Lukasz Gruszczynski

The Role of Science in Risk Regulation under the SPS Agreement

This paper attempts to present a comprehensive and coherent picture of the role performed by science under the Sanitary and Phytosanitary Measures (SPS) Agreement and SPS case law. It argues that the approach adopted by the Appellate Body is predominantly based on a technical paradigm, supplemented, however, with some considerations arising from other paradigms. The paper argues that the approach adopted in the case law is generally compatible with the text of the SPS Agreement and provides a coherent SPS system. However, it also identifies certain areas which lack coherence, as certain standards seem to violate the right of the member states to establish an appropriate level of protection. These are: ascertainability of the risk as a precondition for valid risk assessment; strict specificity of the risk assessment in low-risk situations; the proportionality between the risk identified and the SPS measure; the notion of negligible risks; and the concept of likelihood in the quarantine risk assessments. The paper claims that these standards cannot be generally applied in SPS disputes as, in certain situations, they will result in the violation of the right of member states to establish an appropriate level of SPS protection. Finally, a number of specific issues are highlighted which require further clarification in case law, such as the issue of the quality of minority scientific opinions and the relationship between the insufficiency of scientific evidence and scientific uncertainty. The paper suggests that the ultimate role ascribed to science under the SPS Agreement can be assessed only after an interpretation of those issues is provided by future case law.

Australian Plain Packaging Law, International Litigations and Regulatory Chilling Effect

Introduction of plain packaging law by Australia in 2012 was met with strong opposition from transnational tobacco companies (TTCs). While advocates of the law see it as a logical step in governmental efforts to curb tobacco use and improve public health in Australia, TTCs claim that the new law is scientifically unsound, overly intrusive and that it infringes a number of international law provisions relating to trademark and property protection. Some TTCs, either directly or indirectly,have decided to test the Australian measure before international tribunals. Although, these challenges are connectedwith interests held by TTCs in Australia, they should be seen as a part of a global struggle against new emerging international standards in the field of tobacco control. In this context, it is also submitted that these litigations can produce “regulatory chilling effect” with respect to activities of other states. This article aims to look at this problem more closely.The text proceeds as following. The subsequent part provides a brief overview of the new Australian plain packaging law and international legal proceedings that have been instituted against that country. The third part analyses the problem of regulatory chilling effect in the context of these two international litigations. The last section concludes.

The WHO Protocol to Eliminate Illicit Trade in Tobacco Products: A Next Step in International Control of Tobacco Products

This report discusses the main provisions of the recently adopted WHO Protocol to Eliminate Illicit Trade in Tobacco Products. While recognizing the remarkable achievement of the global community in its efforts to curb illicit trade in tobacco products at the international level, the report also highlights those aspects of the Protocol that may undermine its effectiveness in the long-term perspective. In this context the enforcement capabilities of developing countries are cited as a main concern.

The REACH Regulation and the TBT Agreement: The Role of the TBT Committee in Regulatory Processes

A relatively new frontier for legal and policy analysis, technical barriers to trade (TBT’s) have become more common as traditional border barriers have been reduced. This comprehensive Handbook comprises original essays by eminent trade scholars exploring the implications of the WTO’s TBT Agreement.

Risky Apples Again? Australia – Measures Affecting the Importation of Apples from New Zealand

The section on WTO law highlights the interface between international trade law and national risk regulation. It is meant to cover cases and other legal developments regarding the SPS, TBT and TRIPS Agreements and the general exceptions in both GATT 1994 and GATS as well as to inform about pertinent developments in recognized international standardization bodies and international law. Of recurrent interest in this area are questions of whether precautionary policies can be justified under WTO law, the standard of review with which panels and the Appellate Body assess scientific evidence and the extent to which policy can and should influence risk regulation.

United States: Certain Measures Affecting Imports of Poultry from China – Just Another SPS Case?

The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) may apply to budgetary measures if they are motivated by SPS concerns. Equivalence-based measures are subject to the regular disciplines of the SPS Agreement, including but not limited to Article 4 SPS. This means that WTO Members, when engaging in the recognition process, need to observe other SPS provisions such as the requirement of a scientific risk assessment (Articles 5.1-5.3) or the quasi-consistency obligation of Article 5.5. A measure which has been found inconsistent with certain provisions of the SPS Agreement (e.g. Articles 2 and 5) cannot be later justified under the general exception of Article XX(b) of GATT 1994.

How Deep Should We Go? Searching for an Appropriate Standard of Review in SPS Cases

Although the applicable standard of review under Articles 2.2/5.1 of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) is not de novo, investigation by WTO panels is nevertheless quite intrusive in terms of objectivity and coherence of risk assessment. Moreover, the panel’s review does not end with the final conclusion reached by the WTO Member in its risk assessment; it also extends to the quality of the reasoning employed and the intermediate interferences that led to the conclusion.If a WTO Member relies on expert judgment in its risk assessment, this needs to be sufficiently transparent and well documented. The obligations of Articles 5.1 and 5.6 SPS are distinct and independent from each other. Thus a violation of one provision does not imply infringement of the other.

FCTS's COP6 Meeting and Its Implications for Tobacco Control Polices

The sixth meeting of the Conference of the Parties (COP) of the Framework Conventionon Tobacco Control (FCTC) took place in Moscow on 13-18 October 2014. This report is intended to summarize the outcomes of the COP6, analyzing in more detail three specific issues that were addressed and/or discussed during the meeting: (i) the relationship between international trade regime and the FCTC; (ii) the guidelines for the implementation of Art. 6 of the FCTC (price and tax measures); and (iii) the treatment of electronic nicotine delivery systems.

Re-Tuning Tuna? Appellate Body Report in US – Tuna II

Under the TBT Agreement, a labelling requirement can be qualified as a technical regulation, and not as a standard, even if it does not constitute a precondition for placing a product for sale on the relevant market. Examination of “no less favourable treatment” under Article 2.1 requires determining whether a measure modifies the conditions of competition in the relevant market to the detriment of imported like products, and whether such detrimental impact stems exclusively from a legitimate regulatory distinction rather than reflecting discrimination against the group of imported like products. The evaluation of whether a measure is more trade-restrictive than necessary under Article 2.2 involves a process of balancing different factors, such as the contribution of the measure to the pursued objective, its trade restrictiveness, and risks arising from nonfulfilment.In order for a particular rule to qualify as an international standard for the purpose of Article 2.4, it is necessary to determine whether it has been adopted by a body which has recognized activities in the field of standardization and whose membership is open to the relevant bodies of at least all WTO Members. As far as the last element is concerned, the process for joining such a body by interested WTO Members should be automatic and any required consent from participating Members should be only a pure formality.

Standard of Review of Health and Environmental Regulations by WTO Panels

This paper assesses the applicable standard of review in sanitary and phytosanitary (SPS) disputes with complex factual issues. In particular, the paper analyzes how the new deferential standard, set out by the Appellate Body (AB) in US/Canada - Continued Suspension of Obligations in the EC – Hormones Dispute, is actually applied in practice (determining reasonableness of risk assessment, not its correctness). To this end, the AB report in Australia – Measures Affecting the Importation of Apples from New Zealand is scrutinized. The conclusion is reached that although the applicable standard of review under the SPS Agreement (particularly under Articles 2.2 and 5.1) is not de novo, the investigations of WTO panels remain intrusive when assessing the objectivity and coherence of the reasoning used in a contested risk assessment. The same is true with respect to the permissible inquiry into the underlying methodology. The paper concludes that this may indicate that WTO dispute settlement bodies are unwilling to resign from their investigative prerogatives when adjudicating on national SPS measures.