Recurring hepatitis A outbreaks in the EU/EEA: a national

perspective

Gaia Scavia (DVM)Istituto Superiore di SanitàDep. Veterinary Public Healyh

and Food SafetyRome, Italy

gaia.scavia@iss.it

ESCAIDE – European Scientific Conference on Applied Infectious Diseases Epidemiology 2015

Stockholm, 12 November 2015

Incidence <3 x 100000

Incidence 3-6 x 100000

Incidence 6-9 x 100000

Incidence >9 x 100000

Data not available for seieva

Friuli Venezia Giulia

Apulia

Emilia Romagna

Province ofTrento

Province ofBolzano

Outbreak of Hepatitis A in Italy, 2013-2014:

The final numbers (1) - Epidemic cases 0f Hepatitis A• 1438 cases of HAV infection

reported continuosly between 1 January 2013 and 31 August 2014, all over the country

• 369 cases (25% of the cases reported) with sequencing of HAV performed

• 247 confirmed cases (67% of all sequenced cases) with HAV outbreak strain (HAV gen IA, KF182323)

• Characteristics of cases:Median age: 33 yrs 54,8%: Males86,3%: hospitalized (median duration 7 days) 1 death

• Consumption of frozen berries reported by 52,6% of possible cases and by 78,2% of confirmed cases

Incidence <3 x 100000

Incidence 3-6 x 100000

Incidence 6-9 x 100000

Incidence >9 x 100000

Data not available for seieva

Friuli Venezia Giulia

Apulia

Emilia Romagna

Province ofTrento

Province ofBolzano

Frozen berries was the suspect vehicle

161 outbreak sequences (100% nt intragroup identity 460 base pairs at the region

of VP1/2A)genotype IA

86 sequences genotype IA highly related to the outbreak

sequence (a shorter fragment of 174 base pairs at the region of VP1/2A)

90 sequences unrelated to the "outbreak" sequence

(93-96% nt identity)genotype IA

29 sequences(89.4-93.4% nt identity)

genotype IB

Data source: National Reference Laboratory, ISS

Strong

evidence

1 frozen berry mix outbreak sequence

(100% nt identity region VP1/2A) genotype IA

Strong microbiological evidence:Genotyping and sequencing of HAV (VP1/2A region)

from 369 patients with HA (April 2013 – Jan 2014)

Probable + confirmed cases (n=119) Confirmed cases only (n=24)

Montano-Remacha C. et al. Eurosurveillance 2014;19(37):pii=20906.

Strong epidemiological evidence:Matched Case-Control Study: 119 cases and

419 control

Strong

evidence

Ministry of Health (MoH):•Dir. Public Health and Prevention•Dir. Veterinary Public Health and Food Safety

National Public Health Institute (ISS)•ECDC contact point for FWD – EFSA Focal Point•Hepatitis A dedicated surveillance SEIEVA •Monitoring of outbreak cases of HAV •Coordination of case control study•Molecular characterization of HAV (National Ref. Lab for Hepatitis) •Development of guideline for frozen berry sampling and testing for HAV•Validation of method ISO/TS 15216-1:2013 for detection of HAV in food•Tracing-back analysis on the food supply chain•Inspection to the food processing plants• Food Safety Laboratory

(IZSLER)• Testing food for HAV contamination• Molecular characterization of HAV from

berries

The National Task force for the Hepatitits A

Support to the Local Health Authorities (ASL) which are the competent authorities at the territorial level (See Reg.

EC/178/2002)

Outbreak of HA in Italy: how it all began

EPIS - 8 May: Urgent Inquiry posted by Germany in EPIS

ISS - April: national alert about HA outbreaks in North Europe and tourists from Egypt

EWRS - 9 May: Alert posted by Poland

ISS - 8 May: EPIS Alert forwarded to MoH and regions

RASFF (Italy) - 17 May: HAV detected in frozen mixed berries

ASL-TN- 10 May: Mixed frozen berries were suspected as vehicle of HAV- tracing-back; sampling

ASL 13 May : other clusters of HA cases reported

ISS - 14 May: Italy reply posted in EPIS

ISS – 13, 16 May: Joint report to the MoH

ECDC – EFSA 23 May: First Hepatitits A Rapid Outbreak Assessment, Italy

IZSLER - 22 May: Two lots of frozen mixed berries connected with cases in TN province positive for HAV

ISS - 22 May: Case-Control study drafted

MoH - 23 May: National outbreak declared:- Joint enhanced molecular-based surveillance launched. - Start of berries tracing back activities

RASFF (Italy) – 30 May: (756 - 757) HAV detected in frozen mixed berries connected with the German tourists

Num

ber o

f cas

es o

f Hep

atitis

A Strong evidence that frozen berries were the vehicle of HAV

infection was obtained in 14

days !

Outbreak of Hepatitis A in Italy, 2013-2014:

Control measures adopted during the outbreak • All the contaminated frozen berry

lots were withdrawn and recalled from the market

• Communication to consumers on the risk of consuming frozen berries raw

• Guidance to frozen berry sampling• Testing for HAV soon introduced in HACCP

control plans• Trace-back of the frozen berries suppliersThe preliminary trace-back analysis

of the HAV contaminated lots (RASFF 694-756-757) showed that

all the ingredients had been imported, indicating the potential

for a multinational dimension of the outbreak !

The Food Safety Legal Framework• Regulation (EC) 178/2002: Article 14: Unsafe food shall not be placed on the marketArticle 53: Where it is evident that food is likely to constitute a serious risk to human health, suspension of the placing on the market or use of thefood in question

Case-by-case risk assessment

Outbreak of HA in Italy: how it continued

• Regulation (EC) No 882/2004: Safeguard Measure, Article 56 Conditions for application of Art.53 of Reg. (EC)/178/2002 within the EU

How to adopt more robust control measures against the risk of HAV contamination in the

frozen berry chain?

RASFF 694

756, 757 880, 1087

1229

1134, 1350

1350 1403

Start of EFSA tracing back

EFSA tracing-back published

20142013

Sam

ples

of f

roze

n be

rry

test

ed fo

r HAV

Weekly distribution of frozen berry tested for HAV in Italy, 2013-2014 (n=1982)

Frozen berry food chain:characterization of the risk of HAV contamination

•Testing frozen berries at retail and at processing •Tracing-back of frozen berry suppliers

16 months to complete the tracing back exercise!

Frozen berry food chain: prevalence of contamination with HAV and lots connected with the outbreak

•1982 samples of frozen berries tested for HAV between April 2013 and October 2014• 62 lots from 13 packaging companies (brands) located in 5 countries were connected with the outbreak

15 lots contaminated with HAV (0,8% of total samples tested)47 suspect lots: identified only based on cases’ interviews only

•34 lots with investigation of the supplying chain traced-back

•34 lots traced-back •1691 transactions traced-back• 57 transactions on average, per lot (range: 3–103) • 406 suppliers from 19 countries• Only 1 Italian primary supplier• Explored hypotheses:

Pre-harvest primary contamination

Post Harvest: Cross contamination across the food supplying chain

Tracing back in Italy: characterization of the food supply chain

Num

ber o

f lot

s

20132012 2014 2015

Lots of frozen berry connected with the outbreak, by date of packaging (n=62)

Shelf Life of frozen berries 24 months

Frozen berry food chain: estimated period of presence of HAV contaminated lots on the the

Italian market

contamination present on the market from 2012 to 2015!!

• Frozen berries are associated with an important public health risk:• Very high risk profile: when consumed raw, frozen berries are

ready-to-eat products • When contamination occur in the preharvest phase there

are no points for risk mitigation before the consumers • Once frozen they have a prolonged shelf-life, are easily

traded with the potential of spreading infectivity worlwide • Need for improving tracing back timeliness and compliance by

MSs• Several pieces of evidence concerning the risk profiling of

frozen berries have been produced through the investigation of the HA outbreak in Italy• Update of the Risk Assessment of food of non animal origin

(including NoV and HAV in frozen berries) carried out by EFSA (EFSA Journal 2014:12 (6):3706) preliminary and necessary step for the adoption of a microbiological criterion according to general EU food safety regulations

• Close multidisciplinary collaboration, prepardness and harmonization across sectors are the key-tools for facing foodborne outbreak crisis

Conclusions

AcknowledgmentsThe Italian National Task Force for Hepatits A

Istituto Superiore di Sanità (ISS)Dep. Veterinary Public Health and Food Safety

M Escher, L Busani, D De Medici, S Di Pasquale, G Scavia, National Centre for Epidemiology, Surevillance and Health Promotion

C Rizzo, V Alfonsi, L Ricotta, MC Montaño-Remacha, E Tosti MariaDep. of Infectious Diseases

AR Ciccaglione, S Taffon, R Bruni, M EquestreMinistero della Salute (MoH)Dir. Public Health and Prevention

V Martini, MG PompaDir. Veterinary Public Health and Food Safety

S Guizzardi, B Cappelletti, R Lena, V Martini, M Massaro, A Menghi, D Monteleone, S BorrelloIstituto Zooprofilattico della Lombardia e Emilia Romagna (IZSLER)

MN Losio, E Pavoni, G VariscoE Severi, J Takkinen, L Tavoschi (ECDC-FWD)J Richardson, O Mosbach-Schulz (EFSA)J. Baele, K Kostenzer (EU Commission)L Verhoef (RIVM, Bilthoven, The Netherlands), L De Castelli (IZSPLV, Turin, Italy)G Squintani, M Friedel (Regione Emilia-Romagna, Bologna, Italy) F Lo Monte (USL3 Toscana, Pistoia, Italy)