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Listeria monocytogenes outbreakAssociated with Caramel Apples

2015 InFORM Conference

First reported outbreak associated with whole apples coordinated by CORE

35 cases reported from 12 states• 4 of 5 FDA Regions involved

2 cases reported in Canada• One with reported Caramel Apple consumption

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

• 11/21/14 FDA CORE Signals began evaluating 2 clusters of Listeria

Monocytogenes

• 12/15/14 – 12/16/14 CDC: 9/9 cases reported caramel apple consumption

• 12/18/14 Inspections at firms initiated

• 12/22/14 First of numerous voluntary recalls initiated

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

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Manufacturer A: Brand AGrocery Store Chain B (Store #4)TX Case (#3)

Grocery Store Chain B (Store #3)TX Case (#2)

Grocery Store Chain CUT Case (#1)

Grocery Store Chain B (Store #2)TX Case (#1)

Apple Supplier B

Apple Supplier E

Apple Supplier D

Apple Supplier A

Apple Supplier C

Grocery Store Chain B (Store #1)CA Case (#2)

Bidart Bros.(Bakersfield, CA)Grower/Apple Supplier

Bidart Bros.(Shafter, CA)Cooling/Packing Facility

Chain B Distribution Center (#2)

Chain B Distribution Center (#1)

Grocery Store Chain ACA Case (#1)

Chain A Distribution Center

Grocery Store Chain FWI Case (#1)

Manufacturer C: Brand CDistributor C

Broker B

Distributor D

Grocery Store Chain DMO Case (#1)

Manufacturer B: Brand B Distributor B

Grocery Store Chain EMO Case (#2)

Apple Supplier F

Grocery Store Chain HMN Case (#2)

Distributor F

Grocery Store Chain GMN Case (#1)

Manufacturer D: Brand D

Apple Supplier K

Broker E

Broker D

Apple Suppier H

Apple Suppler G

Apple Supplier I

Apple Supplier J

Broker C

Broker A

Distributor E

Distributor A

Listeria monocytogenes /Caramel ApplesCoordinated National Response

• Inspectional Observations Caramel Apple Production

• Mostly Seasonal• Granny Smith Apples• Commercially Processed• Potential processing issues• Smaller apples

Caramel Apple Distribution• Nationwide

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

• Environmental and Product samples Sampling conducted at multiple

points along distribution chain

Samples from Bidart facility are PFGE and WGS match to clinical cases

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

• Recalls Bidart Bros. Granny Smith and Gala Apples

• December 22, December 24, January 6

Multiple Caramel Apple manufacturers• Happy Apple Company of Washington, Missouri• California Snack Foods, of El Monte, California• Merb’s Candies of St. Louis, Missouri

Canadian recalls

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

Next Steps

1. Implicated product removed from market

2. FDA will continue to work with Industry

3. Transition to Post Response/Prevention

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

Prevention Efforts

• Outbreak strain found in supplier and manufacturing environment

• Federal and Non-Federal entities continue to conduct studies Whole unprocessed apples vs. caramel apples

• Upcoming FDA assignments to determine how caramel apples processing environment may contribute to a contaminated product

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

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• Conducted at the Institute for Food Safety and Health | Illinois Institute of Technology | Moffett Campus

• Characterized the behavior of LM in caramel and fresh apples• Findings: LM survived but did not grow on fresh apples

Growth significant for caramel apples if contamination at the stick end

Growth in caramel apples was slower at 5oC than at 25oC

Both low and high level contamination resulted in approx 1011 pathogen cells per apple

• Submitted for publication in Journal of Food Protection

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Listeria monocytogenes /Caramel ApplesCoordinated National Response

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Upcoming FDA Assignment Purpose

• To observe and document practices that may increase the risk of L. monocytogenes introduction, growth, or contamination in caramel apples

• To provide and give insight into the prevalence of L. monocytogenes in the environment and how contamination occurs

• To develop strategies for reducing the environmental contamination

Listeria monocytogenes /Caramel ApplesCoordinated National Response

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Upcoming FDA Assignment Objectives

• Conduct GMP inspections of firms that produce caramel apples as identified

• Collect and analyze environmental samples at each firm

• Collect evidence necessary to support the appropriate regulatory action when significant violations are observed.

• Upon confirmation of L. monocytogenes positive samples from environmental sampling, determine if L. monocytogenes is linked to reported outbreaks utilizing whole genome sequencing (WGS)

Listeria monocytogenes /Caramel ApplesCoordinated National Response

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Success factors

• Professionals dedicated to promoting public health

• Astute epidemiological work to identify vehicle

• Prompt federal and local response

• Prevention efforts in progress

Listeria monocytogenes /Caramel ApplesCoordinated National Response