Probing the scientific evidence base of the Plant Protection Regulation

Abstract

The appeal taken by Bayer CropScience AG in Bayer CropScience AG v European Commission ¹ probes the precautionary decision-making procedure employed in the regulation of pesticides in the European Union. Scientific data has a central role in the procedure. The decision of the Court of Justice suggests that an expansive approach to the source and type of scientific data is appropriate. Such a broad approach, however, can result in uncertainty with regards to the data to be relied upon and also raises questions over how such broad parameters can be translated into a practical and applied methodology to pesticide management.

Background to the case

In August 2013, the General Court of the European Union (General Court) rejected all claims made by Bayer CropScience AG (Bayer) and Syngenta Crop Protection AG (Syngenta) in their case ² against the European Commission seeking to annul Regulation (EU) No 485/2013 ³ (the Contested Regulation). The Contested Regulation lays down strict conditions regarding the approval of the active substances, clothianidin, thiamethoxam and imidacloprid; neonicotinoids, used in plant protection products, otherwise known as pesticides. Bayer appealed this decision in relation to the substances it produces and markets, clothianidin and imidacloprid, ⁴ and in May 2021, the Court of Justice (CJ) dismissed Bayer's appeal on all grounds.

Clothianidin and imidacloprid (the Active Substances), are part of the neonicotinoid family of insecticides (NNIs). NNIs are systemic pesticides. They migrate to all parts of a plant and so are highly effective in protecting against attack by insects. ⁵ Studies indicate, however, that these pesticides cause acute and chronic toxicity to bees and other non-target organisms. ⁶ In response to incidents involving the accidental release of such pesticides, resulting in losses to honeybee colonies, the Commission adopted legislation strengthening the process of approval for certain NNIs, including the Active Substances. ⁷ The specific conditions were contained in Directive 91/414, ⁸ which was the first EU directive to regulate the use of pesticides. This Directive was subsequently repealed and replaced by Regulation 1107/2009 ⁹ (the Plant Protection Regulation), which now regulates the approval and use of pesticides in the EU.

In support of the action seeking to annul the Contested Regulation, Bayer raised complaints relating to the Plant Protection Regulation, specifically the procedure set down for reviewing the approval of substances. ¹⁰

The Bayer cases are interesting as since the legal proceedings were first brought, more restrictive rules on the use of the Active Substances have been adopted by the Commission. ¹¹ Currently all outdoor uses of these substances are banned. Therefore, even if Bayer was successful in its appeal, it would still not be able to market the substances for use other than within a permanent greenhouse. Bayer's focus, in taking the appeal, was not on securing approval for the Active Substances. In taking the appeal, Bayer was probing the review and amendment procedure for approved substances under the Plant Protection Regulation. Bayer challenged how the Commission uses scientific data in the application of the procedure. Specifically, Bayer contested the strength of the scientific evidence put forward by the Commission, arguing that the evidence presented and used to inform its decision to amend approval was inadequate. In challenging the sufficiency of the data, Bayer was seeking clarity on the type and extent of evidence required to inform the review process. The Plant Protection Regulation is based on the precautionary principle, ¹² therefore this challenge also impacts on how scientific data is used in the application of the principle.

The basis of the appeal follows a long line of European caselaw probing the substance of the approval procedure under the Plant Protection Regulation. In its review of the Regulation, the Court of Justice of the European Union (CJEU or Court) ordinarily defers to the discretion of the legislature, ¹³ due to the complex nature of pesticide regulation. In decisions concerning the Regulation, the scope of judicial review takes an abstract form, focussing on the procedural standard of whether there has been a manifest error of assessment. ¹⁴ Bayer was again attempting to induce the Court to adjudicate on the evidentiary basis of the approval process, and the precautionary threshold by which approval is granted or denied. The Court rejected Bayer's attempt to draw it into a debate on the elements of approval, adopting its established broad interpretation of the Regulation.

Bayer's challenge goes to the heart of the scientific evidence base of the Plant Protection Regulation and the precautionary principle. If Bayer had been successful in its appeal, and the Court had adjudicated on the substance of the approval process, this would open the way for a review of the scientific evidentiary base underpinning pesticide regulation, questioning the protocols of the Commission and European Food Safety Authority (EFSA), as the risk assessment body. A more prescriptive approach to the review procedure would allow Bayer and other producers predict with greater certainty the data that can be consulted during the review of an active substance, how the data is scrutinised, and the outcome of such a review. Such an approach would place greater constraints on the Commission's decision-making power in this area, restricting its discretion.

In permitting the procedure to be questioned, it would provide pesticide producers with an opportunity to challenge the nature and basis of pesticide regulation in the EU. This would possibly be of benefit to the producers, as the European pesticide regulatory system is considered to be one of the most stringent in the world. ¹⁵ It is also possible, however, that in opening this area up to review, the Court may adopt a more restrictive approach to pesticide regulation. Greater evidentiary requirements could be placed on pesticide producers and the threshold for approval raised. ¹⁶ The Plant Protection Regulation provides an avenue for the Court to interpret the provisions of the precautionary principle in a strict manner. ¹⁷ The wording of Article 4(2) of the Regulation implies that the Commission may only approve an active substance if it is satisfied that there will be no harmful effects. If a strict reading of this provision was applied, it would require an authorisation to be refused if there was reasonable scientific doubt that there would be no negative effects. ¹⁸

To date, the Court has not elaborated on the substance of the scientific evidentiary requirements of the Plant Protection Regulation. There is no guarantee that a successful challenge to the approval process would result in a more favourable outcome for pesticide producers. It appears, however, that this is a risk producers are willing to take. It is unlikely that we will see a reduction in the appetite for challenge in this area in the future.

Key elements of the judgment

Bayer raised six grounds of appeal, concerning errors of law relating to the application of the review approval procedure under Article 21(1) and (3) of the Pesticide Regulation. It alleged that the Commission reviewed and amended the approval of the Active Substances in the absence of adequate scientific knowledge, compared to the initial review procedure; it called for a more in-depth scientific risk assessment based on specific guidance; and objected to the conditions for use of the Active Substances in private gardens. The CJ rejected all grounds of appeal, disagreeing with Advocate General Kokott on two points. ¹⁹ This case note will deal with elements of the decision as they apply to the scientific evidentiary base of the review approval procedure.

Commentary

Scientific evidence base – evolving nature of science

One of Bayer's primary grounds of appeal centred on a dispute as to what guidelines should have been followed when carrying out the review of the Active Substances. ²⁰ The Advocate General concluded that, as the General Court didn't examine whether adequate consideration was given to the guidelines in place at the time of the review, there was an error of law. ²¹ The CJ took a different approach, however. It took the focus off the use of guidelines and placed it on the existence of new scientific and technical knowledge, basing its reasoning on the text of the Regulation. ²² It considered that a decision on whether approval criteria are still met ²³ may be “based on any new knowledge, in so far as it is scientific or technical” regardless of the source. ²⁴ This removed the link between the risk assessment and a set of guidelines. It placed the requirement for information on the evolving state of scientific knowledge.

This conclusion reflects the true nature of scientific research, which is in an ever-changing state. As soon as guidelines are adopted, it is likely that scientific knowledge will advance and supersede the content of the guidelines. The approach adopted by the Court reflects the line of reasoning established by the CJEU when discussing the scientific element of the precautionary principle. Many judgments refer to making decisions in light of the ‘best scientific information available’ or the ‘most reliable scientific data available.’ ²⁵ The reference in the Bayer appeal to consulting any new knowledge ‘in so far as it is scientific or technical’ possibly represents a more expansive interpretation of the scientific evidentiary base. The only limitations are that the data should be new and linked to science and technology.

There is an argument to be made that referring to the ‘best scientific information available’ ²⁶ or to any new knowledge ‘in so far as it is scientific or technical’ is a vague concept and brings no clarity to the type of evidence that should be consulted in the decision-making procedure. The lack of a definitive approach, however, gives flexibility to the Commission. In deciding the best precautionary measures or when carrying out the review procedure, the Commission and EFSA have the discretion to decide what evidence should be consulted. This places the focus on the approval process and protocols adopted by the Commission and EFSA, and is indicative of the deferential approach to precautionary decision-making that the Court often adopts in areas deemed to be complex. ²⁷

In permitting a wide evidentiary base, the knowledge that should be used and is considered relevant for the purposes of the approval review procedure is a central consideration. The protocol for the scientific review of pesticides is prescribed in detail by the Plant Protection Regulation and EFSA guidance documents. The scientific evidence relied upon, however, does not always conform to regulatory standards. It can be undermined by issues such as misconduct or the selective use of data. ²⁸ The structure and mandate of EFSA itself has also been criticised as being subjective and possibly value laden. ²⁹ The use of peer reviewed articles is a common and central tool used to establish the quality and reliability of scientific information. The Plant Protection Regulation specifies that EFSA is to determine the scientific peer-reviewed literature to be submitted with the initial approval dossier ³⁰ and EFSA has published supporting guidelines in this regard. ³¹ This ensures, as far as possible, that the data meet current methodological and technological standards. While such an approach attempts to define the parameters of the scientific evidence base, it is not infallible. Basing the decision on whether to approve a substance or not on peer review places reliance on the peer review process and not on broader scientific standards or methodology. ³² Professional and funding pressures demand an increased publication output from scientists. Publications are required in order to advance professionally and also to secure funding. ³³ This means that the quality of output is not always of an adequate standard. Further there are inherent biases in the peer review process which may affect the quality of the research published. ³⁴

Establishing such broad parameters may also feed into weakening the approval procedure, and the application of the precautionary principle, on which the Regulation is based. The absence of clear evidentiary parameters leaves an avenue for precautionary decisions to be taken on a weaker evidentiary basis, based on trust rather than explicit solid evidence. ³⁵

While there is an argument that a broad approach brings no clarity to the type of science that should be consulted in the approval review procedure under the Plant Protection Regulation or in the application of the precautionary principle, viewed in terms of scientific evidence, an expansive approach may have a positive impact on the outcome of a scientific evaluation. Minority science, dissenting science and studies on emerging risks are not readily accepted in mainstream scientific publications, therefore they would not readily fall within the categories of the ‘best scientific information available’ or ‘most recent results’. Such studies, however, would be captured by a phrase such as ‘new scientific and technical knowledge’. Minority and dissenting science act as an early warning system for human and environmental risks. ³⁶ Minority science is, by its nature, viewed with scepticism. Meticulous methodology and quality assurance may further denigrate its standing as it may not withstand harsh critique and comparisons with established methodologies and norms of science. ³⁷ Referring to new scientific and technical knowledge is a more encompassing approach to scientific evidence, potentially supporting the use of minority and dissenting views. Whether minority and contradictory science are incorporated into the review procedure, however, depends on the protocols adopted by the Commission and EFSA. ³⁸ This again places the emphasis on the guidance underpinning the regulatory system, and how the Commission and EFSA handle such evidence.

Scientific evidence base – uncertainty and scientific data

In terms of the approval review procedure under the Plant Protection Regulation, arguably, the CJ has captured the fundamental nature of the scientific paradigm. From a producer point of view, however, this approach may lead to uncertainty as to what evidence should and can be referred to in the procedure, which leads to uncertainty in the outcome of the procedure. An element of Bayer's first ground of appeal concerned the principle of legal certainty. Bayer argued that the review of an approval is justified only if the state of scientific and technical knowledge changes. ³⁹ The CJ considered that the General Court wrongly held that new scientific knowledge was needed to permit the Commission to review the approval of an active substance. ⁴⁰ The Commission may initiate a review at any time. ⁴¹ In her opinion, Advocate General Kokott separated out the initiation of a review, from the approval review process, noting that the principle of legal certainty ⁴² is applicable in the decision to amend or withdraw an approval, but it is not applicable in the decision to initiate a review. ⁴³ In order to withdraw an approval there must be a changed factual situation. ⁴⁴ This means that the Commission can initiate a review at will, but in order to substantiate the outcome of the review, new evidence must exist indicating that the substance no longer satisfies the approval criteria. ⁴⁵

If the review process can be instigated as required by the Commission and the decision-making process is based on current scientific knowledge rather than a standard set of guidelines, it may be difficult for producers of active substances to be able to predict when a review may be undertaken and the outcome of the review, leading to uncertainty. This uncertainty is linked to the nature of scientific evidence however, not to the decision-making process. The decision-making process remains static and is delimited by the existence of new evidence.

Uncertainty is inherent in science, ⁴⁶ and there is an element of uncertainty in all aspects of scientific research. It is an innate limitation in scientific knowledge. ⁴⁷ As scientific knowledge develops, methodologies and conclusions are updated. The precautionary principle is one of a range of tools designed to manage scientific uncertainty in policy and law-making. ⁴⁸ The principle was envisaged as a temporary means of progressing regulatory action in the face of scientific uncertainty. Precautionary measures are to be modified in light of new scientific findings. ⁴⁹ By clarifying that the review process hinges on the existence of new scientific data, the court is emphasising the temporary nature of an authorisation. It is also highlighting the uncertain and progressive nature of scientific knowledge. Any authorisation is subject to the evolution of scientific data. Commentators argue that the requirement for precautionary measures to be subject to review is unworkable. ⁵⁰ A systematic review process can lead to greater scientific uncertainty, and potentially issues with retrospective evaluations resulting in blame being placed on a regulator for an incorrect decision. ⁵¹ The review procedure is an essential feature of pesticide regulation, however, tracking the evolving nature of research into pesticides and their active substances. The procedure has been incorporated into the legislation, permitting the Commission to review the approval of an active substance at any time. ⁵²

The Court's approach reinforces the link between the Plant Protection Regulation and the precautionary principle, on which the Regulation is based. In separating out the initiation of the review from the review approval process, the Court is giving the discretion to the Commission to instigate a review but setting precautionary limits on the review process.

Scientific evidence base – risk assessment and risk management

The Contested Regulation prohibits the Active Substances from being applied to leaves and being used in a private setting. Bayer claimed that the Commission failed to carry out a scientific assessment of the available data when deciding to impose such prohibitions. In relation to the non-professional use, the Advocate General agreed and found that there was a failure on the part of the Commission to carry out an assessment of the available scientific data or to assess the data presented by Bayer. ⁵³ The CJ, however, didn't agree with this point. ⁵⁴ The CJ did not find that the General Court committed an error of law. It found, based on the fact that there are no controls for private users and the high degree of toxicity of the substances, that the General Court was correct in concluding that the ban on the non-professional use was justified and not manifestly inappropriate. ⁵⁵

While the Commission has wide discretion with regard to complex scientific assessments, ⁵⁶ it is arguable that, in this case, the Commission did not fulfil the scientific evidentiary requirements of the Regulation, nor of the precautionary principle. It did not give sufficient consideration to the scientific data in its decision to ban the non-professional use of the substances. The Commission's decision was based on conjecture, which is alluded to by the Advocate General. ⁵⁷ The CJ agreed with the General Court, however, noting that as private users were not subject to any controls, they would more likely fail to comply with instructions for use. ⁵⁸ This claim doesn't appear to be substantiated by any evidence proffered. The CJ also referred to the high degree of toxicity of the substances, ⁵⁹ which while relevant for introducing conditions of use, isn't an adequate reason, without further elaboration, to ban the use of the substances.

The data presented to the General Court by both the Commission and Bayer was inadequate and failed to prove to what extent a private individual would use the substances inappropriately. ⁶⁰ Therefore, neither party justified its position. The data was not uncertain, it was incomplete. While the Commission is permitted to act in a precautionary manner in the face of uncertain data, which can include incomplete data due to resource issues, ⁶¹ in this instance further data could have been sourced.

This indicates that a decision was taken by the Commission without adequate supporting scientific evidence, and this was upheld by the court. Supporting scientific evidence is a core requirement of the Plant Protection Regulation and also of the precautionary principle. The CJ, by finding in favour of the precautionary measures imposed by the Commission is implicitly accepting the reasoning of the Commission without an adequate scientific basis. It indicates that the Commission is making a decision on scientific uncertainty in the absence of a scientific evaluation, which is deemed to be a central element of precautionary decision-making. ⁶²

While the Commission does have discretion in this area, this action relegates the role of scientific evidence in the application of the Regulation and the precautionary principle to a secondary consideration. The precautionary principle governs legitimate regulatory action in circumstances of scientific uncertainty. ⁶³ A decision made in the absence of a factual basis runs the risk of contravening the rule of law. ⁶⁴ It is arguable that the action of the Commission, in banning the private use of the Active Substances without fully reviewing the scientific evidence, was not following legitimate precautionary decision-making.

Other grounds of appeal

The Bayer appeal also challenged the interpretation of the precautionary principle by the Commission, on the basis that a provisional risk assessment only was carried out by EFSA, and that Bayer was not asked to submit updated information as part of the assessment. The Court also dismissed these elements of the appeal, reiterating a fundamental premise of the principle; that a decision-making body is not required to delay a risk assessment indefinitely until new studies appear, and that an exhaustive risk assessment is not required. ⁶⁵ How the General Court interpreted the Commission's approach to the impact assessment was also challenged, with the CJ again dismissing this complaint, agreeing with the General Court's reference to the discretion of the Commission in complex areas. ⁶⁶

Conclusion

While the decision of the CJ has not provided clarity to producers of active substances as to the specific scientific data that is required to be consulted in the review procedure under the Plant Protection Regulation, arguably, the Court's decision reflects the scientific element of the precautionary principle and the dynamic nature of scientific knowledge. The CJ followed the established judicial approach in the area of pesticide regulation, adopting a broad interpretation of the procedure rather than a substantive review of the elements of the approval process, leaving the discretion to the Commission and EFSA.

The CJ was consistent in its interpretation of elements of the principle, on which the Regulation is based, placing importance on the use of current data and by using a broad scientific or technical knowledge source. The CJ adopted an expansive approach to the type of scientific data to be used in the review process, following the wording of the Regulation. The expansive approach is to be welcomed. If managed correctly, such an approach fosters a more encompassing scientific process and encourages the creation of a solid scientific foundation on which to base decisions.

Adopting such an expansive attitude to scientific data, however, may lead to an abstract and indeterminate evidence base. As the Court is not engaging in a substantive debate on pesticide regulation, this leaves an important role to bodies such as EFSA, who have a responsibility to translate evidentiary parameters into practical and methodological guidelines. This will assist in clarifying the functional parameters of the Plant Protection Regulation and the precautionary principle, which underpins its regulatory actions. As indicated, the methodologies developed by EFSA often have their own shortcomings. If the Court adopts a more stringent approach to pesticide regulation, ⁶⁷ the Commission or EFSA may be held accountable for the choices made. As it is unlikely that the appetite for challenge in this area will cease, this places the methodologies and procedures underlying the Plant Protection Regulation into focus.