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

4.0 Findings on Achievements

4.1 Summary

Steady progress is being made in response to the CEPA mandate. A considerable amount of work has been completed which is directly relevant to fulfilling HC's legislative obligations under CEPA, and a number of notable achievements have occurred. For example, significant progress has been made toward achieving the categorization of all 23,000 substances on the Domestic Substances List (DSL). Health Canada is confident that categorization of all DSL substances will be completed by September 2006. Assessments for the Priority Substance List (PSL) 1 and 2 were completed (aside from two PSL substances for which assessment was suspended) within the required timeframes that honoured HC obligations under the Act. There have also been many assessments completed (i.e. screening health assessments on some 60 existing substances), control instruments developed, and considerable communications and outreach activities. NSACB has completed around 3,000 risk assessments and developed 28 control measures over the five-year period 2000-2005 and has been able to successfully work within its stringent timelines of 45-90 day approval times. In addition, an Environmental Assessment Unit has been established in the NSACB and they are steadily progressing at completing screening assessments of organisms on the DSL. The Management of Toxic Substances Division, within SEP, has been successful in meeting legislated timelines for every substance for which it has been responsible. These achievements are based on a solid foundation of HC scientific expertise in biological, chemical, and environmental sciences, and in medicine and engineering. These achievements were obtained despite unstable and limited funding because HC focused on meeting its most pressing legislative requirements. However, although outputs are measured, HC does not have the resources to measure against outcomes; e.g., in the areas of biomonitoring and surveillance. HC requires additional investment in these areas in order to collect evidence-based data that would allow the department to measure improvements in human health.

4.2 Research and Surveillance

A solid science foundation has allowed Health Canada to complete several assessments. There are highly specialized scientists with backgrounds in biological, chemical, or environmental sciences or in medicine or engineering involved in HC's CEPA work. HC's scientific leadership is excellent and is reported by HC to be recognized internationally, especially when it comes to endocrine disruption.

A noteworthy achievement by the Environmental Health Science Bureau is their contribution to the development of Test Guidelines at the Organization for Economic Cooperation and Development (OECD). The EHSB Director is the National Test Guidelines Coordinator, and HC's scientific staff act as subject area experts. Currently, they have submitted a Detailed Review Paper (DRP) on transgenic gene mutation assays. DRPs inevitably lead to the drafting of a Test Guideline. This particular Test Guideline will be very important for CEPA since it fills a regulatory gap that prevented a robust assessment of mutagenicity in live animals (in vivo). EHSB also occasionally tests the range of conditions over which a Test Guideline is reliable. Another important contribution is that EHSB is currently evaluating the method described in the OECD guideline for substance skin penetration (e.g., the method may be reliable for cosmetics, but it is unknown if it is reliable for other substances such as pesticides).

Spanning the 2000/01 through 2004/05 period the outputs related to CEPA research and surveillance activities are shown in Exhibit 4.1:

Exhibit 4.1

Research and Surveillance Activities

Type of Output	Total	00/01	01/02	02/03	03/04	04/05
No. of Studies and Research Reports Completed	109	1	8	18	37	45
No. of Scientific Publications Reviewed	533	18	123	120	124	148
No. of Data Sets Collected, Developed and Analyzed	149	0	6	42.5	46.5	54
No. of Methodologies Developed for Exposure and Trend Analysis	26	0	0	5	10	11
No. of Evaluations of Risk Management Instruments	22	0	5	4	8	5
No. of Toxic Substances Monitored	153	0	0	36	39	78
No. of Research Data Sets Developed	12	0	0	3.5	2.5	6

4.3 Risk Assessment

The major focus has been risk assessments of new substances and the categorization and assessment of substances on the DSL, and significant progress has been made. About 3,000 new substance risk assessments and approximately 700 transitional substance assessments have been completed by the NSACB. The initial proposal for categorization of the 23,000 substances on the Domestic Substances List (DSL) was issued and Health Canada has made significant progress in completing the task of categorization. Meeting the mandated timeframe of September 2006 for completion of this task was not seen by HC as posing any problem. However, funding in other areas has had to be restrained in order to provide priority resource allocation to the categorization work. Assessments for PSL 1 and 2 were completed (aside from two PSL substances for which assessment was suspended) within the required timeframes that honoured HC obligations under the Act. Some 61 existing substance screening health assessments have also been completed. Risk assessment is also a major focus for the Air Health Effects Division. It should be noted that air quality assessments are of a more extensive and long-term nature, with continued updates required. Spanning the 2000/01 through 2004/05 period, the outputs shown in Exhibit 4.2 were achieved related to CEPA risk assessment activities.

Exhibit 4.2

Risk Assessment Activities

Type of Output	Total*	00/01	01/02	02/03	03/04	04/05
N/A = Data not available *Existing Substances Division data were provided in total for the five-year period therefore, adding the annual data in some instances will result in a sum lower than the total.
No. of Existing Substances Categorized	23,000	N/A	N/A	N/A	N/A	N/A
No. of Existing Substance Screenings Completed	61	N/A	N/A	N/A	N/A	1
No. of Priority Substance List Assessments Completed	67	N/A	N/A	N/A	N/A	N/A
No. of Methodologies Developed to Assess Risks	8	1	1	1	N/A	N/A
No. of New Substances Assessments Completed	2979	498	367	567	862	685
No. of New Products of Biotechnology Assessments Completed	11	2	2	3	2	2
No. of Air Quality Assessments	24	4	2	2	6	10
No. of Scientific Publications Reviewed as Part of Risk Assessment Process (Air Health Effects Division only) 3,940 650 600 560 940 1,190	3,940	650	600	560	940	1,190
No. of Transitional Substances	674	126	52	81	230	185
No. of New Substances in Food and Drug Act Products assessed	122	0	4	30	53	35

The initial categorization of DSL substances has been completed using a refined approach based on each substance's potential for human exposure and inherent toxicity to humans. Simple and complex exposure assessment and hazard identification tools were developed and refined. Through this approach, the Existing Substances Division has idenstified a maximum of 1,900 substances being considered for further DSL categorization (i.e., having the potential for screening assessment). These new and refined tools are assisting with prioritization of substances for screening health assessment, are being used in the screening health assessment itself, and are expected to contribute to addressing the DSL substances faster and more efficiently.

Numerous national and international relationships have been established (with organizations such as the European Union, OECD, US Environment Protection Agency, and World Health Organization International Program on Chemical Safety) that are facilitating the sharing of information contributing to delivery of the program. The New Substances Assessment and Control Bureau also has two formal information sharing arrangements in place with the United States and Australia.

The New Substances Assessment and Control Bureau has refined its processes over the period studied and uses a risk-based strategy and high quality risk assessment methodologies to determine appropriate levels of assessment and analysis for new substance notifications. They believe they have been effective at partnership development with industry.

4.4 Risk Management

Demonstrable achievements have been made in the development of risk management measures within the statutory timelines set within CEPA. Health Canada continues to develop and improve the methodologies used in risk assessment and risk management. Risk Management activities are taking place in many of the organizations within Health Canada delivering the CEPA mandate. Over the five year period (2000-2005) risk management activities have addressed existing DSL substances, new substances, products of biotechnology and substances in the Food and Drug Act, and water quality as shown in Exhibit 4.3:

Exhibit 4.3

Risk Management Activities

Type of Output	Total	00/01	01/02	02/03	03/04	04/05
No. of Risk Management Strategies Developed	19	0	3	8	5	3
No. of Risk Control Instruments Developed	51	6	1	11	9	24
No. of National Agreements (e.g., Fed/Prov) Put in Place	22	0	4	4	6	8
No. of International Agreements Put in Place	1	0	0	1	0	0
No. of Standards or Guidelines Put in Place	11	0	2	3	2	4
Number of Significant New Activity conditions	18	1	0	4	5	8

In addition to the creation and renewal of control instruments that support the management of substances identified as toxic under CEPA, HC has also been actively developing and refining the methodologies used in the development of risk management strategies, as shown in Exhibit 4.3.

The Management of Toxic Substances Division, within SEP, has been successful in supporting EC in meeting timelines for every substance for which it has been responsible. The NSACB has also worked with EC to meet the stringent timelines for controlling new substances.

Other specific risk management activities related to DSL substances include the preparation and publication of "It's Your Health" documents on mercury, vermiculite asbestos, and lead (among others); issue-specific analyses for the Port Colborne risk assessment/management and the Flin Flon risk assessment/management; preparation and participation in the Rotterdam Convention Prior Informed Consent position for Canada on asbestos; and the development and publication of Multiple Emissions Reductions Strategy for Oil Refineries.

Contributions to national and international collaboration and agreements were achieved with the signing of the Rotterdam Convention Prior Informed Consent (PIC) agreement. The Rotterdam Convention strengthens the PIC procedure by making PIC binding. Exporters trading in identified hazardous substances must obtain the prior informed consent of importers before proceeding with the trade. The Convention establishes a first line of defense by giving importing countries the tools and information they need to identify potential hazards and exclude chemicals they cannot manage safely. If a country agrees to import chemicals, the Convention promotes their safe use through labeling standards, technical assistance, and other forms of support. It also ensures that exporters comply with the requirements ⁶.

4.5 Communications and Outreach

Effective communications and outreach activities are viewed as a key component in the delivery of the CEPA mandate. One notable element of the consultation activities taking place is PSP's efforts in completing consultations on the renewal and amendment of the New Substances notification Regulations. The SMART (Specific Measurable Attainable Realistic Timely) regulations Secretariat recognized PSP for their transparency and success at "SMART regulations in practice." The amended regulations will come into effect by the fall of 2005. A formal progress report was published in November 2003 and the final progress report will be available in the summer of 2005. Exhibit 4.4 outlines key communications and outreach activities undertaken from 2000/01 to 2004/05:

Exhibit 4.4

CEPA Communication & Outreach Activities

Type of Output	Total	00/01	01/02	02/03	03/04	04/05
No. of Consultation & Communication Plans Developed	16	0	3	3	3	7
No. of Publications/Abstracts Distributed	743	78	82	119	120	144
No. of Collaboration Projects	44	6	8	8	10	12
No. of Stakeholder Agreements Reached	41	2	8	8	11	12
No. of Oral and Poster Presentations Made	681	68	95	130	115	123
No. of Participation in HC and Non-HC Committees	197	24	35	42	45	51
No. of Responses to Inquiries (Public and ATIP)	1,864	24	259	505	501	550
No. of Workshops	7	0	0	4	2	1
No. of Bilateral Arrangements	2	1	1	0	0	0
No. of submissions reviewed under the Four-Corners Agreement	28	6	11	4	3	4
Assessment reports shared with Australia under Canada-Australia arrangement	32	0	2	0	13	17
No. of pre-notification consultations responded to	88	16	21	10	18	23
No. of TV Segments	4	0	0	2	2	0

Another notable achievement is the effort expended to develop and maintain a web presence for the ECB. The Existing Substances Division has created a ListServe were any individual can receive new information as it is released as well as posting fact sheets and methodologies for categorization and health risk assessment on the Division's web site. Exhibit 4.5 presents output data on website activities for the ECB. These data indicate that, for the most part, there has been increased traffic to the Bureau and Divisional sites. The assumption can be made that information is being disseminated to target audiences. (Because of internal reorganization a couple of years ago and the fact that some divisions do no have a web site, it was difficult to obtain data in a consistent manner. As such, data for the first two years cannot be broken down by Division.) As shown in Exhibit 4.6, the amount of web activity has increased steadily over the five-year period.

Exhibit 4.5
Environmental Contaminants Bureau Web Activity Statistics*

*Information has been presented as "Annual Extrapolated", and "Monthly Average." Information was not available for 12 of 12 months in any case.

"Hit" - A single action on the Web server as it appears in the log file. A visitor downloading a single file is logged as a single hit, while a visitor requesting a Web page including two images registers as three hits on the server; one hit is the request for the .html page, and two additional hits are requests for the downloaded image files. While the volume of hits is an indicator of Web server traffic, it is not an accurate reflection of how many pages are being looked at.

"Page Views" - Hits to files designated as pages. Supporting graphics and other non-page files are not counted.

"Unique Visitors"- Individuals who visited the site during the report period. If someone visits more than once, they are counted only the first time they visit.

Exhibit 4.6
Environmental Contaminants Bureau Annual Web Activity*

*Data presented for years 03/04 and 04/05 are the sum of data for Existing Substances, Heath and Air Quality and Water presented in Exhibit 4.5.

4.6 Qualification

Although HC has demonstrated many achievements, the data presently available did not permit the assessment of efficiency or effectiveness. To some extent this is because CEPA 1999 is a relatively new program and no organization, including HC, has extensive experience with the mandated and other necessary activities. It was also not possible to determine the extent to which HC's CEPA activities and outputs compare with best practices. Also, the scope of this report did not allow for the investigation of the intermediate- and long-term impacts of the risk management instruments HC has developed. Management is aware of this and intends to implement the recently developed Results Based Management Accountability Framework to measure and report annually on CEPA results. HC does not have the resources to track human health outcomes related to CEPA activities. HC tends to focus, therefore, on tracking activities and outputs. (It should be said that a similar comment could be made about many federal initiatives, as measurement of outcomes and long-term impacts is substantially more difficult than measurement of activities.)