Protocol for the Classification of Shellfish Harvesting Areas England and Wales

Transcription

1 Protocol for the Classification of Shellfish Harvesting Areas England and Wales Version 15 June Pages Document approved by: Andrew Younger Review date: Not applicable Document prepared by: Lewis Coates Location tbc Food Standards Agency London Food Standards Agency Wales The Centre for Environment, Fisheries & Aquaculture Science Weymouth Laboratory Barrack Road The Nothe Weymouth Dorset, DT4 8UB Tel. +44 (0) Fax +44 (0) Cefas is an executive agency of Defra Version 15 June

2 Contents Introduction Classification system Setting up of a classification monitoring programme Submission of applications Sanitary Surveys Interim assessments and identification of interim RMPs Transition from preliminary to provisional classification Note on classification of scallops Additional items to consider in setting up monitoring programmes TREE 1: Requirements for provisional classifications Ongoing monitoring Requirements for a full classification Requirements for seasonal classification Minimum number of samples Declassified sites Ongoing review of data TREE TREE TREE Temperature recording and reporting Elapsed time between sample collection and receipt is 4 hours or more: Elapsed time between sample collection and receipt is less than 4 hours: Trigger values under classification system Action State Investigative state Criteria for notification: Action: Possible downgrade Criteria for notification Action: Actions following outcome of investigations Areas showing improvement Long Term Classification (LTC) system Introduction LTC criteria Receipt of results and ongoing review of data Shellclass mailbox - result checking and appropriate actions Statistical assessments General items Miscellaneous items Receipt and collation of monitoring results Reviewing existing monitoring programmes Investigative samples Criteria for disregarding results Production and distribution of classification zone maps u3.3 Action States Version 15 June

3 3.3 Action States Local Action Groups (LAGS) and Local Action Plans (LAPS) Action State Trigger Values Dealing with pollution events TREE Procedures Local Enforcement Authorities role under Action State Cefas role under Action State Investigations Sampling Arrangements Ending the Action State Summary reports Version 15 June

4 History of Protocol Issue Date Issued Changes 1 July 2009 First issue 2 October 2009 Page 8 amended 3 March 2011 Amendments to requirements for classification of new areas with regard to need for sanitary surveys. Addition of requirements for scallops. Updated website links to new Cefas website Various minor amendments /points of clarification 4 July 2011 Further definitions added to glossary Detail added in relation to preliminary and provisional classifications Detail added in relation to reclassification of declassified sites 5 January 2012 Detail added in criteria for disregarding results 6 January 2013 New Application procedures detailed(1.1.1) Revisions to Sanitary Surveys (1.1.2) New interim assessment and identification of interim RMPs Version 15 June

5 Local Action Groups (LAGS) and Local Action Plans (LAPS) November 2013 Detail added to update to class B areas (possible upgrade to A) 8 April 2014 Updated following implementation of new classification procedures and sampling plan implementation details 9 July 2014 Correction to page 22. RMP definition added to glossary. 10 October 2014 Contact telephone number for FSA on front page updated Additional notes on parallel monitoring 11 March 2015 Update to sample submission protocol. Revision of time criteria from sample collection to receipt at the testing lab 12 April 2015 Web links updated to reflect new Cefas website ( 13 September 2016 Seasonal classification modification of procedure; Action state closures clarification Update of reference to Food Law Practice Guidance in Glossary 14 February 2017 Update to class A criteria and subsequent changes to Action state and investigation states for class A areas. Refinement to prohibition conditions of sites and initial monitoring Clarification of wording re Class C post-harvest treatment criteria Addition to seasonal classifications to take account Version 15 June

6 of harvesting areas with shortened seasons due to external factors (eg IFCA byelaws) 15 June 2017 Update to sampling information Update to contact details for handling of new applications and further explanation of Provisional Representative Monitoring Point (PRMP) assessments. Some information re: LT system updated/removed now the system is no longer new Version 15 June

7 Glossary Bed Bivalve mollusc Classification zone Initial full classification Provisional Representative Monitoring Point (PRMP) assessment Interim update An underwater or intertidal area within a production area where bivalve molluscs are present Any marine or freshwater mollusc of the class Pelecypoda (formerly Bivalvia or Lamellibranchia) having a laterally compressed body, a shell consisting of two hinged valves and gills for respiration. The group includes clams, cockles, oysters and mussels Area with fixed boundaries encompassing known shellfish beds in which commercial harvesting may take place. Zones as defined on classification zone maps published by Cefas at: Classification awarded after one year of monthly monitoring (including any monitoring carried out towards a provisional classification) This will take the form of a desk study assessment to determine a sampling plan and PRMP(s) in liaison with the LEA. Once agreed, the required classification sampling (E.coli) and subsequent harvesting can commence as soon as practically possible following receipt of a shellfish harvesting application (for new areas or changes to existing classified areas.) The assessment will generally use information in the public domain and will not routinely involve data requests to other bodies. Formal notification (from the FSA) of the revised classification status of a site or sites, including notification of newly classified sites. Interim updates can occur at any time according to need and take place between formal annual updates which are released on the 1 September each year. Version 15 June

8 LEA Preliminary classification Production area Prohibited areas Provisional classification Relaying Representative Monitoring Point Seed shellfish Local Enforcement Authority. An initial classification given to a shellfish bed to allow early industry harvesting. Such a classification may be given without specific monitoring of the new bed and so the level of classification (i.e. A, B or C) will be decided according to the precautionary principle with regard to public health protection. Area of broad geographic location identified by a main estuary or other marine feature encompassing one or more classification zones Areas which are unfit for commercial harvesting for health reasons e.g. those consistently returning results greater than 46,000 E. coli/100g in routine monitoring. These are included in the FSA list of designated prohibited beds. Harvesting of seed shellfish (only) may exceptionally be permitted from Prohibited areas under IFCA and/or LEA supervision. Harvesting for human consumption is also prohibited from unclassified areas, however, seed shellfish for growing on may be transferred from unclassified areas to classified production areas, in accordance with Chapter 7 of Food Law Practice Guidance (England) Classification awarded after a sanitary survey or PRMP assessment and initial monitoring - usually 10 samples over a minimum period of 3 months The transfer of live bivalve molluscs to an area of sea, estuary or lagoon for the purpose of removing any microbiological contamination for the time necessary to remove such contamination. A specified geographical location form which samples are taken to represent either a single, or several, wild bivalve mollusc beds or aquaculture sites. The representative sampling point should reflect the location at highest risk of faecal pollution within the classified area. Immature or juvenile shellfish not suitable for marketing for human consumption (size where applicable usually defined by local Sea Fisheries Committee/IFCA byelaw) Version 15 June

9 Parallel monitoring Temporary closure notice (TCN) LAs may occasionally be asked (as an option) to provide parallel samples between an RMP for a new site and an existing RMP. This option is intended to reduce the time required to classify a new species or extend an already classified area. Sampling sites are identified prior to sampling taking place and samples MUST be collected at the same time (as near as practically possible) on the same day in order to be considered as parallel. Temporary closure made under EC Regulation 854/2004 prohibiting the collection of any live bivalve molluscs from a designated area. Version 15 June

10 Introduction This protocol reflects policy decided by the Food Standards Agency (FSA) as Competent Authority in England and Wales for this area of work. It is intended to meet the legislative requirements of EC Regulation 854/2004 and take into account the recommendations contained in the European Good Practice Guide at: Cefas maintains this protocol on behalf of the FSA and assists in its implementation in England and Wales. The protocol is published on the Cefas website at Classification of harvesting areas is required and implemented directly in England and Wales under European Regulation 854/2004. The co-ordination of the shellfish harvesting area classification monitoring programme in England and Wales is carried out by the Centre for Environment, Fisheries and Aquaculture Science, Weymouth (Cefas) on behalf of the Food Standards Agency (FSA). Cefas will make recommendations on classification according to an agreed protocol (details below) with the FSA making all final classification decisions and setting out the overall policy. Shellfish production areas are classified according to the extent to which shellfish sampled from the area are contaminated with E. coli. The classification of a production area determines the treatment required before the molluscs may be marketed: - Class A (80% of results 230 E.coli/100g, no results exceeding 700 E.coli/100g) - molluscs can be harvested for direct human consumption. Class B (90% of samples must be less than or equal to 4,600 E.coli/100g, all results must be below 46,000) - molluscs can go for human consumption after: o Purification in an approved plant OR o Relaying in an approved class A relaying area OR o After an EC approved heat treatment process. Class C ( 46,000 E.coli/100g) - molluscs can go for human consumption only after either: o Relaying for at least two months in an approved class B relaying area followed by treatment in an approved purification centre. OR o Relaying for at least 2 month in an approved class A relaying area 1. OR o After an EC approved heat treatment process In all cases, the health standards in Annex III of European Regulation 853/2004 and the microbiological criteria adopted under European Regulation 2073/2005 must be met. 1 Harvesters may also wish to apply further purification steps to class A relayed LBMs, however this is not a requirement in legislation. Version 15 June

11 Prohibited 2 areas - molluscs must not be subject to production or be collected. Since 1 September 2006 there have been two systems in place in England and Wales. The annual classification and the Long Term classification (LT). New areas will initially be given an annual classification until they meet the criteria for a LT classification. The monitoring requirements are essentially the same under both classification systems. Sites not meeting LT criteria automatically fall under the annual classification system for which the criteria are set out below. 2 Not a legal definition but used to denote areas which are unfit for commercial harvesting of LBMs for health reasons e.g. those consistently returning prohibited level results. Collection of seed shellfish from such areas may be permitted in exceptional circumstances under IFCA and/or Local Enforcement Authority supervision. Seed shellfish harvested in this way must be subject to a minimum period of 6 months ongrowing in a classified area prior to sale for human consumption with processing appropriate to the classification status of the area harvested. Version 15 June

12 1. Classification system 1.1 Setting up of a classification monitoring programme The requirements under EC Regulation 854/2004 in terms of setting up monitoring programmes for classification purposes fall under paragraph 6 of Annex II of the Regulation and are as follows: 1. Make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area. 2. Examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste water treatment etc. 3. Determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area 4. Establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered Submission of applications A new harvesting area application form should be completed by the applicant in conjunction with the relevant local enforcement authority and forwarded along with a suitable map and any other relevant supporting data to the FSA. A copy of an OS 1:25,000 or 1:50,000 map or Admiralty chart with the position and extent of the shellfish bed(s) clearly marked is the preferred format. The application form is available at: pdf Completed forms for England to be sent to: shellfishharvesting@foodstandards.gsi.gov.uk Completed forms for Wales to be sent to: shellfish.wales@foodstandards.gsi.gov.uk Once the FSA has undertaken an initial verification check, applications will be forwarded to Carcinus to carry out the assessment from there and Matthew Crabb or Stuart Leather from Carcinus will contact the local authority officer about the proposed PRMPs and sampling plan to liaise on its suitability. Carcinus can be contacted at: shellfish@carcinus.co.uk Version 15 June

13 When the assessment has been completed and agreed with the FSA, the FSA will ask Cefas to liaise as usual with the Local Authority on implementation of the sampling plan towards classification. Please note, queries on anything other than new applications should continue to go to FSA/Cefas as usual. Version 15 June

14 1.1.2 Sanitary Surveys Sanitary surveys are required for all new production areas or new species in existing production areas prior to provisional classification. The following are considered in a sanitary survey: 1. Location and extent of the shellfishery 2. Type of shellfishery (species, method of harvest, seasonality of harvest) 3. Location, type and volume of sewage discharges 4. Location of river inputs and other water courses (from OS maps/nautical charts) 5. Location of harbours and marinas (from OS maps/nautical charts) 6. Historical average rainfall by month 7. Existing microbiological data from water quality or shellfish monitoring undertaken in the same area or adjacent areas. The aim of the sanitary survey is to establish a sampling plan which will ensure that monitoring results are as representative as possible for the area to be classified (see section Implementation of sampling plans). The FSA has completed its programme of sanitary surveys to cover all current production areas in England and Wales. Provisional Representative Monitoring Point (PRMP) assessments are currently being used to handle new shellfish harvesting applications. A PRMP assessment (see 1.1.3) will be undertaken by Carcinus upon receipt of a completed application form and formal request from the FSA. New production areas and provisional classification A new production area in this context is one which does not contain any existing classified beds A PRMP assessment should include an assessment of all potential commercially harvestable species mentioned in the application form. It will not be necessary to take samples of all these species for bacteriological surveys at the time of the initial survey until there is interest to commercially harvest them (and this can be done by the LA when the situation arises). Wherever possible PRMP assessments will recommend rationalised sampling plans (to reduce the burden on LAs). It may be possible depending on certain criteria (species colocated geographically, depth grown in the water column etc.) to use an indicator species to represent more than one species of shellfish in an area. This could reduce the level of resource and analysis cost to monitoring each species individually e.g. mussels are known to be suitable for representative monitoring of some other species. Where indicator species monitoring is used, harvesting restrictions (e.g. bed closure, downgrade) following results above the classification tolerance in the indicator species will similarly affect the nonmonitored species represented by this monitoring. Once the sampling plan has been determined by Carcinus in liaison with the LEA and FSA, and passed on to Cefas for liaison with the LEA on implementation, classification sampling may commence. The sampling protocol must be followed and an up-to-date copy of this is kept at: Version 15 June

15 Ten samples taken at least a week apart by the LA will be needed before a provisional classification can be issued. Monthly monitoring is acceptable if the need for classification is not urgent. Where more than one species is to be harvested, the microbiological status of all species may need to be separately determined during the provisional classification stage i.e. separate samples of each species may be needed. For routine monitoring, one or more indicator species may be used to represent the other species if previous evidence base supports this. New species partly within and partly outside existing production areas These should be considered on a case-by-case basis depending on the extent and situation in relation to known and suspected sources of pollution. In certain circumstances, a period of parallel monitoring of different sites and/or species may be required to assess suitability of historical data to represent the new species. New species in existing production areas and preliminary classifications An unclassified species in a production area already classified for another species is not regarded as a new production area. Existing data from classified species in the vicinity will be used to assess faecal contamination in the new species so that a preliminary classification may be assigned in the first instance to allow industry to benefit from early harvesting. Such a classification would be based on the precautionary principle in order to ensure public health is not jeopardised e.g. it may be awarded at class C rather than class B where there is any doubt. In certain circumstances, a period of parallel monitoring of different sites and/or species may be required to assess suitability of historical data to represent the new species. NB. Whilst a preliminary B or C classification may be given without specific monitoring in some cases, the results of 10 samples will be needed before a preliminary Class A classification can be issued. If the production area has been subject to a sanitary survey previously, information contained in the report will be used in the process of assigning the initial preliminary classification. An assessment will then be made to determine whether the sampling plan derived from that survey is appropriate for the new species. If the sampling plan is considered appropriate, it will then be followed in terms of monitoring point location when taking the first 10 samples to eventually assign a provisional (as opposed to preliminary) classification for the new species. If the original sampling plan is not considered appropriate, a PRMP assessment will be undertaken (see 1.1.3). Any new information or changes in sources of pollution or circulation of pollutants within the harvesting area since the sanitary survey was undertaken should also be considered and incorporated into the assessment and sampling point recommendation. A new sampling plan in the PRMP report describing the new fishery and rationale for sampling will be issued (and published) once routine monitoring is established. If a sanitary survey has not been carried out in the production area, then an interim assessment will be carried out as described below. In cases where handling options for individual applications are unclear please contact Cefas (shellclass@cefas.co.uk; tel: and ). Version 15 June

16 1.1.3 Provisional Representative Monitoring Point (PRMP) assessments and identification of Provisional RMPs (PRMPs) After receiving and verifying a shellfish harvesting application form, FSA will instruct Carcinus to carry out a PRMP assessment. This will take the form of a desk study assessment to determine a sampling plan and PRMP(s) in liaison with the LEA. Once agreed, the required classification sampling (E. coli) and subsequent harvesting can commence as soon as practically possible following receipt of a shellfish harvesting application (for new areas or changes to existing classified areas.) The assessment will generally use information in the public domain and will not routinely involve data requests to other bodies. The assessment should normally be provided by Carcinus within 15 working days after receipt of an application form following acceptance by FSA and will include: Location and extent of the shellfishery Type of shellfishery (species, method of harvest, seasonality of harvest) Location, type and volume of sewage discharges Location of major river inputs Location of harbours, docks, marinas and marked anchorages Classification status and available microbiological data from shellfish monitoring undertaken in the same area or adjacent areas. Carcinus will contact the LEA directly to determine the suitability of the proposed sampling plan, before it is forwarded to Cefas for liaison with the LEA on implementation, before sampling commences. RMPs should be representative of the point showing the highest level of contamination i.e. the worst case scenario. If necessary, more than one RMP and associated classification zone (CZ) may be identified if this is deemed necessary to reflect the impact of more than one significant pollution source (where a single RMP cannot be sited to adequately reflect the impact of multiple major sources). If a preliminary classification is deemed appropriate, then a recommendation to FSA for their consideration will be made by the Classification team at Cefas. For guidance on the implementation of sampling plans see Section This procedure is not appropriate for consideration of applications within marinas and docks and any applications relating to such circumstances will need to be highlighted to FSA for separate consideration. Chemical contaminants: Any existing or historical knowledge indicating possible contaminant issues problem (e.g. proximity of bed to large oil refinery, marina/dock/harbour etc.) then this should be identified to the FSA at the earliest opportunity for their further consideration. Please note, queries on anything other than new applications should continue to go to Cefas/FSA as usual. Version 15 June

17 1.1.4 Transition from preliminary to provisional classification The transition from preliminary to provisional classification is essentially a procedural matter which should be cost neutral to the local authority as monthly monitoring will generally be the norm throughout (unless additional zoning and RMPs are deemed necessary as a result of the sanitary survey/prmp assessment). The distinction between the two types of classification serves to highlight whether a sanitary survey/prmp assessment has been carried out (or not) and thus how confident we are in the level of classification and extent of classified area (this may be precautionary - e.g. C rather than B - under preliminary classification). A sanitary survey/prmp assessment having been completed along with subsequent provisional monitoring from points identified in the sampling plan helps provides such confidence. Sites on preliminary classification will be recommended for provisional classification via an interim update recommendation to the FSA once 10 samples (monthly monitoring) are available from each identified point in the sampling plan resulting from the sanitary survey/prmp assessment. If the location of the points identified in the sampling plan coincide with the points used under preliminary classification (or bacteriological survey) and at least 10 sets of samples from each sample point have been collected then a provisional classification may be awarded when the sampling plan is released. If, however, new points are identified under the sampling plan (i.e. different from those used for either preliminary monitoring or the bacteriological survey) then further samples (monthly monitoring) from each point may be needed for provisional classification Note on classification of scallops The current approach in England and Wales is to classify farmed scallop areas within or surrounded by an existing classified shellfish production area, i.e. grown in lanterns or by other aquaculture methods. Data for other species in existing classified beds in the vicinity may be used (depending on evidence base) to enable classification. If scallops are growing wild they can be harvested without classifying the production area. However, harvesting is only permitted providing the controls specified in Regulation 853/2004 (testing by the food business at fish auction, dispatch or processing establishment) are carried out to ensure that the end product standards are met Additional items to consider in setting up monitoring programmes LEAs are responsible for implementing sampling plans recommended through the sanitary survey and/or RMP assessment stage. Sampling plans should be implemented as soon as practicably possible and within one month of being issued. It is therefore essential that LEAs are available to comment during the sanitary survey/prmp assessment process to ensure that all issues that might affect sampling are discussed in advance. A delay in the implementation of sampling plans may affect the classification status of an area, and therefore commercial harvesting. Current sampling plans are available on the Cefas website: Version 15 June

18 Sampling plans should be implemented in their entirety with immediate replacement of existing monitoring requirements, including RMPs. New RMP locations, bed names (replacing old names) and classification zones should be adopted from the outset. An interim update highlighting these changes will be issued by the FSA. Sampling from the old sampling points will be discontinued. However, for compliance assessments, historical data from the old point representing a particular bed should be combined with that from the new point providing both RMPs fall within the new zone and both are the same species A phased implementation may be possible if there is a significant change in monitoring point location and/or classification zone. In these cases, LEAs should contact the FSA and Cefas at the earliest possible opportunity to discuss options. Please note, biotoxin sampling will need to be reviewed and amended accordingly when new sampling arrangements are implemented. As with enforcement of other EU food hygiene rules, LEAs are also responsible for imposing the requirements in classified harvesting areas within their Authority boundaries. Version 15 June

19 TREE 1: FLOW DIAGRAM DETAILING THE PROCEDURES FOR CLASSIFYING NEW AND EXISTING SHELLFISH BEDS FSA receive application from LA/industry Verified and accepted application forwarded to Carcinus by FSA Provisional RMP assessment To assign provisional RMP and classification zone Preliminary classification Based on existing monitoring: COMMERCIAL HARVESTING PERMITTED Provisional classification Based on 10 samples from provisional RMP: COMMERCIAL HARVESTING PERMITTED Full classification after 1 year s monitoring N.B. this flow diagram represents the current process. The policy with regard to the undertaking of full sanitary surveys is currently under review by the FSA Version 15 June

20 1.2 Requirements for provisional classifications Potential class B or C sites: For classification of natural beds (or farmed areas where shellfish have already been growing in situ for at least 3 months), a minimum of 10 samples would normally be required from each identified monitoring point over a 3* month period. Samples should be taken no more frequently than at weekly intervals. Sampling is continued on a monthly basis once a provisional classification is in place. Potential class A sites: More monitoring data may be required for the designation of class A areas depending on the location of the bed (i.e. catchment risk) and outcome of the initial 10 samples (i.e. average level/magnitude of results). Strict compliance with the requirements of the intended classification category (criteria as set out in the Introduction) is required for provisional classifications. Relaying areas: The Regulations require relaying areas to be classified and monitored in a similar manner to production areas. They must be designated by the FSA. Furthermore, relay areas must have clearly identifiable boundaries by the use of poles, buoys or other fixed means and operate on a batch basis i.e. 'all in all out' system. Batches and species may not be mixed at any one time. General note: Sites returning prohibited level results (>46,000) in initial monitoring towards classification may be designated as prohibited for all species, however, each situation will be assessed on a case-by-case basis. Criteria for upgrade will be as described in section 1.10 Trigger values under Annual classification system. *In those cases where shellfish are moved from one unclassified area to another (e.g. to an area considered more suitable for a farming operation) monitoring of the new area would be required over a minimum period of 6 months from the last movement of shellfish before classification is recommended. This period has been set to allow for possible extreme levels of contamination (possibly not adequately reflected by E. coli monitoring) to be removed and to be consistent with the requirements for movement of seed shellfish. Twelve samples will be required from each identified monitoring point. N.B. Shellfish moved in this way must have been in situ for at least two weeks before the first classification sample is taken. 1.3 Ongoing monitoring Ongoing monitoring. Once a provisional classification is in place then the monitoring frequency normally reverts to monthly unless otherwise recommended on the basis of a sanitary survey/prmp assessment. Increased frequency monitoring. Areas that have shown high results (i.e. results outside of the existing classification category of an area) may be required to increase monitoring frequency (e.g. fortnightly). This is in order to assist with the assessment of whether the underlying level of contamination has changed. Reduced frequency monitoring. For areas that become commercially inactive for an extended period of time (6 months or more) due to low stocks or formal closure, it may be possible to agree a reduced frequency of monitoring (sites will then normally be added to the temporarily declassified list). Details of this should be discussed with Cefas in the Version 15 June

21 first instance. Full monthly monitoring must be resumed prior to any recommencement of commercial activity. Prohibited areas. Monitoring may be reduced or suspended in Prohibited areas where no discharge improvements are expected in the near future i.e. generally within a year or more. Where such a suspension has been in place, monthly monitoring should recommence 6 months prior to any planned discharge improvements to create some background data from which the level of any derived shellfish microbiological quality improvements may be assessed. 1.4 Requirements for a full classification At least 1 years worth of results with regular monthly monitoring are necessary for full classification status. In areas where compliance with the existing classification category is marginal, historical data in addition to data from nearby monitoring points should be considered to determine whether the extent of any contamination is significant. 1.5 Requirements for seasonal classification* At least 2 years worth of data is required in order to define a seasonal classification. The season will be allocated in periods where historic results conform to the elevated classification level. e.g. For an active class B season of 1 st March to 30 th of May, all results recorded in previous years between these dates must be equal to or below 4,600 E. coli/100g. (For a class A season, 80% of results must be equal to or below 230, with no result exceeding 700 E. coli/100g) The active season is preceded by a transition period (2 months from class C to B & 1 month from class B to A). The historical results during the transition period must also conform to the "better" classification category. If Local Authority resources allow, the active season may commence early following the receipt of two samples (taken at least 7 days apart) within the transition period, both results must be compliant with the better classification threshold (i.e. less than or equal to 4,600 for class B and 230 for class A areas) for the active season to commence. e.g. For an active class B season of 1 st March to 30 th of May, the transition period will be 1 st of January to 28 th of February. In the event that one or both samples in the transition period are not compliant, the LEA will continue to sample until two consecutive compliant samples (at least 7 days apart) are obtained before the season at the better classification may commence. This may mean the start of the season is delayed. Such decisions will be made on a case-by-case basis by the FSA. If the season is delayed (following non-compliant transitional samples) for two consecutive years then the seasonal classification period will be reviewed. Transitional results will normally be included in the classification dataset (i.e. used for classification assessments). A valid season should be at least 3 months in length and be of benefit to the industry i.e. fall during a period when harvesting would normally take place. Version 15 June

22 It is normally encouraged that monthly monitoring should continue throughout the year (e.g. to check that Prohibited level results do not occur during the closed season). If this is not possible then 12 samples should be taken during the season itself and the preceding 2 months. If the season is short (<6 months) then samples may be taken at fortnightly intervals if necessary. The minimum interval between samples in any event should be 7 days. If a season is less than 3 months, these will be considered on a case by case basis. LAs should contact Cefas/FSA to discuss what sampling arrangements are necessary. If the harvesting season is restricted, for reasons other than compliance, and are beyond industry control (i.e. Inshore Fishery Conservation Authority byelaws). LAs should contact Cefas/FSA to discuss what sampling arrangements are necessary. 1.6 Minimum number of samples A minimum of 8 samples per review year (1 July to 30 June) is required for class B, long term B and C areas and 10 samples for class A areas. Anything less than the minimum requirement may result in declassification of the site(s) concerned. This is an absolute minimum requirement and full monthly monitoring (i.e. 12 samples per year) is the normal expectation for all active classified sites. 1.7 Declassified sites Sites with below the minimum number of samples during any one year (as defined above) will be placed on the declassified sites list unless they have no samples at all over the previous year in which case they may be dropped from the classification listings altogether. Reclassification of sites on declassified sites list For quarterly monitored sites on the declassified list: - Immediate preliminary classification may be given at the previous level providing there are no issues with quarterly monitoring compliance and once there is a resumption of monthly monitoring. If there are problems with compliance during the preceding quarterly monitoring then reclassification will be considered on a case-by-case basis - some further sampling may be necessary before reclassification at the previous level is possible. Alternatively, immediate preliminary classification may be given at one level worse (e.g. C rather than B). For non-monitored sites on the declassified list (no results in the last 12 months): Preliminary classification can be awarded immediately at one level worse than the previous classification (e.g. C rather than B). Alternatively, four samples can be taken at least one week apart, for preliminary classification at the previous level (provided results do not indicate significant deterioration in water quality has occurred since the classification lapsed). In either case monthly monitoring should be resumed to retain classification. A site should only be kept on the declassified list for a maximum of 2 years without any monitoring. The procedure detailed above for non-monitored sites can only be applied if reclassification is sought during that time. Biotoxin monitoring may also be required before harvesting can recommence. Please contact our biotoxin co-ordinator on or biotoxinmonitoring@cefas.co.uk. Version 15 June

23 1.8 Ongoing review of data The results are reviewed on an ongoing basis and any "one off" exceptional results or accumulation of high results must be acted upon according to the criteria laid out below (see section 1.10 on trigger values). Results tested outside 48hrs from sample collection time must not be included in the data assessment. Classifications of B, long term B and class A beds are assessed on a rolling basis following submission of each result and upgrades/downgrades will be issued by the FSA as appropriate (see section 1.11). LEAs should ensure all local industry members within their area of responsibility are aware of the changes. Sites showing marginal classifications will be identified with an explanatory note 4 in the classification list and will be formally reviewed on an annual basis, normally taking into account the last 3 years' data, or all data if less than 3 years' worth is available, or 5 years if the site is classified long term B. Trees 2 and 3 on pages 19 and 20 illustrate how data from class B areas in both the annual and long term classification systems will be assessed upon receipt of each result. Class C areas are currently not included in the rolling assessments. If significant changes in contaminating sources (e.g. significant known changes in sewage discharge arrangements) have occurred then only the data obtained since the change(s) will be included in the review. This will be assessed on a case by case basis. In cases where a sanitary survey/prmp assessment has been carried out historical data from the old point representing a particular bed should be combined with that from the new point providing both RMPs fall within the new zone and both are the same species. The impact of faecal pollution sources may vary according to environmental and other factors and therefore an appropriate assessment of the status of areas can only be made on the basis of a relatively large number of samples spread over a length of time and environmental conditions. Three years is considered to be the minimum period over which much of the range of variability may be seen but this will vary from area to area. Review of a three year dataset is in accordance with recommendations made in the EU Good Practice Guide: Version 15 June

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28 1.9 Temperature recording and reporting In order for an appropriate assessment to be made in the event of anomalous results, sampling officers are asked to measure the temperature of the surrounding seawater at the time of sampling and record this on the collection form. If the nearest water is too far away to measure (e.g. at low tide at some sites) then measuring the internal sample temperature (i.e. between shellfish) is acceptable. Testing laboratories should also record and report the temperature on receipt at the laboratory. Shellfish samples properly packed in a cool box should reach a temperature of less than 10 C within 4 hours and then maintain this for at least 48 hours. Samples should not be received frozen, and if they are, they should not be tested. On receipt at the laboratory, the internal air temperature of the cool box should be checked and recorded. The time between sample collection and commencement of testing should not exceed 48 hours (samples will not be tested if greater than 48 hours between collection and test start). Local Authorities are encouraged to minimise the time in transit wherever possible, and still aim for less than 24 hours between collection and test start, where at all possible practically. Elapsed time between sample collection and receipt at the laboratory is 4 hours or more: If the internal air temperature exceeds 10 C then the between-shellfish temperature should be checked. If this is at or below 10 C, the sample(s) is(are) satisfactory. If this is above 10 C, samples are not satisfactory and will not be tested Elapsed time between sample collection and receipt at the laboratory is less than 4 hours: The air and contents will not necessarily have reached 10 C or less within this period but should be less than the temperature at the time of sampling. Results that are submitted to Cefas without temperature records for sample collection and sample receipt at laboratory will not be accepted for classification purposes. For full definitive details of the requirements for sampling please see the sampling protocol for Local Authorities which is held at: Version 15 June

29 1.10 Trigger values under classification system When results above the classification limit for a production area are returned, an Action State or Investigation State will be put in place. Standard notifications will be sent to the relevant contact at the LEA and EA region by Cefas under each of these. The specific notification sent will depend on the magnitude of the result and the bed s compliance (summarised in the following sections) Action State Applies to all classifications: A class - >700 E. coli/100g of flesh; B class - >18,000 E. coli/100g of flesh C class - >46,000 E. coli/100g of flesh See Action State section (section 3.3) for details Investigative state Criteria for notification: Class A One result >230 but <700 There are two types of notification for class A beds: 1. Cause for concern (investigation only) issued following second result >230 (but <700) in rolling 12 month period. Site still complies with class A criteria so notification for investigative purposes only. 1 year compliance is >79.5% so no change in classification needed at this stage. 2. Possible downgrade issued following a third result >230 (but <700) in rolling 12 month period as compliance has now fallen below 80% limit (based on 10 samples); also issued following one result of >700. Class B and Long Term B areas One result >4,600 but <18,000 There are three types of notification for class B beds: 1. Cause for concern (investigation only) site still complies with class B/B-LT criteria so notification for investigative purposes only. 1 year compliance is >89.5 so no change in classification needed. 2. Cause for concern (Class B/B-LT: marginal compliance) site no longer complies with class B/B-LT criteria but does not meet criteria for immediate downgrade. 1 year compliance is <89.5% and 3 year Version 15 June

30 (B) or 5 year (B-LT) compliance is % so site falls within buffer. Classification will be assessed on an ongoing basis and at annual review (September) if marginal compliance continues. FSA will be advised to update classification list with an explanatory note 4 to denote marginal compliance. 3. Possible downgrade issued following a result > 4,600 and 1 year compliance is <89.5% and 3 year (for Class B) or 5 year (for Class B-LT) compliance is <84.5%. Also issued following a result of >46,000 (See section ) regardless of percentage compliance. For more details on compliance assessments see section 1.8 (Trees 2 and 3 above). Class C areas Not applicable. Action: * LEA requested to inform industry (where possible) and make EA aware of results * LEA asked whether they know of any obvious cause(s) * Standard notifications to be sent to EA and LEA (copied to FSA) requesting information with regard to possible cause(s). * Monitoring arrangements (e.g. frequency) may be discussed with LEA Possible downgrade Applies to all classifications: Criteria for notification Class A areas 3 results >230 but <7,00 or 1 result >700 Class B and Long Term B areas Site meets criteria for downgrade as set out in section 1.8 (Trees 2 and 3). Either: o 1 year compliance is <89.5% and 3 year (B) or 5 year (B-LT) compliance is <84.5%. Or o Result >46,000 returned. Site may be downgraded following outcome of investigation into high result (if this is the second result >46,000 site may be recommended for prohibition, however, each situation will be assessed on a case-by-case basis). Class C areas 2 results >46,000 (site will normally be recommended for prohibition, however, each situation will be assessed on a case-by-case basis) Version 15 June

31 Action: * Cefas to notify FSA * Cefas to inform EA standard notification to be sent * Cefas to advise LEA of situation and ask for industry to be informed standard notification to be sent. * Cefas to refer to relevant dataset and data from neighbouring points to determine whether compliance overall warrants a downgrade and advise FSA via interim update recommendation. FSA to decide whether site will be downgraded and inform LEA and Cefas of their decision Actions following outcome of investigations For areas under notification of possible downgrade (including those under an Action state), results will be reviewed in the light of the outcome of investigations. If deemed appropriate by the FSA, results may be waived if there is sufficient justification (see Criteria for disregarding results section for details) and in this case a downgrade may not be necessary. If, however, all results remain valid and overall compliance is less than that described above for the relevant classification category then a downgrade will be recommended Areas showing improvement Percentage compliance with regard to potential upgrade for all classifications will be reviewed on a rolling basis following receipt of each result. If a site meets the criteria for upgrade then the following action will be taken:- * Cefas to analyse relevant dataset and data from neighbouring points * Cefas provide analysis to FSA for decision * Cefas to discuss proposal with LEA Upgrade Criteria Class B areas (possible upgrade to A) Mandatory requirement: 80% of results must be less than or equal to 230, with no results >700 over the most recent 3 year period (at least 24 samples). Good Practice Guide considerations*: To give a reasonable level of confidence that a water quality improvement has actually occurred and that an upgrade is therefore justified the EU Good Practice Guide recommends that there should ideally be a minimum of 24 results over the most recent 3 years showing at least 80% compliance with 230 and no results >700. Where known discharge improvements have taken place then this period may be reduced with increased monitoring frequency. Class C areas (possible upgrade to B) Mandatory requirement: 90% of results must be less than or equal to 4,600 over the most recent 12 month period (at least 10 samples) with no result over 46,000 within that period. Version 15 June

32 Good Practice Guide considerations*: To give a reasonable level of confidence that a water quality improvement has actually occurred and that an upgrade is therefore justified the EU Good Practice Guide recommends that there should ideally be at least 24 results over a minimum period of 3 years showing 90% (or better) compliance with 4,600. Where known discharge improvements have taken place then this period may be reduced with increased monitoring frequency. Prohibited areas (possible upgrade to C) Mandatory requirement: All results must be less than or equal to 46,000 over the most recent 24 month period with at least 20 samples. Where known discharge improvements have taken place then this period may be reduced with increased monitoring frequency. * Good Practice Guide available at: Interim classifications for new areas and upgrades/downgrades * If areas show sufficient deterioration or improvement in monitoring results during the year to warrant a downgrade or upgrade, or a new area(s) is (are) identified then an interim update is recommended to the FSA. This is achieved via a minute giving brief details of the background to the area, a summary of the results for the period in question, the local EHO's views on enforcement matters and the likely effect on the industry of the proposed change. The criteria for both downgrades and upgrades are listed in section 1.10 (see above). Appropriate actions should be carried out and standard notifications sent according to the criteria specified in this document. An accompanying table is produced that takes the same format as the annual update listing. The contact names and addresses of the relevant enforcement authorities are also given. Version 15 June

33 2. Long Term Classification (LTC) system 2.1 Introduction The aim of a LTC is to introduce greater stability in the classifications which are based on compliance over 5 years (rather than three). This has the effect of smoothing the effect of poor results in anomalous years due to varying factors such as higher than average rainfall thereby allowing industry greater confidence to invest in their businesses. 2.2 LTC criteria LTC only applies for class B beds which meet the following criteria: At least 40 results must be available over the last 5 year period Sites must show 90% or better compliance with 4,600 E.coli/100g Sites must not have returned a result >46,000 in the last 5 year period Where known sewage discharge improvements have been made and data exists to demonstrate that the underlying quality of the water has significantly improved over a three year period, the FSA may consider, following analysis of the data, recommending these sites for inclusion in the LTC system. In the event of persisting deterioration in water quality, affected areas may lose their LTC status (see Tree 3). All recommendations would be based on the statutory classification data and compliance against the classification category thresholds defined in EC Regulation 854/2004. Areas with a mix of A and B classifications over the last five years may be eligible for inclusion in the LTC scheme as class B, but harvesters, in agreement with the LEA, may choose to remain in the annual classification scheme.. Similarly B class areas that satisfy the LTC criteria, but which achieve two years worth of class A results are permitted to opt out of the LTC and revert to the annual classification scheme. The approach to be taken in such situations is to be decided on a case-by-case basis in consultation with the LAG and the FSA. The A and C class action state trigger values have been set to coincide with the upper E. coli limits allowed by EU legislation for these classifications. For practical reasons, a different approach is taken for B class areas. In order to achieve improved consumer health protection in a way which is manageable given existing resources, it is proposed that action is graduated. Version 15 June

34 It is proposed that all B class areas giving a test result in excess of 4,600 E. coli/100g of flesh would, as a minimum, be investigated. However, at levels above 18,000 E. coli/100g of flesh, an action state will be initiated. This risk based, tiered approach is considered proportionate and has the advantage of directing action to where it is most needed. The tiered approach is described in more detail below. 2.3 Receipt of results and ongoing review of data Shellclass mailbox - result checking and appropriate actions Electronic results files (Excel documents) are checked on the day that they arrive at Cefas in the Shellclass mailbox from the testing laboratories. Appropriate actions are instigated on the same day whenever possible. Results failing any of the Annual classification trigger values, LTC class B investigation thresholds or Action State values (all sites) are acted upon on the day of receipt at Cefas. Version 15 June

35 Sample group GM E.coli Statistical assessments Where deemed necessary by the FSA, statistical assessments may be carried out to assist with the interpretation of classification monitoring data. The precise statistical tests to be used will be subject to periodic review based on their performance. These tests are required for all results >4,600 returned for LTC class B sites. If tests fail then a formal 5-year percentage compliance assessment will be made of data at the site against the legislative threshold of 4,600 E.coli/100g (see Tree 2). Essentially two main tests are used with the results being displayed graphically to allow ease of interpretation. For these tests, a graph is created showing the geometric means of groups of 12 results (approx. 1 years worth of results) in sequence over the last 5 years (blue diamonds). The graph (Figure 1) overlays two upper 80% confidence limit lines as warning lines. The first of these is based on the average level of variation seen at the particular site (yellow line) returning the high result - it is designed to show whether the recent results are showing an unusual trend for that site. The second line is based on a national set of data obtained from class B points across England and Wales (pink line referred to as upper legislative limit ). It is therefore intended to show whether the latest results are unusual in the context of sites typically showing class B compliance. Native oysters Geometric mean (12 samples) 100 B upper legislative limit site based limit 10 1 Sample group Figure 1. Site-specific and legislation based 80% confidence warning limits Version 15 June

36 Moving Range Individual Value A third form of graphical analysis will also be used for comparison (Figure 2). The I and MR chart (Figure 2) illustrates the general variability of results (individual values) and the difference in magnitude between consecutive results (moving range). Both indicate that the general level of results remains generally unchanged. I and I and MR Chart for EColi Using MR Box-Cox chart Transformation for With log Lambda E. = coli Subgroup UCL=10.64 Mean=6.638 LCL= UCL=4.912 R=1.504 LCL=0 Figure 2. I and MR chart N.B. Individual value and Moving range numbers on Y axis relate to natural log values (output of statistical software used). UCL = Upper Confidence Limit 3 standard deviations. LCL relates to Lower Confidence Limit 3 standard deviations. In the case of B class areas, a graduated approach is taken under LTC to facilitate prompt investigation of abnormal results and appropriate immediate action to protect public health. In order to restrict costs, the extent of the measures depend on the E. coli levels detected. As a minimum, every result from a B class area which exceeds the statutory levels would be investigated, and the findings acted upon. Control measures should be implemented as appropriate. N.B. The statistical tests used are adapted from parametric methods (a parametric method being a method of testing a hypothesis which requires the user to assume a particular model for the distribution of data, e.g. in this case a log normal distribution). We are aware that with classification data we are dealing with discrete MPN outcome estimates rather than continuous normally distributed measurements. For information on the role of Local Action Groups/Local Action plans (LAG/LAPs) see Section 3.3. Version 15 June

37 3. General items 3.1 Miscellaneous items Receipt and collation of monitoring results * Shellfish harvesting result sheets are received on a daily basis. Results are sent to Cefas directly by the testing laboratories. These arrive by using the addresses shellclass@cefas.co.uk & SHSDataimports@cefas.co.uk. Results are uploaded automatically to the Cefas website results page on a daily basis Reviewing existing monitoring programmes The number of sampling points may be rationalised once historical trends have been established. The point(s) yielding the highest results would normally be maintained and this is particularly relevant if no enforceable split classification would be possible Investigative samples Unless a higher frequency of monitoring (e.g. fortnightly) has been agreed with Cefas, classification datasets will normally consist of monthly data. Ad hoc samples taken following high results should be regarded as investigative samples and not included in the classification dataset so as to avoid possible bias by autocorrelation effects (i.e. over-representation of samples from the period when high E. coli levels were observed) Criteria for disregarding results Results that can be attributed quite clearly to very unusual or one-off events that are unlikely to recur may be excluded from classification considerations. An event occurring up to 48 hours prior to sampling will usually be considered (in the absence of any specific information relating to catchment retention times etc.). This will not, however, preclude the possibility of short-term control measures being applied to protect public health e.g. the issuing of a temporary closure notice (TCN). Examples of events that may lead to results being disregarded are: Sewage treatment works failure* 1 in 5 year (or longer) return period storm event* Failure to comply with the standard sampling protocol in practice this has meant the exclusion of results for samples that have exceeded the 24-hour limit between sampling and testing. Version 15 June

38 * Where it is deemed that the resulting discharges will have markedly impacted on the shellfish bed(s) information obtained from the Environment Agency (EA) and LEA is used to assist in this determination. 3.2 Production and distribution of classification zone maps For newly classified areas: Information taken into account when deciding on the extent of the area to be classified: * Outcome of sanitary survey/prmp assessment * Shellfish bed position and extent in relation to monitoring points * Position of any adjacent classified areas * Position of all likely polluting sources e.g. continuous and intermittent discharges * LEA enforcement issues * Use of identifiable landmarks e.g. low water features, navigation buoys etc where appropriate when defining area to facilitate enforcement and aid identification of classified area for industry The classified area must be defined up to the mean high water line using 8 figure OS grid ref and lat/long co-ordinates (decimalised minutes) at relevant boundary points. The final classified area must fully encompass the bed (or agreed area) initially identified for monitoring and should normally include a margin intended to allow for some natural bed drift/displacement but without compromising public health for example by extending a classified area nearer to a discharge than is adequately reflected by the existing monitoring arrangements. Local circumstances will vary and latitude allowed will depend in particular on intervening dilution factors and size of the discharge. Such aspects would be considered in the sanitary survey/prmp assessment for each area. Once the area to be classified has been defined and mapped it should be thematically mapped using the shading appropriate to the classification status of the area (see example layout below) For existing areas with classification status change (i.e. upgrade or downgrade) * Confirm with LEA whether any enforcement difficulties will arise from the change in classification status of the existing classified area. Individual maps are produced by production area for each species and uploaded to the Cefas website where they can be accessed by the relevant LEA(s) at Version 15 June

39 Example final map layout format: Version 15 June