WORLD TRADE  
ORGANIZATION  G/SPS/W/250 
26 May 2010 
 (10-2885) 
Committee on Sanitary a nd Phytosanitary Measures  
  
 
PROCEDURE TO MONITOR THE PROCESS 
OF INTERNATIONAL HARMONIZATION  
 
Draft Twelfth Annual Report
1 
 
 
A. INTRODUCTION 
1. At its meeting of 15-16 October 1997, the SPS Committee adopted a provisional procedure to 
monitor the process of international harmonization a nd the use of international standards, guidelines 
or recommendations, as provided for in Articles 3. 5 and 12.4 of the SPS Agreement.  The Committee 
extended the provisional monitoring procedure in 1999, 2001, and 2003, and adopted a revision of the 
procedure in October 2004.2  On 28 June 2006, the Committee agreed to extend the provisional 
procedure indefinitely, and to review its operation as an integral part of the periodic review of the 
operation and implementation of the Agreement under Article 12.7.3  This procedure was reviewed as 
part of the Third Review of the Agreem ent adopted by the Committee in March 2010.4 The next such 
review is to be completed in 2013, and every four years subsequently.  
2. The Committee has previously adopted eleven annual reports on the monitoring procedure.5  
These reports summarize several standards-related is sues that the Committee has considered and the 
responses received from the relevant  standard-setting organizations. 
B. NEW  ISSUES 
3. Since the adoption of the Eleventh Annual Report in June 2009, one new issue was raised 
under this procedure.  This issue is with regard to concerns relating to the lack of adoption of an MRL 
for ractopamine by the Codex Alimentarius Commission (Codex).  
Concerns on lack of adoption of MRL for Ractopamine by Codex 
4. At the meeting of the Committee of 28-29 October 2009, Brazil raised the issue of the lack of 
adoption of an MRL for ractopamine by Codex.  Some Members had imposed ractopamine bans 
without sufficient scientific evidence to support th em.  Extensive discussions on this matter occurred 
during the last two Codex sessions and at the 18th session of the Codex Committee on Residues of 
Veterinary Drugs in Foods. Ractopamine had been  approved by over 25 countries and the draft MRL 
was currently at Step 8 in the Codex process.  Ev idence to adopt the ractopamine MRL at Step 8 had 
been presented previously by JECFA and adoptio n had been recommended in 2007 by the Committee 
on Residues of Veterinary Drugs in Foods.  Austra lia, Canada, and the United States agreed with 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the position of Members or to their rights or obligations under the WTO. 
2 G/SPS/14, G/SPS/17,  G/SP S/25 and G/SPS/11/Rev.1. 
3 G/SPS/40. 
4 G/SPS/53. 
5 These were circulated as G/SPS/13, G/ SPS/16, G/SPS/18, G/SPS/2 1, G/SPS/28, G/SPS/31, 
G/SPS/37, G/SPS/42, G/SPS/45  and G/SPS/49, G/SPS/51. G/SPS/W/250 
Page 2  
 
  Brazil on the need for a rapid adoption of a Codex st andard for ractopamine, to avoid further trading 
difficulties.  Codex had not adopted the draft MR L for ractopamine at its 2009 session because of a 
request from China that JECFA conduct additional scientific review.    
5. The European Union noted that in 2009 the Eu ropean Food Safety Agency (EFSA) gave a 
standard opinion regarding the harmfulness of ractopami ne.  China  had also conducted a study on the 
effect of ractopamine on the tissue of pigs.  Norway supported the research conducted by the 
European Union and China, and stressed the need for JECFA to evaluate the latest data submitted by 
China before coming to a final conclusion. 
6. The Codex representative confirmed that Codex had decided in July 2009 that JECFA should 
evaluate the Chinese studies before coming to a decisi on. It was agreed that JECFA would review the 
data that had not been previously reviewed befo re the next session of the Commission in July 2010. 
7. [To be updated following the J une 2010 SPS Committee meeting.] 
C. PREVIOUS
 ISSUES 
8. Since the adoption of the Eleventh Annual report, there was further discussion on one issue 
previously raised under this procedure.  This issue is  with regard to concerns raised relating to a draft 
regional standard of the North American Plant Protection Organization (NAPPO) entitled "Guidelines 
for Regulating the Movement of Ships and Cargoes Aboard those Ships from Areas Infested with the 
Asian Gypsy Moth" (RSPM N 33).  
Concerns on regional standard of the Nort h American Plant Protection Organization 
9. At the meeting of the Committee of 28-29 October 2009, China raised concerns, for the fourth 
time before the SPS Committee, about a regional st andard approved by NAPPO on 10 August 2009, 
which required, with immediate effect, NAPPO memb ers (Canada, Mexico and the United States) to 
impose strict phytosanitary measures on ships a nd cargoes from China, Japan, Korea, Mongolia and 
Russia. 6  This standard implements risk management  options for the movement of ships and cargo 
from areas infected with Asian Gypsy Moth (AGM).  China, Korea, and Japan reiterated their serious 
concerns regarding the trade impact of this regional standard.  These Members had previously 
suggested that this standard was inconsistent with  Articles 2.2 and 5.6 of the SPS Agreement and that 
it had ambiguities regarding the technical applicatio n of the measure in different NAPPO countries 
and in different climatic conditions.  
10. At the meeting of the Committee in March 2010,  Korea stated that it had held technical 
consultations on this issue with Canada and th e United States in February 2010.  Korea hoped 
NAPPO countries would continue to have discussion s with the concerned countries with a view to 
minimize the negative trade impact of this regional standard. 
11. Canada noted that the NAPPO measure on AGM wa s being put in place to control the risk to 
North America's forests.  NAPPO representatives ha d been diligent in ensuring that all concerned 
stakeholders, including the shipping industry, had b een consulted.  The standard would be phased in 
with full implementation taking place in March 2 012.  The standard had taken all possible SPS 
measures into consideration and had been developed to be no more trade restrictive than necessary to 
manage the risk.  Furthermore, all NAPPO member countries were working with affected Members to 
come up with appropriate implementation plans and a number of Members had already participated in 
these meetings.  The risk of the introduction of AGM  to NAPPO member states was acute.  In 2009, 
                                                      
6 G/SPS/R/53, paragraphs 112-120.  G/SPS/W/250 
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  Canadian authorities had detected egg masses, ea ch containing thousands  of eggs, on ten ships 
travelling from the region. 
12. The IPPC indicated that although regional plan t protection organizations were recognized in 
the IPPC Convention and often regional organizati ons deposited a regional st andard with the IPPC, 
this did not make it an international standard.  The IPPC work programme included consideration of 
the need for an international standard on the moveme nt of pests via ship containers and vessels.  In 
such situations, the IPPC might use a regional st andard as the basis for the development of an 
international standard. 
13. [To be updated following the J une 2010 SPS Committee meeting.]  
D. RESPONSES  RECEIVED  FROM  THE  RELEVANT  STANDARD-SETTING  
ORGANIZATIONS 
14. [No further information has been provided by the relevant standard-setting organizations 
regarding other issues previously raised.] 
15. [To be updated following the J une 2010 SPS Committee meeting.] 
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