Environment Canada & Health Canada

CNHHE

June, 2015

Risk Management

Process Overview

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Purpose

To provide an overview of the risk management (RM) process that is undertaken as part of Canada’s Chemicals Management Plan (CMP)

Part 5 of the Canadian Environmental Protection Act, 1999 (CEPA 1999) provides the legal framework for controlling toxic substances

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The Chemical Management Cycle

Legislative and Regulatory Context

The Canadian Environmental Protection Act, 1999 (CEPA 1999) is the

main tool used to manage (e.g. regulate) harmful substances however,

other acts may also be used where they are the best placed to do so

– Canada Consumer Product Safety Act

– Food & Drugs Act

– Pest Control Products Act

CEPA 1999 is administered by the Minister of the Environment

– Certain powers, duties and functions related to the effects of substances on

human health are assigned to the Minister of Health

– In certain cases the Minister of Health is a co-sponsoring Minister

Health Canada administers the three other Acts referenced above

CCPSA - Canada

Consumer Product

Safety Act

CEPA - Canadian

Environmental

Protection Act

FDA - Food and

Drugs Act

HPA - Hazardous

Products Act

PCPA - Pest Control

Products Act

PMRA - Pest

Management

Regulatory Agency

Risk Management of Toxic Substances

A systematic approach to setting a sound course of action for chemicals management by:– Understanding and addressing the level and severity of risk; and

– Prioritizing, acting on and communicating about potential threats

It requires understanding the lifecycle of the substance in Canada by: – Identifying sources (sectors) of releases and exposure pathways so

that risk management activities can be targeted

Risk management is a cyclical process and does not “end” with the implementation of an instrument– Monitoring and performance measurement are used to assess

ongoing relevance, success and effectiveness

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What is a toxic substance? [s.64 of CEPA 1999]

A substance is toxic if it is entering or may

enter the environment in a quantity or

concentration that

a)Have or may have an immediate or long-term 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

The definition of toxicity explicitly excludes the expression “inherently toxic”.

Inherent toxicity refers to laboratory or other study results and is only one of the

weight-of-evidence criteria considered in the assessment

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CEPA Measures [s.77 of CEPA 1999]

As a result of the assessment, the Ministers shall

publish a statement proposing one of the following

measures:

a) Take no further action in respect of a substance;

b) Add the substance to the Priority Substances List

(unless the substance is already on the PSL); or

c) Recommend that the substance be added to the List of

Toxic Substances [Sch. 1 of CEPA 1999] and, where

applicable, recommend the implementation of virtual

elimination

Mandatory proposal under certain circumstances

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Mandatory Proposal [ss.77(3) & (4) of CEPA 1999]

If the substance is determined to be toxic or capable of becoming toxic,

and the Ministers are satisfied that

a) the substance may have a long-term harmful effect on the environment

and is PBiT, and

b) the presence of the substance in the environment results primarily from

human activity,

the Ministers shall propose to recommend the addition of the substance

to Sch. 1

In addition to the above, if the substance is not naturally-occurring (as a

radionuclide or inorganic substance), then the Ministers shall propose

the implementation of virtual elimination

PBiT = Persistent and Bioaccumulative in accordance with the

regulations, and inherently Toxic to human beings or non-human

organisms, as determined by laboratory or other studies

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Legislated Timelines [s.91 & 92 of CEPA 1999]

With the notice publication on the assessment and proposed measure

recommending the addition to Sch.1:

– The Minister of the Environment has 24 months to publish a proposed

regulation or instrument respecting preventive or control actions

– Then has a further 18 months to publish a final regulation or instrument

– Commonly referred to as the “CEPA time-clock provisions”

To meet the CEPA time-clocks, at least one risk management

instrument must be proposed and finalized

– The instrument must be recognized under CEPA and provide specific

preventive or control actions that reduce or eliminate the risks to the

environment or human health

– Each instrument is assessed on a case-by-case basis to determine whether

this requirement is met

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Risk Management Process and Timelines

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Draft Screening

Assessment

CEPA S64

RM Scope

Gazette Notice

(Draft Decision)

CEPA S 68/77

Proposed

Order in

Council

Adding to

Schedule 1

S 77

Final Order

in Council

Adding to

Schedule 1

S 90 (1)

Gazette Notice

(Proposes)

RM Tool

Gazette Notice

(Confirms)

RM Tool

Canada’s Risk Assessment and Management of Existing Substances

24 months 18 months

Assessment Management

Self-imposed Timeline

Information

Gathering

CEPA S 71HC

EC

Final Screening

Assessment

CEPA S64

RM Approach

Gazette Notice

(Final Decision)

CEPA S 68/77

60 day public

comment period

60 day public

comment period

Consideration of RM Options Development of RM tool and socio-economic impact analysis

60 day public

comment period

60 day public

comment period

OPPORTUNITIES FOR ENGAGEMENT AND CONSULTATION

Methods Development,

Information gathering

if and as required

Monitoring,

Voluntary and /or

mandatory Surveys

Targeted

Consultations

As required

Targeted

Consultations

As required

Objectives Setting

The RM instrument(s) are selected to work towards specific objectives,

based upon the assessment findings:

Environmental and/or Human Health (HH) Objectives are “overarching”

quantitative (e.g. environmental level) or qualitative statements of what should

be achieved to address the concerns identified

Risk Management Objectives (RMOs) set quantitative (e.g. release limit,

product content) or qualitative targets to be achieved by the implementation of

RM instrument(s) for a given substance(s)

– RMOs contribute towards achieving the environment and/or HH objectives

– They are set early in the risk management process and will form the basis of future

performance measurement activities

– In the case of mandatory proposals (aka PBiT substances), the ultimate RMO is the virtual elimination of the release of the substance to the environment

The objectives are initially proposed in the RM Scope and Approach documents (they may change over time)

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Selecting the RM Instrument(s)

The process of selecting an instrument (or instruments) is a

critical step in the risk management process:

– It follows the Cabinet Directive on Regulatory Management

– Provides for greater consistency in decision-making by providing a

disciplined approach for assessing and selecting RM instruments

– It allows (and facilitates) for the consideration of the entire suite of

risk management options

– Aims to identify an appropriate mix of instruments and course of

action

There is a standardized framework that is used for selecting

instruments under CEPA 1999

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Risk Management Instruments

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RM Proposals

RM Scope and Approach documents are not mandated by CEPA

but are used to describe the Ministers’ intention respecting

preventative or control actions in relation to a toxic substance

A. RM Scope is used to present the risk management “options” that

could be used to address the risks identified if the substance is

proposed toxic (draft assessment stage)

B. RM Approach is used to outline the risk management “actions”

that are proposed to be developed or carried on moving forward if the

substance is declared toxic (final assessment stage)

Both documents now follow the same format and are

posted online for a 60-day public comment period

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RM Development

C. Proposed RM instrument

– The development of the proposed RM instrument(s) is initiated post-

publication of the RM Approach

– Leading to its publication, further consultations are typically

undertaken (e.g. via specific consultation/discussion document),

additional information may be gathered, analytical methods

developed or finalized, etc.

– Other issues considered in its development include e.g. cost benefit

analyses, socio-economic factors, market reality, distributional

impact, implementation timelines, etc.

– Depending on the RM instrument selected, publication is typically in

Part I of the Canada Gazette and is subject to a 60-day public

comment period

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RM Development (cont’d)

D. Final RM instrument– The proposed RM instrument is reviewed, refined and finalized

following the public consultation process

– Leading to its publication, more targeted consultation may be

conducted and work is continued to ensure availability of analytical

methods, establishing limits, testing and reporting requirements,

timelines for implementation, compliance promotion and enforcement

plans, etc.

– Depending on the instrument selected, publication may be in Part I

or II of the Canada Gazette

– Once the RM instrument has been finalized, it is implemented

(coming into force date is specified in the final instrument)

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CMP Monitoring & Surveillance

A key element of the CMP is the monitoring and

surveillance (M&S) of levels of harmful chemicals in

Canadians and their environment

M&S programs provide the basis for making sound and

effective public health and environmental policies by

– generating science-based information to inform risk assessment

and risk management (at any point in time in the process), and

– measuring the efficacy of control measures (i.e. for performance

measurement)

Nuance in terms:Monitoring: Long-term, routine

sampling to detect and characterize

environmental change

Surveillance: Targeted sampling to

determine the presence of

contaminants in specific environment

vs.

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Performance Measurement (PM)

During and after the implementation of an instrument

PM is conducted to assess ongoing relevance,

success, and effectiveness of the instrument in meeting the

RMO(s)

– Intent is to monitor compliance and effectiveness to achieve/sustain

the RMO(s), measure progress and overall costs/benefits, etc. (e.g.

via testing and reporting, inspections and verifications)

In some cases, broader, substance-based performance

measurement may be performed to determine the

effectiveness in meeting environmental/HH objective(s)

– A framework has been developed and is being applied to a few case

studies that may have reached this stage in the program

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References

CEPA 1999 (incl. a guide to understanding this Act)

– http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=26A03BFA-1

Chemicals Management Plan (incl. fact sheets on RA-RM)

– http://www.chemicalsubstanceschimiques.gc.ca/

Management of Toxic Substances (incl. the Toxic Substances

Management Policy)

– http://www.ec.gc.ca/toxiques-toxics/

Cabinet Directive on Regulatory Management

– http://www.tbs-sct.gc.ca/rtrap-parfa/cdrm-dcgr/cdrm-dcgrtb-eng.asp

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