Montebello announcement
• On August 21, Leaders of North America committed to
strengthening regulatory cooperation in the area of
chemicals
– Leaders have asked their ministers to
” implement the Regulatory Cooperation Framework announced
at the Summit by undertaking trilateral cooperation to accelerate
and strengthen our national and regional risk-based chemical
assessment and management efforts”.
– What does this mean in practice?
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A trilateral regulatory cooperation
framework
• To give life to this commitment, a regulatory cooperation framework was developed
among Canada, the United States and Mexico.
–
The framework will facilitate the exchange of data and knowledge as well as coordination of
actions among our three countries
• The goal of the framework is to enhance coordination between our countries and
increase regional capacity to assess and address the risks posed by chemicals to
protect human health and the environment.
–
Implementation of this framework will also contribute to coordinating programs in a manner
that minimizes cost and unnecessary barriers to trade and business.
• This cooperative trilateral approach will fully apply the results of Canada’s Chemical
Management Plan, ongoing United States assessment and management efforts
related to high production volume chemicals, updated information on inventories, and
Mexican efforts to develop a chemical inventory and implement international
commitments.
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Features of the framework
By 2012:
• the United States to assess and initiate needed action on the over 9,000
existing chemicals produced above 25,000 lbs/yr in the United States;
• Canada to complete assessment and take regulatory action on the Canadian
highest priority substances as well as initiate assessment of medium priority
substances;
• Mexico to develop an information system for dangerous materials; and
• the three countries to enhance appropriate coordination in areas including
testing, research, information gathering, assessment, and risk management
actions.
By 2020, the trilateral cooperation will strive to achieve the following:
• inventories of chemicals in commerce have been established and updated in
all three countries;
• Mexico has enhanced its capacity to assess and manage chemicals; and
• the sound management of chemicals in North America as articulated by the
World Summit on Sustainable Development Johannesburg Plan of
Implementation and reinforced under the Strategic Approach to International
Chemicals Management.
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Next Steps
• Implementation of the framework will begin this fall
through the development of a workplan to implement
the Summit commitments and clarify the
implementation milestones
– The workplan will reinforce our actions on many fronts: SAICM
implementation, CEC, cooperation between North America and
the European Union
• Progress report to be provided to Leaders at the next
Leaders Summit – tentatively set for Spring 2008
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What is the driver behind Canada’s
involvement in the framework?
• In December 2006, Canada’s Prime Minister launched
the Chemicals Management Plan
– The foundation of Canada’s plan is a science-based process
through which priorities were set and actions taken.
• Canada’s commitments at the Leaders Summit are fully
in line with our domestic regime for the assessment and
management of the risks posed by chemicals.
• Having a domestic plan allows Canada to better interact,
in a timely and appropriate manner, with the United
States and Mexico, as well as with other key jurisdictions
such as the European Community and APEC.
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Laying the foundation
•
The Canadian Environmental Protection Act, 1999 required both the Health
and Environment Ministers to categorize 23,000 legacy chemicals.
–
Government of Canada scientists, in co-operation with industry and health and
environmental groups, completed the categorization of the Domestic Substances
List (DSL) by the September 2006 deadline
–
The categorization criteria used during this process considered whether a
substance(s):
▪
▪
–
•
May present the greatest potential for exposure to individuals in Canada; or
Are persistent (P) or bioaccumulative (B), in accordance with the regulations, and
inherently toxic to humans or to non-human organisms, as determined by laboratory or
other studies
The categorization process provided the Government of Canada with a baseline of
information on 23 000 substances and allowed for the prioritization of the
substances’ assessment and management.
The Government is using this information to:
–
–
–
Inform completion of obligatory risk assessments
Launch new programs under the Chemicals Management Plan (CMP) (e.g.
Challenge)
Transform how it protects Canadians and their environment from risks associated
with chemicals
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Results of prioritization
Through categorization, 4300
substances on the DSL were
identified for further action
500 high
priorities
• 4000 met the categorization
criteria
• 300 warranted further
attention from a human
health perspective
4300 Priorities
from
Categorization
2600 med
priorities
1200 low
priorities
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Key Objectives of the CMP
• Significantly strengthen the existing substances regime: Categorization
established a new information baseline that sets clear priorities for action that
are science based
• Integrate government activities: The Chemicals Management Plan will
strengthen CEPA’s coordination with other federal statutes, including:
Hazardous Products Act, Food & Drugs Act, and Pest Control Products Act
• Establish government accountability: The Plan includes regulations that will
draw on:
– Enhanced monitoring and surveillance activities to identify priorities and measure
effectiveness of regulatory actions
– Increased research activities to ensure that action is informed by best available
science
– Enhanced risk communications to Canadians
– Public web portal to ensure consistent access to information
– A cyclical update of the Domestic Substances List that will require industry to report
on use and volume of substances on the Canadian market
• Strengthen industry’s role by proactively identifying and safely managing
risks associated with chemicals they produce and use
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Chemicals Management Plan:
Program Elements
• Stakeholder feedback during design indicated a clear
preference for a phased approach driven by priorities
• The initial focus of the Chemicals Management Plan is
addressed through:
– Challenge Initiative for high concern substances in commerce
– Significant new activity controls (SNAcs) for high concern
substances no longer in commerce
– Petroleum sector as a priority with unique risk assessment and
management circumstances
– Prohibitions on a set of substances and creation of the virtual
elimination list to demonstrate commitment and action by government
– Rapid screening of lower risk chemical substances for market
certainty
– Foundational work (international engagement, science, monitoring,
inventory update) to inform and set priorities for next phase of
priority substances
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Integrating the Government’s Chemical
Activities
• The information base provided by categorization will enable greater
integration across the current federal chemicals regime
• We will know more about the hazards, exposures, uses, sectors, and
regulatory regimes associated with chemicals in Canada
• Activities undertaken under all the regulatory regimes will ensure that the
risks posed to Canadians and the environment are lessened, including:
– Older pesticides will be reviewed and the review process for newer, safer pesticides
will be accelerated
– Control measures will be developed to ensure that Canadians’ food continue to be
safe from the risks associated with chemicals
– Regulations will be developed to address risks to Canadians and Canada’s
ecosystems posed by pharmaceuticals and personal care products that are released
into the environment
– Cosmetics products now require content labels
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Regulatory Actions to date
Proposed prohibitions were announced in December 2006:
• Regulations Amending the Prohibition of Certain Toxic Substances Regulations,
2005 (2-Methoxyethanol, Pentachlorobenzene and Tetrachlorobenzenes) came
into force on February 9, 2007
• Proposed Perfluorooctane Sulfonate, its Salts and Certain Other Compounds
Regulations were published in the Canada Gazette, Part I in December 2006
• Proposed Polybrominated Diphenyl Ethers Regulations were published in the
Canada Gazette, Part I in December 2006 as a first step in the risk management of
PBDEs in Canada
The Virtual Elimination (VE) List was created:
• VE is the reduction of the quantity or concentration of a toxic substance in a release
into the environment below concentrations that can be accurately measured.
• VE applies to substances that are persistent, bioaccumulative, toxic under CEPA
1999 and are predominantly anthropogenic
• The VE List was established on December 13, 2007 with the addition of the
substance Hexachlorobutadiene (HCBD)
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Challenge to Stakeholders: Overview
•
The Categorization exercise identified 193 substances believed to be in-commerce and identified as
high priorities for action. The Challenge focuses on those substances that have been identified as
ecological and human health priorities:
–
–
Ecological: categorized as Persistent (P) and Bioaccumulative (B) and inherently toxic to human and nonhuman organisms (iT):
Human Health: categorized as high hazard and have a high or intermediate potential for exposure
•
For these substances the Government is placing the onus on industry and other stakeholders to
provide information that improves, where possible, knowledge for risk assessment and identification
of industrial best practices in order to set benchmarks for risk management and product stewardship
•
For these substances, the government is predisposed to conclude “toxic” should no new
information come forward, and institute control measures that safeguard human health and the
environment
•
The Government will release, in batches of 15-30 substances every three months, profiles of
chemical substances, mandatory surveys and voluntary questionnaires. All challenge substances
will be released within 3 years.
•
Challenge documentation: http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/index_e.html
Reaction to date:
•
High interest in the Challenge from Canadian stakeholders
–
Interest has also been expressed from other governments, in particular the United States
–
Via their Canadian operations, many international chemical firms are starting to provide information through
the mandatory surveys
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Restrictions on Re-introductions
and New Uses (SNAcs)
• A survey of the domestic chemical industry indicated that some of
the priority substances were no longer in commerce in Canada
• The Government is controlling the re-introduction of 148 highhazard substances from categorization not currently in use in
Canada through the Significant New Activity (SNAc) provisions of
the New Substances Program
– A SNAc notice requires industry to provide data – to be reviewed by
Environment Canada and Health Canada – before the substance can
be re-introduced into Canada
• A further grouping of substances of interest (human health, low
exposure) will be the subject of SNAcs in the coming months
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Petroleum Sector Stream
• High priority petroleum substances were set aside from the
Challenge because of the large number of substances that are
primarily, if not exclusively, related to the petroleum sector. In
addition, most of these substances are complex mixtures that may
need to be considered differently from discrete substances.
• These substances will be addressed according to the same timeline
as the Challenge (risk assessment in three years, with control
measure if appropriate within CEPA timelines)
• The Government is currently developing a work plan and will
consult with stakeholders in fall 2007
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Medium priority substances
• The remaining medium priority substances are expected to be
addressed in total by 2020.
• International programs, support for the research and monitoring
community, and development and update of a cyclical inventory
update will help the Government set priorities.
• In addition, we will work with priority sectors to negotiate and
implement performance agreements
• The Government will consult on the approach and proposed “next
round” of priorities for medium-priority substances starting in the
fall/winter of 2007/2008
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Low hazard, low risk substances
• A number of substances identified through categorization have a low
potential for risk.
• The rapid screening employed for risk assessment used a worst-case
scenario model to confirm the likelihood that a substance may not cause
ecological harm
– Results were released for public comment on June 23, 2007.
– 1066 substances were subject to this approach
– 754 substances were proposed to be “not toxic” for the criteria set out under
section 64 of CEPA 1999
– The government proposes to include the substances in the future inventory
update to validate assumptions, conducting monitoring where appropriate and
revisit some of the substances as part of assessments of “families of chemicals”
at a later date.
– 312 substances have been identified as requiring further assessment and have
therefore been re-prioritized into the group of medium priority substances
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The CMP continuum: key to an efficient science-based
regulatory regime for chemicals
Support for Research:
• The Government will enhance regulatory science by leading research and
partnering with external research bodies in order to inform risk assessments and
regulatory interventions
– Thus ensuring that action on the part of governments, Canadians, and industry
are informed by the best available science
Integrated Monitoring:
• The Government will build on the new baseline of information from categorization by
implementing a national health and environment monitoring and surveillance
program that:
– Identifies emerging priorities and tracks Canadians’ exposure to toxic
substances; and,
– Measures the effectiveness of our regulatory actions so that we know what
works best
Inventory Update
• The Government will develop and implement a cyclical inventory update
provision for CEPA’s Domestic Substances List
– This will require industry to report on the substances they use, and the volume
of these substances on the Canadian market
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CMP Implementation timeframe
Canadian
Environmental
Protection Act
Prohibitions
Apply significant new activity provisions
Notice of Intent for Challenge, DSL Corrections, and Rapid Screening
Implement Assessment Challenge (rolling deadlines decisions)
Negotiated performance agreements
Generic rapid screening
Assessment of medium priorities
Pest Control
Products
Act
Food and
Drugs Act
Accelerate re-evaluation of older pesticides
Review and Registration of New Products (ongoing)
Pesticide Risk Indicators, Incident Reporting System
Cosmetics Regulations: Mandatory Ingredient Labelling
PPCP Regulations
Pharmaceuticals disposal guidelines
Program
Activity
Research, monitoring and surveillance, inventory updates, risk communication
Dec 06
Mar 07
…
200
8
2009
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2010
…
2020
Contact Information
Chemical Substances Web Site:
▪ www.chemicalsubstanceschimiques.gc.ca
Contact for Inquiries or Submissions:
DSL Surveys Coordinator
Existing Substances Program
Place Vincent Massey, 20th Floor
351 Saint Joseph Boulevard, Gatineau QC K1A 0H3
Tel: 1-888-228-0530/819-956-9313 Fax: 1-800-410-4314/819-953-4936
Email: DSL.surveyco@ec.gc.ca
CD ROMS with results of DSL Categorization are available upon
request.
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Thank you!
John Arseneau
Director General
Science and Risk Assessment Directorate
Environment Canada
Email: john.arseneau@ec.gc.ca
Telephone: (819) 953-1114
Fax: (819) 953-5371
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