2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Activities for Listeria monocytogenes, coagulase-positive ...
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2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Activities for Listeria monocytogenes, coagulase-positive staphylococci, Escherichia coli (including STEC), Campylobacter, Salmonella and antimicrobial resistance April 2020 to March 2021 1
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Contents 2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology ..................... 1 Activities for Listeria monocytogenes, coagulase-positive staphylococci, Escherichia coli (including STEC), Campylobacter, Salmonella and antimicrobial resistance ........................... 1 Contents....................................................................................................................................... 2 Executive summary ...................................................................................................................... 4 Abbreviation list ............................................................................................................................ 5 Introduction .................................................................................................................................. 6 COVID-19 and EU Exit ............................................................................................................. 8 Core Function One: Secretariat services ..................................................................................... 9 Dissemination of information from international organisations ................................................. 9 Production of NRL quarterly newsletters ................................................................................ 12 Co-ordination of the 2020 OL User Day ................................................................................. 13 Assist in disseminating and responding to EPIS and other alerts ........................................... 13 2019 Audit: Official Laboratories’ capabilities and requirements ............................................ 14 Review content of the UK Food Examiner register ................................................................. 14 Liaise with APHA regarding mutual NRL activities (Campylobacter, Salmonella and antimicrobial resistance) ......................................................................................................... 14 Liaise with FSA regarding the new Official Control Regulation, (EU) 2017/625 ..................... 15 Liaise with Campden BRI to discuss and implement challenge testing activities ................... 15 Liaise with CEFAS for any overlapping NRL activities............................................................ 16 Provide regular updates to Food Standards Agency .............................................................. 16 NRL Web Content .................................................................................................................. 16 Core Function 2: Advice and representation within the UK and internationally .......................... 17 Provide impartial advice to FSA, OLs and other UK laboratories ........................................... 17 Representation at relevant international meetings and prepare meeting reports ................... 19 Attend training workshops at international organisations........................................................ 20 Keep abreast of methodology developments – membership of FW&E working groups and other PHE steering committees .............................................................................................. 21 Participation in the BSI AW9 microbiology committee and other working groups ................... 22 Core Function 3: Production of standard operating procedures, codes of practice and guidance documents .................................................................................................................. 23 2
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Update and expand food methods archive on NRL website ................................................... 23 Prepare specific guidance protocols for OLs and the FSA ..................................................... 24 Report of 4 years of OL performance of the EFL scheme ...................................................... 25 Core Function 4: Compliance assessment via audits and ring trials .......................................... 25 OL participation in the European Food Microbiology Legislation Proficiency Testing Scheme ............................................................................................................................................... 25 Participate as UK-NRL in EURL ring trials and other initiatives .............................................. 29 Organise Skype/classroom-based workshops for UK OLs ..................................................... 35 Core Function 5: Co-ordination within the UK of international initiatives .................................... 35 Support food aspect of the EU-wide AR monitoring (Decisions 2013/652/EU and 2020/1729) ............................................................................................................................................... 35 Participate in EURL activities relating to Whole Genome Sequencing ................................... 36 Annex – Documents produced from NRL Activities ................................................................... 37 Proposed PHE NRL Activities, April 2021 to March 2022 ......................................................... 40 3
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Executive summary Public Health England provides the service as the UK’s National Reference Laboratory (NRL) for food microbiology for the Food Standards Agency (FSA). This is to comply to the retained Regulation (EU) 2017/625 for Official Control Regulations (OCRs) for food safety, which is now UK Statutory Instrument 2019 No. 665. This annual report details the NRL’s activities between April 2020 and March 2021 related to Listeria monocytogenes, coagulase-positive staphylococci, Escherichia coli (including Shiga-toxin producing E. coli (STEC)), Campylobacter, Salmonella and antimicrobial resistance (AR). Despite the pressure of EU Exit and the COVID-19 (coronavirus disease-19) pandemic have had on the service, the NRL has participated in all relevant EURL activities and have kept the Official Laboratory (OL) network, the FSA and other stakeholders up to date with news and information. NRL quarterly newsletters and EURL information were disseminated, and monthly logs on NRL activities were made. A remote half day annual User Day was held to inform OLs and other invitees of the NRL and EURL activities and foodborne incidents. The report of the third OL audit is ongoing and planned for completion by the end of 2021. The NRL also advised and contributed comments on the new OCRs to other departments in PHE, Department for Environment, Food and Rural Affairs (DEFRA) and FSA. The UK-NRL attended 5 of the 6 European Reference Laboratories (EURL) meetings remotely and impartial advice was provided to FSA, OLs and other laboratories throughout the year. The NRL also attended various EURL online training events and found them invaluable. The NRL was active in the British Standards Institute (BSI) AW9 microbiology committee and has continued to be a member of the European Committee for Standardization (CEN) TAG18 expert working group for the revision of the ISO TS 13136 (Polymerase Chain Reaction (PCR) detection of Shiga toxin-producing Escherichia coli). There are 11 relevant methods provided by the NRL to OLs on GOV.UK, more publications are planned and other methods not on the GOV UK website are available upon request. All 14 OLs registered to the European Food Microbiology Legislation (EFL) External Quality Assessment Scheme (EQA), under NRL support for 2020 to 2021. Overall, OL results were of a high standard, however, detection of Listeria monocytogenes in powdered products are not being identified by some as a relevant test; the legislation is unclear for these product types. The NRL participated in 10 EURL proficiency tests (PTs) and there was satisfactory performance for 8 of the 10 distributions. The NRL did not organise any face-to-face training events but did support a virtual update for OL Laboratories on EU Exit and testing imported foods. Details of the proposed NRL activities for 2021 to 2022, and a timeline to achieve these complete this report. 4
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Abbreviation list AFBI Agri-Food and Biosciences Institute (Northern Ireland) APHA Animal and Plant Health Agency AR Antimicrobial resistance BSI British Standards Institute CEFAS Centre for Environment, Fisheries and Aquaculture Science CEN European Committee for Standardization COVID-19 Coronavirus Disease 2019 CPS Coagulase-positive Staphylococci DEFRA Department for Environment, Food and Rural Affairs ECDC European Centre for Disease Prevention and Control EFL European Food Microbiology Legislation (scheme) EFSA European Food Safety Authority EPIS Epidemic Intelligence Information System EQA External Quality Assurance EURL European Reference Laboratory FAO Food and Agriculture Organization of the United Nations FEPTU Food and Environmental Proficiency Testing Unit FSA Food Standards Agency FSS Food Standards Scotland FW&E Food, Water and Environment FWEMN Food, Water and Environment Microbiology Network GBRU Gastrointestinal Bacteria Reference Unit ISO International Standards Organisation JEMRA Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment MU Measurement Uncertainty MIC Minimum inhibitory concentration MLST Multi-locus sequence typing NRL National Reference Laboratory OL Official Laboratory (previously OCL, Official Control Laboratory) OCR Official Control Regulations PCR Polymerase Chain Reaction PHE Public Health England PT Proficiency Test SOP Standard Operating Procedure STEC Shiga-toxin producing E. coli WGS Whole Genome Sequencing WHO World Health Organisation 5
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Introduction The EU Regulation 2017/625 for Official Controls requires each Member State to have a National Reference Laboratory (NRL) to be responsible for different aspects for Listeria monocytogenes, coagulase-positive staphylococci, Escherichia coli (including STEC), Campylobacter, Salmonella and AMR. Public Health England (PHE) has provided this service as the UK’s NRL for food microbiology since 2011 under a contract with the UK’s Central Competent Authority, the Food Standards Agency (FSA). This and other EU regulations have now been transferred into UK Statutory Instruments as the UK left the EU on 31 December 2020. The FSA has required these activities to continue to provide food safety and security for the UK, with a public health protection consequence. Therefore, the NRL has retained these activities for FSA until March 2023, when the agreement will be reviewed. This report details the secretariat services, advice and representation within the UK/EU, production of documents, coordinating and participating in audits, ring trials and European Reference Laboratories (EURLs) initiatives and communication of results and data between April 2020 and March 2021. Table 1 list the NRL core functions and the activities are described in this annual report. Table 1. PHE NRL Core Functions, April 2020 to March 2021 Core Function Description 1 Secretariat services 1.a Disseminate information/advice from international organisations to FSA, OLs and other UK laboratories in a timely and effective manner 1.a Produce and circulate quarterly newsletters to FSA, OLs and other UK laboratories 1.a Co-ordinate the OL User Day to update UK OLs and other relevant UK laboratories to the NRL core functions 1.a Assist in the dissemination and advice of EPIS and other alerts from the appropriate authority 1.b Analyse and publish the audit results regarding the OL’s capabilities and requirements 1.b Review content of the UK Food Examiner Register 1.b Continue liaison meetings with APHA for AR, Campylobacter and Salmonella 1.c Liaise with FSA in matters arising from implementing the new Official Control Regulation, (EU) 2017/625 1.c Liaise with Campden BRI to discuss and implement challenge testing activities 6
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology 1.c Liaise with CEFAS for any overlapping NRL activities 1.d Provide regular updates to the FSA on NRL activities by producing monthly reports and meet on a quarterly basis 1.d Produce and submit annual report to the FSA on NRL activities for 2020 to 2021 1.e Maintain and update the NRL web content on the PHE website 2 Advice and representation within the UK and internationally 2.a Provide impartial expert advice to FSA, OLs and other UK laboratories, upon request 2.b Represent the UK at relevant international meetings and working groups; consult FSA prior to meetings and submit an internal report after attendance of meetings 2.c Attend training workshop at international organisations, where relevant and after successful applications 2.e Keep abreast of methodology developments and advise FSA and OLs (eg, Service Level Agreement for CPS toxin testing) 2.g Participate in the BSI AW9 microbiology committee 2.g Participate in Working Group to revise the ISO/TS 13136:2012 (PCR detection of STEC) 3 Production of standard operating procedures, codes of practice and guidance documents 3.a Update and expand food methods archive on NRL website 3.a Prepare a guidance document for OLs and the FSA on the use and validation of alternative methods for testing Official Controls 3.a Produce a poor performance protocol for OL participation in the EFL proficiency test scheme 3.a Draft a manuscript for peer-review summarising 4 years of OL performance of the EFL PT scheme 4 Compliance assessment via audits and ring trials 4.a Ensure consistency and quality of testing approached applied by UK OLs and support where necessary 4.b Liaise with FEPTU and monitor OL’s comparative testing performance and assist OLs in the implementation of corrective measures 4.b Evaluate OL’s performance using trend analysis 4.c Coordinate the participation of OLs in international method validation studies and other initiatives and report to FSA 4.d Participate as UK-NRL in proficiency tests and method validation studies organised by the EURL (where available) and report to FSA 7
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology 4.e Organise Skype/classroom-based workshops for UK OLs, dependent on the outcome of the audit (1.b) and OL needs 5 Co-ordination within the UK of international initiatives 5.a Support the food aspect of the EU-wide AR monitoring (Decision 2013/652/EU), liaising with FSA, OLs relevant Reference Laboratories and APHA. 5.a Liaise with APHA, audit and review strategy for harmonization of existing antimicrobial resistance testing 5.a Provide information regarding Whole Genome Sequencing when requested from the EURLs, and participate in any related workshops, proficiency testing, training and guidance documentation, where necessary 6 Communication of results and data use COVID-19 and EU Exit During this annual report’s time period, COVID-19 emerged, spread and caused a pandemic which has forced several lockdowns and different ways of working on a global scale. The NRL activities were directly affected, as all 6 EURLs, situated in different EU countries, had to cancel or postpone their planned activities. The NRL also offered mutual support to UK OLs in terms of advice, procuring consumables or testing diverted samples for public health needs. In addition, the transition period to leave the EU was during this time period. The NRL has liaised with FSA, DEFRA, and PHE EU Exit departments to ensure transparency and planning, as communication and collaboration with the EURLs was at risk. Before the UK was due to leave the EU, the NRL received a letter from the EU Commission, allowing the EURLs to accept the UK (except Northern Ireland) as a third country to participate in their activities. Between December 2020 and February 2021, the NRL have confirmed that all 6 EURLs accept the UK NRL for Food Microbiology as a third country. Therefore, throughout this time the NRL has continued to communicate with the EURLs. Despite these challenges, the NRL has managed to successfully participate in all of the relevant activities that the EURLs have offered, including attending meetings and training and participating in proficiency testing, most of which were arranged between September and December 2020. 8
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Core Function One: Secretariat services Dissemination of information from international organisations The 6 EURLs send information concerning new reports, outbreaks and other related topics to the NRL. Information is also sourced from other international organisations, such as the EU Commission, World Health Organization (WHO), CODEX, European Food Safety Authority (EFSA) and European Centre for Disease Prevention and Control (ECDC). These are then cascaded to the appropriate personnel and stakeholder(s) (For example, OLs, FSA, Food Standards Scotland (FSS), PHE FW&E, Epidemiology and Reference Units, Scottish Reference Laboratories, Animal and Plant Health Agency (APHA), Agri-Food and Biosciences Institute (AFBI) and Centre for Environment, Fisheries and Aquaculture Science (CEFAS)), with any additional information or advice on further steps to be taken. The NRL also receives questionnaires and surveys from the EURLs regarding NRL and/or country-wide practices. These communications are described below by work activity with links to the EURLs’ websites in the Annex; information concerning meetings, training, proficiency tests (PTs) and ISO standards are incorporated into the relevant sections of this report. Where available, the EURLs’ work programmes can be found in the Annex. General information disseminated In April 2020, there was an EFSA call for an AMR tender for epidemiological expertise to support topics related to Regulation 429/2016 or Animal Health Law, which the UK NRL did not submit to. The FSA sent some ‘OCR laboratory guidance’ for Regulation (EU) 2017/625 in July 2020, which was circulated to OLs. Information from DEFRA included a letter and guidance on testing and certification on high risk foods of non-animal origin and a monthly Codex update newsletter, which the NRL have registered for and have received 2 newsletters. The NRL also received an invitation to a Spanish workshop; however, the meeting was local for Spain and not directly applicable for the UK NRL to attend. Listeria monocytogenes From April 2020 to March 2021, the Listeria EURL sent 4 external reports, including the EFSA opinion on ‘Public risk by Listeria monocytogenes in frozen fruit and vegetables including herbs, blanched during processing’ and a Joint ECDC-EFSA; report on European monitoring of L. monocytogenes isolates from food and clinical cases (ELiTE). In addition, 2 EURL-led reports 9
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology were received regarding a frontline typing method to PCR-screen multi-locus sequence typing (MLST) types (GenoListeria), and a review of consumer temperatures used in Europe to further inform challenge testing guidance. The Listeria EURL circulated clarification on the estimation of measurement uncertainty for L. monocytogenes detection and enumeration, in April 2020, stating the unsuitability of ISO 19036 for intermediate values and qualitative methods. In May 2020, the Listeria EURL informed the NRL network that their activities were affected by the COVID-19 pandemic, and that some would be delayed until the Autumn. The EURL also had a change in management announced in September 2020. The Listeria EURL shared information regarding a rhamnose negative Listeria monocytogenes strain, which was circulated to relevant colleagues. Coagulase-positive staphylococci The coagulase-positive staphylococci (CPS) EURL notified the NRLs in May and July 2020 regarding problems with a batch of Ridascreen SET Total kit for detecting staphylococcal enterotoxins. The NRL does not use this kit, but information was sent to OLs. Three EURL-led documents were circulated; 2 for whole genome sequencing (WGS) processes and one to prepare material for proficiency testing for staphylococcal enterotoxins. There was an invitation to submit articles to Toxins journal, which was sent to PHE bacterial toxin experts. Organisational changes were also communicated from the CPS EURL; activities affected by the COVID-19 pandemic, suspension of services for enumeration and typing for 2 weeks in January 2021 due to laboratory renovations and a new EURL CPS manager (Jacques-Antoine Hennekinne) following the departure of Bertrand Lombard in 2020. Escherichia coli (including STEC) The NRL received 4 outbreak alerts from the EURL; 2 from USA, and 2 from Canada. This was lower than previous years, possibly due to the pandemic. The EURL requested all NRLs to check the contact details on the EURL website and also cascaded their planned activities for 2021. In addition, in November 2020, the EURL informed the network that their website was inaccessible due to platform migration work. At the time of writing, the website has recently been launched (see Annex for weblink). In March 2021, the EURL circulated a validation data report pertaining to the ISO TS 13136, detection of STEC. This was forwarded to all OLs and other relevant laboratories. 10
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Campylobacter In June 2020, the EURL sent an email regarding the process hygiene criterion 2.1.9 and reporting the measurement uncertainty (MU); they recommended that the MU should be calculated so if requested by the competent authority it is available. This information was sent to OLs. The EURL concluded that further work is required to define MU in relevant matrices, which will be shared with NRLs. EURL Campylobacter informed the NRL network of an EFSA-ECDC tender to produce the EU One Health Zoonoses Report; however, the UK was unable to apply for this tender due to leaving the EU. The EURL also circulated news of future events to all the NRLs, including the 2021 workshop in September 2021, 2 PTs and 2 ILTs and a WGS training course. Salmonella Four quarterly EURL newsletters were received by email, informing NRLs of EURL activities, such as proficiency tests, workshop preparation and literature searches of relevant Salmonella scientific papers. These were forwarded to the FSA, the OCLs and other relevant laboratories in the UK. The EURL newsletters can be found in the Annex. There was EURL correspondences concerning 2 Epidemic Intelligence Information System (EPIS) Salmonella clusters in May 2020 and September 2020. The NRL log these and contacts the relevant staff in PHE to respond back to the EURL with the requested information. Antimicrobial resistance In April 2020, the EURL-AR forwarded a message from the EU Commission to laboratories regarding maintaining accreditation for diagnostic testing during the COVID-19 crisis; this was sent to FSA for information. The EURL also informed NRLs in September that new rules for monitoring AMR in food will be adopted into EU legislation (published in November as Decision (EU) 2020/1729). Linked to this Decision, a working group meeting report and presentation was sent from the EURL in March 2021 to present the monitoring framework of the new Decision as well as the EURL WGS protocol. The EURL announced in May 2020 of WGS information on their website and in June a list of upcoming activities. The EURL sent their annual newsletter to all NRLs in December 2020 (see Annex), featuring the new AMR Decision (2020/1729/EU) and the new minimum inhibitory concentration (MIC) panels to support this, using ResFinder 4.0 for genotyping and in silico antibiograms and other research and development and projects in the EU. The EURL forwarded external communications regarding antimicrobial resistance over the reporting period to the NRLs, including country AR reports and action plans from Sweden, 11
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Denmark, Canada and the US, meeting invitations and reports for the World Antibiotic Awareness Week, the WHO GLASS Technical document launch, implications of the Nagoya Protocol and an extended-spectrum Beta-Lactamases E.coli Tricycle protocol webinar. An EMA concept paper to reduce resistance for Article 40(5) of Regulation (EU) 2019/6 and an FDA public consultation to discuss ‘Potential Approach for Ranking of Antimicrobial Drugs according to their importance in human medicine; a risk management tool for AR drugs’ was received. The EURL also circulated an external newsletter from Food and Agriculture Organisation of the United Nations, which is funded by the EU Health Programme. These were all assessed and circulated to appropriate colleagues in the UK. Parallel correspondence from various EURLs EURLs are involved in joint horizontal activities and regulations; consequently, the UK NRL receives the same information from different EURLs. Between April 2020 and March 2021, the following were received and cascaded to relevant stakeholders. An in-house ‘Standard Operating Procedure (SOP) on library preparation for sequencing’ from the CPS and Listeria EURLs CEN/ISO 2020 plenary reports from EURL Listeria and CPS, including a tailored report affecting CPS From the CPS and Listeria EURL, a letter of Bertrand Lombard’s retirement as EURL coordinator. Related to Core Function(s): 1.a, 1.c, 2.d, 2.e, 2.f, 4.c, 5.a Production of NRL quarterly newsletters Since 2016, the NRL have produced quarterly newsletters to disseminate information to OLs and other stakeholders of NRL activities and aspects of food microbiology that could affect them. A brief description of the newsletters’ content is listed below and are available in the Annex. June 2020 included EURL and FEPTU activities under lockdown, the 2019 OL Audit, and a brief document update. September 2020 described 3 of the EURL’s workshops, which were held virtually, the OL performance in the 2019 to 2020 EFL PT scheme and upcoming relevant events. December 2020 detailed how EU Exit has affected how the NRL will interact with the EURLs, of the OCRs being transferred into UK Statutory Instruments, the OL User Day in October and a method update. March 2021 reported supporting an EU Exit and testing imported foods session together with the PHE Food, Water and Environment Microbiology Network 12
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology (FWEMN), the EU One Health 2019 Zoonoses report, and the updated Food Law Code of Practice being published. Related to Core Function(s): 1.a, 2.d, 2.e, 2.f Co-ordination of the 2020 OL User Day The NRL held the eighth annual User Day on 20 October 2020. This was arranged via Microsoft Teams, due to COVID-19 restrictions and organised as a shorter half day meeting. The agenda focused on activities from the EURLs, the 2018 EU One Health Zoonotic report and a review of foodborne incidents in 2019 to 2020 (see Annex for agenda). It was well received, with over 30 delegates attending from 13 OLs, PHE’s Gastrointestinal Bacteria Reference Unit (GBRU) and the Food and Environmental Proficiency Testing Unit (FEPTU), FSA, APHA and Campden BRI. Feedback was good from those attended and we had some useful suggestions, including having a second virtual meeting in the Spring and to cut the number of presentations to allow for further discussion. Some delegates replied that it was useful to attend virtual meetings which allowed other colleagues to attend from their laboratory whilst not needing to travel. In contrast, others missed the face-to-face interaction including the opportunity to network. Slide presentations are available on request. Related to Core Function(s): 1.a, 1.b, 1.c, 2.a, 2.d, 2.e, 2.f Assist in disseminating and responding to EPIS and other alerts The NRL have been receiving EPIS and other alerts from the EURLs since April 2018. However, only 2 from the Salmonella EURL were received for this reporting period, and this may be due to both the UK leaving the EU and the COVID-19 pandemic. The EPIS and other alerts are logged by the NRL and relevant staff in PHE are contacted, as the EURL are requesting information on any related isolates from non-human origin. The specialist PHE staff then looks in the UK database to identify any closely related strains relating to the cluster concerned. The NRL then responds to the EURL of any information from PHE colleagues concerning the enquiry. Related to Core Function(s): 1.a, 2.a 13
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology 2019 Audit: Official Laboratories’ capabilities and requirements The UK NRL has undertaken 3 audits since 2013 to ascertain the Official Laboratories’ capabilities and range of microbiological testing for food. These audits have helped identify training and educational gaps, which the NRL organised and delivered to the OLs. The most recent audit in October 2019 was performed to update existing information and to ascertain if OLs need support concerning recent updates in ISO Standards and the new EU Official Control Regulations (EU 2017/625). At the time of writing, the data is being analysed and compared to the previous audits: a report will be published by the end of the year. Related to Core Function(s): 1.b, 2.d, 2.e, 4.a Review content of the UK Food Examiner register Since 2014, the NRL has established and maintained a Food Examiner register to assist FSA to rapidly contact appropriate local support from the OLs. The register was updated using data from the audit and sent in July 2020 to FSA. Related to Core Function(s): 1.b, 4.a Liaise with APHA regarding mutual NRL activities (Campylobacter, Salmonella and antimicrobial resistance) There are shared UK responsibilities for Salmonella, Campylobacter and antimicrobial resistance (AR), and which participation in EURL activities are mutual between PHE and APHA. EU Exit has impacted on these mutual activities and therefore liaison meetings between the NRLs from PHE, APHA and AFBI for Northern Ireland increased from 6-monthly to 3 in the reporting year; July 2020, November 2020 and February 2021. Due to the COVID pandemic, EURL workshops were remote and the UK were allowed to join these at no cost from both PHE and APHA. Contingency planning and participation of all EURL activities such as the annual workshops, training events and participation in ring trials, were discussed and agreed at these liaison meetings. These meetings have strengthened relations and allows transparency between the 2 NRLs, to ensure there is co-ordination of activities. Related to Core Function(s): 1.b, 4.c, 5.a 14
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Liaise with FSA regarding the new Official Control Regulation, (EU) 2017/625 The relevant OCR Articles pertaining to OLs came into force on 14 December 2019, and after some consultation with stakeholders (including the UK NRL), Defra and FSA issued a guidance to OLs to clarify obligations to comply to the new OCRs. Related to this, a workshop was arranged by FSA in September 2020, to provide an update on the government’s plans for EU- GB imports post transition period and how this could affect sampling levels for imports in the future. All the UK NRLs and OLs were invited and the UK NRL contributed to discussions. As a follow-up to this meeting, FWEMN arranged a meeting in March 2021 and invited FSA to present an update regarding EU-GB imports to the UK NRL OLs. FSA has also sent relevant documents for the UK NRL to comment on before issuing and finalising. The ‘Questionnaire for designation of Official food/feed laboratories’ was received in October 2020 and relates to Article 37 in the OCRs which require laboratories to be designated as OLs in writing from the Competent Authority (FSA). The UK NRL sent comments and clarifications back to FSA. The ‘Draft memorandum of understanding between UKAS and FSA and FSS’ was also sent to the UK NRL in October 2020, to clarify the responsibilities for each body in relation to the OCRs, and the UK NRL submitted comments to FSA. The UK NRL will continue to support and advise FSA regarding the new OCRs, as these have been transferred into UK Statutory Instrument 2019 No. 665. Related to Core Function(s): 1.c, 2.a Liaise with Campden BRI to discuss and implement challenge testing activities The UK NRL arranges yearly meetings with Campden BRI, as they are experts in a wide variety of challenge testing approaches. They attend working group meetings and participate in challenge testing proficiency tests organised by the Listeria EURL and are on working groups for relevant ISO Standards. A meeting was held remotely in May 2020 and the ISO Standard 20976 series on challenge tests in food were discussed, along with EURL shelf life documents, participation in PTs and other relevant guidance. Related to Core Function(s): 1.c, 2.a 15
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Liaise with CEFAS for any overlapping NRL activities Since January 2019, as a result of restructuring the EURL for monitoring bacteriological and viral contamination of bivalve molluscs (previously held by CEFAS), CEFAS became the UK NRL for foodborne viruses and bacteriological contaminants of shellfish. Therefore, CEFAS joined the mutual NRL networks for E.coli and Salmonella and the UK NRL forwarded any correspondence from the 2 EURLs relating to PT participation and meeting attendance. Related to Core Function(s): 1.c, 2.a Provide regular updates to Food Standards Agency Due to the pandemic and social restrictions, NRL representatives met with FSA quarterly via MicrosoftTeams (17 June 2020, 16 September 2020, 14 December 2020, 23 March 2021) to discuss progress made, difficulties met, and future or new activities (see Annex for minutes). In addition, monthly reports listing NRL activities have been submitted electronically to the FSA (see Annex). Related to Core Function: 1.d NRL Web Content Information about the NRL has been held on the Public Health England section of the GOV.UK website since 2013. There is access to NRL annual reports, 10 standard methods, a public health management guidance, and reports of the 2016 and 2013 OL audits. There is also general information about the NRL, expert witness information, and contact details on the web page. The standard methods are periodically reviewed and updated, and the NRL will continue to increase the collection, where relevant. For ease of access, OLs and other stakeholders are advised to use a search engine and type ‘fwe nrl’, as the NRL web page is normally the top hit. Related to Core Function(s): 1.a, 1.b, 1.e, 3.a 16
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Core Function 2: Advice and representation within the UK and internationally Provide impartial advice to FSA, OLs and other UK laboratories Requests are received for expert advice to the NRL from small business organisations to European institutes, and these have increased as the UK NRL has become established. Those between April 2020 and March 2021 are briefly reported and categorised below. General 1. Eight separate requests to microbiologically test food or water, which was forwarded to the relevant laboratories. 2. A private biotech company requesting a collection of microorganisms, where they were advised to contact the National Collection of Type Cultures (NCTC). 3. One request for Summer placement at NRL from a biological sciences student; they were referred to the PHE FW&E Microbiology Services. 4. Eight laboratory enquiries concerning methodology; 4 concerning media availability or methods for Salmonella detection, specific testing of STEC detection for irrigation waters, an overseas request for PHE PCR methods and outbreak investigations, enquiry of which DNA extraction method is used for L. monocytogenes and another NRL asking other EU laboratories how they share their WGS data openly; all of these were dealt by NRL experts. 5. Following NRL disseminating material on Measurement Uncertainty (MU), 2 queries were received; one regarding the calculations for MU and the other on the use of MU. 6. Two queries concerning disinfectants against COVID-19. 7. An overseas query as to whether the UK NRL are serving them as their NRL for CPS, which the UK NRL does not. 8. Five FSA requests or consultations for Official Control or Food Law related documentation, including the OL designation questions, a draft memorandum of understanding between FSA, FSS and UKAS, and a review of the Food Law Code of Practice, Food Law Practice Guidance and implementation of the Competency Framework. 9. Five other miscellaneous queries from FSA; 2 concerning testing methods, 2 regarding EURL or NRL activities and a WHO call for Technical Expert Group on Food Safety. 10. Four OL queries including 2 relating to Official Control work and a request for FW&E National and local survey reports. 17
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology 11. General public enquiry regarding yeast allergy and vitamin B; NRL advised enquirer to their local authority trading standards office. 12. One pricing enquiry from an NHS Trust for Listeria testing. 13. Codex call for experts on water safety used in production of fishery and dairy products, which was passed to PHE and NRL experts. Listeria 1. In June 2020, the Listeria EURL informed the NRL network that a working group would be set up for a RT-PCR scheme to screen MLST Clonal Complexes; the UK declined the invitation as WGS is used as the primary typing tool at PHE. 2. All NRLs were requested to update their contact details for the EURL website, which the UK NRL completed. 3. Two guidance documents were circulated from the Listeria EURL and received for comments; the ‘Technical Guidance on challenge test and durability studies’ and ‘technical guidance on sampling food premises for Listeria detection’; the NRL commented on both. Coagulase-positive staphylococci 1. All NRLs were requested to update their contact details for the EURL website, which the UK NRL completed. 2. In November 2020, a draft SOP was circulated to the NRL network on artificial contamination of CPS enterotoxin in food matrices for PT from the EURL; as the UK NRL does not routinely test for staphylococcal enterotoxins in food, this was archived. 3. The EURL requested NRLs to submit strains for their CPS reference strain collection, via a mutual agreement, to develop typing procedures; the UK did not send any relevant isolates. Campylobacter In August 2020, the EURL Campylobacter requested information on foods that have been analysed for Campylobacter in Member States, which the NRL completed. Ahead of the EURL meeting, 2 surveys were received from the EURL regarding transportation and WGS practices and the NRL collated information from experts and submitted responses. In September 2020, the EURL Campylobacter requested information regarding Preston broth use; as the NRL at PHE does not use Preston broth, the NRL did not comment. 18
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Salmonella In March 2020, the EURL launched an EU monitoring of S. Mikawasima isolates in food, animals, animal feed and the environment for 2020, to investigate the source of human cases; the NRL periodically checked the UK database and found no isolates from food or the environment. The Salmonella EURL briefed the NRL network that there would be an ISO vote of whether ISO 6579-4 (identification of monophasic S. Typhimurium using PCR) should become a New Work Item Proposal; the NRL did not comment as the draft was at a very early stage. The EURL notified the network there was a Salmonella Typhimurium/S. Anatum investigation into contaminated nuts; however, the UK was already involved and had sent further WGS data. STEC/E.coli In March 2021, the EURL E.coli requested update contact information to publish on their new website, which the UK NRL completed. Antimicrobial resistance 1. Two emails originating from the One Health Harmony CAP project was forwarded via the AR EURL; in May 2020 requesting AR methods and in September a survey collecting sampling and testing information for Salmonella and Campylobacter; the NRL collated and submitted information. 2. The NRL received a public consultation of an EFSA (BIOHAZ) scientific opinion on the ‘maximum levels of cross-contamination for 24 microbial active substances in non-target feed’. 3. In February 2021, the AR EURL request all NRLs to check and update their contact information, which the UK NRL completed. Related to Core Function(s): 2.a, 2.d Representation at relevant international meetings and prepare meeting reports To be inclusive of all network meetings for 2020 to 2021, the reporting period has been extended back to January 2020 to incorporate all 6 EURL meetings. Due to the COVID-19 pandemic and that the UK had entered that transitionary period of EU Exit, there have been restrictions concerning attendance to EU meetings. Consequently, the UK NRL was unable to 19
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology attend the Listeria EURL meeting but were able to attend the remaining 5 EURL meetings; coagulase-positive staphylococci (CPS), Escherichia coli (incl. STEC), Campylobacter, Salmonella and antimicrobial resistance (see Table 2). Where available, agendas for the meetings were forwarded to the FSA as they were received (see Annex); a presentation from the UK was made at the Campylobacter meeting. Notes were consolidated from attendance and individual meeting reports were submitted to FSA (see Annex). Table 2. List of international meetings, January 2020 to March 2021 EURL Meeting Date: From Date: To Location Attendees Listeria 30 January monocytogenes 29 January 2020 2020 Paris, France Unable to attend Coagulase- Shona Neal positive 24 April Amisha Vibhakar staphylococci 22 April 2020 2020 Virtual Kevin Longmaid Shona Neal Antimicrobial 29 April Amisha Vibhakar resistance 29 April 2020 2020 Virtual Frieda Jorgensen 18 Amisha Vibhakar September Shona Neal Salmonella 17 September 2020 2020 Virtual Marie Chattaway 22 Shona Neal September Amisha Vibhakar E. coli 21 September 2020 2020 Virtual Heather Aird 30 Amisha Vibhakar September Shona Neal Campylobacter 29 September 2020 2020 Virtual Frieda Jorgensen Related to Core Function(s): 1.a, 2.b Attend training workshops at international organisations Due to the COVID-19 pandemic, most of the EURL training was cancelled or postponed, as these are held best in a face-to-face environment and require practical hands-on experience in a laboratory setting. Despite this, the UK NRL were able to register and attend for the ‘implementation of colony-count technique according to Standard ISO 7218’, organised by the Listeria and CPS EURLs, held in September 2020. The training was given online over a day duration and the attending individual found it useful and would recommend it to other 20
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology colleagues. Learning material and links to web sources for further information on this training was circulated to FW&E colleagues. Other training was delivered by the AR EURL, including a 5-day virtual course in October 2020, covering phenotype interpretation and genotype and WGS analysis. As the training was online, several colleagues from the UK NRL/PHE were able to register and attend. The EURL AR used Microsoft Teams as the platform and were able to share documents and recordings of the sessions so that training could be done by participants at their next available free time. The feedback was very good as they learnt about epidemiological cut-off values and MIC reading; microbroth testing will be implemented in PHE. Participants are encouraging others to use the material available for training and knowledge purposes (see Annex). The AR EURL also arranged 3 webinars to present topics related to the new Commission Implementing Decision (EU) 2020/1729 for the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria, which applied from 12 January 2021. The webinars, held in November and December 2020, were; ‘New Sensititre plate production for the EU monitoring of AMR in food’, ‘Compliance to the new AMR Decision’ and ‘Protocol for WGS and bioinformatic analysis of bacterial isolates related to the EU monitoring of AMR’. The UK NRL circulated connection details for all 3 webinars and were attended by at least one person representing the UK NRL. However, it is unclear at the time this report was written, if UK will report AR data to the EU now the UK has left the EU. Related to Core Function(s): 2.c, 2.e Keep abreast of methodology developments – membership of FW&E working groups and other PHE steering committees Due to the low referrals of food to request detection of Staphylococcal enterotoxin, the UK NRL outsources this method to an NRL in the Netherlands. Requests for this test on official control samples has not been received from an OL for over 3 years. This arrangement is known to the FSA. Since 2016, the NRL has increased its involvement within the FW&E methods and training working groups to advise, support and facilitate relevant implementation from international method changes and training events. The NRL participation to meetings, proficiency trials and external working groups equips the NRL team with information to keep abreast with methodology, access to training and key changes in the areas of responsibility. These aspects are used to maintain the UK capability in these areas. 21
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology The NRL has been tasked by the FW&E Methods working group to review EU legislation that has been adopted into UK law and the impact these have on FW&E methodology and guidance documents. The NRL has also advised on improvements to the design of the European Food Legislation proficiency scheme based on a continual assessment of OL performance data and has acted as scheme consultant and attended a FEPTU steering group meeting this year. Related to Core Function(s): 2.e, 2.f Participation in the BSI AW9 microbiology committee and other working groups Due to COVID-19 restrictions, the BSI AW9 committee met virtually twice, in May and August 2020. At least one representative from PHE/UK NRL for food microbiology attended the meetings where the status of the related ISO Standards were reviewed. The UK NRL representative was asked to select and invite representatives from: APHA and a statistician from PHE to join the committee, which they did and had a positive outcome for the APHA representative. The NRL representative receives draft and final draft ISOs (DIS and FDIS) from the BSI AW9 portal throughout the year. Consequently, the NRL submitted comments for the following DIS or FDIS Standards: • parts 3, 4 and 5 of the ISO 16140 series (Method validation) • ISO 20836 (Performance of thermal cyclers) • ISO 6888 parts 1 and 2 (Enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species)) • ISO 23418 (Whole Genome Sequencing for typing and genomic characterization of foodborne bacteria) There was also a call for comparison data for ACC pour vs spread/spiral counts in June 2020. The NRL received data from one OCL and this was forwarded to the working group. A representative of the UK NRL is a member of the CEN TAG18 expert working group for the revision of the ISO TS 13136 standard (PCR detection of shiga toxin-producing Escherichia coli) which met remotely in November 2020. Revision of the 2 parts of the ISO standard were discussed, which included: • changes in the enrichment conditions, including the medium and the temperature, from modified tryptone soya broth or BPW incubated at 37°C to BPW at 41.5°C. • detection of eae to be included in Part 1; it is important to pursue isolation of STEC for all stx positive samples, even when eae is absent 22
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology • informative texts describing dilution and/or acid treatment of enrichment before streaking/plating to enhance the growth of single colonies • to add the identification of all stx subtypes and the presence of the eae gene in Part 2 A UK NRL representative from Campden BRI, who has expertise in challenge and shelf life studies, has attended various working group meetings and commented on the EURL Listeria’s ‘Technical guidance on challenge tests and durability studies for assessing shelf-life of ready-to- eat foods related to Listeria monocytogenes’. In November 2020 a final draft of Version 4 was sent to the NRL network awaiting final approval. There was also an invitation to join 2 working groups from the Listeria EURL; one to update their guidance on ‘Sampling food procession areas and equipment for the detection of Listeria monocytogenes’ and the other to explore a ‘ Multi-Locus Sequence Typing Clonal Complex determination, Real-Time PCR scheme (Geno-Listeria)’. The UK NRL submitted a null response for both working groups; however, comments were sent from the UK NRL for the sampling guidance. Related to Core Function(s): 2.e, 2.f, 2.g Core Function 3: Production of standard operating procedures, codes of practice and guidance documents Update and expand food methods archive on NRL website There are currently 11 Standard Methods and/or guidance available on the NRL website (Table 3). These methods are based on PHE in-house methods and ISO standards, and assist OLs to comply with the requirements of the EU Microbiological Criteria Regulations. Most of the relevant ISOs been revised under Mandate M/381, and the corresponding NRL methods are undergoing review and updates. Other relevant PHE Standard Methods have been identified that complement the NRL activities; these are also under the re-formatting process and will be archived on the NRL website. In addition, PHE SOPs are available to OLs upon request. 23
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology Table 3. List of Standard Methods archived on the NRL website, March 2021 Version Document No. Title No. FNES63 Determination of pH in food and water samples 2 FNES67 Determination of water activity in food 2 FNES8 [F12] Enumeration of coagulase positive staphylococci 4 (Staphylococcus aureus and other species) FNES26 [F2] Preparation of samples and dilutions, plating and sub-culture 4 FNES3 [F8] Enumeration of β-glucuronidase positive Escherichia coli: Pour 3 plate method FNES22 [F19] Detection and enumeration of Listeria monocytogenes and 4 other Listeria species FNES28 [F22] Enumeration of β-glucuronidase positive Escherichia coli – 3 most probable number technique FNES16 [F13] Detection of Salmonella species 4 FNES15 [F21] Detection and enumeration of Campylobacter species 4 FNES4 [E1] Detection and enumeration of bacteria in swabs and other 4 environmental samples FNES18 [Q4] Guidance on Public Health response: involvement of PHE 3 Food Water and Environmental Microbiology laboratory staff in the investigation of outbreaks of food or waterborne disease Related to Core Function(s): 1.a, 1.e, 3.a, 4.a Prepare specific guidance protocols for OLs and the FSA The NRL are producing guidance for validating alternative methods in place of the reference method for the testing of food-borne organisms in food, feed and environmental samples, as requested by the FSA. The ISO/CEN revision of the relevant Standard (ISO 16140 series) has been substantially delayed and has impacted on this guidance. In addition, it is the third and fourth part of this standard which is most relevant to the FSA (Part 3: Protocol for the verification of reference and validated alternative methods implemented in a single laboratory and Part 4: Protocol for single-laboratory (in-house) method validation), and these were published in January 2021 and July 2020 respectively. Therefore, the NRL is leading on a new method for the FWEMN on the Verification and Validation of Methods based on this ISO Standard series. The subsequent guidance for FSA will be finalised in 2021 to 2022. 24
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology A poor performance protocol is required if any OLs generate repeated poor results from the EFL EQA Scheme. However, there has been no consistent poor performance from participant results (see next section). A method for Measurement Uncertainty in Testing was drafted by the NRL and approved for use by the PHE FWEMN in May 2019 (FNES66), and revised in March 2021. To complement this method, an Excel tool for calculations, based on the international standard ISO 19036/2019, was developed and revised in March 2021. In this reporting period, an impact assessment was performed on FNES66 to align this with the new Measurement Uncertainty Standard, ISO 19036:2019, which was published in October 2019. Related to Core Function: 2.a, 2.d, 3.a, 4.a Report of 4 years of OL performance of the EFL scheme There has been some progress made but it is not yet completed, due to other work priorities including COVID-19. Therefore, this activity is transferred to the 2021 to 2022 work programme. Related to Core Function: 3.a, 4.b Core Function 4: Compliance assessment via audits and ring trials OL participation in the European Food Microbiology Legislation Proficiency Testing Scheme The National Reference Laboratory is required by the UK Statutory Instrument 665 that adopts European Regulation (EC) 625/2017 to organise and assess performance of official laboratories through relevant comparative testing such as interlaboratory studies. In January 2020, the UK OLs for Food Microbiology were invited to register to the 2020 to 2021 EFL EQA Scheme, as provided by the PHE FEPTU. Based on the requirements of EU Regulation 2073/2005 (as amended) for the microbiological criteria for foodstuffs, the scheme enables the performance assessment on the identification, examination and interpretation of microbiological results of samples tested against these legislative criteria. A full scheme comprises of 12 samples from 4 distributions based on food categories within the regulation and results are submitted on a webbased form. However, due to the COVID-19 incident and the 25
2020 to 2021 Report of UK National Reference Laboratory for Food Microbiology statutory PHE response, FEPTU suspended their services from April 2020. Business was resumed in July 2020, but with a limited service and a reduced scheduling of PT schemes (see Annex). The EFL scheme was redesigned to comprise of 2 distributions, the first in August 2020 (ready-to-eat (RTE) foods) followed by another in March 2021 for miscellaneous foods. Further details on the food legislation scheme including the revised schedule from July 2020 can be found on the ‘Proficiency testing for food, water and environmental microbiology’ page. The NRL supports OL participation of this scheme which allows direct performance comparison across the network of official laboratories but also act independently from the scheme organisers and the resumption of FEPTU services allowed this to continue for 2020 to 2021. Results are anonymised, and reports do not disclose the identity of any laboratory. However, the NRL does monitor the performance of each laboratory, and invite laboratories to seek assistance from the NRL when experiencing difficulties. Despite an unprecedented year due to COVID-19, all OLs (14) were registered to receive samples for the first distribution (EFL53, RTE foods), and 13 the second distribution (EFL54, miscellaneous foods). Table 4 summarises the samples for 2020 to 2021 and the performance of laboratories that carried out the examinations. All laboratories have continued to demonstrate high proficiency for achieving the correct results to comply with EC 2073/2005 (as amended); all submitting laboratories correctly identified all testing parameters for the 3 samples in the RTE distribution and for 2 samples in the miscellaneous distribution. This was followed by a good return from laboratories for the correct batch requirements for each testing parameter, the correct microbiological results and then providing the correct conclusion based on the result and no issues were observed for the detection of Salmonella species, or the enumeration of Enterobacteriaceae and coagulase- positive staphylococci. Listeria monocytogenes was also identified correctly for most samples, and laboratories went on to score full marks for this examination. However, the need to detect L. monocytogenes in powdered products at manufacture saw few laboratories identifying this test. For sample EFL161 (powdered milk taken at manufacture), only 4 laboratories correctly identified and examined this sample for L. monocytogenes. A fifth laboratory did identify L. monocytogenes to be tested, but this was according to the incorrect food safety criteria 1.3 for the enumeration of L. monocytogenes instead of the correct criteria of 1.2 for the detection of L. monocytogenes. A similar performance was observed in a previous, almost identical sample (EFL143, dried milk powder, February 2019), where only 3 laboratories identified the correct examination for Listeria and the legislation remains unclear on the interpretation of these products types. Overall, result entry for the scheme was very good, with most returns gaining full marks for examination. The reporting of microbiological result remained good with over 97% of detection and enumeration values being reported correctly. Salmonella species and L. monocytogenes were the only pathogens included in the scheme this year for qualitative testing, and the 26
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