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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

4300 Priorities from

Categorization

2600 med priorities

500 high priorities

1200 low priorities

Through categorization, 4300 substances on the DSL were identified for further action

• 4000 met the categorization criteria

• 300 warranted further attention from a human health perspective

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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 dateProposed 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 non-human 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 high-hazard 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

Pest Control Products

Act

Food and Drugs Act

Dec 06 2008

…Mar 07 2009 2010 … 2020

Canadian Environmental Protection Act

PPCP Regulations

Generic rapid screening

Implement Assessment Challenge (rolling deadlines decisions)

ProhibitionsApply significant new activity provisions

Notice of Intent for Challenge, DSL Corrections, and Rapid Screening

Negotiated performance agreements

Assessment of medium priorities

Accelerate re-evaluation of older pesticides

Pesticide Risk Indicators, Incident Reporting System

Review and Registration of New Products (ongoing)

Pharmaceuticals disposal guidelines

Cosmetics Regulations: Mandatory Ingredient Labelling

Research, monitoring and surveillance, inventory updates, risk communicationProgram Activity

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Contact Information

Chemical Substances Web Site: ▪ www.chemicalsubstanceschimiques.gc.ca

Contact for Inquiries or Submissions:DSL Surveys CoordinatorExisting Substances ProgramPlace Vincent Massey, 20th Floor351 Saint Joseph Boulevard, Gatineau QC K1A 0H3Tel: 1-888-228-0530/819-956-9313 Fax: 1-800-410-4314/819-953-4936Email: 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