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STC Number - 215
Public Health Regulation 11
United States of America
Japan; New Zealand
First date raised:
, paras. 42-44
Dates subsequently raised:
June 2005 (
, paras. 45-47)
October 2005 (
, paras. 59-60)
Number of times subsequently raised:
and addenda 1-5
Primary subject keyword:
Control, Inspection and Approval Procedures; Food safety; Human health; International Standards / Harmonization; Members' Regulatory information; Transparency
Date reported as resolved:
Extracts from SPS Committee meeting summary reports
In March 2005, the United States observed that Thailand had notified Public Health Regulation N° 11 to be implemented in December 2004 (G/SPS/N/THA/116). In response to extensive comments, Thailand had delayed implementation to March 2005 (G/SPS/N/THA/116/Add.1), but had not addressed the substantive issues raised by the United States. Many US fresh food products had been categorized in that Regulation as high risk with no scientific basis. As a result, burdensome and costly testing and certification of compliance with pathogen requirements, and pesticides and heavy metals residue levels were now required for US exports to enter the market. The United States urged Thailand to suspend implementation of the Regulation until a science-based risk assessment for each product affected had been conducted.
New Zealand also expressed concerns about the testing and certification requirements of Regulation 11 and requested Thailand to further delay the entry into force of the regulation in order to substantially amend it.
Thailand indicated that the Regulation was part of a national strategic plan on food aimed at strengthening control measures for the safety and quality of Thai food from farm to table or export markets. The Regulation was not intended to discriminate against imports.
In June 2005, the United States recalled that Thailand had notified further revisions to Rule 11 on 23 May 2005, (G/SPS/N/THA/116/Add.3) leaving only 38 days for WTO Members to provide comments. This was not sufficient for exporters to become familiar with the changes, nor for Members to submit comments, or for Thailand to consider comments that might have been provided. The United States still had substantial concerns about the scientific basis for Thailand's categorization of many US products as "high risk". It was also still not clear whether Thailand would require certification and testing on domestic products. On 24 June 2005, the United States had been informed that the implementation of Rule 11 would be delayed until 31 December 2005. The United States appreciated these developments and encouraged Thailand to develop measures consistent with the SPS Agreement to manage any documented risks.
Japan observed that a national strategic plan on food, such as Rule 11, aimed at strengthening the control measures for the safety and quality of domestic and imported food, should be based on a science-based risk assessment and the working principles for risk analysis applied by the Codex Alimentarius. In order to avoid unjustified trade barriers, risk management should ensure transparency and consistency in the decision-making process in all cases. Japan requested information about the relationship between the proposed regulation and the related international standards.
Thailand replied that the food standards that would be applied throughout the country complied with the relevant international standards. Requiring a health certificate was the best option to alleviate the burden on importers at the border and was in compliance with Codex standards. Thailand had addressed most of the comments received from Members. Some food standards inconsistent with the Codex had been withdrawn, pending further science-based evaluation. Thailand notified additional modifications on 12 July 2005 (G/SPS/N/THA/116/Add.4) and cancelled its notification on 12 January 2006 (G/SPS/N/THA/116/Add.5) in order ot undertake a complete review of Rule 11.
In February 2006, the United States expressed appreciation for Thailand's several extensions and eventual cancellation of implementation of Decree 11. However, the underlying decree was still in place and its overall requirement that food must be proven to be safe through unspecified testing and certification processes remained of concern. Thailand was urged to reconsider the framework of the decree and to notify any changes sufficiently in advance for WTO Members to comment before final decisions were made.
Thailand clarified that, on the basis of comments by some Members, the requirements for a food health certificate had been withdrawn and the current review focussed on high risk food products. This review would be based on scientific risk assessment. Thailand was convinced that certifying healthy food on the basis of international standards was a way of facilitating trade. Thailand was also willing to recognize the equivalence of other measures. on the basis of international guidelines.
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