How can I begin to describe the draft regulations for the Food Safety Modernization Act (FSMA)?
On January 4, 2013, FDA came out with two sets of proposed rules, stating that comments from the public are due by May 16, 2013. One set of proposed rules relates to processed foods and the other one to produce. There are three additional sets of proposed rules yet to come; they are related to: imported produce and other foods; accreditation of third-party auditors in other countries; and preventive controls at animal food facilities that are similar to those proposed for human foods. For now, I am limiting my commentary to the produce-related rules.
This proposal applies to the produce industry (including farmers) and is called the Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Proposed Rule (144 pages); it focuses on areas of risk for fruit and vegetable production, including agricultural water; biological soil amendments; health and hygiene; domesticated and wild animals; and equipment, tools and buildings.
The FDA estimated that 1.75 million cases of foodborne illness would be prevented annually by this regulation, with an annual benefit of $1.04 billion. They estimated that compliance with the proposed rule will cost domestic farms $459.6 million. The estimated average annual cost for very small farms (less than $250,000 in annual revenues) is $4,697, $12,972 for small farms (between $250,000 and $500,000 in annual revenues) and $30,566 for large farms.
Reading through the proposed rules is not a simple process. I suggest starting with the published summary, which is available at:
http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm?source=govdelivery
Small farms would be eligible for the qualified exemption; they must meet all of the following conditions during the 3-year period preceding the applicable calendar year:
1. Their average annual revenues were less than $500,000 (adjusted for inflation);
2. Their average annual revenues from products sold directly to consumers, stores and restaurants exceeded the average annual revenues of the farm’s sales to all other buyers;
3. Their direct market sales occurred in the same state as the farm, or within 275 miles of the farm (whichever is greater); and
4. The name and complete business address of the farm where the produce was grown are conspicuously displayed at the point of purchase, if the produce is not otherwise labeled.
I will be back with more information regarding the FSMA’s proposed rule for produce by the end of February.
Shermain Hardesty, shermain@primal.ucdavis.edu