I have been talking about food safety and litigation for the last few decades.  The groups I have spoken to have been all types in the food industry – from beef to leafy greens – as well as the heroes of public and environmental health.  I had a chance today  to talk to leaders in the insurance industry about how they can save money by encouraging their insureds to put food safety first.

According to the CDC, since the last update on December 21, 2018, 63 ill people from 24 states, and the District of Columbia, have been added to this investigation.

As of February 13, 2019, 279 people infected with the outbreak strain of Salmonella Reading have been reported from 41 states and the District of Columbia. 107 people have been hospitalized. One death has been reported from California.

Epidemiologic and laboratory evidence indicates that raw turkey products from a variety of sources are contaminated with Salmonella Reading and are making people sick. In interviews, ill people report eating different types and brands of turkey products purchased from many different locations. Four ill people lived in households where raw turkey pet food was fed to pets. The outbreak strain has been identified in samples taken from raw turkey pet food, raw turkey products, and live turkeys.

Several turkey products have been recalled because they might have been contaminated with Salmonella. Please see the list of recalled items below. A single, common supplier of raw turkey products or of live turkeys has not been identified that could account for the whole outbreak.

The Public Health Agency of Canada has identified ill people in Canada infected with Salmonella Reading bacteria with the same DNA fingerprint.  As of January 31, 2019, there have been 72 confirmed cases of Salmonella Reading illness investigated in the following provinces and territories: British Columbia (20), Alberta (24), Saskatchewan (6), Manitoba (13), Ontario (6), New Brunswick (1), Northwest Territories (1), and Nunavut (1). Individuals became sick between April 2017 and early January 2019. Eighteen individuals have been hospitalized. One individual has died. Individuals who became ill are between 0 and 96 years of age. The majority of cases (55%) are female.

The outbreak strain of Salmonella Reading is present in live turkeys and in many types of raw turkey products, indicating it might be widespread in the turkey industry. CDC and USDA-FSIS have shared this information with representatives from the turkey industry and requested that they take steps to reduce Salmonella contamination.

The FDA today published its “Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7.”

First, a hat tip to the FDA investigators for getting at the report critically fast and during the governmental shutdown.  It is prompt, science based, investigations that will identify the “root cause” of an outbreak that will then be used to stop or at least minimize future foodborne illness clusters of outbreaks. Despite the good work, however, except for the one named farm the rest of the traceback work is shrouded in mystery.  The FDA and the leafy green industry knows way more than it is telling the public, and that is wrong for too many reasons.

Some interesting, and alarming findings the outbreak and the initial investigation impressions:

  • 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. However, the FDA and the CDC just gives the public numbers, not some of the brutal realities of the long-term impacts like the 70-year-old New York woman who will remain on dialysis for the rest of her life or the 3-year-old Canadian boy who suffered severe brain damage and will require a life time of ongoing care.
  • All E. coli O157:H7 isolates in Fall of 2018 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 is significant as it indicates, not only has there been multiple, significant E. coli outbreaks, but they are likely linked to the same growing region and probably the same farm.
  • The romaine lettuce that made people sick was likely harvested between late September and mid-November 2018, a conclusion based on: 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.

Through its investigation the FDA has identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from one farm (Adams Brothers Farm) in Santa Maria in Santa Barbara County, California, that was linked to some illnesses during this outbreak.

  • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria in Santa Barbara County, California.
  • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
  • FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found most likely led to contamination of some romaine lettuce consumed during this outbreak.
  • Traceback investigation analysis indicated that other ranches owned by the same farm as well as other farms may have introduced into commerce contaminated romaine lettuce or other produce items. These other farms did not use water from the water reservoir where the outbreak strain of E. coli O157:H7 was found and FDA was unable to identify a potential source of contamination.
  • FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found was most likely not effectively treated with a sanitizer and this may have led to contaminated water directly contacting romaine lettuce after harvest or by the washing/rinsing harvest equipment food contact surfaces.
  • There are several 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.
  • Foodborne illness outbreaks caused by this specific strain of E. coli O157:H7 occurred in 2016, 2017, and 2018, indicating that the outbreak strain may have either persisted in the environment or may been repeatedly introduced into the environment from an unknown source. Public health officials in the U.S. and Canada were unable to definitively confirm the food vehicle and ultimate source(s) of the 2016 and 2017 illnesses.

Despite finding that E. coli outbreaks spanning years likely came from the same are or farm and was most likely caused by the same factors enumerated above, the FDA only sets forth “recommendations” that growers of leafy greens assess their growing operations for compliance with applicable requirements of the FSMA Produce Safety Rule and GAPs, including (see my snide comments in bold):

  • Assure that all agricultural water (water that directly contacts the harvestable portion of the crop and/or food contact surfaces and harvest equipment) used by growers is safe and of adequate sanitary quality for its intended use. This may (not must) include the development and use of validated and verified treatment of agricultural water, when growers choose to use agricultural water treatment as a preventive measure (any agricultural water treatment must also adhere to any other Federal, State, Local, or other regulations on implementation);
  • Assess and mitigate risks related to wild animal intrusion that may contaminate agricultural water (without a requirement to do so);
  • Assess and mitigate risks related to land uses near or adjacent to agricultural water sources that may contaminate agricultural water (without a requirement to do so); and
  • Perform a root cause analysis when a foodborne pathogen is identified in the growing environment, in agricultural inputs (e.g., agricultural water or soil amendments), in raw agricultural commodities or in fresh-cut ready-to-eat produce. The goal of a root cause analysis is to determine the likely source of the contamination, if prevention measures have failed, and whether additional measures are needed to prevent a reoccurrence (without a requirement to do so).

Other FDA recommendations have a broader target audience.

  • FDA urges (at least it is not begging) other government and non-government entities, produce growers and trade associations both domestically and internationally to develop real time procedures to quickly explore the possible scope, source(s) and route(s) of contamination when human pathogens of public health significance are detected by routine pre-harvest or finished product verification testing. Local in-depth knowledge and actions are critical in helping determine likely potential routes of contamination of leafy greens in the regions in which they are grown. This information is critical to developing and implementing appropriate science and risk based preventive measures to reduce the potential for another outbreak associated with leafy greens or other fresh produce commodities. Widespread sharing of such findings among the leafy greens and produce industry would also be helpful to increase awareness of potential routes of contamination and preventive measures (without a requirement to do so).
  • FDA continues to recommend (suggest, plead, beg, whine) that leafy green growers, buyer/shippers, and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging, point of sale signs, or by other means. In response to this outbreak FDA requested, and the leafy greens industry agreed to provide, voluntary labeling of romaine lettuce products to provide consumers with information on where their romaine lettuce is grown and the date on which it was harvested. The purpose of this new voluntary (why voluntary?) labeling was to help consumers discern, in the event of an outbreak, whether romaine lettuce products available for purchase at retail stores or restaurants were harvested after the outbreak or not grown in an implicated growing region. The voluntary labeling also provides for improved romaine lettuce traceability and, if need be, provides FDA with the ability to focus future public health communications about the safety of romaine lettuce from a particular growing region or harvest date.
  • FDA strongly encourages (emphasis on “strongly”) the entire leafy greens supply chain to adopt traceability best practices and state-of-the-art technology to assure quick, accurate and easy access to key data elements from farm to fork when leafy greens are involved in a potential recall or outbreak. Fresh produce, including leafy greens, are a highly perishable commodity, and traceability information should facilitate the rapid tracking of implicated product throughout the entire supply chain to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions. A key element that would assist tracing efforts during an outbreak is the ability to identify specific farms or ranches and dates of harvest for product that contribute to production lots if product has been commingled. While it is important to understand where the product was grown and not simply the location of the business entity that shipped or processed it, it is equally important to be able to determine which farm(s) and growing region(s) are responsible for supplying the contaminated product, and the time frame when product was supplied.
  • This information is crucial to the development of accurate public health messages to protect the public and empower retail establishments and consumers to take appropriate actions to prevent exposure. Without the ability to identify the growing region or specific suppliers of suspected shipments, public messaging by FDA and other public health partners during outbreaks or recalls will continue to be broad out of necessity, likely including farms and growing regions that are not responsible for the contamination. If supplier data are maintained when the product is co-mingled and consumers can differentiate where and when product was harvested, it is easier to narrow the number of suspected shipments and suppliers of the contaminated product once it is processed – after so many outbreaks the co-mingling and lack of transparency may well be the point – keep things confused and perhaps no one will be singled out?

My takeaway?  FDA has the skill to help industry combat these outbreaks by getting to the likely “root cause” of an outbreak.  However, the FDA is hampered by lack of public transparency with its traceback findings.  This lack of transparency leaves the public in a fog as to how to be smart consumers of a food product that has an unfortunate history that is likely to be its future as well.  Furthermore, it is past time for pleas and voluntary requirements.  The FDA and the leafy green growers know what needs to be done to minimize illnesses and loss of life.  It’s past time for please!

The Centers for Disease Control and Prevention and state health officials are investigating potential exposures to Brucella strain RB51 (RB51) in 19 states, connected to consuming raw (unpasteurized) milk from Miller’s Biodiversity Farm in Quarryville, Pennsylvania. One case of RB51 infection (brucellosis) has been confirmed in New York, and an unknown number of people may have been exposed to RB51 from drinking the milk from this farm. This type of Brucella is resistant to first-line drugs and can be difficult to diagnose because of limited testing options and the fact that early brucellosis symptoms are similar to those of more common illnesses like flu.­

The New York case is the third known instance of an infection with RB51 associated with consuming raw milk or raw milk products produced in the United States. The other two human cases occurred in October 2017 in New Jersey and in August 2017 in Texas. Those cases reported drinking raw milk from an online retailer and a Texas farm, respectively. In addition to these three confirmed cases, hundreds of others were potentially exposed to RB51 during these three incidents.

A New York resident, who drank raw milk purchased from Miller’s Biodiversity Farm in Quarryville, Pennsylvania, was diagnosed with brucellosis in November 2018.

Milk samples from Miller’s Biodiversity tested positive for RB51. A cow that tested positive for RB51 has been removed from the milking herd.

As of January 22, 2019, investigators have determined that people in 19 states have bought or consumed raw milk from the implicated farm. The states are Alabama, California, Connecticut, Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, and Virginia.

From January 1, 2019 through January 31, 2019, 189 hepatitis A cases were reported in 26 counties.

The number of reported hepatitis A cases more than doubled from 2016 to 2017 after remaining relatively stable in previous years. Case counts in January 2019 are higher than those seen in January of previous years.

The number of reported hepatitis A cases steadily increased each month since April 2018 and remained above the previous 5-year average in January 2019. The number of cases reported in January increased from the previous month.

The 189 hepatitis A cases in January were reported in the 26 counties outlined in black. The central Florida region had the highest hepatitis A activity levels. Since January 1, 2018, 97% of cases have likely been acquired locally in Florida.

Lest we forget, as of June 27, 2018, 210 people infected with the outbreak strain of E. coli O157:H7 were reported from 36 states.  Illnesses started on dates ranging from March 13, 2018 to June 6, 2018. Ill people ranged in age from 1 to 88 years, with a median age of 28. Sixty-seven percent of ill people were female. Of 201 people with information available, 96 (48%) were hospitalized, including 27 people who developed hemolytic uremic syndrome, a type of kidney failure. Five deaths were reported from Arkansas, California, Minnesota (2), and New York.

Here is the FDA Traceback chart:

Here is our Traceback chart to date:

I take a ferry to work guarded at times by now unpaid members of the Coast Guard.  Next week with increasing trepidation, I will go through TSA Security with more unpaid professionals on the job monitoring security to then board a plane to be routed to NYC by unpaid Air Traffic Controllers.  I am not sure I could focus on my job while wondering how bills were to be paid.

The shutdown hit close to home this morning when I opened my laptop at 5:30 A.M. to see a flood of hundreds of “Out of Office” notifications responding to emails generated from last night blog posts on Salmonella in flour and spinach.

Here are just a few:

“Thank you for your message. I am not in the office at this time. I am on furlough without access to email, due to the lapse in federal government funding. I will return your message as soon as possible once funding has been restored. For information about available government services, visit USA.gov.”

“Due to the absence of either an FY 2019 appropriation or Continuing Resolution for FDA, I am out of the office on furlough status and I am not able to read or respond to your message.”

“I am currently out of the office.” 

Odd way to run a government.

Satur Farms, 3705 Alvah’s Lane, Cutchogue, NY 11935 is voluntarily recalling Baby Spinach and Mesclun with the specific lot numbers listed below because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. aneurysms), endocarditis and arthritis. The following product was distributed in New York and Florida through retail stores.

Retail product is packed in plastic clamshell containers with Satur Farms brand name:

5 oz, 10 oz, 16 oz
Food service product is packed in sealed poly bags:
2-1/2 lbs, 3#, 4#, 4 x 2.5#, 4 x 3#

Spinach Lot #18494
Spinach Lot #18513
Mesclun Lot #18520

There have been no reported illnesses.

The voluntary recall is being initiated following routine sampling by Florida Department of Agriculture and New York State Department of Agriculture and markets. Consumers who have purchase Satur Farms products with these lot numbers are urged to return it to the place of purchase for a full refund. Satur Farms requests all consignees (wholesalers and retailers) to hold and discontinue selling their existing stock of this product.

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020.

The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product. This recall is being issued out of an abundance of care as General Mills has not received any direct consumer reports of confirmed illnesses related to this product.

This recall only affects this one date code of Gold Medal Unbleached Flour five-pound bags. All other types of Gold Medal Flour are not affected by this recall.

Consumers are asked to check their pantries and dispose of the product affected by this recall.

Guidance from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour. Salmonella is killed by heat through baking, frying, sautéing or boiling products made with flour. All surfaces, hands and utensils should be properly cleaned after contact with flour or dough.

This voluntary recall includes the following code date currently in stores or consumers’ pantries:

Gold Medal Unbleached All Purpose 5LB Flour
Package UPC 000-16000-19610-0
Recalled Better if Used by Date 20APR2020KC

Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

As of January 9, 2019, 62 people infected with the outbreak strain of E. coli O157:H7 were reported from 16 states and the District of Columbia.

Illnesses started on dates ranging from October 7, 2018, to December 4, 2018. Ill people ranged in age from 1 to 84 years, with a median age of 25. Sixty-six percent of ill people were female. Of 54 people with information available, 25 (46%) were hospitalized, including two people who developed hemolytic uremic syndrome, a type of kidney failure. No deaths were reported.

Epidemiologic, laboratory, and traceback evidence indicated that romaine lettuce from the Central Coastal growing regions of northern and central California was the likely source of this outbreak.Two illness clusters were identified at restaurants where ill people reported eating romaine lettuce. An illness cluster is defined as two or more people who do not live in the same household who report eating at the same restaurant location, attending a common event, or shopping at the same location of a grocery store in the week before becoming ill. In these two clusters, several ill people reported eating at the same restaurant or shopping at the same location of a grocery store. Investigating illness clusters provides critical clues about the source of an outbreak. If several unrelated ill people ate or shopped at the same location of a restaurant or store within several days of each other, it suggests that the contaminated food item was served or sold there.

Traceback information from the FDA indicated that ill people in this outbreak ate romaine lettuce harvested from specific counties in the Central Coastal growing regions of northern and central California. The FDA, along with CDC and state partners, investigated farms and cooling facilities in California that were identified in traceback. CDC analyzed water and sediment samples from an Adam Bros. Farming, Inc. farm in Santa Barbara County, which was one of the farms identified in the traceback investigation. The outbreak strain of E. coli O157:H7 was found in sediment within an agricultural water reservoir on the farm. WGS results showed that the E. coli O157:H7 found in the agricultural water reservoir was closely related genetically to the E. coli O157:H7 isolated from ill people.

WGS results also showed that the E. coli O157:H7 strain isolated from ill people in this outbreak is closely related genetically to the E. coli strain isolated from ill people in a 2017 outbreak linked to leafy greens in the United States and to romaine lettuce in Canada. The outbreak described here is not related to a spring 2018 multistate outbreak of E. coli O157:H7 infections linked to romaine lettuce. People in the spring outbreak were infected with E. coli O157:H7 bacteria with a different DNA fingerprint.

In Canada, as of December 24, 2018, there have been 29 confirmed cases of E. coli illness investigated in Ontario (5), Quebec (20), New Brunswick (1), and British Columbia (3). The illnesses in British Columbia were related to travel to Quebec, Ontario and the United States. Individuals became sick between mid-October and mid-November 2018. Ten individuals have been hospitalized, and two individuals suffered from hemolytic-uremic syndrome (HUS), which is a severe complication that can result from an E. coli infection. No deaths have been reported. Individuals who became ill are between 2 and 93 years of age. The majority of cases (52%) are female.

And, there are the real people I have spoken to in last week related to this outbreak:

  1. Husband with wife in rehabilitation after nearly two-month hospitalized in ICU with HUS.  She is still on dialysis three times a week and will be for rest of her life.
  2. Airline pilot who stopped over in Toronto and has now been hospitalized for weeks in the US with HUS.
  3. Father of Canadian child who ate romaine lettuce while on vacation in California and has been hospitalized with HUS for seven weeks in Vancouver, BC.
  4. Mom tonight who I spoke to as her daughter was undergoing a bowel resection do to E. coli O157:H7.
  5. Another mom whose daughter spent 15 days in the hospital undergoing several blood transfusions after being diagnosed with HUS.

Real people.