Ref. Ares(2018)2709936 - 25/05/2018 TABLE of CONTENTS INTRODUCTION

Ref. Ares(2018)2709936 - 25/05/2018 TABLE OF CONTENTS INTRODUCTION ...... 2 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) NO 882/2004 ...... 2 Designation of competent authorities ...... 2 Organisation and implementation of official controls ...... 2 Enforcement measures...... 19 Verification and review of official controls and procedures ...... 20 2 COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS ...... 25 2.1. Control system for animal health...... 25 2.2. Control system for food of animal origin ...... 29 2.3. Control system for imports of animals and food of animal origin...... 32 2.4. Control system for feedingstuffs and animal nutrition ...... 35 2.5. Control system for TSE/ABP...... 38 2.6. Control system for veterinary medicines and residues ...... 44 2.7. Control system for foodstuffs and food hygiene (food of non-animal origin) 48 2.8. Control system for imports of food of non-animal origin...... 51 2.9. Control system for plant protection products (PPP) and pesticide residues ....53 2.10. Control system for animal welfare...... 57 2.11. Control system for plant health...... 59 2.12. Control system for quality labelling (Organic, PDO/PGI/TSG)...... 61 ANNEX – ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS ...... 63

2 DG(SANTE)/2018-6471 Version date April 2018 INTRODUCTION

This overview has been drawn up by the Health and Food Audit and Analysis Directorate of the Directorate-General for Health and Food Safety of the European Commission, based on information supplied by Ireland.

The aim is to present, in summary form, the latest information on how control systems for food and feed safety, animal health, animal welfare, plant health and quality labelling are organised in Ireland.

Chapter 1 describes the overall organisation of the Irish authorities and the respective responsibilities of the ministries and government agencies in relation to the different components of the control system. A chart is used to help the reader better understand the inter- relationships between the responsibilities of the different bodies.

Chapter 2 gives a more detailed description of the main responsibilities for each of the twelve separate systems that form the complete range of control systems in Ireland, covering the whole chain of plant, animal and food production. As in Chapter 1, organisation charts are used to help the reader.

This overview was updated following a general follow-up audit in 2018 and will be updated at regular intervals based on relevant information received by the Commission from the Irish authorities.

Acronyms are used extensively throughout this overview for the sake of brevity. A list of acronyms, abbreviations and special terms is given in the Annex as a guide for the reader.

3 DG(SANTE)/2018-6471 Version date April 2018 Summary

The Department of Agriculture, Food and the Marine (DAFM) and the Department of Health (DoH) are the two departments in Ireland responsible for developing policy and legislation for food safety. Both departments are supported in their roles by the Food Safety Authority of Ireland (FSAI), under the DoH. In addition, DAFM is responsible for developing policy and legislation for feed safety, animal health, animal welfare and plant health as well as enforcement of legislation in relation to food safety at the level of primary production.

The Food Safety Authority of Ireland (FSAI) has overall responsibility for the enforcement of food safety legislation in Ireland, apart from at the level of primary production. FSAI manages its responsibility through contractual arrangements with the individual competent authorities (CA) concerned. These authorities include: the Health Service Executive (HSE), the Sea Fisheries Protection Authority (SFPA), the Marine Institute, Local Authorities (LA), and DAFM, which operates both centrally and regionally, and the National Standards Authority of Ireland (NSAI). The division of responsibilities throughout the country varies according to the control system involved. FSAI has a Memorandum of Understanding with certain bodies which have a role in food safety controls, such as Revenue’s Customs Service, but which are not specifically charged with the enforcement of food legislation. A comprehensive national laboratory network is involved in the analysis of samples and provision of scientific research.

The current version of the multi-annual control plan (MANCP), covering the period 2012 to 2017 (Version 1) and prepared jointly by FSAI and the DAFM is available on the FSAI website. A new National Control Plan covering the period 1 January 2018 to 31 December 2022 is expected to be published in 2018.

The Annual Report on the implementation of the MANCP for 2015 has been submitted to the Commission Services. The Annual Report on the implementation of the MANCP for 2016 had not yet been submitted at the time of the publication of this Country Profile.

4 DG(SANTE)/2018-6471 Version date April 2018 1 ARRANGEMENTS FOR THE IMPLEMENTATION OF CERTAIN REQUIREMENTS OF REGULATION (EC) NO 882/2004

Designation of competent authorities

Competent authorities

The following three charts show the various bodies involved in official control of food, feed, animal health, animal welfare and plant health, the different stages in the food chain and the competent authorities (CA) involved.

Chart 1 - Government departments, competent authorities and other agencies involved in official control of food (apart from primary production)

5 DG(SANTE)/2018-6471 Version date April 2018 Chart 2 - Government departments, competent authorities and other agencies involved in official control of feed, animal health and welfare and plant health

Secto r: Feed Secto r: Plan t Health Secto r: An imal Health an d Welfare

Go v ern men t Dep artmen t o f Ag ricu ltu re, Dep artmen t o f Ag ricu ltu re, Dep artmen t o f Ag ricu ltu re, Dep artmen ts Fo o d an d th e Marin e Fo o d an d th e Marin e Fo o d an d th e Marin e resp o n sib le fo r leg islatio n an d p o licy

Cen tral Co mp eten t Dep artmen t o f Dep artmen t o f Dep artmen t o f Au th o rity Ag ricu ltu re, resp o n sib le fo r Ag ricu ltu re, Ag ricu ltu re, Fo o d an d th e en fo rcemen t o f Fo o d an d th e Fo o d an d th e Marin e Marin e Marin e leg islatio n in th is secto r

Official Marin e In stitu te Ag en cies in v o lv ed in th e en fo rcemen t Lo cal Au th o rities o f leg islatio n in th is secto r

Chart 3 - Stages in the food chain and the competent authorities involved in official controls*

FSAI

Slaughter / Harvesting

Manufacture / Processing SFPA Including primary NSAI LAs production of fish Food contact material DAFM and recognition Wholesale / Distribution HSE of natural mineral waters

Import

Retail / Catering

Consumption

DAFM Department of Agriculture, Food and the Marine FSAI Food Safety Authority of Ireland LAs Local Authorities

6 DG(SANTE)/2018-6471 Version date April 2018 HSE Health Service Executive SFPA Sea Fisheries Protection Authority NSAI National Standards Authority of Ireland * DAFM is responsible for official controls on primary production of both food of animal origin and food of non- animal origin (not illustrated); DAFM Poultry and Control Group conduct official controls on eggs at retail level (not illustrated); DAFM Horticultural and Plant Health Division conduct official controls on horticultural produce at retail level (not illustrated).

Government Departments Responsible for Policy and Legislation Development

As outlined in Chart 1, there are two government departments in Ireland responsible for developing policy and legislation for food safety.

 Department of Agriculture, Food and the Marine (DAFM); and  Department of Health (DoH). As outlined in Chart 2 DAFM is responsible for the development of policy, negotiation of rules at European Union level and implementation in national law of those rules, for:

 Animal health, animal welfare, feed safety, plant health;  Primary production of food;  Slaughter, cutting, preparation and processing of foods of animal origin, including fish, up to but not including, retail level;  Import of food of animal origin and certain foods of non-animal origin control and pesticide residues controls on imported foods of plant origin;  Controls on foods of non-animal origin at primary production level  Controls on foods certified as having protected geographical indication (PGI), protected designation of origin (PDO) and/or traditional specialities guaranteed (TSG);  Pesticide residues;  Organics. The DoH is responsible for the development of policy, the negotiation of rules at European Union level and implementation in national law of those rules for any stage of production, processing or distribution of:

 Food of non-animal origin, beyond primary production level;  Food of animal origin sold directly to the final consumer;  Food of animal origin exempt from Regulation (EC) No 853/2004;  Composite products;  The import or export of foods of non-animal origin or composite products. DAFM is also responsible for the implementation of marketing standards of food from primary producer level to the final consumer.

DAFM and DoH designate competent authorities in national legislation or through administrative procedures.

7 DG(SANTE)/2018-6471 Version date April 2018 The Food Safety Authority of Ireland (FSAI) provides support to the Government departments in the role of formulation of food policy and legislation.

Competent Authorities Responsible for Implementation of Official Controls

Food Safety Authority of Ireland (FSAI)

The FSAI is the central CA with overall responsibility for the enforcement of food legislation in Ireland (apart from at the level of primary production). This responsibility is managed through service contracts between the FSAI and the individual CAs involved in the enforcement of food legislation. FSAI has service contracts with 26 LAs (a small number of LAs provide official control for 2 or more LAs). FSAI has in total 31 Service Contracts for food with all the CAs.

FSAI also has a Memorandum of Understanding (MoU) with certain bodies which have a role in food safety controls but are not specifically involved in the enforcement of food legislation.

The FSAI, established through the FSAI Act 1998, is responsible for protecting peoples’ health and peoples’ interests by ensuring that food consumed and produced in the State meets the highest standards of food safety reasonably achievable and that people have accurate and worthwhile information about the nature of the foods they eat.

The FSAI is structured as follows: a Board, a Scientific Committee, a Food Safety Consultative Council and a Chief Executive Officer responsible for five operational teams: Food Science and Standards; Enforcement Policy; Risk Management and Regulatory Affairs; Audit and Investigations; and Corporate Affairs.

The Scientific Committee is an advisory body composed of scientists from a range of disciplines working with the Authority in a voluntary capacity. The Food Safety Consultative Council comprises representatives of consumers and industry who consider food safety issues and provide input to the agenda of the FSAI. The Food Science and Standards team provides a scientific base to support enforcement and compliance activities. The Enforcement Policy team manages the relationships between FSAI and the competent authorities involved in food safety controls. The Risk Management and Regulatory Affairs team provides technical support in the areas of: environmental health; veterinary public health and agriculture and training and compliance. The Audit and Investigations team is the audit section of the FSAI. The Corporate Affairs team is responsible for finance, human resources and information technology.

The FSAI is responsible for: co-ordination of food control activities between the competent authorities; determining inter-agency supervisory arrangements to minimise gaps and overlaps; and ensuring consistency of performance. This is achieved through:  management of the official control activities through service contract arrangements with other control bodies;  carrying out risk assessment to underpin risk management decisions and actions;  providing scientific and technical support to the competent authorities through publications and training.

FSAI participates in regular, scheduled liaison meetings with relevant CAs, which provide a forum for ensuring that service contract requirements are reflected in the operational plans of the CAs.

8 DG(SANTE)/2018-6471 Version date April 2018 FSAI has developed guidance notes, codes of practice and standard operating procedures for its own operations and where applicable to those of the CAs.

FSAI is the co-ordinating body for food alerts and the contact point for the EU Rapid Alert System for Feed and Food (RASFF) in Ireland.

Service Contracts (SC) FSAI has agreed SCs with the following competent authorities: DAFM; HSE; 27 LAs; SFPA; MI; NSAI. In addition, it has agreed memoranda of understanding with Revenue’s Customs Service, Environmental Protection Agency, the Loughs Agency and Bord Iascaigh Mhara. Service contracts are multi-annual contracts specifying the requirements of the FSAI relating to food inspection and analysis to be carried out by the CAs. They include chapters on: general requirements; monitoring of the service contracts; inspection activities (including frequency of controls); laboratory services; labelling and traceability enforcement; staffing resources; training; data collection and reporting; and information on the means by which FSAI will audit the service contracts.

Department of Agriculture, Food and the Marine (DAFM)

The Minister for Agriculture, Food and the Marine is the competent authority for implementation of official controls on:

 Feed safety;  Animal health (excluding fish) and welfare;  Plant health. In addition, DAFM is the competent authority for the implementation of official controls in the following food control areas:

 Primary production of food of animal and non-animal origin, excluding fish;  Slaughter, cutting, preparation and processing of foods of animal origin, up to, but not including retail level;  Import of food of animal origin and certain foods of non-animal origin control and pesticide residues controls on imported foods of plant origin;  Controls on foods certified as having protected geographical indication (PGI), protected designation of origin (PDO) and/or traditional specialities guaranteed (TSG);  Pesticide residues;  Organics. The following services within DAFM have responsibility for official control:

 Agricultural Inspectorate (AI), represented by the following Divisions: Feedingstuffs, Fertilizers, Grain and Poultry; Pesticide Controls Division; Horticulture and Plant Health; Crop Production and Safety; Dairy Controls and Certification; and the Organic Unit;  State Veterinary Service (SVS), under the Chief Veterinary Officer (CVO), comprising the Animal Health and Welfare Inspectorate (AHWI), the Veterinary Public Health Inspection Service (VPHIS) and the Border Inspection Posts (BIPs);

9 DG(SANTE)/2018-6471 Version date April 2018  Eradication of Animal Disease (ERAD) Division of AHWI;  DAFM Laboratory Service, under the Director of Laboratories;  DAFM Administration.

The Feedingstuffs Division is responsible for enforcing legislation on feedingstuffs. This involves carrying out official controls, including inspection, sampling and analytical activities in relation to all levels of the feed chain.

The Pesticide Controls Division (PCD) is responsible for implementing controls associated with the marketing and use of Plant Protection Products (PPP) and their residues and biocides.

The Horticulture and Plant Health Division (HPHD) is responsible for ensuring the compliance of primary producers of fruit, vegetables, mushrooms and honey with legislative requirements. HPHD is also responsible for ensuring compliance of some processed foods of non-animal origin if these are produced by the primary producer. This Division co-operates with Crop Policy, Production and Safety Division (responsible for registration of primary producers of food of non-animal origin), PCD and Integrated Controls Division (ICD) in the implementation of these control programmes.

The Dairy Controls and Certification Section is responsible for carrying out official controls in milk processing establishments, processing establishments with limited production capacity, collection centres and storage premises. It is responsible for the monitoring, audit, inspection and the surveillance in the establishments. Veterinary Public Health Inspectorate supervises drinking milk pasteurisation establishments.

The Poultry and Egg Control Group is responsible for hygiene and egg marketing standards controls in laying hen production units and at egg packing centres. The Control Group is also responsible for poultry meat marketing standards controls in “special terms” e.g. (free range and corn fed) poultry meat production units, poultry meat processing plants and poultry meat wholesalers, distributors and retailers. They are also responsible for egg marketing standards at wholesale, distribution and retail levels. The Veterinary Public Health Inspection Service supervises egg products facilities.

Staff of Agricultural Environment and Structures and the Organic Unit is responsible for the oversight of the inspection and certification of organic operators. The control and licensing of organic operators is delegated by the Competent Authority to four Organic Control Bodies.

SVS advises the Minister of Agriculture on animal health, animal diseases, zoonoses and public health issues relating to food and products of animal origin. It also assists in the preparation, implementation and enforcement of EU and national legislation, implements control measures to protect the health of animal and human populations and provides certification for animals and animal products intended for export.

SVS has a pyramidal management structure under the CVO. The service is sub-divided into two Regional AHWIs, each under the supervision of a Senior Superintending Veterinary Inspector.

There are 10 Enhanced Regional Offices. Each Enhanced Regional Office is under the supervision of a Superintending Veterinary Inspector (SVI) and staffed by veterinary inspectors, agricultural officers and administrative and clerical staff. Enhanced Regional Offices are responsible for: animal health and animal welfare; on-farm TSE controls; controls

10 DG(SANTE)/2018-6471 Version date April 2018 on premises using animal by-products, feeds containing fishmeal and organic fertilisers; controls of veterinary medicinal products; and for the implementation of controls of residues in live animals.

The Veterinary Public Health Inspection Service (VPHIS) is divided into six veterinary public health regions, each under the supervision of a Regional Superintending Veterinary Inspector. The VPHIS supervises slaughterhouses, meat processing plants, drinking milk pasteurisation establishments and egg product facilities. DAFM is responsible for the control of the importation of live animals (including live fish), products of animal origin and certain products of non-animal origin from non-EU countries at BIPs.

The ERAD Division has responsibility for the eradication of bovine tuberculosis and brucellosis and has a separate management structure within the AHWI.

Marine Institute (MI) - see under Laboratory Services. In addition, the Marine Institute is the competent authority for the implementation of Council Directive 206/88/EC on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals. The Fish Health Unit (FHU) of the MI authorises Aquaculture Production Businesses (as defined in the Directive) and implements risk based surveillance on all finfish and shellfish aquaculture sites in the country. Risk based surveillance visits are carried out by a team of 8 VIs from the SVS, who work part-time for the MI, via a Service Level Agreement between the MI and DAFM and signed by the CEO of the MI and the CVO. 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 in support of the competent authority related duties.

Sea-Fisheries Protection Authority (SFPA)

The SFPA was established under the provisions of the Sea-Fisheries and Maritime Jurisdiction Act (SFMJ Act) 2006 with the independent statutory remit to enforce national and EU Regulations on sea-fisheries conservation and seafood safety. The Department of Agriculture, Food and the Marine (DAFM) is the SFPA’s parent department. Section 44(4) of the SFMJ Act, 2006 gives the SFPA power to enforce food safety law in lieu of the Minister for the purposes of the FSAI Act 1998.

The SFPA has a service contract agreement with the FSAI which outlines the agreed level and standard of seafood safety activity that the SFPA performs as a competent authority. The SFPA has responsibility for the implementation and enforcement of national and EU legislation, which deal with health conditions for the production and placing on the market of fish, shellfish and fisheries products. The SFPA carries out official controls of seafood at all stages of production, processing and distribution with the exclusion of retail establishments.

The SFPA headquarters is in Clonakilty, Co. Cork. The SFPA has a Food Safety Unit which is a specialised unit headed by the Director of Food Safety and based at the headquarters. The Food Safety Unit’s primary function is to support and co-ordinate the food safety regulation activities of the SFPA. The SFPA has seven port offices around the coast with staff carrying out official control duties. Each port office is managed by a Senior Port Officer.

11 DG(SANTE)/2018-6471 Version date April 2018 Health Service Executive (HSE)

The HSE was established under the Health Act 2004. The Department of Health is the parent department of the HSE. The objective of the HSE is to use the resources available to it in the most beneficial, effective and efficient manner to improve, promote and protect the health and welfare of the public. The FSAI has a service contract with the HSE in relation to the official food control activities of the following services:

 Environmental Health Service (EHS)  Food Safety Laboratory Service (FSLS)  Public Health Service (PHS)

The EHS in the HSE carries out inspections of food businesses to assess/ensure compliance with the relevant food law. The services provided by EHS cover inspection of food businesses, including food sampling and the management of food alerts, outbreaks and compliance building.

The EHS is a nationally managed service within the HSE. The EHS management structure includes the Assistant National Director (Environmental Health), 4 Regional Chief Environmental Health Officers (RCEHOs) and 33 Principal Environmental Health Officers (PEHOs).

The HSE EHS is responsible for import controls on most products of non-animal origin.

HSE FSLS – see under Laboratory Services.

HSE PHS includes the Public Health Medical Service (PHMS) which participates in multi- disciplinary teams investigating, managing and controlling outbreaks of food-borne illnesses, along with the EHS and FSLS. Health Protection Surveillance Centre is part of the HSE and is the national agency with responsibility for the surveillance of communicable diseases in Ireland. It collects data on infectious diseases and provides data on food-borne illness to the relevant authorities.

PHS also includes HSE Public Health Nutrition and FSAI and HSE PHS liaise in the context of national policy on public health nutrition as it relates to food legislation.

Local Authority (LA)

Local authorities are multi-purpose bodies which are responsible for an extensive range of services, including veterinary services. The FSAI currently has service contracts for food control activities with 26 individual local authorities which between them provide official controls in all areas.

The majority of local authorities have a local structure involving a Chief Executive, a Director of Services, the County Veterinary Officer, temporary veterinary inspectors and administrative support. The exception is Cork County Council which is made up of four local areas each supervised by a whole-time veterinary officer. The service is managed and co-ordinated by a Chief Veterinary Officer. Under the service contract between the FSAI and Cork County Council, this local authority operates a designated INAB-accredited Veterinary Food Safety Laboratory.

12 DG(SANTE)/2018-6471 Version date April 2018 The local authorities are responsible for official controls in low throughput slaughterhouses; poultry farmers engaged in the slaughter of low volumes of poultry, establishments producing small quantities of fresh meat, minced meat, meat preparations or meat products; cold stores/distribution centres and meat transport vehicles at, or associated with inspected establishments. The local authorities are also responsible for the official controls in wholesaling butcher shops subject to Regulation (EC) No 853/2004. In slaughterhouses, ante- mortem and post-mortem examinations are carried out by the County Veterinary Officers/Inspectors or by temporary veterinary inspectors.

The local authority veterinary service (LAVS) provides a mechanism for Local Authority Veterinary Officers (LAVOs) for sharing information, provision of training and discussion of matters of national and local importance. Meetings are held under the auspices of the Local Authority Veterinary Officers Technical & Liaison Committee. The FSAI also organises national and regional meetings for local authorities which are attended in the main by LAVOs. Standard operating procedures are developed by the LAVS in consultation with FSAI, through the service contract.

National Standards Authority of Ireland (NSAI)

NSAI is the competent authority with responsibility for the enforcement of legislative requirements in relation to

 the recognition and exploitation of natural mineral waters bottled in Ireland and  official controls on the production, distribution and import of food contact materials.

Revenue’s Customs Service

Revenue’s Customs Service (referred to as Customs for remaining text) is the authority with overall responsibility for import and export controls. The FSAI and DAFM have entered into MOUs with Customs as follows:

 FSAI in relation to the control of imports of food of non-animal origin and food contact materials; and  DAFM in relation to the control of imports of animals, products of animal origin, plants, products of plant origin, animal remedies and animal feedingstuffs. Environmental Protection Agency (EPA)

The EPA is the national organisation with responsibility for environmental protection and policing. Included in the EPA Office of Environmental Protection (EPA-ORP) functions are regulatory, monitoring and advisory responsibilities in matters pertaining to ionising radiation. It carries out extensive monitoring of radioactivity in the food chain and the environment. It is also responsible, with FSAI, for granting food irradiation licences to irradiation facilities.

Health Products Regulatory Authority (HPRA)

With effect from 1 July 2014, the Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA). The name change reflected the expansion of the regulatory remit of the authority over the preceding years. HPRA is responsible for the authorisation of all categories of human and veterinary medicinal products (VMP) as well as having a role in regulating medical devices, controlled drugs, clinical trials, blood products and components, tissues and cells, cosmetic products, The protection of animals used for scientific purposes, organs intended for transplantation. 13 DG(SANTE)/2018-6471 Version date April 2018 Cooperation between competent authorities

For FSAI this is primarily achieved through the SC process, which involves regular liaison meetings with and between the different CAs. In addition, memoranda of understanding have been drawn up between both DAFM and FSAI and the Customs.

Cooperation between DAFM and the MI in relation to aquatic animal health is the subject of a formal service level agreement between DAFM and the MI. This agreement was signed in December 2012 and runs for a five year period.

Formal meetings between the MI team and the relevant staff from DAFM are held at least twice yearly (typically one meeting in the first quarter to plan the years’ work and one meeting in the final quarter to review the years’ work).

On-going frequent liaison at management level in relation to work/policy issues takes place between the Manager of the Fish Health Unit in the MI and the SVI/SSVI with responsibility for fish health issues within DAFM as required.

DAFM established a DAFM/LAVS Liaison Committee in July 2012. The objectives of the meetings are to have a forum in dealing with the wider aspects of Regulation (EC) No 882/2004, including animal welfare and animal health. Discussions include: - The Animal Health and Welfare Act - Liaison with Regional Offices of DAFM on animal health and animal welfare - Animal welfare reporting - Control of Horses, animal health and welfare and control aspects - Updates on the discussion on the revision on Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules - Implementation of Regulation (EC) No 1099/2009 and training of LAVS on welfare matters under Regulation (EC) No 1099/2009 - Animal welfare procedures for LAVS - LAVS attendance at Better Training for Safer Food animal welfare training.

Delegation of specific tasks related to official controls

DAFM has delegated certification of organic food, feed and farming to the following bodies:  Irish Organic Farmers and Growers Association,

 Organics Trust Ltd,

 Global Trust Certification Limited,

 Biodynamic Agricultural Association, Demeter UK.

This arrangement is covered under specific contracts with DAFM. All other official controls are carried out directly by the nominated CAs.

14 DG(SANTE)/2018-6471 Version date April 2018 Contingency planning

The FSAI has a crisis management plan which links to contingency plans in the relevant CAs. It is a requirement of the SC to ensure that there are contingency plans in place at central and regional level for dealing with crisis incidents, large-scale food safety incidents and outbreaks of food-related disease.

See Chapter 2.1. Control system for animal health in relation to contingency plans for animal diseases.

Resources for performance of controls

Staff qualifications and training

All of the CAs are responsible for the provision of training to their staff. Training includes induction courses for new staff, together with on-going theoretical and practical training in relevant areas. Systems for identification of training needs are in place across the official agencies. Training needs are identified during annual staff reviews. This information is passed to a central training unit within the CA, where the training priorities are identified and form the basis for developing annual training programmes. FSAI also has an input into training of control staff through the SC process. This may involve the direct provision of training to control staff, particularly of smaller CAs.

Organisation and implementation of official controls

Legal basis for controls

The CAs have sufficient legal powers to carry out their functions.

Food

Food legislation is defined in the Food Safety Authority Act 1998 (FSAI Act) to include the Acts, Statutory Instruments and the EC regulations set out in the First Schedule of that Act insofar as they relate to food safety and hygiene. Food legislation listed in the First Schedule is amended and updated on annual basis through the Section 5 Order - the most recent Section 5 Order was introduced in March 2017. See link: Latest link to FSAI Act 1998

From an enforcement perspective the list of food legislation in the First Schedule of the Section 5 Order forms the basis of the schedule for the service contract agreed between the FSAI and each of the official agencies. The powers of authorised officers are set out in (Sect 50) of the FSAI Act and also include improvement notices and orders (Sect 52), closure orders (Sect 53) and prohibition orders (Sect 54). Each piece of Irish legislation giving effect to specific EU food safety legislation also has enforcement powers appropriate to the EU legislation.

Food businesses supervised by the HSE

The enforcement measures set out in Part 4 (ENFORCEMENT MEASURES) of the European Communities (Official Controls of Foodstuffs) S.I. No 117 of 2010 (as amended) (http://www.irishstatutebook.ie/pdf/2010/en.si.2010.0117.PDF ) provide that the FSAI or HSE (official agency) may adopt a range of measures they deem appropriate in instances of non- compliance with food legislation. Such measures include seizure, removal, detention, destruction and disposal of any food which are suspected to fail to comply with the provisions

15 DG(SANTE)/2018-6471 Version date April 2018 of food legislation. There are also provisions for closure and prohibition orders where an FBO fails to comply with food legislation.

Penalties for offences relating to the protection of public health and the placing of unsafe food on the market are dealt with under the provisions of Regulation 25 of the European Communities (General Food Law) Regulations 2007 (SI No 747 of 2007) (as amended).

S.I. No 369 of 2006 gives effect to Regulation (EC) No 852/2004 on the hygiene of foodstuffs.

Food businesses supervised by DAFM, LA, SFPA and a small number of HSE supervised food businesses

S.I. No 432 of 2009 gives effect to the hygiene package legislation and Regulation (EC) No 178/2002 and applies to food businesses supervised by DAFM, SFPA and LA and a small number of HSE establishments which require approval.

Robust legal procedures are in place to ensure that authorised staff has access to premises and documentation kept by food business operators so as to enable them to accomplish their work effectively. Authorised officers are empowered to seize and detain product where they have reasonable grounds for believing that a contravention of the legislation has occurred.

In addition, DAFM can issue a legal notice requiring a specified activity or operation to cease or only be carried out under specified terms and conditions. There are also provisions for withdrawal / revocation of FBO approval.

DAFM is also authorised under SI 218 of 2010 on contaminants of food and the FSAI Act 1998.

Feed

Since 1973 all EU legislation on feedingstuffs has been given effect under the European Communities Act, 1972, a legal instrument specifically enacted to give effect to the Treaties governing the European Communities and to enable the introduction of regulations giving effect to EC legislation.

The production of animal feedingstuffs is governed by numerous EU Regulations and Directives and which have been duly transposed into domestic legislation, primarily by way of an overarching Statutory Instrument 432 of 2009. This S.I. provides for the consolidation and revision of Irish legislation to enable the Department of Agriculture, Food and the Marine to carry out its duties in respect of all aspects of the production, control and marketing of feed. S.I. 432 of 2009 provides for the appointment of authorised officers to carry out inspections and audits, sets out the extent of their powers, provides for penalties and prosecutions for offences in contravention of EU legislation as well as setting out the roles and responsibilities of feed business operators, including registration and approval. S.I. 432 of 2009 covers all of the above issues in respect of feed hygiene (Regulation (EC) No 183/2005 et seq.), inspections (Regulations (EC) No’s 882/2004, 669/2009 et seq.), marketing and labelling (Regulation (EC) No 767/2009 et seq.) and undesirable substances (Directive 2002/32/EC et seq). This principle S.I. has been subsequently amended to reflect new and amended EU legislation since 2009.

In addition, the Department of Agriculture, Food and the Marine has transposed other aspects of EU legislation relating to animal feed production dealing with medicated feed (S.I. 176 of 1994 and subsequent additional amendments), feed additives (S.I. 242 of 2005), GMOs (S.I. 424 of 2004) and animal health (S.I. 364 of 1991). 16 DG(SANTE)/2018-6471 Version date April 2018 Accordingly robust legal procedures, covering all elements of the feedingstuffs chain, are in place to ensure that authorised staff has access to premises and documentation kept by feed business operators so as to enable them to accomplish their work effectively. Authorised officers are empowered to seize and detain where they have reasonable grounds for believing that a contravention of the feedingstuffs legislation has occurred.

There is also provision under the various regulations on feedingstuffs for specific control measures at national level and penalties in the event of breaches. Under legislation where the activity is the subject of a licence or the issue of an Approval/Registration status, such licences or Approvals/Registrations can be withdrawn by the Minister of Agriculture, Food and the Marine in the case of non-conformity with requirements.

Registration/approval of food business operators

See Chapter 2.2 Control system for food of animal origin See Chapter 2.7 Control system for food of non-animal origin

Prioritisation of official controls

Controls by CAs in the different sectors are prioritised on a risk analysis basis. This takes into account the traditional risk factors, such as nature of the business and risks normally associated with it, previous compliance record of the operator, as well as inspection and laboratory resources. Selection of businesses to prioritise for inspections is generally based on guidance notes and codes of practice. Resources (staff and other) are in general targeted in areas of highest risk. All businesses are subject to official control.

Control activities, methods and techniques

Official controls are carried out using methods and techniques such as monitoring, surveillance, verification, audit, physical inspection of establishments, scrutiny of establishment records, evaluation of the HACCP system in place (where relevant) and sampling and analysis. There is a permanent presence of veterinary inspectors (VI) in slaughterhouses supervised by DAFM. Their duties include the supervision of ante- and post- mortem examination of slaughtered animals and of establishment hygiene procedures. Microbiological sampling is employed routinely (e.g. Listeria testing of ready-to-eat products; Salmonella testing of slaughtered poultry).

Procedures for performance and reporting of control activities

Official controls are carried out in accordance with documented procedures (e.g. standard operating procedures (SOPs), protocols, veterinary procedural notices (VPNs), laboratory procedures, aide memoirs, guidance documents etc.). Documented procedures are updated by the CAs on an on-going basis and are made available to staff. For controls related to food, the FSAI, in addition to its own internal written procedures, performs a co-ordinating and advisory function for the other CAs involved.

Each CA has a formal reporting system in place and a copy of the inspection report is given to the business operator, at least in the case of non-compliance. The DAFM management system, Agricultural Field Inspection and Test (AFIT), allows for field inspection reports to be recorded directly into the central system for all animal health controls. It also facilitates the provision of an immediate copy of the report to the animal owner.

17 DG(SANTE)/2018-6471 Version date April 2018 Sampling and laboratory analysis

Designated official laboratories managed by government departments, HSE, LAs, MI or privately, carry out analyses in relation to food and feed safety, animal health, animal welfare and plant health controls.

The primary DAFM laboratories, as well as the State Laboratory, are located in Backweston Campus, Celbridge, Co. Kildare. These are: the Central Veterinary Research Laboratory; Veterinary Public Health Regulatory laboratory, Pesticide Control Laboratory; Seed Testing, Pesticides and Plant Health Laboratories; and the Dairy Science Laboratories. The latter has two associated regional laboratories in Cork and Limerick. The Blood Testing Laboratory is located in Cork. There are six Regional Veterinary Laboratories throughout the country.

The FSLS of the HSE consists of a network of laboratories comprising of three regional Public Analyst Laboratories (PALs) responsible for physical/chemical analysis of food and food related samples and six Official Food Microbiology Laboratories (OFMLs) responsible for the microbiological testing of foodstuffs (note: the Dublin PAL is considered to be a seventh OFML, as it does microbiological testing). All of these laboratories are accredited to ISO 17025. Each of the nine laboratories has local management structures in place.

The MI is responsible for marine research, technological development and innovation. It provides analytical and technical services to SFPA and in support of its own duties as competent authority for fish health in Ireland. It carries out analysis to ensure compliance with legislative requirements with respect to general food law, official controls, food hygiene, contaminants, residues, microbiological criteria and marine biotoxins and is National Reference Laboratory for certain parameters.

Cork County Council operates a designated ISO 17025 accredited Veterinary Food Safety Laboratory. All microbiological samples taken by LA veterinary inspectors as part of the National Sampling Plan for Local Authority establishments are analysed by this laboratory.

Transparency and confidentiality

The MANCP is published on both DAFM and FSAI websites. FSAI website also provides access to SC, relevant food legislation, audit reports, monitoring activities and strategy and enforcement actions, including names and addresses of food business operators against whom action has been taken. The SFPA and HSE websites also contain information relating to their activities in the food safety area.

In relation to confidentiality, all government employees are covered by the Official Secrets Acts, 1963 and are obliged under the Data Protection Acts 1998 and 2002 not to disclose information of a confidential nature relating to official control activities. In addition, Section 43 of the FSAI Act 1998 lays down provisions regarding the disclosure of information as does the relevant national legislation which transposes food law and there are also specific provisions in national legislation.

Enforcement measures

Measures in the case of non-compliance

A range of enforcement measures are available in each of the sectors which can be applied as necessary.

18 DG(SANTE)/2018-6471 Version date April 2018 In relation to food production, a common system of enforcement is employed by most of the CAs involved. This system derives from the FSAI Act 1998 which enshrines powers to prosecute and issue enforcement notices and orders. These are in addition to the powers provided for in specific national food legislation. The enforcement powers under the FSAI Act 1998 are available to authorised officers for all food legislation listed in Schedule 1 of the relevant SC. All Competent authorities are authorised under the FSAI Act and use enforcement provisions in their Service Contracts. Measures which may be taken in the case of non- compliances include: improvement notices, improvement orders, closure orders, prohibition orders, seizure, removal or detention of products. HSE also use S.I. 117 of 2010 for serious breaches of food legislation such as closure orders and prohibition orders.

For non-food controls, DAFM is empowered to withdraw approval of an establishment where the necessary requirements are not met and may seize or detain animals, animal products and equipment.

Sanctions

Serious and/or repeated breaches of food legislation will be considered for fines or prosecution. Under Regulation 30 of Statutory Instrument No 432/2009, a food business operator who has committed an offence against the relevant regulations may be convicted with a fine not exceeding €250,000 or to imprisonment for a period not exceeding 3 years. In relation to illegal imports of food of animal origin in passengers' luggage, the sanctions imposed are the rejection, destruction or seizure of products.

Under Regulation 25 of the European Communities (General Food Law) Regulations 2007 (S.I. No 747 of 2007) a person who is guilty of an offence is liable on summary conviction, to a fine not exceeding €5,000, or imprisonment for a term not exceeding 3 months or to both or on conviction on indictment, to a fine not exceeding €500,000, or imprisonment for a period not exceeding 3 years, or to both.

For non-food controls, court proceedings may be initiated for serious and/or persistent offences. The range of penalties available includes fines, imprisonment and prohibition of a convicted person from keeping animals. There are a range of enforcement measures contained in other statutory instruments relevant to different sectors.

Verification and review of official controls and procedures

Verification In accordance with the SC all CA must submit detailed reports on their controls to FSAI. There are also annual service contract liaison meetings between the FSAI and each CA which can include a review of the work carried out.

Within DAFM, various means of supervision and verification are employed, depending on the sector concerned. These range from regular supervisory checks by regional hierarchy at pre- determined frequencies, to annual appraisals of inspection staff, to regional co-ordination meetings, to checks that targets have been met and that tasks assigned to individual staff members have been completed. DAFM central level visits each BIP bi-annually to assess the application of import requirements.

Supervision of the activities of HSE officers is performed by line management. Within the LAs, the Director of Services is responsible for administrative supervision.

19 DG(SANTE)/2018-6471 Version date April 2018 More detailed information on verification of the effectiveness of official controls in Ireland is contained in the European Commission audit report DG (SANCO) 2013-6859 which can be found at: http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm

Audit

In the area of official controls on food, each CA is required, under the terms of its service contract with the FSAI, to carry out official controls in accordance with documented procedures.

To comply with statutory requirements set out in the FSAI Act the Authority conducts audits of all CAs to determine the appropriateness and effectiveness of official controls carried out under Regulation (EC) No 882/2004. Audits are conducted by the FSAI in the form of external audits and in accordance with the Service Contract.

FSAI carries out external audits on DAFM, HSE, SFPA, LAs, NSAI and MI; these audits are published on its website since the second half of 2011. FSAI's quality management system is accredited since 2001 under ISO 9001:2008.

FSAI carries out the following three categories of audit under its annual audit programme. These audits fall into three main types and each will follow the same general audit process. Detailed information will be outlined in pre-audit questionnaires and evaluation plans, as appropriate. The three types of audits include:  Audits of Official Controls – These audits examine the effectiveness and appropriateness of official controls as implemented by official agencies in relation to food law, service contracts and MANCP requirements.  Targeted or Focused Audits – These audits examine the effectiveness and appropriateness of official controls and/or food business operators’ compliance with respect to a specific aspect of food law.  Directorate-General for Health and Food Safety of the European Commission Closeout Audits – These audits, when conducted, examine and update the corrective actions taken to address findings from audits carried out by the Directorate-General for Health and Food Safety. They also verify their closure and their current state of compliance.

Follow-up of the Directorate-General for Health and Food Safety audits are carried out by DAFM. FSAI in its risk based planning processes considers whether to carry out a close out audit on the findings in the Directorate-General for Health and Food Safety audit reports. The purpose of these audits when carried out is to examine and update the corrective actions, taken by official agencies in conjunction with Enforcement Policy, to address findings from the Directorate-General for Health and Food Safety audit reports. They also verify their closure and their current state of compliance.

FSAI’s quality management system is accredited since 2001 under ISO 9001:2008.

Other Audits:

The FSAI may carry out from time to time any other audit it considers appropriate to verify that all components of the food safety control network, planned arrangements and/or official controls are adequately safeguarding and protecting consumers’ health and interests.

20 DG(SANTE)/2018-6471 Version date April 2018 Non-EU Country Audits – The FSAI observes non-EU country auditors in their assessment of the food safety standards achieved by the Irish food industry. These audits frequently assess the implementation of the official control system by the competent authorities in Ireland and compliance by food business operators with food law. The FSAI provides detailed information to external auditors on the official control system in place.

Internal audits are carried out in accordance with documented procedures and, as far as possible, by personnel independent of the function being audited.

Internal Audits in Official Agencies:  Two Units of DAFM (VIAU and IAU) carry out internal audits.  LAs have implemented a programme whereby LAs are audited by another independent LA.  The HSE EHS Internal Audit Unit has been established and carries out internal audits.  NSAI does not have an internal audit system.  The SFPA has established an internal audit system to review and verify the application of official controls related to food safety. The SFPA has contracted an external company to conduct internal audits on their behalf. A 5 year road map has been developed. Four internal audits were carried out in 2015, two in 2016 and a further two in 2017  All official laboratories in DAFM, HSE, MI and LA have internal audits carried out under their Quality Management Systems which are accredited to ISO 17025.

 Bilateral meetings take place between the FSAI and the SFPA to discuss and share information between both organisations on internal audits.

FSAI meet with DAFM and SFPA each year to plan and coordinate internal audit projects. The purpose of these meetings is to ensure there is no overlap in projects being considered.

The official laboratories carry out internal audits to monitor for compliance with the requirements of ISO 17025 and determine adherence to defined SOPs/process flows.

The mission, role and objectives of the FSAI audit function are documented in its audit charter which is published on the FSAI website https://www.fsai.ie/uploadedFiles/Monitoring_and_Enforcement/Audit/QM4.pdf

Food fraud occurs when food or food material is subjected to a fraudulent or deceptive practice for economic gain. The Audit and Investigations team of the Authority is responsible for investigating incidents where food fraud is suspected. To support this work FSAI chairs and coordinates the Food Fraud Task Force (FFTF) whose members include An Garda Síochána, Revenue/Customs, DAFM, HSE, SFPA, Local Authorities, Laboratories, Competition and Consumer Protection Commission, Department of Social Protection and Food Standards Agency in Northern Ireland. The FFTF meets three times per year and information on fraud and criminality in the food sector is shared among members. The FFTF also provides a network of contacts who support on-going food fraud investigations being conducted by FSAI. FSAI represents Ireland on the EU Food Fraud Working Group and is the designated contact point for the Administrative Assistance and Cooperation (AAC) system which facilitates the exchange of information where suspected cross border non-compliances are perpetrated

21 DG(SANTE)/2018-6471 Version date April 2018 through fraudulent deceptive practices. The Authority conducts investigations in its own right or in conjunction with official agencies where food fraud is suspected or has been detected. These investigations are designed to determine the nature and extent of non-compliance with food law and the extent of any food fraud. Outcomes of such investigations have resulted in enforcement action including criminal proceedings being taken against offenders.

Multi-annual National Control Plan (MANCP) The current version of the multi-annual control plan (MANCP), covering the period 2012 to 2017 (Version 1) and prepared jointly by FSAI and the DAFM is available on the FSAI website. A new National Control Plan covering the period 1 January 2018 to 31 December 2022 is expected to be published in 2018.

The FSAI is specified as the national contact point for communication with the Commission services regarding the MANCP.

Overview

The following chart gives an overview of the distribution of responsibilities in relation to control systems and operational levels. More detailed descriptions of the allocation of responsibilities between authorities in relation to each control system are given in the following chapters.

Sector Policy Co-ordination Implementation Laboratories Risk co-ordination of controls of controls assessment, scientific advice 1. Animal Health DAFM DAFM/MI DAFM/ CVRL/RVL/ CVRL LA/ MI BTL/ MI 2. Food of Animal DAFM/DoH FSAI FSAI/DAFM/H EPA-ORP CVRL/VPH Origin SE/ /VPHRL/CVRL/ RL/DSL/VF LA/SFPA/ DSL/VFSL SL NSAI MI/ FSLS/SL MI/FSAI 3. Imports of DAFM DAFM/ DAFM/ VPHRL/DSL/ VPHRL/DS animal and food CUSTOMS/ CUSTOMS/ MI/CVRL L/ of animal origin /FSAI /FSAI MI/CVRL/ FSAI 4. Feedingstuffs DAFM DAFM/ DAFM/ SL/PAL/ SL/PAL/ and animal CUSTOMS CUSTOMS PRL/CPL PRL/CPL nutrition 5. TSEs/ABP DAFM DAFM/FSAI* DAFM/FSAI/ CVRL/STS/ CVRL/FSA LA/HSE RVL I/ DAFM 6. Veterinary DAFM/ DAFM/ DAFM/ HRPA HRPA HRPA medicines HRPA HRPA CONTRACTED CONTRAC - authorisation, LABS T-ED marketing and LABS distribution

22 DG(SANTE)/2018-6471 Version date April 2018 Sector Policy Co-ordination Implementation Laboratories Risk co-ordination of controls of controls assessment, scientific advice Veterinary DAFM FSAI/DAFM/ FSAI/DAFM/ VPHRL/SL/MI/ VPHRL/SL/ medicines LA/SFPA LA/SFPA TFRC/PCL/ MI/TFRC/P - residues CL//FSAI 7. Foodstuffs and DAFM/DoH FSAI/DAFM/ FSAI/DAFM/ FSLS/VPHRL/ FSAI/FSLS/ Food HSE HSE VFSL/PALS EHS/DAFM hygiene/GMO NSAI (for NSAI (for recognition of recognition of natural natural mineral mineral water) water) 8. Imports of food DAFM/DoH FSAI/HSE FSAI/HSE FSLS/PCL HSE/FSAI of plant origin DAFM/ DAFM/ CUSTOMS CUSTOMS 9. PPPs – DAFM DAFM DAFM PCL DAFM authorisation, marketing and use PPPs – residues DAFM DAFM DAFM/FSAI PCL PCD/ FSAI 10. Animal Welfare DAFM DAFM DAFM/LA/ CVRL CVRL/ SFPA FAWAC 11. Plant Health DAFM DAFM/ DAFM/ CPL CPL CUSTOMS CUSTOMS 12. Quality labelling DAFM DAFM/FSAI/ DAFM/FSAI/H HSE** DAFM/FSAI HSE SE/SFPA/LA 13. Organic DAFM DAFM DAFM/Organic Accredited DAFM/FSAI Control laboratories Bodies/Customs

*FSAI involvement extends in so far as the matters of ABP relate to food. **HSE labs have a limited role in checks for labelling

23 DG(SANTE)/2018-6471 Version date April 2018 2 COMPETENT AUTHORITIES AND DISTRIBUTION OF RESPONSIBILITIES IN RELATION TO INDIVIDUAL CONTROL SYSTEMS

2.1. Control system for animal health

DAFM

Policy; legislation Policy; legislation

SVS LA MI Co-operation SVS (ERAD + AHD)

Analysis; LAVI DVO results; controls

Analysis; results Identity checks; Identity checks; movement controls; control of ante + post mortem registers; checks CVRL health controls Ante + post mortem checks

Aquaculture High Low throughput Production throughput slaughterhouses Farms Businesses slaughterhouses

AHD Animal Health Division APB Aquaculture Production Businesses CVRL Central Veterinary Research Laboratory DAFM Department of Agriculture, Food and the Marine DVO District Veterinary Offices ERAD Eradication of Animal Disease Division LA Local Authorities LAVI Local Authorities Veterinary Inspector MI Marine Institute SVS State Veterinary Service SFPA Sea-Fisheries Protection Authority

Competent Authorities

1. DAFM

DAFM is the CA for official controls on terrestrial animal health (aquatic animal health is dealt with by the Marine Institute). The Animal Health Division (AHD) within the AHWI carries out the controls. Each LA is the CA for implementing rules and regulations in low throughput slaughterhouses in its area. For Aquaculture Production Businesses, DAFM is responsible for policy and legislation. DAFM is also responsible for enforcement at Aquaculture Production Businesses through a Service Level Agreement with the Marine Institute.

24 DG(SANTE)/2018-6471 Version date April 2018 Holding registration, animal identification and movement controls

Each single unique epidemiologically distinct herd is allocated a unique herd number for the purpose of disease control. The herd number is issued to a registered person, who is termed the keeper, but who is not necessarily the owner of the animals that form the herd. An ‘epidemiological unit’, or herd, is considered to be any number of animals that are held, kept or handled in such a manner that they share the same likelihood of exposure to infectious disease and that the control of the spread of infectious disease from the unit can be facilitated. The animals comprising the herd may be owned solely or jointly with others. The herd occupies parcels of land, used solely or jointly with others, which may comprise parcels of land that are separated by some distance but, because of general proximity and/or management practices, are considered to be one epidemiological unit. Where the parcels of land used by the farmer are located in more than one administrative division, or are sufficiently far distant to warrant being treated as two (or more) epidemiological units, or where disease management controls dictate that it is prudent to regard them as two (or more) epidemiological units, a herd number will be issued to each such unit (herd). All parts of a herd being the epidemiological unit are subject to control if and when disease is identified i.e. the movement restriction applies to all the fragments used by the herd and the legislation empowers the VI to confine animals to particular fragments if disease control so warrants. The determination of the appropriate epidemiological unit is made by DAFM veterinary staff operating in the area and responsible for the administration of the disease eradication programme. Each new herd registration is subject to scrutiny involving: a veterinary approval process; an on-site investigation, including inspection and assessment of the handling and holding facilities for animals as appropriate for the number and type of animals to be kept in the herd. For sheep, goats and pigs, the herds are also registered with DAFM. Sheep and goats on the same unit as cattle will have the same herd number as the cattle herd and all will have the same disease status. The Animal Health Computer System (AHCS) holds all information relating to herd numbers.

Holdings, as defined by Council Regulation (EC) No 73 of 2009 of 19 January 2009, are also registered by a separate section of DAFM. A holding is linked to its relevant herd number(s) in the DAFM Corporate Client System database.

Cattle identification and tracing includes: ear tagging; cattle identity papers/passports; on-farm register; and the Animal Identification and Movement (AIM) database. All cattle are tagged at birth with a unique identification number issued by the AIM system. An official register is supplied to each animal keeper, who is obliged to make all entries in date order within seven days. A facility is in place for a keeper to maintain the herd register online. The AIM system records the origin, identity, movement and disposal of all cattle, using input from: cattle birth and movement data; livestock marts; slaughter plants; and live export points.

Farmers are required to tag all animals born on their holdings either before movement off the holding or by the time they are nine months old, whichever date is the earlier. Tag numbers are issued from the AIM system. Farmers are required to have a holding register to record the details of the animals on the farm and the details of all movements onto and off the farm. DAFM maintains a central register of sheep holdings and movements in its computer database. The data comprising the central register is divided between four inter-linked databases: Corporate Client System; AIM; Animal Health Computer System (AHCS) and Internet Mapping and Area Payments.

Keepers must be approved by the Department to keep pigs. Keepers are assigned a pig herd number. Pigs moving from the farm direct to the slaughterhouse must be identified with a tattoo (“slap mark”) showing the herd identification number. All other pigs leaving the farm 25 DG(SANTE)/2018-6471 Version date April 2018 must be tagged with the herd number. Breeding pigs on the holding must be tagged with a tag bearing both the herd and an individual number.

All goats are registered on the AHCS central database and are identified in accordance with the provisions of Council Regulation 21/2004. Movements are recorded on the AIM system as detailed in the National Goat Identification System (NGIS). Goat tags are issued from the AIM system.

The identification of equidae, since 1 July 2009, requires a passport and microchip – a microchip was not a mandatory requirement prior to 1 July 2009. Current legislation requires that an identification document (passport) must be issued in respect of an equine within 12 months of the animal’s birth. The identification details of equines are recorded on the AIM database. Registration of equine premises is a requirement since 2013 and notification of transfer of ownership is required since 2014.

People who keep poultry must be registered by the DAFM. Poultry Keepers are assigned a flock number. A person to whom registration relates must maintain a daily record of purchases, sales and supplies of eggs used for breeding purposes or poultry and copies of associated health certificates and commercial documents.

Animal health controls

The ERAD is responsible for the eradication of bovine tuberculosis and brucellosis and has its own management structure within the AHWI. It operates alongside the AHD. Holdings are selected by the SVS at central level, based on risk criteria. The control system in place for sheep identification is based on checks carried out on holdings by DAFM.

At the slaughterhouses, checks on animal identification are performed by establishment staff and, in the case of establishments approved for intra-community trade, by temporary veterinary inspectors employed and supervised by the relevant CA (DAFM and LA).

All controls carried out by DAFM are recorded on the Agricultural Field Inspection and Test (AFIT) system. This is a management system which allows field inspection reports to be fed directly to the central system. It has a facility to permit a copy of the report to be immediately provided to the business operator.

Contingency Plans

A comprehensive programme is in place to deal with the threat of Foot and Mouth Disease (FMD), Classical Swine Fever (CSF), Avian Influenza (AI), and new emerging diseases. Sector specific plans are available on the DAFM Animal Health and Welfare internet page. Updated operations manuals are in place for FMD, AI, CSF, Newcastle Disease and Bluetongue. These are subject to constant review to take account of any changes to legislation, etc.

Laboratories

CVRL provides laboratory support (bacteriology/parasitology, pathology and virology) for national disease eradication programmes.

26 DG(SANTE)/2018-6471 Version date April 2018 2. Marine Institute

Authorisation of Aquaculture Production Businesses (APBs)

All APBs in the country have been authorised under S.I. No 261 of 2008 (as amended) which implements Council Directive 2006/88/EC. In order to become authorised, the APB operator applied to the MI and submitted a Fish Health Management Plan which outlined their compliance with the legislation in terms of record keeping; movement and disease notification; biosecurity and participation in a risk based health surveillance system. Based on this, each APB in the country has been given a unique Fish Health Authorisation (FHA) number which identifies a particular business and names the person(s) responsible for compliance with the legislation at that site. All APBs are listed on a public register which is available at www.marine.ie/ fishhealth.

Each APB is inspected on a risk basis by DAFM VIs who work to the MI under a Service Level Agreement. All APBs are visited either once per year or once every two years, depending on their risk of contracting a listed disease and of spreading that disease from the point of infection.

Movement Controls

All movements of live animals for further farming must be notified to the MI and approved prior to movement. Written application must be made to the MI at least 72 hours in advance. All movements are logged on a national database, ensuring full traceability in the event of a disease outbreak.

Contingency Plans

Contingency Plans are in place to deal with:

 Outbreaks of the finfish diseases listed in Directive 2006/88/EC

 Outbreaks of emerging finfish diseases

 Outbreaks of Gyrodactylus salaris

Laboratories

The FHU houses the NRLS for diseases of finfish, molluscs and crustaceans. Tests are accredited to EN 17025 standard and are available to the competent authority in support of national disease control programmes.

27 DG(SANTE)/2018-6471 Version date April 2018 2.2. Control system for food of animal origin Comment [c]: I don’t have the software to delete EPI and replace with PECG

Comment [ML]: EPI in this chart to be DAFM DoH amended

FSAI

Policy; legislation Policy; legislation Policy; legislation Service Contracts

AI SVS HSE SFPA (DI + PECG LA (VPHIS) (EHS) + HPHD)

Analysis; Laboratories results

Regional Regional Regional Regional LAVI Offices Offices Offices Offices

Approvals; Approvals; Approvals; Approvals; Approvals; controls controls controls controls controls

Dairy, Eggs Meat Poultry plants, Fish, Fishery products, Low plants Manufacturing, throughput Honey processing, live bivalve mollusc plants Producers wholesale, plants distribution plants; retail and catering

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine DI Dairy Inspectorate DoH Department of Health EHS Environmental Health Service PECG Poultry and Egg Control Group FSAI Food Safety Authority of Ireland HPHD Horticulture and Plant Health Division HSE Health Service Executive LA Local Authorities LAVI Local Authorities Veterinary Inspector SVS State Veterinary Service VPHIS Veterinary Public Health Inspection Service SFPA Sea-Fisheries Protection Authority

Competent Authorities

DAFM and DoH are responsible for developing food policy and legislation with the support of the FSAI, which has overall responsibility for the enforcement of food legislation in Ireland. DAFM, HSE, LA and SFPA are responsible for enforcement of food legislation in the establishments under their supervision, under their respective service contract with FSAI. Statutory Instrument No 432/2009 implementing the hygiene regulations designates LA as competent authority for low-throughput slaughter and processing establishments and defines the limits of throughput. The FSAI and relevant Competent Authorities have developed a guidance document on determining the supervising agency for Food Businesses (Revision 7), which clearly sets out each CA's areas of responsibility.

28 DG(SANTE)/2018-6471 Version date April 2018 Registration and approval of establishments

DAFM, LA, SFPA and HSE have administrative responsibility for registration or granting approvals.

The majority of establishments supervised by DAFM and LA are approved under Regulation 853/2004. The remainder are registered under Regulation 852/2004. Applications for approval under Regulation (EC) No 853/2004 include information on trade patterns and an estimate of throughput. The evaluation of establishments supervised by DAFM is carried out by a VI and a Regional SVI and approval granted if satisfactory. The evaluation of establishments supervised by LA is carried out by a VI. In the case of the LA, the FSAI assigns the approval number. A certificate of full approval or conditional approval is issued by the LA and a copy forwarded to FSAI.

HSE approves certain establishments subject to Regulation (EC) No 853/2004 which it supervises. Generally such establishments are stand-alone manufacturers processing raw food of animal origin for incorporation into composite products, e.g. lasagne or meat pies.

The SFPA has responsibility for the registration of certain categories of establishments in the seafood sector and approving establishments handling and processing fishery products and live bivalve molluscs. A list of approved establishments is published on the SFPA and FSAI website.

The FSAI maintains the central listing of approved establishments on its website http://www.fsai.ie/food_businesses/approved_food_establishments.html

Official controls and inspection at establishments

DAFM VPHIS is organised centrally, regionally and locally with separate structures for the meat and liquid milk sectors. Large scale meat establishments are supervised by DAFM via the Meat Inspectorate at central and regional levels. VIs permanently located in the larger meat and poultry slaughtering and processing plants assisted by temporary veterinary inspectors are responsible for: carrying out ante- and post-mortem inspections; controls of structural and operational hygiene standards; and controls of residues. Other plants are visited and inspected regularly for compliance with health and hygiene regulations.

Official controls in milk plants, which vary depending on the activity, are carried out by the Dairy Controls and Certification Division (DCCD) at milk manufacturing plants and by the SVS in liquid milk pasteurising plants. The DCCD is organised into five regions. Agricultural inspectors carry out inspection duties at dairy plants and checks on holdings supplying milk to manufacturing and liquid milk pasteurising plants.

The Poultry and Egg Control Group of the Feedingstuffs, Fertiliser, Grain and Poultry Division is responsible for egg and poultry controls in: laying hen units; egg storage and handling facilities; egg packing centres; wholesale and retail establishments; free range broiler/turkey units; and poultry-meat processing, wholesale and retail establishments. The Meat Policy Division is responsible for registration and approval of establishments, and recording of inspections and samplings and collating associated data. The Poultry and Egg Control Group is responsible for inspections, taking samples at producer level for salmonella analysis, sampling eggs at producer level for residues and dioxins and sampling meat at retailer level that is analysed for antimicrobial resistance.

29 DG(SANTE)/2018-6471 Version date April 2018 Controls relating to honey are implemented by DAFM and the HSE in accordance with the supervisory criteria agreed by FSAI and the various enforcement agencies. DAFM’s Agricultural Inspectorate based in HPHD are solely responsible for controls at apiary level relating to beekeepers. DAFM’s Agricultural Inspectorate is also responsible for controls relating to honey packers/distributors under DAFM’s supervision. HSE are responsible for certain honey wrapping/packing establishments mainly dealing with imported honey plus other types of foods. HSE is responsible for official controls in certain manufacturing/processing establishments, certain wholesale/distribution operations, imports of foods of non-animal origin and all retail sector (retail and catering) establishments. HSE is also responsible for approving certain establishments under national legislation implementing Regulation (EC) No 853/2004.

LAs are responsible for the supervision of low-throughput slaughterhouses and meat establishments.

SFPA carries out official controls on fish, shellfish and fishery products from landing or harvesting, transport, processing, wholesale and distribution, up to the point of retail sale.

Official controls on identification mark and traceability

DAFM is responsible for the traceability and labelling of beef and beef products in high- throughput meat establishments. LAs are responsible for carrying out checks on traceability and labelling in low-throughput slaughterhouses and meat establishments. The SFPA is responsible for the traceability and labelling of fish, fishery products and live bivalve molluscs from landing/harvesting along the seafood supply chain up to but excluding retail sale. The HSE is responsible for the retail sector and some wholesale/distribution establishments and manufacturing/processing operations.

Laboratories

See under Sampling and Laboratory Analysis in Chapter 1.

30 DG(SANTE)/2018-6471 Version date April 2018 2.3. Control system for imports of animals and food of animal origin

Revenue DAFM Commissioners

FSAI Policy; legislation Supporting DAFM Policy; legislation

Revenue Service Contracts/ SVS SFPA Customs MoU (BIP/DVO) Service

Co-operation; Laboratories notification Support DAFM Controls of imports Controls of imports advisory role BIPs

Analysis; results

Live animals + animal Live fish + fish Personal luggage; products; ICW; products postal consignments personal luggage

BIP Border Inspection Posts DAFM Department of Agriculture, Food and the Marine RVO Regional Veterinary Offices FSAI Food Safety Authority of Ireland ICW International Catering Waste SFPA Sea-Fisheries Protection Authority SVS State Veterinary Service

Competent Authorities

DAFM, through the SVS, is the CA for veterinary import control of products of animal origin and live animals (including live fish). DAFM operates the controls on illegal imports and international catering waste.

A memorandum of understanding exists between Customs and DAFM with regard to their respective roles in the control of animals, plants, products of animal origin, animal remedies and animal feedingstuffs, and with particular regard to control and search of passenger baggage and cargo. Co-operation with Customs at local level is frequent and informal. Consignments of animal products are flagged on the Customs Automated Entry Processing System which ensures that they are detained pending examination at a BIP. DAFM officials notify Customs of products cleared by them via the common veterinary entry document for products of animal origin and live animals.

31 DG(SANTE)/2018-6471 Version date April 2018 The BIP and TRACES manuals are produced by DAFM. Circulars are issued from DAFM headquarters as the need arises. These provide guidance on procedures or legislation, and are notified to Customs at central level for information and distribution to local level.

FSAI is the contact point for the Rapid Alert System for Feed and Food (RASFF) messages. All BIPs have direct access to the Commission database.

Co-operation between different bodies is ensured through a working group on import control, consisting of staff from FSAI, DAFM, Customs, and representatives of HSE.

Import Controls

The list of approved veterinary BIPs, warehouses and ship suppliers can be found at the following links: http://ec.europa.eu/food/animal/bips/approved_bips_en.htm

And http://ec.europa.eu/food/animal/bips/warehouses_en.htm

Each BIP is supervised by a VI. Portal technical inspectors, who are full-time employees of the CA, assist the VI at BIPs in carrying out these controls.

Customs co-operate with DAFM on control of the imports of live animals and products of animal origin from non-EU countries at BIPs. DAFM controls include documentary, identity and physical checks. DAFM staff carries out checks for detection of illegal imports of products of animal origin and live animals in personal luggage of passengers arriving at the main entry points to Ireland. SFPA officials provide technical support to Veterinary Officers at BIPs when required. In locations where there is no BIP, the local RVO operates the controls on international catering waste disposal and the checks for detection of illegal imports of products of animal origin and live animals in personal luggage of passengers arriving at entry points to Ireland.

Checks on incoming consignments are based on: pre-notification via the common veterinary entry document; manifest checks; flagging on the Customs Automated Entry Processing System; and random spot checks. In addition Customs refer consignments of products of animal origin, detected during their own routine or targeted searches, to DAFM officials.

Customs carry out checks on personal luggage of crew members disembarking from ships from non-EU countries and on postal consignments sent to private persons. Customs are present at all main points of entry. Other points of entry are staffed by Customs when ships from a non- EU country arrive.

Customs use their X-ray scanners to scan freight consignments. Scanning equipment for luggage of passengers at the main points of entry is used systematically by Customs, but DAFM staff use it only in exceptional circumstances.

Landing and disposal of international catering waste is carried out under an annual licence by waste disposal operators who collect the waste in leak-proof skips and transport it for burial at an approved landfill site.

Records of all checks on illegal imports are maintained in paper format at each BIP and seizures are recorded on an electronic database. 32 DG(SANTE)/2018-6471 Version date April 2018 CITES is implemented in Ireland by the National Parks and Wildlife Service (NPWS), which is part of the DEHLG, and by Customs. The CITES Management and Scientific Authorities are part of the NPWS and implement the regulations. Customs deal with CITES enforcement at the points of entry, ports and airports. NPWS conservation staff deal with CITES enforcement within the State.

Laboratories

Approved CA laboratories are available to carry out testing under the sampling plan, for safeguard decisions, or for suspect samples.

33 DG(SANTE)/2018-6471 Version date April 2018 2.4. Control system for feedingstuffs and animal nutrition

Revenue DAFM Commissioners

Policy; legislation Policy; legislation

AFCG Information Revenue Analysis/results (FFGPD Systems Customs +CPSD) Division Service

Co-operation Controls through Implementing Annual pre-notification; SL; control plan; other labs reporting Maintenance of data bases on inspections, sampling results, etc Documentary checks Samples Regional Offices

Controls Field staff inspections; sampling; reporting

Feed importers

FBO

AFCG Animal Feedingstuffs Control Group CPSD Crop Policy, Production and Safety Division DAFM Department of Agriculture, Food and the Marine FBO Feed Business Operator FFGPD Feedingstuffs, Fertilisers, Grain and Poultry Division SL State Laboratory

Competent Authorities

DAFM is the CA for the transposition of EU legislation on feedingstuffs and the control authority for its implementation. Within DAFM at central level, the Animal Feedingstuffs Control Group (AFCG), comprising Feedingstuffs, Fertilisers, Grain and Poultry Division (FFGPD) and the Crop Policy, Production and Safety Division (CPPSD), co-ordinates the national inspection and sampling programme.

For inspection and control purposes, the country is divided into 12 regions, with a Supervisory Agriculture Officer assigned to each region. This officer reports, via a District and Area Superintendent, to the AI at central level.

34 DG(SANTE)/2018-6471 Version date April 2018 The main areas of the co-operation between the Feedingstuffs Inspectorate and DAFM Veterinary Division include: salmonella analysis of environmental samples; the control of processed animal proteins; and medicated feedingstuffs. To ensure co-operation in feed controls, the Feedingstuffs Inspectorate meets with the State Laboratory, Customs, FSAI, and the Irish Grain and Feed Association, to which some 85% of feed business operators are affiliated.

Registration and approval of establishments and intermediaries

The European Communities (Food and Feed Hygiene) Regulations 2009 (Statutory Instrument (S.I.) No 432 of 2009) transposes Regulation (EC) No 882/2004 on Official Food and Feed Controls and Regulation (EC) No 183/2005 on Feed Hygiene. The Regulations provide for: definitions; requirements for approval and registration for feed business operators; withdrawal of such approvals and registration; maintenance of a register; appointment and powers of authorised officers; fees and sanctions.

Official controls

The annual control programme is based on risk analysis, which takes into account: outcome of previous inspections; nature of risks to health or the environment; operators' own controls and history of compliance; EU co-ordinated controls; and information on controls in other Member States or scientific findings. Visits are unannounced and take account of the operators' own- control systems (HACCP) when assessing compliance. The risk assessment criteria for selecting primary producers has recently been amended significantly, resulting in an inspection programme more focused on these producers and their compliance with feed hygiene requirements. The control programme is reviewed quarterly.

The CA has developed application and declaration forms, checklists and inspection report templates for the approval and registration of feed business operators. Existing operators approved or registered under Council Directive 95/69/EC were required to indicate their intentions to continue operations under Regulation (EC) No 183/2005. All other feed business operators coming under the Regulation, with the exception of primary producers, completed appropriate forms for registration. Primary producers have been registered through the 2006 Single Farm Payment System. Compliance is verified and evaluated on an on-going basis by routine, unannounced, official controls carried out by the CA. For each shortcoming detected during an inspection, a non-conformance report is issued. Shortcomings are followed-up in subsequent visits.

In addition to unannounced inspections carried out by field staff, the CA procedures require staff at central level to carry out audits of all establishments manufacturing additives, premixes, mineral mixtures or compound feedingstuffs and food recyclers to check implementation of their own-controls. Staff at central level inspect on-farm mixers requiring approval. Local Supervisory Agriculture Officers visit new intermediaries of mineral mixtures requiring approval. Agriculture officers also audit feed/grain drying operations.

Data on feed business operators are loaded into relevant databases maintained for this purpose by the DAFM Information Systems Division.

35 DG(SANTE)/2018-6471 Version date April 2018 Laboratories

The State Laboratory is responsible for feedingstuffs analysis. It is the designated NRL for feed additives analyses. Testing for antibiotics for use in feed is carried out by Rikilt Laboratory in the Netherlands. The Irish Equine Centre (a commercial laboratory) is used by DAFM to undertake microscopic analysis for the presence of products of animal origin in feed material and compound feeds. The Microscopy Laboratory located at the DAFM Central Plant Laboratory is the designated NRL for microscopic analysis. Rikilt in the Netherlands is the designated NRL for GMO analysis.

36 DG(SANTE)/2018-6471 Version date April 2018 2.5. Control system for TSE/ABP

Transmissible Spongiform Encephalopathy (TSE)

DAFM

Service FSAI Contracts Policy; legislation

SVS AFCG CVRL; LA (VPHIS - (FFGPD RVL; TSE/ABPD) +CPSD) STS; AH&WD Private Laboratory

Epidemio surveillance; Feedban HSE TSE suspects; SRM; controls; EHS Instructions; supervision; sampling plan; sampling plan supervision

Analysis; LAVI PVP DVO Regional results offices Controls on SRM removal

Controls; Controls; Controls; Controls; sampling sampling sampling sampling

Low throughput Meat plants; Farms Feedmills Food Plants slaughterhouses; intermediate plants; establishments rendering plants, farms

ABPD Animal By-products Division AFCG Animal Feedingstuffs Control Group AH&WD Animal Health and Welfare Division CPPSD Crop Policy, Production and Safety Division CVRL Central Veterinary Research Laboratory DAFM Department of Agriculture, Food and the Marine DVO District Veterinary Offices EHS Environmental Health Service FFGPD Feedingstuffs, Fertilisers, Grain and Poultry Division FSAI Food Safety Authority of Ireland HSE Health Service Executive LA Local Authorities LAVI Local Authorities Veterinary Inspector PVP Private Veterinary Practitioner RVL Regional Veterinary Laboratories SRM Specified Risk Material STS Seed Testing Station SVS State Veterinary Service VPHIS Veterinary Public Health Inspection Service

Competent Authorities

DAFM is the CA responsible for the development of policy and legislation and for the implementation of the TSE control and eradication programmes. A number of veterinary and administrative divisions are involved. TSE and Animal By-Products Division (ABPD) have overall responsibility for coordinating activities relating to TSE on the veterinary side. 37 DG(SANTE)/2018-6471 Version date April 2018 FSAI is the CA with overall responsibility for the enforcement of official controls regarding the removal of Specified Risk Material (SRM) in food establishments. This is achieved through the Service Contract mechanism with DAFM in large capacity premises, LAs for low- throughput slaughterhouses and cutting plants, and HSE for retail butcher shops.

Private veterinary practitioners (PVP), working as temporary VIs in slaughterhouses, carry out activities such as ante- and post-mortem inspections and taking samples for TSE testing purposes, where they perform tasks under contract to DAFM or LA.

Epidemio-surveillance

It has been a requirement since January 1, 2009 that all cattle over 48 months of age (previously 30 months) which are destined for human consumption be screened for Bovine Spongiform Encephalopathy (BSE) using a rapid test approved by the European Commission. The sampling is carried out at slaughtering plants by VIs. All parts of the tested animals are detained under official control until the test results are received.

It has been a requirement since January 1, 2009 that fallen cattle over 48 months of age (previously 24 months) also be screened for BSE using a rapid test. In these cases, the sampling is carried out at Category 2 Intermediate Plants by veterinary inspectors.

Statutory Instrument No 61 of 1989 established the obligation for private veterinary practitioners to notify any BSE clinical suspect animal detected while carrying out private work on-farm. It also established the same obligation for the keeper of the animal. The same legal provision lays down that, where a VI has reasonable grounds for believing that the movement of an animal other than a suspected case may give rise to the risk of spread of the disease, the movement may be prohibited.

Standard operating procedures and other information on handling BSE clinical suspects and confirmed cases are in place. When an animal is declared an official BSE suspect, and where BSE cannot be ruled out, it is euthanized on the spot, either on-farm or in the slaughterhouse lairage. The carcase is collected by the Suspect Collection Service of DAFM and taken to one of the Regional Laboratories for sampling and disposal.

An active surveillance programme for small ruminants is carried out in accordance with Regulation (EC) No 999/2001. Standard operating procedures and other information on handling scrapie clinical suspects and confirmed cases in sheep and goats are also in place.

The CA has taken several initiatives to raise awareness about TSE among farmers and PVPs. These include:

 Distribution of videos on BSE and scrapie;  Advisory leaflets distributed to farmers;  Information on the recognition of the diseases distributed to PVPs;  Presentations to veterinary clinical societies;  Presentations to farmers groups;  Posters displayed in the waiting rooms of DVO and in markets;  Attendance at shows and major farming events to promote awareness of BSE and scrapie.

38 DG(SANTE)/2018-6471 Version date April 2018 Specified Risk Material (SRM) SRM from slaughterhouses is sent to processing plants along with any other Category 1 animal by-products (ABP). Category 1 ABP is accompanied by commercial documents signed by the slaughterhouse operator and the haulier. Fallen stock collected by knackeries is also sent to processing plants with a commercial document signed by the knackery operator and haulier. A form completed during audits in slaughterhouses, which lists the relevant factors to be evaluated during the audit, includes SRM and requires a risk value to be attributed to each factor. Removal of SRM from food is verified as part of the official controls in food establishments.

HSE EHS are responsible for controls of SRM removal from bovine animals over 30 months in retail butcher shops. The list of butcher shops authorised for the removal of SRM is published on the FSAI website: https://oapi.fsai.ie/AuthReg99901Establishments.aspx

Official controls on the feed ban are the responsibility of AFCG within the Feedingstuffs Inspectorate, which has an overall co-ordinating role for feed controls carried out by local inspectors.

The total feed ban is implemented by means of Statutory Instrument No 252 of 2008. Derogations have been provided for certain products of animal origin, subject to specified requirements.

In general, the risk assessment for the sampling is made at central level by staff of the AFCG, with some flexibility for sampling at local level. Guidelines for local inspectors sampling on farms where feedingstuffs are present, and for on-farm mixers, have been issued. A regional officer is responsible for carrying out a supervisory visit for the different inspection tasks over a three-year cycle. In order to ensure that the annual inspection programme, including sampling, is harmonised and implemented on schedule by the local inspectors throughout the country, the AFCG draws up a detailed list of establishments to be visited by inspectors and maintains a close follow-up of the inspection and sampling programme.

Laboratories

The Regional Veterinary Laboratories collect tissue samples for TSE confirmatory diagnosis and genotyping, where appropriate, in compliance with Regulation (EC) No 999/2001. Confirmation of TSE cases is carried out in the NRL for TSE at the Central Veterinary Research Laboratory. In addition, private laboratories have been authorised to perform rapid tests for TSE. These are approved by the CA and monitored by the NRL.

A private laboratory is authorised for the performance of microscopic analysis of feed and is contracted by DAFM to carry out testing of all samples of feed for the presence of constituents of animal origin and fishmeal in line with Directive 2003/126/EC. Monitoring of this laboratory is carried out by the Feedingstuffs Microscopy Laboratory.

39 DG(SANTE)/2018-6471 Version date April 2018 Animal By-Products (ABP)

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine DRD Dairy Regions Division DVO District Veterinary Offices EPA Environmental Protection Agency FSAI Food Safety Authority of Ireland HSE Health Service Executive LA Local Authorities LAVI Local Authorities Veterinary Inspector M+MH/ABPD Milk and Meat Hygiene/Animal By-Products Division NDCC National Disease Control Centre and Veterinary International Division PHI Public Health Inspectorate SVS State Veterinary Service TSE&ABPD TSE and Animal By-Products Division (Veterinary) VPHIS Veterinary Public Health Inspection Service

*FSAI involvement extends in so far as the matters of ABP relate to food safety.

40 DG(SANTE)/2018-6471 Version date April 2018 Competent Authorities

Official controls of ABP are carried out by the following departments or agencies:

Large abattoirs and large meat establishments Staff from VPHIS of DAFM Small abattoirs and small meat establishments Staff from the LAs Fish plants Staff from DAFM and from the SFPA Food premises Staff from the HSE Liquid milk plants Staff from Veterinary Public Health Inspection Service (VPHIS) of DAFM Manufacturing milk plants AI of DAFM responsible for dairies Pet food plants Staff from VPHIS of DAFM Other ABP premises (Processing plants, Staff from District Veterinary Offices (DVOs) of Intermediate plants, Compost and Biogas DAFM plants, Incinerators, Storage plants, Technical plants, Thermal boilers, Hauliers, Collection centres, Final users. BIPs NDCC and Veterinary International Division and staff from DVOs of DAFM

Within DAFM, ABP controls are coordinated by TSE and ABP Veterinary Division, Veterinary Public Health Division, Dairy Regions Division and Milk and Meat Hygiene/Animal By-Products Administrative Division. A cross-agency body of the departments and agencies involved in the official controls of ABP was set up in 2007. This generally meets four times per year.

Approval of ABP plants and other premises

The procedures for approving plants supervised by DVO and VPHIS staff are set out in standard operating procedures for the different types of plants. In general, assessment of applications for approval as well as approval and validation inspections are carried out by the central VI with responsibility for this area of work, supported by the VI from the local DVO or slaughterhouse. In some areas of activity, such as storage plants and Category 3 intermediate plants, veterinary staff from the DVO carry out the inspections and complete an inspection form containing a recommendation on whether or not the premises should be approved. Meat Hygiene and Animal By-Products Administrative Division has responsibility for issuing all letters of approval for ABP premises and for other administrative work.

Milk processing establishments, which handle milk and/or milk products and which are registered or approved in accordance with Statutory Instrument No 432 of 2009 which implements Regulation (EC) No 853/2004, are not approved under the ABP Regulations for generating and temporarily storing ABP, as this is an inevitable result of its food activities. Where a premises that stores milk ABP is not approved or registered under this legislation, a separate approval under Statutory Instrument No 252 of 2008 is required.

ABP plants using fish ABP only as a raw material are approved by DAFM as authorised under Statutory Instrument No 252 of 2008, implementing Regulation (EC) No 1774/2002. SFPA provides support in the approval process. The SFPA carries out official control inspections in three specialist fish ABP processing establishments.

Under article 23 of Regulation (EC) No 1774/2002, Ireland has availed of the derogation which permits the authorisation of use of specified ABP for the feeding of specified animals.

41 DG(SANTE)/2018-6471 Version date April 2018 Collection centres and final users are authorised and licensed respectively in accordance with this article. DAFM has notified the Commission of the use they have made of this derogation.

A list of approved plants is placed on the DAFM website.

Official Controls

The on-going monitoring of ABP plants is carried out by VIs and technical staff in the DVO. The monitoring arrangements, including the number of inspections to be carried out at different types of plants, are set out at the beginning of each year. Each DVO RSVI is provided with a list of the inspections to be carried out in his/her area. The intensity of monitoring is determined by a risk assessment for the particular type of plant, based on factors such as the size and throughput of the plant, the nature of the activities and past performance of the operator. The level of inspection varies from permanent supervision in rendering plants to unannounced inspections of a proportion of approved premises. The standard frequency of inspection for most ABP premises, such as intermediate plants, is twice yearly.

Inspections are carried out in accordance with a formal inspection procedure involving a standardised inspection form. An electronic database is maintained centrally which lists the inspections to be carried out and their completion status.

Non-compliances in DVO-supervised plants are dealt with by a procedure, which is laid down in a document called the “Enforcement Protocol” which was circulated to all officers involved in the supervision of ABP plants as well as other areas of ABP in October 2007.

Inspections in plants supervised by VPHIS staff are carried out in accordance with formal documented procedures. Non-compliances in VPHIS-supervised plants are dealt with in accordance with the principles set out in Veterinary Procedure Notice, VPN 7/2004.

The on-going monitoring of approved milk manufacturing plants is carried out by the Dairy Inspectorate. Official control procedures, relating to health rules concerning animal by- products not intended for human consumption, implementing Regulation (EC) No 1774/2002 and Regulation (EC) No 79/2005, are outlined in SOP No 27 of the Dairy Division's procedures.

The ongoing supervision and monitoring of fish plants that generate fish by products and ABP approved plants which handle fish by products is carried out by Sea Fisheries Protection Officers from local SFPA offices throughout the country. The majority of such fish by products is low risk Category 3 material.

The HSE EHS carries out ABP official controls at retail level. The LAs carry out official controls in relation to ABP in small slaughterhouses. This is achieved by using documented procedures which were developed by the LAVS Standardisation Working Group. The system includes advice to the industry and forms to record the movement of ABP.

42 DG(SANTE)/2018-6471 Version date April 2018 2.6. Control system for veterinary medicines and residues

Veterinary Medicinal Products (VMP)

HPRA DAFM

Policy; legislation

SVS Analysis; (VPHI SIU results ERAD-VMS)

Instructions; Authorisations reporting

HPRA DVO contracted labs. Targetted investigations

Controls on marketing/use; licensing; sampling

Manufacturers; VMP wholesalers; retailers; farms; PVP

DAFM Department of Agriculture, Food and the Marine DVO District Veterinary Offices ERAD Eradication of Animal Disease Division HPRA Health Products Regulatory Authority PVP Private Veterinary Practitioner SIU Special Investigation Unit SVS State Veterinary Service VMP Veterinary Medicinal Products VMS Veterinary Medicines Section VPHIS Veterinary Public Health Inspection Service

Competent Authorities

The Health Products Regulatory Authority (HPRA, formerly the Irish Medicines Board (IMB)) is responsible for the authorisation of all categories of VMP. The Veterinary Medicines Section (VMS) of the ERAD Division within DAFM is responsible for controlling the distribution and use of VMP, as well as licensing wholesalers and retailers.

43 DG(SANTE)/2018-6471 Version date April 2018 Official controls on marketing/use

Only products which are licensed for the Irish market by the European Medicines Agency, HPRA or DAFM, as appropriate, may be imported, sold or used. A comprehensive regime of licensing is in place for wholesalers and retailers engaged in distribution of VMP. This does not apply to veterinary practitioners and pharmacists, who are subject to oversight by professional regulatory bodies. As part of the three-year licensing cycle, manufacturers of medicated feed are inspected at least once. While licenses granted to wholesalers and retailers are of indefinite duration, random and risk based inspections are carried out at such premises by DAFM Inspectorate

At the time of licensing, all VMP are assigned a designated mandatory ‘route of supply’ and unique licence number, both of which must appear on the labelling. Checks by DVO staff are supplemented by the DAFM Special Investigation Unit, which carries out focussed investigations arising from intelligence gathered, or as a result of routine residue inspections.

Laboratories

Analysis of samples is carried out by HPRA contracted laboratories.

44 DG(SANTE)/2018-6471 Version date April 2018 Residues in live animals and animal products

DAFM

FSAI SIU Policy; Legislation Policy; legislation

Service SVS Co-operation Contracts (VPHIS SFPA MI LA ERAD-VMS)

Consultation on NRCP; reporting Implementation of NRCP; supervision Targetted LAVI investigation

Various Implementation laboratories of NRCP; DVO supervision

Implementation Implementation Analysis; of NRCP of NRCP results Controls; sampling reporting

Slaughterhouses; Fish processing Low throughput meat plants; farms plants slaughterhouses

DAFM Department of Agriculture, Food and the Marine DVO District Veterinary Offices ERAD Eradication of Animal Disease Division FSAI Food Safety Authority of Ireland LA Local Authorities LAVI Local Authorities Veterinary Inspector MI Marine Institute NRCP National Residue Control Plan SIU Special Investigation Unit SFPA Sea-Fisheries Protection Authority SVS State Veterinary Service VPHIS Veterinary Public Health Inspection Service VMS Veterinary Medicines Section

Competent Authorities

The National Residue Control Plan (NRCP) is developed and implemented by DAFM, in consultation with FSAI, the MI, SFPA and LA, under service contract with FSAI. DAFM is responsible for all sectors, except aquaculture. The Veterinary Medicines Section (VMS), in consultation with appropriate DAFM inspectorates, is responsible for designation and control of laboratories. LA veterinary inspectors carry out meat inspections and supervision of low- throughput slaughterhouses and take samples for NRCP purposes. The SFPA is responsible for follow up on farmed fish while MI are responsible for sampling and analysis of this sector.

Official controls on residues

DAFM issues the annual sampling plan of the NRCP to each DVO, slaughter plant and to Dairy Controls and Certification Division, taking account of the production in each region. Written instructions on the targeting of sampling are distributed to the relevant services, and sampling is organised to achieve an equal distribution throughout the year for each of the 45 DG(SANTE)/2018-6471 Version date April 2018 substances covered by the NRCP. Sampling at farm level is performed unannounced. The results of the NRCP are published annually, in accordance with Council Directive 96/23/EC.

Regular contact takes place between all of the bodies involved in the execution of the NRCP. Each LA carries out sampling for residues in accordance with a local residue sampling plan developed annually by FSAI, which forms part of the NRCP. Samples are taken at farms and establishments by DAFM, MI and LA inspectors. The laboratory sends reports of all results to DAFM, which notifies the relevant district authorities. For aquaculture the MI notify the SFPA in the case of a positive result. The SFPA can use enforcement provisions under the FSAI Act or S.I. 432 of 2009 for residue violations.

When a residue violation is detected under the NRCP, an investigation, initiated at the farm of origin, is carried out, as appropriate, by the DVO and/or the Special Investigation Unit, which is particularly active in this area. It includes an interview with the farmer, and an inspection and/or search of records and premises. Where appropriate, further sampling may be undertaken and advice provided. DAFM and SFPA consider that they have sufficient enforcement powers for follow-up investigations after a residue violation. A number of successful prosecutions have been undertaken by the Special Investigation Unit for VMP misuse.

Laboratories

Analyses under the NRCP are performed in several different laboratories: Veterinary Public Health Regulatory Laboratory and Pesticide Control Laboratory of DAFM; State Laboratory of the Department of Finance; Ashtown Food Research Centre of the Agriculture and Food Development Authority; MI; and a number of private laboratories approved by DAFM provides analysis of NRCP samples.

The annual NRCP is prepared following a co-ordination meeting between DAFM and the relevant laboratories.

46 DG(SANTE)/2018-6471 Version date April 2018 2.7. Control system for foodstuffs and food hygiene (food of non-animal origin)

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine DoH Department of Health EHS Environmental Health Service FCM Food Contact Material1 FSAI Food Safety Authority of Ireland HSE Health Service Executive NSAI National Standards Authority of Ireland NMW Natural Mineral Water2 RASFF Rapid Alert System for Food and Feed

Competent Authorities

DAFM and the DoH are responsible for all policy issues in respect of food safety, formulating and transposing EU food safety legislation, and reviewing existing national regulations. FSAI is the CA with overall responsibility for the official control of food. DAFM, HSE and NSAI share responsibility for controls in their respective areas of competence.

Registration and approval of food establishments

All official agencies where relevant maintain a register of food establishments as required under Regulation (EC) No 882/2004.The HSE maintain a current list of all food establishments. In addition to registration all sprout producers must also be approved by DAFM (i.e. FBOs need to meet the requirements set out in Annex I of Regulation (EC) No 852/2004 and the requirements in the Annex to Commission Regulation (EU) No 210/2013).

1 Relates to official controls in establishments (other than food establishments) that import, manufacture, distribute or supply (other than by retail) food contact materials, 2 Relates to the rrecognition of Natural Mineral waters

47 DG(SANTE)/2018-6471 Version date April 2018 Official controls of food establishments

FSAI co-ordinates official controls by means of a SC with each CA. FSAI carries out audits of food businesses and of the CA to ensure compliance with legislative and contractual requirements. As part of its SC, each CA is required to prepare an annual plan outlining how official controls will be carried out. This plan is agreed with the FSAI. A cross-agency working group review the guideline "Guidance for determining the supervising agency for food businesses’, dated Sept 2015, defining which agency supervises which type of food business, with the aim of eliminating potential overlaps or omissions.

The Environmental Health Service of the HSE carries out official controls including inspections of food businesses, combined with food sampling, to ensure compliance with food law and the management of complaints, food alerts and outbreaks investigations. In addition, it encourages compliance through information and training activities. HSE is responsible for official control of production, processing and distribution of foodstuffs of non-animal origin, retail of foodstuffs and imports of food of non-animal origin.

DAFM is responsible for official controls during primary production and harvesting of foods of non-animal origin. In addition, DAFM is responsible for controls on some processors of food of non-animal origin, if the processing takes place by the primary producer at the place of primary production.

The frequency of inspection visits is risk-based and takes account of the nature of the food business, the type of products traded, the volume of activity and prior history of the establishment.

Good Hygiene Practice Guides

There are four guides covering hygiene in catering, in retail, in bottled water and Safe Catering- guide to making food safely. These are prepared by the sector concerned and issued by the National Standards Authority of Ireland. FSAI and CA staff/representative(s) attend the working groups responsible for the development and revision of these guides.

Rapid Alert System for Food and Feed (RASFF)

The national control point for RASFF is the Risk Management and Regulatory Affairs team of the FSAI, which plays the central role in crisis management and contingency planning. FSAI notifies alerts on the basis of: RASFF notifications; industry recalls or withdrawals; enforcement activity; surveillance sampling and consumer complaints. FSAI bases its assessment on: known distribution of the food in Ireland; possible arrival of food in Ireland from another country known to have received the food; the type and possible uses of the food; the nature of the risk; and any other potential implications for consumers. RASFF information is communicated by means of: e-mail to official agencies, food industry and other stakeholders; SMS/text message; press release, where appropriate and the FSAI website. FSAI hosts a food alert and food allergen section on its website.

Through its service contract arrangements, the FSAI has a central co-ordination role in contingency planning, involving joint development of plans with agencies, providing training and carrying out simulation exercises. Information from alerts and incidents is used proactively in developing surveillance and enforcement plans at national and local level. An Interagency Protocol for the Management of a Food Crisis is in place. A document on the Management of

48 DG(SANTE)/2018-6471 Version date April 2018 Outbreaks of Foodborne Illness has been developed. A simulation exercise has been held to test the procedure and the document may be revised based on feedback from the exercise.

Laboratories

See under Sampling and Laboratory Analysis in Chapter 1. The FSAI, the Environmental Health Service and the Food Safety Laboratory Service meet frequently to discuss food monitoring and surveillance programmes.

Genetically Modified Organisms (GMO)

Competent authorities

DAFM is responsible for enforcing legislation in relation to GM feed and GM seed. The Environmental Protection Agency (EPA) is responsible for enforcing legislation in relation to live GMOs. FSAI is responsible for enforcing legislation in relation to GM food

Official controls of GMO in food, including at import

Random sampling and analysis of foodstuffs for the presence of GM ingredients is carried out by the FSAI and HSE, with foodstuffs containing maize, soya and rice being targeted routinely at import and retail level.

The Environmental Protection Agency (EPA) and the Crop Evaluation and Seed Certification Division in DAFM are responsible for controlling GMOs in propagating material. No GM crops are grown in Ireland,

Imports of maize and oilseed rape as feed must be accompanied by a laboratory certificate stating they are free of GMOs at the 0.1% level of detection. At least 20% of the imported feed lots are sampled by DAFM authorised officers and tested for compliance with the 0.1% level of detection.

Laboratories

Food samples are tested for the qualitative presence of GMOs by the Public Analyst Laboratory (Cork) who are accredited and members of the European Network of GMO Laboratories (ENGL). In the event of a positive test, further quantitative testing is carried out by the NRL (currently RIKILT in the Netherlands).

49 DG(SANTE)/2018-6471 Version date April 2018 2.8. Control system for imports of food of non-animal origin

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine DoH Department of Health EHS Environmental Health Service FSAI Food Safety Authority of Ireland FSLS Food Safety Laboratory Service HSE Health Service Executive MoU Memorandum of Understanding PCD Pesticide Controls Division PCL Pesticide Control Laboratory Competent Authorities The Food Unit of the DoH is responsible for all policy issues in respect of food safety. HSE is responsible for import controls on food of non-animal origin, which are carried out by its Environmental Health Service. However, control of pesticides residues on imported foods of non-animal origin is a function of the Pesticide Controls Division within the AI of DAFM.

FSAI has a memorandum of understanding with the Revenue Customs Service in relation to imports of products of non-animal origin. The FSAI facilitates an interagency working group on import control of products of non-animal origin. Participants include those involved at an operational level i.e. FSAI, HSE, DAFM PCD, Feed, BIPs, Horticulture and Plant Health Division and Revenue Customs Service. FSAI, through an interagency working group, keeps the Revenue Customs Service informed of changes in legislation and any other relevant information.

50 DG(SANTE)/2018-6471 Version date April 2018 Import controls

HSE and DAFM liaise with the Revenue Customs Service at points of entry for food of non- animal origin. HSE Environmental Health Officers carry out routine import controls on food of non-animal origin in the air and sea ports. Documentary, identity and physical checks including sampling are carried out on imported food of non-animal origin. In addition to routine import controls on food of non-animal origin, targeted import controls are carried out on certain products of non-animal origin which there are subject to increased official controls in accordance with EU legislation e.g. Regulation (EC) No 669/2009 and relevant safeguard measures. Dublin Seaport and Dublin Airport have been designated as points of entry / introduction. Information on the legal requirements on the import of food of non-animal origin is available and updated regularly on the FSAI website.

Customs, DAFM, HSE and the FSAI have been liaising closely on the implementation of EU legislation on increased controls for certain foods of non-animal origin. The profiling on the Revenue Customs Service AEP system of foods of non-animal origin is regularly updated to include all the products covered by EU legislation requiring increased official control. All these products are now flagged by the Automated Entry Processing system. This means that when presented to the Revenue Customs Service for clearance, these consignments are referred by Customs staff to DAFM (for pesticide residues) or to the HSE (for all other controls) for relevant checks. Customs will not clear the goods until DAFM or HSE inform them that it is in order to do so.

Laboratories

The Pesticide Control Laboratory of DAFM carries out analysis of food of non-animal origin for pesticide residues and the Food Safety Laboratory Service of the HSE carries out analysis of other imported food of non-animal origin.

51 DG(SANTE)/2018-6471 Version date April 2018 2.9. Control system for plant protection products (PPP) and pesticide residues

PPP

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine EPA Environmental Protection Agency ICD Integrated Controls Division PCL Pesticide Control Laboratory PCD Pesticide Controls Division

Competent authorities

DAFM is the CA for the relevant legislation. The Pesticide Controls Division (PCD) of the Agricultural Inspectorate is a centralised service, with responsibility for the authorisation of pesticides and for controls on the marketing and use of the products. PCD reports annually to the Commission on inspections carried out in Ireland.

Authorisation of PPP

The PCD is responsible for the authorisation of pesticides. Approximately 1000 PPPs containing 200+ active substances are currently authorised for placing on the market in Ireland. It is difficult to provide an accurate figure for the number of products being actively marketed, but it is estimated to be approximately 500 products.

A database of authorised PPPs is available on the PCD website. Following an application by a company, the data is evaluated by the relevant technical units and a decision is issued, normally within 12 months. The CA considers that virtually all of the authorisations are based on mutual recognition with other Member States. The CA co-operates with other Member States, such as UK, Belgium and the Netherlands, in sharing experience on risk management.

52 DG(SANTE)/2018-6471 Version date April 2018 Official controls on marketing/use

Checks on retailers and wholesalers of PPP are planned and performed by the PCD. They are carried out on the basis of an annual control plan in accordance with instructions laid down in a procedures manual for inspection and sampling of plant protection and biocidal products. Some 350 companies in the sector are considered to be major operators. These include agricultural co-operatives, retail outlets, wholesalers and manufacturers. A further 1,000 companies are regarded as minor operators and include garden centres, hardware stores and supermarkets. Inspections are carried out nationally. A database records addresses of retailers and wholesalers and details of all inspections carried out. The criteria used in selecting outlets to be inspected include: those inspected in the previous year with recorded infringements; those not inspected within the last four years; all wholesalers/distributors of PPP; outlets against which complaints have been received and checks on selected parallel imports. As part of this inspection program, businesses using pesticides, but not in receipt of the BPS are also inspected, e.g. Golf Clubs, Co. Councils etc. In cases of minor or repeat infringements, product may be seized and a formal warning issued. Where there is evidence of serious or persistent infringements, the PCD may recommend the issuing of Fixed Penalty Notices or prosecution of the offender by the Minister for Agriculture, Food and the Marine.

As part of the cross-compliance inspections carried out under the basic payment scheme by the DAFM Integrated Controls Division, records of pesticide usage on farms are collected and forwarded to PCD for review. Depending on findings, PCD may recommend a financial penalty to an applicant’s BPS. In addition, with the introduction of the Sustainable Use of Pesticides Directive, all users of Plant Protection Products (PPPs) are required to demonstrate the application of Integrated Pest Management (IPM) practices on their holding, and be appropriately trained with regard to the use of PPPs, and registered with the DAFM as Professional Users (PUs). This is not (currently) a requirement of Cross Compliance, Inspections and users found to be in breach of these requirements may be subject to the issuing of Fixed Penalty Notices or prosecution.

Obsolete pesticides

Obsolete pesticides are defined by the PCD as pesticides which are no longer registered in Ireland or elsewhere in the world. There are no known stocks of such products in Ireland. The disposal of obsolete pesticides is required to be carried out at the owner’s expense by contractors who must be licensed by the EPA. In recent years a ‘Farm Hazardous Waste’ collection scheme has been introduced whereby obsolete pesticides and other hazardous waste can be brought to Centres strategically located around the country for disposal.

Laboratories

A dedicated formulation laboratory within the Pesticide Control Laboratory (PCL) provides support to the PCD to ensure that PPPs comply with their authorised specification.

53 DG(SANTE)/2018-6471 Version date April 2018 Pesticide Residues

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine DoH Department of Health FSAI Food Safety Authority of Ireland HSE Health Service Executive PCD Pesticide Controls Division PCL Pesticide Control Laboratory

Competent Authorities

The DAFM is the CA for legislation on pesticide maximum residue levels (MRL) and the DoH is responsible for legislation on baby food. The FSAI, which is responsible for the enforcement of baby food legislation, has contracted this work to the HSE and DAFM through a SC. The FSAI and DAFM are joint CAs for monitoring and enforcement of legislation on pesticide residues in food. The current SC with DAFM includes some of the work of the PCD, which has the primary technical competence on pesticide residues and the Pesticide Control Laboratory (PCL).

Official controls on residues

The DAFM (PCD and PCL) draws up the annual pesticide residue monitoring plan in consultation with the FSAI. The number of samples per food type is based on consumption data for adults and children of the particular food and data on the presence of pesticides in the food. It also takes account of the capacity of the laboratory to analyse samples. On the basis of this information, the monitoring plan specifies the foods to be sampled, the number of samples to be taken and the pesticides for which they are to be tested. Where residues are detected in foods, FSAI and PCD follow an agreed documented procedure for maximum residue level breaches. This procedure is reviewed regularly to ensure that it remains in line with best practice. Where residues that exceed the maximum residue level are detected, follow-up action

54 DG(SANTE)/2018-6471 Version date April 2018 is taken by the PCD, in consultation with FSAI. All national breaches of MRL legislation is followed up with an ‘on-farm’ inspection by the PCD Enforcement officer.

Laboratories

A dedicated pesticide residue laboratory within the PCL analyses samples of food for pesticide residues. It is accredited to ISO 17025 and is the designated NRL for pesticides residues in: food of non-animal origin; food of animal origin; cereals; and single analytical methods. The samples (+1300), taken by PCD at wholesale and retail level covering both imported and domestic produce, are brought by the sampling officer to the laboratory. Samples are routinely analysed for some 400+ pesticides including their metabolites. If the residue level found is higher than the maximum allowed and the residue is considered a risk to the consumer, the rapid alert process is followed.

55 DG(SANTE)/2018-6471 Version date April 2018 2.10. Control system for animal welfare

Legislation Consultation; DAFM advice

FAWAC Policy; legislation

SVS SVS LA (VPHIS) (AWD)

Regional DVO LAVI Offices

Controls Controls Controls

In transport; High-throughput at destination, Low-throughput Farms slaughterhouses marts, assembly slaughterhouses centres

AWD Animal Welfare Division DAFM Department of Agriculture, Food and the Marine DVO District Veterinary Offices FAWAC Farm Animal Welfare Advisory Council LA Local Authorities LAVI Local Authorities Veterinary Inspectorate SVS State Veterinary Service VPHIS Veterinary Public Health Inspection Service

Competent Authorities

DAFM is the CA for animal welfare. Responsibility for animal welfare on farm and during transport is delegated to the Animal Welfare Division (AWD) of the SVS. Welfare at slaughter in high-throughput slaughterhouses falls under the responsibility of VPHIS, and in low- throughput slaughterhouses, under the LA. The CA is assisted with advice, upon request, by the Farm Animal Welfare Advisory Council. This body represents all the significant stakeholders and provides advice in relation to EU and national legislation and on-farm welfare generally. It has produced guidelines and booklets for farmers on animal welfare for the different species.

56 DG(SANTE)/2018-6471 Version date April 2018 Official controls on farm

The CA sets annual targets for inspections, assigning a number of inspections to be carried out by each DVO, with the aim of covering a statistically representative sample of farms. At local level, the VI selects the holdings for inspection. In some cases, in order to make the best use of resources, the inspections may be carried out in conjunction with checks for other purposes. The criteria applied for the selection of farms include: their previous welfare history; the number of animals; the type of animals; and whether the farming is intensive or extensive. Routine inspections are usually announced in advance, while inspections following complaints and follow-up visits are unannounced.

The CA has taken several initiatives to inform farmers on animal welfare requirements, including: meetings with the sector's associations; publication of advertisements in newspapers; letters to individual farmers; and the production and distribution of information booklets and guidelines. In addition, the CA takes a pro-active role in identifying potential breaches of legislation through an early warning system which takes into account the ageing farming population and other social aspects.

Official controls during transport

A system is in place for the authorisation of transporters and approval of vehicles. A national electronic database of authorised road transporters for long journeys has been established, which is available on the DAFM website.

Inspections are carried out by VIs mainly at places of destination, particularly at markets and slaughterhouses. A target number of inspections per inspection site is set annually. Transportation of casualty and emergency slaughter animals must be certified in advance by a PVP. Such animals must be transported to the nearest available slaughterhouse. In case of serious infringements, legal proceedings may be taken in the courts and a fine imposed. The results of inspections, including infringements detected and actions taken, are recorded on the AFIT system. The majority of animals exported to continental Europe from Ireland pass through approved assembly centres, where controls are carried out, route plans checked and endorsed, and appropriate certification issued. New instructions oblige the transporter to provide evidence of a reservation at a control post in the immediate vicinity of the port of arrival in which to rest the animals, prior to the journey being approved by the CA. Livestock on roll-on/roll-off vessels are subject to a further check at the port of departure. Vehicles used for international transport are also inspected.

Official controls at slaughter

VPHIS inspectors carry out controls on animal welfare in high-throughput slaughterhouses, while the LA VI is responsible in low-throughput slaughterhouses. The aim is to ensure that all animals slaughtered are spared any unavoidable stress, pain, or suffering during movement, lairage, restraint, stunning or slaughter.

57 DG(SANTE)/2018-6471 Version date April 2018 2.11. Control system for plant health

CPL Central Plant Laboratory CPPSD Crop Policy, Production and Safety Division DAFM Department of Agriculture, Food and the Marine FSD Forest Service Division HPHD Horticulture and Plant Health Division

Competent authorities

DAFM, through the Plant Health section of the Horticulture and Plant Health Division and the Crop Production and Safety Division, and in association with the Forest Service Division (FSD), is responsible for the negotiation, transposition and enforcement of legislation in the plant health area. The FSD is responsible for implementing the forestry aspects, such as surveys for harmful forestry organisms and the provisions relating to wood, wood packaging material and forest plants. The three Divisions co-operate closely and a liaison committee is in place.

Plant passport system and internal market checks

For the initial authorisation to issue plant passports, the premises are visited by the HPHD to verify that the plant health requirements can be met and to inform the operator about the requirements. The authorisation is not limited to a specific range of plant species or to a type of passport and it is valid indefinitely as long as regular inspections confirm the eligibility.

58 DG(SANTE)/2018-6471 Version date April 2018 Inspections are carried out on the basis of an annual inspection plan. Control priorities, resource allocation and risk categorisation are detailed in the integrated plant health plan, with the assistance of the FSD and Crop Evaluation and Certification Division where required. The plan includes: type and number of inspections to be undertaken; type and number of samples to be taken; organisms subject to control; and prioritisation of control measures. DAFM maintains a record of registered producers, importers and traders, in line with plant health regulations. DAFM endeavours to maintain protected zone status for relevant organisms and to develop systems for rapid reaction to any outbreak of plant disease by means of surveys and follow-up actions.

Import and Export controls

Controls include: inspection of all relevant direct imports of non-EU country plants and plant products, as well as inspections by the Forest Service of imports of wood and wood packaging material and targeted inspections of plants, cut flowers and ware potatoes for quarantine pests. DAFM has requested Customs to flag imports of specific plants and plant products on its Automated Entry Processing (AEP) customs clearance system. Once flagged, Customs detain the consignments and refer them to DAFM so that the relevant control/s can be carried out before goods are entered into free circulation. Dedicated Border Inspection Post premises have been secured by DAFM for plant health point-of-entry inspections, and the facilities and equipment are being regularly upgraded. In addition, exports to non-EU countries are facilitated by the issuing of plant health certificates in respect of plants and plant products following inspections and sampling where required.

Plant Health Laboratories

The CPL of DAFM comprises the Seed Testing Laboratory and Plant Health Laboratory. The Microscopy Laboratory, the NRL for animal protein, is also located there. The laboratory provides analytical services in support of plant health controls. Other laboratories in particular the Dairy Science Laboratory and the AFBI laboratory in Belfast are also used for specific analyses.

59 DG(SANTE)/2018-6471 Version date April 2018 2.12. Control system for quality labelling (Organic, PDO/PGI/TSG)

Competent Authorities - PDO/PGI/TSG

FSAI Service Contract DAFM External Queries/ Complaints/ Risk [

HSE Policy; Legislation Retail Outlets (EH Outlet s AI Controls/ HSE/EHO/MoU/formal Reporting agreement

Dairy Livestock Controls/ Reporting Controls/ Controls/ Reporting Reporting

AI Agricultural Inspectorate DAFM Department of Agriculture, Food and the Marine EHO Environmental Health Officer FSAI Food Safety Authority of Ireland HSE Health Service Executive MOU Memorandum of Understanding

DAFM, through Food Industry Development Division and in association with the Agricultural Inspectorate (AI), is the CA responsible for the negotiation, transposition and enforcement of legislation for quality labelling (PDO/PGI/TSG). Three EU schemes known as PDO (Protected Designation of Origin), PGI (Protected Geographical Indication) and TSG (Traditional Speciality Guaranteed) promote and protect names of quality agricultural products and foodstuffs.

The following EU schemes encourage diverse agricultural production, protect product names from misuse and imitation and help consumers by giving them information concerning the specific character of the products:  PDO- covers agricultural products and foodstuffs which are produced, processed and prepared in a given geographical area using recognised know-how. All stages of production must take place in the one area.  PGI- covers agricultural products and foodstuffs closely linked to the geographical area. At least one of the stages of production, processing or preparation takes place in the area.  TSG- highlights traditional character, either in the composition or means of production.

DAFM, the HSE and the SFPA are the Competent Authorities responsible for official controls in respect of Protected Designation of Origin and Protected Geographical Indication in accordance with S.I. No 296 of 2015 (European Union (Quality Schemes for Agricultural Products and Foodstuffs) Regulations 2015) and in accordance with Council Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs.

60 DG(SANTE)/2018-6471 Version date April 2018 Official controls and inspection at establishments

Agricultural inspectors carry out inspection duties at dairy plants and carry out checks to ensure that the manufacturing process complies with the product specification for Imokilly Regato (PDO) as registered with the EU Commission.

In addition to carrying out producer site inspection visits, agricultural inspectors also carry out inspection duties at slaughterhouses and meat establishments and carry out checks to ensure that the manufacturing process complies with the product specification for Connemara Hill Lamb (PGI) as registered with the EU Commission.

The HSE is responsible for official controls in certain manufacturing/processing establishments and carry out checks to ensure that the manufacturing process complies with the product specification for Waterford Blaa (PGI) and specifications for Oriel Sea Salt (PDO) and Oriel Sea Minerals (PDO), as registered with the EU Commission.

Competent Authorities and official controls – Organic Labelling

DAFM is the CA for the organic sector. DAFM – technical staff of Agricultural Environment and Structures Division with assistance from Horticulture and Plant Health Division carry out labelling controls on organic produce at wholesale, farmers markets and retail level. The Organic Certifying Bodies during their control visits check, where relevant, labelling of organic produce for compliance with the legislation.

FSAI Service Contract DAFM

Policy/Legislation

Labelling Controls

AES/HPHD OCB

DAFM Department of Agriculture Food and the Marine AES Agricultural Environment and Structures Division HPHD Horticulture and Plant Health Division OCB Organic Control Body

61 DG(SANTE)/2018-6471 Version date April 2018 ANNEX – ACRONYMS, ABBREVIATIONS AND SPECIAL TERMS

ACRONYM DESCRIPTION ABP Animal By-Products AHCS Animal Health Computer System AI Agricultural Inspector AIM Animal Identification Movement system APB Aquaculture Production Businesses BIP Border Inspection Post(s) BSE Bovine Spongiform Encephalopathy CA Competent Authority Convention on international trade in endangered species of wild fauna CITES and flora CPL Central Plant Laboratory CPSD Crop Production and Safety Division CVRL Central Veterinary Research Laboratory CVO Chief Veterinary Officer DAFM Department of Agriculture, Food and the Marine DCCD Dairy Controls and Certification Division DEHLG Department of the Environment, Heritage and Local Government DG SANTE Directorate General for Health and Food Safety (European Commission) DoH Department of Health DVO District Veterinary Offices EHS Environmental Health Service EHO Environmental Health Officer EPA Environmental Protection Agency EPA-ORP Environmental Protection Agency-Office of Radiological Protection ERAD Eradication of Animal Disease Division EU European Union FBO Food/Feed Business Operator FFTF Food Fraud Task Force FHU Fish Health Unit FMD Foot and Mouth Disease FSAI Food Safety Authority of Ireland FSLS Food Safety Laboratory Service GMO Genetically Modified Organisms HACCP Hazard Analysis Critical Control Point HPHD The Horticulture and Plant Health Division HPRA Health Products Regulatory Authority (previously IMB) HSE Health Service Executive IAU Internal Audit Unit ICD Integrated Controls Division IMB The former Irish Medicines Board (now HPRA) INAB Irish National Accreditation Board

62 DG(SANTE)/2018-6471 Version date April 2018 ACRONYM DESCRIPTION ISO International Standards Organisation LA Local Authorities LAVS Local Authority Veterinary Service MANCP Multi-Annual National Control Plan MI Marine Institute NSAI National Standards Authority of Ireland NRCP National Residue Control Plan NRL National Reference Laboratory OL Official Laboratory OFML Official Food Microbiological Laboratory PAL Public Analyst Laboratories PCD Pesticide Controls Division PCL DAFM Pesticide Control Laboratories PCR Polymerase Chain Reaction PDO Protected designation of origin PECG Poultry and Egg Control Group PEHO Principal Environmental Health Officer PGI Protected geographical indication PHL Plant Health Laboratory RASFF Rapid Alert System for Feed and Food RVL Regional Veterinary Laboratories SC Service Contract SFPA Sea-Fisheries Protection Authority S.I. Statutory Instrument SIU Special Investigation Unit SL State Laboratory SRM Specified Risk Material SSVI Senior Superintending Veterinary Inspector STL Seed Testing Laboratory SVI Superintending Veterinary Inspector SVS State Veterinary Service TFRC Teagasc Food Research Centre TSE Transmissible Spongiform Encephalopathy TSG Traditional specialities guaranteed Trade Control and Expert System introduced by Commission Decision TRACES 2004/292/EC VIAU Veterinary Internal Audit Unit VPHIS Veterinary Public Health Inspection Service VPHRL Veterinary Public Health Regulatory Laboratory

63 DG(SANTE)/2018-6471 Version date April 2018