Sacramento County Botulism Outbreak 2017 Sacramento County EMD Mark Barcellos, Supervising ES

Sacramento County Botulism Outbreak 2017 Sacramento County Environmental Health Sacramento County Public Health Colusa, San Joaquin, and Solano Counties CDPH – Food & Drug Laboratory Branch CDPH – Microbial Diseases Laboratory CDPH – Infectious Diseases Branch Sacramento County Sheriff’s Department FBI FDA CDC

What do you know about botulism? Clostridium botulinum Produces neurotoxins under anaerobic conditions – toxins identified as A-H Impairment of cranial nerves, descending paralysis, lack of fever, and clear mental status Onset of botulism symptoms – typically 18-36 hours – could be up to 10 days Requirements for growth and toxin production – pH above 4.6, water activity above 0.85 (0.93), anaerobic conditions What causes botulism – name of organism? Anaerobic? Spore former? Produce toxins? – toxins stable? Heat sensitive? What does it do? – classic symptomology Requirements for growth and toxin production – pH above 4.6, water activity above 0.85 (0.93), anaerobic conditions Onset of botulism symptoms – typically 18-36 hours – could be up to 10 days…

Types of Botulism Infant botulism – colonization of the gut Wound botulism – heroin injection Foodborne botulism – improperly preserved foods Botulism outbreaks are very rare in the US In 2013, CDC reported Total of 153 laboratory-confirmed cases of botulism 2 cases (1%) - foodborne botulism 135 cases (88%) - infant botulism 14 cases (9%) - wound botulism 2 cases (1%) - other

Outbreak Timeline Thursday April 27, 2017 4:30 pm received a call for Patient 1 16 year old Hispanic male Onset on 4/25/2017 Symptoms consistent with botulism No wounds, recent fractures, drug use No ill contacts Resident of Stanislaus/Sacramento County (Walnut Grove), hospitalized in Alameda County. Intubated in the ICU, paralyzed with some ability to move fingers and toes How unusual is a single case?

7:35 pm received a call for Patient 2 Still Thursday April 27, 2017 7:35 pm received a call for Patient 2 16 year old Hispanic male Onset 4/24/2017 Symptoms consistent with botulism No evident wounds but may have had a dental injury two weeks ago and tried marijuana for the first time No ill contacts Resident of San Joaquin County (Stockton), hospitalized in Sacramento

3 botulism calls in 15 hours! Friday April 28, 2017 9:35 am received a call for Patient 3 32 year old Hispanic male Onset 4/25/2017 Symptoms consistent with botulism No wounds, recent fractures, drug use No ill contacts Resident of Sacramento County (Sacramento), hospitalized in Sacramento 3 botulism calls in 15 hours!

Conference call with LHDs Monday May 1, 2017 Clearly have something going on… Temporally and geographically clustered Similar demographics (all 3 M and Hispanic) 1 additional patient to include - Patient 4 44 yo NH Female (notification on 4/24/2017, received antitoxin) Onset on 4/20/2017 Sacramento resident, hospitalized in Sacramento Symptoms consistent with botulism originally suspect wound botulism patient HBAT - Heptavalent botulinum antitoxin

Are they Connected? Do the patients know each other? Did they attend the same event/festival/party? Purchase food at a farmers market? Could it be a marijuana edible? Close to 4/20 and earth day. Travel anywhere? Put together a questionnaire with open ended questions about food consumption in the 7 days before onset Epi and PH asking these types of questions…

Hard to get information…… Patients are all intubated and unable to speak Parents, siblings, girlfriends do not know exactly what patient ate during the 7 days before onset. Corn from a street vendor was mentioned by 2 people (not sure if w/in 7 days before) Nachos from gas station was mentioned by 2 people but not able to get name/location Very hard to get detailed information. Patients can squeeze the hands of family member indicating yes.

Corn? Came up with questionnaire with detailed corn questions (Wednesday May 3, 2017) Street vendor/pushcart Location/description How prepared? Cooked beforehand Eaten on the cobb/in a bowl Served hot Toppings- oils, mayonnaise, cheese, spices, herbs, etc. LHDs interviewed patients/families

Still collecting information on corn and other food……. May 4, 2017 at 4pm received a call for Patient 5 57 year old South Asian Male Onset 4/26/2017 Symptoms consistent with botulism No wounds, recent fractures, drug use No ill contacts Colusa Resident, hospitalized in San Francisco Link to Valley Oak Food and Fuel (VOFF) in Walnut Grove, CA (Patient 1 lives in Walnut Grove)

Valley Oak Food and Fuel? Re-interview all patients to find out if they had been to Walnut Grove, and specifically VOFF Did they eat anything there? If so, what did they consume School nearby with food vendors Try to get any additional information

Where is Walnut Grove? Patients 3 and 4 live in Sacramento VOFF Patient 1 lives in Walnut Grove Patient 3 worked in Rio Vista 3 days before onset Patient 2 lives in Stockton

Case VOFF exposure Date Onset of illness 32 yo, F, Sacramento (Patient 4) Consumed Doritos with nacho cheese Monday, 4/17 or Tuesday, 4/18 Thursday, 4/20 16 yo, M, San Joaquin (Patient 2) Had nacho cheese in the week before illness onset Monday (4/17) – Monday (4/24) Monday, 4/24 16 yo, M, Walnut Grove (Patient 1) Consumed hot Cheetos with nacho cheese sauce with a friend Tuesday morning, 4/25 32 yo, M, Sacramento (Patient 3) Ate nacho cheese at a gas station between Rio Vista and Sacramento, later confirmed VOFF Saturday, 4/22 Tuesday, 4/25 57 yo, M, Colusa (Patient 5) Link to VOFF; nacho cheese exposure has not been confirmed, family states unlikely but possible At VOFF Monday, 4/24 through Wednesday, 4/26 Wednesday night, 4/26

Environmental Health Investigation 5/5/2017 – Sacramento County visits Valley Oak Food and Fuel and completes an inspection 5/5/2017 – Sacramento County impounds nacho cheese and warming unit - temperature of cheese was 111 deg. F. 5/5/2017 – 2 visits by Sac County – 1000 and 1330

Only gas station in Walnut Grove, CA. Approximately 30 miles South of Sacramento Store sells gas, liquor, tobacco, bait, prepared & pre-packaged food items.

Significance of missing cover

Describe product – bagged cheese – aseptic product - ph – 5. 8-6 Describe product – bagged cheese – aseptic product - ph – 5.8-6.0 – water activity – 0.98 Gehl’s Foods in WI – 120 year old business – 1st aseptic processor in the US – “never had a recall” Implicated lot code (4/11/2017) – Gehl’s produced 14,000 bags – shipped in May 2016 to 12 states – estimate over 100,000 servings

Significance of picture #1 (cheese spillage) Significance of picture #2 (expired date code) – Sac County collected on 5/5/2017

Environmental Health Investigation 5/6/2017 – Sacramento County EH closes Valley Oak Food and Fuel 5/8/2017 – Sacramento County EH and FDB inspect Valley Oak Food and Fuel – sample collection by FDB – allow gas station to re-open only selling packaged food 5/8/2017 – Traceback begins – attempting to locate distributor for nacho cheese at gas station 5/8/2017 – ERU collects the following: 4 bags of Gehl’s cheese – sealed bags – best by 12/31/2017 1 bag from warming unit – on 5/5 – best by 4/11/2017 Traceback locates PITCO in W. Sacramento and San Jose as possible supplier – Sam’s Club does not sell product… PITCO last sold Gehl’s product to VOFF on 10/28/2016???

Old bag – 4/11/2017 Newer bag 12/31/2017 and case

Environmental Health Investigation 5/8/2017 – Implicated bag of nacho cheese sauce (4/11/2017) and scrapings delivered to FDLB for testing – C. bot, pH, water activity, visual inspection 5/9/2017 - Implicated bag of nacho cheese sauce presumptive positive for C. bot toxin type A 5/10/2017 – Sealed bag of nacho cheese sauce (12/31/2017) delivered to FDLB for testing – C. bot, pH, and water activity 5/10/2017 – FDB and Sacramento County complete detailed inspection of warming unit Sealed bag of nacho cheese (12/31/2017) was negative for C. bot

Nacho cheese warming unit – brought to store around October or November 2016 Originally provided to “Kwik Korner” in Elk Grove by Gehl’s…

Unit may not be resold… Bag/Cap opener… could not locate in store – describe how this is unique

Hold sauce at 140 deg. F. – when lid and valve guard are in place Internal temperature checks of cheese – who does this? Why do you hold these products at 140 deg. F.???

Cheese can stay in the dispenser for 4 to 6 days… Free replacement parts…

Cause of Outbreak? Contaminated at Gehl’s in WI? Contaminated at Valley Oak Food and Fuel? How can C. bot germinate in an aseptic product? How could toxin be produced? Intentional contamination? Gehl’s product is aseptic – FDA inspection – no issues noted with heat step during time of production… wide distribution of same lot code – no other issues reported Could not locate opening device at gas station – reportedly used plastic knife… product in warmer too long? C. bot needs the correct temperature to grow and produce toxin – contaminated product – correct pH and water activity – correct temperature (above 125 deg. F)! Evidence collected to date indicates that the Gehl’s Jalapeño cheese sauce that tested positive for C. botulinum toxin was likely contaminated at VOFF. VOFF lacked the appropriate tool to open the bags of cheese sauce, did not take temperatures of the cheese sauce to ensure appropriate hot-hold temperatures were maintained, and did not have any records to indicate the bags of cheese sauce were changed at least once every five days. In addition, photos taken on May 5, 2017 indicate that the valve guard was not installed on the dispenser, which may have resulted in temperatures below 140 ˚F. The environmental health, epidemiological, and laboratory investigations conducted in response to this outbreak all indicate that a single bag of Gehl Foods Jalapeño cheese sauce served to the public at VOFF was the likely cause of illness. The practices noted above at VOFF may have led to the contamination of the cheese sauce and subsequent germination of C. botulinum spores and toxin production.

Additional Follow-up 6/8/17 – FDB and Sacramento County working with FBI - surveillance video from inside gas station 6/8/17 – Sacramento County and FBI visited the gas station - collected the potato bin - Sacramento County and CDPH testing 6/13/17 - FDB conducted an environmental sampling at Valley Oak Food and Fuel – 45 swabs collected – all negative Surveillance video DVR may have been reformatted or never used… Is it difficult to swab for C. bot? Is it difficult to test for C. bot? Significance of negative findings…

Challenges – Retail Sales Heating element problems Poor design of bag puncture device Lack of appropriate labeling in cased product Retail stores turning machines on and off Retail stores taking internal temps? Under-heating reported by Gehl’s (2014-2017) – less than 0.1% Hand touches FCS - provide opening tool for each bag? Cased product contains limited directions on product usage – relying on warning statement on heating unit (5 days)

Epidemiology – Summary As of May 17, 2017 there were 10 cases of foodborne botulism in the Sacramento region. (5 confirmed, 4 probable and 1 suspect) Case Definitions Confirmed: Laboratory-confirmed Clostridium botulinum, toxin type A, with exposure to Valley Oak Food and Fuel (VOFF) in Walnut Grove, CA after April 1, 2017 Probable: Clinically compatible botulism neurological symptoms with exposure to VOFF after April 1, 2017, with laboratory tests pending Suspect: Clinically compatible botulism neurological symptoms with laboratory tests pending, with unknown exposure to VOFF

Case VOFF exposure Exposure Date(s) Onset of illness 32 yo, F, Sacramento (Sacramento) Patient 4 Consumed Doritos with nacho cheese Monday, 4/17 or Tuesday, 4/18 Thursday, 4/20 16 yo, M, San Joaquin (Stockton) Patient 2 Consumed nacho cheese in the week before illness onset Monday (4/17) – Monday (4/24) Monday, 4/24 16 yo, M, Sacramento (Walnut Grove) Patient 1 Consumed hot Cheetos with nacho cheese sauce Tuesday morning, 4/25 32 yo, M, Sacramento (Sacramento) Patient 3 ate nacho cheese at VOFF Saturday, 4/22 Tuesday, 4/25 57 yo, M, Colusa (Williams) Patient 5 Owner of VOFF; nacho cheese exposure has not been confirmed Worked at VOFF Monday, 4/24 through Wednesday, 4/26 Wednesday night, 4/26 44 yo, F, Sacramento Patient 6 Consumed tortilla chips with nacho cheese sauce Thursday, 4/27 37 yo, M, Solano (Rio Vista) Patient 7 Unknown exposure to VOFF Unknown but worked in Roseville 4/28-4/29 Monday 5/1 35 yo, M, San Joaquin Patient 8 Friday 5/5 Sunday, 5/7 21 yo, M, San Joaquin Patient 9 Saturday 4/15 41 yo, F, San Joaquin Patient 10 Sunday 5/14 Significance of 5/5/2017 exposure dates – 9/10 report exposure to VOFF – 8/10 to nacho cheese

What could have prevented this? Maintaining proper holding temperatures Follow manufactures recommendations/instructions Minimize all time in the Danger Zone (41°F-135°F) including delivery and preparation

Would like to thank CDPH-FDB for use of this power point. Any Questions??