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How FSMA Will Impact the Wine Industry

Officials outline food safety and hygiene practices, plus due dates for compliance

A lot of winery owners, winemakers and grapegrowers are concerned about changes in food-safety regulations by the federal government, and hundreds of them attended a session about the Food Safety Modernization Act (FSMA) last week during the Unified Wine & Grape Symposium in Sacramento, Calif. Tracy Genesen, vice president and general counsel at the California-based Wine Institute and moderator of the session, noted that while wine is a low-risk product for food safety, there are sections of FSMA that impact both wineries and vineyards. Consequently, the Food and Drug Administration (FDA) has engaged with Wine Institute to work as compliance partners and to develop workshops in several California locations.

Two FDA representatives kicked off the discussion of FSMA. Nicole Yuen from the FDA’s office in San Francisco, Calif., introduced the updated “Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food–21 CFR Part 117,” and noted that the dates for compliance with FSMA vary by the size and type of business.

Wineries, meanwhile, are exempt from some parts of the updated Good Manufacturing Practices (GMP), according to Debra DeVlieger, national food expert with the FDA. The exempted sections include Subpart C (Hazard Analysis and Risk-based Preventive Controls) and Subpart G (Supply-Chain Program). She pointed out that previously non-binding provisions such as education and training in food hygiene and safety are now required, and that records must be maintained.

DeVlieger stated that currently the FDA is training food-safety inspection staff at both the federal and state levels, as compliance for large businesses (those with more than 500 employees) was instituted in September 2016, and the FDA plans to inspect all large facilities in 2017. Those inspections will determine if sanitation procedures are being followed and if employees have been trained in food hygiene and food safety. “The FDA is trying to gain industry compliance and reduce foodborne illness,” DeVlieger said. “We plan to do systems-based inspections, not observation focused, that will be interactive and cooperative.”

Going forward, the FDA wants to provide support to companies that need to comply, and to look at how facilities are working to achieve compliance. Their strategy is to educate both before and during inspections, so that companies will make voluntary corrections and participate cooperatively.

Margaret Kolk, managing director for food and agriculture at SCS Global Services (formerly Scientific Certification Systems Inc.) in Emeryville, Calif., identified two specific rules in FSMA that apply to wineries or vineyards. Under the current GMP, hazard analysis, and risk-based preventive controls for human food, wineries are specifically required to comply with Subpart B, for current GMPs, and Subpart F, for record keeping. Under Subpart B, all individuals who manufacture, process, pack or hold food (including temporary and seasonal personnel) must be qualified by education, training and/or experience and receive training in principles of food hygiene and food safety appropriate to their duties. Records of training must be kept for at least two years.

The second specific rule applies more to vineyards: The sanitary transport rule covers shippers, receivers, loaders and carriers. While there are requirements for each of these steps in the shipping cycle and include vehicles, transportation equipment and operations, there are exemptions for wine grape growers who are transporting grapes. Carriers of grapes will have a document or tag stating that the grapes are “not processed to reduce levels of possible problems,” and an “assurance letter” from a supplier to a grower will state that the grapes will be processed to remove potential problems. The assurance letters will not be required until 2020.

According to Allen Sayler, senior director for food and cosmetic consulting services at EAS Consulting Group in Alexandria, Va., because of the number of exemptions for the wine and grape industry, wineries are not particularly worried about FSMA. Instead they should be considering what they can do to prevent bottling line contamination or contamination of fermentor transfer valves. They should be more concerned about consumer interest in what is actually in wine (such as the recent lawsuit over arsenic), and what consumers are finding on social media, which may or may not be accurate.

Sayler also pointed out that while wine is a low-risk product for food safety, the regulations are different for table grapes, raisins and grape juice. Regulations under the foreign supplier verification program also may have an impact on some wineries.

More information about the Food Safety Modernization Ac is available at the FDA website

SCS Media Contact

Linda Brown

Linda Brown

Senior Vice President