G/SPS/GEN/1897  
 
1 April  2021 
(21-2746) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
 
EU MRLS AND PESTICIDE POLICIES – SPECIFIC TRADE CONCERN 448 :  
EU MRLS FOR BUPROFEZIN, CHLOROTHALONIL, DIFLUBENZURON,  
ETHOXYSULFURON, GLUFOSINATE, IMAZALIL, IOXYNIL,  
IPRODIONE, MOLINATE, PICOXYSTROBIN  
AND TEPRALOXYDIM  
SUBMISSION BY THE UNITED STATES  
The following submission , received on 30 March 2021, is being circulated at the request of the 
Delegation of the United St ates. 
 
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1.1.  The United States thanks Colombia, Costa Rica, Ecuador, and Paraguay for continuing to 
support inclusion of this important issue on the SPS Committee 's March 2021 meeting agenda.  
1.2.  The United States would like to emphasize our share d concern for human, plant, animal, and 
environmental health. However, we are disappointed that the EU continues to lower many MRLs to 
trade -restrictive levels without clear scientific justification or measurable benefit to human health, 
and we remain conc erned that the EU 's hazard -based approach to pesticide regulation and 
implementation of the "precautionary principle " will lead to trade barriers that threaten the security 
of global food systems.  
1.3.  For example,  we note G/SPS/N/EU/394 , which  was notified  to this Committee  on 15 July 2020.  
Despite  a Codex  proposal  to increase  the chlorothalonil  MRL for cranberries,  the EU has not renewed  
the substance  for use, and reduced  the MRL to the limit of quantification  or LOQ. In the same  
notification,  and despite  established  Codex  MRLs,  the EU also reduced  MRLs to the LOQ 
for fenamidone,  a foliar fungicide  used on many  crops  including  leafy green  vegetables  and 
brassicas,  and propiconazole,  a systemic  foliar fungicide  used on mushrooms,  corn, wild rice, 
peanuts,  almonds,  sorghum,  oats, pecans,  apricots,  peaches,  nectarines,  plums  and prunes.  
1.4.  The United States notes that pesticide s can be an important component in integrated pest 
management (IPM) programs, and that unnecessarily removing active ingredients and modes of 
action can actually increase the development of resistance to pesticides, which adds an additional 
challenge for a gricultural producers to face and overcome.  
1.5.  Along this vein, the United States would again like to raise our concern regarding the substance 
clethodim. In its justification for new MRLs, the EU indicated that it could not determine the genotoxic 
capacity of the clethodim metabolite -3 chloroallyl alcohol. Since the consumer risk assessment could 
not be completed, the MRLs were proposed at the LOQ. Although EFSA stated they could not rule 
out genotoxic potential, the United States would like to note that in the 2009 "Conclusion on the 
peer review of the pesticide risk assessment of the active substance (EZ) -1,3-dichloropropene1 " it 
was noted that for the metabolite 3 -chloroallyl alcohol there was no "genotoxic potential ".1   
 
1 Conclusion on the peer review of the pesticide risk assessment of the active substance (EZ) -1,3-
dichloropropene1.  Conclusion on pesticide review , 
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2 009.1341 . G/SPS/GEN/1897  
 
- 2 - 
 
  1.6.  In response to inconclusive genot oxicity potential for the metabolite, the applicant completed 
requested studies. From these data, the Rapporteur member State (Sweden) indicated that the 
"Maximum total dose (MTD) was not proved to be achieved ".   
1.7.  While further data is collected, we would like to remind the EU that both the United States and 
Codex have existing MRLs for clethodim. Clethodim is a useful tool for both EU and US farmers, and 
it is important for soybean, cranberry, rapeseed, peanut, cor n, blueberry, and hop production. We 
further remind the EU that Article 5 of the WTO SPS Agreement requires Members to consider 
available scientific information and the objective of minimizing trade affects.  
1.8.  We would also like to emphasize our concern that  a 6-month transition period for clethodim 
MRLs is insufficient for producers to adapt production methods for newly produced goods to clear 
EU customs. The key products to which clethodim is applied tend to have longer shelf lives and may 
not clear trade c hannels within a 6 -month transition period.   
1.9.  Finally, we recognize that EFSA is currently reviewing ten (10) member States ' emergency 
authorizations for neonicotinoids, which are currently banned within the EU, including clothianidin, 
imidacloprid, and thi amethoxam. It would appear as though producers in the EU view these products 
as integral components of their IPM programs and, accordingly, we request that the EU consider 
affording producers in third countries equal access to these pesticides.   
1.10.   Overall, t he United States continues to be concerned with the EU 's MRL risk assessment 
process. The EU previously noted in its response to G/SPS/GEN/1847  in reference to the 
determination by European Food Safety Authority (EFSA) if an MRL is safe for consumers, "This 
requires that a minimum of supporting data is provided in line with the EU data requirements 
allowing EFSA to reach a conclusion on the safety of the MRL. If such supporting evidence is lacking 
or insufficient, EFSA cannot conclude that the MRL is safe. "  
1.11.   This reasoning suggests that recent MRL decisions, including those for fenamidone, 
propiconazole, chlorothalonil, and clethodim are based on incom plete risk assessments and are thus 
provisional. We ask the EU to clarify the provisional nature of these recent MRL decisions, and 
confirm that scientific data, including from Codex, will be collected and analysed  to maintain these 
measures, consistent with the SPS Agreement.  
1.12.   We note that this is a consistent issue in ongoing pesticide reviews. While the EU has not yet 
lowered MRLs for etoxazole, G/SPS/N/EU/408  indicates that the substance will not be renewed based 
on what appears to be an incomplete risk assessment. EFSA did not finalize its consumer dietary 
risk assessment for processed commodities and the f ate of persistent soil metabolites in rotational 
crops, nor did it complete the isomerization for dietary risk assessment. While the EU states it will 
take additional information into account after the expiration of the grace period for uses on edible 
crops and prior to lowering MRLs, a "stop the clock " approach, that allows EFSA to gather the needed 
data and keep a temporary MRL in place until the process is completed, would facilitate continued 
safe trade.    
1.13.   Finally, the United States would again like to  raise the manner in which the EU enforces newly 
reduced MRLs. The EU enforces new reduced MRLs at the point of production for domestic goods, 
and at point of importation for imported goods. This causes trade inefficiencies and disruptions for 
products des tined for the EU market depending on when a new reduced MRL is enforced and results 
in both an inconsistent application of the SPS measure and an unfair advantage for EU producers.   
1.14.   Moving forward, we are increasingly concerned with the politicization of MRLs, particularly as 
evidenced in the EUs Farm to Fork Strategy, Biodiversity Strategy, and the Pesticide REFIT. We 
believe that science, not politics, should inform development of SPS measures and we look forward 
to productive engagement around the issue s raised above.  
1.15.   On a positive note, we would like to thank the European Commission for the invitation to 
attend the Third Country Information Session on 20 January  2021 on the consideration of 
environmental factors in the MRL setting process. We look forw ard to continued engagement in this 
area and encourage the EU to continue facilitating dialogues with third countries in this context.  
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