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Marine Institute - Foras na Mara

Overview of the Marine Institute (MI)

Organisational structure of the MI (relating to seafood safety)

The Marine Institute (MI) was set up under the Marine Institute Act 1991 and is the state agency responsible for marine research, technology development and innovation in Ireland. The Department of Agriculture, Food and Marine (DAFM) is the parent department of the MI. The MI is made up of 6 service areas, one of which is the Marine Environment and Food Safety Services (MEFSS) division. 

The MEFSS division plays a role in official controls and other official activities of foodstuffs, providing essential scientific advice and a range of marine environmental monitoring services to DAFM, the Sea Fisheries Protection Authority (SFPA), the Food Safety Authority of Ireland (FSAI) and Department of Housing, Local Government and Heritage (DHLGH), to help ensure Irish seafood products meet approved food safety and quality standards. The MI is an official agency of the FSAI, with a service contract agreement, which outlines the agreed level and standard of seafood safety activity that the MI performs.

The MI is also the Competent Authority for the implementation of aquatic animal health controls under Regulation (EU) 2016/429.

Areas of official controls as defined by Art 1(2) of Regulation (EU) 2017/625

  • Article 1(2)(a) Food (production, processing, distribution)
  • Article 1(2)(a) Food contact materials
  • Article 1(2)(d) Animal Health Requirements

Delegation of official controls

Delegated Official Control Laboratories:

Chemistry residues

The MI subcontract private, approved laboratories to conduct testing for certain residues in aquaculture products. All approved laboratories comply with Article 38 of Regulation (EU) 2017/625 and participate in proficiency tests where available. Methods used by the private laboratories are detailed in the aquaculture national residue plan which is submitted to the Commission by DAFM annually.

Microbiology

The MI subcontract private, approved laboratories to conduct testing official control testing for E.coli in shellfish, for the classification of shellfish production areas. All test results are reported to the MI and the SFPA on the day that they are generated as per each laboratory’s testing contract. Official laboratories participate in the Public Health England External Quality Assessment Shellfish scheme. This is mandated in the contract between the national reference laboratory (NRL) and the testing laboratories.

Scope of responsibility of the SFPA for the official control of food

The MI works in partnership with the SFPA and the FSAI to enhance consumer protection and ensure a seamless inspection service. This is achieved through the provision of scientific advice, conducting risk assessments, conducting analyses and monitoring analyses from other laboratories. The MI carries out analyses to ensure compliance with legislative requirements with respect to general food law, official controls, food hygiene, contaminants, residues of veterinary medicines, microbiological criteria and marine biotoxins.

The MI acts as an NRL for certain parameters (further information on the analytical role of the MI is available on the FSAI website.

Further information on the MI’s food control activities can be found in the FSAI Marine Institute service contract.

Scope of responsibility of the MI for the official control of Animal Health

The Marine Institute is the Competent Authority for the implementation of aquatic animal health elements of Regulation (EU) 2016/429. The Fish Health Unit (FHU) of the MI approves aquaculture establishment (as defined in regulation) and implements risk-based surveillance on all finfish and shellfish aquaculture sites in the country. All movements including imports, exports and internal movements of live aquaculture animals intended for further farming are controlled by the MI. Relevant disease diagnostic work is carried out by the FHU laboratories in support of the competent authority related duties.

Official Controls

Risk categorisation and frequency of official controls

Residue Control Plan

The planning process for the national residue control plan for aquaculture is detailed in the MI’s standard operating procedure (SOP) for preparation of the national residues control plan (NRCP), CHE-78 National Plan for Residues Preparation. This SOP details the assessment of what compounds are included in the NRCP, and how they are selected in conjunction with the SFPA. The NRCP complies with the approach outlined in Directive 96/23/EC and details the minimum number of samples and substances to be tested.

Shellfish Biotoxin Sampling

Shellfish production areas are under the Official Control of the SFPA and coordinated by the SFPA Shellfish Monitoring Coordinator. The SFPA liaise with the MI for setting sampling frequencies. The frequency of shellfish sampling is based on an assessment of the latest toxicity information available and seasonal trends, as per the Code of Practice on Biotoxin Monitoring.

Phytoplankton Sampling

Water samples from every classified shellfish production area are tested weekly for phytoplankton. A minimum of three weekly samples is required in every rolling 4-week period to maintain an Open status, as per the Code of Practice on Biotoxin Monitoring.

National control plans

The MI is involved with the following specific National Control Plans:

Other Areas of Work

Other control programmes that the MI are involved in and provide advice to include:

National Reference Laboratory

The MI has been designated as Ireland’s NRL in several areas:

  • Microbiology

    • Foodborne viruses (shellfish only).
    • E. coli (shellfish only).
    • Microbiological classification of shellfish production areas (this duty falls under the Marine Biotoxins NRL).

  • Chemistry residues

    • Group B (2) (a) Anthelmintics – Emamectin in Aquaculture only,
    • Group B (2)(f) Teflubenzuron & Diflubenzuron in Aquaculture only,
    • Group B (3)(e) Malachite Green, Leuco Malachite Green and other dyes in Aquaculture only
    • Group B (3) (a) Chemistry Metals - for mercury, lead and cadmium in finfish (aquaculture).

  • Fish health unit

    • Finfish, crustacean and mollusc diseases.

  • Biotoxin chemistry

    • Marine Toxins.

A full list of Ireland’s NRLs and their designated parameters can be found on FSAI website.

The MI have obtained accreditation from the Irish National Accreditation Board (INAB) to the ISO Standard ISO17025-2017. The ISO17025-2017 standard outlines all the requirements that testing laboratories must demonstrate to prove that they are technically competent, and that the laboratory generates technically valid results. As part of INAB accreditation, the MEFSS quality system and test methods are audited by independent technical experts to ensure compliance with the standard. The MI have 35 accredited test methods and are accredited for taking samples for surveillance monitoring of finfish farming products. The scope of the MI’s accreditation can be seen here.

The MI’s Quality Manager manages and oversees the quality program. The laboratories are audited annually by INAB. The MI’s quality system is made up of an internal audit program, control of non-conforming work, risk and opportunities for improvement, complaint feedback, document control, impartiality, traceability, validation, technical records, test reports.

In compliance with Article 100 (2) and (3) of Regulation (EU) 2017/625, the MI is impartial and free from any conflict of interests. This is part of the MI’s accreditation to ISO17025-2017 and is reviewed as a standard agenda item at quality meetings. The MI labs have suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence.
Competency and training are reviewed and updated where required. Analysts have competency updated annually. The MI labs are suitability equipped and have access to the infrastructure, equipment and products to carry out their role effectively.

The MI organises and participates in proficiency/ring testing. Proficiency tests are documented in the MI’s quality system and updated with the type of proficiency test being carried out, the proficiency test provider, the scheme, the analytes being tested, the participants, the results obtained and non-conformance number if applicable, throughout the year. The laboratory also participates in external proficiency testing.

Resources and Facilities

Staffing resources

The MI provides the staff and all resources required to ensure delivery of service outputs/activity as outlined in the current service contract with the FSAI. 

Training needs are identified through performance management and development system, requirements in the laboratory, quality meetings, technical lab meetings and training, facilitated mainly through Human Resources department in the MI.

The quality system has training records for all staff. All certificates received are added to training records. All staff must complete evaluation forms when completing a training course and this is kept by the Human Resource training unit. All training related to the lab is recorded in individuals training records.

Laboratory resources

MI is a laboratory which provides analytical services. In addition, the MI provides the FSAI with details of external laboratories used for official controls.

IT resources

The MI has its own IT department. Documented procedures (SOPs) are available to all MI staff through an intranet service. The MI maintains the National Biotoxin and phytoplankton Database (HABS) and various other databases for maintaining and monitoring programme results.

Office facilities

The MI has office facilities as part of its premises in Oranmore, Co. Galway.

Regulation (EU) 2017/625 (General Obligations)

Article 5(1)(a) Effectiveness and appropriateness of official controls
Staff are given appropriate training in their area of competence, enabling them to undertake their duties competently. As part of ISO17025 accreditation for the laboratories and ISO9001 certification for FHU Competent Authority ongoing competency and training is carried out and maintained.

Article 5(1)(b) Consistency in the delivery of official controls
SOPs are in place as per ISO17025 accreditation for MEFSS laboratories and ISO9001 certification for FHU Competent Authority. Quality control procedures and measures are also in place. External proficiency testing is conducted for all accredited tests for ISO17025. Annual ongoing competency required for all analysts. Ongoing training where required.

Article 5(1)(c) Ensuring staff performing official controls are free from conflicts of interest
As per the ISO17025-2017 standard, labs are impartial and free from any conflict of interests, this is reviewed as a standard agenda item at quality meetings. The MI have procedures and/or arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels. Impartiality and conflict of interest statements are part of initial training and are signed off in training records. In addition, as part of official controls for residue monitoring (Council Directive 96/23/EC) all members of the residue programme complete a conflict-of-interest declaration form.

Article 5(1)(d) Access to adequate laboratory capacity
This is audited annually as part of the environmental conditions and accommodation audit. SOPs are in place in the laboratory.

Article 5(1)(e) Access to suitably qualified and experienced staff
It is the MI’s policy to recruit staff with appropriate academic and professional training and skills for the job function undertaken. The selection of personnel to work in the laboratory is carried out through a recruitment process by the MI’s Human Resource department. The Director/Section Manager/Technical Manager has input into the personnel required and the specific competency requirements for education, qualification, technical knowledge, skills and experience required for each role.

Article 5(1)(f) Access to adequate facilities and equipment
This is audited annually as part of the environmental conditions and accommodation audit and equipment audit. SOPs are in place for all equipment and all equipment is maintained through equipment records on Paradigm 3, the MI’s electronic document management system.

Article 5(1)(g) Ensuring staff have adequate legal powers to perform official controls
The MI’s residue team are Authorised Officers under the Animal Remedies Act to carry out sampling under Council Directive 96/23/EC.

Article 5(1)(i) Contingency Plans
The MI Fish Health Unit has developed a multi-agency contingency plan for responding to outbreaks of listed diseases of fish in Regulation EU 2016/429. 
The MI also operates a Business Continuity Plan and Corporate Risk Register that provides an overview of all eventualities in relation to MEFSS operations.

Relationships, Memoranda of Understanding and Service Level Agreements with other Competent Authorities

Shellfish monitoring

The MI work closely with the SFPA to coordinate the Shellfish Monitoring Programme for Ireland, in accordance with documented procedures – Microbiological Monitoring of Bivalve Mollusc Production Areas and Monitoring of Marine Biotoxins in Bivalve Molluscs from Production Areas

The MI also collaborate with the EU-RL's to improve co-ordination, in their area of competence, of the activities of official laboratories and, where appropriate, organise comparative tests between official laboratories. The MI also ensure the dissemination of information from the EU-RL to the Authority and the official laboratories.

Residues

The MI carries out monitoring of chemical residues for aquaculture on behalf of DAFM to comply with Official Control Regulation 2017/625 and Annexes of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in animals and animal products. The MI is the official laboratory for sampling and analysis and is the NRL for certain residue substances. The FSAI co-ordinates the activities of the various departments and agencies involved in delivering this programme. For the aquaculture sector, the SFPA, with technical support from the MI, is responsible for residue controls on farmed finfish to ensure compliance with the Residue Directive (Council Directive 96/23/EC).

The Marine Institute has a service contract with the FSAI which is available on the FSAI website.

The MI have a Memorandum of Understanding with the SFPA for the monitoring of chemical contaminants in fish and shellfish.

Communication procedures

The MI have the following measures in place to ensure effective and efficient communication:

Within the competent authority:

  • Communication within the MI takes place through various channels such as meetings, email, phone calls and online platforms such as Microsoft teams.

With other competent authorities and the FSAI

Formal communication:

  • Twice yearly bilateral liaison meetings with the FSAI
  • Quarterly bilateral liaison meetings with SFPA management and the Food and Fisheries Support Unit
  • Regional workshops with Senior Port Officers and Sea Fisheries Protection Officers
  • Trilateral meetings with the FSAI and the MI
  • Cross-agency meetings with other competent authorities
  • Participation in the Molluscan Shellfish Safety Committee
  • Working groups
  • Collaboration in development of guidance documents

Semi-formal communication:

  • Regular email contact
  • Phone calls

The reporting and communication channels between the FSAI and the MI are set out in the Marine Institute Service Contract. These requirements include a schedule of liaison meetings between the FSAI and the MI, data transmission in the form of agreed datasets and the annual report.

Documented Procedures

Availability of documented procedures to MI Staff

The MI is fully electronic and all SOPs, forms etc. are controlled and are accessible to MI staff on an electronic document management system called Paradigm 3. This is a fully traceable and auditable system.

Availability of documented procedures to the FSAI and auditors

The FSAI communicate with the MI on an ongoing basis on any relevant documentation via email or at regular meetings as required.

Prior to and during audits, documented procedures are made available to the auditors. Documentation is supplied to the Commission as requested, for example, in advance of Santé F audits.

Reviewing & updating procedures

All procedures are reviewed every 2 years by the technical manager or the quality manager. They are traceable and auditable on the electronic document management system. All staff are notified of any changes made.

Audit

Internal audit

The MI manages and maintains an internal auditing programme annually to comply with ISO17025 requirements. The internal auditing programme is managed by the Quality Manager and MEFSS Director. Approximately 40 audits are carried out annually including all aspects of the quality system, vertical audits and test witness audits. QAU-5 is the MI’s internal audit procedure and F-31 is the MI’s audit schedule. For ISO9001 Certification the Quality Manager also manages the internal audit programme with approximately 22 audits annually. 
The official laboratories contracted for E.coli testing are also audited by the MI, once every 2 years. The MI audit involves test witness and vertical audits as well as an audit of the laboratories overall quality system.

External audit

The MI MEFSS laboratories are audited annually by INAB to ensure accreditation for ISO17025-2017 for testing laboratories. ISO9001 Certification, for FHU Competent Authority is audited annually by NSAI. The MI may also be subject to audits by the FSAI and the European Commission. 
The MI have procedures in place to carry out risk assessments and risk register is maintained. The quality manager manages the risk register and ensures all procedures are reviewed and updated where required.