Article 6.3

Article 6.3 stands apart from Articles 6.1 and 6.2 (India-Agricultural Products, AB, para 5.121). Exporting from an endemic area begins with examination of Article 6.3 specifically where “an exporting Member claims that areas within its territory are pest- or disease-free or of low pest or disease prevalence”(R(z.v.s7«-p/g.v, para 5.96). Russia-Pigs made it clear that Article 6.3 only comes into play at the time when an exporting Member claims areas of pest- or disease-free (or low prevalence) (para 5.96) and then satisfaction of Articles 6.1 and

6.2 must be observed (ibid.). The obligation rests with the exporters to prove products are clean, that is, provide “the necessary evidence” in support of its claim “in order to objectively demonstrate to the importing Member” that the relevant areas “are, and are likely to remain, pest- or disease-free or of low pest or disease prevalence” (Russia-Pigs, para 5.61).

Article 6.1 may be used to inform a determination of whether an exporting Member has recognised pest- or disease-free or low prevalence areas (objectively demonstrated using the information required for an assessment of SPS characteristics under Article 6.1), but nothing denotes this to be strictly necessary (India-Agricultural Products, AB. para 5.120 and 5.158). Whether the Arctic or Antarctic will be able to make a claim for disease-freedom or more likely, where increasing pathogens result from unknown transmission, epidemiology and virulence, whether these nations will satisfy this provision, will impact upon a Member’s ability to be an exporter.

The first sentence of Article 6.3 relates to exporting members in terms of being able to objectively assess the nature, quantity and quality of the evidence (Russia-Pigs, AB. para 5.70), but this specifically does not apply to importation (Russia-Pigs, AB, para 5.70). Importation requirements are met in reading the second sentences of Articles 6.1 (re SPS characteristics) and 6.2 (determining pest or disease status) (Russia-Pigs, AB, para 5.71). All evidence needs to be evaluated and verified by an importing nation (Russia-Pigs, AB. para 5.62) and to this end. access needs to be given to requesting importing nations for purposes of assessing whether measures are adapted to SPS characteristics of area (Russia-Pigs, AB, para 5.61). Again, “where relevant, the importing Member may analyse data gathered through on-site visits to the area concerned and rely upon any other information that it may have acquired from other sources, including from competent international organizations” (ibid.. 5.62).

Such international organisations’ guidelines include “Article 5.3.7(d) of the Terrestrial Code, which requires an importing Member to “determine ... whether it accepts an area as a zone for the importation of animal products”” (Russia-pigs, footnote 192). However, the importing Member’s evaluation of the relevant evidence is not covered by Article 6.3, which addresses the “duties that apply to ... exporting Members”. (Russia-Pigs, AB, para 5.62). An importing Member’s ““determination” of the pest or disease status of a given area is addressed by the second sentence of Article 6.2, and forms part of that Member’s “assessfment]” of the SPS characteristics of that area within the meaning of the second sentence of Article 6.1” (Russia-Pigs, AB. para 5.59 and 5.60).

The fulcrum of Article 6.3 turns on the understanding of “necessary evidence” and “likely to remain so”.

Necessary evidence

Necessary means that which can be demonstrated not to be “excessive or not pertinent to a determination by the importing Member

Applying the SPS protocol 47 with respect to the pest or disease status of the relevant area” (Russia-Pigs, AB. para 5.64). Evidence may include that collected from on-site visits or from international organisations (Russia-Pigs, AB, para 5.71), and also includes “testimony, documents and tangible objects that...tend to prove or disprove the existence of an alleged fact” (Russia-Pigs, AB, para 5.63 using the dictionary definition from Black’s Law Dictionary, 7th ed.. B.A. Garner (Ed.) West Group, 1999, p. 578).

Evidence provided by an exporting Member to an importing Member must be of a “nature, quantity, and quality sufficient to enable the importing Member’s authorities ultimately to make a determination as to the pest or disease status of the relevant areas within the exporting Member’s territory” (Russia-Pigs, AB, para 5.66). Thus, the aim of the evidence is to demonstrate the pest or disease status of the Member (Russia-Pigs, AB, para 5.63). A panel review of compliance is limited to this (Russia-Pigs, AB. para 5.66). Evidence is required to be particularised to:

“the pest or disease and the area concerned, and cannot merely adduce generic information or unsubstantiated assertions...this evidence may encompass laboratory-type scientific information (e.g. the pathogenicity of a given disease) and/or technical information about the situation on the ground (e.g. the effectiveness of SPS controls in place in the area covered by the exporting Member’s claim)...(as well as the) non-exhaustive list of factors enumerated in the second sentence of Article 6.2 - including geography, ecosystems, epidemiological surveillance, and the effectiveness of SPS controls - may shed light on the type of evidence that an exporting Member is expected to provide under Article 6.3”. (Russia-Pigs, AB, para 5.63)

A Member’s appropriate level of protection (ALOP) may inform the nature, quantity, and quality of the evidence that an exporting Member is expected to provide in order to make the objective demonstration provided for in Article 6.3 (Russia-Pigs, AB, para 5.65). Importantly, Russia’s claims in the Russia-Pigs case makes an interesting point that time needs to be considered in the evaluation of compliance, specifically that “what constitutes a “reasonable” time period depends on various factors including: the timespan that has elapsed between the disease outbreak and the “regionalization” request; the expansion of disease-free areas and/or the establishment of new disease-free areas; the differences in veterinary services and geography between exporting countries; whether the exporting country is dealing with an outbreakfor the first time or has already accumulated experience from prior outbreaks; and whether, during the importing Member’s evaluation, disease outbreaks occur in the alleged disease-free areas” (para 5.77).

Time periods are not adequately considered in the SPS Agreement, with Annex C (l)(a) to the Agreement the only stipulation that "Members to “ensure, with respect to any procedure to check and ensure the fulfilment of [SPS] measures, that...such procedures are undertaken and completed without undue delay”” (Russia-Pigs, AB, para 5.81).

An exporting member needs to have “necessary evidence” that is, evidence tending to “prove or disprove the existence of an alleged fact” (Russia-Pigs, AB, para 5.63, using Black’s law Dictionary). This definition was from 1999 according to the reference. Advances in diagnostic ability have been made however and are continual and necessary evidence disproving or proving the definitive disease presence let alone status is an evolving field. First, disease presence does not indicate prevalence and prevalence may be considered only one aspect of disease status. Proof and disproof is built over time, very often after significant protocols have been adhered to for clinical research, including ethics protocols, which may take substantial time and are rigorous. Veterinary proof/disproof is based on Koch’s postulates which requires its own significant satisfaction/dissatisfaction of proofs. Thus, the question of whether there exists “necessary proof or disproof” is a matter of timing. The more important question is whether exportation should be enabled where disease-status and determinative prevalence are still unknown and yet deductive reasoning allows us to consider with scientific maturity that there may in fact be a rising disease prevalence occurring. In this regard, the law, as in the past, falls behind the science, it being utilised as a stagnant tool of application rather than as dynamic response to changing science.

It may be a benefit that in the Russia-Pigs case, the panel agreed that firstly, the list of factors in Article 6.2 (including ecosystems, geography, epidemiological surveillance and SPS controls) was non-exhaustive and that “the situation on the ground (e.g. the effectiveness of SPS controls in place in the area covered by the exporting Member’s claim)” was relevant (para 5.63). However, the assertion in the same paragraph that “an exporting Member is expected to provide particularized evidence with respect to the pest or disease and the area concerned, and cannot merely adduce generic information or unsubstantiated assertions” seems, scientifically at least, onerous particularly given that, within the meaning of science, proof and disproof carry such a heavy burden. This relies very much on the ability of those

Applying the SPS protocol 49 hearing cases to adjudge fairly, with consideration of both the science and the law, the SPS measure in question, the legal basis for it, and the scientific information available.

“Necessary” refers to the ability of an importing member to make an assessment of the SPS characteristics of an area, based on the objective demonstration by the exporting member, taking account of the nature, quantity, quality of the evidence which may be shown in the ALOP (Russia-Pigs, AB, paras 5.64-5.65). Necessary may be informed by Articles 6.1 and 6.2 (second sentences) (Russia-Pigs, AB, para 5.65). The panel recuses itself in this case (Russia-Pigs) from a scientific mandate, stating “[h]owever, a panel assessing compliance with

Article 6.3 is not called upon to determine for itself, based on the evidence provided by the exporting Member, whether the relevant areas are, and are likely to remain, pest- or disease-free or of low pest or disease prevalence” (para 5.66); however, it is a nonsense that a panel can determine whether evidence was sufficiently delivered to an importing Member without some knowledge of whether that evidence was of sound enough scientific value to enable an importing Member to make an objective determination of whether disease- or pest-free areas were likely to remain so. That is, a panel cannot adjudge whether the evidence delivered was of due weight, as regards the disease- or pest-free area, unless it understands the scientific value of the evidence. Secondly, in an altering climate, it is not certain that even scientific evidence to date can predict whether previously disease- or pest-free areas are likely to remain so. This qualification is difficult and cumbersome. It may have been better to make a determination based on, firstly, the volume of evidence provided and, secondly, whether any absence of information was warranted given a changing climate.

In Russia-Pigs, the Appellate body did not complete the legal analysis of the mechanism to determine whether a country may recognise the concepts of disease-free, pest-free or areas of low pest or disease prevalence nor did the panel prescribe a particular manner in the India-Agricultural Products case for how to recognise pest-free, dis-ease-free or low prevalence areas. Where intricate science is involved in understanding food-borne pathogens and zoonotic disease, there is an inability to either accurately portray such by legal representatives or be adjudged by legal minds.

Likely to remain so

SPS measures must be dynamic and adaptable over time (India-

Agricultural Products, AB, para. 5.157.) The Appellate Body has notedthat this requirement “is an ongoing obligation that applies upon adoption of an SPS measure as well as thereafter” (ibid.). Referring back to Article 6, SPS measures must be “adapted to regional SPS characteristics, and that the nature of that obligation” is not static, but rather ongoing...[and] adjusted over time so as to establish and maintain their continued suitability”” (India-Agricultural Products, AB. paras 126-127).