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FDA Tree Nut Risk Assessment FDA Tree Nut Risk Assessment

FDA Tree Nut Risk Assessment - PowerPoint Presentation

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FDA Tree Nut Risk Assessment - PPT Presentation

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

tree salmonella assessment risk salmonella tree risk assessment data nuts fda food raw notice human nut www request 2013 cdc contamination cases

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Presentation Transcript

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