A fresh perspective on alleged pesto outbreak in Italy

It’s better to rely on locals who know their stuff, so I turned to our Italian food safety friend, Luca Bucchini to clarify the alleged-botulism-in-pesto story. He writes:

There was probably no botulin toxin in the Italian basil pesto that sent more than 100 people to the emergency departments across Italy. Of the 100, 10 have been initially hospitalised, but 8 were later sent home: none had symptoms which suggested botulism. While tests on products and humans are still pending, the toxin has yet to be found in any sample.

The company, Bruzzone and Ferrari, which has been producing basil for pesto for two centuries, had identified a “potentially pathogenic microorganism” in a lot of its pesto: it is widely believed that the organism was C. botulinum, the bacterium which basil.salmonellacan, under certain conditions, produce the lethal toxin. The product, which is a fresh sauce requiring refrigeration, was already on the market: when the shelf life of a product is relatively short and time required for testing is relatively long, products are shipped before the results of the testing are known. This procedure is often required by retailers. When Bruzzone and Ferrari realised that they had a positive finding for the pathogen, though not for the toxin, they decided to issue a recall; a public recall is uncommon in Italy.

Italy’s Ministry of Health, usually stingy with information, issued a Press Release (http://www.salute.gov.it/portale/news/p3_2_4_1_1.jsp?lingua=italiano&menu=salastampa&p=comunicatistampa&id=4053) on July 20, 2013, calling the incident an “alarm” and explained that the botulin toxin is potentially fatal. However, it failed to mention the retail brands under which the product was sold, and did not offer advice to consumers, for example on when to seek medical care. Only the lot, the sell-by date and the producer’s name were mentioned; it was assumed that consumers are able to scan the back of the label and identify the small print needed to identify the producer. The press release also suggested that products were mostly off the shelf and the recall was limited. Ministry of Health press releases are immediately taken up by the main press agencies, and automatically become major news.

It soon became apparent that 15,000 jars were affected, and that many consumers had eaten the product, which had been on the market for at least a week; there was no information for them in the official communication. Panic ensued. Officials communicated sparingly, with the exception of Liguria, the region where the company is based. Hospitals were slow to explain that no cases were confirmed and that people without symptoms did not need hospitalisation; the Facebook site of Bruzzone & Ferrari was the pesto.basil.cyclosporaonly formal source of information, with only a few independent media outlets providing further details. The affected lot had been sold under several brands, including those of Italy’s top supermarket chains. The supermarket chains posted alert signs in shops and frantically e-mailed and phoned customers with loyalty cards to inform them of the recall; they probably hoped to avoid going public. As consumers reported about the calls received on Facebook and on other sites, some eventually capitulated and published on their website a recall notice, while others are still silent.

At this point in time, it seems likely that there was no toxin in most or all jars, and that people sought medical attention for reasons unrelated to product content. Some suspect that other pathogens may be present; however, no specific information supports this, and reported symptoms by few patients (vomit, diarrhea) may be unrelated to the exposure.

Nevertheless, the presence of the toxin in some jars cannot be excluded. The product does not appear to be heat-treated; it is part of a broad global trend to produce raw, semi-raw fresh products which require refrigeration. The pH of the product is permissive for growth of botulin (specifications: 4.8-5.8); it is rich in oil providing anaerobic conditions; it is used on pasta as a sauce without cooking; it has a shelf life of 30 days. While the product is to be refrigerated, the cold chain, especially in summer, with ambient temperatures above 30 C, is often not reliable: retailers often don’t prioritise temperature control. Consumers may not understand the difference between shelf-stable pesto (which is more common) and the refrigerated variety, or underestimate the importance of refrigeration.

Though food safety officials praised the company for not hesitating to issue a public recall, magistrates, as it is usual in Italy, were quick to start a criminal investigation for alleged unintentional injuries. In Italy, companies fear issuing precautionary recalls as magistrates generally try and convict in criminal court those who publicly confess to the mere presence of a pathogen in their products. This has been a factor in the hesitation of businesses to embrace European food law which requires issuing immediate recalls.

Overall, it is early to draw final conclusions from this episode. Hopefully, the results of the testing will be made public and confirm that there was no outbreak (incidentally, Italy has an ongoing foodborne Hepatitis A outbreak with hundreds of cases of which were little is being said). It is perhaps time to question products which, while nicely fresh, depend on the cold chain for being safe from botulin. It is quite clear that the authorities, and particularly the Ministry of Health, need risk communication training: consumers need to reliably identify products, get quickly rid of them, and not rush to the ER if they don’t need to.

30 hospitalized from botulism in pesto in Italy

At least 30 people were admitted to Italian hospitals for suspected botulism poisoning after eating pesto produced by Bruzzone and Ferrari. All reported having consumed the same pesto. Samples of blood, urine, feces and pesto pesto.Bruzzone and Ferrarisame were sent to the Ministry of Health, Rome, for analysis.

In 2012, the UK Food Standards Agency identified an outbreak of botulism linked to olives from Italy.

Mad cows and mushy peas; is Italy really better than UK at food safety? Don’t look, don’t find

Friend of the barfblog Luca Bucchini writes that, “Food safety is a British problem, they have bad food,” or so says one of Italy’s top food safety officials, Umberto Agrimi of Italy’s National Institute of Health, or the Istituto Superiore di Sanità (ISS).

In Italy, the ISS is the chief scientific adviser to the Ministry of Health, which is the food safety regulator. Dr Agrimi heads the Veterinary Public Health italy.foodand Food Safety Department within ISS.

In an article which debated the consumption of foods past their use-by or sell-by date , the journalist cited the 1.7 million cases of food poisoning recently reported in the England and Wales alone.

In his remarks, Agrimi dismisses the idea that the problem has a similar magnitude in Italy, jokingly adding that the problem was down to the low quality of British cuisine and diet. He also added that, though Italy has its share of food poisonings, the statistics, contrary to the UK ones, do not raise any alarm. Later in the article he adds that most cases of food poisoning in the UK are down to pork and poultry, whereas in Italy they can be attributed to fish.

These statements are illustrative of how not to deal with food safety – in any country.

Such statements often are the consequence of ignoring or misreading – in good faith – the data.

Campylobacteriosis is the leading cause of foodborne disease in the European Union since 2005. In the most recent European data Italy reported 468. A difference of this magnitude can only be explained by vastly different surveillance systems: Italy does not have a reliable system of reporting, and, having never heard of Campylobacter (as Italy has no alarming food safety problem, communication is not a priority), physicians do not probably prescribe any testing. In the same report, Latvia looks almost immune to the disease (7 cases in 2011, 1 or no cases in previous years), whereas other Baltic states are orders of magnitude worse.

For salmonellosis, the European Food Safety Authority (EFSA) data figures look comparable, with Italy at 3,344, and the UK at 9,455, and in favor of surveillanceItaly. In 2012, however, EFSA tried to estimate the true incidence of salmonellosis across Europe using data from Swedes returning from different European countries with salmonellosis (useful table in http://www.efsa.europa.eu/en/efsajournal/doc/2616.pdf, page 75). Using that estimate, Italy had 298,000 cases in the reference year, the UK had 76,500, or less than a third. Most likely, Italy has many more cases of salmonellosis than the UK.

The EFSA report on zoonoses, (page 231) maintains Italy reported no outbreaks with strong evidence of the virus as the culprit. Are Italians immune to norovirus? I doubt it. Is Italian food norovirus free?  Nothing would suggest as much.  We have the same viral strains that circulate in Europe but Italy does not have a surveillance system for norovirus (and if one’s been set up very recently it has not been publicized), unlike the UK.

Italy seems to have had fewer cases of listeriosis than the Netherlands in 2011, and more or less half the cases of the UK. Do Italy and UK have comparable surveillance systems? Hard to say. Until recently, the only Italian region (16% of national population) with a more accurate reporting system contributed 55% of the total reported cases raising doubts on the overall figures. Is there an effect of food habits? Impossible to draw a firm conclusion.

Whatever the real situation with listeriosis, there is little evidence to say that Italy has a better epidemiological situation for foodborne pathogens than the UK: campylobacteriosis (no reliable data), salmonellosis (UK seems to fare better) and norovirus (no data). The only reliable data, for salmonellosis, actually suggest the opposite. If the situation in the UK is alarming, than Italy should rush to get better data.

Is fish really the main vehicle of concern? The EFSA report which I have cited above looked at food vehicle/pathogen correlations, but unfortunately Italy seems to have contributed no data. If there are unpublished data Agrimi was referring to, they would present an interesting finding as seafood is normally a significant, but not leading, contributor to foodborne disease burden.

Italy has many good food safety officials. They often state that we have more and better controls – especially better than the Brits.

Ignoring data leads to biased resource allocation, inadequate risk management and risk communication (there is still no news on how the Italian hepatitis A outbreak is evolving, after the initial admission on May 23 that there could be one). In dealing with the media, scientists should be mindful of what they communicate.

There are excellent food safety officials in most countries, including Italy; it is important that they are led and do not fall into complacency traps, in all cases, but especially when data warrant no complacency at all.

Hepatitis A in Italy? We’ll see

Food safety friend of the blog, Luca Bucchini, offers an Italian perspective on the ongoing Hepatitis A outbreaks:

You are responsible for the control of infectious diseases in the Italian Region of Trentino-Alto Adige.

In your position you know that Hepatitis A is a highly infectious disease, due to a small picornavirus RNA, often asymptomatic in children under 5 years, but which causes in older individuals jaundice, fever, weakness, and abdominal frozen.berry.hep.1.jun.13pain. The symptoms last for a week or two, sometimes months. In 15% of cases, the symptoms last more than a year.

In adults over 50 years (and in those who have liver problems) the risk of death is important (to 1.8%). It is often transmitted by foods (strawberries, shellfish, etc.), or water, given the resistance of the virus in the environment, via the classic fecal-oral route (which means eating foods which has come in contact with contaminated feces). You also know that an epidemiological difficulty is the long incubation period (28-30 days).

Back to your office. No cases have been reported in 2011 and even in 2012 from the entire Trentino. But, between January and April 2013, reports for 15 cases have come in. May’s not over, and a further 11 cases have been reported. Because you know that for every case reported to your attention, there are may be 10 unreported cases (if you can apply in Italy CDC’s estimate for underreporting of hepatits A http://www.cdc.gov/hepatitis/statistics/2009surveillance/Commentary.htm), the cases could be many more.

So, reasonably you suspect that there is a problem and work to uncover what is making people form Trentino ill with hepatitis A.

You ask the Istituto Superiore di Sanità, Italy’s National Institute of Health, whether the problem concerns Trentino, or also other parts of Italy. A surveillance system, SEIEVA http://www.iss.it/seieva/?lang=1&id=37&tipo=4 collects this type of data. It is not know what the Institute told you, but we can assume that they may have told you that, of the 16 regions (out of 20) that have sent updated data, comparing the period September 2012-April 2013 to the corresponding period one year earlier, cases of Hepatitis A shot to 417 cases (from 167 a year earlier), an increase of 70%.

There is probably a significant ongoing epidemic of hepatitis A in Italy, potentially with hundreds of cases.

Is this an aggressive epidemiological investigation? We do not know what Trentinian and Italian authorities did till May 2013; no action is documented in the report of the European Centre for Disease Control (ECDC) and the European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en/supporting/doc/439e.pdf .

On May 8, however, Germany, through the systems dedicated to these epidemic alerts, reported seven cases of hepatitis A in Germans who had been skiing in Trentino and had probably contracted the virus there in mid-March. Following this report, the Netherlands and Poland also reported similar cases, for a total of 15: after the winter holiday in Trentino, they had returned home and became ill with hepatitis A.

According to the European document, only then Italy took notice of the situation in Trentino and of the 70% increase nationwide.

On May 23, the Ministry of Health finally alerted all regions, asking the notification of cases within 48 hours, instead of the usual and cumbersome passive system.

Is the conclusion that, in order to find out that in Northern Italy there is an outbreak of hepatitis A, Italians  need to wait for a few Germans skiing here, get hepatitis A and then seek advice from their own health care system?

The problem is related to lack of resources; also, and there are details that are not known and which may explain delays. But certainly there is also a cultural problem.

The Americans may have reported the news differently. There is a similar ongoing Hepatitis A otubreak in the U.S

(http://www.cdc.gov/hepatitis/Outbreaks/2013/A1b-03-31/index.html ) and they may be connected through a common source for ingredients in frozen berries https://barfblog.com/2013/06/30-sick-hepatitis-a-outbreak-linked-to-frozen-berries-in-us-same-source-as-eu-outbreaks/):

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and state and local officials are Investigating a multi-state outbreak of Hepatitis A illnesses potentially associated with a frozen food sorenne.strawberry.13blend. We are moving quickly to learn as much as possible and prevent additional people from becoming ill. We recognize that people will be concerned about this outbreak, and we will continue to provide updates and advice.

The full text is here http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm354698.htm. Let’s focus on the part that in bold.

The urgency is evident: we know that there is a cause (a contaminated food), we must identify it (and have done so already in fact), remove it from the market and tell consumers to throw it away if they have it in their homes, so nobody’s going to get ill anymore. We know that you are worried, but you should know that we are moving at top speed.

Too much adrenaline? It’s the American approach.

Instead let’s hear the Italian bell:

In April 2013 two international outbreaks of Hepatitis A have been reported, the first involving patients in the North-European countries (clusters allegedly linked to the consumption of frozen berries from extra-EU countries), the second of tourists returning from Egypt . In recent months, moreover, a significant increase compared to previous years of cases of hepatitis A in Italy was noted. In light of the increase of cases in our country and of the two epidemics that are involving other European countries, the Ministry of Health has prepared the Circular 23 May 2013 (http://www.trovanorme.salute.gov.it/renderNormsanPdf?anno=0&codLeg=46074&parte=1%20&serie=) to strengthen surveillance of hepatitis A virus and initiate investigations aimed at identifying both the existence of possible autochthonous cases related to the outbreak and, where appropriate, the potential sources of infection.

The Germans warned Italy in early May. On the 23th, Italy is strengthening the surveillance system. We, Italians, wonder if there are “possible” related cases in Italy (which sounds a little like saying that in Trentino they have served contaminated products exclusively to German, Polish and Dutch tourists). If there are really Italian cases related to the outbreaks, we might then ask “where appropriate”, of course, if a cause – potentially – exists. Caution prevails, perhaps resignation or, if you will, a wise detachment.

As the Ecclesiastes say, “the sun rises and the sun goes down” (or, if you will, hepatitis A comes and goes again) “Is there any thing whereof it may be said, See, this is new?”

In short, no urgency, a cause still to be found to prevent diseases, but above all prudence.

Potentially, possibly, maybe, and even if.

In reality, however, there seems to be a point of concern. Authorities know about the suspected foods (frozen berries, known to spread viruses if not fully cooked, and in 2013 this is not new) including lots and brands. Italy has sent an alert about these products to the EU, making clear (https://webgate.ec.europa.eu/rasff-window/portal/index.cfm?event=notificationDetail&NOTIF_REFERENCE=2013.0756): mix frozen berries from Italy, with raw material from Canada, Serbia, Bulgaria and Poland, via Switzerland that is, it may well be a product made in Italy by an Italian company, but it is not our good Italian food. Same goes for the other alert (to use the words of the Ministry, “extra-EU imports”).

As Americans and northern Europeans import contaminated fruit from countries, where agricultural workers have no access to proper sanitation facilities (and thus, for example, collect the fruit with unwashed hands after using the bathroom), and get sometimes sick, now it’s up to us. Stigmatizing extra-EU imports is however in line with the current anti-import attitude.

Probably, however, the ordinary citizen would like to know the brand of the suspected products, so she, while keeping the brand in mind for future purchases, an throw away the product before eating it, and potentially getting sick.

On this point, as it is customary, in a strange game of different actors (blaming an individual official is superficial), the silence is absolute (NB: update June 6th at 13:26. I was informed that the Autonomous Province of Bolzano, on its site http://www.provincia.bz.it/usp/service/321.asp?archiv_action=4&archiv_article_id=427075  – I do not know how often visited by consumers across Italy – reported on May 31 the details of the suspected food. Well done to the Province, but what about the rest of the Italians? ilfattoalimentare reports from that a cheesecake and a third product sold at Coop may be involved http://www.ilfattoalimentare.it/allerta-alimentare-frutti-di-bosco-surgelati-contaminati-da-virus-epatite-a-ritirati-dal-mercato.html).

When you hear that in America or in Germany there is an outbreak with hundreds of people sick, and so you think you have the luxury to get concerned about the theoretical risks of GMOs, do not console yourself thinking that those things do not happen to us Italians. Perhaps media and risk communicators just let you free not to worry about foodborne disease.

PS: it should be clear that I hold in great esteem many officials from the local health authorities, of the Ministry of Health, and of ISS, particulary knowing the conditions in which they have to operate. This article is not addressed to them, the problem is political and cultural.

An Italian view on food safety responsibility and law

This column initially appeared in the Italian publication, On promoteus, where food safety friend and consultant Luca Bucchini has a weekly column called Food Wars. An edited version appears below.

In early 2009, an American manufacturer of peanut butter and other peanut-based ingredients such as paste, ordered one of the most impressive  recalls in recent years.

The recall involved 3900 products, since as many as 350 different companies used ingredients by the Peanut Corporation of America (PCA).

It was not precautionary action: the contamination of peanut butter with Salmonella Typhymurium was already spreading infection and death across promoteus.luca.may.13United States. According to estimates, at least 714 people were eventually sickened, alog with nine deaths.

Investigations later showed that PCA had obtained analytical results from external laboratories that confirmed the presence of the pathogen earlier than the recall was ordered, but managers decided to ignore them and hide them from their customers. Management even went so far as to invent false analytical results, altering those with unwelcome results and inventing results of tests never made.

If all this is true, it is difficult to disagree with the intention of the U.S. Department of Justice to prosecute and potentially have those responsible jailed. Meanwhile, PCA is bankrupt, and some managers have since explained that financial concerns contributed to a delayed recall and falsified results.

Leaders of food companies are sometimes, though rarely, forced to make a choice: consumers’ lives or corporate survival.

That decision is influenced by moral fiber, courage, and legal incentives.

If a similar case occurs in the Belpaese (Italy, aka the beautiful country), two things are likely to happen. First, if cases were not very concentrated geographically, and the number of cases were a bit less dramatic, from the epidemiological side (epidemiologists collect data on cases of disease and try to interpret them, but they must have an effective surveillance system to do their job) there would be no alert. Second, if the contamination had become known somehow by the authorities, with or without illness, managers would have faced criminal charges.

In Italy’s system, with a few recent exceptions, a company’s relevant manager is criminally responsible for the contamination of food, regardless of causes. European food law imposes a duty on same manager to immediately report to the authority and to take action to recall food as soon as he or she discovers that their food, despite all efforts, is found to be contaminated.

Since for the Italian mentality, prevention is less important than doling out punishment for cases of the disease, who communicates to authorities that their company’s food is contaminated may bring upon herself or himself a criminal trial.

It is not uncommon to hear QA managers of food companies (to whom legal responsibility has been prudently delegated by higher management) quietly say when in confidence: I would not do it. I’m pretty convinced that, when there is evidence of cases of illness, all would agree to “fall on their sword” and risk criminal charges but rarely, when you have early analytical results, you know with certainty that one of your products is causing illness and sometimes death.

The result is that the incentives in Italy are still too much in favor of providing the public the satisfaction of the pillory, in the rare cases where authorities found that there has been an issue, and not in favour of protecting people’s health.

When draconian laws are urged, does this system favors investment in better detection techniques given the dilemmas posed by to managers when they learn that their own food is contaminated, or does it encourage inertia.

When I think that, in Italy, a manager of a supermarket can be treated as a criminal because the supermarket he supervises unwittingly sold a sausage laced with Salmonella (even if manufactured by another business and even if it is virtually impossible to test each received batch), I much admire those who, if they are aware of the risks, continue to assume responsibility in the food sector.

8 sickened; 5 families sue butcher for Salmonella in sausages in Italy

Five households have banded together to pursue legal action against an Italian butcher alleged to have provided Salmonella-infested sausage.

The butcher is accused of manslaughter and trade of food substances harmful and leading to unintentional injuries.

The butcher’s shop is open after the premises were cleaned and restored.

Mozzarella King arrested over ceramic in cheese

Giuseppe Mandara, whose mozzarella is sold by British supermarkets and UK-based online food suppliers, was also accused of producing batches contaminated with ceramic shards from a faulty machine.

The Telegraph reports investigators said his Mandara Group had received significant injections of cash from the Camorra mafia, the organized crime group based in Campania, the region where mozzarella is produced.

Police seized assets worth more than £78 million, including the company.

They said the 56 year-old, who once described himself as the “Armani of mozzarella”, had struck up a secret commercial relationship with the Casalesi clan of the Camorra in the 1980s after he ran into financial difficulties.

The clan is based in and around the town of Casal di Principe, at the heart of a region famous for its mozzarella, which is produced from the milk of domesticated buffalo.

Police said Mr Mandara, who was photographed chomping on a cigar as he was led away by officers, was arrested on suspicion of mafia association and endangering public health. They said two tons of the company’s mozzarella may have been contaminated with minute ceramic fragments from a broken machine.

The company was also accused of passing off ordinary provolone cheese as being of a more superior quality with false labelling. Following news of his arrest, Mr Mandara was expelled from the Consortium for the Promotion of Buffalo Mozzarella after an emergency meeting of its council, which described the allegations as “very serious.”

3 sick with salmonella in kindergarten in Italy

Three cases of salmonellosis were found in three children attending the Parish Kindergarten in the Centrol per la Famiglia of Cassinone in Seriate, Italy. They belong to the spring group, consisting of children between 2- and 3-years-old.

A boy of two-and-a-half years began showing symptoms Friday and by Sunday, had to be hospitalized.

Lab testing prompted a salmonellosis diagnosis, as in the case of two other children from the kindergarten who have been hospitalized at the Pesenti Fenaroli hospital in Alzano.

The local health department has initiated an epidemiological study. As a precaution, the kindergarten has informed families with a letter.

Is a letter really a precaution?

Thanks to our Italian food safety friend for the notification and translation.

Surveillance of acute infectious gastroenteritis (1992–2009) and foodborne disease outbreaks (1996–2009) in Italy

From this week’s Eurosurveillance, Mughini-Gras et al. describe trends in the occurrence of acute infectious gastroenteritis (1992 to 2009) and food-borne disease outbreaks (1996 to 2009) in Italy.

In 2002, the Piedmont region implemented a surveillance system for early detection and control of foodborne disease outbreaks; in 2004, the Lombardy region implemented a system for surveillance of all notifiable human infectious diseases. Both systems are Internet based.

We compared the regional figures with the national mean using official notification data provided by the National Infectious Diseases Notification System (SIMI) and the National Institute of Statistics (ISTAT), in order to provide additional information about the epidemiology of these diseases in Italy. When compared with the national mean, data from the two regional systems showed a significant increase in notification rates of non-typhoid salmonellosis and infectious diarrhea other than non-typhoid salmonellosis, but for foodborne disease outbreaks, the increase was not statistically significant.

Although the two regional systems have different objectives and structures, they showed improved sensitivity regarding notification of cases of acute infectious gastroenteritis and, to a lesser extent, food-borne disease outbreaks, and thus provide a more complete picture of the epidemiology of these diseases in Italy.

Going public Italian style: I tell you but you tell I sue

As Americans grapple with the public health implications about going public either too early or too late, the Italians have added an unique variation: a company issued a public warning, then prohibited people from speaking or writing about it.

A food safety friend based in Italy who has followed the machinations of Taco-Restaurant-A-Bell and a recent salmonella outbreak, noted that going public with a food safety recall is an exception in Italy. Companies have plans for disseminating information to the public in their recall procedures, but are reluctant to put them into practice. National authorities don’t insist on much. A recall for foreign bodies is also exceptional as officials don’t mind foreign bodies much. What is typically Italian is the threatening message at the end: we tell the public because we have to, but we will sue you if you talk about it to anyone, or you link to our page.

The press release, translated from Italian, says, “Leaf Italia informs its consumers of the possible presence of foreign bodies inside some boxes of chocolate pralines "Sperlari Granperle plain chocolate with crushed nougat" gr. 160 which belong only to production lots L11284 – L11285 – L11287 – L11294 – L11296 – L11300 as indicated on the package.

“As a precautionary measure, it is therefore recommended not to consume the product in the image and to call the toll free number 800829008 for more information.

“This information is owned by LEAF. The information is intended for exclusive use for the purposes covered by this statement and any different use must be authorized in writing by LEAF: in the absence of such authorization, any dissemination and reproduction is forbidden."