ARTICLE
10 February 2022

The Federal Court Of Appeal Has Weighed In On Re-Evaluation Decisions Made By The Pest Management Regulatory Agency

BJ
Bennett Jones LLP

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The Federal Court of Appeal in Canada released its first ever judgment involving the review of a decision by the Pest Management Regulatory Agency (the PMRA)...
Canada Food, Drugs, Healthcare, Life Sciences
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The Federal Court of Appeal in Canada released its first ever judgment involving the review of a decision by the Pest Management Regulatory Agency (the PMRA), allowing the judicial review appeal, returning the issue to the PMRA for reconsideration and directing the PMRA to clearly state how it interprets certain key sections of its home statute, the Pest Control Products Act, SC 2002, c 28 (the Act). This will be of significant assistance to those companies, consultants and counsel working in the industry.  

The case of Safe Food Matters Inc. v Canada (Attorney General), 2022 FCA 19 involved an appeal of a dismissal by the Federal Court of a judicial review application filed by Safe Food Matters Inc. (Safe Food). The judicial review request concerned the PMRA's decision not to establish a review panel, following the filing by Safe Food of a notice of objection (the NOO) in relation to the PMRA's re-evaluation decision to permit glyphosate to continue to be registered for use in Canada.  

Background 

The PMRA, a branch of Health Canada and an agent of the Minister of Health, is responsible for regulating pesticides in accordance with the Act. Glyphosate, the active ingredient in many herbicides, has been continuously registered for use in Canada since 1976.   

In accordance with its authority under the Act, in 2009, the PMRA initiated a post-market review of glyphosate through the re-evaluation process. In 2015, it released its proposed re-evaluation decision and invited the public to participate in the consultation process. Safe Food offered comments during this process. 

In 2017, the PMRA released its final re-evaluation decision, concluding that it was acceptable to continue the registration of glyphosate products for use in Canada. Under section 35(1) of the Act, any person is entitled to object to a re-evaluation decision issued by the PMRA by filing a notice of objection within 60 days of the decision date. Safe Food filed a NOO, citing nine objections to the PMRA's conclusions that, in its view, raised "scientifically founded doubt" about the validity of the PMRA's evaluations concerning glyphosate products. It hoped the PMRA would exercise its statutory discretion to appoint a review panel in accordance with subsection 35(3) of the Act and section four of the Review Panel Regulations (the Regulations) to consider the objections, with a view to confirming, reversing or varying the re-evaluation decision.

In determining whether to establish a review panel, the PMRA is directed by subsections 3(a) and (b) of the Regulations to consider two factors. The first factor addresses whether the information in the NOO raises "scientifically founded doubt" as to (i) the validity of the PMRA's evaluations of the health and environmental risks; and (ii) the value of the pest control product. The second factor considers whether the advice of expert scientists would assist in addressing the subject matter of the objection. Where the PMRA decides not to establish a panel, section 35(5) of the Act requires the PMRA to provide written reasons. In January 2019, the PMRA provided its reasons for not establishing a review panel, claiming that the NOO did not satisfy the two required factors. Safe Food sought judicial review of the PMRA's decision. 

The Lower Court Decision

In February 2020, the Federal Court dismissed Safe Food's application, concluding that the PMRA's decision was reasonable as the objections within the NOO did not raise scientifically founded doubt about the PMRA's risk evaluations. Since there had been no prior jurisprudence on the issue, the lower court took the opportunity to interpret the term "scientifically founded doubt," holding that this "must be demonstrated by at least one controlled peer reviewed study published in a reputable journal that contradicts or raises a reasonable doubt about the Evaluations' conclusions" (McDonald v Canada (Attorney General), 2020 FC 242 at para 19). Safe Food appealed this decision to the Federal Court of Appeal. 

The Court of Appeal Decision

The Federal Court of Appeal began with an analysis of the appropriate standard of review, noting that, for an appeal from a judicial review decision, it was required to step into the shoes of the lower court and determine whether the PMRA's decision was reasonable (in accordance with Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 [Vavilov]). Thus, as long as the PMRA's interpretation of the Act and Regulations is reasonable, and the reasons it provides for its decision are justifiable, clear and intelligible, the PMRA is to be given deference and the court should not interfere with its decision. 

In deciding that the PMRA's decision was not reasonable, the court cited two main reasons. First, it focused on the PMRA's lack of legislative interpretation. In its written reasons in response to the NOO, the PMRA did not explicitly or implicitly consider the text, purpose or context of section 35 of the Act or section 3 of the Regulations. Specifically, the court stated that, among other gaps in the PMRA's interpretative analysis, the PMRA did not justify the decision by looking to the preamble of the Act, did not consider the primary objective of the legislation, did not explain the meaning of "scientifically founded doubt" and did not address the factor in section 3(b) of the Regulations that assesses the need for expert scientist assistance. The Federal Court of Appeal emphasized that the Act and both mandatory factors within section three of the Regulations must be considered. The court concluded that, because of the lack of legislative interpretation within the PMRA's written reasons, it was unclear why the PMRA decided that the objections in the NOO did not satisfy the required factors. 

The Federal Court of Appeal went on to consider whether the record or written reasons could assist in understanding the basis for the PMRA's decision. The court ultimately found that the PMRA's references to scientifically founded doubts and concerns within the record could not clearly be interpreted as a thorough evaluation of the two factors in section three of the Regulations. In concluding that the PMRA's decision was unreasonable on this second branch of reasoning, the court emphasized that the PMRA did not meet the standard of justification, transparency and intelligibility required of decision makers (Vavilov at para 99).

The Federal Court of Appeal specifically rejected the attempt by the lower court to give meaning to "scientifically founded doubt," indicating that the interpretation of this phrase was for the PMRA to clarify, not the court. 

In granting Safe Food's application for judicial review, the Federal Court of Appeal quashed the PMRA's decision not to establish a review panel and sent it back to the PMRA for redetermination. Notably, the court offered some guidance to the PMRA to assist in its reconsideration and how to communicate that decision, including to have regard to: 

  • the specific text, context and purpose of the preamble of the Act;
  • the definitions of "health risk" and "acceptable risks" in subsections 2(1) and 2(2) of the Act;
  • consideration of the primary objective of the Act set out in subsection 4(1) of the Act; 
  • the meaning of "a scientifically based approach" when the PMRA undertakes a reevaluation of a pest control product as set out in subsection 19(2) of the Act;
  • the specific role of the PMRA and its tasks to perform when it undertakes a review of a notice of objection pursuant to subsection 35(3) of the Act;
  • the specific role and purpose of a review panel, in contrast to the role and purpose of the PMRA, when it receives a notice of objection under subsection 35(1) of the Act;
  • the specific threshold to be met when assessing "scientifically founded doubt" pursuant to the factors set out in section three of the Regulations; and
  • the criteria that would determine whether the advice of expert scientists would assist in addressing the subject matter of the notice of objection under section three of the Regulations.

Once this analysis has been undertaken, the court stated that the PMRA should then explain why it has made the decision it has, based on the interpretation of the legislation it has reached and the facts it has found. 

Takeaways

This case represents the first time the Federal Court of Appeal has reviewed a PMRA decision. This case gives key guidance to the PMRA in terms of its decision making process when determining whether to establish a review panel in the face of a notice of objection filed in response to a re-evaluation decision. Beyond solely considering the PMRA's decision, the case reaffirms that the courts are not the proper place for the PMRA's scientific decisions to be challenged. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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