Docket: T-1604-09
Citation: 2011 FC 1322
Ottawa, Ontario, November 21, 2011
PRESENT: The Honourable Mr. Justice Kelen
BETWEEN:
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JOSETTE WIER
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Applicant
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and
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THE MINISTER OF HEALTH
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Respondent
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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.
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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.
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[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.
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«
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.
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“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.
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«
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.
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[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.
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« 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.
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[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.
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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.
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[55]
The
Act prohibits the use of unregistered pest control products in section 6(1):
6.
(1) No person shall manufacture, possess, handle, store, transport, import,
distribute or use a pest control product that is not registered under this
Act, except as otherwise authorized under subsection 21(5) or 41(1), any of
sections 53 to 59 or the regulations.
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6. (1)
Sauf dans les cas autorisés par les paragraphes 21(5) et 41(1), les articles
53 à 59 et les règlements, il est interdit de fabriquer, de posséder, de
manipuler, de stocker, de transporter, d’importer, de distribuer ou
d’utiliser un produit antiparasitaire non homologué en vertu de la présente
loi.
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[56]
Section
6(5) prohibits the misuse of pest control products:
6. (5)
No person shall handle, store, transport, use or dispose of a pest control
product in a way that is inconsistent with
(a)
the regulations; or
(b)
if the product is registered, the directions on the label recorded in the
Register, subject to the regulations.
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6. (5)
No person shall handle, store, transport, use or dispose of a pest control
product in a way that is inconsistent with
(a)
the regulations; or
(b)
if the product is registered, the directions on the label recorded in the
Register, subject to the regulations.
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[57]
The
penalties for committing the above offences are stated in section 6(9):
6. (9) A
person who contravenes any provision of this section is guilty of an offence
and liable
(a) on summary
conviction, to a fine of not more than $200,000 or to imprisonment for a term
of not more than six months, or to both; or
(b) on
conviction on indictment, to a fine of not more than $500,000 or to
imprisonment for a term of not more than three years, or to both.
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6. (9)
Quiconque contrevient à toute disposition du présent article commet une
infraction et encourt, sur déclaration de culpabilité :
a) par
procédure sommaire, une amende maximale de 200 000 $ et un emprisonnement
maximal de six mois, ou l’une de ces peines;
b) par
mise en accusation, une amende maximale de 500 000 $ et un emprisonnement
maximal de trois ans, ou l’une de ces peines.
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[58]
Section
16(1) gives the Minister discretion to initiate a re-evaluation under the Act,
subject to the requirements in section 16(2):
16.
(1) 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 of pest
control products of the same class or kind.
(2)
Without limiting the generality of subsection (1),
(a)
if a decision of a type referred to in paragraph 28(1)(a) or (b) was made in
relation to a pest control product on or after April 1, 1995, the Minister
shall initiate a re-evaluation of that product no later than one year after
15 years have elapsed since the most recent decision of that type; and
(b)
if the most recent decision of a type referred to in paragraph 28(1)(a) or
(b) was made in relation to a pest control product before April 1, 1995, the
Minister shall initiate a re-evaluation of that product no later than April
1, 2005 or the date that is one year after 15 years have elapsed since that
decision, whichever date is later.
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16.
(1) Le ministre peut procéder à la réévaluation d’un produit antiparasitaire
homologué s’il estime que, depuis son homologation, il y a eu un changement
en ce qui touche les renseignements exigés ou la procédure à suivre pour
l’évaluation de la valeur des produits de même catégorie ou de même nature ou
des risques sanitaires ou environnementaux qu’ils présentent.
(2)
Sans que soit limitée la portée générale du paragraphe (1) :
a)
lorsqu’une décision sur l’homologation d’un produit antiparasitaire, du même
type que celle visée aux alinéas 28(1)a) ou b), est prise le 1er avril 1995
ou après cette date, le ministre procède à une réévaluation du produit au
plus tard un an après la période de quinze ans écoulée depuis la plus récente
décision de ce type;
b)
lorsque la plus récente décision sur l’homologation d’un produit
antiparasitaire, du même type que celle visée aux alinéas 28(1)a) ou b), a
été prise avant le 1er avril 1995, le ministre procède à une réévaluation du
produit au plus tard le 1er avril 2005 ou, si cette date est postérieure, la
date qui suit d’un an la période de quinze ans écoulée depuis la décision.
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[59]
The
requirement that the Minister conduct a special review in certain circumstances
is contained in section 17 of the Act:
17. (1) The
Minister shall initiate a special review of the registration of a pest
control product if the Minister has reasonable grounds to believe that the
health or environmental risks of the product are, or its value is,
unacceptable.
(2) Without
limiting the generality of subsection (1), when a member country of the
Organisation for Economic Co-operation and Development prohibits all uses of
an active ingredient for health or environmental reasons, the Minister shall
initiate a special review of registered pest control products containing that
active ingredient.
(3) Without
limiting the generality of subsection (1), the Minister shall initiate a
special review of the registration of a pest control product if a federal or
provincial government department or agency has provided information to the
Minister that relates to the health or environmental risks or the value of
the product and if, after considering the information provided, the Minister
has reasonable grounds to believe that the health or environmental risks of
the product are, or its value is, unacceptable.
(4) Any
person may request a special review of the registration of a pest control
product by making a request to the Minister in the form and manner directed
by the Minister.
(5) Within
a reasonable time after receiving a request, the Minister shall decide
whether to initiate a special review and shall respond to the request with
written reasons for the decision.
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17. (1) Le
ministre procède à l’examen spécial de l’homologation du produit
antiparasitaire lorsqu’il a des motifs raisonnables de croire que la valeur
du produit ou les risques sanitaires ou environnementaux qu’il présente sont
inacceptables.
(2) Sans
que soit limitée la portée générale du paragraphe (1), lorsqu’un pays membre
de l’Organisation de coopération et de développement économiques interdit
l’utilisation d’un principe actif pour des raisons sanitaires ou
environnementales, le ministre procède à l’examen spécial des produits
antiparasitaires homologués contenant ce principe actif.
(3) Sans
que soit limitée la portée générale du paragraphe (1), le ministre procède à
l’examen spécial de l’homologation du produit antiparasitaire lorsqu’un
ministère ou organisme public fédéral ou provincial lui fournit les
renseignements relatifs aux risques sanitaires ou environnementaux ou à la
valeur du produit visé et, à la suite de l’étude de ces renseignements, le
ministre a des motifs raisonnables de croire que la valeur du produit ou les
risques sanitaires ou environnementaux qu’il présente sont inacceptables.
(4) Toute
personne peut faire une demande d’examen spécial au ministre, en la forme et
de la façon qu’il précise.
(5) Dans
un délai raisonnable suivant la réception de la demande, le ministre décide
s’il procède ou non à l’examen et communique à son auteur sa décision en la
motivant par écrit.
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ISSUES
[60]
The
applicant raises the following issues on this judicial review application:
1.
Did the
Minister err by only considering “new evidence”, and by failing to consider the
entire body of evidence relevant to the existence of an environmental risk,
including information that he had prior to the applicant’s request?
2.
Did the
Minister err by concluding that a mandatory special review under section 17 is
not required if he intends to engage in a periodic review under section 16 of
the Act in the near future?
3.
Did the
Minister err in interpreting the evidentiary threshold required to initiate a
special review under section 17?
4.
Did the
Minister err in his interpretation of his statutory obligation to apply the
precautionary principle?
5.
Was the
Minister’s finding, that glyphosate herbicides containing POEA do not present
an unacceptable risk, unreasonable?
[61]
The
respondent raises a sixth issue: whether relief should be granted. Although an
earlier motion to strike the application as moot was dismissed, the respondent
submits that the applicant is not entitled to relief because there is little or
no practical value to her of such relief, and refusing to grant the relief is
in the public interest. This is because a re-evaluation pursuant to section 16
of the Act was commenced in November 2009. Thus, were the Minister to
reconsider his decision and order a special review under section 17, the
respondent submits this would simply replicate the work that has already begun
pursuant to section 16.
STANDARD OF REVIEW
[62]
In
New Brunswick (Board of Management) v. Dunsmuir, 2008 SCC 9, the Supreme
Court of Canada held at paragraph 62 that the first step in conducting a
standard of review analysis is to "ascertain whether the jurisprudence has
already determined in a satisfactory manner the degree of (deference) to be
accorded with regard to a particular category of question": see also Khosa
v. Canada (Minister of Citizenship & Immigration), 2009 SCC 12, per
Justice Binnie at paragraph 53.
[63]
This
application seeks to review a decision of the Minister under section 17 of the
Act. The provision requires the Minister to initiate a special review where he
finds reasonable grounds for believing that health or environmental risks
associated with a product use are unacceptable.
[64]
Neither
party has pointed the Court to a case in which the standard of review of a
Minister’s decision under this section of the Act was considered. The
respondent did, however, rely on a 1994 decision of the Federal Court of
Appeal, Pulp, Paper and Woodworkers of Canada Local 8 v. Canada (Minister of
Agriculture, Pesticides Directorate) (F.C.A.), [1994] F.C.J.
No. 1067 (Q.L.), reviewing a decision of the Minister to register a product
under the former version of the Act. The case is useful insofar as it discusses
the scope of a Minister’s discretion under the Act.
[65]
In
Pulp, Paper and Woodworkers of Canada, the Court
of Appeal considered an appeal from a Federal Court decision granting the
applicant a writ of certiorari to quash a decision by the Minister to register
a pesticide as a controlled product. The legislation at issue was similar to
that applicable in this case. There, the Minister had discretion, under section
18 of the former Act, to refuse to register a product when the Minister felt
that he did not have enough information to assess or evaluate the product, or
felt that the use of the product would lead to an unacceptable risk of harm to
public health. The Court of Appeal stated the following with regard to the
standard a court should use in reviewing a Minister’s decision in these
circumstances (references omitted):
¶25. It
follows, from section 18, that once the necessary information is before the
Minister, a court of law has no jurisdiction to question the sufficiency of
that information. The trial judge was, therefore, in error when he proceeded to
analyze the lack of depth of Ralph's [Mr. C.D. Ralph, the Product Management
Division of the Pesticides Directorate of the Department of Agriculture and
Minister’s delegate] evaluation and research since it was clear from the
affidavit that Ralph had addressed his mind to the nature and quality of the
information he had received. The trial judge certainly went too far when he
concluded that "[e]ven if the Minister addressed his mind to the
appropriate question and found that the information supplied in relation to the
application for registration of Busan 30WB was sufficient to enable the control
product to be assessed and evaluated, the Minister nevertheless exceeded his
authority in exercising his discretion to cause Busan 30WB to be registered
because the sufficiency decision was patently in error". In the case of Re
Maple Lodge Farms Ltd. and Government of Canada, McIntyre J., for the
Supreme Court of Canada, made it very clear that:
...
It is, as well, a clearly-established rule that the courts should not interfere
with the exercise of a discretion by a statutory authority merely because the
court might have exercised the discretion in a different manner had it been
charged with that responsibility.
[66]
Subsequent
jurisprudence has reinforced this approach. Thus, the Court will evaluate the
Minister’s interpretations of the legal standards applicable to him on a
standard of correctness, but once the Minister has correctly interpreted his
duties, his exercise of discretion in performing those duties will be reviewed
on a standard of reasonableness: see also, Dunsmuir, above, at paragraphs
47, 49-50, and 53.
[67]
Issues
1 and 5 raised by the applicant challenge the Minister’s evaluation of the
evidence and application of the evidence to the law. These are reviewable on a
standard of reasonableness.
[68]
The
remaining issues concern the Minister’s interpretation of the legal
requirements of the Act. These are not areas within the Minister’s specialized
area of expertise and there is no privative clause that suggests a more
deferential standard should apply to the Minister’s legal interpretations. As
such, they are to be reviewed on a standard of correctness: see Dunsmuir
at paragraph 55.
ANALYSIS
Statutory Framework of the
Pest Control Products Act
[69]
The
Act’s objectives are stated in section 4. Subsection 4(1) states that the
Minister’s “primary” objective in administering the Act is to “prevent
unacceptable risks to people and the environment from the use of pest control
products.”
[70]
Companies
seeking to sell a pest control product in Canada must submit
an application for registration to the Regulatory Agency, which is an agency of
experts that the Minister has charged with administering the Act and Regulations.
The Regulatory Agency has a detailed process of review and analysis that it
undertakes prior to making its decision regarding the registration of a
pesticide.
[71]
A
pesticide’s registration under the Act includes a number of details, including
conditions relating to the manufacture, use, composition, labelling of the
product, and the period for which the registration is valid. Products are registered
for specific uses, and if registrants want to expand a product’s registered
uses, they must re-apply to the Regulatory Agency and provide any additional
required data.
[72]
Once
a pesticide is registered, its registration is maintained subject to additional
evaluations that may be undertaken by the Minister. There are two ways in which
such evaluations occur. First, “re-evaluations” pursuant to section 16 of the
Act are conducted periodically (such as every 15 years) or where the Minister
believes that evaluation procedures or information requirements for the
pesticide’s registration have changed since the product was registered.
[73]
Second,
“special reviews” pursuant to section 17 of the Act must be initiated where the
Minister “has reasonable grounds to believe that the health or environmental
risks of the pesticide are, or its value is, unacceptable”; where “a member
country of the Organisation for Economic Co-operation and Development prohibits
all uses of an active ingredient for health or environmental reasons”; or where
a federal or provincial government has alerted the Minister to information that
the Minister thinks provide reasonable grounds for finding that the risks to
health or the environment are unacceptable.
[74]
Any
person may make a request that the Minister initiate a special review of the
safety of a particular pesticide under subsection 17(4) of the Act. This
ensures that any individual in Canada worried about the safety of a pesticide
can have its safety examined by the scientific experts.
[75]
The
Minister has an obligation to initiate a review under section 17(1), if the
Minister has reasonable grounds to believe that the health or environmental
risks of the pesticide are unacceptable, or the value of the pesticide is
unacceptable. As provided in section 4 of the Act, the Minister’s primary
objective is to prevent unacceptable risks to people and the environment from
the use of pest control products.
[76]
In
determining whether a product poses an unacceptable risk under section 17, the
Regulatory Agency has a review process, described above in paragraph 21.
The Court’s Analysis of the
Request for Special Review in this Case
[77]
The
request for a special review of glyphosate herbicides containing POEA was
contained in a 29 page letter dated May 25, 2009 together with a binder of
studies referred to in the letter. The grounds for a special review were “the
enclosed significant new evidence which establishes reasonable grounds to
believe the health or environmental risks” of the pesticide in issue are unacceptable.
[78]
The
letter referred to several medical studies which the letter said raise
reasonable grounds to believe that the health risks of the pesticides are
unacceptable, “because they adversely affect human reproduction and
development; cause endocrine disruption and may cause cancer”. At the hearing
of this application for judicial review, the applicant abandoned these “health
risks” as a ground for review. Accordingly the applicant did not challenge the
respondent’s decision that there was not evidence to support a special review
of health effects of the pesticide in issue.
[79]
Another
ground for the review was “new evidence of toxicity to amphibians”, in
particular the silvicultural use of this pesticide. The decision under review
recognized the toxicity of the pesticide to aquatic organisms including
amphibians. This evidence was known to the respondent and it was for this
reason that there are as a result mitigation measures existed, namely labels
restricting the use of the pesticide to, inter alia:
1. “avoid direct applications to
any body of water”,
2. “avoid drifting of
spray on to any body of water or other non-target areas”,
3. “Specified buffer
zones should be observed”, and
4. “avoid the drift
hazard when aerially treating silvicultural sites by ensuring that appropriate
buffer zones are maintained”
[80]
The
applicant did not challenge this part of the decision, i.e. avoiding bodies of
water mitigates the toxicity to amphibians. Accordingly, the main reasons
allegedly submitted for the need for a special review in the 29 page letter
with attached studies were not maintained at the hearing before the Court.
Rather, at the hearing, the applicant relied on one narrow aspect in one of the
studies submitted with the request. This aspect is referred to in two places in
the 29 page letter.
[81]
The
only aspect of the request for review relied on by the applicant at the hearing
is referred to in two places in the 29 page letter: the possible environmental
risk to amphibians in ephemeral wetlands from the silvicultural use of the
pesticide. Accordingly, the only basis for the request for special review which
is still in contention by the applicant relies upon the BC Literature Review
which states in its Executive Summary…
…There is insufficient information on the
levels of glyphosate contamination in small ephemeral wetlands, which are
favoured habitats of amphibians, and which may be exposed to direct over
spraying with herbicide under current use guidelines…
[82]
These
ephemeral wetlands are transitory wetlands which come and go in the clear cut
areas where the forest has been replanted. The BC Literature Review states
that:
Glyphosate herbicides are applied once
during the silvicultural cycle (50 – 80 years), primarily during summer and
early fall (July – September), but applications are repeated if further weed
suppression is required.
The concern
raised by the BC Report is that there is insufficient information on the levels
of this pesticide in these transitory wetlands which are used by frogs and
salamanders. The BC Literature Review concludes that these knowledge gaps need
to be addressed.
[83]
Accordingly,
this 29 page request was virtually withdrawn by counsel for the applicant at
the hearings and only proceeded on the alleged environmental risk to amphibians
in small transitory wetlands in the forest.
Issue 1: Did the Minister err by only
considering “new evidence”, and by failing to consider the entire body of
evidence relevant to the existence of an environmental risk, including
information that he had prior to the applicant’s request?
[84]
The
applicant submits that the Minister had a duty to consider all evidence in the
Minister’s possession regarding potential risks posed by POEA-containing
glyphosate products that had arisen since the Minister’s last evaluation of the
products. The applicant submits that by framing one of the four questions as
“Are the studies new or have they been reviewed by the PMRA previously?” the
Minister excluded from consideration those studies that had been reviewed
already by the Regulatory Agency after the registration of the product, and so
had not been subject to risk analysis under review.
[85]
The
applicant submits that even if scientists at the Regulatory Agency were aware
of developments in the literature, the Minister had an obligation to formally
consider that evidence as a possible basis for a special review. In particular,
the applicant submits that the fact that the Regulatory Agency had been
consulted on, and discussed, the BC Literature Review did not give it grounds
to escape evaluating this report in terms of the risks that it raised.
[86]
The
respondent submits that the Regulatory Agency did consider all of the
information in its possession, including that which was not included in the
applicant’s request materials. Furthermore, the respondent submits that the
language chosen by the Minister was chosen in part to reflect the applicant’s
own characterization of her evidence as “new” because it post-dated the
products’ registration.
[87]
The
Court agrees with the applicant that the Minister had an obligation to consider
all of the evidence in determining whether there are reasonable grounds for
finding a risk unacceptable. The Act specifies neither that the evidence
presented in the request for a special review be significant nor new – this was
language chosen by the applicant as grounds for initiating the special review.
[88]
The
Court agrees with the respondent, however, that the Minister understood her
duty. The reports submitted by the scientists indicate that they were
evaluating the applicant’s evidence in light of their existing knowledge, which
included all of the evidence in their possession. The Minister’s conclusion was
not that the evidence had already been considered and therefore did not present
reasonable grounds for believing there to be an unacceptable risk, but that the
evidence did not raise any concerns that there was an unacceptable risk. That
is, the Minister’s concern with the novelty of the evidence was properly
focused on whether the evidence changed any of the analysis that had already
been undertaken at the time that the pesticides were registered.
Issue 2: Did the Minister err by
concluding that a mandatory special review under section 17 is not required if she
intends to engage in a re-evaluation under section 16 of the Act at some point
in the future?
[89]
The
applicant submits that the Minister is not entitled to find that a special
review is not necessary because a re-evaluation is planned. The applicant
submits that the Minister’s discretion under section 17 is limited to determining
whether there are reasonable grounds to believe that there is an unacceptable
risk. If the Minister so finds, the Minister “shall” initiate a special review.
The applicant submits that the Minister has no discretion to substitute a
future re-evaluation in such circumstances.
[90]
The
respondent submits that the Minister did not refuse the applicant’s request
because a re-evaluation was to be undertaken. Rather, the Minister refused the
applicant’s request because the Minister found that there were not reasonable
grounds to believe that the products pose an unacceptable environmental risk.
This decision was based on an evaluation of all of the evidence and the
findings of the Regulatory Agency’s scientists. The respondent notes that the
following key factors played into the Minister’s decision:
1.
The
Regulatory Agency was aware of the toxicity of glyphosate end-use products
containing POEA and had put in place mitigation measures to address concerns
about harm to aquatic species in agricultural settings, especially by
preventing the direct application of the products to water. The applicant’s
information did not alter the Regulatory Agency’s assessments in this regard.
2.
In
particular, what evidence the applicant submitted that may have changed the
risk assessment was found to be not convincing because it was done in a
laboratory setting as opposed to in more realistic settings. Field studies
showed no significant adverse effects under actual use conditions.
3.
Mitigation
measures were already in place to protect organisms that are significantly
sensitive to the application of glyphosate end-use products like amphibians.
[92]
The
decision did not explicitly address the alleged risk of the pesticide to
amphibians in ephemeral wetlands, which are aerially sprayed in silviculture.
However, the letter did repeatedly (six times) refer to the re-evaluation of
the pesticide under section 16 suggesting that a special review under section
17 was therefore not necessary. The decision stated:
1.
…there are
other mechanisms, such as re-evaluations that may be better suited to
responding to the risk concerns that a special review.
2.
…The
upcoming re-evaluation of glyphosate will include the consideration of
amphibians and of the surfactant POEA.
3.
…mitigation
measures…are appropriate until a re-evaluation is conducted.
4.
…The PMRA
will address concerns…in the broader re-evaluation…this will lead to a more
complete consideration of the concerns.
5.
…the
re-evaluation of glyphosate will be officially announced within the year and
will include particular consideration of glyphosate products containing POEA.
6.
…a public
request for data to address specific topics…encourage you to submit any
additional information regarding glyphosate at that time.
From these
six references in the decision, the Court can only conclude that the respondent
fettered her discretion under section 17 because a section 16 re-evaluation of
the same environmental risks was planned. The Court concludes that the Minister
erred in law by misinterpreting the mandatory wording of section 7 which
requires that a “special review” be conducted regardless of whether a section
16 re-evaluation is planned or is underway.
Issue 3: Did the Minister err in
interpreting the evidentiary threshold required to initiate a special review
under section 17?
[93]
The
applicant submits that the Minister applied a wrong test to the determination
of whether to initiate a special review. The applicant submits that the
Minister required the applicant to establish an unacceptable risk, rather than
requiring only that the applicant establish “reasonable grounds to believe that
there may be a possibility of a risk to the environment.”
[94]
The
respondent submits that the four questions used by the Regulatory Agency were
derived from the “Criteria for a special review” developed by the Regulatory
Agency in 2007. According to these criteria, a special review is not required
if the active ingredient is under re-evaluation; the risk concern is imminent
in nature so that immediate regulatory action will be taken instead; the concern
can be addressed more quickly through other existing mechanisms, the Regulatory
Agency has done an assessment addressing the concern; or the information does
not change the current risk assessment.
[95]
The
respondent submits that these criteria are consistent with the Act because they
are specifically designed to further the Act’s purpose of protecting Canadians.
The respondent submits that this purpose is furthered when the Regulatory
Agency is able to draw on a number of possible responses to potential dangers.
In some cases, for example, where risk is imminent, immediate regulatory action
will further the aims of the Act better than a special review. In others, for
example, where a re-evaluation is underway, a special review will be
superfluous and simply take resources from more efficient uses.
[96]
Finally,
the respondent submits that the Minister has the authority under section 20(1)
of the Act to immediately cancel or amend a product registration during the
course of a re-evaluation or a special review if the Minister has reasonable
grounds to believe that such a step is necessary to protect human health or
safety or the environment.
[97]
With
regard to the proper test that the Minister must use to determine whether to
initiate a special review under section 17(1) of the Act, the Court finds that
“reasonable grounds to believe that the health or environmental risks of the
product are, or its value is, unacceptable” means the Minister has compelling
and credible evidence that gives rise to a serious possibility that the
pesticide may cause an unacceptable health or environmental risk. From another
statutory perspective, in accordance with the definition of an “acceptable”
risk in subsection 2(2) of the Act, the Minister is reasonably certain that the
pesticide will cause no harm to human health or the environment taking into
account its conditions of use. “Reasonable grounds” was explained by the
Supreme Court of Canada in Mugesera v. Canada (Minister of
Citizenship and Immigration), 2005 SCC 40, at paragraph 114:
¶114
The first issue raised by s. 19(1)(j) of the Immigration Act is the meaning of
the evidentiary standard that there be “reasonable grounds to believe” that a
person has committed a crime against humanity. The FCA has found, and we agree,
that the “reasonable grounds to believe” standard requires something more than
mere suspicion, but less than the standard applicable in civil matters of proof
on the balance of probabilities: Sivakumar v. Canada (Minister of Employment
and Immigration), [1994] 1 F.C. 433 (C.A.), at p. 445; Chiau v. Canada
(Minister of Citizenship and Immigration), [2001] 2 F.C. 297 (C.A.), at
para. 60. In essence, reasonable grounds will exist where there is an objective
basis for the belief which is based on compelling and credible information: Sabour
v. Canada (Minister of Citizenship
& Immigration)
(2000), 9 Imm. L.R. (3d) 61 (F.C.T.D.).
[98]
Based
on the record before the Court upon which this decision was made, there is
conflicting evidence that the pesticide in issue presents an acceptable risk to
amphibians in ephemeral wetlands which are aerially sprayed with the pesticide
in silviculture. The briefing notes for the Science Operations Committee and
the Science Management Committee and the draft letter all recognize that there
is an uncertainty about whether the pesticide will harm amphibians in this
environment. The Regulatory Agency recognizes that the pesticide is toxic to
amphibians in bodies of water and for this reason the pesticide cannot be
sprayed over or close to bodies of water. On the other hand, Dr. Delorme and an
official at the Environmental Risk Directorate were of the opinion that the
field studies done by the Canadian Forestry Service showed that there was no
environmental risk to amphibians in ephemeral wetlands as a result of the
pesticide. However, there were no reports of these field studies or any other
documentary evidence in the record before the decision-maker in this case.
Accordingly the Court finds that the Minister did err in interpreting the
evidentiary threshold required to initiate a special review under section 17 of
the Act with respect to one small aspect of the request.
[99]
The
Minister’s decision to engage in a re-evaluation of glyphosate products under
section 16 of the Act demonstrates a concern with keeping product registrations
current. Section 16 permits the Minister to initiate a re-evaluation where the
Minister considers that procedures for evaluating products, or the information
required to register them, has changed since a product was registered. The re-evaluation
therefore allows the Minister to keep registrations current. The fact that the
Minister chose to initiate a re-evaluation is therefore not evidence that the
Minister believed that there were reasonable grounds for finding the risks
posed by glyphosate products are unacceptable.
Issue 4: Did the Minister err in his
interpretation of his statutory obligation to apply the precautionary
principle?
[100] Section 20(2)
of the Act 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.” The applicant submits that this section should
apply to the Minister’s determinations under section 17 of the Act.
[101] With opinions
within the Regulatory Agency on both sides of the question as to whether the
pesticide presents an unacceptable environmental risk to amphibians in
ephemeral wetlands, the precautionary principle would require that the Minister
initiate a special review into that issue.
Issue 5: Was the Minister’s finding
that glyphosate herbicides containing POEA do not present an unacceptable risk,
unreasonable?
[102] The applicant
submits that the findings of the BC Literature Review, the report of the
Regulatory Agency’s own scientists from the Environmental Assessment
Directorate, and the Minister’s own statement of risk in its decision,
demonstrate that the Minister’s decision is unreasonable.
[103] In Pulp,
Paper and Woodworkers of Canada, above, the Court of
Appeal stated the degree of deference to be given to the Minister in her
determinations of risks under the Act. In that case, the Court stated the
following, as quoted above:
It
follows, from section 18, that once the necessary information is before the
Minister, a court of law has no jurisdiction to question the sufficiency of
that information.
[104] As stated
above, the Minister’s decision will be reasonable where it is based on the
evidence, is justified, transparent and intelligible, and where it falls within
the range of acceptable outcomes.
[105] In this case,
there was evidence on both sides of the issue. The evidence relied upon my Dr.
Delorme that the Canadian Forestry Service had done field studies which showed
there was not an environmental risk to amphibians from this pesticide in
ephemeral wetlands was not consistent with the briefing notes prepared by the
scientists in the Regulatory Agency, was not consistent with the BC Literature
Review and was not consistent with the recognition by the Minister that a
re-evaluation of the environmental risk of the pesticide to amphibians in
ephemeral wetlands was necessary.
[106] Moreover, the
decision is not transparent or intelligible, because the decision does not
expressly address the narrow environmental risk at issue in this case. The
Court recognizes that the 29 page letter requesting the special review barely
referred to this narrow risk and instead emphasized a health risk and other
issues. Accordingly, it is understandable that the decision did not expressly
address this narrow risk. At the same time, since this application seeks review
on this narrow ground, the Court must concede that the decision is not
transparent or intelligible with respect to this risk. It would have been
preferable if the letter had referred to the Canadian Forestry Service field
studies and had specifically addressed the risk. Accordingly, the Court agrees
with the applicant that the Minister’s decision is not transparent or
intelligible with respect to the narrow risk at issue before the Court, and
that the evidence with respect to this risk is not properly documented in the
record such that it could be relied upon as the basis for the decision.
Issue 6: Should the Court Grant
Relief?
[107] The
respondent submits that even if the Court agrees that the Minister erred, the
Court should decline to refer the matter back to the Minister because there
will be little, if any, practical value to the applicant since the section 16
re-evaluation of the pesticide is underway. The Court does not agree. If the
criteria for a special review under section 17 have been met, Parliament
mandates that the Minister shall conduct the special review. The special review
can co-exist with the section 16 re-evaluation of the pesticide. The special
review will be narrower than the comprehensive re-evaluation being conducted in
the conjunction with the United States. For this reason, the
special review will be targeted and possibly quicker. The applicant is entitled
to a proper analysis as to whether the pesticide in issue presents an
environmental risk to amphibians inhabiting ephemeral wetlands which are
subject to the aerial spraying of the pesticide in silviculture. The evidence
alluded to is that the two year field studies have just been completed and that
the studies may present new evidence upon which the Minister can make a
transparent and intelligible decision under section 17 of the Act.
CONCLUSION
[108] For these
reasons, this application for judicial review will be allowed with costs and
the matter referred back to the Minister for reconsideration.
COSTS
[109] The
applicant is a public interest litigant concerned that the registered pesticide
“glyphosate containing POEA” presents a health and environmental risk and asks
the Minister of Health under the Act to initiate a “special review”. While this
application for judicial review is allowed, the Court notes that most of the grounds
for the applicant’s request for the special review were abandoned before this
Court at the hearing of the application. At the same time the application did
raise complex and important issues. For these reasons, the Court will exercise
its discretion under Rule 400 of the Federal Courts Rules over the
amount and allocation of costs in considering the factors set out in subsection
3 of Rule 400. Costs awarded to the applicant will be calculated under Tariff
B, Column III at the mid-point number of units allowed under that column.
JUDGMENT
THIS COURT’S JUDGMENT
is that:
1. This
application for judicial review is allowed with costs.
2. The decision
of the Minister of Health, dated August 24, 2009 not to initiate a “special
review” is set aside, and the matter is referred back to the Minister for
reconsideration in accordance with these reasons for judgment.
“Michael
A. Kelen”