APPROVAL

PROCESS

for

BOVINE IDENTIFICATION

TAGS

January 2018

TABLE OF CONTENTS

Page
APPROVAL PROCESS FOR BOVINE TAGS / 2
ADVISORY NOTE on the supply of tissue tags for the National BVD Eradication Programme / 4
BOVINE IDENTIFICATION / 5
OVERVIEW OF THE ANIMAL IDENTIFICATION AND MOVEMENT SYSTEM (AIM) AND CORRESPONDING TAG SPECIFICATIONS AND REQUIREMENTS / 6
APPROVAL PROCESS including CONDITIONS OF APPROVAL / 8
Annex
1. CONVENTIONAL TAGS / 14
2. SECOND TAG
3. TISSUE TAGS / 16
16
4. TAG STANDARDS – MINIMUMTECHNICAL REQUIREMENTS / 17
5. TAGNUMBERINGSYSTEM – MINIMUMSPECIFICATION / 18
6. TAG APPLICATORS
7. INFORMATION/INSTRUCTION LEAFLET / 20
20
8. REPLACEMENT TAGS / 21
9. LOW LOSS RATE – CONVENTIONAL TAGS / 21
10. SERVICES / 22
11. TAG ORDERING PROCESS / 23
12. ORDER SIZEAND PRICING / 25
13. PACKAGING / 25
14. ISSUEOF TAGS / 25
15. ISSUEOF BIRTH REGISTRATION DOCUMENT / 25
16. HELPDESK FACILITY / 26
17. ICBF CONTRIBUTION / 26
18. MANAGEMENTARRANGEMENTS including record keeping and business / 26
continuity plan
19. IT Requirements / 27
20. Confidentiality and security of information / 27
21. Security of premises / 28
22. Freedom of Information / 28
Appendices
Appendix 1. Tag Certification / 29
Appendix 2. AIM Interface for Tag Orders / 30
Appendix 3. Birth Registration Document / 31
Appendix 4. FRAMEWORK DOCUMENT COVERING THE WORKINGS OF THE ICBF / 32
Appendix 5. Confidentiality Agreement / 34

Approval Process for Bovine Identification Tags

  1. The Technical specifications of the tags to be approved for supply in Ireland are set out in the attached Annex. The suite of ear tags includes conventional tags and, at the option of the tag supplier, tissue sample collection tags (Tissue Tags) and Electronic Tags.
  1. Tags submitted for approval will be subjected to appropriate assessment to verify that the tag meets the standards set out in this document.
  1. Payment for the Tags will be made directly by Keepers. The Department will not be liable for any fees, expenses, costs, outlay or liabilities incurred including the non-payment by Keepers in the delivery of the Services.
  1. All Applicants, as part of the application process for approval to supply bovine tags must provide all of the following:

(a)Conventional Tags (and applicators);

(b) Individual and pairs of Replacement Tags;

(c) Birth Registration Documents; and

(d) Written submission of the Applicant’s proposal for approval to supply bovine identification tags and services, including an outline of how it proposes to address the service requirements set out in this document.

In addition, Applicants, as part of the application process for approval to supply bovine identification tags, may submit Tissue Tags (and applicators) which provide for a tissue sample suitable for detection of BVD virus. Furthermore Applicants may wish to provide an electronic tag as an option for a second tag.All tags must comply with the requirements set down in this document for an identification tag.

Applications for approval to supply bovine Identification Tags should be submitted to

Tag Approval Application

Animal Identification and Movement Division

Department of Agriculture, Food and the Marine

Administration Block

Backweston Campus

Celbridge

Co. Kildare

W23 X3PH

Email

ADVISORY NOTE on the supply of tissue tags for the National BVD Eradication Programme

  • Tag suppliers are reminded of the legal obligation upon owners and keepers of animals to undertake BVD testing of newborn calves using an ear tag that is enabled to take a tissue sample (Regulation 3 of Statutory Instrument 118 of 2014.) To discharge this legal obligation, owners and keepers of bovines must use either tissue tags or supplementary tags as defined in Regulation 2 of Statutory Instrument 118 of 2014.
  • Ear tags meeting the requirements of a tissue tag as set down in SI 118 of 2014 may also be used to fulfil the requirements of a second ear tag for the purposes of Article 4 of Regulation 911/2004.
  • Tag suppliers should note the definition of a “tissue tag” in SI No 118 of 2014 as “an approved tag that includes a robust container thatoperates in such a manner that when the tag is attached to a bovine, the tagtakes a sample from the bovine, seals itself or is sealable in the container withoutinterfering with the integrity of the sample and has marked on it the identification of the bovine”.Alternatively a “supplementary tag” as defined in SI 118 of 2014, which is not an approved tag but which is capable of taking a sample in the manner set out above, may be used by owners or keepers to fulfil their requirements under SI 118 of 2014.
  • Tag suppliers are advised to seek guidance from the national reference laboratory to ensure that tags offered on the market for BVD testing purposes (tissue tags or supplementary tags as defined in SI No 118 of 2014) are capable of taking a tissue sample that is suitable for BVD virus detection by both antigen detection ELISA and RT-PCR.

BOVINE IDENTIFICATION

The objective of the Irish bovine identification system is to guarantee the safety of beef, beef products and dairy products by the operation of an effective, secure animal identification and tracing system under which each bovine animal is required to maintain the same identity for life in typical Irish conditions. The identification and traceability system has four elements: tagging, bovine passport, on farm bovine herd register and a computerised database called the Animal Identification and Movement System (AIM).

The Irish bovine identification and traceability system must comply with Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 (as amended) establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97.

In addition to Regulation (EC) No 1760/2000, the Irish bovine identification and traceability system must comply with other relevant EU Legislation including

  • Commission Regulation (EC) No 494/98 of 27 February 1998 as amended;
  • Commission Regulation (EC) No 1082/2003 of 23 June 2003 as amended;
  • Commission Regulation (EC) No 911/2004 of 29 April 2004 as amended.

The relevant national legislation is S.I. No. 77/2009 European Communities (Identification of Bovines) Regulations and S.I. No. 521/2014 Animal Health and Welfare (Bovine Movement) Regulations).

This approval system is an exercise of the Minister’s powers under Regulation 4 of European Communities (Identification of Bovines) Regulations (S.I. No. 77 of 2009) in order to implement the requirements of Regulation (EC) No 1760/2000 and Regulation (EC) No 911/2004.

Ireland introduced an approval system for multiple tag vendors in November 2016. Under this system suppliers that meet minimum requirements, will be approved to supply bovine ear tags in Ireland.

OVERVIEW OFTHE ANIMAL IDENTIFICATION SYSTEM (AIM) AND CORRESPONDING TAG SPECIFICATIONS AND REQUIREMENTS

The purpose of the identification system is to ensure that each animal born in or imported into the State:

(a)is identified securely for life by appropriate tagging arrangements;

(b)is registered in the manner provided for in the Regulation (EC) No. 1760/2000 and Commission Regulation (EC) No. 911/2004;

(c)any and all subsequent movements and disposal details concerning the animal are recorded onto a central database known as AIM; and

(d)is fully traceable from birth to ultimate exit by death or export.

The Animal Identification and Movement (AIM) System is a generic animal identification and movement system (database) covering bovines and other species. Tag vendors have access to AIM to process orders from keepers and to notify the details of the tags issued to the keepers. The facilities required for bovine animals are particularly demanding as there is a requirement to register and identify individual animals early in their lives and to record such registration and identification on the AIM database such that identification and registration is completed within a maximum 27 days of birth (identification within 20 days of birth and registration within 7 days of identification). The identification system also comprises a comprehensive movement monitoring system that includes clearance against the AIM database prior to movement from holding to holding, both directly and via markets, entry into the human food chain or export and finally recording of the date of death.

An Approved Supplier will be required to provide Calf Birth Registration Documents with each pair of tags at first issue to keepers (i.e. not for Replacement Tags). The keeper, as part of the application process for calf birth registrations, where not availing of online registration options, is required to submit completed Calf Birth Registration Documents to the Calf Registration Agency which is responsible for registering all calf births and movements on the AIM system.

The main elements of this system are set down below:

  1. Approximately 2.4 million bovine animals are tagged and registered each year mainly in the Spring/early Summer period in approximately 80,000 breeding herds.
  1. Each Keeper is obliged to attach two official ear-tags within a maximum period of twenty days following the birth of each animal and in any event before an animal may move off the holding. These tags will be supplied to Keepers by an Approved Supplier. The animal must be registered within 7 days of tagging.
  1. One of the ear tags may be a Tissue Tag as part of the national programme for the eradication of Bovine Viral Diarrhoea (BVD).
  1. All tags, both male and female part, must be “Flag Tags”.
  1. Each Tag Set issued to a Keeper by an Approved Supplier must be accompanied by a corresponding Birth Registration Document as set out in Appendix 3. A prepaid postage envelope for bulk return of Birth Registration Documents that is pre-addressed to the National Bovine Animal Birth Registration Service, P.O. Box 1997, FREEPOST, West Cork Technology Park, Clonakilty, Co. Cork will be supplied by an Approved Supplier to a Keeper in respect of each issue of 10 tags or a smaller number of tags.
  1. A Replacement Tag must bear the same unique identification number and barcode as the original Tag and display the logo of the Department. A Replacement Tag must be supplied by an Approved Supplier within 3 days of a request from the Keeper.However, orders for Replacement Tags indicated as urgent must be issued within two working days of the order being received.

Approval Process

including Conditions of Approval

In order to become an Approved Supplier, an Applicant must:

  1. Submit an application (in English), which must include:
  • Name, postal address, telephone number and e-mail address of Applicant and nominated contact personnel to whom all communications shall be directed;
  • Name, address, telephone number and e-mail address of any third parties involved in the application.
  • Demonstration of understanding of the Minister’s requirements in a project plan for delivery of the service.

Provide a project plan for delivery of the service setting out at least the following information:

  • the categories of activities to be undertaken; and
  • the arrangements for management of the project.
  1. Arrangements for processing Tag orders

Applicants are required to include with their application a description of the methodology

for delivery of the service including:

  • arrangements for processing orders for Tags from Keepers, including online ordering systems and user friendliness of the systems;
  • fulfilling orders, including sourcing of Tags, delivery of orders (Tags and Birth Registration Documents);
  • accounting arrangements, including recording payments for Tags issued; and
  • calculating the amount due to ICBF and transfer of the funds to ICBF.
  1. Helpdesk for responding to farmer requests and queries

Applicants are referred to paragraph 16of the Annex. The telephone help desk must be available at a minimum between the hours of 09:00 to 17:00 hours daily except bank holidays, public holidays and weekends. Applicants should describe their arrangements for the help desk service including any arrangements for requests received out of hours or at weekends, electronically and any additional features. An Approved Supplier shall not use in the operation of the Helpdesk facility any arrangements that incur additional cost to Keepers including premium phone numbers.

  1. Security of Premises

Applicants are required to provide evidence that they have secure premises to conduct all the operations of a bovine tag supplier, including storage of tags, information on applications, IT and printing facilities.

  1. Arrangements for document storage and retrieval and measures to ensure confidentiality and protection of data

The Department may require certain documents at short notice. Applicants are required to provide details of their document storage and retrieval systems. Applicants are required to store documents securely for up to 7 years. Applicants are requested to provide a description of their proposed secure arrangements for recording personal details of Keepers, including payment arrangements and the measures to be taken. This is to ensure there is no risk of unauthorised access to or use of any of the information received or stored by an Approved Supplier relating to Keepers and the Department.

  1. Arrangements for management of the relationship with herd keepers

Applicants must include with their application a description of their arrangements for management of the relationship with keepers, including an after sales service.

  1. Arrangements for the Business Continuity Plan including arrangements for dealing with unforeseen events

It is essential that Tags requested are supplied to keepers in a timely fashion and Applicants should be aware that any interruption to service can have a significant negative impact on the integrity of the animal identification system and on the freedom of Keepers to move animals. Applicants must include in their application a description of how they propose to deal with unforeseen events such as disruption in the supply of tags, industrial action, postal interruptions, electricity and IT breakdowns and their contingency arrangements.

  1. Applicants must also submit:

a)details of verified loss rates of less than 7% by an internationally recognised body in accordance with paragraph 9 of the Annex;

b)copies of certification and validation as outlined in paragraph 1of the Annex;

c)proof that they are in good financial standing, supported by a current bank reference, Profit and Loss Accounts and Balance Sheets for the last 3 financial years or provide other evidence of financial standing and a current tax compliance certificate; and

d)an undertaking to only supply appropriate numbered official ear tags to keepers.

The Department of Agriculture, Food and the Marine will conduct a site visit as part of the approval process.

  1. Applicants must submit the following with their application for testing/inspection
  • 200 samples of the Conventional Tag taken at random from various production batches.
  • 8 samples of the packaging proposed per type of tag;
  • 5 samples of each applicator for each type of tag including instructions;
  • 10 samples of the proposed Birth Registration Document; and

The above tag samples must be submitted using the numbering format set out in paragraph 5.1 of the Annex and include the Department logo.

Where an Applicant is seeking approval of a Tissue Tag or Electronic Tag as an official identification tag, the Applicant must also submit with their application 200 samples of the Tissue and/or Electronic Tag (and applicators)taken at random from various production batches.The tags will be tested to ensure that they comply with the requirements as set down in this document for an identification tag (paragraphs 1, 2, 3 and 4 of the Annex as appropriate).

  1. Notification of Decision on Application for Approval

The Department will make a decision as soon as possible after receipt of an application. Further information may be required and requested. In order to expedite the approval process, applicants are advised to provide all of the information set out in this document with their initial application, including the ear tags which are being submitted for approval.

The Department will provide a written decision, including the reasons for the decision taken to an Applicant as soon as possible. In the case of a refusal, the Department will provide a written decision to an Applicant that clearly sets out the reasons for a refusal.

An Applicant for approval may request a review of a decision to refuse approval. An Approved Supplier may also request a review of the Decision to suspend or revoke an approval. Where such a review is sought the Applicant or Approved Supplier shall write to the Principal Officer in Animal Identification and Movement Division setting out the grounds on which they are seeking review of the relevant decision. A request to review a decision to refuse, suspend or revoke an approval should be lodged within 30 days of the decision being made.

A Review Committee shall consider such a request for review of a decision to refuse, suspend or revoke an approval and provide a written determination as soon as practicable but in any event within two months of the request. Such a review may result in a decision to affirm the original decision, to grant approval or to restore approval to an Applicant or Approved Supplier.

  1. Duration of an Approval

Approval granted to an Applicant will remain in place up to 31 December 2018 or for a longer period as determined by the Department.

  1. Maintenance of Approval to Supply Tags

a)Approval in accordance with this standard shall be valid during the period referred to in the preceding paragraph provided that all of the conditions of approval continue to be met and anApproved Supplier retains a capability to deliver the service to keepers in line with the terms of approvalor new requirements provided for in new EU legislation.

b)An Approved Supplier may be requested to confirm that they are conforming to the conditions of the approval and supply relevant details in order to maintain the approval.

c)The Department of Agriculture, Food and the Marine reserves the right to conduct periodic audits to establish compliance with the terms of the approval including storage and site visits.

d)An Approved Supplier must:

  • comply with data protection legislation and the Department’s data protectionpolicy;
  • have secure storage of all documents with a record of all personnel who have access to the premises; and
  • immediately report any theft, security breaches or security concerns to the Department.
  1. Monitoring

The Department reserves the right to request a sample of tags from any Approved Supplier and subject these tags to a range of tests to assess their continued compliance with this standard at any point during the tenure of the approval. An Approved Supplier supplying ear tags not conforming to this standard will be removed from the list of approved tag companies.

  1. Withdrawal of Approval

a)The Department reserves the right to withdraw approval if an Approved Supplier is in breach of any of the conditions set out in this document.

b)An approval may also be withdrawn if an Approved Supplier is in breach of existing European or domestic law.