S71 FSMA Preventive Controls for Produce Packing and Cooling Operations: A Reality Check and Near-term Aspirational Compliance Roadmap

Wednesday, August 3, 2016: 1:30 PM-3:30 PM
223-224 (America's Center - St. Louis)
Primary Contact: Trevor Suslow
Organizers: Annemarie Buchholz , Michelle Danyluk , Joseph Stout and Trevor Suslow
Convenor: Michelle Smith
With the release of several key final rules under FSMA, a significant proportion of the fresh produce industry responsible for handling and shipping Raw Agricultural Commodities (RACs), will not ‘qualify’ as ‘primary activities farms’ or ‘secondary activities farms’, as defined in the Preventive Controls Rule. As a consequence, many of these facilities will be challenged to make unprecedented infrastructural and cultural changes to meet applicable compliance expectations. A food safety systems approach to proactively manage compliance may align with directives within FSMA or customer requirements. Currently, customer requirements are taking a broader scope of inclusivity among packing operations and a prescriptive approach to certain standards, critical limits, and testing/monitoring programs. Fundamental to culture change is recognizing that RAC is barrier term to progress and all packing operations should refashion themselves as food handlers. Whether legally or market-reality bound to implement Preventive Controls, many handlers and shippers of RACs are currently operating significantly outside the parameters of design and management expectations for optimal cleaning and sanitation. Sanitary equipment design and fabrication of surfaces would not currently meet the criteria for FSMA-PC compliance. For most operations, but especially midsize and smaller packers, the cost of retrofitting or replacing equipment and related facility functional zones to achieve risk reduction and preventive control programs is economically burdensome. This mini-symposium will review key observations from the outbreak and associated environmental investigations at RAC packing operations and current research-based surveys and environmental monitoring data from a range of small-scale to large shipping-point facilities. Within the context of an aspirational roadmap and realistic timeline, prioritized implementation goals for the industry and the research and development community will be presented for participatory session discussion.


1:30 PM
Lessons Learned from Investigations and Inspections
Annemarie Buchholz, U.S. Food and Drug Administration
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