FEDERATION TO THE WORLD TRADE ORGANIZATION 38 страница

1014. The representative of the Russian Federation explained that the CU Commission had adopted a Decision "On Equivalence of Sanitary, Veterinary, or Phytosanitary Measures and Conduct of Risk Assessment, CU Commission Decision No. 835 of 18 October 2011 (hereinafter "Decision on Equivalence and Risk Assessment"). Under this Decision, CU Parties were required, consistent with Article 5 of the WTO SPS Agreement, to ensure that sanitary, veterinary, or phytosanitary measures were based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations, including Codex, OIE, and the IPPC. He further explained that the CU requirements for conducting risk assessments corresponded to the provisions of Article 5 of the WTO SPS Agreement, including a requirement that, as provided in Article 5.3 of the WTO SPS Agreement, in assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary, veterinary or phytosanitary protection from such risk, the CU Parties would take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease, the costs of control or eradication in the territory of the Parties, and the relative cost-effectiveness of alternative approaches to limiting risks.

1015. Recalling that phytosanitary measures were adopted and applied at the national level, he added that from the perspective of the Russian Federation, all of its phytosanitary measures were applied in accordance with IPPC standards and were based on a risk assessment. The Federal State Establishment "All-Russian Centre on Plant Quarantine" (FGU "VNIIKR"; Moscow region) was responsible for conducting these assessments.

1016. In the context of the Customs Union, the representative of the Russian Federation explained that, as of the date of accession of the Russian Federation to the WTO, the CU Commission Decision "On Application of International Standards, Guidelines, and Recommendations" would ensure that SPS measures, applied in the Russian Federation, would be based on science and a risk assessment. Moreover, in the absence of scientific proofs (scientific basis) of risk to the life or health of people, animals or plants, the relevant international standards, guidelines and recommendations would be applied in the territory of the CU. This required competent authorities of the CU Parties to conduct risk assessments to justify CU SPS requirements, including in the form of technical regulations.

1017. The representative of the Russian Federation informed Members that, numerous (more than 200) institutions were involved in conducting risk assessments related to sanitary and veterinary measures. The following institutions were responsible for risk assessment in the SPS field: the FGU "Federal Centre for Animal Health Protection" (Vladimir) and the FGU "All-Russian Centre on Quality of Medicine for Animals and Feed" (Moscow), the Federal Centre of Hygiene and Epidemiology (which was subordinated to Rospotrebnadzor), the Federal Scientific Centre of Hygiene, named after А. Erisman (which was subordinated to Rospotrebnadzor), and the Scientific Research Institute of Nutrition of the Russian Academy of Medical Science, and the All-Russian Institute of Grain and Its Products. He also noted that, in accordance with Federal Law No. 184-FZ "On Technical Regulation", significant attention would be paid to public education programmes in the area of food safety. Risk assessment for food products will be harmonized with the standards recommended by the Codex Alimentarius Commission.

1018. A Member asked whether decisions made by Rosselkhoznadzor in its auditing and inspection practices would also be based on a risk assessment to determine if detected non-compliances to some SPS requirements justified restrictive measures on the products concerned, including taking into account some risk mitigating measures put in place by the producer or the exporting countries. In response, the representative of the Russian Federation noted that the EurAsEC Agreement on Implementation of Coordinated Policy in the Field of Technical Regulation, Sanitary and Phytosanitary Measures of 25 January 2008, CU Commission Decision No. 625 of 7 April 2011, CU Commission Decision No. 721 of 22 June 2011 "On Harmonization with International Standards, Recommendations and Guidelines", CU Commission Decision No. 834 of 18 October 2011 "On Common System of Joint Inspection of Objects and Sampling Goods (Products) Subject to Veterinary Control (Supervision)", and Government Resolutions Nos. 159 and 329 of the Russian Federation, all required the Russian Federation and the competent CU Bodies, as appropriate, to base SPS measures, including restrictive measures, on an assessment of risk.

(iii) Regionalization

1019. The representative of the Russian Federation explained that Russian officials widely used the principle of regionalization, as defined in the WTO SPS Agreement, when deciding to take a measure. The Common Veterinary Requirements (each chapter) adopted by the CU Commission Decision No. 317 of 18 June 2010 stipulated that the regionalization principle was recognized. The procedures for carrying out regionalization in the sphere of applying veterinary measures were in accordance with the OIE Code (Chapter 4.3. OIE, 2010). Russian legislation in the plant quarantine sphere was based on IPPC provisions and international standards on phytosanitary measures. Accordingly, regionalization applied to all imported regulated products. Phytosanitary certificates were issued in the exporting country by agencies of the official National Plant Protection Organization. Regional characteristics were a factor for the purposes of devising phytosanitary measures for use in a particular region.

1020. The representative of the Russian Federation added that procedures for carrying out regionalization in the sphere of applying veterinary measures were in accordance with the OIE Code (Chapter 1.3.5). The compliance of veterinary measures with OIE standards was accomplished through application of the Decision of the Government of the Russian Federation No. 159 of 24 March 2006 "On Implementation of the Veterinary Measures Regarding Importation of Live Animals and Products of Animal Origin to the Customs Territory of the Russian Federation".

1021. He further stated that the principle of regionalization was applied in full accordance with provisions of IPPC and ISPM Nos. 1, 4, 10, 14, and 29. This had to be respected, including in the formulation of veterinary certificates.

(iv) Equivalence

1022. Some Members expressed concern that the Russian Federation, in its national law or through CU Agreements, CU Commission Decisions, or other CU Acts, did not appear to apply the principle of measures or systems equivalence for food safety, as provided for in Article 4 of the WTO SPS Agreement and relevant international guidelines. Members explained that the WTO Committee on Sanitary and Phytosanitary Measures had issued a Decision "On the Implementation of Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures" (G/SPS/19/Rev.2 of 23 July 2004) to make the provisions of Article 4 of the WTO SPS Agreement operational. In the view of these Members, the Russian Federation needed to adopt a formal and effective process for the determination and establishment of equivalency at the national and CU level. These Members requested assurances that an effective process was in place for determining whether the system of sanitary or phytosanitary measures of a WTO Member for a certain product or categories of products achieved the appropriate level of protection of the Russian Federation or the CU and complied with the WTO SPS Agreement and relevant international standards.

1023. Members noted that equivalence could be accomplished through different measures for a specific product or categories of products or on a systems-wide basis. Article 4 of the WTO SPS Agreement and the relevant internationals standards (i.e., those of the Codex, OIE, and IPPC) did not require the exporting Member to apply the same requirements/measures as the importing Member, but only that the exporting Member achieves the appropriate level of protection of the importing Member. Members also stated that, under Article 4 of the WTO SPS Agreement, as explained in the Decision of the WTO SPS Committee (G/SPS/19/Rev.2), equivalence can be accepted for a specific measure or measures related to a certain product or categories of products, or on a systems-wide basis. One Member explained that recognition of systems equivalence encompassed the recognition of the central authority of the exporting Member as competent in maintaining compliance with food safety inspection system laws and regulations, including compliance with that exporting Members' sanitary, veterinary and phytosanitary requirements.

1024. In response, the representative of the Russian Federation explained that the appropriate level of protection was determined by the CU bodies with regard to sanitary and veterinary measures and by each CU Party on the national level with regard to phytosanitary measures, and were reflected in technical regulations for products produced on the territory of the CU and individual CU Parties, respectively. Furthermore, the representative of the Russian Federation recalled that the CU Commission had adopted CU Commission Decision No. 835 of 18 October 2011 "On Equivalence and Risk Assessment", which provided:

- for CU Parties to recognise equivalence if an exporting country objectively demonstrated that its measures achieved the appropriate level of sanitary or veterinary protection of the CU or the appropriate level of phytosanitary protection of an individual CU Party;

- the procedure to follow as regards consultations with the exporting country(ies) and relevant information to be provided by the exporting country(ies);

- procedural and substantive requirements as regards the judgement on recognition of equivalence; and

- the possibility of inspection, testing or audit in the exporting country(ies) upon a request by the CU Parties.

In addition, under the CU Commission Decision "On Equivalence and Risk Assessment", CU Parties committed to apply the same approach to requests for national recognition of equivalence in the phytosanitary field addressed to individual CU Parties. He also noted that the CU Commission Decision "On Equivalence and Risk Assessment" provided for the possibility for exporting countries to request equivalence recognition by the CU or its Parties (depending on respective competences) of their control or inspection systems. He explained that CU Commission Decision No. 835 of 18 October 2011 "On Equivalence and Risk Assessment", and all procedures necessary to apply this Decision, would be in effect as of the date of accession of the Russian Federation to the WTO.

1025. A Member sought clarification regarding the process to be followed, time periods and any review or appeal mechanisms applied in the CU and the Russian Federation for recognition of equivalence. In response, the representative of the Russian Federation stated that, the CU Decision "On Equivalence and Risk Assessment" foresaw the following procedure:

- submission of a request for equivalence recognition to a competent authority of a CU Party, including, inter alia, information on the type and scope of equivalence agreement requested, description of product(s), measure(s) or system(s) of control and inspections concerned, an evaluation of how the measure(s) or system(s) of the exporting country achieved the appropriate level of protection of the CU or a CU Party, and information on the feasibility and performance of the measure(s);

- interactions between the CU Party and the exporting country in the context of the determination of equivalence;

- prior to taking a decision on equivalence, the CU Party would, upon request, provide to the requesting exporting country an explanation of the CU's or its level of protection; and

- notification by the CU Commission or a CU Party to the exporting country of its judgement as regards recognition of equivalence in a timely manner and with appropriate explanation where it was found that the measure was not equivalent.

1026. Furthermore, the representative of the Russian Federation specified that, in applying this CU Commission Decision, CU Parties would follow international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission, the International Office of Epizootics and the relevant international and regional organizations operating within the framework of the International Plant Protection Convention. Members noted that, as set-out in the Decision of the WTO SPS Committee, the importing Member had certain responsibilities: to provide an explanation of the objective and rationale of the sanitary or phytosanitary measure and identify clearly the risks that the relevant measure intended to address. Moreover, the importing Member should indicate the appropriate level of protection which its sanitary or phytosanitary measure was designed to achieve and should provide a copy of the risk assessment on which the sanitary or phytosanitary measure was based. As stated in the WTO Committee Decision, an importing Member was to consider the relevant information and experience that the sanitary and phytosanitary services had on the measure(s) for which recognition of equivalence was requested. A key element for consideration was the historic knowledge and confidence that the competent authority of the importing Member had of the competent authority of the exporting Member.

1027. Some Members noted that CU Decision No. 607 of 7 April 2011 adopted 40 CU Common Forms of veterinary certificates for import into the CU territory from any third country. They also recalled that they had bilateral agreements with the Russian Federation concluded prior to the entry into force of the CU. They questioned whether these agreements would be superseded by the CU Common Forms and, if so, they were concerned that the legal basis for the Russian Federation did not provide the possibility to apply systems equivalence as called for in Article 4 of the WTO SPS Agreement.

1028. In response, the representative of the Russian Federation stated that the CU Commission had adopted Decision No. 726 of 15 July 2011 that authorised the CU Parties to negotiate and agree to specific forms of veterinary certificates with requirements that differed from the Common Forms of Veterinary Certificates and the specific provisions of the CU Common Requirements with WTO Members that made a substantiated request for such negotiations by 1 January 2013. He referred Members to paragraphs 886 through 894 for information on this issue and on the period for continued use of bilateral certificates.

1029. A Member of the Working Party expressed concern that processes for the determination and recognition of equivalence of the measures of an exporting country with the requirements set in the legislation of the Russian Federation did not seem to be operational since this Member had requested the recognition of equivalence with Federal Law No. 88 "On Milk and Dairy Products" without obtaining clear conclusions on the equivalence itself.

1030. The representative of the Russian Federation confirmed that the request of this Member would be re-evaluated in accordance with Codex Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems (CAC/GL 53-2003). The Working party took note of this commitment.

1031. The representative of the Russian Federation confirmed that the Russian Federation, from the date of its accession to the WTO, would ensure compliance with Article 4 of the WTO SPS Agreement. He further confirmed that, as provided for in Article 4 of the WTO SPS Agreement, sanitary, veterinary, and phytosanitary measures of other Members, even when they were different from measures of the Russian Federation or the CU, would be accepted as equivalent, if the exporting country objectively demonstrated that its measures achieved the appropriate level of SPS protection applied in the Russian Federation. The representative of the Russian Federation also confirmed that, as of the date of accession of the Russian Federation to the WTO, procedures for recognition and determination of equivalence, consistent with the WTO SPS Agreement, including Article 4 thereof, whether applied by the Russian Federation or competent bodies of the CU, would be based on relevant international standards, guidelines and recommendations, namely the Decision of the WTO SPS Committee (G/SPS/19/Rev.2), Codex Guidelines on the Judgment of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems (CAC/GL 53-2003), Codex Guidelines for the Development of Equivalence Agreements Regarding Food Import and Export Inspection and Certification Systems (CAC/GL 34-1999); Chapter 5.3 of the OIE Terrestrial Animal Health Code "OIE Procedures relevant to the Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization", and ISPM 24 "Guidelines for the Determination and Recognition of Equivalence of Phytosanitary Measures." The Working Party took note of these commitments.

(v) Non-discrimination

1032. Some Members also requested clarification of whether SPS measures applied in the Russian Federation established similar treatment for domestic and foreign like products. The representative of the Russian Federation stated that, in his view, non-discriminatory treatment was provided by the current legislation of the Russian Federation and CU Agreements, CU Commission Decisions, and other CU Acts. CU Agreements, CU Commission Decisions and other CU Acts did not set-out separate SPS measures for imported goods. Sanitary-epidemiological, veterinary and phytosanitary rules, criteria, measures and requirements were applied uniformly and without discrimination to all foreign, CU, and domestic products and suppliers. He stated that in accordance with Article 29.2 of the Federal Law No. 164-FZ of 8 December 2003 "On Basics of Regulation of Foreign Trade Activity", SPS requirements were implemented with respect to goods originating from foreign countries in the same way, they were applied in respect of similar products of Russian origin. CU Agreements, CU Commission Decisions, and other CU Acts, as well as the current legislation of the Russian Federation in the veterinary/sanitary sphere (Articles 1, 14, 15, 18 of the Law of the Russian Federation No. 4979-1 of 14 May 1993 "On Veterinary Practices") were uniform for all veterinary services of subjects of the Russian Federation and established identical requirements for both foreign, CU, and domestic goods and manufacturers, including requirements for putting products on the domestic market. Finally, according to Article 6 of the draft Quarantine Law, phytosanitary requirements applied to regulated products originating from a foreign country in the same manner as they applied to the same regulated products of Russian origin.

1033. The representative of the Russian Federation confirmed that all SPS measures developed and applied in the Russian Federation, whether by the Russian Federation or competent bodies of the CU, would comply with the non-discrimination provisions of the WTO SPS Agreement, including those relating to the principles of national and most-favoured nation treatment. The Working Party took note of this commitment.

1034. Some Members of the Working Party expressed concern over the fact that imported products were tested in the Russian Federation for residues of veterinary medicinal products in the VGNKI laboratory, which was the only laboratory equipped with the most sensitive and performing equipment (LC-MS/MS), whereas other laboratories performing official controls in the Russian Federation, on domestic products, mostly used ELISA methods, which were less performing for confirming residues of antibiotics at the low levels of detection foreseen by the food safety requirements of the Russian Federation and the CU. In the view of these Members, this represented discrimination between domestic and imported goods.

1035. The representative of the Russian Federation confirmed that the draft Federal Law "On Veterinary Practices" provided that official control could be done only in accredited laboratories and that such accredited laboratories must use unified and validated methods and equipment for official control purposes. He further confirmed that imports could be tested in any of these accredited laboratories. This would, in his view, ensure uniformity of treatment. The Working Party took note of these commitments.

(i) Transparency, Notification and Enquiry Point Obligations

1036. Some Members expressed concern that existing rules and changes in the SPS regimes of the Customs Union and the Russian Federation were not always published in draft for comment from interested parties before they were implemented. In the view of these Members, neither CU bodies, nor Russian authorities consistently took the views of interested persons and Members into consideration before taking regulatory actions that affected trade. In addition, Members expressed concerns that all existing mandatory requirements for importing products to the Russian Federation were not readily available to them or traders. As a result, some Members suggested that the Russian Federation would need to modify its procedures on notifying and seeking comments on measures to come into compliance with the transparency obligations of the WTO SPS Agreement.

1037. In response, the representative of the Russian Federation stated that, with regard to SPS measures of the Russian Federation, the transparency in the legislative process in the SPS sphere was provided through publication of all regulatory legal acts related to SPS measures in official editions of the following publications: "Rossiiyskaya Gazeta", "Sobranie Zakonodatelsctva Rossiyckoy Federatsii", "The Bulletin of Regulatory Acts of Federal Executive Authorities", "The Bulletin of International Agreements", "The Bulletin of Regulatory and Methodical Acts of the Ministry of Health and Social Development of the Russian Federation", and "The Information Bulletin of the Ministry of Agriculture of the Russian Federation". Some SPS measures were also published in some non-official publications, such as "Veterinariya" magazine, newspapers "Veterinarniy Konsultant", "Veterinary Gazette" and "Zatschita i karantin rasteniy" (monthly edition), as well as in electronic database for legal reference and other special publications. In response to a question from a Member, the representative of the Russian Federation stated that the main official journals were "Rossiiyskaya Gazeta", and "Sobranie Zakonodatelsctva Rossicyckoy Federatsii", in which the publication of all normative legal acts that dealt with the rights, freedoms and obligations of a person and citizens, including the orders of Federal Ministries, was mandatory. Thus, all normative legal acts relating to SPS measures would be published in these two journals.

1038. Members of the Working Party noted that, as of 1 July 2010, the CU Commission was responsible for the adoption of CU SPS technical regulations and other CU SPS documents and requested information regarding how transparency would be ensured in connection with the development of SPS measures and their application. In response, the representative of the Russian Federation explained that the Annex to CU Commission Decision No. 625 entitled "Amendments to the Regulation on Coordination Committee on Technical Regulation, Application of Sanitary, Veterinary and Phytosanitary Measures", approved by the CU Commission Decision No. 319 as of 18 June 2010 provided for publication of proposals of CU Decisions and CU legal acts in the SPS field, on the CU Commission website (www.tsouz.ru), and that interested persons would have at least 60 days to provide comments on the proposals. The CU Secretariat was required to send comments to the relevant working group (referred to in paragraph 819) for consideration. Furthermore, the representative of the Russian Federation explained that, according to point 6 of the Annex of CU Commission Decision No. 527 of 28 January 2011, which set a procedure for the development, adoption, amendment and repealing of technical regulations of the CU, draft technical regulations must be published on the website of the CU and should be available for public consultation for at least two months. Comments received from interested parties would then be taken into account to amend the draft technical regulations. Some Members of the Working Party expressed concern that, according to an amendment of this procedure adopted by CU Commission Decision No. 606, if a draft technical regulation developed in the framework of the EurAsEC was taken as a basis for a technical regulation of the CU, and had already undergone a process of public consultation through publication of a draft on the website of the EurAsEC, the CU may decide not to organize a public discussion at CU level on this text. In the view of these Members, the consultation on the EurAsEC website did not fulfil the necessary conditions of transparency since, at the time of this consultation, it was not clear that the draft technical regulation could become mandatory requirements also for exporters. These Members took as an example a draft Technical Regulation "On Milk and Milk Products", which had undergone a public consultation at EurAsEC level and for which the Russian Federation indicated that the CU did not intend to carry out a public consultation through the website of the CU.

1039. In response to a question from a Member, the representative of the Russian Federation stated that the date for entry into force of each technical regulation was set-out in the respective technical regulation or the CU Commission Decision adopting the technical regulation. A minimum period of six months between the date of publication of a technical regulation and the date of its entry into force was established by the CU Commission Decision No. 752 of 16 August 2011, so that entities were able to comply with the provisions of a new technical regulation or amendments to a technical regulation. The transition period for economic operators to become acquainted with and comply with technical regulations was established after public consultation on draft technical regulations, in particular with those that would need to comply with the technical regulation, including foreign producers.

1040. Some Members of the Working Party expressed concern that, in some cases, SPS measures of the Russian Federation were not laid down in legal texts, and were thus not clearly transparent. This was the case, for example, for rules on the listing of establishments before the entry into force of CU requirements, or for rules on pre-notification of shipments or for conditions according to which the Russian Federation implemented the CU provision allowing a list of establishments authorised to export to the CU member to be based on the list provided by the exporting country.

1041. The representative of the Russian Federation explained that pre-notification of a shipment was to ensure that certificates were valid and not fraudulent. He noted that pre-notification was not a mandatory requirement in the SPS field, but was dealt with by the customs services. Moreover, information on pre-notification was posted on the Rosselkhoznadzor website (http://www.fsvps.ru). According to 6.12.3 of the Common Procedures of Veterinary Control in CU Commission Decision No. 317, when the controlled goods were imported by sea, pre-notification on actual shipment of the lots to CU recipient was requested. The pre-notification was presented in electronic manner by the veterinary service of the exporting country. The form of the pre-notification was attached to the Common Procedures of Veterinary Control.

1042. Some Members expressed serious concerns that the pre-notification requirements could be expanded to apply to all products subject to veterinary control and to other modes of transport. The requirement that pre-notification comes from the competent authorities of the exporting country raised additional concerns. In these Members' views alternative, less burdensome, and less trade restrictive means were available to address any concerns regarding fraudulent certificates.

1043. In response, the representative of the Russian Federation stated that amendments to the current pre-notification provisions were being considered. These amendments would limit the scope of the pre-notification requirement to shipments of beef, pork, sheep, horse, and poultry products, i.e., covered goods, imported using sea transport. These amendments would allow for the competent authority of a third country to provide information on the issuance of a veterinary certificate for the relevant covered goods by providing a copy of certificate or the information indicated in the form in Annex 8 to CU Commission Decision No. 317, via e-mail notification, completion of a corresponding website, or by any other means agreed between a third-country and a CU Party, taking into account conditions in the third-country, to the competent authorities of the CU Parties. The representative of the Russian Federation confirmed that these amendments as described above would be adopted and enter into force no later than the date of accession of the Russian Federation to the WTO.