Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'Correspondance about environmental and food safety standards in relation to TTIP'.




Ref. Ares(2016)7049618 - 19/12/2016
 
 
Proposal on US-EU Regulatory Cooperation 
March 7, 2014 
 
The European Crop Protection Association (ECPA) and CropLife America (CLA) propose 
the following areas of collaboration: 

 
1.  Sectoral negotiation on agricultural chemicals: ECPA and CLA propose to the EU and 
US negotiators a sectoral negotiation on agricultural chemicals as part of a single 
undertaking, which should aim to analyze the current divergences in both regulatory 
systems, explore ways to promote cooperation and harmonization, and find solutions to 
emerging trade problems. 
2.  Risk assessment as the basis for the regulatory framework: CLA and ECPA strongly 
support the use of risk assessment as the basis for the pesticide regulatory process for all 
active substances and plant protection products.  Risk assessment includes hazard 
identification, hazard characterization, and exposure assessment.  We request our EU and 
US negotiators to take necessary steps toward the inclusion of science-based risk 
assessment as the unified basis for pesticide regulation.  Without science-based risk 
assessment as the basis of pesticide regulation, any additional requests for regulatory 
convergence are unattainable. Furthermore, risk assessment is a fundamental principle of 
the World Trade Organization (WTO) Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS), to which the EU and US are signatories. 
3.  Harmonization regarding Maximum Residue Levels (MRLs): Under a risk 
assessment framework for pesticide regulation, ECPA and CLA seek significant 
harmonization in the processes for establishing MRLs. MRLs (and the MRL setting 
processes) are a key element of a unified framework among the EU and the US.  
4.  Protection of intellectual property: ECPA and CLA support robust protection of 
intellectual property, and specifically Confidential Business Information (CBI). The EU 
and US should agree to promote a common set of minimum standards in free trade 
negotiations with other countries. These standards should include 10 years for protecting 
regulatory data, and the protection of CBI, in line with Article 39 of the Agreement on 
Trade-Related Aspects of Intellectual Property Rights (TRIPS).  
 
A harmonised risk assessment framework for pesticide regulation is necessary to ensure the 

highest level of consumer and environmental protection, while promoting international trade, 
creating jobs, and enhancing social and economic viability of the EU and the US. 
 
 

Proposed Areas of Collaboration; 3/7/2014 
Page 2 of 14 
Introduction 
The European Crop Protection Association (ECPA1) and CropLife America (CLA2) are pleased 
to respond jointly to the solicitation of comments on “how to promote greater trans-Atlantic 
regulatory compatibility” and promote regulatory cooperation activities that would help 
eliminate or reduce barriers to trade.  While ECPA and CLA have provided initial comments on 
these issues, this document further develops our views while focusing on areas where we believe 
that real progress can be achieved. 
 
There are inevitable differences between the United States (US) and the European Union (EU) in 
the regulation of crop protection products that have arisen for various reasons.  Our aim is to 
promote regulatory cooperation and harmonization to reduce the regulatory burden that results 
from such differences and improve efficiency. Our major area of concern relates to differences 
that may ultimately affect international agricultural trade, economic progress, and job creation. 
 
Many regulatory issues pertaining to pesticides could benefit from greater regulatory cooperation 
between pesticide regulatory authorities in the EU and the US.  Our proposals focus on three 
broad topics of high importance: 
1.  The use of risk assessment as the foundation for regulatory decisions, including joint 
reviews; 
2.  The need for greater harmonization in the processes for establishing Maximum Residue 
Levels (MRLs); and 
3.  Protection of Intellectual Property, in particular, Confidential Business Information 
(CBI), which incentivizes innovation. 
 
We would also take the opportunity to promote: 
  Greater bi-lateral regulatory cooperation on issues of common regulatory interest and 
concern. 
  The management of Good Laboratory Practice (GLP) standards to ensure acceptance of 
regulatory data by national regulatory authorities. 
 
The challenges in regulatory cooperation 
Increased regulatory cooperation must seek to enhance convergence of regulatory approaches 
while maintaining high levels of protection for human health and the environment.  Notable 
examples of beneficial regulatory convergence are the reasonably similar approaches to the 
setting of MRLs and the protection of regulatory data in the US and EU.  
                                                 
1 ECPA is the voice of the Crop Protection Industry in Europe, with a clear focus on the research 
and development of innovative crop protection solutions.  The membership includes a wide 
range of corporate entities and industry associations involved in chemical crop protection 
throughout Europe.  ECPA has 19 member companies and 32 national crop protection 
associations in the EU and other countries within the wider European area. 
2 CLA is the not-for-profit national trade organization representing the developers, 
manufacturers, formulators, and distributors of plant science solutions for agriculture and pest 
management in the US.  CLA’s member companies produce, sell and distribute virtually all the 
crop protection technology products used by American farmers. 

Proposed Areas of Collaboration; 3/7/2014 
Page 3 of 14 
 
Existing regulatory divergences have broad potential for intermediate and long-term negative 
impacts on trade in agricultural commodities, and raise costs for producers on both sides of the 
Atlantic.  The primary divergence includes different approaches in assessing pesticides with 
different emphasis on the evaluation of risk and hazard.  Allowing additional divergence in 
regulatory processes may contribute to potentially large negative impacts on trade in agricultural 
goods between the US and the EU.  
 
The EU and the US have the most highly developed pesticide regulatory systems in the world.  
Combined, the crop protection markets in these two regions overshadow the rest of the world.  
How the EU and the US regulate pesticides is carefully monitored by other nations, large and 
small.  Consideration of the international consequences must be built into the decision-making 
processes for both governments.  How this happens must be transparent to stakeholders in the US 
and the EU.  Well-regulated in-person forums with multiple opportunities for reviewer-to-
reviewer communications must be available for exchange of information between EU and US 
authorities as decisions are underway.  Furthermore, expert consultations between EU and US 
agencies on data requirements, guidance, and guideline development would help to avoid future 
divergence in regulation and assessment of substances. 
 
Once risk assessment is adopted uniformly for both EU and US pesticide regulation, there is the 
possibility to harmonize MRL processes.  Harmonization of MRL procedures offers an 
opportunity to maintain and promote trade in agricultural products between the EU and US, 
applying a robust evaluation system based on risk assessment.  We would point to the Regulatory 
Cooperation Council established under the US-Canada Free Trade Agreement as a worthy and 
successful model to follow. 
 
Key areas of focus: 
1.  Science- and Risk-based Assessment, including joint reviews 

  CLA and ECPA strongly support the use of risk assessment as the basis for the 
pesticide regulatory process. 
Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, 
Drug and Cosmetic Act (FFDCA), the US has a long record of science-based risk assessment to 
inform regulatory decisions by EPA for pesticides.  A robust body of laboratory and field data 
must accompany an application for a new pesticide active substance (called “active ingredient” 
in the US), or a new crop use of an already registered product.  Assessment of these data by EPA 
scientists and managers results in solid decisions that must withstand rigorous scientific and 
policy scrutiny.  The benefits for product uses are taken into consideration, and decisions are 
subject to periodic review to account for any new data requirements or new information 
regarding the use of the products. 
 
The US approach relies on conservative risk assessment to determine the conditions under which 
a product may or may not be registered and used.  It requires exposure assessments for the 
general population, children, workers, other subpopulations, and wildlife. 
 

Proposed Areas of Collaboration; 3/7/2014 
Page 4 of 14 
The legislative framework in the EU is set out in Regulation 1107/2009, and the EU relies on 
very similar data requirements and body of data in making its corresponding pesticide regulatory 
decisions, for a given active substance and product. An active substance or product shall only be 
approved if the risk assessment demonstrates risks to be acceptable, based on realistic 
“maximum exposure” conditions of its use in crop protection. While the EU’s regulatory 
framework is risk based, Regulation 1107/2009 does introduce hazard-based criteria as the first 
step in the evaluation process; where substances with certain hazard classifications do not reach 
the risk assessment stage. 
 
Risk assessment is an internationally agreed principle (e.g. WTO SPS Agreement), and a 
uniform approach of the EU and the US to risk assessment would provide further clarity and 
confidence for both farmers and consumers in EU and US markets, including for trade partners 
who adhere to a risk-based approach when setting import tolerances. Reliance on a hazard-based 
approach, to the exclusion of risk assessment, is not compliant with the WTO SPS agreement.  
Defining a common risk assessment approach would be one of the most valuable principles in 
creating a level playing field across the trans-Atlantic economy.  If the EU and US had similar 
principles whereby pesticide regulations are based on risk assessment, this would enable the 
convergence that we request in the following technical issues.  We fully realize the complexity of 
the task; but the TTIP negotiations offer an opportunity and a lever toward greater coherence. 
 
  Joint reviews 
International joint reviews, as introduced and guided by the vision on “A Global Approach to the 
Regulation of Agricultural Pesticides”3 developed by the Organization for Economic 
Cooperation and Development (OECD) in 2004, have become the de facto process for bringing 
new crop protection products to the world market.  The pesticide regulatory authorities of 
multiple countries collaborate to review the application and its supporting scientific data 
simultaneously, sharing the numerous tasks involved in endpoint evaluation, and accepting the 
results of each other’s reviews of studies.  Ideally this approach reduces the workload for all, 
improves general understanding of the chemistry and uses of the product, results in better and 
more consistent decision making, enhances convergence of regulatory approaches, and brings 
improved crop protection technology to more farmers more quickly. 
 
However, we often observe that the same data set is still evaluated multiple times, by different 
experts, who come to different conclusions.  The US and EU use different approaches to describe 
and regulate the uncertainties in scientific study information.  The lack of consistency drives 
further precaution, because the lowest common denominator is usually applied, leading to 
conflicting messages to the public.  For example, how can the same substance be considered a 
carcinogen with relevance for human health in the EU but not in the US, or vice versa?  In recent 
years, the EU has been a distant or reluctant participant in international joint reviews.  We would 
strongly encourage the EU to actively reengage, so as to both contribute to and benefit from this 
most important endeavor.  This is particularly important within the context of a Free Trade 
Agreement, where shared knowledge enables a more convergent approach to regulation. 
 
                                                 
3 http://www.oecd.org/fr/securitechimique/pesticides-biocides/33854658.pdf 

Proposed Areas of Collaboration; 3/7/2014 
Page 5 of 14 
2.  Maximum Residue Levels 
  ECPA and CLA strongly support greater harmonization of the processes for 
establishing MRLs.   
Despite comparatively high tariffs and a host of non-tariff trade barriers, especially in the 
sanitary-phytosanitary (SPS) arena, trade of agricultural commodities continues to increase 
between the US and Europe.  The EU is the biggest net importer of raw agricultural commodities 
(unprocessed products that are mainly traded in bulk, such as grains and oilseeds).  The EU is 
also by far the biggest importer of agricultural products in general, from all geographic sources, 
which includes intermediate and final [processed] products.  Total agricultural imports into the 
EU reached €98 billion in 2011.  The biggest exporters are North and South American countries, 
where modern biotechnology crops, together with chemical crop protection tools, have 
contributed to higher productivity.  In 2011, the US exported US$136.3 billion in agricultural 
commodities to all countries.  After meat and meat products, soybean exports are second in 
volume and third in financial value.  Specialty crops (collectively) are second in financial value.  
For its part, the US is a major importer of European wines and processed dairy products.  Trade 
of commodities is international in scope; the regulatory approaches to decisions should be 
similar.  Today growers, traders, and food processors insist that commodities be acceptable in 
global trade.  The financial risk of a commodity shipment being rejected at the port of entry due 
to the absence of legal or harmonized trading standards is not acceptable to the food chain. 
 
Trade in agricultural products between the EU and the US amounted to US$31.5 billion (€22.5 
billion) in 2011.  The vast majority of crops are, of necessity, treated with crop protection 
products while growing in the field and/or post-harvest, in order to reduce losses caused by 
weeds, arthropod pests, and plant diseases.  In order to protect public health, national laws and 
regulations throughout the world establish systems of MRLs or tolerances to govern the 
allowable levels of residues from the active substances in crop protection products that may 
remain on or in food and feed products.  Each MRL is expressed in terms of mg/kg or parts per 
million (ppm) of a specific active substance in a particular harvested crop commodity, reflecting 
the residues arising from the use of the crop protection product as recommended on the label.  
Each country is concerned about residues on crops grown in that country for domestic 
consumption (domestic MRLs); on foods imported from other countries (import MRLs); and on 
commodities, produce, and foods exported by its growers to other international markets.  MRLs 
are compliance standards and not, as is commonly thought, directly related to the toxicity of the 
active substance. 
 
As international trade in agricultural commodities increases, growers must constantly be aware 
of the changing regulation of pesticide residues internationally, because their crops may be sent 
to any of numerous different international markets.  If chemical analysis of imported food 
shipments reveals pesticide residues that (a) are not covered by MRLs, or (b) exceed MRLs 
established in the importing country, the shipments may be denied entry.  If the appropriate MRL 
has not been established or accepted in one or more countries where the harvested crop might be 
shipped, growers will not be able to use particular crop protection product approved for this use 
by their home country, thus limiting their options to treat pests and disease.  Absence of an 
adequate MRL for this product and crop use in importing countries restricts trade of the treated 
commodity and impedes the use of more effective and potentially safer technology. 

Proposed Areas of Collaboration; 3/7/2014 
Page 6 of 14 
 
Therefore, differences among the national systems for setting, maintaining, revising, and 
enforcing the MRLs can lead to multiple types of non-tariff trade barriers, while not contributing 
to consumer safety.  For example, the differences can – 
  restrain trade in agricultural produce, food and feed commodities, and grains;; 
  complicate crop production decisions by growers at the field level; 
  prevent access to certain crop protection technologies; and 
  limit growers’ options for crop protection, as relevant decisions must usually be made 
when the market for the harvested crop is yet unknown. 
The net effect is unnecessary increase in crop-production costs, without enhancing the protection 
of human health and the environment. 
 
To ensure international trade in agricultural products, a key element is the need to ensure a 
robust and harmonized system for the setting of MRLs. Trade difficulties between the EU and 
US arise when MRLs are required for imported agricultural products; this situation may arise 
where a crop is not grown in the importing country or region, or where a particular active 
ingredient is not authorized for use in the relevant crop in the importing country or region. 
 
To allow trade, clear procedures are required to allow the setting of MRLs for traded products. 
Such procedures must be based on a system of robust risk assessment, and should not lead to 
higher barriers for active ingredients and crop uses that are not authorized in the evaluating 
region. We fear that political and administrative processes in the EU and US could place 
unnecessary hurdles in the evaluation system for such MRLs; in this context, we have particular 
concern about the EU’s hazard-based cut off criteria. The crop protection industry however 
stresses the need for legislation governing the setting of MRLs to be based on a system of risk 
assessment, thus ensuring compliance with the WTO SPS provisions.  
 
Both the EU and the US actively participate in two primary international standard-setting bodies 
heavily involved in pesticide regulation: 
First, under the auspices of the United Nations Food and Agriculture Organization 
(FAO) and the World Health Organizations (WHO), the Codex Alimentarius 
Commission (CAC) establishes international “Codex MRLs” intended to foster 
international trade of agricultural products, avoid trade irritants, and protect the 
consumers of all countries.  The effort also supports countries lacking the regulatory and 
technical capacity to establish their own MRLs.  This work is assigned to the Codex 
Committee on Pesticide Residues (CCPR), supported by the Joint Meeting on Pesticide 
Residues (JMPR) (see http://www.fao.org/agriculture/crops/core-
themes/theme/pests/jmpr/en/).  
Second, OECD conducts a robust program to develop international standards for 
pesticide regulation to aid its member countries (see 
http://www.oecd.org/env/ehs/pesticides-biocides/).    
Despite their participation in these forums, the EU and US have differing approaches to and 
timelines for the recognition of Codex MRLs. 
 
With the aim of enhancing convergence of regulatory approaches and achieving decisions that 
will avoid trade irritants, while safeguarding the safety of consumers, ECPA and CLA see a need 

Proposed Areas of Collaboration; 3/7/2014 
Page 7 of 14 
of cooperation towards more harmonization, primarily in the following processes (see Annex for 
detailed explanation): 
 
a.  Regulatory processes for setting MRLs 
b.  Timelines for the MRL setting process differ between the US and the EU 
c.  Crop grouping
 to establish crop group MRLs. 
d.  The Residue Definition for MRL enforcement 
e.  Recognition of Codex MRLs
 
f.  Data Submission formats 
 
CLA and ECPA strongly support efforts to achieve greater harmonization in the processes for 
establishing MRLs. 
 
 
  Trade impact 
New active substances authorized more quickly in the US than in the EU, and vice versa, can 
only be used by farmers to a limited extent in those countries, while EU MRLs/US tolerances are 
not established simultaneously.  Today’s growers, traders and food processors produce for 
worldwide customers, and therefore require that commodities can be traded globally. The 
financial risk of goods being rejected at the port of entry is not acceptable by the food chain and 
is misinterpreted by the consumers as a health concern.  
 
New innovative active substances can offer farmers more security for a good harvest of higher 
quality with reduced environmental burden.  They are often more suitable for integrated pest 
management (IPM), as well as responsible resistance management, which are key factors to 
respond to current and future food and feed demands.  Ideally a new active substance should be 
authorized in parallel in US and EU, while MRLs and Import Tolerances should be set 
concurrently for the domestically produced and imported produce.  The current [US?] 
requirement for providing a registered label from the country where the product is registered in 
support of an Import Tolerance submission effectively promotes a step-wise process and slows 
synchronization of MRLs between the EU and US. 
 
Another option that can be explored is the use of temporary “provisional” MRLs in either the EU 
or US, relying on initial approval by the other party.  The “provisional” MRLs can be confirmed 
or revised later, based on subsequent review under the current respective systems. 
 
The regulatory systems in the EU and US are the most advanced in the world, and adopting 
provisional MRLs automatically by either the EU or the US will demonstrate trust in the 
decision-making by the Authorities in each region.  A workable regulatory process for setting 
MRLs, agreed and applied by the leaders, could then be extended as a model to other regions of 
the world.  
 
As previously pointed out, not only timing is relevant.  Industry acknowledges the efforts in the 
US and the EU to harmonize data requirements, but significant further efforts are necessary to 
overcome technical barriers, as even already established MRLs and tolerances can be impacted 
and lead to major trade impediments. 

Proposed Areas of Collaboration; 3/7/2014 
Page 8 of 14 
 
  On Maximum Residue Levels, steps that the EU and US should consider: 
As a first step, we would support the establishment of a specific working group charged with 
responsibility for overcoming differences in processes impacting review timelines, technical 
matters, and regulatory policies.  The points to harmonize, are, in priority order: 
  By default, jointly and concurrently review EU MRL/US tolerance dossiers. 
  Both EU authorities and US agencies need to give a clear commitment to adhere to 
agreed timelines. 
  Both parties should mutually accept all residue studies conducted in the EU and the US, 
provided the Good Agricultural Practices (GAP) are comparable.  The requirement for 
local studies should be reduced, as the GAP and cropping practices are the dominant 
factors for the variability of residue levels, not the location/country or climate.  This has 
been shown in extensive studies conducted under the OECD and Codex umbrellas. 
  Identify technical and policy-related reasons for differences in MRL proposals, and work 
to overcome them. 
  Agree on common formats for submission of study reports.  The US may need to update 
the reporting requirements in its PR Notice 2011-3 to conform. 
  Agree on the OECD Tier 2 format for data summaries, which allows for customization of 
the output, but is common with respect to data input. 
   Agree on the use of the OECD guidance document on the residue definition4 to establish 
residue definitions for MRL setting.  Furthermore, look for opportunities to rely upon the 
scientific evaluations of other reputable Authorities in order to minimize redundancies in 
effort that lead to longer review timelines. 
  Agree on one common (or compatible) evaluation format to be used by US-EPA, EU 
Member States, and EFSA, in order to enhance efficiency. 
  Both partners should agree to adopt a common classification for crop groups, preferably 
according to the Codex Classification.  This would mainly require a change in regulation 
EC 396/2005. 
 
3.  Protection of Intellectual Property 
ECPA and CLA strongly support that the EU and US continue to promote (a) minimum 
standards of 10 years for protecting regulatory data, and (b) protection of CBI through Free 
Trade Agreements with other countries, where protection of regulatory data is sub-optimal.  
Protection of regulatory data from unauthorized use by competitors is essential for stimulating 
investment in research and development of agricultural crop protection products.  This protection 
provides benefits to all stakeholders – from farmers to consumers – ultimately contributing to the 
economic development of industrialized and developing countries alike.  The requirement to 
protect data from disclosure and “unfair commercial use” is recognized under Article 39 of the 
                                                 
4 Organisation for Economic Co-operation and Development. 28-Jul-2009. Series on Testing and 
Assessment No. 63 and Series on Pesticides No. 31. Guidance Document on The Definition of 
Residue. Rev. 2009. ENV/JM/MONO(2009)30. 
http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)30&doc
language=en 

Proposed Areas of Collaboration; 3/7/2014 
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Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), under the World 
Trade Organization (WTO). 
 
Intellectual property can be protected in a number of specific ways that are well recognized and 
regulated under national and international laws.  Aside from patents, pesticide regulatory 
authorities have direct responsibility under corresponding national legislation for protecting 
information correctly claimed as CBI.  Furthermore, strong national pesticide legislation 
prohibits use of regulatory data belonging to one company from being used by another company 
to support a product registration for a reasonable period of time, unless the data owner formally 
consents and/or is compensated appropriately.  It is critical that industry and regulatory 
authorities work together to safeguard regulatory data, especially CBI.  Regulatory authorities 
must be properly trained in order to take affirmative steps to safeguard data against unfair 
commercial use. 
 
It is important that EU and US continue to promote (a) minimum standards of 10 years for 
protecting regulatory data, and (b) protection of CBI through Free Trade Agreements with other 
countries, where protection of regulatory data is sub-optimal.  We hope that the Trans-Pacific 
Partnership (TPP), now under negotiation, will raise the standard to 10 years for some of these 
countries. 
 
On Protection of Intellectual Property Rights, Steps that the EU and US should take: 
  Ensure a common approach in free trade negotiations with all countries to promote a 
minimum 10 year standard for the protection of regulatory data; 
  Develop a common framework for the protection of CBI, to be included in a Free Trade 
Agreement between the EU and US, as a clear example for all other multilateral Free 
Trade Agreements worldwide; 
  Provide training routinely to regulatory authorities to ensure protection of regulatory data 
against unfair commercial use; and 
  Ensure that Article 39 of TRIPS is enforced in all WTO-member countries. 
 
Opportunities for bi-lateral regulatory cooperation on issues of common 
regulatory interest and concern. 

ECPA and CLA emphasize that the top priority to achieve regulatory convergence is to 
harmonize pesticide regulation to include the science-based risk assessment.
  From time to 
time, agencies, directorates, and departments within a government come to diverging decisions 
and actions with respect to regulation of crop protection products.  To improve cooperation and 
harmonization, a mechanism is needed to alert the respective authorities to potential problems.  
Both the EU and US can benefit from transparent processes and avenues of high-level 
cooperation and appeal or reconsideration, occurring before decisions are made, before actions 
have been undertaken and reversal may be difficult, and well in advance of stakeholders 
considering litigation for “bad” decisions.  We recommend that EU and US regulators adopt a 
broader consultation process, at the earliest stages.  This will help to identify differences and 
potential opportunities to further cooperate and ensure minimum unfair competitive impact 
before regulation is proposed and implemented.  We believe agreeing on concrete processes to 

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foster mutual recognition and other forms of cooperation for regulations and standard setting 
should be a key priority. 
 
A number of areas offer opportunities for cooperation in the short to medium term: 
 
  Endocrine disruptors – ECPA and CLA support a risk assessment approach to 
evaluation of endocrine disruptors.  It is clear that the EU and US have taken very 
different approaches to managing endocrine disruption screening, testing, and regulation.   
It should be highlighted that there are still opportunities for regulatory convergence in 
the data requirements and the scientific assessment and risk assessment procedures. 
 
  Nanotechnology – This is an area with significant and divergent regulatory 
developments in the EU and US.  There are clearly some opportunities to further consider 
common solutions. 
 
  Low-dose effects – With this issue being high on the current political and regulatory 
agenda internationally, there are clear opportunities to cooperate in ensuring a common 
understanding of the issues to be considered, and to ensure proportional and coordinated 
regulatory action. 
 
  Pollinators – This is an area where available data have led to very different conclusions 
in the US and EU.  It would be helpful to promote further cooperation, in particular with 
the aim of ensuring a better common understanding of the management of pollinator 
populations and the role played by pesticides in that management. 
 
In addition to cooperation on such specific scientific issues, ECPA and CLA would support 
greater cooperation among the relevant scientific committees and panels that provide support for 
the regulatory agencies in the EU and US.  Due to the increasing detail and complexity in many 
areas of pesticide regulation, there is limited available expertise in some science and policy 
areas, and further cooperation would help to ensure that this expertise is part of the scientific 
dialogue in both trading blocks. 
 
Additional specific areas where policy developments could help regulatory 
cooperation 

  The management of Good Laboratory Practice (GLP) standards to ensure acceptance of 
regulatory data. 
 
Adherence to GLP standards by industry, along with enforcement by governments, are essential 
to ensure that the studies and data supporting decisions on pesticide registration, MRLs, and 
tolerances are robust, reliable, repeatable, and accurate.  Human health, worker safety, crop 
protection, environmental quality, and public confidence are at stake.  US and EU governments 
must collaborate on (a) continued recognition of common GLP standards, (b) Mutual Acceptance 
of Data (MAD) developed according to GLP from their respective countries, (c) rigorous 
supervision of GLP labs and studies, (d) adequate frequency of inspection programs, and (e) 

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adequate resources to assure one another of GLP compliance, so that GLP studies conducted in 
one region can be considered by another, without doubts concerning data quality. GLP 
Guidelines applicable to crop protection products have been published by OECD, US-EPA and 
US-FDA, and tare harmonized to a large extent5.. 
 
 
Conclusions 
The EU and the US share a common objective: ensure and maintain excellent food safety 
standards, while maintaining a sustainable and affordable food supply.  Relatively similar safety 
standards exist, but a few significant differences still prevail.  We therefore jointly encourage the 
US and the EU to intensify their cooperation, take the lead to overcome existing barriers, and 
jointly send a strong signal to other countries, such as OECD member countries and other trading 
partners. 
 
  ECPA and CLA strongly support a risk assessment approach to regulation of pesticides 
which includes a hazard identification, hazard characterization, and exposure 
assessment.
    
  A uniform approach to risk assessment in the regulation of crop protection products would 
provide clarity and confidence for both operators and consumers in EU and US markets. 
  Defining a common risk assessment approach would be one of the most valuable principles 
in creating a level playing field across the trans-Atlantic economy. 
  Enhancing effective protection of intellectual property and CBI will foster a climate of 
innovation, and set a standard for the rest of the world. 
  Harmonization of MRLs and the MRL setting process will reduce costs in the entire food 
chain. 
In these comments, ECPA and CLA have presented concrete suggestions on how to make 
regulatory regimes for agricultural crop protection products more compatible, and thus facilitate 
international trade in key agricultural commodities between the US and the EU.  CLA and 
ECPA would appreciate and welcome the opportunity to meet and engage in discussion 
with authorities on these matters.  We offer our support and assistance as the EU and the 
US government work to enhance their trade relationship. 
 

 
                                                 
5 A very useful comparative analysis “Comparison Chart of FDA and EPA Good Laboratory 
Practice (GLP) Regulations and the OECD Principles of GLP” has been published by the 
Division of Compliance Policy (HFC-230) of FDA’s Office of Regulatory Affairs (ORA) in 
2004 and it’s available for consultation online at http://www.fda.gov/ora/compliance ref/bimo. 

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ANNEX 
CropLife America and European Crop Protection Association  
Comments on US-EU Regulatory Cooperation 
 
Detailed Explanation of Key Area of Focus, Maximum Residue Levels 
 
a.  Regulatory processes for setting MRLs 
Regulatory approval processes in the EU and US differ in important ways.  The differences are 
linked in large part to the historical procedures in place, and little effort has been made to 
improve synchronization.  While there are specific areas where greater synchronization may be 
achieved through greater dialogue, we would support a more detailed review to consider how the 
two regulatory processes can be brought together – to ensure efficiency in the evaluation process 
and in decisions on use authorizations. 
 
b.  Timelines for the MRL setting process differ between the US and the EU 
For initial approval, subsequent periodic review, and revision as necessary of MRLs for specific 
crops and pesticide active substances, authorities in both regions should investigate how they 
could modify procedures to meet each other’s legal obligations for review. 
 
Under the re-registration program initiated in the EU in the early 1990s, the number of registered 
crop protection active substances (called “active ingredients” in the US) was reduced by more 
than two-thirds.  Many of the active substances cancelled in the EU are still on the US market, 
and thus commodities treated with them are in international trade. As long as EU MRLs and US 
tolerances can be maintained, the lack of synchronicity in regulatory decision making does not 
necessarily affect trade.   
 
For new active substances (for which MRLs and US tolerances have yet to be established), 
several OECD member countries have agreed on a vision and established a joint effort to review 
new active substances by shared resources, in order to increase trust in each other’s decisions and 
credibility with the public.  Joint reviews have been a reality among EU Member States for a 
long time, with a strong coordinating role of the European Food Safety Authority (EFSA).  This 
is similarly true between the US and Canada. 
 
However under Regulation 1107/2009, there is no encouragement nor benefit for the EU 
Member States and EFSA to participate in global joint reviews, with EFSA mandated to follow 
the EU timelines only.  Still, a number of EU Member States have cooperated in joint reviews 
with the US authorities, on a voluntary basis, in their role as rapporteur Member States under 
Regulation 1107/2009.  While such initiatives have significantly increased the dialogue among 
regulators across the Atlantic, the implementation of the EU process as a separate step might lead 
to a different MRL decision. US and EU conclusions may differ due to differences associated 
with the risk assessment evaluation principles applied.  This makes the participation of EFSA a 
necessity to develop improved processes for the benefit of all participants of the joint reviews.  
Consideration needs to be given to a more streamlined EU process in support of the decisions in 
joint reviews and their integration within the EU approval process, where EFSA is permitted and 
encouraged to participate in the joint review process. 
 

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c.  Data requirements for consideration, evaluation, and approval of MRLs.   
There is already a fair amount of consistency between the EU and US in the regulatory data 
requirements for setting domestic and import MRLs, but certain persistent differences are 
problematic.  For example, the cost of generating and reviewing regulatory residue data could be 
streamlined if regulatory experts from both sides could agree on common representative crops 
for generating crop group residue data; have common rules for the extrapolation of residue data 
from one crop to another; and agree on a common minimum number of residue trials to be 
generated for each crop for the purposes of registration and MRL/Tolerance setting.  Just to 
illustrate the problem, five residue trials conducted on cherries (as one a representative crop for 
the Stone Fruits crop group in the US) are not enough to obtain an import MRL for cherries in 
the EU. 
 
Work under OECD initiatives is addressing such differences, but unless the resulting OECD 
guidelines and guidance documents are unequivocally accepted and adopted into 
regional/national data requirements in the EU and US, no real value is obtained from such work. 
 
d.  Numeric Values for the MRLs, the regulatory rationale and the calculations used to 
derive them. 
Methods to calculate MRLs have differed in the past between the US and EU, leading to 
significant numeric differences in EU MRLs and US tolerances derived from the same or similar 
sets of residue data.  However, with the introduction of the OECD MRL Calculator, and the 
commitment from both sides to use the Calculator, better predictability in the MRL setting 
process is achieved and greater harmonization between EU MRLs and US Tolerances occurs. 
Consistent use of the Calculator is encouraged so that this positive step toward MRL 
harmonization may continue, especially in setting import tolerances, which relies upon the 
evaluation and use of foreign residue data from the exporting country.  Thus, the MRL 
established in the importing country should be the same as that established in the exporting 
country, when the same data set is used. 
 
e.  Crop grouping to establish crop group MRLs. 
Crops may be grouped according to similarity in botanical and morphological characteristics, as 
well as agronomic production practices, which combined may favor similar residue levels, in 
order to establish a common MRL for all crop commodities in the entire group.  In such a case, 
the whole group is covered, using a reduced data set derived from representative crops.  
Differences between the US and EU crop group systems inevitably create problems with MRL 
harmonization and ultimately hinder trans-Atlantic trade.  The International Crop Grouping 
Consulting Committee (ICGCC), led by the IR-4 Project with strong input from the US, EU, 
Canada, and more than 30 other nations, is driving the much-needed revision of the crop groups 
of the Codex Classification of Foods and Animal Feeds.  Acceptance of the revised, updated 
Codex crop groups and their corresponding representative crops (including the flexibility of 
different representative crops, depending on country) by both the US and EU would help 
rationalize residue data generation and lead to greater MRL harmonization.  The ultimate goal in 
this area would be recognition and acceptance of crop group tolerances/MRLs by either side for 
setting import MRLs. 
 

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f.  The Residue Definition for MRL enforcement 
Differences in Residue Definitions can often be the source of real and perceived trade barriers.  
The Residue Definition for enforcement of an MRL in the EU is typically the active substance or 
a significant metabolite or degradation product that can be used as a marker and analyzed readily 
to determine residue levels.  Residue definitions for enforcement and risk assessment may differ 
in the EU; if possible a conversion factor is used to convert the residue monitored to the residue 
definition used in risk assessment.  In recent years during the EU registration review program, 
the Residue Definition for risk assessment has been changed for a number of active substances to 
include additional metabolites or degradation products. 
 
In the US there is usually no distinction between the Residue Definitions for enforcement and for 
risk assessment.  The Residue Definition for enforcement in the US can include metabolites and 
degradation products, which would typically be monitored by analysis of either a common 
chemical moiety, or each of the specific chemical entities. 
 
g.  Recognition of Codex MRLs 
New Codex MRLs which meet EU requirements are considered annually for adoption into EC 
Reg No 396/2005, resulting in greater MRL harmonization for some active ingredients between 
the EU and the countries following Codex. Unlike the EU, the US does not automatically 
consider the adoption of newly established Codex MRLs as US tolerances, but rather EPA 
considers whether alignment with existing Codex MRLs is possible during its regulatory reviews 
of active ingredients involving Tolerance setting.  In the absence of an EU MRL or a US 
tolerance, respectively, none of the EU Member States nor the US defer to Codex MRLs for the 
monitoring of imported produce. This is an unfortunate situation because it results in MRL 
violations. If the laws were amended in the EU and US such that Codex MRLs could be accepted 
as the reference compliance standards for the purposes of monitoring imported foods in the 
absence of national/regional MRLs, international trade would be facilitated in general on both 
sides. 
 
h.  Data Submission formats 
The EU and US specify different reporting formats for registrants to summarize study 
information, and use different reporting formats for their evaluations.  The levels of detail 
requested by reviewing authorities in the EU and the US can also differ significantly.  This 
makes the exchange of their reviews for peer review purposes more difficult, and leads to longer 
review times and higher costs for authorities.  Preferably, the North American and EU 
Authorities should focus on establishing a common electronic format, such as XML templates, to 
accommodate desired customized reports, while relying on a common input data set.   
 
The OECD dossier format is used in the EU and an option in the US. Consideration should be 
given to using the same evaluation reports (monographs) and dossiers in both countries .