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European Commission’s Public Consultation on Defining Criteria for Identifying 
Endocrine Disruptors (EDs) in the Context of the Implementation of the Plant Protection 
Product Regulation and Biocidal Products Regulation 
 
 
 
 
 
 
 
 
 

Comments of the U.S. Government 
 
 
 
 
 
 
 

January 16, 2015 
 
 
 

 
 
 
 

Introduction 
 
The United States Government appreciates this opportunity to comment on the European 
Commission Roadmap with respect to the “Defining Criteria for Identifying Endocrine 
Disruptors (EDs) in the Context of the Implementation of the Plant Protection Product 
Regulation and Biocidal Products Regulation”. The United States strongly supports 
strengthening public health and environmental protection by properly identifying, 
understanding, and regulating the use of plant protection products1 that may have endocrine 
disrupting properties.  This U.S. commitment is longstanding one stretching back almost two 
decades to the enactment of legislation charging the U.S. Environmental Protection Agency 
(EPA) to develop a screening program for plant protection products based on their potential to 
be endocrine disruptors.2  The U.S. experience in this area has emphasized that a principle 
applicable to all public health measures is particularly true and relevant with respect to 
regulating endocrine disruptors:  the measures must be developed in accordance with scientific 
principles and based on the relevant scientific evidence.  Plant protection products play a critical 
role in our lives. Imposing unnecessary restrictions could have far-reaching and particularly 
detrimental consequences.  The following are just some of the key considerations that arise 
when considering plant protection products in the context of endocrine disruptor regulation.      
 
Public Health:  Plant protection products serve an important public health 
objective by controlling pests and diseases.  Notably, the pesticides used 
for plant protection not only prevent the spread of diseases and pests that 
impact  plants,  but  also  mitigate  the  risks  of  pest-borne  diseases  and 
carcinogens that directly affect humans.3  As noted by the World Health 
Organization (WHO), “Vector control plays a key role in prevention and 
control of major vector-borne diseases… and often constitutes the first line 
of activity in case of epidemics of vector-borne diseases.  Chemical control 
(use  of  pesticides)  is  still  the  most  important  element  in  the  integrated 

                                                           
1  
Our use of the term “plant protection product” encompasses both pesticides and antimicrobial 
substances.   
2  
Congress passed legislation back in 1996.  See Food Quality Protection Act of 1996, 110 Stat. 
489, 7 U.S.C. § 136 et. seq. & The Safe Drinking Water Act Amendments of 1996, 110 Stat. 1613, 42 
U.S.C. § 300f. 
3  
See e.g., Eds. Hideo Ohkawa, Hisashi Miyagawa, et. al, Pesticide Chemistry:  Crop Protection, 
Public Health, Environmental Safety (2007), p. 318 (noting one way of preventing the carcinogen 
aflatoxin from spreading is to control insect pests that feed on nuts.); M. Peraica, B. Radic, et. al., Toxic 
Effects of Mycotoxins in humans, Bulletin of the World Health Organization (1999); UK Food 
Standards Agency, Code of Good Agricultural Practice to Reuce Fusarium Mycotoxins in Cereals (Feb. 
2007), available at http://www.food.gov.uk/sites/default/files/multimedia/pdfs/fusariumcop.pdf  
(“Recommended fungicides applied as an ear spray … at a robust rate can reduce ear blight and 
subsequent mycotoxin production. Growers should consider the use of fungicides and PGRs for fusarium 
mycotoxin reduction in conjunction with the Food Standards Agency’s Pesticide Residue Minimisation 
Crop Guide for Cereals.”) 
Page 1 of  18   
 

approach to vector control.”4        
 
Environmental  Protection  and  Climate  Change:    Plant  protection 
products help control invasive pests that can damage the environment and 
undermine  ecological  diversity.    The  European  Food  Safety  Authority 
(EFSA) estimates that the cost to Europe to control and eradicate invasive 
species—and repair the damage wrought by them—is more than ten billion 
euros a year.5  This figure, which excludes the costs of human pathogens 
and outbreaks of animal diseases, could rise significantly if plant protection 
products are removed from the market.6  Moreover, these products make 
farming  more  efficient,  reducing  fuel  and  energy  consumption.    For 
example,  crop  protection  products  may  allow  for  reduced  conservation 
tillage, meaning less soil erosion as well as less fossil fuel consumption.7      
 
Food  Security:    Despite  the  current  challenges  presented  by  crop 
pathogens,  it  is  important  to  recognize  that  modern  crop  protection 
products  have  resulted  in  drastic  improvements  that  have  strengthened 
food security.  For example, the Irish Potato blight in the mid-19th century 
led  to  nearly  one  million  deaths.8    Today,  advanced  treatments  prevent 
similar epidemics, although the head of research and development of the 
                                                           
4  
World Health Organization, WHOPES:  WHO Pesticides Evaluation Scheme, available at 
http://www.who.int/whopes/questions/en/ (last accessed January 9, 2015). 
5  
EFSA, Invasive Species, available at 
http://www.efsa.europa.eu/en/topics/topic/invasivealienspecies.htm.  (last accessed January 12, 2015).   
6  
The Food and Environment Research Agency, Agronomic and economic impact assessment for 
possible human health and ecotoxicology criteria for endocrine disrupting substances, Sand Hutton, 
York UK. June 2013. 
7  
See Jerry Cooper and Hans Dobson, The Benefits of Pesticides to Mankind and the 
Environment, CROP PROTECTION (2007) (“For example, the use of herbicides saves money or effort on 
mechanical weed control at the community level, brings medium term social benefits of reduced 
drudgery, improvement of the living environment on public and personal-use amenity or sports-use land 
at national levels, and longer term environmental benefits of reduced fossil fuel use, soil disturbance and 
moisture loss from tillage—a global scale benefit to us all.”’ University of Nebraska – Lincoln, 
CropWatch, available at http://cropwatch.unl.edu/tillage/advdisadv (last accessed January 12, 2015) 
(noting that while a disadvantage of a no till system is the increased need to rely on herbicides, benefits 
include erosion control. oil moisture conservation, and minimum fuel and labor costs; compare The 
Economist, Frankenfood Reduce Global Warming (May 4, 2013) (“GM crops in general need fewer 
field operations, such as tillage. Reducing tillage allows more residue to remain in the ground, 
sequestering more CO2 in the soil and reducing greenhouse gas emissions. Fewer field operations also 
means lower fuel consumption and less CO2.”). 
8  
Joel Mokyr, Irish Potato Famine, Encyclopaedia Brittanica (2014); John Reader, The Fungus 
That Conquered Europe, N.Y. Times (Mar. 17, 2008). 
Page 2 of  18   
 

Potato Council in Great Britain has noted that the loss of a specific crop 
protection  product  identified  in  the  EU  endocrine  disruptor  proposal 
“would also lead to serious concerns over resistance management of potato 
blight  as  an  increased  numbers  of  applications  of  single  mode  of  action 
active  substances  could  be  required  in  its  absence.”9    Moreover,  absent 
plant  protection  products,  more  land  would  have  to  be  dedicated  to 
cultivation even though most available farmland is already being farmed.10 
 
Consumer Welfare:  Plant protection products are critical to maintaining 
current  agricultural  yields—and  even  the  viability  of  some  agricultural 
commodities for producers and possibly countries.  For example, one study 
suggested that the production of apples in the United Kingdom—the most 
import  tree  fruit  grown  there  on  the  basis  of  area,  volume,  and  value—
would  not  be  commercially  viable  absent  the  use  of  pesticides.    Thus, 
reducing  plant protection products  without developing substitutes would 
likely  “reduce  the  availability,  affordability  and  overall  consumption  of 
fruit and vegetables….” for consumers.11 
 
Trade and Jobs:  Needlessly restricting plant protection products could 
have significant economic consequences for EU producers and the EU’s 
trading  partners.    The  Agriculture  and  Horticulture  Development  Board 
has  expressed  fears  that  if  the  EU  were  to  reject  a  scientific  risk  based 
approach  to  regulating  endocrine  disruptors,  the  cost  to  UK  agriculture 
alone could exceed £905 million.  U.S. stakeholder analysis suggests the 
failure to adopt a scientific approach could impact €65.3 billion worth of 
imports  into  the  EU  (of  which  over  €4  billion  worth  would  be  U.S. 
exports).  
The particular options identified in the Roadmap seem to suggest that the Commission is 
inclined to adopt a hazard-based approach to regulating endocrine disruptors, whereby 
endocrine active substances would be identified—and then proscribed from use—on the basis 
                                                           
9  
Potato Council, “Endocrine disruptor legislation ‘could cost UK industry over £905 million” 
(December 9, 2004), available at http://23.253.170.141:16396/news/endocrine-disruptor-legislation-
%E2%80%98could-cost-uk-industry-over-%C2%A3905-million%E2%80%99-ahdb 
10  
Associated Press, UN: farmers must produce 70% more food by 2050 to feed population, The 
Guardian (Nov. 28, 2011), available at http://www.theguardian.com/environment/2011/nov/28/un-
farmers-produce-food-population 
(last accessed January 12, 2015) (“The report found that climate 
change coupled with poor farming practices had contributed to a decrease in productivity of the world's 
farmland following the boom years of the "green revolution", when crop yields soared thanks to new 
technologies, pesticides and the introduction of high-yield crops.”) 
11  
Jerry Cooper and Hans Dobson, The Benefits of Pesticides to Mankind and the Environment, 
CROP PROTECTION (2007), citing Gattuso, D., Understanding the benefits of pesticides. Consum. 
Res.Mag. 83 (2000) 
Page 3 of  18   
 

that they have a potential to impact the endocrine system or cause an impact on the endocrine 
system without any further examination.12  In other words, the Commission’s hazard-based 
approach would impose restrictions even if there is no risk from exposure.; without considering 
what impact the potential hazard has on health (including beneficial impacts),13 and even if safe 
uses or mitigation techniques are available that might ameliorate the possibility of any adverse 
impacts. 
It is unclear how a hazard-based approach could logically potentially advance a general 
objective identified in the Roadmap:  “a high level of protection to human health and the 
environment.”  Staple agricultural products such as coffee, garlic, cherries, apples, and carrots 
contain naturally occurring endocrine active substances—and could be construed as hazards 
following the letter of the proposal.14  As a practical matter, however, the “hazards” in these 
crops present negligible risks because individuals do not consume the amount necessary to incur 
any adverse impacts. No additional protection is afforded to the public by banning these 
products.  Yet for reasons not stated, the options in the Roadmap envision such an approach 
with respect to plant protection products. 
Further, the Commission has only provided information of a very general nature in the 
Roadmap regarding what could be covered by these options to regulate endocrine disruptors.  
Consequently, it is difficult to understand from the Roadmap how the Commission arrived at 
these four options and leaves much uncertainty regarding the impact on a particular sector, 
product, or chemistry.  It would be helpful to know what other options were considered, or 
rejected and the reasons why. Also, if the Commission were to be provided with evidence 
supporting an option not among the four presented, would this be considered? 
These comments are divided into two sections.  Part I presents systemic concerns 
regarding the Commission’s regulatory process with respect to endocrine disruptors to date.  
These comments include:  process concerns, information concerning the U.S. approach, and a 
discussion of trade obligations and impacts. Part II of these comments review the four 
regulatory options listed in the Roadmap.  In the U.S. view, selection of options 2 or 4, with 
certain modifications, as set out in more detail in our comments, could potentially allow for a 
suitable risk-based approach and foster continued U.S.-EU cooperation to increase transatlantic 
and global regulatory compatibility for endocrine disruptors in bilateral and intergovernmental 
fora. 
                                                           
12  
Although we understand that the proposal may establish a default MRL of 0.01 PPM in lieu of 
complete market withdrawal,  the reality is that an MRL at that level is a practically proscription on 
nearly all the substances at issue.    
13  
For example, birth control pills, corticosteroids used to treat cancers, and medicines to treat 
psychiatric conditions are all endocrine disrupting substances.  Canadian Centre for Occupational Health 
and Safety, Endocrine Disruptors, available at 
http://www.ccohs.ca/oshanswers/chemicals/endocrine.html (last accessed January 12, 2015). 
14  
See e.g., S. Ozen & S. Darcan, Effects of Encrine Disruptors on Pubertal Development, J. Clin. 
Res. Pediatric Endocrinology (March 2011). 
Page 4 of  18   
 


 
Systemic Comments Regarding the Commission’s Overall Regulatory Approach 
 
A. 

Further Transparency to Promote Public Participation 
 
The U.S. experience with respect to regulating endocrine disruptors, and regulating writ 
large, is that the regulatory development process needs to be transparent and predictable in order 
to fully leverage the public's expertise.  Here though, the Commission has only provided the 
most general parameters of how it might regulate endocrine disruptors.  Consequently, it is 
unclear from the Roadmap what evidence supports a particular option, how a potential option 
might impact a particular sector, product, or chemistry, or how each option would be put into 
effect. In the next revision of the Roadmap, the additional information detailed below will be 
important in ensuring that these ambiguities can be sufficiently resolved. 
First, the Roadmap should precisely identify the scientific evidence that the Commission 
has considered in presenting each of the options and explain why the evidence led to the 
selection of a particular option.  The Roadmap broadly notes that it convened expert groups and 
commissioned an EFSA scientific opinion, but there is no explanation what aspects of their 
work the Commission found relevant in arriving at these options.  Indeed, the EFSA opinion 
appears inconsistent with the options listed in the Roadmap to identify endocrine disruptors.  
Specifically, the EFSA opinion recognizes that a risk-based approach is the scientifically sound 
basis for regulation: 
“to  inform  on  risk  and  level  of  concern  for  the  purpose  of  risk  management 
decisions  it  is  the  opinion  of  the  SC  that  risk  assessment  (taking  into  account 
hazard  and  exposure  data/predictions)  makes  best  use  of  available  information. 
EDs  can  therefore  be  treated  like  most  other  substances  of  concern  for  human 
health  and  the  environment,  i.e.  be  subject  to  risk  assessment  and  not  only  to 
hazard assessment.”15  
* * * 
“It is the opinion of the SC that, if regulation of identified EDs is to be based on a 
level  of  concern,  whether  or  not  this  level  of  concern  is  reached,  can  only  be 
determined by risk assessment. This should take actual or predicted exposure into 
account,  and  consider  the  whole  body  of  evidence  in  a  combined  manner  to 
characterise the risk.”16 
The omission in the Roadmap of references to scientific evidence and the relationship of that 
evidence to the options is particularly striking considering the questions that are being asked in 
                                                           
15  
EFSA Scientific Committee; Scientific Opinion on the hazard assessment of endocrine 
disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing 
test methods for assessing effects mediated by these substances on human health and the environment. 
EFSA Journal 2013;11(3):3132., available at http://www.efsa.europa.eu/en/search/doc/3132.pdf, p. 3. 
16  
Id. at 43. 
Page 5 of  18   
 

the public consultation process.  For example, the Commission is asking for stakeholders 
whether they “[h]ave … conducted or are … aware of an assessment of substances which would 
be identified as endocrine disruptors according” to each of the options.  The public’s ability to 
respond in an informed manner, to critique the options presented, and to provide relevant 
information would be greatly improved if the Roadmap indicated the initial evidentiary support 
that led to the formulation of these options.   
 
Second, although the Roadmap identifies Member State impact assessments and 
provides links to them, there is no explanation of what aspects of those assessments were 
considered relevant—including who might be affected and how.  Delineating that information 
will help the public know more precisely how their interests might be affected. 
Third, the process should be transparent and accountable to the public moving 
forward.  Transparency must be an ongoing process moving forward, particularly 
considering the limited information available in the Roadmap.  In particular:  
(i) 
Information should continue to be made available as it develops, and 
(ii) 
the Commission should take steps to assure the public that their views on 
its proposals are being considered as the regulatory development process 
moves forward. 
Furthermore, once the Commission has developed a draft text of its preferred 
option, it should be published in addition to the risk assessment and any impact 
assessments that are carried out.  In addition, once the Commission takes a final decision 
it should explain in a public document how it took significant comments into account. 
The Roadmap, and the request for consultations, seems to suggest that the only 
approaches to be considered are the ones identified in the Roadmap. To the extent there 
are legal or institutional impediments for consideration of alternatives, these 
impediments should be identified so comments can take them into account or suggest 
potential flexibilities. If the public can identify an alternative approach that is more 
effective in terms of public health and socio-economic costs, the consultation document 
should be open to that possibility. 
B. 
Regulatory Compatibility and The U.S. Approach to Regulating Endocrine 
Disruptors 

 
The Final Report by the U.S.-EU High Level Working Group on Jobs, Growth, issued in 
February 2013, cited “enhancing the compatibility of regulatory regimes” as a primary objective 
of a comprehensive T-TIP agreement.  The June 2011 United States-European Commission 
High-Level Regulatory Cooperation Forum Common Understanding on Regulatory Principles 
and Best Practices
 also notes that “[r]egulatory measures should aim to avoid unnecessarily 
divergent or duplicative requirements between the U.S. and the EU, when appropriate.”  In this 
context, it is important that the Commission’s approach to endocrine disruptors not foreclose 
U.S.-EU cooperation to increase transatlantic and global compatibility in the regulation of 
endocrine disruptors in bilateral and intergovernmental fora. 
Page 6 of  18   
 

Establishing a transatlantic approach to endocrine disruptors would set the highest 
global standard for the protection of public health and the environment while ensuring that 
global trade is not unnecessarily disrupted.  To that end, the Commission and EPA began a 
series of meetings in October 2014 to discuss opportunities and ideas to harmonize:  (i) priority 
setting methodologies to identify potential endocrine disruption; (ii) screening methods to 
identify potential endocrine disruption, and (iii) assessment of potential endocrine disruption 
incorporating endocrine bioactivity, hazard, exposure, and risk.  In future meetings, both parties 
will present case studies of potential endocrine disruption, in order to identify commonalities, 
understand differences, and discuss why such differences exist.  Efforts to achieve greater 
regulatory compatibility can benefit from these ongoing scientific exchanges.  Moreover, in the 
context of this Roadmap options more consistent with the risk-based approach to regulating 
chemicals would create opportunities for greater regulatory compatibility of the scientific 
approach for endocrine disruptor prioritization, screening, and testing between the Commission 
and the EPA. 
A brief summary of the U.S. approach to regulating endocrine disruptors may be 
informative. 
As noted, in 1996 Congress mandated that EPA develop the Endocrine Disruptor 
Screening Program (EDSP) to identify those pesticide chemicals which might be having 
undesirable effects.  Under the Food Quality Protection Act, EPA must make a safety finding 
that a ”reasonable certainty that no harm” will result from aggregate exposure to the pesticide 
chemical residue, including all anticipated dietary exposures and all other exposures for which 
there is reliable information. In the United States, EPA regulates chemicals using risk-based 
methods accounting for both hazard and exposure, including its EDSP. 
The first compounds being put through this program are the crop protection products 
(hereinafter referred to as ‘pesticides’). This decision was made based on the amount of data 
available on pesticide products, which is generated as part of the registration process.  In EPA’s 
experience, an appropriate regulatory definition of “endocrine disruptor” is one that causes 
harm, or an adverse effect; this regulatory definition would require:  hazard identification, 
hazard characterization, exposure assessment, and risk characterization.  Whereas the EU 
process employs only the first two, the U.S. regulatory definition of endocrine disruptors 
includes all four steps of a risk analysis.   
In EPA’s experience, private sector participation in EPA’s EDSP can provide regulatory 
authorities the necessary data on which to base such an approach to chemical and plant 
protection products. 
To that end, EPA is using a two-tiered screening and testing process. Tier 1 tests screen 
the pesticides in order to identify which, if any, have the potential to interact with the endocrine 
system.  The current EDSP Tier 1 battery consists of 11 diverse, yet complementary in vitro and 
in vivo screening assays.  The battery of assays was designed to be conducted as a whole to 
maximize sensitivity and reliability for determining the potential of a chemical to interact with 
the estrogen, androgen, or thyroid hormonal pathways.  A detailed characterization of each Tier 
1 screening assay, including its development, validation, strengths, and limitations, can be 
Page 7 of  18   
 

found in EPA Integrated Summary Reports or OECD Final Reports for individual assays at the 
EDSP website (http://epa.gov/endo/pubs/assayvalidation/index.htm). 
 
The subsequent Tier 2 tests are designed to determine whether or not that interaction has 
a negative impact on the performance of the organism—in much the same way current 
toxicological testing is already conducted.  Specifically, there are three goals: 
  
1. 
Determining whether a substance may cause endocrine-mediated effects through 
or involving estrogen, androgen, or thyroid hormone systems, 
2. 
Determining the consequences to the organism of the activities observed in Tier 
1; and 
3. 
Establishing the relationship between doses of an endocrine-active substance 
administered in the test and the effects observed. 
These tests will enable EPA to obtain a more comprehensive profile of the biological 
consequences of a chemical exposure and identify the dose or exposure that caused the 
consequences. Effects associated with endocrine disruption may not be expressed until later in 
the test subject's life, or may not appear until the reproductive period is reached. Therefore, Tier 
2 tests usually encompass two generations and include effects on fertility and mating, 
embryonic development, sensitive neonatal growth and development, and transformation from 
the juvenile life stage to sexual maturity. 
 
 
In addition, the EPA is seeking to develop rapid, non-animal based screening 
methodologies that ultimately—if deemed scientifically appropriate—will be used to replace the 
Tier 1 screens.  Initially, however they will be used to whittle down the universe of chemicals 
that could potentially be evaluated to a more relevant and manageable number, before being 
submitted for Tier 1 screening and Tier 2 testing. Tier 2 test results will allow EPA to proceed 
with a full, science-based risk assessment which takes into account exposure to the chemical in 
the context of the effects at various dosage levels. 
 
U.S. standards as set by the EPA are rigorous, extensive and ensure safe use of pesticidal 
and non-pesticidal chemicals.  EPA has developed the EDSP framework to prioritize, screen 
and test pesticidal and non-pesticidal chemicals potential to disrupt endocrine systems in 
humans and wildlife in the United States. The EDSP has three stages of implementation: 
 
 
Prioritization determines which chemicals require further screening using high 
throughput and computational methods to quantify endocrine bioactivity, 
exposure, and thus potential endocrine disruption.  
 
 
Screening identifies potential endocrine bioactivity of chemicals utilizing a 
weight of evidence approach according to EPA and Organization for Economic 
Co-Operation and Development (OECD) guidance and test guidelines, and 
incorporating other scientifically relevant information from prioritization and 
testing stages of the program. 
 
Page 8 of  18   
 

 
Testing identifies potential endocrine-mediated adverse outcomes (i.e., hazard) 
and provides quantitative dose-response information that may be used for risk 
assessment.  Testing consists of long-term reproductive tests across multiple 
generations for endocrine-mediated adverse effects relevant to humans and 
wildlife, using EPA and OECD test guidelines for mammalian and non-
mammalian species. 
 
Prioritization, screening and testing results from the EDSP are integrated within adverse 
outcome pathway frameworks, combined with exposure data and modeling, and used to 
strengthen quantitative hazard and risk assessments for both humans and wildlife. 
 
As noted previously, this is only a very brief description of the U.S. approach.  Below, 
please find a list of certain documents for your review and consideration that might provide 
further insight on some of the critical issues EPA has encountered in its work on endocrine 
disruptors. 
 
1. 
Scientific Issues Associated with Prioritizing the Universe of Endocrine   
Disruptor Screening Program (EDSP) Chemicals Using Computational 
Toxicology Tools
 
http://www.epa.gov/scipoly/sap/meetings/2013/012913meeting.html 
 
2. 
Endocrine Disruptor Screening Program (EDSP) Tier 1 Screening Assays and 
Battery Performance
 
http://www.epa.gov/scipoly/sap/meetings/2013/052113meeting.html 
 
3. 
Endocrine Disruptor Screening Program (EDSP) Tier 2 Ecotoxicity Tests 
http://www.epa.gov/scipoly/sap/meetings/2013/062513meeting.html 
 
4. 
Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening 
http://www.epa.gov/scipoly/sap/meetings/2013/073013meeting.html 
 
5. 
New High Throughput Methods to Estimate Chemical Exposure 
http://www.epa.gov/scipoly/sap/meetings/2014/072914meeting.html 
 
C. 
EU Principles Applicable to the Regulation of Endocrine Disruptors  
 
Adoption of a risk-based approach for regulating endocrine disruptors is consistent with 
long-standing EU policy.  We understand elements of the EU policy include: 
 
 
The analysis of risk … comprises three elements: risk assessment, risk 
management, risk communication. 
 
 
Risk can rarely be reduced to zero, but incomplete risk assessments may greatly 
reduce the range of options open to risk managers. 
 
Page 9 of  18   
 

 
Any assessment of risk that is made should be based on the existing body of 
scientific and statistical data. 
 
 
Risk assessment consists of four components - namely hazard identification, 
hazard characterization, appraisal of exposure and risk characterization … 
 
 
Measures should be proportional to the desired level of protection. 
 
 
The measures envisaged must produce an overall advantage as regards reducing 
risks to an acceptable level. 
 
The risk assessment should consist of four components, including considerations of exposure 
and risk characterization, and be based on the existing science.  Any resulting regulation should 
be proportionate, which means reducing risk—as opposed to reducing or eliminating hazard—to 
an acceptable level (i.e., not zero, which will likely be impossible).  A hazard-based approach, 
which is based on a more limited set of data than a risk-based approach, would not improve the 
protection of public health and the environment as much as a risk-based approach since such an 
approach ignores risk from exposure. 
 
To that end, great care should be taken that any measure adopted should not create the 
unintended effect of taking products—which can be safely used—off the market (e.g., by 
creating lists of “suspected” endocrine disruptors).  This would not only disrupt global supply 
chains, but could inadvertently increase the probability of exposure to other risks and deprive 
the public of the health, safety, and environmental benefits (e.g., disease reduction, crop 
protection, increased yields) provided by certain substances. 
 
Taking a risk-based approach would also be consistent with the report of the EC’s 
Endocrine Disrupters Expert Advisory Group.17  The report recommends the use of a Weight of 
Evidence approach for assessing endocrine disruptors, examining both whether a substance 
interacts with the endocrine system and whether it causes adverse effects.  In addition, the report 
recommends that any approach taken consider data quality, study reliability, and reproducibility 
of reported effects, which the United States also supports. 
D. Trade Obligations and Impact 
 
1. 
Trade Obligations 
The regulation of endocrine disruptors is intended to protect human and animal health 
and will undoubtedly have a significant impact on trade.  Accordingly, the EU’s measures on 
endocrine disruptors must comport with the EU’s obligations under the WTO Agreement on the 
Application of Sanitary and Phytosanitary Measures (“SPS Agreement”).  As the EU is aware, 
the SPS Agreement recognizes that governments have the right to set their appropriate level of 
protection and to adopt appropriate measures that achieve those levels of protection.  We 
                                                           
17  
“Key scientific issues relevant to the identification and characterization of endocrine disrupting 
substances,” European Commission, JRC Scientific and Policy Reports, Report of the Endocrine Disrupters Expert 
Advisory Group (March 2013). 
 
Page 10 of  18   
 

strongly concur as reflected by the high level of protection for endocrine disrupting substances 
in the United States. 
To ensure, however, that such measures are not a disguised barrier to trade, the SPS 
Agreement requires measures grounded in science. Specifically, Article 2.2 of the SPS 
Agreement provides that: 
Members shall ensure that any sanitary or phytosanitary measure is applied only 
to the extent necessary to protect human, animal or plant life or health, is based on 
scientific principles and is not maintained without sufficient scientific evidence, 
except as provided for in paragraph 7 of Article 5. 
Article 5.1 of the SPS Agreement further provides: 
Members shall ensure that their sanitary or phytosanitary measures are based on 
an assessment, as appropriate to the circumstances, of the risks to human, animal 
or plant life or health, taking into account risk assessment techniques developed 
by the relevant international organizations. 
The WTO Appellate Body has found that the requirement for a risk assessment is a specific 
application of the basic obligation in Article 2.2 and that these provisions should be read 
together as a result.18  Thus, undertaking a risk assessment is an integral part of having science 
based measures; this is not a formality but a careful exercise.  To that end, “one of the basic 
principles of a risk assessment appears to be that it needs to be carried out for each individual 
substance.”19  These principles counsel against the adoption of a hazard-based approach to 
regulating endocrine disruptors, since such an approach categorically reject examining available 
scientific evidence regarding whether an endocrine disruptor will have an adverse impact in 
light of exposure, dosage, and intrinsic properties.  Moreover, Article 5.2 of the SPS Agreement 
requires Members to take into account the risk assessment techniques developed by the 
specialist agencies.  Although their techniques vary, all—as recognized by EFSA—promote 
asking the same five questions: 
 
What can cause an adverse effect?  
 
How can it cause an adverse effect?  
 
What is the probability of an adverse effect occurring (i.e. what is the risk)?  
 
What are the consequences?  
                                                           
18  
Appellate Body, EC – Hormones (US), para. 180.   
19  
Panel Report, EC – Hormones (US), para. 8.257. 
Page 11 of  18   
 

 
What are the prerequisites for an adverse effect to indeed occur? 20 
To the extent one argues there is a paucity of scientific data on endocrine disruptors that 
might call for an exception, two points are notable.  First, the WTO Appellate Body has found 
that “the existence of unknown and uncertain elements does not justify a departure from the 
requirements … for a risk assessment.”21  Second, the summary of the EFSA opinion is 
instructive: 
The SC considers that a reasonably complete suite of assays is (or will soon be) 
available to identify and characterise the important hazards of EATS substances 
in  mammals  and  fish,  with  fewer  tests  available  for  birds  and  amphibians. 
Furthermore, these evaluation methods should, in principle, be fit for the purpose 
of establishing safe doses/concentrations of EDs if (1) certain aspects (e.g. follow 
up  of  exposure  in  critical  windows  of  susceptibility  to  later  life  stages)  are 
addressed  and  (2)  used  with  all  available  information  in  a  weight-of-evidence 
approach. 
*** 
Furthermore,  to  inform  on  risk  and  level  of  concern  for  the  purpose  of  risk 
management decisions it is the opinion of the SC that risk assessment (taking into 
account  hazard  and  exposure  data/predictions)  makes  best  use  of  available 
information. EDs can therefore be treated like most other substances of concern 
for human health and the environment, i.e. be subject to risk assessment and not 
only to hazard assessment.22  
There is no reason to believe that a risk-based approach to regulating endocrine disruptors is 
unavailable.  EU scientific experts believe it feasible, and U.S. regulators have twenty years of 
experience doing it in practice.  Accordingly, in the United States experience it is possible to 
regulate to the highest levels of protection in accordance with our trade obligations. 
 
2. 
Trade Impact 
The European Union and the United States have realized substantial economic benefits 
as a result of the stable agricultural trade relationship between our countries.  The EU is the fifth 
largest export market for U.S. agricultural products, while the United States is the largest export 
market for EU agricultural products.  
                                                           
20  
EFSA Scientific Committee; Scientific Opinion on Risk Assessment Terminology. EFSA 
Journal2012;10(5):2664, p. 9.   
21  
Appellate Body, Australia – Salmon, para. 130.   
22  
EFSA Scientific Committee; Scientific Opinion on the hazard assessment of endocrine 
disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing 
test methods for assessing effects mediated by these substances on human health and the environment. 
EFSA Journal 2013;11(3):3132., available at http://www.efsa.europa.eu/en/search/doc/3132.pdf, 
Page 12 of  18   
 

 
Implementation of any hazard-based “cut off” option, as outlined in the EC roadmap, 
that removes the requirement for conducting a full risk assessment could have severe 
implications for EU imports of U.S. agricultural goods.  U.S. agricultural producers rely on a 
variety of plant protection products to control pests and plant diseases, improve quality and 
yield, and limit human disease outbreaks associated with rodent and insect populations.  
Without the availability of viable pest mitigation alternatives, the elimination of important 
pesticides could significantly limit the quantity and quality of U.S. agricultural goods intended 
for export to the EU. 
 
In 2013, the United States exported approximately €4.4 billion worth of fresh and 
processed plant products to the EU that could be potentially impacted if hazard based criteria 
are applied by the EU. 
 
 
Page 13 of  18   
 


 
EU Imports of U.S. Fresh and Processed Plant-Based Products in 201323 
Commodity  
Value in Euros 
Edible Fruits and Nuts 
€ 1,836,384,000 
Edible Vegetables and certain roots and tubers 
€ 253,421,000 
Cereals  
€ 402,388,000 
Oilseeds and Oleaginous fruits; Miscellaneous grains, seeds and 
€ 1,975,156,000 
fruit 
Total  
€ 4,467,349,000 
 
This data does not include potential changes in trade flows in active pesticide ingredients 
exported from the United States to the EU, nor does it estimate total economic effects that 
may be caused by these changes in trade flows.  Non-trade effects may include disruption in 
production, marketing, and prices for U.S. commodities and development of resistance to 
remaining acceptable active substances.  For this reason, these trade impact estimates are 
conservative. 
 
 
Specific Comments Regarding the Options in the Commission’s Roadmap 
A. 
Options for Criteria for Determination of Endocrine Disrupting properties 
 
The preamble to the roadmap states: 
 
“There is general consensus on the WHO/IPCS (2002) definition of an Endocrine 
Disruptor.  It  is  defined  as  an  exogenous  substance  or  mixture  that  alters 
function(s)  of  the  endocrine  system  .  .  .    and  .  .  .  consequently  causes  adverse 
health effects in an intact organism, or its progeny, or (sub)populations
.” 
 
The roadmap focuses on making a determination of the first condition of altered function 
(hazard analysis), and not on the second condition of adverse health effects (risk assessment).  
If this definition of endocrine disruptors is the “general consensus,” then why would the 
roadmap not allow for a full risk assessment? 
 
The preamble further states: 
 
“The  BPR  and  the  PPPR  also  set  the  regulatory consequences for  substances 
considered  as  ED:  Annex  II, Section 3.6.5 of the PPPR and Article 5 of the 
BPR stipulate that ... substances having endocrine disrupting properties . . . 
which may cause adverse effects 
will not be approved for the respective use […]” 
 
A hazard analysis may be able to determine “endocrine disrupting properties,” but only a risk 
assessment can determine “which may cause adverse effects.”  Full risk assessment for 
agriculture chemicals is not a component of an option set forth in the roadmap. 
                                                           
23 European Commission Trade Market Access Database http://madb.europa.eu/madb/indexPubli.htm accessed: 
January 14, 2015 
Page 14 of  18   
 

 
Our understanding on this point is shaped by the relevant EU legislation referenced in 
the Roadmap.  Specifically, the two different EU regulations that respectively govern plant 
protection products (PPP) and biocidal products (BP).  For BP (non-food), the consideration is 
“risk;” for PPP, the consideration is only “exposure.”  This relegates the consideration of 
chemicals protecting crops to a less rigorous process than regulating disinfectants.  Both 
should consider risk, and only then the socio-economic impacts of having or not having these 
products available. 
 

Risk Assessment is the scientific gold standard as set forth by all three WTO SPS 
organizations (OIE, IPPC, CODEX).  To abandon this standard weakens scientific credibility, 
creates confusion, makes regulatory harmonization and risk communication very difficult, and 
in the end produces an inferior product.  The simplest solution to the broad range of policy and 
regulatory options is to standardize the use of risk assessment in all cases. The roadmap itself 
states that: “These criteria have to  be  operational, i.e.  they have to  allow for science-based 
regulatory decision-making.”  Risk assessments present results that are more complete and 
informative.  Conversely, hazard based assessments may result in decision-making that neglects 
relevant science and results in poor outcomes from a variety of perspectives including public 
health, environmental protection, and socio-economic interests. 
 
In the event the Commission is not so amenable, in the U.S. view, selection of options 2 
or 4, with certain modifications (as set out in more detail below) could potentially allow for a 
risk-based approach.  Utilizing such an approach would also reduce the potential for 
unwarranted trade impacts. 
 
1. 
Option One 
 
This option only determines if a certain chemical can have an effect on an endocrine 
system in some animal—irrespective of whether in the real world there is a situation where this 
would actually happen.  We can agree with the EC’s own initial rejection of Option 1 and its 
assessment that Option 1 would not meet objectives 2 and 3 as set forth: 2) scientific criteria 
and regulatory operability, and 3) “horizontal” application to all legislation. 
 
Under  this  policy,  the  accepted  science-based risk assessment process found in 
international standards and guidelines would not be followed.  Rather, regulatory policy would 
be based on the existence of a hazard—irrespective of exposure to the hazard, the risk of the 
hazard to human health, or whether safe uses can be identified.  Products would be removed 
from the market, and maximum residue levels (MRLs) in commodities produced with active 
crop protection substances identified under this categorization system could either be 
withdrawn entirely or set at a default level of 0.01 ppm, which is effectively a ban.24 
 
A proposed EU rule taken pursuant to Option 1 would also discriminate among end 
uses of the same chemical product, by differentiating among the following uses:  cosmetic, 
industrial, biocide, and pesticide.  Agriculture use falls under pesticides, and this is the class 
                                                           
24  
Achieving such a low MRL is difficult, and testing to this low level is subject to false positives. 
Page 15 of  18   
 

with most draconian restrictions proposed:  no exposure assessment, no socio-economic 
assessment, and no registration. 
2. 
Option Two 
 
Policy Option 2 for Aspect I of the EU criteria is based on the WHO/IPCS definition to 
identify endocrine disruptors (hazard identification).  In addition, Option 2 includes scientific 
issues in articles (a) through (e) that the EPA relates to endocrine bioactivity (including 
potency), hazard, exposure, and risk in the context of a systematic consideration of whether a 
substance has the capacity to cause endocrine-mediated adverse effects in humans or 
population-relevant endocrine-mediated adverse effects on animal species living in the 
environment, which EPA interprets to mean capacity under an assumption of ordinary exposure.  
In the U.S. view, Option 2 appears to have some potential consistency with a risk-based 
approach to regulating chemicals.  However, Option 2 does not explicitly mention potency, 
exposure or risk in any direct terms. 
Taking a risk-based approach would also be consistent with the report of the EC’s own 
Endocrine Disrupters Expert Advisory Group.25  That report recommends the use of a Weight of 
Evidence approach for assessing endocrine disruptors, examining both whether a substance 
interacts with the endocrine system and whether it causes adverse effects.  In addition, the report 
sensibly recommends that any approach taken consider data quality, study reliability, and 
reproducibility of reported effects, which the United States also supports. 
 
3. 
Option Three 
 
The EC’s own initial assessment that there are inconsistencies within Option 3 is sound, 
as stated in the roadmap: “for  sectors  with  decision making  mainly  based  on  hazard 
identification (PPPR, BPR general public uses), the impact on number of identified substances 
are expected to be higher as compared to the sectors with decision making based on risk or on 
socioeconomic considerations (BPR, REACH, MDR, WFD).” 
 
Indeed, it is unclear why a chemical/class of chemicals would be differently classified, 
depending on what form of analysis one uses (hazard vs. risk).  Specifically, chemicals are 
expected to have the same effect at the same concentrations in the same situation.  The different 
classifications of the same chemical/class of chemicals are an artifact of the system of analysis, 
not a scientific quality of the chemical itself or its effects.  Also we note two references in 
Option 3 to “mode of action.”  A chemical could have a mode of action which under some 
circumstances could disrupt endocrine systems, but would the chemical use in the real world (as 
per label), and at the actual concentration found in the environment, cause an adverse effect in a 
specific exposed organism?  This is a defect which could be remedied by a full risk analysis. 
 
                                                           
25 “Key scientific issues relevant to the identification and characterisation of endocrine 
disrupting substances,” European Commission, JRC Scientific and Policy Reports, Report of the 
Endocrine Disrupters Expert Advisory Group (March 2013). 
Page 16 of  18   
 

4. 
  Option Four 
Policy Option 4 for Aspect I is also based on the WHO/IPCS definition to identify 
endocrine disruptors, with the inclusion of potency as an element of hazard characterization 
(hazard identification and characterization).  In the U.S. view, the mention of potency in Option 
4 is related to endocrine bioactivity, hazard, exposure and risk in the context of a systematic 
consideration of whether a substance has the capacity to cause endocrine-mediated adverse 
effects in humans or population-relevant endocrine-mediated adverse effects on animal species 
living in the environment. 
 
However, it is not clear that Option 4 includes articles (a) through (e) associated with 
Option 2.  If Option 4 includes articles (a) through (e), similar to Option 2, and explicitly adds 
potency as an element of hazard characterization relevant to dose-response and critical for 
comparisons to exposure for risk-based methods, then Option 4 would be more consistent with a 
risk-based approach to regulating chemicals, including its approach to endocrine disruption in 
the EDSP. 
 
B. 
Approaches for Regulating Endocrine Disruptors 
 
The roadmap asserts the possibility of three approaches for regulating endocrine 
disruptors. It is unclear why the Commission identifies only these three approaches, but the 
following comments outline specific concerns regarding those approaches. 
With respect to Option A, “no policy change,” the Roadmap explicitly characterizes this 
option as not meeting the requirements of the BPR and PPPR or any of the other objectives 
listed).  Accordingly, despite being mentioned, it does not seem to be an option under 
consideration. 
Option B provides the introduction of additional elements of risk assessment into 
sectoral legislation.  Here, the document gives the example of the exemption in the BPR for 
cases where negligible risk can be demonstrated. It says such an exemption could be introduced 
into the PPPR.  While this is a positive step, it insufficient.  In the U.S. view, it would be 
preferable to modify Option B to ensure that risk assessment is a core and fundamental 
component with respect to endocrine disruptors writ large.  Option C demonstrates well why 
such should be the case. 
Option C, proposes the introduction of further socio-economic considerations, including 
risk-benefit analysis, into sectoral legislation. The Roadmap says such an approach is needed if 
banning an endocrine disruptor would have a disproportionate negative effect.  The Roadmap 
does not define what a disproportionate negative effect would be or what socio-economic costs 
would be considered.  That information would be helpful in being able to intelligently comment 
on this provision.  But put plainly, the United States has no issue with the EU seeking the 
highest level of protection possible—and is not suggesting that the level of protection be 
compromised.  On the contrary, what the United States has noted is that it is possible to regulate 
intelligently and effectively to raise public health without unnecessarily impeding commerce.  
The U.S. system for example does not allow chemicals unless there is reasonable certainty of no 
harm—a very high level of protection.  The U.S. system avoids unnecessary detrimental effects 
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by applying a risk-based system to chemical management.  In short, the U.S. view is that Option 
C is a false choice—the Commission can limit negative socio-economic benefits by applying a 
risk-based approach to endocrine disruptors. 
C.  
Horizontal Issues 
 
It is concerning, that within this consultation for identifying EDs for implementation and 
application in the PPPR and BPR, there is discussion about the horizontal application of the 
criteria to medical devices, cosmetics, workplace products, pharmaceuticals and food contact 
materials.  This secondary objective is not clearly stated in the in the announcement of the 
initiative. Further, each of these product categories has a different uses for chemicals and 
different levels of risk associated with their use. 
In particular, the language in the Roadmap referring to “the general calls on  the 
Commission to establish horizontal hazard-based scientific criteria to identify endocrine 
disruptors…”, which then goes on to mention: 1) a 1999 Commission Strategy which calls for 
“horizontal criteria for identifying endocrine disruptors,” and 2) two Commission expert 
groups established in 2010 to provide “advice/orientation  on scientific criteria for the 
identification of endocrine disrupting substances.”  Neither of these refers to “hazard based” 
assessment as the preferred form of scientific analysis to be used.  
 
The potential scope and ramifications of this measure beyond food and agriculture are 
unclear from the Commission roadmap.  In addition to pesticidal and biocidal products, which 
are specifically referenced in the subject line, such a measure could also impact—whether 
directly or indirectly—other economic sectors, or parts thereof, including: chemicals and 
products containing chemicals and cosmetics.  Thus, depending on its content the impact of a 
measure could be very dramatic.  For example, endocrine disruptors may be included in Annex 
XIV of REACH (Regulation 1907/2006) as Substances of Very High Concern (SVHCs), 
pursuant to article 57f.  Consequently, if certain substances were identified as endocrine 
disruptors as part of this exercise, they could potentially be listed in Annex XIV of REACH as 
well; as a result, companies would need to expect to incur costs similar to other SVHCs to 
obtain an authorization for such substances. 
 
To the extent this horizontal application is not intended to protect plant, animal health or 
food safety, any such measures that constitute technical regulations could still be subject to 
disciplines under the Agreement on Technical Barriers to Trade (TBT Agreement).  Article 2.2 
& Article 2.4 of the TBT Agreement are particularly relevant: 
Article 2.2: Members shall ensure that technical regulations are not prepared, adopted or 
applied with a view to or with the effect of creating unnecessary obstacles to 
international trade. For this purpose, technical regulations shall not be more trade-
restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-
fulfilment would create. Such legitimate objectives are, inter alia: national security 
requirements; the prevention of deceptive practices; protection of human health or 
safety, animal or plant life or health, or the environment. In assessing such risks, 
relevant elements of consideration are, inter alia: available scientific and technical 
information, related processing technology or intended end-uses of products. 
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Article 2.4: Where technical regulations are required and relevant international standards 
exist or their completion is imminent, Members shall use them, or the relevant parts of 
them, as a basis for their technical regulations except when such international standards 
or relevant parts would be an ineffective or inappropriate means for the fulfilment of the 
legitimate objectives pursued, for instance because of fundamental climatic or 
geographical factors or fundamental technological problems. 
Creating technical regulations on the basis of hazard based criteria are often (i) more 
trade restrictive than necessary because risk based mitigation measures exist and because (ii) 
they do not fulfill a legitimate objective as they are not supported by scientific evidence.   
 
 
CONCLUSION 
 
The United States Government fully supports measures to protect public health and the 
environment.  We urge the Commission to take the U.S. comments into account and to adopt an 
approach that fully considers the vital role that pesticide chemicals play in food safety and 
security, while promoting strong levels of protection, inspiring public confidence, and avoiding 
unwarranted burdens.  Such consideration is critical to accomplishing our joint purpose and to 
ensuring that any decisions are informed by risk assessments. 
 
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