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This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.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.

 

The only thing certain is more uncertainty: Europe tries new uncertainty approach

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The European Food Safety Authority (EFSA) has developed a harmonised approach to assessing and taking account of uncertainties in food safety, and animal and plant health. This approach will boost the transparency of the resulting scientific advice and make it more robust for decision-making.

Maybe.

The EFSA Scientific Committee guidance on uncertainty in scientific assessments offers a diverse toolbox of scientific methods and technical tools for uncertainty analysis. It is sufficiently flexible to be implemented in such diverse areas as plant pests, microbiological hazards and chemical substances.

Prof Tony Hardy, Chair of the Scientific Committee said: “Since 2016, we have tested, refined and tailored our new approach to uncertainty analysis, benefiting from open consultations with EFSA’s partners and the wider public. Crucially, we learnt a great deal about how to apply the new approach by trialling it across all EFSA’s scientific areas of activity.

The approach is described in two separate documents: a short user-friendly (says who?) guidance with practical instructions and tips, and a supporting scientific opinion with all the detailed scientific reasoning and methods.

The long-term goal is that the new guidance on uncertainty will be an integral step in all EFSA’s scientific assessments.

Prof Hans Verhagen is head of EFSA’s department for risk assessment. He said: “The trial showed that in areas like plant health, an explicit uncertainty analysis is already being used, with positive feedback from risk managers who say this helps them with their decision-making. In other areas, where uncertainty analysis is not yet integrated in the assessment process, the testing phase has helped give a clearer idea how to develop tailored approaches.”

EFSA will implement the approach in two stages. In general scientific areas, the guidance will apply from autumn 2018 after the renewal of the Authority’s scientific panels.

In regulated products areas such as pesticides, food additives or food contact materials it will be phased in later on, in light of the experience gained in the ‘non-regulated’ areas.

In parallel, EFSA is developing practical guidance for communication specialists on how to communicate the results of uncertainty analysis to different target audiences, including the public. A public consultation will be held on a draft of the communication approach in 2018.

Others have been working on this for 40 years. When the goal is public health – so more people don’t barf – we already know it’s better to go public early and oftern.

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.

Food Safety Talk 144: They Look and Taste Like Green Turds

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The guys jumped right into the food safety talk this week with a discussion of the Jimmy John’s sprout outbreak. From there the conversation turns to a whole lot of listener questions and feedback: Instant Pot, more on edible gold and silver, the safety of pots left on the stove as well as refrigerator leftovers, fiddleheads, proper spatula use, burger temperatures, and food safety gadgets. There’s a little bit of popular culture talk right at the end. Below are show notes so you can follow along at home.

Episode 144 is available on iTunes and here.

Show notes so you can follow along at home:

 

 

Europe models: Listeria monocytogenes contamination of ready-to-eat foods and the risk for human health in the EU

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Here’s an idea: don’t serve cold cuts and raw sprouts to old people.

Duh.

The European Food Safety Authority reports that food safety criteria for Listeria monocytogenes in ready-to-eat (RTE) foods have been applied from 2006 onwards (Commission Regulation (EC) 2073/2005). Still, human invasive listeriosis was reported to increase over the period 2009–2013 in the European Union and European Economic Area (EU/EEA). Time series analysis for the 2008–2015 period in the EU/EEA indicated an increasing trend of the monthly notified incidence rate of confirmed human invasive listeriosis of the over 75 age groups and female age group between 25 and 44 years old (probably related to pregnancies).

A conceptual model was used to identify factors in the food chain as potential drivers for L. monocytogenes contamination of RTE foods and listeriosis. Factors were related to the host (i. population size of the elderly and/or susceptible people; ii. underlying condition rate), the food (iii. L. monocytogenes prevalence in RTE food at retail; iv. L. monocytogenes concentration in RTE food at retail; v. storage conditions after retail; vi. consumption), the national surveillance systems (vii. improved surveillance), and/or the bacterium (viii. virulence).

Factors considered likely to be responsible for the increasing trend in cases are the increased population size of the elderly and susceptible population except for the 25–44 female age group. For the increased incidence rates and cases, the likely factor is the increased proportion of susceptible persons in the age groups over 45 years old for both genders. Quantitative modelling suggests that more than 90% of invasive listeriosis is caused by ingestion of RTE food containing > 2,000 colony forming units (CFU)/g, and that one-third of cases are due to growth in the consumer phase. Awareness should be increased among stakeholders, especially in relation to susceptible risk groups. Innovative methodologies including whole genome sequencing (WGS) for strain identification and monitoring of trends are recommended.

Public health folks in Detroit offering free hep A shots for uninsured food handlers

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One cost that’s been debated in food service for over twenty years is whether or not employers or public health folks should require food handlers to be vaccinated for hepatitis A. Jacobs and colleagues arrived at the conclusion that the public health benefit of vaccinating for hep A doesn’t equal the costs – but doesn’t factor in all the bad publicity, hassle and incident management costs.

How about free vaccines for uninsured food handlers. Sounds good to me. That’s what’s happening in Detroit after 692 hep A cases in southeast Michigan have occurred recently, according to the Detroit Free Press.

Food workers are being encouraged to get a Hepatitis A vaccine shot on Monday by the Detroit Health Department in the wake of an outbreak hitting southeast Michigan.
The vaccination clinic is scheduled for Monday from 10 a.m. to 8 p.m. at the Samaritan Center, Kilpatrick Conference Room, 5555 Conner.

The Detroit Health Department is recommending that all food establishments in the city make arrangements for workers to get vaccinated. Food workers include those who work at restaurants, bars, fast food establishments and delis.
Food workers are encouraged to bring a photo identification and health insurance card if they have insurance. Uninsured food workers may be eligible for a free vaccine.
The department has extended its hours to 8 p.m. to accommodate workers with busy schedules.

Fish-linked botulism in Nigeria

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I’ve chronicled my fear of botulism many times before. I still can stuff, but I really pay attention to what I’m doing.

Dried fish and botulism seem to go together. Five bot cases in Germany and Spain were linked to dried fish in 2016.

There were 90 illnesses and nine deaths in 2017 from foodborne botulism in Ukraine. That’s a lot. Fish were a factor in many of these illnesses.

According to Outbreak News Daily, two unlucky Nigerians have died from botulism after consuming fish.

Three family members contracted suspected foodborne botulism, resulting in the deaths of the father and mother, according to the  the Nigerian Centres for Disease Control (NCDC). Fish appears to be the common food source.

The event descriptions of the two fatalities is provided by the World Health Organization (WHO):

The woman, a 47 year-old, presented to King’s Care Hospital, Abuja, on 7 January 2018, with vomiting, fever, sudden blurring of vision, generalized body weakness, dysphagia and odynophagia, and left ptosis. She was semi-conscious. She was initially diagnosed with ischaemic heart disease, with esophageal stricture and central retinal vein thrombosis. However, her neurological symptoms worsened rapidly, progressing to complete bilateral ptosis, paralysis of her respiratory muscles, and respiratory failure. She was referred approximately 24 hours after admission and died in transit.

Her 49 year-old husband presented to the same hospital with nausea, dizziness, vomiting, progressive dysarthria, odynophagia and partial ptosis. He was transferred to Zenith Medical and Kidney Centre, where his symptoms worsened. He suffered progressive respiratory failure, which required a tracheostomy and ventilation, and died on 15 January 2018.

Their 15-year-old daughter also developed symptoms and was hospitalized as of last week.

All three cases had eaten fish at home in the previous 24 hours. Two further children, who stayed in the same house, are currently in Lagos and are being monitored remotely. A third child is in Karu, but monitoring has been hampered by uncooperative relatives.

 

Fancy food ain’t safe food: UK-steak-house edition (Jamie Oliver is a food-safety idiot) and quinoa ain’t steak

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Ruki Sayid of the Mirror writes the meat supplier behind Wetherspoon’s sudden move to axe steak for its Steak Club menu is at the centre of a food hygiene investigation.

The Food Standards Agency revealed Russell Hume’s sites have been inspected and products recalled after allegations it was in “serious non-compliance with food hygiene regulations.”

The firm has previously supplied meat for Jamie Oliver’s restaurants, but bosses today confirmed that they switched suppliers as soon as they became aware of problems.

Following a tip, the FSA carried out a spot check on the firm’s Birmingham site and then sent teams to other locations which also failed to meet regulations.

The FSA said: “There is no indication that people have become ill from eating meat supplied by Russell Hume.

“However, we are concerned about the poor practices in place at their premises so that is why we have taken proportionate action to ensure no meat can leave their sites at present.

“We are continuing to assess the situation.”

Customers were up in arms when Wetherspoon scrapped steak from its menu without warning at its 900 pubs.

The decision meant servings of the Aberdeen Angus rump steak, sirloin steak and gammon were unavailable to order as customers were reportedly offered quinoa and halloumi salad alternatives instead.

One furious diner told how he stormed out of a branch in Scarborough when he learned of the Steak Club shortcomings.

James Jarvis, 27, told The Sun : “One of their suggestions was a quinoa salad with grilled halloumi. I came in for a steak — not a poncey salad!”

While Michael Rousell, 62, who visited a Wetherspoon in Weston-super-Mare, Somerset, told the newspaper: “I can’t believe a multi- million pound organisation like Wetherspoon can’t sort this out ­— it beggars belief.”

A notice apparently pictured at one pub read: “Due to a supplier failure, the following meals are unavailable: 8oz and 14oz Aberdeen Angus rump steak, 8oz sirloin steak, 5oz and 10z gammon.”

In memorandum: Wisconsin epidemiologist Jeffrey Davis identified Milwaukee’s Cryptosporidium outbreak

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I was a new doctoral student when cryptosporidiosis sickened over 400,000 people and killed 69 in Wisconsin in the spring of 1993.

I had recently started the Food Safety Network, which was bringing daily updates to scientists and public health folks who usually had to wait 6 months for the U.S. Centers for Disease Control’s Morbidity and Mortality Weekly to arrive.

It may seem trivial now, but it was a big deal in its day.

Lotsa posers and copycats over the years, so we went to barfblog.com.

Later that year, cryptosporidiosis would sicken hundreds in Kitchener-Waterloo, where I was living with my young family.

Somehow, I was speaking about this to our home-renovator-contractor-and-therapist yesterday while he unplugged our kitchen faucet.

And then I got this.

Meg Jones of the Milwaukee Journal Sentinel writes that as doctors’ offices filled with Milwaukeeans suffering from a mysterious illness in 1993, Mayor John Norquist called a meeting with state and local officials.

Norquist asked state epidemiologist Jeffrey Davis whether he would drink a glass of Milwaukee’s water and when Davis said he would not, Norquist issued a massive boil water advisory that affected more than 1 million residents.

With decades of work in public health, Davis was the perfect person to figure out a little-known parasite cryptosporidiosis could be the culprit that sickened more than 400,000 people.

As state epidemiologist for the past four decades, Davis was Wisconsin’s doctor.

He was a medical sleuth who figured out the connection between toxic shock syndrome and tampons and helped determine the infectious agent transmitted by ticks that causes Lyme disease. 

Davis, 72, died of pneumonia in Madison Jan. 16.

“Jeff’s knowledge of the literature helped identify the (Cryptosporidium) outbreak earlier. Cryptosporidiosis at that point was a pretty rare pathogen,” said State Public Health Veterinarian James Kazmierczak.

Knowing about a similar waterborne outbreak elsewhere in the U.S., Davis asked to see data on water quality in Milwaukee and noticed a spike in turbidity at the same time that people began to get sick. At the time, city water supplies were not tested for Cryptosporidium.

“Because of Jeff’s knowledge of what happened earlier with cryptosporidiosis, that became the leading suspect,” said Kazmierczak.

Davis grew up in Whitefish Bay and earned an undergraduate degree in chemistry in 1967 at University of Wisconsin-Madison and his medical degree in 1971 at the University of Chicago. He did his internship and residency in pediatrics in Florida and from 1973 to 1975 worked for the U.S. Centers for Disease Control and the South Carolina Department of Health.

After a stint at Duke University Medical Center, he returned to Wisconsin in 1978 as state epidemiologist and chief of the division of acute and communicable diseases. In 1991, his job title changed to chief medical officer and state epidemiologist for communicable diseases.

“He loved being a sleuth and medical detective, leading investigations of all sorts, from toxic shock syndrome to Legionnaires’ outbreaks, to the Cryptosporidium water supply outbreak, which was huge,” said his wife Roseanne Clark.

“He really was passionate about trying to figure out the source to reduce the impact on as many people as possible. He cared about the health of the people of Wisconsin.”

Questions: Why would a family use a poop knife?

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Sarah Montgomery of Complex writes that everybody poops. But not everyone uses the same tools to carry out that biological necessity. One Reddit user recently discovered that a tool he’s been using his whole life was not, in fact, a staple in bathrooms around the world.

Cue the “poop knife,” a mechanism used by @LearnedButt’s family to break up their apparently gargantuan shits. “My family poops big,” he wrote in a post. “If anyone has laid a mega-poop, you know that sometimes it won’t flush. It lays across the hole in the bottom of the bowl and the vortex of draining water merely gives it a spin as it mocks you.” What imagery.

The user went on to explain via Reddit how his family has used an old kitchen knife for decades to slice up their fecal matter. The knife hung on a nail in their laundry room, constantly waiting for its next big task. “It was normal to walk through the hallway and have someone call out ‘hey, can you get me the poop knife?’” he explains. “I thought it was standard kit. You have your plunger, your toilet brush, and your poop knife.”

Gross.

It came out of the sky: Frozen airplane poop – blue ice — raises questions in India town

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A rumble in the sky and a loud thud a few seconds later shook villagers in Gurugram’s Fazilpur Badli on Saturday, leaving them wondering what had happened.

Rajbir Yadav was in a wheat field when a “large rock” made its way to the ground, forming a one-foot crater.

Was it a missile, a bomb or a meteor?

A terrified, befuddled Yadav sprinted to the village head, another villager, Sukhbir Singh, said.

The news spread like wildfire and a few minutes later, a large number of the villagers had circled the frigid “rock”, which later turned out to be human excret – a human poop.

While the elders wracked their brains to make a good guess, the children brimming with curiosity declared it was a gift by the aliens.

“It is a white, holy stone gifted by the aliens,” a child exclaimed.

Sub-Divisional Magistrate, Pataudi, Vivek Kalia told PTI a few people approached the district administration, and a team comprising officials from the Meteorological department and the National Disaster Management Authority was formed under Kalia.

The team found the “celestial gift” the whole village was talking about the entire day was “blue ice”, a term used for frozen toilet waste leaking from aircraft, Kalia said.