G/TBT/W/703  
 
29 November 2019  
(19-8218) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION - REGULATION CONCERNIN G THE NON -RENEWAL OF  THE APPROVAL 
OF THE ACTIVE SUBSTA NCE CHOLORTHALONIL  
STATEMENT BY THE UNITED STATES TO THE COMMITTEE ON TECHNICAL BARRIERS T O TRADE  
13 – 15 NOVEMBER  2019 
The following communication, dated 13 November  2019, is being circulated at the request of the 
delegation of  the United States. 
 
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1.  The United States remains concerned with the European Union 's approach to pesticide regulation, 
and specifica lly with the December 2018 Draft Commission Implementing Regulation concerning the 
non-renewal of the approval of Chlorothalonil. Further, the United States is concerned with the 
rationale given for the non -renewal.  
2.  The EU has voted to finalize the measure  without recognizing the comments and other concerns 
raised by not only the United States but also Colombia, Guatemala, Brazil, Panama, Ecuador, Costa 
Rica, Paraguay and Honduras.  
3.  The United States has also repeatedly expressed concern regarding the EU 's process for product 
registration approvals and establishment of maximum residue limits (MRLs), as well as the 
unreasonable timelines for implementing measures.  
4.  For Chlorothalonil and other active substances, the United States has repeatedly expressed 
conce rn that the EU 's reliance on data gaps and hazard -based standards as regulatory principles 
inhibits its ability to conduct risk assessments as required by the WTO SPS Agreement. Many data 
gaps cited by the EU are not problematic for other internationally r espected scientific organizations 
and standard -setting bodies that conduct risk assessments.  
5.  The EU has listed concerns about the genotoxicity of specific metabolites because of inconclusive 
and equivocal test results. We ask why the EU requires an excessi ve level of certainty when other 
respected regulatory agencies are able to determine safe levels of use and exposure.  
6.  The EU has asserted that the non -renewal of active substances does not restrict trade; however, 
it creates significant problems for produc ers who expect to trade in their products in the future.  
7.  As stated in the March TBT Committee meeting, following the EU 's removal of MRLs for 
Chlorothalonil in 2014, the U.S. cranberry industry suffered significant crop damage due to the loss 
of this effective crop protection tool, without any measurable benefit to food safety. To regain access 
to this important tool the U.S. cranberry industry invested significant resources generating new data 
to support an import tolerance application for submission to the European Food Safety Authority 
(EFSA), to allow for the use of Chlorothalonil on U.S. cranberries destined for the EU.  
8.  The U.S. almond industry has also expressed concern about the loss of Chlorothalonil and other 
substances from its pest management  programs, as producers rely on a robust rotation of products 
to manage pest resistance and protect against unnecessary crop damage as well as food waste.  
9.  The uncertainty created by the nonrenewal of Chlorothalonil creates a burden for U.S. growers 
who ma y have already made crop protection decisions for their 2020 crops. The uncertainty causes G/TBT/W/703  
 
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  particular difficulties for producers of commodities with longer shelf lives (e.g., dried fruits, nuts), 
for which there may be significant periods between applicati on, harvest, processing, and distribution.  
10.  When producers are unable to determine whether their crops will comply with export market 
standards, trade has been affected. U.S. producers cannot make key decisions without knowing if a 
pesticide MRL will be in existence in one or two years.  
11.  Will the EU confirm it will not take action on Chlorothalonil MRLs prior to the conclusion of a 
comprehensive risk assessment to address data gaps, support any changes to existing MRLs, and 
import tolerances? While the EU cla ims the purpose of the nonrenewal of approval was not to amend 
MRLs, its common practice has been to remove MRLs immediately following nonrenewal of approval.  
12.  We believe that the EU 's process for approving and establishing residue limits for active 
substan ces raises significant concerns. We continue to request that the EU establish risk -based 
approaches, which comport with the principles of sound science, non -discrimination, transparency, 
and predictability. Unquantified levels of uncertainty are not a scie ntifically valid reason to remove 
access to active substances.  
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