Results of Categorization and Next Steps

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Results of Categorization and Next Steps
George Enei Director, Existing Substances
Division May, 2006
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Categorization is mandated under Canadian
Environmental Protection Act (CEPA 1999).

• Ministers of Environment and Health are required
  to categorize the 23,000 substances on the
  Domestic Substances List by September 14, 2006
• Categorization is a priority setting exercise
  that involves the systematic identification of
  substances on the DSL that should be subject to
  screening assessment
• This includes identifying substances, based on
  available information that
• May present, to individuals in Canada, the
  greatest potential for exposure (GPE) or
• Are persistent (P) or bioaccumulative (B), in
  accordance with the P and B regulations, and
  inherently toxic to humans or to non-human
  organisms, as determined by lab or other studies

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Industry has been part of the process thus far,
including

• June 2004, Canada launched an 18 month voluntary
  challenge to industrial stakeholders and
  interested parties to submit experimental study
  or other information that could help refine
  categorization decisions
• We have received approx 20 larger data
  submissions for consideration and 375 individual
  P, B or iT aquatic toxicity studies
• Approx. 20 submissions have been received
  covering the human health aspects of
  categorization

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Industry Associations
The following associations have been working with
Environment Canada to provide data on groups of
substances
Associations of Substances
ACC - Diisocyanates sub-group 7 (organic list)
ACC - Phthalate Esters Panel 100
Association of Synthetic Amorphous Silica Producers 8
Canadian Chlorine Chemistry Council 70 discrete organics
Canadian Petroleum Products Institute 600 UVCBs, 300 organics
Colour Pigments Manufacturers Association 300
Ecological Toxicological Association of Dyes Organic Pigments Manufacturers 1000
Forest Products Association of Canada 300
ICG bioaccumulation working group (aliphatic materials) 400
Research Institute for Fragrance Materials 2500-4500
Silicones Environment Health Safety Council 58
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Request for References from MSDS

• A search of online Material Safety Data Sheet
  databases identified MSDS which contains P, B or
  iT values which could be pivotal values for the
  categorization of UVCBs and Polymers
• Mailings were sent in 2005 to 107 companies to
  request the studies on which P, B and iT values
  were based. (373 values)
• gt80 of companies contacted responded, providing
  data for 107 values.
• Of these, 50 studies were received of which
  approximately 2/3 meet acceptable criteria

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A critical step involves setting priorities.

• Large number of substances meet the criteria for
  categorization
• Assessment is not the appropriate next step for
  many substances
• Based on the information collected through
  categorization, the following actions have been
  identified
• Screening assessments
• Data gap filling
• Cooperation with other initiatives and
  jurisdictions
• The highest priorities for action include
• Substances with greatest and intermediate
  potential for exposure and hazardous to humans
  (260 subs.)
• Substances that are inherently toxic, and both
  persistent and bioaccumulative (PBiT) ( 400
  subs)

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Categorization Results April 2006
GPE or IPE and iT IPE, P/B, IT unknown GPE iT Do not meet health criteria
PBiT 26 19 3 10 362
PiT or BiT 63 75 99 47 3052
Uncertain 2 16 19 9 1487
Do not meet eco criteria 157 117 587 232 15667
Health
Eco
Do not meet criteria, but further consideration
For immediate action
Do not meet criteria
Meet categorization criteria
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• A few comments about our survey work

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Industry obligations under CEPA Section 70

• Where a person
• (a) imports, manufactures, transports, processes
  or distributes a substance for commercial
  purposes, or
• (b) uses a substance in a commercial
  manufacturing or processing activity,
• and obtains information that reasonably supports
  the conclusion that the substance is toxic or is
  capable of becoming toxic,
• the person shall without delay provide the
  information to the Minister unless the person has
  actual knowledge that either Minister already has
  the information.

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S.71 Notice with Respect to Selected Substances
identified as Priority for Action

• Action being taken on first results of
  categorization
• Notice issued in Canada Gazette on March 4, 2006
• Compliance deadline June 22, 2006
• Requires Canadian companies who manufactured or
  imported gt100 kg of listed substances in 2005 to
  respond
• 500 substances in the notice
• Courtesy copies mailed to 6000 companies and
  industry associations
• Survey designed to 1) Identify which substances
  are in commerce in Canada and 2) Identify
  stakeholders and sectors before action is taken
  on these substances
• Opportunity for Non-Canadian companies to
  identify as stakeholders where they do business
  with these chemicals

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Simplified S.71 Notice
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• Chemicals Management and Categorization
• the broader context

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Canadas categorization work is a world first
in addressing the legacy of existing substances.

• The assessment and better management of chemical
  risks is a global problem. No jurisdiction has
  had a good information base about the many
  thousands of substances that were in commercial
  use before the new substance requirements came
  into place.
• In Canada, there is a legacy of 23,000 substances
  on the Domestic Substance List that need to be
  categorized by September 2006 for the risks they
  pose to the environment and human health.
• Categorization will be completed on time in
  September 2006. Substances are being categorized
  according to criteria related to their
  persistence ability to bioaccumulate their
  inherent toxicity to humans or the environment
  and their greatest potential for exposure to
  humans. Approximately 4000 chemicals are
  expected to meet the criteria.
• Canada is working toward positioning the results
  of categorization in the context of a broader
  chemicals management framework. At its core is
  the recognition of the need to promote greater
  consistency in assessment and management
  practices, and to eliminate unnecessary costs and
  duplication of work for governments and industry
  alike.

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Canadas roadmap to a broader chemicals
management framework needs to be grounded in a
series of clear objectives...

• A number of initiatives beyond the categorization
  effort (e.g., CEPA Review environmental
  assessment regime for new substances in products
  regulated under the Food and Drug Act) have
  necessitated that Government ensures its path
  forward includes
• a new decision-making model among governments,
  industry and key stakeholders, reflecting shared
  responsibility for achieving ambitious domestic
  and global environmental objectives
• enhanced information for decision-making and
  accountability, through improved monitoring,
  collection, analysis and sharing practices
• An integrated, streamlined, fair and predictable
  regulatory regime, including the use of
  market-based incentives and regulatory backstops
  and
• an integrated national approach to science and
  technology, focused on key priorities, linked to
  market needs, and conducted in partnership with
  academia, NGOs, industry and governments.
• By achieving our objectives, Canada will be a
  world leader in chemicals management and will
  ensure protection of the environment and human
  health for all Canadians, for both present and
  future generations.

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as well as an action agenda to ensure we are
collectively successful.

• Activities that contribute to success would
  include
• A chemicals risk management approach that is
  mindful of basic economic and business principles
  while maintaining natures diversity,
  productivity and capacity for renewal.
• Excellence in science for decision making.
• Sharing responsibility with industry that
  promotes competitiveness and development of safer
  alternatives
• A public priority setting framework that ensures
  the appropriate use of resources of government,
  stakeholders and the international community by
  spending more time on the substances of greatest
  concern
• Information management systems that communicate
  and reduce uncertainty, makes information
  accessible, and involves Canadians in the
  process.
• Participation in and influence of international
  work, including a North American approach for
  greater efficiency.
• Compliance promotion through new and innovative
  approaches.
• Looking at problems from an ecosystem approach in
  designing solutions.

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What is next for Existing Substances that meet
the categorization criteria?

• Report results of categorization within the
  context of the next steps that are planned for
  substances meeting the categorization criteria.
• Develop a mechanism to group substances according
  to the anticipated post-categorization actions of
  government, industry and stakeholders
• Challenge stakeholders to provide additional data
  that are not publicly available.
• Develop a long-term plan to engage the research
  community to support priorities by filling data
  gaps and identifying emerging trends for new and
  existing substances of concern.
• Align the domestic program with international
  initiatives.
• Recognize initiatives undertaken by stakeholders
  who want to play a leadership role
• We will be consulting with stakeholders over the
  coming months on the work following
  categorization and how we manage chemicals in a
  broader context.