INSTALACIÓN SANITARIA GENERALIDADES

To make inferences, case study methods require reliable data. Data collection refers to methods for collecting reliable evidence, e.g. participant observation, randomised experiments, content analysis or sample surveys (King, Keohane & Verba 1994: 51). The choice of a data collection method needs to reflect the choice of the method of data analysis. For the use of process-tracing in case study research, Bennett and Elman state that “the researcher examines histories, archival documents, interview transcripts, and other sources to see whether the causal process (…) is in fact evident” (2007: 6). This implies that all data that can help to elucidate the constraints relevant for the strategy formation process of the Commission is relevant. The formation of regulatory cooperation strategies is not only a recent process, but has been relevant since the inception of the transatlantic regulatory cooperation in the early 1990s. This book thus needs to rely on both recent and historical documents to understand the constraints considered in the strategy formation process. The data collection combines document analysis with expert interviews. This section will discuss both document analysis and expert interviewing.

Document analysis

One of the methods frequently applied in case study research is document analysis (King, Keohane & Verba, 1994: 51). Document analysis is also an important source of collecting reliable data. The next paragraphs discuss how and which documents were collected for the within-case analyses of this book. They adopt the frequent distinction between primary and secondary sources. A primary source is a document which is created during the process examined whereas a secondary source constitutes an analysis or interpretation of a primary source.

This book is interested in all primary and secondary sources that help it trace the decision-making process for the formation of a strategy in the Commission. This involves documents from first drafts of issues for cooperation written by technical officials in a Commission DG to the adoption of negotiating texts in the College of Commissioners and conclusions of EU-US working groups or Summit meetings. Relevant primary sources are both public documents of the Commission that refer to the strategy that the Commission seeks to adopt in regulatory dialogues with the US and non-public documents that offer background information and explanations of the Commission’s choice of strategy.

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Public primary documents can be mostly obtained from the website of the Commission. For the Commission’s formation of a strategy for regulatory cooperation, the most important public documents are annual Trade Barriers Reports, roadmaps for regulatory cooperation dialogues, the position papers for regulatory cooperation in individual sectors in the TTIP negotiations, textual proposals for the TTIP negotiations and EU-US Summit conclusions. Trade Barriers Reports indicate which regulatory measures the Commission considers as particularly important for potential discussion in regulatory cooperation. The contrast of EU-US Summit conclusions with Trade Barriers Reports and internal Commission documents reveals how and which issues the Commission translated from the definition of trade barriers into demands for regulatory cooperation.

Non-public primary documents of the Commissions which were produced as a preparation or in the context of regulatory cooperation discussions are equally essential. Examples for internal documents are meeting reports, drafts for inter-service consultations and strategic notes sent by the Commission to the Trade Policy Committee in the Council. Usually, internal documents are not accessible to the public and need to be retrieved by researchers by filing an Access to Document request under Regulation 1049/2001. Many internal documents on the TTIP negotiations have, however, been requested by NGOs, especially Greenpeace and the Corporate Europe Observatory, under the Regulation and have subsequently been released to the public on the websites of these organisations. Confidential documents have also been leaked by Members of the European Parliament and members of national parliaments, notably the German Bundestag, and have been placed on platforms such as Correctiv.org. Internal Commission documents on the HLRCF and TEC have been released by the platform Wikileaks. The empirical chapters will refer to these documents.

Secondary sources analysing or commenting the Commission’s engagement in regulatory cooperation comprise several kinds of documents. This book obtained essential information from academics and policy-observers following the Commission’s pursuit of regulatory cooperation. Important sources were policy papers published by Brussels-based think tanks, e.g. the TTIP series published by the Centre of European Policy Studies. Position papers published by societal actors offered background information on the content of regulations and the design of implementation procedures in the EU and the US as perceived by societal actors. Their use in this book is nonetheless important as descriptions in these position papers also informed Commission officials and offered background knowledge to their decision-making behaviour. Insights into discussions among Commission DGs were further retrieved from articles by the specialist journal ‘Inside US Trade’. Information on decision-making in the Commission and its behaviour in meetings with US officials could also be obtained from classified reports of the US government that were released on Wikileaks. Other sources include academic journal articles which examine regulatory cooperation notably within the NTA and regulatory cooperation

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between the EU and other third countries67_{. A crucial source were also legal science articles on EU and}

US regulatory frameworks and policy papers commissioned by the European Commission, notably the Ecorys Impact Assessment studies, as well as International Trade (INTA) Committee of the EP. Secondary sources are referenced in the empirical chapters.

Expert interviews

Case study research further often requires additional ‘insider knowledge’ that cannot be obtained from document analysis alone, but relies on expert interviews (Cohen, 1999; Leech, 2002). Following Manheim and Rich (1995: 161), ‘experts’ are understood as those individuals who were directly involved in the process under examination and who have first-hand knowledge that can help to answer the research questions (Manheim & Rich 1995: 161-2). A person is interviewed because of her knowledge of an issue. As this book concentrates on the decision-making that takes place within the Commission, process-tracing needs to consider the views and experiences of the officials who are involved in the formation of the regulatory cooperation strategy. The goal of expert interviews is to ‘assist in reconstructing some event or discerning a pattern in specific behaviors’ (Manheim & Rich, 1995: 162). Expert interviews are often used in case study research relying on process-tracing because they increase the number of observations and allow shedding light on the actions and decisions that establish the chain of events producing a decision and thus elucidate the functioning of the causal mechanism (Tansey, 2007: 765-66). An interview can thus gain access to information that is otherwise not available. They also enable assuming an ‘insider perspective’ and gain insights on the importance of individual actors. Moreover, expert interviews allow triangulating inferences that were drawn from document analysis.

By assuming an ‘insider perspective’, the expert interviews helped structure the research in two ways: First, they allowed better understanding the relevance of regulatory cooperation as a topic. The initial objective of this study was to understand why the EU only reduced some non-tariff trade barriers in its trade liberalisation efforts, but left others in place. Early interviews with both government officials and business representatives indicated that this question was both too broad and abstract to be effectively addressed through a dissertation. Instead, interviewees drew attention to the regulatory cooperation efforts that the Commission was undertaking in the context of the TTIP negotiations and before. Moreover, they stressed that it was much more important to understand the political dynamics that were underlying these efforts than the patterns of business mobilisation shaping traditional trade negotiations.

67 _{For a discussion of the use of previous academic literature as observations in process-tracing see (Leuffen, 2007:}

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Expert interviews thus helped make the research question both more precise and direct it to dynamics which were considered as relevant by policy experts.

Second, the expert interviews guided the search for empirical information already available elsewhere. Little of the information obtained through expert interviews is new or unavailable. Interviews, however, show a researcher what information to look for to understand an issue or a process. Moreover, the interviews clarified which officials and associations are ultimately closely involved in the consultation for and the drafting of position papers and thus the formation of the EU’s regulatory cooperation strategy. An internet search of these people helped find documents, including often detailed minutes, of meetings they attended, positions they took in interviews with other researchers or journalists, or even personal or scientific accounts of their reflections on regulatory cooperation interactions in the past. Frequently employed interview techniques are standardised questionnaires, semi-structured and non- structured, open question interviews (Leech, 2002). Standardised interviews frequently measure political attitudes or specific political behaviour such as voting. Non-structured interviews often take the form of a conversation in which the role of the researcher is comparable to that of an ethnographer. This book builds on semi-structured interviews as a method to carry out expert interviews. Semi- structured interviews aim at grasping the experiences, opinions and perspectives of interviewees. They give interviewees the opportunity to elaborate certain points and share personal reflections and interpretations of an event or process (Marsh & Stoker, 2010: 138). Moreover, interviewees share the relative weight they attach to individual factors for a decision. Despite its embedding in rational-choice literature, opinions and perceptions are important in institutionalist accounts. The technical details, but also the personal observations, reflections and experiences of interviewees help to reconstruct the considerations that led to the development of a specific regulatory cooperation strategy. Semi-structured interviews are thus a suitable technique for the conduct of expert interviews for this book.

Semi-structured interviews rely on an interview guide of building block questions that interviewees respond to freely and in a non-standardised way. The interviewer may change and adapt the order of questions to the interview context and handle the interview guide flexibly. Besides, during the interview the interviewee may add further information or suggest additional topics. Responses of interviewees are not coded or analysed by statistical means.

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The interview guides were constructed according to a comparable structure for all interviews even if questions were adapted to both the role and the likely knowledge of interviewees. The following box offers general examples of questions that were asked in most of the interviews (for full interview guides see Annex 2).

Many of these questions address sensitive information on intra-institutional relations and relations with US regulators. To ensure that responses would constitute reliable information, interviewees were assured both in the initial contact with the interview request and at the beginning of the interview that their answers would be treated anonymously. To further demonstrate interviewees that their responses would be handled with care, the interviews were not recorded. Instead, extensive notes were taken during the interview. A list of all interviews is provided in the annex. To protect the identity of interviewees, only their affiliation is indicated (Commission / societal actor).

The selection of interviewees for semi-structured expert interviews is crucial. Unlike other interview techniques, expert interviews are not based on random sampling. Instead, interviewees are selected deliberately because of their knowledge. To identify adequate interviewees, this study relied on purposive sampling and snowball sampling (Tansey, 2007: 770). For purposive sampling, research was carried out to identify the units and officials that were responsible for regulatory cooperation within a sector. Rather than selecting several interviewees from the same DG, the selection of interviewees focused on ensuring interviews with officials from all DGs that contributed to the formation of the strategy in the relevant processes. Interviewees were also identified and contacted through the participation in two Stakeholder Dialogues on 24 February 2016 and 13 July 2016 at the margins of the TTIP negotiations. Moreover, through snowball sampling interviewees were asked to suggest persons that could be contacted for the research project.

The number of interviewees who are sufficiently knowledgeable of the processes that influence the formation of the Commission’s strategy on regulatory cooperation as well as the factors and technical

• Which processes have contributed to the formation of the Commission’s regulatory cooperation strategy in …?

• How were you involved in these processes? How has the agenda of … been set? • Why did you participate in these processes? What has been your interest?

• Please describe the US regulatory approach on …. How do you think that it differs from the EU approach on this issue?

• Why did you decide to take position … on issue … ? • Have you changed your position later?

• Which actors in the Commission have contributed to … [inter-service consultations]? • What have been the positions of these actors?

• How do you assess your ability to influence these processes?

• How have the EP/the Council/societal actors influenced the Commission’s decision? • What other influences have there been?

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issues determining its choice of strategy is limited. In many cases, snowball sampling illustrated that it was enough to speak to one person within a DG to understand how this DG contributed to the Commission’s strategy. This study concentrated on obtaining interviews with all relevant interviewees. Substantial time was spent on ensuring that all relevant interviewees could be contacted. In many cases, the frequent travels of Commission officials between Brussels and Washington during the TTIP negotiations made it difficult to contact officials on an issue that was in itself already politically highly sensitive. Moreover, due to the rotation of officials between DGs, EU institutions and even between the Commission and private organisations it proved difficult in some cases to identify interviewees through either purposive or snowball sampling that had knowledge of the Commission’s behaviour in regulatory cooperation initiatives before the TTIP negotiations. In a considerable number of cases, however, officials had been working on an issue, even if not always in the same position, for more than 10 years and freely shared their impressions and recollections of regulatory cooperation under the TEC and before.

Almost all interviews were conducted in person. Only in three cases was the interview conducted over the phone. Nonetheless, the level of depth attained in particular on a technically complex and politically sensitive issue was higher in the interviews that were held in person. No conversation was shorter than 30 minutes and interviews lasted mainly between 60 and 120 minutes. In three cases, the interviews lasted three hours and interview partners continued sharing their perceptions and insights after all topics on the interview guide had been addressed.

It proved essential for the conduct of the interviews to demonstrate both professionality and expertise towards interview partners. Several interview partners shared their discontent that despite anonymity requests, previous researchers had not only publicly attributed statements to individual interview partners, but also cited them incorrectly or changed crucial elements of statements. While all interview partners contacted for this book signalled their openness to conduct an interview and their interest in the topic, creating an atmosphere of trust proved a challenge. The decision to take extensive notes rather than recording the conversation noticeably eased the atmosphere in a number of cases. Moreover, demonstrating expertise in the subject was a crucial factor to establishing this trust. Knowing the meaning of ‘SDoC’ or of a ‘Notified Body’ was as important as using regionalisation or audits in the appropriate context. In one interview, mistaking terms caused the concentration of the interviewee to drop and required considerable effort to win back the attention of the interviewee. Each interview thus required substantial preparation. Besides, interviewees who had been described as particularly knowledgeable or insightful on regulatory cooperation across sectors were only at the later stage of the research to ensure that they could be approached with sufficient expertise.

The reliance on expert interviews to ascertain the importance of the independent variables must be put into perspective. Extrapolating their relative weight relied on building a ‘narrative’ or story that linked the insights and perceptions shared by interviewees. The constraints identified in this way rely on

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observation. The actual preference of an actor is difficult to identify. Yet, it seems that there are no better research methods to approach this question. Sending out standardised questionnaires would be subject to the same measurement problems in this regard as observations based on expert interviews and document analysis. To ensure the reliability of the responses shared by interviewees, statements of interviewees were triangulated with responses collected in interviews with member state representatives and societal actors. The selection of interviewees for triangulation also followed purposive and snowball sampling. Interviews with societal actors concentrated on representatives of firms and business associations as both purposive and snowball sampling indicated that these were more likely to have the technical knowledge of EU and US regulations and implementation procedures. This technical knowledge was considered as necessary to be able to understand and reconstruct the Commission’s decision to choose one rather another strategy regarding a specific issue.

Rules for identifying the number of necessary and sufficient expert interviews are less clear-cut than for standardised interviews. An indicator for the number of interviews to be conducted became the knowledge of the subject. In the last interview conducted for each sector, the responses of interviewees could be often anticipated. Moreover, interviewees confirmed that the most relevant interviewees had been identified and contacted.

In sum, 26 interviews were carried out between 2015 and 2017. Table 3 lists the interviews broken down to governance regimes, government and business representatives, and their level of activity, i.e. at the EU or member state-level (for the full list of interview see Annex 1).

Chemicals Engineering Food ICT Horizontal Sum

Gov. Business Gov. Business Gov. Business Gov. Business Gov. Business

EU 1 1 2 1 2 2 2 2 1 2 16

MS 1 1 1 1 1 5 10

Sum 3 5 5 4 9 26

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Nonetheless, in the context of strategy formation for regulatory cooperation a few indicators can be developed. First, early interviews with member state representatives confirmed that strategy formation on regulatory cooperation occurs mainly at the EU level. While member states’ support and endorsement of regulatory cooperation is essential for the pursuit of regulatory cooperation by the Commission and its success, member states are usually little involved in the details of strategy formation as long as it involves issues on which EU-level rules already exist. This reduced the necessity to speak to a large number of member state representatives. Second, the number of Commission officials working on regulatory cooperation on a specific issue is relatively small- in many cases position papers are drafted and meetings are attended by two or three people. They are well connected and maintain close working relationships. Quickly, interview partners confirmed that important actors shaping the strategy formation process had been contacted.

5.4. Summary

This chapter has discussed the methodology of this book to employ a case study-based research design. The book combines case selection according to a least-likely logic with the method of difference. Out of eight possible third countries with which the EU has pursued bilateral regulatory cooperation in the