Tag Archives: Going Public

Huh? COVID-19 science and the uncertainty dance

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My friend Tim Caufield, professor of law at the University of Alberta, the Research Director of its Health Law Institute, and current Canada Research Chair in Health Law and Policy, writes in an op-ed for the Globe and Mail that COVID public health policies have been with us for a year. So has uncertainty. We’ve all lived through twelve months of “huh”? And this has added to the public’s frustration, fatigue, and stress.

In the early weeks and months of the pandemic, there was uncertainty about masks and asymptomatic spread. There was uncertainty about if and when we’d get a vaccine. There was uncertainty about what type of public health policies worked best and were most needed. We have all had to tolerate a lot of ambiguity. And as the vaccines roll out, we are being asked to tolerate even more. (When will I get a vaccine? Which one will I get? And what about the variants?)

For public health communications to be effective, the public must have confidence in the message. And, unfortunately, for some, that confidence isn’t there. A recent study from the University of Calgary explored pandemic communication and found, not surprisingly, that “participants felt that public health messaging to date has been conflicting and at times unclear.”

This perception is understandable. An atmosphere of seemingly relentless uncertainty and confusion has been created by a combination of scientific realities, media practices, some less-than-ideal communication from policy makers, and the spread of misinformation and conspiracy theories.

The science surrounding COVID was – and, for some topics, continues to be – highly uncertain. While a growing body of evidence has emerged around the most contested issues (such as the value of masks and physical distancing strategies), early in the pandemic there wasn’t much that was unequivocal. The science evolved and, as you would hope with any evidence-informed approach, the resulting science advice and recommendations evolved too. But for some, shifting policies, even if appropriate, just added to a sense, rightly or not, of chaos.

In addition, the media has been reporting on the research as it unfolds, including referencing studies that have not yet been peer reviewed. Often the preliminary or uncertain nature of the relevant research is not reported in the media, thus creating a false impression about the actual state of the science – as exemplified by the “hydroxychloroquine works!” debacle (PS, it doesn’t). Perhaps worse, relatively fringe perspectives – such as those pushing the value of “natural herd immunity” – have been given a relatively high profile in both the conventional press and on social media. This can create a false balance (fringe idea vs. broad scientific consensus) that we know can be detrimental to both public discourse and health behaviours.

Despite the frustration that uncertainty can create, the public has a demonstrated preference for honesty about the limits of our knowledge. A recent study from Germany found that “a majority of respondents indicated a preference for open communication of scientific uncertainty in the context of the COVID-19 pandemic.” This finding agrees with other research that has found that when uncertainty is relevant to their lives, the public wants to know about it.

People may want to hear about uncertainty, but will communicating it do more harm than good? Will it just add to an already confused information environment? The data on this point are actually fairly mixed, but recent research exploring the impact of communicating scientific uncertainty found that it either increased perceptions of trust in science or had almost no impact. This is good news. As the authors of one of the studies notes, “this should allow academics and science communicators to be more transparent about the limits of human knowledge.” Other studies have found that being honest about uncertainties in media reports about research can actually boost the perceived credibility of journalists.

And over the long term, honesty about the uncertainties of the evidence used to inform policy seems essential to the maintenance of public trust. For example, being overly dogmatic about a policy or predictive model could hurt the credibility of decision makers if new evidence requires a revision of a past positions.

When possible, public health authorities (or anyone seeking to communicate science) should start with well-defined and well-supported takeaway messages (e.g., please get vaccinated with whatever vaccine is available to and recommended for you!).But then be honest about what is not known (e.g., while vaccines are our best defense, we aren’t sure how long immunity will last).

Depending on the medium used (a social media post, for example, may not be the best venue for a long discourse on methodological challenges), it may also be wise to explain the limits of the research approach (e.g., observational studies can’t prove causation). If there are areas of scientific disagreement, be honest about that too – but be specific about what is being disputed. Often there is broad agreement about the big stuff (e.g., vaccines work!), but academic debate about some details. Often those trying to sow doubt – like those in the anti-vaccine community – will try to weaponize and over-emphasize small academic disagreements. Don’t give them that room.

When communicating about uncertainty it is also important to highlight what is being done to reduce it, such as forthcoming research or new data analysis. This provides a road map forward and invites the public to follow the science as it unfolds. It is also a way to stress that uncertainty is a natural part of the scientific process.

For the public, try not to let the uncertainty kerfuffle distract you from the big picture. Remember that there are many clear knowns. Vaccines, physical distancing, hand washing, masks, and being responsible when symptoms emerge will get us through this pandemic.

Finally, it is also important to take a break from all the uncertainty noise. Studies have shown that the constant consumption of conflicting COVID news can (no surprise here) add to our stress. Put down the phone, back away from the screen, and take ten from “huh?”

23 sick from Romaine lettuce: Was FDA’s outbreak announcement delay inexcusable or sensible

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I love Mondays in Australia because it’s Sunday in the U.S., football and hockey are on TV for background, the kid is at school when not in France, and I write (Sorenne painting in France).

Fourteen years ago, me and Chapman went on a road trip to Prince George (where Ben thought he would be eaten by bears) to Seattle, then to Manhattan, Kansas, where in the first week I met a girl, got a job, and then spinach happened.

Leafy greens are still covered in shit.

I am drowning in nostalgia, but things haven’t changed, and, as John Prine wrote, all the news just repeats itself.

Same with relationships.

Former U.S. Food and Drug Administration food safety chief, David Acheson, writes that on October 31, 2019, FDA announced a romaine lettuce E. coli O157:H7 outbreak for which the active investigation had ended and the outbreak appeared to be over. As such FDA stated there was no “current or ongoing risk to the public” and no avoidance of the produce was recommended.

Since that announcement, however, I have seen a number of articles condemning FDA and CDC. Why? Because the traceback investigation of the outbreak began in mid-September when CDC notified FDA of an illness cluster that had sickened 23 people across 12 states. So why the delay in announcing it to the public?

Despite the critical (and rather self-serving; always self-serving) stance on the “inexcusable” delay taken by a prominent foodborne illness attorney and his Food Safety “News” publication – which blasted a headline FDA “hid” the outbreak – my stance, having been an FDA official myself involved in outbreak investigations, is that the delay was practical and sensible.

Why? As FDA states right in its announcement:

When romaine lettuce was identified as the likely source, the available data indicated that the outbreak was not ongoing and romaine lettuce eaten by sick people was past its shelf life and no longer available for sale.

Even once romaine was identified as the likely cause, no common source or point of contamination was identified that could be used to further protect the public.

During the traceback investigation, the outbreak strain was not detected in any of the samples collected from farms, and there were no new cases.

Thus, neither FDA nor CDC identified any actionable information for consumers.

So, if it is not in consumers’ best interest to publicize an issue that no longer exists, why should they be driven away from a healthy food alternative? Why should unfounded unease be generated that will damage the industry, providing no benefit for consumers but ultimately impacting their pockets? There is just no upside to making an allegation without information. We’ve seen the impact on consumers and the industry when an announcement of a suspected food turns out to be incorrect; specifically “don’t eat the tomatoes” when it turned out to be jalapeno and serrano peppers. Having learned from such incidents, FDA’s approach is: If we don’t have a message that will help protect the public, then there is no message to be imparted.

So, rather than condemn FDA and CDC, I would commend them for getting the balance correct. And, perhaps, instead of any condemning, we should be working together to get the answers faster, to get outbreak data through better, faster, more efficient and coordinated traceability. Our entire system is too slow – a topic we have discussed many times in these newsletters.

I disagree.

The public and the scientific community need to be informed to prevent additional people from barfing.

I also rarely eat lettuce of any sort because it is overrated and the hygiene controls are not adequate.

Greek salad without lettuce is my fave.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

Going public: Norovirus ‘sweet spot’ at Pennsylvania college

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“It hit me like a train wreck.” This is how one of the many infected students described his symptoms of what is likely norovirus.

Stool tests performed on those who are ill haven’t confirmed this diagnosis, but Director of Health Services Dr. Goldstein said that norovirus is “likely” the culprit of the students’ symptoms, which include vomiting, diarrhea and stomach pain. Resident Advisors on campus have reported 103 cases of students having contracted the debilitating stomach bug as of Wednesday evening, according to Goldstein, Director of Health Services.

Goldstein first notified the campus community about the virus in a campus-wide email sent Monday, Feb. 4 at 2:40 p.m., but didn’t name the illness as norovirus at that time.

Some students, however, felt this email did not come soon enough. Haley Matthes ‘19 voiced her frustrations and warned students to be aware of its spreading in a post in the Lafayette College Class of 2019 Facebook group on Feb. 2.

“I’m just tired of the school waiting for a campus-wide sickness to escalate to a point where they need to send out a bulletin [or] cancel classes,” Matthes said in a follow-up email.

Matthes was also upset that extended hours weren’t offered at Bailey Health Center.

Several students in the Phi Kappa Psi fraternity have also had the virus. According to Mikey Burke ‘21, approximately 12 to 15 members of the fraternity had contracted the virus as of Tuesday, although he said he expected that number to grow.

“I think it just spread really quickly throughout the house, it originated there and spread to a lot of the brotherhood, I live in McKeen and only hung out at the [Phi Psi] house for a couple hours…and got sick,” Burke said in an email.

Bobby Longo ‘21, another Phi Psi fraternity member to have the virus, said he believed the email warning on Monday was “too late.”

“Norovirus is an extremely contagious stomach virus that spreads like wildfire. After the first or second case on campus we should have been notified… it ramps up as people go from class to class spreading it,” Longo said in an email.

According to Goldstein, his level of concern about the virus was raised when the health center began receiving phone calls and emails from concerned students and parents, as the health center was “not overwhelmed” by the number of students coming to Bailey about the virus. 

Goldstein said he wanted to find a “sweet spot” of not raising a level of hysteria but also communicating with the students. He decided to send the campus-wide email more based on “the feedback from students,” Goldstein said.

“I think what’s happening is students are self-treating and getting through this without needing to see a provider, but the numbers are pretty significant on campus. The students communicating with me was a good thing,” he said.

According to Goldstein, reports from Resident Advisors and Bailey total a little over 150, but Goldstein said there may be overlap among these reports, if for example, a student both went to Bailey and reported their illness to their RA.

While Goldstein said that the discussion of the school closing “hasn’t happened yet,” he believes certain social gatherings will be cancelled if the virus continues spreading rapidly. One event, the Lunar New Year dumpling making party hosted by ISA and ACA, was cancelled on Tuesday as a result of the spreading sickness.

University students’ hand hygiene practice during a gastrointestinal outbreak in residence: What they say they do and what they actually do
01.sep.09
Journal of Environmental Health Sept. issue 72(2): 24-28
Brae V. Surgeoner, MS, Benjamin J. Chapman, PhD, and Douglas A. Powell, PhD

Abstract
Published research on outbreaks of gastrointestinal illness has focused primarily on the results of epidemiological and clinical data collected postoutbreak; little research has been done on actual preventative practices during an outbreak. In this study, the authors observed student compliance with hand hygiene recommendations at the height of a suspected norovirus outbreak in a university residence in Ontario, Canada. Data on observed practices was compared to post-outbreak self-report surveys administered to students to examine their beliefs and perceptions about hand hygiene. Observed compliance with prescribed hand hygiene recommendations occurred 17.4% of the time. Despite knowledge of hand hygiene protocols and low compliance, 83.0% of students indicated that they practiced correct hand hygiene during the outbreak. To proactively prepare for future outbreaks, a current and thorough crisis communications and management strategy, targeted at a university student audience and supplemented with proper hand washing tools, should be enacted by residence administration.

Going public: FDA to disclose retailer information for certain food recalls to improve consumer safety

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Americans depend on the U.S. Food and Drug Administration to help ensure that the foods they buy and consume are safe.

No they don’t. Food safety is faith-based.

When we learn that potentially dangerous food products may be available in the U.S. marketplace, we must move quickly and efficiently to remove these food products from the market.

Our teams routinely work with food producers on voluntary recalls, and when necessary and where applicable, mandate recalls in order to keep people from getting sick or being harmed. We recognize that an important part of the recall process is also arming consumers with actionable information that they can use to avoid potentially contaminated food products. We’re committed to providing consumers with more information to take these actions. This is an area where we see more opportunity to improve the FDA’s role in protecting public health. To promote these goals, we’re advancing an important new policy.

When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information. The aim is to enable consumers to identify whether they have the recalled product and take appropriate actions. That often includes discarding the product or returning it to the place of purchase.

The agency has not traditionally released lists of specific retailers where recalled foods may have been purchased. This is because certain supply chain information is confidential between the supplier and retailer. Moreover, in most cases, information publicized by the recalling company is sufficient to allow consumers to identify and avoid recalled product. But there are some cases where additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption. It is particularly important in situations where the product has already been linked to foodborne illness. In these situations, providing retailer information can help consumers more quickly and accurately recognize recalled product and take action to avoid the product or seek assistance if they’ve already been exposed.

We recognize the importance of providing consumers with actionable information related to recalled food products. That’s why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate. The draft guidance outlines the circumstances when the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food. These circumstances will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Based on this new policy, moving forward the FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption. Some examples of this may include foods sold directly to consumers with no universal product code or UPC, or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually.

The new draft guidance also states that the FDA may disclose retail consignee lists in certain recall situations, including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers. For example, the FDA might release retailer information for a packaged food that was distributed in a particular geographic region or through a particular online retailer if providing that information could help consumers protect their health and wellbeing from a recalled food potentially purchased at one of these establishments.

In recent months, we’ve already begun taking actions that align with this approach.

For example, this summer the agency released detailed retail distribution information by state during a recall of pre-cut melon associated with an outbreak of Salmonella infections so consumers could better identify where the recalled food may have been purchased. The draft guidance released today, provides greater transparency on our intention to regularly use this approach in these and other scenarios.

We believe that providing retailer information for certain recalls will also improve the efficiency of recalls by helping the public to identify and focus on the foods that are recalled. It’s important to note that in sharing this information, the FDA may also not be able to fully verify the accuracy or completeness of the information it receives from recalling companies or distributors, and information may change over time.

Identifying retail locations can be complex. It can involve obtaining information from multiple parts of the supply chain, including the recalling company and intermediate distributors. But we also know this information can be very important to consumers. Knowing where a recalled product was sold during the most dangerous food recalls can be the difference between a consumer going to the hospital or not. While we can’t prevent every illness, we can make sure we provide information to consumers to prevent more people from becoming sick from a recalled or hazardous food product.

Chapman told USA Today that, “We can never become too vigilant when talking about food safety. We’re talking about 48 million cases of food-borne illnesses a year and that estimate being stable over the last 10 years. There are lots of ways for improvement.”

He said he personally shops at numerous grocery stores for his family, so he doesn’t always remember where he buys what, especially unmarked items, such as sweet potatoes and onions.

The FDA plan to cite specific retailers “can trigger that ‘Oh, I did shop at these places. Maybe I need to start looking,’ ” Chapman said.

Nice to see Chapman stepping up to fill the gap I left. But he still needs me to write it up.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

Victims blame FDA for food-recall failures

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I don’t blame any regulatory type for going early or going late in a foodborne disease outbreak.

There’s lots of armchair quarterbacks out there, and we’ve tried to present the various viewpoints on many an outbreak.

There’s also a lot people out there with nothing but a personal agenda, based on profit rather than peer review.

Christine Haughney of Politico reports that people had been getting sick from eating I.M. Healthy Original Creamy SoyNut Butter for more than two months when Peter Ebb, a 59-year-old Boston lawyer and health enthusiast, went for a run and then ate his usual gluten-free English muffin smeared with soy nut butter.

Later that morning — March 6, 2017 — Ebb saw a message from Amazon, which had sold him the nut butter, that the manufacturer had recalled it for contamination by E. coli bacteria. Ebb threw away a protein drink he had made with the soy nut butter, but didn’t worry too much. The Food and Drug Administration warning that was linked to the email was worded very cautiously: Though serious illnesses might result, even potentially leading to death, “most healthy adults can recover completely within a week.”

Six days later, Ebb was hospitalized and developed a deadly type of kidney failure. Within days, doctors told his wife to send for their children in case they needed to bid him a last goodbye. He survived, but remains unable to work full time and has trouble climbing the stairs. Now, he’s joining with 18 other victims to file claims against the companies responsible and call attention to the inadequacy of the nation’s recall system.

“If I had heard about the problem even one week earlier and stopped then, I might have been able to avoid the disease completely, and life today would be very different,” Ebb said.

A POLITICO investigation found that the I.M. Healthy SoyNut Butter case — which officials at the FDA and the Centers for Disease Control and Prevention have hailed as an improvement over past failures — was nonetheless emblematic of persistent weaknesses in the nation’s food-safety system, some of which haven’t been corrected for two years after being flagged by the agency’s inspector general.

Two months elapsed between the first person sickened by eating I.M. Healthy SoyNut Butter on Jan. 4 and the recall orders that began on March 3 and expanded three more times until March 10. The FDA, working through a national network of labs that identifies outbreaks, pinpointed the contamination on Feb. 22. The nine-day lag time in persuading the manufacturer to begin recalling the tainted products was a significant improvement over previous lag times — which were as high as 165 days in one infamous case, according to the inspector general. But victims maintain that the FDA should have ordered a recall on its own authority, given that a few days or even hours can make a difference in a deadly outbreak.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

105 sickened, 1 death linked to Salmonella Newport outbreak originating in beef from dairy cattle, 2016-17

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Contaminated ground beef was the likely source of a protracted outbreak of 106 Salmonella Newport infections, 42 hospitalizations, and one death in 21 states during October 2016–July 2017. While no direct link was found, whole genome sequencing suggests dairy cows were the ultimate outbreak source.

Foodborne outbreak investigations could be enhanced by improvements in the traceability of cows from their originating farms or sale barns, through slaughter and processing establishments, to ground beef sold to consumers.

In January 2017, the U.S. Centers for Disease Control (CDC) identified a cluster of Salmonella enterica serotype Newport infections with isolates sharing an indistinguishable pulsed-field gel electrophoresis (PFGE) pattern, JJPX01.0010 (pattern 10), through PulseNet, the national molecular subtyping network for foodborne disease surveillance. This report summarizes the investigation by CDC, state and local health and agriculture departments, and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) and discusses the possible role of dairy cows as a reservoir for strains of Salmonella that persistently cause human illness. This investigation combined epidemiologic and whole genome sequencing (WGS) data to link the outbreak to contaminated ground beef; dairy cows were hypothesized to be the ultimate source of Salmonella contamination.

A case was defined as infection with Salmonella Newport with PFGE pattern 10 closely related to the outbreak strain by WGS, with bacterial isolation during October 1, 2016, through July 31, 2017. A total of 106 cases were identified in 21 states (Figure 1). Most illnesses ([72%]) were reported from southwestern states, including Arizona (30), California (25), New Mexico (14), and Texas (seven). Illness onset dates ranged from October 4, 2016, through July 19, 2017. Patients ranged in age from <1–88 years (median = 44 years), and 53 (50%) were female. Among 88 (83%) patients with known outcomes, 42 (48%) were hospitalized, and one died.

Initial interviews identified consumption of ground beef as a common exposure among patients. A focused questionnaire was developed to collect detailed information on ground beef exposure and to obtain shopper card information and receipts. Among 65 interviewed patients, 52 (80%) reported eating ground beef at home in the week before illness began. This percentage was significantly higher than the 2006–2007 FoodNet Population Survey, in which 40% of healthy persons reported eating ground beef at home in the week before they were interviewed (p<0.001) (1). Among the 52 patients who ate ground beef at home, 31 (60%) reported that they bought it or maybe bought it from multiple locations of two national grocery chains, and 21 (40%) reported that they bought ground beef from locations of 15 other grocery chains. Specific ground beef information was available for 35 patients. Among these, 15 (43%) purchased ground beef as chubs (rolls) of varying sizes (range = 2–10 lbs), 18 purchased it on a tray wrapped in plastic, and two purchased preformed hamburger patties. Twenty-nine patients reported that they bought fresh ground beef, four bought frozen ground beef, and four did not recall whether it was fresh or frozen when purchased. When asked about ground beef preparation, 12 (36%) of 33 patients reported that they definitely or possibly undercooked it.

Traceback Investigation

USDA-FSIS conducted traceback on ground beef purchased within 3 months of illness onset for 11 patients who provided shopper card records or receipts. Approximately 20 ground beef suppliers belonging to at least 10 corporations were identified; 10 of the 11 records traced back to five company A slaughter/processing establishments, seven of 11 traced back to five company B slaughter/processing establishments, and four of 11 traced back to two company C slaughter/processing establishments.

Product and Animal Testing

Opened, leftover samples of ground beef from three patients’ homes were collected for testing. All were purchased from one of two national grocery chains that had been identified by a majority of patients. One sample, collected from ground beef removed from its original packaging, yielded the outbreak strain. The other two samples did not yield Salmonella.

The outbreak strain was also isolated from four New Mexico dairy cattle. One was collected from a spontaneously aborted fetus in July 2016, and one was isolated from feces from a young calf in November 2016. The third isolate was identified by searching the USDA Animal and Plant Health Inspection Service National Veterinary Services Laboratory (USDA-APHIS NVSL) database for Salmonella Newport isolates collected from cattle in Arizona, California, Texas, New Mexico, and Wisconsin during January 2016–March 2017. Eighteen Salmonella Newport isolates were identified, including 13 from Texas, three from New Mexico, and two from Wisconsin. The only Salmonella Newport pattern 10 isolate identified was from a fecal sample from a New Mexico dairy cow collected during November 2016. The fourth isolate was from a USDA-FSIS routine cattle fecal sample collected at a Texas slaughter establishment in December 2016; USDA-FSIS determined the sample was from a dairy cow and identified the New Mexico farm of origin. Because of confidentiality practices, officials were not able to identify the farm or farms of origin for the dairy cows associated with the other three samples or whether the four dairy cows were associated with a single farm. None of the 11 patients with information for traceback ate ground beef produced at the Texas slaughter establishment.

Whole genome high-quality single nucleotide polymorphism (SNP) analysis* showed that 106 clinical isolates were closely related to each other genetically, to the four dairy cattle isolates, and to the leftover ground beef isolate (range = 0–12 SNP differences), suggesting that the Salmonella bacteria found in patients, ground beef, and dairy cattle all shared a common source. Thirty-nine additional clinical isolates with PFGE pattern 10 were determined to not be closely related and were excluded from the outbreak. No antibiotic resistance was detected among three clinical isolates tested by CDC’s National Antimicrobial Resistance Monitoring Laboratory.†

Because the USDA-FSIS traceback investigation did not converge on a common production lot of ground beef or a single slaughter/processing establishment, and no ground beef in the original packaging yielded the outbreak strain, a recall of specific product was not requested. A public warning was not issued to consumers because specific, actionable information was not available (e.g., a specific brand or type of ground beef). Officials in New Mexico visited the dairy farm that was the source of the cow at the Texas establishment and noted no concerns about conditions or practices. However, this visit occurred late in the investigation, and conditions at the time of the visit might not have represented those present immediately before and during the outbreak. No samples from the environment or cows were collected during this visit.

Epidemiologic and laboratory evidence indicated that contaminated ground beef was the likely source of this protracted outbreak of Salmonella Newport infections. A significantly higher percentage of patients than expected ate ground beef at home, and a patient’s leftover ground beef yielded the outbreak strain. Dairy cows colonized or infected with the outbreak strain before slaughter are hypothesized to be the ultimate outbreak source. Most U.S. ground beef is produced from beef cattle; however, 18% is produced from dairy cows (2). Dairy cows are sold for beef production through sale barns or directly to slaughter establishments as they age or if their milk production is insufficient (2). Previous studies have demonstrated long-term persistence of Salmonella Newport in dairy herds (3,4), and a 1987 Salmonella Newport outbreak was linked to contaminated ground beef from slaughtered dairy cows (5). In the current outbreak, as has been observed in previous outbreaks, ground beef purchases traced back to numerous lots and slaughter/processing establishments (6). One possible explanation is that dairy cows carrying a high Salmonella load that overwhelmed antimicrobial interventions could have gone to multiple slaughter/processing establishments (7), resulting in contamination of multiple brands and lots of ground beef. This might explain the reason for failure to identify a single, specific source of contaminated ground beef.

This investigation identified the outbreak strain only in samples from dairy cattle from New Mexico. All four isolates from dairy cattle samples were closely related genetically by WGS to isolates from patients, providing further evidence of a connection between dairy cattle in New Mexico and the outbreak. The disproportionate geographic distribution of cases in the U.S. Southwest, including New Mexico, also suggests a possible regional outbreak source. Although limited in scope, the query of the USDA-APHIS NVSL data identified the outbreak strain only from one New Mexico dairy cow (isolate 3), and the sample collection date was consistent with the timing of illnesses in this outbreak. The overall prevalence and geographic distribution of the outbreak strain in cattle is not known, and it is possible that cattle in states other than New Mexico might have been infected or colonized with the outbreak strain.

This was a complex and challenging investigation for several reasons. First, the PFGE pattern in the outbreak was not uncommon in PulseNet, making it difficult to distinguish outbreak cases from sporadic illnesses associated with the same Salmonella Newport pattern. WGS analysis provided more discriminatory power to refine the outbreak case definition and excluded 39 cases of illness from the outbreak. However, sequencing is not currently performed in real time for Salmonella, thereby slowing the process of determining which cases were likely outbreak-associated. In addition, a direct pathway linking outbreak cases to dairy cows infected with the outbreak strain of Salmonella Newport could not be established. This is because product traceback did not converge on a single contaminated lot of ground beef, and investigators were unable to ascertain a link between the beef slaughter/processing establishments identified during traceback and the farms with dairy cows that yielded the outbreak strain. Tracing back ground beef purchased by patients to slaughter/processing establishments requires documentation such as receipts or shopper card records, and only 10% of patients had this information available. For this outbreak, tracing back cows at slaughter/processing establishments to the farm from which they originated was problematic because cows were not systematically tracked from farm to slaughter/processing establishments.

Four points along the “farm to fork” continuum provide opportunities to prevent consumers from becoming ill from contaminated ground beef. First, farms can implement good management practices for cattle health, including vaccination, biosecurity (e.g., controlling movement of persons and animals on farms, keeping a closed herd [so that no animals on the farm are purchased, loaned to other farms, or have contact with other animals], planning introduction of new animals and quarantining them, and performing microbiologic testing of animals), and cleaning and disinfection measures to decrease Salmonella burden in animals and the environments in which they reside, reducing the likelihood that Salmonella will enter beef slaughter/processing establishments (8). Second, slaughter/processing establishments are required to maintain Hazard Analysis and Critical Control Points systems to reduce Salmonella contamination as well as slaughter and sanitary dressing procedures to prevent carcass contamination (9). Third, although Salmonella is not considered an adulterant in not-ready-to eat (NRTE) meat products, USDA-FSIS likely will consider the product to be adulterated when NRTE meat products are associated with an outbreak (9). Finally, consumers are advised to cook ground beef to 160°F (71°C) as measured by a food thermometer to destroy any bacteria that might be present. Consumers are also advised to wash hands, utensils, and surfaces often; separate and not cross-contaminate foods; and refrigerate foods promptly and properly.

This investigation emphasizes the utility of WGS during outbreak investigations and identifies the need for improvements in traceability from the consumer to the farm. It also highlights the importance of continued evaluation of farm practices to help reduce persistent Salmonella contamination on farms, contamination of ground beef, and ultimately human illness.

Protracted outbreak of Salmonella Newport infections linked to ground beef: Possible role of Dairy Cows-21 states, 2016-2017

CDC

https://www.cdc.gov/mmwr/volumes/67/wr/mm6715a2.htm

Kis Robertson Hale, Food Safety and Inspection Service, U.S. Department of Agriculture; territorial, state, city, and county health departments and laboratories; Danya Alvarez, John Crandall, Hillary Berman-Watson, California Department of Public Health Microbial Diseases Laboratory.

 

Going public, Salmonella-in-French-cheese-style: Morbier and Mont d’Or cheese behind 10 deaths in France, 2015-16

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In a country where reporting foodborne illness is deemed unpatriotic an investigation by France Inter radio revealed that at least 10 people died in the Franche-Comté region in the east of France linked to two cheeses made from unpasteurized milk  in late 2015 and early 2016.

The investigation produced a document which showed that in January 2016 national health authorities had discovered an unusually high number of salmonella contaminations in France that was centred on Franche-Comté.

Five cheese making companies in the region, between them making 60 different brands, were later identified as being at the source of the contaminations that began in November 2015 and continued until April the following year.

In a way that is truly French in its description, those who died in the outbreak were old people who were physically weak or who suffered from another illness.

Jean-Yves Mano, the president of the CLCV consumer association, said he was surprised that a product recall had not been ordered of products that might have been infected with salmonella.

“We do not understand why a general alert was not issued by state officials, or at least information given on what precautions to take,” he told France Inter.

The state food agency, the Direction générale de l’alimentation (DGAL), said there were two reasons why a recall was not ordered.

The first was that it would have allegedly been very difficult to identify which exact brand of the cheeses were contaminated because there were a total of 60 that were produced in the cheese-making firms where the outbreak originated.

The second was that by the time the authorities found out where the outbreak had come from, the contaminated cheeses had already been consumed and the new batches in the cheesemakers’ premises were not infected.

“It is perhaps due to these two factors that this contamination was not in the media, even though all the data was public nothing was hidden,” said Fany Molin of the DGAL food agency.

That’s French-bureau-speak.

Go public: Further illnesses may be prevented; others learn; citizens may not come with torches demanding change; and it’s the right thing to do.

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

Going public (not): One dead 33 sick from Salmonella at Colorado restaurant in November

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The Tri-County Health Department said one person has died from salmonella poisoning related to eating at a restaurant in Aurora (not the Aurora, Ill. of Wayne’s World). The outbreak put three other people in the hospital.

The health department said 33 people were sickened by eating at La California restaurant on Peoria Street in November.

The health department said lab tests show the family combination meal might have led to the poisoning. The meal includes ingredients such as meat, beans and cilantro.

But investigators could not pinpoint what started the outbreak.

The health department said the outbreak affected people who ate at La California from Nov. 4-26. Almost all of the people infected experienced diarrhea and abdominal cramping.

La California is at 1685 Peoria St.

The health department’s report said 13 of the 33 cases are confirmed, and 20 of the cases are probable for salmonella.

The illnesses involved 32 restaurant patrons and one employee.

Twenty-five cases had exposures at the restaurant with their meals within a five-day period from Nov. 10-14.

“It was significantly associated with the illness. But we couldn’t ID a single item in the family combo that was associated with the illness. … Everybody ate everything in the family combo,” Tri County Health spokeswoman Jen Chase told CBS Denver.

Going public: US FDA version

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The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.

The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it.

It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7. 1 This guidance has been prepared by the Office of Strategic Planning and Operational Policy (OSPOP), in the Office of Regulatory Affairs (ORA), in cooperation with the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Center for Tobacco Products (CTP), and the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under part 21 Part 1240. However, it does not apply to radiation emitting electronics which are governed by 21 CFR Part 1003 and 1004.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Public warning and notification recalls under 21 CFR part 7, subpart C guidance for industry and FDA staff, 17 January 2018

FDA

https://www.fda.gov/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.

 

Going public: FDA leaves tainted foods on shelves too long, report finds

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The U.S. Food and Drug Administration is not moving quickly enough to ensure that contaminated food is removed from store shelves, despite being given the necessary authority, federal investigators have concluded.

The inspector general of the Department of Health and Human Services examined 30 of 1,557 food recalls between 2012 and 2015. The investigators found that the F.D.A. did not always evaluate foodborne hazards in a timely manner or ensure that companies initiated recalls promptly, leaving consumers at risk.

Food companies took an average of 57 days to recall items after the F.D.A. was apprised of the potential hazards. One recall did not begin for 303 days, the investigators said.

“Each and every day is important, because every day the product remains on the shelf, consumers are potentially at risk for serious illness or death,’’ said George Nedder, an assistant regional inspector general at Health and Human Services and lead author of the new report.

The F.D.A. has jurisdiction over most of the food supply in the United States, including virtually all processed food. (The Department of Agriculture oversees meat and poultry, and handles recalls of those products.)

About 48 million Americans get sick from food-borne diseases each year, according to the agency. Of those, 128,000 are hospitalized and 3,000 die.

Food recalls are announced frequently, but the vast majority are voluntary. Sometimes a company comes forward to report contamination, adulteration or mislabeling to the F.D.A. Sometimes the agency approaches a manufacturer after learning of a hazard from a state agency or other source.

In the past few months, the F.D.A. has announced recalls of contaminated apple slices (with listeria), biscotti (undeclared nuts) and adobo sauce (salmonella), among other problems.

The report noted numerous failings, among them “deficiencies in F.D.A.’s oversight of recall initiation, monitoring of recalls,” and in collecting and tracking recall data. Investigators also found that the F.D.A. did always not evaluate health hazards in a timely manner.

Many of the problems detailed in the report were the subject of an unusual “early alert memorandum” from the inspector general’s office in June 2016, which warned that “consumers remained at risk of illness or death for several weeks after F.D.A. was aware of a potentially hazardous food in the supply chain.’’

The new report noted that it took the agency 165 days to start a recall of nut butters that may have been tainted with salmonella; 151 days to recall hazelnuts that also suspected of salmonella contamination; 82 days to recall frozen spinach suspected of high levels of cadmium; and 27 days to start a recall of cooked duck eggs carrying the bacteria that cause botulism.

F.D.A. Commissioner Scott Gottlieb said that the agency had taken to heart the inspector general’s earlier warning and had already started to address recall enforcement problems that have persisted for years.

Dr. Gottlieb said that most food recalls occur within four days of a problem being reported, an assertion that Mr. Nedder disputed.

“Delay is deeply concerning to me as well,” Gottlieb, a physician, said in an interview. “I think it’s working a lot better now.”

FDA will also release guidance in the first half of 2018 on what information it can release about where recalled food and diet supplements were sold. A coalition of safety advocates urged Gottlieb in August to release the names of the stores that sell recalled food items, which FDA has claimed is confidential business information. The Agriculture Department releases it, as do other agencies including the Consumer Product Safety Commission.

FDA Commissioner Scott Gottlieb, MD said in a statement (edited below) that, “One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me. While the FDA has addressed many of the findings after the draft version was first released in 2016, we still have more work to do. I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission. …

“Among other steps, the agency will issue guidance on recall communications in the first half of 2018. As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.”

Here’s some suggestions:

Going public: Early disclosure of food risks for the benefit of public health

Mar.17

NEHA, Volume 79.7, Pages 8-14

Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell

http://www.neha.org/node/58904

Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.