Scope and Key Objectives of the Audit Programme (and Audit Methodology and Design)

For the purposes of the audit programme, “shellfish” means live bivalve molluscs (LBM) which are defined by assimilated Regulation (EU) No. 853/2004 as filter feeding lamellibranch molluscs and can include oysters (pacific and native), mussels, clams, cockles. The programme also included checks on pectinadae in particular scallops and on gastropods such as periwinkles and whelks.

The audit examined LA delivery of official controls particularly in relation to Article 18 of assimilated Regulation (EU) No.178/2002 and relevant sections of assimilated Regulation (EU) No. 853/2004, assimilated Regulation (EU) 2017/625 and 2019/627 at establishments selling, storing and/or otherwise handling shellfish against the relevant legislation and any centrally issued guidance including the ‘Standard’ in Chapter 2 of the Framework Agreement, FLCoP and FLPG.

The audit programme sought to gain assurance that relevant LA food law enforcement services (including any relevant Port Health Authorities) are effective in their control of shellfish traceability, and to disseminate good practice related to the delivery of controls in this area.

The objectives of the audit programme were to:

• verify compliance with planned arrangements in order to provide assurance that controls are carried out as intended and required by theFLCoP, the Framework Agreement, relevant, central and locally issued guidance
• verify the effective implementation of planned arrangements by LAs
• assess whether planned arrangements are suitable to achieve the objectives of relevant legislation. In particular, the strategic objectives stemming from Assimilated Regulations (EC) 178/2002, (EU) No.625/2017 and specific legislation relating to the approval of
• establishments e.g., Assimilated Regulations (EC) 852/2004, (EC) 853/2004, (EC) 210/2013 and (EC) 2073/2005
• disseminate good practice
• identify issues that relate to FSA delivery policy

As of January 2024 there were 43 coastal LAs across England with shellfish harvesting activities taking place in their area. Only authorities with harvesting activities in their area were considered for the audit programme.

The audit programme consisted of audits of eight LA Food Safety Services across England. The audits focused on arrangements for delivery of official controls in relation to shellfish traceability and in particular the issuing of SRDs to harvesters by LAs. For the purposes of the statistics in this report, any shared services are considered as being single entities, as audited.

The programme was split into two phases, taking place between February 2024 and December 2024. As a starting point for the traceability assessment, Phase 1 of the programme began with the selection of batches of LBM from relevant coastal LAs in England, based upon the nature and scale of shellfish harvesting activities in their areas and their geographical location. A total of six LAs were audited as part of Phase 1.

Phase 2 of the programme involved following these batches of LBM to the next location in the supply chains and the corresponding LAs. These secondary LAs received a focused audit assessment of the delivery of traceability controls in relation to the batches of LBM. Phase 2 tracked the shellfish product through the supply chain and relevant LAs to the point at which an identification mark was required to be added to the product, normally a shellfish dispatch centre. Two LAs were audited as part of phase 2.

LAs for audit were initially selected based on the authority type and geographical location, excluding LAs that had been audited by the FSA in the previous five years. A list of the authorities audited can be found at Annex C.

The audit programme focused on controls that LAs had in place to deliver shellfish traceability requirements. These included the following areas, specifically in relation to shellfish traceability controls and issues:

• Organisation, Service Planning and Management
• Officer Authorisation, Competency and Training
• Guidance for Officers-Documented Policies and Procedures
• Food Establishments Database
• SRDs
• Food Establishments Interventions
• Reality Visits
• Enforcement
• Food Safety Incidents, Complaints and Infectious Disease Outbreaks
• Internal Monitoring and Corrective Actions

Audit Methodology and Design

Details of the audit methodology, design, and the evaluation and assessment framework used during the audits are set out in Annex D.