Report on Health Canada's Achievements (2000-2004) Under the Canadian Environmental Protection Act of 1999 (CEPA 1999) in Support of Parliamentary Review

5.0 Findings on Organization and Work Flow

5.1 Summary

HC is aware of its overall challenges. Over the past five years there have been numerous organizational and operational studies that have been undertaken in relation to Health Canada's CEPA mandate, and several initiatives to improve program delivery have been started as a result of opportunities identified. Many have not been implemented yet but are seen by HC as setting the groundwork for future improvements (i.e., achieving maturity and consistency of processes). Overall, HC still lacks a horizontal, integrated approach to planning, resourcing, managing, and reporting on CEPA activities, expenditures, outputs, and impacts.

SEP is working on responding to its challenges. Initiatives have been launched in response to some of the opportunity areas previously identified. One of the key initiatives is work being undertaken to establish a formalized performance measurement framework that includes a Results Based Management Accountability Framework (RMAF) and a Results Based Audit initiative. Other initiatives include an integrated management framework addressing governance and strategic priority setting and improvements to project management processes and tools. These initiatives are ongoing but are still relatively early in their lifecycle.

As another example, the Water Quality and Health Bureau has developed a five year plan that identifies which contaminants they will address, and will implement redefined processes with increased rigour that will enable an increase in the number of water quality guidelines they are able to produce annually. The Bureau is targeting the development of a minimum of four guidelines per year, which is a significant increase compared to previous years.

A Human Resources (HR) plan has been developed to address some of the key issues surfacing over the last several years, but only for the Environmental Contaminants Bureau. Some work has also been targeted towards the development of staff. A "Managers 360 Degree" feedback review process was undertaken as well as "HR Coaching of Managers" that focuses on personnel and career development that will address skill gaps and succession planning in ECB.

Some progress has been made in PSP. A triage process has started for the significant backlog of approximately 9,000 substances on the In-Commerce List (Food and Drugs Act), for which HC actions have been limited to date. PSP is currently trying to develop a new regulatory framework that would streamline the process and increase the effectiveness of addressing the In-Commerce List. There is only 1 FTE allocated to assessing these 9,000 substances and this is not considered sufficient. If the new resources being set aside in the February 2005 budget are provided, PSP will be able to increase efforts in this area.

Where PSP has made other progress is in addressing corporate risk management and the prioritization of issues. Screening and triage of new substance notifications is taking place, with PSP focusing on the most problematic issues and difficult substances first. The prioritization workflow is seen to be effective although it is not well-documented.

An HR Strategy was also initiated that saw the creation of five separate projects. This included the development of an HR plan and planning process, and the development of an HR toolkit that would support the Programme's monitoring/tracking requirements to support the key HR efforts (orientation, recruitment, staffing process, Manager HR learning, succession planning, and HR Planning); the development and implementation of an effective HR learning framework for PSP managers; and the development and implementation of an effective recruitment process to support the Bureaux that included a marketing strategy and marketing materials. However, these initiatives have been slow to move forward due to lack of resources.

ORIA is progressing in their efforts on regulatory development and activities supporting new Environmental Assessment Regulations. ORIA launched the Environmental Impact Initiative (EII) that encompasses scientific research, best practices review and new regulation development in support of substances and products regulated under the FDA that currently fall under the CEPA mandate. Several multi-stakeholder workshops have been held over the past 5 years. An Issues Identification Paper and Options Analysis Paper have been developed and distributed in moving forward the policy development work required to create an appropriate regulatory framework.

Overall, HC lacks the resources to engage in active management of joint CEPA issues with Environment Canada.

5.2 Previous Analyses of HC and CEPA

A number of organizational and workflow challenges were found to exist. Achieving effective service delivery and high quality of service, while obtaining value for money continues to be a priority of the Treasury Board Secretariat and the Government of Canada, and a number of operational reviews of CEPA as delivered by HECS, SEP, and PSP have already been done. Some observations from these recent studies ⁷ regarding CEPA's current service delivery model included:

• Quality service management practices to define and meet the needs of each stakeholder group needed to be developed across the Program;
• The delivery of service was not always uniform;
• HC and Environment Canada have structural and organizational differences that sometimes have been a source of frustration;
• The assessment processes were paper-based, with limited support from enabling technology;
• Measurable service/performance indicators would be a value-added component;
• The different ways CEPA is delivered was not uniformly understood by all stakeholders.

The remainder of section 5 discusses recent results in more detail.

5.3 Overall Program Management

Operational and organizational issues and challenges have begun to be addressed. To assist with increasing efficiency in operations and program delivery, the Strategic Science and Operations Division (SSOD) was established in 2002. SSOD integrates science and policy intra-departmentally and inter-departmentally on environmental chemical issues to facilitate the development of coherent and integrated national and international approaches to the sound management of chemicals and to coordinate responses to environmental chemical emergencies in addition to managing HC CEPA regulatory affairs. Numerous initiatives have been undertaken during the 2000/01 through 2004/05 period, including those shown in Exhibit 5.1:

Exhibit 5.1
HECSB CEPA Related Initiatives

Product	Year Produced
Assessment Reports
• Communications Assessment	2001; 2003
• Operational Review	2003
• Regulatory Management Capacity Check	2001, 2004
• DMF analysis	2003
• MAF Gap analysis	2004
• HRM analysis	2005
• Environmental Scan	2003
Evaluations
• OAG Review Response	2003
• CEPA HC Evaluation of CEPA, 1999	2005
Performance Reports
• ECB Annual Report	2002/03, 2003/04
• HC contributions to CEPA Annual Report	2000/01, 2001/02, 2002/03, 2003/04
Guides
• Personal Learning Plans	2004
• Financial guide	2004
TB Submissions
• Program Integrity II	2001
• Budget 2003	2004
Memoranda to Cabinet	2002, 2003, 2005
• Resource Ask	2003

5.4 Safe Environments Programme

The Safe Environments Programme continues to address the issues and opportunities identified in the 2003/04 Regulatory Management Capacity Check, but challenges remain. Follow-up with participants from many of the divisions within SEP indicated varying amounts of progress being made. Just over a year ago, 17 issues and/or opportunities were identified that mainly fell into three key criteria areas:

• Developing Solutions: formalizing partnership management.
• Program Delivery: internal and external stakeholder partnerships, enhancing external communications.
• Strategic Support Capabilities: morale issues, building knowledge and expertise, setting priorities, improve internal communication, risk management, planning, performance measurement, knowledge management, information management/technology, human resources strategy, project management, review corporate support initiatives, review committee resource commitments.

High level follow-ups against these opportunity areas indicate that there have been small improvements over the past year. Exhibit 5.2 identifies the average perceived change in addressing the opportunity areas and their relative importance in the delivery of CEPA:

Exhibit 5.2
HC Response to Opportunity Areas - Average Rating by HC Respondents

Even though initiatives have started and improvements are being made, opportunities to better deliver the program exist. Many of the efforts initiated as a result of the many operational and organization studies have been focused at the bureaux or division level, but not formalized or delivered consistently across the several programmes responsible for the delivery of CEPA. Where efforts to respond to opportunities at the program level have commenced, resource levels have not been adequate to maintain momentum and, in some cases, to pursue formal projects.

Priority setting is still seen as an opportunity area. Although modestly improved from the previous year, mechanisms for priority setting across the various HC organizations that deliver CEPA were still noted to be lacking. Interviewees noted that there was a definite disconnect between new issues and substances that are materializing as important, compared to focusing solely on what is currently being reviewed. Prioritization of problems/issues is done on an informal and unstructured basis and is primarily based on timelines rather than risk. For example, both the Environmental Health Science Bureau and the Management of Toxic Substances Division were unsure about the priorities coming out of the Existing Substances Division (which will ultimately affect the workload of EHSB and MTSD) and how they could be aligned. Another example is in the adoption of population- based approaches to assessing substances. If a substance is of greater risk and impact to humans through one route as opposed to another (via air as opposed to via water, for instance), the focus should be on the route that poses the greatest impact. Currently there is no planning or resource allocation mechanism that addresses this. It was noted that increased integration across the various HC groups conducting CEPA activities (e.g., perhaps priority setting by "committee") would be of benefit.

Internal communication, coordination, and integration continue to be a challenge. Although it was found that there were some individual efforts to increase internal communications among SEP Divisions, there still remain difficulties to overcome related to the overall coordination, communications and knowledge sharing among and between programmes, bureaux and divisions. Interviewees identified internal communications as still ad-hoc, conducted vertically through the organizational structure, rather than horizontally across divisions and bureaux. Interviewees felt that this was still an area that required increased attention in order to efficiently deliver on the CEPA mandate. For example, currently there are numerous methods used to assess health implications that eventually drive standards and guidelines. These methods should be shared and reviewed across HC organizations to take advantage of internal expertise and demonstrated practices. In addition, the information obtained during the ongoing identification and assessment of toxic substances could be shared to leverage the use of materials and efforts. One of the Divisions was noted to be progressively making improvements in this area. The Existing Substances Division is developing an approach to provide guidance to risk managers in prioritizing options for existing substances considered toxic as well as posting fact sheets on various activities and the methodology developed for categorization and health risk assessment on the Division's web site. In addition, a ListServe has been established that will provide newly released information to subscribers automatically. The availability of this service was noted to be widely communicated within Health Canada.

One example where the supporting mechanisms are not consistent with the remainder of HC's CEPA organizations is with the Air Health Effects Division. The AHED is operating under its own Logic Model, separate from the HC CEPA logic model being promoted by the Environmental Contaminants Bureau (of which they are one division). Until now, AHED has been operating under a shared RMAF and Logic Model with EC. In addition, AHED was not included in the compilation of planning data using PMRS this past year. AHED is currently being incorporated into a HC CEPA RMAF and Logic Model.

5.5 Product Safety Programme

The Product Safety Programme (PSP) is still facing some of the same pressures and challenges from almost three years ago. The Programme underwent a Regulatory Management Capacity Check and resource Review in 2001/02 that assessed the capabilities of PSP in delivering its mandate. Pressures and challenges identified historically and that are still relevant today include:

• Funding levels have not kept pace with the increasing level of notifications. The volume of new substances to be assessed is increasing along with the complexity of the assessments required. This requires an increase in the level of resources required to make the appropriate decisions.
• There has been steady growth in the number of New Substance notifications over the last five years. The number of notifications has increased to about 1,000 per year for the past three fiscal years. Original funding levels were based on 150 notifications per year, but the actual number of notifications was about 300 per year in 1994, and has increased to the current level of about 1,000 per year.
• Biotechnology and Nanotechnology. These are major technical challenges as these are emerging areas for environmental health assessments. They require a new range of knowledge and skills be built up in order to conduct risk assessment and risk management activities.
• Environmental assessment will create new resource pressures. The need to conduct environmental assessments, in addition to the current assessments, will require additional resources with specialized education and skill sets.

For the most part, the findings from the 2002 Regulatory Management Capacity Check are still relevant today. PSP is still finding it difficult to secure new investments to address issues and report that they have a serious lack of capacity to respond effectively. Issues still exist within the management infrastructure including, as a first priority:

• HR management
• online service delivery
• intelligence gathering
• risk management
• prioritization of issues
• knowledge management
• performance measurement

As second priorities there remain challenges in:

• internal communications
• relationships with stakeholders
• harmonization at the international level
• inquiries/ complaints
• emergency management
• IM/IT systems to address PSP-wide needs.

And in third priority are project management, quality assurance, and cost recovery.

5.6 Office of Regulatory and International Affairs

Even though there have been delays, ORIA is progressing in their efforts on regulatory development. ORIA launched the Environmental Impact Initiative (EII) that encompasses scientific research, best practices review and new regulation development in support of substances in FDA products that currently fall under the CEPA mandate. Several multi-stakeholder workshops have been held over the past five years. An Issues Identification Paper and Options Analysis Paper have been developed and distributed in moving forward the policy development work required to create an appropriate regulatory framework. These successes have been slow to develop mainly because of staff turnover and resource issues. Currently the staffing issues are being addressed and ORIA is actively engaged in accelerating the related policy and consultation activities. In regard to resourcing, environmental assessment and management are creating new resource challenges as these activities require a specialized skill set and funding levels are impacting research and surveillance activities.

5.7 Relationships with Environment Canada

The very nature of the CEPA program requires Environment Canada and Health Canada to work together on many fronts. Relationships between the two departments are numerous and exist at various levels from departmental heads to specific individuals working in the various CEPA organizations. Several CEPA management teams pointed out that Health Canada was playing a passive role in comparison to Environment Canada. The basic reason is that EC's funding allowed for an active management of joint HC/EC CEPA issues while the opposite was true for HC. Interviewees indicated that HC CEPA organizations would like to be more active in managing joint issues but that HC lacks the resources to do so.