G/SPS/GEN/1550  
 
8 June 2017 
(17-3053) Page: 1/5 
Committee on Sanitary and Phytosanitary Measures    
 
ANNUAL REPORT ON THE  PROCEDURE TO MONITOR  THE PROCESS  
OF INTERNATIONAL HAR MONIZATION  
NOTE BY THE SECRETAR IAT1 
1  INTRODUCTION  
1.1.  At its meeting of 15 -16 October 1997, the SPS Committee adopted a provisional procedure to 
monitor the process of international harmo nization and 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 
revised the procedure in  October 2004.2 In 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 The procedure w as reviewed 
as part of the Third Review of the Agreement4, and again in the context of the Fourth Review.5 
1.2.  The Committee has previously considered eighteen annual reports on the monitoring 
procedure.6 These reports summarize several standards -related issue s that the Committee has 
considered and the responses received from the relevant standard -setting organizations.  
2  NEW ISSUES  
2.1.  Since the 201 6 Annual Report, no new issues have been raised under this procedure . 
3  PREVIOUS ISSUES  
3.1.  Since the 201 6 Annual Report, the re was further discussion on five issues previously raised 
under this procedure  regarding : (i) IPPC phytosanitary certificate requirements for processed food 
products ; (ii) use of the Codex international standard on glyphosate ; (iii) BSE restrictions not 
consistent with the OIE international standard ; (iv) HPAI restrictions not consistent with the OIE 
International Standard;  and (v) application of ISPM 13 on notifications of non -compliance.  
3.1  IPPC phytosanitary c ertificate requirements for processed f ood products 
3.2.  At the July 2016 Committee meeting, t he United States reiterated its c oncerns regarding 
Members' use of phytosanitary certificate requirements for processed products, addressed in 
ISPM 32 on 'Categorization of Commodities according to their Pest Ri sk.' A key provision of 
ISPM 32 was 'intended use', which was defined as the declared purpose for which plant products or 
other articles were imported , produced or used. The intended use of a commodity might be for 
planting, processing or consumption and othe r uses such as decorative products and cut flowers. 
The United States noted that some intended uses of a commodity were associated with a higher 
probability of a regulated pest establishing than others. This might result in the application of 
                                                
1 This document has been prepared und er the Secretariat's own responsibility and is without prejudice 
to the position of Members  or to their rights and  obligations under the WTO.  
2 G/SPS/14, G/SPS/17, G/SPS/25 and  G/SPS/11/Rev.1.  
3 G/SPS/40.  
4 G/SPS/53.  
5 The draft report of the Fourth Review  is contained in document G/SPS/W/280/Rev.2.  
6 These were circulated as G/SPS/13, G/SPS/16, G/SPS/18, G/SPS/21, G/SPS/28, G/SPS/31, G/SPS/37, 
G/SPS/42, G/SPS/45, G/SPS/4 9, G/SPS/51, G/SPS/54, G/SPS/56, G/SPS/59 , G/SPS/60 , G/SPS/GEN/1332 , 
G/SPS/GEN/1411  and G/SPS/GEN/1490 . G/SPS/GEN/1550  
 
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  different phy tosanitary measures for a commodity based on its intended use. The USDA -APHIS 
was currently examining its miscellaneous and processed products manual to update and clarify its 
guidance on processed foods and vegetable products covered by ISPM 32, Annex 1 t o more closely 
reflect the intent of the standard. Additional work was underway on national - and regional -level 
guidelines by NAPPO. The United States would welcome an exchange of Members' experiences in 
implementing ISPM 32. Furthermore, the United States  urged Members to employ a risk -based 
approach and to act in consistency with the guidance of ISPM 32, in that measures applied should 
be proportional to the pest risk identified for the intended use. In closing, the United States 
highlighted and applauded  IPPC for a training session focused on better implementation of ISPM  32 
held on 3 April 2016 in Rome, Italy.  
3.3.  Canada shared the concerns of the United States and encouraged Members to use 
international standards when establishing phytosanitary measures, in cluding IPPC standards where 
these existed, and to support the principles as set out in ISPM 32. Canada encouraged Members to 
take into consideration factors such as the intended use of the commodity when establishing 
requirements.  
3.4.  New Zealand also shared the concerns raised and, as a Member that recovered costs from its 
exporters, requested unjustified activities and costs related to certification be avoided so as not to 
penalise exporters.  
3.5.  At the March 2017 Committee meeting, the United States reiterated its concerns, previously 
raised in the March and July 2016 Committee, regarding Members' use of phytosanitary certificate 
requirements for processed products, as set out in ISPM 32 on 'Categorization of Commodities 
according to their Pest Risk'. The United  States recalled that it had outlined the key provisions of 
the standard, as well as highlighted the category of commodities defined as having been processed 
to the point where they did not remain capable of being infested with quarantine pests. The United  
States explained that in such cases, no phytosanitary measures should be required, and that such 
a commodity should not be deemed to require phytosanitary certification. The United States noted 
an increasing trend, where Members continued to require phyto sanitary certifications for products 
sufficiently processed to mitigate any pest risk (e.g. dehydrated pot atoes, frozen blueberries). 
The United States urged Members to follow the international standards, as set out in ISPM 32, in 
order to facilitate saf e trade in plant products.  
3.6.  Canada shared the concerns of the United States and encouraged Members to use 
international standards when establishing phytosanitary measures, and to support the principles as 
set out in ISPM 32. Canada highlighted that this stand ard encouraged Members to take into 
account several factors, such as the method and the level of processing of the products prior to 
export, and the intended use of the commodity in establish ing phytosanitary requirements.  
3.7.  Chile supported the concerns of t he United States, noting that certifications were sometimes 
required in bilateral trade which went beyond the necessary authorizations, creating additional 
burden and infringing international standards. Australia and Mexico similarly echoed the concerns 
raised and encouraged Members to refer to IPPC ISPM 32 for guidance on the processed products 
that did not require phytosanitary certificates in trade.  
3.2  Use of the Codex international standard on g lyphosate  
3.8.  At the July 2016 Committee meeting, t he United State s reiterated its concern over the fact 
that some Members had already taken action, or were considering taking action, to no longer 
apply the Codex MRL for glyphosate. The United States understood that the measures being 
considered did not appear to be base d on international st andards or risk of exposure. The United 
States highlighted a recent JMPR report from May 2016 that had concluded that glyphosate was 
"unlikely to be genotoxic" and "unlikely to pose a carcinogenic risk to humans from exposure 
through d iet." It was therefor e important to distinguish these findings from that of IARC, which 
were based on hazard and not risk. The US EPA was currently re -reviewing glyphosate using all 
available data and would also seek external peer review of the US cancer a ssessment later in 
2016. The United States stressed the importance of following international standards to minimize 
adverse impacts on trade, recalling Article 12 paragraph 4 of the SPS Agreement and the direction 
given in G/SPS/11/Rev.2. The United States  also expressed its concerns with recent developments 
in the European Union, in particular not basing its import tolerance for glyphosate on Codex G/SPS/GEN/1550  
 
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  standards, and the 18 -month extension - as opposed to the usual 15 -year reauthorization - of 
glyphosate use. This could have a significant impact on trade flows. The United States welcomed 
any update from Codex on these developments, particularly information on the May 2016 JMPR 
report and the steps that WHO had taken to clarify the relation between the JMPR and IARC 
reports.  
3.9.  Argentina, Canada and Brazil shared the concern of the United States and stressed the 
importance of following the Codex standard. They also noted the findings of the recent JMPR report 
and encouraged Members to take the guidance provided by J MPR and CCPR into consideration 
when developing, applying, re -evaluating or reauthorizing measures.  
3.10.   At the October 2016 Committee meeting, the United States  again  reiterated its concerns 
raised in the July 2016 Committee meeting regarding the use of the Co dex international standard 
on glyphosate. The US EPA had recently published its review on glyphosate using all available data 
and would be seeking external peer re view from a scientific advisory panel under the Federal 
Insecticide, Fungicide, and Rodentici de Act. The US EPA review had classified glyphosate as "not 
likely to be carcinogenic to humans at doses relevant for human health risk assessment." The US 
EPA was  currently in the process of rescheduling the meeting of the fifth scientific advisory panel 
to ensure additional epidemiological expertise would be available to the panel. The United States 
stressed the importance of following international standards and basing SPS measures on risk 
assessments, recalling Article 12.4 of the SPS Agreement and the direction given in 
G/SPS/11/Rev.2. The United States invited Members to think of how the Committee could provide 
greater understanding of how risk -based regulation of pesticides could ensure food safety in trade.  
3.11.   Argentina, Australia, Brazil, Canada and Ne w Zealand echoed the concern of the United 
States and stressed the importance of aligning national MRLs for glyphosate with the relevant 
Codex standard.  
3.12.   During the March 2017 SPS Committee, Argentina reiterated concern s that some Members 
were considering t he possibility of rescinding the use of glyphosate and thereby no longer apply 
the Codex MRL. In particular, Argentina noted that although the European Commission had 
approved the extension of the authorization for glyphosate use until the end of 2017, the re still 
remained concerns regarding the immediate impact on trade of agricultural products if the 
authorization was not further renewed. Argentina highlighted the JMPR report from May 2016 that 
had concluded that glyphosate was "unlikely to be genotoxic" and "unlikely to pose a carcinogenic 
risk to humans from exposure through diet". A recent European Chemical Agency (ECHA) 
publication, dated 15 March 2017, had also concluded that the available scientific evidence did not 
meet the criteria to classify glyp hosate as being carcinogenic, mutagenic or toxic for reproduction. 
Argentina noted that the ECHA conclusion was in accordance with previous statements from the 
European Food Safety Authority (EFSA). Argentina recalled the obligations of Article 3 of the 
SPS Agreement, highlighting that Members had the obligation to base their food safety measures 
on Codex standards or on scientific evidence. No scientific evidence had been provided by the 
European Union to justify deviation from the Codex standard. Argentin a urged the European 
Commission to take into account the Codex standard, the EFSA opinion and the ECHA risk 
assessment in its next decision on the renewal of the authorization of glyphosate use.  
3.13.   The United States also reiterated its concerns over the fact that some Members had already 
taken action, or were considering taking action, to no longer apply the Codex MRL for glyphosate. 
The United States understood that the measures being considered did not appear to be based on 
international standards or on risk  of exposure. Multiple robust risk assessments had been 
undertaken by international and national authorities (e.g. JMPR, EFSA, ECHA) on glyphosate, none 
of which had found convincing evidence regarding a carcinogenic risk to humans. In addition, 
glyphosate  was subject to a periodic registration review by the US Environmental Protection 
Agency (EPA), in order to ensure that pesticides containing glyphosate continued to meet the 
statutory safety standard for registration. The United States further informed th at in 2016 , the EPA 
had published a review of all available data on the potential carcinogenicity of glyphosate, where it 
had proposed to classify glyphosate as "not likely to be carcinogenic to humans at doses relevant 
for human health risk assessment". T his review had included, but also extended beyond, the 
studies reviewed by WHO and the International Agency for Research and Cancer (IARC) which had 
assigned a classification of "probable human carcinogen" to glyphosate. The EPA review had been 
evaluated b y an independent scientific advisory panel, which h ad released its report in 
March  2017. The EPA was now currently reviewing the panel's report, and other comments, before G/SPS/GEN/1550  
 
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  making a final determination on the potential carcinogenicity of glyphosate. Draft h uman health 
and ecological risk assessments on glyphosate were also scheduled to be published later in 2017, 
for public comments. The United States underscored the importance of distinguishing between the 
assessments conducted by JMPR, EFSA, ECHA and the p ending EPA risk assessment, from the 
report of IARC, which was based on an assessment of hazard only and not on risk. The United 
States further encouraged all Members to follow Codex glyphosate MRLs or to base SPS measures 
on science -driven risk assessment s that incorporate realistic exposure scenarios.  
3.14.   Australia, Brazil, Canada, Chile and New Zealand echoed the concerns of Argentina and 
stressed the importance of following the Codex standard. The findings of the JMPR report of May 
2016 were also noted and Members encouraged to take into account the guidance provided by 
JMPR and CCPR when developing, applying, re -evaluating or reauthorizing measures.  
3.15.   The WHO, on behalf of WHO and JMPR, confirmed the JMPR conclusions on glyphosate as 
outlined in the JMPR repo rt of May 2016, and indicated that the process to review glyphosate was 
ongoing. The WHO further explained that JMPR would report to the CCPR in April 2017, and would 
not request a change in the MRLs for glyphosate.  
3.3  BSE restrictio ns not consistent with the  OIE i nternational standard   
3.16.   At the October 2016 Committee meeting, t he United States announced that in August 2016 
the USDA Anima l and Plant Health Inspection Service (APHIS) had published a Notice in the 
Federal Register that finalized the recognition of  the OIE's negligi ble BSE risk designation for 
14 countries. The United States noted that it was also recognized as negligible ris k for BSE by the 
OIE, yet faced many restrictions on certain meat exports, inconsistent with this status. Some of 
these trade restrictions had been lifted in the past years and the United States called for the 
remaining BSE -related import prohibitions to be removed. The United States reminded Members 
that certain products such as protein -free tallow and blood products were deemed  safe by the OIE 
regardless of a country's BSE risk status, and thus should not be subject to BSE -related import 
restrictions.  
3.17.   In the March 2017 Committee meeting, the United States reiterated its concerns that some 
Members maintained unjustified BSE restr ictions that were inconsistent with the OIE international 
standards. The United States reiterated its commitment to aligning its impor t regulations 
governing BSE OIE guidelines and further recalled that in the October 2016 Committee, it had 
announced that the USDA 's Animal and Plant Health Inspection Service (APHIS), had published a 
Notice in the Federal Register that finalized the recog nition of the OIE 's BSE negligible risk 
designations for 14 countries. The United States indicated that APHIS had publishe d another 
Notice in the Federal Register on 23 January 2017, which indicated the preliminary concurrence 
with the OIE 's risk designation for seven countries (Costa Rica, Germany, Lithuania, Mexico, 
Namibia, Romania and Spain) as negligible risk for BSE, an d solicited comments on this proposed 
action by 24 March 2017. The United States noted that it was also recognized as negligible risk for 
BSE by the OIE, yet faced numerous unjustified restrictions on certain meat exports . The United 
States reminded Member s that certain products such as protein -free tallow, and blood products 
were deemed safe by the OIE regardless of a country's BSE risk status and thus should not be 
subject to BSE -related import restrictions.  
3.4  HPAI restrictio ns not consistent with the OIE i nternational s tandard   
3.18.   At the October 2016 Committee meeting, t he United States  reminded Members that in 
April 2016 it had regained country -wide freedom from HPAI consistent with the OIE guidelines. 
The United States highlighted the importance of the stamp ing out and surveillance policies 
encouraged by the OIE guidelines as effective means towards guaranteed eradication of HPAI. 
Some AI -related restrictions on imports from the United States had been recently lifted, and the 
United States acknowledged Ecuado r, Indonesia, Saudi Arabia and Turkey for their efforts. 
The United States urged Members to swiftly lift all remaining HPAI -related restrictions on US 
exports.  G/SPS/GEN/1550  
 
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  3.5  Application of ISPM 13 on notifications of non -compliance  
3.19.   In the March 2017 Committee meeting, Senegal raised concerns regarding the provisions 
contained in ISPM 13 on notifications of non -compliance, noting that non -conformity in relation to 
emergency actions was not well documented by Members. Senegal observed that in some cases, 
products that were  judged to be i n conformity by the relevant authority  were then destroyed 
without the relevant exporting authority being informed. Senegal indicated that this breached the 
guidelines outlined in ISPM 13, which required the importing party to deliver a rang e of 
documentation, in the event of destruction, to the relevant competent authority. Senegal 
emphasized the importance of providing this information to the exporting country through the 
official channels, in order to ensure reliable flows of information a nd to main tain trust between 
authorities.  
3.20.   Burkina Faso and Seychelles supported Senegal's concern. In particular, Burkina Faso 
highlighted its similar experience in receiving late notifications of non -compliance from enquiry 
points, and in some cases not b eing informed.  
4  RESPONSES RECEIVED F ROM THE RELEVANT STA NDARD -SETTING ORGANIZATION S 
4.1.  There have been no further responses received from the relevant standard -setting 
organizations  since the last annual report . 
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