Office of the Privy Council, Government of Canada  [Printer-friendly version]
July 25, 2003

A FRAMEWORK FOR THE APPLICATION OF PRECAUTION IN CANADA

[Rachel's introduction: Canada has adopted formal guidelines for
using the precautionary principle in science-based decisions.]

1.0 Introduction

This Framework outlines guiding principles for the application of
precaution to science-based decision making in areas of federal
regulatory activity for the protection of health and safety and the
environment and the conservation of natural resources.

What is the application of precaution?

The application of "precaution", "the precautionary principle" or "the
precautionary approach" recognizes that the absence of full scientific
certainty shall not be used as a reason for postponing decisions where
there is a risk of serious or irreversible harm.

The application of precaution is distinctive within science-based risk
management and is characterized by three basic tenets: the need for a
decision, a risk of serious or irreversible harm and a lack of full
scientific certainty.

Canada has a long-standing history of applying precaution in areas of
federal regulatory activities. The Government's obligations in this
regard are governed by applicable provisions of federal law, binding
federal-provincial agreements and international agreements to which
Canada is a party.

Are guidance and assurance needed?

Given the distinctive circumstances associated with the application of
precaution, notably the lack of full scientific certainty about a risk
of serious or irreversible harm, guidance and assurance are required
as to the conditions governing decision making. Guidance and assurance
are particularly needed in circumstances when the scientific
uncertainty is high.

What is the purpose of the framework?

This Framework serves to strengthen and describe existing Canadian
practice. The purpose of the framework is to:

** improve the predictability, credibility and consistency of the
federal government's application of precaution to ensure adequate,
reasonable and cost-effective decisions;

** support sound federal government decision making while minimizing
crises and controversies and capitalizing on opportunities;

** increase public and stakeholder confidence, in Canada and abroad,
that federal precautionary decision making is rigorous, sound and
credible; and

** increase Canada's ability to positively influence international
standards and the application of precaution.

Ultimately, the Framework provides a lens to assess whether
precautionary decision making is in keeping with Canadians' social,
environmental and economic values and priorities. It complements the
Government's Integrated Risk Management Framework and A Framework
for Science and Technology Advice: Principles and Guidelines for the
Effective Use of Science and Technology Advice in Government Decision
making.

2.0 Context

Canada has a long-standing history of applying precaution in science-
based regulatory programs. Technology, globalization and the
knowledge-based economy are driving tremendous changes in both the
private and public sector. Risk, inherent in the activities of
individuals and business, contributes to even greater uncertainty.
When combined with high-profile, risk-based events, these changes
highlight the need for more effective strategies to manage risk and
seize the opportunities that change presents.

Governments can rarely act on the basis of full scientific certainty
and cannot guarantee zero risk. Indeed, they are traditionally called
upon and continue to address new or emerging risks and potential
opportunities, and to manage issues where there is significant
scientific uncertainty. However, the need for decision making in the
face of scientific uncertainty has grown both in scope and public
visibility and this has led to a growing awareness of and emphasis on
the application of precaution to decision making.

While the application of precaution primarily affects the development
of options and the decision phases within science-based risk
management, it is clearly linked to scientific analysis (it cannot be
applied without an appropriate assessment of scientific factors and
consequent risks). Ultimately, it is guided by judgment, based on
values and priorities but its application is complicated by the
inherent dynamics of science -- even though scientific information may
be inconclusive, decisions will still have to be made as society
expects risks to be addressed and managed and living standards
enhanced.

Canada's application of precaution is flexible and responsive to
particular circumstances. Moreover, rules-based approaches are
employed to achieve the results required by specific legislation or
international obligations (e.g., fisheries management).

3.0 Science and uncertainty in decision making

As the scientific process is often characterized by uncertainty and
debate, the decision-making process for managing risks associated with
scientific information requires sound judgment. The application of
precaution to decision making is distinctive within traditional risk
management on the basis of a higher degree of scientific uncertainty
and the parameters that can establish what constitutes an adequate
scientific basis and sound and rigorous judgment. As it applies here,
judgment focuses on addressing:

** what is a sufficiently sound or credible scientific basis?

** what follow-up activities may be warranted?

** who should produce a credible scientific basis? and

** the inherent dynamics of science on decision making.

What is a sufficiently sound or credible scientific basis?

In traditional situations of decision making to manage risks, "sound
scientific evidence" is generally interpreted as either definitive and
compelling evidence that supports a scientific theory or significant
empirical information that clearly establishes the seriousness of a
risk.

Within the context of precaution, determining what constitutes a
sufficiently sound or credible scientific basis is often challenging
and can be controversial. The emphasis should be on providing a sound
and credible case that a risk of serious or irreversible harm exists.
"Sufficiently sound" or credible scientific basis should be
interpreted as a body of scientific information -- whether empirical
or
theoretical -- that can establish reasonable evidence of a theory's
validity, including its uncertainties and that indicates the potential
for such a risk.

What follow-up activities may be warranted?

Given the significant scientific uncertainty implicit in the
application of precaution, follow-up activities such as research and
scientific monitoring are usually a key part of the application of
precaution. In some cases, international agreements (e.g., World Trade
Organization Agreement on the Application of Sanitary and
Phytosanitary Measures) require scientific monitoring and follow-up
when precaution is applied. Such efforts can help reduce the
scientific uncertainty associated with certain risks and allow
informed follow-up decisions to be made. In other circumstances,
scientific uncertainty may take a long time to resolve or, for
practical purposes, never be resolved to any significant degree.

In order to capture the full diversity of scientific thought and
opinion, the basis for decision making should be drawn from a variety
of scientific sources and experts from many disciplines. Decision
makers should give particular weight, however, to peer-reviewed
science and reasonableness in their judgments. Moreover, the science
function can be further supplemented by formal, structured and, where
warranted, independent advisory processes that include widely
recognized and credible individuals.

Who should produce a credible scientific basis?

Establishing who should be responsible for producing a credible
scientific basis raises a different question: Who should be designated
as having the responsibility to produce the scientific data and
provide the basis for decision making? Decision makers should assess
such criteria as who holds the legal responsibility or authority
(e.g., the proponent who is designated as the legal agent in Canada),
who would be in the best position to provide the scientific data and
who has the capacity to produce timely and credible information.

While the party who is taking an action associated with potential
serious harm is generally designated as the responsible party, this
may best be decided on a case-by-case basis. Innovative strategies may
also be introduced, such as collaborative arrangements among different
levels of government and industry. As the scientific knowledge
evolves, this responsibility may shift among governments, industry or
another proponent (e.g., health practitioners documenting adverse
effects from a product already on the market).

The inherent dynamics of science on decision making

The inherent dynamics of uncertainty in science present unique
challenges. Climate change provides a good example. There is
international consensus that human activities are increasing the
amounts of greenhouse gases in the atmosphere and that these increases
are contributing to changes in the earth's climate. However, there is
scientific uncertainty regarding the sensitivity of climate to these
increases, particularly the timing and regional character of climate
change. There is also a degree of uncertainty in the economic costs of
potential measures to reduce greenhouse gases, although the modelling
suggests that these impacts are manageable, as well as the economic
costs, to adapt to the expected changes in climate.

While scientific information is still inconclusive, decisions will
have to be made to meet society's expectations about enhancing living
standards and addressing the potential for risks. An understanding of
the full potential of the products and processes arising from rapidly
evolving science and technology is critical to shaping Canada's laws
and regulations, as well as international agreements and guidelines.
The implications are only now starting to emerge and will ultimately
influence decisions.

4.0 Guiding Principles for the application of precaution to science-
based decision making.

As noted earlier, the application of precaution to science-based
decision making to manage risk is driven by specific circumstances and
factors and is characterized by three basic tenets: the need for a
decision, a risk of serious or irreversible harm and a lack of full
scientific certainty.

Guiding principles outlined in this Framework reflect current
practices and, in their entirety, are intended to support overall
consistency in application, allow for flexibility to respond to
specific circumstances and factors and help to counter misuse or
abuse. While they focus on those aspects of the process that are
distinctive within risk management overall, they could not direct
decision makers to act in a way inconsistent with their legal
authority. Moreover, this Framework is not meant to create any new
legal obligations to apply precaution.

General principles of application outline distinguishing features of
precautionary decision making whereas principles for precautionary
measures describe specific characteristics that apply once a decision
has been taken that measures are warranted.

Five General Principles of Application

4.1 The application of precaution is a legitimate and distinctive
decision-making approach within risk management.
While precaution primarily affects the development of options and the
decision phases, it is clearly linked to scientific analysis (it
cannot be applied without an appropriate assessment of scientific
factors and consequent risks). Ultimately, it is guided by judgment,
based on values and priorities.

The Government's obligations to apply precaution are governed by
applicable provisions of federal law, binding federal-provincial
agreements and international agreements to which Canada is a party.
The Government does not yet consider the precautionary
principle/approach to be a rule of customary international law.

4.2 It is legitimate that decisions be guided by society's chosen
level of protection against risk.

To the extent possible, the level of protection should be established
in advance through domestic policy instruments such as legislation and
international agreements.

While societal values and public willingness to accept risk are key in
determining the level of protection, in all cases sound scientific
evidence is a fundamental prerequisite to applying the precautionary
approach.

It should be recognized that some risks are new or emerging and
evolution of scientific knowledge may influence society's tolerances
and its chosen level of protection. In such circumstances, public
involvement mechanisms that seek the input of those most affected by
decisions should help advance understanding of the level of protection
against risk.

4.3 Sound scientific information and its evaluation must be the basis
for applying precaution; the scientific information base and
responsibility for producing it may shift as knowledge evolves.
It is particularly relevant that sound scientific information and its
evaluation be the basis for (i) the decision to act or not to act
(i.e., to implement precautionary measures or not) and (ii) the
measures taken once a decision is made.

In determining what constitutes a sufficiently sound or credible
scientific basis, the emphasis should be on providing a sound and
credible case that a risk of serious or irreversible harm exists.
"Sufficiently sound" or credible scientific basis should be
interpreted as a body of scientific information -- whether empirical
or
theoretical -- that can establish reasonable evidence of a theory's
validity, including its uncertainties and that indicates the potential
for such a risk.

Scientific data relevant to the risk must be evaluated through a
sound, credible, transparent and inclusive mechanism leading to a
conclusion that expresses the possibility of occurrence of harm and
the magnitude of that harm (including the extent of possible damage,
persistency, reversibility and delayed effect).

Available scientific information must be evaluated with emphasis on
securing high quality scientific evidence (not quantity). Reports
should summarize the existing state of knowledge, provide scientific
views on the reliability of the assessment and address remaining
uncertainties and areas for further scientific research or monitoring.
Peer review represents a concrete test for the practical application
of precaution to decision making. A peer-review process can assess the
soundness of the scientific evidence and its inherent credibility
within the scientific community.

Scientific advice should be drawn from a variety of sources and
experts and should reflect the full diversity of scientific
interpretations consistent with the evidence available. This does not
preclude contributions of traditional knowledge from sources such as
Aboriginal peoples or fishing communities; these have a valid role in
providing both evidence and its interpretations. Scientific advisors
should give weight to peer-reviewed science and aim at sound and
reasonable evidence on which to base their judgments.

In circumstances where there is a potential for imminent harm, it may
be appropriate to make decisions and implement precautionary measures
in the near term, with an understanding that close monitoring would
occur to assess the effectiveness of the measures in addressing risk
and overall impacts.

Follow-up activities, including research and monitoring, are key to
reducing scientific uncertainty and allow improved decisions to be
made in the future.

Overall, the responsibility for providing the sound scientific basis
should rest with the party who is taking an action associated with a
risk of serious harm (e.g., the party engaged in marketing a product,
employing a process or extracting natural resources). However, when
faced with a concrete scenario, there should be an assessment of who
would be in the best position to provide the information base. This
could depend upon which party holds the responsibility or authority,
and could also be informed by such criteria as who has the capacity to
produce timely and credible information.

The responsibility for providing the sound scientific basis may best
be decided on a case-by-case basis and may be collaborative. Moreover,
it should be recognized that what constitutes an appropriate
scientific base and responsibility for producing it may shift as the
knowledge grows and roles of the public and private sectors evolve.

4.4 Mechanisms should exist for re-evaluating the basis for decision
and for providing a transparent process for further consideration.
It is desirable that those affected by a decision have input into the
re-evaluation process.

The impact (benefits and drawbacks) of re-evaluation and consultative
mechanisms in any particular situation should be assessed (i.e., in
some cases, they may not be practical or productive). Given some
existing re-evaluation and consultative mechanisms (e.g., fishery
conservation), it should be recognized that additional mechanisms may
not be appropriate.

A re-evaluation may be triggered by the emergence of new scientific
information, new technology or a change in society's tolerance for
risk. Effective review of decisions requires monitoring the
effectiveness of decisions on an ongoing basis with provision for
regular feedback and reporting of performance measurements results.
The decision-making hierarchy and the duties and responsibilities of
participants in the process should be clearly laid out so that
accountabilities can be understood, respected and communicated. This
would also facilitate requests for additional re-evaluation and
consultation.

The nature, type and frequency of re-evaluation and consultation
mechanisms may be related to the specific circumstances of a
situation, for example whether precaution is applied within an ongoing
mechanism for conservation of resources or in circumstances where
there is a potential for imminent harm.

4.5 A high degree of transparency, clear accountability and meaningful
public involvement are appropriate.

An understanding of the "public's tolerance for risks" or "society's
chosen level of protection" underpins the need for high transparency,
clear accountability and meaningful public involvement.
Transparency in documenting the rationale for making decisions
strengthens accountability.

Two-way sharing of information and the inclusion of a range of
perspectives in the decision-making process can become the cornerstone
of openness and transparency for the decision-making process and
enhance credibility of and trust in the decisions that the Government
makes. The Government's Communications Policy provides principles for
well co-ordinated, effectively managed and responsive communications.
Public involvement can provide a platform to resolve conflict or
engage in joint problem solving by a specific set of rules. It can
bring about the recognition of ambiguities and uncertainties, and
promote acceptance of different perspectives. Moreover, it can provide
impetus for peer review and an opportunity to receive interpretations
on uncertainty and risk from the public.

Public involvement should be structured into the scientific review and
advisory process, as well as the decision-making process. At the same
time, it should be recognized that the opportunity for public
involvement often depends on the specific context and timeliness of
the required decision. In situations of significant uncertainty
(regarding the magnitude and/or likelihood of harm or the most
effective means of addressing the harm, combined with complex
science), public involvement is needed to provide an opportunity to
receive interpretations on uncertainty and risk.

Five principles for Precautionary Measures

4.6 Precautionary measures should be subject to reconsideration, on
the basis of the evolution of science, technology and society's chosen
level of protection.

Precautionary measures should generally be implemented on a
provisional basis; that is, they should be subject to review in light
of new scientific information or other relevant considerations, such
as society's chosen level of protection against risk.

Given the limitations of evolving scientific knowledge, decision
makers should recognize that scientific uncertainty may not be
resolved quickly and, in some cases is intrinsic to the situation
(e.g., change is intrinsic to natural resources) -- they should review
new scientific knowledge if and as it evolves. In certain instances,
setting time considerations would be counter-productive.

Domestic or international obligations may require that some
precautionary measures be deemed explicitly provisional and subject to
re-evaluation; they may include obligations requiring mechanisms for
ongoing monitoring and reporting.

Regardless of whether there is a formal obligation, follow-up
scientific activity (e.g., further research and monitoring) should be
promoted, as it can help reduce uncertainty and allow improved
decisions as the science evolves.

4.7 Precautionary measures should be proportional to the potential
severity of the risk being addressed and to society's chosen level of
protection.

There is an implicit need to identify, where possible, both the level
of society's tolerance for risks and potential risk-mitigating
measures. This information should be the basis for deciding whether
measures are proportional to the severity of the risk being addressed
and whether the measures achieve the level of protection, recognizing
that this level of protection may evolve.

While judgments should be based on scientific evidence to the fullest
extent, decision makers should also consider other factors such as
societal values and willingness to accept risk and economic and
international considerations. This would allow for a clearer
assessment of the proportionality of the measure and ultimately help
maintain credibility in the application of precaution.

Generally, the assessment of whether measures are considered
proportional to the severity of risk should be in relation to the
magnitude and nature of the potential harm in a particular
circumstance, not in comparison with measures taken in other contexts.

4.8 Precautionary measures should be non-discriminatory and consistent
with measures taken in similar circumstances.

Consistent approaches should be used for determining an appropriate
level of protection against risk. Ultimately, the level of protection
should be set in the public interest by weighing potential (or
perceived) costs and benefits of assuming the risk in a manner that is
consistent overall with societal values.

Similar situations should not be treated substantially differently and
decision makers should consider using processes used in comparable
situations to ensure consistency. Except where the choice of
precautionary measures is predetermined in agreements or legislation,
it should be flexible and determined on a case-by-case basis.

Domestic applications of precaution should be consistent with Canada's
obligations arising from international agreements to which it is a
party and where applicable, meet the requirements established by the
Regulatory Policy.

4.9 Precautionary measures should be cost-effective, with the goal of
generating (i) an overall net benefit for society at least cost, and
(ii) efficiency in the choice of measures.

The real and potential impacts of making a precautionary decision
(whether to act or not to act), including social, economic and other
relevant factors, should be assessed.

Decision making should identify potential costs and benefits as
explicitly and as soon as possible, and distinguish what risk the
public is prepared to accept on the basis of sound and reasonable,
albeit incomplete, scientific evidence.

Consideration of risk-risk tradeoffs or comparative assessments of
different risks would generally be appropriate, although this may not
be possible in circumstances where urgent action is needed. This can
ensure that society receives net benefits from decision making and
that the application of precaution is inherently responsive to the
potential from innovation or technological change and the overall
benefits that such change can entail.

Assessing the efficiency of precautionary measures generally involves
comparing various policy instruments to determine which options could
most efficiently address the risk at least overall cost. The outcome
of this process should result in any measures taken imposing the least
cost or other negative impact while reducing risks to an acceptable
level.

As science evolves, it is inherently appropriate that the cost-
effectiveness of decisions and associated measures be assessed and
taken into account at the start, in the interim and, possibly, over
the longer term. For some issues, a net benefit may not be realized
for a long period of time, for example, decisions associated with
biodiversity. However, the emphasis should always be on ensuring that
ongoing costs are assessed and minimized, so that new scientific data
that alters cost-effectiveness considerations can be incorporated
(including performance monitoring results), while maintaining the
reduction of risks and, where appropriate, maximizing the benefits
(e.g., from innovation).

Decision makers should consider broader costs and benefits from
decisions to help ensure that society receives net benefits overall
(e.g., benefits associated with enhanced health status of children as
a segment of the population or benefits from innovation or
technological change).

4.10 Where more than one option reasonably meets the above
characteristics, then the least trade-restrictive measures should be
applied.

When making a choice among different types of measures that would
provide a similar level of response to the potential for harm, there
should be an endeavour to select measures that would be "least trade-
restrictive".

Least trade-restrictive considerations should apply to both
international and internal trade. This is especially relevant in terms
of international trade where disciplines and mechanisms exist for
other States to challenge the nature and impact of precautionary
measures.

5.0 Conclusion

A Framework for the Application of Precaution in Science-based
Decision Making About Risk sets out guiding principles to achieve
coherent and cohesive application of precaution to decision making
about risks of serious or irreversible harm where there is lack of
full scientific certainty, with regard to federal domestic policies,
laws and agreements and international agreements and guidelines in
areas where science is implicated.

Departmental and agency officials are expected to consider its guiding
principles in decision making and to work together in developing, in
consultation with their stakeholders, guidance for the application of
precaution in their particular area of responsibility.