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Food Standards Agency Scotland

Food Standards Agency Scotland. Norway November 2009. Lorna Murray Scottish Marine Biotoxin Monitoring programme – harvesters risk assessments and the role of end product testing in official decision making. Presentation overview. Shellfish industry in Scotland Overview of legal requirements

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Food Standards Agency Scotland

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  1. Food Standards Agency Scotland Norway November 2009 Lorna Murray Scottish Marine Biotoxin Monitoring programme – harvesters risk assessments and the role of end product testing in official decision making

  2. Presentation overview Shellfish industry in Scotland Overview of legal requirements Biotoxin monitoring programme Public health risk/Incident impact Risk assessment in the shellfish industry Role of end product testing in Scottish system Culture Conclusions

  3. Shellfish Biotoxins Three main groups: • Amnesic Shellfish Poisoning (ASP) • Diarrhetic Shellfish Poisoning (DSP) • Paralytic Shellfish Poisoning (PSP) • All 3 groups of toxins detected in bivalve molluscs from Scottish waters • EU854/2004 – sampling must comprise: • Intensive sampling - where results suggest an accumulation of toxins in flesh • Weekly testing unless risk assessment suggests a lesser frequency • Periodic review of the risk assessment

  4. Scottish risk assessment approach 2009 • Data from April 2001 to March 2008 • All test results were assigned to so-called Pods (was done by FSAS) • Models – Toxin patterns with time – Variation between sites • Risk assessment of 2006 monitoring scheme • Revised monitoring schemes

  5. Map of Loch Roag showing monitoring points

  6. Frequency of sampling at 94 Representative Monitoring Points ASP DSP PSP Weekly - June to Oct Weekly - April to Dec Weekly – Apr Oct Fortnightly - May Fortnightly – Nov - Mar Monthly – Jan – April, Nov & Dec Monthly - Jan to March

  7. Application of risk assessment outputs Must be fully inclusive and transparent Must be simple and easy to apply in practice (pragmatic approach) Independence of the risk assessment is essential Working Group of Agency Officials, Local Authority Enforcement Officers, Shellfish Harvesters and Businesses, Official Control Laboratories

  8. Public health risk/Incident impact(Marine biotoxins) Scottish originated DSP outbreak 2007 • Over 57 people ill (June) Critical PSP levels recorded in 2006 leading to major product withdrawal 287µg/100g (rising to 413, highest mouse at 694) Incidents leading to product recalls • 6 in 2006 • 5 in 2007 • 7 in 2008 • 10 so far 2009

  9. Public health risk/Incident impact(Marine biotoxins) Agency Incident Prevention Strategy (general) Uniqueness of sector Uniqueness of risk Impact of Scottish producers for UK/EU market (and 3rd Country) Scottish Shellfish Marketing Group Loch Fyne oysters Ltd Significant and growing wild catch sector (59,000 tonnes in 2007) Significant processing activity Expansion of industry being positively promoted by Scottish government

  10. Potential for risk(closures 2007) UK Area ASP DSP PSP Total Scotland 4 40 7 51 NI 0 4 0 4 E&W 0 4 1 5 Total UK 4 48 8 60

  11. Risk assessment in the shellfish sector (considerations for industry) Previous and current end product test results Previous and current Official Control results Previous and current Phytoplankton results Time of year Other closures in the area If in doubt ……

  12. Biotoxin risk matrix Use for Regulators although Industry may observe Covers ASP, DSP and PSP Scoring system to inform action

  13. Type of toxin - PSP Low (0 - 5) Medium (6 - 10) High (11 - 20) Score Current status Open Flesh result – Not detected Water results - Zero Above 0 to alert level - 0 - 40 µg/100g 40 - 80 µg/100g End Product Test flesh result (Ridascreen/HPLC/other method) Not detected Above 0 to alert level - 0 - 40 µg/100g Close to closure level, at closure level or above – 41 - 80 µg/100g Official Control result Not detected Above zero/ Negative/ND/LOD but under closure level Close to closure level, at closure level or above Phytoplankton Zero Level of detection Greater than 20cells/L (level of detection) Time of year Not applicable December to February March to November Previous history (Monitoring programme) Historically not detected at this time (green status from OC results) Historically 0 - 40 µg/100g (amber status from OC results) Historically 41 - 80 µg/100g at this time (red status from OC results) Area implicated in recent illness/ food incident No Suspected Confirmed Total score Total Score Alert levels : Water – Greater than 0 cells/ L Flesh – Greater than 40µg/g in flesh Low – 0-35 Medium – 40-70 High – 75-140 Low – End Product Test (ept) applied to each batch Medium – ept as positive release High – not accepted/not harvested Biotoxin Risk Matrix - Paralytic Shellfish Poisoning (PSP)

  14. STAND ALONE RMP IS OFFICIAL CONTROL SAMPLE ABOVE REG LIMIT FOR ANY 3 TOXINS? IS TOXIN OR ASSOCIATED PHYTOPLANKTON RESULT ABOVE ALERT LEVELS? DSP: 100 DINOPHYSIS CELLS/L &/OR MBA CLINICAL SIGNS ASP: 10µG/100G &/OR 50,000 PSEUDONITZCHIA CELLS/L PSP: 40µG/100G &/OR 20 ALEXANDRIUM CELLS/L No No Yes Yes Yes SITE CLOSED. MUST HAVE 2 CONSECUTIVE NEGATIVE SAMPLES 7 DAYS APART SAMPLE 2: TEST ALL 3 TOXINS. IS IT BELOW REG LIMITS FOR ALL TOXINS? ALERT STATUS INCREASED TOXIN RISK EMPLOY SUITABLE E.P.T OR OTHER PRECAUTIONS No No SAMPLE 1: TEST FOR CLOSURE TOXIN IS IT BELOW REG LIMITS SITE OPEN Yes

  15. RMP/AHA OC RESULT EXCEEDS STATUTORY LEVEL PRODUCT CAN BE RE-DEPOSITED INTO ORIGINATING HARVESTING AREA WITH LFA SUPERVISION WHERE NECESSARY. HARVESTED PRODUCT HAS NOT LEFT THE LFA AREA. PRODUCT HARVESTED ON OR AFTER DATE OF OC SAMPLE BEING GATHERED AND POSITIVE OC RESULT RECEIPT . PRODUCT IS ON THE MARKET AT WHOLESALE, RETAIL OR DIRECT TO CONSUMER. PRODUCT HAS BEEN HARVESTED AND TRANSPORTED TO APPROVED DEPURATION/DISPATCH CENTRE OUTWITH THE AREA. NO PRODUCT HARVESTED IN INTERVAL BETWEEN OC SAMPLE BEING GATHERED AND POITIVE OC RESULT RECEIPT. *FOOD BUISNESS OPERATOR HAS FULL RISK ASSESSMENT/HACCP INCLUDING, BUT NOT CONFINED TO, EPT RESULTS FROM BATCH, WHICH PROVIDES SUITABLE EVIDENCE OF PRODUCT COMPLIANCE WITH 853/2004 CHAPTER V, AS ASSESSED BY FSAS AND LFA. FOOD BUSINESS CAN PROVIDE EVIDENCE (EPT) THAT PRODUCT IS COMPLIANT WITH CHAPTER V OF 853/2004 OR PRODUCT IS CONFIRMED BY LFA AS SUITABLE FOR RETURN TOORIGINATING HARVESTING AREA. I.E. IT HAS NOT BEEN ALTERED NO ACTION NECESSARY RMP/AHA CLOSED AS PER PROTOCOL. Yes Yes No No PRODUCT CAN REMAIN ON THE MARKET PRODUCT CAN BE PLACED ON THE MARKET OR RE-DEPOSIT INTO ORIGINATING HARVESTING AREA PRODUCT TO BE DESTROYED. USE OF POWERS OF SEIZURE AND DETENTION (REG 27 THE FOOD HYGIENE (SCOTLAND) REGS 2006, SECTION 9 THE FOOD SAFETY ACT 1990) PRODUCT RECALL RECOMMENDED UNDER ARTICLE 19 178/2004

  16. RMP and AHA IS RMP OC SAMPLE BELOW REG LIMITS FOR ALL 3 TOXINS? Y IS TOXIN OR ASSOCIATED PHYTOPLANKTON RESULT ABOVE ALERT LEVELS? DSP: 100 DINOPHYSIS CELLS/L &/OR MBA CLINICAL SIGNS ASP: 10µG/100G &/OR 50,000 PSEUDONITZCHIA CELLS/L PSP: 40µG/100G &/OR 20 ALEXANDRIUM CELLS/L No No AREA CLOSED. MUST HAVE 2 CONSECUTIVE NEGATIVE SAMPLES TAKEN 7 DAYS APART Y Y No SAMPLE 2: TEST ALL 3 TOXINS. IS IT BELOW REG LIMITS FOR ALL TOXINS? ALERT STATUS INCREASED TOXIN RISK. EMPLOY SUITABLE E.P.T OR OTHER PRECAUTIONS No SAMPLE 1: TEST FOR CLOSURE TOXIN. IS IT BELOW REG LIMITS? Y AREA OPEN AHA WANTS TO HARVEST 2ND OC SAMPLE IS IT BELOW REG LIMITS FOR ALL TOXINS? No AHA CANNOT HARVEST Y AHA CAN HARVEST Y CLEAR E.P.T EVIDENCE (where required if placing on market) TAKEN IN INTERVAL BETWEEN LAST NEGATIVE AND 1ST POSITIVE RESULT No No 1ST OC SAMPLE IS IT BELOW REG LIMIS FOR CLOSURE TOXIN? Y

  17. The environment we need Increasinglyinformed GENERATIVE Food Safety is how we do business PROACTIVE We work on all the risks we identify CALCULATIVE We have systems in place to manage risks REACTIVE Food safety is important, we do a lot when we have an incident PATHOLOGICAL Who cares as long as we’re not caught Increasing trust/accountability

  18. End product testing considerations What it is not: Easy (Use of methods and interpretation of results. Training and support essential) Frozen in time The only element of risk assessment * Sample collection and verification important What it is: Related to time and place Hopefully affordable and accessible (support initiatives) About providing information to assist with business own risk assessment = empowerment About assisting in due diligence evidence About compliance with Community law (EU 853/2004)

  19. Conclusions Food Business Operator must understand, implement and maintain risk assessments and appreciate legal duties in reporting unsafe food Local Food Authority's must review HACCP plans at every inspection and maintain close liaison with their Food Business Operator’s The Agency must provide clear andconcise guidance A supportive environment must be facilitated

  20. Thank You for your Attention Lorna Murray Local Authority Food Law Enforcement Branch Food Standards Agency Scotland 01224 285114 07776 172156 lorna.murray@foodstandards.gsi.gov.uk www.food.gov.uk

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