“The checklist grew out of our ongoing program at Iowa State to work with grain handlers and processors on critical issues, but more than that, we have a contract with the FDA to train inspectors on what to look for during site visits, and how to audit for FSMA in grain and grain processing facilities,” Hurburgh says. “It is the start of our efforts to help [the feed and grain industries] that have had no experience with [food safety plans or Hazard Analysis and Critical Control Points (HACCP)] to work through and think about their processes from a hazard control standpoint. We can’t tell everybody what to do and every facility is different — but you can provide a guideline for the things they need to be addressing at their facilities.”
The Iowa State University team keeps in regular contact with the FDA, as it’s their objective to make sure the regulators are educated on the grain industry (see the Editor’s Note at the end of the article), while creating the tools to best enable FSMA education and outreach to the grain industry.
“This checklist walks through major key points within HACCP and the food safety portion of a quality management plan — since they are essentially linked together — and really focuses on biological, chemical, physical hazards, but it also encompasses employee training and improvement of general management practices,” Shaw says.
She suggests using the checklist as the starting point in developing a Food Safety Plan — not only because it definitely covers what FDA inspectors will be looking for, but because it prompts owners to start to ask themselves questions they may or may not be able to answer.
“In the U.S. regulatory system, intent is everything. The written Food Safety Plan doesn’t need to be complicated,” Hurburgh adds. “One thing about regulatory systems in new areas, typically they don’t start with the greatest degree of complexity. The complexity of the requirements comes with time after the reviewers see what the industry can do. Right now, the first thing to do is to just sit down and identify what your primary risks are and what simple, possible controls you can put in place to address them.”
What about HACCP?
While FSMA doesn’t mandate HACCP certification, much of Section 103 does align with the seven principles of HACCP (shown below). To achieve the prospective FSMA requirements, a Food Safety Plan requires more of a systemwide view of risks and controls; however, companies may to refer to HACCP as an additional resource in creating a plan.
“No matter what comes out of the regulation, it will take time, effort and resources for companies to work toward FSMA compliance,” says Matt Frederking, vice president of regulatory affairs and operations for Ralco Nutrition. “Whether you’ve started the process or not, HACCP principles serve as a good guide to what will be in the FSMA.”
Frederking suggests if your company hasn’t already begun the compliance portion of Section 103, the first step is to assemble a team of four to six individuals, who fully understand the operation, and refer to the seven principles of HACCP to identify significant food safety hazards, implement effective preventive controls and verification criteria. He notes that when developing a food safety team, it is essential to include maintenance personnel.
“If you’re not, you’re missing a large part of the equation,” he says. “The maintenance personnel will know more about the facility and the hazards you have to control than any other employee.”
In practice, the goal of the team is to cite examples of potential hazards; define what actions would be taken to prevent an incident; and provide the necessary records to demonstrate what measures the company has taken to prevent an incident or how to address it if one should occur.
“You don’t need to become an HACCP-certified facility, but if you refer to these principles and apply them, you will see they fall in line with FSMA regulations,” he concludes.
The benefits of FSMA
Despite the fact that FSMA is the law of the land, the benefits lie in the fact that it offers an opportunity to perform a thorough examination of your company’s operation.
“Playing to the requirements of the government is probably the worst motivation for doing this, because if that’s all you’re wanting, then any system you put in place will be shallow and not in-depth, it will not be executed faithfully, and it will not capture information that the company can use in its own internal quality control processes,” Hurburgh says.
FSMA compliance will not only expose ways to prevent contamination, but it can also improve maintenance, establish employee accountability and investment, and can offer more control over a site’s inventory management.