Getting Started with Brewery GMPs

The Food Safety and Modernization Act (FSMA) of 2011 (pronounced “fiz-muh”) requires that breweries, wineries, cideries and distilleries follow Good Manufacturing Practices (GMPs) to keep consumers safe. This may seem like a daunting task for breweries that are just getting started or have a small staff. The regs were originally designed for food manufacturers until the FDA deemed beer “food” in 2011. As of September 2018, all breweries - regardless of size - must comply. It can be difficult to find the FSMA regulations in a format that is easy to understand. FDA regulations require a commitment to documentation, training and compliance, but it doesn’t take that much to cover the basics. The important thing is that you don’t want to commit “gross negligence” and completely ignore the safety of your consumers. Below are some simple ways to get started toward Good Brewing Practices (GBPs) so you’re prepared for your next FDA audit.

THE BASICS

• FSMA signed into law in 2011 (specifically 21 CFR Part 117 )
• As of September 2018, all breweries, regardless of size, must comply with parts of FSMA
• Designed to proactively manage food safety hazards involved with manufacture and transport of FDA-regulated food products
• FDA declared alcoholic beverages (beer) as food
• Breweries, wineries, cider producers and distilleries under direct FDA regulation in addition to TTB

BEER IS SAFE - WHY WORRY?

It is true that beer is inherently safe because of the alcohol content, the boil, low pH and absence of oxygen. However, there are a number of risks to consumer that you must consider, including physical, biological and chemical hazards such as mold, pests, broken glass/metal, chemical residues and allergens. All of these need to be mitigated with your food safety plan. If you’re producing more high risk beverages, such as non-alcoholic or gluten-free beer, a full hazard analysis is recommended.

GETTING STARTED

There’s an old rule within FDA that “if it isn’t written down, it didn’t happen!” This exists in everything from pharmaceutical drug trials to food safety. A verbal food safety plan is not acceptable. The simplest way to start is to begin writing down key processes around your business. The Brewers Association is an excellent resource for independent breweries. They have a FSMA FAQ for Brewers that’s an excellent primer. They also provide a number of self-assessment checklists that cover the GMP requirements . These can become the foundation of your documented plan.

LOW HANGING FRUIT

There are a number of common issues found during audits/inspections that you can address immediately to protect your customers:

1. Employee Hand Washing
   Basic hygiene requires that all employees wash their hands when entering the production area, leaving the restroom, or after eating/drinking/smoking. We offer a number of stainless steel sinks which can give your staff ample wash-down stations.
2. Employees Consuming Food & Beverage in Production Areas
   Don’t let your employees eat their meals in the production areas. Give them the necessary breaks and designated areas to consume food and beverages so they aren’t contaminating your product.
   
3. Employees Carrying Phones, Keys and Earbuds into Production Areas
   It is common that employees carry their mobile phone and/or listen to music while brewing. But you should have lockers for these items, keys and body piercings so they don’t become a foreign object contaminant. Have uniforms without pockets so they aren’t carrying potential hazards around.
4. Wooden Utensils
   It’s pretty common to find brewers using wooden mash paddles. They are an old favorite. However, they often contain harmful laminates or can splinter into your batch to create foreign object contamination. Read our blog post on this topic to understand how to use an FDA-approved mash paddle.
5. Spent Grain Removal
   It is important that these containers are properly labeled/identified and aren’t mixed with trash before being fed to livestock. We have an entire blog post regarding the FDA regulations around spent grain removal because there are a number of risk and considerations.
6. Hair/Beard Covers / Restraints
   No one wants hair in their IPA. Cover your head with a hat or hair net and cover your beard with a beard net.

FINAL THOUGHTS

There are both ethical and regulatory reasons for complying with the GMP guidelines from the FSMA regulations. Breweries are required to document a food safety plan. The important thing is to create a process that you and your staff can follow, enforce and maintain. Don’t over complicate it. If you don’t do something, document the justification for not doing it instead of skipping it altogether. Make sure you are covering the Good Manufacturing Practices (GMPs) basics so that you aren’t deemed negligent by the FDA during an audit and face expensive penalties or recalls. More importantly, take this as a challenge to your organization’s culture to protect your brand and your consumers! Clean beer tastes better!

Union Jack -- Your Partner in FSMA /HACCP Compliance

Keeping it Clean Since 2006