G/SPS/GEN/1749  
 
14 November 2019  
(19-7751) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
FLOOR STATEMENTS  
NOVEMBER 2019 WTO SP S COMMITTEE - FORMAL  MEETING  
AGENDA ITEM 3(B)(I): EU MRLS FOR BUPROFEZ IN, CHLOROTHALONIL, DIFLUBENZURON, 
ETHOXYSULFURON, GLUF OSINATE, IMAZALIL, I OXYNIL, IPRODIONE, M OLINATE, PICOXYSTROB IN 
AND TEPRALOXYDIM  
Communication from the United States of America  
The follow ing communication, received on 12 November  2019, is being circulated at the request of 
the Delegation of  the United States of America . 
 
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1.  The United States thanks Colombia, Costa Ric a, Côte d'Ivoire, Ecuador, Guatemala, India, 
Panama, and Paraguay for keeping this important issue on the Committee 's agenda.  
2.  Given the serious concerns raised in this forum over the past several years  — particularly 
regarding the profound adverse impacts on producer livelihoods in developing countries  — we are 
disappointed that the European Union  continues to lower many MRLs to trade -restrictive levels 
without clear scientific justification or measurable benefit to human health.  
3.  In responding to the recent  concerns of Members, the European Union has referred to its 
statements from the November 2018 and March 2019 meetings. We have carefully considered the 
explanations that were offered, along with those from the July 2019 meeting, and find that they do 
not address our current concerns. In fact, they raise additional questions about the consistency of 
the EU explanation with its actions alongside the fundamental provisions of the SPS Agreement.  
4.  For example, in its November 2018 statement to this Committee, th e European Union indicated 
that the basis for its decision to lower all buprofezin MRLs was its identification of "important 
consumer health concerns ". The European Union alleged that the metabolite aniline was a carcinogen 
for which a genotoxic mechanism could not be excluded, and no threshold for acceptable exposure 
could be assumed. The European Union stated that, therefore, a consumer risk assessment was not 
completed.  
5.  We note that the European Food Safety Authority (EFSA) evaluated buprofezin and found that 
aniline only occurs in processed commodities. For commodities that typically do not undergo 
processing, EFSA stated that a dietary risk assessment for aniline would not be required. We ask the 
European Union , then, why a risk assessment was not completed for commodities that are typically 
unprocessed —such as avocados, bananas, grapes, mangoes, and melons —in order to establish MRLs 
for buprofezin.  
6.  In November 2018, the  European Union also underscored that it based its risk management 
measures for buprofezin and aniline on the evaluations carried out by its own risk assessment body. 
We note that the European Medicines Agency (EMA), an EU risk assessment body that evaluat es 
medicinal products, reviewed the available data for aniline and concluded that the weight of evidence 
supports non -genotoxic mode of action. The EMA established a threshold for use in regulatory risk 
assessments.  G/SPS/GEN/1749  
 
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  7.  In light of the discrepancies between EF SA and EMA 's approaches, we ask the European Union 
how it is achieving consistency in the application of the level of protection it considers appropriate 
for aniline. We further ask the European Union to explain the basis for the distinctions in its approa ch 
to consumer exposure to aniline from different sources. We remind the European Union that such 
distinctions must not be unjustified or arbitrary.  
8.  If the European Union seeks to limit consumer exposure to aniline, we ask the European Union 
to quantify th e level of protection and reduction in risk that is achieved by lowering buprofezin MRLs 
for commodities in which no measurable aniline is present.  
9.  In November 2018, the European Union conveyed that it would be submitting a concern form to 
Codex regarding EFSA's findings and conclusions on buprofezin and aniline in order to "raise 
international awareness ". 
10.  We draw the Committee 's attention to the Summary Report of the September 2019 Joint 
FAO/WHO Meeting on Pesticide Residues, which notes that the JMPR eval uated the EU concern form 
and determined that aniline is unlikely to be carcinogenic to humans at estimated dietary exposure 
levels. The JMPR established a reference dose and concluded, on the basis of a risk assessment, that 
exposure to aniline does not r epresent a health concern. The JMPR also recommended new and 
increased MRLs for buprofezin that will facilitate trade of safe food.  
11.  In November 2018, the European Union also explained that during its evaluation of 
picoxystrobin, it had identified concerns related to the clastogenic and aneugenic potential of a 
metabolite, and had not been able to complete an assessment of genotoxicity for the substance. 
In this case too, the European Union indicated that it would be submitting a concern form to Codex.  
12.  We ag ain turn to the Summary Report of the September 2019 Joint FAO/WHO Meeting on 
Pesticide Residues, which notes that the JMPR evaluated the EU concern form. The JMPR 's 
interpretation of the data differed from the European Union's , and the JMPR confirmed that  dietary 
exposure to picoxystrobin is unlikely to represent a public health concern. The JMPR further 
confirmed that the WHO panel of JMPR included an independent specialist genotoxicity expert.  
13.  Since the European Union requested that JMPR divert resources  towards evaluating its concerns, 
we ask the European Union how it now plans to take into account the JMPR 's responses.  
14.  In July 2019, the European Union conveyed to the Committee that lowering MRLs for imazalil 
was considered necessary to ensure its approp riate level of protection. The European Union 
referenced two evaluations by EFSA which indicated that available data did not support 
establishment of MRLs sufficiently protective for consumers.  
15.  We note that EFSA cited uncertainty around genotoxic potential , as well as concerns about a 
metabolite present in commodities that are treated post -harvest, including citrus fruits, apples, 
pears, bananas, and potatoes. Consequently, EFSA stated that no MRLs could be recommended for 
these commodities.  
16.  Given EFSA 's opinion, we ask the European Union to explain its rationale for retaining MRLs for 
citrus fruits at 4 mg/kg, while lowering the MRL for bananas to the limit of determination, or 
0.01 mg/kg.  
17.  The June 2019 report of the Standing Committee on Plant, Animal, Foo d and Feed (PAFF) 
suggests that EU risk managers took into consideration the fact that citrus fruits are peeled, and 
therefore based consumer exposure estimates on the residues available in the pulp. We ask the 
European Union why a similar peeling factor w as not utilized for bananas.  
18.  Indeed, the June 2019 PAFF report stated that multiple member State delegations expressed 
reservations about the lowering of the MRL for imazalil in bananas. One member State asserted that 
the final position of the Commission on bananas had not been consistent with the approach given to 
other post -harvest uses in food commodities, even when the scenario was very similar to bananas.  
19.  We ask the European Union how it is achieving consistency in the application of the le vel of 
protection it considers appropriate for imazalil, and how its risk management approach distinguishes G/SPS/GEN/1749  
 
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  commodities, such as oranges and bananas. We note again that such distinctions must not be 
unjustified or arbitrary.  
20.  We also note that during the Fe bruary 2019 meeting of the PAFF, the Commission and EU 
member States discussed how to interpret genotoxicity data when all studies show no concern except 
for one equivocal, or indeterminate, result.  
21.  Given that uncertainty about genotoxicity has been freque ntly cited by the European Union as 
justification for invoking the so -called precautionary principle and basing measures on a priori 
hazards, and given the apparent divergence of the EU approach to evaluating genotoxicity data from 
that of the WHO and othe r national scientific and regulatory authorities, we ask the European Union 
to provide further details on the outcomes of this discussion, including:  
− whether or not it applies an objective weight of evidence approach when considering 
genotoxicity data;  
− how it considers the critical distinction between possibility and probability of exposure; and  
− whether it has considered provisional measures, such as temporary MRLs, so that it can 
avoid unnecessary barriers to trade while still seeking to obtain additional information 
necessary for its assessment.  
22.  Chair, the questions we have posed to the E uropean Union speak to the fundamental principles 
and obligations of the SPS Agreement, and are at the core of the concerns expressed by an 
unprecedented number of Members  in this forum, as well as at the July 2019 meeting of the Council 
for Trade in Goods.  
23.  Rather than referencing previous statements that do not address the specific concerns and 
questions posed by Members, we hope that the European Union will engage product ively in future 
discussions on this important matter so that the Committee can gain a better collective 
understanding of how the European Union is establishing MRLs in a manner consistent with its 
obligations under the SPS Agreement.  
24.  Since the EU implement ing regulations for MRLs specify relevance to the European Economic 
Area (EEA), we also invite Iceland, Liechtenstein, and Norway to respond, as we understand that 
they operate within the EU 's single market and harmonize their MRLs to those of the European  Union. 
We are not clear how or when EU MRLs are adopted by non -EU members of the EEA, as these actions 
do not appear to be notified to the WTO.  
25.  Chair, we appreciate the discussions in this Committee on actions to improve transparency and 
support greater s hared understanding of concerns raised in Committee. We will therefore submit 
this statement to the Secretariat and request its issuance as a GEN document.  
 
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