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

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United States
animal product
live animal
public health
trade agreement (EU)
veterinary inspection

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text: 21. 4. 98 EN Official Journal of the European Communities L 118/3 AGREEMENT between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products THE EUROPEAN COMMUNITY, of the one part, and THE GOVERNMENT OF THE UNITED STATES OF AMERICA, of the other part, DESIRING to safeguard public and animal health and to facilitate trade in animals and animal products between the European Community (hereinafter referred to as ‘the Community’) and the United States of America (hereinafter referred to as ‘the USA’); RESOLVED to take the fullest account of the risk of spread of animal diseases and the measures put in place to control and eradicate such diseases, and in particular to avoid disruptions to trade; REAFFIRMING their commitment to the rights and obligations established under the World Trade Organisation Agreement on the application of sanitary and phytosanitary measures (hereinafter referred to as the ‘SPS Agreement’); WHEREAS the Parties acknowledge that their systems of sanitary measures are intended to address similar objectives of providing comparable health assurances; NOTING that the recognition by an importing country of the sanitary measures applied by an exporting country can permit greater efficiency in the utilisation of inspection and verification resources; HAVE DECIDED to conclude this Agreement and to this end have designated respectively as their plenipotentiaries: THE EUROPEAN COMMUNITY THE GOVERNMENT OF THE UNITED STATES OF AMERICA WHO HAVE AGREED AS FOLLOWS: Article 1 Objective establishing the World Trade Organisation and Annexes, in particular the SPS Agreement. its 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 the Agreement the Parties under obligations of 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 L 118/4 EN Official Journal of the European Communities 21. 4. 98 residues), chemicals originating from the migration of substances labelling of from packaging materials; foodstuffs (including nutritional labelling); feed additives, animal feedingstuffs, medicated feeds and premixes. The Parties may agree to modify this Agreement in 3. 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. The Community: control in veterinary affairs is as 2. described in part B of Annex II. Article 5 Definitions For the purposes of this Agreement the following definitions shall apply: (a) (b) (c) ‘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; ‘appropriate level of sanitary protection’ means the appropriate level of sanitary protection as defined in Annex A, paragraph 5, of the SPS Agreement; ‘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 The importing Party shall recognise for trade the 1. health status of regions, as determined by the exporting Party, with respect to the animal and aquaculture diseases specified in Annex III. The importing Party shall recognise regionalisation 2. 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 In reaching a determination whether a sanitary 1. 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 standards, procedures, policies, infrastructure, enforcement and control; regulations regarding 21. 4. 98 EN Official Journal of the European Communities L 118/5 (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 its enforcement and control efficacy of 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 the status of consultations regarding the recognition of equivalency of a Party’s sanitary measures and the applicable trade conditions. thereof, sets forth 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. special conditions (b) Where the trade conditions specified in Annex V include 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. required by The Parties shall carry out the respective actions set 3. 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. frontier, In addition to carrying out checks on imports at the 2. external importing Party may verify compliance with the provisions of this Agreement through the application of procedures which may include, but are not limited to: the (a) an assessment of all or part of the exporting Party’s including, where programme, the exporting Party’s total appropriate, inspection and audit programmes, and reviews of control (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. The US agencies identified in Annex II will carry 4. in the verification procedures provided out paragraph 2. The Community shall the performance of these verification procedures by those agencies. for facilitate 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. Each Party the verification shall carry out 6. 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. L 118/6 EN Official Journal of the European Communities 21. 4. 98 Article 10 Information exchange The Parties shall exchange information on a 1. uniform and systematic basis to improve communication, to engender mutual confidence, and to demonstrate the efficacy of controlled. Where appropriate, this may be supported by exchanges of officials between the Parties. the programmes 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. The Parties agree to establish an appropriate means 5. import exchanging of consignments, relevant information, and other problem areas concerning public or animal health. inspection-related information on rejected The contact points for this information exchange 6. 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 consumption of animal products; the (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. Such notifications shall be made to the contact 2. 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 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. in such situations to provide all 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 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. issues listed Article 14 Joint Management Committee ‘the Committee’), Joint Management Committee to as (hereinafter 1. A referred 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 21. 4. 98 EN Official Journal of the European Communities L 118/7 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 its entire United States of America territory. in respect of Article 16 Final provisions This Agreement shall be approved by the Parties in 1. 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. Each Party shall implement the commitments and 2. obligations arising from this Agreement in accordance with its laws and procedures. Any changes to the Annexes to this Agreement that are agreed by the Parties shall be implemented accordingly. 3. Either Party may at any time propose modifications to this Agreement. Either Party may, on six months’ notice withdraw from the Agreement. 4. This Agreement shall be drawn up in two copies in the English language, each of these texts being equally authentic. For the European Community For the Government of the United States of America L 118/8 EN Official Journal of the European Communities 21. 4. 98 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 21. 4. 98 EN Official Journal of the European Communities L 118/9 ANNEX I PRODUCT COVERAGE Tariff line General description (1) 01 02 03 04 05 1501 1502 1503 1504 1505 1506 Live animals Meat and edible meat offal Fish and crustaceans, molluscs and other aquatic invertebrates Dairy produce; birds’ eggs; natural honey; edible products of animal origin not elsewhere specified or included Products of animal origin, not elsewhere specified or included, except for products of human origin Lard; other pig and poultry fat, rendered Fats of bovine animals, sheep or goats Lard stearin, lard oil, oleostearin, oleo-oil and tallow oil Fats and oils and their fractions, of fish and marine mammals Wool grease and fatty substances derived therefrom (including lanolin) Other animal fats and oils and their fractions 1516 10 Animal fats and oils and their fractions 1517 1518 1522 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 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 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 1902 2104 2105 2106 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 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 Soups and broths and preparations therefor; homogenised composite food preparations; except such products consisting solely of products of non-animal origin Ice cream and other edible ice, whether or not containing cocoa; except such products consisting solely of products of non-animal origin Food preparations not elsewhere specified or included; except such products consisting solely of products of non-animal origin L 118/10 EN Official Journal of the European Communities 21. 4. 98 Tariff line 2301 2309 3001 3002 3101 3501 3502 3503 3504 3507 4101 4102 4103 4301 5101 5102 5103 5105 9705 General description (1) 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 Preparations of a kind used in animal feeding; except such products consisting solely of products of non-animal origin 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 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 Animal or vegetable fertilisers, except such products consisting solely of products of non-animal origin Casein, caseinates and other casein derivatives; casein glues Albumins, albuminates and other albumin derivatives Gelatin and gelatin derivatives; isinglass; other glues of animal origin, excluding casein glues of heading No 3501 Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed Enzymes; except such products consisting solely of products of non-animal origin Raw hides and skins of bovine or equine animals Raw skins of sheep or lambs Other raw hides or skins Raw furskins Wool Fine or coarse animal hair Waste of wool or of fine or coarse animal hair Wool and fine or coarse animal hair Collections and collectors’ pieces of zoological interest (1) For definitive description refer to tariff code. 21. 4. 98 EN Official Journal of the European Communities L 118/11 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). (1) With very limited exceptions, the USDA/FSIS has sole jurisdiction for these foods until the time they leave the slaughterhouse. After the meat and products have left the slaughterhouse, the USDA/FSIS and the FDA share jurisdiction. The FDA is responsible for the approval of veterinary drugs and food additives in meat and poultry. (2) See preceding footnote. L 118/12 EN Official Journal of the European Communities 21. 4. 98 (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 (1). 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. (1) The FDA and FSIS share jurisdiction over these products after they have left the processing plant. 21. 4. 98 EN Official Journal of the European Communities L 118/13 B. Public health 1. Fresh meat and meat products (1) 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 (2). 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 and products from (a) Fresh meat domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and chickens, and domesticated turkeys, ducks, geese, and guinea fowl farmed (b) Snakes (c) Fresh meat and products from species other than above × × × × × × × × × × × × × × (1) These meat products must be made from fresh meat slaughtered under the USDA/FSIS voluntary programme. (2) Note that the listing of a product in Section II does not mean that certificates will necessarily be required as part of agreements reached on equivalence. Such decisions will be made on a product-by-product basis. L 118/14 EN Official Journal of the European Communities 21. 4. 98 DOC/ NMFS DOI/ FWS FDA USDA/ AMS USDA/ APHIS USDA/ FSIS 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, and snakes), (except snails reptiles 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. 21. 4. 98 EN Official Journal of the European Communities L 118/15 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 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. Aquaculture diseases L 118/16 EN Official Journal of the European Communities 21. 4. 98 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. 21. 4. 98 EN Official Journal of the European Communities L 118/17 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. L 118/18 EN Official Journal of the European Communities 21. 4. 98 ANNEX V RECOGNITION OF SANITARY MEASURES The following glossary applies to the attached Annex V: 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 E AI ASF BSE Not evaluated. Trade shall occur on the basis of compliance with the importing Party’s requirements. Still evaluating. Trade shall occur on the basis of compliance with the importing Party’s requirements. Avian influenza African swine fever Bovine spongiform encephalopathy CEM Contagious equine metritis CFR Code of Federal Regulations CSF EBL EC Classical swine fever (hog cholera) Enzootic bovine leucosis 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 ND OIE Infectious bovine rhinotracheitis Newcastle disease 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 USA Transmissible spongiform encephalopathy United States of America WTO World Trade Organisation — Commodity — Species — Animal/public health 1. Live animals Animal health — Equidae European Community exports to the United States United States exports to the European Community Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 9 CFR 71, 75, 91 E 90/426 92/260 93/195 93/196 93/197 94/467 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. 9 CFR 92 E 90/426 Annexes B and C 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. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 1 9 European Community exports to the United States United States exports to the European Community Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 1. Live animals — animal health (cont’d) — Equidae (cont’d) — Bovine animals 9 CFR 92 E 64/432 72/462 90/425 US to review their CEM and piroplasmosis requirements within three months of the entry into force of this Agreement. US to review BSE policy with respect to high and low incidence. 9 CFR 71, 72, 73, 77, 78, 80, 91 72/462 E US to produce generic conditions for EC. — 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 — Swine 9 CFR 92 E 64/432 72/462 90/425 US to produce generic conditions for EC. 72/462 E 9 CFR 71, 76, 77, 78, 85 — Dogs and cats 92/65 9 CFR 92 NE — ‘Balai’ animals 92/65 9 CFR 92 NE 92/65 NE 92/65 NE L 1 1 8 / 2 0 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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. 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. EC to produce conditions for US. 2. Live poultry and hatching eggs 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 Animal health 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 — 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 — Canine 92/65 9 CFR 98 NE — Feline 92/65 NE 92/65 NE 92/65 NE. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 1 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. EC to examine US request that CSF tests not be required on entry and exit from centres in countries free of the disease. European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 4. Equine semen, ova and embryos Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 92/65 95/307 92/65 95/294 92/65 95/294 9 CFR 98 NE 9 CFR 98 NE 9 CFR 98 NE Animal health — Semen — Ova — Embryos 5. Embryos Animal health 9 CFR 71, 75 92/65 96/539 9 CFR 71, 75 92/65 96/540 9 CFR 71, 75 92/65 96/540 NE NE NE — Bovine 89/556 9 CFR 98 E US to produce generic conditions for EC. 9 CFR 71, 77, 78 89/556 92/471 E US to review suspension of imports from BSE affected countries. — Ovine/caprine 92/65 9 CFR 98 NE 92/65 NE 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. L 1 1 8 / 2 2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. — Equidae — Porcine animals 9 CFR 94 Yes 1 9 CFR 94 Yes 1 64/432 72/461 72/462 64/432 72/461 72/462 9 CFR 53 72/462 82/426 Yes 2 Three month residence. 9 CFR 53 72/462 82/426 Yes 2 Three month residence. Holding freedom from brucellosis. Public health Ruminants (8) Equidae Porcine Ovine Caprine 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). 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). 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 3 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. European Community exports to the United States United States exports to the European Community Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 6. Fresh meat — public health (cont’d) Ruminants (8) Equidae Porcine Ovine Caprine (cont’d) 7. Poultry meat Animal health Public health 91/494 94/438 71/118 96/22 96/23 9 CFR 94 Yes 1 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 53 9 CFR 381. 1— 381. 5 91/494 93/342 94/984 71/118 96/22 96/23 96/712 Yes 1 Yes 3 Establishments listed in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3), (4) and (6). L 1 1 8 / 2 4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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. 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). 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 5 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 8. Meat products — animal health (cont’d) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions — Pigs — Poultry 64/432 72/461 72/462 80/215 92/118 72/462 80/215 94/438 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). 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. NE 92/495 92/45 97/221 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). 9 CFR 301—335, 354, 381. 1— 381. 500 72/462 77/99 92/118 96/22 96/23 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. 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. L 1 1 8 / 2 6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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 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 NE 77/99 92/118 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 9. Farmed game meat Animal health — Deer — Rabbit — Porcine 72/461 92/118 91/495 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. 9 CFR 94 Yes 1 NE 92/118 91/495 97/219 92/118 NE. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 7 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 9. Farmed game meat — Animal health (cont’d) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 9 CFR 94 Yes 1 9 CFR 94 92/118 97/219 NE — Feathered Public health See footnote (8) for ruminants 92/118 72/462 80/215 94/438 91/495 96/22 96/23 97/219 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 10. Wild game meat Animal health — Deer — Rabbit 92/45 9 CFR 94 E — Porcine 92/45 9 CFR 94 E — Feathered 92/45 9 CFR 94 E NE 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 92/45 97/218 92/45 97/220 92/45 97/218 NE NE NE L 1 1 8 / 2 8 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. Public health See footnote (8) for ruminants 92/45 96/22 96/23 97/218 97/220 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 11. Fisheries products for human consumption USDI & Title 50 USDI & Title 50 NE NE Animal health — Fish/fisheries products 91/67 — Bivalve 91/67 molluscs/ crustaceans (excl. live) Public health — Fish/fisheries products 91/493 96/22 96/23 NE 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 USDI & Title 50 USDI & Title 50 91/67 NE 91/67 NE Yes 3 Low-acid canned food requirement. 21 CFR 123, 1240 FFDCA, FIFRA, PHSA, 21 CFR 70—82, 180, 110. 3— 110. 93, 113, 114, 123, 172—193, 1240 Yes 3 95/328 91/493 95/328 96/22 96/23 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. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 9 EC to evaluate new US standards if applicable. 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. European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 11. Fish/fisheries products — public health (cont’d) — Fish/fisheries products (cont’d) Yes 1 NMFS Voluntary HACCP based Pro- gramme 50 CFR 260 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. — Bivalve 91/492 molluscs/ crustaceans (excl. live) National shellfish sanitation pro- gramme. Yes 3 Existing trade conditions. 91/492 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. National shellfish sanitation pro- gramme. 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’. 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. L 1 1 8 / 3 0 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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 finalized, and any necessary procedures carried out. 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 NE National shellfish sanitation pro- gramme, FFDCA, FIFRA, PHSA, 21 CFR 110. 3— 110. 93, 123, 1240, DVM NE 91/493 96/22 96/23 National shellfish sanitation pro- gramme, FFDCA, FIFRA, PHSA, 21 CFR 110. 3— 110. 93, 123, 1240, DVM. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 3 1 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 12. Live fish/shellfish and gametes Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 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 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. 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 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. 92/46 94/71 95/340 95/342 95/343 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 L 1 1 8 / 3 2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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. 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. 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. Yes 3 Existing trade conditions. US to review Import Milk Act. E coli requirement (for cheeses). Discussions on differences in finished product criteria for E-coli to continue. Joint assessment of laboratories to be completed. 92/46 94/71 95/340 95/342 95/343 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 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. Pasteurised milk Ordinance for grade A products and related documents. 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 — Pasteurised products 92/46 94/71 95/340 95/342 96/22 96/23 97/115 91/180 92/608 92/118 96/90. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 3 3 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 13. Milk and milk-based products for human consumption — public health (cont’d) — Pasteurised products (cont’d) 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. 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. L 1 1 8 / 3 4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s 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. 2 1 4 9 8. Yes 3 Compliance with E-coli requirement (for cheeses). — 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 EC requirements for somatic cell and plate counts certification as per 95/343. 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 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. 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. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 3 5 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 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 — Pigs 64/432 72/461 72/462 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 9 CFR 94 Yes 1 72/462 NE L 1 1 8 / 3 6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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). 2 1 4 9 8. 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. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 3 7 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 16. Meat preparations Animal health — Ruminants — Equidae — Pigs — Poultry/Wild game/ Farmed game Public health Ruminants (8) Equidae Pigs Poultry 64/432 72/461 72/462 64/432 72/461 72/462 92/118 72/462 80/215 94/438 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 9 CFR 94 Yes 1 72/462 NE 9 CFR 94 Yes 1 NE 91/494 93/342 94/984 94/65 9 CFR 301—381 Yes 2/3 9 CFR 301—381 94/65 97/29 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. 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. L 1 1 8 / 3 8 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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 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 FIFRA, FFDCA, PHSA 21 CFR 70—82, 101, 109, 110. 3— 110. 93, 113, 170—189, 510—529, 556 40 CFR 180, 185 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. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 3 9 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 17. Animal casings for human consumption — animal health (cont’d) — Pigs — Sheep — Goats 92/118 64/432 72/461 72/462 92/118 64/432 72/461 72/462 Public health 77/99 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). US to review 94. 8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE Certification attesting to process and origin for casings originating in ASF free countries/regions but processed in ASF affected country/region. 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). US to review 94. 8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE 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. 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 NE 77/99 92/118 Draft Decision notified to WTO. FFDCA, FIFRA, PHSA 21 CFR 70—82, 101, 109, 110. 3— 110. 93, 113, 114, 170—189, 510—529, 556 40 CFR 180, 185 L 1 1 8 / 4 0 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 18. Animal casings not for human consumption Animal health — Cattle — Pigs — Sheep — Goats 92/118 64/432 72/461 72/462 92/118 64/432 72/461 72/462 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. 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). 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. US to review 94. 8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE 92/118 94/187 NE Certification attesting to process and origin for casings originating in ASF free countries/regions but processed in ASF affected country/region. 9 CFR 96 Yes 2 Non-comminglement (see footnote (9)). US to review 94. 8 (a) (i) (v) of CFR for non-comminglement. 92/118 94/187 NE 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. 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. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 4 1 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 20. Canned petfood containing high/low risk material Yes 2 Special rules for BSE countries. Shelf stable for remainder. US to review rules on BSE with respect to high/low incidence regions. Yes 2 Shelf stable for remainder. — Containing mammalian material 92/118 90/667 92/562 — Containing only non-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 99 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 21. Canned petfood containing only low risk material — Containing mammalian material 92/118 90/667 Yes 2 Special rules for BSE countries. Shelf stable for remainder. US to review rules on BSE with respect to high/low incidence regions. 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 E E E 92/118 94/309 96/449 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 92/118 94/309 96/449 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 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. Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. L 1 1 8 / 4 2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. — Containing only non-mammalian material 92/118 90/667 Yes 2 Shelf stable. 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 22. Dry and semi moist petfood containing only low risk material 92/118 94/309 96/449 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 Yes 2 Restrictions for BSE countries. 92/118 94/309 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 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 23. Dry and semi moist petfood containing high/low risk material — Containing mammalian material 92/118 94/309 — Containing only non-mammalian material 92/118 94/309 Yes 2 Restrictions for BSE countries. Yes 1 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 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. US to examine EC 90 °C core temperature requirement as providing sufficient guarantees against ND. 92/118 94/344 96/449 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 92/118 94/344 97/199 FFDCA, FIFRA 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 E E E E Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 4 3 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. European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 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. 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. US to review rules on BSE with respect to high/low incidence regions. 72/462 97/221 NE 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 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 91/495 NE 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. L 1 1 8 / 4 4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. Feathered, farmed and wild game (8) 64/433 77/99 92/118 NE FIFRA, FFDCA, 21 CFR 70—82, 108, 109, 110. 3— 110. 93, 113, 170—189, 510—529, 556 NE 77/99 92/118 Draft Decision notified to WTO. FIFRA, FFDCA, 21 CFR 70—82, 108, 109, 110. 3— 110. 93, 113, 170—189, 510—529, 556 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 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. 2 1 4 9 8. 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. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 4 5 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 26. Processed animal protein for human consumption — Animal health (cont’d) 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) Feathered, farmed and wild game (8) 77/99 92/118 77/99 Yes 1 NE FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110. 3— 110. 93, 113, 170—189, 510—529, 556 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. NE NE 77/99 92/118 77/99 92/118 Draft Decisions notified to WTO. FIFRA, PHSA, FFDCA, 21 CFR 70—82, 108, 109, 110. 3— 110. 93, 113, 170—189, 510—529, 556 NE 90/667 92/118 92/562 94/344 96/449 97/198 FIFRA, FFDCA, 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 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. L 1 1 8 / 4 6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. Non-ruminants 92/118 90/667 Yes 3 9 CFR 95 FIFRA, FFDCA, 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 Containing only material of non-mammalian origin Poultry and fish 92/118 90/667 9 CFR 95 Yes 1 Non-ruminants 92/118 90/667 9 CFR 95 Yes 1 28. Serum of equidae Animal health 92/118 94/143 9 CFR 95, 122 NE 29. Blood and blood products intended for human consumption NE 92/118 90/667 96/449 Establishments shall have been validated by the US for alternative heat treatment including 30 day freedom from clostridia. FIFRA, FFDCA, 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 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. 92/118 90/667 NE 92/118 94/143 NE Animal health Fresh meat (ruminants, equidae, pigs) 9 CFR 95, 122 E 64/432 72/461 80/215 72/462 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 91/495 NE BSE with respect to high/low incidence regions. Fresh meat — Poultry 9 CFR 95, 122 Yes 1 92/118 80/215 72/462 94/438 92/118 NE. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 4 7 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 29. Blood and blood products intended for human consumption — animal health (cont’d) Feathered, farmed and wild game 92/45 91/495 9 CFR 95, 122 Yes 1 Wild game — Pigs, deer 92/45 9 CFR 95, 122 Yes 1 Public health 77/99 NE 9 CFR 301—381, 416, 417 FFDCA, FIFRA, 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 30. Blood and blood products not intended for human consumption 92/45 91/495 NE 92/45 NE NE 77/99 92/118 Draft Decision notified to WTO. 9 CFR 301—381, 416, 417 FFDCA, FIFRA, 21 CFR 110. 3— 110. 93, 507—509, 570, 573—589 EC to consider establishing conditions. 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 L 1 1 8 / 4 8 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. Farmed game — Pigs, deer Fresh meat — Poultry Feathered, farmed and wild game Wild game — Pigs, deer Public health All species (8) Feathered, farmed and wild game (8) 91/495 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on 91/495 NE BSE with respect to high/low incidence regions. 92/118 80/215 94/438 92/45 91/495 9 CFR 95 Yes 1 92/118 NE 9 CFR 95 Yes 1 92/45 91/495 NE 92/45 9 CFR 95 Yes 2 BSE rules for ruminants. US to review rules on 92/45 NE BSE with respect to high/low incidence regions. 77/99 92/118 77/99 NE 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 NE NE 77/99 92/118 77/99 92/118 Draft Decision notified to WTO. 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 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. NE 92/118 Draft Decision notified to WTO. EC to review requirements to consider inclusion of alternative heat treatment systems. EC to review US bacteriological testing regime for protein fraction. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 4 9 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 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 35. Game trophies Animal health 92/118 9 CFR 95 Yes 1 36. Manure Animal health 92/118 9 CFR 95 E 37. Wool, feathers and hair Animal health 92/118 94/860 NE 9 CFR 53 92/118 96/590 E 9 CFR 53 92/118 E US to provide temperature requirements for manure from regions affected by serious transmissible disease. — Wool 92/118 9 CFR 95 Yes 1 9 CFR 53 92/118 NE — Pig bristles 92/118 9 CFR 95 Yes 1 Public health NE FFDCA, PHSA 21 CFR 1240. 70 9 CFR 53 92/118 94/435 FFDCA, PHSA 21 CFR 1240. 70 NE NE L 1 1 8 / 5 0 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 38. Honey Animal health Public health 92/118 NE NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110. 3— 110. 93, 520. 182, 520. 1660d 39. Frogs’ legs Animal health Public health 92/118 96/340 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110. 3— 110. 93, 113, 114, 123, 1240 40. Snails for human consumption Animal health Public health 92/118 96/340 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110. 3— 110. 93, 113, 114, 123, 1240. 2 1 4 9 8. NE 92/118 NE 92/118 96/340 NE EC to review US HACCP rules when submitted. 92/118 96/340 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110. 3— 110. 93, 520. 182, 520. 1660d FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110. 3— 110. 93, 113, 114, 123, 1240 FFDCA, FIFRA, PHSA 21 CFR 70—82, 108, 110. 3— 110. 93, 113, 114, 123, 1240 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 5 1 European Community exports to the United States United States exports to the European Community — Commodity — Species — Animal/public health Trade conditions EC standards US standards Equiv. (Cat. ) 41. Egg products for human consumption Special conditions Actions Trade conditions US standards EC standards Equiv. (Cat. ) Special conditions Actions 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 E 7 CFR 59 EPIA Public Law 91-597 US to supply information on the legal basis for recognition of equivalence. E 7 CFR 59 EPIA Public Law 91-597 89/437 91/684 92/118 96/23 97/38 US to complete assessment of EC public health legislation. EC to complete assessment of US public health legislation. 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. L 1 1 8 / 5 2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s. 2 1 4 9 8. 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 E 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 43. Gelatin for human consumption and technical use Animal health 9 CFR 94 NE Public health 92/118 NE FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110. 3— 110. 93, 570, 573—589 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 FFDCA, FIFRA, PHSA 21 CFR 70—82, 109, 110. 3— 110. 93, 570, 573—589 89/437 91/684 94/371 96/23 E Footnote (4). EC to complete assessment of US public health legislation. NE 92/118 NE. 2 1 4 9 8. E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 5 3 L 118/54 EN Official Journal of the European Communities 21. 4. 98 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 and E-coli testing 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. 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. 21. 4. 98 EN Official Journal of the European Communities L 118/55 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. L 118/56 EN Official Journal of the European Communities 21. 4. 98 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 aand 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: 21. 4. 98 EN Official Journal of the European Communities L 118/57 1. 2. 3. 4. 5. 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; the QA shall include an establishment monitoring schedule and a log to document both monitoring actions and corrective actions; 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; 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; 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 L 118/58 EN Official Journal of the European Communities 21. 4. 98 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 (*). 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. (*) The EC will carry out this commitment in accordance with the procedure laid down in Article 5 of Council Decision 95/408/EC. The USA will carry out this commitment in accordance with a similar timetable. 21. 4. 98 EN Official Journal of the European Communities L 118/59 ANNEX VI GUIDELINES FOR CONDUCTING AN AUDIT Where standards, guidelines, or recommendations pertaining to the conduct of audits are adopted by one of the relevant international standard-setting organisations, the Parties will review the contents of this Annex, and make any appropriate modifications. GENERAL PROVISIONS 1. Definitions The following definitions shall apply to terms used in this Annex: 1. 1. audit: assessment of performance; 1. 2. auditee: the exporting Party whose enforcement and control programme is the subject of the audit; 1. 3. auditor: the importing Party that conducts the audit; 1. 4. establishment: processing plant for animals or animal products; 1. 5. facility: site other than processing plants where animals or animal products might be handled, excluding retail premises. 2. General principles 2. 1. The auditor and the auditee should cooperate in carrying out audits in accordance with the provisions set out in this Annex. The audit team should include representatives of both the auditor and the auditee, and the auditee should designate personnel responsible for facilitating the audit. Specialised professional skills may be necessary to carry out audits of specialised systems and programmes. 2. 2. Audits should be designed to check the effectiveness of the auditee’s enforcement and control programme rather than to reject individual animals, consignments of food or establishments. 2. 3. The auditee must operate a documented programme to demonstrate to the auditor that standards are being met on a consistent basis. 2. 4. The frequency of audits should be based on the performance of the exporting Party in carrying out its enforcement and control programme. A low level of performance should result in an increased frequency of audit, for example to ensure that unsatisfactory performance has been corrected. 2. 5. Audits, and the decisions based on them, should be made in a transparent and consistent manner. PROCEDURES 3. Preparation of the audit plan In consultation with the auditee, the auditor should prepare an audit plan that covers the following points: 3. 1. the subject, depth and scope of the audit; 3. 2. the date and place of the audit, and the types of any establishments or facilities to be visited so that appropriate audit team members may be chosen; 3. 3. a timetable up to and including the presentation of the final report; 3. 4. the language or languages in which the audit will be conducted and the report written; 3. 5. the identity of the members of the audit team, including the leader; 3. 6. a schedule of meetings with officials and visits to establishments or facilities, including unannounced visits, as appropriate; 3. 7. provisions for respect of commercial confidentiality and avoidance of conflicts of interest. L 118/60 EN Official Journal of the European Communities 21. 4. 98 4. Opening meeting An opening meeting should be held between representatives of both Parties. At this meeting the auditor will review the audit plan and confirm that adequate resources and documentation are available and all necessary arrangements have been made for conducting the audit. 5. Document review 5. 1. The document review may include, for example, the following: — records concerning compliance programmes, — inspection and internal audit reports, — documentation concerning corrective actions and sanctions, — records of compliance actions taken, — sampling plans and their results, — documents associated with verification, — regulatory procedures followed by the auditee. 5. 2. In the case of an audit that is subsequent to a determination of equivalence, the document review may also consist of a review of relevant changes to the inspection and certification systems since the determination of equivalence or since the previous audit. 5. 3. The auditee will cooperate fully with the auditor in the document review process and help to ensure that the auditor has access to requested documents and records. 6. On-site verification 6. 1. The decision to conduct on-site verification should take into account factors such as the risks associated with the animals or animal products concerned, the history of conformity with requirements by the industry sector or exporting country, the volume of product produced and imported or exported, changes in infrastructure and the nature of the inspection and certification systems. 6. 2. On-site verification may involve visits to production and manufacturing establishments, facilities, food handling or storage areas and control laboratories to check the accuracy of the information contained in the documentary material referred to in 5. 1. 6. 3. When checks of establishments or facilities are carried out, the auditee will carry out the check of the establishment or facility, following the auditee’s usual procedures, and the auditor will generally participate as an observer, though is free to check other aspects of performance if deemed necessary. 6. 4. The auditee will cooperate fully with the auditor in the on-site verification process and facilitate the auditor’s entry into the establishments and facilities that are the subject of the on-site verification. 7. Follow-up audit A follow-up audit may be conducted to verify the correction of deficiencies identified in a prior audit. 8. Working documents Working documents may include checklists of elements to evaluate, such as the following: — legislation, — structure and operations of inspection and certification services, — establishment and facility structure, layout, operations and working procedures, — health statistics, sampling plans and results, — compliance action and procedures, — reporting and complaint procedures, — training programmes. 21. 4. 98 EN Official Journal of the European Communities L 118/61 9. Closing meeting A closing meeting shall be held between representatives of both Parties, including officials responsible for the inspection and certification programmes of the auditee. At this meeting the auditor will present the findings of the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit are clearly understood. 10. Audit report The auditor shall provide the auditee with a draft report of the audit generally within 60 days of the conclusion of the audit. To the extent possible, the report shall be presented in a standardised format to be agreed on by the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will assess the adequacy of the auditee’s enforcement and control programme and identify any deficiencies noted during the conduct of the audit. Thereafter, the auditee may, within 60 days, comment on the draft report and shall describe any specific corrective actions that will be taken, preferably with target dates for completion. Any comments made by the auditee shall be included in the final report. L 118/62 EN Official Journal of the European Communities 21. 4. 98 ANNEX VII FRONTIER CHECKS The Parties recognise the distinction between documentary, identity and physical checks carried out at external frontiers on imports of live animals and animal products. The Parties further recognise the need to take a systematic approach to carrying out frontier checks. Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of Annex C to the SPS Agreement. Live animals The Parties may apply physical checks to all consignments of live animals. Animal products In setting their physical checking frequencies for imports of animal products, the Parties shall take due account of the checks applied by the exporting Party prior to export and the historic performance of products imported from the exporting Party. The Parties may modulate their physical checking frequencies for imports of animal products, notably in the light of progress made toward the recognition of equivalence under the consultative process provided for in Article 7. ANNEX VIII OUTSTANDING ISSUES The Parties agree to work to further develop agreed arrangements concerning frontier checks, including the frequency of physical checks. The Parties agree to work together on their respective arrangements concerning feed additives, animal feedingstuffs, medicated feeds and premixes. 21. 4. 98 EN Official Journal of the European Communities L 118/63 ANNEX IX CONTACT POINTS The USA will send the information provided for in Article 10, and carry out the notifications provided for in Article 11, to: Agricultural Counsellor European Union Delegation of the European Commission to the United States 2300 M Street NW Washington DC 20037 Tel. 1 202 862 9560 Fax 1 202 429 1766 The Community will send the information provided for in Article 10, and carry out the notifications provided for in Article 11, to: Agricultural Attaché Office of Agricultural Affairs US Mission of the European Union 40 Blvd du Regent B-1000 Brussels Tel. 32 2 508 2760 Fax 32 2 511 0918