FDA Tree Nut Risk Assessmentand Human Salmonellosis

National Pecan Shellers AssociationMid-Winter Meeting, Nashville, TN

March 25, 2014

1.Why is FDA doing a risk assessment and what does this mean?

2.What does FDA need to know from nut processors?

3.What is Salmonella and why should I be concerned about it?

4.What should I be doing about Salmonella?

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Presentation Outline:

The Federal Register notice: Request for data & comments

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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-request

• Model outputs:- Number of cases / serving; number of cases / year- Impact 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 almonds– Quantification of uncertainty – Sensitivity analysis

Why is FDA Doing a Risk Assessment?

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Data needs identified in the FR notice:

1. Salmonella prevalence & concentration on tree nuts2. Salmonella survival, growth or inactivation dynamics3. Relevant food consumption practices in the U.S.4. Storage, handling and processing conditions5. 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

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Salmonella Basics

• Common bacterium found in soil, water, birds, reptiles and mammals– An organism living in the environment from which

it infects/colonizes animals and plants• A major cause of occasionally fatal foodborne

illness• Becoming more resistant to drugs• A highly evolved organism that persists in the

environment for decades 6

Is Salmonella a Major Problem?

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• 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 supply

• Inadequate controls for processed food

• From CDC, Incidence of Human Infection, 2010 http://www.cdc.gov/Features/dsFoodborneIllness/

Salmonella Ecology

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Salmonella in Peanuts and Tree Nuts

• Commonly found in all species of raw tree nuts

• Found in 2.3% of raw shelled peanuts when testing 375 grams of nuts1

• Similar prevalence found in raw almonds, pistachios, and pecan

1 Journal of Food Protection, Vol. 76, No. 4, 2013, Pages 575–579 9

The Impact of New Technology

• Identifying specific strains of Salmonella– Serotyping– PFGE typing– Genome sequencing

Courtesy New Hampshire Public Health Lab

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The Good and the Bad

• Salmonella sickens and kills people• An ever greater number of cases are now being

linked to the source• Processors involved in an outbreak are often

bankrupted or suffer major business reversals

• It is possible to entirely prevent Salmonella contamination in processed foods like roasted nuts and nut butters

The Bad:

The Good:

Salmonella Control in Nut Processing

• Leadership engagement, understanding and commitment is most important

• Implementation of process controls, cGMPs, preventive controls, HACCP, and environmental and finished product testing

• Ensuring that the facility is designed and maintained to prevent contamination of the environment

• Promote control of Salmonella with others in the industry• Refer to the GMA guidance on Salmonella control:• http://www.gmaonline.org

/downloads/technical-guidance-and-tools/SalmonellaControlGuidance.pdf