Issue link: http://winesandvines.uberflip.com/i/152772
winery safety Final thoughts While the core requirements for the wine sector are not entirely new, the FSMA increased inspection directive means that more wineries will be interacting with the FDA than in previous years. Wineries are currently subject to FDA inspection and should be prepared to demonstrate to an inspector that they are in compliance with the core requirements of Section 116. Facility registrations should be up to date, basic Good Manufacturing Practices should be in place, and winery personnel should be able to speak knowledgeably about the facility's compliance with relevant county health requirements. For many wineries, this may mean revisiting their compliance efforts with an eye toward avoiding food safety pitfalls. For example, the FDA has gone so far as to pronounce that a truck-mounted bottling operation that travels from winery to winery is a food facility subject to federal registration requirements, because bottling wine is an activity included in the definition of "manufacturing/processing," even under the pre-FSMA regulations. Careful attention to these regulatory details will serve wineries well. The question of what the FSMA will mean to the wine sector in two years or 20 is still an open one. The FSMA does grant the FDA broad authority, but the way that authority will be exercised depends heavily on the rules that are currently being developed and commented on. Onerous FDA oversight is not a forgone conclusion: The agency has sought (and will continue to seek) comments from members of the public regarding the reach, breadth and science behind each of its proposed rules. The FDA has publicly acknowledged that it sees wine production as a relatively low-risk activity, but it has also unambiguously stated that it will apply the FSMA to wineries. The current comment period is a unique opportunity for the wine sector: The FDA is actively soliciting feedback from the public regarding interpretation and application of Section 116 (the gateway to FSMA winery applications) in the context of the Preventative Controls Rule. In July 2013, the FDA announced its intention to extend the deadline for comments on the Preventative Controls Rule and Produce Safety Rule an additional 60 days, from Sept. 16, 2013, to mid-November 2013. Comments on the recent Foreign Supplier Verification and Third-Party Auditor Accreditation rules will be accepted until late November. Further information about comment submission can be found at fda.gov/ Food/GuidanceRegulation/FSMA/ ucm261689.htm. PWV Rebecca Anderson Smith is an attorney in Downey Brand LLP's Food and Ag riculture L aw practice. Anderson Smith is a leader on the firm's food safety compliance team, which is dedicated to counseling vineyards, wineries, farmers, grocers, ranchers and food processors on state and federal regulatory compliance issues, including the Food Safety Modern- ization Act. She counsels clients about vineyard acquisitions, permitting and water supply issues. Anderson Smith practices in Downey Brand's Sacramento, Calif., of fice, and may be reached at rsmith@downeybrand.com, or by phone at (916) 444-1000. Read more about winery responsibilities and record-keeping for FDA inspections in "What Wineries Need to Know About the Food-Safety Modernization Act," a story from Wine Business Monthly, at winesandvines.com/pdf/ Howe_FSM.pdf Green, Green Wine with Energy Savings COOL-FIT® Plus Systems! Your pre-insulated piping solution for glycol installations. www.cool-fit.georgfischer.com 2882 Dow Avenue, Tustin, CA 92780-7258 • Phone (714) 731-8800, Toll Free (800) 854-4090 e-mail: us.ps@georgfischer.com • www.gfpiping.com WineVinyard 6-13.indd 1 pr actica l win ery & vin eya r d S EPTE M B ER 20 13 PM 5/31/13 1:30 57