David Suzuki Foundation v. Canada (Health)

David Suzuki Foundation v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2019-12-18
Neutral citation
2019 FC 1637
File numbers
T-784-19
Notes
Digest
Decision Content
Date: 20191218
Docket: T-784-19
Citation: 2019 FC 1637
Ottawa, Ontario, December 18, 2019
PRESENT: The Honourable Mr. Justice Southcott
BETWEEN:
DAVID SUZUKI FOUNDATION, FRIENDS OF THE EARTH CANADA,
ÉQUITERRE, and WILDERNESS COMMITTEE
Applicants
and
MINISTER OF HEALTH and SYNGENTA CANADA INC.
Respondents
and
CROPLIFE CANADA
Intervener
JUDGMENT AND REASONS
I. Overview
[1] This decision relates to an application for judicial review, challenging a decision by the Pest Management Regulatory Agency [PMRA] dated April 11, 2019 [the Decision] to amend certain registrations for a pest control product following a re-evaluation under section 16 of the Pest Control Products Act, SC 2002, c 28 [the Act]. Specifically, the Applicants challenge the portion of the Decision that provides a 24-month transition period for implementation of the risk mitigation measures required by these amendments.
[2] The Applicants seek an order: (a) declaring that the PMRA lacks the jurisdiction to provide the transition period in the Decision; (b) declaring that the PMRA’s practice of providing a transition period in connection with amendments, pursuant to its Policy on Cancellations and Amendments Following Re-evaluation and Special Review [the Policy], is ultra vires the Act; and (c) quashing the transition period in the Decision.
[3] For the reasons explained in greater detail below, this application is dismissed. I have found to be reasonable both the PMRA’s interpretation of the Act, as providing it authority to include the transition period in the Decision, and its decision to include the transition period.
II. Background
[4] The Applicants are the David Suzuki Foundation [Suzuki], Friends of the Earth Canada, Équiterre, and Wilderness Committee. They are all non-governmental organizations that engage in environmental advocacy.
[5] The Respondents are the Minister of Health [the Minister], who is responsible for the Act and has delegated this responsibility to the PMRA, and Syngenta Canada Inc [Syngenta], the registrant of the neonicotinoid pest control product Thiamethoxam Technical Active [TMX] and 17 associated end-use products in which TMX is the active ingredient [together, the TMX Products]. These products include sprays to be applied to plants and to bare soil (respectively, foliar application and soil application) as well as products used as a coating on crop seeds to prevent insects from eating the seeds when they are planted in the ground and to protect the plants grown from treated seeds (seed treatment).
[6] This proceeding also includes an Intervener, CropLife Canada [CropLife], a trade association representing developers, manufacturers, and distributors of plant science products.
[7] The Act governs the regulation of pest control products in Canada, including both active ingredients and their end-use commercial applications. The provisions of the Act referenced in this Judgment and Reasons are set out in Appendix “A” hereto. Subject to certain exceptions, s 6(1) of the Act prohibits a person from manufacturing, possessing, handling, storing, transporting, importing, distributing, or using a pest control product that is not registered under the Act. For a product to be registered, or for an existing registration to be amended, an application must be made to the Minister, who then conducts any evaluation considered necessary with respect to the health or environmental risks or the value of the pest control product (ss 7(1) and (3) of the Act).
[8] If the Minister then considers that the health and environmental risks and the value of the pest control product are acceptable, the Minister must register the product or amend its registration, as applicable, by, inter alia, specifying conditions related to its manufacture, handling, storage, transport, import, export, packaging, distribution, use or disposition, composition, and labelling (s 8(1)(a)). Otherwise, the Minister must deny the application (s 8(4)). Prior to the events giving rise to this application for judicial review, the TMX Products were registered under the Act upon the application of Syngenta to the PMRA.
[9] After registration, the Minister may initiate the re-evaluation of a registered pest control product if the Minister considers that, since the product was registered, there has been a change in the information required, or the procedures used, for the evaluation of the health or environmental risks or the value such products (s 16(1)). Similar to the initial registration, the Minister conducts any evaluation considered necessary with respect to the health or environmental risks or the value of the product and carries out any public consultation required by s 28 of the Act (s 16(6)).
[10] If the Minister considers that the health and environmental risks and the value of the pest control product are acceptable after any required evaluations and consultations have been completed, the Minister must confirm the registration (s 21(1)). If the Minister does not consider these to be acceptable, the Minister’s obligations are provided as follows by s 21(2):
Pest Control Products Act, SC 2002, c 28
Loi sur les produits antiparasitaires, LC 2002, ch 28
Amendment or cancellation
Modification ou révocation
21 (2) If the Minister does not consider that the health or environmental risks or value of a pest control product are acceptable, the Minister shall
21 (2) Dans le cas où il n’arrive pas à cette conclusion, le ministre modifie l’homologation s’il estime qu’à la suite de la modification la valeur du produit et les risques sanitaires et environnementaux qu’il présente seraient acceptables, ou il la révoque.
(a) amend the registration if the Minister considers that the health and environmental risks and value of the product would be acceptable after the amendment; or
[Blank]
(b) cancel the registration.
[Blank]
[11] The meaning of acceptable risk is set out in s 2(2), which provides as follows:
Acceptable risks
Risques acceptables
2 (2) For the purposes of this Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
2 (2) Pour l’application de la présente loi, les risques sanitaires ou environnementaux d’un produit antiparasitaire sont acceptables s’il existe une certitude raisonnable qu’aucun dommage à la santé humaine, aux générations futures ou à l’environnement ne résultera de l’exposition au produit ou de l’utilisation de celui-ci, compte tenu des conditions d’homologation proposées ou fixées.
[12] On June 12, 2012, the PMRA gave notice that it was initiating a re-evaluation of TMX and another neonicotinoid, in light of emerging science on neonicotinoids and their potential effects on pollinators, as well as global updates to the pollinator risk assessment framework. This re-evaluation proceeded over the course of five years, following which the PMRA published the results in its Proposed Re-Evaluation Decision dated December 19, 2017 [the Proposed Decision]. The Proposed Decision then underwent a 90-day consultation period under s 28 of the Act, during which the PMRA received comments from various categories of interested parties including Syngenta and other registrants, non-profit organizations including the Applicants Suzuki and Équiterre, and other industry participants, including CropLife.
[13] On April 11, 2019, the PMRA issued the final Decision, which is the subject of this application for judicial review.
III. Re-Evaluation Decision
[14] The Decision is almost 250 pages including appendices and, to be fully understood, must be read in conjunction with the Proposed Decision, which is another 400 pages. However, the PMRA’s conclusions are summarized at the beginning of the Decision as follows:
Outcome of Science Evaluation
The risk assessment, conducted according to the Guidance for Assessing Pesticide Risks to Bees, determined that there are varying degrees of effects on bees. Some current uses of thiamethoxam are not expected to affect bees. For some uses, mitigation measures (in other words, changes to the conditions of registration) are required to minimize potential exposure to bees. Mitigation measures include changes to the use pattern and label improvements. When thiamethoxam is used in accordance with these new risk reduction measures, the reduced environmental exposure is considered adequate and risks are acceptable. Label statements informing users of the potential for toxicity to pollinators are required on product labels. For other uses, risks to pollinators were not found to be acceptable; therefore, these uses are cancelled.
Regulatory Decision for Thiamethoxam
Health Canada has completed the pollinator re-evaluation of thiamethoxam. Under the authority of the Pest Control Products Act, Health Canada has determined that, with required amendments, continued registration of products containing thiamethoxam is acceptable; however, certain uses of thiamethoxam are cancelled to address potential risks of concern to pollinators. An evaluation of available scientific information found that some uses of thiamethoxam products meet current standards for protection of pollinators when used according to the conditions of registration, which include required amendments to label directions. Label amendments, as summarized below and listed in Appendix III, are required for all end-use products. No additional data are requested.
Risk Mitigation Measures to Protect Pollinators
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. As a result of this re-evaluation of thiamethoxam, further risk mitigation measures for product labels are required.
Certain crops are highly attractive to bees when their flowers are in bloom. Since large numbers of bees are attracted to these crops when they are in bloom and based on an assessment of the risks to bees, the application of pesticides containing thiamethoxam can lead to effects that may have an impact on the survival of bee colonies or solitary bee species.
In order to protect pollinators, Health Canada is cancelling the following uses of thiamethoxam:
● Foliar and soil application to ornamental crops that will result in pollinator exposure (in other words, are planted outdoors and are attractive to pollinators)
● Soil application to berry crops, cucurbit crops and fruiting vegetables, and
● Foliar application to orchard trees.
Due to the attractiveness of some crops to bees and based on an assessment of the risks to bees, application of pesticides containing thiamethoxam before and during crop flowering can lead to effects that may have an impact on the survival of bee colonies or solitary bee species.
In order to protect pollinators, Health Canada is changing the timing of application for the following uses of thiamethoxam
The following crops cannot be sprayed before or during bloom:
● Foliar application to legume and outdoor fruiting vegetables, and
● Foliar application to berry crops (without renovation required for woody berries).
The following crops cannot be sprayed during bloom:
● Foliar application to sweet potato and potato
To minimize bee exposure to dust during planting of treated seed, additional label statements are required for the following use:
● Seed treatment of cereal and legume crops.
Thiamethoxam has value to crop production in Canada as an insecticide to control a variety of insect pests when applied as a foliar or soil application, as well as a seed treatment. An assessment of the registered products determined a lack of alternatives for the following pests and sites:
● Brown marmorated stink bug on apple, crab apple, pear, and oriental pear;
● Brown marmorated stink bug and obscure root weevil on bushberries;
● Black vine weevil, cranberry weevil and strawberry root weevil on low growing berries (except strawberry and lowbush blueberry); and
Brown marmorated stink bug and black vine weevils on outdoor ornamentals.
The additional risk mitigation measures described above will be implemented over a 24-month period. The risks identified are not considered imminent because they are not expected to cause irreversible harm over this period. Potential effects include sublethal effects on colonies or solitary bees, but affected pollinator populations are expected to recover following implementation of the additional restrictions which will reduce exposure. Moreover, recovery is expected because risks to pollinators are geographically limited to areas where these products are applied and areas adjacent to application sites. The presence of unaffected solitary bees, bumble bees, and honey bees in areas where products are not being used will further facilitate recovery since unaffected bees in the environment can move back into areas where effects may have occurred. Overall, risk to pollinators is acceptable over the time period required to implement the mitigation measures.
As a result of this decision, growers will be required to change their pest management practices. Pesticides have extensive and precise instructions and often require specialized application and safety equipment and training. This transition period will allow for an orderly and safe implementation of these new restrictions, and should reduce the risk of product misuse or the improper disposal of products as users switch to alternatives, where required. This approach is consistent with Health Canada’s current policy and practice with respect to phase out of uses as a result of a re-evaluation (Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review) and with the practice of other international regulators.
A small subset of uses were found to lack alternatives for the management of serious pests (the invasive brown marmorated stink bug and certain weevils) on a very few crops present in limited geographical areas of Canada. As a result, the implementation of the re-evaluation decision for these uses will be delayed for an additional year to allow growers to find pest management solutions. During this period, the overall exposure to pollinators will be significantly reduced through both removal of uses to control other pests on these crops and other crops that pose a risk to bees, as well as through implementation of additional restrictions in application timing which will further reduce pollinator exposure. The risks to pollinators are therefore considered acceptable for an additional year for this small subset of uses.
Next Steps
To comply with this decision, taking into account Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing thiamethoxam that are registered under the authority of the Pest Control Products Act.
Other Information
Any person may file a notice of objection regarding this decision on thiamethoxam within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service.
[Internal cites omitted; underlining emphasis added; bold emphasis in original]
IV. Policy
[15] This application seeks relief not only against the portion of the Decision underlined above, but also in relation to the portion of the Policy referenced and relied upon in the Decision. The PMRA published the Policy on March 7, 2018 describing its purpose as follows:
1.0 Purpose
The purpose of this policy is to provide a framework for the cancellation of pesticide products or amendments to pesticide product uses, labels, or other conditions of registration following a re-evaluation or special review decision. The policy also outlines the process, the associated timelines as well as how the timelines for cancellation or amendment of pesticide products are established.
This policy is intended to enhance transparency of the process and associated timelines when regulatory action is required to remove products from the market, change approved uses, or introduce amendments to labels. It is intended to facilitate efficient and effective implementation of re-evaluation and special review decisions. Standardized timelines aim to clarify expectations, obligations and communications around the implementation of regulatory decisions.
[16] The PMRA practice, which the Applicants ask this Court to declare ultra vires the Act, is set out in Section 6.2 of the Policy as follows:
6.2 Amendment Timelines
When an amendment to a registration is determined to be necessary as a result of the product not meeting current standards for human health and/or environmental protection, such as the need for additional risk mitigation measures or the cancellation of certain uses (refer to Appendix I.a):
● The PMRA notifies registrants of the need to amend their product registration and update product labels to reflect the required amendments. The PMRA also communicates the required process and implementation timelines.
● Registrants submit an application. The PMRA reviews the applications within the performance standard (i.e., 37 calendar days for completeness check followed by 240 calendar days for review).
When there are no imminent and serious risks to human health or environment, registrants will generally have up to two (2) years from the date of the decision to transition to selling the product with the newly amended labels.
Subsequent to the decision, if at any point it is determined that imminent and serious risks to human health and/or the environment may exist, expedited timelines will be determined on a case-by-case basis commensurate with the likelihood and severity of the risk.
[Underlining emphasis added]
V. Issues
[17] The Applicants take issue with the underlined portions of the above paragraphs of the Decision and the Policy, which afford a 24-month transition period for implementation of risk mitigation measures. The Applicants argue that this transition period represents a delay which is outside the PMRA’s statutory authority. Their arguments rely significantly on s 21(3) of the Act, which provides as follows:
Delay of effective date
Report de la modification ou de la révocation
21 (3) The Minister may delay the effective date of the amendment or cancellation if
21 (3) Le ministre peut différer la modification ou la révocation de l’homologation lorsqu’il n’existe aucune solution de rechange satisfaisante à l’utilisation du produit antiparasitaire et qu’il juge que la valeur du produit et les risques sanitaires et environnementaux qu’il présente sont, jusqu’à la date de modification ou de révocation, acceptables.
(a) no suitable alternative to the use of the pest control product is available; and
[BLANK]
(b) the Minister considers that the health and environmental risks and value of the product are acceptable until the effective date of the amendment or cancellation.
[BLANK]
[18] The Applicants do not take issue with the delay of an additional year for the subset of uses that the Decision found lacked alternatives for the management of serious pests [the Subset Uses], as they consider that delay to be permitted by s 21(3).
[19] The Applicants and each of the Respondents articulate the substantive issues for the Court’s determination somewhat differently. However, in my view, the following set of issues provides a framework for consideration of the arguments raised by all parties, including the Intervener, in determining whether the Applicants are entitled to any of the relief claimed:
Which standard of review applies to the issues raised by the Applicants?
Does the PMRA lack the authority to provide a transition period in connection with amendments following a re-evaluation, where the requirements of s 21(3) of the Act are not met?
If the PMRA does have such authority, did the PMRA nevertheless commit reviewable error in providing the transition period in the Decision, through either its adoption or its application of the test for acceptable risk employed in the Decision?
If the Court concludes that it should quash the portion of the Decision that provides the transition period, should it quash just that portion of the Decision or the entire Decision?
VI. Preliminary Issue – Motion to Strike the Syngenta Affidavit
[20] Before turning to the above issues, it is necessary to address a preliminary issue that the Applicants raise concerning Syngenta’s supporting affidavit. Syngenta relies on an affidavit of its Head of Crop Protection Development, Dr. Nancy Tout, sworn on June 21, 2019. On July 3, 2019, the Applicants filed a motion seeking to strike portions of Dr. Tout’s affidavit, as well as exhibits thereto. The parties subsequently agreed this motion would be argued at the main hearing of this application for judicial review and could be addressed in this Judgment and Reasons.
[21] The portions of Dr. Tout’s affidavit and exhibits the Applicants seek to strike fall broadly into the following categories:
Evidence concerning the past, present or intended commercialization of particular TMX Products, which the Applicants submit: (i) represents irrelevant information not before the decision-maker, (ii) is based on information and belief contrary to Rule 81(1) of the Federal Courts Rules, and/or (iii) represents argument;
Evidence as to categories of information included on TMX Product labels, which the Applicants submit represents unqualified expert opinion and argument; and
Evidence as to Syngenta’s preparation and submission of draft amended product labels pursuant to the Decision, including copies of such draft labels attached as exhibits, which the Applicants submit represents irrelevant information not before the decision-maker and/or represents argument.
A. Evidence of Commercialization of TMX Products
[22] Dr. Tout deposes that four of Syngenta’s seed treatment pest control products, which are registered under the Act, are not currently commercialized for sale and are not intended to be commercialized. She states that Syngenta is moving forward to discontinue these products. Dr. Tout also identifies one of Syngenta’s soil and foliar pest control products which, while registered, has never been commercialized for sale in Canada.
[23] In her affidavit, Dr. Tout states that she has knowledge of the matters to which she deposes and that the statements in her affidavit are made to the best of her knowledge, based on her own experience and involvement in the matters which are the subject of the affidavit and her review and knowledge of the contents of documents related to such matters. She also explains that, where her statements are based on information and belief, she has stated the source of that information and believes such information to be true. The only subjects in the affidavit, in relation to which Dr. Tout states a source of information and her belief therein, are the commercialization of the products described above.
[24] The Applicants therefore argue that Dr. Tout’s evidence surrounding commercialization of Syngenta’s products (found in paragraphs 11, 13, 48 and 50) should be struck from her affidavit, because it offends Rule 81(1). This Rule provides that affidavits shall be confined to facts within the deponent’s personal knowledge, except on certain motions. I agree with Syngenta’s response to this argument, that this evidence from Dr. Tout constitutes corporate evidence which relevant authority recognizes does not infringe Rule 81(1).
[25] In Twentieth Century Fox Home Entertainment Canada Ltd v Canada (Attorney General), 2012 FC 823 [Twentieth Century Fox] at paragraphs 22 to 23, Justice Phelan noted that Rule 81(1) must be considered in light of the Supreme Court’s acceptance of hearsay on a principled basis and that this Court has accepted evidence on information and belief. Justice Phelan described the evidence of the deponent in that case as “corporate” evidence, noting that he acted in a supervisory capacity and was responsible for the subordinate who provided information to the deponent, such that he was in a position to know if the facts were true.
[26] In O’Grady v Canada (Attorney General), 2016 FC 9 at paragraphs 19 to 20, Justice LeBlanc relied on Twentieth Century Fox in concluding that, while the respondent’s affiant had sworn her affidavit on information and belief, her position with Statistics Canada was such that she was probably aware of the particular facts to which she had deposed and was therefore in a position to swear the affidavit. On appeal, the Federal Court of Appeal confirmed that Justice LeBlanc had not erred in considering the admissibility of the affidavit and had correctly determined that the affiant, by virtue of her responsibilities in the Government of Canada, was in a position to depose to the matters in question without necessarily having personal knowledge (2016 FCA 221 at para 10).
[27] The same analysis applies in the present circumstances. Dr. Tout deposes that she has been the Head of Crop Protection Development for Syngenta since March 2016 and describes her responsibilities in that role, including working closely with Syngenta’s regulatory team. The individuals, who Dr. Tout states advised her as to the commercialization of the products to which the disputed evidence relates, are the respective Regulatory Portfolio Managers for those products. Given her role, and the nature of her evidence as corporate evidence, I am satisfied that Rule 81(1) does not preclude admission of this evidence.
[28] The Applicants also argue that this evidence is irrelevant and argumentative. I find no merit to the submission that the evidence is argumentative, as it represents simple statements of fact surrounding the past, present, or future commercialization of certain products. Syngenta submits that the evidence is relevant, because the PMRA would have been aware of the commercialization of the various TMX Products that were the subject of its re-evaluation. Syngenta observes that s 8(5) of the Act requires a registrant of pest control product, as a condition of registration, to report to the Minister information on sales of the product. I accept that the evidence is relevant and find no basis to strike it from Dr. Tout’s affidavit. However, I also note that nothing turns on this decision, as this evidence is not material to the analysis of the substantive issues in this application.
B. Evidence of Categories of Information on TMX Product Labels
[29] Dr. Tout’s affidavit includes evidence (in paragraph 16) in which she provides examples of categories of information that are included among the environmental precautionary measures and directions for use on TMX Product labels. The Applicants submit this evidence represents unqualified expert opinion and argument.
[30] I find nothing argumentative about this evidence. While it represents examples of categories of information provided on product labels, and therefore is not an exhaustive list, the evidence remains factual and is not offered in a manner that I consider to represent advocacy or argument.
[31] Nor is there merit to the Applicants’ argument that this paragraph represents unqualified expert opinion. Dr. Tout’s affidavit explains that an integral part of her duties at Syngenta includes knowing and understanding the product label requirements of the PMRA and the Act, including identifying what information Syngenta is required to list on its pest control product labels to satisfy applicable statutory, regulatory, and policy requirements. The evidence in the disputed paragraph does not represent opinion but rather is factual testimony based on Dr. Tout’s experience with the regulatory process that is the subject of this application for judicial review.
[32] I find no basis to strike this paragraph of the affidavit.
C. Evidence of Syngenta’s Draft Amended Product Labels
[33] Dr. Tout’s affidavit includes (in paragraphs 21, 23, 29, 35, 38, 42, 46 and 50) evidence surrounding Syngenta’s preparation and submission to the PMRA of draft TMX Product labels, in compliance with the requirements of the Decision, and attaches copies of such draft labels as exhibits. The Applicants submit this evidence represents irrelevant information not before the decision-maker and argument.
[34] Again, I find nothing argumentative about this evidence, as it is purely factual. However, the Applicants’ submissions, that this evidence is irrelevant and was not before the PMRA when it made its decision, require more detailed consideration. As the Applicants correctly submit, as a general rule, evidence on judicial review is restricted to the evidentiary record that was before the administrative decision-maker, and evidence that goes to the merits of the matter before the decision-maker is not admissible on judicial review (see Association of Universities and Colleges of Canada v Canadian Copyright Licensing Agency (Access Copyright), 2012 FCA 22 [Access Copyright] at para 19; Delios v Canada (Attorney General), 2015 FCA 117 [Delios] at para 42).
[35] There are exceptions to this general rule (see Access Copyright at para 20), but the only exception potentially applicable to the present circumstances is the so-called “general background” exception (see Delios at para 43 et seq). Both the Applicants and the Respondents refer the Court to Bernard v Canada (Revenue Agency), 2015 FCA 263 [Bernard] at paras 20 to 23, which describes this exception as follows:
20 The first recognized exception is the background information exception. Sometimes on judicial review parties will file an affidavit that contains summaries and background aimed at assisting the reviewing court in understanding the record before it. For example, where there is a large record consisting of many thousands of documents, it is permissible for a party to file an affidavit identifying, summarizing and highlighting, without argumentation, the documents that are key to the reviewing court’s understanding of the record.
21 In Delios, above, I put it this way (at paragraph 45):
The “general background” exception applies to non-argumentative orienting statements that assist the reviewing court in understanding the history and nature of the case that was before the administrative decision-maker. In judicial reviews of complex administrative decisions where there is procedural and factual complexity and a record comprised of hundreds or thousands of documents, reviewing courts find it useful to receive an affidavit that briefly reviews in a neutral and uncontroversial way the procedures that took place below and the categories of evidence that the parties placed before the administrator. As long as the affidavit does not engage in spin or advocacy – that is the role of the memorandum of fact and law – it is admissible as an exception to the general rule.
22 But “[c]are must be taken to ensure that the affidavit does not go further and provide [fresh] evidence relevant to the merits of the matter decided by the administrative decision-maker, invading the role of the latter as fact-finder and merits-decider”: Access Copyright, above at paragraph 20; Delios, above at paragraph 46.
23 The background information exception exists because it is entirely consistent with the rationale behind the general rule and administrative law values more generally. The background information exception respects the differing roles of the administrative decision-maker and the reviewing court, the roles of merits-decider and reviewer, respectively, and in so doing respects the separation of powers. The background information placed in the affidavit is not new information going to the merits. Rather, it is just a summary of the evidence relevant to the merits that was before the merits-decider, the administrative decision-maker. In no way is the reviewing court encouraged to invade the administrative decision-maker’s role as merits-decider, a role given to it by Parliament. Further, the background information exception assists this Court’s task of reviewing the administrative decision (i.e., this Court’s task of applying rule of law standards) by identifying, summarizing and highlighting the evidence most relevant to that task.
[36] Syngenta takes the position that the disputed evidence was before the PMRA and also that it falls within the general background exception. To be clear, Syngenta is not arguing that the proposed amended labels were actually before the decision-maker in that form. Rather, it submits that the Court should take a broad view of what constitutes information before the decision-maker, including the decision-maker’s regulatory experience (see Bell Canada v 7262591 Canada Ltd, 2016 FCA 123 at para 15). I understand Syngenta’s argument to be that, given the PMRA’s experience in administering the regulatory scheme under the Act, it made the Decision with an understanding of the nature of the product label amendments that would be required as a result of the Decision.
[37] Alternatively, Syngenta submits that provision to the Court of copies of the proposed amended labels falls within the background exception, because it represents a distillation of the amended conditions of registration resulting from the Decision and therefore assists the Court to understand the Decision.
[38] I find merit to both of Syngenta’s arguments. As explained in the above passage from Bernard, both the general rule and the background exception are intended to respect the differing roles of the administrative decision-maker and the reviewing court. In the present case, the draft labels are provided to the Court for a purpose that respects these differing roles and do not represent an effort to introduce fresh evidence, relevant to the merits, that was not before the PMRA.
[39] The labels appended to Dr. Tout’s affidavit are presented in a form which demonstrates through black-lining the proposed changes from the existing labels that predated the Decision. The principal issue the Court must address in this application for judicial review surrounds the PMRA’s interpretation of its statutory authority. The arguments advanced by the parties in connection with this issue include submissions that require an understanding of the practical implications of the Decision, such as the requirement to generate amended labels. It is therefore potentially useful for the Court to understand what is required on the ground to implement the Decision through these labels. Presumably, the PMRA had such an understanding, and the proposed amended labels represent a means by which the Court can develop such an understanding more easily than by attempting to parse the amended conditions of registration set out in the Decision.
[40] In conclusion on the motion, I find no basis to strike any of the impugned portions of Dr. Tout’s affidavit. The Applicants’ motion is therefore dismissed in its entirety.
VII. Analysis
A. Which standard of review applies to the issues raised by the Applicants?
[41] Before turning to analysis of the substantive issues in this application, it is necessary to address the applicable standard of review, on which the parties disagree for most of the issues.
[42] Other than in connection with one of its last arguments, surrounding the application of the test for acceptable risk in the Decision, the Applicants take the position that the issues raised in this application are reviewable on a standard of correctness, because they involve statutory interpretation by the PMRA. In contrast, the Respondents take the position that all issues in this application, including those involving statutory interpretation, are reviewable on the reasonableness standard.
[43] The Applicants’ arguments on standard of review begin with the Supreme Court’s explanation in Dunsmuir v New Brunswick, [2008] 1 SCR 190 [Dunsmuir] at para 62, that the process of judicial review involves two steps. First, courts ascertain whether the jurisprudence has already determined in a satisfactory manner the degree of deference to be afforded with regard to a particular category of question. Second, where the first inquiry proves unfruitful, courts must proceed to an analysis of the factors making it possible to identify the proper standard of review. The Applicants take the position that applicable jurisprudence has already established that questions relating to the Minister’s interpretation of the Act are reviewable on a standard of correctness.
[44] The Applicants rely principally on Équiterre v Canada (Minister of Health), 2016 FC 554 [Équiterre] at paragraphs 45-48, in which the Federal Court addressed the standard of review applicable to a question of statutory interpretation surrounding s 17 of the Act (relating to the Minister’s obligations to conduct a special review of the registration of a pest control product) as follows:
45 The Supreme Court of Canada has reiterated that the presumptive standard of review is “reasonableness”, including for interpretations of the decision-makers’ home statute. The reach of that presumption is more case-dependent. However, the elegantly simple analysis in Wier v Canada (Minister of Health), 2011 FC 1322, 400 FTR 212, that the Minister’s interpretation of the legal standards imposed on him by statute is reviewable on the standard of correctness but the performance of the duties rests on reasonableness, does not hold the same force and effect.
46 The Federal Court of Appeal in Canada (Fisheries and Oceans) v David Suzuki Foundation, 2012 FCA 40, [2013] 4 FCR 155 [David Suzuki], recognized that the presumption can and will be rebutted:
[88] However, deference on a question of law will not always apply, notably where the administrative body whose decision or action is subject to review is not acting as an adjudicative tribunal, is not protected by a privative clause, and is not empowered by its enabling legislation to authoritatively decide questions of law. A standard of review analysis is still required in appropriate cases. As noted by Justices Bastarache and LeBel at paragraphs 63 and 64 of Dunsmuir:
[63] The existing approach to determining the appropriate standard of review has commonly been referred to as “pragmatic and functional”. That name is unimportant. Reviewing courts must not get fixated on the label at the expense of a proper understanding of what the inquiry actually entails. Because the phrase “pragmatic and functional approach” may have misguided courts in the past, we prefer to refer simply to the “standard of review analysis” in the future.
[64] The analysis must be contextual. As mentioned above, it is dependent on the application of a number of relevant factors, including: (1) the presence or absence of a privative clause; (2) the purpose of the tribunal as determined by interpretation of enabling legislation; (3) the nature of the question at issue, and; (4) the expertise of the tribunal. In many cases, it will not be necessary to consider all of the factors, as some of them may be determinative in the application of the reasonableness standard in a specific case.
47 Recognizing that the Agency is a specialized body and entit