A survey of EU Member States and Norway was conducted. The questionnaire98 contained
questions on the zonal system and the zonal authorisation procedure established in the Member State, the application of the principles of precaution, substitution and sustainability and the independence and transparency of the CAs.
1.1
Zonal authorisation procedure
Questions 1-7 concerned the zonal authorisation procedure in the respondent Member State and covered the procedure itself, who evaluates the application, the status of expert advice received, frequency and reason for communication with other Member States in the same zone and the benefits of the zonal system for Member States.
1.2
Precaution, sustainability and substitution
The questions on precaution, substitution and sustainability were developed by reference to the provisions of the Regulation, EU case law, guidance, in particular on substitution and academic literature, as discussed in section IV. Guidance, policy and literature on these three principles is vast and entire discrete surveys could be conducted on the application by CAs of each. However, in order not to overload CAs (and therefore encourage responses) only a few questions were included on each principle, while acknowledging that it is impossible to capture a full understanding of national interpretations and application of such nuanced and complex concepts on this basis. These questions focused, therefore, on assessing the level of CA ambition in their application and the consistency of interpretation and application, by individual CAs and across Member States, of these three principles. Comparative assessment occurs at national level. However, consistency in its application may still be valuable in terms of the predictability of this procedure from an applicant’s point of view. The following questions were asked99:
8. The PPPR provides that a PPP may only be authorised if, in the light of current scientific and technical knowledge it has no immediate or delayed harmful effect on human health, it does not have any unacceptable effects on plants or plant products, it does not cause unnecessary suffering and pain to vertebrates to be controlled and it has no unacceptable effects on the environment (Articles 29(1)(e) and 4(3)(b)-(e)). Taking into account all the evidence of the safety of the PPP and the restrictions that may be placed on its use (Article 31), please indicate the standard of proof the evidence must meet in order for the PPP to be authorised.
9. Does the competent authority produce and follow any internal guidance in its application of the precautionary principle during the authorisation process?
98 The full questionnaire could be submitted upon request.
11. Does the competent authority take the principle of sustainability into account in its decision-making regarding the authorisation of PPPs?
12. On what basis does the competent authority decide whether or not to take the principle of sustainability into account in its decision-making regarding the authorisation of PPPs? 13. Sustainability can be interpreted in many different ways. Which interpretation does the competent authority apply in its decision-making?
14. Does the competent authority produce and follow any internal guidance, or follow any external guidance when applying the principle of sustainability in order to apply it consistently?
15. Recital 29 PPPR provides that Member States may impose ‘appropriate conditions’ on the use of PPPs having regard to the objectives of their National Action Plan adopted in accordance with Directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides [2009] OJ L309/71. In practice, how often does the competent authority do this?
16. Article 50(4) PPPR requires Member States to perform a comparative assessment of PPPs containing a candidate for substitution ‘regularly and at the latest at renewal or amendment’ of its authorisation. How often does the competent authority perform such a comparative assessment on PPPs containing a candidate for substitution?
17. On what PPPs does the competent authority conduct comparative assessment?
18. Does the competent authority produce and follow any internal guidance, or follow any external guidance (e.g. from EPPO, Commission etc.), on substitution/comparative assessment in order to deliver consistent results?
1.3
Independence
The questions concerning independence drew heavily on a survey of independent energy regulators in eight European countries conducted by Johannsen (2003) and her operationalisation of the concept of regulatory independence (Johannsen, 2003, pp.31–37). Johannsen’s research took, as its starting point, research into, and a previous survey of, IRAs in the pharmaceutical and electricity sectors in the UK and Italy conducted by Gilardi (2001) which, in turn, drew on research by Cukierman, Webb and Neyapti (1992) into the independence of central banks. Following Johannsen, the survey investigates independence in formal, legal/organisational terms, rather than in terms of the operation of these formal rules in practice.
Johannsen’s operationalisation of the concept of regulatory independence, relies on Smith’s definition of regulatory independence (Smith, 1997): discussed in section II. It measures four key variables: 1. Formal independence from government and the legislature; 2. Independence from stakeholders; 3. Substantive independence (Larsen et al., 2006, p.2860; Johannsen, 2003, p.36) from government and the legislature (concerning competencies and independent
These key variables were largely adhered to. Questions 22-27 concern formal independence from government and the legislature:
22. What is the term of the agency head or commissioners? 23. Is the appointment renewable?
24. Who appoints the agency head or the commissioners?
25. What are the provisions regarding dismissal of the agency head or commissioners? 26. May the agency head or the commissioners hold other offices in government? 27. Is independence a formal requirement for the appointment?
Questions 28-30 concern independence from the regulated industry:
28. According to your national legislation, is it possible for the commissioners/the agency head to have held a position in the plant protection product industry/industrial associations in the years preceding his or her appointment?
29. Are there provisions (in your national legislation) restricting the commissioners’/the agency head’s possibilities of accepting a job in the plant protection product industry/industrial associations after their term?
30. Are there any provisions (in your national legislation) forbidding the agency head/commissioners to have any personal or financial interest in the plant protection product industry?
Questions 31, 33, 34 and 36 concern financial and organisational autonomy: 31. What is the source of the competent authority’s budget?
33. When the budget has been approved, who controls the budgetary spending?
34. Who decides the competent authority’s internal organisation (internal procedures, allocation of responsibility, tasks etc.?)
36. Who is in charge of the competent authority’s personnel policy (recruitment, promotion, salaries)?
Question 42 concerns substantive independence:
42. To what extent is the competent authority responsible for the authorisation of new plant protection products under the zonal authorisation procedure?
While many questions were incorporated into this survey with little or no amendment, others were omitted or re-drafted and additional questions were included to reflect the specific features of regulating PPPs and the requirements of this research. Three particular changes may be noted. Firstly, Johannsen’s question on the permissibility of ‘discussions of pending
cases’ between stakeholders and the regulator was omitted as irrelevant to regulator-regulatee relationship in question. Pre-submission meetings between applicants and CAs are encouraged (Commission, 2014b, p.8) and CAs are entitled to contact applicants during the authorisation process for further information.100 Secondly, due to the EPRS’s particular interest
in CA resources, Johannsen’s questions on financial and organisational autonomy are dealt with under the heading of ‘Capacities’ and interspersed with questions relating to the sufficiency of these resources. Finally, Johannsen declined to include questions on information asymmetry due to the difficulty of constructing an indicator about which information can be collected (Johannsen, 2003, p.35). Information asymmetry is connected to the matter of (expert) resources so an attempt is made in this survey to tap this concept by introducing three simple questions (Q38-40) regarding the ease (or otherwise) of recruiting and retaining staff and of buying in resources unavailable in-house. It is acknowledged though that these questions can only scratch the surface of this complex concept.
1.4
Transparency and accountability
The questions concerning transparency and accountability were developed on the basis of research into, and guidance on achieving, transparency in regulatory authorities (for example, OECD, 2013, 2016; Jarvis and Sovacool, 2011; Dudley and Wegrich, 2016). These questions aim to get a sense both of the formal, legal obligations of the CA and the CA’s practice. Three dimensions of the concept of transparency are assessed. Firstly, clarity with respect to the authorisation rules, procedures and requirements:
43. How much information regarding the zonal authorisation procedure is publicly available (for example on the competent authority website) in the national language(s)? In this question, information includes guidance addressed to applicants on how to apply, the required documents, information about the authorisation procedure and how decisions are made. Secondly, access to, and publication of, information held by CAs:
44. Does the competent authority publish its decisions regarding authorisation of PPPs? 45. To what extent does the competent authority disclose/publish the information sources on which its decisions are based?
46. Is there a clear basis in law or policy for public access to information held by the competent authority, including a clear statement of the limitations to that access (for example, due to commercial confidentiality)?
Thirdly the strength of any consultation processes conducted during zonal authorisation procedures and access to related information:
47. With whom, in addition to the applicant, does the competent authority consult during its authorisation decision-making processes (including comparative assessment)?
48. If the competent authority consults any of the actors listed in question 47, please briefly state how this consultation/engagement is conducted.
49. If the competent authority consults any of the actors listed in question 47 does the competent authority publish or make publicly available their submissions?
50. Is the competent authority required by law to respond formally to these submissions? 51. If YES, are these responses published/made publicly available?
52. Is the competent authority required by law to take into account the comments provided during consultation processes in its decision-making?
The final five questions concerned accountability of the CAs and scrutiny of CA decisions: 53. What are the formal obligations of accountability of the competent authority vis-à-vis the government?
54. What are the formal obligations of accountability of the competent authority vis-à-vis the legislature?
55. Where the competent authority is required to produce an annual report, is this report also made public?
56. Are authorisation decisions reviewed or audited?
57. Article 36(3) fourth sub-paragraph PPPR requires that Member States provide the possibility to challenge a decision refusing authorisation of a PPP ‘before national courts or other instances of appeal’. Who, other than a court, can overturn the competent authority’s decision where it has exclusive competence?
Questions were predominantly closed, incorporating space for additional comments, with some open-ended questions. The questionnaire was lengthy and the aim in choice of question format was to strike a balance between enabling respondents to answer questions quickly and encouraging willing respondents to elaborate on their answers, thereby attempting a balance between depth and breadth. As such, respondents provided information of varying degrees of exhaustiveness and clarity.
1.5
Procedure
The survey took the form of a self-completion questionnaire contained within an MS word document. It was distributed to all 28 EU Member State CAs and the Norwegian CA by email at the end of October with the final deadline set in early December 2017. Twelve CAs responded within the deadline. It should be noted that the participating Member States represent all three zones; each zone is covered by the responses of at least two Member States, which, although not enough to ensure full representativeness for the EU as a whole, allows for some comparison.
Respondents were allowed to specify the level of anonymity accorded their answers. The three options were: consent to direct publication of information provided in the survey identifying the respondent CA; consent to direct publication of information provided in the survey without identifying the respondent CA; and consent to the inclusion of the information provided within statistical data but not to direct publication. The availability of different levels of anonymity was intended to encourage responses, while retaining flexibility for willing Member States to agree to the publication and attribution of their responses. Four CAs selected the first option; three CAs selected the second and five CAs selected the third. Selection of the first two options was regarded as most valuable in terms of the clear presentation of results and the development of an understanding of CA activity across the three zones. Therefore, where CAs provided information regarded as particularly helpful to the research, these CAs were approached individually and asked to waive their chosen anonymity level with respect to the relevant information. Some agreed to this request. Results are presented accordingly, with CAs identified and/or quoted where permitted. Information about the authorisation procedures of the 16 CAs which did not respond, gathered from CA websites (where available) is presented alongside these results. In all cases, the position stated is regarded as the official position of the competent authority.
Of the 12 questionnaires which were returned, six were complete.101 The reasons for the
incomplete questionnaires are unclear. Given the length of the questionnaire, it could have been that questions were accidentally missed, or skipped in the interests of time, if questions were regarded as too time-consuming to respond to. Alternatively, it may be that certain questions were not regarded by the individual respondent as relevant to the CA or perhaps that, despite the guarantee of anonymity, CAs were still loath to provide certain information. It should be noted that this tool allowed for factual information as well as opinions (subjective perceptions) to be collected.