En la mesa, se sirve la comida y pasa la fuente (5 6 años) QUE DEBE HACERSE:

The Complainant’s third allegation concerned ‘certain Measures adopted and maintained by EU Member States prohibiting or restricting the marketing of biotech products.’143 _{Under the ‘Deliberate Release Directive’ and the ‘Novel Food}

Regulation’ some EU Member States (Austria, France, Germany, Greece, Italy and Luxembourg) continued to maintain safeguard measures in respect of Biotech products or GMOs that had obtained approval for EU wide marketing under the EU law because they considered them too risky. In their view, GMO risks should be scientifically determined and assessed, such that an absence of sound science supporting regulation is fatal to its legitimacy.144

The complaining parties alleged that the safeguard measures violated Article 5.1 of the SPS Agreement,145 _{which provides:}

142 _{Panel Reports, Biotech, paras. 8.20.} 143 _{Panel Reports, Biotech, para. 7.2529.}

144 _{Panel Reports, Biotech, paras. 7.2530- 7.2533; US First Submission, Biotech, p. 109-111,}

Canadian Submission, Biotech, p. 192-94;

145 _{It should be read with Article 2.2 of the SPS Agreement. Article 2.2 of the SPS Agreement states}

45 Members shall ensure that their sanitary or phytosanitary measures are 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 organization.

The Panel determined, step by step, whether the SPS Agreement applied, whether the safeguard measures were SPS measures for the purpose of the SPS Agreement. First, the Panel had to establish that the SPS Agreement was applicable to the measures. The Panel analysed the documents submitted by these Member States to justify their adoption of safeguard measures, as well as text and structural features of the measures, in order to ascertain their purposes.146 _{Taking into account the}

evidence pertinent to each individual safeguard measure, the Panel held that the Member State safeguard measures (the national bans) were SPS measures in their purpose, form and nature, and in their effect on international trade.147

The Panel concluded that they were all SPS measures, so they were subject to the substantive requirements of the SPS Agreement. The SPS measure should have been ‘based on scientific principles and ... not maintained without sufficient evidence’, and ‘based on’ an acceptable form of risk assessment.148

Risk assessment is defined in Annex A(4) of the SPS Agreement. The definition differentiates two types of risks. The first is risk assessment made on ‘the evaluation of the likelihood of entry, establishment or spread of pest or disease within the territory of an importing Member’. The second is related to measures adopted to limit or avoid the ‘presence of additives, contaminants, toxins or disease-causing

animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence.’

146 _{Panel Reports, Biotech, para. 7.2546.}

147 _{Panel Reports, Biotech, paras. 7.2610, 7.2662, and 7.2702 (Austria), 7.2749 and 7.2774 (France),}

7.2813 (Germany), 7.2854 (Greece), 7.2891 (Italy), and 7.2922 (Luxembourg).

46 organisms in food, beverages or feedstuffs’. In this case the risk assessment should focus on the potential adverse effect on human or animal health.

In defence, the EU argued that the extent of scientific uncertainty surrounding GMOs triggers the SPS provision, allowing precautionary ‘provisional measures’ which render risk assessment unnecessary as a basis for national safeguard provisions.Additionally the EU argued that the safeguard measures were based on other risk assessments.149 _{The EU’s view of the role of risk assessment was}

supported by amicus curiae submission from a group of academics. 150

The Panel did not question the right of EU Member States to ban GMOs, which was recognised in its main Directive 2001/18, and under Article 5.7 of the SPS Agreement, which permits Members to adopt temporary SPS measures ‘where relevant scientific evidence is insufficient’.

The Panel detailed that for each of the products in question, the EU’s relevant scientific committee conducted risk assessment, evaluated the potential risks to human health and/or the environment and the supporting arguments presented by the relevant Member States. The Panel also noted that some EU Member States did provide additional reports and scientific studies to support their national product- specific bans. The Panel asserted that a risk assessment must determine the likelihood or the probability of a risk. In contrast, scientific studies demonstrating a mere possibility of risk were not sufficient to justify the imposition of SPS measures. The Panel argued that many of the studies on which the national governments based their measures did not contain all of the elements it considered necessary to qualify as proper risk assessment. The Panel identified that most studies were missing the likelihood element, i.e. ‘the probability of entry, establishment or spread of diseases and associated biological and economic consequences’.The Panel considered that this was not a risk assessment that meets

149 _{EU First Written Submission. Biotech, paras. 574, 590-1, 610.} 150 _{Group of Academics (n 23).}

47 the requirements of the SPS Agreement.151 _{In the case of all safeguard measures,}

the Panel therefore found that the failure to base the safeguard measures (national bans) on risk assessment violated Article 5.1 of the SPS Agreement. By implication, the Panel also found a violation of Article 2.2, which requires SPS measures to be based on scientific principles.152

While Article 5.7 permits Members to adopt SPS measures ‘where relevant scientific evidence is insufficient’, the Panel held that the safeguard measures fell outside the scope of Article 5.7, which would, according to the Panel, only apply in cases where there was insufficient evidence to conduct such risk assessment. The Panel found that the EU Member States imposing the safeguard measures had not conducted separate risk assessments, and the risk assessments conducted by the EU did not support the imposition of SPS measures.153

In order to provide a scientific justification, Members must follow the principle laid down in Article 5 of the SPS Agreement. The general rule is that full risk assessment must be presented, with the only exception being if it is a provisional application for precautionary measures as specified in Article 5(7). In order to invoke Article 5(7) there has to be not only ‘insufficient’ scientific evidence, but also has to be some kind of qualified risk present. The phrase ‘on the basis of available pertinent information’ clarifies that the risk present cannot merely be a hypothetical risk. The measure has to be temporary. The Panel in Biotech dispute explained: 154

a Member may provisionally adopt an SPS measure on the basis of available pertinent information in situations where the scientific evidence is insufficient for an adequate risk assessment, as required by Article 5(1) and as defined in Annex A(4), it makes sense to require, as the second sentence of Article 5(7) does, that that Member seek to obtain ‘the additional

151 _{Panel Reports, Biotech, paras. 8.22-30.}

152 _{Panel Reports, Biotech, pp. 958-1007, and paras. 8.22- 8.31.} 153 _{Panel Reports, Biotech, pp.1008-1055, and paras. 8.22- 8.31.} 154 _{Panel Reports, Biotech, para. 7.2990.}

48 information necessary’ for such a risk assessment. Once a Member has obtained the additional information necessary for risk assessment which meets definition of Annex A(4), it will be in a position to comply with its obligation in Article 5(1) to base its SPS measure on a risk assessment which satisfies the definition of Annex A(4).

With regard to risk assessment, the Panel admitted that it may include diverse and divergent scientific opinions. Moreover, the Panel asserted that this did not prevent states from adopting a precautionary approach where there were scientific uncertainties. However, in these cases, the individual Member States of the EU had not carried out risk assessments which supported a precautionary approach.155

When a measure has a higher level of protection than laid down in international standards, this higher level needs to be scientifically justified, and if no international standard exists, an SPS measure equally needs to be scientifically justified.156

A risk assessment is described in Article 5.2 as:

In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest or disease free areas; relevant ecological and environmental conditions; and quarantine or other treatment

In Hormones, the Appellate Body (AB) has interpreted Article 5.2 with a view to real life situations:

…there is nothing to indicate that the listing of factors that may be taken into account in a risk assessment of Article 5.2 was intended to be a closed

155 _{Panel Reports, Biotech, para 7.3219.} 156 _{See SPS Agreement, Article 3.3.}

49 list. It is essential to bear in mind that the risk is to be evaluated in risk assessment under Article 5.1 is not only risk ascertainable in science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world where people live and work and die.157

In EC-Hormones the Appellate Body declared that what constitutes a sufficient risk assessment is not defined in the SPS Agreement, either substantially or procedurally. A Member, therefore, is free to consider both Article 5(2) (‘available scientific evidence’) and Article 5(3) (‘relevant economic factors’), but there must be a ‘rational relationship between the trade measure and the risk assessment’.158

Notably, the Panel in Biotech held that the decision in the EC – Hormones case, which permitted the imposition of SPS measures based on divergent scientific views, applied only to cases where the divergent views were expressed within the same risk assessment.159

Furthermore, based on Japan – Apples case160_{, the Panel stated that SPS measures}

may be imposed when there is insufficient scientific evidence to perform an ‘adequate’ assessment of risks. The Panel instead held that a risk assessment is ‘adequate’ if it meets the definition of a risk assessment in Annex A(4), which only requires an ‘evaluation’ of likelihood of entry of a pest or disease and its potential adverse effects without reference to any qualitative standard determined by the Member.161

In the Biotech case, the Panel recommended that the DSB request the EU bring the relevant Member States’ safeguard measures into conformity with its obligation

157 _{See Hormones, (n 79 ) para. 187.} 158 _{See Hormones, (n 79) para.193.} 159 _{Panel Reports, Biotech, para. 7.3024.}

160 _{The Panel found that the risk assessment report submitted by Japan was not ‘sufficiently specific’}

to qualify as a risk assessment under the SPS Agreement, See Japan- of Apples, (n 82) para. 8.270.

50 under the SPS Agreement, either by revoking or justifying them based on an SPS- compliant risk assessment.162

The Panel found most of the challenged measures fell under the scope of the SPS Agreement, whose assessment is more risk and science-based relative to the GATT or TBT Agreement, which could also have been found applicable.

This restrictive interpretation raises concerns as to the leeway for WTO Members to protect their environment and public health. The Panel ruling ignores the relevance of the precautionary principle in determining the scope of risk assessments by not addressing the issue of insufficiency of scientific evidence. It reveals the real issue, which is the broader division on the international level over the use of science-based and precaution-based models for risk regulation in conditions of uncertainty. Chapter 4 expands on this issue.