2016 chemicals management workplan: regulatory cooperation council
United States Environmental Protection AgencyHealth CanadaEnvironment and Climate Change Canada
Table of Content
- Regulatory area to be addressed
- Work Stream A - Significant New Activity (SNAc) provisions and Significant New Use Rules (SNURs)
- Work Stream B - Risk Assessment
- Areas of Interest for Future Work Plans
- For further information please contact
Regulatory area to be addressed
The United States Environmental Protection Agency (EPA), Health Canada (HC) and Environment and Climate Change Canada (ECCC) have common policy objectives under the Canadian Environmental Protection Act (CEPA) and Toxic Substances Control Act (TSCA) to reduce risks to human health and the environment posed by chemicals. Both Canada and the U.S. have in place programs to meet these objectives including aspects such as: information gathering, priority-setting, scientific research, risk assessment and risk management. Canada-U.S. collaboration in these areas will make work more effective and efficient for both governments, as they work towards joint program initiatives, and for stakeholders who will benefit from an aligned approach on chemicals management.
The U.S. Environmental Protection Agency, Environment and Climate Change Canada and Health Canada published an RCC Chemicals Management Work Plan in May 2015 that focused on two areas:
- Significant New Activity (SNAc) Provisions and Significant New Use Rules (SNURs)
- Risk Assessment
This 2016 RCC Chemicals Management Work Plan shares information on progress and results to date in these two work plan areas and provides timelines for remaining planned work and deliverables.
Also identified in the 2016 RCC Chemicals Management Work Plan are several areas where Canadian and U.S. stakeholders have noted potential benefits of a future collaboration between these partners. Discussions to scope a future RCC Work Plan in one or more of these areas will be undertaken throughout 2016/17, with the intent to publish a new Chemicals Management Work Plan in June 2017.
Web conferences will be offered in December 2016, June 2017 and December 2017 to provide updates on progress in implementation of the activities described in this Work Plan Update.
Work Stream A - Significant New Activity (SNAc) provisions and Significant New Use Rules (SNURs)
Environment and Climate Change Canada, Health Canada and the U.S. Environmental Protection Agency will collaborate in efforts to develop common approaches for regulatory reporting requirements for new uses of chemical substances (Significant New Activity provisions in Canada and Significant New Use Rules in the U.S.). The work plan will also provide an opportunity to collaborate on efforts to improve the flow of information on chemicals throughout the supply chain and develop consistent and effective approaches to compliance promotion for SNAcs and SNURs.
Outcomes will include: recommendations for alignment opportunities requiring legislative amendments; development of joint guidance materials to support compliance promotion efforts both within Canada/U.S. and internationally; and the identification of options to increase adoption of best practices for supply chain communication on chemicals subject to SNAc/SNUR requirements.
Progress to Date: May 2015 to June 2016
An RCC SNAc/SNUR Technical Working Group (RCC SNAc/SNUR TWG) (composed of industry, non-governmental organization (NGO) and government representatives) was formed in May 2015 to assist in implementation of the SNAc/SNUR work plan.
During the first phase of work, a number of activities were completed including:
- A comparative analysis of jurisdictional, regulatory, policy and program aspects of SNAc and SNUR provisions;
- A series of stakeholder interviews with Canadian and U.S. industry and NGO representatives to solicit input on relevant differences between and challenges with SNAcs and SNURs;
- Two roundtable exercises that allowed invited Canadian and U.S. industry representatives from various points of the supply chain and NGO participants to share their experience and viewpoints on challenges and best practices for sharing information on chemicals throughout the supply chain and for complying with SNAcs and SNURs.
The results of these information gathering activities and RCC SNAc/SNUR TWG discussions identified several areas of focus for further analysis including:
- Bilateral Consultation and Sharing Information - Identification of options for facilitating and enhancing communication between jurisdictions during SNAc/SNUR development including: promoting opportunities for joint/simultaneous notification of new chemicals/new substances, developing information for companies on how to allow jurisdictions to share and discuss CBI, establishing regular communication opportunities between Canada and U.S. on new substance evaluation outcomes and SNAcs/SNURs.
- SNAc/SNUR Design Elements - Development of materials and approaches to improve understanding of several aspects of SNAcs and SNURs including: notification requirements (SNANs/SNUNs), key terms (including consumer product), standard exemptions (including manufactured items/articles). Discussions also focused on consideration of alignment for some of these aspects.
- Supply Chain Communication - Identification of alignment opportunities for Canadian and U.S. downstream recipient notification and an increased adoption of best practices for supply chain communication on SNAcs/SNURs.
Next Steps: July 2016 to June 2017
- Through regular meetings between departments and with the RCC SNAc/SNUR TWG, in-depth discussions will continue in several areas with the intent to improve stakeholder understanding of these aspects and identify the potential for alignment between Canadian and U.S. approaches (where possible) (July to December 2016):
- Downstream recipient notification requirements
- Standard exemptions to SNAcs/SNURs (including the approach to SNAcs and SNURs applying to manufactured items/articles)
- Common terminology (including consumer product)
- A face-to-face RCC SNAc/SNUR TWG meeting will be held in October 2016.
- Building on the outcome of RCC SNAc/SNUR TWG discussions on areas of interest identified above, joint compliance promotion materials will be developed to promote better understanding of regulatory aspects of SNAcs and SNURs. The RCC SNAc/SNUR TWG will act as an advisory body in development of these materials to ensure format and content is easily accessible to a range of stakeholders (January to June 2017).
- In line with the development of joint compliance promotion materials, a plan for government and industry promotion of best practices for supply chain communication regarding SNAcs and SNURs will be developed (January to June 2017).
- The potential to collaborate on the design of a similar SNAc and SNUR currently under consideration in each jurisdiction will be investigated. This work will involve discussions between government partners and depend on the ability to identify a suitable SNAc/SNUR (EPA/ECCC/HC discussions) (Ongoing).
- Publication of a final reference document and summary outlining findings, recommendations and plan for short term and long term implementation activities (June 2017).
Work Stream B - Risk Assessment
Environment and Climate Change Canada, Health Canada and the U.S. Environmental Protection Agency will collaborate in efforts to develop common approaches to address emerging risk issues and jointly considering how the use of novel data can inform the assessment of chemicals. These partners will continue to work together to develop an Assessment Collaboration Framework that will facilitate and enhance cooperation between these organizations for the risk assessment of chemicals in their respective regulatory frameworks.This Framework will inform future work towards joint Canadian and U.S. risk assessment activities.
Progress to Date: May 2015 to June 2016
Initiative A: Comparative analysis of regulatory risk assessment frameworks
A comparative analysis of regulatory frameworks and approaches for the risk assessment of existing chemicals in Canada under CEPA, 1999 and in the U.S. under TSCA was completed in August 2015 that investigated similarities and differences in aspects such as: regulatory authority, timelines, priority-setting, information gathering, science-based risk assessments, science policy, and public consultation.
Initiative B: Collaboration on common priority/priorities
An RCC Risk Assessment Technical Working Group (RCC RA TWG) (composed of industry, non-governmental organization and government representatives) was formed in May 2015 to assist in implementation of the risk assessment work plan.
A list of chemicals that are forward priorities for risk assessment in Canada and United States was compiled. From this list, five chemicals were selected in May 2015 as case studies to examine differences and similarities in certain approaches used in risk assessment in Canada and United States.
Work on the five case studies was carried out by Case Study Sub-Groups that were composed of certain members of the RCC RA TWG. The case studies were scoped during Summer 2015 and discussed at an RCC RA TWG Workshop held in October 2015. As a result of this workshop, the assessment approaches that were selected for comparison between jurisdictions are:
- Setting Predicted No-Effect Concentration (PNEC) or Concentration of Concern (COC) for aquatic organisms
- Gathering data on uses, releases and exposure of chemicals
- Defining a chemical category
- Use of biomonitoring data in the risk assessment process
Work on cases studies in relation with the selected assessment approaches began in November 2015 and will continue until October 2016, as described below.
Next Steps: July 2016 to December 2017
Initiative B: Collaboration on common priority/priorities (July to October 2016)
The Case Study Sub-Groups will complete work on the five case studies. A face-to-face meeting of the RCC RA TWG will take place in October 2016 to discuss findings from case studies and to launch work on the Assessment Collaboration Framework.
Initiative C: Development of Assessment Collaboration Framework (November 2016 to December 2017)
Building on the results of the comparative analysis of regulatory frameworks (Initiative A) and the case studies (Initiative B), an Assessment Collaboration Framework will be developed and include:
- Common high-level principles for chemical risk assessment
- Identification of opportunities and impediments to joint work
- Forward plan to build on opportunities and to explore mechanisms to address impediments
A final summary document outlining findings and the Assessment Collaboration Framework will be published (December 2017).
Areas of Interest for Future Work Plans
Based on input from stakeholders received by ECCC/HC/EPA in Spring 2016, several areas of interest for future workplans were identified. These areas include:
- Joint work on prioritization and risk assessment
- Data sharing between jurisdictions
- Areas of potential alignment for chemical inventories
- Alignment opportunities on the notification and assessment of new chemicals
- Supply chain communication on chemicals
- Investigation of differences in approaches to workplace exposure and risk
- Collaboration on approaches in other program areas
The development of an RCC work stream in one or more of these areas will be discussed by partners and subject to consultation with stakeholders starting in Fall 2016, with the intent to publish an updated Chemicals Management RCC Work Plan in June 2017.
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