November 19, 2014
The US Food and Drug Administration’s (FDA) new proposed food safety rules for food facilities apply to those facilities that are required to register with the government. Hence the question of who must register as a food facility with the FDA has been central to the Food Safety Modernization Act (FSMA) rulemaking process since it began in early 2013.
The new rules are not expected to be finalized until late August 2015. The requirement to register, however, is not new. Since the Bioterrorism Act of 2003, facilities that manufacture, process, pack, or hold food for human consumption have been required to register with FDA. The Bioterrorism Act also established two important exemptions from this requirement: one for farms, and one for retail food establishments.
Under existing law, many farms are exempt from the requirement to register. However, some farms do have to register if they do more than what FDA considers a “farm” activity.
The proposed FSMA rules change the farm definition so that farms that pack or hold raw agriculture products from other farms are not considered facilities. This is a big improvement, given that packing and holding products from other farms is a common and cost-effective practice, particularly for farms that are aggregating products for sale to local and regional markets. As long as these farms aren’t doing other manufacturing or processing, then they will be treated like the farms they are, not like facilities.
FDA has just released new guidance that illustrates the high likelihood that this proposed definition will be finalized into the agency’s regulations. This means that, despite the fact that the rules aren’t yet finalized, FDA is not expecting farms that pack or hold raw agricultural products from other farms to register in this interim period.
Retail food establishment exemption
Under existing law, retail food establishments are exempt from the requirement to register. Retail food establishments are defined as an “establishment that sells food products directly to consumers as its primary function.” When Congress passed FSMA, it directed FDA to clarify that farmers markets, community supported agriculture, and other direct-to-consumer platforms also fall within that exemption. FDA has said that they will issue a separate proposed rule that provides this clarification, though in the nearly four years since FSMA became law, they have not yet done so.
Meanwhile, the updated guidance that FDA published on November 18 provides some clarity on the issue. It explains the changes to the retail food establishment exemption that are expected as a result of FSMA:
“[I]n determining the primary function of an establishment or a retail food establishment, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include:
NSAC appreciates FDA’s responsiveness to our concerns that additional clarity was needed on this issue. It is important to note, however, that these changes are not yet finalized in the regulations.
Visit our FSMA Action Page for more information on FDA’s proposed food safety rules and how to submit comments.
Trying to figure out whether or to what extent farms and food businesses might be subject to the proposed rules? Check out our new flow charts that diagram coverage under the proposed rules!