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Consultations on the CEPA New Substances Notification Regulations and New Substances Program (Chemicals and Polymers Portion) Report on Progress

4. Progress in Implementing the Recommendations - By Consultation Theme

4.1 Theme 1: Improving the Environmental and Health Assessments for New Substances

Recommendations under Theme 1, Improving the Environmental and Health Assessments for New Substances involve regulatory and program matters associated with various aspects of the assessment of environmental and human health risks. They concern the clarity of guidance for requiring additional information for the risk assessment, incorporation of endocrine disrupting substance (EDSs) considerations, data requirements, the occupational work environment, waiver requests, Good Laboratory Practice, toxicity testing using animals, improved characterization of exposure, and the evaluation and validation of data and data quality.

Status and Next Steps

Endocrine Disrupting Substances (EDSs)
An in-house EDS Analogs Database has been completed. The database is used to identify whether new substances have structural similarities to substances with known EDS potential. In addition, new commercially available modeling software is being evaluated as tools for estimating a substance's potential for binding to estrogen receptors, and hence signaling a possible relationship to endocrine disruption.

Occupational Exposure Information Sharing Agreement (Intergovernmental)
Preliminary discussions with provincial government representatives regarding occupational exposure were initiated in 2003 by Health Canada. Next steps: Will depend on the outcome of the discussions.

Process to Inform Notifiers of Potential Hazards
A process to communicate with notifiers about potential hazards about which they are unaware, is being developed by Health Canada. Next steps: The communication process will be finalized.

Toxic Substances Management Policy
Though it was drafted and finalized following several stakeholder comment periods, the Implementation Strategy for New Substances is being re-examined in light of obligations incorporated in the Stockholm Protocol. Next steps: Once the internal evaluation is completed and any potential amendments are identified, stakeholders will be asked again to comment if necessary.

Exposure Template
The exposure template was developed with input from industry. It is being used by some notifiers and is included with their notifications. It is also being used by Environment Canada to request additional exposure information when necessary. Next steps: The exposure template is undergoing further development and review by industry. Although there are no immediate plans to make its use mandatory, the exposure template will be made available on the New Substances website.

Peer Review of Assessment Data
A contract through Health Canada is underway to determine a process for external peer review of program risk assessments. The resulting report, expected in Fall 2003, will make recommendations on a process of external review, and will include recommendations on frequency, process, products, information submitted, conflict of interest considerations, etc. Next steps: Following a review of the recommendations in the external peer review report, steps will be taken to implement a periodic external review, expected to begin in 2004.

Class Waivers
A document outlining "class waivers" for acid dyes meeting certain criteria has been drafted. Amendments that incorporate this class waiver are already being factored into the regulatory amendments. Next steps: The draft document for "class waivers" for acid dyes will be circulated by end of 2003 to external stakeholders (e.g. other regulatory agencies, Industry) for review and comment.

Suspicion of Toxicity
A draft document describing how Health Canada has interpreted the suspicion of toxicity provisions of CEPA has been prepared. Next steps: An internal review will occur by end of 2003, followed by external comment before being published.

Feasibility Study for Verification of Test Data
Terms of Reference for a contract to carry out a feasibility study for a government-funded process to verify test data submitted to the program are being developed. Next steps: A contractor will be hired in early 2004 to undertake this study to examine other government-funded processes to verify submitted test data that exist elsewhere and to recommend whether any such processes would be appropriate for the NS Program.

Requiring Additional Information
Clarification is currently being sought on the use of section 84 of CEPA 1999 to require additional information when the prescribed information suggests a suspicion of toxicity, but is considered insufficient to adequately characterize the risk.

4.2 Theme 2: The Regulatory Framework

Recommendations under Theme 2, The Regulatory Framework, largely involve changes to the NSNR themselves. These include revisions to the notification triggers, the framework for and the specification of data in schedules, special categories such as R&D, product development, site-limited intermediate and export-only substances, and assessment periods. In addition, amendments relating to record-keeping and enforcement were identified.

Status and Next Steps

Entry-level Volume Trigger and Cumulative and In-Possession Triggers
The recommendations pertaining to the entry-level volume trigger and the elimination of cumulative and in-possession triggers have been incorporated in the draft amended NSNR.

NSNR Framework, Special Categories, and Assessment Periods
Changes to the framework for the NSNR, to R&D substances and product development substances, to site-limited intermediate substances and export-only substances, and to assessment periods, have been incorporated into the draft amended NSNR as per the consultation recommendations.

SNAc Provisions
An internal consultation was held to develop guidelines for the use of SNAc provisions. Next steps: A preliminary guidance document for the use of SNAc provisions is being finalized and distributed to program personnel for their use. This guidance document will form the basis of a public document expected to be completed and included in the New Substances Program Operational Policies Manual in late Fall 2003.

Flagging Polymers of Low Concern
A mechanism for listing polymers of low concern on the DSL has been developed, as well as a specific definition, based on the existing regulatory criteria, for polymers of low concern which will be published in the Canada Gazette, Part II. The first DSL amendment was published on October 22nd using this mechanism. Next steps: An Advisory Note regarding the DSL polymers of low concern flagging mechanism will be drafted and published.

Early Termination of Assessments
An operational policy document has been drafted and will be incorporated into the New Substances Program Operational Policies Manual.

Smart Tool
The Smart Tool is intended to simplify the notification and assessment of low concern polymers. Funding and resources for this project are currently being explored. The subject has been raised with the U.S. and other OECD countries to solicit interest and possible support.

Record-keeping Requirements
The Departments will clarify notifier/Canadian agent obligations with respect to record-keeping requirements and incorporate the changes in the amended NSNR and Guidelines.

4.3 Theme 3: Transparency of the NSN Regulatory Process

Theme 3, Transparency of the NSN Regulatory Process, recommendations relate primarily to transforming the NS Program into a more open and transparent operation. They include the use of plain, understandable language for the NSNR, the Guidelines and program policy documents. They address the NS Program web site and links, CEPA Environmental Registry search options, confidential business information, access to decisions and the supporting risk assessments, and mechanisms for challenging assessment decisions.

Status and Next Steps

New Substances Program Operational Policies Manual
A New Substances Program Operational Policies Manual containing operational policies documents that describe how the New Substances Program operates has been prepared. The manual includes policies addressing general program operations, processing of New Substance Notifications, risk assessment, and risk management. The manual will be continually updated and will be useful to New Substances Program staff, stakeholders, and the general public. Next steps: The New Substances Program Operational Policies Manual will be published after input from stakeholders has been sought in Fall 2003. The Manual will be updated as new operational policies are developed.

Standardized Formats for Assessment Report
Under the OECD New Chemicals Task Force, various governments are working toward establishing a standard format for risk assessment reports, by using an Australian assessment template as a starting point. Discussions have centered on organizational structure and essential template elements. The Working Group has developed an organizational structure of headings and subheadings for risk assessment reports. The proposed structure was put forward to the Task Force for review and discussion in October 2003.

A pilot project was initiated for Health Canada's revised assessment report format for new chemicals' use. Next steps: A review of the results of the pilot project will occur in December 2003.

Progress Reports
Progress reports for the implementation of the consultation recommendations, such as this current document, will continue to be issued regularly.

Third Party Information and Confidential Business Information
A draft document for the handling of third party information has been prepared. Assessment templates are being developed to provide the notifier/public with assessment summaries that do not contain Confidential Business Information.

4.4 Theme 4: Improving Responsiveness of the NSN Regulations and NS Program in the Global Context

Theme 4, Improving Responsiveness of the NSNR and NS Program in the Global Context, recommendations concern a number of initiatives under way within the program relating to international harmonization, such as information- and work-sharing, bilateral/multilateral arrangements and management of confidential business information.

Status and Next Steps

International Cooperation
A strategic plan relating to international regulatory and scientific cooperation is being developed, and will be finalized by early 2004, after stakeholders have been consulted. In following the strategy, Canada will work with other countries to find common ways of doing business that will improve decision-making about new chemicals and polymers in Canada and internationally. Next steps: The Departments intend to seek stakeholder perspectives on a draft strategic plan, to amend the plan as appropriate and to make it public. The departments will review progress on implementation of the plan and will release a report by the end of 2005.

4.5 Theme 5: Service Delivery

Recommendations under Theme 5, Service Delivery, address operational program changes and resource considerations. These include service quality standards and delivery initiatives, performance indicators, education and training, leadership for cultural change and innovation (for example, an electronic filing system, the Four Corners Agreement, personnel exchanges, compliance promotion activities, and assessment methods for complex hazard and risk assessment challenges).

Recommendations relating to service delivery will be implemented via operational program changes within available resources. An important initiative in this regard will be the Service Delivery Improvement Strategy.

Status and Next Steps

Service Delivery Improvement Strategy
A Service Delivery Improvement Strategy is being developed to guide improvements, as well as develop tools to measure stakeholder satisfaction. Next steps: The Strategy will be communicated to senior management in both Environment Canada and Health Canada as well as stakeholders in Spring 2004. Work on recommendations relating to Information Technology will continue, including feasibility of the Smart Tool and development of electronic filing tracking. The departments intend to issue public progress reports such as this one on a regular basis to keep stakeholders and other interested parties informed.

OECD New Chemicals Task Force
The New Substances Program is leading the OECD new chemicals task force. With respect to information sharing activities, following an initial comparison study of assessments conducted by a number of jurisdictions, a second comparison round is underway. Currently, assessment reports on chemicals of higher hazard are being exchanged. The objective is to build on the knowledge gained from the initial comparisons and to understand the risk assessment decision-making process of other jurisdictions. This work may facilitate future sharing between jurisdictions of data, decisions and work. Next steps: A consensus document on the comparative study for information sharing activities will be developed and discussed at an OECD workshop in Spring 2004.

Science Capacity
With respect to hazard assessments, opportunities for harmonizing approaches to reporting effects data are being explored with other governments. Next steps: Future work for hazard assessments will include evaluating chemical hazard report summaries from various countries and will involve identifying essential elements of a hazard report. Depending on the outcome, this work may lead to sharing hazard reports between various OECD jurisdictions.

Compliance Promotion
The National Compliance Promotion group continues to make progress with respect to projects they identified and for which resources have been secured.

Service / Performance Indicators
A client expectations/satisfaction survey is being developed. Next steps: The survey will be distributed in February 2004.

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