Ref. Ares(2016)5134589 - 09/09/2016
Ref. Ares(2017)676538 - 07/02/2017
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.”)
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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).
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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).
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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.
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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.
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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.
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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,
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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.
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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
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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.
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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).
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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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