The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington

The FDA’s Food Safety Modernization Act (FSMA) is something all breweries, especially brewpubs, should keep an eye on over the next couple years as the FDA continues to increase quality control measures in order to prevent future food-borne illnesses.

Remember the FSMA? Neither do we. It’s probably safe to say that many have already forgotten what it does or didn’t even notice when it became law.

Signed into law by the Obama administration back in January of 2011, the FSMA is the latest amendment to the Food, Drug & Cosmetic Act that originated back in 1938 during the Roosevelt era.

Why is this important? The law is finally resurfacing after the government recently announced required registration of all applicable food facilities by December 31st, 2012. True to its slow-moving nature, the FDA is beginning to enforce a law it signed into effect nearly a year ago.

In case you didn’t know, the FSMA is “…the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.” –

The FSMA is reassuring news for consumers, but potentially worrisome news for the food and beverage industry. This will equate to stricter regulations, higher standards and steeper penalties for non-compliance. We won’t put you to sleep with the entire legal text of the act, but there are some major compliance issues you should monitor as we enter an age of increased regulatory laws for the food & beverage industry.

This new compliance Act applies only to domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. As you may already know, it’s the TTB that monitors the alcohol industry. Despite their current jurisdiction, the TTB has the authority to involve the FDA in cases of tainted batches of beer.

The FDA can intervene and circumvent the TTB’s jurisdiction if the TTB has cause to believe that a batch of craft beer is “adulterated”, may cause a health risk to consumers,  and recommend a subsequent FDA investigation and immediate recall. It’s a likely scenario that we all hope never happens. The FDA’s website provides the following definition of  “adulterated” food or beverages:

“When label/product analysis indicates a potential risk to public health or safety, immediate action is required. Any food product (including an alcohol beverage) is considered adulterated under the Federal Food, Drug, and Cosmetic Act (FSMA) if it contains a poisonous or deleterious substance or an unapproved food additive.

Contaminated alcohol beverages will be considered adulterated for purposes of the Food, Drug, and Cosmetic Act and subject to enforcement action by the FDA, as determined by TTB. Under the terms of the MOU between the two agencies, TTB will notify the FDA when an adulterated alcohol beverage is encountered, request a health hazard assessment (as needed), seek a voluntary recall (as needed) and keep the FDA apprised of the situation.”

It’s also important to note that every ingredient used to produce food (or beer) must be permissible by FDA standards. Anything made with impermissible ingredients will be considered “adulterated” under FDA standards.

How the FSMA will Impact the food industry:

  • Stricter sanitation policies, regulations & preventative controls

The FSMA requires food facilities to evaluate potential hazards, implement and monitor precautionary measures to prevent contamination, and create plans to take any necessary corrective actions. It also requires FDA to establish science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious illnesses or death.

  • Mandatory Inspections & Compliance

For the first time, FDA will have mandatory recall authority for all food products.

  • Stiff Penalties for Non-compliance

The FDA will perform regular on-site compliancy inspections to all appropriate facilities without charge. However, if the facility fails to meet compliancy standards on the first visit, FDA will reinspect at a later date at a rate of $221/hour if no foreign travel is required and $289/hour if foreign travel is required.

What the FSMA means for Breweries:

At this point in time, the FSMA will not effect breweries unless a routine TTB inspection finds a batch of your beer to be a health risk to consumers. However, it is important to note that the TTB intends to audit EVERY BREWERY by 2016. That may sound a long way off, but now is the time to research and implement processes to ensure compliance with the TTB and avoid future failed inspections. The Brewer’s Association dedicated an entire Power Hour to addressing TTB compliance and how to avoid the common mistakes. The BA has also put together some great presentations summarizing the FDA’s involvement in the beer industry. We highly suggest that you consult these resources to get a more comprehensive understanding of how these changes will affect you.

Many of you already have appropriate methods in place in order to track what the TTB is looking for if you were to be inspected. Spreadsheets and notes may work for now, but it’s important to think about the future long-term practicality of these tools. Do you really want to be entering all this data manually? We present the facts and provide solutions, but it’s up to you to find out what works best for your brewery.

How OrchestratedBEER Can Help:

  • TTB reporting

Our built-in TTB reporting feature comes standard with all OrchestratedBEER products. The software populates your database with relevant data as you go about daily activities and reduces a 6-8 hour data gathering process down to a matter of minutes. We break down the numbers and specifics of TTB reporting functionality in a previous blog titled: TTB Reports: How much time are you spending?

  • Traceability

The software tracks specific batch measurables from raw materials to packaging, and all the QC data and processes in between. Make sure you can trace the source of a bad batch with software that can manage the production process.

  • Readily Accessible info in a Centralized System

It’s important to keep all data in a centralized place in order to have data, forms and other information readily accessible and consolidated when the TTB decides to pay you a visit. Having this information accessible to employees in other departments is the key initial step to streamlining processes.

Our advice is to anticipate annual visits by the TTB and have appropriate measures in place to track everything that goes into your beer. It’s only a matter of time before the TTB/FDA’s joint efforts and plans are fully implemented. Don’t wait until it’s too late.