4. Planning stages
The level of implementation of the register depends on the available budget. We recommend starting with a small-scale pilot before setting up a full-scale register, because that will allow us to identify challenges involved in the development of a biocide register on a small scale. One advantage of this approach is that we can use this small-scale beginning as a basis to build upon. Once we have the pilot, there are various ways to scale up to a biocide register. This chapter presents three such scenarios.
The topics in this chapter are in part a response to the last question in the research proposal:
What can the CBS contribute in this regard (Ed.: setting up a system for biocide registration), in conformity with the CBS [Statistics Netherlands] Act, during the observation phase and the setting up of the register, and what scenarios could be adopted to that end?
This chapter will focus on the scenarios and less so on the role of the CBS.
4.1 Pilot
The purpose of the pilot is to examine the various choices that have to be made in setting up a biocide register, without using the registered data primarily for long-term goals such as policy monitoring. With regard to the selection of product types, such as PT14 (rodenticides) for example, we will follow the steps that are part of setting up a register. Authorisation holders will be asked to report voluntarily on the quantities of active substances and/or products sold during the reference year. Asking for both variables will enable us to find out which of these variables will lead to the best data quality.
Data can be collected by means of a template CSV file; the authorisation holders will be asked to enter the requested data and upload the file to a portal. The advantage of using a template CSV file is that it is relatively cost-effective. There is no need for a scalable software solution for data collection at that point. The data processing can be done manually at this scale, for example by using an R script.
The resulting tooling and code will not be scalable to a full register, but the obtained insights will most likely be valuable for the efficient structuring of scalable tooling for a complete register. The output of the pilot is a list with recommendations for setting up a biocide register, to supplement the recommendations in this report. The estimated runtime of this pilot is one year.
Fytostat has indicated that they are interested in participating in the pilot. Data collection can be done in full or in part by Fytostat, in cooperation with the CBS for example, and the aggregated data for active substances can be shared with the commissioning authority (Ministry of IenW). It is not clear yet what the pilot will look like, exactly.
The lessons from the pilot can then be applied to the implementation of a register for multiple PTs. If we decide to start with a complete register right away, we still recommend designing the first project phase as described above for the pilot. The following section describes three different variants of a register in order of size (minimal, medium and extended variant).
4.2 Minimal register variant
The purpose of the minimal variant is to provide information about the sale of active biocides in the Netherlands for a few selected PTs. Lists of authorisation holders who bring biocidal products to the Dutch market for professional use of certain product types (see section 2.4.12) are collected on the basis of the ECHA and Ctgb databases. These authorisation holders form the basis of the register.
A sample of authorisation holders will be approached and asked to voluntary report the quantities of active substances sold during the reference year by completing a web survey. If the expectation is that the data quality will be higher if we ask about product sales rather than the quantities of active substances sold, that is an option as well. To reduce post-processing costs for this minimal variant, we recommend choosing one of the two variables. One likely benefit of a survey as opposed to a template CSV file (as described in section 4.1 in the context of the pilot) is that this will be a more user-friendly experience for the authorisation holders.
The sample could consist of all “large” authorisation holders (based, for example, on number of employees or profit, taken from other sources), with another sample consisting of the other authorisation holders. At the start of the project we will ask for data from the past two years for reference purposes. Authorisation holders in the sample group will be asked to participate for several consecutive years (panel design) in order to promote the accuracy of the calculations of changes over time.
Only active substances, i.e. no products, will be registered (or the other way around if this would yield higher-quality data). This will be followed by a minimal (automated) check of the completeness and quality of the submitted data. If information is missing or does not appear to be plausible, the companies in question will not be contacted. The benefit of a sample approach is that it relieves many authorisation holders of the response burden. The smaller scale of the data collection will probably result in lower costs.
The output consists of statistically secure aggregates of the quantities of active substances that were sold. This sample approach does mean that further breakdown of the output is probably not an option (to prevent disclosure). The structure of this register is designed to make it possible at a later point to request data on active substance quantities (and/or product quantities) for more PTs and more authorisation holders.
4.3 Medium register variant
The purpose of the medium variant is to provide information about a large selection of PTs about the sale of active biocides in the Netherlands. The design of this “medium” variant is largely the same as that of the abovementioned minimal variant.
However, this register is populated with more data; it could include all PTs, for example, or a larger selection of authorisation holders than the minimum sample. All authorisation holders will be asked to report on the quantities of active substances or the quantities of (sub)products they sold. The authorisation holders can choose the option that is most feasible in light of their own administration, to promote submission of quality data.
The data collection is followed by extensive quality control where authorisation holders are contacted in the event of missing or potentially incorrect information. Since the respondents are given a choice on what to report, the next step is to convert all data to active substance quantity. One option would be to start with the minimal variant and then work towards the medium variant as more data are collected over time.
4.4 Comprehensive register variant
The purpose of the comprehensive variant is to provide information about all PTs about the sale of active substances and biocidal products in the Netherlands. The structure and design of this register variant is more comprehensive than that of the two variants above.
This register has as much information as possible and includes all PTs and authorisation holders. The most comprehensive version could also include products for non-professional use. All authorisation holders will be asked to report on the quantities of active substances or the quantities of (sub)products they sold. The authorisation holders can choose the option that is most feasible in light of their own administration, to promote submission of quality data. In addition to the authorisation holder table (see section 3.8.1), the register will have a product table (see section 3.8.2) and an active substance table (see section 3.8.3) as well. The toxic impact of each active substance is listed in the active substance table and the H statements for each product are listed in the product table.
The data collection is followed by extensive quality control where authorisation holders are contacted in the event of missing or potentially incorrect information. Since the respondents are given a choice on what to report, the next step is to convert all data to active substance quantity. The output consists of statistically secure aggregates of the quantities of active substances that are sold, with breakdowns by toxic impact (based on active substance) or, in the most comprehensive variant, by H statement (based on products).