Chiltern Farm Chemicals Ltd, R (on the application of) v The Health and Safety Executive

Article 62 of Regulation 1107/2009 is an exception to the general protection given to test and study reports, so it must be interpreted strictly. A field-monitoring exercise is nevertheless a vertebrate study where it is conducted as a scientific study to assess the risk of a product to birds and may cause them distress, suffering or lasting harm. The fact that the product is already authorised, that its ordinary use resembles standard agricultural practice, or that actual harm was not shown does not prevent the study from falling within Article 62. The relevant question is whether the exercise amounts to an experimental or other scientific procedure within the applicable animal-protection framework. A decision applying that construction will not be irrational merely because the study also resembles ordinary agricultural practice.

Chiltern Farm Chemicals Ltd sought judicial review of the Health and Safety Executive’s decision that a bird field-monitoring study concerning metaldehyde slug pellets was a vertebrate study subject to the data-sharing provisions of Article 62 of Regulation 1107/2009.

The study involved applying standard slug pellets to agricultural fields and monitoring free-living birds, including by mist-netting, ringing and radio-tagging. The claimant argued that the exercise was harmless monitoring of ordinary agricultural practice and was outside the concepts of an experiment and regulated procedure. The defendant relied on the study’s purpose, namely assessing possible risks to birds from the pellets and contaminated invertebrates. The central issue was whether the study fell within Article 62 when read with the applicable animal-protection legislation and guidance.

1. The claim was dismissed. The court upheld the decision that the Prosser Study was a vertebrate study subject to the data-sharing provisions of Article 62 of Regulation 1107/2009.
2. Article 59 establishes the general principle of data protection for test and study reports. Article 62 is an exception to, and derogation from, that principle. It therefore required strict interpretation.
3. The parties accepted that the study fell within Article 62 only if it constituted a regulated procedure under the Animals (Scientific Procedures) Act 1986 and an experiment under the applicable 1986 Directive. The concepts of application and use of animals could not be given a different meaning merely because the product was an established formulation rather than a new one.
4. Although the application of slug pellets could resemble standard agricultural practice, the pellets were distributed on the particular fields and dates for the scientific purpose of assessing their effects on birds. The recognised agricultural-practice exclusion did not apply where the practice formed part of a scientific study.
5. The relevant risk was the possible distress, suffering or lasting harm to birds. It was unnecessary to establish that actual distress or harm had occurred. The study’s stated purpose acknowledged that such risks might exist, and the applicable framework extended to procedures that might cause the relevant effects.
6. The defendant was entitled to conclude that the study was a scientific study of birds and that its purpose was to determine whether metaldehyde killed birds or caused clinical or behavioural effects. That conclusion was neither unlawful nor irrational. The apparent inconsistency with earlier guidance did not alter the proper construction of Article 62.
7. The court noted, but did not rely on, the view apparently reached by Austria that materially similar studies were vertebrate studies.