# EUR-Lex - 21998A0421(01) - EN

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# 21998A0421(01)

**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 **

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Official Journal L 118 , 21/04/1998 P. 0003 - 0063 *

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 EUROPEAN COMMUNITY,

of the one part, and

THE GOVERNMENT OF THE UNITED STATES OF AMERICA,

of the other part,

DESIRING to safeguard public and animal health and to facilitate trade in animals and animal products between the European Community (hereinafter referred to as 'the Community`) and the United States of America (hereinafter referred to as 'the USA`);

RESOLVED to take the fullest account of the risk of spread of animal diseases and the measures put in place to control and eradicate such diseases, and in particular to avoid disruptions to trade;

REAFFIRMING their commitment to the rights and obligations established under the World Trade Organisation Agreement on the application of sanitary and phytosanitary measures (hereinafter referred to as the 'SPS Agreement`);

WHEREAS the Parties acknowledge that their systems of sanitary measures are intended to address similar objectives of providing comparable health assurances;

NOTING that the recognition by an importing country of the sanitary measures applied by an exporting country can permit greater efficiency in the utilisation of inspection and verification resources;

HAVE DECIDED to conclude this Agreement and to this end have designated respectively as their plenipotentiaries:

THE EUROPEAN COMMUNITY

THE GOVERNMENT OF THE UNITED STATES OF AMERICA

WHO HAVE AGREED AS FOLLOWS:

Article 1 Objective

The objective of this Agreement is to facilitate trade in live animals and animal products between the Community and the USA by establishing a mechanism for the recognition of equivalence of sanitary measures maintained by a Party consistent with the protection of public and animal health, and to improve communication and cooperation on sanitary measures.

Article 2 Multilateral obligations

Nothing in this Agreement shall limit the rights or obligations of the Parties under the Agreement establishing the World Trade Organisation and its Annexes, in particular the SPS Agreement.

Article 3 Scope

1. This Agreement shall initially be limited to the sanitary measures applied by either Party to the live animals and animal products listed in Annex I, except as provided for in paragraph 2.

2. Unless otherwise specified under the provisions set out in the Annexes to this Agreement, this Agreement shall not apply to sanitary measures related to food additives, processing aids, flavours, colour additives, sanitary stamps, irradiation (ionisation), contaminants (including pesticides, chemical residues, mycotoxins, natural toxins, physical contaminants and animal drug residues), chemicals originating from the migration of substances from packaging materials; labelling of foodstuffs (including nutritional labelling); feed additives, animal feedingstuffs, medicated feeds and premixes.

3. The Parties may agree to modify this Agreement in the future to extend the scope to other sanitary or phytosanitary measures affecting trade between the Parties.

Article 4 Regulatory authorities

1. The USA: regulatory authority for imports and exports of live animals and animal products is as described in part A of Annex II.

2. The Community: control in veterinary affairs is as described in part B of Annex II.

Article 5 Definitions

For the purposes of this Agreement the following definitions shall apply:

(a) 'sanitary measures` means sanitary measures as defined in Annex A, paragraph 1, of the SPS Agreement and falling within the scope of this Agreement. The reference to sanitary measures may cover individual sanitary measures or groups of sanitary measures for product areas, sectors, or parts of sectors, as appropriate;

(b) 'appropriate level of sanitary protection` means the appropriate level of sanitary protection as defined in Annex A, paragraph 5, of the SPS Agreement;

(c) 'region` means zones or regions as defined in the Animal Health Code of the Office international des epizooties (OIE), and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE;

(d) 'Agreement` means the entire text of this Agreement and all its Annexes.

Article 6 Animal health status

1. The importing Party shall recognise for trade the health status of regions, as determined by the exporting Party, with respect to the animal and aquaculture diseases specified in Annex III.

2. The importing Party shall recognise regionalisation decisions taken by the exporting Party in accordance with the criteria set out in Annex IV as the basis for trade from a Party where an area is affected by one or more of the diseases listed in Annex III.

3. Where a Party considers that it has a special status with respect to a specific disease other than those in Annex III, it may request recognition of this status. The importing Party may also request additional guarantees in respect of imports of live animals and animal products appropriate to the agreed status. The guarantees for specific diseases are specified in Annex V.

The exporting Party shall, if requested by the importing Party, provide full explanation and supporting data for the determinations and decisions covered by this Article. The importing Party may, where necessary for the protection of animal health, invoke the provisions of Article 12.

Article 7 Equivalence

1. In reaching a determination whether a sanitary measure maintained by an exporting Party achieves the importing Party's appropriate level of sanitary protection, the Parties shall follow a consultative process that includes the following steps:

(i) identification of the sanitary measure for which recognition of equivalence is sought;

(ii) explanation by the importing Party of the objective of its sanitary measure, including an assessment, as appropriate to the circumstances, of the risk or risks, that the sanitary measure is intended to address, and identification by the importing Party of its appropriate level of sanitary protection;

(iii) demonstration by the exporting party that its sanitary measure achieves the importing Party's appropriate level of sanitary protection;

(iv) determination by the importing party whether a sanitary measure achieves its appropriate level of sanitary protection after consideration of various factors, including where appropriate:

(a) risks identified by the importing Party and evidence provided by the exporting Party that its sanitary measures effectively address those risks;

(b) provisions of the exporting Party's legislation and regulations regarding standards, procedures, policies, infrastructure, enforcement and control;

(c) powers of the exporting Party's regulatory authorities and their structure, including their chain of command, modus operandi, and resources;

(d) evidence provided by the exporting Party of the efficacy of its enforcement and control programmes.

The importing Party may carry out verification, as set out in Article 9, to assist this determination.

2. In carrying out the consultative process described in paragraph 1, and setting the trade conditions referred to in Article 8(2)(b), the Parties shall take account of experience and information already acquired.

3. Work under, or conclusion of, the consultative process for one product area, sector, or part of sector, shall not be dependent on or delayed by work on any other product area, sector, or part of sector.

4. The final determination whether a sanitary measure maintained by an exporting Party achieves the importing Party's appropriate level of sanitary protection rests solely with the importing Party acting in accordance with its administrative and legislative framework.

Article 8 Status of consultations

1. Annex V lists the live animals and animal product areas, sectors, or parts of sectors, and, for each area, sector or part thereof, sets forth the status of consultations regarding the recognition of equivalency of a Party's sanitary measures and the applicable trade conditions.

2. (a) With respect to sanitary measures recognised as equivalent for trade purposes at the date of entry into force of this Agreement, each Party, within its responsibilities, shall initiate the necessary legislative and administrative actions within three months to implement these recognitions. For sanitary measures that will be recognised as equivalent in the future, each Party shall take prompt and necessary steps to implement the recognitions.

(b) Where the trade conditions specified in Annex V include special conditions required by the importing Party to meet its appropriate level of protection, trade shall take place where the exporting Party meets the importing Party's conditions, without prejudice to the continuing consultative process.

3. The Parties shall carry out the respective actions set out in Annex V, taking into account the target deadlines for each product area, sector, or part of sector, with a view, where possible, to reaching recognition of equivalence, and to facilitate trade.

4. Annex V may be modified in accordance with Articles 14(2) and 16(2) to reflect changes made by each Party in recognitions or trade conditions.

Article 9 Verification provisions

1. The determination of the nature and frequency of checks to be applied to imports of live animals and animal products at external frontiers rests solely with the importing Party. Annex VII contains principles which shall guide such frontier checks.

2. In addition to carrying out checks on imports at the external frontier, the importing Party may verify compliance with the provisions of this Agreement through the application of procedures which may include, but are not limited to:

(a) an assessment of all or part of the exporting Party's total control programme, including, where appropriate, reviews of the exporting Party's inspection and audit programmes, and

(b) on-site checks and inspections.

3. The Community will carry out the verification procedures provided for in paragraph 2. The US agencies identified in Annex II shall facilitate the performance of these verification procedures by the Community.

4. The US agencies identified in Annex II will carry out the verification procedures provided for in paragraph 2. The Community shall facilitate the performance of these verification procedures by those agencies.

5. On the mutual consent of the Parties to this Agreement, either Party may:

(a) share the results and conclusions of its verification procedures with countries that are not parties to this Agreement, or

(b) use the results and conclusions of verification procedures carried out by countries that are not parties to this Agreement.

6. Each Party shall carry out the verification procedures in accordance with Annex VI. The Parties may agree to modify Annex VI, taking due account of relevant work carried out by international organisations.

Article 10 Information exchange

1. The Parties shall exchange information on a uniform and systematic basis to improve communication, to engender mutual confidence, and to demonstrate the efficacy of the programmes controlled. Where appropriate, this may be supported by exchanges of officials between the Parties.

2. The Parties shall notify each other of proposals to introduce new sanitary measures or to change existing sanitary measures, and shall provide the opportunity to comment on such proposals.

3. In addition to information on changes in sanitary measures, or to change existing sanitary measures, the Parties shall also exchange information on other relevant topics including:

- current developments affecting trade in live animals and animal products,

- the results of the checks and verification procedures provided for in Article 9.

4. Where a Party establishes, maintains or recognises a scientific committee, commission, expert group or other similar entity competent to study an issue relevant to this Agreement, the Party shall ensure timely consideration of, and response to, relevant scientific papers or studies submitted by the other Party.

5. The Parties agree to establish an appropriate means of exchanging information on rejected import consignments, relevant inspection-related information, and other problem areas concerning public or animal health.

6. The contact points for this information exchange are set out in Annex IX.

Article 11 Notification

1. Each Party shall notify the other:

(a) immediately by oral communication followed within 24 hours in writing: of any serious or significant public or animal health risk, notably including any food control emergencies or situations where there is a clearly identified risk of serious health effects associated with the consumption of animal products;

(b) within 24 hours in writing: of the presence or evolution of any disease listed in Annex III;

(c) without delay and in writing: of any significant changes in animal health status or of findings of epidemiological importance with respect to diseases other than those listed in Annex III; of changes in preventive policies, including vaccination policies; or, of any non-routine measures taken to protect public health or to control or eradicate animal disease.

2. Such notifications shall be made to the contact points set out in Annex IX.

3. Where either Party has serious concerns regarding a risk to public or animal health, consultations regarding the situation shall, on request, take place as soon as possible, and in any case within 14 days. Each party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution consistent with the protection of public or animal health.

Article 12 Safeguards

Either Party may take provisional measures necessary for the protection of public or animal health. These measures shall be notified within 24 hours to the other Party, and, on request, consultations regarding the situation shall be held within 14 days. The Parties shall take due account of any information provided through such consultations, and shall endeavour to avoid unnecessary disruption to trade, taking advantage where possible of the provisions of Article 11(3).

Article 13 Outstanding issues

The principles of this Agreement shall also be applied to address outstanding issues listed in Annex VIII. Modifications shall be made to this Annex and, as appropriate, other Annexes, to take account of progress made and new issues identified.

Article 14 Joint Management Committee

1. A Joint Management Committee (hereinafter referred to as 'the Committee`), consisting of representatives of the USA and the Community, is hereby established to guide the activities carried out under this Agreement. The Committee shall meet within one year of the entry into force of this Agreement and at least annually thereafter. The Committee may also address issues out of session by correspondence.

2. The Committee shall, at least once a year, review the Annexes to this Agreement. As appropriate, this review will take account of progress made on the continuing consultative process towards the recognition by the importing Party of the equivalence of sanitary measures maintained by the exporting Party and progress in completing the actions set out in Annex V. The Committee may recommend changes to the Annexes.

3. The Parties agree to establish technical working groups, consisting of expert-level representatives of the USA and the Community, which shall identify and address technical and scientific issues arising from this Agreement.

When additional expertise is needed, the Parties may also establish ad hoc technical working groups, notably scientific groups, whose membership need not be restricted to representatives of the Parties.

Article 15 Territorial application

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty, and on the other hand, to the United States of America in respect of its entire territory.

Article 16 Final provisions

1. This Agreement shall be approved by the Parties in accordance with their respective procedures.

This Agreement shall enter into force on the first day of the month following the date on which the Parties notify each other that the procedures mentioned in the preceding subparagraph have been completed.

2. Each Party shall implement the commitments and obligations arising from this Agreement in accordance with its laws and procedures. Any changes to the Annexes to this Agreement that are agreed by the Parties shall be implemented accordingly.

3. Either Party may at any time propose modifications to this Agreement. Either Party may, on six months' notice withdraw from the Agreement.

4. This Agreement shall be drawn up in two copies in the English language, each of these texts being equally authentic.

For the European Community

For the Government of the United States of America

ANNEX I

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ANNEX II

REGULATORY AUTHORITIES

A. UNITED STATES OF AMERICA

I. USA CONTROL AUTHORITY

The federal agencies listed in this section are responsible for both domestically-produced and imported animal products, unless otherwise noted.

In relation to imports into the USA, these agencies are responsible for:

- conducting frontier checks provided for in the Agreement,

- carrying out the consultations provided for pursuant to Article 7 of the Agreement,

- carrying out the verification procedures provided for in Article 9 of the Agreement,

- carrying out the information exchange provided for in Article 10, the notifications provided for in Article 11, and the safeguards provided for in Article 12 of the Agreement.

In relation to exports from the USA, unless otherwise noted, these agencies are responsible for:

- controlling the circumstances of domestic production and processing,

- providing information concerning compliance with agreed regulatory requirements,

- providing agreed additional guarantees,

- carrying out the consultations provided for pursuant to Article 7 of this Agreement,

- carrying out the information exchange provided for in Article 10, the notifications provided for in Article 11, and the safeguards provided for in Article 12 of the Agreement.

A. Control of animal health

1. Animal diseases/pests

(a) Live animals (including apiculture bees), embryos, ova, semen and animal products - US Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS).

(b) Imports of salmonid live fish, gametes and fertilised ova - Department of Interior/Fish and Wildlife Service (DOI/FWS).

(c) Imports of uneviscerated salmonid fish - DOI/FWS.

(d) Animal feed (including pet foods)

1. Transmission of disease from feed - USDA/APHIS.

2. Adulteration, pesticides, chemical and microbial contamination, food additives, substances 'generally recognised as safe` - Food and Drug Administration (FDA).

B. Control of public health

1. Meat and poultry for human consumption

(a) Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats and equine - US Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) (1).

(b) Fresh meat and products from domestic and farmed chickens, turkeys, ducks, geese, and guinea fowl - USDA/FSIS (2).

(c) Fresh meat and products from wild and farmed game, with the exception of those from IB1(a) and IB1(b) above - (FDA).

(d) Fresh meat and products from species other than above - FDA.

(e) Enforcing adulteration provisions of the law and limits for residues of drugs, pesticides, heavy metals, mycotoxins, and other contaminants in food:

1. sampling of fresh meat and animal products and control of the fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and for domesticated and farmed chickens (including liquid, frozen and dried egg products), turkeys, ducks, geese, and guinea fowl - USDA/FSIS;

2. sampling of fresh meat and animal products (including animal feed) and control of the fresh meat and products of other species - FDA.

2. Eggs and egg products

(a) Shell eggs, hard-cooked eggs, ethnic egg delicacies, and imitation egg products - FDA.

(b) Shell eggs (including cracks and dirties) for breaking for the production of liquid, frozen, and dried egg products (egg yolks, albumen, or any combination) - USDA/FSIS (3).

3. Dairy

(a) All dairy products - FDA.

4. Other animal-derived foods (including fish and fishery products)

(a) All other animal-derived foods - FDA.

5. Animal feed

(a) Adulteration, pesticides, chemical and microbial contamination, food additives, substances 'generally recognised as safe` - FDA.

II. COMPETENT AUTHORITIES FOR VOLUNTARY PROGRAMMES

The federal agencies listed in this section are responsible for voluntary inspection and certification programmes for domestically-produced animal products.

In relation to exports from the USA, these agencies are responsible for:

- oversight of the circumstances of domestic production and processing for firms who participate in the voluntary programme,

- providing information concerning compliance with agreed requirements for firms who participate in the voluntary programme,

- providing agreed additional guarantees for firms who participate in the agreed programme.

A. Animal health

1. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova - USDA/APHIS, Department of Commerce/National Marine Fisheries Service (CommerceNMFS).

2. Salmonid live fish, gametes, and fertilised ova - USDA/APHIS, Commerce/NMFS.

3. Animal feed (including pet foods) containing fish and fishery products - USDA/APHIS, Commerce/NMFS.

B. Public health

1. Fresh meat and meat products (4) from wild and farmed bison, ostrich, emu, rhea, rabbit, deer, partridge, and quail - USDA/FSIS.

2. Snakes for human consumption - Commerce/NMFS.

3. Shell eggs - USDA/AMS.

4. Cooked omelets made from egg products, diced eggs made from egg products - USDA/FSIS.

5. Dairy - USDA/AMS.

6. Seafood (including live seafood) - Commerce/NMFS.

III. FEDERAL AGENCIES THAT ISSUE CERTIFICATION

This section lists the USA national agencies that issue export certificates agreed to by the EC and the USA (5). The agency issuing certificates may be the control authority or another national agency that is recognised by the control authority for that purpose. More than one agency may issue certificates for a product.

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B. EUROPEAN COMMUNITY

Control is shared between the national services in the individual Member States and the European Commission. In this respect the following applies:

- in terms of exports to the USA, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections, and issuing health certification attesting to the agreed standards and requirements,

- the European Commission is responsible for overall coordination, inspections/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single European Market.

(1) With very limited exceptions, the USDA/FSIS has sole jurisdiction for these foods until the time they leave the slaughterhouse. After the meat and products have left the slaughterhouse, the USDA/FSIS and the FDA share jurisdiction. The FDA is responsible for the approval of veterinary drugs and food additives in meat and poultry.

(2) See preceding footnote.

(3) The FDA and FSIS share jurisdiction over these products after they have left the processing plant.

(4) These meat products must be made from fresh meat slaughtered under the USDA/FSIS voluntary programme.

(5) Note that the listing of a product in Section II does not mean that certificates will necessarily be required as part of agreements reached on equivalence. Such decisions will be made on a product-by-product basis.

ANNEX III

LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED

Animal diseases

Foot and mouth disease

Swine vesicular disease

Peste de petits ruminants

Contagious caprine pleuropneumonia

Sheep and goat pox

African swine fever

Enterovirus encephalomyelitis

Newcastle disease

Pseudorabies/Aujeszky's disease

Vesicular stomatitis

Rinderpest

Contagious bovine pleuropneumonia

Bluetongue

African horse sickness

Classical swine fever

Fowl plague (avian influenza)

Venezuelan equine encephalomyelitis

Aquaculture diseases

The list of aquaculture diseases is to be discussed further by the Parties on the basis of the International Aquatic Animal Health Code of the OIE.

ANNEX IV

ZONING AND REGIONALISATION

The Parties have jointly determined that the following forms the basis for regionalisation decisions for the diseases listed in accordance with Annex III. Each Party will recognise regionalisation decisions taken in accordance with the standard contained within this Annex.

Animal diseases

In assessing risk from a given proposed importation of animals or animal products, three sets of factors may be considered:

1. Source risk factors

2. Commodity risk factors

3. Destination risk factors

Source risk factors

The primary determinant of the risk of importing disease is the status of the country of origin in respect of the disease in question. However, declarations of disease freedom must be backed up by effective surveillance programmes.

The overriding consideration in this context, therefore, is the quality of the veterinary infrastructure. No other factors can be assessed without full confidence in the veterinary administration. In particular, its ability to detect and control an outbreak of disease and to provide meaningful certification is crucial.

The ability to detect the presence of disease depends on the surveillance carried out. This surveillance can be active, passive, or both.

Active surveillance implies definitive action intended to identify the presence of disease, such as systematic clinical inspections, ante and post mortem examination, serology on farm or in abattoir, referral of pathological material for laboratory diagnosis, sentinel animals.

Passive surveillance means that the disease must be compulsorily notifiable and that there must be a sufficiently high level of supervision of the animals in order to ensure that the disease will be observed quickly and reported as a suspect. There must also be a mechanism for investigation and confirmation, and a high level of awareness of the disease and its symptoms by farmers and veterinarians.

Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, particularly those which ensure a regular veterinary presence on the farm.

Other factors to be considered include:

- disease history,

- vaccination history,

- controls on movements into the zone, out of the zone and within the zone,

- animal identification and recording,

- presence of disease in adjacent areas,

- physical barriers between zones of differing status,

- meteorological conditions,

- use of buffer zones (with or without vaccination),

- presence of vectors and/or reservoirs,

- active control and eradication programmes (where appropriate),

- ante and post mortem inspection.

On the basis of these factors, a zone may be defined.

The authority with the responsibility for implementing the zoning policy is in the best position to define and maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the basis for trade.

The zones so defined may be assigned a risk category.

Possible categories are:

- low/negligible risk,

- medium risk,

- high risk,

- unknown risk.

Calculation of estimates of risk for, for example, live animals may assist in this categorisation. Import conditions may then be defined for each category, disease and commodity, individually or in groups.

Low/negligible risk implies that importation may take place based on a simple guarantee of origin.

Medium risk implies that some combination of certification and/or guarantees may be required before or after importation.

High risk implies that importation will only take place under conditions which significantly reduce the risk, for example by additional guarantees, testing or treatment.

Unknown risk implies that importation will only take place if the commodity itself is of very low risk, for example hides, wool, or under the conditions for 'high risk` if the commodity factors warrant.

Commodity risk factors

These include:

- is the disease transmissible by the commodity?

- could the agent be present in the commodity if derived from a healthy and/or clinically affected animal?

- can the preceding factor be reduced, for example by vaccination?

- what is the likelihood that the commodity has been exposed to infection?

- has the commodity been obtained in such a way as to reduce the risk, for example deboning?

- has the commodity been subjected to a treatment which inactivates the agent?

Appropriate tests and quarantine will reduce the risk.

Destination risk factors

- presence of susceptible animals,

- presence of vectors,

- possible vector-free period,

- preventive measures such as waste food feeding and animal waste rendering rules,

- intended use of product for example petfood, human consumption only.

These factors are inherent in, or are under the control of the importing country, and some may therefore be modified to facilitate trade. These may, for example, include restricted entry conditions, for example animals to be confined to a certain vector free region until the incubation period has passed, or canalisation systems.

However, destination risk factors will also be taken into account by the infected country with respect to the risk presented by movements from the infected part to the free part of its territory.

Aquaculture diseases

Pending the development of any specific provisions to be included in this Annex, the basis for regionalisation decisions for aquaculture diseases will be the International Aquatic Animal Health Code of the OIE.

ANNEX V

RECOGNITION OF SANITARY MEASURES

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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:

1.1. audit: assessment of performance;

1.2. auditee: the exporting Party whose enforcement and control programme is the subject of the audit;

1.3. auditor: the importing Party that conducts the audit;

1.4. establishment: processing plant for animals or animal products;

1.5. facility: site other than processing plants where animals or animal products might be handled, excluding retail premises.

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.

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.

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.

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

PROCEDURES

3. Preparation of the audit plan

In consultation with the auditee, the auditor should prepare an audit plan that covers the following points:

3.1. the subject, depth and scope of the audit;

3.2. the date and place of the audit, and the types of any establishments or facilities to be visited so that appropriate audit team members may be chosen;

3.3. a timetable up to and including the presentation of the final report;

3.4. the language or languages in which the audit will be conducted and the report written;

3.5. the identity of the members of the audit team, including the leader;

3.6. a schedule of meetings with officials and visits to establishments or facilities, including unannounced visits, as appropriate;

3.7. provisions for respect of commercial confidentiality and avoidance of conflicts of interest.

4. Opening meeting

An opening meeting should be held between representatives of both Parties. At this meeting the auditor will review the audit plan and confirm that adequate resources and documentation are available and all necessary arrangements have been made for conducting the audit.

5. Document review

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

- records concerning compliance programmes,

- inspection and internal audit reports,

- documentation concerning corrective actions and sanctions,

- records of compliance actions taken,

- sampling plans and their results,

- documents associated with verification,

- regulatory procedures followed by the auditee.

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 to conduct on-site verification should take into account factors such as the risks associated with the animals or animal products concerned, the history of conformity with requirements by the industry sector or exporting country, the volume of product produced and imported or exported, changes in infrastructure and the nature of the 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 is free to check other aspects of performance if deemed necessary.

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.

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:

- legislation,

- structure and operations of inspection and certification services,

- establishment and facility structure, layout, operations and working procedures,

- health statistics, sampling plans and results,

- compliance action and procedures,

- reporting and complaint procedures,

- training programmes.

9. Closing meeting

A closing meeting shall be held between representatives of both Parties, including officials responsible for the inspection and certification programmes of the auditee. At this meeting the auditor will present the findings of the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit are clearly understood.

10. Audit report

The auditor shall provide the auditee with a draft report of the audit generally within 60 days of the conclusion of the audit. To the extent possible, the report shall be presented in a standardised format to be agreed on by the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will assess the adequacy of the auditee's enforcement and control programme and identify any deficiencies noted during the conduct of the audit. Thereafter, the auditee may, within 60 days, comment on the draft report and shall describe any specific corrective actions that will be taken, preferably with target dates for completion. Any comments made by the auditee shall be included in the final report.

ANNEX VII

FRONTIER CHECKS

The Parties recognise the distinction between documentary, identity and physical checks carried out at external frontiers on imports of live animals and animal products.

The Parties further recognise the need to take a systematic approach to carrying out frontier checks.

Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of Annex C to the SPS Agreement.

Live animals

The Parties may apply physical checks to all consignments of live animals.

Animal products

In setting their physical checking frequencies for imports of animal products, the Parties shall take due account of the checks applied by the exporting Party prior to export and the historic performance of products imported from the exporting Party.

The Parties may modulate their physical checking frequencies for imports of animal products, notably in the light of progress made toward the recognition of equivalence under the consultative process provided for in Article 7.

ANNEX VIII

OUTSTANDING ISSUES

The Parties agree to work to further develop agreed arrangements concerning frontier checks, including the frequency of physical checks.

The Parties agree to work together on their respective arrangements concerning feed additives, animal feedingstuffs, medicated feeds and premixes.

ANNEX IX

CONTACT POINTS

The USA will send the information provided for in Article 10, and carry out the notifications provided for in Article 11, to:

Agricultural Counsellor

European Union

Delegation of the European Commission to the United States

2300 M Street NW

Washington DC 20037

Tel. 1 202 862 9560

Fax 1 202 429 1766

The Community will send the information provided for in Article 10, and carry out the notifications provided for in Article 11, to:

Agricultural Attaché

Office of Agricultural Affairs

US Mission of the European Union

40 Blvd du Regent

B-1000 Brussels

Tel. 32 2 508 2760

Fax 32 2 511 0918