Wier v. Canada (Health)

Wier v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2011-11-21
Neutral citation
2011 FC 1322
File numbers
T-1604-09
Notes
Reported Decision
Decision Content
Date: 20111121
Docket: T-1604-09
Citation: 2011 FC 1322
Ottawa, Ontario, November 21, 2011
PRESENT: The Honourable Mr. Justice Kelen
BETWEEN:
JOSETTE WIER
Applicant
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application for judicial review of a decision, dated August 24, 2009, of the Minister of Health (the Minister), to not initiate a “special review” of the health or environmental risks of certain pest control products under section 17 of the Pest Control Products Act, S.C. 2002, c. 28 (the Act).
[2] Under the Act, any person may request a “special review” of the health or environmental risks of a registered pesticide, which the Minister “shall” perform unless there is reasonable certainty that no harm will result from exposure to the pesticide.
[3] The applicant, Josette Wier, did not file an affidavit or attend the hearings. In response to a question from the Court as to the identity of the applicant, counsel for the applicant stated that Josette Wier was an “environmental researcher” in Smithers, BC (a town in north-central British Columbia). The applicant was a medical doctor in France but is not qualified to practice medicine in Canada.
FACTS
The Applicant’s Section 17 Request
[4] In a 29-page letter dated May 25, 2009, together with a binder of medical and scientific studies, the applicant (through her counsel) made a request to the Minister to initiate a “special review” of the registered pesticide glyphosate containing polyoxyethylene tallow amines (POEA) (the pesticide). Counsel advised the Court that the pesticide is aerially sprayed in forests near where the applicant lives, and that she is concerned about the health and environmental risks of this pesticide.
[5] Glyphosate is a herbicide (a “weed-killer”) registered under the Act for many uses and in many locations, including killing weeds in forests which would otherwise smother re-plantings; in agriculture on food and fibre crops; in gardens for flowers and other ornamentals; and on turf or grass. This pesticide is one of the most popular and widely used pesticides. It was first registered for use in 1976 and sold under the trade name “Roundup”. As of 2009, there were 192 glyphosate-used products registered for a variety of uses in Canada.
[6] POEA are formulants added to glyphosate products. They allow the glyphosate products to spread more evenly on the waxy surface of leaves. As of September 2009, there were 137 glyphosate products containing POEA registered for use in Canada. Two of the most common glyphosate herbicides containing POEAs registered for use in Canada are “Vision”, the trade name of a product produced by Monsanto and used in the forest industry, and “Vantage”, the trade name of a product produced by DowAgro for the same use.
The 17(1) Request
[7] The applicant made distinct requests under three subsections of section 17 of the Act. In her subsection 17(1) request, the applicant stated that there is “significant new evidence” which provides reasonable grounds to believe that glyphosate herbicides containing POEA pose unacceptable risks to health or to the environment. In particular, the applicant identified the following evidence, which she stated provide cause for the Minister to initiate a special review under section 17(1) of the Act:
a. Three studies –dated 2009, 2007, and 2005 – that demonstrated risks to human embryonic and placental cells posed by glyphosate in concentrations much lower than those found with farm and agricultural use: N. Benachour and G.E. Seralini, (2009) “Glyphosate Formulations induce Apoptosis and Necrosis in Human Umbilical, Embryonic and Placental Cells”, Chem. Res. Toxicol 2009, 22, 97-105; Benachour et al. “Time and dose-dependent effects of Roundup on human embryonic and placental cells” Arch. Environ. Contam. Toxicol. 2007 Jul, 53(1): 126-33; and Richard et al., (2005) “Differential Effects of Glyphosate and Roundup on Human Placental Cells and Aromatase”, Environ. Health Perspect. 113: 716-720.
b. The applicant also cited two studies – dated 2001 and 2003 – that the applicant submitted corroborated the finding of increased risk of miscarriage from exposure to glyphosate in humans and animals.
c. Two studies – dated 2001 and 2002 – that were case studies of men who had Non-Hodgkin’s Lymphoma and that linked the disease to the mens’ exposure to pesticides: Hardell et al. “Exposure to pesticides as a risk factor for Non-Hodgkin’s Lymphoma and hairy cell leukemia: pooled analysis for two Swedish case-control studies” Leuk. Lymphoma 2002 May, 43(5): 1043-9; and Roos et al., “Integrative assessment of multiple pesticides as risk factors for Non-Hodgkin’s Lymphoma among men”, Occup. Environ. Med 2003 September, 60(9): E11.
d. A 2008 study conducted by the British Columbia Ministry of the Environment concluding that there is evidence that POEA has toxic effects on amphibians (such as frogs), that there are “knowledge gaps” hindering an “effective and realistic assessment” of the impacts of glyphosate on amphibians, and that there has been no assessment of the whether using surfactants with lower toxicity than POEA would be effective: B.C. Ministry of the Environment, (2008) “Literature review of impacts of glyphosate herbicide on amphibians: What risks can the silvicultural use of this herbicide pose for amphibians in B.C.?” (the BC Literature Review).
e. The applicant submitted that amphibians are a sensitive indicator species, and cited two 1999 studies, two 2001 studies, and two 2002 studies for the proposition that pesticides and POEA surfactant in particular have contributed to amphibian population declines.
f. A 2005 study finding that glyphosate-based pesticides impeded the hatching process for sea urchin embryos: Marc J., et al. “A glyphosate-based pesticide impinges on transcription”, Toxicol. Appl. Pharmacol., 2005 Feb. 15, 203(1): 1-8.
[8] The applicant stated that the evidence in the studies was “new” because it post-dated the registration of the “Vision” and “Vantage” herbicides. The applicant stated that the health and environmental risks identified in the studies above were not known or considered when Vision and Vantage were registered for use in Canada.
[9] The applicant stated that the evidence in the studies was “significant” because it presented scientific, peer-reviewed, published data indicating that the pesticide has human health and environmental risks in Canada that were not considered when it was registered.
[10] The applicant submitted in her request that the evidence “challenges the scientific validity of the previous evaluations” that led to the registration of the glyphosate herbicides containing POEA.
[11] At the hearing before the Court, counsel for the applicant conceded that the evidence does not demonstrate a “health risk” to humans or animals from the pesticide in issue. Accordingly, that part of the applicant’s request was withdrawn. Also at the hearing, counsel from the applicant withdrew the applicant’s reliance on eleven of the twelve studies submitted in support of the request. The only documentary evidence relied upon by the applicant at the hearing was document “d” above, The BC Literature Review on the impact of the pesticide in issue on amphibians in silvicultural (forest cultivation) use. Accordingly the original section 17(1) request to the respondent was substantially narrowed at the hearing.
The Section 17(2) Request
[12] In her request for special review, the applicant further submitted that there were grounds for a special review under section 17(2) of the Act, which requires the Minister to initiate a special review of a registered pest control product where a member country of the Organization for Economic Co-operation and Development (OECD) has prohibited all uses of its active ingredient.
[13] The applicant stated that Australia, a member country of the OECD, had prohibited the use of glyphosate herbicides containing POEA surfactants in aquatic habitats because it is unreasonably toxic to amphibians. The applicant included an Australian document, dated June 1996, in support of this claim: “Special Review of Glyphosate”, NRA Special Review Series 96.1.
[14] At the hearing, counsel for the applicant withdrew this section 17(2) request because the applicant’s original understanding of the situation in Australia was mistaken.
The Section 17(3) Request
[15] Finally, the applicant submitted that there were grounds for a special review under section 17(3) of the Act, which requires the Minister to initiate a special review where there is information from a federal or provincial government that gives the Minister reasonable grounds to believe that the product’s health or environmental risks are unacceptable. The applicant referred to the BC Literature Review, above, to support this submission. The applicant submitted that the “summary of glyphosate impacts on amphibians” contained in the BC Literature Review contained information regarding the impact of glyphosate on amphibians that had not previously been considered by the Minister. The Court notes that BC has its own provincial legislation to ban pesticides, and BC has not banned the pesticide.
[16] At the hearing, counsel for the Applicant also withdrew the section 17(3) request.
The Precautionary Principle
[17] In her request, the applicant referred to the “precautionary principle”, which the Supreme Court of Canada defined in 114957 Canada Ltée (Spraytech, Société d'arrosage) v. Hudson (Town), 2001 SCC 40, at paragraph 31, quoting from paragraph 7 of the Bergen Ministerial Declaration on Sustainable Development (1990):
In order to achieve sustainable development, policies must be based on the precautionary principle. Environmental measures must anticipate, prevent and attack the causes of environmental degradation. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation
[18] The precautionary principle has now been legislated in section 20(2) of the Act which states that :
Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent adverse health impact or environmental degradation.
[19] The applicant submitted that, environmental protection is a “fundamental value” in Canadian society, and that the precautionary principle requires the Minister to review the “new evidence” relating to toxicity of the pesticide to amphibians in ephemeral wetlands.
[20] The applicant submitted that the studies enclosed in her request demonstrated that the current registrations for glyphosate herbicides containing POEA are not based on the precautionary principle. She stated that there are reasonable grounds for finding the health or environmental risks posed by the glyphosate herbicides containing POEA are unacceptable.
The BC Literature Review
[21] The BC Literature Review on the impacts of the pesticide in silvicultural use on amphibians is the only evidence relied upon at the hearing by the applicant for this request. It is a report from the British Columbia Ministry of Environment dated June, 2008. It reviews over 100 research papers and studies. It concludes that the pesticide in issue has a toxic effect in amphibians. The restrictions on the use of the pesticide in silviculture require that sensitive areas around water are protected by a buffer zone where the pesticide cannot be used. However, the report states in the executive summary:
In B.C. these requirements apply to large and moderate-sized wetlands and streams and are intended to protect aquatic organisms from impacts of glyphosate herbicides. Although most water bodies and many riparian areas are afforded protection, glyphosate may be sprayed over dry creeks as well as over certain types of temporary, isolated ponds that are habitats frequently used by amphibians.
The BC Literature Review states at page 10 that the over spraying of wetlands could result in the loss of certain foods that tadpoles graze on. In the summary, at page 31 of the BC Literature Review, the conclusion is that there is a harmful effect to tadpoles and “late-stage anuran embryos” from the pesticide. Under the heading “Knowledge Gaps” the BC report states at page 32:
There is sufficient research to suggest that glyphosate herbicides use could pose a risk to amphibians and that its use needs to be re-evaluated…However, almost no research has been conducted to assess the impact on amphibians from silvicultural use of glyphosate herbicides in B.C.
It continues at page 33 to state:
More research is essential to determine the impact of glyphosate use on amphibian populations using these habitats [i.e. the ephemeral wetlands].
Risk Analysis Conducted by Regulatory Agency in Response to the Applicant’s Request
[22] The Minister has delegated responsibility for evaluating requests for special review to the Pest Management Regulatory Agency at Health Canada (the Regulatory Agency), which is an agency of experts at Health Canada charged with administering the Act and its Regulations. The Regulatory Agency has developed a process for reviewing and responding to requests for special review. In essence, this process involves three steps:
a. risk assessments by teams of scientists,
b. review by the “Science Operations Committee” of the Regulatory Agency, and
c. review and final decision by the “Science Management Committee” of the Regulatory Agency.
First Step in the Analysis of the Request by the Regulatory Agency
[23] Upon receipt of the applicant’s request for a special review, the Regulatory Agency assigned the request to three teams of scientists for review:
a. the Environmental Assessment Directorate,
b. the Health Evaluation Directorate, and
c. the Chemistry Section of Compliance, Laboratory Services and Regional Operations.
[24] The scientists were asked to address the following four questions:
1. Do the data provided give reasonable grounds to believe that the environmental/health risks of the products are unacceptable (and justify a special review, as per subsection 17(1) of the PCPA) or managed via a normal re-evaluation?
2. Are the data provided credible (scientifically valid)?
3. Are the studies new or have they been reviewed by the PMRA previously?
4. Does it appear that the risks are associated with glyphosate only, POEA only or their combination?
[24] The findings of each of the three groups were set out in separate memoranda. No group found that the risk posed by the products under review warranted initiating a special review.
[25] The Environmental Assessment Directorate reviewed the two documents related to toxicity of glyphosate to amphibians (the Australian report and the BC Literature Review). Its findings are set out in its memorandum dated July 10, 2009, “EAD’s evaluation of the application for a special review of glyphosate herbicides containing polyethoxylated tallow amines (POEA)” which stated in response to questions 1 and 3:
Question 1: Do the data provided give reasonable grounds to believe that the environment risks of products are unacceptable (and justify a special review, as per subsection 17(1) of the PCPA) or managed via normal re-evaluation?
· The studies cited in the two review documents indicate that glyphosate formulations are toxic to amphibians and other aquatic organisms. The PMRA was aware of this information.
· There is, however, controversy as to the effects of glyphosate formulations on amphibians in small ephemeral wetlands following realistic conditions of applications of glyphosate formulations.
· The lack of field studies hinders effective and realistic assessments of the risk to amphibians from the use of glyphosate formulations.
· To address this uncertainty, a two-year study is being conducted (research authorization requests 2009-0879 and 2009-0593) to provide critical information to fill in knowledge gaps regarding:
o data on glyphosate levels in small wetlands following use under forestry and agriculture settings; and
o effects of glyphosate formulations on amphibians in small wetlands representative of those in agricultural and forestry sectors.
· The re-evaluation of glyphosate is anticipated to occur early in the next cycle of re-evaluation. By then, the results of the above-mentioned two-year research study would be considered.
……
Question 3: Are the studies new or have they been reviewed by PMRA previously?
· The PMRA was aware of the information presented in the two review documents.
· The literature review from the British Columbia Ministry of the Environment cites publications from 1974 to 2006 on the effects of glyphosate formulations on amphibians. The PMRA commented on, and attended a conference call to discuss, this literature review prior to its publication in 2008. The PMRA has not directly reviewed the majority of the studies cited in the document.
· The special review document by Australia (1996) cites studies published from 1974 to 1995 on the toxicity of glyphosate and/or surfactants on various species of aquatic organisms. Several of the same studies were used in our assessment of the pre-harvest use of glyphosate in 1991 (R91-01).
(Bold emphasis in original document)
[26] The Environmental Assessment Directorate’s memorandum does not contain an explicit conclusion regarding the acceptability of the risk posed by glyphosate substances. In response to question 1, the Environmental Assessment Directorate stated that the studies confirm that glyphosate formulations are toxic to amphibians and other aquatic organisms, but that there is uncertainty in the effects that they have in realistic, as opposed to engineered, scenarios.
[27] The respondent’s affiant in this application for judicial review, Dr. Peter Delorme, is the Director of Product Assessment within the Environmental Assessment Directorate of the Regulatory Agency. He deposed that the memorandum, which was intended for internal use at the Regulatory Agency’s discussions prior to making the decision, in effect concluded that the risks were not unacceptable. First, as stated in the memorandum, the Environmental Assessment Directorate concluded that the risks identified had already been addressed. In particular, the study referred to above (R91-01), was a discussion document written by the Regulatory Agency in 1991. It states that glyphosate products containing POEAs are toxic to aquatic organisms, but suggests mitigation measures to mitigate the risks. Also, as discussed in the memorandum, Health Canada was in fact involved in the BC Literature Review prior to its publication, and itself consulted many of the studies relied on by the Australian review.
[28] Second, Dr. Delorme stated that the memorandum demonstrated that the Directorate felt that the risk was not unacceptable because of the nature of evaluations.
[29] In the Affidavit, Dr. Delorme deposed that recent field studies by the Canadian Forestry Service, Natural Resources Canada showed that the pesticide in issue had no significant adverse effects on amphibians under the actual use conditions (see paragraph 67 of his Affidavit). He further deposed that there will be additional field study research related to the environmental effects of this pesticide on amphibians and stated that results from this research are expected to be available within the next one to two years. At the time of his cross-examination, the preliminary results from the field studies were known. However this information was not available at the time of the decision under review, and the applicant objected to its introduction. This Court has therefore disregarded this new evidence not before the decision-maker.
Second Step in the Analysis of the Request by the Regulatory Agency
[30] The second stage of review of the applicant’s request was undertaken by the “Science Operations Committee.” The Science Operations Committee is a committee of senior managers from each directorate. The Science Operations Committee receives a briefing note that is prepared by scientific staff of Health Canada and is circulated in advance of their meeting. The scientific staff also participated at the meeting to answer technical questions that may arise.
[31] The Science Operation Committee briefing note dated July 15, 2009 stated under the heading “Environmental Risk Assessment”:
E. ENVIRONMENTAL RISK ASSESSMENT (based on two provided publications)
· The toxicity of glyphosate formulations to aquatic organisms including amphibians is recognized. Most of the toxicity studies indicate that the toxicity of glyphosate formulations to aquatic organisms is mainly attributed to the surfactant, POEA.
· There is controversy as to the effects of glyphosate formulations on amphibians in small ephemeral wetlands following application of glyphosate formulations. This uncertainty currently hinders effective and realistic assessments of the risk to amphibians from the use of glyphosate formulations.
· A two-year study is currently underway that will provide critical information to fill in knowledge gaps regarding:
a. Field data on glyphosate levels in small wetlands following use under forestry and agricultural settings; and
b. Effects of glyphosate formulations on amphibians in small wetlands representative of those in agricultural and forestry sectors.
(Bold emphasis in original document)
Third Step in the Analysis of the Request by the Regulatory Agency
[32] Following its meeting, the Science Operations Committee makes recommendations that are then forwarded to the “Science Management Committee”. The Science Management Committee is chaired by the Chief Registrar and includes all of the Health Canada Regulatory Agency’s Directors General. They receive the Science Operations Committee recommendations in a briefing note that, like the briefing note prepared for the Science Operations Committee, is prepared by scientific staff.
[33] In this case, the Science Management Committee briefing note, dated July 30, 2009, recommended that a special review not be initiated, but that the scheduled re-evaluation of glyphosate be expanded to include a risk assessment of POEA/glyphosate combinations:
B. Considerations
· There is some uncertainty as to the effects of glyphosate formulations on amphibians in small ephemeral wetlands. A field based study by a group of university researchers with collaboration of Environment Canada scientists was initiatied in 2009,which may help to resolve uncertainties. However, the final results of those studies are anticipated until 2011 or later…
C. Recommendations
· SOC recommended proceeding with the scheduled re-evaluation of glyphosate with the inclusion of a risk assessment of POEA/glyphosate combinations rather than initiating a special review (option #1 of the SOC briefing note)
(Bold emphasis in original document)
[34] In appropriate cases, the Science Management Committee may recommend further investigations be conducted. In this case, the Science Management Committee decided that a special review did not need to be initiated, but it decided to include a POEA risk assessment in the scheduled re-evaluation. Its decision, dated July 30, 2009, was reflected in the minutes of the meeting which read as follows:
SMC agreed to not initiate a special review; proceed with the scheduled re-evaluation of glyphosate and include a risk assessment of POEA/glyphosate combinations.
A Draft Letter from the Regulatory Agency in Response to the Special Review Request by the Applicant
[35] The evidence before the Court showed that a draft letter was prepared, in response to the applicant’s request. The letter originally contained two paragraphs which were later deleted. The first deleted paragraph recognized the controversy as to the effects of the pesticide in issue on amphibians in small ephemeral wetlands. The original words in the draft letter stated:
There is controversy as to the effects of glyphosate formulations on amphibians in small ephemeral wetlands following the application of glyphosate formulations.
This uncertainty currently hinders effective and realistic assessments of the risk to amphibians from the use of glyphosate formulations.
[36] This deletion was made by Dr. Delorme. The reason for the deletion can be seen in a comment about the draft letter by another member of the EAD, Janine Glacier. She wrote about the draft letter:
Field studies by CFS under operational (and realistic) conditions provide the most useful information to address the concern about amphibians. I don’t believe that the uncertainty “hinders effective or realistic assessment”. Quite the contrary, there is a large amount of information available that enables an effective and realistic assessment.
The Decision Under Review
[37] By letter dated August 24, 2009 the Regulatory Agency declined the applicant’s request to initiate a special review. The Regulatory Agency explained the process by which such requests are assessed – namely, by a team of scientists who recommend whether to initiate a special review based on their assessments of the merit of the scientific evidence presented in the request and whether the evidence changes existing risk assessment or risk mitigation measures, and whether there may be other mechanisms, such as re-evaluation that would be better suited to responding to the identified risks.
[38] The letter listed the evidence submitted by the applicant: six documents related to health risks, two documents related to environmental risks, two court decisions, an annex from the UN Human Rights Council, and a media article reporting on the results of a study included in the above.
[39] With regard to the health concerns, the Regulatory Agency stated that the overall conclusion of the evidence presented is that POEA formulants make glyphosate-containing products more toxic than those without the added POEA. But the letter states that all of the studies presented by the applicant were performed in vitro using cell cultures. In contrast, the letter states that the Regulatory Agency considers in vivo studies, which are conducted in more realistic settings, to be more indicative of the risks:
Although information from in vitro studies is considered in the overall assessment of a product, in vivo studies by various routes (oral, dermal, inhalation) are more representative of the hazard potential. PMRA assessments such as those that were conducted for glyphosate products containing POEA are based primarily on in vivo studies.
[40] The letter further stated that the data presented in one study, “An exploratory analysis of the effect of pesticide exposure on the risk of spontaneous abortion in an Ontario farm population,” were not convincing, due to the nature of the study itself, which included “unvalidated self-reported exposure information and lack of control for potentially important confounding factors such as maternal age.”
[41] As stated above, the applicant did not challenge this health risk finding before the Court.
[42] With regard to the environmental risks raised by the applicant, the Regulatory Agency recognized the danger posed to aquatic organisms:
In response to environmental concerns (documents 1 and 8), the PMRA recognizes the toxicity of glyphosate formulations to aquatic organisms and that the toxicity of those formulations is at least in part attributable to the surfactant, POEA.
[43] The Regulatory Agency stated, however, that no registered uses of glyphosate allow for direct application to water. The Regulatory Agency further concluded that existing measures are effective at protecting amphibians:
Based on the currently available toxicity data, it is expected that the existing mitigation measures on labels, that limit drift into aquatic systems from agricultural uses, will be protective of amphibians in small ephemeral wetlands. Labels for forestry uses also indicate that appropriate buffer zones should be maintained for the protection of aquatic species.
There is insufficient new evidence of unacceptable risk to amphibians in the submitted information to support a special review of environmental effects. The upcoming re-evaluation of glyphosate will include consideration of amphibians and of the surfactant POEA.
[44] The Regulatory Agency concluded that the applicant had failed to bring enough new evidence of unacceptable risk to amphibians to support a special review. While the letter mentioned existing mitigation measures for forestry uses of the pesticide, it did not address the risk raised by the BC Literature Review – namely, the risk to amphibians in ephemeral wetlands when the pesticide is aerially sprayed in clear cut areas, which are not currently covered by the existing mitigations measures.
[45] The Regulatory Agency noted further that an upcoming re-evaluation of glyphosate would include “consideration of amphibians and of the surfactant POEA.”
[46] With regard to the applicant’s claims under section 17(2) of the Act, the Regulatory Agency found that Australia does not prohibit all uses of glyphosate, but rather has restricted uses allowing for direct application to water. The Regulatory Agency repeated that no such uses are approved in Canada. With regard to the applicant’s arguments under section 17(3), the Regulatory Agency stated that the literature review published by the government of British Columbia did not give grounds for a special review for the reasons stated with regard to section 17(1). The applicant did not challenge these two parts of the decision.
[47] As for the precautionary principle, the Regulatory Agency stated that the entire process by which products are registered under the Act incorporates the precautionary principle:
The PMRA wishes to assure you that the approach, which the PCPA prescribes for PMRA regulatory activities, is inherently precautionary. This applies to all product registrations, including glyphosate herbicides containing POEA. The Act places the onus on industry to conduct extensive scientific testing that will enable the PMRA to thoroughly evaluate a pesticide and consider its acceptability. PMRA evaluators use conservative assumptions in assessing health and environmental risks and when prescribing protective measures such as conditions of registration. A pesticide is only registered for use or sale in Canada if the rigorous scientific assessment process provides reasonable certainty that no harm to human health, future generations or the environment will result when the product is used according to label instructions.
The very high standard of “acceptable risk” imposed by the Act in a pre-market approval regulatory system is designed to prevent pest control products from posing the types of threat of harm identified in the Rio Declaration. However, Section 20 of the Act does make provision for the use that particular precautionary approach on an interim basis if, in the course of a re-evaluation or special review, it is determined to be appropriate pending completion of the process. Once the re-evaluation or special review is completed, if it is determined that the product no longer meets the acceptable risks or value standard the registration must be amended or cancelled, as the case may be, in accordance with subsection 21(2).
[48] The Regulatory Agency found that the current risk mitigation measures in place for the impugned pesticides “are appropriate until a re-evaluation of glyphosate-containing products is considered.” The Regulatory Agency found that the applicant’s evidence did not provide reasonable grounds for finding unacceptable health or environmental risks.
[49] The Regulatory Agency informed the applicant that a re-evaluation of glyphosate was anticipated in the near future. The re-evaluation would be conducted jointly with the United States Environmental Protection Agency. The US Environmental Protection Agency had published its initial workplan for that project on July 22, 2009, and acknowledged that the US would be working cooperatively with the Regulatory Agency. It informed the applicant that there is a public request for data involved in that process, and that the applicant could re-submit her information at that time.
[50] The decision repeatedly referred to the re-evaluation under section 16 suggesting that a special review under section 17 was therefore not necessary. The decision stated as follows:
On page 1: “…If risk concerns are recognized, the PMRA also considers whether there are other mechanisms, such as re-evaluation that may be better suited to responding to the risk concerns than a special review.”
On page 2: “There is insufficient new evidence of unacceptable risk to amphibians in the submitted information to support a special review of environmental effects. The upcoming re-evaluation of glyphosate will include consideration of amphibians and of the surfactant POEA.”
On page 4: “The PMRA has determined that the current risk mitigation measures in place for glyphosate (including no registered uses for direct application to water and other risk mitigation measures to minimise non-target exposures from spray drift)” are appropriate until a re-evaluation of glyphosate-containing products is conducted.”
On page 4: “Based on the overall assessment of your request, the PMRA has determined that the information submitted does not meet the requirements to invoke a special review. However, the PMRA will address concerns around the potential environmental risks associated with POEA in the broader re-evaluation of all glyphosate products. While this may entail additional work due to the broader scope, this will lead to a more complete consideration of the concerns.”
On page 4: “The PMRA anticipates that the re-evaluation of glyphosate will be officially announced within the year and will include particular consideration of glyphosate products containing POEA.”
On page 4: “One of the initial steps of the re-evaluation will be a public request for data to address specific topics. We appreciate your interest in the regulation of pesticides and would encourage you to submit any additional information regarding glyphosate at that time.”
LEGISLATION
[51] The Minister’s objectives in administering the Pest Control Products Act, S.C. 2002, c. 28, are set out in section 4:
4.(1) In the administration of this Act, the Minister’s primary objective is to prevent unacceptable risks to people and the environment from the use of pest control products.
(2) Consistent with, and in furtherance of, the primary objective, the Minister shall
(a) support sustainable development designed to enable the needs of the present to be met without compromising the ability of future generations to meet their own needs;
(b) seek to minimize health and environmental risks posed by pest control products and encourage the development and implementation of innovative, sustainable pest management strategies by facilitating access to pest control products that pose lower risks and by other appropriate measures;
(c) encourage public awareness in relation to pest control products by informing the public, facilitating public access to relevant information and public participation in the decision-making process; and
(d) ensure that only those pest control products that are determined to be of acceptable value are approved for use in Canada.
4.1 For greater certainty, protection and consideration afforded to children in this Act shall also extend to future generations.
4.(1) Pour l’application de la présente loi, le ministre a comme objectif premier de prévenir les risques inacceptables pour les personnes et l’environnement que présente l’utilisation des produits antiparasitaires.
(2) À cet égard, le ministre doit :
a) promouvoir le développement durable, soit un développement qui permet de répondre aux besoins du présent sans compromettre la possibilité pour les générations futures de satisfaire les leurs;
b) tenter de réduire au minimum les risques sanitaires et environnementaux que présentent les produits antiparasitaires et d’encourager le développement et la mise en oeuvre de stratégies de lutte antiparasitaire durables et innovatrices — en facilitant l’accès à des produits antiparasitaires à risque réduit — et d’autres mesures indiquées;
c) sensibiliser le public aux produits antiparasitaires en l’informant, en favorisant son accès aux renseignements pertinents et en encourageant sa participation au processus de prise de décision;
d) veiller à ce que seuls les produits antiparasitaires dont la valeur a été déterminée comme acceptable soient approuvés pour utilisation au Canada.
4.1 Il est entendu que la protection et la considération que la présente loi accorde aux enfants s’étendent aux générations futures.
[52] The Act defines “environmental risk” and “pest” in section 2(1):
“environmental risk”, in respect of a pest control product, means the possibility of harm to the environment, including its biological diversity, resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
« risque environnemental » Risque de dommage à l’environnement, notamment à sa diversité biologique, résultant de l’exposition au produit antiparasitaire ou de l’utilisation de celui-ci, compte tenu des conditions d’homologation proposées ou fixées.
“pest” means an animal, a plant or other organism that is injurious, noxious or troublesome, whether directly or indirectly, and an injurious, noxious or troublesome condition or organic function of an animal, a plant or other organism.
« parasite » Animal, plante ou autre organisme qui est, directement ou non, nuisible, nocif ou gênant, ainsi que toute fonction organique ou condition nuisible, nocive ou gênante d’un animal, d’une plante ou d’un autre organisme.
[53] The definition of a “pest control product” is also established in section 2(1) of the Act:
“pest control product” means
(a) a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;
(b) an active ingredient that is used to manufacture anything described in paragraph (a); or
(c) any other thing that is prescribed to be a pest control product.
« produit antiparasitaire »
a) Produit, substance ou organisme — notamment ceux résultant de la biotechnologie — constitué d’un principe actif ainsi que de formulants et de contaminants et fabriqué, présenté, distribué ou utilisé comme moyen de lutte direct ou indirect contre les parasites par destruction, attraction ou répulsion, ou encore par atténuation ou prévention de leurs effets nuisibles, nocifs ou gênants;
b) tout principe actif servant à la fabrication de ces éléments;
c) toute chose désignée comme tel par règlement.
[54] The definition of what constitutes an “acceptable risk” is set out in section 2(2):
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 dommag