fda core report for november 2 through 5,...
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For internal FDA use only. This document may contain non-public information.
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FDA CORE Report for November 2 through 5, 2015
For internal FDA use only. This document may contain non-public information, including
information for which public disclosure is prohibited by law, such as confidential commercial
information, trade secrets, and personal privacy information. This document was prepared by
the Coordinated Outbreak Response and Evaluation Network (CORE).
All information found in this report is available on the FDA CORE intranet site on the “CORE
Incident Status Board” (http://inside.fda.gov:9003/CFSAN/CORE/ucm273650.htm).
Click on the EON URL to receive the latest and most detailed information on specific incidents.
*The new information presented in today’s report has been included below in BOLD, dark red
text.
CONTENTS
High-Profile Outbreaks
1. Salmonella Poona/Cucumbers/ML/Aug 2015 - EON 220710
2. E. coli O26 / Unknown / ML / Oct 2015 EON-231814
Other Active Outbreaks
3. Salmonella Javiana (0094)/ Tomatoes (suspect)/ML/Aug 2015 - EON-219807
4. Salmonella Newport (0030/0011)/Tomatoes (suspect)/ML/Aug 2015
5. Salmonella Enteritidis (pattern JEGX01.0008) / Unknown / ML / September 2015
CORE Signals Activities - On the Radar
6. Salmonella Javiana (0135)/Unknown/ML/Sept 2015
CORE Post Response Activities
HIGH PROFILE- OUTBREAKS
1. Salmonella Poona/Cucumbers/ML/Aug 2015 - EON 220710
On August 13, 2015, FDA CORE was notified through a PulseNet SharePoint Database posting
of 16 Salmonella Poona 0018 human cases in 10 states (IL, LA, NY, OK, AK, AZ, CA, ID, NV,
and UT).
A strong epidemiologic signal indicated cucumbers as a suspect vehicle. FDA traced back six
sub clusters from: 1) two Red Lobster restaurant locations in Minnesota, 2) a daycare in Alaska,
3) a sushi restaurant in California 4) a family party in Nevada, 5) two grocery store locations in
Utah, and 6) a Marine Recruit Depot in California. FDA and state partners identified a common
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supplier, Andrew & Williamson Fresh Produce as the source of the cucumbers for all points of
service selected for the traceback investigation.
At least 48 product samples were collected by FDA and state partners in response to this
incident. FDA collected 10 samples of cucumbers and 11 samples of tomatoes. State partners
collected 23 samples of cucumbers and four samples of tomatoes.
FDA Denver Lab, PRLNW, NRL, PRLSW, and ARL analyzed samples collected by FDA and
the Utah Department of Food and Agriculture. Salmonella Poona 0018 was recovered from 15
samples, all of the positive samples were cucumbers sourced from Rancho Don Juanito of Baja
California, MX.
On September 4, 2015, Andrew & Williamson Fresh Produce issued a recall of all Limited
Edition cucumbers supplied from August 1, 2015 through September 3, 2015. FDA and CDC
provided six incident related updates to their webpostings.
On September 10, 2015, FDA Office of International Programs inspected the source of the
implicated cucumbers, Rancho Don Juanito and issued a FDA Form 483 to the firm.
Strong epidemiologic association, traceback convergence, and positive product samples
matching the outbreak strain led the investigative partners to the conclusion that the outbreak
was associated with cucumbers supplied by Andrew & Williamson Fresh Produce and sourced
from Rancho Don Juanito.
Investigation partners: ATL-DO, CHI-DO, CIN-DO, DAL-DO, DEN-DO, DET-DO,
KAN-DO, LOS-DO, MIN-DO, NOL-DO, NYK-DO, SAN-DO, SEA-DO. SWI-DO
Initial monitoring/involvement by FDA CORE: 8/2/15
Transferred to CORE Response Team 1: 8/24/2015
CORE Response Team: [email protected]
Emergency Operations Network URL: https://eon.fda.gov/eon/i#browse/EON-220710
Surveillance Information/Epidemiology:
As of 10/29/2015, CDC reports*:
806 cases have been reported from 37 states
AL (1), AK (17), AR (11), AZ (123), CA (220), CO (19), CT (1), FL (1), HI (1), ID (24),
IL (9), IN (5), IA (7), KS (2), KY (1), LA (5), MD (1), MN (38), MO (14), MT (15), NE
(8), NM (31), NV (15), NY (6), ND (8), OH (3), OK (12), OR (22), PA (2), SC (10), SD
(3), TX (42), UT (54), VA (1), WA (24), WI (43), and WY (7).
Reported onset date range: 7/3/15 to 10/02/15
Deaths: 4
Hospitalizations: 165
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*Data is preliminary and all cases may not be related. The numbers are subject to change
pending further information and analysis. Cases identified may be secondary cases.
Laboratory:
Utah Department of Ag collected 2 cucumber samples (sample #917942 and #917943) from
Associated Food Stores (supplied by Andrew and Williamson Fresh Produce) and pending
analysis at DEN-LAB. Sample 917942 tested positive for Salmonella and matches the
outbreak strain.
Sample #925147 collected by Southwest Import District (SWID) on 9/3/2015 has been
reported as positive for Salmonella from Northeast Regional Laboratory (NRL).
Sample #925033 collected by SWID on 9/2/2015 has been reported from NRL as positive for
Salmonella and matches the outbreak strain.
Sample #925067 collected by SWID on 9/2/2015 has been reported as negative from NRL.
San Diego County Environmental Health collected samples from Andrew & Williamson
Fresh Produce, they report 4 samples have tested positive for Salmonella and at least 2 match
the outbreak strain.
Arizona officials collected from a Fry’s grocery store in AZ, reported as negative for
Salmonella.
Arizona officials collected Andrew & Williamson Fresh Produce cucumbers from a Red
Lobster restaurant in AZ. Reported as positive for Salmonella and matching the outbreak
strain.
Missouri officials collected cucumbers from a case patients home reported to be purchased
from Wal-Mart. Samples tested negative for Salmonella.
Montana officials collected cucumbers from an Alberston’s grocery store. Salmonella was
detected in these samples.
Nevada Washoe County Health District collected Andrew & Williamson Fresh Produce
cucumbers from Save Mart grocery store, in Reno NV. Salmonella Poona was detected in
these samples and matches the outbreak strain.
Samples #926239 and 926260 of Rancho Don Juanito roma tomatoes were collected by
SWID and reported as negative for Salmonella by PRL-NW.
Sample # 926288 of Rancho Don Juanito roma tomatoes were collected by SWID and sent to
ARL for analysis. The tomatoes were reported as negative for Salmonella.
Serology results for sample #925033 confirm that the isolate is Salmonella Poona.
Import samples collected by SWID have as follows: 4 from Viva Organica S DE RL DE CV,
Ensenada, Mexico (Sample #927504 analyzed by DEN-LAB; #927493, 927486, and 927472
analyzed by PRLNW) and 2 from Productora Agricola Industrial del Noroeste, Ensenada,
Mexico (Sample #927592 analyzed by DEN-LAB and #927479 analyzed by PRLNW).
Import sample 927479 from Viva Organica (Ensenada, Mexico) and samples 927493,
927486, and 927472 from Productora Agricola Industrial del Noroeste (Ensenada, Mexico)
and negative for Salmonella.
Samples 927592 and 927504 are negative for Salmonella. SWID collected a new sample
#927809 from Viva Organica (Ensenada, MX). The samples were reported as negative for
Salmonella.
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On 10/01/15, CDC provided an updated WGS tree using a different reference to root the tree.
The clinical and cucumber isolates are 0 – 4 SNPs different.
Sample # 928120 of Viva Organica (Ensenada, MX) tomatoes were collected by SWID and
sent to PRL-NW for analysis. The sample was reported as negative for Salmonella.
Completed Actions:
The most recent CDC states call was held on 10/06/2015. The only significant produce
exposure was for cucumber consumption (garden variety).
The most recent CORE tactics call was held on 10/15/2015.
Andrew and Williamson Fresh Produce announced a recall on 9/4/2015.
On 9/9/2015, CDC completed whole genome sequencing on 15 clinical samples related to
this outbreak. The samples seem to cluster tightly together with some less than 7 SNPs apart.
CDC will continue to analyze additional samples and determine the similarity between
clinical samples. WGS analysis for UT Department of Agriculture seem to be highly related
to 15 clinical isolates CDC previously analyzed.
On 9/10/2015, an inspection was initiated at Rancho Don Juanito in MX. The firm reports
that they have completed the packing of cucumbers for the year. The season is from June to
August or even to the first week of September. The farms are located in the valley of
Vizcaino southern Baja California Sur.
On 9/11/2015, as part of the Andrew & Williamson Fresh Produce recall audits, District
Offices identified Customs Produce Sales of Parlie, CA as a repacker of Andrew &
Williamson Fresh Produce cucumbers into Fat Boy Fresh Produce brand. Custom Produce
Sales (“Custom Produce”) of Parlier, California voluntarily recalled Fat Boy ® products.
On 9/14/2015, the FDA issued Import Alert 99-23 for cucumbers from Rancho Don Juanito
de R.L. de C.V. located in Baja, Mexico.
On 9/17/2015, FDA issued a 483 to Rancho Don Juanito. Findings included rodents control,
waste water management, equipment design and storage of materials.
Whole Genome sequencing analysis of the Andrew & Williamson Fresh Produce cucumber
samples collected at retail locations by NV and UT are highly related to the clinical isolates
that have been sequenced.
On 9/24/2015, Import Alert 99-35 was updated to include Rancho Don Juanito.
Rancho Don Juanito has hired a rodent consultant. They plan to begin harvesting tomatoes on
10/20/2015. They do not plan to ship tomatoes from the Guadalupe farm to the US. They also
plan to implement increased microbiological testing of tomatoes.
On 10/02/2015, FDA and CDC held a meeting with SENASICA and COFEPRIS to discuss
the outbreak. FDA and counterparts in MX will continue to work together on this
investigation.
On 10/06/2015, FDA and CDC updated the case count on its web investigation page.
On 10/14/2015, FDA and CDC updated the case count on the web.
On 10/15/2015, FDA discussed next steps for tomatoes supplied by Rancho Don Juanito.
Increased sampling will occur for tomatoes with the Rancho Don Juanito packing house
identified.
On 10/30/2015, an After Action Review for this incident was held with FDA, CDC, DoD and
state partners.
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On 10/30/2015, SENASICA reports that the Guadalupe Farm of Rancho Don Juanito is not
in production at this time. The firm has agreed to participate in SENASICA’s Risk Reduction
program. The firm is also working with the Baja California’s State Food Safety Committee to
assure compliance with SENASICA’s Risk Reduction program and addressing of 483
observations.
Ongoing Actions:
CORE is preparing final incident documents.
Pending Actions:
Incident Transfer to CORE Post Response is TBD.
Recent Media Coverage:
2. E. coli 026 / Unknown / ML / Oct 2015 -- EON-231814
On October 30, 2015 the FDA's Emergency Response Coordinator (ERC) for the Seattle District
Office (SEA-DO) notified CORE Signals of a potential outbreak of Shiga Toxin-Producing E.
coli (STEC) with 23 cases in WA (19) and OR (4). (Please note that the states have publicly
announced only 22 cases.) Case interviews suggested a strong association with consuming foods
at Chipotle Mexican Grill restaurants. Additional cases are pending in OR, as is further
subtyping on all cases including serotyping and PFGE. The case count is preliminary and is
expected to change often in the coming days.
Estimated and reported illness onset dates range from October 12 to October 25, 2015. Cases
range in age between 11-61 years (median 22 years) and 14 (78%) cases are female. Nine cases
(43%) have been hospitalized, but there have been no cases of hemolytic uremic syndrome
(HUS) or fatalities to date. As of November 1, 20 of 21 interviewed cases consumed foods from
Chipotle Mexican Grill. No vehicle has been identified yet; however, produce foods have been
identified as items of interest.
Several county health departments have collected multiple produce items from Chipotle
restaurant locations for analysis, including jalapeno, oregano, cilantro, onion, tomato, and
Romaine lettuce. FDA is assisting with the laboratory analysis.
Preliminary supply information for romaine lettuce was provided based on historical associations
between this commodity and STEC outbreaks; other traceback information is pending.
Reports are that Chipotle headquarters, in Denver, CO., has closed 43 restaurants in Washington
and Oregon. Multiple counties released press late Friday October 30 naming Chipotle in
reference to this outbreak, and FDA posted a web page on Saturday, October 31.
CORE Signals transferred this incident to CORE Response Team 3 on November 2, 2015. That
afternoon CORE consulted with Chipotle to request records that would aid in the investigation.
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CORE will review these records once received to try and identify potential food items for further
investigation.
Investigation partners: DEN-DO, SEA-DO
Initial monitoring/involvement by FDA CORE: 10/30/15
Transferred to CORE Response Team 3: 11/02/15
CORE Response Team: [email protected]
Emergency Operations Network URL: https://eon.fda.gov/eon/i#browse/EON-231814
Surveillance Information/Epidemiology:
As of 11/04/15, Washington and Oregon report*:
40 cases have been reported from 2 states
OR (12), WA (28)
Reported onset date range: 10/12/15 to 10/25/15
Reported exposure date range: 10/14/15 to 10/23/15
Deaths: 0
Hospitalizations: 12
*Data is preliminary and all cases may not be related. The numbers are subject to change
pending further information and analysis.
Laboratory:
Product samples from Skagit Co. and Clark Co., WA, and Washington Co. and
Multnomah Co., OR have been submitted to Pacific Regional Laboratory Northwest – 44
out of 44 product samples are negative.
As of 11/04/05, ten cases are confirmed with PFGE pattern EVCX01.1180 and one
case has confirmed serotype O26.
Completed Actions:
Call with Chipotle Headquarters – 11/02/15
Washington and Oregon State & County Call – 11/02/15, 11/03/15, 11/04/15
Tactics Call – 11/03/15
Operations Briefing – 11/03/15
On 11/04/15, FDA and King Co., WA investigators collected product samples at two
point-of-service locations associated with the more recent exposure dates for cases.
On 11/04/15, the states reported the locations of the associated Chipotle restaurants.
Ongoing Actions:
Chipotle is testing bell peppers, lettuce, tomatoes, oregano, jalapeno peppers, cilantro,
cheese, red onion, poblano peppers, lemon juice, and environmental samples from ~4
restaurant locations.
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Starting 11/04/15, Chipotle is disposing of the remaining produce at the closed
point-of-service locations.
Pending Actions:
Tactics Call – 11/05/15
Operations Briefing – 11/05/15
Washington and Oregon State & County Call – 11/05/15
Recent Media Coverage:
NBCNews
Fortune
USAToday
NPR
CNN
NY Times
Washington Post
OTHER ACTIVE OUTBREAKS
3. Salmonella Javiana (0094)/Tomatoes (suspect)/ML/Aug 2015 - EON-
219807
This incident involved a total of 37 cases of Salmonella Javiana (including 17 hospitalizations
and 0 deaths). Cases were identified in five states, though the majority of cases (33) were
reported in New Jersey; illness onsets ranged from 7/9/2015 through 8/21/2015. For cases with
information known, 18/27 (67%) reported eating at a Chipotle location between 7/7/2015 and
7/15/2015. Restaurant specific interviews were conducted. Cilantro (82%) and tomatoes (76%)
were the highest reported exposures. Based on distribution of products and traceback, tomatoes
were identified as the primary vehicle of interest.
FDA and state investigators conducted an informational traceback investigation in an effort to
determine the source of the tomatoes that had reportedly been consumed by numerous cases at
Chipotle restaurants. Through this informational traceback investigation, the distribution of
tomatoes was traced from three points of service (Sea Girt, NJ; New York, NY; Lexington, KY).
It was determined tomatoes were supplied to these restaurant locations by two different
distributors (Gordon Food Service; Food Authority) during the timeframe of interest. These
distributors received product from two repackers/distributors (R.S. Hanline; Thomas Colace
Co.). These distributors are affiliates of Lipman Produce Co. located in Immokalee, FL, which is
a common tomato supplier to Chipotle restaurants nationwide.
As a result of this investigation, tomatoes could not be confirmed as the vehicle for this outbreak,
though they remain the primary vehicle of interest. The investigation determined that Lipman
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Produce Co. supplied tomatoes to the various Chipotle points of service using product was
grown in California, Florida, or South Carolina during the timeframe of interest, with South
Carolina being the most likely source.
Investigation partners: DEN-DO; FLA-DO; NWJ-DO; and state/local investigators from NJ
Initial monitoring/involvement by FDA/CORE: 8/13/2015
CORE Response Team: [email protected]
Emergency Operations Network URL: EON-219807
Surveillance Information/Epidemiology:
Total Cases: 37
Deaths: 0
Hospitalizations: 17
Location of Cases: FL (1), KY (1), NJ (33), NY (1), and PA (1)
Estimated Illness Onset Date Range: 7/9/2015– 8/21/2015
Laboratory:
Total Samples: 0
Completed Actions:
The most recent Operations Briefing was issued on 10/7/2015.
The most recent Tactics Meeting was held on 10/7/2015.
On 8/24/2015, FDA and CDC held a conference call with representatives from Chipotle in
order to discuss the ongoing investigation and to request supplier information for the 6
Chipotle restaurant locations (4 in NJ, 1 in NY, and 1 in KY) associated with illnesses.
Chipotle representatives have provided supplier information for various commodities of
interest, including tomatoes, cilantro, and fresh oregano.
o While several common lots of cilantro (grown in CA) were found to have been
distributed to the chipotle locations of interest, those same lots had also been
distributed to a number of other restaurant locations throughout the country that have
not been associated with illness.
o Fresh oregano is only used in 3 dishes served by Chipotle. Upon follow-up, it was
determined that a limited number of cases who report eating at a Chipotle location
had consumed either of these three dishes, while tomato and cilantro exposure was
much higher among these cases. Because of this, CDC and FDA were able to rule out
fresh oregano as a suspected vehicle.
On 10/13/2015, CDC reported that WGS analysis had been completed for a representative
sample of isolates from this cluster; 9 isolates from FL, KY, NJ (5), NY, and PA were found
to be highly related by WGS. Of these cases, 7/9 reported eating at 5 different locations of
Chipotle in KY, NJ (3), and NY; the 2 additional cases from FL and NJ reported no Chipotle
exposure. CDC’s investigation of the Salmonella Javiana cluster 1508NJJGG-1 has been
closed.
Ongoing Actions:
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FDA/CORE is preparing final incident documents.
FDA/CORE is soliciting recommendations from investigation partners related to process
improvements, prevention efforts, research opportunities, and education/training.
Pending Actions:
An After Action Review (AAR) meeting is scheduled for 11/05/2015.
This incident is scheduled to be transferred to the CORE Post Response Team on
11/09/2015.
Recent Media Coverage:
4. Salmonella Newport (0030/0011)/Tomatoes (suspect)/ML/Aug 2015
This incident involved a total of 83 cases of Salmonella Newport (including 15 hospitalizations
and 0 deaths). Cases were identified in two states: MN (79) and WI (4); known illness onsets
ranged from 8/2/2015 through 9/15/2015. Among cases with known exposure information,
82/83 cases reported "yes" or "maybe" to exposure at a Chipotle restaurant prior to illness
onset. The remaining case was identified as a secondary case. Minnesota investigators
conducted a case-control study which indicated tomatoes are the likely vehicle. The
distribution of products and tomato traceback support the identification of tomatoes as the
primary vehicle of interest.
FDA/CORE in coordination with FDA District Offices and state investigators conducted a
traceback investigation to determine the source of the tomatoes reportedly consumed by 19 cases
at four Minnesota Chipotle restaurants of interest. Through this traceback investigation, it has
been determined that tomatoes shipped to these Chipotle restaurants of interest would have been
grown in California and Virginia during the timeframe of interest, with three Virginia farms
identified as the likely source. According to information collected by FDA and
state investigators, Minnesota and western Wisconsin Chipotle locations reported by cases
received tomatoes from Reinhart Food Service, a distributor located in Rogers, MN. It was later
determined that Reinhart Food Service had been supplied tomatoes from affiliates of Lipman
Produce Co. located in Immokalee, FL through Wholesale Produce Supply LLC, a repacker and
distributor located in Minneapolis, MN. Furthermore, the traceback investigation revealed that
Wholesale Produce Supply LLC. had received tomatoes from Kuzzens, Inc., a packer and
distributor located in Painter, VA.
FDA/CORE issued assignments to the Minneapolis and Baltimore District Offices for
inspections at the Wholesale Produce Supply LLC and Kuzzens, Inc. facilities respectively. As a
result of the assignment and inspection, the FDA Minneapolis District Office collected six
product (tomato) samples. One environmental sample (consisting of 100 swabs) was collected by
Minnesota investigators from Wholesale Produce Supply LLC. The samples were negative for
Salmonella, but a 483 was issued for product residue buildup on three tomato lines and worn and
damaged equipment surfaces. As a result of the assignment and inspection, the FDA Baltimore
District Office investigators collected one environmental sample (consisting of 120 swabs) from
Kuzzens, Inc. The samples were negative for Salmonella and a 483 was not issued.
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As a result of this investigation, tomatoes could not be confirmed as the vehicle for this outbreak,
though they remain the primary vehicle of interest. The investigation determined Lipman
Produce Co. supplied tomatoes that were grown in Virginia to the four Chipotle points of service
included in the traceback investigation during the timeframe of interest.
Investigation partners: Baltimore District Office; Denver District Office; Florida District
Office; Minneapolis District Office; and state/local investigators (including RRTs) from FL,
MN, and VA
Initial monitoring/involvement by FDA/CORE: 9/3/2015
CORE Response Team: [email protected]
Emergency Operations Network URL: EON-222253
Surveillance Information/Epidemiology:
Total Cases: 83
Hospitalizations: 15
Deaths: 0
Estimated Illness Onset Date Range: 8/2/2015 – 9/27/2015
Location of Cases: MN (79), WI (4),
Laboratory:
Total Samples: 8
Positive Samples: 0
Negative Samples: 8
Pending Samples: 0
Completed Actions:
The most recent Operations Briefing was issued on 10/21/2015
The most recent Tactics Meeting was held on 10/21/2015
Chipotle representatives have been made aware of the situation and have provided
supplier information for a variety of commodities, including tomatoes.
According to traceback investigation conducted by state investigators, each of the MN
and WI Chipotle locations reported by cases had received tomatoes from Reinhart Food
Service (distributor; Rogers, MN). It was later determined that Reinhart Food Service had
been supplied tomatoes from affiliates of Lipman Produce (distributor; Immokalee, FL)
via Wholesale Produce Supply (repacker, distributor; Minneapolis, MN).
MN identified 4 clusters with strong exposure history; the Chipotle locations associated
with these clusters served as the points of service for FDA’s traceback investigation.
On 9/23/2015 CORE issued a FACTS Assignment (FACTS #11568050; Ops ID #
8212384) to Minneapolis District Office for inspection/sample collection from Wholesale
Produce Supply (repacker/distributor; Minneapolis, MN).
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On 09/28/2015 MIN-DO initiated an inspection at Wholesale Produce Supply.
Investigators report that 6 tomato samples and 1 environmental sample (consisting of 100
swabs) were collected.
On 09/30/2015 MIN-DO issued a 483 at Wholesale Produce Supply on three tomato lines
for buildup of product residue; and worn and damaged equipment surfaces. The
inspection was reportedly closed.
On 9/30/2015 CORE issued a FACTS assignment (FACTS #11568050; Ops ID 8213284)
to Baltimore District Office for inspection/sample collection at Kuzzens Inc. (packer,
distributor; Painter, Virginia).
As of 10/1/2015, FDA’s Detroit Laboratory reported that the 1 environmental sample
(consisting of 100 swabs from multiple locations) collected by MIN-DO from Wholesale
Produce Supply was negative for Salmonella.
As of 10/1/2015, FDA’s Denver Laboratory reported that the 6 tomato samples (various
types; from before and after the washing/packing process) collected by MIN-DO from
Wholesale Produce Supply were negative for Salmonella.
On 10/6/2015, BLT-DO made an onsite visit to Kuzzens Inc. (packer, distributor; Painter,
Virginia) to conduct an inspection. It was noted that the firm was not packing during the
inspection.
On 10/14/2015, BLT-DO collected 120 environmental swabs under sample number
928213. The swabs are scheduled to arrive at Detroit Laboratory on 10/15/2015 and
tentative results are expected by 10/17/2015. The inspection was closed and a 483 was
not issued.
On 10/14/2015, CORE issued a FACTS assignment (11568050; Ops ID 8244011) to the
Baltimore District Office for a farm investigation at 3 Virginia farms (EJP, Custis Farms
and Newman) of interest owned by Kuzzens, Inc. located in Painter, VA.
On 10/16/2015, the proposed farm investigation at 3 Virginia farms (EJP, Custis Farms,
and Newman) of interest owned by Kuzzens, Inc. located in Painter, VA was deferred to
the next growing season.
On 10/18/2015, FDA’s Detroit Laboratory reported that all subs from the environmental
sample collected by BLT-DO from Kuzzens Inc. located in Painter, VA are negative for
Salmonella.
On 10/21/2015, MN informed FDA/CORE they were in the process of closing their
epidemiological investigation. Whole Genome Sequencing conducted by MN was
reportedly completed and uploaded to NCBI.
On 10/21/2015, CDC informed FDA/CORE of plans to close their Epi investigation next
week.
On 11/04/2015, CDC provided the WGS tree for the 26 MN Salmonella Newport
.0030/.0011 clinical isolates that had been sequenced. All of the MN clinical isolates
except two reported Chipotle exposure. One of the MN isolates for a case not
reporting Chipotle exposure fell within 0-1 SNP of the larger outbreak cluster by
WGS. The other MN isolate for a case not reporting Chipotle exposure was found to
be 13-19 SNPs from the larger outbreak cluster. Additionally, a NYC Salmonella
Newport isolate for a case that reported Chipotle exposure in NYC in August 2015
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was also requested to be sequenced and the results for this isolate fell within a 0-6
SNP cluster compared to other MN Chipotle-associated isolates. However, this NYC
isolate was also found not to match the larger outbreak cluster by WGS.
On 11/04/2015, CFSAN/OAO reported that a FDA historical isolate (354851-1)
consisting of tomato wash water collected from a farm in the Delmarva region by
BLT-DO in 2006 related to a previous outbreak of Salmonella associated with
tomatoes, was sequenced and found to be a borderline match (18-19 SNP) to four
clinical Salmonella Newport isolates, including one of the two MN clinical isolates of
cases not reporting Chipotle exposure that were sequenced. However, this FDA
historical isolate was found not to match a larger outbreak cluster of MN isolates by
WGS.
On 11/04/2015, BLT-DO provided the final closing information relating to FACTS
assignment (11568050; Ops ID 8244011). This information included sample
collection receipts, Notice of Inspection, customer list, invoices, and the completed
inspection questionnaire.
Ongoing Actions:
FDA/CORE is preparing final incident documents.
FDA/CORE is soliciting recommendations from investigation partners related to process
improvements, prevention efforts, research opportunities, and education/training.
Pending Actions:
An After Action Review (AAR) meeting is scheduled for 11/12/2015
This incident is scheduled to be transferred to the CORE Post Response Team on
11/16/2015
Recent Media Coverage:
5. Salmonella Enteritidis (0008)/Unknown/ML/September 2015
On 9/10/2015, CORE Signals began evaluating a cluster of Salmonella Enteritidis (cluster code
1509MLJEG-1). No one food item has been identified as the causal source of illnesses. The
investigations by Washington D.C. Department of Health and Los Angeles County Department
of Public Health have a strong signal for food items that contain truffle mushrooms, dried black
trumpet mushrooms, truffle paste, mushroom oil puree, and truffle oil. Some of the menu items
that include these ingredients are mushroom croquettes, truffle fries, mushroom risotto, and some
brunch items. This incident transferred to CORE Response Team 3 on 9/28/2015.
Investigation partners:
Initial monitoring/involvement by FDA/CORE: 9/10/2015
CORE Response Team: [email protected]
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Emergency Operations Network URL: EON-226510
Surveillance Information/Epidemiology: As of 10/30/2015, CDC reports*:
49 cases in 10 states: AZ (1), CA (19), DC (7), IL (2), MA (1), MD (9), MI (1), NY (1), PA (1),
VA (7).
The median age is 31 years (range: 18 – 85).
Estimated Isolation Dates: 8/10/15 – 9/23/15
Hospitalizations: 2
*The numbers are subject to change pending further information and analysis. Many of these
cases may be considered background.
Laboratory:
Total Samples: 1
Positive Samples:
Negative Samples: 1 (Sample 861105)
Pending Samples:
Completed Actions:
Tactics Meeting- 10/20/2015
Ops Brief- 10/20/2015
On 9/28/2015, a States Call was held to discuss updates from State partners to provide an
investigational update.
On 9/29/2015, CDC held a call with FDA and Los Angeles County Department of Health
to discuss epidemiologic findings related to their illness cluster investigation.
Baltimore District Office has provided recipes and testing records collected by the
District of Columbia Department of Health (DC DOH). DC DOH collected and analyzed
food samples all of which were negative for Salmonella.
On 10/1/2015, New York District Office began an inspection with New York State
Department of Agriculture and Markets at the Fig & Olive Commissary (Long Island
City, NY) for record and information collection in addition to sampling. The firm is not
currently operating due to staffing adjustments. On 10/8/15, New York District Office
collected an environmental sample (861105) containing 103 subs as well as some of the
requested records. Subsequent analysis of the sample was negative for Salmonella.
On 10/23/15, CDC held a call with FDA and Los Angeles County Department of Health
to discuss epidemiologic and traceback findings related to outbreak investigation.
On 10/30/15, FDA participated on a final close-out States Call to discuss final incident
updates from State partners.
Ongoing Actions:
For internal FDA use only. This document may contain non-public information.
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Pending Actions:
Recent Media Coverage:
CORE SIGNALS ACTIVITIES –ON THE RADAR
6. Salmonella Javiana (0135)/Unknown/ML/Sept 2015
On 9/10/15, CORE Signals began evaluating a cluster of Salmonella Javiana (cluster code
1509MLJGG-1), PFGE XbaI pattern JGGX01.0135. As of October 28, 2015, 45 cases from 18
states have been identified: CO(5), GA(9), IN(2), KS, KY, MA, MD, NC, NJ, NM(5), OH(3),
OK(3), PA(3), SC(2), TX(3), VA(2), WI, and WV. Isolation dates range from 8/1/2015 to
10/7/2015. The age range for the cases is from less than 1 to 80 years with a median of 36; 51%
of the cases are female.
No specific vehicle has been identified; however, multiple cases have reported exposure to
Mexican-style foods, specifically chilies or spicy foods. In addition, this PFGE pattern is a rare
pattern and has been isolated from an FDA environmental sample in 2011 in NM from a chile
processing plant. Whole genome sequencing (WGS) has recently linked these environmental
samples to two clinical cases from OH that dined at the same pizza restaurant. CDC anticipates
further WGS analysis for other clinical isolates.
CORE POST RESPONSE ACTIVITIES