Issue link: http://winesandvines.uberflip.com/i/152772
winery safety Requirements for Winery Facilities Requirement Facility registration through the FDA Record keeping Subject to FDA inspection Must comply with current Good Manufacturing Practices Subject to proposed Preventative Controls Rule* Subject to proposed Produce Safety Rule* Subject to FDA recall authority Subject to FDA administrative detention authority Applies to Any facility that manufactures, processes, packs or holds food for human or animal consumption in the United States (including wineries, truck-mounted bottling operations, custom-crush and storage facilities), but not most retail facilities or farms. All registered facilities. All registered facilities. All registered facilities. Most food processors and wineries that sell a) unpackaged, non-alcohol food including juice or grapes not destined for winemaking, or pomace destined for human consumption; or b) packaged non-alcohol food that composes more than 5% of the total facility sales. Farms or vineyards that grow, harvest, pack or hold raw fruits and vegetables (for example, table grapes or restaurant gardens), subject to limited exceptions. All food facilities, transporters and warehouses. All food facilities, transporters and warehouses. * Not yet a final regulation Because the FSMA directs the FDA both to increase its inspection frequency and to conduct its operations in cooperation with state and local food-safety authorities, wineries are receiving new attention, both from the FDA and from state and local compliance officers. In fact, the FDA is explicitly authorized to rely on inspections of other federal, state and local agencies to meet its increased inspection mandate, so these regulatory requirements may continue to be considered side by side in the future. FSMA today: An update to the status quo The FSMA is the first major update to U.S. food safety law in 70 years, and it was designed to shift the focus of the law from a reactive system to a comprehensive, prevention-based, foodsafety program, from planting to shelf, across the U.S. Designed as a "farm to fork" approach, the FSMA touches every piece of the food and beverage production chain and implements variable (and often complex) standards based on the particular risks associated with certain food-production activities. Due in part to steady efforts from the wine sector and other stakeholders to educate Congress about the low foodsafety risk associated with winemaking, the FSMA's application to wineries was limited from the outset. Under Section 116 of the Act, a facility that produces an alcoholic beverage and must register with or be permitted by the Alcohol and Tobacco Tax and Trade Bureau (TTB) is excused from all but a few of the FSMA requirements. Still, the FSMA granted the FDA the following key authorities over winemaking operations: 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 FSMA to wineries. • Registration requirements: The FSMA adapted the Federal Bioterrorism Act's registration requirements and requires wineries to register biennially with the FDA. If the FDA determines that the food "manufactured, processed, packed, received or held" by a registered facility poses a serious health risk, the FSMA allows suspension of that facility's registration and bar the facility from selling its products until the risk is resolved. (FSMA Section 102). • Mandatory recalls and administrative detention: The FDA may order a mandatory recall of a product if it determines that there is a reasonable probability that the product is adulterated or misbranded—and that the exposure to that product poses a health risk to humans 54 p racti c al w i ne ry & v i n e yard S EPTE MBER 20 13 or animals. It also has the authority to hold (or "administratively detain") a food product, if it has reason to believe it is adulterated or misbranded, to prevent it from entering the market. It is not clear how this labeling oversight will be impacted by TTB's current oversight of wineries. The FSMA directs the FDA to develop regulations that set out exactly how and when it will exercise this authority (FSMA Sections 206 and 207). • Import controls: The FSMA gives the FDA authority to establish a certification program for importers seeking to expedite the FDA's review of their facilities and products. It also gives the FDA limited authority to set out regulations governing the treatment of imported products (FSMA Sections 302 and 304). • Inspection authority: The FDA has authority, under the federal Bioterrorism Act, to inspect registered facilities including wineries and even mobile bottling lines. The FSMA directs the FDA to inspect every registered facility in the U.S. by 2018. Subsequent inspections will be based on risk assessments and facility compliance history. Even when the FSMA was adopted, however, it was clear that the limitations in Section 116 were directed at alcoholic beverage production, and not at ancillary activities at those facilities. Section 116 (c) includes a special directive: "This section shall not be construed to exempt any food, other than alcoholic beverages… from the requirements of (FSMA)." For non-alcoholic foods, additional requirements apply. The onerousness of these requirements is often tied to the particular level of food-safety risk that a product poses. For example: Foods designated as a "high-risk food," are subject to more intense risk-management procedures and testing, while foods subject to a kill-step during processing (including pasteurization, distilling, fermenting or brewing) enjoy more limited oversight. The FDA cites two reasons for this special treatment of alcoholic beverages. First, alcoholic beverage producers are already subject to considerable oversight by the TTB, which made additional oversight by the FDA redundant in many regards. Second, both the FDA and Congress have acknowledged that compared to other consumables, wine poses a relatively low food-safety risk and therefore may "warrant lower priority from a public health perspective than other foods." Pomace, hard press and other surprising "foods" Section 116, however, does not take every activity at a winery out of the