Docket: T-2114-13
Citation:
2015 FC 1412
Ottawa, Ontario, December 22, 2015
PRESENT: The
Honourable Mr. Justice Zinn
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BETWEEN:
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ECOLOGY ACTION
CENTRE AND
LIVING OCEANS
SOCIETY
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Applicants
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and
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MINISTER OF THE
ENVIRONMENT, MINISTER OF HEALTH AND
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AQUABOUNTY
CANADA INC.
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Respondents
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JUDGMENT AND REASONS
Introduction
[1]
The application before the Court involves two
Ministerial decisions concerning a genetically engineered Atlantic salmon (Salmo
salar) containing a single copy of the opAFP-GHc2 transgene at the
EO-1α locus, known as the AquAdvantage Salmon [AAS].
[2]
Genetically modified food is controversial;
however, this application solely concerns two decisions made by the respondent
Ministers of the Environment and Health [collectively the Ministers]. The
issue is not whether the Ministers were right, but whether their decisions were
reasonable and made in conformity with the relevant legislation.
[3]
For the reasons that follow, I find that the
Ministers’ decisions were reasonable and were made in the manner prescribed by the
Canadian Environmental Protection Act, 1999, SC 1999, c 33 [CEPA]. Accordingly,
this application must be dismissed.
The Parties
[4]
The applicants are registered non-profit
societies committed to the public interest in marine environment protection.
The respondents accept that they are public interest litigants and have
standing to bring this application.
[5]
The Ministers have responsibilities under CEPA
and specifically in relation to the issues before the Court under Part 6
thereof entitled Animate Products of Biotechnology. Also relevant to
this application and the challenges brought by the applicants are the regulations
issued with respect to Part 6, the New Substances Notification Regulations
(Organisms), SOR/2005-248 [NSN Regs].
[6]
The respondent, AquaBounty Canada Inc. [AquaBounty]
is a biotechnology company that developed and owns the rights to AAS. It
claims that AAS grow to market size significantly more rapidly than wild or
farmed salmon. It operates a “secure land-based experimental/research
hatchery” in Souris, Prince Edward Island [the PEI Facility].
AquaBounty proposes to produce sterile, all female AAS eggs on a commercial
scale at the PEI Facility, which will be exported to a contained, land-based,
grow-out facility in Panama. In order to do so, AquaBounty was required to
make an application under Part 6 of CEPA. The decisions under review result
from that application.
The Application
[7]
The applicants make two general submissions:
1.
That the Minister of the Environment failed to
comply with the requirements of CEPA when on November 23, 2013, she published in
the Canada Gazette a Significant New Activity Notice [SNAc Notice] in
respect of AAS; and
2.
That the Ministers failed to obtain and assess
legally required information for the toxicity assessment they conducted under
section 108 of CEPA.
[8]
I propose to first set out the regulatory
framework in CEPA and the NSN Regs that are at play. I shall then outline the
relevant facts and the specific issues raised by the applicants. Lastly, I
will analyze the parties’ positions on those issues and the reasons for the
conclusions I have reached.
The
Regulatory Framework for Living Organisms
[9]
Part 6 of CEPA sets out a regulatory framework
for the assessment and approval of animate products of biotechnology [living
organisms]. The full text of Part 6 is attached as Annex A. This framework
revolves around a list maintained by the Minister of the Environment called the
Domestic Substances List [DSL].
[10]
If a living organism is not on the DSL, it
cannot be manufactured or imported unless certain prescribed information has
been provided to the Minister of the Environment [a New Substances Notification
or Notification] by the person wishing to do so [the Notifier], and the period
for assessing that information has expired: CEPA, subsection 106(1). The
living organism must be assessed as to whether it is toxic or capable of
becoming toxic: CEPA subsection 108(1). Section 64 of CEPA specifies that, for
the purposes of Part 6,
…a substance is toxic if it is entering or
may enter the environment in a quantity or concentration or under conditions
that
(a) have or may
have an immediate or long-term harmful effect on the environment or its
biological diversity;
(b) constitute
or may constitute a danger to the environment on which life depends; or
(c) constitute
or may constitute a danger in Canada to human life or health.
An organism that
meets or is capable of meeting the definition in section 64 of CEPA is described
as being CEPA-toxic.
[11]
In the case of AAS, section 4 of the NSN Regs
specifies that the Notifier must provide the information set out in Schedule 5
of the NSN Regs. Schedule 5 includes, in paragraph 3(b), information with
respect to “the intended and potential uses of the
organism, and the potential locations of introduction” and, in paragraph
5(a), “the data from a test conducted to determine its
pathogenicity, toxicity or invasiveness.” The prescribed information
set out in Schedule 5 must be provided at least 120 days before the Notifier manufactures
or imports the organism: NSN Regs, paragraph 5(d).
[12]
The Notifier may request the Ministers to waive any
of the information requirements imposed by Schedule 5, and the Ministers may do
so if one of the three conditions set out in subsection 106(8) apply; namely
if:
(a) in the opinion of the Ministers, the
information is not needed in order to determine whether the living organism is
toxic or capable of becoming toxic;
(b) a living organism is to be used for a
prescribed purpose or manufactured at a location where, in the opinion of the
Ministers, the person requesting the waiver is able to contain the living
organism so as to satisfactorily protect the environment and human health; or
(c) it is not, in the opinion of the
Ministers, practicable or feasible to obtain the test data necessary to
generate the information.
[13]
If a waiver is granted, then subsection 106(9)
of CEPA provides that the Minister of the Environment “shall
publish in the Canada Gazette a notice stating the name of any person to whom a
waiver is granted and the type of information to which it relates.”
[14]
Moreover, if a waiver is granted under subsection
106(8)(b) because the Ministers are of the opinion that the Notifier “is able to contain the living organism so as to
satisfactorily protect the environment and human health,” then
subsection 106(10) of CEPA stipulates, in relevant part, that “the person to whom the waiver is granted shall not use,
manufacture or import the living organism unless it is … at the location
specified in the request for the waiver….”
[15]
Paragraph 6(d) of the NSN Regs provides that,
for the purposes of the toxicity assessment conducted by the Ministers under subsection
108 of CEPA “the Ministers must assess the information”
provided pursuant to Schedule 5 of the NSN Regs within “120
days after receiving the information.”
[16]
Although the Ministers have sole legislative
authority to assess whether an organism is CEPA-toxic, their departments have
entered into a memorandum of understanding with the Department of Fisheries and
Oceans [DFO] whereby DFO provides advice on the toxicity of any fish that are
subject to assessment.
[17]
Following the Ministers’ assessment, CEPA
provides the Minister of the Environment with four options. She:
1.
may, before the expiry of the assessment period,
permit any person to manufacture or import the living organism on conditions
where she suspects the living organism is toxic or capable of becoming toxic:
CEPA, paragraph 109(1)(a);
2. may, before the expiry of the assessment period, prohibit any person
from manufacturing or importing the living organism where she suspects the
living organism is toxic or capable of becoming toxic: CEPA, paragraph
109(1)(b);
3. may, within 90 days after the expiry of the assessment period, permit
the manufacture or importation of the organism, but require a further toxicity
assessment if a person proposes to engage in a “significant
new activity” that may result in the living organism becoming toxic:
CEPA, subsections 110(1) and 106(4); or
4. shall, with 120 days after several conditions are met, permit any
person to manufacture or import the organism by adding it to the DSL: CEPA, subsection
112(1).
[18]
Section 104 of CEPA defines a “significant new activity” as including any activity
that, in the opinion of the Ministers, results or may result in the entry or
release of the living organism into the environment in a quantity or
concentration, or in a manner and circumstances, that are significantly
greater, or significantly different, than that which has previously occurred.
[19]
If the Ministers suspect that a significant new
activity may result in the living organism becoming toxic, then the Minister of
the Environment may publish a SNAc Notice in the Canada Gazette within
90 days of the end of the assessment period: CEPA, subsection 110(1). Once the
SNAc Notice is published, no person may use the organism for a significant new
activity that is indicated in the notice unless that person has provided the Minister
of the Environment with the prescribed information (i.e. the information listed
in Schedule 5 of the NSN Regs) and the period for assessing that information
has expired: CEPA, subsections 110(3) and 106(4).
The Facts
[20]
There is no dispute on the facts. For ease of
reference, the facts are set out chronologically.
[21]
On April 29, 2013, AquaBounty submitted a New
Substances Notification with respect to AAS. In its Notification, AquaBounty
declared its intent to manufacture sterile all-female AAS eggs at its contained
PEI Facility and export up to 100,000 eggs annually for grow-out and processing
in Panama. The processed fish would then be sold as food in approved retail
markets. AquaBounty’s Notification included a request for a waiver of the
requirement to submit “the data from a test conducted
to determine [AAS’s] pathogenicity, toxicity or invasiveness.” Filing
the Notification triggered the 120 day assessment period provided for in
section 108 of CEPA, such that the assessment period would end on August 27,
2013.
[22]
On August 13, 2013, DFO provided the Minister of
the Environment with its assessment of AAS entitled Summary of the
Environmental and Indirect Human Health Risk Assessment of AquAdvantage Salmon
[the DFO Report]. The DFO Report concluded that, for the specific use scenario
that had been notified, AAS was not CEPA-toxic or capable of becoming
CEPA-toxic:
1 - Indirect Human Health Risk
The finding of negligible for the exposure
assessment with reasonable certainty and low for the indirect health hazard
assessment with reasonable certainty resulted in a risk assessment outcome of
low with reasonable certainty and a conclusion of not “CEPA toxic”.
2 - Environmental Risk
The finding of negligible for the exposure
assessment with reasonable certainty and high for the environmental hazard
assessment with reasonable uncertainty resulted in a risk assessment outcome of
low with reasonable certainty and a conclusion of not “CEPA toxic”.
[23]
The DFO Report also indicated that DFO did not
object to AquaBounty’s waiver request. It considered that the information
sought to be waived was unnecessary because AquaBounty would be operating in a
contained facility:
Given the use scenario and that the information provided in support of the waiver request
was considered sufficient to demonstrate that the organism will be contained so
as to satisfactorily protect the environment and human health, data on
invasiveness as specified in paragraph 5(a) of Schedule 5 of the New
Substances Notification Regulations (Organisms) is not needed to determine
whether the organism is toxic as defined under section 64 of CEPA 1999. [emphasis
added]
[24]
DFO also recommended that the Minister of the
Environment issue a SNAc Notice that would require further assessment of any
use of AAS beyond that proposed by AquaBounty at its PEI Facility or export of
AAS other than to AquaBounty’s facility in Panama:
The emphasis that has been placed on
containment to prevent exposure to the Canadian environment and in particular
on physical containment of AAS, makes it imperative that the use scenario
proposed by AquaBounty be maintained including all physical, biological,
geographical and operational containment measures. Therefore, any activities
outside of the well-defined parameters that have been described in the notification
may be considered a significant new activity and could require a Significant
New Activity Notice.
[25]
On August 19, 2013, the Minister of the
Environment granted the waiver that AquaBounty had requested.
[26]
On August 27, 2013, the assessment period
ended. The Ministers agreed with DFO that the manufacture and use of AAS proposed
by AquaBounty is not CEPA-toxic or capable of becoming CEPA-toxic. The
Ministers also agreed with DFO that a SNAc Notice should be issued but differed
from DFO on its scope.
[27]
As noted above, DFO wanted the SNAc Notice to
indicate that a “significant new activity” would
be defined, in part, as an activity at a location other than the PEI Facility
and for export other than to Panama. However, the Ministers ultimately accepted
the different recommendation of their own officials in a report entitled Record
of Decision and Rationale (RDR): Control Measures for New Organisms [RDR].
In that report, the officials took a more functional approach to defining a
significant new activity. They took the view that “the
existing activity is not defined by its location but rather by the containment
measures put in place in Canada to prevent any release of the live fish into
the Canadian environment” and that restricting export to a particular
location was probably unenforceable.
[28]
On November 23, 2013, the Minister of the
Environment published a SNAc Notice in the Canada Gazette in relation to
AAS. As proposed by her officials, the SNAc Notice was broader than that
recommended by DFO. It defined a “significant new
activity” as any activity other than the uses of AAS proposed by
AquaBounty within a “contained facility” or the
grow-out of female triploid AAS within a “contained
facility,” provided that they are euthanized before leaving the facility:
1. In relation to the living organism
identified as genetically engineered Atlantic salmon (Salmo salar) containing a
single copy of the opAFP-GHc2 transgene at the EO-1α locus, a significant
new activity is any activity other than:
(a) the use of any non-triploid [i.e. offspring producing] living
organism within a contained facility:
(i) as a research and development organism, or
(ii) for producing
triploid [i.e. sterile], all-female living organism;
(b) the use
of the male, triploid living organism within a contained facility as a research
and development organism;
(c) the use of the female, triploid
living organism within a contained facility:
(i) as a research
and development organism, or
(ii) for
grow-out where it is euthanized before leaving the contained facility; or
(d) the export of the female,
triploid living organism at the eyed-egg stage. [emphasis added]
The Issues
[29]
The applicants submit that there are eight questions
to be addressed:
1. What is the standard of review?
2. Did the Ministers err in
purporting to conclude a section 108 assessment of AAS by failing to collect
and assess information regarding potential uses of the organism and potential
locations of introduction?
3. Did the Ministers unlawfully
conclude a section 108 assessment of AAS prior to granting a waiver of
information requirements for toxicity and invasiveness data and publishing
notice of such a waiver in the Gazette?
4. Did the Minister of the
Environment err in publishing the SNAc Notice prior to the expiry of the
assessment period?
5. Did the Minister of the
Environment, through the publication of the SNAc Notice, unlawfully permit uses
of AAS contrary to subsection 106(10)?
6. Did the Minister of the
Environment, through the publication of the SNAc Notice, unreasonably permit
uses of AAS that were not considered as part of the section 108 assessment?
7. Do the applicants have standing
to bring this application?
8. What is the appropriate remedy?
[30]
In light of the concession of the respondents
that the applicants have public interest standing, item (vii) does not need to
be addressed. In light of the result, item (viii) does not need to be
addressed.
[31]
Fundamentally, the applicants challenge two
decisions: (1) the decision made pursuant to section 108 of CEPA, assessing the
information on AAS provided pursuant to section 106; and (2) the decision to
publish the SNAc Notice.
The Standard of Review
[32]
The applicants submit that, although no
jurisprudence has determined the standard of review applicable to the specific
decisions at issue in this case, courts have determined that “the discharge of mandatory Ministerial obligations under
CEPA is reviewable on [the] standard of correctness:” Great Lakes
United v Canada (Minister of the Environment), 2009 FC 408, [2010] 2 FCR
515 [Great Lakes].
[33]
The applicants submit that the impugned
decisions involved the discharge of mandatory Ministerial obligations. They
note that subsection 106(9) of CEPA states that the Minister of the Environment
“shall publish in the Canada Gazette” a
notice of a waiver of any information requirements [emphasis added]. Similarly,
subsection 108(1) of CEPA states that the Ministers “shall…assess”
the prescribed information in order to determine whether an organism is toxic
or capable of becoming toxic [emphasis added]. Their submission, briefly
stated, is that because the validity of the impugned decisions turns on whether
the Ministers discharged these obligations, their decisions are to be reviewed
on a standard of correctness.
[34]
The applicants cite three decisions in support
of their submission that the applicable standard is correctness. They cite Great
Lakes at paragraphs 237-240 for the proposition that “[a] failure to comply with a statutory requirement is an
error of law subject to a standard of correctness.” They cite Canada
(Minister of Citizenship and Immigration) v Kandola, 2014 FCA 85 [Kandola]
at paragraphs 42-43 for the proposition that, when it comes to a “pure question of statutory construction embodying no
discretionary element” the Minister “cannot
claim to have any expertise over and above” that of the Court. Lastly,
they cite Save Halkett Bay Marine Park Society v Canada (Environment),
2015 FC 302 [Halkett Bay Marine] in which the Court applied Kandola
in the context of a review of the Minister of the Environment’s decision to
grant a permit authorizing the sinking of a ship in order to turn it into an
artificial reef. In Halkett Bay Marine the applicant claimed that the
Minister of the Environment was not authorized to permit the sinking because
the ship contained banned substances in its hull, known as TBTs. The Court
held that, to the extent that the Minister’s decision turned on issues of
statutory interpretation, her interpretation was subject to a correctness
standard of review. It stated at para 54 that:
The purely legal component concerns
subsection 127(1) of the Vessel Pollution Regulations and certain provisions in
the CEPA, which the Society states establish an outright ban on TBTs. This
Court’s review of whether those provisions in fact establish an outright ban on
TBTs in Canada that rendered the issuance of the Permit contrary to law is
conducted on a correctness standard. This is because this is “a pure question
of statutory construction embodying no discretionary element,” the Minister
“cannot claim to have any expertise over and above” that of the Court in
respect of such questions, and there is no privative clause in the CEPA (Canada
(Citizenship and Immigration) v Kandola, 2014 FCA 85 (CanLII), at para
43). Moreover, insofar as the Vessel Pollution Regulations are concerned, they
were passed pursuant to the CSA, above, which is not the Minister’s “home
statute” and no evidence was adduced to demonstrate that she has any particular
familiarity with that statute (Agraira v Canada (Public Safety and Emergency
Preparedness), 2013 SCC 36 (CanLII), at para 50).
[35]
I am not persuaded that these authorities mandate
a correctness standard in the present case. A review of the points in dispute
reveals that many of them are not “pure”
questions of law; rather, they involve issues of mixed fact and law, such as
whether the Ministers considered all relevant factors when coming to their
decisions. Second, to the extent that the Ministers’ decisions could be said
to turn on “pure” questions of law (such as when
a waiver becomes effective under subsection 106(8), when it has to be granted,
and what the word “location” means in subsection
106(10)) these are “nuts and bolts” questions of
statutory interpretation that are confined to a particular context within the
Ministers’ home (or closely connected) statutes. They therefore warrant a
degree of deference: McLean v British Columbia (Securities Commission),
2013 SCC 67, [2013] 3 S.C.R. 895 at paragraph 28 [McLean].
[36]
This case involves the review of routine
decisions made within a complex regulatory framework. In this context, I think
that it is important to emphasize, as the Supreme Court did in McLean at
paragraph 31, that “courts ‘may not be as well
qualified as a given agency to provide interpretations of that agency’s
constitutive statute that make sense given the broad policy context within
which that agency must work’” (citing National Corn Growers Assn. v
Canada (Import Tribunal), [1990] 2 S.C.R. 1324). The Ministers have adopted an
interpretation of CEPA in light of their day-to-day experience administering the
Act. They have expertise “over and above” that of the Court. Their interpretation must
not be unreasonable but, as long as that threshold is met, this Court should
defer.
[37]
Applying a reasonableness standard to the issues
in dispute, they may be summarized as follows: (1) was the Ministers’ decision
that AAS is not CEPA-toxic reasonable; and (2) was the Minister of the
Environment’s publication of the SNAc Notice reasonable?
The Toxicity Assessment
[38]
The applicants make three submissions with
respect to the Ministers’ toxicity assessment.
A. Potential Uses and Locations
[39]
The applicants say that the Ministers erred in
failing to consider information with respect to “the…potential
uses of [AAS]” and “potential locations of
introduction,” information for which no waiver was sought or given.
They point to subsection 108(1) of CEPA, which provides that “the Ministers shall … assess information provided under
subsection 106(1) [being the prescribed information in Schedule 5 of the NSN
Regs].” Paragraph 3(b) of Schedule 5 states that “the intended and potential uses of the organism, and the
potential locations of introduction” are to be provided by a Notifier.
The applicants submit that the Ministers failed to assess potential uses
and locations of AAS; instead, they only assessed AquaBounty’s proposed
use and location. They point to the DFO Report which states: “The risk assessment is conducted on AquaBounty’s proposed
use scenario to grow AAS under the containment conditions specified in the
regulatory submission for the PEI and Panamanian facilities.”
[40]
I suspect that the reason for the applicants’
concern here is that they believe that the Ministers’ alleged failure to
consider potential uses and locations resulted in an assessment that was too
narrow to encompass the range of possible uses and locations that the Minister
of the Environment ultimately approved in the SNAc Notice. The applicants may
believe that others can now rely on the SNAc Notice and engage in “potentially” toxic endeavours that have not been adequately
assessed. If that is their concern, then it is misplaced as shall be seen
below.
[41]
In any event, I agree with the respondents that
the Ministers did consider information with respect to the potential
uses and locations of introduction of AAS. All parties accept that the
Ministers relied on the DFO Report. As the applicants note, the report did
state that DFO’s assessment was based on the use scenario proposed by
AquaBounty. However, the report goes on to observe that:
Changes to the proposed use scenario or to
the proposed containment measures may result in the entry or release of AAS
into the environment in a quantity, manner or circumstances significantly
different to the potential exposure of AAS assessed in the current risk
assessment. Given the potential hazard of AAS to the environment and
associated uncertainty, including potential invasiveness, any significant new
activity may result in an altered exposure and consequently in a different risk
assessment conclusion than provided in this report.
[42]
As a result, DFO recommended that the Minister
of the Environment issue a SNAc Notice that would require further assessment of
any use of AAS beyond that specifically proposed by AquaBounty.
[43]
In addition to the DFO Report, the Ministers
relied on the RDR, which was prepared by officials at Environment and Health
Canada. Under the heading “Control Measure(s)
Rationale: Scientific Rationale” that report states:
• Within a contained facility, as
proposed by the notifier, there is no environmental exposure and therefore a
conclusion of CEPA Toxic was not reached.
• Should a new activity result in
environmental exposure, the available data as provided by the notifier or as
available in the public domain, is insufficient to determine whether or not the
organism poses any hazards that will result in an environmental risk
particularly given the uncertainty regarding the survival or persistence of the
organism in the environment.
• Given this level of uncertainty,
a significant new activity (SNAc) notice is therefore recommended in order
to ensure that any potential activities outside of a contained facility undergo
further evaluation. [emphasis added]
[44]
Contrary to the applicants’ submission that the
above-quoted statement in the DFO Report shows that the Ministers did not
consider other potential uses of AAS or locations of introduction, it shows
that they did. That statement, and the similar statement in the RDR, shows
that the Ministers did consider the potential uses of AAS and reached some
conclusions with respect to them. They concluded that they did not have enough
information to determine whether some potential uses could result in AAS
becoming toxic. They also concluded that other potential uses, such as uses outside
of the PEI Facility but within a contained facility, could be approved based on
the information provided. As a result, the Minister of the Environment issued
a SNAc Notice that permitted potential uses of AAS that the Ministers determined
would not result in toxicity, while requiring additional assessment for other
uses.
[45]
The applicants further submit that “[b]ecause there was no information before the Ministers on
potential uses or locations of introduction beyond the use scenario identified
by AquaBounty, they could not have fulfilled their statutory duty to give
consideration to such information.” Again, I disagree. First, as noted
above, the Ministers did consider, and were even able to make an assessment of,
some potential uses and locations of introduction based on the information
provided by AquaBounty. Second, it would not be reasonable to interpret the
NSN Regs to require that AquaBounty submit, or the Ministers assess,
information about speculative potential uses that are unrelated to AquaBounty’s
actual intended use. An assessment based on speculative potential uses would
be unlikely to yield reliable conclusions about toxicity. Furthermore, the
purpose of a SNAc Notice is to avoid the need for such speculation; it allows
the Ministers to permit uses that they have found to be non-toxic, while
subjecting significantly new uses to additional assessment, if and when they
are concretely proposed.
[46]
In my view, the requirement to provide
information with respect to potential uses and locations of introduction is
intended to ensure that Notifiers provide information about how an organism
might be used, and where it might be introduced, as a result of the Notifiers’
intended use. This reading is supported by the Government of Canada’s Guidelines
for the Notification and Testing of New Substances: Organisms [the
Guidelines], which state that:
A description of the intended and potential
uses of the organism or product containing the organism should be provided.
Potential locations of introduction includes identification, in general
terms, of the ecozone (identified on the map referred to in the definition
of “ecozone” a reduced version of which is given in Appendix 2) and types of
habitat (e.g. aquatic, terrestrial) where the organism could be predicted to
be used. [emphasis added]
According to the Guidelines, the potential
locations of introduction of AAS are those that could be predicted in general
terms. These locations are presumably predicted based on AquaBounty’s intended
use of AAS. Therefore, what is required is not information about where AAS
might be introduced in all possible worlds, but where it might be introduced
given AquaBounty’s intended use. This information was provided. The DFO Report
explicitly considers whether AAS might escape into the Bay of Fortune estuary
in PEI, or into the watershed near AquaBounty’s facility in Panama. These are
the potential locations of introduction. DFO considered them at length.
B. Validity of Waiver
[47]
The applicants submit secondly that the
Ministers erred in failing to consider “the data from a
test conducted to determine [AAS’s] pathogenicity, toxicity or invasiveness” because
the Minister of the Environment’s waiver of this requirement was invalid.
[48]
The applicants submit that a waiver is effective
only when notice of it has been published in the Canada Gazette. They
say that the purpose of publication is to ensure accountability, which cannot
be achieved if a notice is allowed to be published months, or even years, after
the waiver is granted. They also rely on the wording of subsection 106(9) of
CEPA; namely, that “[t]he Minister shall publish…a
notice stating the name of any person to whom a waiver is granted…”
[emphasis added]. They submit that Parliament’s use of the word “is” suggests that a waiver “is”
granted upon publication of the notice. If Parliament had intended that a
waiver could be granted before a notice is published, then it could have used
the words “was” or “has
been” to convey that intent.
[49]
The applicants say that the Minister of the
Environment cannot wait as long as she wants before publishing notice of a waiver
she has granted. I agree that the Minister cannot wait as long as she wants
because unnecessary and unreasonable delay would subvert the will of Parliament.
The 1999 Committee debate suggests that the publication requirement was
included to afford some degree of transparency and accountability, including
political accountability, to the public. For example, in that debate, Ms.
Paddy Torsney, the Parliamentary Secretary to the Minister of the Environment,
stated that the notice of waiver “would in fact ensure
that there is publication, that information is available, and that ministers of
the Crown remain accountable to the public through the House and other
mechanisms. So to suggest that without this paragraph somehow things are going
to be done in obscurity is not accurate”. This goal, of ensuring
transparency and accountability, is undermined when a notice is published too
long after the assessment period has ended.
[50]
However, I cannot agree with the applicants that
the Minister waited too long in this case when she delayed publishing the
notice of waiver for almost six months. While publication must take place
within a reasonable time following the grant of the waiver, failing which mandamus
may lie to order it, there is no statutory requirement that these events must
occur at the exact same time or even in close proximity. Even if the goal of
publication is that of promoting accountability, it will be met regardless of
whether the notice is published precisely when the waiver is granted, or within
a reasonable time thereafter. I am unable to conclude that the delay in this
case was unreasonable as there is no evidence to suggest that these applicants
were thwarted in bringing their concerns to the public or court, nor is it
sufficient to find that the will of Parliament was subverted.
[51]
I also do not think that Parliament’s use of the
word “is” necessitates a finding that a waiver
is only granted once notice is published. There is authority for an
interpretation of “is” that includes a reference
to past events. As the Court stated in R v Letkeman, [1983] SJ No 1045
(SKQB) at para 7, “[w]hile the word ‘is’ most often
will refer to the present, it can have a grammatically correct past
signification, as in the sense of ‘has been’: see, Black’s Law Dictionary (5th
ed.), p 745” and see also Village Gate Resorts Ltd v Moore, (1997),
47 BCLR (3d) 153 (BCCA) at paras 35-37.
[52]
It is also noteworthy in this regard that the
grant and notice of a waiver are dealt with by distinct provisions of CEPA,
subsections 106(8) and (9), respectively. If Parliament had intended that a
notice itself would bring about the legal effect of waiving an information
requirement, it could have conveyed its intention in a single, explicit,
provision that links the notice to its legal effect. This is what was done in
subsection 106(4). According to that subsection, “[w]here…the
Minister publishes a notice in the Canada Gazette indicating that this
subsection applies with respect to the living organism, no person shall use the
living organism for a significant new activity that is indicated in the
notice…”
[53]
Finally, during the Standing Committee on
Environment and Sustainable Development’s review of the waiver requirement in
1999, members of the committee conveyed their understanding that a notice of
waiver is published after the waiver itself is granted. For example, Mr. Rick
Laliberte described the notice requirement as an “after-the-fact
publishing of a waiver that has been made.”
[54]
These factors suggest that the grant and notice
of a waiver need not be simultaneous. The notice may follow the grant of a
waiver and the Minister’s six month delay does not impact the validity of the
grant or the date when the waiver was granted.
C. Timing of Waiver
[55]
The applicants’ third submission is that the
Minister of the Environment erred in failing to grant the waiver before the
start of the toxicity assessment.
[56]
The applicants point out that, according to
paragraph 6(d) of the NSN Regs, the Ministers’ toxicity assessment runs for “120 days after receiving the information referred to in
Schedule 5.” They submit that, until a waiver of an information
requirement is granted, all of the Schedule 5 information is still required.
Therefore, they say, the 120 day period can only start to run after all waivers
have been granted, and all of the other prescribed information has been
provided.
[57]
The applicants’ submission may reflect a
reasonable interpretation of the NSN Regs. However, the question is not
whether their interpretation is reasonable, but whether the Ministers’
interpretation is unreasonable. According to the Ministers’ interpretation,
the assessment period begins to run when the required information has been
provided or, if any information has not been provided, when a waiver has been
requested with respect to it. This approach has the advantage of allowing the
Ministers to proceed with an assessment without having to wait until all waiver
requests have been dealt with. It also has the disadvantage of creating a
possibility that the Ministers will proceed with an assessment in the face of a
pending waiver request, only to have that request refused, giving rise to the
need for additional assessment. This disadvantage is recognized and addressed
in the Guidelines, which state in section 5 that:
A waiver request must be submitted in
writing as part of a notification package and
should include a well-documented rationale to support it. Rejection of a
waiver request will delay the assessment (see section 9.1 of these
Guidelines). To avoid delays, it is recommended that notifies discuss the
proposed waiver request with appropriate officials at Environment Canada and
Health Canada before submitting the notification (see Section 6 of these
Guidelines). [emphasis added]
[58]
The question then is whether the Ministers’
interpretation is consistent with the terms of CEPA and its associated
regulations. In order to answer this question, we must look to the text of
this legislation and, in particular, paragraph 6(d) of the NSN Regs, which states
that the Ministers’ toxicity assessment runs for “120
days after receiving the information referred to in Schedule 5.” The
important thing to note about this provision is that it simply does not address
how a waiver request, and a corresponding failure to provide all of the
information referred to in Schedule 5, affects the running of the assessment
period. Instead, it simply states that the assessment period will begin to run
once the information in Schedule 5 is received. Therefore, on a parochial and
strictly literal reading of the provision, the assessment period cannot begin
to run even after a waiver is granted, because the information that is waived will
still be “information referred to in Schedule 5”
and will still be outstanding. Recognizing this difficulty, the applicants
suggest that, when read in context, paragraph 6(d) really means that the
assessment period will begin to run when the Ministers have received the “information referred to in Schedule 5” or a
waiver has been granted in respect of any information that they have not
received. The Ministers, on the other hand, maintain that the assessment
period will begin to run when they have received the “information
referred to in Schedule 5” or have received a request for a
waiver with respect to any information that they have not received, and that
request is ultimately granted. Neither of these contextual elaborations upon
the meaning of paragraph 6(d) is explicit in the NSN Regs. However, it is
clear that some elaboration is required to make that paragraph consistent with
the reality of waivers. I cannot say that the Ministers’ interpretation is
unreasonable. In fact, it seems more practical and arguably more reasonable
than the applicants’ proposed interpretation because, until some assessment of
the prescribed information has been done, it will be impossible to determine
whether the requested waiver ought to be granted or not. It makes little sense
to do one assessment for that purpose and then re-do the assessment for the
purpose of determining toxicity.
D. Right of Public Participation
[59]
Pervading the applicants’ submissions with
respect to the waiver is the view that a notice of waiver is intended to, and
does, provide an opportunity for public participation in a toxicity
assessment. While not strictly necessary to dispose of the challenge to the
toxicity determination I wish to address that view, as I disagree that such an
opportunity exists in the manner they describe.
[60]
First, as the respondents note, the Standing Committee
on Environment and Sustainable Development considered a proposed amendment to
CEPA in 1999 that would have required public comment before a waiver could be
issued. The Committee rejected this amendment on the ground that it would
create undue delay in the issuance of waivers. Given that public participation
in the waiver process was specifically considered, and rejected by the
Committee in 1999, it should not be read into CEPA today.
[61]
Second, according to subsection 106(9) of CEPA,
a published notice of waiver need only state the name of the person to whom the
waiver is granted and the type of information to which it relates. As the applicants
themselves complain at paragraph 67 of their memorandum, this format “makes it impossible to discern what substances or organisms
[the notices] relate to or how long [those substances or organisms] may have
been present in Canada.” While such minimal information may provide a
modicum of transparency, it is implausible to think that it gives rise to any
participatory rights. This point was explicitly acknowledged during the 1999
Committee meeting, when a member remarked that a notice of waiver “just identifies the name of the person and the type of
information to which it relates. It certainly doesn’t allow for public
comment.”
[62]
Finally, I agree with the respondents that, had
Parliament intended to allow public participation in toxicity assessments, it
would have explicitly said so, as it does in several other areas of CEPA,
including section 332, which sets out a notice and comment process for every
order or regulation made under the Act.
[63]
Toxicity assessments are not simple and quick
processes. A select group of experts is chosen to review a complex Notification
and report with recommendations. Publishing the full Notification and
soliciting public comments, which would then also have to be considered, would
make it virtually certain that no decision would be made within the 120 day
period Parliament provided.
The SNAc Notice
[64]
The applicants make two submissions that the
Minister of the Environment’s SNAc Notice is overbroad. First, they submit
that, because subsection 106(10) of CEPA restricts AquaBounty to using AAS “at the location specified in [its] request for [a] waiver”
(i.e. its PEI Facility) the SNAc Notice is overbroad insofar as it permits the
use of AAS at any “contained facility.” Second,
the applicants submit that the SNAc Notice is unlawful because it permits the
commercial grow-out of AAS in Canada, even though this scenario was not
considered in the Ministers’ assessment.
1. Overbroad Definition of “Location”
[65]
Subsection 106(10) of CEPA states that, where
the Minister of the Environment has waived an information requirement under
paragraph 106(8)(b), “the person to whom the waiver is
granted shall not use, manufacture or import the living organism unless it
is…at the location specified in the request for the waiver…” The applicants
submit that, in this case, the “location specified in
the request for the waiver” is AquaBounty’s PEI Facility. They
therefore submit that the terms of the SNAc Notice are inconsistent with
subsection 106(10) because they permit the use of AAS in any “contained facility,” rather than the PEI Facility in
particular.
[66]
The respondents submit that there is no
inconsistency between the scope of the restrictions in the SNAc Notice and
those in subsection 106(10). They submit that, in issuing the SNAc Notice that
she did, the Minister of the Environment implicitly held that the word “location” in subsection 106(10) of CEPA should be
construed broadly so as to include any location that is functionally equivalent
to AquaBounty’s PEI Facility (i.e. any “contained
facility”). In this way, the scope of the SNAc Notice is the same as
the scope of subsection 106(10): both restrict the use of AAS to a “contained facility.”
[67]
I agree with the applicants that subsection
106(10) restricts AquaBounty to using AAS at its PEI Facility. I therefore do
not accept the respondents’ interpretation of “location”
in that subsection. That interpretation is simply not supported by the plain
meaning of the provision and the relevant sections of CEPA.
[68]
As noted above, subsection 106(10) of CEPA stipulates,
in relevant part, that “[w]here the Minister waives any
of the requirements for information under paragraph (8)(b), the person to whom
the waiver is granted shall not use, manufacture or import the living organism
unless it is … at the location specified in the request for the waiver”
[emphasis added].
[69]
The Court was not provided with AquaBounty’s
request for waiver or its Notification. Therefore, the Court does not have
direct evidence of what location was specified in that request. However, paragraph
8(1)(d) of the NSN Regs does state that “any
information to be provided to the Minister under these Regulations must include
… the civic address of the site of manufacture … of the organism.” The
Guidelines provide at page 87 that “[i]f the notified
organism is to be manufactured in Canada, provide the manufacturer and the
location of the manufacturing site(s).” And the form contained therein
at page 108 indicates that the “Proposed Site of
Manufacture in Canada” is to be indicated by street, city, and
Province. Finally, when the DFO Report considered, and made a recommendation
with respect to, AquaBounty’s request for a waiver, it did so on the basis that
the “location” in question was AquaBounty’s PEI
Facility. It is therefore clear that the “location
specified in the request for the waiver” was the address of the PEI Facility.
It is not reasonably open to the Minister, when interpreting subsection
106(10), to interpret “location” more broadly or
ascribe a different meaning to it than the precise location an applicant
specifies in its request for a waiver. In any case, there is no evidence that
the Minister adopted such an interpretation.
[70]
In my view, there is only one reasonable
interpretation of subsection 106(10) on the facts before the Court. AquaBounty
requested and was granted a waiver from providing “the
data from a test conducted to determine [AAS’s] pathogenicity, toxicity or
invasiveness.” The waiver was granted because the Ministers were of the
opinion that AquaBounty was “able to contain the living
organism so as to satisfactorily protect the environment and human health:”
CEPA, paragraph 106(8)(b). That decision was made with specific reference to
the PEI Facility identified and described in the application. Accordingly,
AquaBounty, having received the waiver, “shall not use,
manufacture or import living organism unless it is … at the location specified
in the request for the waiver:” CEPA, subsection 106(10).
[71]
The applicants submit that, once this Court
concludes that subsection 106(10) restricts AquaBounty to the use of AAS at its
PEI Facility, it must also conclude that the SNAc Notice is inconsistent with
subsection 106(10) and, therefore, is unreasonable. As noted above, the
applicants emphasize that the uses permitted by the SNAc Notice are broader
than the uses permitted by subsection 106(10). In particular, while subsection
106(10) restricts AquaBounty to using AAS at its PEI Facility in
particular, the SNAc Notice permits any person to use AAS at any
contained facility. The applicants submit that allowing the SNAc Notice to
stand would lead to the absurd result that, although AquaBounty would be restricted
to using AAS at its PEI Facility in particular, other persons would be able to
use it at any “contained facility.”
[72]
The parties appear to agree that it would be
absurd to interpret CEPA in a manner that would restrict AquaBounty’s use of AAS
more than that of other persons, whose uses have not been assessed at all.
Where the parties differ is in their proposed solution to this alleged absurdity.
The applicants would resolve the tension between subsection 106(10) and the
SNAc Notice by “getting rid” of the SNAc Notice;
they submit that the SNAc Notice is unreasonably broad, and should be quashed
on that basis. AquaBounty, on the other hand, would resolve the tension by “getting rid” of subsection 106(10); it submits that,
when a SNAc Notice is issued, the restrictions in the Notice supersede and
replace the restrictions in subsection 106(10), thereby placing AquaBounty on
equal footing with all others. I accept neither view. In order to understand
why, it is necessary to consider the relationship between a SNAc Notice that
engages subsection 106(4) of CEPA and the application required under subsection
106(1).
[73]
I asked the parties at the hearing whether subsection
106(1) continues to apply even though AquaBounty has submitted a Notification
under that subsection and a SNAc Notice has been issued. In particular, I
asked whether all persons wishing to manufacture AAS in Canada, including
AquaBounty if it wishes to manufacture AAS at a different location, will be
required to submit a new Notification under subsection 106(1). It was my
impression that all parties were of the view that no such Notification would be
required. I do not agree.
[74]
Part 6 of CEPA refers to three ways of dealing
with living organisms: manufacture, importation, and use.
[75]
The Notification and assessment process provided
for in subsection 106(1) of CEPA is directed only to manufacture and
importation – not use. It is quite specific in stating that “[w]here a living organism is not on the Domestic Substances
List … no person shall manufacture or import the living organism
unless … the prescribed information … has been provided by that person to the
Minister … and … the period for assessing the information … has expired”
[emphasis added].
[76]
On the other hand, a SNAc Notice issued under
subsection 110(1) of CEPA is directed only to use – not manufacture and
importation. This can be seen in subsection 106(4), which provides that “where a living organism is not specified on the Domestic
Substances List and the Minister publishes a notice in the Canada Gazette
indicating that this subsection applies with respect to the living organism, no
person shall use the living organism for a significant new activity that
is indicated in the notice unless … the person has provided the Minister with
the prescribed information … and … the period for assessing the information …
has expired” [emphasis added].
[77]
This difference in focus between subsection
106(1) (manufacture and importation) and subsection 106(4) (use) means that,
even though a SNAc Notice was issued that permits use at a contained
facility, any person seeking to manufacture or import AAS must still
file a Notification under subsection 106(1). This includes even AquaBounty who,
because it received a waiver under paragraph 106(8)(b), is limited by
subsection 106(10) to using and manufacturing AAS at its PEI Facility, and so
cannot manufacture elsewhere without undergoing further assessment.
[78]
To summarize, the impact of Part 6 of CEPA on
AquaBounty is the following. Having filed a Notification and been provided
with the requested waiver, and the assessment period having passed, it can “manufacture” and “use”
AAS (provided it is not a use that is a significant new activity) only at the
PEI Facility. If it wishes to manufacture AAS at a different location, or
import AAS, then it must file a new Notification under subsection 106(1). If
it wishes to use AAS for a significant new activity, then it must file a
Notification under subsection 106(4).
[79]
The impact of Part 6 of CEPA on persons other
than AquaBounty is that they must file a Notification under subsection 106(1) in
order to be permitted to manufacture or import AAS and, if they are proposing a
use that is a significant new activity, they must file a Notification under
subsection 106(4).
[80]
What impact does this interpretation have on the
alleged absurdity outlined above? It causes it to disappear. In particular, it
demonstrates that AquaBounty is not placed in an unequal position by the operation
of subsection 106(10). Like AquaBounty, all persons are required to submit a
Notification if they wish to manufacture or import AAS. As part of their
Notification, they can request a waiver. If, like AquaBounty, they request a
waiver pursuant to subsection 106(8)(b), then their use, manufacture, and
import of AAS will be limited to the location specified in their request for a waiver,
pursuant to subsection 106(10). If, on the other hand, they do not request a
waiver, then their use will only be constrained by the scope of the SNAc Notice.
In this way, AquaBounty is placed on equal footing with everyone else. There
is therefore no absurdity, nor any unreasonableness, in the Minister issuing a
SNAc Notice that permits a wider range of uses of AAS than that permitted by
subsection 106(10). The applicants’ objection dissolves.
2. Overbroad Definition of Permitted
Uses
[81]
I agree with the applicants that “commercial grow-out in Canada was not assessed as part of
the DFO Risk Assessment.” However, DFO did assess the risks posed by
commercial grow-out in Panama. I agree with the submission of AquaBounty that,
when the Certified Tribunal Record is read as a whole, it is clear that the
Minister of the Environment’s functional approach to the SNAc Notice led her to
conclude that “the containment measures required by the
AAS SNAc Notice will work equally well regardless of whether the AAS are being
grown out for research, reproduction or commercial grow-out.” Adult AAS
leaving the contained facility in Canada are required to have been euthanized. There
is no evidence in the record that euthanized AAS are a danger to the
environment. Moreover, they cannot be used for human consumption unless
approved by Health Canada, which, if called upon to issue an approval, would
examine risk to human health. Accordingly, I am not persuaded that the scope
of the SNAc Notice was overly broad and unreasonable.
Disposition and Costs
[82]
For these reasons, this application must be
dismissed. The applicants as public interest litigants submit that they ought
not to have costs visited upon them and they asked for and were granted an
opportunity after these reasons issued to make written submissions on costs.
If the parties are unable to reach an agreement on costs, the applicants shall
serve and file their written submissions (not exceeding 5 pages) within 3 weeks
of the date of the Judgment, and the respondents shall service and file their
responses (not exceeding 5 pages) within 2 weeks thereafter.
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