Pest Committee Hearing

In advance of the public hearing taking place on 15th May - as part of the PEST Committee established by the European Parliament - ECPA received a set of questions submitted by MEPs.  We responded to these questions in writing; in full transparency, the answers to the questions can be found below.
 
You can access the answers to the questions by clicking the “Read answer” hyperlink, or by scrolling down on the page.

1. The Committee has raised questions, among others, about three characteristics of the legislation:

  • the fact that most of the scientific studies are paid for by the company seeking product approval;
  • that some of the studies are not public because of business confidentiality considerations;
  • the company seeking approval can choose which Member State it wishes to be the rapporteur.

To what extent are these special provisions particular to EU pesticides legislation, and to what extent are they features of EU legislation for other types of products? Are you aware of any other sectors that share these characteristics?

2. In a previous hearing, the Committee discussed the fact that the company seeking approval can choose which EU Member State they wish to be rapporteur.

  • For the industry overall, can you tell us over the last five years, how many times has each Member State been chosen as rapporteur, and can you give your view why some Member States are chosen more than others.
  • How does industry chose the Rapport Member State for the risk assessment? Which criteria are important?
  • Why do you think it is important that industry can chose the member state?
  • For the re-approval of a substance the Commission choses the responsible member state. How do you see this grouping in comparison to the selection process of the industry?

3. Last month, the industry pledged to release undisclosed documents containing safety data on their pesticides as a move for greater transparency. The move comes at a time when the industry is being pressured for their lack of transparency in conducting internal studies used to determine the safety of active substances.

  • How come it took the industry so long to come up with a committee on the transparency of data?
  • Do you believe that an increased transparency will resolve a more fundamental problem about how much work on product safety is entrusted to industry?

4. What’s your industry position on the IARC assessment of Glyphosate?

5. Industry has to follow strict GLP Guidelines to ensure that all research is reproducible, consistent and uniform.

Could you please explain GLPs and how it is checked whether GLP are applied?

6. The burden of proof that a substance and product is safe relies on industry. Same for the burden of financing the studies for these proofs.

  • Which only seems fair as industry also makes money with the products in the end. How much money are we talking when it comes to the approval of a substance/product and how is the comparison with the return of investment?
  • What impacts would it have to outsource the burden of proof to for example EFSA?

7. What is your budget? Can you describe your role? What are your sources of funding?

8. Why do you keep repeating that "glyphosate is safe" even though ECHA has found a number of substantial risks (damage to eyes, aquatic environment, etc.) to its use?

9. In Monsanto Papers, it appears that Monsanto knew perfectly well that its commercial formulations were dangerous and yet never ordered tests to find out more. Do you confirm these allegations? If so, do you think that under such conditions, the legislator can trust the industry?

10. Do you think that Croplife, the international lobbying association of the pesticide industry, of which you are the European branch, serves the interests of the industry by supporting a campaign launched by the American Chemistry Council (ACC) to undermine the credibility of IARC and in particular its monographs?

11. Is it legitimate, in your opinion, for industry to have full latitude to choose the Rapporteur State?

12. How many meetings have you had with the European Commission and European agencies in the last two years?

13. Can the ECPA detail the life-cycle of a new product placed on the market in Europe, covering the requirements, procedures and timeframes for inception, development, approval and deployment and the corresponding costs for industry throughout?

14. Does the industry review the Maximum Residue Levels (MRLs) set by EFSA, or have a view on the methods used to determine these?

15. What aspects of the approval process could be reformed? If you could strengthen some areas, what would you choose to prioritise for change?

16. So far EFSA is coordinating the assessment of active substances but it is being considered whether they should assess plant protection products without Member State oversight or control. Do you support this proposal?

17. How many dossiers have been submitted by the ECPA’s member companies since 2011 under Regulation (EC) 1107/2009 and how many have been approved for use, withdrawn or rejected?

18. Are the SME's demanding to approve active substances in disadvantage vis-à-vis the multinationals? Are the standards for application for approval not too high?

19. EU regulations require that pesticide risk assessment is objective and independent. It can be assumed that your members would like to see a certain outcome from the assessment and will therefore prepare an application dossier and supplementary information that support such an outcome. However, it should also be the case that they accept the final outcome of the scientific assessment.

One of your members, Syngenta, has however continued to pressure EFSA and the Commission to modify the risk assessment of diquat, a herbicide, even after it had been finalised. As a result, the Commission has tasked EFSA to review part of its assessment. Do you agree that EU scientific assessment should be fully independent? How would you define that independence? At what point do your members draw the line, i.e. leave EU experts alone so they can do their job without any interference from political or industry interests?

20. In your public communications on glyphosate you often referred to (favourable) regulatory assessments around the world, including by EU agencies. However, when it comes to substances that are not allowed in the EU, or whose licence is running out, your members tend to ignore those assessments. Examples include herbicides such as paraquat, atrazine and glufosinate which your members continue to produce in the EU for export. Do your members accept the outcome of the EU assessments on these substances? Do they accept that the health effects identified in the EU can also occur outside the EU? If so, why don't your members stop the production altogether and focus on less toxic alternatives instead?

21. How are decisions made regarding the direction of your actions? Specifically, is the influence of your members on your board of directors or orientation proportional to their turnover, their number of employees or the contribution they make you?

116. According to EFSA: “The integrity of the findings and raw data rely on the fact that the laboratories carrying out the tests are certified and audited under the GLP system”. How reliable is the certification of these laboratories, where the applicant is carrying out tests? Especially in light of the OECD’s good laboratory practices.

117. Are these laboratories public or private bodies? Who is certifying them? Who is financing the certification? How can you ensure that the OECD’s good laboratory practices are actually applied?

118. Can we presume that these laboratories are totally independent and reliable?

119. In a recent debate on the re-approval of an active substance where the BfR has served as RMS there has been confusion and a broad debate about how the RMS conducts its assessment of the application. Could you therefore explain what rules are applicable for the RMS in the assessment of an application for the approval or re-approval of an active substance and how you applied these rules in the past?

120. Could you please explain your specific role as RMS in the process of the assessment of an application for the approval or re-approval of an active substance?

121. Could you please explain what measures are in place to secure that you as RMS fulfilled your role adequately and how these measures were applied in the past?

122. In the light of recent experiences with the assessment of applications for the approval or re-approval of active substances and with their public perception, do you have specific recommendations on how to improve the system as well as communication to increase its comprehensibility and hence public trust?

123. EFSA states that the Glyphosate Renewal Assessment Report portion of the Plagiarism Charge is not intended to represent "the actual risk assessment of glyphosate". The agency states that the rapporteur Member State must simply confirm whether, from its point of view, the search has been carried out correctly and that the information provided by the applicant in the field of scientific literature is accurate. Also, for what reasons did the BfR consider it necessary to insert directly, in its report, a hundred or so pages of text – if not more – from the documents provided by the manufacturers, since at this stage it was not a risk assessment?

124. On what basis do companies choose a rapporteur member state?

125. The fact that a company can choose its country of origin as rapporteur member state for an application for approval in itself is not a problem, but what then do you propose to avoid any suspicion of collusion or favouritism?

126. In the case of glyphosate, the plagiarism of Monsanto's report by BfR, then EFSA, caused a scandal. In what proportions and for what type of information is the data provided by the company transferred? What is the added value of the BfR or EFSA report?

127. Does the applicant company submit an application in English or in the language of the reporting member state? Idem, is the report transmitted by the latter to EFSA in English or in the national language of the agency?

128. Since the EU pesticide regulation entered into force in 2011, public authorities must also include independent studies in the risk assessment of pesticides. However, according to the German BfR, manufacturers' studies are preferred because they correspond to the so-called "good laboratory practice" by contrast to other studies, for example from universities or other scientific
institutes, who cannot match this standard even though they are working scientifically and submit themselves to a peer review process.

129. To what extent does the requirement of "good laboratory practice" limit the independence and breadth of the studies used? Are there alternatives to using this practice?

1. The Committee has raised questions, among others, about three characteristics of the legislation:

  • the fact that most of the scientific studies are paid for by the company seeking product approval;
  • that some of the studies are not public because of business confidentiality considerations;
  • the company seeking approval can choose which Member State it wishes to be the rapporteur.

To what extent are these special provisions particular to EU pesticides legislation, and to what extent are they features of EU legislation for other types of products? Are you aware of any other sectors that share these characteristics?

The Commission may be better placed to respond to these questions given that they have a broader knowledge of the legislation applied in different sectors, however our understanding is that many of the characteristics of the EU approval system for pesticides are not unique to our sector.

In a number of other sectors EU legislation places the duty on businesses to pay for and submit evidence supporting applications for claims or product authorisation. These include: technical dossiers for ‘CE’ safety marking, human and veterinary medicines, food additives, biocides, cosmetics, nutrition and health claims, novel foods, food for special nutritional purposes, information on fuel for vehicles including biofuel content and household chemicals (REACH).

The same sectors and many others will also rely on the protection of confidential business information in order to protect their investment. The importance of protecting IP is acknowledged in existing legislation, the Commission’s proposal amending the General Food Law and in an EPRS report published in April1. Only a fraction of the data supplied for product approval is confidential business information.

We are aware that for Biocides, companies can choose the rapporteur Member State. We are not aware of other examples, however that is not to say others do not exist.

2. In a previous hearing, the Committee discussed the fact that the company seeking approval can choose which EU Member State they wish to be rapporteur.

  • For the industry overall, can you tell us over the last five years, how many times has each Member State been chosen as rapporteur, and can you give your view why some Member States are chosen more than others.

Before answering the specific question, it is important to recall that in the answers given during the meeting of PEST on 12th April both the Commission and EFSA confirmed that in the case of active substance renewals the Commission chooses the rapporteur Member State. It is only in the case of new active substance authorisations that industry makes the choice.

No application for approval of a new active substance in the EU has been received in the last 2 years. This is unprecedented. It is also noteworthy that in the 7 years that regulation 1107/2009 has been in operation, although 20 of 43 applications for new active substance have been approved only 8 of these new active substances have been authorised for use in plant protection products in the EU.

In the last 5 years, 26 applications have been received for new active substances. 12 of these are of a synthetic chemical nature, 2 of which have been approved, 1 not approved and 9 are still pending an approval decision. 14 of these new active substance applications have been for substances of a biological nature, 5 of which have been approved and 9 are still pending an approval decision.

Additionally 19 applications have been received for approval of basic substances, defined in Regulation 1107/2009 as active substances not placed on the market as a plant protection product and not predominantly used for plant protection purposes but nevertheless useful in plant protection. Of these basic substance applications 12 have been approved, 6 have not been approved and 1 is pending. Only for 1 of the basic substances did the applicant select a rapporteur Member State. This is included in the 27 substances detailed in the table and diagram below)

Where industry has chosen the Member State rapporteur this has covered 11 of 28 Member States.

Member State No. times selected by applicant as RMS since Apr 2013
France 7
The Netherlands 7
United Kingdom 5
Germany 1
Italy 1
Poland 1
Belgium 1
Greece 1
Austria 1
Denmark 1
Ireland 1
Others 0

One example of why some Member States are chosen more than others would be where there is more than one agency involved in the evaluation, and due to this complex structure, the country is more likely to miss evaluation and decision deadlines. Some countries also refuse to accept applications.

  • How does industry choose the Rapport Member State for the risk assessment? Which criteria are important?

There are a number of criteria which influence the industry choice of rapporteur Member State. Many of these criteria would be similar to other industries seeking approval for a new product/substance. Given the significant cost and time involved, industry benefits from a tough assessment of its dossier at an initial stage as this can highlight any inconsistencies or issues at an earlier stage, meaning less potential for wasted time later in the process.

The quality of the assessment will depend on a number of factors, most notably:

  • Capacity: availability of scientific experts with a balance of expertise across the required areas
  • Ability to meet timelines
  • Potential importance of the product for the local market and the expectation that the rapporteur agency understands the crop(s) the product will be used on
  • Familiarity with equivalent types of active substances
  • Ability to achieve a scientifically robust outcome
  • Willingness to participate in Global Joint Reviews (with US EPA, Canadian PMRA, etc.) as appropriate
  • Why do you think it is important that industry can chose the member state?

Bearing in mind the limited length of patent protection, any company looking to bring a product to market anywhere in the world, will want to get that product on to the market as efficiently as possible in order to start to make a return on the significant investment required to develop that product (in the case of pesticides this averages 250M euros). In order to minimise the time it takes – the current time to market for a pesticide is 11 years – the quality of assessment is of utmost importance.

  • For the re-approval of a substance the Commission choses the responsible member state. How do you see this grouping in comparison to the selection process of the industry?

The criteria (capacity, timelines, importance of substance to local growers) used by the Commission to allocate reapprovals of active substances are in essence not dissimilar to those that would be used by industry (with the obvious exception of commercial interest in getting the substance to market as efficiently as possible).

Where the Commission has chosen the Member State to be rapporteur, it has chosen 24 out of the 28 Member States. This also demonstrates a distribution in line with the size and population of Member States.

3. Last month, the industry pledged to release undisclosed documents containing safety data on their pesticides as a move for greater transparency. The move comes at a time when the industry is being pressured for their lack of transparency in conducting internal studies used to determine the safety of active substances.
  • How come it took the industry so long to come up with a committee on the transparency of data?

It is important to say at the outset that when it comes to data transparency our industry complies with the law as laid down in the relevant pieces of EU legislation. It’s those pieces of legislation that set out what data should be made available during the process. We note the Commission recently published a proposal changing those rules to make more data available. We welcome this initiative.

It’s also worth recalling that for any company in any industry, advantage lies in the ability to develop and bring to market new and innovative solutions. Although ECPA represents the whole industry, these companies are also competitors on a global market. Bringing a new product to market implies a significant cost (for us on average 250M euros for a new active substance), and the ultimate interest of business is not in protecting its intellectual property from the public, but from each other, or from those who would use it to produce counterfeit or illegal products (this figure according to a 2017 European Commission report, now stands at 15% of the market).

Despite this, we acknowledged that there was a clear demand for increased access to the data produced and submitted as part of the approval process, and as an industry sought the commitment of all CLI Member Companies* globally to making relevant safety related data available. This commitment covers 7 companies globally, and 23 companies at a European level. Bayer has already taken an important first step by making data available on a dedicated website. Other companies are currently working on their own platforms in order to give effect to the commitment.

Further information on the commitment can be found at: http://www.ecpa.eu/industry-data-transparency and https://www.croplife.org/data-transparency/

*CLI Member companies are: BASF, Bayer, Corteva Agriscience (a division of Dow DuPont), Monsanto, FMC and Sumitomo Chemical. These companies are also members of ECPA.

  • Do you believe that an increased transparency will resolve a more fundamental problem about how much work on product safety is entrusted to industry?

Anything that can increase trust in the current system can only be to the benefit of, citizens, industry and decision makers alike. We recognise that there is no silver bullet and that our reputation in Europe poses a significant challenge, however we want the public and decision makers to see that we have nothing to hide.

4. What’s your industry position on the IARC assessment of Glyphosate?

As an industry founded in science we welcome all contributions to the continued advancement of scientific knowledge, and have huge respect for the WHO (of which IARC is a body). However, as with other highly regulated substances, IARC has no formal role in the regulatory approval process of pesticide active substance, as IARC itself clearly states in the preamble to its Monographs2. The IARC assessment is governed by procedures, rules criteria and a classification system that are fundamentally different to those that have to be used by law for pesticide active ingredient evaluations3.

IARC is a hazard based assessment, not one based on risk. If the IARC classification was to be used as the starting point for the regulatory system in Europe, then arguably those who used IARC as the basis of the argument to ban glyphosate should also be arguing to ban charcuterie and wine (IARC classified processed meats and alcoholic drinks as category 1 ‘definite’ carcinogens)

In addition to this, a number of irregularities in the IARC evaluation were reported by Reuters (dismissal of a comprehensive review paper on animal carcinogenicity studies, redaction of draft version of monograph without the full panel’s awareness,…) The implications of these accusations, if found to be true, would call in to question the outcome of the entire IARC assessment.

2 “Therefore, no recommendation is given with regard to regulation or legislation, which are the responsibility of individual governments or other international organizations.” PREAMBLE TO THE IARC MONOGRAPHS, A. GENERAL PRINCIPLES AND PROCEDURES, 2. Objective and scope
http://monographs.iarc.fr/ENG/Preamble/currenta2objective0706.php

3 http://monographs.iarc.fr/ENG/Preamble/index.php

5. Industry has to follow strict GLP Guidelines to ensure that all research is reproducible, consistent and uniform.

Could your please explain GLPs and how it is checked whether GLP are applied?

Good Laboratory Practice (GLP) is the application of standardised organisational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing of chemicals for the protection of man, animals and the environment. GLP also requires the retention and archiving of raw data making it possible to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies. The principles of GLP promote the quality and validity of data generated in the testing of chemicals and prevent fraudulent practices and thereby contribute to the reassurance of Authorities as to the quality of the test data generated. GLP underpins the mutual acceptance of test data between countries, which avoids duplicative testing, is beneficial to animal welfare, and reduces costs for industry and governments. Common principles for GLP also facilitate the exchange of information and prevents the emergence of non-tariff barriers to trade, while contributing to the protection of human health and the environment.

The principles have been developed in accordance with the Organisation for Economic Cooperation and Development (OECD) and the EU has adopted these principles and the revised OECD Guides for Compliance Monitoring Procedures for GLP as annexes to its two GLP Directives.

  • 2004/9/EC – Inspection and verification of GLP (recodified)
  • 2004/10/EC – Harmonisation of laws, regulations and administrative provisions relating to the application of GLP (re-codified)

Directive 2004/9/EC requires Member States verify the compliance with GLP of any testing laboratory within their territory claiming to use GLP in the conduct of tests on chemicals. Member States are required to designate authorities responsible for GLP inspections in their territory. Each year, Member States draw up a report with a list of laboratories inspected, the date on which such inspection was carried out and a brief summary of the conclusions of the inspections. The reports are forwarded to the Commission each year. Where a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply with GLP to the extent that the integrity or authenticity of the studies it performs might be compromised, it must inform the Commission which informs the other Member States. Where a Member State has sufficient reason to believe that a laboratory in another Member State claiming GLP compliance has not carried out a test in accordance with GLP, it may request further information from that Member State and in particular may request a study audit, possibly in conjunction with a new inspection.

The inspections determine whether

  • the test facility has sufficient qualified personnel, resources and support
  • the mechanisms used to assure management that studies are conducted in accordance with GLP principles are adequate
  • the test facility is of suitable size, design and location
  • the test facility, if engaged in studies using animals or other biological test systems, has support facilities and conditions for their care, housing and containment, adequate to prevent stress and other problems which could affect the quality of data
  • the test facility has suitably located, operational apparatus in sufficient quantity and of adequate capacity to meet the requirements of the tests being conducted and that the materials, reagents and specimens are properly labelled, used and stored
  • adequate procedures exist for the handling and control of the variety of test systems required
  • the test facility has procedures designed
    • to ensure that the identity, potency, quantity and composition of test and reference substances are in accordance with their specifications, and
    • to properly receive and store test and reference substances.
  • the test facility has written SOPs relating to all the important aspects of its operations
  • written study plans exist and that the plans and the conduct of the study are in accordance with GLP principles
  • final reports are prepared in accordance with GLP principles
  • the facility has generated adequate records and reports and whether adequate provision has been made for the safe storage and retention of records and materials.

In summary, GLP supports scientifically robust testing, prevents scientific falsification and allows a product lifetime traceability of the testing results.

Additionally, ECPA makes it prerequisite that all of our Members respect and fulfil the standards of the UN FAO International Code of Conduct on the Distribution and use of Pesticides. This code includes a section governing testing.

6. The burden of proof that a substance and product is safe relies on industry. Same for the burden of financing the studies for these proofs.
  • Which only seems fair as industry also makes money with the products in the end. How much money are we talking when it comes to the approval of a substance/product and how is the comparison with the return of investment?

For a new active substance, human health and environmental safety studies amount to $64MM (Phillips McDougall, March 2016). Costs of additional safety studies to renew the approval of an active substance in the EU vary highly and range between $5MM and $15MM.

These costs do not include discovery, administrative, regulatory costs; they also do not include field biology, nor do they include product chemistry at any stage of development for example setting up a new manufacturing line. The total cost for an innovator to bring a new active substance on the market has been estimated to be $286MM (Phillips McDougall, March 2016).

As an industry association we cannot give specific figures on return of investment, not least because of antitrust reasons. We can however confirm that companies expect to achieve a return on investment at least equal to their cost of capital, which for most of our members is in the range of 8-15%. The actual return can be higher, but can also be lower or even negative, as there is always a risk that a new product will not deliver the market results which were expected.

  • What impacts would it have to outsource the burden of proof to for example EFSA?

As Commissioner Andriukaitis stated in his appearance at the ENVI Committee on 26 April, it would be difficult for EFSA to be both the data generator and data controller at the same time. This could potentially threaten the independence of EFSA in the process, and undermine trust in the agency.

As an industry we develop substances for use globally – very rarely would a substance be produced just for a European market. If EFSA was to design studies, then it would only do so for Europe. Industry would then have to replicate these studies for other markets, bringing with it an increased cost and also - in terms of areas where there is also concern voiced by citizens – an increase in the amount of animal testing required (something that as an industry we are committed to reducing)

7. What is your budget? Can you describe your role? What are your sources of funding?

The total budget for ECPA in 2018 is €8,930,598

Made up of:

€4,175,358 – Secretariat Costs (Personnel, rent, expenses and other variable costs)

€1,211,000 Company investment projects are joint company scientific research studies to generate additional scientific data (for instance in the field of operator exposure, re-entry)

€3,544,240 – Operational Costs (Outlined below)

Of which:



€1,460,000 is for our pan-European stewardship activities (for instance: conducting advisory service trainings for the implementation of best management practices to protect water, protect user health, and supporting programs for the recycling of empty containers)

€441,500 is for supporting our regulatory working groups (for instance: scientific study reviews and external legal reviews)

€1,269,240 is for our public affairs work and includes €1 Million for our communications work for continuing with our campaign which is an awareness raising campaign of the role that our products have in keeping plants healthy.

Our role

We represent the crop protection industry in Europe; innovative and science-based, our solutions keep crops healthy and contribute to providing Europeans with a safe, affordable, healthy, and sustainable food supply. We promote modern farming practices and champion the use of crop protection technology important for the sustainable intensification of agriculture. Our awareness raising and stewardship activities further the safe and sustainable use of pesticides in Europe, encouraging management practices that safeguard harvests, human health, and the environment.

Sources of funding

  1. ECPA operational budget is fully funded via its membership fees with all members, both company and associations, contributing to the budget. The planned annual work programs, budget and funding are approved at the annual General Assembly meeting by our General Assembly members. (All company members have 2 votes at the General A, all full member associations have 1 vote at the GA)
  2. The company investment projects are approved by all the company experts in the related working groups, signed off by the regulatory policy team and funded via a working fund that is financially paid for by the corporate company members. SME members are made aware of the projects and may contribute to them if they choose to.  

8. Why do you keep repeating that "glyphosate is safe" even though ECHA has found a number of substantial risks (damage to eyes, aquatic environment, etc.) to its use?

The answer to this question lies in the difference between the hazard properties of a substance and the risk attached to exposure to it. Hazard is the potential for a substance to cause harm. Risk is the likelihood of that harm occurring under realistic use or exposure. To put this in to context, a good example would be a car. A car is by its nature a hazard: its use implies risks for passengers, other road users and pedestrians, as well as other vehicles and/or property. The risk of this happening is limited by a number of factors: the use of seat belts, booster seats or car seats for babies/infants, speed limits, safety cameras, automatic braking systems, smart motorways.

The same principle applies to glyphosate. Glyphosate acid is by nature a strong acid but is never used in commercial products as such. Glyphosate is always formulated as a salt. The latter neutralizes the acidic and hazardous properties and eliminates the need for classification of the active substance. In addition the acute hazard properties of the end-use products are thoroughly tested and documented. The critical endpoints of these tests are compared to realistic yet conservative exposure levels in a regulatory risk assessment for users (operators), bystanders and consumers, as well as environmental risk assessments. Only when the risk associated with the intended (labeled) uses meets the legal acceptability criteria -it is when safe use is guaranteed- a product can be authorised for commercial use.

So it is fair to say glyphosate based products are safe to use, when used as directed.

9. In Monsanto Papers, it appears that Monsanto knew perfectly well that its commercial formulations were dangerous and yet never ordered tests to find out more. Do you confirm these allegations? If so, do you think that under such conditions, the legislator can trust the industry?

Glyphosate-based herbicides, including formulated products with surfactants, all have a long history of safe use and do not pose any unreasonable risk to human health when used according to label directions. The safety of each labeled use of a pesticide formulation must be evaluated and approved by regulatory authorities before it is authorised for sale.

These documents, referred to as the “Monsanto Papers” in your question, which were produced in the context of U.S. litigation, are not linked to the decisions of EFSA, ECHA or any regulator. The documents largely involve several “literature review papers,” which are not part of the regulatory process in the first place. This has been confirmed by the regulatory agencies.

These “literature review papers” were intended to add perspective and highlight previously unpublished data regarding glyphosate – but they were not the basis for any regulatory decision. Literature reviews are common place in scientific community; Regulatory agencies look at raw data (produced according to GLP) behind the reviews; and, the reviews are not the basis of any regulatory decision.

As an industry we respect, and are committed to complying with, the legislation governing approval of our products in all jurisdictions.

10. Do you think that Croplife, the international lobbying association of the pesticide industry, of which you are the European branch, serves the interests of the industry by supporting a campaign launched by the American Chemistry Council (ACC) to undermine the credibility of IARC and in particular its monographs?

We assume that the question relates to the Campaign for Accuracy in Public Health Research supported by CropLife America. We, in common, with our industry globally, believe in the accuracy of research to inform public health policy in all forums – whether that be in IARC, EU or UN bodies, national governments or any other institution where science is the basis for public health decision making.

If any of the irregularities surround IARC and its work prove to be true, then it is the presence of these irregularities, rather than raising questions about them, that undermine its work. It’s also worth noting that the US House Science, Space and Technology Committee recently held a hearing questioning the “selective use of data, and lack of public disclosure” in the IARC process. We believe IARC declined an invitation to attend that hearing.

11. Is it legitimate, in your opinion, for industry to have full latitude to choose the Rapporteur State?

In the case of new active substances, yes there are legitimate reasons for industry to be able to choose the rapporteur member state. These reasons are further elaborated in the answer to question 2.

12. How many meetings have you had with the European Commission and European agencies in the last two years?

Please find below the breakdown of ECPA contact with the EU institutions and agencies for 2016 (Table 1) and 2017 (Table 2). This is the information submitted to, and found in the ECPA entry of the Transparency Register.

Surname Name Commission
hours
EP hours Council hours/
MS reps/
other
EFSA hours ECHA Total hours
Bocquet Jean-Charles 35 13 16 0 0 64
Azoulay Jean-Philippe 24 1 1 18 0 44
Jones Euros 42 16 0 60 0 118
Rutherford Stuart 104 6 0 2 0 112
Day Peter 12 4 0 12 0 28
Whitmore Gavin 10 18 0 2   30
Dhaussy Aurèlie 19 0 7 8 0 34
Kicinski Michal 16 25 0 0 0 41
Wozniacki Lukasz 19 0 13 12 0 44
Oger Laurent 11 4 0 30 0 45
O'Flynn Jess 5 67 0 0 0 72
Taylor Graeme 15 80 9 0 0 104
Rowe Rocky 53 0 0 0 149 202
    365 234 46 144 149 938


Data 2017 Register Activities

Surname Name Commission hours EP hours Council hours/
MS reps
EFSA hours other
(minor use/
ECSG Gly hearing)
EUIPO ECHA Total hours
Azoulay Jean-Philippe 11 22           33
Jones Euros 32 14           46
Rutherford Stuart 75 3           78
Day Peter 5 5   10       20
Whitmore Gavin   10.5           10.5
Dhaussy Aurèlie 23   18   1 0 2 44
Kicinski Michal 48 60 3         111
Wozniacki Lukasz 4         54   58
Oger Laurent 5 2   8 7     22
O'Flynn Jess 0 60 32         92
Burgholzer Nico 10 16           26
Taylor Graeme 14 40 16   2     72
Rowe Rocky 20           159 179
    247 232.5 69 18     161 791.5

13. Can the ECPA detail the life-cycle of a new product placed on the market in Europe, covering the requirements, procedures and timeframes for inception, development, approval and deployment and the corresponding costs for industry throughout?

  • Discovery and research phase: this is the phase between the first synthesis of a new molecule and the date by which a decision to market is made. This phase is largely about selecting the most appropriate molecule in a group of chemical analogues, characterising registerability, biological activity and its adequacy to current or predicted future market needs, identifying commercial perspectives (countries, crops, pests). On average it takes 160.000 molecules to find one that is commercially viable. Typical duration: 4-6 years
  • Development is the phase between a decision to market a new active substance and its first approval/authorisation. This is the phase during which most of the regulatory dossier (biology and safety sections) is developed. The phase includes submission for regulatory approval, evaluation and decisions by agencies globally. The active substance is produced at pilot, not yet industrial, scale. In parallel to the dossier submission and evaluation, investment is made in scale up and manufacturing facilities intended to come online in a synchronised way with product authorisation. Typical duration: 5 years to dossier submission, followed by 4 years to first commercial authorisation.
  • Commercial phase: this is the phase during which authorised products containing the approved active substance are placed on the market and used by growers. The active substance and commercial products containing it are produced at industrial scale. Typically 1 or 2 industrial plants provide the global supply of the active substance. No typical duration (<10 to > 40 years)
  • Renewal phase: while new data are generated on a permanent basis to address global regulatory requirements for an active substance, renewing its approval in the EU (or the US) represents a peak in regulatory activities. A significant number of new safety studies are conducted to update regulatory dossiers necessary to renew approval at community level or authorisations in Member States. Most of them are generated to address technical progress in data requirements and scientific guidance issued since first approval. Typical duration: 5 years from the stage when applicant starts updating the regulatory dossier and the effective renewal of the active substance in the EU. Add 4-5 years to effective renewal of authorisations in MS.
  • Phasing-out: when, for economic, agricultural, technical or regulatory reasons, the approval of an active substance in the EU is discontinued (the decision may come from regulatory authorities or from applicants themselves), authorisations are withdrawn by Member States. If a period of grace is granted by the Commission and Member States in compliance with applicable legislation, stocks of the products are sold-out to distributors and growers and used up by growers. Industrial production is scaled down or stopped depending on possible global supply needs. Uses in the EU become illegal. Typical duration: while Regulation 1107/2009 provides that periods of grace may last for up to 18 months, periods of grace practically granted by the Commission range from 6 to 15 months.

14. Does the industry review the Maximum Residue Levels (MRLs) set by EFSA, or have a view on the methods used to determine these?

While industry initiates the process by submitting an application containing all the necessary information and a proposal for an MRL, it does not review the MRLs. MRLs are proposed by EFSA independently and are legally established by the European Commission. Once set, all traders are legally obliged to ensure that they are complied with.

MRLs are evaluated according to precise requirements and processes published by the Commission and EFSA, and Industry is required to submit relevant studies and data. They are then established by risk managers after discussion in the Residues section of the PAFF Committee.

Prior to establishment, a defined assessment procedure is taking place with a double evaluation of the residue data and the risk assessment submitted by the notifier, for each crop MRL, by a Rapporteur Member State and by EFSA. The relevant data requirements are included in Reg. 283/2013 and MRLs are only granted when there are no relevant consumer concerns. 

15. What aspects of the approval process could be reformed? If you could strengthen some areas, what would you choose to prioritise for change?

Like any other system, improvements can be made. The recent assessments carried out by the EPRS and Ecorys (the consultant chosen to work on the REFIT of Regulation 1107/2009) show some deficiencies, particularly when it comes to implementation. Separate from its objectives to protect health and the environment, the regulation falls short when it comes to its objective of developing competitive agriculture in Europe. Due to the strict nature of EU legislation the number of substances on the market has decreased. In 2000 there was over 900 substances authorised, by 2008 that number was down to 425. The number in 2018 stands at 352, including 75 bio control. Only 5-8% of these substances have been removed due to safety reasons. A recent study commissioned by ECPA highlighted the impact that further reductions in the number of substances available could have4.

Update 04/10/2018: As a reaction to the IPOL report we are publishing a complete list of all authorised synthetic chemical substances in the EU.

ECPA would give priority to simplification, greater efficiency and more transparency. This could be achieved through:

  • EFSA guidance documents being fit for purpose – Guidance documents should be workable for risk managers (drafted by Member States and peer reviewed by EFSA, to avoid current complexity and un-workability). The impact of individual guidance documents, and their cumulative impact, should be assessed;
  • Scientific dialogue with EFSA during the risk assessment – EFSA to allow scientific dialogue with all stakeholders, in order to clarify issues raised, gain efficiency and avoid inconclusive opinions;
  • Improvement in zonal delivery & efficiency – Increase efficiency through more zonal and inter-zonal coordination, in order to share more the workload, and make the best use of each Member State’s scarce resources;
  • Improve mutual recognition – Minimise national data requirements for more predictability, and efficiency through all Members States accepting each other’s evaluations;
  • Faster & more efficient MRL setting – More consistency though harmonisation of timelines of evaluations between MRLs and approval/renewal of approval.

16. So far EFSA is coordinating the assessment of active substances but it is being considered whether they should assess plant protection products without Member State oversight or control. Do you support this proposal?

This proposal would not enhance the current approval system. If anything it could be a retrograde step. Setting aside the question of the resource that would be necessary to take on this additional work, centralisation would remove essential knowledge from the process at zonal and national levels.

Knowledge of a range of factors that can regularly change, including: national geography, geology, soils, spatial planning, aquatic systems, ecosystems, weather patterns, climate, farming techniques, cultural conditions, pest pressure and other local agricultural use conditions are key to the determination of the relevance of potential risks from the use of plant protection products and the effective management of those risks. Member States are currently best placed to ensure proper consideration of all relevant factors in the authorisation and safe use of plant protection products.

17. How many dossiers have been submitted by the ECPA’s member companies since 2011 under Regulation (EC) 1107/2009 and how many have been approved for use, withdrawn or rejected?

According to data compiled from the European Commission database, the EFSA register of questions as well as a screening of publications in the Official Journal of the European Union, we collected the following estimation

Since June 2011 under Regulation (EC) 1107/2009 ECPA member companies have submitted 22 applications for approval of a new active substance. Of these 12 have been approved, 2 not approved and 8 are pending a decision on approval.

Since June 2011 under Regulation (EC) 1107/2009 ECPA member companies have submitted 148 applications for renewal of active substance approval. Of these 32 have been approved, 8 not approved, 1 was withdrawn and 107 are pending a decision on renewal of approval. ECPA member decided not to support an application for the renewal of approval of a further 19 actives substances.

In addition, during this period the approval of 4 substances were restricted to use only in greenhouses.

18. Are the SME's demanding to approve active substances in disadvantage vis-à-vis the multinationals? Are the standards for application for approval not too high?

As with any regulatory framework, the more complex it is the costlier it is for a company to gain approval. When you consider that it costs on average 250 Million Euros to successfully bring a product to market this clearly presents an advantage to larger companies from a purely financial perspective. The regulatory cost of developing any solution, whether they are synthetic chemical or biological, is essentially the same.

Aside from the financial cost, the requirements imposed by the regulation are the same for all companies regardless of size.

It is important to understand that SMEs cannot be distinguished from R&D multinationals by the type of products they develop and market: low risk products such as biologicals, as well as products used in organic farming can be developed by SMEs or multinationals. Some SMEs only market synthetic pesticides. Also, generic SMEs depend on the continued flow of new active substances developed by multinational R&D companies. Thus SMEs are impacted when this flow declines.

All companies in our sector (multinational or SME) share the same concerns around the deficiencies, and inefficiencies, in the system.

19. EU regulations require that pesticide risk assessment is objective and independent. It can be assumed that your members would like to see a certain outcome from the assessment and will therefore prepare an application dossier and supplementary information that support such an outcome. However, it should also be the case that they accept the final outcome of the scientific assessment.

One of your members, Syngenta, has however continued to pressure EFSA and the Commission to modify the risk assessment of diquat, a herbicide, even after it had been finalised. As a result, the Commission has tasked EFSA to review part of its assessment. Do you agree that EU scientific assessment should be fully independent? How would you define that independence? At what point do your members draw the line, i.e. leave EU experts alone so they can do their job without any interference from political or industry interests?

We fully respect the opinions of EFSA, however it is possible to respect an institution and its opinion and still disagree with it or the steps taken. Where a company has legitimate questions about the work that has been carried out by EFSA on a specific substance, they should be at liberty to raise these questions with the expectation that at least their view point will be considered.

The current approval process allows few opportunities for direct contact with EFSA to discuss any issues with the evaluation. Contact only takes place in a formal, written and structured way. We do not have the ability to “interfere” with the process, nor would we wish to.

It is worth noting that for other sectors (i.e. pharmaceuticals) contact with the assessor (i.e EMA) is a normal part of the process.

20. In your public communications on glyphosate you often referred to (favourable) regulatory assessments around the world, including by EU agencies. However, when it comes to substances that are not allowed in the EU, or whose licence is running out, your members tend to ignore those assessments. Examples include herbicides such as paraquat, atrazine and glufosinate which your members continue to produce in the EU for export. Do your members accept the outcome of the EU assessments on these substances? Do they accept that the health effects identified in the EU can also occur outside the EU? If so, why don't your members stop the production altogether and focus on less toxic alternatives instead?

Yes our Members recognise and accept the decisions of the EU authorities for those herbicides. Our Members also respect the right of 3rd country competent authorities to reach their own approval decisions.

The basis for the regulatory status in the EU for all three examples was not driven by human or environmental health risks.

Regulation 1107/2009 anticipates the legitimate need for manufacture for export even when this product has not been authorised in the Member State of concern and consequently in Article 28 provides for production, storage or movement of a plant protection product intended for use in a third country.

21. How are decisions made regarding the direction of your actions? Specifically, is the influence of your members on your board of directors or orientation proportional to their turnover, their number of employees or the contribution they make you?

ECPA has a structure of committees supported by our member companies and the secretariat which work on a number of different areas from scientific research to advocacy, from stewardship programs to pollinators

The General Assembly approves the general policy of the association and approves the annual work program. In the interval between meetings of the General Assembly, and in accordance with decisions reached by the latter, the Association is governed an Executive Committee which has the power to undertake any acts necessary or useful to achieve the objectives of the Association, with the exception of the powers which the law or the Articles of Association reserve to the Presidency, the Director General or to the General Assembly. This Committee, among other things: ensures the effective operation of the Association by proposing the policies, strategies, budget, and funding of the Association, for approval by the General Assembly; based on the above, guide, approve and control the implementation of the decisions taken, and with best efforts, contribute itself to their implementation; decide the initiation of projects within the scope of the general policy of the Association.

The Executive Committee is made up of 7 corporate member companies which are currently: Bayer, Syngenta, Monsanto, Adama, BASF, DowDupont (Corteva) and FMC. Our SME Members are represented by 1 SME member, currently by Nufarm; along with 3 full association members from the countries with the largest market share (currently: FR, IT, DE)

Although the membership fee paid to ECPA is directly linked to turnover, this does not give any greater influence of those members over the decisions taken by the executive committee, as confirmed by the following extract from our constitution: “Each member of the Executive Committee shall have one vote. A simple majority of the members present is required for taking decisions. For decisions to be taken, at least half of the representatives of the Corporate Members, and half of the representatives of the Full Member Associations, need to be present. However, where this quorum is not reached, a new meeting shall be convened, where the Executive Committee shall decide, regardless of the number of members present. A voting member cannot represent other voting members by proxy.”

In addition, all 23 company members have 2 votes at the GA and all 25 full member associations have 1 vote at the GA

116. According to EFSA: “The integrity of the findings and raw data rely on the fact that the laboratories carrying out the tests are certified and audited under the GLP system”. How reliable is the certification of these laboratories, where the applicant is carrying out tests? Especially in light of the OECD’s good laboratory practices.

GLP is the highest level of quality assurance for studies conducted for the non-clinical testing of chemicals for the protection of man, animals and the environment.

The principles of GLP have been developed in accordance with the Organisation for Economic Cooperation and Development (OECD) and the EU has adopted these principles and the revised OECD Guides for Compliance Monitoring Procedures for GLP as annexes to its two GLP Directives.

  • 2004/9/EC – Inspection and verification of GLP (recodified)
  • 2004/10/EC – Harmonisation of laws, regulations and administrative provisions relating to the application of GLP (re-codified)

117. Are these laboratories public or private bodies? Who is certifying them? Who is financing the certification? How can you ensure that the OECD’s good laboratory practices are actually applied?

The GLP laboratories that conduct regulatory studies are in general private bodies. They are sometimes in-house laboratories of the ECPA member companies but more typically are external contract research laboratories.

In addition to commercial contract terms and work specifications for laboratories that our members use, many jurisdictions, including the EU, have laws that govern checks on GLP. In Europe, Member States are required to designate authorities responsible for GLP inspections in their territory. Under EU law, the required inspections must be carried out in accordance with internationally accepted OECD procedures.

118. Can we presume that these laboratories are totally independent and reliable?

The GLP certification of the laboratories provides assurance that the studies were conducted to standard operating procedures, by qualified experts, in suitably designed, equipped and resourced facilities and under appropriate conditions. The GLP certification also provides reassurance that the raw data have been retained and archived, making it possible to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.

In summary, GLP supports scientifically robust testing, prevents scientific falsification and allows a product lifetime traceability of the testing results.

The independence of the vast majority of the studies are further supported by the fact that they are conducted to internationally agreed OECD test guidelines.

119. In a recent debate on the re-approval of an active substance where the BfR has served as RMS there has been confusion and a broad debate about how the RMS conducts its assessment of the application. Could you therefore explain what rules are applicable for the RMS in the assessment of an application for the approval or re-approval of an active substance and how you applied these rules in the past?

If we have correctly understood the question it appears to be directed at the rapporteur member state.

120. Could you please explain your specific role as RMS in the process of the assessment of an application for the approval or re-approval of an active substance?

If we have correctly understood the question it appears to be directed at the rapporteur member state.

121. Could you please explain what measures are in place to secure that you as RMS fulfilled your role adequately and how these measures were applied in the past?

If we have correctly understood the question it appears to be directed at the rapporteur member state.

122. In the light of recent experiences with the assessment of applications for the approval or re-approval of active substances and with their public perception, do you have specific recommendations on how to improve the system as well as communication to increase its comprehensibility and hence public trust?

Like any other system, improvements can be made. The recent assessments carried out by the EPRS and Ecorys (the consultant chosen to work on the REFIT of Regulation 1107/2009) show some deficiencies, particularly when it comes to implementation. Separate from its objectives to protect health and the environment, the regulation falls short when it comes to its objective of developing competitive agriculture in Europe. Due to the strict nature of EU legislation the number of substances on the market has decreased from 900 in 2000 to 352 today. Only 5-8% of these substances have been removed due to safety reasons. A recent study commissioned by ECPA highlighted the impact that further reductions in the number of substances available could have.

ECPA would give priority to simplification, greater efficiency and more transparency. This could be achieved through:

  • EFSA guidance documents being fit for purpose – Guidance documents should be workable for risk managers (drafted by Member States and peer reviewed by EFSA, to avoid current complexity and un-workability). The impact of individual guidance documents, and their cumulative impact, should be assessed;
  • Scientific dialogue with EFSA during the risk assessment - EFSA to allow scientific dialogue with all stakeholders, in order to clarify issues raised, gain efficiency and avoid inconclusive opinions;
  • Improvement in zonal delivery & efficiency - Increase efficiency through more zonal and inter-zonal coordination, in order to share more the workload, and make the best use of each Member State’s scarce resources;
  • Improve mutual recognition - Minimise national data requirements for more predictability, and efficiency through all Members States accepting each other’s evaluations;
  • Faster & more efficient MRL setting - More consistency though harmonisation of timelines of evaluations between MRLs and approval/renewal of approval.

We believe that both industry, evaluators and policy makers all have a role to play in risk communication. ECPA welcome the efforts of the Commission and the EFSA to explain the evaluation process on their respective website, as well as the recent Commission proposal in the framework of transparency in the food chain, to develop an effective risk communication strategy. ECPA is requesting that EU and Member States authorities continue to defend the high level of scientific work they are delivering for the protection of EU citizens and their environment. When the institutions have agreed to adopt a decision making system it is to the benefit of everyone, from industry to consumers, to defend that system, and build public trust in it.

123. EFSA states that the Glyphosate Renewal Assessment Report portion of the Plagiarism Charge is not intended to represent "the actual risk assessment of glyphosate". The agency states that the rapporteur Member State must simply confirm whether, from its point of view, the search has been carried out correctly and that the information provided by the applicant in the field of scientific literature is accurate. Also, for what reasons did the BfR consider it necessary to insert directly, in its report, a hundred or so pages of text - if not more - from the documents provided by the manufacturers, since at this stage it was not a risk assessment?

[Inofficial translation of the French original: L'EFSA affirme que la partie du Rapport d'évaluation du renouvellement du glyphosate visée par les accusations de plagiat n'est pas censée représenter « l'évaluation réelle du risque du glyphosate ». L'agence précise que l'État membre rapporteur doit simplement confirmer si, de son point de vue, la recherche a été effectuée correctement et que les informations fournies par le demandeur en matière de littérature scientifique sont exactes. Aussi, pour quelles raisons le BfR a-t-il jugé indispensable d’insérer directement, dans son rapport, une centaine de pages de texte - si ce n'est davantage - provenant des documents fournis par les industriels, puisque à ce stade il ne s’agissait pas d’une évaluation du risque ?]

If we have correctly understood the question it appears to directed at the BfR for answer.

124. On what basis do companies choose a rapporteur member state?

Please refer to our answer to question 2.

125. The fact that a company can choose its country of origin as rapporteur member state for an application for approval in itself is not a problem, but what then do you propose to avoid any suspicion of collusion or favouritism?

The system of Rapporteur Member States is designed in a way that ensures no collusion or favoritism. The RMS is just the first level of control: All reports are peer-reviewed by other member states in the end as well as being subject to final scrutiny by EFSA. Companies have an interest in a rigorous early assessment to spot any irregularities which could delay the process in later stages.

126. In the case of glyphosate, the plagiarism of Monsanto's report by BfR, then EFSA, caused a scandal. In what proportions and for what type of information is the data provided by the company transferred? What is the added value of the BfR or EFSA report?

Industry is required to present its active substance dossiers in a format that has been specified in Commission guidance that was adopted by the Standing Committee on the Food chain and animal Health (now SCOPAFF). The format is based on a format agreed by the Organisation for Economic Co-operation and Development (OECD). This is an internationally agreed format for regulatory dossier structure.

In such a dossier full study reports as well as summaries of studies that cover all data requirements have to be presented. The study summaries need to be presented according to a standard format.

It is the role of the evaluating competent authority to check the summarised information and scientific conclusions for scientific accuracy based on the study reports. If the competent authority agrees with the summary provided by industry there is no need for change and the summary is adopted and transferred into the draft (or renewal) assessment report. Where information is not adequately or accurately summarised, the authority will make changes accordingly or provide its own summary.

When Industry summaries are accepted by the competent authority, it is misleading to present this as plagiarism. Industry is required to provide a first draft document which is a living document. Following the editing or incorporation with amendments considered necessary by the Rapporteur Member State and peer review comments, serves as the basis for the final version of the assessment report issued by the authorities. This procedures reduces duplication of work without compromising regulatory scrutiny.

127. Does the applicant company submit an application in English or in the language of the reporting member state? Idem, is the report transmitted by the latter to EFSA in English or in the national language of the agency?

For applications for approval of chemical active substances we are not aware of guidance on language but the accepted norm is to present the application in English to facilitate exchange and commenting between EFSA and the Member States.

128. Since the EU pesticide regulation entered into force in 2011, public authorities must also include independent studies in the risk assessment of pesticides. However, according to the German BfR, manufacturers' studies are preferred because they correspond to the so-called "good laboratory practice" by contrast to other studies, for example from universities or other scientific
institutes, who cannot match this standard even though they are working scientifically and submit themselves to a peer review process.

GLP is the highest standard of quality assurance and whilst it is theoretically possible for universities and other scientific institutes to adopt GLP certification, in practice this is cost-prohibitive for them. There are however alternative quality assurance schemes that these universities and institutes could consider implementing such as ISO 9001:2008 ‘Quality management systems – Requirements’ or ISO/IEC 17025:2005 ‘General requirements for the competence of testing and calibration laboratories’.

These schemes and the use of internationally agreed OECD test guidelines may provide greater reassurance to public authorities on the reliability of the data from universities or other scientific institutes for use as part of the weight of evidence in regulatory decision making.

129. To what extent does the requirement of "good laboratory practice" limit the independence and breadth of the studies used? Are there alternatives to using this practice?

See answer to question 128.