​​Food Safety Modernization Act: Insights for Breweries

​By Aaron Brodniak, Director of Quality, Diamond Knot Craft Brewing, on behalf of the Master Brewers Food Safety Committee

Recently, I attended training on “Preventative Controls for Human Food,” where I took a deep dive into the new rules in the U.S. Food Safety Modernization Act. Admittedly, it was more beneficial to food processors such as in the dairy and agriculture industries. However, I was fortunate to have both FDA and Washington State Department of Agriculture employees in the same class and I gained insights as to what they are looking for during inspections. I also learned that although some information may not be required for breweries, there is value in having certain things outlined in a written food safety plan that is beneficial to both FDA inspectors and breweries.

New rules (CFR 21 Part 117) for breweries are rolling in and being prepared to meet the requirements means getting documentation ready for FDA inspectors in a format they are familiar with. A good place to start is by reading “Quality Management: Essential Planning for Breweries” available through the Brewers Association. This resource is an excellent guide for creating the foundation for a quality management system consisting of:

  1. Standard operating procedures (SOPs)
  2. Good manufacturing practices (GMPs)
    a. aka good brewing practices (GBPs)
  3. Hazard analysis​
  4. Master sanitation schedule

This will require some time and effort; however, there are benefits for breweries, FDA inspectors, and consumers. SOPs create a solid foundation for a quality program and get everybody rowing in the same direction. GMPs can be defined by your SOPs since they should cover the details about how you clean, sanitize, and control processes. Hazard Analysis and Preventative Controls are a bit trickier.

Basically, hazard analysis is a process to collect and evaluate information to help determine if there is a significant risk to food safety (CFR 21 117.3 Definitions). Preventative controls are meant to be utilized by a person experienced about food safety to reduce or avoid a known hazard. One of the major ones for breweries tends to be when bottles break during the filling process. The preceding covers the basics, but there are also some recommended (not required) parts of a food safety plan that may help make an inspection go smoother. In fact, although I had compiled our SOPs, master sanitation schedule, recall plan, and good manufacturing processes, I wish I had included the following prior to inspection as it would have saved me from having to supply much of the information during an interview with the inspector.

  1. Background information
    1. Where are you located and how many locations do you have?
    2. How many employees do you have at the brewery?
    3. What do you produce? Be aware, soft drinks require an additional license!
    4. Where do you distribute to?
      1. Down to the approximate territory or county level in your own state.
      2. What percentage of sales in each approximate territory, county, and/or in each state?
    5. Who distributes your products?
  2. Flow diagram of brewing process
    1. Include times and temperatures at each stage. PowerPoint works well for this.
  3. Hazard analysis
    1. Glass breakage needs to have a procedure of how it will be addressed.
    2. How will product be protected?
    3. How will suspected product be isolated?
    4. Cover lights in areas where broken elements could get into product.
    5. List of ingredients.
    6. List of Suppliers.
  4. Training
    1. How are production workers trained?
      1. It’s o.k. to use SOPs and on-the-job training.
There is a recommended format to supply this information that may speed up the inspection process as well (the FDA provides Food Safety Plan Forms). You won’t need all the forms as they don’t all apply to breweries, but they do provide insights about background information, flow diagrams, hazard analysis, recall, and sanitation. I found the formats contained in “Quality Management: Essential Planning for Breweries” worked well during our inspection. Plus, with a little editing most of the supplied text should work well for most breweries!

Benefits to supplying more information:
  1. Saves you time. Handing an inspector this information saves you from taking time to answer these questions in an interview.
  2. Knowing where you sell your beer and how much you sell there provides good data. Did you sell more or less? Why? This may provide an opportunity to adjust your strategy in certain markets.
  3. Provides an overall guiding document for your quality plan that captures essential information.
Want more FSMA information for brewers? Attend the October 10-11 Hazard Analysis and Critical Control Points training course  held in conjunction with the 2017 Conference in Atlanta, GA. Get an overview of FSMA as well as a deep-dive into GBPs and developing a HACCP plan.