1998A1421 — EN — 10.03.2006 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:









▼B

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: 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.

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Annexes







ANNEX I Product coverage ANNEX II Regulatory authorities ANNEX III List of diseases for which regional freedom is recognised ANNEX IV Zoning and regionalisation ANNEX V Recognition of sanitary measures ANNEX VI Guidelines for conducting an audit ANNEX VII Frontier checks ANNEX VIII Outstanding issues ANNEX IX Contact points

ANNEX I

PRODUCT COVERAGE







Tariff line General description (1) 01 Live animals 02 Meat and edible meat offal 03 Fish and crustaceans, molluscs and other aquatic invertebrates 04 Dairy produce; birds' eggs; natural honey; edible products of animal origin not elsewhere specified or included 05 Products of animal origin, not elsewhere specified or included, except for products of human origin 1501 Lard; other pig and poultry fat, rendered 1502 Fats of bovine animals, sheep or goats 1503 Lard stearin, lard oil, oleostearin, oleo-oil and tallow oil 1504 Fats and oils and their fractions, of fish and marine mammals 1505 Wool grease and fatty substances derived there from (including lanolin) 1506 Other animal fats and oils and their fractions 1516 10 Animal fats and oils and their fractions 1517 Margarine; edible mixtures or preparations of animal or vegetable fats or oils, except for such products consisting solely of vegetable fats or oils or their fractions 1518 Animal or vegetable fats and oils; inedible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, not elsewhere specified or included, except for such products consisting solely of vegetable fats or oils or their fractions 1522 Degras; residues resulting from the treatment of fatty substances or animal or vegetable waxes, except for such products consisting solely of material of non-animal origin 16 Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates 1702 10 Lactose and lactose syrup 1901 Malt extract; food preparations of flour, meal, starch or malt extract; food preparations of goods of heading Nos 0401 to 0404, not elsewhere specified or included; except for such products consisting solely of material of non-animal origin 1902 Pasta, whether or not cooked or stuffed (with meat or other substances) or otherwise prepared; couscous, whether or not prepared; except such products consisting solely of products of non-animal origin 2104 Soups and broths and preparations therefor; homogenised composite food preparations; except such products consisting solely of products of non-animal origin 2105 Ice cream and other edible ice, whether or not containing cocoa; except such products consisting solely of products of non-animal origin 2106 Food preparations not elsewhere specified or included; except such products consisting solely of products of non-animal origin 2301 Flours, meals and pellets, of meat or meat offal, of fish or of crustaceans, molluscs or other aquatic invertebrates, unfit for human consumption; greaves; except such products consisting solely of products of non-animal origin 2309 Preparations of a kind used in animal feeding; except such products consisting solely of products of non-animal origin 3001 Glands and other organs for organo-therapeutic uses; heparin and its salts; other animal substances prepared for therapeutic or prophylactic uses; except such products of human origin 3002 Animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products 3101 Animal or vegetable fertilisers, except such products consisting solely of products of non-animal origin 3501 Casein, caseinates and other casein derivatives; casein glues 3502 Albumins, albuminates and other albumin derivatives 3503 Gelatin and gelatin derivatives; isinglass; other glues of animal origin, excluding casein glues of heading No 3501 3504 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed 3507 Enzymes; except such products consisting solely of products of non-animal origin 4101 Raw hides and skins of bovine or equine animals 4102 Raw skins of sheep or lambs 4103 Other raw hides or skins 4301 Raw furskins 5101 Wool 5102 Fine or coarse animal hair 5103 Waste of wool or of fine or coarse animal hair 5105 Wool and fine or coarse animal hair 9705 Collections and collectors' pieces of zoological interest (1) For definitive description refer to tariff code.

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 (Commerce/NMFS).

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.







DOC/NMFS DOI/FWS FDA USDA/AMS USDA/APHIS USDA/FSIS A. Animal health certifications 1. Live animals (including apiculture bees), embryos, ova, semen, and products of animal origin × 2. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova × × 3. Salmonid live fish, gametes, and fertilised ova × × × 4. Wild waterfowl × 5. Animal feed × × B. Public health certifications 1. Meat and poultry for human consumption (a) Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and domesticated and farmed chickens, turkeys, ducks, geese, and guinea fowl × (b) Snakes × × (c) Fresh meat and products from species other than above × × 2. Eggs (a) Shell eggs, hard cooked eggs, ethnic egg delicacies, and imitation egg products × × (b) Liquid, frozen and dried egg products × 3. Dairy (a) Butter, cheese, frozen desserts, and dried milk products × × (b) Fluid milk × 4. Seafood (a) Fish and fishery products including fish oil, reptiles (except snakes), snails and amphibians × × (b) Live fish (including shellfish and molluscs) × ×

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.

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







Yes (1) The importing Party agrees that the exporting Party's measures achieve the importing Party's appropriate level of sanitary protection. Yes (2) The importing Party agrees that the exporting Party's measures, with the special conditions set out, achieve the importing Party's appropriate level of sanitary protection. Yes (3) Equivalence agreed in principle, subject to satisfactory completion of the actions. Pending completion, trade shall occur on the basis of the special conditions set out. NE Not evaluated. Trade shall occur on the basis of compliance with the importing Party's requirements. E Still evaluating. Trade shall occur on the basis of compliance with the importing Party's requirements. AI Avian influenza ASF African swine fever BSE Bovine spongiform encephalopathy CEM Contagious equine metritis CFR Code of Federal Regulations CSF Classical swine fever (hog cholera) EBL Enzootic bovine leucosis EC European Community EPIA Egg Products Inspection Act FFDCA Federal Food, Drug and Cosmetics Act FIFRA Federal Insecticide, Fungicide and Rodenticide Act FMD Food and mouth disease IBR Infectious bovine rhinotracheitis ND Newcastle disease OIE Office International des Epizooties PHSA Public Health Service Act PM Post mortem ScVC Scientific Veterinary Committee SVD Swine vesicular disease TB Bovine tuberculosis TME Transmissible mink encephalopathy TSE Transmissible spongiform encephalopathy USA United States of America WTO World Trade Organisation







— Commodity — Species — Animal/public health European Community exports to the United States United States exports to the European Community Trade conditions Equiv. (Cat.) Special conditions Actions Trade conditions Equiv. (Cat.) Special conditions Actions EC standards US standards US standards EC standards 1. Live animals Animal health — Equidae 90/426 Annexes B and C 9 CFR 92 E EC to submit for each EC laboratory the testing procedures, antigens/reagents used, audit/quality control programme, external control/laboratory approval programme. Inter-laboratory reference testing and exchange of samples between designated EC and US laboratories for CEM, glanders, dourine, piroplasmosis, equine infectious anaemia and equine viral arteritis to be carried out within three months of the entry into force of this Agreement. US to consider, within five months of the entry into force of this Agreement, withdrawing requirement for post-import quarantine on the bases of results. US to assess EC request on disease status for dourine and glanders within three months of EC submission. US to review their CEM and piroplasmosis requirements within three months of the entry into force of this Agreement. 9 CFR 71, 75, 91 90/426 92/260 93/195 93/196 93/197 94/467 E US to consider identifying horses by passport from 31.12.1997. EC to consider withdrawing requirement for isolation before departure for permanent imports within six months of the submission of the final report on VS outbreak. — Bovine animals 64/432 72/462 90/425 9 CFR 92 E US to review BSE policy with respect to high and low incidence. US to produce generic conditions for EC. 9 CFR 71, 72, 73, 77, 78, 80, 91 72/462 E EC to review US dossier on bluetongue. US to provide details of RB51 brucellosis vaccine, for review by EC. EC to produce conditions for US. — Sheep/goats 91/68 9 CFR 92 E US to produce generic conditions for EC. 9 CFR 54, 71, 79, 77 91/68 97/231 E EC to review US dossier on bluetongue. US to submit scrapie programme when final review is completed. EC to comment. EC to produce conditions for US. — Swine 64/432 72/462 90/425 9 CFR 92 E US to produce generic conditions for EC. 9 CFR 71, 76, 77, 78, 85 72/462 E EC to produce conditions for US. — Dogs and cats 92/65 9 CFR 92 NE 92/65 NE — ‘Balai’ animals 92/65 9 CFR 92 NE 92/65 NE 2. Live poultry and hatching eggs Animal health 90/539 93/342 9 CFR 92 E US to produce generic conditions. 9 CFR 71, 82, 145, 147 90/539 93/432 96/482 96/483 E 3. Semen Animal health — Bovine 88/407 9 CFR 98 E US to produce generic conditions for EC. 9 CFR 71, 77, 78 88/407 94/577 E EC to produce conditions to allow use of new elisa test kit for bluetongue. EC to consider allowing movement between centres in two approved third countries. — Sheep/goats 92/65 9 CFR 98 E US to produce generic conditions for EC. 9 CFR 71, 79 Directive 92/65 NE — Porcine 90/429 9 CFR 98 E US to produce generic conditions for EC. 9 CFR 71, 78, 85 90/429 93/199 E EC to examine US request that CSF tests not be required on entry and exit from centres in countries free of the disease. — Canine 92/65 9 CFR 98 NE 92/65 NE — Feline 92/65 NE 92/65 NE 4. Equine semen, ova and embryos Animal health — Semen 92/65 95/307 9 CFR 98 NE 9 CFR 71, 75 92/65 96/539 NE — Ova 92/65 95/294 9 CFR 98 NE 9 CFR 71, 75 92/65 96/540 NE — Embryos 92/65 95/294 9 CFR 98 NE 9 CFR 71, 75 92/65 96/540 NE 5. Embryos Animal health — Bovine 89/556 9 CFR 98 E US to produce generic conditions for EC. US to review suspension of imports from BSE affected countries. 9 CFR 71, 77, 78 89/556 92/471 E — Ovine/caprine 92/65 9 CFR 98 NE 92/65 NE ▼M2 6. Fresh meat Animal health — Ruminants 64/432 72/461 72/462 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries US to review rules on BSE with respect to high/low incidence regions 9 CFR 53 (in the case of an outbreak of exotic disease) 72/462 82/426 Yes 2 Three month residence Holding freedom from brucellosis for ovines and caprines — Equidae 64/432 72/461 72/462 9 CFR 94 Yes 1 9 CFR 53 72/462 82/426 Yes 2 Three month residence — Porcine animals 64/432 72/461 72/462 9 CFR 94 Yes 1 9 CFR 53 72/462 82/426 Yes 2 Three month residence Holding freedom from brucellosis Public health Ruminants (8) Equidae Porcine Ovine Caprine Ruminants (8) Equidae Porcine Ovine Caprine (cont’d) 64/433 96/22 96/23 9 CFR 301-381, 416, 417 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1) Testing for Enterobacteriaceae and total viable count carried out as per Decision 2001/471/EC of 8 June 2001, except that: — random sampling must be carried out throughout the slaughter period — the four sample collection sites for cattle, swine, sheep, goats and horses cannot be changed from those specified in Decision 2001/471/EC of 8 June 2001 Equivalency (Yes 2) shall be granted after the US has completed verification of veterinary delivery systems This process shall be completed within 12 months of the date of entry into force of this Agreement 9 CFR 301-381, 416, 417 72/462 93/158 96/22 96/23 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3), (4) and (5) The EC shall evaluate the US residue programme, and additional information to be submitted by the US, to determine whether it meets the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement The EC shall evaluate the US water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC to evaluate a US request, when submitted, on the need for continued trichinae testing of horsemeat. Regarding footnote 5(e), the results of the inspections after incision of pig hearts shall be jointly evaluated after 12 months, with a view to determining if modifications should be made to the provisions of footnote 5(e). Equivalency (Yes 2) shall be granted after the EC has completed verification of the application of the specified conditions. This process shall be completed within 12 months of the entry into force of this Agreement. ▼B 7. Poultry meat Animal health 91/494 94/438 9 CFR 94 Yes 1 9 CFR 53 91/494 93/342 94/984 Yes 1 Public health 71/118 96/22 96/23 9 CFR 381 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). Post-mortem inspection to be carried out by official inspectors. Equivalency (Yes 2) shall be granted after the US has completed verification of veterinary delivery systems. This process shall be completed within 12 months of the date of entry into force of the Agreement. 9 CFR 381.1—381.5 71/118 96/22 96/23 96/712 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3), (4) and (6). The EC shall evaluate the US residue programme, and additional information to be submitted by the US to determine whether it meets the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC shall evaluate the US water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC shall carry out a scientific review of the use of antimicrobial techniques, and in particular the use of TSP and/or organic acids, with full participation of US scientists. The scientific review should be completed as soon as possible. Equivalency (Yes 2) shall be granted after the EC has completed verification of the application of the specified conditions. This process shall be completed within 12 months of the entry into force of this Agreement. 8. Meat products Animal health — Red meat (ruminants/equidae) 64/432 72/461 72/462 80/215 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. US to review rules on BSE with respect to high/low incidence regions. 9 CFR 53 72/462 97/221 Yes 2 Derived from meat meeting the conditions of point 6 (fresh meat). — Pigs 64/432 72/461 72/462 80/215 9 CFR 94 Yes 1 9 CFR 53 72/462 97/221 Yes 2 Derived from meat meeting the conditions of point 6 (fresh meat). — Poultry 92/118 72/462 80/215 94/438 9 CFR 94 Yes 1 9 CFR 53 97/221 Yes 2 Derived from meat meeting the conditions of point 7 (poultry meat). — Wild game and farmed game 92/495 92/45 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. US to review rules on BSE with respect to high/low incidence regions. 92/495 92/45 97/221 NE Public health Ruminants (8) Equidae Pigs Poultry 77/99 96/22 96/23 CFR 301—335, 354, 381.1—381.500 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). Equivalency (Yes 2) shall be granted after the US has completed verification of veterinary delivery systems. This process shall be completed within 12 months of the date of entry into force of this Agreement. 9 CFR 301—335, 354, 381.1—381.500 72/462 77/99 92/118 96/22 96/23 Yes 3 Derived from meat meeting the conditions of point 6 (fresh meat) and/or 7 (poultrymeat). Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3) and (4). The EC shall evaluate the US residue programme, and additional information to be submitted by the US, to determine whether it meets the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC shall evaluate the US water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. Equivalency shall be granted after the EC has completed verification of the application of the specified conditions. This process shall be completed within 12 months of the entry into force of this Agreement. Wild game (8) Farmed game (8) 77/99 96/22 96/23 FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 114, 170—189, 510—529, 556 40 CFR 180, 185 NE Existing trade conditions. FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 114, 170—189, 510—529, 556 40 CFR 180, 185 77/99 92/118 96/22 96/23 NE 9. Farmed game meat Animal health — Deer — Rabbit 72/461 92/118 91/495 9 CFR 94 Yes 2 Yes 1 Additional certification from BSE affected countries. US to review rules on BSE with respect to high/low incidence regions. 92/118 91/495 97/219 NE — Porcine 72/461 92/118 91/495 9 CFR 94 Yes 1 92/118 NE — Feathered 92/118 72/462 80/215 94/438 9 CFR 94 Yes 1 9 CFR 94 92/118 97/219 NE Public health See footnote (8) for ruminants 91/495 96/22 96/23 97/219 FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 170—189, 510—529, 556 40 CFR 180, 185 9 CFR 301—335, 352, 354 NE Existing trade conditions. FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 170—189, 510—529, 556 40 CFR 180, 185 9 CFR 301—335, 352, 354 91/495 96/22 96/23 97/219 NE 10. Wild game meat Animal health — Deer — Rabbit 92/45 9 CFR 94 E 92/45 97/218 NE — Porcine 92/45 9 CFR 94 E 92/45 97/220 NE — Feathered 92/45 9 CFR 94 E 92/45 97/218 NE Public health See footnote (8) for ruminants 92/45 96/22 96/23 97/218 97/220 FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 170—189, 510—529, 556 9 CFR 301—335 40 CFR 180, 185 NE Existing trade conditions. FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 170—189, 510—529, 556 9 CFR 301—335 40 CFR 180, 185 92/45 96/22 96/23 97/218 97/220 NE ▼M3 11. Fisheries products for human consumption Animal health — Fish/fisheries products 91/67 USDI & Title 50 NE USDI & Title 50 91/67 NE EC to evaluate new US standards if applicable. — Bivalve molluscs/crustaceans (excl. live) 91/67 USDI & Title 50 NE USDI & Title 50 91/67 NE Public health — Fish/fisheries products 91/493 96/22 96/23 21 CFR 123, 1240 FFDCA, FIFRA, PHSA, 21 CFR 70-82, 180, 110.3-110.93, 113, 114, 123, 172-193, 1240 Yes 3 Low-acid canned food requirement. US to provide a detailed indication of how the EC request for equivalence for low-acid canned food can be considered. EC to provide (1) appropriate information and documentation on procedures for audit and control of implementation by Member States, and (2) information on application of HACCP systems in Member States. 21 CFR 123, 1240 FFDCA, FIFRA, PHSA, 21 CFR 70-82, 180, 110.3-110.93, 113, 114, 123, 172-193, 1240 91/493 96/22 96/23 Yes 2 [SANCO/10169/2005] Rev 3 — Fish/fisheries products (cont’d) US to conduct on-site verification of EC system (including visit to EC central offices and observation of Commission audits of a number of Member States). US to indicate any outstanding problems following above actions. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. NMFS Voluntary HACCP based programme 50 CFR 260 Yes 1 — Bivalve molluscs/crustaceans (excl. live) 91/492 National shellfish sanitation programme Yes 3 Existing trade conditions. EC to supply the raw data used for the scientific assessment on flesh/water testing. US shall respond to results of scientific assessment within 90 days of receipts of raw data. EC to provide (1) appropriate information and documentation on procedures for audit and control of implementation by Member States, and (2) information on application of HACCP systems in Member States. US to conduct on-site verification of EC system (including visit to EC central offices and observation of Commission audits of a number of Member States). US to indicate any outstanding problems following above actions. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. National shellfish sanitation programme 91/492 Yes 3 Existing trade conditions. Joint comparison of flesh/water testing for classification of production areas. US to inform the EC when the US is ready to have the implementation of its seafood HACCP Regulation reviewed. EC to carry out review, involving as necessary examination of information and documentation to be provided by US on procedures for audit and control of implementation. On-site verification of US system to be carried out within six months of US request. EC to indicate any outstanding problems following above actions within 45 days of on-site verification. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. ‘Establishments’ do not include ‘brokers or traders’. — Aquaculture animals and products 91/493 96/22 96/23 National shellfish sanitation programme, FFDCA, FIFRA, PHSA, 21 CFR 110.3-110.93, 123, 1240, DVM NE National shellfish sanitation programme, FFDCA, FIFRA, PHSA, 21 CFR 110.3-110.93, 123, 1240, DVM 91/493 96/22 96/23 NE ▼B 12. Live fish/shellfish and gametes Animal health 91/67 NE 91/67 NE 13. Milk and milk-based products for human consumption Animal health — Cattle including buffalo — Sheep — Goats 64/432 92/46 9 CFR 94 Yes 2 Certification to UHT for FMD affected regions. For non-FMD affected countries/regions a certificate of origin is required. US to review whether double pasteurisation acceptable. 9 CFR 77, 78 92/46 95/343 Yes 2 TB and Brucella requirements for non-heat treated. EC to review US TB and brucella programmes. Public health — UHT-milk/sterilised Milk 92/46 94/71 95/340 95/342 96/22 96/23 97/115 91/180 92/608 92/118 96/90 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 131, 133, 135, 172, 184, 510—520, 556, 1210, 1240 40 CFR 180, 185 Yes 3 Existing trade conditions. US to review Import Milk Act. US to provide a detailed indication of how the EC request for equivalence for low-acid canned food can be considered. Joint assessment of laboratories to be completed. EC to provide appropriate information and documentation on procedures for audit and control of implementation by Member States. US to review information provided, and to carry out on-site verification of EC system. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 131, 133, 135, 172, 184, 510—520, 556, 1210, 1240 40 CFR 180, 185 92/46 94/71 95/340 95/342 95/343 96/22 96/23 97/115 91/180 92/608 92/118 96/90 Yes 3 EC requirements for somatic cell and plate counts certification as per 95/343. US to consider including HACCP system in dairy products. Joint assessment of laboratories to be completed. Discussions on somatic cells and plate counts to continue. US to provide appropriate information and documentation on procedures for audit and control of implementation. EC to review information provided, and to carry out on-site verification of US system. The outcome of the on-site verification to be discussed with US. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. Pasteurised milk Ordinance for grade A products and related documents. The US to provide a detailed indication of how the EC request for equivalence to ‘grade A’ can be considered, and thus to allow the possibility of export of such products to the US. Pasteurised milk Ordinance for grade A products and related documents. — Pasteurised products 92/46 94/71 95/340 95/342 96/22 96/23 97/115 91/180 92/608 92/118 96/90 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 131, 133, 135, 172, 184, 510—520, 556, 1210, 1240 40 CFR 180, 185 Yes 3 Existing trade conditions. E coli requirement (for cheeses). US to review Import Milk Act. Discussions on differences in finished product criteria for E-coli to continue. Joint assessment of laboratories to be completed. EC to provide appropriate information and documentation on procedures for audit and control of implementation by Member States. US to review information provided, and to carry out on-site verification of EC system. The outcome of the on-site verification to be discussed with US. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 131, 133, 135, 172, 184, 510—520, 556, 1210, 1240 40 CFR 180, 185 92/46 94/71 95/340 95/342 95/343 96/22 96/23 97/115 91/180 92/608 92/118 96/90 Yes 3 EC requirements for somatic cell and plate counts certification as per 95/343. US to consider including HACCP system in dairy products. Joint assessment of laboratories to be completed. Discussions on somatic cells and plate counts to continue. US to provide appropriate information and documentation on procedures for audit and control of implementation. EC to review information provided, and to carry out on-site verification of US system. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. Pasteurised milk Ordinance for grade A products and related documents. The US to provide a detailed indication of how the EC request for equivalence to ‘grade A’ can be considered, and thus to allow the possibility of export of such products to the US. Pasteurised milk Ordinance for grade A products and related documents. — Not pasteurised (raw or thermised) 92/46 94/71 95/340 95/342 97/115 91/180 92/608 92/118 96/22 96/23 96/90 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110, 113, 133, 172, 184, 185, 510—520, 556, 1240 40 CFR 180 Yes 3 Compliance with E-coli requirement (for cheeses). Discussions on differences in finished product criteria for E-coli to continue. Joint assessment of laboratories to be completed. EC to provide appropriate information and documentation on procedures for audit and control of implementation by Member States. US to review information provided, and to carry out on-site verification of EC system. The outcome of the on-site verification to be discussed with EC. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110, 113, 133, 172, 184, 185, 510—520, 556, 1240 40 CFR 180 92/46 94/71 95/340 95/342 95/343 97/115 91/180 92/608 92/118 96/22 96/23 96/90 Yes 3 Compliance with EC requirements for somatic cell and plate counts certification as per 95/343. US to consider including HACCP system in dairy products. Joint assessment of laboratories to be completed. Discussions on somatic cells and plate counts to continue. US to provide appropriate information and documentation on procedures for audit and control of implementation. EC to review information provided, and to carry out on-site verification of US system. The outcome of the on-site verification to be discussed with US. If on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. Prohibition on products not matured for more than 60 days at temperature above 35 °F (+2°C). The US to consider a dossier, to be submitted by the EC, for cheese not matured for more than 60 days, and thus to allow the possibility of export of such products to the US. 14. Milk and milk-based products not for human consumption Animal health — Cattle including buffalo — Sheep — Goats All pasteurised or UHT or sterilised 92/118 64/432 9 CFR 94.16 Yes 2 For non-FMD affected regions, a certificate of origin is required. For FMD affected regions, certification to UHT. US to review if double pasteurisation of products from FMD affected regions is acceptable. 9 CFR 77, 78 92/118 95/341 NE — Unpasteurised colostrum for pharmaceutical use (10) 92/118 9 CFR 94.16 NE 9 CFR 77, 78 92/118 NE 15. Minced meat Animal health — Ruminants 64/432 72/461 72/462 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. US to review rules on BSE with respect to high/low incidence regions. 72/462 NE — Pigs 64/432 72/461 72/462 9 CFR 94 Yes 1 72/462 NE Public health Ruminants (8) Pigs 94/65 9 CFR 301—381 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1) Equivalency shall be granted after the US has completed verification of veterinary delivery systems. This process shall be completed within 12 months of the date of entry into force of this Agreement. 9 CFR 301—381 94/65 97/29 Yes 3 Derived from meat meeting the conditions of point six (fresh meat). Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3) and (4). The EC shall evaluate the US residue programme, and additional information to be submitted by the US, to determine whether it meets the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC shall evaluate the US water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. Equivalency (Yes 2) shall be granted after the EC has completed verification of the application of the specified conditions. This process shall be completed within 12 months of the entry into force of this Agreement. EC to consider reviewing scope of definition of minced meat. 16. Meat preparations Animal health — Ruminants — Equidae 64/432 72/461 72/462 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. US to review rules on BSE with respect to high/low incidence regions. 72/462 NE — Pigs 64/432 72/461 72/462 9 CFR 94 Yes 1 72/462 NE — Poultry/Wild game/ Farmed game 92/118 72/462 80/215 94/438 9 CFR 94 Yes 1 91/494 93/342 94/984 NE Public health Ruminants (8) Equidae Pigs Poultry 94/65 9 CFR 301—381 Yes 2/3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). Equivalency shall be granted after the US has completed verification of veterinary delivery systems. This process shall be completed within 12 months of the date of entry into force of this Agreement. 9 CFR 301—381 94/65 97/29 Yes 3 Derived from meat meeting the conditions of point 6 (fresh meat) and/or 7 (poultry meat). Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3) and (4). The EC shall evaluate the US residue programme, and additional information to be submitted by the US, to determine whether it meets the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. The EC shall evaluate the US water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within six months of the entry into force of this Agreement. Equivalency shall be granted after the EC has completed verification of the application of the specified conditions. This process shall be completed within 12 months of the entry into force of this Agreement. Wild game (8) Farmed game (8) 94/65 FIFRA, FFDCA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 170—189, 510—529, 556 40 CFR 180, 185 NE Existing trade conditions FIFRA, FFDCA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 170—189, 510—529, 556 40 CFR 180, 185 94/65 NE 17. Animal casings for human consumption Animal health — Cattle 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)) No trade allowed for countries affected by BSE. US to review rules on BSE with respect to high/low incidence regions. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE — Pigs 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). Certification attesting to process and origin for casings originating in ASF free countries/regions but processed in ASF affected country/region. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE — Sheep — Goats 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). No trade allowed for countries affected by BSE. Certification attesting to process and country of origin for casings originating in BSE free countries but processed in BSE affected country. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE Public health 77/99 FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 114, 170—189, 510—529, 556 40 CFR 180, 185 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110.3—110.93, 113, 114, 170—189, 510—529, 556 40 CFR 180, 185 77/99 92/118 Draft Decision notified to WTO. NE 18. Animal casings not for human consumption Animal health — Cattle 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). No trade allowed for countries affected by BSE. US to review rules on BSE with respect to high/low incidence regions. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE — Pigs 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). Certification attesting to process and origin for casings originating in ASF free countries/regions but processed in ASF affected country/region. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE — Sheep — Goats 92/118 64/432 72/461 72/462 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). No trade allowed for countries affected by BSE. Certification attesting to process and country of origin for casings originating in BSE free countries but processed in BSE affected country. US to review 94.8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE 19. Hides and skins Animal health — Cattle — Sheep — Goats — Pigs 92/118 72/461 72/462 9 CFR 95.5, 95.6 Yes 1 92/118 97/168 E EC to identify basis for salting requirement. 20. Canned petfood containing high/low risk material — Containing mammalian material 92/118 90/667 92/562 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Special rules for BSE countries. Shelf stable for remainder. US to review rules on BSE with respect to high/low incidence regions. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 E EC to examine US claim to be BSE free. EC to consider alternative guarantees for mammalian material, including US proposal to remove all risk material of known US TSE species from petfood. — Containing only non-mammalian material 92/118 90/667 92/562 99 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Shelf stable for remainder. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 E Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. 21. Canned petfood containing only low risk material — Containing mammalian material 92/118 90/667 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Special rules for BSE countries. Shelf stable for remainder. US to review rules on BSE with respect to high/low incidence regions. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 E — Containing only non-mammalian material 92/118 90/667 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Shelf stable. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 E Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. 22. Dry and semi moist petfood containing only low risk material 92/118 94/309 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Restrictions for BSE countries. US to examine EC 90 °C core temperature requirement as providing sufficient guarantees against FMD, CSF, SVD, ASF and ND. US to review rules on BSE. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 E Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. 23. Dry and semi moist petfood containing high/low risk material — Containing mammalian material 92/118 94/309 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Restrictions for BSE countries. US to examine EC 90 °C core temperature requirement as providing sufficient guarantees against FMD, CSF, SVD, ASF and ND. US to review rules on BSE with respect to high/low incidence regions. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/344 96/449 97/199 E EC to examine US claim to be BSE free. EC to consider alternative guarantees for mammalian material, including US proposal to remove all risk material of known US TSE species from petfood. — Containing only non-mammalian material 92/118 94/309 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 1 US to examine EC 90 °C core temperature requirement as providing sufficient guarantees against ND. FFDCA, FIFRA 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 94/344 97/199 E Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. 24. Bones and bone products for human consumption (‘other products’ as defined in Directive 77/99/EEC) Animal health Fresh meat (ruminants, horses, pigs) 64/432 72/461 80/215 72/462 9 CFR 95 Yes 2 Restrictions for BSE countries. US to review rules on BSE with respect to high/low incidence regions. 72/462 97/221 NE Farmed game — Pigs, deer 91/495 9 CFR 95 Yes 2 Restrictions for BSE countries. US to review rules on BSE with respect to high/low incidence regions. 91/495 NE Fresh meat — Poultry 92/118 80/215 72/462 94/438 9 CFR 95 Yes 1 92/118 NE Feathered, farmed and wild game 92/45 91/495 9 CFR 95 Yes 1 92/45 91/495 NE Wild game — Pigs, deer 92/45 9 CFR 95 Yes 2 Restrictions for BSE countries. US to review rules on BSE with respect to high/low incidence regions. 92/45 NE Public health All species (8) 77/99 92/118 9 CFR 95 NE 77/99 92/118 NE EC to consider establishing conditions. Feathered, farmed and wild game (8) 64/433 77/99 92/118 FIFRA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 NE FIFRA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 77/99 92/118 Draft Decision notified to WTO. NE 25. Bones, horns and hooves and their products not for human consumption Animal health 96/239 9 CFR 95 Yes 1 9 CFR 53 94/446 NE 26. Processed animal protein for human consumption Animal health Fresh meat (ruminants, equidae, pigs) 64/432 72/461 80/215 72/462 9 CFR 95 Yes 2 Not accepted from BSE countries. US to review rules on BSE with respect to high/low incidence regions. 72/462 97/221 NE EC to examine US claim to be BSE free. EC to consider alternative guarantees for mammalian material, including US proposal to remove all risk material of known US TSE species from petfood. Farmed game — Pigs, deer 91/495 9 CFR 95 Yes 2 Not accepted from BSE countries. US to review rules on BSE with respect to high/low incidence regions. 91/495 NE Fresh meat — Poultry 92/118 80/215 72/462 94/438 9 CFR 95 Yes 1 92/118 NE Feathered, farmed and wild game 92/45 91/495 9 CFR 95 Yes 1 92/45 91/495 NE Wild game — Pigs, deer 92/45 9 CFR 95 Yes 2 Not accepted from BSE countries. US to review rules on BSE with respect to high/low incidence regions. 92/45 NE Public health All species (8) 77/99 92/118 Yes 1 77/99 92/118 NE Feathered, farmed and wild game (8) 77/99 FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 NE FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 77/99 92/118 Draft Decisions notified to WTO. NE 27. Processed animal protein not for human consumption Containing material of mammalian origin Ruminants 92/118 90/667 9 CFR 95 FIFRA, FFDCA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 2 Not accepted from BSE countries. US to review rules on BSE with respect to high/low incidence regions. FIFRA, FFDCA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 90/667 92/118 92/562 94/344 96/449 97/198 NE EC to examine US claim to be BSE free. EC to consider alternative guarantees for mammalian material, including US proposal to remove all risk material of known US TSE species from petfood. Non-ruminants 92/118 90/667 9 CFR 95 FIFRA, FFDCA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 Yes 3 FIFRA, FFDCA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 92/118 90/667 96/449 NE Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. Containing only material of non-mammalian origin Poultry and fish 92/118 90/667 9 CFR 95 Yes 1 90/667 92/118 92/562 94/344 97/198 NE Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. Non-ruminants 92/118 90/667 9 CFR 95 Yes 1 92/118 90/667 NE 28. Serum of equidae Animal health 92/118 94/143 9 CFR 95, 122 NE 92/118 94/143 NE 29. Blood and blood products intended for human consumption Animal health Fresh meat (ruminants, equidae, pigs) 64/432 72/461 80/215 72/462 9 CFR 95, 122 E BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. US to produce generic conditions for EC. 9 CFR 53 72/462 97/221 NE Farmed game — Pigs, deer 91/495 9 CFR 95, 122 Yes 2 BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. 91/495 NE Fresh meat — Poultry 92/118 80/215 72/462 94/438 9 CFR 95, 122 Yes 1 92/118 NE Feathered, farmed and wild game 92/45 91/495 9 CFR 95, 122 Yes 1 92/45 91/495 NE Wild game — Pigs, deer 92/45 9 CFR 95, 122 Yes 1 92/45 NE Public health 77/99 9 CFR 301—381, 416, 417 FFDCA, FIFRA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 NE 9 CFR 301—381, 416, 417 FFDCA, FIFRA, 21 CFR 110.3—110.93, 507—509, 570, 573—589 77/99 92/118 Draft Decision notified to WTO. NE EC to consider establishing conditions. 30. Blood and blood products not intended for human consumption Animal health 92/183 92/118 9 CFR 95.4, 122 Yes 2 BSE rules for ruminants. Permit required. US to review rules on BSE with respect to high/low incidence regions. 9 CFR 53 92/183 92/118 Yes 2 Bluetongue treatment requirements. EC to consider use of tests for bluetongue in place of treatment. 31. Lard and rendered fats intended for human consumption Animal health Fresh meat (ruminants, horses, pigs) 64/432 72/461 80/215 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. 72/462 97/221 NE Farmed game — Pigs, deer 91/495 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. 91/495 NE Fresh meat — Poultry 92/118 80/215 94/438 9 CFR 95 Yes 1 92/118 NE Feathered, farmed and wild game 92/45 91/495 9 CFR 95 Yes 1 92/45 91/495 NE Wild game — Pigs, deer 92/45 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. 92/45 NE Public health All species (8) 77/99 92/118 NE 77/99 92/118 NE Feathered, farmed and wild game (8) 77/99 9 CFR 301—381, 416, 417 FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 NE 9 CFR 301—381, 416, 417 FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110.3—110.93, 113, 170—189, 510—529, 556 77/99 92/118 Draft Decision notified to WTO. NE 32. Lard and rendered fats not intended for human consumption 92/118 90/667 72/461 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on BSE with respect to high/low incidence regions. 92/118 Draft Decision notified to WTO. NE EC to review requirements to consider inclusion of alternative heat treatment systems. EC to review US bacteriological testing regime for protein fraction. 33. Raw material for feeding stuffs, pharmaceutical or technical use Animal health 92/118 9 CFR 95, 122 Yes 1 9 CFR 53 92/118 E EC to consider laying down certification requirements for imports. 34. Apiculture products for apiculture Animal health 92/118 E 92/118 94/860 NE 35. Game trophies Animal health 92/118 9 CFR 95 Yes 1 9 CFR 53 92/118 96/590 E 36. Manure Animal health 92/118 9 CFR 95 E US to provide temperature requirements for manure from regions affected by serious transmissible disease. 9 CFR 53 92/118 E 37. Wool, feathers and hair Animal health — Wool 92/118 9 CFR 95 Yes 1 9 CFR 53 92/118 NE — Pig bristles 92/118 9 CFR 95 Yes 1 9 CFR 53 92/118 94/435 NE Public health FFDCA, PHSA 21 CFR 1240.70 NE FFDCA, PHSA 21 CFR 1240.70 NE 38. Honey Animal health NE NE Public health 92/118 FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110.3—110.93, 520.182, 520.1660d NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110.3—110.93, 520.182, 520.1660d 92/118 NE 39. Frogs' legs Animal health Public health 92/118 96/340 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 114, 123, 1240 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 114, 123, 1240 92/118 96/340 NE EC to review US HACCP rules when submitted. 40. Snails for human consumption Animal health Public health 92/118 96/340 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 114, 123, 1240 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110.3—110.93, 113, 114, 123, 1240 92/118 96/340 NE 41. Egg products for human consumption Animal health 90/539 9 CFR 94 Yes 2 Permit required from areas affected by Newcastle disease. US to review permit requirement. 90/539 93/342 Yes 1 Public health 89/437 91/684 92/118 96/23 7 CFR 59 EPIA Public Law 91-597 E US to supply information on the legal basis for recognition of equivalence. US to complete assessment of EC public health legislation. 7 CFR 59 EPIA Public Law 91-597 89/437 91/684 92/118 96/23 97/38 E Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnote (2). The following tests are to be conducted, as specified in Annex VI to Directive 89/437, on US egg products for dispatch to Europe: Chemical tests — 3 OH butyric acid — lactic acid — succinic acid — egg shell remains, egg membrane, other particles. Bacteriological tests — mesophile counts — enterobacteriaceae — salmonella — staphylococcus Methods Internationally recognised methods such as: ISO, NMKL, AOAC. EC to complete assessment of US public health legislation. 42. Shell eggs Animal health 90/539 9 CFR 94 Yes 2 Permit required from areas affected by Newcastle disease. US to review permit requirement. 9 CFR 94 90/539 93/342 Yes 1 Public health 89/437 91/684 94/371 96/23 FFDCA, FIFRA, PHSA, EPIA 21 CFR 5.10(a)(4) and (a)(13), 70—82, 100.135, 110.3—110.93, 172.140, 172.882, 182.884, 178, 520, 524, 556, 558, 1240 40 CFR 180 7 CFR 56 E US to review legal basis for recognition of equivalence. US to complete assessment of EC public health legislation. FFDCA, FIFRA, PHSA, EPIA 21 CFR 5.10(a)(4) and (a)(13), 70—82, 100.135, 110.3—110.93, 172.140, 172.882, 182.884, 178, 520, 524, 556, 558, 1240 40 CFR 180 7 CFR 56 89/437 91/684 94/371 96/23 E Footnote (4). EC to complete assessment of US public health legislation. ▼M1 43. Gelatin for human consumption Animal health 92/118 9 CFR 93, 94, 95, 309, 310, 311 NE 9 CFR 93, 94, 95, 309, 310, 311 92/118 Yes (2) (SANCO/10451/2003 Rev. 1 Draft Commission Decision on health certificates for the importation of animal products from the United States) Public health 92/118 FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.110, 570, 573-589 NE FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.110, 570, 573-589 92/118 Yes (2) (SANCO/10451/2003 Rev. 1 Draft Commission Decision on health certificates for the importation of animal products from the United States) 44. Gelatin for technical use Animal health 1774/2002 9 CFR 94 NE 9 CFR 94 1774/2002 NE Public health 1774/2002 FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.93, 570, 573-589 NE FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.93, 570, 573-589 1774/2002 NE 45. Collagen for human consumption Animal health 92/118 9 CFR 94 NE 9 CFR 93, 94, 95, 309, 310, 311 92/118 Yes (2) (SANCO/10451/2003 Rev. 1 Draft Commission Decision on health certificates for the importation of animal products from the United States) Public health 92/118 FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.93, 570, 573-589 NE FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110.3-110.93, 570, 573-589 92/118 Yes (2) (SANCO/10451/2003 Rev. 1 Draft Commission Decision on health certificates for the importation of animal products from the United States).

▼M2

FOOTNOTE 1

The pathogen reduction: hazard analysis and critical control point (HACCP) systems; final rule was published at 61 Federal Register 38806—38989 and amends various provisions of CFR parts 304, 310, 320, 327, 381, 416 and 417.

Provisions on SSOPs applicable.

The USA and the EC shall discuss, well in advance of their date of implementation, the staged elements in the above rule to determine whether any further special conditions are needed.

▼B

FOOTNOTE 2

Horizontal issues, fresh meat, meat products, game meat, poultry meat, minced meat, meat preparations, egg products

(a) Packaging material

Packaging material shall be kept in separate rooms that are used exclusively for this purpose and free of dust and vermin.

Packaging material shall not be stored on the floor.

Waxed assembled boxes shall not be nested, unless a liner is added.

Assembled boxes with liners shall not be nested.

Boxes shall not be handled by personnel who are handling exposed product.

Boxes shall be assembled in a sanitary manner, either in a separate room or, if on the cutting room floor, never within 3 metres of exposed product.

(b) Facility requirements for light coloured walls and cove molding

Walls shall be smooth, durable, impermeable, and of a colour which permits detection of insanitary conditions.

Walls shall have washable surfaces.

Walls and floor junctures shall be constructed and maintained so as to assure that surfaces are clean and free of contamination. Establishments that do not use cove molding to provide a smooth transition from floor to wall to facilitate cleaning must provide an equivalent alternative means, such as sealing of cracks between walls and floors, to maintain sanitary conditions.

(c) Medical certification by a medical doctor

Prior to employment, new employees shall be examined by a medical doctor or by another medically qualified person who is sufficiently trained to identify communicable diseases and working under the supervision of a medical doctor.

Establishments shall have in place an appropriate programme to continuously monitor employee health.

Pre-employment examinations and ongoing health monitoring shall be carried out either by a medical doctor or by a person with appropriate medical training (e.g. a physician's assistant or a registered nurse).

All cases of suspected disease shall be referred to a medical doctor for diagnosis.

Establishments shall keep records of medical examinations and shall make those records available to auditors upon request.

(d) Wooden pallets in exposed product areas

The use of wooden pallets in areas where there is exposed product shall be phased out. In the interim:

— no wooden pallets shall be used within 3 metres of exposed product,

— pallets shall be clean, structurally sound, and covered with a sanitary plastic sheet.

Those establishments which are already using plastic pallets shall continue to do so.

When wooden pallets are used in coolers or freezers, all product present shall be hygienically packaged to prevent contact of product with wood.

(e) Separation of lavatories and work areas

Toilet rooms shall be properly ventilated and shall be separated from exposed product rooms by either a vestibule or a dressing room.

(f) Dry storage of non-food material

Detergents, disinfectants and similar substances shall be stored separately from food and from wrapping and packaging material.

(g) Water testing

Water testing shall continue to be carried out in accordance with EC requirements.

FOOTNOTE 3

Fresh meat, game meat, meat products, minced meat and meat preparations of red meat species and poultry.

(a) Waste water

All establishments shall have an efficient drainage and plumbing system, and all drains and gutters shall be properly installed with traps and vents approved by FSIS, in accordance with 9 CFR 381.49 (a), (c).

(b) Separate storage of edible and inedible products

Condemned and other inedible meat and offal shall be removed in a hygienic manner, and as quickly as possible, from rooms containing edible material.

(c) Separate storage of packaged and unpackaged products

Unpackaged meat may not be stored in chilling or freezer rooms containing packaged meat.

(d) Structural wood

Wooden structures shall be in good condition, impermeable, smooth, durable rot-proof and sealed with a waterproof coating.

(e) Use of suspended showers, sprays and hoses

Meat shall not be contaminated by splashing.

They shall not be used as a substitute for handwashing facilities.

(f) Sterilisation of equipment

Establishments shall provide sterilisation equipment (batch or local sterilisers) to clean utensils as often as necessary. Implements such as knives or hooks which come into contact with meat shall be cleaned and sterilised frequently, and in any case whenever they have been in contact with contaminated material or surfaces such as the external surfaces of hides. Sterilisation shall be done with hot (> 82 °C) water.

FOOTNOTE 4

Additional guarantees for Finland and Sweden

For trade from the USA to Sweden and Finland, the USA will certify in accordance with Council Decision 95/409/EC (fresh: veal, beef and pigmeat), Council Decision 95/410/EC (live poultry for slaughter), Council Decision 95/411/EC (fresh poultrymeat), Commission Decision 95/160/EC (breeding poultry and day old chicks), Commission Decision 95/161/EC (laying hens) and Commission Decision 95/168/EC (table eggs for human consumption).

No attestation is required for fresh meat as defined in Council Directive 72/462/EEC intended for an establishment for the purposes of pasteurisation, sterilisation or for treatment having an equivalent effect.

FOOTNOTE 5

Fresh meat, game meat, meat products, minced meat, meat preparations

(a) Accommodation for sick and suspect animals

Wood shall not be used for pens for sick and suspect animals.

Sick and suspect animals shall not be allowed to come into contact with animals intended for slaughter for export to the Community.

Pens for sick and suspect animals shall be sited and constructed to preclude contact with animals intended for slaughter for export to the Community and effluent from such pens shall not flow into adjoining pens or passageways.

(b) Veterinary supervision of ante-mortem inspection

All cattle intended for slaughter for export to the EC shall be inspected by an official FSIS veterinarian, except:

— feedlot animals inspected at the feedlot by a USDA accredited veterinarian,

— other fattening animals under the age of 30 months inspected at the holding by a USDA accredited veterinarian,

which shall be inspected by an official FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this function.

All pigs intended for slaughter for export to the EC shall be inspected by an official FSIS veterinarian, except for market hogs (animals up to one year of age), which shall be inspected by an official FSIS inspector with appropriate training, knowledge, skills and abilities to carry out this function.

All animals demonstrating abnormal signs shall be diagnosed and disposed of by an official FSIS veterinarian.

(c) Trichina testing

Establishments shall test horsemeat for trichinae.

Pigmeat shall be tested or subjected to cold treatment in accordance with 9 CFR 318.10.

(d) Opening of stomachs and intestines

There must be a separate room for emptying and cleaning stomachs and intestines, unless the processing is done by closed-circuit mechanical equipment which avoids contamination and eliminates odours.

(e) Pig hearts incision

For market hogs (animals up to one year old) which are destined or from which some part is destined for the EC a statistically representative sample, both in numbers or percentage and geographical origin, of hearts shall be incised and their interior surfaces inspected by FSIS personnel, with the results being recorded.

The USA shall inform the EC of the sampling methodology, level of confidence, and programme they intend to use for the sampling referred to above.

Hearts of all sows and boars (animals over one year of age) which are destined or from which some part is destined for the EC shall be incised and their interior surfaces inspected by FSIS personnel, with the results being recorded.

(f) Batch condemnation

If carcases, offal and blood are not correlated at the final post-mortem inspection point, a batch system shall be operated in such a way that FSIS can demonstrate that if a carcase is condemned its offal and blood shall also be condemned.

(g) Partial approval

The veterinary authorities of the EC and the USA may on a bilateral basis grant request for partial approval of red-meat establishments for certain products, in accordance with the general and specific provisions of this Agreement in respect of hygienic production and ante and post-mortem inspection of slaughter animals, under the following conditions:

1. the establishment shall develop a quality assurance (QA) programme which addresses the mode of operation, the identification of product, and the segregation of the product from receiving to shipping. Establishments which want to apply for partial approval must meet the facility requirements to ensure physical and/or time separation of approved and non-approved products;

2. the QA shall include an establishment monitoring schedule and a log to document both monitoring actions and corrective actions;

3. the QA programme shall be acceptable to the regulatory inspector in charge of the establishment and the controlling veterinary authority of the importing party on request;

4. the regulatory inspector in charge of the establishment shall monitor the establishment's application of the QA programme and document such monitoring and ensure correction of deficiencies;

5. the importing Party may verify the practical implementation of the QA programme. In this case, the establishment needs to be in a position to demonstrate the programme on the spot during an inspection. For this purpose, all relevant documentation shall be presented;

6. should an inspection on the spot and/or the document-check in an establishment reveal serious deficiencies, the possibility of partial approval may either be refused or revoked.

FOOTNOTE 6

Poultrymeat

(a) Counterflow chilling

Where counterflow chilling systems are used, alternative chilling systems to the EC standards may be used providing equivalent guarantees as regards avoidance of cross contamination, and carcase temperatures at the point of exit from the chilling systems as set out under point (b), which have been validated and assessed by FSIS before the establishment is proposed for listing for export to the EC. This validation and assessment shall be carried out without the use of antimicrobial treatment (decontamination), throughout a full day's production, and with microbiological analyses for aerobic plate counts, enterobacteriacae and E-coli before and after chilling. This assessment shall be carried out each time any changes are made to a plant's chilling system. Records shall be kept of the validations and assessments, and FSIS shall make these available to the EC.

(b) Poultry product temperature requirements

Poultry shall be chilled to an internal temperature of 40 °F (4,4 °C) in the shortest time possible after slaughter.

— In the case of small birds (up to 6 lbs), the internal temperature of 40 °F shall be achieved by the end of the immersion chilling process,

— where crushed ice is used to chill large birds (over 6 lbs) after immersion chilling, such use must not result in cross contamination of the product.

When further processing (cutting) occurs after poultry has been chilled to 40 °F, the internal temperature may exceed 40 °F for a maximum of one hour, but may not exceed 50 °F (10 °C).

(Transportation temperature shall be in accordance with 9 CFR 381.66.)

(c) Crushed ice

The use of crushed ice must not result in cross contamination of the product. When crushed ice is used for further transport or storage, stacking of boxes with leakholes or other practices which could result in cross contamination shall be prohibited.

FOOTNOTE 7

Establishment listing (applicable to all products where listing provisions apply)

1. The exporting Party is responsible for ensuring that establishments/plants authorised to export, and products certified for export, meet the relevant requirements. The exporting Party shall screen establishments to ensure that they meet the relevant requirements before proposing establishments for listing for export. The list, or lists, of approved establishments, and additions and deletions to such lists, shall be supplied to the importing Party by the exporting Party. The importing Party shall make modifications to the lists of approved establishments efficiently, on the basis of the information supplied by the exporting Party. Dissemination of such lists shall be carried out without delay ( 6 ).

2. The importing Party may carry out verification procedures, including inspection of the establishments, to ensure that the relevant requirements are being met.

3. The Parties will work towards increasing the responsibility for the management of lists of establishments by the exporting Party in the light of experience obtained under the operation of the provisions of paragraphs 1 and 2.

4. The Parties will review the functioning of the abovementioned provisions regarding lists of establishments in the light of experience at each meeting of the Committee provided for under Article 14, and for the first time no later than 31 December 1997.

FOOTNOTE 8

Bison and Water Buffalo

For exports to the USA, bison and water buffalo are considered as game meat.

For exports to the EC, bison and water buffalo are considered as fresh meat.

FOOTNOTE 9

Non-comminglement — meat, meat products, game meat, poultry meat, minced meat, meat preparations

Establishments which slaughter both animals whose meat is eligible for export and animals whose meat is not eligible for export to one of the Parties, or handle such meat, shall comply with the following conditions.

1. Animals from which the meat is intended for export shall be kept separate from those which are not of the same status while at the slaughter establishment.

2. Following slaughter of animals which are not eligible for export and before slaughter of animals eligible for export purposes, all areas, utensils and equipment liable to contact the live animals and meat, including stunning, bleeding, flaying, deboning, cutting and packing areas shall be cleaned and disinfected. Staff shall change into clean protective clothing and wash their hands and boots thoroughly.

3. Meat intended for export shall not be handled, cut or otherwise processed in the same room at the same time as meat not eligible for export.

4. Meat intended for export shall be packed in clean new packaging which is clearly distinguishable from that containing meat not eligible for export. It shall be stored in such a way as to ensure that no cross contamination occurs.

5. Records of the origin of the animals from which the meat is produced shall be retained for a period of six months after export. They shall be available for inspection by the Regulatory Authority.

6. Compliance with the above conditions shall be certified by an official veterinarian.

FOOTNOTE 10

Milk and milk products not for human consumption

Excludes products regulated as animal drugs in the USA.

FOOTNOTE 11

Residue testing

Residue testing shall continue to be carried out by the USA in accordance with applicable EC requirements.

▼M2

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;

1.6. animal health investigation — a site visit undertaken to gather or verify information related to the status or conditions of a particular region with regard to one or more of the animal diseases identified in Annex III.

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: — epidemiological analysis, — the results of previous audits, — results from veterinary checks at the border (including results from collection and analysis of samples from import consignments), — period since last audit, — volume of trade, — public health surveillance results, — animal disease list freedom, — and environmental and geographical factors.

2.5. Audits, and the decisions based on them, should be made in a transparent and consistent manner. The auditor should: 2.5.1. Ensure that audit conclusions are based on objective evidence or data and observations, which can be verified as accurate and reliable; 2.5.2. Remain free of any conflicting interest or improper influence; 2.5.3. Ensure that the audit procedure is conducted