Authorities in Hungary have not acted to strengthen the system of official controls for food businesses despite a deadly multi-country Listeria outbreak, according to DG Sante in Europe.
The agency, which is responsible for the European Commission’s policy on food safety and health, found the system is not sufficient to verify food of non-animal origin (FNAO) is produced under conditions which comply with regulation No 852/2004 to prevent contamination with pathogens.
Official controls and enforcement would not help prevent further Listeria monocytogenes contamination in frozen FNAO, or limit the risk of non-compliant products being placed on the market, according to an audit report.
Greenyard’s frozen vegetable factory in Baju, Hungary, was the source of a Listeria outbreak in 2018 that sickened 54 people in six countries, killing 10 of them. The outbreak is thought to have started in 2015. Implicated frozen products were distributed to 116 countries. Greenyard incurred a cost of €25.7 million ($28.5 million) related to the recall and destruction of frozen vegetables. In June this year, Greenyard sold the plant to Roger & Roger, a producer of potato and corn snacks.
Lack of resources
The DG Sante audit in Hungary in May this year included visits to two county offices, one national reference laboratory, two farms producing strawberries, two green leafy vegetable farms, two frozen green vegetable processors — one of which was Greenyard — and two approved sprout producing plants.
Development of a guide on GAP for fruit and vegetable production, including information to prevent microbiological contamination for primary producers, is still under development, as it was during the previous audit in 2016.
Authorities told the audit team that due to shortages in resources the official control plan cannot be fully implemented and inspection reports are not systematically uploaded in the central IT system.
The audit team was told that during 2016, 2017 and 2018, 315 of 1,050 planned inspections were carried out for leafy green vegetables and soft fruits with zero non-compliances.
Freezing and pre-cut fruits and vegetables is classed as a medium risk activity (class 2 of four). Freezing sites have not been moved to a high-risk class and no changes were made to controls after the outbreak related to frozen corn processed in Hungary.
The audit team was told that during 2016, 2017 and 2018, 148 inspections were carried out in freezing and pre-cut establishments of FNAO with one non-compliance in 2016 and two in 2018. In 2018, after the Listeria outbreak, the number of official samples for frozen vegetables was 458 and 48 were positive for Listeria monocytogenes
Sampling of frozen vegetables and fruits only started significantly after the outbreak and showed a large percentage of contaminated samples, according to the audit team.
In 2018 and 2019, 1,064 samples of FNAO were analyzed with 65 non-compliances for Listeria monocytogenes and one for norovirus in quick-frozen raspberries.
In 2016 and 2017, 27 official inspections at freezing factories found one non-compliance relating to hygiene and HACCP. In 2018, after the Listeria outbreak, 56 official inspections detected two non-compliances related to water quality and hygiene.
Nine of these 56 visits were by a special taskforce without informing those responsible for the establishment. Inspections highlighted that hygiene, maintenance and technology conditions were not good enough to avoid cross-contamination; labeling was not clear enough and companies believe consumers are aware of correct use of these frozen products and no environmental sampling was performed by food firms.
Issues at Greenyard
In February 2018, Greenyard received information from its Polish partner company about Listeria in its produce but authorities were not informed. In the same month, the agency in charge of official control inspected the firm due to a RASFF notification.
Official sampling was performed and the National Reference Lab found the sample was Listeria positive at 1,400 colony forming units per gram. It was noticed the in house-lab of the company which did tests for Listeria and Salmonella spp. was not registered but no measures were taken to stop its activities.
A March inspection identified structure and maintenance non compliances; specific microbiological hazards such as Listeria not addressed in the HACCP plan’s risk analysis; methods used by the company´s lab not in line with regulations due to the number of sample units taken, cross contamination risks and absence of a high care zone. Authorities stopped production and ordered a recall of all batches of corn produced after Aug. 13, 2016.
Results of environmental samples taken on production lines revealed a contaminated chopper plate after the blanching step as the possible source. As Listeria monocytogenes serotype IVb was found in a surface sample after cleaning and disinfection on production lines, the recall was expanded to all production between Aug. 13, 2016 and June 20, 2018 and remaining production lines were stopped.
After reviewing the new hygienic plant design and upgraded sampling plan, authorities allowed production to restart in mid-August 2018 but Listeria was identified in the packaging area. This was not able to be explained. However, in inspections in January and May 2019, no non-compliances were detected.
Frozen sweet corn samples from the second freezing plant were taken in 2018 at retail level and four of five were positive for Listeria monocytogenes. Surface sampling using a quick test for presence of Listeria spp. during production and after cleaning has found seven positives in 2019 from drains and brooms but not product contact surfaces.
Identified non-compliances not resolved
DG Sante found there is an official control system covering primary production which includes risk based inspections at farm level. However, corrective actions are only required in case of non-compliant lab results so identified non-compliances which may impact microbiological safety of products, are not corrected and continue to be a potential risk.
At primary production, the inspection and reporting system does not ensure identified shortcomings are systematically followed-up.
“The documentation regarding primary producers and processors official controls showed that non-compliances were rarely detected and, when detected, rarely followed up. This indicates that the official control system is not sufficiently able to identify and rectify shortcomings.”
Due to a lack of data on parameters such as production volume, outcome of non-planned inspections and history of compliance, the IT system used to categorize sites according to risk cannot prioritize FNAO processing establishments with higher microbiological risks for official controls. Hungarian officials said data on capacities of processing plants will be recorded in an IT system and included in the risk assessment algorithm by the end of 2020.
Risk based planning showed major deficiencies concerning the prioritization of official controls of FNAO and their organization, including lack of supervision. The system does not allow inspectors to gain and maintain sufficient experience to perform effective controls.
This impacts on the implementation and effectiveness of official controls. Non-compliances are rarely detected and enforcement of relevant requirements is seriously affected. Hungarian officials said staff will be given additional training on the system and an increase in people to do official controls would be looked at.
The audit team evaluated one RASFF notification from a Hungarian company. It was handled correctly but the recall procedure was launched six days after receiving the RASFF. Absence of deadlines for launching actions could lead to unsafe products being on the market longer than necessary and increasing risk, according to the report.
Hungarian officials said RASFF notifications will be forwarded to the regional authority within 24 hours of receipt as of January 2019 or investigated by the National Food Chain Safety Office Food and Feed Safety Directorate.
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