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978. Some of these Members also expressed concern that the requirements of the MOH were not always clear, consistent with international standards (e.g., OIE or the Codex Alimentarius) or sufficiently supported by scientific justification. These Members noted that maximum residue levels laid down in the Russian legislation for pesticide residues and veterinary drugs, such as the MRL for tetracyclines which are, however, authorised in use in the Russian Federation for animals, were in many cases well below the levels set in the Codex Alimentarius and that the Russian Federation had not provided any scientific justification to substantiate the deviation. They also noted that maximum levels for contaminants and radio nuclides, as well as microbiological standards, were not set following methodology recommended by international guidelines. In the view of these Members, the decision-making process for determining the approval for distribution of a product on the Russian market was sometimes arbitrary and it appeared that the regulation of products by the MOH, duplicated the State Registration process, and should be eliminated.

979. The representative of the Russian Federation responded that pursuant to Article 38 of Federal Law No. 52-FZ of 30 March 1999 "On Sanitary and Epidemiological Well-being of the Population", sanitary rules and safety criteria must be based on a risk assessment using, as appropriate, the results of scientific research and epidemiological studies, as well as on monitoring of human health and harmful environmental factors. Sanitary requirements were aimed at ensuring the safety of products and human life and health. He asserted that all rules, criteria and requirements in respective fields were applied uniformly and without discrimination between domestic and imported goods, Article 38 and the Statute on the State Sanitary and Epidemiological Regulation approved by Resolution of the Government of the Russian Federation No. 554 of 24 July 2000 (Sections 5 and 6), required that international requirements and recommendations must be analysed and used in national sanitary regulations and legislation to the extent it is practicable and reasonable to do so. The harmonization proceeded with reference to documents of the FAO/WHO Codex Alimentarius Commission, OIE, WHO recommendations, and documents of other international organizations.

980. The representative of the Russian Federation stated that the harmonization process would be carried out in cooperation with the interested WTO Members. The representative of the Russian Federation informed Members that, as regards MRLs of pesticides, between 2009 and 2010, the CU had adopted levels corresponding to the international standards for 244 pesticides active substances in CU Commission Decision No. 622 of 7 April 2011.

981. The representative of the Russian Federation confirmed that the CU would apply MRLs on chlorothalonil, clofentezine, cyprodinil, kresoxim-methyl, iprodione, propamocarb, pirimicarb, thiabendazole, carbendazim, famoxadone, copper compounds, and lambda cyhalothrin that corresponded to international standards in conformity with the WTO SPS Agreement no later than the date of the accession of the Russian Federation to the WTO, and that these MRLs would be set-out in CU acts. The Working Party took note of this commitment.

982. As regards MRLs of veterinary drugs, the representative of the Russian Federation confirmed that MRLs for penicillins, streptomycin and bacitracin (in rabbit meat and milk for the latter) had been harmonized with Codex standards and were set-out in Addendum 22 to SanPiN 2.3.2.1078-01. Furthermore, grisin was no longer authorised for use by the MOA. Tetracyclines MRLs had not been harmonised with international standards, because the Russian Federation considered that the Codex levels represented a too high risk for the health of its citizens, due to large scale use of tetracyclines in both veterinary and human medicine.

983. Some Members of the Working Party noted that on 31 August 2011, the Russian Federation had issued a report entitled "Scientific Justification for Requirements for Residual Levels of Tetracycline Antibiotics in Foods". These Members reviewed the report and noted that the analysis and procedures set-out in the report were not consistent with international standards for conducting a health risk analysis, and did not support maintaining MRLs for tetracyclines antibiotic residues in excess of relevant Codex standards. The data in the report actually supported the conclusion that even at the reported dietary intakes, with all foods at the maximum MRLs recommended by Codex, no consumer group was likely to exceed the international recommendation for acceptable daily intake. Members also noted many methodological problems with the report. The report, for example, did not include a proper identification of the risk, incorrectly over-estimated exposures; failed to characterise or compare the different impacts on human health from its recommended actions; omitted an analysis of variability, uncertainty, and sensitivity of its conclusions, and presented purely hypothetical scenarios and concerns as if they were scientific evidence. Members expressed concern that the report had not undergone peer review in a manner consistent with international standards. Thus, in their view, the report did not justify the maintenance and application in the Russian Federation of MRLs for tetracyclines that were more stringent than Codex standards, lacked a scientific justification and was not in conformity with the WTO SPS Agreement or relevant international standards. These Members requested that the MRLs for tetracyclines, applied in the Russian Federation, be revised to correspond to Codex standards.

984. The representative of the Russian Federation confirmed that the Russian Federation, before the date of its accession to the WTO, would provide to any interested Member scientific evidence and an assessment of the risk associated with tetracyclines antibiotics residues, developed in accordance with methods of scientific evaluation set by the Codex Alimentarius, sufficient to justify the application of MRLs more stringent than those provided for in the relevant Codex standards. If such a scientific justification and risk assessment for a more stringent MRL was not provided, the MRLs for tetracyclines would be revised to correspond to Codex standards in national and CU acts as of the date of the accession of the Russian Federation to the WTO consistent with the provisions of the WTO SPS Agreement. The Working Party took note of this commitment.

985. Some Members noted that the Russian Federation had maintained MRLs for tetracyclines that were much more stringent than international standards for many years and that despite repeated requests to be provided any risk assessment and scientific justification for these stringent requirements, Members had not received any scientific justification or risk assessment. These Members noted that it appeared that some form of risk assessment was now being done and expressed concern regarding the timing and procedures being followed. In the view of these Members, the risk assessment was not being done in a manner consistent with international standards, recommendations and guidelines for conducting such assessments. For example, the risk assessment had not been subject to peer review and/or public comment. This called into question the validity of the assessment.

986. A Member of the Working Party noted that the harmonization process for MRLs of veterinary drugs should also include elimination of non-tolerance or very low tolerance in food of veterinary substances when these substances are authorised in use in the Russian Federation under similar conditions to those in place in exporting countries.

987. The representative of the Russian Federation stated that norms for veterinary drugs were under revision and this work was expected to be finalised no later than December 2011.

988. As regards maximum levels for contaminants, the representative of the Russian Federation informed Members that maximum levels for nitrates in lettuce and cadmium in poppy seeds had been reviewed and revised in accordance with international recommendations and set-out in Addenda 10 and 18 of SanPiN 2.3.2.1078-01. These revised levels had been included in amendments to the Unified Sanitary and Epidemiological Requirements set in CU Commission Decision No. 299.

989. Furthermore, the representative of the Russian Federation confirmed that as of the date of the accession of the Russian Federation to the WTO, the maximum levels of nitrates would be revised in accordance with international standards, recommendations, and guidelines. The Working Party took note of this commitment.

990. The representative of the Russian Federation stated that radio nucleide levels and microbiological standards were being revised in accordance with international recommendations. The proposals would be transmitted to the CU Commission in due course to avoid inconsistency with international standards as of the date of the accession of the Russian Federation to the WTO.

991. Members expressed concern about a measure (SanPiN), adopted pursuant to Federal Law No. 52-FZ, which would limit the use of frozen poultry meat for further processing. These Members noted that similar provisions appeared to be included in a CU Commission Decision. Members questioned the scientific basis for this measure and noted that no risk assessment had been provided to Members despite requests for the assessment.

992. In response the representative of the Russian Federation stated that these norms were operated as recommendations and their entering into force had been postponed. If the scientific justification of these norms would be identified as insufficient upon the date of accession of the Russian Federation to the WTO, they would be eliminated. Specifically, the representative of the Russian Federation explained that the ban on the use of frozen poultry for the production of all types of poultry products, foreseen to enter into force from 1 January 2011, had been delayed and revised. The ban on the use of frozen poultry meat in the manufacture of dietetic food, baby food and food for pregnant or breastfeeding women, which had been in place since 1 January 2010, would be extended to gourmet products (pastrami, raw dried and raw smoked products). Further, only chilled poultry meat would be allowed for the production of chilled semi-finished products and products that have not undergone heat treatment. An amendment to SanPiN 2.3.2.1078-01 introducing these changes was available on the website of Rospotrebnadzor. The representative of the Russian Federation indicated that at the CU level, CU Commission Decision No. 299 included a ban on the use of frozen poultry meat in the manufacture of dietetic food, baby food and food for pregnant or breastfeeding women (point 16 of Chapter II, Part 1 of the Uniform Sanitary and Epidemiological and Hygienic Requirements). He stated that the CU Parties would not extend this ban to other categories of persons or products.

993. The representative of the Russian Federation further explained that pursuant to Federal Law No. 52-FZ "On Sanitary and Epidemiological Well-being of the Population" sanitary-epidemiological rules and norms "Hygienic Requirements on Food Safety and Food Value" (SERN) had been enacted. SERN set up hygienic safety and value norms on food for humans, and also requirements on compliance with these norms for production, importation and turnover of food products. Furthermore, Article 2 of Federal Law No. 29-FZ "On Quality and Safety of Food Products" provided for the implementation of the international norms, when they contradicted the mentioned Law.

994. The representative of the Russian Federation also recalled that Government Resolutions No. 159 and No. 329 established the necessary legislative framework to allow for the compliance of Russian veterinary and phytosanitary measures with the relevant international standards; guidelines and recommendations in the OIE and IPPC. He added that specific provisions of international standards relating to procedures for State control and surveillance, including Codex Alimentarius, OIE, and IPPC were included in the draft technical regulations in the SPS sphere. A Member noted that Government Resolution Nos. 159 and 329 related to the OIE and IPPC and asked if a similar Government Resolution had been adopted for the Codex Alimentarius. If such a resolution did not exist, this Member asked when the Russian Federation expected to adopt it. The representative of the Russian Federation explained that pursuant to CU Commission Decision No. 721 of 22 June 2011, in the absence of CU or national documents in force on the territory of the CU, establishing obligatory veterinary (veterinary-sanitary) requirements for live animals and products of animal origin; obligatory phytosanitary requirements for plants and plant products; obligatory sanitary-and-epidemiologic and hygienic requirements for products of animal origin and products of plant origin, it was necessary to apply standards, recommendations and guidance of the International Office of Epizootics, the International Plant Protection Convention, and the Commission of Codex Alimentarius, respectively. Furthermore, if veterinary, phytosanitary and sanitary-and-epidemiologic and hygienic requirements in force on the territory of the CU were more stringent than relevant international standards, in the absence of scientific justification of risk to human, animal or plant life or health, in corresponding part international standards were applied.

995. Some Members expressed concerns that, according to Federal Law No. 52-FZ and also requirements adopted pursuant to CU Commission Decision No. 299, sanitary and phytosanitary import policy of the Russian Federation, rules and legislation appeared to be based on the results of scientific research, epidemiological studies and monitoring rather than on international standards, guidelines and recommendations, which were only used "to the extent practicable". In the view of these Members, Article 3.1 of the WTO SPS Agreement required that sanitary and phytosanitary measures be based on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in the WTO SPS Agreement, in Article 3.3. These Members sought a commitment that the Russian Federation would respect the provisions of Article 3 of the WTO SPS Agreement and amend Federal Law No. 52-FZ and CU Commission Decision No. 299 to ensure compliance with the SPS provisions.

996. A Member noted that the Russian Federation had required some sanitary and phytosanitary certificates that included provisions that appeared to be inconsistent with international standards, guidelines and recommendations e.g., those of the OIE, Codex, IPPC, and the WTO SPS Agreement. This Member asked whether the Russian Federation was prepared to undertake modifications of these certificates to bring them into compliance with these standards and obligations. Members also asked the Russian Federation to confirm that it did not require the exporting country to have identical or very similar measures to those applied in the Russian Federation as long as the exporting Member demonstrated that its measures achieved the appropriate level of sanitary or phytosanitary protection of the Russian Federation.

997. The representative of the Russian Federation explained that his Government had adopted Resolution No. 761 of 28 September 2009 "On Implementing Harmonisation of the Russian Sanitary-Epidemiological, Veterinary and Phytosanitary Measures in Compliance with International Standards" which established a process to amend measures that were found to be more stringent than international standards. The Resolution instructed the Ministry of Health and the Ministry of Agriculture to review all legal acts establishing sanitary-epidemiological requirements, veterinary and phytosanitary measures for their compliance with international (IPPC, OIE, Codex Alimentarius) standards and to bring them in line with such standards when the deviation was not supported by scientific justification. This Resolution had been supplemented by administrative procedures on the implementation of this review (Order of the MOA No. 3 of 11 January 2010 and Order of the MOH No. 581n of 30 July 2010). The representative of the Russian Federation explained that participation by foreign governments in bringing cases of more stringent requirements to the attention of the Russian Government was welcomed and that foreign governments could participate in the evaluation of the Russian measure.

998. A Member of the Working Party expressed concern that requests submitted by this Party in the framework of Resolution No. 761 had received negative answers from Rosselkhoznadzor without scientific justification. Thus, in the view of this Member, Resolution No. 761 did not have the expected effect on harmonization of Russian norms with international standards and recommendations.

999. In response, the representative of the Russian Federation explained that in order to improve the situation, relevant authorised bodies had established an internal procedure of forwarding requests from interested parties, including foreign governments, and had determined the responsible divisions for the examination procedure. The procedure was adopted by relevant Orders of the MOA (No. 49 of 21 February 2011), Rosselkhoznadzor (No. 39 of 10 February 2011) and the MOH (No. 98 of 10 February 2011, No. 378 of 29 April 2011).

1000. A Member indicated that, despite adoption of the said procedure, the situation remained alarming as most submitted comments were ignored by the Russian authorities.

1001. Some Members noted that CU Parties now had competence to regulate SPS measures and requested information on how the CU technical regulations on SPS and other acts at the CU and national level would be harmonized with international standards, guidelines, and recommendations. These Members expressed concern that recent draft CU SPS technical regulations did not reflect international standards, guidelines and recommendations. Members also requested information on what SPS measures would apply until such time as the CU Commission adopted SPS technical regulations.

1002. The representative of the Russian Federation informed Members of the Working Party that the CU Commission had adopted Decision No. 625 of 7 April 2011 "On Harmonization of CU Legal Acts in the Field of Sanitary, Veterinary and Phytosanitary Measures with International Standards". This CU Commission Decision created at CU level a procedure similar to Resolution No. 761 of the Russian Federation. CU SPS measures that, after examination, were recognized as more stringent than international standards, without scientific justification for such restriction or risk to human, animal or plant life or health would be brought into conformity with international standards. He noted that foreign governments could bring measures to the attention of the CU Parties and participate in the examination.

1003. The representative of the Russian Federation further informed Members of the Working Party that in connection with implementation of CU Commission Decision No. 625, the CU Commission had by Decision No. 801 of 23 September 2011, adopted the Regulation "On the Uniform Procedure of Carrying Out Examination of Legal Acts of the Customs Union in the Sphere of Implementation of Sanitary, Veterinary, and Phytosanitary Measures" which entered into effect on 29 October 2011. Some Members of the Working Party expressed concern that the implementation procedure was unnecessarily burdensome and lengthy.

1004. The representative of the Russian Federation stated that once the procedure for implementation of the harmonization process set-out in CU Commission Decision No. 625 had entered into effect, the Russian Federation would start the process of aligning its procedures under Resolution No. 761 with the CU procedures.

1005. Some Members of the Working Party expressed concern as regards the timing envisaged by the Russian Federation for harmonization of SPS measures applicable on the territory of the Russian Federation with international standards, requirements and guidelines and asked the representative of the Russian Federation to clarify how the Russian Federation would ensure that SPS measures applied in the Russian Federation would be harmonized with international standards, guidelines and recommendations by the date of its accession to the WTO.

1006. The representative of the Russian Federation replied that from the date of entry into force of CU Commission Decision No. 721 of 22 June 2011 "On Application of International Standards, Guidelines and Recommendations", such international standards, recommendations and guidelines, as provided in paragraphs 830, 894, 897, 898 and 994 would be applied in the territory of the Russian Federation. In accordance with this Decision, such standards would continue to apply unless the review of a measure pursuant to CU Commission Decision No. 625 or Government Resolution No. 761, as appropriate, resulted in a finding that there was a risk assessment and scientific justification that complied with the WTO SPS Agreement, and which justified the application of a standard which was more stringent than the relevant international standard. Some Members expressed concerns over the fact that, pursuant to CU Commission Decision No. 773 of 16 August 2011, CU Commission Decision No. 721 would enter into force not earlier than the date of accession of the first CU Party to the WTO. In response, the representative of the Russian Federation specified that CU Commission Decision No. 721 would enter into force on the date of accession of the Russian Federation to WTO.

1007. The representative of the Russian Federation stated that according to paragraph 4 of Article 15 of the Constitution of the Russian Federation, the universally-recognised norms of international law and international treaties and agreements of the Russian Federation were an integral part of its legal system. If an international treaty or agreement of the Russian Federation established other rules than those envisaged by law, the rules of the international agreement must be applied. Furthermore, pursuant to Article 2 of Federal Law No. 29-FZ of 2 January 2000 "On Quality and Safety of Food Products", if an international treaty of the Russian Federation established any rules other than those stipulated by the legislation of the Russian Federation in the field of ensuring the quality and safety of food products, then the rules of the international treaty were to apply. He also referred Members to the Section "Framework for Making and Enforcing Policies", which described the status of international agreements, including the WTO Agreement, once the Russian Federation had ratified its Protocol of Accession, within the national legal system of the Russian Federation and within the framework of the CU. In this regard, the representative of the Russian Federation noted the effect of the Treaty on the Multilateral System in ensuring that CU Agreements, CU Commission Decisions, and other CU Acts were consistent with the WTO commitments of a CU Party, including those under the WTO SPS Agreement. The representative of the Russian Federation also recalled that under Article 2 of the Treaty on the Multilateral System, the CU Parties would adopt measures to adjust the legal framework of the CU and the decisions of its Bodies to comply with the WTO Agreement. Prior to adoption of such adjustment measures, the relevant provisions of the WTO Agreement including those of the WTO SPS Agreement, would prevail over respective provisions of treaties concluded within the framework of the CU and of decisions adopted by its Bodies.

1008. One Member requested the Russian Federation to confirm that, in application of Article 3.1 of the WTO SPS Agreement, the Russian Federation would review all of its existing sanitary and phytosanitary measures to ensure that, by the date of accession, they were based on international standards, guidelines and recommendations or, in the event that the Russian Federation considered that international standards did not meet its appropriate level of protection, they were scientifically justified in accordance with Article 3.3 of the WTO SPS Agreement. In cases where relevant scientific evidence was insufficient, he requested that the Russian Federation confirm that it would comply with Article 5.7 of the WTO SPS Agreement.

1009. The representative of the Russian Federation confirmed that, as of the date of accession, in application of Article 3.1 of the WTO SPS Agreement, all sanitary and phytosanitary measures, whether adopted by Russian Federation or the competent bodies of the CU, would be based on international standards, guidelines or recommendations as provided for in the WTO Agreement. Further, the representative of the Russian Federation confirmed that measures which were not based on international standards, guidelines and recommendations, where they exist, would not be applied in the Russian Federation without providing Members a scientifically based justification of the measures, in accordance with the WTO SPS Agreement, including Article 3.3. In cases where relevant scientific evidence was insufficient, he confirmed that any measure adopted, whether by the Russian Federation or the competent bodies of the CU would comply with the WTO SPS Agreement, in particular with Article 5.7 thereof. In the event that international standards were not considered to meet the appropriate level of protection, the Russian Federation would provide scientific justification for measures applied in the Russian Federation, in accordance with Article 5.8 of the WTO SPS Agreement. The Working Party took note of these commitments.

(ii) Risk Assessment

1010. Some Members of the Working Party noted the requirement applied to certain goods on the Common List of Goods Subject to Veterinary Control that imports come from establishments on the Unified Registry, as described in paragraph 907. These Members expressed concern that applying this requirement to certain of the products on the Common List of Goods Subject to Veterinary Control was not based on science or a risk assessment. In addition, there could also be a requirement for an establishment to be included in the Unified Registry prior to being permitted to export products to the territory of the CU where a veterinary certificate, import permit and State Registration which appeared to be more trade restrictive than required to achieve the appropriate level of protection of the CU. Moreover, these Members recalled their concerns about the absence of risk assessments and science to justify measures maintained by the CU and the Russian Federation that were more stringent than international standards, guidelines, and recommendations.

1011. In response, the representative of the Russian Federation informed Members of the Working Party that as noted in paragraph 907, the CU Commission in Decision No. 810 of 23 September 2011 had amended the Common veterinary requirements. Pursuant to this CU Commission Decision and CU Commission Decision No. 830 of 18 October 2011 certain goods were not subject to any of the three forms of veterinary control when they were destined for the Russian Federation, as reflected in Table 41. The representative of the Russian Federation confirmed that, as of the date of the accession of the Russian Federation to the WTO, goods would be included on the Common List of Goods Subject to Veterinary Control only if application of veterinary measures was in compliance with international standards, guidelines and recommendations, or if science and a risk assessment justified, consistent with the WTO SPS Agreement, subjecting a category of goods to veterinary measures. Similarly, the veterinary measures applied to each category of goods would also be in compliance with international standards, recommendations and guidelines or based on science and a risk assessment. The Working Party took note of these commitments.

1012. With regard to risk assessments, some Members emphasized the need, in conformity with the WTO SPS Agreement, to comply with international standards, recommendations and guidelines for conducting and reviewing risk assessments. They noted the relevance and applicability of Codex standards: CAC/GL-62-2007-Working Principles for Risk Analysis for Food Safety for Application by National Government and CAC/GL/30-1999-Principles and Guidelines for the Conduct of Microbiological Risk Assessments, and the FAO document; WHO-EHC-240.5-Principles and Methods for the Risk Assessment of Chemicals In Food; Chapter 2; Risk Assessment and its Role in Risk Analysis. In the view of these Members, a risk assessment should be limited to an examination of the measure already in place or favoured by the importing country. It should not be distorted by preconceived views on the nature and the content of the measure to be taken, nor should it develop into an exercise tailored to and carried out for the purpose of justifying decisions ex post facto.

1013. In the view of these Members, the conduct of a risk assessment, whether for a biological, chemical, or physical food safety hazard, was one part of a broader effort to describe the relevance and understanding of scientific-based decisions. The analysis of risk allowed regulatory officials to focus finite resources on those hazards that posed the greatest risk to human health protection. Risk assessment provided a framework for evaluating food safety hazards relevant to the national context, predicting the likelihood of exposure to those hazards, and estimating the resulting public health impact associated with a wide variety of variables. Experts involved in risk assessment, including government officials and subject matter experts from outside government must be objective in their scientific work and not be subject to any conflict of interest that may compromise the integrity of the assessment. These experts should be selected in a transparent manner on the basis of their expertise and their independence with regard to the interests involved, including disclosure of conflicts of interest in connection with risk assessment. Elements of an effective assessment and analysis of that assessment needed to include a public process for seeking input on the design of the risk assessment, documentation of those decisions, and then ensuring that the public has access to the documentation. A peer review process whereby subject matter experts provide critical analysis of the design features and the assumption made was recommended. Such contributions through the peer review and public process could improve transparency, increase the quality of the analysis, and facilitate risk communication by increasing the credibility and acceptance of the results. There needed to be a formal record of all decisions associated with the risk assessment and which would be made available to interested independent parties so that other risk assessors could repeat and critique the work. The formal record and summary should indicate any constraints, uncertainties, assumptions, and their impact on the risk assessment. Members sought assurances from the Russian Federation that these internationally recognized principles and recommendations would be used in risk assessments for SPS measures adopted and applied in the Russian Federation.