By: Heather Williams

Vino.Wine.  Paired with your meal or enjoyed by the glass, wine complements just about any occasion.  But is it a food?  More specifically, should it follow food manufacturer regulations.  The federal government acting with the U.S. Food and Drug Administration (FDA) says yes.  Under the Food Safety Modernization Act, wineries are now required to adhere to particular regulations and record keeping requirements in addition to surprise FDA inspections.

Wineries have known this day was coming.  The Food Safety Modernization Act began in 2011 in which they presented a timeline for many industries to become compliant over a period of years.  Wineries have known since about 2011 that the FDA would be knocking on the door and asking questions anytime thereafter.  Not surprising, this past Spring brought a slew of inspections, starting with those who have not yet registered.

These inspections may be conducted by the FDA or state and/or local inspectors as applicable.  The FDA is working with state and local governments to ensure all aspects of the Food Safety Modernization Act is enforced.  Whether feds or local authorities, they will all be looking for the same things.  Compliance with the Food Safety Modernization Act.  Inspections are most likely to be by surprise, so that the actual processes can be observed instead of giving employees and the facility notice.  The purpose of surprise inspections is to demonstrate what goes on when they expect it and are on their best behavior. With surprise inspections, the inspectors can catch issues in a more real-world scenario rather than in the best-case scenario to accurately capture deficiencies in the processes.

New Record Keeping Requirements

Wineries are required to register as food-production facilities with the FDA and also renew their registration every two years under the Bioterrorism Preparedness and Response Act in addition to their existing regulations, permits, and certifications.  Wineries are also expected to comply with Good Manufacturing Practices (GMPs) expected for food manufacturers.  One of the main documentation requirements includes documented employee training.  Others include sanitation record keeping, equipment verification, process validation, complaint handling, and more.  While these tasks are good practices that were likely already performed, the documentation aspect is where many wineries must adjust what they are already doing.

The Food Safety Modernization Act does exempt wineries from the “risk based preventative controls” and “supply chain program”, or Subparts C and G respectively.  These are good practices to use, but at this time not required for wineries.  It is possible this exemption may be revisited.  But for now, wineries can focus on what is in front of them.

It is a good idea for more than one person working at the winery to know where this documentation is kept, as surprise inspections are going to be more of a normal occurrence, much like their food manufacturing counter-parts.  While activities might be performed and completely compliant, if an inspector cannot see the documentation the winery may be cited anyway.

 Sanitation Checks

FDA inspectors will be looking for a number of potential sanitation issues in the winery process.  While wine dogs are an adorable and beloved attribute for some wineries, animals in food-production areas is an industry standard that must be adhered to at wineries as well.  Inspectors will be checking for pest control and evidence of rodents and insects.  If the winery has outdoor crush pads, inspectors will be evaluating how birds are kept away from harvested grapes.

Bottling lines are also an area of interest often scrutinized in food manufacturing facilities.  Wineries will be inspected at this process as well, primarily because this is a key area for contamination.  While inspectors aren’t going to expect small wineries to have ozone capabilities (a common industry sanitation procedure) they will be looking for what the facility is doing to clean and sanitize their wine processing equipment.  This includes both the products used and the procedures employed.

Inspectors will be verifying that pesticides and chemicals are kept in an area away from the ingredients and processing tasks.  All products and ingredients should be clearly labeled and stored properly.

Employee hygiene is another key topic for inspectors.  Cellar employees must have access to hot water for proper hand washing.  Documentation for employee food hygiene educations must also be retained.  These are some of the training documentation items that must be provided to inspectors upon request.

Product Tracking

In addition to employee training and sanitation documentation, product tracking information may need to be provided to inspectors.  Weigh tags may need to be presented to inspectors.  Certificates of Label Approval may also be retained as it could be requested at a moment’s notice.  The winery may also be asked where their products were shipped or delivered to.  While they are exempt from the Subchapter on Supply Chain Program, outgoing products should be traceable in the event a recall is necessary.

 What Does This Mean for Your Vino?

So, what exactly does this mean for your vino?  Most likely, nothing will change for the consumer.  Wineries have always been subjected to inspections.  Any food or beverage product, and particular alcoholic beverages undergo routine inspection.  The new umbrella of the Food Safety Modernization act that now includes wineries only means these facilities are expected to abide by the newly enforced regulations and perhaps keep a little more paperwork on file for inspectors.

And where price is concerned?  It is doubtful that strengthened regulations for wineries will impact the price of goods sold and the final retail cost for the consumer.  What it does mean, however, is that you can have piece of mind that products purchased from U.S. wineries have potentially safer practices.  It is very likely that most wineries are already doing at least most of what they are expected to do under the Food Safety Modernization Act, as good and safe business practice.  Many will just need to amp up their documentation so that when an inspector comes knocking, they can give them what they want and send them on their way so that they can get back to what they are good at doing.  Making delicious wine.

 

Sources:

https://pennstatefoodsafety.blogspot.com/2017/12/wineries-begin-seeing-surprise-fda.html

https://www.winesandvines.com/news/article/186032/FDA-Begins-Winery-Inspections

https://www.ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp