WORLD TRADE  
ORGANIZATION  G/SPS/W/250/Rev.3 
13 October 2010 
 (10-5147) 
Committee on Sanitary a nd Phytosanitary Measures  
  
 
PROCEDURE TO MONITOR THE PROCESS 
OF INTERNATIONAL HARMONIZATION  
 
Draft Twelfth Annual Report
1 
 
Revision  
   The draft Twelfth Annual Report on the Proce dure to Monitor the Process of International 
Harmonization was considered by the SPS Committ ee at its meeting of 29-30 June 2010.  The 
Committee agreed to adopt the report subject to its revision to include information arising from 
discussions under the relevant agenda item at that meeting.  The proposed revision was circulated to 
Members on 20 July 2010.  Following comments by China and the United States, a new revision was circulated on 1 September, with a deadline for comments of 24 September 2010. 
 
 Japan has proposed further modifications to the report, as indicated below in paragraph 10.  
The Committee will be invited to adopt this revised  report at its meeting of 20-21 October 2010. 
 
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 A. I
NTRODUCTION  
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. 
                                                      
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 , G/SPS/49 and G/SPS/51. G/SPS/W/250/Rev.3 
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  B. N
EW 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.  The United States added that some Members had 
imposed ractopamine bans without sufficient sci entific evidence to support them.  Extensive 
discussions on this matter occurred during th e 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.  Advice from 
JECFA to adopt the ractopamine MRL at Step 8 ha d been presented previously and adoption had been 
recommended in 2007 by the Committ ee on Residues of Veterinary Drugs in Foods.  Australia, 
Canada, and the United States agreed with Brazil on th e need for a rapid adoption of a Codex standard 
for ractopamine, to avoid further trading difficulties.  Codex had not adopted the draft MRL 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 April 2009 the European Food Safety Authority (EFSA) 
had issued a scientific opinion regarding the harmfu lness of this substance.  China had also conducted 
a study on the effect of ractopamine on the tissue of  pigs.  Norway supported the intervention of 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. At the meeting of the Committee in June 2010, the United States recalled the earlier 
discussions on this topic and explained that JECF A had recently concluded that the 2009 Chinese 
studies confirmed the validity of the proposed MRls .  In light of the JECFA findings, the United 
States expressed strong support that the eight MRLs for ractopamine would be adopted at the July 
2010 meeting of the Codex Alimentarius Commission.   Canada, Brazil and South Africa agreed that 
there was scientific evidence to establish the MRLs at  this time.  The Europ ean Union stated that it 
was too early to prejudge the outcome of that discussion.  China supported the position of the 
European Union and was of the opinion that Code x should continue its discussion based on science.  
The representative of South Africa noted that when the standard-setting process takes several years, it 
may encourage the emergence of private standards. 
8. The representative of Chile indicated that this type of situation made clear the need for a 
procedure to voice a concern when a standard  is held at Step 8 for several years.  
C. PREVIOUS ISSUES  
9. 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).  G/SPS/W/250/Rev.3 
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  Concerns on regional standard of the Nort h American Plant Protection Organization 
10. 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 sta ndard approved by NAPPO on 10 August 2009.  
This standard provides NAPPO member countries (Canada, Mexico and the United States) with 
guidelines for risk management aimed at minimizing the entry and establishment of the Asian gypsy 
moth (AGM) in North America.  It describes risk  management options for ships which called on ports 
where the AGM is present, including China, Japan, Ko rea, Mongolia and Russia.  It also describes 
measures necessary for cargo from or passing through infested areas destined to North America.  
Specific risk management options are adopted and applied by each NAPPO member country.  China, 
Korea, and Japan reiterated their serious concerns rega rding the trade impact of this regional standard.  
These Members  China  had previously suggested that this sta ndard was inconsistent with Articles 2.2 
and 5.6 of the SPS Agreement and that it had ambigu ities regarding the technical application of the 
measure in different NAPPO countries and in differe nt climatic conditions.  The concern had been 
supported by Korea and Japan.  
11. 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. 
12. 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, 
Canadian authorities had detected egg masses, ea ch containing thousands  of eggs, on ten ships 
travelling from the region. 
13. The representative of Chile suggested that th is topic should be addressed as a specific trade 
concern.  The IPPC indicated that although regional  plant 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. 
14. This standard was distributed by NAPPO to the FAO/IPPC Secretariat and the Administrative 
heads of the Regional Plant Protection Organizations. 
15. At the meeting of the Committee in June 2010, Chile again questioned whether it was 
appropriate to consider a regi onal standard under an agenda item that monitored the use of 
international standards.  Chile and New Zealand s uggested that this topic not be included in this 
report, but rather in the compilation of specific trade concerns (G/SPS/GEN/204/Rev.10).  China maintained that this report should include all issues that had been discussed under this agenda item, so 
as to provide a complete record of the Committee's deliberations. G/SPS/W/250/Rev.3 
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  D. R
ESPONSES RECEIVED FROM THE RELEVANT STANDARD -SETTING ORGANIZATIONS  
16. No further information has been provided by the relevant standard-setting organizations 
regarding other issues previously raised.  
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