Procedure for introducing current scientific and technical knowledge into the authorisation procedure for plant protection products

Procedure for introducing current scientific and technical knowledge into the authorisation procedure for plant protection products

Contact address: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienststelle Braunschweig Messeweg 11/12 38104 Braunschweig Germany www.bvl.bund.de March 2004

Index 1. Introduction 1 Page 2. Legal principles 2 2.1. Continuous updates and determining current scientific and technical knowledge 2 2.2. Legal principles 3 3. Implementation of current scientific and technical knowledge in the authorisation procedure 4 3.1. Adoption of test guidelines and procedures compiled by third parties 4 3.2. Compilation of new test guidelines and procedures under the supervision of the BVL 5 4. References 7

1 1. Introduction The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (Federal Office of Consumer Protection and Food Safety, BVL) authorises a plant protection product in accordance with 15 of PflSchG (German Plant Protection Act) if, according to current scientific and technical knowledge and when used properly and for the intended use, or as a consequence of such an application, it is sufficiently effective, there are no unacceptable effects on the plants and plant products to be treated, it has no harmful effects on the health of humans or animals or groundwater and has no other unacceptable effects, especially on the environment, as well as the hormonal balance of humans and animals. When authorising plant protection products, the Member States of the European Union must comply with the requirements stated in Article 4 (1) b), c), d) and e) of Directive 91/414/EEC uniformly and consistently, as stipulated in the Directive with regard to the protection of human and animal health as well as the environment. Uniform principles were therefore established to assess the information on plant protection products submitted by the applicants as well as to decide on authorisation on the basis of this assessment (Annex VI of the Directive). The data requirements for assessing the plant protection products are contained in Annex III of the Directive; the data requirements for the active substance contained in the plant protection products are derived from Annex II of the Directive. They serve as a basis for the authorisation of a plant protection product, which must take into consideration current scientific and technical knowledge. Furthermore, guidance documents from the European Commission have been compiled on various test areas, which are to help in substantiating the annexes mentioned. Although these are not legally binding, they are in principle taken into consideration for assessment. Science and technology are developed continually, leading to new findings and knowledge which have to be taken into consideration. This does not just mean introducing new test methods but also exposure models, assessment principles or even new test areas. In a wider sense, this also means, for example, the introduction of new directions for use. A large part of the new findings and knowledge to be introduced in future to the authorisation procedure will be assigned to the regulatory areas of Annexes II, III, IV, V and VI of Directive 91/414/EEC. Long-term independent and national solutions will therefore not be permitted. Experience has shown however that individual Member States take the initiative to introduce new findings and knowledge into the authorisation procedure. This document has the task of defining acceptable principles for this. It is necessary and practical to also involve experts and/or representatives from authorities from other Member States early on in the procedure.

2 2. Legal principles In the past few years, various commissions have looked into how to increase the trust citizens place in decisions made by authorities on risks concerned with health and the environment and how to improve the acceptance of these decisions (report by the president of the Federal Audit Office in 2001, final report by the risk commission in 2003, see references in chapter 4). Following this, those concerned and the general and scientific public are to be involved in a transparent decision-making procedure. In this respect, the proposed procedure offers a great deal of transparency, ways of involvement and calculability. There are several different ways concerning the procedure for introducing current scientific and technical knowledge depending on the emphasis. EC Member States, for example, have taken into consideration current scientific and technical knowledge when introducing new methods of analysis to such an extent that the list of accepted measuring procedures for monitoring is inspected and adapted to the current state of knowledge at defined points in time (in the corresponding guidance document). In other areas, there are sometimes very different specifications for implementing current scientific and technical knowledge, which is less helpful as far as transparency and understanding decisions is concerned. The lack of clarity which results can lead to considerable delays in the authorisation procedure, unnecessary workloads for applicants and authorities and confusion on the part of those applying plant protection products. In this context, deadlines for fulfilling new data requirements must be agreed on and exact dates fixed for introducing new test guidelines or adequate information on the period of implementation. 2.1 Continuous updates and determining current scientific and technical knowledge Data requirements for an application for authorisation are specified first of all in 12 (3) of the German Plant Protection Act (PflSchG) and 1 (2) of the Plant Protection Products Ordinance in line with Annexes II and III of Directive 91/414/EEC. If the application does not comply with the criteria specified, authorisation is not considered ( 15 (1) No. 1 PflSchG). The deadline for decision-making (12 months) in accordance with 15 (3) p. 3 PflSchG does not begin until data gaps have been filled with supplementary data. Data gaps can arise even though the application satisfies the requirements of Annexes II and III. In accordance with 15 (1) No. 3 PflSchG the evaluation procedure for authorisation must be orientated towards current scientific and technical knowledge. If this changes, the data submitted by the applicant according to Annexes II and III may not be sufficient to assess whether the prerequisites for authorisation are also fulfilled by the new current scientific and technical knowledge The discussion on how to cope with this discrepancy, in particular whose responsibility it is to acquire the missing data and how this should be introduced to ongoing authorisation procedures, is just as lively as the discussion on the logically paramount question of who determines current scientific and technical knowledge for the authorisation procedure and what the procedure for incorporating the respective current scientific and technical knowledge should look like.

3 2.2 Legal principles From a legal point of view, the following principles must be considered: 1. The meaning of the term `current scientific and technical knowledge is not defined legally. Legal literature agrees however that reference to current scientific and technical knowledge is stricter than, for example, the phrase, 'state of the art technology' in the Bundes- Immissionsschutzgesetz (Law Concerning the Protection against Harmful Effects on the Environment through Air Pollution, Noise, Vibrations, and Similar Factors). The latter concentrates on the practical implementation of new findings. In contrast, according to current scientific and technical knowledge, precautions against harmful effects are to be taken which are necessary according to the latest scientific findings. If they are technically (still) not possible, authorisation/approval is not granted; precautions are not limited by what is currently technically possible (BVerfGE 49, 89, 136). 2. By using the undefined legal term, `current scientific and technical knowledge in the Plant Protection Act, the legislator has delegated determining `current scientific and technical knowledge to administration. 3. However, it is not sufficient to justify every individual opinion in scientific literature as a current scientific and technical knowledge. The capacity of the state on the decision to determine `current scientific and technical knowledge as a criterion by way of an environmental approval is derived from the precautionary principle of environmental law, which, due to the significance of the goods to be protected which are at stake, allows the state to enforce protection measures below the danger threshold. In the authorisation procedure for plant protection products, current scientific and technical knowledge is laid as a foundation in all test areas, not only for protection against harm to humans and the environment, but also with regard to the protection of crops (efficacy). The precautionary principle meets its limits, as every state-made action, in the principle of proportionality. The state is not allowed to limit the rights of individuals (the applicant in this case) on the basis of assumptions or vague theories. According to law this is not possible until acceptable scientific findings have been submitted. 4. In order to determine current scientific and technical knowledge in the process, a procedure should be established which fulfils the following requirements proposed by the risk commission working on behalf of the Federal Ministries for Health and Social Security and Environment, Nature Conservation and Nuclear Safety (p. 11 of the final report): guarantee a high degree of scientific transparency, involve the scientific public, document the procedure, justify decisions. Moreover, the following constitutional requirements can be established: ensure objectivity, coherency and the involvement of all those concerned. 5. It seems pertinent, as far as the discourse with the scientific public is concerned, to also discuss whether in a concrete case, from a scientific point of view, it is necessary to introduce the new current scientific and technical knowledge into ongoing procedures or whether it is sufficient to apply it to future procedures or whether it is even sufficient to determine a date in the future on which to introduce it. In order to comply with the principle of proportionality, the risk potential supported by the new findings on the one hand must be opposed to the rights of applicants, in particular the right to receive notification of a decision within one year, on the other hand ( 15 (3) p. 3 PflSchG). Thus, the question of whether the new findings would result in a revocation of authorisation, or if not considered, in authorisation being granted, can be of assistance in deciding on whether it is necessary to introduce the new findings into ongoing procedures or not.

4 6. The final decision on the date of introduction is made by the authorities involved in the authorisation procedure. They must also keep to the criteria stated under 5. The proposal resulting from the scientific discussion regarding the date of introduction should also be taken into consideration. 7. Should a procedure which is in line with these criteria have led to a new state of science and technology, this must be introduced in accordance with the decision made in the discussion. 3. Implementation of current scientific and technical knowledge in the authorisation procedure New scientific findings can make it necessary to check the assessments or risk mitigation measures in ongoing procedures or procedures which have already been closed or even in individual cases to generally change procedures. For example, new trial results from studies, the adoption of new test guidelines (e.g. OECD, EC), current risk assessments, monitoring data or communications from expert scientific circles can contribute to the development of science and technology. The following two procedures could be used for implementing current scientific and technical knowledge into the national authorisation procedure: adopting guidelines or procedures from third parties (EC, OECD, EPPO, CIPAC etc.) compiling a new test guideline or a new procedure under the supervision of the BVL Both procedures will be explained in more detail in the following. 3.1 Adoption of test guidelines and procedures compiled by third parties For the test areas, 'methods of analysis' and 'physico-chemical data and identity', guidance documents are normally used as the way to introduce new procedures, data requirements and assessment criteria which result from a new current scientific and technical knowledge They interpret and substantiate the general stipulations in Annex II and III, may not however go beyond the data requirements and decision-making principles set out in Annexes II and III. This procedure is generally also relevant for other test areas (e. g. crop protection, environment) and when adopting directives from international organisations (e.g. OECD). Proposals are made by one or several Member States to the Commission. The Commission decides on how to proceed further (e.g. collecting and processing comments). After adopting the guidance document, it is published in the Bundesanzeiger (Federal Gazette), in the German plant protection services' newsletter and on the BVL's website.

5 An adequate transitional period is fixed which refers to the date for submission of the applications. A reference to guidance documents compiled up to the present can be found in the chapter titled references. 3.2 Compilation of new test guidelines and procedures under the supervision of the BVL As a rule new findings are introduced in stages according to a process/approach by the BVL and with the involvement of the respective authority of consent/consulting authority (see diagram on page 6) as follows: 1. Describing problems The authorities describe where the suspicious facts come from on the basis of the new findings and the expected significance of the respective new findings for the decisions to be made in the authorisation procedure. Furthermore, they name the existing data gaps or other deficits which must be solved. Describing problems is the duty of the BVL. 2. Project planning If changes are thought necessary to the risk assessment procedure, a proposal is made for a project for introducing new findings. The project proposal is then subjected to a hearing. The project is either pursued or rejected on the basis of the results of the hearing. 3. Scientific work If experiments have to be carried out, e. g. ring tests, not only laboratories from the plant protection product industry should be involved, but also other institutions such as universities or research institutes. In addition, literature searches can be done or comments from expert scientists be used. The relevant expert committees of the BVL are also to be involved. With regard to the introduction of new findings at EC level, experts from other Member States may need to be involved. 4. Decision-making procedure The authorities check their decision proposal using the results from the hearing and amend this if appropriate. The final proposal for the decision including transitional periods for the introduction of new findings in the authorisation procedure is discussed at an expert hearing. Finally, the decision including all the authority's grounds for consideration are described and published in a document. 5. Publication New data requirements or guidelines on risk assessment are made public in the Bundesanzeiger, in the German plant protection services' newsletter and on the BVL's website including details on entry into force and transitional periods. If the proposed closing of assessment/data gaps in the national procedure may be relevant for the procedures of the other Member States of the European Community, problems should be outlined (in English) and if possible an English version of the new directive/guideline be sent via the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) to the European Commission in Brussels. The authorities will attempt to estimate the relevance for the procedures in the other Member States of the European Community as soon as the decision including all grounds for consideration is described and to aim for EC-wide co-operation.

6 Procedure for compiling a new test guideline or a new procedure under the supervision of the BVL New findings and knowledge Describing problems Hearing Problem relevant for authorisation? no Project not pursued yes Results of scientific work sufficient? no Scientific work (experiments, literature search, ring test) yes Compile a decision proposal Hearing Publication of decision

4. References Organisation of consumer health protection (focal point food): recommendations by the president of the Federal Audit Office as the person in charge of the economic efficiency of administration, issued by the president of the Federal Audit Office, Stuttgart, Berlin, Cologne, Kohlhammer, 2001. ad hoc commission "Neuordnung der Verfahren und Strukturen zur Risikobewertung und Standardsetzung im gesundheitlichen Umweltschutz der Bundesrepublik Deutschland", final report by the risk commission on behalf of the Federal Ministries for Health and Social Security and Environment, Nature Conservation and Nuclear Safety, Limbach Druck- und Verlag GmbH, Juni 2003. Note: The guidance documents compiled up to present are available on the BVL's website.