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21998A0421(01)

21998A0421(01) 21998A0421(01) Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal pro

Article 11, and the safeguards provided for in Article 12 of the Agreement.

In relation to exports from the USA, unless otherwise noted, these agencies are responsible for: - controlling the circumstances of domestic production and processing, - providing information concerning compliance with agreed regulatory requirements, - providing agreed additional guarantees, - carrying out the consultations provided for pursuant to Article 7 of this Agreement, - carrying out the information exchange provided for in Article 10,

Article 11, and the safeguards provided for in Article 12 of the Agreement.

A. Control of animal health 1. Animal diseases/pests (

  1. a)Live animals (including apiculture bees), embryos, ova, semen and animal products - US Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS). (
  2. b)Imports of salmonid live fish, gametes and fertilised ova - Department of Interior/Fish and Wildlife Service (DOI/FWS). (
  3. c)Imports of uneviscerated salmonid fish - DOI/FWS. (
  4. d)Animal feed (including pet foods) 1. Transmission of disease from feed - USDA/APHIS. 2. Adulteration, pesticides, chemical and microbial contamination, food additives, substances 'generally recognised as safe` - Food and Drug Administration (FDA). B. Control of public health 1. Meat and poultry for human consumption (
  5. a)Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats and equine - US Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS)

(1). (b) Fresh meat and products from domestic and farmed chickens, turkeys, ducks, geese, and guinea fowl - USDA/FSIS
(2). (
  1. c)Fresh meat and products from wild and farmed game, with the exception of those from IB1(
  2. a)and IB1(
  3. b)above - (FDA). (
  4. d)Fresh meat and products from species other than above - FDA. (
  5. e)Enforcing adulteration provisions of the law and limits for residues of drugs, pesticides, heavy metals, mycotoxins, and other contaminants in food: 1. sampling of fresh meat and animal products and control of the fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and for domesticated and farmed chickens (including liquid, frozen and dried egg products), turkeys, ducks, geese, and guinea fowl - USDA/FSIS; 2. sampling of fresh meat and animal products (including animal feed) and control of the fresh meat and products of other species - FDA. 2. Eggs and egg products (
  6. a)Shell eggs, hard-cooked eggs, ethnic egg delicacies, and imitation egg products - FDA. (
  7. b)Shell eggs (including cracks and dirties) for breaking for the production of liquid, frozen, and dried egg products (egg yolks, albumen, or any combination) - USDA/FSIS
(3). 3. Dairy (
  1. a)All dairy products - FDA. 4. Other animal-derived foods (including fish and fishery products) (
  2. a)All other animal-derived foods - FDA. 5. Animal feed (
  3. a)Adulteration, pesticides, chemical and microbial contamination, food additives, substances 'generally recognised as safe` - FDA. II. COMPETENT AUTHORITIES FOR VOLUNTARY PROGRAMMES The federal agencies listed in this section are responsible for voluntary inspection and certification programmes for domestically-produced animal products. In relation to exports from the USA, these agencies are responsible for: - oversight of the circumstances of domestic production and processing for firms who participate in the voluntary programme, - providing information concerning compliance with agreed requirements for firms who participate in the voluntary programme, - providing agreed additional guarantees for firms who participate in the agreed programme. A. Animal health 1. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova - USDA/APHIS, Department of Commerce/National Marine Fisheries Service (CommerceNMFS). 2. Salmonid live fish, gametes, and fertilised ova - USDA/APHIS, Commerce/NMFS. 3. Animal feed (including pet foods) containing fish and fishery products - USDA/APHIS, Commerce/NMFS. B. Public health 1. Fresh meat and meat products
(4)from wild and farmed bison, ostrich, emu, rhea, rabbit, deer, partridge, and quail - USDA/FSIS.
  1. Snakes for human consumption - Commerce/NMFS.
  2. Shell eggs - USDA/AMS.
  3. Cooked omelets made from egg products, diced eggs made from egg products - USDA/FSIS.
  4. Dairy - USDA/AMS.
  5. Seafood (including live seafood) - Commerce/NMFS. III. FEDERAL AGENCIES THAT ISSUE CERTIFICATION This section lists the USA national agencies that issue export certificates agreed to by the EC and the USA
(5). The agency issuing certificates may be the control authority or another national agency that is recognised by the control authority for that purpose. More than one agency may issue certificates for a product. >TABLE POSITION> B. EUROPEAN COMMUNITY Control is shared between the national services in the individual Member States and the European Commission. In this respect the following applies: - in terms of exports to the USA, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections, and issuing health certification attesting to the agreed standards and requirements, - the European Commission is responsible for overall coordination, inspections/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single European Market.
(1)With very limited exceptions, the USDA/FSIS has sole jurisdiction for these foods until the time they leave the slaughterhouse. After the meat and products have left the slaughterhouse, the USDA/FSIS and the FDA share jurisdiction. The FDA is responsible for the approval of veterinary drugs and food additives in meat and poultry.
(2)See preceding footnote.
(3)The FDA and FSIS share jurisdiction over these products after they have left the processing plant.
(4)These meat products must be made from fresh meat slaughtered under the USDA/FSIS voluntary programme.
(5)Note that the listing of a product in Section II does not mean that certificates will necessarily be required as part of agreements reached on equivalence. Such decisions will be made on a product-by-product basis. ANNEX III LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED Animal diseases Foot and mouth disease Swine vesicular disease Peste de petits ruminants Contagious caprine pleuropneumonia Sheep and goat pox African swine fever Enterovirus encephalomyelitis Newcastle disease Pseudorabies/Aujeszky's disease Vesicular stomatitis Rinderpest Contagious bovine pleuropneumonia Bluetongue African horse sickness Classical swine fever Fowl plague (avian influenza) Venezuelan equine encephalomyelitis Aquaculture diseases The list of aquaculture diseases is to be discussed further by the Parties on the basis of the International Aquatic Animal Health Code of the OIE. ANNEX IV ZONING AND REGIONALISATION The Parties have jointly determined that the following forms the basis for regionalisation decisions for the diseases listed in accordance with Annex III. Each Party will recognise regionalisation decisions taken in accordance with the standard contained within this Annex. Animal diseases In assessing risk from a given proposed importation of animals or animal products, three sets of factors may be considered:
  1. Source risk factors
  2. Commodity risk factors
  3. Destination risk factors Source risk factors The primary determinant of the risk of importing disease is the status of the country of origin in respect of the disease in question. However, declarations of disease freedom must be backed up by effective surveillance programmes. The overriding consideration in this context, therefore, is the quality of the veterinary infrastructure. No other factors can be assessed without full confidence in the veterinary administration. In particular, its ability to detect and control an outbreak of disease and to provide meaningful certification is crucial. The ability to detect the presence of disease depends on the surveillance carried out. This surveillance can be active, passive, or both. Active surveillance implies definitive action intended to identify the presence of disease, such as systematic clinical inspections, ante and post mortem examination, serology on farm or in abattoir, referral of pathological material for laboratory diagnosis, sentinel animals. Passive surveillance means that the disease must be compulsorily notifiable and that there must be a sufficiently high level of supervision of the animals in order to ensure that the disease will be observed quickly and reported as a suspect. There must also be a mechanism for investigation and confirmation, and a high level of awareness of the disease and its symptoms by farmers and veterinarians. Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, particularly those which ensure a regular veterinary presence on the farm. Other factors to be considered include: - disease history, - vaccination history, - controls on movements into the zone, out of the zone and within the zone, - animal identification and recording, - presence of disease in adjacent areas, - physical barriers between zones of differing status, - meteorological conditions, - use of buffer zones (with or without vaccination), - presence of vectors and/or reservoirs, - active control and eradication programmes (where appropriate), - ante and post mortem inspection. On the basis of these factors, a zone may be defined. The authority with the responsibility for implementing the zoning policy is in the best position to define and maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the basis for trade. The zones so defined may be assigned a risk category. Possible categories are: - low/negligible risk, - medium risk, - high risk, - unknown risk. Calculation of estimates of risk for, for example, live animals may assist in this categorisation. Import conditions may then be defined for each category, disease and commodity, individually or in groups. Low/negligible risk implies that importation may take place based on a simple guarantee of origin. Medium risk implies that some combination of certification and/or guarantees may be required before or after importation. High risk implies that importation will only take place under conditions which significantly reduce the risk, for example by additional guarantees, testing or treatment. Unknown risk implies that importation will only take place if the commodity itself is of very low risk, for example hides, wool, or under the conditions for 'high risk` if the commodity factors warrant. Commodity risk factors These include: - is the disease transmissible by the commodity? - could the agent be present in the commodity if derived from a healthy and/or clinically affected animal? - can the preceding factor be reduced, for example by vaccination? - what is the likelihood that the commodity has been exposed to infection? - has the commodity been obtained in such a way as to reduce the risk, for example deboning? - has the commodity been subjected to a treatment which inactivates the agent? Appropriate tests and quarantine will reduce the risk. Destination risk factors - presence of susceptible animals, - presence of vectors, - possible vector-free period, - preventive measures such as waste food feeding and animal waste rendering rules, - intended use of product for example petfood, human consumption only. These factors are inherent in, or are under the control of the importing country, and some may therefore be modified to facilitate trade. These may, for example, include restricted entry conditions, for example animals to be confined to a certain vector free region until the incubation period has passed, or canalisation systems. However, destination risk factors will also be taken into account by the infected country with respect to the risk presented by movements from the infected part to the free part of its territory. Aquaculture diseases Pending the development of any specific provisions to be included in this Annex, the basis for regionalisation decisions for aquaculture diseases will be the International Aquatic Animal Health Code of the OIE. ANNEX V RECOGNITION OF SANITARY MEASURES >TABLE POSITION> >TABLE POSITION> 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
  4. Definitions The following definitions shall apply to terms used in this Annex: 1.
  5. audit: assessment of performance; 1.
  6. auditee: the exporting Party whose enforcement and control programme is the subject of the audit; 1.
  7. auditor: the importing Party that conducts the audit; 1.
  8. establishment: processing plant for animals or animal products; 1.
  9. facility: site other than processing plants where animals or animal products might be handled, excluding retail premises.
  10. General principles 2.
  11. The auditor and the auditee should cooperate in carrying out audits in accordance with the provisions set out in this Annex. The audit team should include representatives of both the auditor and the auditee, and the auditee should designate personnel responsible for facilitating the audit. Specialised professional skills may be necessary to carry out audits of specialised systems and programmes. 2.
  12. 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.
  13. The auditee must operate a documented programme to demonstrate to the auditor that standards are being met on a consistent basis. 2.
  14. 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.
  15. Audits, and the decisions based on them, should be made in a transparent and consistent manner. PROCEDURES
  16. Preparation of the audit plan In consultation with the auditee, the auditor should prepare an audit plan that covers the following points: 3.
  17. the subject, depth and scope of the audit; 3.
  18. 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.
  19. a timetable up to and including the presentation of the final report; 3.
  20. the language or languages in which the audit will be conducted and the report written; 3.
  21. the identity of the members of the audit team, including the leader; 3.
  22. a schedule of meetings with officials and visits to establishments or facilities, including unannounced visits, as appropriate; 3.
  23. provisions for respect of commercial confidentiality and avoidance of conflicts of interest.
  24. 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.
  25. Document review 5.
  26. The document review may include, for example, the following: - records concerning compliance programmes, - inspection and internal audit reports, - documentation concerning corrective actions and sanctions, - records of compliance actions taken, - sampling plans and their results, - documents associated with verification, - regulatory procedures followed by the auditee. 5.
  27. 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.
  28. The auditee will cooperate fully with the auditor in the document review process and help to ensure that the auditor has access to requested documents and records.
  29. On-site verification 6.
  30. 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.
  31. 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.
  32. 6.
  33. 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.
  34. The auditee will cooperate fully with the auditor in the on-site verification process and facilitate the auditor's entry into the establishments and facilities that are the subject of the on-site verification.
  35. Follow-up audit A follow-up audit may be conducted to verify the correction of deficiencies identified in a prior audit.
  36. Working documents Working documents may include checklists of elements to evaluate, such as the following: - legislation, - structure and operations of inspection and certification services, - establishment and facility structure, layout, operations and working procedures, - health statistics, sampling plans and results, - compliance action and procedures, - reporting and complaint procedures, - training programmes.
  37. Closing meeting A closing meeting shall be held between representatives of both Parties, including officials responsible for the inspection and certification programmes of the auditee. At this meeting the auditor will present the findings of the audit. The information should be presented in a clear, concise manner so that the conclusions of the audit are clearly understood.
  38. Audit report The auditor shall provide the auditee with a draft report of the audit generally within 60 days of the conclusion of the audit. To the extent possible, the report shall be presented in a standardised format to be agreed on by the Parties in order to make the approach to audit more uniform, transparent and efficient. The report will assess the adequacy of the auditee's enforcement and control programme and identify any deficiencies noted during the conduct of the audit. Thereafter, the auditee may, within 60 days, comment on the draft report and shall describe any specific corrective actions that will be taken, preferably with target dates for completion. Any comments made by the auditee shall be included in the final report. ANNEX VII FRONTIER CHECKS The Parties recognise the distinction between documentary, identity and physical checks carried out at external frontiers on imports of live animals and animal products. The Parties further recognise the need to take a systematic approach to carrying out frontier checks. Both Parties agree that charges may be made for these checks, in conformity with the relevant provisions of Annex C to the SPS Agreement. Live animals The Parties may apply physical checks to all consignments of live animals. Animal products In setting their physical checking frequencies for imports of animal products, the Parties shall take due account of the checks applied by the exporting Party prior to export and the historic performance of products imported from the exporting Party. The Parties may modulate their physical checking frequencies for imports of animal products, notably in the light of progress made toward the recognition of equivalence under the consultative process provided for in Article
  39. ANNEX VIII OUTSTANDING ISSUES The Parties agree to work to further develop agreed arrangements concerning frontier checks, including the frequency of physical checks. The Parties agree to work together on their respective arrangements concerning feed additives, animal feedingstuffs, medicated feeds and premixes. ANNEX IX CONTACT POINTS The USA will send the information provided for in Article 10, and carry out

Article 11

, to: Agricultural Counsellor European Union Delegation of the European Commission to the United States 2300 M Street NW Washington DC 20037 Tel. 1 202 862 9560 Fax 1 202 429 1766 The Community will send the information provided for in Article 10, and carry out

Article 11

, to: Agricultural Attachł Office of Agricultural Affairs US Mission of the European Union 40 Blvd du Regent B-1000 Brussels Tel. 32 2 508 2760 Fax 32 2 511 0918

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