A Cause of Action for Regulatory Negligence? The Regulatory Framework for GM Crops in Canada and the Potential for Regulator Liability Thomas Moran, Nola M. Ries and David Castle
The Research Question Fact: Debate continues about the human health and environmental safety of GM in Canada and abroad Fact: Canada has not enacted statutory compensation regimes, so harms from GM use must be assessed through the common law of torts Fact: Focus has been on producer/user liability (eg Prodigene, Starlink, Bayer s LRICE601) Fact: Regulator responsibility and liability for GM approval has not received much attention Question: Can a government agency in Canada be found liable for negligent regulation with respect to the approval of GM crops?
Two Other Important Facts Canada is a common law jurisdiction in which the idea of Crown immunity has long been abandoned The often distant relationship between a The often distant relationship between a regulator and individuals or groups means a private law duty of care is often difficult to establish
Canadian Regulatory Framework for GM Canadian Food Inspection Agency Seeds Act Fertilizers Act Feeds Act Heath of Animals Act Health Canada Food and Drugs Act Environment Canada Canadian Environmental Protection Act Product based regulation Seeds Regulation Plant with novel traits (PNT) is the regulatory trigger Substantial equivalence
Seeds Regulation Part V novel trait, in respect of seed, means a characteristic of the seed that (a) has been intentionally selected, created or introduced into a distinct, stable population of cultivated seed of the same species through a specific genetic change, and (b) based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.
Substantial Equivalence Ambiguity The decision threshold approach: a PNT is SE relative to conventional comparator in all respects except the novel trait The safety standard approach: a PNT is SE if it poses no more health or environmental risks than its conventional counterpart Government uses the decision threshold approach to make decisions but communicates those decisions using the safety standard approach The two approaches imply different scientific standards; there is a lack of transparency about how actual decisions are made Government promotes and regulates agricultural biotechnology
The Two Part Anns Test First one has to ask whether, as between the alleged wrongdoer and the person who has suffered damage there is a sufficient relationship of proximity or neighbourhood such that, in the reasonable contemplation of the former, carelessness on his part may be likely to cause damage to the latter in which case a prima facie duty of care arises. Secondly, if the first question is answered affirmatively, it is necessary to consider whether there are any considerations which ought to negative, or to reduce or limit the scope of the duty or the class of person to whom it is owed or the damages to which a breach of it may give rise... Anns v. Merton London Borough Council, [1978] A.C. 728 (H.L.) at 751-752
Supreme Court of Canada s Use of Anns [a]t the first stage of the Anns test, two questions arise: (1) was the harm that occurred the reasonably foreseeable consequence of the defendant's act? and (2) are there reasons, notwithstanding the proximity between the parties established in the first part of this test, that tort liability should not be recognized here? Cooper v. Hobart, 2001 SCC 79, [2001] 3 S.C.R. 537 [Cooper] at para 30
A Challenge from an Organic Producer To whom is a duty owed? CFIA does not regulate for any specific individual or group Failure to act in compliance with the governing statute One court decision concluded that a breach of statutory duty should not give rise to liability in negligence (but may be actionable on public law grounds) Failure to regulate in a particular manner Risk determination is part government policy, part regulatory operational activity (substantial equivalence) Transparency in Regulation Ambiguity about decisions raised by AG s report in 2004; caseby-case PNT regulation chaotic for producers wanting frameworks
Conclusions Ambiguities and shortcomings in GMO regulations exist, but have not resulted in Canadian legal cases Those who wish to assert regulatory negligence against the CFIA face significant legal barriers The Anns test limits regulatory liability because the relationship between the regulator and the aggrieved is generally too remote to evoke a private law duty of care Policy considerations limit the extension of private law obligations to government actors like the CFIA The distinction between government policy and operational activities protect the government
Acknowledgements Stuart Smyth, University of Saskatchewan