and Human Salmonellosis National Pecan Shellers Association MidWinter Meeting Nashville TN March 25 2014 Why is FDA doing a risk assessment and what does this mean What does FDA need to know from nut processors ID: 580522
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Slide1
FDA Tree Nut Risk Assessment
and Human Salmonellosis
National Pecan
Shellers
Association
Mid-Winter Meeting, Nashville, TN
March 25, 2014Slide2
Why is FDA doing a risk assessment and what does this mean?
What does FDA need to know from nut processors?
What is
Salmonella
and why should I be concerned about it?What should I be doing about Salmonella?
2
Presentation Outline:Slide3
The Federal Register notice: Request for data & comments
3
Federal Register Notice
Request for:
Comments
Scientific data
Information
Published: 07/18/2013
Comment period:
90-days
Extended 60 days to 12/16/13
Available at
:
https
://www.federalregister.gov/articles/2013/07/18/2013-17211/assessment-of-the-risk-of-human-salmonellosis-associated-with-the-consumption-of-tree-nuts-requestSlide4
Model outputs:
Number of cases / serving; number of cases / yearImpact of interventions through “what-if scenarios”
Model will build upon peer-reviewed risk assessment models: e.g. Lambertini et al., 2012 (developed for U.S. almonds)
Model will evaluate product pathway: harvest to consumption
Expected extensions beyond currently published models:Adaptation to consider other tree nuts in addition to almondsQuantification of uncertainty Sensitivity analysis
Why is FDA Doing a Risk Assessment?
4Slide5
Data needs identified in the FR notice:
Salmonella
prevalence & concentration on tree nuts
Salmonella
survival, growth or inactivation dynamicsRelevant food consumption practices in the U.S.Storage, handling and processing conditions
Other comments (e.g., types of tree nuts to include)Additional information for each data need can be found in the FR notice.
Data gaps: Data needs for the
risk assessment
5Slide6
Salmonella Basics
Common bacterium found in soil, water, birds, reptiles and mammalsAn organism living in the environment from which it infects/colonizes animals and plantsA major cause of occasionally fatal foodborne illnessBecoming more resistant to drugsA highly evolved organism that persists in the environment for decades
6Slide7
Is Salmonella
a Major Problem?7
Despite significant efforts by FDA, CDC, and FSIS and the food industry, Salmonella continues to more than hold its own.The success of Salmonella as a pathogen could be due to:Its global distribution in the environment
The many routes of contamination of raw foods
Sources of human infection outside the food supplyInadequate controls for processed foodFrom CDC, Incidence of Human Infection, 2010 http://www.cdc.gov/Features/dsFoodborneIllness/Slide8
Salmonella Ecology
8Slide9
Salmonella in Peanuts and Tree Nuts
Commonly found in all species of raw tree nutsFound in 2.3% of raw shelled peanuts when testing 375 grams of nuts1 Similar prevalence found in raw almonds, pistachios, and pecan1 Journal of Food Protection, Vol. 76, No. 4, 2013, Pages 575–579
9Slide10
The Impact of New Technology
Identifying specific strains of SalmonellaSerotypingPFGE typingGenome sequencing
Courtesy New Hampshire Public Health Lab
10Slide11
The Good and the Bad
Salmonella sickens and kills peopleAn ever greater number of cases are now being linked to the sourceProcessors involved in an outbreak are often bankrupted or suffer major business reversalsIt is possible to entirely prevent Salmonella contamination in processed foods like roasted nuts and nut butters
The Bad:The Good:Slide12
Salmonella Control in Nut Processing
Leadership engagement, understanding and commitment is most importantImplementation of process controls, cGMPs, preventive controls, HACCP, and environmental and finished product testingEnsuring that the facility is designed and maintained to prevent contamination of the environmentPromote control of Salmonella with others in the industryRefer to the GMA guidance on Salmonella control:
http://www.gmaonline.org/downloads/technical-guidance-and-tools/SalmonellaControlGuidance.pdf