A four letter acronym was buzzing around the food and beverage industries for several months, the excitement of which has mostly subsided but the importance of which still remains active. FSMA, or the Food Safety Modernization Act, changed a lot for the food industry and is probably one of the most significant changes to U.S. food law in decades. The act was signed into law in January 2011 by President Obama and amended sections of the Food, Drug, and Cosmetic Act (“FD&C Act”). FSMA aims to stop foodborne illness breakouts before adulterated or misbranded food items are released into interstate commerce for sale or consumption.
Some of the new requirements established by the act include updating facility registrations every two years (otherwise known as biennial renewal, the first of which concluded on January 31, 2013), mandating e-mail certain addresses on food facility registrations, and requiring that food facilities establish preventative control measures (or, essentially, a HACCP plan). Additionally, FSMA bestows the FDA with considerable power: the ability to suspend a food facility’s FDA registration should the agency determine the facility’s food has a reasonable probability of causing death or serious illness to humans or animals. FDA first used its suspension powers in November of 2012 when the agency suspended the FDA registration of New Mexico-based peanut butter producer Sunland, Inc.
While it is undeniable that FSMA has many layers, through my experiences thus far, I think FSMA is a great example of how food and alcohol beverages interact in the legal world. Alcohol beverage facilities are not exempt from FSMA, although they are excused from certain provisions of the law (provided they are required to have a permit or register with the Department of Treasury as per the Federal Alcohol Administration Act and are also required to register with FDA). FSMA and related provisions consider alcohol beverage facilities to be food facilities. In general, both domestic and foreign facilities that manufacture, process, package, or hold alcohol beverages for human consumption within the U.S. are required to register with FDA. (And those previously registered were required to renew their registrations by January 31, 2013.) The registration requirement is not new–alcohol beverage facilities have been required to register with FDA since the 2002 Bioterrorism Act.
In addition, wineries and other alcohol beverage facilities are subject to FDA inspections. While this rule is not new either, pre-FSMA winery inspections were not very common. In fact, Wine Spectator reports that, during the 2009-2010 fiscal year, FDA only conducted 132 winery inspections in the U.S. However, this number is growing what with inspection frequency mandates established by FSMA. See Food and Drug Administration: Inspection & Compliance. As 2013 progresses, we are starting to hear about a number of winery inspections by FDA (or state agencies). (Note that a foreign facility is not exempt from FDA inspection assuming that said facility manufactures, processes, packages, or holds food for human or animal consumption within the U.S.) While FDA inspections may be new to a winery, an establishment that is alert, maintained, and informed should not fear an inspection.
While non-alcohol food facilities are held to more onerous standards, FSMA created specific carve out provisions for alcohol beverage facilities. Furthermore, thanks to the assistance of many wine trade associations, some subsequent proposed rules by FDA do not apply in entirety to wineries. In particular, wineries are not required to implement preventative control measures that are required of other food facilities. This is a particularly significant requirement from which wineries are exempted. Wineries, however, should still be aware that they are required to register with FDA (if wines are for human consumption in the U.S.), that the registration must be updated biennially, and that they are subject to FDA inspections (which can be conducted by a state agency). In addition, wineries should understand that they are required to maintain records of the source and destination of their wines and additives and will be held to current good manufacturing procedures.
* Note wineries are still subject to certain provisions of FSMA, such as registration, mandatory recall, and prior notice (for foreign facilities). The applicable sections to alcohol beverage facilities are noted in Section 116 of the Act.