G/TBT/W/454  
 
10 November 2017  
(17-6115) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
EUROPEAN UNION — REVISED PROPOSAL FOR  THE CATEGORIZATION O F COMPOUNDS 
AS ENDOCRINE DISRUPT ORS OF 19 FEBRUARY 2 013 BY DG ENVIRONMEN T 
STATEMENT BY THE UNI TED STATES TO THE TBT COMMITTEE,  8-9 NOVEMBER 2017  
The following communication, dated 8 November 2017, is being circulated at the request of the 
delegation of the United States . 
 
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1.  The United States again takes the floor to raise concern regarding the EU 's hazard -based 
approach to regulatio n. While we strongly supports efforts by Members to strengthen public health 
and environmental protections by regulating the use of pesticides, we remain concerned that the 
EU's hazard -based pesticide regulations are insufficiently grounded in science and risk, and that 
these regulations will harm global agricultural production, food security, and international trade 
without providing meaningful benefits to public health.  
2.  The EU 's proposals for identifying and regulating endocrine disruptors (EDs), in parti cular, have 
generated great concern and uncertainty for agricultural producers, exporters, crop protection 
product manufacturers, and regulators around the world.  The extraordinary number of 
interventions at this Committee and the SPS Committee highlights the seriousness of the concerns 
surrounding the EU 's pesticide and ED regulations.  
3.  As Members of this Committee are aware, on 4 July  2017, the EU 's Standing Committee on 
Plants, Animals, Food and Feed (SCoPAFF) voted to approve hazard -based criteria for id entifying 
EDs. However, last month on 4 October, the European Parliament rejected the Commission 's 
proposed criteria for identifying EDs, with members of the opposition essentially calling for stricter 
criteria that would lead to many additional substances  being classified as EDs and subsequently 
banned.  
4.  While the United States has made it clear in this forum and others that it does not support the 
EU's use of hazard -based criteria to ban indiscriminately substances identified as EDs, we are 
concerned that  additional delay and prolonged uncertainty on how the EU will move forward with 
regulating EDs is detrimental on many fronts.  
5.  Delays may only serve to undermine European consumer confidence in the ability of regulators 
to carry out their responsibilities  to protect public health and the environment and authorize the 
use of safe and effective crop protection tools to support agricultural producers. Furthermore, the 
case-by-case application of interim criteria and lack of clear policies and regulatory requi rements 
could discourage innovation in the crop protection sector.  
1  Endocrine Disruptor Criteria  
6.  On the EU 's proposed criteria, it is critical to make the distinction between applying hazard 
criteria for the purpose of hazard identification (which can be a ppropriate when used in 
conjunction with exposure information to estimate risk), versus the EU 's approach, which applies 
hazard criteria as the sole basis for denying or withdrawing authorizations for pesticides and their 
corresponding maximum residue limi ts (MRLs), without conducting risk assessments.  G/TBT/W/454  
 
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  7.  We understand from comments previously made by the EU to this Committee that their legal 
framework mandates the establishment of hazard -based criteria, however, this does not diminish 
our concerns or relieve  the EU of meeting its obligations under the WTO TBT or SPS Agreements to 
ensure that technical regulations are not more trade -restrictive than necessary, or to base SPS 
measures on risk.  
8.  For these reasons, we urge the EU to consider seriously the concerns  voiced by Members of this 
Committee as it moves forward with its next steps in establishing criteria to identify and ultimately 
regulate substances with the potential to disrupt endocrine systems.  
9.  The United States strongly supports regulating endocrine d isrupting substances to protect 
human health and the environment. We have been doing so for more than two decades now.  We 
believe there are approaches that provide the high level of human health and environmental 
protection sought by the EU without unneces sarily disrupting international trade. The US 
Environmental Protection Agency 's Endocrine Disruptor Screening Program, for example, is a 
rigorous evaluation program initiated in 1996. It has since been reviewed by numerous 
independent scientific advisory p anels to ensure robust scientific criteria and processes to support 
sound risk management decisions.  
2  MRLs and Import Tolerances  
10.  With regard to MRLs and import tolerances (ITs), also troubling are recent statements by the 
European Commission suggesting that  EU legislation precludes the establishment of MRLs and ITs 
for substances banned due to the hazard -based cut -off criteria.  
11.  The Commission 's interpretation would appear to be inconsistent with the risk -based 
provisions of the EU 's MRL legislation, Regulat ion 396/2005.  It also raises questions about how the 
EU would ensure consistency with the WTO SPS agreement if it withdraws MRLs without 
conducting risk assessments, and refuses to consider ITs or relevant Codex MRLs. It is our 
understanding that some EU M ember States have also raised concerns about this approach.  
12.  Producers around the world are concerned that they will no longer be able to export products 
to the EU if MRLs for banned substances are set at default levels and ITs are refused. This would 
not o nly adversely impact agricultural producers and consumers, but would also harm EU food 
importers and manufacturers who source ingredients from third countries.  
3  Impact on Global Agricultural Trade  
13.  The EU 's endocrine disruptor impact assessment report discusses potential negative impacts 
that the loss of crop protection tools could have on agricultural production, food sec urity, and 
economic livelihoods - both domestically and in third countries. While the impact assessment is 
limited to endocrine disru ptors, concerns about the loss of crop protection tools in the EU extend 
far beyond endocrine disrupting substances.  
14.  The United States shares these concerns, particularly as they relate to negative impacts on 
agricultural productivity and increased risk of resistance in pests and diseases as pesticide 
authorizations are withdrawn. The lack of viable crop protection tools  and alternatives would mean 
lower yields, as well as increased food waste due to post -harvest losses. The need for a diverse set 
of tools to control pests and diseases will only become more important as we see an increase in 
extreme weather events due to global climate change.  
15.  While we recognize that there are political sensitivities surrounding pesticide legislation, 
agricultural producers and consumers of rely on government regulators to take objective, science - 
and risk -based approaches that allow for responsible use of safe and effective crop protection tools 
while also meeting food safety and food security goals.   
16.  Discontinuing the use of critical substances without a proper science -based risk assessment is 
likely to have serious adverse effects on ag ricultural productivity and global markets, without 
improving public he alth. The potential damage to US  exports once EC 1107/2009 is fully 
implemented, according to a 2016 independent analysi s has been estimated at nearly USD  5 billion 
and global trade dam age at over USD  75 billion.  G/TBT/W/454  
 
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  17.  Thus, we continue to impress upon the EU the need to take a risk -based approach in 
establishing technical regulations on the authorization of endocrine disruptors and other pesticides, 
and for establishing their corresponding MR Ls and ITs.  This is an approach that protects both 
consumers and growers, and is consistent with the WTO TBT and SPS Agreements.  
18.  Additionally, we stress the importance of non -discrimination, transparency, and predictability 
in the implementation of TBT me asures.  
 
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