Based on the information received and other available information, “screening assessments” are developed in order to assess whether substances meet the criteria of section 64. These screening assessments are required under section 74 of the Act. They are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government pertaining to the application of precaution and/or weight of evidence in screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www. chemicalsubstances.gc.ca along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

Pursuant to section 91 of the Act, the Ministers are required to publish in the Canada Gazette a proposed regulation or other instrument establishing preventive or control actions within two years of publishing a screening assessment and a notice indicating that they propose to take further risk management action. Section 92 then requires that the instrument be finalized within a further 18 months.

Listing these substances on Schedule 1 of the Act allows the Ministers to develop risk management tools to meet these obligations. CEPA 1999 provides the Government of Canada with strong risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health that can be developed for any aspect of the substance’s life cycle from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. “Risk management approach” documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 3 substances and are available online.

On August 23, 2008, the draft screening assessments for the third batch of the Challenge comprising 19 substances were published on the Chemical Substances Web site, and notices were published in the Canada Gazette. Of the 19 substances in Batch 3, 4 have been concluded to meet the criteria of section 64, the 15 others have not. These 4 substances are considered to be human health priority substances.

Assessment summaries and conclusions and an overview of the public comments received during the public comment period for the 4 substances being proposed for addition to Schedule 1 of the Act are presented below.

Substance descriptions and assessment summaries

2-MEA

2-Methoxypropanol

2-Methoxypropanol, also known as “1-Propanol, 2-methoxy-” or “2-Methoxy-1-propanol,” is a by-product in the manufacture of propylene glycol monomethyl ether (PGME), a solvent used in various products including paint remover, polyurethane varnish, and concrete primer. It may also be found as an impurity in industrial and consumer paints and some cosmetic products such as nail enamel, nail polish remover, hair conditioners and hair dyes. Based on the most recent data available, 2-methoxypropanol is not manufactured commercially in Canada, but 10 000 to 100 000 kg is imported into Canada annually.

2-Methoxypropanol was assessed as a high priority for human health risk. The assessment has determined that it can cause harm to the developing fetus. This assessment is based principally on the weight-of-evidence-based classification of 2-methoxypropanol by the European Commission as Category 2 for developmental toxicity (clear evidence of a specific effect on either fertility or developmental hazard), and consideration of available relevant data for the substance (including peer-reviewed journal articles and international reports) as well as for related chemicals.

Pigment Red 3

Pigment Red 3, also know as “2-Naphthalenol, 1-[(4-methyl-2-nitrophenyl)azo]-,” is a man-made red pigment used mainly for paints. It has also been found to be used in minimal amounts in some cosmetics, including nail polish, skin cleanser, and bath soap. Based on the most recent data, Pigment Red 3 is currently produced in Canada and is used in products that are sold in Canada. The total amount in use for 2006 was approximately 40 000 kg.

While Pigment Red 3 was initially assessed as a high priority for ecological assessment, it was concluded that it may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. The assessment has determined that it can cause cancer in laboratory animals, based on consideration of relevant available information, including a weight-of-evidence-based assessment by International Agency for Research on Cancer, an international authority on cancer research. Exposure-related tumours were also observed at multiple sites in experimental animals.

Assessment conclusions

On the basis of the carcinogenicity for which there is a possibility of harm at any level of exposure, it is concluded that these four substances are entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health, thus meeting the criteria of section 64 of CEPA 1999. They are thus proposed for addition to Schedule 1 of CEPA 1999.

Based on the information received, none of these substances were found to be entering or have the possibility of entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity as defined under section 64 of CEPA 1999. There are therefore no ecological priority substances proposed for addition to Schedule 1 of CEPA 1999 as part of this batch.

The final screening assessments for all substances and the risk management approach documents may be obtained from the Chemical Substances Web site at www.chemicalsubstances. gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-4936 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

Alternatives

The following measures can be applied after an assessment is conducted under CEPA 1999:

• adding the substance to the Priority Substances List for further assessment (when additional information is required to determine if a substance meets the criteria in section 64 or not);
• taking no further action in respect of the substance; or
• recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable, the implementation of virtual elimination.

It has been concluded in the final screening assessments that 2-MEA, DEGME, 2-methoxypropanol and Pigment Red 3 are entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as defined under section 64 of CEPA 1999. These substances pose a risk to human health and they meet one or more of the criteria under section 64 of CEPA 1999. Adding these substances to Schedule 1, which will enable the development of risk management instruments, is therefore the best option.

Benefits and costs

Listing these substances on Schedule 1 of CEPA 1999 enables the Ministers to develop risk management proposals for these substances, which may be both regulatory and non-regulatory (such as pollution prevention plans, environmental emergency plans, guidelines, codes of practice or regulations), to help protect human health and the environment. The Government will undertake an assessment of the potential impacts, including an economic analysis, and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

In accordance with the Act, on August 23, 2008, the Ministers published a summary of the scientific assessments for the 19 substances of Batch 3 in the Canada Gazette, Part I, for a 60-day public comment period. Risk management scope documents outlining the preliminary options being examined for the management of these substances were also released on the same date for substances proposed to be considered toxic under section 64 of the Act. Prior to this publication, Environment Canada and Health Canada informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessments on the 19 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC or the Challenge Advisory Panel.

During the 60-day public comment period, a total of 15 submissions were received from industry stakeholders, industry associations, non-governmental organizations, research centers and foreign government agencies on the scientific assessment and risk management scope documents. All comments were considered in developing the final screening assessments.

Comments received on the risk management scope regarding the substances were considered when developing the proposed risk management approach documents, which are also subject to a 60-day public comment period.

Below is a summary of new comments received for the Batch 3 assessments and responses relevant to the overall process and approach to the assessments. In cases where comments have been made concerning whether or not a substance meets the criteria of section 64 of the Act due to lack of information or uncertainty, the Government errs on the side of precaution to protect the health of Canadians and their environment. The complete responses to comments received may be obtained at the Web site, address, fax number or email address listed above.

Summary of general comments

• A number of non-governmental organizations (NGOs) suggested that risk assessments should consider more information relating to exposure variables within Canada, including all routes, durations, levels and variables of exposure (e.g. waste disposal, occupational) that may impact health effects.

 The Government of Canada strives to take into consideration all potential releases to the Canadian environment during the assessment process. Information from a variety of sources (section 71 data, published scientific reports, etc.) is used to identify sources of exposure to a substance. Assessment of risk then focuses on those sources that are most likely to be of concern. Potential exposure of the general population, including different age groups, is examined. Uncertainties in exposure characterization and assumptions used in deriving exposure estimates are considered.

 Further investigation on disposal methods for the sewage sludge (e.g. land application, landfill) or through incinerators can be added to the assessment when relevant and available. In only a very limited number of cases is sufficient information available to allow estimation of the quantity of substance released. Occupational exposure is largely a provincial mandate and is therefore beyond the scope of assessments under CEPA 1999. However, hazard information obtained from occupational settings is considered in the assessments as appropriate.

Summary of substance-specific comments

2-MEA

• NGOs were supportive of the conclusion of the assessment, that 2-MEA be considered harmful to human health.

 The assessment is based on available information using the current state of the science. Based on this information the Government has found that 2-MEA meets the criteria of paragraph 64(c) of CEPA 1999.

DEGME

• One industry stakeholder commented that the model selected for estimating exposure to DEGME from consumer products was inappropriate and that the default inputs used in the modelling were too conservative.

 In order to have as full a spectrum of information as possible, the exposure model selected by the Government of Canada includes both dermal exposure (i.e. contact with skin) and inhalation exposure (i.e. exposure from breathing air). Exposure of the public was estimated using the maximum concentrations of DEGME in products based on information available from literature searches or data submitted by industry, with a preference for Canadian-specific data when available. Government of Canada scientists also make efforts to determine reasonable product concentration values, which is acceptable within the context of a screening assessment.

• One industry stakeholder indicated that there is no alternative for the use of DEGME as an additive in jet fuel (its main use) and that it is also found in a large number of consumer products in Canada. The stakeholder suggested that the Government of Canada should conclusively determine that an unacceptable risk is present before concluding that the chemical may cause harm to human health or the environment.

 The screening assessment examined multiple sources of exposure to the general public. The assessment included indirect exposures from environmental media (including releases from the use of jet fuel) and direct exposures from the use of consumer products. While exposure to the public from the use of DEGME in jet fuel was determined to not pose a concern for human health, it was determined that there is a risk to human health based on its uses in consumer products.

2-Methoxypropanol

• One industry stakeholder commented that the default values used in the model to estimate exposure to 2-methoxypropanol were too conservative.

 To protect the health of Canadians, the default assumptions in the exposure model aid in predicting a conservative potential exposure to the general population. In determining the scenario for exposure to 2-methoxypropanol, Government of Canada scientists included information specific to Canadian personal care products that was obtained from a proprietary database maintained by Health Canada (through the Cosmetic Notification System). Additional product-specific information obtained from the survey of industry under section 71 of CEPA 1999 was also used in the exposure scenario. Government of Canada scientists also make efforts to determine reasonable product concentration values, which is acceptable within the context of a screening assessment. Furthermore, the models were re-run to verify the exposure outcomes and this resulted in the same conclusion as previously reported.

Pigment Red 3

• NGOs were generally supportive of the conclusion of the assessment, that Pigment Red 3 be considered harmful to human health. Some NGOs commented that there is a need for further information (e.g. monitoring, data on product use, consideration of international uses of similar products) to determine the extent of the environmental releases and human exposures.

 Information from a variety of sources (section 71 data, published scientific reports, etc.) was used to identify sources of exposure to and prepare the assessment for Pigment Red 3, and these data sources were sufficient for deriving the conclusion that it be considered harmful to human health. That being said, the Government of Canada strives to take into consideration all potential sources of information. These potential sources will be considered when setting priorities for future monitoring work.

Implementation, enforcement and service standards

The proposed Order would add the four above-mentioned substances to Schedule 1 of CEPA 1999. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. The Government will undertake an appropriate assessment of implementation, compliance and enforcement during the development of a proposed regulation or control instrument(s) respecting preventive or control actions for these substances.