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

Overview

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.

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 1^st 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

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.