The wine indstry had been warned that the FDA would get around to inspecting winery operations for compliance with the Food Safety Modernization Act. And now some have been caught off guard by unscheduled visits.
Passed by Congress in late 2010 and signed into law by President Obama on January 4, 2011, the Food Safety Modernization Act (FSMA) allows the FDA to “focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.” Under Federal law, wineries are “food manufacturing plants.” As a food manufacturing plant, every winery must be registered with the FDA under the Bioterrorism Act (BTA), re-register every two years, and keep records of every source of food received and the destination of food shipped.
According to California-based Hinman & Carmichael law firm, most wineries have never had an FDA inspection before and said the best way for a winery to prepare is to do an internal inspection now on all compliance requirements. The firm lists these suggestions:
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. 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 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: those required to maintain clean and sanitary conditions; those necessary for use in laboratory testing procedures, and those used for plant and equipment maintenance and operation. 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. 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.
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.