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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

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

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


Shellfish biotoxins

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


Scottish risk assessment approach 2009

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


Map of loch roag showing monitoring points

Map of Loch Roag showing monitoring points


Frequency of sampling at 94 representative monitoring points

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


Application of risk assessment outputs

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


Public health risk incident impact marine biotoxins

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


Public health risk incident impact marine biotoxins1

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


Potential for risk closures 2007

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


Risk assessment in the shellfish sector considerations for industry

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 ……


Biotoxin risk matrix

Biotoxin risk matrix

Use for Regulators although Industry may observe

Covers ASP, DSP and PSP

Scoring system to inform action


Food standards agency scotland

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)


Food standards agency scotland

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


Food standards agency scotland

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


Food standards agency scotland

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


The environment we need

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


End product testing considerations

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)


Conclusions

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


Food standards agency scotland

Thank You for your Attention

Lorna Murray

Local Authority Food Law Enforcement Branch

Food Standards Agency Scotland

01224 285114

07776 172156

[email protected]

www.food.gov.uk


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