Here is attorney Gary Cox’s analysis of the new Food Safety Control law. –Augie
Recent Food Safety Legislation – Part 1
By David G. Cox
In November 2010, the U.S. Senate passed Senate Bill 510, the so-called “Food Safety Modernization Act” (the Act). On December 21, the House voted to pass the Senate version of the bill, House Resolution 3082, which was signed into law by President Obama later that month.
So, how exactly does Act affect the majority of small farmers and food producers? Beginning at Section 6101 of H.R. 3082, the Act generally amends the Federal Food, Drug, and Cosmetic Act and expands the authority of the Food and Drug Administration (FDA) to regulate “articles” of food. Specifically, the Act, in part, provides for the following:
(1) It narrows the definition of “facility” that must register with FDA under the Act yet eases the conditions under which FDA may “suspend” a facility’s registration status;
(2) It requires facilities to develop what was formerly called a Hazard Analysis and Critical Control Plan (HAACP);
(3) FDA can now assess and collect fees related to the inspections of facilities and the monitoring of recalls from each facility;
(4) FDA is authorized to enhance food-borne illness surveillance systems.
In short, the Act in some ways broadens the already overreaching authority of the FDA. In this issue, I will address the Act’s impact on “facilities” and what some of the “facility” requirements are.
What is a facility? Prior to the Act, a “facility” was defined as “any factory, warehouse, or establishment that manufactures, processes, packs, or holds food” and under the 2002 Bioterrorism Act all facilities must register with the FDA. However, the following were excluded from the definition of facility: “farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels.”
The Act narrows the definition of “facility” by “clarifying” Congress’ “intent” in what constitutes a “retail food establishment.” Under the Act at Section 6102, a retail food establishment now includes all of the following:
(1) The sale of food directly to the consumer at a “roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed;”
(2) The “sale and distribution of such food through a community supported agriculture program;” and
(3) The “sale and distribution of such food at any other such direct sales platform as determined by” FDA.
Section 6102 states that the term consumer “does not include a business.” Therefore, farmers’ markets and roadside stands that sell food to “consumers” (but not businesses) at a place other than the farm would not have to “register” as a “facility” with the FDA under the Act. In addition, CSA’s would be exempted from the definition of facility and would not have to register with FDA.
Under Section 6103, qualified facilities do not need to comply with the HACCP provisions. A “qualified facility” will eventually include a “small business” and a “very small business” once FDA issues regulations that define those terms. At present, however, a qualified facility is one where (1) the total sales of its products directly to consumers combined with its sales to all other “qualified end users” (e.g., restaurants and retail food establishments located in the same state or within 275 miles of the facility) exceeds the total sales of its products to all other purchasers (e.g., distributors, warehouses, auction barns, etc.), and (2) its total sales to consumers, qualified end users, and all other purchasers combined do not exceed $500,000.
Instead of having to comply with the HACCP requirements, a qualified facility has two options: first, it could provide documentation to FDA that it is in compliance with all applicable state, local, or county requirements, or; second, it has “identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective.” Moreover, qualified facilities that do not have to comply with the HACCP requirements are required to either (1) place a label on all of their products (if already required by law to do so), (2) hang a sign at the facility’s place of purchase, or (3) post an electronic notice if they engage in internet sales.
Thus, with the bill signed into law, farmers and food producers can expect a more intrusive FDA role in their agricultural operations. Next time I will describe the impact of the Act on vegetable production and the interplay with the Organic Foods Production Act.
Gary Cox is General Counsel for the Farm-to-Consumer Legal Defense Fund, a national non-profit organization dedicated to defending the right to buy and protecting the right to sell nutritious food directly from the farm. This article is intended for educational and informational purposes only and is not intended to be nor should it be construed as either a legal opinion or as legal advice. The opinions expressed in this article are those of the author and not of anyone else.
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