Docket: T-169-23
Citation: 2025 FC 300
Vancouver, British Columbia, February 18, 2025
PRESENT: The Honourable Mr. Justice Zinn
BETWEEN: |
FRIENDS OF THE EARTH CANADA, DAVID SUZUKI FOUNDATION, SAFE FOOD MATTERS INC, AND ENVIRONMENTAL DEFENCE CANADA INC |
Applicants |
and |
ATTORNEY GENERAL OF CANADA, MINISTER OF HEALTH, AND LOVELAND PRODUCTS CANADA INC |
Respondents |
JUDGMENT AND REASONS
[1] This application is for judicial review of the decision by the Pest Management Regulatory Agency [PMRA or Agency] to renew the registration of Mad Dog Plus, a glyphosate-based pesticide, for a five-year term pursuant to section 13 of the Pest Control Products Regulations, SOR/2006-124 [Regulations]. The Applicants, Friends of the Earth Canada, David Suzuki Foundation, Safe Food Matters Inc., and Environmental Defence Canada Inc., challenge the renewal decision on the basis that PMRA relied on dated risk assessments without properly considering new scientific evidence they submitted.
[2] The Applicants are charitable, non-governmental organizations dedicated to protecting human health and the environment in Canada from pesticide risks. They meet the criteria for public interest standing necessary to bring this application for judicial review.
[3] The Respondent, the Attorney General of Canada, represents the Minister of Health [Minister], who oversees the PMRA. As a branch of Health Canada, the PMRA is responsible for registering and renewing pest control products in Canada under the Regulations and Pest Control Products Act, SC 2002, c 28 [Act]. Its mandate is to regulate pest control products in a way that safeguards the health and safety of Canadians.
[4] The Respondent Loveland Products Canada Inc. [Loveland] is the registrant of the pesticide Mad Dog Plus, which is registered for various agricultural and non-agricultural uses.
[5] Glyphosate has been registered for use in Canada since the 1970s. It is the most heavily used pesticide active ingredient in Canada today, according to PMRA sales reports. Currently, there are over 169 registered pest control products containing glyphosate in Canada, authorized for various agricultural and non-agricultural uses.
[6] In 2015, the World Health Organization’s International Agency for Research on Cancer [IARC] classified glyphosate and glyphosate end-use products as “probably carcinogenic.”
Between 2004 and 2017, PMRA conducted a re-evaluation of glyphosate’s health and environmental risks under sections 17-21 of the Act. The Agency completed its analysis in 2015 and issued a proposed re-evaluation decision for public consultation on April 13, 2015. Following this consultation, the PMRA issued its final re-evaluation decision in 2017, concluding that glyphosate posed acceptable health and environmental risks and, contrary to the IARC’s findings, was not carcinogenic. This decision allowed the continued registration of glyphosate products in Canada. The PMRA has repeated on several occasions that the re‑evaluation considered both the active ingredient and formulated products, and it is based on reviews of hundreds of scientific documents, including information submitted by registrants and findings from scientific literature.
[7] Some of the Applicants have actively engaged with PMRA’s glyphosate assessments. They participated in public consultations for re-evaluations, filed notices of objection to PMRA’s 2017 re-evaluation decision, and followed through with litigation in the Federal Courts.
[8] On October 27, 2022, the Applicants sent a letter to PMRA, urging the Agency to suspend all renewals of glyphosate products until it has assessed the risks of glyphosate using updated science. The Applicants attached 61 new scientific studies identifying new or increased risks associated with glyphosate-based pesticides discovered since the 2017 re-evaluation. These risks included findings of increased toxicity in formulated products compared to glyphosate alone, potential hazards to human health through microbiome effects, evidence of neurodegenerative and reproductive toxicity, environmental risks to freshwater habitats, indications that glyphosate exacerbates wildfire risks, and additional ecological risks to wild pollinators.
[9] On August 8, 2022, Loveland applied to renew the registration of Mad Dog Plus. The PMRA did not require, and Loveland did not submit, any new data in support of the renewal. On December 28, 2022, PMRA renewed Loveland’s registration for another five years.
[10] The PMRA responded to the Applicants’ letter in February 2023, after this application for judicial review was filed. The Agency’s response was that it was “aware of the scientific publications.”
It did not discuss any of the 61 studies or explain whether or how PMRA used this evidence to assess risks associated with Mad Dog Plus. It further reiterated that PMRA’s assessment of the health and environmental risks of glyphosate is consistent with other international regulators and supported by the Incident Reporting Program.
[11] The Applicants sought production of PMRA’s underlying assessments of the 61 new scientific studies through correspondence with counsel and a Rule 317 motion before this Court. Justice Fothergill granted that motion, specifically noting that the Court could not engage in meaningful judicial review without understanding PMRA’s rationale: Friends of the Earth Canada v. Canada (Attorney General), 2023 FC 1438 at para 20. In response to this production order, the Agency confirmed it had no documents “specifically prepared”
regarding the renewal of Mad Dog Plus that addressed the 61 scientific publications. No further information was provided, and the Minister of Health did not submit an affidavit or any other explanation clarifying the lack of documented analysis.
[12] The PMRA provided no formal reasons for its December 2022 decision to renew the registration of Mad Dog Plus. However, the record reveals the decision-making process it followed. After Loveland submitted its renewal application in August 2022, the PMRA relied on its 2017 re-evaluation of glyphosate as the primary risk assessment baseline. This evaluation served as the foundation for any updates prompted by new evidence. When the Applicants later submitted their letter presenting new scientific studies alleging increased toxicity and environmental harm associated with glyphosate-based products, the PMRA conducted an internal review, which resulted in four brief memoranda.
[13] Three of these are internal memoranda produced by the Health Evaluation Directorate and Environmental Assessment Directorate. All of them contain near-identical language that acknowledge awareness of the new publications and state, without any elaboration, that the new evidence “does not change the current assessment on file that risks are acceptable when label directions are followed.”
The fourth is a memorandum issued by the Agency’s Incident Reporting Program, which analyzed 84 post-2017 incident reports involving glyphosate. This memorandum similarly concluded that “no serious health concerns or increasing health trends”
had emerged, reaffirming that the PMRA’s prior baseline findings remained unchanged. This memorandum focused exclusively on incident data and provided no evaluation of the 61 scientific studies submitted by the Applicants.
[14] Beyond these four internal documents, the record contains no additional notes or analysis of the 61 articles. Relying on these internal materials, the PMRA renewed Mad Dog Plus for another five-year term. The “Renewal Registration Certificate”
issued by the PMRA is a standardized form that primarily restates details from the application and confirms that the renewal was granted.
[15] The main issue for determination is whether PMRA’s December 2022 decision to renew the registration of Mad Dog Plus is reasonable. Specifically, the focus is on the Agency’s interpretation of statutory provisions governing renewal, its treatment of the new scientific evidence submitted by the Applicants, and the adequacy of its decision-making process as revealed by the record.
[16] Additionally, the parties ask the Court to determine the appropriate remedy, if the decision is found to be unreasonable.
[17] For substantive review, I agree with the parties that PMRA’s renewal decision is reviewable on the standard of reasonableness, as articulated by the Supreme Court of Canada in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 [Vavilov].
[18] When conducting a reasonableness review of decisions involving highly scientific and technical subject matters, courts must pay careful attention to the decision-maker’s expertise: Vavilov at paras 92 and 93. This expertise warrants judicial deference in the assessment of facts: Vavilov at para 125; Safe Food Matters Inc. v Canada (Attorney General), 2023 FC 1471 [Safe Food Matters] at para 121; Dias v Canada (Attorney General), 2018 FCA 126 at para 8. Similarly, deference is warranted in the interpretation of law, particularly when it pertains to the decision-maker’s home statutes: Safe Food Matters at paras 8 and 111; Balogh v Canada (Citizenship and Immigration), 2022 FC 447 at para 18. However, as Vavilov makes clear, deference is contingent on the decision-maker demonstrating its expertise and is not to be presumed: Vavilov at para 93; Mason v Canada (Citizenship and Immigration), 2023 SCC 21 [Mason] at para 70.
[19] Where, as in the present case, there are no formal written reasons, the reviewing court does not have a diminished obligation to conduct a robust reasonableness review, but the analysis necessarily shifts to evaluating the outcome and decision-making process to determine whether they align with the legal and factual constraints on the decision-maker: Vavilov at para 138. The court must adhere to the “reasons first”
approach by examining the record and broader context to discern the decision-maker’s rationale: Vavilov at para 137; Mason at para 69. This requires the court to scrutinize the evidentiary record to reconstruct the reasoning process and ensure that statutory objectives are respected even where the reasoning is implicit. If the record and outcome reveal “dots on the page where the lines, and the direction they are headed, may be readily drawn,”
reviewing courts may connect those lines: Vavilov at para 97, citing Komolafe v Canada (Minister of Citizenship and Immigration), 2013 FC 431 at para 11. However, reviewing courts must not create these dots to fill gaps in the decision-maker’s reasoning, particularly when the gaps involve failures to comply with key statutory mandates or grapple with significant evidentiary submissions: Vavilov at 96.
[20] The same approach applies to the decision-maker’s statutory interpretation. Even absent explicit reasons, courts must still assess whether the interpretation adopted is consistent with the text, context, and purpose of the statutory provision: Vavilov at para 120; Mason at para 69. Regardless of the degree of discretion enjoyed by administrative decision-makers under their enabling statutes, their interpretation and application of statutory requirements must align with the legislative purpose: Forbid Roads Over Green Spaces v Canada (Attorney General), 2023 FC 580 at paras 72-81. Administrative decision-makers in Canada hold no “absolute and untrammelled ‘discretion’”
: Roncarelli v Duplessis, [1959] S.C.R. 121 at page 140. Ultimately, for a decision without formal written reasons to be found reasonable, the decision-making process, reflected in the record and the outcome, must allow the reviewing courts to understand why the decision was made.
[21] The relevant provisions of the Act and Regulations can be grouped into four categories that collectively structure the various risk assessment mechanisms and the renewal process for pesticide registration. The full text of these provisions is appended to these Reasons.
[22] The first category articulates the legislative objective and risk assessment standard. Section 4(1) of the Act establishes the Minister’s primary mandate is to “prevent unacceptable risks to individuals and the environment from the use of pest control products”
when administering the Act. Subsection 2(2) of the Act defines the standard of “acceptable risk”
as requiring “reasonable certainty that no harm to human health, future generations, or the environment will result from exposure to or use of the product.”
[23] The second category establishes a framework for transparency and public accountability, with section 42 of the Act as its cornerstone. This section operationalizes the Act’s commitment to public awareness under paragraph 4(2)(c) by providing a mechanism for scrutinizing the scientific and regulatory rationale behind the PMRA’s decisions. It mandates the establishment and maintenance of a publicly accessible Register of Pest Control Products, which serves as a repository of key information, including applications, registrations, re-evaluations, special reviews, and evaluation reports prepared by the Minister. To facilitate ongoing public oversight, the Register discloses non-confidential data, including active ingredients, registration conditions, and summaries of scientific evaluations, as provided in paragraph 42(2)(f) and subsection 42(4). However, section 42 does not require the creation or publication of new documents for renewal decisions.
[24] The third category contains four mechanisms through which risk assessments of pesticide registration might happen:
1)Initial Registration – When a pesticide is first registered, the Minister must conduct an assessment pursuant to section 7 of the Act to analyze risks to human health and the environment.Subsection 7(7) of the Act specifically requires that this assessment be conducted using a scientific approach.Approved products are then registered with specific conditions under subsection 8(1) of the Act.
2)Re-evaluation – Pursuant to section 16 of the Act, registered products must undergo a re-evaluation within a maximum of 15 years or sooner if warranted.This process involves a reassessment using more current scientific data and methodologies, and it may result in amendments to or cancellations of registrations.
3)Special Review – Under section 17 of the Act, the Minister must trigger a special review “if the Minister has reasonable grounds to believe that the health or environmental risks of the product are, or its value is, unacceptable.”
Such review involves a detailed assessment of emerging risks, such as those indicated by foreign regulatory actions or scientific studies, with potential for consultation and modifications to the product’s registration.
4)Renewal – While paragraph 8(1)(c) of the Act contemplates both finite and indefinite “validity period”
of registration, section 13 of the Regulations imposes a five-year maximum term.The logical result of this is there must be a process for renewal.
[25] The fourth category details the operational framework of the renewal process, which is governed entirely by the Regulations. The primary provision of section 16 establishes the requirements for a renewal application. These include the information outlined in subsection 6(1), such as product composition, hazards, and safe use instructions, as well as a declaration under subsection 6(3) attesting to the accuracy and completeness of the application. Renewal applications must also include information that the Minister may require under section 8, including information on health and environmental risks, product value, and scientific investigations “relevant to the product and its conditions or proposed conditions of registration.”
[26] The parties have advanced a variety of arguments pertaining to the reasonableness of PMRA’s decision. I find they converge to two core disputes. First, whether PMRA reasonably interpreted its statutory obligations under the Act and Regulations when considering renewal applications. Second, whether the PMRA sufficiently and transparently grappled with the Applicants’ submissions, namely the 61 new scientific articles.
[27] The Applicants characterize the PMRA’s interpretation of the legislative framework as one that treats renewal decisions as purely administrative processes that neither consider new scientific evidence on health and environmental risks nor provide explanation of the rationale for its conclusions. According to the Applicants, this interpretation improperly confines substantive risk assessment exclusively to re-evaluation and special review processes.
[28] In opposition to this approach, the Applicants advance what they maintain is the only reasonable interpretation of the statutory and regulatory scheme governing renewal applications. The Applicants’ interpretation builds on three main points.
[29] First, they contend that a combined reading of subsections 2(2), 4(1), 7(1), 8(4), and paragraph 8(1)(c) of the Act creates a clear obligation for the PMRA to ensure that risks remain acceptable before amending any registration term, including through renewal. This obligation, they argue, is further supported by the explicit powers granted under subsection 7(4) of the Act and section 8 and subsection 16(2) of the Regulations, which establish mandatory risk information requirements at the time of renewal.
[30] Second, the Applicants contend that the legislative choice of imposing finite registration periods in section 13 of the Regulations, coupled with substantive information requirements under subsection 16(2), necessarily establishes mandatory checkpoints where substantive risk assessments must occur. They argue that this interpretation is necessary to fulfill the legislation’s goal of protecting Canadians’ health and Canada’s environment, especially given the documented delays in re-evaluation and special review processes that might otherwise leave unacceptable risks unaddressed for prolonged periods.
[31] Third, the Applicants contend that accepting the PMRA’s interpretation would frustrate the protective purposes of the Act and render key provisions ineffective. They argue that the various provisions requiring risk information submissions and ongoing monitoring demonstrate Parliament’s clear intent that renewals should involve substantive reviews incorporating new scientific evidence, rather than serving as mere administrative rubber stamps.
[32] I respectfully disagree with the Applicants’ position. While their interpretation is plausible, it is not the only reasonable one. The PMRA’s approach also falls within the range of reasonable interpretations following the modern principle of statutory interpretation.
[33] To begin, I will describe my understanding of the PMRA’s interpretation of the legislative framework governing renewals based on the materials before me. Although the PMRA has provided no written reasons specific to this renewal, its interpretation of section 8 of the Act and sections 13 and 16 of the Regulations can be inferred from the decision-making process as revealed by the record and the outcome.
[34] In my view, the record indicates that the PMRA views the entire risk assessment and review framework as allowing for varying levels of scrutiny, contingent on the type of decision under the Act and Regulations. For renewal decisions specifically, the PMRA appears to have adopted a more streamlined, less intensive substantive review of risks. Two contextual observations support my characterization. First, the PMRA’s reliance on the 2017 re-evaluation as the more comprehensive assessment suggests that it treats renewals as decisions informed by prior evaluations rather than as similar instances for new, full blown substantive analysis. Second, the PMRA’s engagement with new scientific evidence through brief memoranda that confirm awareness of the information rather than through detailed analyses reflects a more selective and streamlined approach. In my view, these practices suggest the PMRA sees renewals as distinct checkpoints, separate from the more rigorous and substantive risk assessments performed during re-evaluations or special reviews.
[35] My characterization of the PMRA’s approach finds further support in its stakeholder consultations regarding improvements on its risk assessment and product review programs. On June 21, 2022, the PMRA sent an email to the CEO of the Applicant, Friends of the Earth, attaching a PowerPoint document titled Proposed Integrated Approach to Pesticide Evaluation in preparation for a stakeholder consultation meeting the following day. In this document, the Agency describes its vision for an “expanded renewal process as a pulse check and consider information throughout the pesticide lifecycle”
in addition to the usual safeguard of periodic re‑evaluations. The slides acknowledge that full re‑evaluations can be unwieldy, sometimes causing issues with substantive updates, delays, and protracted backlog. By contrast, the desired “expanded renewal process”
allows the PMRA to consider, at more frequent intervals, whether “any emerging risk issues… require review,”
to identify what data might be needed in the future, and to consider taking action, such as initiating a special review, if new evidence raises alarm. While these consultation materials outline proposed future changes and do not, on their own, establish the PMRA’s interpretation at the time of the decision six months later, I find that they provide useful context. Specifically, they reinforce the understanding that the Agency itself has been viewing renewals not as a mere “rubber stamping”
formality, but as streamlined yet still substantive “pulse checks”
that use newly available information to reassess the risk level of registered products up for renewal.
[36] I find this interpretation reasonable for several reasons. First, it stays alive to the operational realities the PMRA faces in regulating over 7,000 products at various stages of the registration cycle. Repeating the fulsome risk assessments performed at registration or re‑evaluation for every renewal can impose paralyzing administrative burdens. Second, it respects how the Act structures different pathways for risk oversight: full or amended registrations, re-evaluations, and special reviews require more rigorous consultation processes and mandatory formal reasons, whereas the renewal processes carry no such requirements. Third, it remains faithful to the protective purposes of the Act. If alarming new information arises, the PMRA can invoke the re-evaluation and special review mechanisms of the Act to conduct a full-scale substantive review. In tandem, subsection 16(2) and section 8 of the Regulations empower the PMRA to request additional information on a product and its risks. This discretion supports the interpretation that renewals by default involve a streamlined risk assessment process, with the operational flexibility to escalate to more comprehensive reviews if deemed necessary.
[37] Taken as a whole, I conclude that the PMRA’s interpretation is reasonable. Contrary to the Applicants’ contention, nothing in the Act and Regulations requires a de novo assessment each time a registration term nears its end. The PMRA’s reading provides for a continuing oversight of product risks—an oversight that can escalate to include a more rigorous assessment if warranted—while avoiding unnecessary duplication of the thoroughness of a re-evaluation or special review at every renewal. Renewal, as the PMRA has understood and implemented it, is neither a mere rubber-stamping exercise, as the Applicants suggest the PMRA has done, nor a mandatory second round of rigorous and substantive re-evaluation, as the Applicants seem to demand. Instead, it is a reasonable, workable understanding of renewals as a streamlined checkpoint within a larger and layered regulatory system that provides different mechanisms for risk assessment for different situations.
[38] I now turn to the issue of whether the PMRA’s handling of the Applicants’ letter of October 27, 2022, particularly the 61 attached scientific studies, constituted a reasonable exercise of its expertise and discretion under the renewal regime.
[39] The Applicants’ core contention is that the PMRA offered merely a bare assertion of “awareness”
of new science, with no notes, logs, or underlying analysis to demonstrate how it weighed or tested that evidence. They say this leaves the reviewing court with the same “trust us, we got it right”
problem identified in Vancouver International Airport Authority v Public Service Alliance of Canada, 2010 FCA 158 [Vancouver International Airport Authority] at paras 20–21. In their view, this absence of transparent reasoning is incompatible with the high protective standard set out in subsection 2(2) of the Act, which requires “reasonable certainty that no harm”
will result.
[40] In particular, the Applicants emphasize the “serious new findings”
found in the 61 studies, including indications of reproductive toxicity and enhanced dangers from glyphosate “formulations”
rather than glyphosate alone. They characterize these findings as directly contradicting the PMRA’s conclusions and argue that they should have been more transparently addressed. Because the PMRA’s four internal documents do not even outline a cursory evaluation, no summary view of the studies as a whole or quick notes on thoughts about these articles, the Applicants submit the record is too opaque to allow for a meaningful reasonableness review. They assert that this is particularly problematic given the Act’s focus on providing scientifically grounded and transparent justifications for regulatory decisions.
[41] The Applicants further argue that this opacity was further exposed by the Rule 317 order from Justice Fothergill, which compelled the PMRA to produce any specific assessment of the submitted studies. Despite initially resisting production, the Agency ultimately confirmed, after being ordered to comply, that it had no documents specifically addressing the 61 articles before renewing the product. The Applicants contend that this absence of documentation effectively prevents both them and this Court from determining whether, or to what extent, the new evidence was substantively reviewed.
[42] The Respondent, in both written submissions and oral argument, emphasizes that a renewal under the Act is intended as a streamlined administrative process rather than a formal, comprehensive re-evaluation. They note that the PMRA’s 2017 re‑evaluation of glyphosate was extensive, covering hundreds of scientific documents, and say the experts at the Agency remain continuously aware of current science. While acknowledging that the four internal memoranda are terse, the Respondent insists they are sufficient to show that PMRA scientists “did look at”
the 61 new articles and concluded none warranted altering the existing acceptable‑risk finding. Furthermore, the Respondent stresses that no specific statutory provision obliges the PMRA to publish detailed reasoning at renewal, pointing to the Act’s clear distinction between routine renewals and full-scale re‑evaluations or special reviews, which do mandate more elaborate analysis and public engagement.
[43] When asked by this Court how the PMRA’s decision could be reviewed without any record of how the 61 studies were examined, which potentially leaves the Court with nothing more than the Respondent’s assurance of “trust us, we got it right,”
counsel responded that the governing scheme contemplates a lighter form of scrutiny for renewals. The Respondent argued that “no formal reasons”
are required and that Vavilov permits a reviewing court to glean rationale from the record. They maintained that deferring to the PMRA’s scientific expertise is especially apt here because the Agency determined that the new studies simply did not “move the needle”
considering the robust 2017 re-evaluation. When pressed on whether the available material was sufficient to confirm that a genuine review had taken place, given the absence of any written engagement with the Applicants’ evidence, counsel insisted that the short memos, plus the PMRA’s proven track record of ongoing monitoring, collectively meet Vavilov’s reasonableness requirement.
[44] I agree with the Applicants. While I accept that the PMRA’s interpretation of renewals as involving a more limited risk assessment is reasonable, I do not see how a valid “streamlined”
approach can eliminate the need for a transparent and intelligible rationale. This is particularly true when the Applicants have provided new, specific, and allegedly contradictory health and environmental evidence from recent scientific research. Deference to administrative decision-makers on technical and scientific matters is not warranted when they have grappled with the Applicants’ core submission in only a superficial manner, if at all. Although Vavilov allows me to infer reasoning from the record and outcome in the absence of formal written reasons, I cannot deem a decision reasonable when the record offers virtually no sign of whether the Agency has considered evidence that directly challenges its conclusions. All the record shows me are mere unsubstantiated assurances communicated through standardized language. Simply put, I cannot connect the dots when there are none.
[45] The situation at hand bears many similarities to that in Catalyst Pharmaceuticals, Inc. v Canada (Attorney General), 2021 FC 505. In that case, Justice St-Louis found that the administrative record at hand failed to show any meaningful trace of how Health Canada considered the applicant’s data protection rights, or whether it assessed the regulatory framework governing such protections. Justice St-Louis emphasized that a record lacking transparency offers no discernible insight into whether the relevant materials were meaningfully considered, making it fundamentally incompatible with meaningful judicial review. An opaque or skeletal record, in essence, prevents the reviewing court from determining whether the decision-maker properly engaged with the key requirements laid out by the legislative framework.
[46] In this case, all we see are four internal PMRA documents asserting the new evidence does not change the existing assessment. There is no indication of any log or short summary recording the reviewing scientists’ considerations of the new evidence, even if very briefly. Indeed, the memoranda and incident report do not substantively address any studies at all, they merely acknowledge their existence, despite the gravity of the concerns flagged by the Applicants. This leaves the Court unable to determine whether the PMRA genuinely weighed the new data against the existing risk assessment or merely acknowledged the Applicants’ submission as a procedural formality.
[47] Furthermore, while one of the PMRA’s documents referenced the 84 post-2017 incident reports and concluded that there were no concerning trends, this document alone cannot justify the lack of any documented engagement with 61 separate pieces of scientific scholarship. Although monitoring incident reports demonstrates the PMRA’s efforts to stay informed of recent developments in the field, these reports are categorically different from the scientific studies provided in the Applicants’ letter. The incident reports may intersect with, overlap, or even contradict the Applicants’ scientific evidence, yet the record does not clarify whether or how the analysis of these incident reports was integrated into the review of the Applicants’ evidence. The PMRA might well have had valid reasons to discount or set aside the new material, but the record does not reveal them. In my view, this lack of transparency reflects exactly the “trust us, we got it right”
approach that is incompatible with the principles set out in Vavilov.
[48] The Respondent urges that the Court should defer to the PMRA’s “recognized expertise, the significant review undertaken during the re-evaluation, the thousands of pest control products that PMRA regulates, and the nature of a renewal decision.”
I agree that the legislative framework likely does not require a full-scale re-evaluation or special review each time new data is submitted at the renewal stage. But the complete absence of any notes, logs, or even a brief summary outlining the PMRA’s thought process regarding the Applicants’ evidence means its decision fails to meet the legal standard of reasonableness. As the Federal Court of Appeal emphasized in Vancouver International Airport Authority at paragraph 25, administrative decision-makers can “address fundamental purposes”
with only “a sentence or two”
per study or even category of evidence. Where administrative expertise is not demonstrated, deference is not warranted: Vavilov at paras 92 and 93.
[49] I also reject that asking the PMRA to provide brief explanations of the Applicants’ evidence would impose the overwhelming operational burden described by the Respondent, even considering the Agency’s daily responsibilities. As I noted during the hearing, if the scientists genuinely reviewed 61 new studies, they must have formed some reasoning as to why those studies did not raise concerns. I agree with the Applicants that a scientifically based conclusion must inherently include a rationale, as the very nature of scientific inquiry demands a logical path from evidence to conclusion. This is fundamental to the scientific method’s core principles of testability, reproducibility, and peer review. Recording a few lines to document relevant reasoning in a format convenient for the reviewing scientists would hardly be onerous if the reviewers have indeed turned their mind to the studies submitted by the Applicants. I am not expecting a detailed rationale akin to a court decision, nor an exhaustive meta-analysis or systematic literature review to justify why the Applicants’ studies do not warrant further scrutiny. Arbitrating scientific truth is not this Court’s role—it is the role of the PMRA. Yet, this Court does require some indication of genuine analysis in the record to demonstrate that the PMRA meaningfully grappled with the Applicants’ evidence. We do not see that here. Without it, there is no discernible chain of reasoning, as required by Vavilov.
[50] It follows that the PMRA’s approach here fails on transparency and justifiability grounds, rather than on a misinterpretation of the Act and Regulations. The PMRA’s statutory interpretation that a renewal is not a second re-evaluation or special review is defensible, but its application of its interpretation in this case precludes meaningful scrutiny. The four internal documents in the record do not do so. Each, in my view, reads more like a generic statement of “no change,”
offering no clue how 61 separate studies were weighed, tested, or rejected. In short, the PMRA’s implementation of its own renewal approach here leaves no path forward for reasonableness review.
[51] Beyond asking this Court to set aside the renewal of Mad Dog Plus, the Applicants also seek a declaration that would establish their more stringent interpretation of the renewal scheme as binding. The Respondents, by contrast, request that any remedial order only remit the decision to the PMRA for reconsideration, without a declaratory ruling.
[52] I decline to make the Applicants’ requested declaration. As discussed, I find the PMRA’s underlying view that renewals do not require a complete re-evaluation to be reasonable. The flaw in this case arises not from that interpretation but from the PMRA’s application of it. Hence, there is no need for a binding pronouncement in the manner the Applicants propose.
[53] Turning to whether I should also quash the renewal, counsel for Loveland raised concerns during oral submissions about the potentially severe consequences of outright invalidation. Among other things, losing the renewal status could subject Loveland to liability under section 32 of the Act, should the product be sold or distributed without valid registration. That provision exposes registrants to fines ranging from $200,000 upon summary conviction to $500,000 on indictment, as well as possible imprisonment.
[54] I find Loveland’s arguments persuasive in the present circumstances. Mad Dog Plus is but one glyphosate-based product among many similarly renewed by the PMRA. It would be disproportionately onerous to force Loveland, and all parties in its distribution chain, to endure an abrupt invalidation of the renewal, pending reconsideration, particularly given that the statutory breach at issue is the PMRA’s lack of transparent reasons rather than Loveland’s wrongdoing.
[55] However, I also find that maintaining the renewal indefinitely without sufficient justification would undermine regulatory accountability. The PMRA’s failure to provide a meaningful explanation regarding the 61 new scientific studies cannot be overlooked. To balance these concerns, I remit the matter to the PMRA for redetermination in accordance with these Reasons, without quashing the renewal immediately. The decision under review shall be quashed on the date that is the earlier of the date that is six months from the date hereof, or the date the Agency provides a decision in accordance with these Reasons on the redetermination. Should additional time be required, the issue may be put to me with reasons why the time provided was insufficient. This approach ensures accountability while avoiding immediate disruption to Loveland and downstream users.
[56] I conclude that the PMRA’s interpretation that renewals under the Act and Regulations serve as a streamlined checkpoint distinct from a full re‑evaluation is reasonable. Nothing in the relevant provisions requires a de novo, substantive risk assessment whenever a registration term expires, provided the PMRA retains sufficient flexibility to escalate its review when presented with compelling new evidence.
[57] However, the PMRA’s application of that interpretation in this case is unreasonable. The record offers no meaningful insight into how the PMRA considered the 61 new scientific studies the Applicants submitted, if it gave them any consideration at all. This leaves this Court with a “trust us, we got it right”
stance incompatible with Vavilov. Brief and conclusory internal documents indicating mere “awareness”
of the evidence do not meet the “justification, transparency, and intelligibility”
threshold necessary for reasonableness review.
[58] As for remedy, I decline to issue the Applicants’ requested declaration. The Applicants’ proposed interpretation is not the only reasonable one allowed by the statutory scheme. The PMRA’s “streamlined”
reading of renewals is also reasonable. Further, I accept Loveland’s submission that quashing the renewal decision entirely would cause overly harsh consequences, potentially exposing the registrant to liability under section 32 of the Act and abruptly disrupting supply chains.
[59] Therefore, I remit the matter to the PMRA without immediately quashing the renewal. The Agency must revisit its decision on Mad Dog Plus, and within six months provide an intelligible explanation, consistent with these Reasons, of how it weighs the Applicants’ 61 studies before confirming whether the existing acceptable‑risk conclusion should remain in place. In doing so, nothing prevents the PMRA from maintaining its current outcome if, upon a more transparent review, it still finds the new evidence unpersuasive. However, it must supply a minimal level of rationale sufficient to permit meaningful judicial scrutiny under Vavilov.
[60] Accordingly, I grant the judicial review application in part: the PMRA’s decision is found unreasonable, but the renewal stands for only six months pending the PMRA’s redetermination.
[61] Each party shall bear their own costs, as requested.