Don’t Let FSMA Delays Hold You Back

It is certainly not news that the government has missed numerous deadlines and is far behind in enacting of rules for the Food Safety Modernization Act (FSMA). It seems that the delays, as well as predictions for passage and expectations of the substance of the rules, have been written about in every iteration possible. Unfortunately, despite all those who attempt to predict and define, no one really knows the when or what of the four key proposed rules for FSMA (preventive controls for human and animal foods, produce rules, and foreign supplier verification). Whether this is because no one at the FDA or the Office of Management and Budget, where FDA’s proposed rules are sitting, knows, or because they are simply not talking is, also ... unknown.

However, this does not mean that the industry should simply sit back and wait for someone to move the rules forward. Rather, as has long been best practice in this industry for which “guidance” is the standard, food and beverage processing plants need to step up to the plate and take ownership of continuing improvements and forward movement in food safety. Not only does this protect consumers, as well as your own brand, it will undoubtedly help prepare you for that time that the rules do start coming down. Because, despite the delays, I am convinced they will emerge at some point irrespective of who is sitting in the White House.

This is because an important component of food safety is the same as the primary focus of FSMA. That is: Prevention.

As explained in a January 3, 2011, posting from Commissioner of Food and Drugs Margaret Hamburg, “Food Safety Modernization Act: Putting the Focus on Prevention,” FSMA directs FDA “to build a new system of food safety oversight—one focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick.” 

As she stated in that article, the idea of prevention is not new. It is a standard component of FDA and USDA guidance and was a key component of FDA’s Food Protection Plan introduced in 2007 during my term as assistant commissioner for foods. In fact, the plan was the cover feature of QA’s February 2008 issue, with the prominent headline: “Prevention. Intervention. Response.”

Today’s Prevention, Intervention, and Response. So how do you apply this today in ways that will not only help keep your food safe, but also prepare you for the eventual regulations of FSMA? Once again, we can use Hamburg’s own words on the requirements of FSMA from that pre-Presidential-signing article: “processors of all types of food will now be required to evaluate the hazards in their operations, implement, and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.”

What does this mean? Let’s take it a piece at a time. Processors of all types of food will now be required to:

...evaluate the hazards in their operations. Hazard, or risk, assessment is critical for consumer and brand protection. As such, it is a key aspect of the preventive provisions of FSMA. In fact, the pending rule, Hazard Analysis and Risk-Based Preventive Controls (Section 103) focuses directly on this area. For all hazards identified, preventive controls will need to be identified and implemented to assure that all will be significantly minimized or prevented and the food produced by a facility is not adulterated or misbranded. Additionally, preventive controls should be tied to preventing foodborne illness, not just decreasing product contamination. Implementing—and continuously evaluating and improving—such assessment and prevention plans are important, not only within your plant, but throughout your supply chain.

Even were it not a component of FSMA, recent outbreaks have shown that it is not enough to focus on historical incidents (e.g., whole cantaloupe was not known to be a source of Listeria; peanut butter was not known to be so good at allowing the survival of Salmonella; and raw flour was not considered to be a possible source of E. coli O157:H7 as in the raw cookie dough related outbreak). Thus, it is becoming increasingly important that you spend time assessing and addressing risk across your product line supply chains and be ready to change when new risks are identifed.

... implement and monitor effective measures to prevent contamination. In addition to having specific preventive controls for each hazard identified, facilities will need to have broad prerequisite programs in place similar to Good Manufacturing Practices (GMPs), which may include sanitation procedures; supervisor, manager, and employee hygiene training; environmental monitoring programs to verify the effectiveness of pathogen controls; food allergen control programs; recall plans; and supplier verification activities. Those who are looking to stay ahead of the new regulations should be thinking about this broad scope of preventive controls including specific hazards and critical controls points in their facility, as well as more broadly applied GMPs and identifying where preventive controls are needed to mitigate their specific facility hazards and reduce risks. One suggested approach is to undertake a “gap analysis” in which the current systems are compared with what will likely be required as part of FSMA. This will then provide firms with insight into areas that need more work in a time frame that is reasonable in terms of ultimate time to compliance.

...have a plan in place to take any corrective actions that are necessary. FSMA regulation will make documentation even more critical. A key component of the Act is the requirement that facilities create, and share with FDA inspectors upon request, a written food safety plan that documents and describes the facility’s procedures for complying with the preventive controls provision. Facilities will need to validate and document that the preventive controls have the desired effect in reducing risk and verify that they are operating appropriately. The plan will need to include provisions for monitoring the effectiveness of the preventive controls and establishing corrective action procedures to address any situation where the preventive controls fail to adequately control the risks and to assure that affected food is prevented from entering into commerce. While most facilities have had preventive and corrective action practices in place, many did not have them written into a plan. If you are one of these, and you have not yet built your practices into a written food safety plan, you can place yourself well down the road of compliance by doing so now.

Hamburg could not have known the uphill challenges that she and the FDA—and the industry which has begun rising up in demand of regulation—would be facing when she said, “Now, the task falls to the FDA to carry out the direction we’ve been given.” The task may still be in limbo, but it will eventually make its way to regulation. And the more you prepare now, the better off you will be then ... and your brand and customers will be throughout.

Earlier this year, I wrote a question and answer article which included the question “Is there anything I should do now to get ready (for FSMA)?” The answer remains the same now as it was then: an unequivocal “Yes!” And the advice remains the same as well: Get out in front of it now by establishing a team to examine current systems and compare them with what new requirements currently look like and where new preventive control and food safety plans are headed. When the new preventive control requirements do emerge, the time to enforcement will likely be short. So to that end, look at your current preventive control strategies (HACCP and GMPs) and update as necessary. Look at upstream supply chains and how you are controlling risks. Look at what records you are keeping and how you are doing that, and ask yourself the question: “How readily will I be able to demonstrate to FDA that my systems are under control?”