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ERAD Document No. ER4 (2020 Version) TERMS OF ENGAGEMENT: VETERINARY PRACTITIONERS (VPs) INVOLVED IN TESTING AND SAMPLING UNDER THE BOVINE TUBERCULOSIS ERADICATION AND BRUCELLOSIS MONITORING PROGRAMMES. ACKNOWLEDGEMENT AND ACCEPTANCE OF THESE TERMS OF ENGAGEMENT IS REQUIRED FROM VETERINARY PRACTITIONERS 1 (VPs) AS THE APPLICATION FOR CONTINUED APPROVAL TO TEST/SAMPLE FOR THESE PROGRAMMES UNDER THE APPLICABLE LEGISLATION. ACKNOWLEDGEMENT AND ACCEPTANCE OF THESE TERMS OF ENGAGEMENT MUST BE MADE ONLINE VIA THE ANIMAL HEALTH COMPUTER SYSTEM (PVP LINK). Please Note: If there is any element of this document that is unclear or that you do not understand please contact the SVI in your 1 Please note that in acknowledging and accepting these Terms of Engagement the only obligations arising for WTVIs are those that are not in conflict with their status as Civil Servants, i.e. Sections 1, 2, 5, 10, 11 of Part A and Part B. Page 1 of 118 ER4 2020

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Page 1: €¦  · Web viewERAD Document No. ER4 (20. 20. Ver. sion) TERMS. OF ENGAGEMENT: VETERINARY PRACTITIONERS (VPs) INVOLVED IN TESTING AND SAMPLING UNDER …

ERAD Document No. ER4 (2020 Version)

TERMS OF ENGAGEMENT:

VETERINARY PRACTITIONERS (VPs) INVOLVED IN TESTING AND SAMPLING UNDER THE

BOVINE TUBERCULOSIS ERADICATION AND BRUCELLOSIS MONITORING PROGRAMMES.

ACKNOWLEDGEMENT AND ACCEPTANCE OF THESE TERMS OF ENGAGEMENT IS REQUIRED

FROM VETERINARY PRACTITIONERS1 (VPs) AS THE APPLICATION FOR CONTINUED

APPROVAL TO TEST/SAMPLE FOR THESE PROGRAMMES UNDER THE APPLICABLE

LEGISLATION.

ACKNOWLEDGEMENT AND ACCEPTANCE OF THESE TERMS OF ENGAGEMENT MUST BE

MADE ONLINE VIA THE ANIMAL HEALTH COMPUTER SYSTEM (PVP LINK).

Please Note: If there is any element of this document that is unclear or that you do not understand please contact the SVI in your RVO to discuss the matter.

1 Please note that in acknowledging and accepting these Terms of Engagement the only obligations arising for WTVIs are those that are not in conflict with their status as Civil Servants, i.e. Sections 1, 2, 5, 10, 11 of Part A and Part B.

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ContentsPart A - Terms of Engagement for VPs undertaking Tuberculin testing and Brucellosis sampling.....41. Applicable Terms and Conditions for Eligibility to Test/Sample.............................................42. Number and volume of tests issued and completed..................................................................73. Conflict of interest.....................................................................................................................74. Newly qualified practitioners....................................................................................................85. Quality Control of Testing/Sampling.....................................................................................96. Sanctions.................................................................................................................................117. VP – Practice Association..................................................................................................................148. Payment of Fees.................................................................................................................................159. Tax Clearance Procedures.......................................................................................................1610. Confidentiality.........................................................................................................................1711. Data Protection........................................................................................................................18

Part B – Terms of Engagement – VP Procedures relating to SICTT Bovine TB Testing in Ireland..2212. Definitions...............................................................................................................................2213. Introduction.............................................................................................................................2314. Scheduling of Tests.................................................................................................................2515. Preparation prior to performing a Test....................................................................................2716. Testing – General Points.........................................................................................................2917. Performance of the SICTT......................................................................................................3118. Reactors...................................................................................................................................3519. VP Advice to Keepers.............................................................................................................3520. Reporting and Records............................................................................................................3621. Certification.............................................................................................................................3822. Medicating Animals under Test..............................................................................................3923. Pharmacovigilance..................................................................................................................39

Appendix 1 – Non-Compliance Procedures........................................................................................40Appendix 2 – ER13.............................................................................................................................53Appendix 3 – Required Employment, Bank and Premises Information.............................................57Appendix 4 - Confidentiality Agreement............................................................................................61Appendix 5 - Data Protection Notice..................................................................................................64Appendix 6 – Letter to Farmers..........................................................................................................69Appendix 7 – Equipment Checklist....................................................................................................74Appendix 8 – Providers of McLintock Syringes.................................................................................75Appendix 9 – NOTES ON COMPLETION OF PRE PRINTED ER15B...........................................76

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Part A - Terms of Engagement for VPs undertaking Tuberculin testing and Brucellosis sampling

1. Applicable Terms and Conditions for Eligibility to Test/Sample

To conduct testing2 or sampling3 for Tuberculosis and Brucellosis under the Animal Health

and Welfare Act 2013, Regulations made there-under and related EU legislation, VPs must

commit formally and adhere strictly to the terms and conditions set out in Parts A and B of this

ER4 Terms of Engagement. Approval to test/sample takes place on an annual basis following

online acknowledgement/acceptance of the ER4 Terms of Engagement. Approval/re-approval

for testing/sampling is conditional on acknowledgment/acceptance of the ER4 Terms of

Engagement. Failure to acknowledge/accept the ER4 Terms of Engagement will result in no

approval or re-approval as the case may be.

1.1 To be eligible for consideration for approval to carry out approved tests, to conduct the

single intradermal comparative tuberculin test (SICTT) for bovine Tuberculosis and

sampling for Brucellosis under the Animal Health and Welfare Act 2013, Regulations made

thereunder and related EU legislation, VPs must:

• Be entered in the current Register of Veterinary Practitioners for Ireland;

• Be appointed by the Minister for Agriculture, Food and the Marine, in exercise of the

powers conferred on him by Section 37(1) of the Animal Health and Welfare Act 2013 (No

15 of 2013), to exercise the functions of an authorised officer set out in Section 38(1) of

that Act for the purposes of carrying out bovine tuberculosis and brucellosis

testing/sampling under the Brucellosis in Cattle (General Provisions) Order 1991 (SI 114

of 1991) as amended and the Animal Health and Welfare (Bovine Tuberculosis)

Regulations 2015 (SI 58 of 2015);

• Commit formally and adhere strictly to the terms, conditions and instructions laid down in

this ER4 Terms of Engagement;

• Confirm that they have completed and submitted to the Veterinary Council of

Ireland a Premises Accreditation Scheme declaration form which requires each

registered person to declare which veterinary premises or exempted place they are

carrying out the practice of veterinary medicine at/from or to declare that they are

retired and/or non-practising;

2 The Single Intradermal Comparative Tuberculin Test (SICTT)3 Any blood sampling required under the Programme

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• Attend at a training course if required to do so by the Minister;

• Ensure that the equipment used in the tests meets the requirements specified in Part B;

• Comply with such criteria in relation to testing and sampling as the Minister may

determine from time to time;

• Use and update the unique identity codes (user code and password) and access number

(Personal Identification number (PIN)) issued for personal use in respect of the Animal

Health Computer System (AHCS4) and keep details of these confidential. A VP must not

allow any other person access to their identity codes and/or PIN as this would fail to

protect the integrity of the veterinary certification process and could facilitate false

certification of a test.

1.2 In addition to the above, new applicants must:

Apply to the RVO for approval to test by submitting form ER3. The RVO will then

arrange a meeting with the SVI at which time the ER4 Terms of Engagement will be

acknowledged/accepted by the new VP;

Attend a TB training course as prescribed by the Minister;

Have their first test supervised to confirm competency.

The following diagram describes the approval to test process:

4 Guidance in use of AHCS e.g. data entry, part herd test date recording etc. is available from the RVO

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1.3 No liability shall attach to the Minister for compensation or damages or costs in respect of

any claims arising from the performance of testing/sampling under the Programmes.

1.4 Failure to comply with the ER4 Terms of Engagement may, depending on the nature of the

non-compliance (minor or non-minor5), result in sanction up to and including the

withdrawal of approval to conduct the SICTT and Blood sampling.

1.5 The approval to test/sample may be withdrawn by notice of either party or following a

decision in the context of the Appeals Procedure referred to at a) below and subject to b)

below:

a) Disputes arising regarding the performance of testing/sampling by an approved VP shall

be subject to the appeals procedures set out at Appendix 1;

b) This right of appeal shall not affect the obligation of the Minister to take prompt action to

eliminate or contain risks to human, animal or plant health, to animal welfare or to the

environment;

c) Notwithstanding the above the decision of the Minister in relation to all aspects of

approval shall be final.

5 Please refer to Section 6

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ER3VP applies for approval to test – ER3 Part A

ER4SVI gives ER4 to VP to read and understand – ER4 Part A (Terms & Conditions) & ER4 Part B (Instructions)

CCSRVO gives CCS set up forms / Bank detail forms to VP to complete

ER3

SVI completes ER3 Part B – having (1) received Syringe info from VP, (2) supervised the VP who received a satisfactory report and (3) confirmed training attendance – and approves the VP to carry out tuberculin testing

ER3

RVO Admin completes ER3 Part C – having checked Minister has signed the Authorisation for the PVP - and issues equipment to PVP (a taggers, reactor tags , red discs and a stamper)

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1.6 A VP who has been suspended from testing/sampling, or who has had his/her approval to

test withdrawn in Northern Ireland may likewise be suspended/have approval withdrawn

in Ireland.

1.7 Requesting test approval at animal or herd level

Tests must have the prior approval of the Minister and it is illegal to carry out a test

without such approval. Test approval, in every case, is subject to the receipt of an advance

itinerary, within the instructed timeframe.

2. Number and volume of tests issued and completed

2.1 The number of approved tests issued to an approved VP will be determined, at any

particular time, by:

The requirements of the Programmes, at any particular time; and

Farmer nominations.

3. Conflict of interest

3.1 Certification of animals or products owned or from a holding, land or premises owned, in

whole or in part by the certifier, their close relatives or by his/her veterinary

partner/assistant is prohibited. A close relative includes parents, parents in law, siblings,

spouse/partner, aunts, uncles and children and children of spouse/partner.

3.2 The VP hereby confirms that s/he has carried out a conflicts of interest check and is

satisfied that neither s/he nor any subcontractor nor agent as the case may be has any

conflicts in relation to the testing/sampling to be conducted under the ER4 Terms of

Engagement. The VP hereby undertakes to notify the RVO immediately should any conflict

or potential conflict of interest come to his/her attention during the currency of the ER4

Terms of Engagement, not to test the herd/animal(s) in question and to comply with the

RVO’s directions in respect thereof. The responsibility lies with the VP to ensure that no

conflict of interest exists or may be inferred. Therefore, should a VP become aware that

s/he has been issued an approval to test in respect of which there is a conflict, or potential

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conflict, of interest under S.I. No. 380 of 1999, European Communities (Certification of

Animals and Animal Products) Regulations 1999, or otherwise where a conflict, or potential

conflict, of interest might be inferred, the onus is on the VP to bring this fact to the notice of

the SVI or the VI in charge. The VP may not test the herd/animal(s) in question.

3.3 See also the Veterinary Council of Ireland website which states that Adherence to the Code

of Professional Conduct is frequently more exacting than conformity with the law and also

that Veterinary Practitioners should not issue a certificate which might raise questions of a

possible conflict of interest.

3.4 The VP shall not offer or agree to give any public servant or civil servant any gift or

consideration or commission of any kind as an inducement or reward for doing or

forbearing to do or having done or forborne to do any action in relation to the obtaining or

execution of the ER4 Terms of Engagement. Any breach of this provision or the

commission of any non-compliance by the VP, any subcontractor, agent or employee with

the Prevention of Corruption Acts, 1889 to 2005 shall result in the immediate withdrawal of

approval to conduct the SICTT and Blood sampling without liability for compensation or

damages and to recover the amount of any loss resulting from such cancellation, including

but not limited to recovery from the VP of the amount or value of any such gift,

consideration or commission.

4. Newly qualified practitioners

4.1 A newly qualified veterinary practitioner is one who is within the first year of

graduation/registration, and in the context of TB testing/Brucellosis sampling one who is

within the first year of approval to conduct testing/sampling. It is the Minister’s view that

graduates/registrants should be facilitated and supported and accordingly the Minister

expects a Practice that employs a newly authorised graduate/registrant for the purpose of

testing/sampling animals/herds to arrange technical and communication support of the

performance of the graduate until both graduate and employer are satisfied they are

competent and confident. The Principal(s) of the Practice should endeavour to ensure that

testing/sampling carried out by employees of the Practice can be conducted in compliance

with the ER4 Terms of Engagement.

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5. Quality Control of Testing/Sampling

5.1 The Minister, recognised as the Competent Authority by the EU, is obliged under EU

legislation to ensure that tests/sampling are performed correctly. As part of the Minister’s

quality control of the Programmes, test/sampling performance and results are monitored

and assessed on a risk basis.

5.2 The testing/sampling performance and outcome profiles are monitored by the local RVO

under the direction of the relevant Area Management Team led by a Senior Superintending

Veterinary Inspector. This aims to ensure the consistent application of uniform standards

across the country to function as a safeguard in relation to the maintenance of high

standards and to ensure that VPs are treated fairly and equitably.

5.3 The local RVO carries out regular monitoring of VP testing/sampling technique and

performance using a combination of:

Administrative checks on VP performance, based on analysis of testing data, ER13A

reports;

Investigation into discrepancies and requests for certification changes; and

Supervisory field inspections carried out by a Veterinary Inspector (VI). Supervisory field

inspections take place on a risk, random and opportunistic basis. The frequency of

supervisions in respect of individual Practitioners are determined by, amongst other

things, the VP’s record of compliance with quality control criteria, including ER13A

reports, previous history of non-compliance and the length of time since previous

supervision.

In addition, RVOs respond to reports/complaints received regarding misleading

certification.

5.4 For each approved VP conducting testing/sampling, the RVO will, on a risk basis, amongst

other things, arrange:

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The supervision/inspection of equipment, test methodology and procedure including

recording of data, biosecurity, cleansing and disinfection protocols while actually

performing a test (ER13);

Check tests of herds;

Checks of animals after completion of a test;

Monitoring recently tested animals for proper identification, the presence and location of

SICTT clip marks, the presence, nature, location and accurate recording of reactions,

sampling of animals nominated as tuberculin reactors for presence of a correlating

Interferon- assay response and/or DNA match with blood sample submission,ϒ

investigation of matters that come to the notice of the RVO post reporting of test

(including where it becomes apparent that the same VP has certified s/he has tested

animals on the holding in the same yard/crush under separate herd numbers); and

Carrying out any other monitoring considered appropriate.

In communications with veterinary practices in their area of responsibility, RVO Veterinary

Inspectors (VI/SVI) outline such items as the annual testing programme and the level of

service expected of the VP in that respect. The VI/SVI may also examine the equipment and

related computer software being used in the field and at the practice office for

testing/sampling, including tuberculin storage and stock control procedures. Periodic

information meetings may also be organised by the area VI/SVI. It is a condition for

approval to test/sample that prior to the annual testing programme a declaration that the

ER4 Terms of Engagement has been received, read, and understood must be received from

each approved VP. In addition, in order to qualify for approval, each VP must submit

certificates of purchase or servicing of a pair of McLintock syringes each year.

5.5 The Minister conducts regular audits on administrative procedures such as test approval

requests, advance itinerary submission and accuracy, compliance with legal requirements

viz. a viz. accurate recording of identity details of animals/herds tested (taking into

consideration animal movement records), prompt sample and/or test report submission,

rate of submission of amendments to test reports, and other computer based procedures.

5.6 A copy of the ER13A performance report (Appendix 2), as generated from data routinely

held on AHCS, will be made available to each VP on a six monthly basis. The ER13A report

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for the vast majority of VPs will indicate that they are carrying out their testing to a high

standard in compliance with the requirements of the Programme. However, the ER13A,

which is a factual report compiled from records submitted by the VP, may help to identify

areas where a VP’s testing performance is out of line with wider trends and therefore may

need to improve aspects of his/her performance. In some cases the ER13A report may

indicate that a VP’s testing performance is out of line with expectations. In those cases,

which are anticipated to involve a very small number of VPs, follow up action will be taken

to assess the issue further in line with Section 6 as appropriate. Any VP who is unclear as to

any element of the ER4 Terms of Engagement, or the meaning or significance of matters on

his/her ER13A or who wishes to clarify any matter related thereto, should contact the

VI/SVI in the RVO area to which the testing relates.

5.7 Two information sessions will be held in each calendar year by DAFM. Those VPs who test

more than 21,000 cattle in the previous calendar year must attend one of these sessions.

DAFM will notify the relevant VPs of the dates of the sessions.

5.8 From the commencement of the 2020 Programme, and entirely separate to the training

provided to new graduates, it will be a requirement on all VPs to attend mandatory training

at least once every five years6. This will be a new mandatory training Programme that the

Minister is developing with a view to promoting the continuous professional development7

of VPs involved in the bTB Eradication Programme which will be provided over two training

sessions8 per year. It is intended that 1 in 5 VPs (or 20% of all VPs approved for testing)

will attend this training on an annual basis and failure to attend, without adequate

explanation, will be viewed as non-compliance with the ER4 Terms of Engagement. The

Minister will nominate VPs to attend each session and contact will be made directly with

VPs to put necessary arrangements in place. In addition, the Minister is examining options

to provide VPs with other mandatory training opportunities such as online modules.

Further information will issue in due course.

6 No charge will be levied by the Minister, and the Minister will not be liable for expenses that accrue to attendees, in respect of attendance at these training sessions.7 Attendance at these training sessions will be eligible for the award of CPD points.8 Unlike training provided to newly qualified VPs, this training will not focus on the technical aspects of performing the SICTT.

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6. Sanctions

6.1 The purpose of this Section is to set out the arrangements for dealing with non-compliances

by VPs with official controls implemented by the Minister as part of the Eradication of TB

and Brucellosis Monitoring Programmes as set out in the ER4 Terms of Engagement. It is

also to ensure that all VPs are aware that if there is a failure to adhere to the required

standards of testing/sampling performance, the test may be invalidated9 and the

procedures set out in Appendix 1 will apply. These procedures will be initiated where a

concern arises about the testing/sampling performance of VPs and will provide a fair,

equitable and impartial process for dealing with any such concern.

6.2 Principles

The Minister is obliged under EU legislation to ensure that tests are performed correctly.

All VPs shall comply with the ER4 Terms of Engagement and in circumstances where a

concern arises about the standards of testing/sampling performance, it may be necessary to

apply appropriate sanctions. Where such circumstances arise, all VPs will be treated in a

fair, equitable and impartial manner in accordance with the principles of natural justice

which may, depending upon the context, include any or all of the following:

The right to be informed of any concern about his/her performance;

The right of reply to any such concern;

The right to be represented;

The right to a fair and impartial determination of the matter, after all relevant facts have

been considered.

6.3 Non-compliance6.3.1 ‘Non-minor non-compliance’

A ‘non-minor non-compliance’ reflects performance that may or may not present risks

to the integrity of the TB test or Brucellosis sampling but which in either case may be

sufficiently serious to warrant a serious sanction up to and including withdrawal of

approval to test from TB testing and Brucellosis sampling work. A ‘non-minor non-

compliance’ may also include a failure to remedy a ‘minor non-compliance’ or repeated

instances of a ‘minor non-compliance’.

9 In line with Section 7.1 fees shall be paid in respect of tests satisfactorily completed. Tests performed outside the timeframe, or otherwise outside the ER4 Terms of Engagement, specified by the RVO and so notified to the farmer will not be paid for by the Minister except where a case is accepted on a force majeure basis.

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The following examples of performance, which are non-exhaustive, may lead to serious

sanctions as set out in Appendix 1, up to and including withdrawal of approval to test

from TB testing/Brucellosis sampling work.

False or misleading certification;

Carrying out tests without prior approval of the Department;

Failure to accurately record all tag numbers at commencement and completion of

test;

Failure, without adequate explanation, to accurately record all animals present on

the holding at the time of the test;

Failure to raise a pea like swelling at each injection site;

Repeated failure to either properly locate or properly clip injection site, without

adequate explanation;

Failure to accurately measure and/or record the skin thickness at each injection site

on either or both injection day and reading day;

Certification of test report by an unauthorised person(s) other than the testing VP

e.g. lay staff. [In exceptional circumstances (e.g. injury) with prior agreement of

RVO, certification by another authorized VP may be acceptable];

Failure, without adequate explanation, to comply with approved test itinerary (time

and date) for Day 1 and/or Day 2 (including private test);

Failure to conduct testing in compliance with permission (date range/interpretation

level), including material failure to comply with approved test itinerary (time and

date) for Day 1 and/or Day 2 (including private test);

Testing unidentified animals;

Using improperly functioning/identified/certified syringe(s);

Failure, without adequate explanation, to co-operate with inspecting VI, including

refusal to surrender records to the inspecting VI as required;

The use of unacceptable and unwarranted ‘screening’, prior to reading, in a manner

which may be viewed as an examination of cattle without recording all of the

numbers and measuring all of the skin reactions;

Failure, without adequate explanation, to attend a training session as nominated or

otherwise requested by the Minister;

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More serious and/or ongoing instances/or a combination of the types of minor non-

compliances listed below.

6.3.2 ‘Minor non-compliance’

In addition to the above, occasionally performance, though falling short of the expected

performance of a VP under the ER4 Terms of Engagement, may not be deemed

sufficiently serious to be a ‘non-minor non-compliance’ as above, but instead may be

deemed to be a ‘minor non-compliance’ and may lead to sanctions set out in Appendix

1.

A ‘minor non-compliance’ reflects performance that falls short of the expected

performance of a VP under the ER4 Terms of Engagement but which will not ordinarily

present a risk to the integrity of the TB test or Brucellosis sampling. A ‘minor non-

compliance’ can be a single act, or a series of acts and what constitutes a ‘minor non-

compliance’ may vary depending on the particular circumstance of the case.

Repeated instances of ‘minor non-compliances’ are deemed to be non-minor in nature

and as such may lead to the more serious sanctions set out in Appendix 1 up to and

including withdrawal of approval to test from TB testing/Brucellosis sampling work.

Furthermore, as set out in paragraph 6.3.1, ‘non-minor non-compliance’ may also

include a failure to remedy a ‘minor non-compliance’.

The following non-exhaustive list provides examples of ‘minor non-compliances’:

Failure to submit test reports on time;

Failure to advise keeper as to precautions with regard to reactor/inconclusive

reactor;

Failure to submit passports of inconclusive reactors with test reports;

High incidence of subsequent alterations to test reports which are not related to test

certification;

Inconsistent confirmation of ‘pea’ after injection in all animals;

Failure to record skin TB/Clinical remarks, e.g. extraneous lumps;

Failure to use approved disinfectant;

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Improper storage of Tuberculin;

Possession of improperly functioning/identified/certified syringes (Day 1);

Failure to have prescribed equipment available as required;

Arrival on the holding with unhygienic protective clothing or footwear and/or use of

unhygienic equipment if cleansing and disinfection completed upon arrival;

Using unhygienic protective clothing or footwear and/or use of unhygienic

equipment at the test;

Failure to have current (within 7 days) herd profile at the time of the test;

Failure to properly locate and/or clip injection sites;

Failure, without adequate explanation, to apply a reactor disc to a reactor animal.

7. VP – Practice Association

7.1 Each Practice must have at least one and may have any number of VPs associated with it.

For VPs to become associated to a Practice an SS02 form must be submitted to the relevant

RVO. Likewise, if a VP is no longer associated with a Practice the association must be

removed by submitting an SS02 form to the relevant RVO.

7.2 VPs must have completed and submitted to the Veterinary Council of Ireland a Premises

Accreditation Scheme declaration form which requires each registered person to declare

which veterinary premises or exempted place they are carrying out the practice of

veterinary medicine at/from or to declare that they are retired and/or non-practising. The

VP must confirm to the Minister on an annual basis details of the premises s/he works at or

from as submitted to the Veterinary Council of Ireland.

8. Payment of Fees8.1 Please note that to prevent delays in processing the payment of fees, VPs must keep the

Minister informed with up to date financial, employment and premises information as set

out in Appendix 3. In particular, it is critically important that VPs’ records are regularly

reviewed to:

Ensure that the Veterinary Practice payee name and tax number correspond to that

registered with Revenue;

Ensure the Veterinary Practice payee tax clearance status is up to date.

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8.2 Any changes to the information supplied by the VP in his/her application for approval to

test should be notified to the Minister immediately, by emailing

[email protected], including in particular where there is any change in the

ownership of Veterinary Practices.

8.3 The Minister does not accept any responsibility for payments issued to an incorrect payee

due to late or non-notification of change of VP association or ownership of a Veterinary

Practice.

8.4 Fees calculated in accordance with the scale of fees applicable at that time shall be paid in

respect of tests satisfactorily completed, including reporting timeframe, and which were

nominated to be paid for by the Minister. Tests performed outside the timeframe, or

otherwise outside the ER4 Terms of Engagement, specified by the RVO and so notified to

the farmer will not be paid for by the Minister except where a case is accepted on a force

majeure basis.

8.5 The Minister reserves the right to allocate testing for which s/he is paying and fees will not

be paid by the Minister in respect of unapproved tests and such tests may be invalidated

by the Minister. In addition, the Minister reserves the right to refuse or reduce payment in

respect of testing which was not carried out and/or not reported in accordance with the

ER4 Terms of Engagement and any other conditions of testing set down in legislation.

8.6 Where a reactor is disclosed on a test nominated to be paid for by the farmer, the Minister

will ordinarily assume responsibility for such payment subject to adherence with ER4

Terms of Engagement. Exceptions include private tests and tests conducted on herds

registered as controlled finishing units (feedlots) where the herd-owner has agreed with

the Minister to pay for one test annually and tests that have been declared null and void

due to the detection of test irregularities.

8.7 Where a VP refuses to or finds s/he cannot proceed with testing because of inadequate

handling facilities and/or assistance and certifies this to the RVO, the Minister will pay the

appropriate visit fee to the VP and follow-up with the keeper as necessary.

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8.8 Department pay tests will not be eligible for payment if not completed within 14-days of

commencement except with prior approval from the RVO.

9. Tax Clearance Procedures

9.1 Please note the terms of Department of Finance Circular 43/2006 – www.circulars.gov.ie –

whereby suppliers of goods and services are required to furnish a current valid eTC if

payments to them in any 12 month period exceed €10,000 (inclusive of VAT). All payments

in excess of €10,000 will be withheld until such a certificate is provided. The VP shall

comply with all EU and domestic taxation law and requirements.

9.2 To comply with obligations set down by the Office of the Revenue Commissioners, the VP

must ensure that a current electronic Tax Clearance (eTC) is supplied to the Minister (or, in

the case of VPs providing the service on behalf of a Practice, the Practice’s ACCESS Code and

TRN for eTC) and that any changes are notified to the Minister as quickly as possible.

9.3 Professional services withholding tax (PSWT) is deducted from payments to VPs by the

Minister. Where the VP provides the services in the capacity of an employee of a Private

Veterinary Practice, s/he has no beneficial entitlement to the relevant payment or attaching

credit. In these circumstances Form F45 should not be made out in the name of the

individual VP, but instead payments due to VPs who provide the service on behalf of a

Practice will be paid direct to the Practice along with the associated F45 withholding tax

certificates (with the Practice name on them).

10. Confidentiality

10.1 VPs agree to hold confidential all information, documentation and other material

received, provided or obtained arising from their participation in the Programmes

(“Confidential Information”) and shall not disclose same to any third party except:-

To its professional advisers subject to the provisions of this paragraph; or

As may be required by law; or

As may be necessary to give effect to the terms of the ER4 Terms of Engagement subject

to the provisions of this paragraph.

10.2 The VP hereby undertakes to comply with all reasonable directions of the Minister

with regard to the use and application of all and any of its Confidential Information and

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shall comply with the confidentiality agreement (“the Confidentiality Agreement”) at

Appendix 4.

10.3 The obligations in this Section will not apply to any Confidential Information:

In the receiving Party’s possession (with full right to disclose) before receiving it from the

other Party; or

Which is or becomes public knowledge other than by breach of this clause; or

Is independently developed by the disclosing Party without access to or use of the

Confidential Information; or

Is lawfully received by the disclosing Party from a third party (with full right to disclose).

10.4 The VP acknowledges that the security of the State and its information is of

paramount importance to the Minister. Accordingly the VP hereby confirms that s/he will,

if requested by the Minister, from time to time, submit full personal details of staff who are

assigned to provide the services (or any part thereof) under the ER4 Terms of Engagement.

The VP further acknowledges that checks may be carried out in relation to all such

personnel by appropriate authorities and the VP shall comply with all reasonable directions

of the Minister arising there-from.

10.5 In circumstances where the Minister is subject to the provisions of the Freedom of

Information Act 2014 or the European Communities (Access to Information on the

Environment) Regulations 2007 to 2014, then in the event of the Minister receiving a

request for information related to the ER4 Terms of Engagement, the Minister shall consult

with the VP in respect of the request. The VP shall identify any information that is not to be

disclosed on grounds of confidentiality or commercial sensitivity, and shall state the

reasons for this sensitivity. The Minister will consult the VP about this confidential or

commercially sensitive information before making a decision on any request received under

the above legislation.

11. Data Protection

11.1 GDPR Data Processor

In the ER4 Terms of Engagement “Data Protection Law” means all applicable data

protection law. From 25 May 2018 the key legislative frameworks in Ireland are:

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the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679);

Data Protection Act 2018 ;

the “Law Enforcement Directive” (Directive (EU) 2016/680) which has been transposed

into Irish law by way of the Data Protection Act 2018;

the Data Protection Acts 1988 and 2003;

the Data Protection Act 2018;

the 2011 “e-Privacy Regulations” (S.I. No. 336 of 2011 – the European Communities

(Electronic Communications Networks And Services) (Privacy And Electronic

Communications) Regulations 2011).

The terms ‘personal data’, ‘data controller’, ‘data processor’ and ‘process’ shall have the

meanings given to them under Data Protection Law.

The VP acknowledges that in providing services under the ER4 Terms of Engagement it will

process personal data on behalf of the Minister. In such circumstances, the VP

acknowledges that the Minister is the data controller and the VP is the data processor and

the VP agrees that:

The VP will only process such personal data in accordance with the documented

instructions of the Minister, including with regard to transfers of personal data to a third

country and solely as strictly necessary for the performance of its obligations under the

ER4 Terms of Engagement;

The VP shall ensure that the persons authorised by the VP to process such personal data

are bound by appropriate confidentiality obligations;

The VP shall implement such technical and organisational security measures as are

required to comply with the data security obligations under Data Protection Law;

The VP shall not engage any sub-processor without the prior written consent of the

Minister and where the Minister has consented to the appointment of a sub-processor, the

VP shall not replace or engage other sub-processors without the prior written consent of

the Minister;

Where any sub-contractor of the VP will be processing such personal data on behalf of the

Minister, the VP shall ensure that a written contract exists between the VP and the sub-

contractor containing clauses equivalent to those imposed on the VP in this clause. In the

event that any sub-processor fails to meet its data protection obligations, the VP shall

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remain fully liable to the Minister for the performance of the sub-processor’s obligations;

The VP shall inform the Minister immediately in the event of receiving a request from a

data subject to exercise their rights under Data Protection Law and provide such co-

operation and assistance as may be required to enable the Minister to deal with such

request in accordance with the provisions of Data Protection Law;

The VP shall assist the Minister by implementing appropriate technical and organisational

measures to allow the Minister to comply with requests from data subjects to exercise

their rights under Data Protection Law;

The VP shall assist the Minister in ensuring compliance with its obligations in respect of

security of personal data, data protection impact assessments and prior consultation

requirements under Data Protection Law;

When the VP ceases to provide services relating to data processing the VP shall:

a) At the choice of the Minister, delete or return all such personal data to the Minister;

and

b) Delete all existing copies of such personal data unless EU law or the laws of an EU

Member State require storage of the personal data;

The VP shall:

Make available to the Minister all information necessary to demonstrate compliance

with the obligations laid down in this clause; and

Allow for and assist with audits, including inspections, conducted by the Minister or

another auditor mandated by the Minister, in order to ensure compliance with the

obligations laid down in this clause, including its data security obligations under

Data Protection Law [provided however that the Minister shall be entitled, at its

discretion, to accept adherence by the VP to an approved code of conduct or an

approved certification mechanism to aid demonstration by the VP that it is

compliant with the provisions of this clause ];

The VP shall inform the Minister immediately if, in its opinion, it receives an instruction

from the Minister which infringes Data Protection Law;

The VP shall notify the Minister without undue delay (and in any event within 24 hours)

after becoming aware of any breach of security leading to the accidental or unlawful

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destruction, loss, alteration, unauthorised disclosure of, or access to, personal data

transmitted, stored or otherwise processed and provide the Minister with such co-

operation and assistance as may be required to mitigate against the effects of, and comply

with any reporting obligations which may apply in respect of, any such breach;

No such personal data shall be transferred outside of the European Economic Area by the

Service Provider or any of its agents or sub-processors without the prior written consent

of the Minister which consent may be subject to terms and conditions (including, without

limitation, that the data importer enters into model clauses in the form approved by the

European Commission and, where relevant, complies with the provisions regarding sub-

processors contained in such model contracts in respect of any sub-processors). The VP

shall comply with the requirements of Data Protection Law in respect of transfers of such

personal data outside of the European Economic Area, to the extent that the Minister

consents to any such transfer.

11.2 In addition to the foregoing, the VP undertakes to comply with all requirements of

data protection law and such guidelines as may be issued by the Data Protection

Commissioner from time to time including but not limited to (i) the General Data Protection

Regulations, (ii) the Data Protection Acts 1988, 2003 and 2018 (and any amendments

thereto); and (iii) all EU requirements arising (including but not limited to provisions

relating to the processing of data, ensuring the security of data and restrictions on transfer

of data abroad) and any legislation and regulations implementing same.

11.3 Without prejudice to the generality of the preceding paragraph, the VP shall in

respect of any Personal Data (as defined in the Data Protection Acts):

Process the Personal Data only on and subject to the instructions and authorization of the

Minister;

Adopt and maintain, for the term of the ER4 Terms of Engagement and prior to processing

any Personal Data, appropriate technical and organizational security and other measures

for processing Personal Data in order to protect against unauthorized or accidental access,

loss, alteration, disclosure or destruction of such data and against all other unlawful forms

of processing of such data;

Ensure that records of tests or sampling carried out by him/her shall be retained for not

less than 6 years and that these records shall be made available to the Minister on request;

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Take all reasonable steps to ensure that its officers, employees and agents are aware of

and comply with this paragraph;

Fully comply with, and implement any data protection, data retention or other related

policies which are communicated or notified to the VP by the Minister from time to time;

Promptly comply with any request from the Minister requiring the VP to amend, transfer

or delete the Personal Data;

Promptly notify the Minister if it receives a request from a data subject (as defined in the

Data Protection Acts) to have access to any Personal Data or any other complaint,

correspondence, notice or request relating to the Minister’s obligations under the data

protection law and provide full co-operation and assistance to the Minister in relation to

any such complaint or request; and

Shall not process or otherwise transfer any Personal Data outside of the EEA without the

Minister’s prior written consent. The VP hereby acknowledges and accepts that any

consent given may be contingent upon compliance with additional terms;

The terms of this paragraph shall survive expiry, completion or termination for whatever

reason of this ER4 Terms of Engagement;

Data Protection Notice at Appendix 5 - for further information on data protection please

see the following: https://www.agriculture.gov.ie/dataprotection/;

The Data Protection Officer can be contacted at [email protected]

or Data Protection Officer, Data Protection Unit, Department of Agriculture, Food and the

Marine, Grattan Business Park, Dublin Road, Portlaoise, Co Laois R32 K857.

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Part B – Terms of Engagement – VP Procedures relating to SICTT Bovine TB Testing in Ireland

12. Definitions

Actual Date of TB Test

The date, on which, the test was read

AHCS The Department of Agriculture, Food and the Marine’s Animal Health Computer System

Certificate A certificate is a hand-written, printed or electronic statement of fact made with authority, whether or not it contains the word ‘certificate’. It is an offence if a veterinary practitioner issues any certificate which is untrue, misleading or improper.

A certificate can only be issued after all the necessary steps have been taken to ascertain that the matters to be certified are in fact true.

Due Date of TB Test

The date, as listed by the Minister, before which the test must commence

Field Book Refers to any one of the following approved recording methods:1. A hand-held computer operating a version of software

approved by the Minister. When a hand-held computer is routinely used, in the event of a malfunction, a back-up manual recording system must be available when the test is being conducted, i.e. Department supplied ER14.

2. An official field book (ER14) with the current herd profile of the herd to be tested (drawn down no earlier than one week prior to test commencement).

3. Form ER15B.Herd An animal or group of animals kept on a holding (within the

meaning of SI No 58/2015) an epidemiological unit; if more than one herd is kept on a holding, these herds shall form a single

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distinct unit and shall have the same health status.Herd Number An identifier associated with a Herd as defined in S.I. No 58 of

2015Herd Profile The herd profile provided from AHCS (either pre-

printed or downloaded electronically to the testing VP by the Department) is a list of all the animals present on the holding as notified to the Department by the keeper or his/her agent in compliance with the legal obligation to so notify.

The VP must have a copy (either electronic or hard copy) of the current herd profile whilst carrying out a herd test.

Planned Date of TB Test

The date of commencement of the test as per the Veterinary Practitioner’s itinerary

Scheduled Date of TB Test

The date, as listed by the Minister, on or after which the test must commence

Test A SICTT test conducted at animal level or at herd level

13. Introduction

13.1 The SICTT

Purpose of the Test

In the case of a herd test, to determine the TB status of the herd in accordance

with Council Directive 64/432/EEC and OIE requirements;

To identify those cattle affected with bovine tuberculosis or capable of infecting other

animals with bovine tuberculosis;

In order for the test to be valid it must comply with all criteria set out in this document;

The integrity of the herd/epidemiological unit is a fundamental concept in disease control.

13.2 The Herd

‘Council Directive 64/432/EEC, as amended, requires that, when conducting a herd test in

order to establish, retain or restore officially TB free status, all animals on the holding,

with the exception of calves under six-weeks old which were born in the holding, must be

subjected to routine tuberculin testing. However, the Minister may request the testing of

animals less than 6 weeks of age if deemed necessary;

Bovine animals kept on the same holding form part of the same epidemiological unit and

therefore cannot be tested and certified under different herdnumbers;

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All sheds within the same yard are regarded as being on the same holding and therefore

under a single herdnumber. It is not permitted to have animals under different

herdnumbers in the same holding or the same yard even if in different fields on the farm

or different sheds in the yard. The herd is all the bovine animals on the holding comprising

an epidemiological unit;

When a full-herd test is being conducted, the TB status of the herd will be interpreted by

DAFM subsequent to results being uploaded and certified on AHCS. In the case of a herd-

level test:

o All eligible animals on the holding are to be tested as part of the same herd;

o The presence of bovine animals on the holding, known or apparent to the VP,

that are not presented for testing must be reported to the R.V.O.;

o If all eligible bovine animals on the holding are not tested the trading status of

the herd may be suspended;

o Where there is evidence of mixed herds the VP must report this to the RVO. In

case of doubt, please contact the RVO to discuss the particular situation before

returning to read the test;

Animals moved into the herd between commencement and completion of a full herd

level test will require testing before the test results of the herd (i.e. the status of all

animals in the herd) may be certified;

Under no circumstance is tuberculin testing for TB permitted at or on a Mart or Abattoir

premises;

The integrity10 of the herd/epidemiological unit is a fundamental concept in disease

control.

13.3 Farmer Notification and Declaration

Farmers are reminded in the test notification letter sent with each herd test scheduled that:

o It is an offence on the part of the keeper not to present all animals on the

holding at time of herd test.

o It is an offence to move animals out of the herd between the

commencement and completion of the test, even for slaughter.

10 When issued with a herdnumber, farmers formally undertake to maintain the herd as a discrete epidemiological unit and not to mix or keep bovine animals on the holding under a different herdnumber. Farmers found to be in breach of this condition will have their eligibility for a herdnumber reassessed.

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VPs are provided with access to a copy of the material sent to their clients so that they may

be aware of these requirements and that farmers have been so informed – copy of letter to

farmers is at Appendix 6.

Where the RVO has requested completion of the ER11 (Declaration by keeper of

presentation of all animals), it must be presented to the keeper for signature and it is a

legal offence if the keeper refuses to sign same.

13.4 Part Testing

A test may be conducted in parts. Where a test is conducted in parts, all parts must be

completed by the same VP within 14-days of commencement of the first part. The

Minister will not pay for Department-paid-tests that do not comply with this requirement;

The test must be completed on all parts of the herd before the test result can be certified

and in particular before the individual animal test date can be inserted on the

passport/identity card and returned to the keeper.

14. Scheduling of Tests

14.1 Listing of Tests

Tests are listed to a VP, and associated Practice, as nominated by a herd keeper. Any VP

associated with the same Practice can do the test subject to the approval procedures

outlined in this document;

Listed tests appear in AHCS VP link;

When a test is listed it will have a scheduled date and a due date. If the test is not

commenced by the due date, without adequate explanation, the Minister may consider

withholding issue of further tests to the VP to whom the test had been listed;

If approved tests are not completed (a) within the allotted time or (b) on the planned

dates submitted to the RVO, in the absence of a valid reason given in writing, and/or test

reports are not submitted within the prescribed timeframes, further approved tests may

not be issued to the VP at all under the programme, other than in exceptional

circumstances;

The VP, having been listed with a test may, in exceptional circumstances, request the

SVI or the Veterinary Inspector (VI) in charge for permission not to carry out the test as

listed. This should be requested at the earliest opportunity and not later than one week

prior to the due date. This request must be in writing;

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Where a VP refuses or is unavailable to undertake a test and where an alternative VP

from the same Practice is not available the herd-owner should be contacted and

requested to choose one of the following two options: (i) to assign an alternative VP and

associated Practice to undertake this specific test or (ii) to assign an alternative VP and

associated Practice for all subsequent TB testing. In the event of no reply from the herd-

owner, the RVO should assign an alternative VP and associated Practice (or VI) for the

test in question.

14.2 Itineraries and Test Approval

Tests must have the prior approval of the Minister and it is illegal to carry out a test

without such approval. Test approval, in every case, is subject to the receipt of an advance

itinerary, within the instructed timeframe for a test that has been listed by DAFM to the

VP. Itinerary must comply with the test details as listed (date range).

A private test must not be performed without explicit prior AHCS approval.

Herd test itineraries with the planned date, time and VP must be submitted to the RVO

through AHCS by midnight prior to the commencement of the test. Itineraries for private

tests can be submitted on AHCS on or before the planned date prior to the time of

commencement of the test;

A test is only valid if it is carried out in accordance with the itinerary submitted and

complies with Section 17;

Cancellations must be submitted to the RVO through AHCS prior to the planned date and

time on the advanced itinerary, or exceptionally after the time of the test but on the date

with adequate explanation;

In exceptional circumstances, alterations or change of VP, are permitted even on the date

of the test if notified to the RVO prior to the commencement of the test.

VPs must inform the RVO in cases where test reading has been arranged with the keeper

to be carried out at a time other than that submitted on the advance itinerary using the

dedicated e-mail facility: [email protected]. Please note that this

email facility relates only to change in reading time of test and not to change of

planned date of test which should be done by resubmission of a new itinerary by

midnight on the date prior to the date of test.

This dedicated email address is not to be used for any purpose other than emergency

change in test reading time. The following information must be inputted:

o VP Name

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o VP Reference Code

o Herd Number

o Date of test reading

o Time of Test reading as per itinerary

o Proposed amended time of test reading

o Reason for change in reading time

Sunday testing (commencement or completion) must, in particular, be notified to and

receive individual approval from the SVI at the RVO prior to commencement.

15. Preparation prior to performing a Test

15.1 Herd Profile

A current pre-printed or downloaded herd profile, drawn down from AHCS no earlier

than one week prior to test commencement, must be used for each test.

15.2 Equipment General

All equipment as detailed in Appendix 7 should be available to the tester at the test. It

must be clean, maintained and in working order;

All equipment must be presented when requested and surrendered for

inspection/examination.

15.3 Syringes, Needles, Holsters

Syringes used for testing must be individually identified (engraved) such that certification is

specific to a particular syringe. Syringes must be sourced from/serviced by a Provider that

DAFM has inspected and decided has reached an acceptable standard for the provision,

servicing and repair of McLintock syringes. See Appendix 8. Hence VPs must ensure that

any syringes in their possession at the performance of a SICTT conform to this requirement.

Only McLintock syringes may be used to perform a SICTT.

The syringes and needles used in the SICTT must be reserved for this purpose alone;

Dedicated leak proof holsters capable of containing cotton wool and a syringe must be used;

Syringes must be clearly marked to distinguish between those used for avian tuberculin

(red) and those used for bovine tuberculin (blue);

Veterinary practitioners must have a minimum of 3, properly identified working syringes

in their possession and immediately available each day when planning to inject tuberculin

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for the purpose of conducting a SICTT. These syringes must have been serviced or newly

purchased within the preceding 12 months;

Spare needles and adaptors must be carried at all times. Syringes must be empty before

commencing a test in a new herd;

In order to qualify for testing under the programme each VP must record on AHCS t h e

purchase or service of at least two syringes within the previous 12-month period.

Syringes used for testing must be individually identified such that certification is specific

to a particular syringe.

15.4 Callipers, Clippers

Two callipers must be carried and maintained in good working order. Both lugs,

together with the thumb-piece, must be stable and both the millimetre measurements and

the reference mark must be clearly legible;

A suitable clipping device, with a sharp cutting edge should be used and maintained in

good working order. A suitable back-up device should also be carried.

15.5 Temporary Tags

Scheme metal ear tags (marked TT – temporary tag) are officially supplied by DAFM

for temporary ID purposes only and must be stored in a secure place until required;

It is mandatory to have a supply immediately available together with a tagger (i.e. both

physically present) when testing since performance of SICTT on un-identified animals is

prohibited in law and will result in withdrawal of approval to test under the Disease

Eradication Programme;

No other tags may be used for the temporary identification of animals;

15.6 Other Equipment

The following other items of equipment must be available at the time of the tuberculin test:

A field-book;

Thermometer and stethoscope - appropriate for veterinary clinical examination of cattle;

Reactor Tags/Discs and Taggers – Scheme Reactor Tags, Red discs and Taggers;

Protective Clothing/Disinfection – Normal biosafety measures must be taken, such as

boots, protective clothing and an officially approved disinfectant effective against M. bovis

and appropriate cleaning utensils must be used;

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Tuberculin - Bovine PPD and Avian PPD in the proprietary packs as supplied by the

Minister. The tuberculin should be kept refrigerated between 2 to 8°C and protected

from light until it is required for use. Not more than a single day’s supply of tuberculin

should be kept un-refrigerated at any time. Tuberculin is provided in packs where the

bovine and avian tuberculin PPDs are paired according to the potencies as measured by

the manufacturer. When a herd is being tested avian and bovine tuberculin must be used

from the same paired pack.

15.7 Removal of Test Materials from Holdings

It is essential that the residue of all test materials employed in the test procedure, including

syringe parts, used tuberculin vials, needles, cartons and other items, are gathered and

removed at the time of leaving the holding;

The safe and proper disposal of such materials in compliance with relevant legislation is the

responsibility of the testing veterinary practitioner.

16. Testing – General Points

16.1 Testing Facilities

All animals to be tested must be assembled in a yard, shed or paddock, located convenient

to the testing facilities which must be such that the VP can safely and effectively inject

the tuberculin and conduct the reading. The VP should not proceed with the test unless

satisfied that the on-farm facilities are suitable and animals can be adequately restrained

for the accurate performance of the test;

Under the legislation keepers are required to provide assistance as may be reasonably

required. Assistance in restraining cattle is, ordinarily, essential to proper testing;

Where a VP has concerns as to the facilities and assistance provided to enable him/her to

conduct the test properly he/she should report such inadequacies to the RVO SVI/VI in

charge of the area. The SVI/VI in the RVO shall act on such a report and maintain the

confidentiality of the VP as the person lodging the report;

Please also note the guidance provided by the Health and Safety Authority with respect to

the obligation of VPs and other professionals handling animals in farms, based on their

professional training and experience, to ensure that safe systems of work are used. Please

see HSA leaflet and website (www.hsa.ie) for further information. If an adequate degree of

safety cannot be provided the test should not continue until some remedy is put in place.

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16.2 Herd Profile and Animal Recording

A current pre-printed or downloaded herd profile, drawn down from AHCS no earlier than

one week prior to test commencement, must be used for each test;

All passports pertaining to the herd must be taken into possession by the VP on the day of

the test (injection);

All the digits on the animal’s identification tag must be verified and recorded;

Where an animal does not have an official identification tag, it must be temporarily tagged

in its left ear with an official DAFM supplied temporary tag;

The location of each animal or group of animal must be recorded;

All animals on the holding, with the exception of calves under six-weeks old which were

born in the holding, must be recorded;

Any animals that are on the herd profile but are not presented for testing must have a

comment inserted as to how the keeper accounted for their absence;

Any animal not presented for reading on Day 2 will be regarded as untested and the

explanation for the missing animal must be recorded in the clinical remarks column.

Where missing animals are not adequately accounted for, the certifier (VP) must present

the keeper with an ER11 for completion (i.e. do not delay submitting the test report if the

keeper cannot provide an answer immediately);

If other animals, not on the profile, are evident on the holding, as previously stated, these

must be tested. When the certifying veterinary practitioner is satisfied on the basis of what

is evident to him, including other animals visible or audible to the VP in the same

yard/sheds and/or adjacent fields/paddocks and otherwise the keeper’s information that

all animals on the holding have been tested as required, then test certification may

proceed;

When an animal not on the profile is being tested, the following must be recorded:

tagnumber, breed, sex and estimated age, all of which must be checked against the

animal’s passport;

Where animals, evident on the holding, are not presented for test and the keeper refuses

to present them or claims that they are under a different herdnumber the VP should

contact the SVI/area VI as soon as practicable to notify of such refusal to present all

animals. The SVI/VI will arrange for a VI to attend on day of test reading in order to ensure

that the test for all animals is reported under one herdnumber;

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When a test has been certified as complete and submitted to the Minister, it shall be

understood by veterinary officers of the Minister that the VP is satisfied that all animals on

the holding have been tested as required;

Any deviation from the performance of the test as outlined in Section 17 must be recorded;

Clinical and other observations or other treatments likely to have a bearing on the results

of the test must be recorded under Clinical Remarks on handheld devices or ER15B and,

where appropriate, linked by tagnumber reference to the individual animal(s).

17. Performance of the SICTT

17.1 Equipment

All of the relevant equipment outlined in Section 15 must be used in the performance of

the test;

Before a test commences, it is essential to ensure that the loaded syringe is free of air and

contains the correct tuberculin.

A fresh plug of cotton wool, soaked in methylated or surgical spirits, must be placed in

each syringe holster at commencement of the tuberculin test.

New vials of both avian and bovine tuberculin must be used for each new herd.

17.2 Siting

For accurate and consistent testing, the injection site is critical. The approved injection sites

specified by OIE and in Directive 64/432/EEC are situated at the border of the anterior and

middle thirds of either side of the neck;

The upper site (for avian tuberculin) must be approx. 10cm from the crest of the neck and

the lower site (for bovine tuberculin) must be approx. 13cm below;

In the case of pre-existing scar tissue or old injection reactions(lumps) this area must be

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avoided;

In calves under six weeks of age, or in younger/smaller animals where there is insufficient

space to separate the sites sufficiently on one side of the neck, one injection shall be made

on each side of the neck (avian on the left, bovine on the right), at identical sites in the

centre of the middle third of the neck;

If the correct site on the side of the neck presented for test is unsuitable for some reason

(scarring, old injection reactions etc.) tuberculin injection should be performed on the other

side of the neck or if there is insufficient space for both injections in a suitable location on

the same side of the neck one injection may be given on each side of the neck and a

notation providing appropriate details made to that effect in the field book.

17.3 Clipping

It is required by OIE, EU and national legislation that the selected sites should be clipped (an

area not less than 2.5cm in diameter) and cleansed (any dirt/debris removed) prior to

injection.

17.4 Measuring

The testing VP must measure a fold of skin at each of the injection sites and within the

clipped area by taking the skin between the forefinger and thumb. This must be accurately

measured using the callipers rounded up to the nearest millimeter, and recorded in the field

book.

17.5 Injecting

The tuberculin should be injected intradermally ensuring that the appropriate dose 0.1ml is

delivered resulting in a pea like swelling. This must be at the centre of the site.

17.6 Verifying

A correct injection shall be confirmed by palpating a small pea like swelling at each site of

injection.

If there is any doubt about either of the injections being delivered intradermally, a further

injection should be made, preferably at a corresponding site on the other side of the neck.

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17.7 Reading the test

The SICTT must be completed by the same VP who commenced the test;

The reading of the SICTT must be done in compliance with the test scheduling and between

68 and 76 hours of day-1 commencement of the test;

As set out in Section 14.2, VPs must inform the RVO in cases where test reading has been

arranged with the keeper to be carried out at a time other than that submitted on the

advance itinerary using the dedicated e-mail facility:

[email protected];

The test must be read at the interpretation level as listed to the VP by the Minister;

The field book/records used on day 1 must be used on day 2;

Each animal must again have its eartag number verified in full;

Each site where tuberculin was injected must be examined, palpated and measured.

Measurements must be taken by first determining, by palpation, the nature of any response

present at the broadest width of the response and then by carefully placing the callipers

across the broadest width of the response without applying undue pressure and recording

the findings in the field book;

Clinical signs directly associated with all reactions to the tuberculin must also be recorded

at the time of the reading in the field book. These signs include the presence of oedema,

exudative necrosis, heat pain or swelling at the individual injection site and/or heat pain or

swelling of the related prescapular lymph node;

The presence of diffuse oedema, necrosis, heat, pain at the bovine injection site and/or

swelling of the lymphatic ducts in the region or the related prescapular lymph node are

regarded as clinical signs and always indicative of likely tuberculosis infection and the

presence of such reactions must be reported. Animals showing such reactions to bovine

tuberculin or with diffuse or extensive oedema, necrosis, heat or pain at the injection site

must always be deemed reactors, irrespective of measurements recorded.

17.8 Interpreting the test

While the VI in the RVO will make the final interpretation of the test, the following should be

applied by VPs when interpreting the test:

a) Standard Interpretation:

Standard interpretation is applied when testing clear herds with a disease-free

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history or ‘restricted’ herds where an instruction has been received to apply

standard interpretation. Standard interpretation of the single intradermal comparative

tuberculin is as follows:

Positive (Reactor): - a bovine reaction that is more than 4mm greater than the

avian reaction or the presence of clinical signs.

Inconclusive: - a bovine reaction, which is more than 2 mm, and where the bovine

reaction is from 1 to 4mm greater than the avian reaction and the absence of

clinical signs.

Negative (Clear Animal): - all animals that are neither positive nor inconclusive.

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Where 1 or more standard interpretation positives are found in a ‘clear’ herd (i.e. OTF

status before the test) standard interpretation inconclusive reactors must be punched

and tagged as reactors and recorded on the test report – unless instructed by the RVO to

the contrary;

Where the number of standard inconclusive reactors exceeds the number of standard

reactors, the RVO must be telephoned as soon as is practicable and apprised of the

situation. The RVO will then advise re further punching and tagging of standard

inconclusive animals as reactors;

b) Severe Interpretation:

Severe interpretation of the SICTT must be used when a test is listed by DAFM as a

severe interpretation test and in the circumstances outlined above at Section 17.8(a).

Positive (Reactor): a bovine reaction which is more than 2mm and the bovine

reaction is greater than the avian increase.

Inconclusive: a bovine reaction which is more than 2 mm and the bovine reaction

is equal to/or 1 to 2mm less than the avian reaction.

Negative (Clear animal): all animals not described above.

Animals displaying reactions to tuberculin, which cause them to be classified as

reactors or inconclusive reactors must be identified and recorded as such in all

cases.

c) Export Eligibility

In order for animals to be eligible for export, the reaction at the bovine site must not

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exceed 2mm. Where an unresolved standard inconclusive is present in a herd, no other

animals will be eligible for export.

18. ReactorsIn the event that any animal gives a reactor result to a test, the testing VP should retain

custody of the passport/identity card for that animal for four months from the date of the test

and, unless its surrender has been requested by an authorised officer, to then destroy it. In

addition, the testing VP must inform the keeper of the reactors of their status and advise

him/her as set out in Section 19 outlining that the herd is restricted and that, while the

passports/identity cards for the remaining clear animals are being returned to him/her,

a. reactors including inconclusive reactors may only be moved directly to an approved

slaughterhouse under a movement permit which must be surrendered to the

slaughterhouse operative at time of presentation of the reactor; and

b. clear animals may be only moved directly to a slaughterhouse.

VPs should note:

1. Reactors: All animals classified as reactor must have a reactor tag, together with a

red disc inserted in the left ear for Identification;

2. Inconclusive: All animals classified as inconclusive reactors must have their

respective passports forwarded to RVO and the keeper must be advised to isolate

them from the herd pending a retest.

3. Severe Inconclusive Reactors: These animals will not ordinarily require a retest at

an individual animal level or be removed if severe inconclusive again but, if

considered epidemiologically appropriate, a VI may remove them and/or any animal

with a positive bovine response as reactor.

4. Abnormal Reactors: Should the VP suspect that the reaction is not the normal

tuberculin response, he/she must contact the VI at the RVO at the earliest possible

opportunity

If any reactors have been medicated and have an unexpired withdrawal period this should be

noted in the clinical remarks columns.

19. VP Advice to Keepers

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When reactors are identified the keeper must be informed and advised that all movements

out of the holding/herd are prohibited effective immediately (except for slaughter) until the

RVO determines if the herd is eligible for a derogation to allow such movements within

Ireland.

In addition, when animal(s) are deemed reactor, including inconclusive reactor, the keepers

must be advised:

o to isolate them, pending slaughter on permit issued by the RVO (or retest in the

case of an inconclusive reactor);

o that milk from a reactor/inconclusive reactor animals may not be used for any

purpose (excepting feeding to a reactor) even if heat-treated and must not

be supplied to the dairy/creamery;

o that milk from healthy animals belonging to reactor herds may not be used for the

manufacture of heat-treated milk or for the manufacture of milk-based products

unless it is first heat-treated at an establishment authorised by the Department;

o that the EU Requires keepers to retain a record of how much milk was produced

by reactor and/or inconclusive reactor animals on the holding from the date of

disclosure until the date of removal from the holding, how and where the milk

was stored, how it was disposed of and the date it was disposed of;

o that no reactor/inconclusive reactor on the holding may leave without permission

from the RVO; and

o that non-reactor animals, in reactor herds, may be not be moved off the

holding, except direct to slaughter on permit to an approved premises;

o that if the herd has an inconclusive reactor the RVO may allow trade within

Ireland in which case a restriction notice will not be served but that (s)he should

check with the RVO first if planning to move animals;

o that any animal disclosing a standard inconclusive reactor reaction will not be

permitted to move from the holding concerned for the duration of its lifetime

except to slaughter. RVOs may, if necessary, allow movement of inconclusive

reactor animals that have passed the inconclusive reactor re-test, to a registered

controlled finishing unit (feedlot) from where it shall go direct to slaughter within

a reasonable timeframe;

o of their obligation to notify the VP if any medicine has been administered to an

animal that has been recorded as a reactor, the nature of the medicine and when it

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was administered.

20. Reporting and Records

Specific details on the completion of the three types of ‘field book’ are to be found at the

front of the field book (ER14) or from the appropriate software manuals for the handheld

devices. Instructions for the completion of the pre-printed ER15B are at Appendix 8;

The RVO must be informed on the day or at latest by the morning of the following working

day, by telephone, electronic submission of test results or otherwise, of all tests where

reactors have been disclosed;

The full test report on which a reactor or inconclusive reactor is disclosed must reach the

RVO not later than three (3) working days after the completion of the test;

If any reactors have been medicated and have an unexpired withdrawal period this should

be noted in the clinical remarks columns;

Test reports on which no reactors are disclosed must reach the RVO within seven (7)

working days of test completion;

The passport/identity card for clear animals must be stamped with the date of the test by

the testing veterinary practitioner except following a test where reactors are disclosed or

a reactor retest that is not a clearance test. When the date of test has been inserted on the

passports/identity cards for the clear animals, they should be returned to the keeper;

The only valid test date is that held on AHCS and it is this system that determines an

animal’s eligibility for movement. It is thus extremely important that the most recent test

is signed off on AHCS before movement of the animals;

The keeper should have all cattle properly identified by means of a pair of official plastic

ear tags (one in each ear). Testing of unidentified animals is deemed to be a ‘non-minor

non-compliance’ as set out in Section 6.3.1 which may lead to serious sanctions as set out

in Appendix 1;

All surplus passports/identity cards should be submitted to the RVO with an

accompanying ER124 (VP Passport submission);

When keepers correlate the temporary tag numbers using the ER96, the testing VP who

temporarily tagged the animal will be required to sign a declaration that the correlation is

correct;

The location of each part of the herd must be recorded and reported;

In cases where a keeper who has been listed for a herd test and has been notified by you to

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test has no bovine animals, a no stock report should be submitted by the due date on the

listing to the RVO;

All relevant details must be recorded contemporaneous to the conducting of the test

and paper based records must be kept as the contemporaneous record for a period of

not less than 6 years;

Test records must be made available immediately upon request to a veterinary inspector

or other authorised officer;

VPs are also advised to keep back-up records of electronic data (print-out, CD, DVD or

other), being the contemporaneous record, for a period of 6 years.

VPs are advised that they may be required to attend court or other hearings and be

required to produce such contemporaneous records and/or attest to details they have

submitted to the Minister.

21. Certification

The legal bases for veterinary certification are the European Communities (Certification of

Animals and Animal Products) Regulations 1999 (S.I. No. 380 of 1999), the TB Regulations

and Brucellosis Regulations where relevant and, otherwise, the principles of certification

as defined by the Veterinary Council apply;

The VP carrying out a SICTT or blood sampling is solely responsible for the accuracy of

technique, recording, and is the only person who may certify any aspect of the

test/sampling;

The VP’s certifying signature must be clearly legible on all reports (where such are not

certified electronically) or other certifying documents;

In accordance with the principles of veterinary certification, Certification of a SICTT

and/or blood sampling shall be taken as confirmation by the VP that the test was

performed within the terms of the ER4 Terms of Engagement;

The VP who performed the test must personally sign off and certify the test on-line using

the unique access codes and identity number assigned for that purpose. The test is

certified on AHCS as follows:

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Certification is a reserved Veterinary function. If a VP believes that his/her AHCS

password and/or PIN have become known to a third party s/he must immediately change

the password and/or PIN;

Subsequent requests for changes to original certification are regarded as a very serious

matter and will only be considered when made by the original certifier and where

appropriate justification, supported as necessary by documentary evidence, is provided.

Form AHCS1 must be used to request a change where the test results are submitted

electronically. The RVO will require explanation and/or evidence of the reason for the

original error and/or details for validation of the change in certification. Animals will not

be added to, deleted from, nor have readings changed on a certified test unless there is

documentary evidence to verify that the change in certification is fully supported and this

has been accepted by the Minister’s veterinary staff.

22. Medicating Animals under Test

VPs should not treat any cattle with a veterinary medicine in the course of carrying out the

SICTT/sampling unless:

o the medication is urgently required;

o is unlikely to interfere with the cell-mediated response;

o the withdrawal period is likely to elapse before any reactor is required to be

removed from the herd (unless there is no alternative treatment for the condition

requiring urgent treatment);

If the medication urgently required is to be administered by injection, the side of the neck

and particularly areas adjacent to the sites used for the tuberculin test should be avoided;

In cases where routine medication has been requested to coincide with a test, animals

must not be treated until the individual animal test result is known. Such routine

treatments will delay removal of reactor animals from the holding and prolong the

restriction period accordingly. No compensation shall be payable, by the Minister, for the

additional testing or restriction period attributable to such treatments. Where routine

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treatments are necessary the test may, where it will not result in additional testing and/or

delay in derestriction, be advanced with the permission from the RVO so that results are

available before treatment;

In line with best practice and for public health protection reasons if a VP is aware that any

reactors, which are intended for slaughter, have been treated with a veterinary medicine

and that the withdrawal period will not have elapsed before the reactors are required to

be removed from the holding, (s)he is requested to notify the RVO when reporting the

reactors.

23. Pharmacovigilance

As with all medicinal products any adverse reaction to tuberculin whether in a human or

an animal must be reported to the Hea lth P r odu c ts R e g u l a to r y A utho r i t y (HPRA). Please

copy such notifications to ERAD Headquarters.

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Appendix 1 – Non-Compliance Procedures

1. Veterinary Inspector / Superintending Veterinary Inspector

1.1 Any reference to VI/SVI shall mean the Superintendent Veterinary Inspector or Veterinary

Inspector, as appropriate to the specific situation. It is generally expected that the VI/SVI

will administer verbal warnings and written warnings. A VI//SVI may administer a final

written warning and more serious sanctions, where appropriate, having consulted the SSVI.

2. ‘Non-minor non-compliances’

2.1 Where a concern arises regarding an alleged ‘non-minor non-compliance’ on the part of a

VP, which can occur as part of an ER13 report or otherwise, in general, the VI/SVI will deal

with the matter as follows (see Diagram 1)11:

a) The VI/SVI will notify the VP in writing of the alleged ‘non-minor non-compliance(s)’ and

the likely sanction such non-compliance(s) could attract. For example, on conclusion of a

field inspection, the VI/SVI will provide a copy of a completed standardised report form

ER13 setting out the VI/SVI’s findings. The VP will be invited to reply in writing (within 3

working days). In a field inspection the VP will be invited to provide a written response on

the ER13 report form and depending on the circumstances of the case, the VP may do so

on the occasion that gives rise to the concern or within three working days;

b) It will be open to the VI/SVI to issue a verbal warning at that stage, if he or she decides,

having considered the written response made by the VP (on the occasion that gives rise to

the concern or within the three working days provided), that such a warning is

appropriate;

c) In the case of a field inspection, the ER13 report, including an indication of whether a

verbal warning was issued to the VP, and the nature of the alleged ‘non-minor non-

compliance(s)’, will be reviewed by the VI/SVI and taking into account any written

submissions made by the VP, a decision will be made as to whether the report is

unsatisfactory warranting an ‘inconclusive’ or ‘fail’ record on AHCS;

d) The VI/SVI will communicate this decision and any follow-up action to the VP;

11 Please note that the steps (a) – (h) involve the processing of an inspection on AFIT/AHCS which goes through various statuses, eg AW RES ENTRY, AW VI/TAO sign off, AW SVI SIGN OFF AW SSVI sign off, AW HQ SSVI sign off. The steps above may take account of the various sign offs.

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e) If a verbal warning is not deemed appropriate, the VI/SVI may invite the VP to a meeting

to offer an opportunity to discuss and provide an explanation for the alleged ‘non-minor

non-compliance’ and/or explain the findings of the ER13;

f) The SVI/SSVI shall outline for the VP the appropriate suite of sanctions under

consideration, should the facts of the alleged ‘non-minor non-compliance’ be deemed to

have occurred. The VP shall be entitled to make submissions in this specific regard;

g) If the alleged ‘non-minor non-compliance’ can be adequately explained, no further action

will take place on this occasion;

h) If the matter cannot be adequately explained, it will be open to the VI/SVI to issue a

written warning, if he or she decides, having considered the representations of the VP, that

such a warning is appropriate. In addition, the VP may have an unannounced supervision.

The outcome of that unannounced supervision will determine what further action, if any,

will take place.

Diagram 1

2.2 Where the use of the measures at (a) to (h) above to resolve the concern is considered

inappropriate, e.g. where the alleged non-compliance(s) is sufficiently serious to warrant

immediate action, or where these measures have proven unsuccessful, the VI/SVI may

commence the procedure set out in the following steps (see in Diagram 2).

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VI/SVIWritten notification to VP setting out alleged non-compliance and likely sanction, e.g. ER13 on conclusion of a field inspection

PVPWritten reply within 3 working days / Comment on ER13

VI/SVI

May issue verbal warningDecide whether ER13 report is unsatisfactory and whether ‘inconclusive’ recorded on AHCS

VI/SVIVerbal warning not appropriate, invite VP to meeting to discuss and provide explanation

VI/SVINo further action if matter adequately explained Otherwise, written warning and unannounced supervision

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a) Investigation as part of ER13 process or otherwise :

The necessity for and nature of any investigation will depend on the complexity and

seriousness of the issue and will be a matter for the VI/SVI to determine. However,

an investigation is particularly appropriate when evidence emerges from

documentation submitted after a test, e.g. AHCS1 or mart amendment;

Gathering information : The VI/SVI may gather available information prior to

commencing an investigation and/or by undertaking a meeting with the VP. A VP

should not normally be the subject of a prolonged information-gathering process

without his/her knowledge. The VP should be informed without delay as soon as

the VI/SVI decides that an investigation should be commenced or a meeting should

be undertaken.

Where the VI/SVI considers that a meeting with the VP is necessary as part of the

investigation:

o The VP should be informed of the purpose of the meeting which is to gather

information regarding one or more concerns that have arisen around a

potential non-compliance with the ER4 Terms of Engagement;

o The VP has the right to be accompanied at the meeting;

o A record of the meeting will form part of the investigation report, if any, that

will be compiled.

b) Meet the VP subsequent to information gathering / investigation :

PREPARATION

o The purpose of the meeting will be to put any concerns (including, where

appropriate, any ER13 and/or investigation report) to the VP and allow the

VP to respond;

o The VP is entitled to receive reasonable notice of the meeting (normally up

to 10 working days’ notice in advance of the meeting);

o A copy of the ER4 Terms of Engagement should be sent to the VP along with

notice of the meeting, a copy of the ER13 report if relevant and any material

obtained by the VI/SVI in their investigation of the matter, whether or not

the VI/SVI intends to rely upon that material;

o The notice of the meeting should state:

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o The purpose of the meeting with a clear statement of the matter(s)

which is/are the subject of the meeting;

o That it is necessary to comply with this paragraph and attend the meeting so as to allow the VI/SVI the opportunity to learn about the scope/nature of any alleged non-compliances with a view to preserving the integrity of the TB Eradication Programme in the public interest;

o That the VP has the right to be accompanied at the meeting;

o That the VI/SVI may make a decision on the basis of the evidence

available in the event that the VP fails to attend or participate at the

meeting (without adequate explanation) and at a minimum the VP’s

approval to test will be immediately suspended;

o That approval to test will not be restored until the VP has attended

and participated at a meeting with the RVO;

o That the outcome of the meeting may be the application of a serious

sanction as set out in Appendix 1 of the ER4 Terms of Engagement up

to and including withdrawal of approval to test from TB

testing/Brucellosis sampling; and

o All relevant evidence should be provided to the VP in reasonable time

in advance of the meeting.

THE MEETING

o The meeting will be conducted by an SVI and/or SSVI.

o If there has been a prior investigation, it will not generally be necessary to

establish the facts again at the meeting, but the findings of the investigation

will be put to the VP at the meeting. The VP will be given an opportunity to

respond to any concerns raised at the meeting including the opportunity to

respond to any investigation report and to answer appropriate questions.

o The SVI/SSVI shall outline for the VP and his/her representative the

appropriate suite of sanctions under consideration, should the facts of the

alleged non-minor non-compliance be deemed to have occurred. The VP

shall be entitled to make submissions in this specific regard;

o All parties will be entitled to take notes of all such meetings.

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o Neither the VP, nor his or her representative, will be allowed to record

meetings on audio, visual or other recording device except where (and as)

agreed in advance with the SVI/SSVI chairing the meeting.

o Where a VP fails to attend a meeting (without adequate explanation) or fails

to answer questions or otherwise cooperate with the conduct of the meeting

(without adequate explanation) then the SVI/SSVI may make a decision on

the basis of the evidence available.

OUTCOME

o It is important to ensure that decisions are fair and consistent and that

the facts of each case are considered carefully. In establishing the facts,

the SVI/SSVI is required to consider whether, on the balance of

probabilities, the suspected concern is proved, whether this amounts to a

‘non-minor non-compliance’, and if so, the appropriate outcome;

o A decision on the outcome will be made by the SVI/SSVI. The following

outcomes are possible:

o A finding that no ‘non-minor non-compliance’ occurred;

o A finding that further investigation is required to ensure all facts

are being considered, in which case the VI/SVI will make

appropriate arrangements for such further investigation;

o A finding that a ‘non-compliance (minor or non-minor)’ occurred

but no sanction will be applied in respect of this instance;

o A finding that the application of a sanction is appropriate, in

which case one of the sanctions specified in Section 4 below will

be considered, in line with the procedures set out below and with

due regard to the submissions of the VP with respect to possible

sanctions;

o As far as possible, at the end of the meeting the VI/SVI will notify the VP

of the outcome of the meeting, the reasons for the decision that has been

reached. Otherwise, the VI/SVI should notify the VP in writing, within 3

working days;

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o In addition, the VI/SVI will notify the VP of his/her right of appeal and of

the procedure for same, as set down in Section 6 of Appendix 1 to this

ER4 Terms of Engagement.

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Diagram 2

3. ‘Minor non-compliances’

Where a concern arises regarding an alleged ‘minor non-compliance’ on the part of a VP, in

general, the VI/SVI will deal with the matter as follows (see Diagram 3):

a) The VI/SVI will notify the VP in writing of the alleged ‘minor non-compliance(s)’ and the

likely sanction such non-compliance(s) could attract. For example, on conclusion of a field

inspection, the VI/SVI will provide a copy of a completed standardised report form ER13

setting out the VI/SVI’s findings. The VP will be invited to reply in writing (within three

working days). In a field inspection the VP will be invited to provide a written response on

the ER13 report form and depending on the circumstances of the case, the VP may do so

on the occasion that gives rise to the concern or within three working days;

b) It will be open to the VI/SVI to issue a verbal warning at that stage, if he or she decides,

having considered the written response made by the VP (on the occasion that gives rise to

the concern or within the three working days provided), that such a warning is

appropriate;

c) In the case of a field inspection, the ER13 report, including an indication of whether a

verbal warning was issued to the VP, and the nature of the alleged ‘minor non-

compliance(s)’, will be reviewed by the VI/SVI and taking into account any submissions

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VI/SVI

Gather informationConsider investigation or meeting with VP to gather infoInform VP without delayInvestigate, as appropriate

VI/SVI

Meet the VP subsequent to information gathering / investigationGive notice to VP of meeting, providing documentation

SVI / SSVI

Meet VP, provide VP opportunity to respond and make submissionsDecide if non-minor non-compliance occurred and outcomeNotify VP of decision, reasons for decision, right of appeal/procedures

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made by the VP, a decision will be made as to whether the report is unsatisfactory

warranting an ‘inconclusive’ record on AHCS;

d) The VI/SVI will communicate this decision and any follow-up action to the VP.

Diagram 3

It should be noted that either a failure to remedy a ‘minor non-compliance’ or a repetition of

‘minor non-compliances’ may result in a deviation from the above-mentioned procedure, and

require the matter to be treated as a ‘non-minor non-compliance’.

4. Decide appropriate sanction

4.1 Factors to consider in deciding what sanction is appropriate : The following should be taken

into account when reaching a decision on what sanction is appropriate:

The nature and seriousness of the non-compliance;

Any active warnings issued to the VP;

The explanation provided by the VP;

The submissions by the VP at the Meeting with specific regard to possible sanctions;

Any mitigating circumstances presented by the VP; and

Any other matters which, in all the circumstances, are relevant.

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VI/SVI

Written notification to VP setting out alleged minor non-compliance and likely sanction, e.g. ER13 on conclusion of a field inspection

PVPWritten reply within 3 working days / comment on ER13

VI/SVI

May issue verbal warningDecide whether ER13 report is unsatisfactory and whether ‘inconclusive’ recorded on AHCS

VI/SVICommunicates decision to VP including any follow-up action needed

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4.2 A VI/SVI may also consider prior non-compliances (minor or non-minor) where such non-

compliances are relevant and such consideration is reasonable and appropriate in the

circumstances of the case.

4.3 Sanctions that may be applied: The following suite of sanctions, which are in no particular

order of priority, may be appropriate should the facts of the alleged non-compliance be

deemed to have occurred:

‘Non-minor non-compliance’: Withdrawal of approval to test from TB Programme/Brucellosis sampling;

Immediate or future suspension of approval to test, ordinarily on a temporary basis

pending investigation;

Temporary suspension of approval to test;

Verbal warning;

Written warning;

Additional administrative checks and/or supervisory checks and/or field inspections.

Re-training at the VP’s own expense and/or one or more supervised test to ensure

competency, also at the VP’s own expense.

‘Minor non-compliance’:

Verbal warning

Written warning

Additional administrative checks and/or supervisory checks and/or field inspections.

Re-training at the VP’s expense and/or one or more supervised test to ensure competency,

also at the VP’s own expense.

4.4 Warnings

Verbal Warning: normally applied for a first incident or ‘minor non-compliance(s)’ and

conveyed by the inspecting VI on the day of inspection (recorded on AHCS), setting out

details of the non-compliance, providing an opportunity to remedy the matter and setting

out any remedial action required. If there is a repetition of the non-compliance(s) or if

remedial actions have not been implemented as required, then further action and a written

warning may be appropriate.

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Written Warning: normally applied where there has been a repetition of a ‘minor non-

compliance’, or where a verbal warning has not resulted in the implementation of remedial

actions and compliance with the ER4 Terms of Engagement. If there is a repetition of the

non-compliance or if remedial actions have not been implemented as required, then further

action and a final written warning may be appropriate.

Final Written Warning: a final written warning may be considered where the alleged non-

compliance(s) is considered to be more serious in nature but is not yet a ‘non-minor non-

compliance’, or where there has been a continuation of behaviour which has led to previous

warnings. If there is a repetition of the non-compliance, or if remedial actions have not been

implemented as required, then further action up to and including withdrawal of approval to

test from TB testing and Brucellosis sampling work may be appropriate.

4.5 While the preference is to deal with matters in a progressive manner, in some cases non-

compliances may justify more serious sanctions where no earlier warning has issued or

where earlier warnings have become inactive. For example, VI/SVIs may issue a second or

final written warning for a first non-compliance where the alleged non-compliance is

considered to be sufficiently serious to warrant such action. In addition where the alleged

non-compliance(s) is non-minor, the VI/SVI, in consultation with the SSVI, may arrange for

the immediate or future suspension of approval to test, ordinarily on a temporary basis

pending investigation.

4.6 At all stages, it will be open to the VI/SVI to decide that re-training 12 is necessary for a VP to

ensure s/he is fully competent in testing/sampling work. . In some cases, in order to

satisfy him/herself regarding the VP’s competence, the VI/SVI will require the VP to

undergo one or more supervised tests.

4.7 In the event that a VP’s performance involves repeated non-compliances, whether repeating

the same type of non-compliance or a combination of one or more non-compliances,

cumulative sanctions will apply, i.e. sanctions that increase the penalty on VPs whose

performance repeatedly presents a concern to the TB Eradication or Brucellosis Monitoring

Programmes. Therefore, depending on the circumstances of each case, VPs who have their

12 No charge will be levied by the Minister, and the Minister will not be liable for expenses that accrue to attendees, in respect of attending such training.

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approval to test suspended on a temporary basis will, in cases of repeat non-compliances,

accumulate the number of suspension days, meaning that VPs may be excluded from the

testing/sampling work for long periods.

4.8 Other sanctions up to, and including, withdrawal of approval to test from TB testing and

Brucellosis work may be considered appropriate for cases involving ‘non-minor non-

compliance(s)’, or where previous warnings have not produced the required performance.

4.9 Written warnings will be kept on VPs’ files and, subsequent to satisfactory improvement,

will become inactive after the time frames set out below, after which time the warnings will

be removed, no regard will be had to that warning when considering any future ‘minor’ or

‘non-minor compliance’ which may arise:

o Verbal Warning – 12 months

o Written Warning – 18 months

o Final Written Warning – 24 months

4.10Taking any of the sanctions identified in Appendix 1 : Where the VI/SVI has decided that any

of the sanctions set out in Appendix 1 is/are appropriate s/he may proceed to take that

action. The VP should be informed of the action being taken and the reasons for the

decision. If a warning is issued then the VP should be informed of the period of validity of

the warning, the improvement required, the timescale for improvement, the consequences

of failure to improve and the right to appeal the decision in accordance with the appeals

process set out in Section 6 below.

4.11No sanction will be imposed until there is a reasonably held belief that the VP committed

the non-compliance(s) in question. However, in the public interest of preserving the

integrity of the TB Eradication and Brucellosis Monitoring Programmes, sanctions will be

applied pending the outcome of any appeal submitted under Section 6 below.

5. Timelines

It is in the interest of all parties that matters are progressed in a timely and efficient fashion, in

compliance with the timelines in the above procedures. However, it is recognised that on

occasion it may be necessary to extend timelines to ensure all parties can participate fully in the

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process. All references to days within the timelines refer to working days13.

6. Appeals Process

Any sanction imposed by a VI/SVI other than a verbal warning may be appealed by the VP.

6.1 Grounds for appeal

A VP may lodge an appeal on one or more of the following grounds, providing specific details of

each ground relied upon:

The provisions of Appendix 1 were not adhered to;

All the relevant facts were not ascertained;

The relevant facts were not proven;

All the relevant facts were not considered, or not considered in a reasonable manner;

The VP was not afforded a reasonable opportunity to answer any allegation, suspicion or

other concern arising about him or her;

The VP could not reasonably have been expected to have understood that the non-

compliance(s) alleged would attract a sanction;

The sanction was disproportionate to the alleged non-compliance(s).

6.2 Where to make an appeal

The notice of the sanction will specify that an appeal may be made to the ERAD Appeals Board.

The ERAD Appeals Board will comprise individuals with no prior knowledge or involvement

with the case subject to the appeal:

Chairperson: Principal Officer in ERAD

Senior Supervisory Veterinary Inspector in ERAD

Assistant Principal Officer in ERAD

A Secretary – HEO with responsibility for ERAD Legal – who will be responsible for the

management of the work of the Board on the advice and instruction of the Chairperson of

the Board.

6.3 How to make an appeal

A VP may request an appeal following a decision of a VI/SVI/SSVI to impose any of the

sanctions set out in Appendix 1, with the exception of a verbal warning;

13 “Working day” means a day which is not a Saturday, Sunday or public holiday

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A VP may request an appeal following a determination by an VI/SVI/SSVI that a non-

compliance(s) has occurred, and where no sanctions are imposed;

An appeal shall be lodged with the Secretary to the ERAD Appeals Board at the following

address: HEO, ERAD Legal, ERAD Division, Backweston Business Campus, Celbridge, Co.

Kildare, W23 X3PH or the following email: [email protected];

The appeal should specify, in writing, the grounds on which the appeal is being made, and

provide specific details of each of the grounds relied upon;

The information should be submitted to the Secretary to the ERAD Appeals Board in

accordance with the timelines listed in Section 6.4 following.

6.4 Timeframes for lodging an appeal

Notification of the intention to appeal must be made to the Secretary to the ERAD Appeals

Board, and copied to the relevant VI/SVI, in writing no later than ten working days from

the date of the decision of the VI/SVI to impose a sanction. However, an extension of time

to appeal may be granted, in exceptional circumstances, at the discretion of the Secretary

to the ERAD Appeals Board.

All documentation relevant to the appeal should be submitted by the VP to the Secretary to

the ERAD Appeals Board, and simultaneously copied by the VP to the relevant

VI/SVI/SSVI, in writing no later than ten working days from the date of the notification of

the intention to appeal.

A counterstatement by the relevant VI/SVI/SSVI should be submitted by the VI/SVI/SSVI

to the Secretary to the ERAD Appeals Board, and simultaneously copied by the

VI/SVI/SSVI to the VP, in writing no later than ten working days from receipt by the

relevant VI/SVI/SSVI of all documentation relevant to the appeal.

The Board will make a decision on the basis of the documentation submitted and may

contact the parties directly should clarification on any point be needed.

Oral hearings will be arranged for appeals of sanctions applied in respect of ‘non-minor

non-compliances’ only and hearings will be held as soon as practicable, ordinarily not later

than one month from receipt of the documentation by the Secretary to the Board.

The relevant VI/SVI/SSVI and VP concerned will attend the hearing.

Where a VP fails to attend an oral hearing (without adequate explanation) or fails to

answer questions or otherwise cooperate with the conduct of the hearing (without

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adequate explanation) then the Board may make a decision on the basis of the evidence

available.

6.5 Outcome of the Appeal Process

The outcome of the appeal process shall be one of the following:

Uphold the sanction;

Determine that no wrongdoing/non-compliance occurred and/or that no sanction shall be

applied;

Apply another, more appropriate, sanction;

Appeal identifies the need for the case to be reconsidered by the relevant VI/SVI/SSVI to

remedy a specified deficiency in the proceedings.

6.6 Effect of sanctions that have been appealed

No sanction will be imposed until there is a reasonably held belief that the VP committed

the non-compliance(s) in question.

In the public interest of preserving the integrity of the TB Eradication and Brucellosis

Monitoring Programmes, sanctions will be applied immediately following the decision of

the relevant VI/SVI/SSVI pending the outcome of any appeal submitted under this Section

6.

The decision of ERAD Appeals Board shall be final.

6.7 Further matters relating to appeals

Nothing in this Section affects the right of the Minister to remove a VP’s authorisation

under the Animal Health and Welfare Act 2013, to lodge a complaint with the Veterinary

Council of Ireland14 in the case of alleged professional misconduct or fraudulent behaviour,

or to initiate prosecution proceedings, to notify relevant agencies or bodies with regard to

initiating proceedings or to engage with any other relevant third party investigative or

regulatory process.

14 See the Veterinary Council of Ireland Code of Professional Conduct which states that Adherence to the Code of Professional Conduct is frequently more exacting that conformity with the law” [http://www.vci.ie/getmedia/fde5e04b-b8ad-4432-b44f-8928e0575524/CPC-VP-Booklet-Issue-7-Date-11SEP14.pdf?ext=.pdf]

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Appendix 2 – ER13ER13 Field Inspection Report Serial No.

Department of Agriculture, Food and the MarineReport of on-farm supervision of Testing under Tuberculosis Eradication Programme

(Original to VP on completion of inspection. Copy for retention by RVO.)

All Sections must be completed, tick as appropriate.

Veterinary Practitioner __________________________ VP Code _________________ Vet Register No ________________________________ Date of Supervision: No of herds supervised: ______________________ Herd Nos: ________________ Total No of Animals supervised: ___________________

Section A – Scheduling of Test Supervision: Announced Unannounced: Day1 Day 2Is the planned VP present as on the advanced itinerary ER9? Yes NoIf No – Was cancellation, alteration or change of VP permitted in advance of the test? Yes No Scheduled Date & Time of test: _____________________ Actual Date & Time of test: ______________________Was RVO informed in case where test reading arranged with the keeper to be carried out at a time other than that submitted on the advance itinerary using the dedicated e-mail facility? Yes NoPlanned VP code: ___________________________ Actual VP code: _________________________Was test completed on time? Yes No N/A VI Comments

Section B – Preparation prior to performing a Test – VP should have in his/her possession for use at the test:

Yes No N/A

1. Bio-security compliance, satisfactory protective clothing and OFFICIALLY approved Disinfectant used.............................................................................................................................................................

2. An electronic recording device with an authorised programme having an AHCS profile downloadednot less than 7 days prior to test commencement, or an official Field Book (see overleaf) with apre-printed AHCS profile downloaded not less than 7 days prior to test commencement.......................

3. A spare official Field Book……………………………………………………........................................

4. Dedicated leak proof holsters containing freshly replaced cotton wool soaked in Methylated/Surgical spirit ……......................................................................................................................................................

5. Spare needles, adaptors and a minimum of 3, properly identified, working syringes.................................6. Syringes are clearly marked to distinguish between those used for avian...................................................

tuberculin (red) and those used for bovine tuberculin (blue)……………….............................................. 7. Syringes are empty before commencing the test…………………………...................................................8. Two callipers, maintained in good working order. Both lugs, together with the thumb-piece, are

stable and both the millimetre measurements and the reference marks are clearly legible ......................9. A suitable clipping device, with a sharp cutting edge, maintained in good working order and a suitable

back up clipping device……………………………………………………..................................................10. Thermometer and Stethoscope appropriate for veterinary clinical examination of cattle……………….........11. Temporary Tags, Scheme Reactor Tags, Red discs and Taggers....................................................................12. Appropriate supply of tuberculin – Bovine PPD and Avian PPD in the proprietary packs as supplied by

the Minister, used from the same paired pack………………………...............................................................Field Book Software Version___________________________________________________________________________________

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VI Comments _________________ ____________

Section C – Test Procedures and Performance Yes No

N/A1. TAG numbers accurately recorded for all animals present on the holding at commencement

of test (Day 1) ………………………………………………………………..................................................2. TAG numbers accurately recorded for all animals present on the holding at Completion of test (Day 2)3. Comments inserted regarding discrepant animal(s)…………………………………………………………. 4. ER11presented to keeper for signing and witnessed by VP if required........................................................5. Loaded syringe was free of air and contained correct tuberculin…………………………………………..

(ER13 - Page 1)

Overleaf to page 1:

An ‘official Field Book’ refers to any one of the following approved recording methods:

A hand-held computer operating a version of software approved by the Minister. When a hand-held computer is routinely used, in the event of a malfunction, a back-up manual recording system must be available when the test is being conducted, i.e. Department supplied ER14.

An official field book (ER14) with the current herd profile of the herd to be tested (drawn down no earlier than one week prior to test commencement).

Form ER15B.

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Section C – Test Procedures and Performance – continued Yes No

N/A6. Accurate measurement and recording skin thickness at each injection site on day 1..................................7. Accurate measurement and recording skin thickness at each injection site on day 2..................................8. Satisfactory clipping of injection sites…………………………………………….........................................9. Satisfactory location of injection sites……………………………………………........................................10. Callipers used in measuring all animals…………………………………………….......................................11. Was an intradermal injection achieved at each injection site on each animal………………………………..12. Was the ‘pea’ confirmed after injection at each injection site by the tester …………………………………13. Was the nature of the 72 hour reaction recorded? ....................................................................................14. Presence of so-called Skin TB or other swellings noted and recorded? .....................................................15. Reactor (s) identified and tagged with brass tags and red discs………………….........................................16. Keeper instructed to isolate reactors and withhold milk from human and animal food chain………………….

VI Comments: ____________

____________

Section D – Reporting and Records Electronic Recording Field Book Herd Profile

Yes No N/A

1. Approved version of software used ………………………………………………........................................ 2. Field book recording device tendered to VI on request………………………………………………………3. Field book examined and any faults noted in respect of records for other tests........................................

VI Comments ____________

____________

Section E – Blood Sampling (if applicable)

Yes No N/A1. Was the field book properly completed? ……………………………………………………………………..2. If samples were taken prior to inspection commencing, are an appropriate number of the used

needles held for safe disposal? ……………………………………………………………………………….3. Were all samples properly labelled and co-related to the ear-tag number of the animals sampled? ……….

VI Comments ____________

____________

Section F – Informing VP of Findings _______________ Yes No

N/A 1. Was VP informed of the above findings? ………………………………………………………………….. 2. Did VP accept an offer to comment and sign this Section of the form? ..………………………………..

VP Comments ____________________________________________________________________________________________________________________________________________________________________________________________________________________________

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____________________________________________________________________________________________________________________VI Signature Date VP Signature Date

Section G – Results & Recommendations (see overleaf) – NB: this section may be completed on the day of the test or subsequently to allow for a short period of reflectionProvisional Supervision of Testing result …………………… Pass: *Minor Non-Compliance: *Non-Minor Non-Compliance:VI Comments (Please provide details of any alleged non-compliance) ____________________________________________________________ ____________ _____________________________ ___________

Yes No N/A

1. Was VP informed of the above results and recommendations?…………………………………………….2. Did VP accept an offer to comment and sign this Section of the form? ……………………………………..

VP Comments _____________________ ______________________ ______________________________________________________________________________________________________________VI Signature Date VP Signature Date (ER13 - Page 2)Overleaf to page 2:In the event of alleged non-compliance, please refer to Non-Compliance Procedures set out in Appendix 1 of ER4 Terms of Engagement: Veterinary Practitioners (VPs) involved in testing and sampling under the Bovine Tuberculosis Eradication and Brucellosis Monitoring Programmes. Sanctions that may be applied should the facts of the alleged non-compliance(s) be deemed to have occurred are set out in Section 4, Appendix 1.

The following suite of sanctions, which are in no particular order of priority, may be appropriate should the facts of the alleged non-compliance be deemed to have occurred:

‘Non-minor non-compliance’: Withdrawal of approval to test from TB Programme/Brucellosis sampling;

Immediate or future suspension of approval to test, ordinarily on a temporary basis pending investigation;

Temporary suspension of approval to test;

Verbal warning

Written warning

Additional administrative checks and/or supervisory checks and/or field inspections;

Re-training at the VP’s own expense and/or one or more supervised test to ensure competency, also at the VP’s own expense.

‘Minor non-compliance’: Verbal warning

Written warning

Additional administrative checks and/or supervisory checks and/or field inspections;

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Re-training at the VP’s expense and/or one or more supervised test to ensure competency, also at the VP’s own expense.

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Appendix 3 – Required Employment, Bank and Premises Information

It is the responsibility of VPs at all times to make sure that the Contact and Account Details provided to DAFM are correct and up to date. The following is an overview of information required by DAFM to ensure that payments due to VPs are processed efficiently.

If the VP is providing the service on behalf of a Practice, the following details are required:

1. Practice Tax Ref Number /VAT Number (if applicable): ______________________________

2. Practice six digit Access Code and TRN for eTCC: _________________________

3. Practice Legal Trading/Business Name associated with this Tax Ref Number: _____________________________________________________________

Name of Practice, Premises Name, Address Line 1, Address Line 2, Address Line 3, Address Line 4NB: The Name and Address provided should reflect the details registered under the Veterinary Council of Ireland’s mandatory Premises Accreditation Scheme and of the employer Practice.

If the VP is providing the service on his/her own behalf, the following details are required:

1. Your Personal Tax Ref Number (i.e. PPSN) /VAT Number (if applicable)2. Your six digit Access Code and TRN for eTCC3. Your Name associated with this Tax Ref Number

Name, Premises Name, Address Line 1, Address Line 2, Address Line 3, Address Line 4NB: The Name and Address provided should reflect the details registered under the Veterinary Council of Ireland’s mandatory Premises Accreditation Scheme.

Bank Account Details:

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As set out on the following form (which should be used for changes to bank account details):

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AUTHORISATION TO ADD or CHANGE BANK, CREDIT UNION or AN POST ACCOUNT DETAILS

To be completed by VETERINARY PRACTICES for TB ERAD testing payments

Notes:1. The provision of incorrect or incomplete details may result in payments to an incorrect account.2. It is your responsibility to ensure that the account details supplied are correct and up to date and that the account you select is capable of receiving Electronic Fund Transfer (EFT) payments.3. Payments may be delayed if the Veterinary Practice name does not match the name on Revenue’s record for the VAT or Tax Registration number supplied.4. Please see overleaf for relevant Data Protection information.

For queries regarding the completion of this form contact Direct Credit Section on 049 4368283.

VETERINARY PRACTICE (V.P.) DETAILS

Name of Veterinary Practice: __________________________________________________________

Trading name (if different):__________________________________________________________

Address:______________________________________________________________________________

E-mail address: _______________________________ Phone Number: ___________________________

Veterinary Practice DAFM Registration Number: V P

VAT or Tax Registration Number:

BANK / CREDIT UNION / AN POST ACCOUNT DETAILS

IBAN No:

BIC / Swift Code:

Name of Bank /Credit Union/ Post Office:____________________________________________________

Address of Bank /Credit Union/ Post Office:____________________________________________________

Name of Account holder:

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____________________________________________________

Please ensure that the account you select is compatible with EFT payments

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I hereby authorise the Department of Agriculture, Food and the Marine (DAFM) to send all payments directly to the account detailed above.

Signed: ______________________________________________Date: ___________________________(Authorised Signatory of Veterinary Practice)

NAME: _____________________________________________ (BLOCK CAPITALS)

RETURN TO: Direct Credit Section Department of Agriculture, Food and the MarineFarnham St., CavanCo. Cavan H12 D459

AUTHORISATION TO ADD or CHANGE BANK, C.U. or AN POST ACCOUNT DETAILS

To be completed by VETERINARY PRACTICES for TB ERAD testing payments

Important Data Protection Notes:

The purpose of collecting this data, including your account details, is to release payments (if any) that fall due to you from the Department and when necessary to net payments. Payments cannot issue and netting cannot occur if account details are not provided.

The legal basis for processing the personal data is Article 6(1)(c) of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (the General Data Protection Regulation) i.e. processing is necessary for compliance with a legal obligation to which the controller is subject. The data provided for this purpose is in line with our statutory obligations and with current Data Protection legislation.

The data provided on this form will be provided to other business areas within the Department for the purpose of processing payments. The Department is also currently obliged by law to provide information concerning applicants in response to requests received from the office of the Revenue Commissioners, An Garda Síochána and other bodies in accordance with current Data Protection legislation.

The data collected for this purpose will be held by the Department only as long as there is a business need to do so in line with the purpose(s) for which it was collected. After this time it will be marked for destruction and will be destroyed in line with internal guidelines or guidelines for destruction received from the National Archives Office or associated permissions received from them.

Each individual has data protection rights, which were further enhanced by the introduction of the General Data Protection Regulation (GDPR) on 25 May 2018. These rights are:

a. the right to access their personal data, correct or rectify their personal data or to erasure.b. the right to restriction of processing or to object or withdraw consent to processing.c. the right to data portability or to make a complaint to the Data Protection Commissioner’s Office.

You may contact the Data Protection Unit in relation to any of your rights as outlined above.Data Protection Unit

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OFFICAL USE ONLY Account details entered: SIGNED _____________ CHECKED ______________

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Department of Agriculture, Food and the MarinePavilion A, Grattan Business Park Dublin Road, PortlaoiseCo. LaoisEmail: [email protected]

Full information on Data Protection rights for the Department’s clients can be found on the Data Protection page of our website. See under Customer Service on www.agriculture.gov.ie or go directly to https://www.agriculture.gov.ie/dataprotection/.

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Appendix 4 - Confidentiality Agreement

THIS AGREEMENT is made on the 1st day of January 2020 BETWEEN:

The Minister for Agriculture, Food and the Marine of ERAD Division, Backweston, Celbridge, Co.

Kildare (hereinafter “the Contracting Authority”) of the one part; and

Veterinary Practitioners (VPs) (hereinafter called “the Contractor”) of the other part.

NOW IT IS HEREBY AGREED as follows:

1. The Contractor acknowledges that Confidential Information may be provided to him/her by

the Contracting Authority and that each item of Confidential Information shall be governed

by the terms of this Agreement and the ER4 2020 Terms of Engagement for Veterinary

Practitioners involved in testing and sampling under the Bovine Tuberculosis Eradication

and the Brucellosis Monitoring Programmes.

2. For the purpose of this Agreement “Confidential Information” means:

2.1 Unless specified in writing to the contrary by the Contracting Authority all and any

information (whether in documentary form, oral, electronic, audio-visual, audio-recorded or

otherwise including any copy or copies thereof and whether scientific, commercial,

financial, technical, operational or otherwise) relating to the Contracting Authority, the

provision of services under the ER4 2020 and all and any information supplied or made

available to the Contractor (to include agents, Subcontractors, customers and suppliers) for

the purposes of the ER4 2020; and

2.2 Any and all information which has been derived or obtained from information described in

sub-paragraph 2.1

3. Save as may be required by law, the Contractor agrees in respect of the Confidential Information:

3.1 to treat such confidential information as confidential and to take all necessary steps to

ensure that such confidentiality is maintained,

3.2 Not without the prior written consent of the Contracting Authority, to communicate or

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disclose any part of such Confidential Information to any person except

i. to those employees, agents, Subcontractors and other suppliers on a need to know basis;

and/or

ii. to the Contractor’s auditors, professional advisers and any other persons or bodies having a

legal right or duty to have access to or knowledge of the Confidential Information in

connection with the business or the contractor

PROVIDED ALWAYS that the contractor shall ensure that all such persons and bodies are made

aware, prior to the disclosure, of the confidential nature of the Confidential Information and

that they owe a duty of confidence to the Contracting Authority , and shall use all

reasonable endeavours to ensure that such persons and bodies comply with the provisions

of this Agreement.

4. The obligations in this Agreement will not apply to any Confidential Information:

i. in the Contractor’s possession (with full rights to disclose) before receiving it from the

Contracting Authority; or

ii. which is or becomes public knowledge other than by breach of this clause; or

iii. is independently known by the Contractor without access to or use of the confidential

Information; or

iv. is lawfully received from a third party (with full right to disclose).

5. The Contractor undertakes:

5.1 to comply with all direction of the Contracting Authority with regard to use and application

to all and any Confidential Information or data (including personal data as defined in the

Date Protection legislation);

5.2 to comply with all direction as to local security arrangements deemed reasonably necessary

by the Contracting Authority including, if required, completion of documentation under the

Official Secrets Act, 1963 and comply with any vetting requirements of the Contracting

Authority including by police authorities;

5.3 upon termination of the relationship pursuant to ER4 2020 for whatever reason to furnish

to the Contracting Authority, all Confidential Information or at the written direction of the

Contracting Authority to destroy in a secure manner all (or such part or parts thereof as

may be identified by the Contracting Authority) Confidential Information in its possession

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and shall erase any Confidential Information held by the Contractor in electronic form. The

Contractor will upon request furnish a certificate to that effect should the contracting

authority so request in writing. For the avoidance of doubt “document” includes documents

stored on a computer storage medium and data in digital form whether legible or not; and

5.4 to comply with the requirements of Data protection law and such guidelines as may be

issued by the Date Protection Commissioner from time to time, including but not being

limited to:

i. the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679);

ii. Data Protection Act 2018 ;

iii. the “Law Enforcement Directive” (Directive (EU) 2016/680) which has been transposed

into Irish law by way of the Data Protection Act 2018;

iv. the Data Protection Acts 1988 and 2003;

v. the Data Protection Act 2018;

vi. the 2011 “e-Privacy Regulations” (S.I. No. 336 of 2011 – the European Communities

(Electronic Communications Networks And Services) (Privacy And Electronic

Communications) Regulations 2011).

6. The Contractor shall not obtain any proprietary interest or any other interest whatsoever in

the Confidential Information furnished to him by the Contracting Authority and the

Contractor so acknowledges and confirms.

7. The Contractor shall, in the performance of the Contract, access only such hardware,

software, infrastructure, or any part of the databases, data or OCT system(s) of the

Contracting Authority as may be necessary for the purposes of the competition (and

obligations thereunder or arising thereform) and only as directed by the Contracting

Authority and in the manner agreed in writing between the parties.

8. The Contractor agrees that this Agreement will continue in force notwithstanding any court

order relating to the Competition or termination of the ER4 2020 for any reason.

9. The Contractor agrees that this Agreement shall in all aspects be governed by and construed

in accordance with the laws of Ireland and the Contractor hereby further agrees that the

courts of Ireland have exclusive jurisdiction to hear and determine any disputes arising out

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of or in connection with this Agreement.

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Appendix 5 - Data Protection Notice

Part A: Information applicable to all Department of Agriculture, Food and the Marine (DAFM) customers

The Department of Agriculture, Food and the Marine (DAFM) is fully committed to keeping all personal data submitted by its customers, fully safe and secure during administrative processes. All necessary technical measures have been put in place to ensure the safety and security of the systems which hold this data. DAFM staff are also considered as customers of DAFM from a Data Protection perspective and may exercise their data protection rights in the same way.

Transparency and openness in the use of personal data held is important to DAFM and therefore the Department aims to fully inform all its customers about the purpose(s) for which their data will be used and why, where it may be shared elsewhere and why and how long their data may be held by DAFM. Information on the rights of the customers will also be provided.

From 25 May 2018 the key legislative frameworks in Ireland are: the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679); Data Protection Act 2018 ; the “Law Enforcement Directive” (Directive (EU) 2016/680) which has been

transposed into Irish law by way of the Data Protection Act 2018; the Data Protection Acts 1988 and 2003; the Data Protection Act 2018; the 2011 “e-Privacy Regulations” (S.I. No. 336 of 2011 – the European

Communities (Electronic Communications Networks And Services) (Privacy And Electronic Communications) Regulations 2011).

The Data Controller for the collection and processing of all personal data in DAFM is the Department itself, as a legal entity.

The Data Protection Officer can be contacted as follows:

Data Protection Officer,Data Protection Unit, Corporate Affairs, Department of Agriculture, Food and the Marine,Grattan Business Park, Dublin Road,Portlaoise, Co Laois.Email: [email protected]

Personal data processed by DAFM will only be used for the specific purpose(s) as outlined when the data is collected, or in later communications, in accordance with the Data Protection legislation in force.

Rights of the individual in relation to personal data held by DAFMWhen you, as a customer, provide personal data to DAFM you have certain rights available to you in relation to that data. These rights are outlined below and can be exercised by contacting the Data Protection Officer, as detailed above, indicating which right(s) you wish to exercise:

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1. DAFM customers have the following rights: Access to their data; Rectification of their data; Erasure of their data; Right to lodge a complaint with the Supervisory Authority.

2. From 25 May 2018 onwards all DAFM customers also have the following additional rights:

Restriction of processing; Data portability; Objection to processing; Withdraw consent if they previously gave it in relation to processing of their

personal data; Relating to automated decision making, including profiling.

NB: Technical information on data collectedTechnical information on the cookies used on the Department’s website is available at the following link: https://www.agriculture.gov.ie/legalnotices/privacy

ERAD Division’s Data Protection Notice is available online at https://www.agriculture.gov.ie/dataprotection/otherdataprotectionnoticesonourwebsite/ or from ERAD Division, Department of Agriculture, Food and the Marine, Admin Building, Backweston Business Campus, Celbridge, Co. Kildare W23 X3PH

Part B – Information specific to the personal data being collected

From Data Subjects testing/sampling animals as part of the TB Eradication and Brucellosis Monitoring Programmes

The following is specific information in relation to the personal data collected from applicants seeking approval or approved to test animals as part of the TB Eradication and Brucellosis Monitoring Programmes (the Programmes).

Specified purpose:The primary purpose for collecting this information is to approve applicants to test animals as part of the Programmes.

Specifically, this data is processed by ERAD Division for the purposes of: Furthering the development of policy underpinning the Programmes; Providing training and payment to applicants and ensuring compliance with

taxation rules; Facilitating public good research; Routine quality control of the Programme(s); Appeal hearings and imposition of sanctions; Ensuring the highest standards of financial management, including procurement

and revenue collection, to ensure full compliance with EU and national financial, audit and control requirements;

Appointing persons as authorised officers under the Animal Health and Welfare Act 2013.

Legal basis: This processing is necessary for compliance with a legal obligation to which DAFM is

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subject, for the performance of a task carried out in the public interest or in the exercise of official authority vested in DAFM.Legislation:Treaty on the Functioning of the EU art. 287 para. 3COUNCIL DIRECTIVE of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swineThe Comptroller and Auditor General (Amendment) Act 1993Chapter 1 of Part 18 of the Taxes Consolidation Act 1997 (TCA 1997)Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1999 (S.I . No. 277/1999)REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffsREGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rulesCOMMISSION REGULATION (EC) No 885/2006 of 21 June 2006 laying down detailed rules for the application of Council regulation (EC) No 1290/2005 as regards the accreditation of paying agencies and other bodies and the clearance of the accounts of the EAGF and of the EAFRDS.I. No. 673/2006 - Bovine Diseases (Levies) Regulations 2006S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007Commission Regulation (EC) No 341/2008 of 16 April 2008 on the issuing of import licences for applications lodged in April 2008 under tariff quotas opened by Regulation (EC) No 616/2007 for poultry meat - Point 5(d) Annex to

S.I. No. 77/2009 - European Communities (Identification of Bovines) Regulations 2009Animal Health and Welfare Act 2013 (S.I. 15 of 2013)REGULATION (EU) No 1306/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008REGULATION (EU) No 652/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/ECAnimal Health & Welfare (Bovine Tuberculosis) Regulations 2015 (S.I. 58 of 2015)REGULATION (EU) 2017/625 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council

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Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/ EC and Council Decision 92/438/EEC (Official Controls Regulation)

Recipients: Information may be shared with:

Other Divisions in DAFM that have a compatible purpose to process the data; Research bodies for the purpose of public good research; External bodies such as: Ombudsman, Farming Representative Organisations,

Independent Agricultural Appeals Office; Members of the Dáil through Parliamentary Questions and Ministerial

Representations; EU Commission Auditors in the context of the Department's annual EU funding

claim; EU Commission Auditors (Sante G) (Sante F), European Court of Auditors, Food

Safety Authority of Ireland, Comptroller & Auditor General, Internal Audit Unit for the purposes of satisfying EU and national financial, audit and control requirements;

Veterinary Council of Ireland in the event of alleged professional misconduct or fraudulent behaviour ;

Office of the Revenue Commissioners where data subjects have authorised DAFM to use the Revenue On-Line Verification facility to access and confirm tax clearance status.

Transferred outside the EU:Not applicable.

Retention Period: All records containing personal data will be retained by ERAD only for as long as the original purpose of collecting/processing it and the data processed for these purposes will generally be held by DAFM only as long as the Data Subject continues to test as part of the TB Eradication and Brucellosis Monitoring Programmes, accepts on an annual basis the ER4 Terms of Engagement and continues to be subject to PSWT. However, in certain cases data will only be retained for the duration of time-limited processes, e.g. data relating to TB testing or sampling work will be retained for not less than 6 years while data will be retained for up to 24 months in the case of appeal hearings conducted under the terms of the ER4 Terms of Engagement, or 7 years in the case of financial management obligations. In addition, DAFM may retain the personal data where the processing is deemed necessary for compliance with a legal obligation which requires processing by law to which DAFM is subject and/or for the performance of a task carried out in the public interest and/or in the exercise of official authority vested in DAFM and/or for archiving purposes in the public interest, scientific or

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historical research purposes or statistical purposes and/or or where it is necessary for the establishment, exercise or defence of legal claims.

After this time data will be marked for destruction or permanent preservation and will be destroyed or preserved in line with internal guidelines or guidelines received from the National Archives Office or associated permissions received from them.

Data provision being statutory or contractual obligation: The data processed for these purposes is provided under (1) the process to approve Data Subjects to test animals as part of the Programmes in line with the requirements of the Animal Health and Welfare Act 2013 (Section 37(1) & Section 38(1) & Section 73), S.I. 58 of 2015 Animal Health & Welfare (Bovine Tuberculosis) Regulations 2015 (Sections 7(1) and 7(2)), EU Regulations 882/2004 and 625/2017, and ER4 2018, and (2) with a view to compliance with Chapter 1 of Part 18 of the Taxes Consolidation Act 1997 (TCA 1997). The processing is necessary for compliance with a legal obligation to which DAFM is subject, for the performance of a task carried out in the public interest or in the exercise of official authority vested in DAFM and/or for the performance of a contract to which the data subject is party. If the Data Subject chooses not to provide this information his/her application for approval to test cannot proceed and he/she may not receive payment for professional services rendered to DAFM as DAFM will not be in a position to deduct PSWT at source as required by law.

Automated Decision Making: Not applicable.

Information from Third Party: Not applicable.

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Appendix 6 – Letter to Farmers

Animal Health and Welfare Act 2013 (No 15 of 2013)Animal Health and Welfare (Bovine Tuberculosis) Regulations 2015 (SI No 58 of 2015)

Dear XXX,

2020 TB Eradication Programme - Round Test

You are now required to have the TB test printed below carried out on your herd.

Type of Test Complete By Payment Details Listed ToROUND TEST Farmer

The above TB test is based on the anniversary of the full TB test in your herd.

You may bring forward the test date, please contact your Regional Veterinary Office (RVO) if you wish to do so.

Please see the attached Herd Keeper's Guidance on Requirements for TB Testing, which includes potential consequences for non-compliance with these requirements.

Failure to complete the test by the date specified above and other breaches of the rules applying to the TB Eradication Programme may result in some or all of the potential consequences outlined in the attached Herd Keeper's Guidance on Requirements for TB Testing being imposed.

Further details of the TB testing requirements are available from your RVO or on the Department’s website at: http://www.agriculture.gov.ie/animalhealthwelfare/diseasecontrol/bovinetb/

Yours sincerely,

Superintending Veterinary Inspector

For information on data protection please see the following: https://www.agriculture.gov.ie/dataprotection/. The Data Protection Officer can be contacted at [email protected] or, Data Protection Officer, Data Protection Unit, Department of Agriculture, Food and the Marine, Grattan Business Park, Dublin Road, Portlaoise, Co Laois R32 K857.

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ER5R

Herd Keeper’s Guidance on Requirements for TB Testing

This document is for informational purposes only and does not purport to be a legal instrument.

This document aims to summarise the requirements and prohibitions which arise for Herd Keepers engaged in TB Testing. Herd Keepers’ must adhere to a number of legal requirements arising from the Domestic and EU provisions detailed below.

·Animal Health and Welfare Act 2013 (No 15 of 2013).

·Animal Health and Welfare (Bovine Tuberculosis) Regulations 2015 (S.I. No 58 of 2015).

·Bovine Tuberculosis (Attestation of the State and General Provisions) Order, 1999 (S.I. No. 277/1999).

·European Communities (Animal Remedies) (No. 2) Regulations 2007 (S.I. No. 786/2007).

·European Communities (Identification of Bovines) Regulations 2009 (S.I. No. 77/2009).

·Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.

·Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008

DO – General Advice

Complete form ER83 (if you are a dairy farmer) – pre-declaration of Beef Breed Suckler Cows and submit to your RVO before commencement of the test. It is available from the RVO or online at the Department’s website at http://www.agriculture.gov.ie.

Once your herd test has been completed and is clear, before moving animals off your holding check with your Veterinary Practitioner to ensure that the test results have been reported on the Department’s Animal Health Computer System (AHCS).

Notify your RVO if your herd no longer has stock.

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Page 2 of 5

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ER5R

DO before and during the test – Summary of Legal Requirements Ensure there are adequate handling and testing facilities on your holding to allow the test to be completed accurately and safely on the scheduled date.

Ensure adequate assistance is provided to allow the test to be completed accurately and safely.

Ensure any routine medication (e.g. worm and fluke dosing) has had its withdrawal period expired before the commencement of the test.

Ensure all treatments are recorded on your Animal Remedies Register.

Obtain veterinary certification where animals require urgent treatment prior to a test.

Notify the testing practitioner of any medication administered.

Ensure all animals are properly tagged and registered.

Ensure any temporary brass tagged animals are properly identified with two plastic tags.

Account for all animals listed on your AIM herd profile or herd register.

Keep your herd register up to date.

Complete the herd test on time.

Present for testing all animals, regardless of ownership, on your holding. It is optional to test calves born on your holding that are less than 6 weeks of age.

If animals move into your holding between starting and completing a test, present them for testing.

Present all animals on both days of the test.

Notify the Regional Veterinary Office (RVO) and the testing Veterinary Practitioner of any animals that die between injection on day 1 and reading on day 2.

Notify the testing Veterinary Practitioner of any animals on your herd register that are not present for the test and the reasons why.

Give all passports to your Veterinary Practitioner prior to commencement of a test.

Complete and sign an ER11 form if requested declaring that all eligible animals have been presented for test.

Present any animal for testing when requested to do so, including additional blood tests.

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DO after the test – Summary of Legal Requirements Only move clear animals from a restricted holding direct to slaughter. Such animals do not need a movement permit and may be moved with their passport and the FCI declaration (Food chain information for cattle) available from the RVO or online at http://www.agriculture.gov.ie/foodchaininformation.

Isolate reactors and inconclusive reactors on your holding.

Ensure milk from reactors, inconclusive reactors or animals showing signs of TB is immediately withheld and not included in the milk dispatched to the processor.

Facilitate the removal of reactors.

Retain a record of disposal of milk from any reactors or inconclusive reactors from the date of test.

Disinfect your holding or other land as directed.

Give all surplus passports to your Veterinary Practitioner.

Co-operate with herd inspections.

DO NOT – Summary of Legal Requirements

Do not treat animals with veterinary medication including wormers and flukicides once you receive a notification to test, from the Department, except if treatment is urgently advised and certified by a veterinary practitioner.

Do not treat reactor herds with veterinary medication including wormers and flukicides except if treatment is urgently advised and certified by a veterinary practitioner as further tests may be required.

Do not move animals off your holding between starting and completing a test.

Do not allow your stock to mix with stock from another herd or keep animals under more than one herdnumber on your holding.

Do not slaughter animals treated with veterinary medicine prior to the expiry of the withdrawal period.

Do not drink raw milk from reactor or inconclusive reactor animals.

Do not feed milk, from reactors or inconclusive reactors, that has not been heat treated to calves or other animals – this milk may be fed to reactor animals.

Do not interfere with the integrity of a TB test.

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POTENTIAL CONSEQUENCES OFNON-COMPLIANCE

Invalidation of test.

Liability to pay for the test.

Re-test at your expense.

Restrictions on the movement of animals into and out of your herd.

Seizure and destruction of animals without compensation.

Movement of animals to a knackery at your expense.

Possible consequences for disease compensation pursuant to the Animal Health and Welfare Act 2013.

Possible Penalties on Farm Scheme Payments under EU Cross Compliance Rules.

Withdrawal of herd health certification.

Prosecution pursuant to Statutory Instrument 58/2015.

Biosecurity Advice Maintain the security of boundary fences.

Ensure there is no contact between cattle in your herd and other cattle.

Isolate cattle entering your holding either from another holding or on return from a mart or show, etc.

Isolate sick animals.

Provide disinfection footbaths and overalls for personnel visiting your holding.

Provide clean drinking water for all animals.

Secure feedstores to prevent access by livestock, wildlife or vermin.

Provide secure, clean feeding troughs not accessible to wildlife.

Control rodents.

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Appendix 7 – Equipment Checklist

1. An official Field Book with a current pre-printed or downloaded herd profile drawn down fromAHCS within one week prior to test commencement.…………………………………………………………………

2. A spare Field Book…………………………………………………………………………………………………………………….

3. Dedicated leak proof holsters capable of containing cotton wool and a syringe…………………………...

4. A minimum of 3, properly identified, working syringes……………………………………………………………..

a. Syringes are clearly marked to distinguish between those used for aviantuberculin (red) and those used for bovine tuberculin (blue)……………………………………….

b. Syringes are empty before commencing the test…………………………………………………………..

5. Spare needles and adaptors……………………………………………………………………………………………………

6. Two callipers, maintained in good working order. Both lugs, together withthe thumb-piece, are stable and both the millimetre measurements and the reference mark must be clearly legible……………………………………………………………………………….

7. A suitable clipping device, with a sharp cutting edge, maintained in good working order……………………………………………………………………………………………………………………………………..

8. A suitable back-up clipping device…………………………………………………………………………………………..

9. Thermometer appropriate for veterinary clinical examination of cattle…………………………………….

10. Stethoscope appropriate for veterinary clinical examination of cattle………………………………………

11. Temporary Tags…………………………………………………………………………………………………………………….

12. Scheme Reactor Tags, Red discs and Taggers…………………………………………………………………………..

13. Protective Clothing…………………………………………………………………………………………………………………

14. Approved Disinfection…………………………………………………………………………..………………………………..

15. Appropriate supply of tuberculin – Bovine PPD and Avian PPD in the proprietarypacks as supplied by the Minister, used from the same paired pack………………………………………….

16. Methylated/surgical spirits……………………………………………………………………………………………………..

17. Cotton Wool……………………………………………………………………………………………………………………………

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Appendix 8 – Providers of McLintock Syringes

Ronnie Grace and John Harty, Grace and Harty Ltd., Ballyvoneen, Thurles, Co. Tipperary.

Channelle Veterinary, Unit 2, Beside Langan Courier, Oranmore Business Park, Oranmore, Co. Galway

Duggan Veterinary Supplies Ltd., Holycross, Thurles, Co. Tipperary

Bar Knight McLintock, Low Blochairn Farm, Baldernock, Glasgow, G62 6HE

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Cow C Bull BHeifer H Bullock/Steer S

Cough CO Emaciation EMSnoring SN Enlarged lymph glands GLSkin TB ST Mastitis MA

Appendix 9 – NOTES ON COMPLETION OF PRE PRINTED ER15B1. In column headed ‘Breed’ the following entries only should be used:

Angus AA Danish Red RD Kerry KE Romagnola RMAngler AN Dexter DX Limousin LM Rotbunte RBAubrac AU Droimeann IM Maine Anjou MA Salers SAAyshire AY Galloway GA Montbelliarde MO Shorthorn SHBelgian Blue BB Guernsey GU MRI/MRY MY Simmental SIBison BI Hereford HE Murray Grey GS South Devon SDBlone D’Aquitane BA Highland HI Normande NO Swedish Red SRBrown Swiss BS Holstein/Friesian FR Norwegian Red NR Wagyu WACharolais CH Irish Maol IM Parthenaise PTChianina CI Jersey JE Piemontese PI

In the case of a breed not listed please record the full name. Cross Breeds should be entered with an X after the dominant breed, e.g. HEX for a Hereford Cross.

2. All animals should be presented with two plastic ear tags for identification purposes. In the case of plastic tags containing an alpha-numeric identifier, the tag number should be written in the format: Letters: numbers: check digit e.g. BEA 19731-4 or Letters: numbers: check letter e.g. BCDF 0025Y. The tag number of plastic tags containing an all-numeric identifier should be written in the order in which the numbers appear on the tag. All zeros included in the number must be recorded. Normally the full space allocated should be used for recording an animal’s tag number.

The tag space itself is partitioned into top and bottom halves to facilitate a double entry where a temporary tagging for test ID purposes takes place. The temporary tag number should be entered on the lower space and the permanent tag number (i.e. where the old tag or passport/animal ID card is available) is entered on the top line. In cases where the permanent identity of the animal is not known leave the top line blank. Where a temporary brass tag is inserted record TT in the Tag/Pass column. Brass tagging of animals for temporary identification for test purposes, is only allowed where <10% of herd require such. Otherwise return to complete test after farmer has regularised the identification of the animals. Correlation of temporary tag with permanent identification number, is required before any test certification may be completed on individual passport/animal I.D. card, export certificate etc. See letter Ref: 6A/2000 for details.

3. Tag/Pass - The absence of identification documentation (Passport/ID Card) should be indicated by:

(i) NC No Card ----- Or (ii) FC Full Card ------- Or (iii) WC Wrong Card Where a temporary tag was used to identify the animal TT should be inserted.

4. Age/DOB should be recorded in the following order – year/month or actual age.

e.g. 1/0 one year old 1/6 one year and six months 0/10 ten months

5. The following codes should be used for recording the sex of the animal:

If an animal is pregnant state the length of pregnancy (e.g. C4 = cow pregnant 4 months).

6. The column headed ‘Clinical Remarks’ is intended for recovering conditions relevant to both TB and Brucellosis testing. In the case of TB the following clinical conditions should be recorded if present:

In the case of Brucellosis blood testing any abortion history (i.e. date of abortion) should be entered.

7. In the column headed ‘Reaction’ the following are the appropriate entries.(i) Diffuse Oedema D.O. (ii) Extensive OedemaE.O. (iii) Circumscribed C.

8. In the column headed ‘Result’ you should indicate the result of both increases. In the column headed ‘Test Result’ you should indicate the overall result of the test:

(i) Positive + Or (ii) Doubtful 0 Or (iii) Negative --

The column headed ‘BR Tested’ must be completed where a prepared list of the animals to be tested is provided by the D.V.O. If an animal has been blood tested the letter ‘Y’ should be inserted in this column to indicate that the animal was blood tested.

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