4 Things You Need to Know About FSMA

Is there anyone reading this that would be happy about the expansion of regulatory reach into their operation or business? When I ask the QA managers, sanitation personnel, or business leaders within our food-processing accounts, “What keeps you up at night?” they tell me regulations like FSMA, 3^rd party audits, food safety, recall mitigation, productivity, turnover, and staff training are the most common answers. The purpose of this article is to walk you through some of the steps needed to prepare for FSMA compliance as of September 11^th, 2016. After we discuss the steps to compliance, we’ll walk you through the expectations you should set for your supplier partner(s). When we’ve concluded, you’ll have a clearer understanding of FSMA (pronounced Fizz-muh) as well as how you can anticipate and be proactive with your efforts.

Depending on the approach taken towards FSMA compliance, you fall into 2 categories. You’ve been preparing your operations to meet the FSMA requirements, rather than waiting for them to come full scale. The flip-side is that you’ve been waiting to see whether the requirements would become law or would be further delayed. This is a valid sentiment, as FSMA first came onto the scene in 2011. Whether you’re prepared or scrambling, you need to continue reading.

A refresher on FSMA or “Fizma”. It is the Food Safety Modernization Act and was written into law in 2011. This legislation was enacted to give the FDA broader powers in order to shift their strategy from response to prevention, as it relates to food-borne illnesses. Although none of us prefer additional government oversight, the reasoning behind this regulation is noble. FSMA’s expansion of the FDA’s inspective powers will grant authority for imposing mandatory recalls, access to a facility’s records, and mandated frequencies for site visits. As you can see from some of the statistics relating to food production, there is an opportunity for a collective benefit:

• 1 in 6 American’s will get sick
• 128,000 will be hospitalized this year
• 3,000 will die from food-borne illnesses this year
• Medical & Industry costs of food-borne illnesses are estimated at $15.5 billion
• The Grocery Manufacturers’ Association reports that a product recall in the past 5 years has an estimated financial impact of $10 million – $30 million per recall
• Estimates show that a 10% reduction in food-borne infections would prevent 5 million Americans from getting sick each year

To simplify the law, there are 4 main areas of FSMA that you should familiarize yourself with:

1. First is Relying on your Capacity to Prevent Food Safety Problems. As discussed above, the shift from reaction to prevention is a primary focus. Accountability measures will be beefed up in relation to a food processor controlling contamination hazards and in-turn being required to support those efforts with written documentation. It can be best categorized as, say what you do, do what you say, and then validate what you do and say. This is the paradigm of validation, which we are all too familiar with in the food-production industry. However, I bet that if I asked you to identify one of your most critical control measures in mitigating food-borne illness risks, documented procedures and validation measures would be among your top answers.
2. Improving your Capacity to Detect and Respond to Food Safety Problems. With the institution of FSMA, every food-processing facility will be required to register with the FDA. This was set to take effect on 01/04/2016. Have you completed the biennial registration for your facility yet? If you haven’t registered here is a link to the FDA’s guide for online registering, which needs to be completed between 10/1 & 12/31.
3. Improving the Safety of Imported Food. FSMA expands the oversight of the FDA to the millions of food products coming into the US from other countries. This will be labeled as the FSVP or Foreign Supplier Verification Program. For American food producers, this will most directly affect your supply-chain and more specifically the ingredients you import for use in producing your products. As stated above, the FDA will be cracking down even harder on foreign food producers that fail to comply with the FDA registration measures. We will discuss a few ideas on how to proactively evaluate your supply chain.
4. Miscellaneous Provisions. These include the funding of the FDA food safety functions, expansion of the FDA workforce to accommodate the increase in responsibility and whistleblower protections for those reporting failures to the FDA. This also includes an advisory role for the FDA in which they make training recommendations for other local, county, state, and territorial to advance their food safety efforts.

These four provisions provide a 30,000-foot view into the legislation and simplify it into manageable segments as they apply to your business. In Part 2 of this article series, we will drill down at a more micro-level and identify steps that can be taken to address the specific requirements affecting your operation.

At the beginning of this article, I made a statement that characterized the disdain felt by many for growing regulatory measures. Hopefully, after reading more about FSMA and how it is organized, you are able to understand and more importantly develop plans for compliance. In our next article, we will share ways we have helped our food-production partners through this process. In the climate of new challenging compliance, time demands increase, costs are incurred, and workforce is generally expanded. Having a trusted partner like FlexPAC that can help you navigate and assume some of the responsibility is invaluable.

As big of a headache FSMA can cause, I truly believe that this proactive approach will pay favorable dividends for the food production industry. The nobility of this regulation does not change the fact that it creates some new and demanding processes that will need to be implemented. But, the long-term payoff will be efficiencies, increased food-safety, and a consistently high-quality product. See you in part 2!