By Barbara Snider* and Erin Kelleher
The FDA is on the march and busy auditing food processors under their jurisdiction. While this leads to angst for the business caught up in the FDA bureaucracy, it is a fact of life for those who handle food and beverages, which are substances that are ingested by the public. No one argues against food and beverage safety and it’s one of the reasons we have the most respected alcoholic beverage industry in the world. Our products are safe and the world knows it. The FDA is one reason why.
The purpose of this post is to give some comfort to those who are FDA compliant (or are small enough to be outside of the ambit of the FDA’s inspection power but who comply anyway) and to give some guidance to those who may have missed the message until now.
At the end of the post are important checklists. We urge you to pay close attention to the acronyms, and to the guidelines. There will be a test, but hopefully not one that starts with a knock on the winery’s door.
Federal Law, Wineries and the Very Narrow Small Winery Exemption
Under Federal law, wineries are “food manufacturing plants.” As a food manufacturing plant, every winery must:
(1) Be registered with the FDA under the Bioterrorism Act (BTA),
(2) Re-register every two years, and
(3) Keep records of every source of food received (for example, grapes) and the destination of food (in this case, wine) shipped.
Wineries with fewer than 11 employees and that sell more than 50% of their product out the front door (direct to consumer is how we interpret this) are exempted from this regulation.
Because the fermentation process kills pathogens and wine is low pH, wineries are categorized to be “low risk” food manufacturing facilities. Thus, inspections of wineries have been a low priority for the FDA. Most wineries have never even had an FDA inspection.
That is now changing because of the FSMA.
The FSMA Priorities
The Food Safety Modernization Act (“FSMA”) was signed into law in January 2011, and made sweeping changes to food safety laws. The FSMA focus changed food safety regulations from responding to food contamination to preventing food contamination. Under the new FSMA law, even all “low risk” facilities (such as wineries) must be inspected within seven years of the Act becoming law, which means the FDA has now stepped up winery inspections for 2017.
The Good Manufacturing Practices (“GMP”) and the Sub-parts Applicable to Wineries
The FSMA also updated the Good Manufacturing Practices (“GMP”) regulations. The FDA notes that wineries are exempted from Subpart C (Hazard Analysis and Risk-based Preventative Controls) and Subpart G (Supply-Chain Program) both of which require a written and documented food safety plan at the facility. Wineries, however, must specifically comply with Subpart B (education and training of employees in food hygiene and safety) and Subpart F (record-keeping).
FDA Inspections – No Prior Notice Required and What to Prepare for
The FDA is not required to, and generally does not give prior notification of an inspection. The FDA also partners with state agencies to help get the inspections done; so, for example, in California, the inspection could be made by the California Department of Food and Agriculture (“CDFA”) on the FDA’s behalf. Other states also have counterpart agencies with the same functions as the CDFA. There can be no doubt that the FDA has geared up for inspecting the wineries, thus, wineries should be prepared.
The best way for a winery to prepare is to do an internal inspection now, ahead of time, on all compliance requirements. Here is our suggested checklist:
1. The winery should designate one or two persons who can be available on-site during an inspection without prior notice.
2. The winery should be sure all necessary documents are up-to-date and readily available. This includes the Bioterrorism reporting on food ingredients received and used in each wine shipped by the winery (see BTA checklist below). Copies of approved COLAs should also be readily available.
3. Wineries should be aware that one important change under the FSMA for wineries is that education and training in food hygiene and safety is now required for all employees. The winery must maintain records of the training for two years. Each employee must be trained as necessary to conduct the winery processes.
4. It is best to have a written flow chart of the winery processes demonstrating sanitation in the stages of winemaking. The flow chart should also include monitoring with adequate frequency.
5. One area of concern raised by the FDA inspections has been outdoor receiving of product, washing and fermentation tanks. Wineries should document efforts to assure these processes and the area are kept as sanitary as possible (the FDA has specifically raised concerns regarding birds, dogs, cats in the area which could contaminate the grapes/juice).
6. Everything in the winery should be clearly labeled, even sanitizer spray bottles, etc.
7. The FDA is particularly concerned that bottling rooms/areas be kept clean and sanitized to avoid contamination during bottling.
8. The Code of Federal Regulations (21 CFR 110.35) sets forth very specific sanitation issues with which wineries should be sure to comply. Briefly, the only toxic materials that may be used or stored in a plant where food is processed or exposed include:
(a) Those required to maintain clean and sanitary conditions;
(b) Those necessary for use in laboratory testing procedures;
(c) Those necessary for plant and equipment maintenance and operation;
(d) Those necessary for use in the plant’s operations.
(e) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
(f) Pest control, and pets. No pests shall be allowed in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. With respect to Pets, the CFR states that guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.
9. Make sure sufficient water, hot water and water pressure is available for sanitizing and that all drainage and sewage facilities are in working order.
10. The FDA also requires adequate toilet and hand-washing facilities be available for employees with proper signage requiring hand-washing.
Remember the Bio-terrorism Report requirement? We have a checklist for that also
For immediate previous food sources (yeast, fining, eggs, etc.), the report must include:
● Name of the firm providing the food source
● Name of responsible individual
● Telephone number
● Fax number and e-mail address, if available
● Type of food, including brand name and specific variety
● Date received
● Lot number or other identifier if available
● Quantity and type and size of packaging (e.g., 750 ml bottles)
● Name of carrier that brought the item to you
● Carrier's address
● Carrier's telephone number
● If available, carrier's fax number and e-mail address
The winery must also keep track of each ingredient used in each wine that is produced, bottled and shipped by the winery.
The FDA has not prescribed specific penalties, but simply reminds food facility operators and importers that non-compliance with registration, prior notice, or recordkeeping requirements (once they are mandatory) are prohibited acts, and violators are subject to civil or criminal court action. Foods imported from non-registered facilities or without proper prior notice are subject to being detained at the port of entry.
Conclusion: Preventative Maintenance Works
If your eyes aren’t fatigued by reading these checklists, then you haven’t been paying attention! Because these regulations apply to almost all wineries, being prepared is much better than being audited, found wanting, perhaps fined and faced with the possibility of future audits.
*As a former winery owner (and a skilled Hinman & Carmichael LLP attorney), Barbara Snider approaches FDA matters from experience, a realistic compliance perspective, and a thorough appreciation for best practices.