Alan asked this morning “Won’t vast majority of US craft brewers deal well with new FDA requirements on spent grain because of exemptions?” Because of exemptions, no but brewers will deal with the new rule well and I’ll explain why. More importantly I think the final rule will not mean the end of brewer and farmer cooperation.
Let me back up and give you some background before I go into the why. For almost 5 years I worked for Congress, specifically for two members of the House of Representatives one of which was in a leadership role. In addition I worked for a trade association for 2 years part that was monitoring the federal rulemaking process for our members. Later I was at a medical device company for 5 years and dealt with FDA regulations and auditing. From this I feel comfortable making educated guesses about where the final rule will end up.
Currently we are in the first publishing of the rule. The person who wrote it probably lives in Washington DC and wrote in respect to best practices for animal feed without awareness of how daily operations for breweries and farms work. Mostly the intent is to prevent harm that might occur even though there is no evidence it has occurred. They will likely look at the response and talk with groups like the Brewers Association for a middle ground. Then the FDA will publish a new draft of the regulation that will implement. Make no mistake we are not getting out of this requirement.
To work around I have heard a few proposals. Some ask “what if we give away the grain?” the lawyers on the Brewers Association recent briefing made it clear that will not change anything. Some suggest “if we only give it to a farm for compost?” Unless there are no animals on the farm I doubt that will be permitted and for your own protection it would be better you assume it may occur to avoid any liability. Exemptions based on company size will likely be rejected though smaller companies may be given greater time to implement the process.
So what may the final rule look like? I think it will be bookkeeping in two forms. One a log sheet at the brew deck or spent grain area that records beer lot number, time/date, and brewer. When it is picked up we will add the farm picking up, time/date, and the farm person’s name. It all can fit on one page sheet on a clipboard. Considering the life cycle of beer and food we will have to maintain that documentation for at least 180 days, but 2 years to be on the safe side. That in itself is not burdensome.
The second part that may become required through this rule and some of the safety rules are more of a written Standard Operating Procedures(SOP) documents. They will get more detailed for the safety requirements, that is a separate agency, but for the spent grain rule it will designate a spent grain location, the logsheet and training for it’s use. As long as you have a process and follow it the FDA will be satisfied, but traceability will be the requirement.
Based on my experiences in medical device industry and brewing practices I am already establishing SOPs for brewery operations for Compass Rose from the start and I intend to add this record keeping into the list. With greater FDA attention to the brewing world, I think more record keeping, training, and documentation will become an industry standard. It will be more burdensome for existing breweries that work in an ad hoc manner, but in the long term it has potential bring a higher standard of quality across the brewing community.