Scientific Panel on Biological Hazards

Transcription

1 BIOLOGICAL HAZARDS AND CONTAMINANTS UNIT Scientific Panel on Biological Hazards Minutes of the 108 th Plenary meeting Held on October, 2016, Parma (Italy) Participants (Agreed on 31 October 2016) Panel Members: Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo S. Fernandez-Escamez, Rosina Girones, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, and Helene Wahlström. Hearing Experts: None European Commission and/or Member States representatives: Marina Marini and Matjaz Klemencic (for item 6.1) from DG SANTE. EFSA: BIOCONTAM Unit: Ernesto Liebana, Valentina Rizzi, Winy Messens, Sandra Correia, Maria Teresa da Silva Felício, Beatriz Guerra, Michaela Hempen, Angel Ortiz Pelaez, Pietro Stella, Yves Van Der Stede, Katleen Baert, Marta Hugas (Scientific staff). ALPHA Unit: Andrea Gervelmeyer & Denise Candiani (for item 5.3). COMMUNICATIONS Unit: Francesca Matteucci. Observers: (In application of the guidelines for Observers 1 ) Not Applicable 1 European Food Safety Authority Via Carlo Magno 1A Parma ITALY Tel Fax

2 Others: Not Applicable 1. Welcome and apologies for absence The Chair welcomed the participants. No Apologies were received for this meeting. Marion Simmons and Giuseppe Ru did not participate in discussions on selected items under agenda point 7.7 due to a Conflict of Interest being identified for the agenda item. 2. Adoption of agenda The agenda was adopted without changes. 3. Declarations of Interest of Scientific Committee/Scientific Panel/ Members In accordance with EFSA s Policy on Independence and Scientific Decision- Making Processes 2 and the Decision of the Executive Director on Declarations of Interest 3, EFSA screened the Annual Declarations of Interest and the Specific Declarations of Interest filled in by the Panel Members invited for the present meeting. For further details on the outcome of the screening of the ADoI or the SDoI, please refer to Annex I. Oral Declaration of Interest was asked at the beginning of the meeting and no additional interest was declared. 4. Agreement of the minutes of the 107th Plenary meeting held on 7-8 Sep 2016, Brussels (Belgium) The minutes of the 107 th Plenary were agreed by written procedure on 19 th September

3 5. Scientific outputs submitted for discussion 5.1. Scientific Opinion on the update of the list of QPS recommended biological agents intentionally added to food or feed as notified to EFSA 5 The last WG meeting took place on 6 and 7 October in Madrid. The WG Chair explained the main outcomes from this meeting and the current draft opinion was thoroughly presented. The issues rose by the Panel during the last plenary in September were taken into consideration by the WG and changes were made accordingly. Further small improvements in the two first chapters, Introduction and Data and methodology were made after discussion. The third chapter Assessment was presented as a whole for the first time to the Panel. This chapter was the result of the evaluations made by the WG experts based on the outcomes from the ELS on safety concerns related to the taxonomic units of the QPS list. Some amendments were made and some suggestions were indicated for improvement before the next plenary. The section on conclusions and recommendations as well the annexes, will be discussed during the next plenary. The EFSA Units (Feed, Pesticides, FIP and Nutrition) and respective Panels will provide further feedback on the current draft opinion. The Scientific Opinion is to be finalised by December Panel Statement on the update of the list of QPSrecommended biological agents intentionally added to food or feed as notified to EFSA. 5: Suitability of taxonomic units notified to EFSA until September The last WG meeting took place on 6 and 7 October in Madrid. The WG Chair explained the main outcomes from this meeting and the current draft opinion was thoroughly presented. The WG Chair explained that new notifications were considered until the beginning of September From a total of 59 new notifications received, 4 were considered for the QPS evaluation, corresponding to three taxonomic units (TU). These three TU were evaluated for a possible QPS recommendation. The Panel Statement is to be adopted on December Joint EFSA and EMA (European Medicines Agency) Scientific Opinion on measures to reduce the need to use

4 antimicrobial agents in animal husbandry in the European Union and the resulting impacts on food safety 7 The last WG meeting was held on 20 September 2016, jointly with the corresponding EMA WG. The WG Chair updated the Panel on the status of progress of WG activities, on the development of the draft opinion since the previous BIOHAZ Plenary meeting, and on how the comments and advice of the BIOHAZ Panel raised during the previous plenary meeting were addressed. The WG Chair presented in detail to the BIOHAZ Panel the draft conclusions and recommendations of the draft opinion, including the draft answers to the terms of reference of the mandate. The changes brought by the EFSA AHAW Panel during their concurrent Plenary meeting were also presented and discussed thoroughly. The BIOHAZ Panel suggested some further changes to the draft opinion, for consideration in the next, and last, WG meeting, scheduled for 25 October 2016, by webconference. The BIOHAZ Panel was informed of the endorsement of two chapters of the draft opinion by the EFSA AHAW and FEEDAP Panels during their October Plenary meetings. The deadline to adopt the EFSA- EMA Joint Scientific Opinion is 20 December Request for a Scientific Opinion on hazard analysis approaches for certain small retail establishments in view of the application of their food safety management system (HACCP) 8 The last WG meeting took place on 7 October The WG chair presented the progress of this mandate. The Panel appreciated the progress made in the draft opinion. Both, the current HACCP approach and a suggested simplified food safety management system (FSMS) for small retailers are described. For each of the five retail establishments, a FSMS table is developed. For each hazard group (biological, chemical, physical and allergen) and processing step, a control activity is described for activities that may contribute to increased occurrence of the hazard. Control activities are mainly in the form of pre-requisite programmes. A chapter on record keeping and documentation is being developed. The next WG meeting is on 10 November The deadline to deliver the Scientific Opinion is 31 January Scientific Opinion on Listeria monocytogenes contamination of ready-to-eat (RTE) foods and the risk for human health in the EU 9 Two WG meetings were held since the last plenary meeting: on 21 September 2016 by web conference and on October 2016 in

5 Parma. The Chair of the WG provided a short update on the three outsourcing activities under Closing gaps for performing a Risk Assessment on Listeria monocytogenes in RTE foods, for which the final reports have been received. The consortium of the third activity on Whole Genome Sequencing (WGS) presented the final report to the WG on 21 September The exclusion criteria for the Time Series Analysis (TSA) were discussed. The analysis would be done for the EU including EEA countries. Countries which have not reported data for the whole study period would be excludes as well as cases with missing or unknown data for age and/or sex. The analysis would be done for and period. The uncertainty analysis will be discussed at the next WG meeting. The hypotheses and assessment questions have been reformulated and examples were provided. The possibility to organise a stakeholder event linked to this Opinion is under consideration l by EFSA. The next WG meetings will be held on November 2016 in Parma. In addition, a sub-wg meeting will be arranged by web meeting on 27 October 2016 to discuss the final deliverable of the Listeria outsourcing activity 2. The current deadline to deliver the scientific opinion is 31 July In case the stakeholder event takes place, the adoption date would be postponed Request for an EFSA Scientific Opinion on the risk for the development of Antimicrobial Resistance (AMR) due to feeding calves with milk 10 The 7th WG meeting took place on 4-5 October This meeting was preceded by a short Web-Meeting (2h) on 14 September. The WG chair updated the BIOHAZ Panel on the progress of the draft Opinion and the activities of the WG since the last Panel Plenary meeting. The Draft Opinion had been revised by two FEEDAP Panel members, and by FEED Unit staff. All comments received were addressed together with comments received from the last BIOHAZ Panel Plenary. The WG chair presented the draft Opinion for thorough reading, which covers: farming practices, antimicrobial residues, occurrence and development of AMR, possible mitigation options, conclusions and recommendations. The scientific opinion is one of the selected opinions for an EFSA pilot study to evaluate and give feedback on the Draft for Internal Testing of the Guidance on Uncertainty in EFSA Scientific Assessment. The uncertainty analysis approach followed by the WG supported by a hearing expert (member of the EFSA Working Group on Uncertainty in Risk Assessment) was discussed. Additional feed-back from Panel members suggesting adaption of the text was also given. The next Web conference meeting is scheduled for 7th November. The deadline for the delivery of the Scientific Opinion is December

6 5.7. Request for a scientific opinion on genetic resistance to TSEs in goats 11 There was nothing new to report to the Panel because there had not been any meetings since the previous plenary. Work continues as planned. The next WG meeting will take place on 31 October, physical meeting in Parma Self-task mandate on requirements for the development of microbiological criteria 12 The first WG meeting took place on 2 September in Copenhagen. The WG Chair reported back to the plenary on the agreements made regarding the preliminary structure of the draft opinion. An additional WG member has joined the WG. The next WG meeting will take place in Parma from 20 October to 21 October 2016 and the deadline for adoption of the Scientific Opinion is 31 October Self-task mandate on public health risks associated with hepatitis E virus as a food-borne pathogen 13 The last meeting of the WG was held on 4 th October Large parts of the draft opinion are already drafted. The terms of reference are addressed by searching the relevant scientific literature. Public health information is provided by ECDC. The next WG meeting is on 25 th October The deadline for adoption of this opinion is June Request for a scientific opinion on BSE cases born after the total feed ban 14 There was nothing new to report to the Panel because there had not been any meetings since the previous plenary. Work continues as planned. The chair reported the implementation of the questionnaire survey on the investigation of the BSE BARB cases in the 11 member states, in collaboration with the BSE-TSE Network. The presentation with preliminary results to the Network members during the last meeting held on 5-6 October in Parma, as well as the rest of the presentations, were shared with the panel members prior to this plenary meeting. The next WG meeting will take place on 1-2 December, linked to the next BIOHAZ plenary meeting

7 5.11. Request for a scientific opinion on Chronic Wasting Disease (CWD) in cervids The state of affairs was presented by the chair. Since the previous plenary meeting, a web-conference had taken place on 7 October. The last WG meeting will take place in Oslo on November. The chair highlighted the constraints and difficulties of this mandate given: the short deadline, the wide scope of the three ToRs, the uncertainties inherent to a disease detected for the first time in Europe, the time needed for setting up the working group and having the first meeting, and the fact that the panel will not be exposed to the answers to the ToRs, conclusions and recommendations until the last plenary meeting of the year where the panel will have to discuss the adoption of the scientific opinion. The chair explained the approach towards the answers to the ToRs. There is a substantial amount of background information already collated that will inform the decisions of the WG on surveillance and risk mitigation recommendations. Equally the review of the zoonotic potential of scrapie in EFSA s 2015 opinion will be the basis for the answer to ToR2. The Panel was informed that the EC has been made aware of the current situation. The chair of the panel requested the chair of the WG to review the position and decide whether to submit the opinion for adoption in December or to request an extension. In case the WG manages to finalize the opinion in time, the chair recommended to submit the draft at least one week before the next plenary meeting and encouraged panel members to send comments to the secretariat beforehand. 6. New Mandates 6.1. Request for a scientific opinion on establishing of the end point mentioned in the art. 5 of the Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 for distilled fatty acids, stearin and glycerin produced by high standard processing method 15 A new application on Installation for processing technical animal fats and vegetable oils for distilled fatty acids, stearin and glycerine was received from the Polish competent authority (CA). The application received was for an evaluation related to Article 5 ( end point in the manufacturing

8 chain of Regulation (EC) No 1069/2009. A similar dossier was received by EFSA last year through the European Commission (EC), and the mandate was subsequently withdrawn. The animal by-product alternative method in the application cannot be considered as approved at EU level. In line with previous discussions, and in consultation with the EC, it was concluded during the plenary discussions that the Polish CA should have sent an application under Article 20 before applying to Article 5. It was decided that EFSA will inform the CA and applicant that a new complete application based on Article 20 should be resubmitted to EFSA Request for a joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food-producing animals 16 A new mandate was received on 10 October 2016 for a joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food-producing animals. The Panel decided to establish an ad hoc WG to help with the preparation of the draft Opinion, in collaboration with respective WGs of ECDC and EMA. Antonia Ricci accepted to take the role of Chair of the EFSA ad hoc WG. The first meeting is possibly taking place before the end of Feedback from the Scientific Committee/Scientific Panels, EFSA, the European Commission 7.1. Scientific Committee and/or Scientific Panel(s) including their Working Groups Scientific Committee The 80 th Plenary meeting of the Scientific Committee took place in Parma on the 14 September None Scientific Committee Working Group on Uncertainty in risk assessment

9 None Scientific Committee Working Group on Biological Relevance Scientific Committee Working Group on Weight of Evidence H. Wahlström updated the Panel members on the status of progress of the WG activities. The draft opinion will be presented to the Scientific Committee in November 2016 and in February 2017 a public consultation will be launched. The next WG meeting is on 25-27October None Scientific Committee standing WG on Guidance review 7.2. EFSA including its Working Groups /Task Forces Scientific Networks on BSE-TSE and MRA The annual meeting of the BSE-TSE Network took place on 5/6 October 2016 in Parma. The final agenda for the meeting was presented to the Panel members. Participants included representatives from 23 EU Member States, Norway, Switzerland, European Commission (DG SANTE), the World Organization for Animal Health (OIE) and a hearing expert from the OIE reference laboratory for CWD and scrapie. The MRA Network meeting took place on 11/12 October 2016 in Parma. It was followed by a joint session with the EFSA Scientific Network on Zoonoses Monitoring Data on the second day. The MRA Network was attended by 24 MS and Norway. Apologies were received from Finland and Switzerland. The agenda was presented to the Panel Joint interagency antimicrobial consumption and resistance analysis (JIACRA) report-follow up-request for data analysis from 2013 and

10 As a follow up to a previous mandate to EFSA, a second report aimed at analysing the relationships between antimicrobial use and resistance in humans, animal and food addressing available data for years 2013, 2014 and 2015 is required by the EC. The deadline agreed for completion of this activity is end of June An interagency working group (EFSA, EMA, ECDC) has been established. The next meeting of the Working group is scheduled for 27 October None Emerging Risks None European Commission 8. Other scientific topics for information and/or discussion 8.1. Proposal for renewal of the self-tasking mandate for Scientific opinion/statements on the update of the list of QPS-recommended biological agents intentionally added to the food or feed as notified to EFSA A new internal mandate on QPS with draft terms of reference (ToR) was presented to the Panel. With the experience gained during the current three years mandate, small improvements were made on the description of the current proposal. Collaboration with AMU and the concerned EFSA Units is foreseen. The deadline proposed is December of Proposal for a self-tasking mandate for scientific opinion on public health risks associated with Cryptosporidium as a food-borne pathogen A draft self-task mandate was presented to the BIOHAZ Panel, and the draft ToRs were discussed in detail. The Panel agreed on the relevance of the topic, and proposed to work in a new draft that would include foodborne parasites in general. There was agreement to present the new draft to the Panel at a future meeting in Recommendations from the Panel on a possible update of joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and efficacy of 10

11 substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption Following the adoption of the opinion Evaluation of the safety and efficacy of Listex P100 for reduction of pathogens on different ready-toeat (RTE) food products 20 and as part of lessons learned by using this scientific opinion as a case study for EFSA s project on PROmoting METHods for Evidence Use in Scientific assessments 21, the BIOHAZ Panel recommends to review and update the existing guidance document Revision of the joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption 22.Particularly this update should consider the requirements for the approach for the literature search, the study selection process to identify relevant experiments, the assessment of the relevance and reliability of the included experiments, and the data synthesis. It should also be done in close dialogue with risk managers Presentation on Weight of Evidence, the French (ANSES) experience Discussion on this item was postponed for a future meeting of the BIOHAZ Panel. 9. Any other business 9.1. Information on Potential Conflicts of Interest for EFSA experts receiving prizes/awards. EFSA s secretariat informed the Panel about the importance of an early and thorough declaration of this kind of scientific activities

12 Annex I Interests and actions resulting from the screening of Annual Declarations of Interest (ADoI) or Specific Declarations of Interest (SDoI) CONFLICT OF INTEREST: In the ADoI and SDoI filled for the present meeting Dr. M. Simmons declared the following interest: Consultancy support provided at the request of the European Commission to the design and interpretation of the Cypriot studies into genetic resistance in Cypriot goats, and Dr. Giuseppe Ru declared the following interest: Based on a specific mandate from the Italian Ministry of Health he was involved in drafting a scientific dossier titled "The K222 allele of the goat PRNP gene as candidate for selective culling in scrapie outbreaks and for future breeding programs for TSE resistance in Italian goat breeds". In accordance with EFSA s Policy on Independence and Scientific Decision- Making Processes 23 and the Decision of the Executive Director on Declarations of Interest 24, and taking into account the specific matters discussed at the meeting in question, the interests above were deemed to represent a Conflict of Interest. This results in exclusion of the experts from any discussion, voting or other processing of the above mentioned reports under agenda item 5.7 by the concerned scientific group