3. Environment Canada/Health Canada Response to Consultation Recommendations, by Themes and Issues

• 3.1 Theme 1 - Improving the Environmental and Health Assessments for New Substances
• 3.2 Theme 2 - The Regulatory Framework
• 3.3 Theme 3 - Transparency of the NSN Regulatory Process (Recommendations 58 to 65)
• 3.4 Theme 4 - Improving Responsiveness of the NSN Regulations and NS Program in the Global Context (Recommendation 66)
• 3.5 Theme 5 - Service Delivery (Recommendations 67 to 76)

The Environment Canada/Health Canada response to the final recommendations of the NSN Multistakeholder Consultations for improving the NSN Regulations and the NS Program is captured in this section. A brief description of each theme and associated issues is provided, as well as details of the Environment Canada/Health Canada response with respect to each recommendation. See Appendix 3 for a listing of all recommendations as included in the Final Report and the details of our reaction and planned course of action.

The reader will notice that throughout the recommendations there is continual reference to the Guidelines and the revisions that were considered necessary to address many of the issues discussed. It is the intention of the departments to revise the Guidelines as recommended throughout the consultation. Drafting of revisions to the Guidelines will be initiated in 2002 and will continue until all topics have been adequately addressed. Some revisions will involve further consultation. The departments believe that final publication of the Guidelines will not be possible prior to promulgation of the amended NSN Regulations; however, they will continue to communicate guidance to notifiers through Advisory Notes and e-mail web site notification updates. The Guidelines have always been, and will remain, a "living" document that is reviewed and revised from time to time to incorporate new technical guidance.

Issues associated with Theme 1 involve regulatory and program matters associated with various aspects of the assessment of environmental and human health risks. Recommendations concern finalization of the Toxic Substances Management Policy (TSMP) Implementation Strategy for New Substances, development of a mechanism for requiring additional information for the risk assessment, incorporation of endocrine disrupting substances (EDSs) considerations, data requirements, the occupational work environment, waiver requests, GLP, toxicity testing using animals, improved characterization of exposure, and the evaluation and validation of data and data quality.

The departments recognize the need for clarity with respect to implementation of the federal TSMP. During the course of the consultation, stakeholders were consulted on a draft document entitled TSMP - Environment Canada Implementation Strategy for New Substances (Draft, April 2001). The final draft of the document and a summary of comments received during the consultations are in the final stages of preparation and will be posted on Environment Canada's Green Lane and the NS Program web site in 2002.

No specific recommendations were made in this section.

The departments are in favour of having clear authority to request additional information beyond that prescribed within the NSN Regulations when it is critical to determining whether a substance is toxic. Since the consultation recognized section 84 of CEPA as a possible authority, the departments will seek legal advice to confirm that it can be used as suggested by the Table. At the same time, the Department of Justice will be asked whether there are any other existing or new mechanisms within CEPA that can be used for this purpose.

Environment Canada and Health Canada will develop criteria by spring 2003 for using authorities, such as section 84, for requesting additional information. The criteria will cover the type of information that could be requested, and under what circumstances. These criteria will be used to prepare guidance, in the form of an Operational Policy for evaluators, by summer 2003.

Environment Canada and Health Canada recognize the potential significance of endocrine disruption on the environment and human health and the urgency to address this issue. At the same time, they face the challenge of awaiting international validation and acceptance of screening and other test methods and of developing the means for interpreting the results in the context of new substance assessments. The departments view the work being done under the 5NR Working Group¹ as well as the efforts taking place within the Test Guideline Program of the Organisation for Economic Co-operation and Development (OECD) as critical to acquiring test methods that could be incorporated within the NSN Regulations. As such, they will continue to support these initiatives and press for timely results. Once suitable test protocols are available, the departments will initiate amendments to appropriately incorporate them within the NS Program by the most appropriate mechanism.

As the test methods associated with endocrine disruption evolve, the Guidelines will reflect new developments, indicating internationally accepted test protocols and how the information will be used in the assessment. Guidance material for notifiers, such as an Advisory Note, will be developed during 2003 and incorporated in the Guidelines. As recommended, information will be included concerning the departments' approach to assessing endocrine disrupting effects and how this would be integrated into a determination of suspicion of toxic. As well, a database of EDS analogues will continue to be developed with other government agencies and research institutes, and peer review from other national governments will be sought. At an appropriate time, this database will be made available to notifiers and the public to assist in understanding this aspect of chemical substances.

Health Canada and Environment Canada acknowledge the importance of these recommendations to establish an effective means to evaluate the potential risks to people exposed in the workplace and to widely communicate this and related information. At the same time, the departments believe that other jurisdictions, federally and provincially, have a dominant role to play in achieving the intent of these recommendations.

The departments see information sharing as a key intent of these recommendations; as such, the departments will initiate discussions by the end of 2002 to define the information-sharing arrangements that should be put into place at the federal level and with provinces. This will be done through the federal/provincial Committee on Environmental and Occupational Health (CEOH) and through direct discussion with the provinces. These arrangements will address the type of information to be shared, with whom and under what timeframes. These discussions will also investigate whether more formal sharing agreements of the type that are authorized under section 316 of CEPA are appropriate. Health Canada is working towards the development of an effective and efficient process for informing relevant agencies and notifiers of hazards identified during the course of an NSN assessment.

The recommendation to undertake a multistakeholder consultation in relation to the occupational environment remains a priority for the departments. Health Canada intends to undertake a consultative process by the beginning of 2003 after seeking the involvement of the CEOH.

(i) Suite of Data Requirements for Chemicals and Polymers (Recommendations 14, 16 and 17)

This set of recommendations concerns the identification of data that should be prescribed in the schedules of the NSN Regulations and the recognition that other relevant data are best addressed in the Guidelines. The departments believe that the tiered system of prescribed data and the request of waivers as authorized by CEPA 1999 ought to remain the basis of the notification system. They are supportive of the data that were identified by the Table for inclusion in the NSN Regulations and, in combination with recommendations under Theme 2, when the data should be notified. They are also supportive of the need to elaborate in the Guidelines what additional data may be necessary and under what circumstances they should be generated. Implementation of these recommendations will be pursued within the timelines described for renewal of the Guidelines through a multistakeholder Working Group.

(ii) Class Considerations (Recommendations 20 and 21)

As recommended, the departments will describe the classes of substances and circumstances for which waivers will be accepted for certain tests if requested by the notifier. Furthermore, the departments will describe where additional information will be recommended if a substance meets certain criteria. The Guidelines will describe the benefits of using the waiver provisions. The Guidelines will be used as the principal means to communicate this information, although Advisory Notes will also be used.

(iii) Good Laboratory Practice (Recommendations 22 to 24)

The recommendations pertaining to GLP are aimed at strengthening compliance with GLP principles. This will serve to facilitate review of notified data and the acceptance of these same data by other jurisdictions. The departments will amend the NSN Regulations to reflect the shift to mandatory compliance for toxicological and biodegradation studies, while offering greater flexibility for testing and reporting of physical and chemical data. Also, the obligation of reporting laboratories to state their accreditation will be included in the amendments, as recommended.

(iv) Toxicity Testing Using Animals (Recommendations 25 to 27)

Environment Canada and Health Canada remain committed to minimizing the use of animals in testing, and this includes the NS Program. Modification of test protocols to rely on fewer animals while ensuring valid results is one aspect of the strategy, while pursuit of alternative testing that does not require animals is another. The departments consider the development and validation of new test guidelines by the OECD Test Guidelines Program to be key in implementing this strategy. They are committed to encouraging the use of revised or new protocols as they are adopted in this forum for data submitted under the NSN Regulations. Furthermore, through GLP and other practices, the departments will accept data generated for other purposes or in other jurisdictions, thereby eliminating the need for unnecessary duplication of testing. The Guidelines will also identify the availability of alternative, validated test protocols.

(v) Exposure Template (Recommendations 28 to 30)

During the consultation, limitations relating to notified exposure information and to the assessment of exposure were discussed. An exposure template was identified as a tool to clearly specify the information that should be submitted by notifiers for chemicals and polymers. It will also identify reduced information requirements for exposure data for entry-level polymers and PLCs. The recommendation to evaluate and finalize an exposure template will be addressed in 2002. Notifiers will be encouraged in an Advisory Note to use the template and will be provided with instructions in the Guidelines on how to complete it.

(i) Scrutiny by NS Program Evaluators (Recommendation 31)

In addition to the internal peer review processes utilized by the departments, Environment Canada will expand its periodic, retrospective review of environmental risk assessments, as described to the Table. Health Canada will also initiate, in 2002, a similar practice of periodic review of its assessment reports by group(s) outside the NS Program. By the end of 2004, the departments will make the results of these periodic reviews available to the public.

(ii) Government Verification of Test Results (Recommendation 32)

As part of the feasibility study recommended by the Table, the departments will review, during 2003, existing policies, programs and practices in the area of government-funded verification testing in Canada and elsewhere. The results of this review will be made public, as well as the decision whether to proceed with a cost-benefit analysis, if such a program were to be implemented for the NSN Regulations.

Environment Canada and Health Canada view Theme 2 and the issues associated with it as having the greatest impact on the NSN Regulations themselves. This theme addressed 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 waivers for substances used for prescribed purposes and to record-keeping and enforcement were identified. Finally, scrutiny was given to updates made to the NDSL. The departments are fully supportive of retaining the tiered approach and of the amendments proposed by the Table.

The recommendations pertaining to the entry-level volume trigger and the elimination of cumulative and in-possession triggers will be incorporated in the drafting instructions and, subsequently, in the NSN Regulations.

The recommendation to update the NDSL annually based on the TSCA inventory from the previous year pertains to the administrative aspects of the program. During 2003, Environment Canada will initiate preparations for the initial update; however, given that certain amendments to the NSN Regulations are necessary relative to increased information requirements for NDSL substances (Schedule 3), the initial update cannot be published until the amended NSN Regulations are promulgated. Meanwhile, the departments are willing to meet with industry to discuss how this issue might be addressed in the interim.

The framework for each of the categories of substances identified by the Table in this theme² will be incorporated into the drafting instructions and into the amended NSN Regulations. The Guidelines will also be revised to reflect the new framework and the information required at each tier.

The intent of the Significant New Activity (SNAc) provisions is to allow new or existing substances to be added to or remain on the Domestic Substances List (DSL) with an attached list of new "activities" that are not ongoing at the time of the assessment. Activities may relate to the use, process, type of release, disposal, handling, recycling, etc., of the substance. Once the SNAc'd substance is listed on the DSL with a flag, the substance cannot be used outside the bounds of the notice unless additional information about its potential uses or activities is submitted and assessed.

The departments are currently developing Guidelines for use of the SNAc provisions (sections 80, 81 and 85 of CEPA 1999) and will be consulting with stakeholders as per section 69(2). The departments feel that the use of SNAcs is appropriate but are open to investigating a more streamlined method in the next review of CEPA.

Under the current NSN Regulations, PLCs eligible for listing on the DSL could subsequently be manufactured or imported in variations with characteristics outside the low-concern boundaries. The departments will develop administrative procedures in 2002 to identify PLCs on the DSL. These polymers will have to be renotified if they are subsequently imported or manufactured in a form that no longer meets the low-concern criteria. The departments do not intend to make this process retroactive.

The departments will analyze, in 2002, the results of a feasibility study to determine the approach and timing of the implementation of a new "smart tool system" to classify PLCs. The computer software-based "smart system" would assist notifiers in the identification of PLCs. Depending on the outcome of this feasibility study, an appropriate course of action will be developed in consultation with stakeholders.

(i) Research and Development and Product Development Substances (Recommendations 42 to 48)

The departments recognize that R&D activities in the chemical sector are important to Canada's innovation agenda. The recommended changes pertaining to R&D substances and to product development substances will reflect the consensus that an amalgamated definition is an important step towards simplification of special categories under the NSN Regulations. Furthermore, revising trigger volumes and schedules associated with these non-commercial activities is considered appropriate.

(ii) Site-limited Intermediate Substances and Export-only Substances (Recommendations 50 and 51)

An important aspect of the recommendations in this section pertains to clarity of definitions. The departments intend to introduce the definitions agreed to by the Table for site-limited intermediate substances, export only substances and sufficient containment, following thorough legal and enforcement reviews to ensure that the definitions can be operationalized.

Environment Canada and Health Canada will amend the NSN Regulations to incorporate the assessment periods recommended by the Table. Furthermore, in 2002, internal procedures of the NS Program will be reviewed and amended where warranted to increase efficiency, thereby shortening the time needed to reach decisions.

The departments also intend to apply the procedures described above to PLCs. Should the "smart tool system" described in Recommendation 41 prove effective at determining the classification of a polymer (low concern versus not low concern), the efficiency gained may help in completing polymer assessments more quickly, and the "greenlighting" provisions may be applied. In the longer term, the possibility of reducing the regulatory assessment period for PLCs will be examined.

Consistent with the new authorities in CEPA for "greenlighting," the departments will terminate assessment periods on a routine basis where assessments are completed early and will report annually on the extent to which this occurs.

The Table also expressed its view that mechanisms that enable the application of the "prescribed purposes" portion of paragraph 81(8)(b) of CEPA to special categories should be explored and the term "purpose" defined or replaced within CEPA. Environment Canada and Health Canada intend to describe and make public by mid-2003 what these mechanisms and changes might be and how to involve stakeholders in discussions on this subject.

The departments will initiate consultations with stakeholders in fall 2003 to identify purposes of use and/or categories of substances that are associated with negligible risk to the point where certain exposure or effect information can be systematically waived. If successful, then the departments will use the authority of paragraph 89(1)(f) to incorporate provisions to this effect in the amended NSN Regulations.

To enable effective enforcement of the NSN Regulations, Environment Canada requires notifiers to maintain appropriate records associated with their notifications and to make these records available to enforcement officers when required. Accordingly, the NSN Regulations and associated sections of the Guidelines will be revised to clarify notifier/Canadian agent obligations with respect to record-keeping requirements.

Environment Canada and Health Canada regard Theme 3 as critical in transforming the NS Program into a more open and transparent operation. The recommendations in this theme relate to the use of plain, understandable language for the NSN Regulations, the Guidelines and program policy documents. Furthermore, 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.

Environment Canada and Health Canada will alert the Department of Justice to recommendations of the Table pertaining to the requests for plain-language Regulations and to the offer of certain stakeholders to provide feedback on initial drafts. Similarly, the Guidelines will be revised using plain language. This will be done with input from multistakeholder working groups comprising individuals from government and industry, followed by a public review process. As recommended, where appropriate, case studies will be used to illustrate concepts in the Guidelines and will be made available electronically on Environment Canada's web site.

Discussions will occur in 2003 with CEPA Environmental Registry administrators and other impacted programs to address recommendations concerning simplified search facilities and links to other important and related national and international web sites. The departments will engage industry and other stakeholders by 2003 to assist in identifying appropriate sites to be linked to the NS Program web site in a timely manner.

Finally, Environment Canada and Health Canada will, in 2002, inventory and revise as required, the operational policies associated with the NS Program, including the policy documents outlined in the consultation recommendations. Subsequent to this review, the departments will establish an ongoing process for the preparation, review and publication of operational policies and ensure that they are complete and clearly written. As an early example of this exercise, a document entitled Screening-level Environmental Risk Assessment Guidance Document for New and Existing Substances will be issued in 2002. As recommended by stakeholders, regularly updated NS Program statistics will become a regular feature of the web site.

The principal element of these recommendations concerns access to decisions and the supporting risk assessment reports. Environment Canada and Health Canada have been facing challenges, since the NSN Regulations came into force, to balance timely decision making and addressing program-wide issues with the desire to make information public. The recommendations display the "reasonableness" on the part of the Table in guiding where the departments should attribute priority in this area. As such, the departments are currently embarking on a review of the documents developed, their format, use of third-party information, target audience and other relevant matters as a basis for implementing the Table's recommendations. As an additional priority, the departments will also develop a process to provide notifiers with assessment reports and the public with summaries when substances are subject to section 84 or when they become eligible for addition to the DSL. Every effort will be made to put this process in place by the end of 2002.

Environment Canada and Health Canada acknowledge the desire of stakeholders to amend CEPA to provide appeal mechanisms. Accordingly, by the end of 2003, the departments will initiate a process that will examine the feasibility of incorporating appeal mechanisms into the NS Program and, if appropriate, will develop concrete proposals for amending CEPA.

This theme concerned 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. The Table was clear about the eventual economic and social benefits of these initiatives, but equally clear that Canada must withstand any pressure to drop its standards in terms of science-based decision-making.

Equally important, the Table challenged the departments to develop and implement a strategic plan that would guide the program in the international harmonization and cooperation activities it pursues and to continually engage stakeholders in the process. Environment Canada and Health Canada will initiate, by the end of 2002, a process to develop the plan envisaged by the Table. At the same time, the departments will continue their efforts within OECD and through bilateral arrangements with other countries, such as the United States and Australia, and will seek other opportunities relating to this subject. For example, the departments will examine the possibility of introducing a foreign scheme into the NS Program's framework based on the progress made through bilateral arrangements with other countries and through OECD work. By the middle of 2003, the departments intend to seek stakeholder perspectives on the draft plan, to amend the plan as appropriate and to make it public. The departments will review progress on implementation of the plan and release a report by the end of 2005.

Issues associated with Theme 5, Service Delivery, involve operational program changes and resource considerations. These issues apply to 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).

The departments will investigate in 2002 what already exists in the departments and elsewhere to document best practices and will adopt a long-term phased approach that will include stakeholders for the implementation of measurable service quality standards and performance indicators. This approach will be in line with the framework developed by the Treasury Board Secretariat and the National Quality Institute. Meanwhile, the departments will develop simple tools to measure stakeholder satisfaction. Internal preliminary discussions have begun to initiate a project to develop an appropriate model associated with performance indicators.

The departments will also endeavour to keep up to date with international service delivery initiatives through participation in international fora such as the OECD New Chemicals Task Force. The departments will periodically review the service and performance indicators and compare them against international service delivery initiatives.

The aim of the departments is to continue to be responsive to client needs by building on current initiatives and considering new ways of enhancing service delivery (i.e., information technology). For compliance promotion activities, the departments have already started to consider the involvement of stakeholders in compliance promotion projects. Discussions with industry will be initiated when the revised Regulations are nearing completion, to identify opportunities for mutually beneficial personnel exchanges.

Senior management in both Environment Canada and Health Canada will work in cooperation with managers of other CEPA programs in 2002 to meet expectations for increased transparency and implementation of quality service approaches that are centred on principles of sustainability.

The departments will also continue to explore other avenues for delivering more effective service, including giving consideration to co-location of staff.

The departments are committed to moving towards a system that allows electronic filing and access to electronic files as resources become available and client demand warrants. The potential for industry financial support in this area will be investigated in 2003. The outcome of the OECD workshop on electronic information systems, held in Ottawa in October 2002, will be considered as part of the path forward for development of electronic filing submission systems.

Canada will continue to exercise its leadership in the area of international cooperation. The departments intend to continue ongoing initiatives, such as the Four Corners Agreement, the impending Canada-Australia arrangement and the OECD new chemicals multilateral exercise.

The departments have expanded their interaction with groups involved in hazard and risk assessment and will continue to allocate resources to the important activity of continuous improvement of science capacity and assessment methodologies.

¹ The 5NR Working Group consists of the following government departments: Environment Canada, Health Canada, Natural Resources Canada, Department of Fisheries and Oceans and Agriculture and Agri-Food Canada.
² Non-NDSL chemicals, NDSL chemicals, PLCs, non-NDSL polymers excluding PLCs and those with all monomers listed on the Domestic Substances List (DSL)/NDSL, and NDSL polymers.