prior to the full FSMA implementation.

Even though your facility already operates in alignment with a number of industry standard cGMPs, it’s important to give these your full attention since they are now part of a much larger regulatory framework that places you under the oversight of the Food and Drug Administration (FDA).

Facilities generally have an employee training program and written Standard Operating Procedures (SOPs) to manage the cGMPs and document the results of the corresponding programs.

While you may have until 2017 (or even 2018) to have FSMA “Current Good Manufacturing Processes” (cGMPs) officially in place based on the FDA’s tiered deadlines, there isn’t any particular reason to delay compliance beyond September 2016.

In fact, ensuring the broadest possible market for your co-products means you should be prepared to handle potential downstream market dynamics that demand ‘day-1’ compliance from suppliers, without regard to their size.

If the FDA showed up at your plant tomorrow to evaluate the state of your current compliance with forthcoming requirements how do you imagine that conversation would go? Of course, they won’t be showing up tomorrow; however, it’s a helpful question to think about if you’re evaluating how confident you and your team are about where you are now and where you need to be in September.

While an in-depth reading of the cGMP regulations is important to ensure that the specific requirements are addressed, here are five indicators your facility is on the path to phase-1 FSMA-readiness:

1. You have assigned key staff to be involved with FSMA implementation, monitoring, and oversight for your facility, and credentialed someone as a “Preventive Controls Qualified Individual” (PCQI). In other words, you know whose job it is going to be to work on this, and have staff assigned to start working on it now.

2. You understand which of the FSMA compliance deadlines you’re required to adhere, and you’ve made a decision about the timeline you will elect to follow.

3. You have a copy of the FDA’s finalized cGMP requirements, have assessed your current capabilities, and have determined the areas of your operation that will demand the most attention to be brought up to standard. Our FSMA white paper can help with this.

4. You’ve identified an industry expert you can partner with to ensure you’re working with the most up-to-date information and make decisions that achieve the required results while balancing the risks of under-compliance and the burdens of over-compliance. A partner can help you keep on track and avoid letting competing priorities and ongoing commitments of time and resources get in the way of timely, proactive implementation.

5. You’re aware of the broad scope of the FDA’s new rules and subsequent inspection powers and are already anticipating how you’ll adopt and incorporate itsbrand of formal food safety into your operations as efficiently and effectively as possible.

Determining your overall approach to compliance before the pressure builds to have your comprehensive written food safety plan correctly documented, formalized, and implemented will help you address your most immediate compliance needs now while also developing and expanding your resources for ongoing compliance.

Proactive management of this new relationship with the FDA is essential to minimize the cost and burden of the regulatory transition.

About the Author:

Phil Cleary has a B.A. in Political Science and works with Christianson & Associates, PLLP, a full service public accounting firm serving the biofuels and agribusiness industries for more than 28 years. Cleary researches, identifies, and develops projects in biofuels compliance and service programs, including those related to the Renewable Fuel Standard (RFS), Low Carbon Fuel Standard (LCFS), and the Food Safety Modernization Act (FSMA). Christianson & Associates, PLLP is a strategic partner of Lee Enterprises Consulting, Inc., the world’s largest bioenergy and biofuels consulting group.