Results of Categorization and Next Steps

George Enei

Director, Existing Substances Division

May, 2006

2

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

3

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

4

Industry Associations

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

The following associations have been working with Environment Canada to provide data on groups of substances:

5

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)

• >80% of companies contacted responded, providing data for 107 values.

• Of these, 50 studies were received of which approximately 2/3 meet acceptable criteria

6

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)

7

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

Categorization Results April 2006

For immediate action

Meet categorization criteria

Do not meet criteria, but further consideration

Do not meet criteria

8

A few comments about our survey work

9

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.

10

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

>100 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

11

Simplified S.71 Notice

12

Chemicals Management and Categorization: the broader context

13

Canada’s 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.

14

Canada’s ‘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.

15

…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 nature’s 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.

16

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.