Friday, February 15, 2019

FDA Investigation of 2018 E. coli Outbreak Associated with Central California Grown Romaine Lettuce

FDA released their investigation report of the 2018 E. coli outbreak associated with romaine lettuce from Central California.  In this outbreak, there were "62 reported illnesses in 16 states and the District of Columbia, resulting in 25 hospitalizations and two cases of hemolytic uremic syndrome (HUS). There were no deaths."

What is clear is the difficulty of surface water contamination events can be for farms.
A summarized collection of the items of note from that report:

The E. coli Outbreak and identification of source:

  • The romaine lettuce that made people sick was likely harvested between late September and mid-November 2018.   This is based upon "known production practices; the anticipated shelf-life of romaine lettuce; and the fact that reported illness-onset dates occurred from October 7 through December 4, 2018."
  • "All E. coli O157:H7 isolates from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing, that was closely related to one previously seen in ill consumers in the U.S. and Canada in the Fall of 2016 and the Fall of 2017.  This source of this outbreak was not definitively proven, but it was felt that romaine lettuce was the source.
  • The traceback indicated that multiple farms may have been involved, however only one reservoir sample was found to be positive linking that one farm. "An alternative explanation for this lack of traceback convergence to a single farm may be due to ill consumers having multiple romaine lettuce exposures and limited recollection of exposures and brands they ate."
  • With regard to the progression of identification of the growing area - "By November 26, 2018, tracebacks identified a specific California growing region where romaine lettuce contaminated with the outbreak strain likely originated and this was narrowed down by December 13, 2018, to three specific California counties.

On the sediment-positive sample in the farm's reservoir system:

  • "A sediment sample taken from an on-farm water reservoir in Santa Maria in Santa Barbara County, California tested positive for the outbreak strain of E. coli O157:H7. "
  • "This farm, identified in multiple legs of the Fall 2018 U.S. and Canadian traceback investigations, was also identified as one of the potential suppliers of leafy greens or romaine lettuce in the 2017 U.S. and Canadian traceback investigations. 
  • "Bacteria, such as E. coli O157:H7 can float freely in water but because they have a charged surface, they are predominantly associated with fine particulate matter, such as sediment in bodies of water, where they can persist for extended periods of time. The sediment in the bottom of reservoirs where E. coli O157:H7 can persist is likely to be stirred up into the water when pumps are used to convey water out of a reservoir. " 
  • "The investigation team was not able to determine how this on-farm water reservoir became contaminated with the outbreak strain.:
  • "This reservoir was not interconnected to other water sources or distribution systems in the growing region.  In the case of the Santa Maria farm, the precise route of contamination is uncertain. However, based on interviews with the grower, there are several plausible ways in which water from the on-farm water reservoir may have come into contact with the implicated romaine lettuce, including direct harvest/postharvest application to the crop and/or use of reservoir agricultural water on harvest equipment food contact surfaces."  
  • "The use of agricultural water from a reservoir open to the environment has higher food safety risk as compared to that associated with use of ground water, because of the increased potential for human pathogens to contaminate surface water."

On water treatment of reservoir water:

  • "In this case, the farm did have a procedure in place to collect and test reservoir agricultural water for generic E. coli and treat the agricultural water with a sanitizer before use. However, the investigation team noted that verification procedure records did not document that the water sanitizer was present at levels that would assure that the water used to contact romaine lettuce at harvest, during postharvest handling, and to wash/rinse harvest equipment food contact surfaces was not contaminated with pathogenic bacteria."
  • "Inspection of water tank sanitizer treatment systems used in harvest/postharvest handling revealed that some units had undissolved sanitizer cakes and that some tank systems were constructed in a manner that likely did not allow for optimal sanitizer treatment of the agricultural water before use. Additionally, untreated water from the contaminated reservoir was used to fill tank trucks which broadly sprayed water on roads for dust abatement and these roads were traveled on by harvest equipment prior to commencing harvest operations."  

On persistence of E. coli in water and potential contamination sources:

  • "The first illnesses in this outbreak occurred in early October 2018, and therefore the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample, or the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source. Generic E. coli has been demonstrated to survive in sediments much longer than in the overlying water.  The investigation team did not identify any obvious route for contamination of the on-farm water reservoir."
  • "However, evidence of extensive wild animal activity, including waterfowl, rodents, coyotes, etc., and animal burrows near the contaminated reservoir sediment was noted by the investigation team and likely warrants consideration as a possible source(s) of the human pathogen found in the on-farm water reservoir.  Additionally, adjacent land use including the use of soil amendments, or for animal grazing on nearby land by cattle and horses, may have had the potential to be reservoirs of E. coli O157:H7."


FDA Outbreak Investigation Report
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm631243.htm
Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7
PDF - 80KB
 February 13, 2019

Monday, February 11, 2019

FDA Investigating Multistate Salmonella Outbreak Linked to Tahini

FDA, CDC, and local health agencies are investigating a multistate outbreak of Salmonella Concord illnesses linked to tahini imported from an Israeli manufacturer, Achdut Ltd., located in Ari’el, Israel.

Tahini is made from toasted ground hulled sesame that is used as a dip / spread or as an ingredient in hummus, baba ghanoush, and halva.   It is similar in consistency to peanut butter and has a nutty creamy flavor.

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm626790.htm
FDA Investigating a Multistate Outbreak of Salmonella Concord Linked to Tahini Produced by Achdut Ltd.
Update: February 08, 2019

Cannabis in Food - Hot Culinary Trend, But What About the Mental Health Research?

Cannabis has become the hot trend as more states legalize it.  But a recent article,  Marijuana, Mental Illness, and Violence  points out that much of the research on marijuana's impact on mental health is being overlooked.  It references numerous research studies completed over the last 20+ years that point to the fact that there are issues of dependence, increasing existing symptoms in those with forms of psychosis, and links to violence.

So reviewing the medical research via google search (selected journal articles below), it is easy to see that there are issues with extended use, especially today when the levels of THC can be much higher than years ago.  So for those companies embarking on new ventures involving cannabis, what will be the legal concerns in the coming years when people file lawsuits - perhaps the parents of a schizophrenic youth, or the victims of  accident involving a long term user?

Note - The focus here is on THC containing foods.  CBP oil is a nonpsychoactive chemical derived from hemp or marijuana.

Results - "An appreciable proportion of cannabis users report short-lived adverse effects, including psychotic states following heavy consumption, and regular users are at risk of dependence. People with major mental illnesses such as schizophrenia are especially vulnerable in that cannabis generally provokes relapse and aggravates existing symptoms. Health workers need to recognise, and respond to, the adverse effects of cannabis on mental health."

Florida - Increasing Number of Hepatitis A Cases Reported

In Florida, there is an steadily increasing number of Hepatitis A cases.  In January of this year, 189 Hepatitis A cases were reported.  Most of the activity has been in central Florida,  In one case, a Disney food service worker was infected.  (Disney has been vaccinating employees).

Florida Department of Health
http://www.floridahealth.gov/diseases-and-conditions/vaccine-preventable-disease/hepatitis-a/index.html
Hepatitis A Surveillance
January 2019

This Week in Mislabeled Products for Week Ending February 10, 2019

Co-Pack Customer Discover's Label Issue - VICS Acquisition, LLC, a Harlingen, Texas, establishment, is recalling approximately 99,975 pounds of chicken products due to misbranding and undeclared allergens - the products contain eggs, a known allergen, that is not declared on the product label.  A company that VICS Acquisition, LLC co-packs for discovered the problem on Feb. 8, 2019 during a label review.

Cashews Missing on New Label - Birdseed Food CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. The mislabeling of the product happened upon attaining new packaging in October 2018 and the firm became aware of the issue via customer email.

Watch Those Therapeutic Claims - Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body.  Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

Wrong Potato Chip Bag - Frito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy’s Simply Naked Pita Chips because they may contain undeclared milk ingredients. The recall was initiated after it was discovered that 228 bags of Stacy’s Simply Naked Pita Chips were inadvertently filled with another flavor of pita chips, potentially exposing consumers to undeclared milk.

Hipster Chipster Label Missing Allergens - The Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “Hipster Chipster” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-014-2019-release
VICS Acquisition, LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens 
Class I Recall
014-2019
Health Risk: High
Feb 10, 2019

Sunday, February 10, 2019

FDA Issues Final Guidance on Conducting Recalls

FDA issued a final guidance document on conducting recalls - Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff.  The document can be found here:  LINK

Your own recall procedures should reflect what is in the guidance.

A few key items to note:

Friday, February 8, 2019

Inspection Reveals Meth Concealed in Shipment of Bell Peppers

US Border Protection Agents seized 1000 lbs or $14 million worth of methamphetamine, or crystal meth, in a shipment of bell peppers at the Pharr International Bridge cargo facility in southeast TX along the Rio Grande.

The Produce News
http://theproducenews.com/the-produce-news-today-s-headlines/25954-14-million-of-meth-in-produce-shipment
$14 million of meth in pepper shipment
    February 08, 2019

Thursday, February 7, 2019

Canadian Food Law Goes Into Effect, Impact on US Suppliers to Canada

Canada's updated food safety laws went into effect on January 15th.  These are HACCP based regulations that require preventive controls for hazards identified within food processes.
Companies that want to ship into Canada must work with a licensed Canadian importer.  For exporting to the US, a Canadian company with a license is a qualified foreign supplier as part of the FSVP regulations.

According to the web page for food importation into Canada, foreign suppliers do not need to license, but they must work with a Canadian importer who does have a license.  In essence, this put all of the responsibility on the Canadian importer.
 "Foreign businesses preparing foods for export to Canada do not need a licence under the Safe Food for Canadians Regulations (SFCR). The Canadian business importing food into Canada needs a licence under the SFCR to import and any other permission as required by other Canadian Departments and Agencies. Work with an SFC-licensed importer to ensure that your food products meet all applicable requirements of the SFCR. Only in limited situations would you qualify to apply for a licence as a non-resident importer. "  
The CFIA has published a Step-by-Step guide for importers.  "This guide describes the recommended steps you can follow to meet the requirements to import food into Canada and to maintain a food import licence. As an importer, it's your responsibility to make sure the food you import is safe and that it meets Canadian requirements."
Before you import 
Step 1: Know your food what are the risks? (Guide for Preventive Control Plan for Importers)
Step 2: Familiarize yourself with Canadian requirements for importing food - in addition to controlling hazards, there is requirements for ensuring standards, grades, net quantity, and labeling.
Step 3: Select an appropriate foreign supplier
Step 4: Preventive control plan create it and implement it
Step 5: Develop a recall and complaints procedure
Step 6: Apply for your licence to import from the CFIA

When it's time to import 
Step 7: Provide the CFIA with information about each of your shipments

After you've imported 
Step 8: Keep traceability records
Step 9: Preventive control plan maintain it
Step 10: Implement a recall and complaints procedure

Food Safety Magazine
https://www.foodsafetymagazine.com/news/canadae28099s-new-food-safety-regulations/
Canada’s New Food Safety Regulations
By Staff
News | January 22, 2019

SC - Potential Hepatitis A Exposure at Brew Pub

In South Carolina, patrons of a brew pub in Aiken, SC, during a time period of Jan. 21 through Jan. 26, 2019, are being advised to get a Hepatitis A vaccination after a restaurant worker had been diagnosed with Hepatitis A.   Those who ate there from Jan 11 though Jan 20 may also have been exposed, but vaccination will probably not help them, so those unfortunate folks are asked to watch for symptoms.

Post-exposure vaccination is recommended for individuals if it can be administered less than two weeks (14 days) from when they may have been exposed. 

South Carolina Department of Health and Enviromental Control (DHEC)
https://www.scdhec.gov/news-releases/dhec-advises-possible-hepatitis-exposures-local-aiken-restaurant
DHEC Advises of Possible Hepatitis A Exposures At local Aiken Restaurant

FOR IMMEDIATE RELEASE:
February 4, 2019