Robert L Roos - Comment

I would like to offer the following comments on the proposed rules for Preventative Controls for Human Food, FDA-2011-N-0920 and Draft Qualitative Risk Assessment of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm, FDA-2012-N-1258 It does not appear that the Draft Qualitative Risk Assessment considered the production of olive oil. Olive oil production is a growing agricultural industry in California, Texas and Georgia. Olive oil is made from the fruit of the olive tree and the production of virgin and extra virgin olive oil that is done without the use of chemicals and high temperatures should be considered a low risk activity. Biological hazards such as E. Coli and Salmonella are not associated with the olive fruit and the processing of the fruit into oil does increase or introduce any pathogens or food allergens. It is not reasonable to assume that there is a likelihood that the production of olive oil will cause serious adverse health consequences or death to humans. The Olive Center at the University of California at Davis has published a study on the Microbiological food safety of olive oil that is available at: http://olivecenter.ucdavis.edu/files/microbial%20safety%20120511.pdf that concludes that “based on the currently available literature, food born pathogens are not likely to occur in extra virgin or virgin olive oils”. For these reasons please revise the Draft Qualitative Risk Assessment to identify olive oil as a low risk activity/food and add it to the list of exempt foods such as honey and seed oil in the Proposed Rule for Preventative Controls for Human Food, FDA-2011-N-0920.