Chemical Management Plan

Batch 2- Con't

Batch 2- con't

• The next step is the preparation of the draft screening health assessment and supporting working documentation
• A lab report underlining issues like identity, production and uses, sources of level of human exposure and health effects.
• The report should outline the objectives of the screening assessment, the approach to decision-making and conclusion and clearly describes the databases that serve as the basis for determination Existing Substance Division (ExSD) critical effect levels and upper-bound exposure estimates

Chemical Management Plan

• Screen health assessment can be considered the most important step in the CMP
• 3 ways for a substance to be identified
• Also be conducted on any other substances for which preliminary assessment is desirable
• Collecting data is the next step
• Information on exposure and effects are obtained from multiple different web-based databases, surveys and previous reviews or assessments conducted by national international agencies.

Newest Developments

Agenda item 3A - New Substances Program: Transparency in the New Substances Program

Development of the decision, making more transparent by online publications and resources availability ,in order to inform interested parties of the program's processes and policies, including advisory notes, policy and guidance documents.

• Agenda item 3B - New Substances Program: Confidential Business Information

Along with providing public transparency, protective information should also not be revealed, therefore, the proposed refinements aim to maximize transparency by balancing public access to information with industry's right to protect confidential business information.

• Agenda item 4 - The Regulatory Co-operation Council 2

Government officials put in front the overview of the second phase of the Regulatory Cooperation Council (RCC), presenting its goal, areas of work, launch of the Forward Plan (in August 2014) and the elements of the Proposed Work Plans.

• Agenda item 5 - The Strategic Approach to International Chemicals Management

Aim to prepare for the fourth international Conference on Chemicals Management in September 2015 where priorities for global action towards the 2020 goal will be discussed.

• Agenda item 6 - SAC Evaluation

Government officials presented the plan for the upcoming SAC evaluation. This presentation aim to get the Council's early thoughts on some questions regarding the upcoming event.

Decision Making

• The “margin of exposure” is the magnitude of the ratio between the level (dose) at which the critical effect is observed in studies conducted in animals or, in some cases, humans and the upper-bound estimated (or measured) level of human exposure to a substance.
• Recommendations are based on the adequacy of this margin of exposure, taking into account confidence in the completeness of the identified databases on effects and exposure.
• Margins over than 1000 are adequate as a basis for recommending no further action for substances where the databases on exposure and effects are relatively done.
• Margins under 1000 are limited and confidence in the exposure and effects databases are cautiously measured and documented

Batch 2- con't

Batch 2- Con't

• Lastly a joint amalgamate has to be done.
• It is a brief (3–6 paragraphs) scientific summary of the Health Canada and Environment Canada screening assessments and the Ministers’ proposed measure, this measures are than published in the Canada Gazette.
• After all these reports are completed the substance reaches the next step which is internal peer review.

Batch 2- con't

• The draft screening health assessment report and supporting working documentation is reviewed at meetings including a senior ExSD technical staff to consider the critical issues and conclusion.
• After the draft screening health assessment report and supporting working documentation goes through internal peer-review it will go through an external peer-review.
• After the external peer-review, the screening health assessment has been completed and will be open to the public to comment on the Canadian Gazette for up to 60 days.

• A detailed summary is included in the text, and more detailed information that constitutes the basis for estimations of exposure and assessment of effects is presented in accompanying tables.
• After the screening assessment report is completed, a supporting working document is to be done.
• This unpublished document provides greater detail on the information used in the screening health assessment and decision-making process. It is available upon request from (ExSD).

The CMP Stakeholder Advisory Council published a new development that took place in October 2014 in a summary report.

The meeting of chemical management plan stakeholder advisory council was held where different agendas were being discussed as follow:

• Agenda item 1 - Program updates

The discussion of further plans for the next CMP reports like, the upcoming issues and their usefulness and also related challenges, suggestions were made to reach better goals.

• Agenda item 2 - Future of CMP Engagement Workshop

Involves early thinking of government on the next phase of the CMP, a number of information and engagement sessions with stakeholders in 2014,

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Decision Making - con't

Batching con't

CMP con't

The Chemicals Management Plan (CMP)

• The relative uncertainty of and degree of confidence in exposure and effects, affects databases that serve as the basis for decision-making in the assessment of high intrinsic toxicity or the adequacy of margins of exposure are explicitly described and consistent across screening assessments.
• They are consistent with similar considerations made for the health risk assessment of Priority Substances under CEPA.

• When a risk is identified from a chemical substance, the CMP will develop and implement steps to avoid risks and how to take care of them.
• This is done by consulting: the Canadian Environmental Protection Act 1999, the Canada Consumer Product Safety Act and other acts that affect the environment and the health of humans.
• So far, 4,300 chemicals out of 23,000 chemicals identified by the Government of Canada have been put as a higher risk.
• The CMP has set a goal to apply focus to these selected chemicals by 2020.

Batching- The Challenge

• Formed by the Canadian Government on December 8, 2006
• Purpose: to build on previous initiatives that intend to serve the health of Canadians and the environment by monitoring and having surveillance on chemicals that are considered harmful and require control measures
• This plan is a combined effort made by both Environment Canada and Health Canada with partnership of stakeholders

• Posting under the Gazette interests stakeholders, industries and general public to give their trustworthy opinion on matters regarding risk assessment and risk management.
• In May 2007, the government decided to release the remaining substances in batches to be evaluated separately

• Roughly 200 chemical substances of the highest priority have been divided up into smaller groups of substances
• Government started posting in the Canadian Gazette in February 2007 under "The Challenge"
• New group of substance every 3 months

Environmental Monitoring

• The major type of monitoring done by the CMP is environmental.
• Environmental monitoring consists of collecting and assessing data that may be physical, chemical and biological.
• The data from environmental media focuses on sources such as air, water, sediment, wildlife, and landfill leachate.
• Major changes in any of these sources are put through risk assessment and risk management where decisions will be made.

What are Chemicals?

Batch 2 -con't

Walk through - Batch 2

Timelines

• According to the government website, chemicals can be considered as the basic building blocks that make up all living and non living things on the planet.
• Some may occur naturally, while others may be synthetic.
• Depending on the amount released will be how much the chemical affects the environment.
• If harmful chemicals are released in large amounts, this can have long lasting effects on both human health and the environment.

• If the chemical substance has great potential for human exposure, if the substance(s) that are persistent or bioaccumulative, inherently toxic to humans, inherently toxic non-human organisms, then the substance has to go through a screening health assessment.

• After the assessment is done, its classified as CEPA Toxic or put through an in depth assessment
• In depth assessment will deem it CEPA Toxic or no further action will be taken
• Section 76 (3) allows any civilian to write the Minister of the Environment and request a substance to be added to the Priority Substance List (PSL).
• Substances nominated for addition to the PSL will typically go through a health screening assessment.

Categorizing

• Risk management takes 18 months to develop and 24 months to implement
• Both the draft and the final risk assessment is posted on the Canada Gazette where the public and stakeholders has the opportunity to comment on the risk assessment for up to 60 days before it is taken off the Canada Gazette.
• Screening health assessment is limited mainly to the info that is considered most critical in assessment of human exposure to a substance and health related effects.

• Categorizing chemical substances are required by section 73 in the Canadian Environmental Protection Act 1999.
• These chemicals are featured on the Domestic Substances List (DSL), which was first presented with the greatest, intermediate and lowest potentials for exposure (GPE, IPE, and LPE).
• These can be inherently toxic, persistent, and/or bio accumulative.

Categorizing - con't

• Inherently toxic would be harmful to humans and the environment.
• Persistent would include chemicals that have a long life and are hard to break down.
• Bio accumulative would consider chemicals that build up in living organisms and enter the food chain.

Tools used to assist Categorizing

• In 2003, a simple exposure tool (SimET), a complex exposure tool (ComET), and simple and complex hazard tools (SimHaz and ComHaz) were all made to help figure which chemicals on the DSL had the greatest potential for exposure (GPE).
• These tools were used on the DSL that developed in October 2004 and released to the public in June 2005.
• The list then had a set of goals to be achieved. Firstly, going over and prioritizing the list of substances that needed more attention, secondly, deciding if more classifying should done and making sure that all substances are accountable.

Tools- con't

• For exposure, the SimET assisted with ranking the DSL substances based by submitters, quantity and expert ranked use.
• ComET also assisting in exposure gave estimates of human and environmental exposure with scenarios.
• For hazards, SimHaz determined whether or not compounds were high or low based on evidence.
• ComHaz used multiple endpoints and data sources to give a more hierarchical standpoint along with the weight of evidence.

Some of the changes addressed were:

• Intensifying timelines
• setting objectives
• RM strategies

The High and Moderate Priority Groups on the DSL

• The DSL list was then separated into two groups; the high and moderate health priorities for action.
• The high group consisted of around 100 substances that are GPE or IPE, approximately 160 substances that were LPE and an estimated amount of 260 petroleum streams that were GPE, IPE and LPE.
• The moderate group was composed of around 630 substances that could be GPE, IPE, persistent and bio accumulative.
• In September 2006, more substances were added and a finalized version of the draft was posted, which included the next steps for the two groups.

The DSL Now

• Over the years, taking in consideration exposure time and hazard, a better way was developed.
• Chemicals are now classified as those with the greatest potential for exposure.
• Along with the Domestic Substance List comes the Priority Substances Lists that include in depth analyses of the selected chemicals that cause harm.
• The major challenge associated with this process was deciding how much a substance should be classified and how much classifications there should be.

Accompolished by:

Program similar to CMP

Lake Ontario Lake wide Management Plan

Gap Analysis

• accelerated activities
• reinvesting in R&D
• new partnership - industries and other countries (common goals)

Priority Substance List

Timelines

• Assessment of chemical - toxicity
• List based on the priority
• Different steps to add substance on the list

• bi-national plan based on reducing chemical pollutants entering the lake and protecting the health of Lake Ontario
• The LaMP participating agencies will focus to track new and emerging issues such as newly recognized chemicals of concern, invasive species, potential effects of climate change and water level regulation.

Fast Track Chemical Assessments

Gap Identified

• Time consumed - Risk Assessment
• Time lapse - risk to human heath
• Some substances; no conclusion reached

Programs Complement Each Other

• Both program work on same principles and help to reduce chemical pollutants and protect the environment.

Under CEPA 1999 :

• Section 70 - Industry Information gathering
• Section 71 - Ask of established information to prioritize and implement regulations, also sampling and testing of the data.

Ways to Streamline the Assessment Process

Thank you for listening :)

• Reducing two Cabinet Approvals to one : Section 90(1)
• reducing the five year plan to two years plan and dead lines should be effective to complete the risk assessment section 78(1)

Screening level Assessment

The Challenge