Shellfish Review : Bivalve mollusc classification and monitoring: consultation on changes to the official control programme

Closed 19 May 2017

Opened 17 Feb 2017

Results updated 18 Oct 2017

We would like to thank all stakeholders that took the time to provide their considered views in relation to this consultation. 

We have published a work plan to deliver a more efficient and effective suite of official controls in the shellfish sector.  This was outlined in the FSS Board paper published in August 2017.

We have set up a Shellfish Classification and Monitoring Industry Forum to progress this work and hope to achieve appropriate change through collaboration and innovative approaches.  Our first meeting took place in October 2017 and terms of reference will be published shortly.




Bivalve shellfish, such as mussels, oysters, scallops (pectinidae) and razor clams, are filter feeders and can accumulate dangerous toxins and pathogens quickly.  Shellfish toxins, which can be fatal, are heat stable which means that, unlike microbiological and viral contaminants, they cannot be removed through cooking.  These toxins are produced by naturally occurring phytoplankton (algae) and therefore present a different risk management challenge to faecal-borne pathogenic contaminants, such as norovirus, which derive from man-made inputs such as sewage discharges.  However neither of these contaminant risks are inputs over which shellfish harvesters have any control.  Given this multi-factorial environment, as well as the potential severity  and history of illness associated with shellfish, an extensive raft of official controls is explicitly set out in EU law.

FSS is defined in law as a competent authority in relation to the delivery of a significant number of shellfish official controls (OC) with a particular focus on the monitoring of harvesting waters for the presence of E. coli (as an indicator of microbiological quality) and shellfish toxins.  There are no other areas of food law where routine environmental monitoring (as opposed to monitoring within individual businesses) is required to be carried out by the competent authority to such an extent and where the outcome of such monitoring will have such an immediate and direct effect on specific businesses.  Official control monitoring is primarily used in order to prohibit fishing in areas when statutory levels are breached.  However, the data generated by the programme also provide evidence for biotoxin trends in harvesting areas which should be reviewed on an on-going basis to identify periods of increased risk and inform appropriate risk management decisions by harvesters and processors. 

The FSS shellfish OC programme budget in 2016-17 is £2.4m within an overall FSS programme budget of £8m.  Given that monitoring, which constitutes the bulk of the OC function, becomes a statutory requirement once FSS provides a classification, it is appropriate that we consider not only our approach to classification and monitoring, but how we might ensure that official control delivery in this sector is as efficient and sustainable as it  can be in future.  This issue is being considered within the wider context of a FSS Shellfish Review which is currently underway.

FSS Shellfish Official Control budget 2016/17 is detailed below.

Official control

FSS programme Budget at April 16

Biotoxin Monitoring of Classified Shellfish Production Areas


E. coli Monitoring


Inspection of Depuration Plants


Phytoplankton monitoring


Sanitary Survey of Classified Shellfish Production Areas Prmp[2]


Shellfish Chemical Monitoring


Sampling Officers




Why your views matter

This consultation invites views from harvesters, processors, local authorities and all those with an interest in the shellfish safety, on proposed changes in the following areas:

Shellfish classification.  We want to consider ways in which FSS and industry can work together to deliver a targeted official control programme by looking at the way we classify areas.   Proposals on the principles regarding an FSS decision to classify an area in the first place are outlined in Annex 1 of the main consultation document.

New legislative criteria for classifications and end product standards applied from 1st January 2017.  A separate consultation has been issued outlining proposed changes to the FSS protocol for determining classifications based on results received. You can access this via the following link:  proposed changes to the way classification determinations are made.

Depuration.  FSS currently provides specific support to local authorities and businesses involved in purifying/depurating shellfish.  However given that food businesses are required to put in place and validate their own food safety management systems, we consider it appropriate to review approaches in this area.  Annex 2 of the consultation document describes FSS proposals that will affect both food businesses involved in purifying shellfish and local authorities which are responsible for approval.

Biotoxin monitoring.  Given that biotoxin monitoring accounts for 45% of the shellfish budget within FSS, we are taking the opportunity to review how we deliver this element of the programme in order to ensure best value and effective delivery.  See Annex 3 of the consultation document for detail.

Sampling, phytoplankton monitoring and general programme issues.  This section invites views on the ways samples could be collected and verified particularly for wild shellfish areas.  We are also interested to hear from stakeholders on the ways they use the phytoplankton programme to monitor risk, and to invite wider views on the ways the official control monitoring programme for shellfish could be improved as a whole.  See Annex 4 of the consultation document.

This consultation informs the overall outcome of the Shellfish Review Project which is referenced in the FSS Corporate Plan under Strategic Outcome 1 as follows:

FSS Corporate Plan under Strategic Outcome 1

Carry out a comprehensive policy and delivery review of the FSS shellfish official controls, including small scale and local supply chains, working in partnership:

Ensure proportionate and targeted interventions to protect public health and maintain consumer confidence thereby promoting sustainable growth.

Review and modify as required, such that resources match policy and delivery priorities.

The consultation will be considered through the prism of the FSS Regulatory Strategy and aligns with the principles for effective and sustainable official controls agreed by the FSS Board in August 2016.  

Please note this consultation period has been extended by 1 week and will now close on 19th May 2017.

What happens next

Your response to these questions and any other issues raised in the course of this consultation will assist in ensuring that proportionate and consistent controls apply across Scotland.


  • Food Producer
  • Fisherman
  • Local Authority
  • Local Authority
  • Public analyst laboratory
  • Commercial food testing laboratory
  • Local authority
  • Primary producer
  • Scottish Government
  • FSA
  • local authority
  • Society of Chief Officers of Environmental Health


  • Microbiological safety of food
  • food authenticity
  • food surveillance
  • environmental monitoring
  • foodborne illness
  • laboratory assurance
  • food analysis
  • scientific advice
  • food safety
  • allergens
  • food-bourne disease
  • food-bourne pathogens
  • regulation
  • enforcement
  • primary production
  • Local Authority Enforcement Monitoring System
  • food safety
  • food authenticity
  • food surveillance
  • foodborne illness
  • food analysis