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COMMISSION DECISION

of 4 May 2005

approving on behalf of the European Community amendments to the annexes to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

(notified under document number C(2005) 1369)

(Text with EEA relevance)

(2005/405/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 98/258/EC of 16 March 1998 on the conclusion of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products (1), and in particular the third paragraph of Article 4 thereof,

Whereas:

HAS ADOPTED THIS DECISION:

Article 1

Pursuant to the recommendations made by the Joint Management Committee established under Article 14 of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products, the amendments to point 6 of Annex V, to Annex VI, and to footnote (1) to the said Agreement are hereby approved on behalf of the European Community.

The text of the Agreement in the form of an Exchange of Letters, including the amendments to point 6 of Annex V, to footnote (1) and to Annex VI to the Agreement, is attached to this Decision.

Article 2

The Director-General for Health and Consumer Protection is hereby empowered to sign the Agreement in the form of an Exchange of Letters in order to bind the Community.

Article 3

This Decision shall apply from the first day of the month following the month in which the United States of America notifies the Commission in writing that its internal procedures for the approval of the amendments referred to in Article 1 have been completed.

Done at Brussels, 4 May 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)OJ L 118, 21.4.1998, p. 1. Decision last amended by Commission Decision 2003/833/EC (OJ L 316, 29.11.2003, p. 20).

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AGREEMENT IN THE FORM OF AN EXCHANGE OF LETTERS

Concerning amendments to the annexes to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

Brussels, 7 October 2004

Your Excellency,

With reference to the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products, I have the honour to propose to you to amend the Annexes of the Agreement as follows:

As recommended by the Joint Management Committee established under Article 14(1) of the Agreement, replace the texts of point 6 of Annex V and of footnote (1) to the Agreement with the text in Appendix A to the present letter, and replace the text of Annex VI to the Agreement, with the text in Appendix B to the present letter.

I would be obliged if you would confirm the agreement of the United States of America to such amendments to point 6 of Annex V, to footnote (1), and to Annex VI to the Agreement.

Please accept, Sir, the assurance of my highest consideration.

 (1)

For the European Community

Jaana HUSU-KALLIO

Brussels, 6 April 2005

Dear Madam,

I refer to your letter of 7 October 2004 containing details of the proposed Appendix A to replace Annex V, point 6 and footnote (1) and Appendix B to replace Annex VI of the Agreement of July 20 1999 between the United States of America and the European Community on the sanitary measures to protect public and animal health in trade in live animals and animal products.

In this regard, I have the honor to confirm the acceptability to the United States of America of the proposed amendments as recommended by the Joint Management Committee established under Article 14(1) of the Agreement, a copy of which is attached hereto. It is my understanding that these amendments shall take effect on the date on which the EC notifies the US that it has completed the necessary procedures for implementing these amendments.

Please accept the assurances of my high consideration.

 (2)

For the Ambassador

Norval E. FRANCIS

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(1)

(2)

APPENDIX A

‘ANNEX V

FOOTNOTE 1

APPENDIX B

‘ANNEX VI

GUIDELINES FOR CONDUCTING AN AUDIT

Where standards, guidelines, or recommendations pertaining to the conduct of audits are adopted by one of the relevant international standard-setting organisations, the Parties will review the contents of this Annex, and make any appropriate modifications.

General Provisions

1.   Definitions

The following definitions shall apply to terms used in this Annex:

2.   General principles

2.1.   The auditor and the auditee should cooperate in carrying out audits in accordance with the provisions set out in this Annex. The audit team should include representatives of both the auditor and the auditee, and the auditee should designate personnel responsible for facilitating the audit. Specialised professional skills may be necessary to carry out audits of specialised systems and programmes.

Information is collected through interviews, review of documents and records, and site visits. Changes to controls since the adoption of the Agreement or since the previous audit are included. Information may be verified through inquiries and checks on other sources; these may include physical observation, measurements, samples and records. Information obtained during the course of the audit should be documented.

2.2.   Audits should be designed to check the effectiveness of the auditee's enforcement and control programme rather than to reject individual animals, consignments of food or establishments. The auditee's enforcement and control programme covered by the Agreement should be adequately assessed.

2.2.1.   The basis for the assessment of all audits conducted in accordance with the Agreement is provided by the standards of either the exporting party, or a combination of the standards of the exporting party and importing party, and any special conditions as appropriate for the particular audit. Such standards and appropriate special conditions are outlined in Annex V, and provided for in Article 6.

2.2.2.   It is recognised that on-site audits undertaken in the process of determining initial equivalence will normally be conducted using only the standards of the exporting country, whereas subsequent on-site audits undertaken for the purpose of verifying delivery of a previously established condition of equivalence will be conducted using the standards of the exporting party, those relevant standards of the importing party that have not been determined to be equivalent and for which compliance is required, and any agreed special conditions outlined in Annex V.

2.3.   The auditee must operate a documented programme to demonstrate to the auditor that standards are being met on a consistent basis.

2.4.   The frequency of audits should be based on the performance of the exporting Party in carrying out its enforcement and control programme. A low level of performance should result in an increased frequency of audit, for example to ensure that unsatisfactory performance has been corrected.

2.4.1.   Information to be used in establishing the frequency of audits may include, inter alia:

2.5.   Audits, and the decisions based on them, should be made in a transparent and consistent manner.

The auditor should:

The auditee should:

2.6.   Animal health investigations

Animal health investigations are conducted in order to gather appropriate epidemiological and other information concerning the disease status of a particular region (whether a Member State/State, part of a Member State/State or parts of more than one Member State/State). An animal health investigation may be carried out by one party (referred to here as the importing party) to support the initial determination made by the other party (referred to here as the exporting party) of the disease status of a region (i.e. first-time recognition of freedom from a specified disease), or following a disease outbreak.

OPERATIONAL GUIDELINES

Preparing for audits

3.   Advance preparation

3.1.   Programming of audits

In order to ensure that audits can be adequately prepared and carried out in the most efficient manner, the Parties should:

3.2.   Audit initiation

The following will normally provide a basis for the initiation of audits:

In all cases, the auditor should provide the auditee with sufficient notice of the intended audit, in order to enable it to make the arrangements necessary for a satisfactory completion of the audit. The advance time of this notice should reflect the urgency related to public and animal health associated with its performance.

Communication by the auditor to the auditee

3.3.   Pre-audit activities

3.3.1.   Preparation of the audit plan

In consultation with the auditee, the auditor should prepare an audit plan. The audit plan should be submitted by the auditor to the auditee sufficiently in advance of the audit to allow time for information to be supplied by the auditee, preferably 60 days prior to the intended commencement date of the audit. The audit should be designed to be flexible in order to permit changes in emphasis based on information gathered prior to, or during the audit.

The plan should include:

3.3.2.   Agreement with the auditee of the plan and dates

If the auditee objects to any provisions detailed in the audit plan, such objections are to be made known immediately to the auditor, usually within 10 working days after receipt of the audit plan. Objections should be resolved between the auditor and the auditee. Proposed amendment(s) to the audit plan, as a consequence of information obtained either prior to or during the audit, should be communicated by the proposing party to the other party as soon as practicable.

3.3.3.   Obtaining the necessary documentation from the auditee

Prior to the audit, the auditor may request documentation from the auditee that is relevant to its preparation and execution. Such documentation may include, for example:

The auditor may request clarification from the auditee concerning any documentation that has been submitted.

Conducting the audit

4.   Opening meeting

The auditee and auditor should have an opening meeting at a site agreed to in advance by both sides. Where necessary and appropriate to clarify issues pertaining to the audit, the opening meeting may be held in Washington, D.C. for audits conducted by European Commission teams, or in either Brussels, Belgium or Grange, Ireland for audits conducted by US teams. In other cases, opening meetings may be held at appropriate sites, such as EU Member State capitals or US cities, as may be practical and convenient for the particular audit. Wherever the opening meeting takes place, it should be chaired by an appropriate representative of the auditee's competent authority(ies). The purpose of an opening meeting is to:

5.   Document review

5.1.   The document review may include, for example, the following:

5.2.   In the case of an audit that is subsequent to a determination of equivalence, the document review may also consist of a review of relevant changes to the inspection and certification systems since the determination of equivalence or since the previous audit.

5.3.   The auditee will cooperate fully with the auditor in the document review process and help to ensure that the auditor has access to requested documents and records.

6.   On-site verification

6.1.   The decision by the auditor as to the nature and extent of on-site verifications should take into account factors such as the area concerned, the history of conformity with requirements by the sector or exporting country as determined by prior audits and/or veterinary checks at the border (including results of sampling and analysis of import consignments), the volume of product produced and imported or exported, changes to the infrastructure and the nature and operation of the national inspection and certification systems.

6.2.   On-site verification may involve visits to production and manufacturing establishments, facilities, food handling or storage areas and control laboratories to check the accuracy of the information contained in the documentary material referred to in 5.1.

6.3.   When checks of establishments or facilities are carried out, the auditee will carry out the check of the establishment or facility, following the auditee’s usual procedures, and the auditor will generally participate as an observer, though the auditor is free to check other aspects of performance, if deemed necessary. Due to time constraints, the auditor may elect not to observe a full, comprehensive inspection by the auditee, but may, instead, verify particular inspection practices through off-site interviews with the auditee’s inspection staff.

6.4.   The auditee will cooperate fully with the auditor in the on-site verification process and facilitate the auditor's entry into the establishments and facilities that are the subject of the on-site verification.

6.5.   Where on-the-spot checks reveal a serious potential or actual risk to human or animal health, the auditor should immediately inform the auditee of such an assessment, who should take appropriate action to correct an identified and confirmed risk.

7.   Follow-up audit

A follow-up audit may be conducted to verify the correction of deficiencies identified in a prior audit.

8.   Working documents

Working documents may include checklists of elements to evaluate, such as the following:

8.1.   Support documents

Documents supporting audit findings, conclusions and recommendations should be standardised as much as possible in order to make the performance of the audit and the presentation of its findings uniform, transparent and reliable. The support documents may include any aides memoire or other background information of elements to evaluate.

9.   Closing meeting

As with the opening meeting, the closing meeting may be held at a site that is mutually convenient to both the auditee and the auditor. The closing meeting should also be chaired by an appropriate representative of the auditee's competent authority(ies).

The purpose of the closing meeting is to:

Post-audit activities

10.   Audit report

The audit report should provide a balanced picture of the audit findings, and include conclusions and recommendations that accurately reflect these findings. It should normally cover the following:

10.1.   Commercial confidentiality must be respected in the preparation and subsequent distribution of the audit report. Prior to the audit, each party will inform the other of its laws and procedures for protecting confidential commercial information and other information that may be deemed sensitive by one or both parties. Each party will respect fully its own requirements for protecting confidential information. Where significant differences exist between the parties in the nature of information that must be protected, the parties will identify these differences prior to the audit and agree on the appropriate procedures to be followed.

10.2.   Draft reports are to be sent to the auditee within the time limits specified in the Agreement. The auditee may comment within 60 days, and should describe any specific corrective actions that will be or have been taken in order to deliver equivalence initially, or to continue to deliver equivalence, including target dates for completion.

10.3.   Amendments to the text of the final report in response to comments from the competent authority should be limited to the correction of factual inaccuracies. However, other comments made by the auditee may be indicated separately in the report if they serve to clarify the report’s contents. The auditee’s comments should, in any case, be attached to the final report.

11.   Corrective action follow up

Verification of corrective action necessary to deliver equivalence will vary according to the nature of the original deficiency. Verification of corrective action by the auditee may include the following:

The follow up audit process is similar to the normal audit, but it would focus on confirming that the action taken by the auditee satisfactorily addresses and resolves the identified deficiencies. A follow up report concerning the corrective action should be prepared and distributed in a manner similar to the original audit report.

Animal health investigations

12.   Animal health investigations

12.1.   General principles

All parties involved in an animal health investigation should cooperate in carrying out the investigation in an open and transparent manner, with a view to completing all necessary procedures as quickly as possible.

12.2.   Procedures

12.2.1.   Programming of animal health investigation and animal health investigation initiation

In most cases, this investigation will be undertaken at the request of the exporting party. The results of an animal health investigation should provide essential information regarding disease risk associated with exports of specified commodities from that region. The importing party shall acknowledge such a request in a timely manner, and shall identify a contact person to work closely with representatives of the exporting party. Necessary site visits will be scheduled expeditiously with the input of all parties.

In the event of an outbreak of one of the diseases identified in Annex III and in case that safeguard or regionalisation measures have been adopted, the importing party may require that an animal health investigation take place before trade in affected products can be resumed. In order to minimise the disruption of trade and facilitate the recognition of disease freedom or identification or appropriate risk mitigation measures, the appropriate representatives of both the importing and exporting parties will work to schedule the investigation as quickly as possible. While the timing of the visit will depend on progress in bringing the outbreak under control, the two parties should enter into discussions at the earliest practical stage.

12.2.2.   Pre-visit activities

The importing party will identify the regions to be visited as part of the site visit, as well as the types of entities to be included, in direct communication with the exporting party. The two parties should work in close consultation to prepare an investigation plan that covers the following points:

The investigation plan should be completed prior to the departure of the investigation team and transmitted to all parties involved in the animal health investigation.

12.2.3.   Conducting the investigation

12.2.3.1.   Opening meeting

An opening meeting should be held between representatives of all parties. At this meeting, the investigating party will review the investigation plan and confirm that the necessary arrangements have been made for conducting the investigation.

The location of the opening meeting will be determined as part of the investigation plan, and may, if appropriate, be hosted by representatives of the appropriate regulatory authorities.

The purpose of this opening meeting is to:

12.2.3.2.   Documenting the investigation

The officials conducting the investigation will keep a written record of their findings, together with documentation supplied by the host party representatives. The record will include the locations visited, including farms, and the names and titles of officials interviewed as part of the investigation.

12.2.3.3.   Closing meeting

A closing meeting shall be held between representatives of both parties. The location of the meeting will be determined as part of the investigation plan, and may, if appropriate, be hosted by officials of the appropriate regulatory authorities.

The purpose of the meeting is to:

12.2.4.   Evaluation

The evaluation should be science based, transparent, and consistent with relevant international standards and with similar evaluations conducted by the importing party.

Depending on the procedures of the importing party, the assessment and/or the report may be made public. Comments on the assessment and/or the report by the exporting party will be governed by existing regulatory requirements of the importing party.’

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