Proposal for a Council Decision on the conclusion of the Agreement between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in live animals and animal products
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 12. 11. 1997 COM(97) 566 final 97/0301 (ACC) Proposal for a COUNCIL DECISION on the conclusion of the Agreement between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in live animals and animal products (presented by the Commission) EXPLANATORY MEMORANDUM Background Since the Commission started making inspections of meat-exporting establishments in the USA in the mid 1980s, trade difficulties have arisen because of the differences in approach to health measures adopted by the EC and the USA. In order to overcome these trade problems, an agreement (the "red meat agreement") was negotiated in the early 1990s and adopted by the Council in October 19921. This Agreement recognized that the regulatory systems of both parties basically provide equivalent safeguards against public health risks. It set out the technical solutions needed to allow trade to continue and concluded that the two parties would initiate discussions as soon as possible on other problems in the veterinary field in relation to trade in animals and products of animal origin. Further impetus was given to these discussions by the entry into force on 1 January 1995 of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement), which provides, in Article 4, that Members shall accept the sanitary measures of other Members as equivalent, even if those measures differ from their own, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary protection. This Article also requires Members, upon request, to enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of sanitary measures. On 20 February 1995, the Council agreed a mandate authorizing the Commission to conduct negotiations with a view to the conclusion of agreements between the Community and third countries on sanitary and phytosanitary measures, on the basis of negotiating directives annexed to its decision. Following this mandate, the Commission has, with the participation of experts from the Member States, conducted negotiations with a number of third countries. Agreements have been concluded with New Zealand and the Czech Republic, and negotiations are continuing with Australia, Canada, Uruguay, Chile and Argentina. This proposal presents the results of negotiations with the USA, which are now ready to be proposed to the Council. The legal base for the agreement is Article 113 and the first sentence of Article 228(2) of the Treaty, as in the case of the most recent agreement with the Czech Republic. Council Decision 93/158/EEC, OJ N° L 68, 19. 3. 1993, p. 1 7^ Scope and purpose of the draft Agreement The draft Agreement covers sanitary measures affecting trade in the animals and animal products listed in Annex I of the text. However, due to the very significant differences in approach to certain measures, the draft Agreement excludes the matters referred to Article 3(2), including measures related to drug residues (e. g. hormones). These remain subject to the legislation of each party in respect of trade. The purpose of the draft Agreement is to facilitate trade between the parties in live animals and animal products by establishing a mechanism for the recognition of equivalence of sanitary measures where this is possible, and establishing a framework for working towards equivalence in other areas. For each party, equivalence can only be accepted in cases where the party is satisfied that the agreed conditions of trade meet its chosen level of sanitary protection. In all cases, it is the right of the importing party to determine if the measures of the exporting party meet its level of protection. The rights of parties under the WTO Agreements are not affected by the provisions of the draft Agreement, but the intention of the draft Agreement is to work towards mutually acceptable solutions instead of allowing damaging trade disputes to develop. Provisions are included for the exchange of information on matters relating to the draft Agreement, including specific provisions for the notification to each other of outbreaks of disease. A safeguard clause is also included, allowing parties to take unilateral emergency measures to protect human or animal health. The agreement makes reference to those responsibilities which fall to the Member States and those which are Community responsibilities (see Annex II. B). In effect, the Community is responsible for sanitary measures relating to the placing on the Community market of live animals and animal products, whether produced domestically or imported, while the Member States are responsible for ensuring compliance of exports with USA requirements. Joint Management Committee The draft Agreement establishes a Joint Management Committee with responsibilities for guiding the activities provided for in the text and for carrying out a regular review, at least once per year, of progress made in the recognition of equivalence. As the draft Agreement represents a starting point, and contains a very comprehensive work programme in Annex V, this Committee will play an important role in coordinating progress with the implementation of the programme. In addition, the Joint Committee may recommend changes to the Annexes as and when these become necessary as a result of progress in the continuing negotiations. 1b Implementation of changes to the Agreement Each party will have to implement any agreed changes in accordance with its legislative procedures procedures (Article 16. 2 of the Framework text). In the case of the Community, it is proposed to do this by Commission Decision, following an opinion of the Standing Veterinary Committee (3b "contrefilet" procedure). It should be stressed that nothing in this draft Agreement changes Community legislation; any such change which could be necessary in the future would have to been made by the Council and Parliament on the basis of Article 100A, if there are implications for public health, or any other appropriate legal basis. -7 c *^*';fJUv#ri PROPOSAL FOR A COUNCIL DECISION ^ on the conclusion of the Agreement between the United States of America and the ' European Community on sanitary measures to protect public and animal health in trade in live animals and animal products THE COUNCIL OF THE EUROPEAN UNION,. ; Having regard to the Treaty establishing the European Community, and in particular Article 113 and Article 228, paragraph 2, first sentence, thereof, Having regard to the proposal from the Commission, Wheieas the Agreement between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in live animals and animal products provides an adequate means for putting into practice the provisions of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures as regards public and animal health measures; Whereas the Agreement will contribute towards facilitating bilateral trade between the United States • of America and the European Community in live animals and animal products through the progressive recognition of the equivalence of sanitary measures, the recognition of animal health status, the application of régionalisation and the improvement of communication and cooperation; Whereas it. is appropriate to make provisions for a procedure establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee; Whereas the Agreement should be approved on behalf of the Community, HAS DECIDED AS FOLLOWS: Article 1 The Agreement between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in liye animals and animal products is hereby approved on behalf of the Community. The text of the Agreement and the Annexes thereto are attached to this Decision. Article 2 The President of the Council is hereby autliorised to designate the person empowered to sign the Agreement in order to bind the Community. 1 d- Article 3 i'y'vâîî-:'' 3|0t|||;^Trî^ measures' necessary for the implementation of this Agreement, including as regards "l^^^â^ineaf-randtmeat, based products guarantees equivalent to those laid down by ^^^V6ïrectivâ7^462/EEC(I>, shall be established pursuant to the procedure laid down in s «. ^j«ç^?Ârticle 30' of that Directive. -, ~ ^-^^^PHfeSK-îC*-: « * ' • ••:$& • - '- • ::^A Article 4 /. '•- - > ;^TheXommission, assisted by representatives of Member States' veterinary services, shall /s - -^represent: ^. Community in. the'Joint Management Committee referred to in Article 14 Z (1) of the Agreement The Commission is authorized to approve modifications to the annexes to the Agreement of behalf of the Community, in accordance with the recommendations of the Joint Management Committee, pursuant to the procedure laid down in Article 29 of Directive 72/462/EEC. Articles This Decision shall be published in the Official Journal of the European Communities. This Decision shall take effect on the date of its publication. Done at Brussels, For the Council The President (1) OJ. N° L 302, 31. 12. 1972, p. 28. Directive ZLS last amended by Directive Nc 96/91/EC(OJ. N°L 13, 16. 01. 1996, p. 26). 7<* DRAFT AGREEMENT between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in live animals and animal products / DRAFT AGREEMENT between the United States of America and the European Community on sanitary measures to protect public and animal health in trade in live animals and animal products THE GOVERNMENT OF THE UNITED STATES OF AMERICA ofthetme part, and THE EUROPEAN COMMUNITY of the other part, DESIRING to safeguard public and animal health and to facilitate trade in animals and animal products between the United States of America (hereinafter referred to as 'the U. S. ') and the European Community (hereinafter referred to as 'the Community'); 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 utilization of inspection and verification resources; HAVE DECIDED to conclude this Agreement and to this end have designated respectively as their plenipotentiaries: THE GOVERNMENT OF THE UNITED STATES OF AMERICA THE EUROPEAN COMMUNITY WHO HAVE AGREED AS FOLLOWS: Article 1 Objective The objective of this agreement is to facilitate trade in live animals and animal products between the U. S. and the Community by establishing a mechanism for the recognition of equivalence of sanitary measures maintained by a Party consistent with the protection of public and animal health, and to improve communication and cooperation on sanitary measures. Article 2 Multilateral Obligations Nothing in this Agreement shall limit the rights or obligations of the Parties under the Agreement establishing the World Trade Organisation and its Annexes, in particular the Agreement on the Application of Sanitary and Phytosanitary Measures. Article 3 Scope 1. This Agreement shall initially be limited to the sanitary measures applied by either Party to the live animals and animal products listed in Annex I, except as provided for in paragraph 2. 2. Unless otherwise specified under the provisions set out in the Annexes to this Agreement, this Agreement shall not apply to sanitary measures related to food additives, processing aids, flavours, colour additives, sanitary stamps, irradiation (ionisation), contaminants (including pesticides, chemical residues, mycotoxins, natural toxins, physical contaminants and animal drug residues), chemicals originating from the migration of substances from packaging materials; labelling of foodstuffs (including nutritional labelling); feed additives, animal feedingstuffs, medicated feeds and premixes. 3. The Parties may agree to modify this Agreement in the future to extend the scope to other sanitary or phytosanitary measures affecting trade between the Parties. Article 4 Regulatory Authorities 1. The U. S. - regulatory authority for imports and exports of live animals and animal products is as described in part A of Annex II. 2. The Community - control in veterinary affairs is as described in part B of Annex II. Article 5 Definitions For the purposes of this Agreement the following definitions shall apply: (a) sanitary measures means sanitary measures as defined in Annex A, paragraph 1, of the SPS Agreement and falling within the scope of this Agreement. The reference to sanitary measures may cover individual sanitary measures or groups of sanitary measures for product areas, sectors, or parts of sectors, as appropriate; (b) appropriate level of sanitary protection means the appropriate level of sanitary protection as defined in Annex A, paragraph 5, of the SPS Agreement; (c) region means "zones" or "regions" as defined in the Animal Health Code of the Office International des Epizooties (OIE), and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE; (d) Agreement means the entire text of this Agreement and all its annexes. Article 6 Animal Health Status The importing Party shall recognise for trade the health status of regions, as determined by the exporting Party, with respect to the animal and aquaculture diseases specified in Annex III. 2. The importing Party shall recognise régionalisation 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 art 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 measure maintained by an exporting Party achieves the importing Party's appropriate level of sanitary protection, the Parties shall follow a consultative process that includes the following steps: i) identification of the sanitary measure for which recognition of equivalence is sought; ii) explanation by the importing Party of the objective of its sanitary measure, including an assessment, as appropriate to the circumstances, of the risk or risks, that the sanitary measure is intended to address, and identification by the importing Party of its appropriate level of sanitary protection; iii) demonstration by the exporting Party that its sanitary measure achieves the importing Party's appropriate level of sanitary protection ; iv) determination by the importing Party whether a sanitary measure achieves its appropriate level of sanitary protection after consideration of various factors, including where appropriate: (a) risks identified by the importing Party and evidence provided by the exporting Party that its sanitary measures effectively address those risks; (b) provisions of the exporting Party's legislation and regulations regarding standards, procedures, policies, infrastructure, enforcement and control; (c) powers of the exporting Party's regulatory authorities and their structure, including their chain of command, modus operandi, and resources; (d) evidence provided by the exporting Party of the efficacy of its enforcement and control programs. 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 upon 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 Annex V lists the live animals and animal product areas, sectors, or parts of sectors, and, for each area, sector or part thereof, sets forth the status of consultations regarding the recognition of equivalency of a Party's sanitary measures and the applicable trade conditions. 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 3 months to implement these recognitions. For sanitary measures that will be recognised as equivalent in the future, each Party shall take prompt and necessary steps to implement the recognitions. b) Where the trade conditions specified in Annex V include special conditions required by the importing Party to meet its appropriate level of protection, trade shall take place where the exporting Party meets the importing Party's conditions, without prejudice to the continuing consultative process. 3. The Parties shall carry out the respective actions set out in Annex V, taking into account the target deadlines for each product area, sector, or part of sector, with a view, where possible, to reaching recognition of equivalence, and to facilitate trade. 4. Annex V may be modified in accordance with Articles 14. 2 and 16. 2 to reflect changes made by each Party in recognitions or trade conditions. Article 9 Verification Provisions 1. The determination of the nature and frequency of checks to be applied to imports of live animals and animal products at external frontiers rests solely with the importing Party. Annex VII contains principles which shall guide such frontier checks. 2. In addition to carrying out checks on imports at the external frontier, the importing Party may verify compliance with the provisions of this Agreement through the application of procedures which may include, but are not limited to: (a) an assessment of all or part of the exporting Party's total control programme, including, where appropriate, reviews of the exporting Party's inspection and audit programmes; and (b) on-site checks and inspections. 3. The Community will carry out the verification procedures provided for in paragraph 2. The U. S. agencies identified in Annex II shall facilitate the performance of these verification procedures by the Community. 4. The U. S. agencies identified in Annex II will carry out the verification procedures provided for in paragraph 2. The Community shall facilitate the performance of these verification procedures by those agencies. Upon 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 shall carry out the verification procedures in accordance with Annex VI. The Parties may agree to modify Annex VI, taking due account of relevant work carried out by International Organisations. Article 10 Information Exchange 1. The Parties shall exchange information on a uniform and systematic basis to improve communication, to engender mutual confidence, and to demonstrate the efficacy of the programs controlled. Where appropriate, this may be supported by exchanges of officials between the Parties. 2. The Parties shall notify each other of proposals to introduce new sanitary measures or to change existing sanitary measures, and shall provide the opportunity to comment on such proposals. 3. In addition to information on changes in sanitary measures, 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 otlier Party. 5. The Parties agree to establish an appropriate means of exchanging information on rejected import consignments, relevant inspection-related information, and other problem areas concerning public or animal health. 6. The contact points for this information exchange arc set out in Annex IX. Article 11 Notification 1. Each Party shall notify the other: (a) immediately by oral communication followed within 24 hours in writing: of any serious or significant public or animal health risk, notably including any food control emergencies or situations where there is a clearly identified risk of serious health effects associated with the consumption of animal products; (b) within 24 hours in writing: of the presence or evolution of any disease listed in Annex III; and (c) without delay and in writing: of any significant changes in animal health status or of findings of epidemiological importance with respect to diseases other than those listed in Annex III; of changes in preventive policies, including vaccination policies; or, of any non- routine measures taken to protect public health or to control or eradicate animal disease. 2. 3. Such notifications shall be made to the contact points set out in Annex IX. Where either Party has serious concerns regarding a risk to public or animal health, consultations regarding the situation shall, on request, take place as soon as possible, and in any case within 14 days. Each Party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution consistent with the protection of public or animal health. Article 12 Safeguards Either Party may take provisional measures necessary for the protection of public or animal health. These measures shall be notified within 24 hours to the other Party, and, on request, consultations regarding the situation shall be held within 14 days. The Parties shall take due account of any information provided through such consultations, and shall endeavour to avoid unnecessary disruption to trade, taking advantage where possible of the provisions of Article 11. 3. Article 13 Outstanding Issues The principles of this Agreement shall also be applied to address outstanding issues listed in Annex VIII. Modifications shall be made to this Annex and, as appropriate, other Annexes, to take account of progress made and new issues identified. Article 14 Joint Management Committee 1. A Joint Management Committee (hereinafter referred to as 'the Committee'), consisting of representatives of the U. S. and the Community, is hereby established to guide the activities carried out under this Agreement. The Committee shall meet within one year of the entry into force of this Agreement and at least annually thereafter. The Committee may also address issues out of session by correspondence. 2. The Committee shall, at least once a year, review the Annexes to this Agreement As appropriate, this review will take account of progress made on the continuing consultative process towards the recognition by the importing Party of the equivalence of sanitary measures maintained by the exporting Party and progress in completing the actions set out in Annex V. The Committee may recommend changes to the Annexes. 3. The Parties agree to establish Technical Working Groups, consisting of expert-level representatives of the U. S. 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. 10 Article 15 Territorial Application This Agreement shall apply, on the one hand, to the United States in respect of its entire territory, and, on the other hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty. Article 16 Final Provisions 1. This Agreement shall be approved by the Parties in accordance with their respective procedures. > This Agreement shall enter into force on the first day of the month following the date on which the Parties notify each other that the procedures mentioned in the preceding sub-paragraph have been completed. 2. Each Party shall implement the commitments and obligations arising from this Agreement in accordance with its laws and procedures. Any changes to the annexes to this Agreement that are agreed by the Parties shall be implemented accordingly. 3. Either Party may at any time propose modifications to this Agreement. Either Party may, upon 6 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 Government of the For the European Community United States of A merica 11 LIST OF ANNEXES ANNEX I PRODUCT COVERAGE ANNEX II REGULATORY AUTHORITIES ANNEX III LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED ANNEX IV ZONING AND RÉGIONALISATION 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 12 ANNEX I PRODUCT COVERAGE Tariff Line General Description* 01 02 03 04 05 15 01 15 02 15 03 15 04 15 05 15 06 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-oil1 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, 15 16 10 Animal fats and oils and their fractions, 15 17 15 18 15 22 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 mixture 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 For definitive description, refer to Tariff Code 16 Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates 17 02 10 Lactose and lactose syrup 19 01 19 02 21 04 21 05 21 06 23 01 23 09 30 01 30 02 3101 35 01 35 02 35 03 35 04 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; homogenized 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 Flours, meals and pellets, of meat or meat offal, offish 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 35 07 Enzymes; except such products consisting solely of products of non-animal origin 14 4101 41 02 41 03 Raw hides and skins of bovine or equine animals Raw skins of sheep or lambs Other raw hides or skins 43 01 Raw furskins 51 01 51 02 51 03 51 05 Wool Fine or coarse animal hair Waste of wool or of fine or coarse animal hair Wool and fine or coarse animal hair 97 05 Collections and collectors' pieces of zoological interest 15 \ M « f t< • "• ANNEX II A. I. U. S. REGULATORY AUTHORITY US Control Authority The federal agencies listed in this section are responsible for both domestically-produced and imported animals and animal products, unless otherwise noted. In relation to imports into the U. S. , these agencies are responsible for: conducting frontier checks provided for in the Agreement; carrying out the consultations provided for under Article 7 of the Agreement; carrying out the verification procedures provided for in Article 9 of the Agreement; and 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 U. S. , unless otherwise noted, these agencies are responsible for: controlling the circumstances of domestic production and processing; providing information concerning compliance with agreed upon regulatory requirements; providing agreed additional guarantees; carrying out the consultations provided for under 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) b) c) d) Live animals (including apiculture bees), embryos, ova, semen and animal products - U. S. Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS) Imports of salmonid live fish, gametes and fertilized ova — Department of Interior/Fish and Wildlife Service (DOI/FWS) Imports of uneviscerated salmonid fish - DOI/FWS Animal Feed (including Pet Foods) 1) 2) Transmission of disease from feed - USDA/APHIS Adulteration, pesticides, chemical and microbial contamination, food additives, substances "generally recognised as safe" - Food and Drug Administration (FDA) 16 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 - U. S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS)2 b) Fresh meat and products from domestic and farmed chickens, turkeys, ducks, geese, and guinea fowl - USDA/FSIS-^ c) d) e) Fresh meat and products from wild and farmed game, with the exception of those from IB 1(a) and IB 1(b) above - (FDÀ) Fresh meat and products from species other than above - FDA Enforcing adulteration provisions of the law and limits for residues of drugs, pesticides, heavy metals, mycotoxins, and other contaminants in food 1. 2. 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 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) b) Shell eggs, hard-cooked eggs, ethnic egg delicacies, and imitation egg products - FDA 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/FSIS4 3. Dairy a) All dairy products - FDA With very limited exceptions, USDA/FSIS has sole jurisdiction for these foods until the time they leave the slaughterhouse. After the meat and products have left the slaughterhouse, USDA/FSIS and FDA share jurisdiction. FDA is responsible for the approval of veterinary drugs and food additives in meat and poultry See preceding footnote FDA and FSIS share jurisdiction over these products after they have left the processing plant 17 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 Programs The federal agencies listed in this section are responsible for voluntary inspection and certification programs for domestically-produced animal product?. In relation to exports from the U. S. , these agencies are responsible for: oversight of the circumstances of domestic production and processing for firms who participate in the voluntary program. providing information concerning compliance with agreed upon requirements for firms who participate in the voluntary program. providing agreed additional guarantees for firms who participate in the agreed program. A. ANIMAL HEALTH 1. 2. 3. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova - USDA/APHIS, Department of Commerce/National Marine Fisheries Service (Commerce/NMFS) Salmonid live fish, gametes, and fertilised ova - USDA/APHIS, Commerce/NMFS Animal feed (including pet foods) containing fish and fishery products - USDA/APHIS, Commerce/NMFS B. PUBLIC HEALTH 1. 2. 3. 4. 5. 6. Fresh meat and meat products^ from wild and farmed bison, ostrich, emu, rhea, rabbit, deer, partridge, and quail - USDA/FSIS Snakes for human consumption - Commerce/NMFS - Shell eggs - USDA/AMS Cooked omelets made from egg products, diced eggs made from egg products - USDA/FSIS Dairy - USDA/AMS Seafood (including live seafood) - Commerce/NMFS These meat products must be made from fresh meat slaughtered under the USDA/FSIS voluntary program. 18 III. Federal Agencies that Issue Certification This section lists the U. S. national agencies that issue export certificates agreed to by the EC and the US*>. 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 USDA/ USDA/ USDA/ FSIS APHIS AMS FDA 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 !X 3. Salmonid live fish, gametes, and fertilised ova X 4. Wild waterfowl 5. Animal feed X X X X X X X B. PUBLIC HEALTH CERTIFICATIONS 1. Meat and poultrv for human consumption a) Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and domesticated and farmed chickens, turkeys, ducks, geese, and guinea fowl b) Snakes X c) Fresh meat and products from species other than above X X X X 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. 19 DOC/ DOI/ USDA/ USDA/ USDA/ NMFS FWS FDA AMS APHIS FSIS Public health certifications cont'd 2. Eggs a) Shell eggs,, hard cooked eggs, ethnic egg delicacies, and imitation egg products b) Liquid, frozen and dried egg products a) Butter, cheese, frozen desserts, and dried milk products 3. Dairv b) Fluid milk 4. Seafood a) Fish and fishery products including fish oil, reptiles (except snakes), snails and amphibians b) Live fish (including shellfish and molluscs) X X B. EUROPEAN COMMUNITY X X X X X X X X 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 U. S. , 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 co-ordination, inspections/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single European Market. 20 ANNEX III LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED Animal diseases Foot and mouth disease Vesicular stomatitis Swine vesicular disease Rinderpest Peste de petits ruminants Contagious bovine pleuropneumonia Contagious caprine pleuropneumonia Bluetongue Sheep and goat pox African swine fever African horse sickness Classical swine fever Enterovirus encephalomyelitis Fowl plague (avian influenza) Newcastle Disease Pseudorabies/Aujeszky's Venezuelan Equine Encephalomeyelitis Aquaculture diseases The list of aquaculture diseases is to be discussed further by the Parties on the basis of the International Aquatic Animal Health Code of the OIE 21 ANNEX IV ZONING AND REGIONALISATION The Parties have jointly determined that the following forms the basis for Régionalisation decisions for the diseases listed in accordance with Annex III. Each Party will recognise régionalisation 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. 2. 3. Source risk factors. Commodity risk factors. 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 over-riding 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 mat 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. 22 Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, particularly those which ensure a regular veterinary presence on the farm. Other factors to be considered include: disease history vaccination history controls on movements into the zone, out of the zone and within the zone animal identification and recording presence of disease in adjacent areas physical barriers between zones of differing status meteorological conditions use of buffer zones (with or without vaccination) presence of vectors and/or reservoirs active control and eradication programmes (where appropriate) ante and post mortem inspection. On the basis of these factors, a zone, may be defined. The authority with the responsibility for implementing the zoning policy is in the best position to define and maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the basis for trade. The zones so defined may be assigned a risk category. Possible categories are: low/negligible risk medium risk high risk unknown risk. Calculation of estimates of risk for e. g. 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, e. g. by additional guarantees, testing or treatment. Unknown risk implies that importation will only take place if the commodity itself is of very low risk, e. g. 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, e. g. 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, e. g. 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 , preventative measures such as waste food feeding and animal waste rendering rules intended use of product e. g. 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 e. g. 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 Régionalisation decisions for aquaculture diseases will be the International Aquatic Animal Health Code of the OIE. 24 ANNEX V SANITARY MEASURES RECOGNISED AS EQUIVALENT 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 CEM CFR CSF EBL EC 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 Contagious Equine Metritis Code of Federal Regulations Classical Swine Fever (Hog Cholera) Enzootic Bovine Leucosis European Community EPIA Egg Products Inspection Act FFDCA Federal Food, Drug and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FMD Foot and Mouth Disease IBR ND OIE Infectious Bovine Rhinotracheitis Newcastle Disease Organisation International des Epizooties PHSA Public Health Service Act PM ScVC SVD Post Mortem Scientific Veterinary Committee Swine Vesicular Disease Bovine Tuberculosis TB Transmissible Mink Encephalopathy TME Transmissible Spongiform Encephalopathy TSE U. S. United States of America WTO World Trade Organisation 25 - Commodity - Species European Community Exports to the United States United States Exports to the European Community | Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 1. Live animals Animal health - Equidae 90/426 Annex DandC 9 CFR 92 for the each EC to submit by 1 July EC 1997, testing laboratory procedures, antigens/ reagents used, audit/quality control program, external control/laboratory approval programme. Inter-laboratory reference testing and exchange of samples between designated EC and U. S laboratories for CEM, glanders, dourine, equine piroplasmosis, and infectious equine viral arteritis to be carried out by 1 July 1997. anaemia to consider, by 1 U. S. September 1997, withdrawing requirement for post-import quarantine on the bases of results. U. S. to assess EC request on disease status for dourine 3 and glanders within months of EC submission. U. S. to review their CEM and piroplasmosis requirements by 1 January 1998. 9 CFR 75,91 71, 90/426, 92/260, 93/195, 93/196, 93/197,94/467 U. S. to consider identifying horses by passport from 31. 12. 1997. for departure EC to consider withdrawing isolation requirement before for permanent imports within 6 months of the submission of I the final report on VS outbreak - 26 Commodity Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) I. Live animals (cont. ) animal health - Bovine 9 CFR 92 64/432, 72/462, 90/425 Animals E U. S. to review BSE policy with respect to high and low incidence. 9 CFR 71, 72, 73, 77, 78, 80 91 72/462 E to produce generic U. S. conditions for EC - Shccp/Goats 91/68 9 CFR 92 E to produce generic U. S. conditions for EC 9 CFR 54, 71, 79,77 91/68,97/231 E j EC to review U. S. dossier on I 1 bluetongue U. S. to provide details ofj RB51 brucellosis vaccine, fori fl review by EC EC to produce conditions fori 1 U. S. EC to review U. S. dossier onl | bluetongue to submit scrapie! U. S. final | programme when review is completed. EC to J 1 comment • Swine 64/432, 72/462, 90/425 9 CFR 92 E to produce generic U. S. conditions for EC 9 CFR 71, 76, 77,78, 85 72/462 E EC to produce conditions fori | U. S. EC to produce conditions fori U. S. - - Dogs and cats 92/65 9 CFR 92 NE 92/65 NE —j——————-——— • "Balai" animals 92/65 9 CFR 92 NE 92/65 NE i 27 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health '' • — 2. Live poultry and hatching eggs Animal health 90/539, 93/342 9 CFR 92 to produce generic U. S. conditions 9 CFR 71, 82, 145, 147 90/539, 93/432 96/482,96/483 3. Semen Animal health - Bovine 88/407 9CFR98 E to produce generic U. S. conditions for EC 9CFR 71,77,78 88/407,94/577 E - Sheep/Goats 92/65 9CFR98 • Porcine 90/429 9CFR98 E E to produce generic U. S. conditions for EC 9 CFR 71,79 Directive 92/65 NE to produce generic U. S. conditions for EC 9 CFR 71, 78, 85 90/429,93/199 E - Canine - Feline. 92/65 92/65 9CFR 98 NE NE 92/65 92/65 NE NE f I | EC to produce conditions to allow use of new elisa test kill | for bluetongue EC to consider allowing | movement between centres I third | in two | countries approved EC to examine U. S. request! that CSF tests not be required I on entry and exit from! centres in countries free ofl the disease. • , 28 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animai/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) |U. Equine semen, ova and embryos Animal health Semen 92/65, 95/307 9 CFR 98 NE 9 CFR 71, 75 92/65,96/539 NE 3 29 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actjons Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 4. Equine semen, ova and embryos - animal health - cont'd 9 CFR 98 - Ova 92/65,95/294 NE 9 CFR 71,75 92/65,96/540 NE - I-mbryos 92/65, 95/294 9 CFR 98 NE 9 CFR 71, 75 92/65,96/540 NE 5. Embrvos Animal health - Bovine 89/556 9 CFR 98 E to produce generic U. S. conditions for EC. 9 CFR 71, 77, 78 89/556,92/471 E -: U. S. to review suspension of imports from BSE affected countries -Ovine/Caprine 92/65 9 CFR 98 NE 92/65 NE | 30 Commodity Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) 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 U. S. to review rules on BSE to high/low with incidence regions respect 9 CFR 53 (in the case of an outbreak of exotic disease) •IZquidae 64/432, 72/461, 72/462 9 CFR 94 Yesl 9 CFR 53 72/462, 82/426 Yes 2 72/462, 82/426 Yes 2 3 month residence. • freedom Holding from brucellosis for ovines and caprines 3 month residence -Porcine 64/432, 72/461, 72/462 9 CFR 94 Yesl. • 9 CFR 53 72/462, 82/426 Yes 2 3 month residence. Holding brucellosis freedom from | 31 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 6. Fresh meat cont'd 'ublic health 64/433, 96/22 9 CFR 301-381, 416,417 Yes 3 listed Establishments in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). (8) Ruminants Equidae Porcine Ovine Caprine Equivalency (Yes 2) shall be granted after the U. S. has completed verification of veterinary delivery systems. This be completed within 12 months of the date of entry into force of the agreement. process shall 9 CFR 301-381, 416,417 72/462, 93/158, 96/22 Yes 3 listed Establishments in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3) (4) and (5). The EC shall evaluate the U. S. residue programme, and additional information to be submitted by the U. S. , to determine whether it meets the EC level of protection. shall be This evaluation completed within 6 months of the entiy into force of this Agreement he I The EC shall evaluate the U. S. water standards to determine whether they meet the EC level of protection. This evaluation shall be completed within 6 months of the entry into force of this Agreement The EC to evaluate a U. S. I request, when submitted, onl continued! for the need of| testing trichinae ' horsemcat. 32 -Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public FX Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 6. Fresh meat - public health - cont'd 7. Poultry meat Animal health 91/494,94/438 9 CFR 94 Yesl Public health 71/118, 96/22, 96/23 9 CFR 381 Yes 3 listed Establishments in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). Post-mortem inspection to be carried official out by inspectors Equivalency (Yes 2) shall be granted after the U. S. has completed verification of veterinary delivery systems. This be completed within 12 months of the date of entry into force of the agreement. process shall -j Re footnote 5 (e), the results of the after inspections 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 the agreement The EC shall evaluate the U. S. residue programme, and additional information to be submitted by the U. S. , to determine whether it meets the EC level of protection. This evaluation shall be completed within 6 months of the entry into force of this Agreement ' 33 9 CFR 53 9 CFR 381. 1 381. 5 91/494,93/342 94/984 71/118, 96/22, 96/23,96/712 Yesl Yes 3 listed Establishments in accordance with footnote (7), fulfilling the relevant and provisions of footnotes (2), (3), (4) and (6). - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public FX Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 7. Poultry meat - public health - cont'd standards The EC shall evaluate the to U. S. water determine whether they meet the EC level of protection. This evaluation shall be completed within 6 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 U. S. 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 the agreement. 34 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 8. Meat Products Animal health • Red Meat (ruminants/ equidae) Pies. 64/432, 72/461, 72/462, 80/215 64/432, 72/461, 72/462,80/215 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries U. S. to review rules on BSE with to high/low incidence regions respect 9 CFR 53 72/462,97/221 Yes 2 9 CFR 94 Yesl 9 CFR 53 72/462,97/221 Yes 2 Poultry 92/118, 72/462, 80/215,94/438 9 CFR 94 Y e sl 9 CFR 53 97/221 Yes 2 • Wild game and fanned eame 92/495, 92/45 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries U. S. to review rules on BSE with to high/low incidence regions respect 92/495,92/45 97/221 NE Derived from meat meeting the conditions of point 6 (fresh meat). Derived from meat meeting the conditions of point 6 (fresh meat). Derived from meat meeting the conditions of point 7 (poultrymeat). I | 35 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public FC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 8. Meat Products cont'd Public health Ruminants w Equidae Pigs \ Poultry 77/99, 96/22 Yes 3 CFR 301-335, 354, 381. 1- 381. 500 listed Establishments in accordance with footnote (7), the relevant and fulfilling provisions of footnote 1. 9 CFR 301-335, 354, 381. 1- 381. 500 72/462, 77/99, 92/118,96/22 Yes 3 Equivalency (Yes 2)shall be granted after the U. S. has of completed verification veterinary delivery systems. This be completed within 12 months of the date of entry into force of the agreement. process shall and/or Derived from meat meeting the conditions of point 6 7 (fresh meat) (poultrymeat). Establishments in accordance with footnote (7), and fulfilling the relevant provisions of footnotes (2), (3) and (4). listed The EC shall evaluate the U. S. residue programme, and additional information to be submitted by the U. S. , to determine whether it meets the EC level of protection. This evaluation shall be completed within 6 months of the entry into force of this Agreement. standards The EC shall evaluate the to U. S. water determine whether they meet the EC level of protection. This evaluation shall be completed within 6 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 shall be completed within 12 months of the entry into forpe of the agreement. process 36 - Commodity - S pee les. European Community Exports to the United States United States Exports to the European Community I Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health FFDCA, FIFRA, PHSA 21 CFR 70-82, 101, 109, 110. 3-110. 93, 113, 114, 170- 189, 510-529, 556 40 CFR 180, 185 Existing trade conditions 77/99, 92/118, 96/22 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 8. Meat Products - public health - cont'd Wild came W NE 77/99, 96/22 Farmed came (8) 9. Farmed game meat Animal health -Deer 72/461, 92/118, 91/495 9 CFR 94 Yes 2 Additional certification from BSE affected countries U. S. to review rules on BSE with to high/low incidence regions respect 92/118,91/495 97/219 NE -Rabbit Yesl -Porcine 72/461, 92/118, 91/495 9 CFR 94 Yesl -Feathered 92/118, 72/462, 80/215,94/438 9 CFR 94 Yesl 92/118 NE 9 CFR 94 92/118,97/219 NE 1 J 37 • Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public F. C Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 9. Farmed game meat cont'd Public health (8) footnote See 91/495, 96/22, 97/219 for ruminants FFDCA, FIFRA, PHSA 21 CFR 70-82, 101, 109, 110. 3-110. 93, 113, 170-189, 510-529,556 40 CFR 180, 185 9 CFR 301-335, 352,354 NE Existing trade conditions 91/495, 96/22, 97/219 NE FFDCA, FIFRA, PHSA 21 CFR 70-82, 101, 109, 110. 3-110. 93, 113, 510-529,556 40 CFR 180, 185 9 CFR 301-335, 352,354 170-189, 10. Wild game meat Animal health -Deer 92/45 9 CFR 94 E 92/45,97/218 NE -Rabbit -Porcine 92/45 9 CFR 94 E • , 92/45,97/220 NE ] , 38 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions ' ' •' i Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 10. Wild game meat - animal health - cont'd -Feathered 9 CFR 94 92/45 £ NE Existing trade conditions Public health See (8) footnote for ruminants 96/22, 92/45, 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 92/45,97/218 NE 96/22, 92/45, 96/23, 97/218, 97/220 NE 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 39 Commodity Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards l U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 11. Fisheries products for human consumption Animal health -Fish/fisheries products USDI & Title 50 91/67 NE -Bivalve molluscs/ crustaceans (excl. live) Public health -Fish/fisheries products 91/67 USDI & Title 50 NE 91/493, 96/22, 96/23 21 CFR 123, 1240 Yes 3 Low Acid Canned Food requirement USDI & Title 50 91/67 USDI & Title 50 91/67 NE NE 21 CFR 123, 1240 91/493, 95/328, 96/22,96/23 Yes 3 95/328 U. S. to respond, by 1 July detailed with 1997, indication of how the EC request for equivalence for Low Acid Canned Food can be considered. By May 15, EC to provide (1) appropriate information and on documentation procedures for audit and control of implementation by Member States, and (2) information on application of HACCP in Member States. systems EC to evaluate new U. S. standards if applicable U. S. to inform the EC when the U. S. is ready to have the implementation of its seafood HACCP Regulation reviewed. EC to carry out review, involving necessary as examination of information to be and documentation provided by U. S. on procedures for audit and control of implementation. On-site verification of U. S. system to be carried out within 6 months of U. S. request. ' 40 - Commodity -. Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) 1 health 1 1 ~l 11. Fisheries products for human consumption - Public Health - cont'd - Fisli/fisheries products cont'd Before 1 September 1997, U. S. to conduct on-site verification of EC system to EC visit (including central and offices observation of Commission audits of a number of Member States). to indicate any U. S. outstanding problems following above actions by 15 October 1997. If EC. The outcome of the on-site verification to be discussed on-site with verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. NMFS Voluntary HACCP based Program 50 CFR 260 Yesl to indicate any EC problems outstanding following actions within 45 days of on-site verification. above If EC. The outcome of the on-site verification to be discussed with on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. "Establishments" do not include "brokers or traders". 41 - Commodity - Species European Community Exports to the United States United States Exports to the European Community — 1 Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 11. Fisheries products for human consumption - Public Health - cont'd -Bivalve molluscs/ crustaceans excl. live) 91/492, National Shellfish Sanitation Programme Yes 3 I Existing trade conditions for EC to supply the raw data used scientific the assessment on flesh/water testing. U. S. shall respond to results scientific assessment within 90 days of receipts of raw data. of documentation By May 15, EC to provide information (1) appropriate ' on and for audit and procedures implementation control of by Member States, and (2) information on application of HACCP in Member States. systems Before 1 September 1997, U. S. to conduct on-sitt verification of EC system to EC visit (including and offices central observation of Commission audits of a number of Member States). to indicate U. S. any problems outstanding following above actions by 15 October 1997. 91/492 Yes 3 Existing trade conditions National Shellfish Sanitation Programme comparison testing of Joint for flesh/water classification of production areas. U. S. to inform the EC when the U. S. is ready to have the its implementation seafood HACCP Regulation, reviewed. of by U. S. EC to carry out review, necessary as involving examination of information and documentation to be provided on procedures for audit and control of implementation. On-site verification of U. S. system to be carried out within 6 months of U. S. request. to indicate any EC problems outstanding following above ' actions within 45 days of on-site verification. 42 - Commodity - Species European Community Exports to the United States Umted States Exports to the European Community 1 Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) ===== 11. Fisheries products for human consumption - Public Health - cont'd -Bivalve molluscs/ crustaceans (excl. cont'd Live) The outcome of the on-site verification to be discussed with on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. EC. If If EC. The outcome of the on-site verification to be discussed with on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. - Aquaculture animals and products 91/493, 96/22, 96/23 NE National Shellfish Sanitation Programme, FFDCA, FIFRA, PHSA, 21 CFR 110. 3- 123, 110. 93, 1240, DVM 12. Live fish / shellfish and gametes Animal health 91/67 NE 91/493, 96/22, 96/23 NE National Shellfish Sanitation Programme, FFDCA, FIFRA, PHSA, 21 CFR 110. 3- 123, 110. 93, 1240, DVM 91/67 NE "Establishments" do not include "brokers or traders". 43 - Commodity - Species European Commumty Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public IZC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 113. Milk and milk based products for human consumption Animal health -Cattle including buffalo Certification FMD affected regions 64/432, 92/46 9 CFR 94 Yes 2 to UHT non-FMD affected For countries/regions a certificate of origin is required. for to U. S. double acceptable. review whether pasteurisation 9 CFR 77,78 92/46,95/343 Yes 2 TB and requirements treated Brucella for non-heat EC to review U. S. TB and Brucella programmes -Sheep -Goats i t 44 - Commodity - Species European Community Exports to the United States United States Exports to the European Commumty Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 3. Milk and milk based products for human consumption cont'd 'ubiic health •UHT-Milk/ sterilised Milk Existing trade conditions. Yes 3 92/46, 94/71, 95/340, 95/342, 96/23, 96/22, 97/115, 91/180, 92/608, 92/118, 96/90 FFDCA,FIFRA, PHSA 21 CFR 108, 70-82, 110. 3-110. 93, 113, 131, 172, 184, 510-520, 556, 1210, 1240 40 CFR 180, 185 U. S. to review Import Milk Act. U. S. to respond, by 1 July 1997, with detailed indication of how the EC request for equivalence for Low Acid be Food Canned considered. can Joint laboratories to be completed assessment of EC to provide appropriate and information documentation on for audit and procedures control of implementation by Member States. U. S. to review information provided, and to carry out on-site verification of EC system. 92/46, 94/71, 95/340, 95/342, 95/343, 96/22, 96723, 97/115, 91/180, 92/608, 92/118,96/90 FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 110. 93, 113, 131, 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 U. S. to consider including HACCP system in dairy products Joint laboratories to be completed assessment of Discussions on somatic cells and plate counts to continue U. S. to provide appropriate and information on documentation procedures for audit and control of implementation. EC to review information provided, and to cany out on-site verification of U. S. system. If The outcome of the on-site verification to be discussed with U. S. on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out 45 1 j-Commodity -Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) i- ! health l. 3. Milk and milk based products for human consumption - public health - cont'd •UHT-Miik/ sterilised Milk cont'd -Pasteurised products 92/46, 94/71, 95/340, 95/342, 96/23, 96/22, 97/115, 91/180, 92/608, 92/118, 96/90 Pasteurised Milk Ordinance for Grade A Products and related documents FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3-. 108, 110. 93, 113, 131, 133, 135, 172, 184, 510- 556, 520, 1210,1240 40 CFR 180, 185 Yes 3 Existing trade conditions coli E cheeses) requirement (for If EC. The outcome of the on-site verification to be discussed with on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out. can The U. S. to respond, by 1 July 1997, with a detailed indication of how the EC request for equivalence to be "Grade A" considered, and to the possibility of allow export of such products to the U. S. V. S. to review Import Milk Act. thus Discussions on differences in finished product criteria for E coli to continue. Joint laboratories to be completed assessment of Pasteurised Milk Ordinance for Grade A Products and related documents FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 110. 93, 113, 131, 133, 135, 172, 184, 510- 556, 520, 1210,1240 40 CFR 180, 185. 92/46, 94/71, 95/340, 95/342, 95/343, 96/22, 96/23, 97/115, 91/180, 92/608, 92/118,96/90 Yes 3 EC requirements for somatic cell and plate counts Certification as per 95/343 U. S. to consider HACCP system products including in dairy Joint laboratories to be completed assessment of Discussions on somatic cells and plate counts to continue U. S. to provide appropriate , and information on documentation procedures for audit and control of implementation 46 - Commodity - Species European Commumty Exports to the United States United States Exports to the European Community 1 Trade Conditions Equiv Special Conditions Actions , Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health -Pasteurised products cont'd 13. Milk and milk based products for human consumption - public health - cont'd EC to provide appropriate and information on documentation for audit and procedures control of implementation by Member States U. S. to review information provided, and to carry out on-site verification of EC system. If EC. The outcome of the on-site verification to be discussed with on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out Pasteurised Milk Ordinance for Grade A Products and related documents The U. S. to respond, by 1 July 1997, with a detailed indication of how the EC request for equivalence to be "Grade considered, and to allow the possibility of export of such products to the U. S. thus can A" EC to review information provided, and to cany out on-site verification of U. S. system. If The outcome of the on-site verification to be discussed on-site with U. S. verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out 47 Pasteurised Milk Ordinance for Grade A Products and related documents - Commodity - Species European Community Exports to the United States , u United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 13. Milk and milk based products for human consumption - public health - cont'd -Not Pasteurised (raw or thermiscd) 91756;—547717 95/340, 95/342, 97/115, 91/180, 92/608, 92/118, 96/23, 96/22, 96/90 Discussions on ditterences in finished product criteria for E coli to continue. Compliance with E coli requirement (for cheeses) Joint laboratories to be completed assessment Y ê sT of WUCK, FIFRA, PHSA 21 CFR 70-82, 108, 110, 113, 133, 172, 184, 185, 510-520, 556, 1240 40 CFR 180 EC to provide appropriate and information on documentation for audit and procedures control of implementation by Member States. U. S. 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 U. S. 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 U. S. Prohibition on products not matured for more than 60 days at temperature above 35°F (+2°C). 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 YêsT with Compliance EC requirements for somatic celt and plate counts Certification as per 95/343 TTS^oconsiaePTncluding J HACCP system in dairy | products. of Joint laboratories to be completed. assessment Discussions on somatic cells and plate counts to continue. U. S. to provide appropriate and information documentation on for audit and procedures of control implementation. EC to review information provided, and to carry out on-site verification of U. S. system. If The outcome of the on-site verification to be discussed with VS. on-site verification satisfactory, the equivalence determination to be finalised, and any necessary procedures carried out •J 48 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 92/118,64/432 14. Milk and milk based products not for human consumption Animal health -Cattle including buffalo -Sheep -Goats For affected regions, a certificate of origin is required. For FMD affected regions, certification to UHT 9 CFR 94. 16 non-FMD Yes 2 to review U. S. if double pasteurisation of products from FMD affected regions is acceptable. 9 CFR 77,78 92/118, 95/341 NE - All- pasteurised or UHT or Sterilised -Unpasteurised colostrum for pharmaceu tical use (l0) 92/118 9 CFR 94. 16 NE 9 CFR 77, 78 92/118 NE 1 | | 49 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions 1 1 Animal/Public EC Standards U. S. Standards (Cat) health. U. S. Standards EC Standards (Cat) ^ ^ = S = a B S = S S S = S S B ^ xJ 15. Minced meat Animal health - Ruminants 64/432, 72/461, 72/462 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. U. S. to review rules on BSE with to high/low incidence regions. respect - Pigs 64/432, 72/461, 72/462 9 CFR 94 Yesl Public health VS)— 94/65 9 CFR 301-381 Yes 3. Ruminants Pigs listed Establishments in accordance with footnote (7), and fulfilling the relevant provisions of footnote (1). Equivalency shall be granted after the U. S. has completed of veterinary verification delivery This process shall be completed within 12 months of the date of entry into force of the agreement. systems. 72/462 NE 72/462 NE 9 CFR 301-381 94/65,97/29 Yes 3 Derived from meat meeting the conditions of point 6 (fresh meat). listed in Establishments accordance with footnote (7), and the relevant provisions of footnotes (2), (3) and (4). fulfilling • The EC shall evaluate the U. S. residue programme, and additional information to be submitted by the U. S. , to determine whether it meets the EC level of protection. This evaluation shall be completed within 6 months of the entry into force of this Agreement. standards The EC shall evaluate the U. S. water to determine whether they meet thé EC level of protection. This evaluation shall be completed within 61 months of the entry into force of this Agreement. 50 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 1 I 1 15. Minced meat - public health - cont'd 16. Meat preparations Animal health -Ruminants 64/432, 72/461, 72/462 9 CFR 94 Yes 2 Additional certification for bovines from BSE affected countries. U. S. to review rules on BSE with to high/low incidence regions. respect 72/462 NE -Equidae -Pigs 64/432, 72/461, 72/462 9 CFR 94 Yesl 92/118, 72/462, 80/215,94/438 9 CFR 94 Yesl -Poultry / Wild game / Fanned game 72/462 NE 91/494, 93/342, 94/984 NE 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 the agreement EC to consider reviewing scope of definition of minced meat. | I 51 • - Commodity - Species European Community Exports to the United States United States Exports to the European Community I Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 16. Meat preparations cont'd Public health Ruminants (t>> Equidae Pigs Poultry 94/65 9 CFR 301-381 Yes 2/3 Establishments listed in accordance with footnote (7), the relevant and fulfilling provisions of footnote (1). 9 CFR 301-381 94/65,97/29 Yes 3 Equivalency shall be granted after the U. S. has completed veterinary of verification delivery This systems. process shall be completed within 12 months of the date of entry into force of the agreement. Derived from meat meeting the conditions of point 6 7 (fresh meat) (poultrymeat). and/or listed Establishments in accordance with footnote (7), fulfilling the relevant and provisions ' of footnotes (2), (3) and (4). The EC shall evaluate the U. S. residue programme, and additional information to be submitted by the U. S. , to determine whether it meets the EC level of protection. This evaluation shall be completed within 6 months of the entry into force of this Agreement. standards The EC shall evaluate the U. S. water to determine whether they meet the EC level of protection. This evaluation shall be completed within 6 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 be completed within 12 months of the entry into force of the agreement. process shall 52 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 1 1 -, 16. Meat preparations - public health - cont'd Wild name W 94/65 NE Existing trade conditions :armed game (S) 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, 510-529,556 40 CFR 180, 185 170-189, — - —i " ' ' i i. n i i ,,. -. i — — _ • _. —_ i _ —— * " " ~ "3 17. Animal casings for human consumption Animal health -Cattle 9 CFR 96 Yes 2 92/118, 64/432, 72/461,72/462 Non-comminglement footnote 9). (see trade allowed No countries affected by BSE. for -Pigs 92/118, 64/432, 72/461,72/462 9 CFR 96 Yes 2 Non-comminglement footnote 9). (see attesting to Certification process and origin for casings free originating countries/regions but processed in ASF affected country/region. in ASF U. S. to review rules on BSE with to high/low respect incidence regions. U. S. to review 94. 8(a)(i)(v) of non- comminglement U. S. to review 94. 8(a)(i)(v) of non- CFR comminglement. CFR for for 92/118 94/187 NE 92/118 94/187 NE | • 53 1 - Commodity - Species European Community Exports to the United States United States Exports to the European Commumty Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 17. Animal casings for human consumption - animal health - cont'd •Sheep •Goats 92/118, 64/432, 72/461,72/462 9 CFR 96 Yes 2 Non-comminglement footnote 9). (see U. S. to review 94. 8(a)(i)(v) of non- CFR comminglement. for 92/118 94/187 NE trade No countries affected by BSE allowed for attesting Certification to process and country of origin in for casings originating but BSE processed in BSE affected country. countries free Public health 77/99 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 to notified 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 1 1 1 54 1 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public T;C Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health i 18. Animal casings not for human consumption Animal health •Cattle 9 CFR 96 Yes 2 92/118,64/432 72/461,72/462 Non-comminglement footnote 9). (sec U. S. to review rules on BSE with to high/low respect incidence regions. 92/118 94/1^7 NE trade No countries affected by BSE allowed for -Pigs 92/118,64/4327 2/461,72/462 9 CFR 96 Yes 2 Non-comminglement footnote 9). (see -Sheep -Goats 92/118,64/4327 2/461,72/462 9 CFR 96 Yes 2 attesting in ASF Certification to process and origin for casings free originating but countries/regions processed in ASF affected country/region. Non-comminglement footnote 9). (see trade No countries affected by BSE. allowed for attesting Certification to process and country of origin in for casings originating BSE but processed in BSE affected country. countries free U. S. to review 94. 8(a)(i)(v) non- of comminglement CFR for U. S. to review 94. 8(a)(i)(v) of non- comminglement CFR for U. S. to review 94. 8(a)(i)(v) of non- comminglement CFR for 92/118 94/187 NE 92/118 94/187 NE 1 1 | 1 '• 55 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions - Animal/Public HC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) ij health. ! 19. Hides and skins Animal health -Cattle -Sheep -Goats 92/118, 72/461, 72/462 ! TV - P i gs 9 CFR 95. 5, 95. 6 Yesl 120. Canned petfood containing high/low risk material - 92/118 97/168 E Containing mammalian. material 92/118 90/667 92/562 92/118 90/667 92/562 Containing non- only mammalian material 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- 507- 110. 93, 509, 570, 573- 589 Yes 2 rules Special for BSE countries. Shelf stable for remainder. U. S. to review rules on BSE to high/low with incidence regions. respect FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 92/118 94/309 96/449 97/199 Yes 2 Shelf stable for remainder. FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 92/118 94/309 96/449 97/199 Establishments shall have been validated by the U. S. for alternative heat treatment including 30 day freedom from Clostridia • to EC salting requirement identify basis 1 fori | EC to examine U. S. claim to | be BSE free. EC to consider alternative! guarantees for mammalian material, including U. S. proposal to remove all risk material of known U. S. TSE species from petfood. 56 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health Containing 21. Canned petfood containing only low risk material rules 92/118,90/667 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3- 507- 110. 93, 509, 570, 573- 589 mammalian material Yes 2 for Special BSE countries. Shelf stable for remainder. Containing non- ' - only mammalian material 92/118,90/667 9 CFR 94, 95 Yes 2 Shelf stable. FFDCA, FIFRA 21 CFR 110. 3- 507- 110. 93, 509, 570, 573- 589 U. S. to review rules on BSE with to high/low incidence regions respect 92/118,94/309 96/449,97/199 92/118,94/309 96/449,97/199 FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 Establishments shall have been validated by the U. S. for alternative heat treatment including 30 day freedom from Clostridia 22. Dry and semi moist petfood containing only low risk material Yes 2 Restrictions countries for 92/118 94/309 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3- 507- 110. 93, 509, 570, 573- 589 BSE U. S. to examine EC 90° core temperature requirement as sufficient providing against FMD, guarantees CSF,SVD,ASFandND. U. S. 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 Î Establishments shall have been validated by the U. S. for alternative heat treatment including 30 day freedom from Clostridia 1 - 57 1 - Commodity - Species European Community Exports to the United States United States Exports to the European Community j Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions , 8 /\ninial/Ptiblic EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health. < 1 H -, — ' 92/118,94/309 123. Dry and semi moist petfood containing high/low risk material 1 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 Contain m mal i an terial Restrictions countries ma ma ~ Yes 2 inc >• for. 1 ~ 1. -. ~ ~^ 1. BSE U. S. to examine EC 90° C core temperature requirement as sufficient guarantees against FMD, CSF. SVD. ASFandND. providing U. S. to review rules on BSE with to high/low respect incidence regions. 92/118,94/344 96/449,97/199 FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 EC to examine U. S. claim to be BSE free. EC to consider alternative for mammalian guarantees material, including U. S. proposal to remove all risk material of known U. S. TSE species from petfood. 92/118,94/309 Containing non- only mammalian material Yesl 9 CFR 94, 95 FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 U. S. to examine EC 90° C core temperature requirement as sufficient providing guarantees against ND. FFDCA, FIFRA 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 92/118,94/344 97/199 Establishments shall have been validated by the V. S. for alternative heat treatment including 30 day freedom from Clostridia 58 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions J 1 Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health for for BSE BSE Yesl Yes 2 Yes 2 91/495 respect 9 CFR 95 9 CFR 95 9 CFR 95 Restrictions countries. Restrictions countries. 92/118,80/215 72/462, 94/438 64/432 72/461 80/215 72/462 U. S. to review rules on BSE with to high/low incidence regions. 24. Bones and bone products for human consumption ("other products" as defined in 77/99/EEC) Animal health Fresh meat (ruminants, horses, pigs) Farmed game - pigs, deer Fresh meat - poultry Feathered farmed wild same Wild Game, Pics Deer Public health •Ml IM • All species Feathered, farmed wild game U. S. to review rules on BSE with to high/low incidence regions. U. S. to review rules on BSE with to high/low incidence regions. 64/433, 77/99, 92/118 Restrictions countries. 92/45 91/495 77/99,92/118 9 CFR 95 9 CFR 95 9 CFR 95 and and respect respect Yes 2 92/45 Yesl BSE NE NE for 72/462 97/221 91/495 92/118 92/45 91/495 92/45 FIFRA, FFDCA, 21 CFR 70-82, 108, 109, 110. 3-110. 93, 113, 170-189, 510-529/556 77/99,92/118 77/99,92/118 Draft Decision to notified WTO FIFRA, FFDCA, 21 CFR 70-82, 108, 109, 110. 3-110. 93, 113, 510-529,556 170-189, NE NE NE NE NE NE NE EC to consider establishing! \ conditions. 59 j - Commodity J- Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public F. C Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) fhclth P25. Bones, horns and hooves and their products not for human consumption Ycsl Animal health 96/239 9CFR95 9 CFR 53 94/446 NE 26. Processed animal protein for human consumption Animal health Fresh meat (•/uminants, equidae, pigs) 64/432,72/461 80/215,72/462 Not accepted countries. 9 CFR 95 Yes 2 from BSE U. S. to review rules on BSE with to high/low incidence regions. respect 72/462,97/221 NE Farmed game - nigs, deer Fresh meat - poultry Feathered farmed wild name Wild Game, Pigs Deer and 91/495 9 CFR 95 Yes 2 Not accepted countries. from BSE U. S. to review rules on BSE to high/low with incidence regions. respect 92/118,80/215 72/462,94/438 9 CFR 95 Yesl 92/45 91/495 9 CFR 95 Yesl 92/45 9 CFR 95 Yes 2 Not accepted countries. from BSE U. S. to review rules on BSE with to high/low respect incidence regions. 91/495 NE 92/118 NE 92/45 91/495 NE 92/45 NE EC to examine U. S. claim to be BSE free. EC to consider alternative guarantees for mammalian material, including U. S. proposal to remove all risk! material of known U. S. TSEI | species from petfood. I 60 1 J - CiMiunoditv 1 i - 'sj'OsU'S European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animiil'Tulilii; I'C Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) j • ihcilih II 26. Processed animal protein for human consumption cont'd Public health All species (A> Feathered. farmed wild game 77/99,92/118 and 77/99 Yesl NE (<s) •i i FIFRA, PHSA, FFDCA, 21 CFR 70-82, 108, 109, 110. 3-110. 93, 113, 170-189, 510-529,556 I 27. Processed animal protein not for human consumption Containing material of manu Ruminants Yes 2 95 Not accepted countries. 92/118 90/667 from BSE malian origin 9 CFR FIFRA, FFDCA, 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 1 Non-ruminants 92/118 90/667 Yes 3 95 9 CFR FIFRA, FFDCA, 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 77/99,92/118 NE NE 77/99,92/118 Draft Decision notified to WTO FIFRA, PHSA, FFDCA, 21 CFR 70-82, 108, 109, 110. 3-110. 93, 113, 510-529,556 170-189, U. S. to review rules on BSE with to high/low incidence regions. respect FIFRA, FFDCA, 21 CFR 110. 3- 110. 93, 507- 509, 570, 573- 589 FIFRA, FFDCA, 21 CFR 110. 3- 507- 110. 93, 509, 570, 573- 589 90/667,92/118 92/562,94/344 96/449,97/198 NE 92/118, 90/667, 96/449 NE Establishments shall have been validated by the U. S. for treatment alternative heat freedom including 30 day from Clostridia |. ' 1 EC to examine U. S. claim to | j be BSE free. EC to consider alternative for mammalian guarantees material, including U. S. proposal to remove all risk material of known U. S. TSE species from petfood. i 61 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 27. Processed animal protein not for human consumption cont'd Containing only material of non mammalian origin Poultry fish and 92/118,90/667 9 CFR 95 Yesl Non-ruminants 92/1 IS, 90/667 9 CFR 95 Yesl 28. Scrum of eq uidae Animal health 92/118,94/143 9 CFR 95,122 NE 90/667,92/118 92/562, 94/344, 97/198 NE 92/118,90/667 NE Establishments shall have been validated by the U. S. for treatment alternative heat including 30 day freedom from Clostridia. 92/118,94/143 NE 29. Blood and blood products intended for human consumption Animal health Fresh meat (ruminants, equidac, pigs) 64/432, 72/461 80/215,72/462 BSE rules for ruminants. 9 CFR 95,122 E Farmed game - pigs, deer Fresh meat - poultry 91/495 9 CFR 95,122 Yes 2 BSE rules for ruminants. 92/118,80/215 72/462, 94/438 9 CFR 95, 122 Yesl U. S. to review rules on BSE with to high/low respect incidence regions. 9 CFR 53 72/462 97/221 to produce generic U. S. conditions for EC U. S. to review rules on BSE with to high/low incidence regions. respect 91/495 92/118 NE NE NE J 1 I I 62 | 8 [ 1 EC to consider establishing! j conditions. - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/l'ublic HC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health Yesl and 92/45,91/495 9 CFR 95, 122 29. Blood and blood products intended for human consumption - Animal health - cont'd Feathered fanned wild game Wild Game, Pius Deer Public health 9 CFR 95,122 92/45 77/99 Yesl NE 9 CFR 301-381, 416, 417 FFDCA, FIFRA, 21 CFR 110. 3-110. 93, 507-509, 570, 573-589 NE NE NE 92/45 91/495 92/45 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 30. Blood and blood products not intended for human consumption Animal health 92/183,92/118 9 CFR 95. 4, BSE rules for ruminants. Permit required Yes 2 122 U. S. to review rules on BSE with to high/low incidence regions. respect 9 CFR 53 92/183,92/118 Yes 2 Bluetongue. requirements. treatment EC to consider use of tests for Bluetongue in place ofj treatment 63 - Commodity - Species European Community Exports to the United States United States Exports to the European Commumty Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions 1 1 Animal/Public EC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 1 31. Lard and rendered fats intended for human consumption Animal health meat Fresh BSE rules for ruminants. 9 CFR 95 Yes 2 J (ruminants. horses, pigs) 64/432 72/461 80/215 Fanned game - 91/495 9 CFR 95 Yes 2 BSE rules for ruminants. pigs, deer Fresh meat poultry Feathered farmed and wild game 92/118 80/215 94/438 92/45 91/495 9 CFR 95 Yesl 9 CFR 95 Yesl Wild G a m e. Pigs 92/45 9 CFR 95 Yes 2 BSE rules for ruminants: i Deer Public health All species ^' Feathered, farmed and • i. • ( S) wild game 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, j 510-529, 556 ^ U. S. to review rules on BSE with to high/low respect incidence regions. U. S. to review rules on BSE with to high/low incidence regions. respect * U. S. to review rules on BSE with to high/low incidence regions. respect 72/462 97/221 NE 91/495 NE 92/118 NE 92/45 91/495 92/45 NE NE 77/99,92/118 NE NE 77/99,92/118 Draft Decision to notified WTO 9 CFR 301-381, 416, 417 FIFRA, PHSA, FFDCA, 21 CFR 70-82, 108, 109, 110. 3-110. 93, 113, 510-529,556 170-189, • 64 - Commodity - Species European Community Exports to the United States — — • — — — — —— ' ' —' ' —'—» United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 32. Lard and rendered fats not intended for human consumption 9 CFR 95 Yes 2 BSE rules for ruminants. 92/118 90/667 72/461 U. S. to review rules on BSE to high/low with incidence regions. respect NE 92/118 Draft Decision notified to WTO EC to review requirements to of consider alternative heat treatment systems. inclusion to review EC U. S. bacteriological testing regime for protein fraction 33. Raw material for feeding stuffs, pharmaceutical or technical use Animal h e a l t h !9 2"18 ]9CFR95,i22 Yesl 9 CFR 53 92/118 EC to consider laying downl certification requirements for) imports 34. Apiculture products for apiculture Animal health |9 2 / 1 18 35. Game trophies Animal health 92/118 9 CFR 95 Yesl 92/118,94/860 NE 9 CFR 53 92/118 96/590 65 Commodity Species European Community Exports to the United States United States Exports to the European Commumty Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animnl/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 36. Manure Animal health P1 18 9 CFR 95 37. Wool, feathers and hair Animal health U. S. to provide temperature for manure requirements from regions affected by serious transmissible disease 9 CFR 53 92/118 92/118 92/118 9 CFR 95 9 CFR 95 AVool -Pigbristlc Public health 38. Honey Animal health Public health 92/118 Yesl Yesl NE NE NE NE NE NE NE NE r 9 CFR 53 9 CFR 53 92/118 92/118 94/435 FFDCA, PHSA 21 CFR 1240. 70 -. 92/118 FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110. 3- 110. 93, 520. 182, 520. 1660d FFDCA, PHSA 21 CFR 1240. 70 FFDCA, FIFRA, PHSA 21 CFR 70-82, 109, 110. 3- 110. 93, 520. 182, 520. 1660d i ! | 1 66 - Commodity - Species European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions • Animnl/Public EC Standards U. S. Standards (Cat) health U. S. Standards EC Standards (Cat) 39. Frog's legs Animal health Public health 92/118,96/340 FFDCA, NE FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 110. 93, 113, 114,123,1240 40. Snails for human consumption Animal health Public health 92/118,96/340 FFDCA, NE FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 113, 110. 93, 114,123,1240 - FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 110. 93, 113, 114,123,1240 FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3- 108, 113, 110. 93, 114,123,1240 92/118,96/340 NE EC to review U. S. HACCP j rules when submitted. | 92/118,96/340 NE • | 67 Commoditv S;vcies European Community Exports to the United States United States Exports to the European Community Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions l1 • Animal/Public F. C Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) S-U. Egg products for human consumption r-,—: Yes 2 /viumal health 90/539 9 CFR 94 r Public health 89/437, 92/118. 91/684, 96/23 7 CFR 59 EPIA Law 91-597 Public Permit required from areas affected Newcastle by disease. to U. S. requirement. review permit 90/539,93/342 Yesl U. S. to supply information on the legal basis for recognition of equivalence. 7 CFR 59 EPIA Law 91-597 Public 89/437, 91/684, 92/118, 96/23, 97/38 U. S. to complete assessment of health EC legislation public Establishments accordance with (7), and relevant footnote (2). fulfilling provisions listed footnote the of EC to complete assessment of U. S. public health legislation. The following tests are to be in conducted, as specified to Directive Annex VI on U. S. egg 89/437, products to Europe: for dispatch Chemical tests - 3 OH butyric acid - lactic acid - succinic acid - egg shell remains, egg membrane, other particles Bacteriological tests - mesophile counts - cntcrobactcriaccac - salmonella - staphylococcus Methods Internationally methods such as: NMKL, AOAC recognised ISO, 68 - Commodity i - Species European Community Exports to the United States United States Exports to the European Commumty 1 Trade Conditions Equiv Special Conditions Actions Trade Conditions Equiv Special Conditions Actions Animal/Public FC Standards U. S. Standards (Cat) U. S. Standards EC Standards (Cat) health 42. Shell Eggs Animal health P5 39 Public health 89/437,91/684 94/371,96/23 9 CFR 94 Yes 2 Permit required from areas Newcastle by affected disease. 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, 520, 524, 558,1240 40 CFR 180 7 CFR 56 178, 556, 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, 110. 3- 109, 110. 93, 570, 573-589 to U. S. requirement. review permit 9 CFR 94 90/539,93/342 Yesl U. S. to review legal basis for recognition of equivalence. U. S. to complete assessment health of legislation. public EC 89/437,91/684 94/371,96/23 EC to complete assessment of j U. S. 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, 520, 524, 558,1240 40 CFR 180 7 CFR 56 178, 556, NE NE 92/118 FFDCA, FIFRA, PHSA 21 CFR 70-82, 110. 3- 109, 110. 93, 570, 573-589 | ' I 69 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 U. S. 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, 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 will be 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. 70 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 program 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 meters of exposed product; pallets shall be clean, structurally sound, and covered with a sanitary plastic sheet. Those establishments which are already using plastic pallets shall continue to do so. When wooden pallets arc used in coolers or freezers, all product present shall be hygienically packaged to prevent contact of product with wood. 71 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. 0 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, dot note 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 Un packaged 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, spravs and hoses Meat shall not be contaminated by splashing. They shall not be used as a substitute for handwashing facilities. 72 0 Sterilization of equipment Establishments shall provide sterilization equipment (batch or local sterilizers) to clean utensils as often as necessary. Implements such as knives or hooks which come into contact with meat shall be cleaned and sterilized frequently, and in any case whenever they have been in contact with contaminated material or surfaces such as the external surfaces of hides. Sterilization shall be done with hot (>82°C) water. Footnote 4 Additional Guarantees for Finland and Sweden For trade from the U. S. to Sweden and Finland, the U. S. 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 72/462/EEC destined for manufacturing into meat products within Sweden/Finland. Footnote 5 Fresh meat, game meat, meat products, minced meat, meat preparations a) Accommodation for sick and suspect animals Wood shall not be used for pens for sick and suspect animals. Sick and suspect animals shall not be allowed to come into contact with animals intended for slaughter for export to the Community. Pens for sick and suspect animals shall be sited and constructed to preclude contact with animals intended for slaughter for export to the Community and effluent from such pens shall not flow into adjoining pens or passageways. b) Veterinary supervision of ante-mortem inspection All cattle intended for slaughter for export to the EC shall be inspected by an official FSIS veterinarian, except: feedlot animals inspected at the feedlot by a USDA accredited veterinarian; and 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. 73 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 1 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 9CFR 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 1 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 U. S. 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 1 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, offals 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 carcass is condemned its offal and blood shall also be condemned. 74 g) Partial Approval The veterinary authorities of the -EC and the U. S. may on a bilateral basis grant request for partial approval of red meat establishments for certain products, in accordance with the general and specific provisions of this agreement in respect of hygienic production and ante and post mortem inspection of slaughter animals, under the following conditions: 1. 2. 3. 4 5. 6. The establishment shall develop a Quality Assurance (QA) program 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 program 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 program and document such monitoring and ensure correction of deficiencies. The importing Party may verify the practical implementation of the QA program. In this case, the establishment needs to be in a position to demonstrate the program on the spot during an inspection. For this purpose, all relevant documentation shall be presented. 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 P o u l t r y m e at n) Countcrflow Chilline Where countcrflow chilling systems are used, alternative chilling systems to the EC standards may be used providing equivalent guarantees as regards avoidance of cross contamination, and carcass temperatures at the point of exit from the chilling systems as set out under point (b) below, 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. , 75 b) Poultry product temperature requirements Poultry shall be chilled to an internal temperature of 40 degrees F (4. 4 degrees C) in the shortest time possible after slaughter. In the case of small birds (up to 6 pounds), the internal temperature of 40 degrees shall be achieved by the end of the immersion chilling process. Where crushed ice is used to chill large birds (over 6 pounds) 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 degrees F, the internal temperature may exceed 40 degrees F for a maximum of one hour, but may not exceed 50 degrees F (10 degrees 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. ootnotc 7 Establishment Listing (applicable to all products where listing provisions apply) 1. The exporting Party is responsible for ensuring that establishments/plants authorised to export, and products certified for export, meet the relevant requirements. The exporting Party shall screen establishments to ensure that they meet the relevant requirements before proposing establishments for listing for export. The list, or lists, of approved establishments, and additions and deletions to such lists, shall be supplied to the importing Party by the exporting Party. The importing Party shall make modifications to the lists of approved establishments efficiently, on the basis of the information supplied by the exporting Party. Dissemination of such lists shall be carried out without delay*. The importing Party may carry out verification procedures, including inspection of the establishments, to ensure that the relevant requirements are being met. 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. 2. 3. ' 4. The Parties will review the functioning of the above mentioned 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. * The EC will carry out this commitment in accordance with the procedure laid down in Article 5 of Council Decision 95/408/EC. The U. S. will carry out this commitment in accordance with a similar timetable. i 76 Footnote 8 Bison and Water Buffalo For exports to the U. S. 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-Comminglemcnt - 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. 2. 3. 4. 5. 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. 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. 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. 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. Records of the origin of the animals from which the meat is produced shall be retained for a period of 6 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 U. S. ' Footnote 11 Residue Testing Residue testing shall continue to be carried out by the U. S. in accordance with applicable EC requirements. 77 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 a processing plants where animals or animal products might be handled, excluding retail premises. 2. general Principles 2. 1. The auditor and the auditee should co-operate 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. 78 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; and 3. 7. provisions for respect of commercial confidentiality and avoidance of conflicts of interest. 4. Opening Meeting An opening meeting should be held between representatives of both Parties. At this meeting the auditor will' review the audit plan and confirm that adequate resources and documentation are available and all necessary arrangements have been made for conducting the audit. 5. Document Review 5. 1. The document review may include, for example, the following: * * * * * * * records concerning compliance programmes; inspection and internal audit reports; documentation concerning corrective actions and sanctions; records of compliance actions taken; sampling plans and their results; documents associated with verification; and 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 audilec will co-operate fully with the auditor in the document review process and help to ensure that the auditor has access to requested documents and records. 79 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 co-operate 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; and training programmes. 9. Closing Meeting A closing meeting shall be held between representatives of both Parties, including officials responsible for the inspection and certification programmes of the auditee. At this meeting the auditor will present the findings of the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit arc clearly understood. 80 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 upon by the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will assess the adequacy of the auditee's enforcement and control programme and identify any deficiencies noted during the conduct of the audit. Thereafter, the auditee may within 60 days comment on the draft report and shall describe any specific corrective actions that will be taken, preferably with target dates for completion. Any comments made by the auditee shall be included in the final report. ANNEX VII FRONTIER CHECKS The Parties recognise the distinction between documentary, identity and physical checks carried out at external frontiers on imports of live animals and animal products. The Parties further recognise the need to take a systematic approach to carrying out frontier checks. Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of Annex C to the SPS Agreement. Live Animals The Parties may apply physical checks to all consignments of live animals. Animal Products In setting their physical checking frequencies for imports of animal products, the Parties shall take due account of the checks applied by the exporting Party prior to export and the historic performance of products imported from the exporting Party. The Parties may modulate the;r 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. 82 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. 83 ANNEX IX CONTACT POINTS The U. S. 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 phone: 1 202 862 9560 fax: 1202 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 U. S. Mission of the European Union 40 Blvd du Regent 1000 Brussels, Belgium phone: 32 2 508 2760 fax: 32 2 5110918 84 ISSN 0254-1475 COM(97) 566 final DOCUMENTS EN 11 03 02 05 Catalogue number : CB-CO-97-615-EN-C ISBN 92-78-27561-1 Office for Official Publications of the European Communities L-2985 Luxembourg