Persistence, Bioaccumulation and inherent Toxicity - Draft

Canadian Environmental Protection Act, 1999
Environment Canada and Health Canada

Draft Screening Assessment Report for the Screening Assessment of

The Canadian Environmental Protection Act, 1999 (CEPA 1999) requires the Ministers of the Environment and of Health (the Ministers) to conduct screening assessments of substances that meet the Categorization criteria set out in the Act and Regulations to determine whether substances present or may present a risk to the environment or to human health. Based on the results of a screening assessment, the Ministers can propose taking no further action with respect to the substance, adding the substance to the Priority Substances List (PSL) for further assessment, or recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable, the implementation of virtual elimination.

The supporting working documentation for this screening assessment is available in electronic format upon submitting a request by e-mail to ESB.DSE@ec.gc.ca or by mail from:

Existing Substances Division
Environment Canada
20th Floor, Place Vincent Massey
Gatineau, Québec
K1A 0H3

The critical information and considerations upon which the assessment is based are summarized below.

CEPA 1999 requires that existing substances be sorted or “categorized” by the Ministers to determine which need further attention. Categorization is the first step in scientifically assessing all chemical substances on the Domestic Substance List (DSL). Using information from Canadian industry, academic research and other countries, Government of Canada scientists from the Existing Substances Program at Health Canada and Environment Canada worked with partners in applying a set of rigorous tools to each of the approximately 23 000 chemical substances on the DSL. In September 2006, the Ministers completed this scientific evaluation or "categorization” exercise. The information from Categorization is now available and is being used to focus attention on those chemical substances of highest priority for assessment or further research, and those in need of controls to protect human health and the environment.

According to paragraph 73(1)(b) the purpose of the categorization of the DSL substances was to identify those that are suspected to be:

Either one of:

1. Persistent (P): chemical substances that take a very long time to break down in the environment – sometimes many years. These substances can affect the environment for a long period of time. Because they last for so long, they can travel long distances and pollute a much wider area than those that break down quickly.
   
2. Bioaccumulative (B): chemical substances that can be stored in the organs, fat cells or blood of living organisms and remain for a long time. Over time, concentrations can build up and reach very high levels, and can also be transferred up the food chain.
   
   AND
   
3. Inherently Toxic to the Environment (iTE):chemical substances that are known or suspected, through laboratory and other studies, to have a harmful effect on wildlife and the natural environment on which it depends.

More information on the ecological aspects of categorization can be found at: (http://www.ec.gc.ca/substances/ese/eng/dsl/dslprog.cfm)

According to subsection 73(1), the purpose of the categorization of the DSL was to identify substances that have the Greatest Potential for Exposure or that are Inherently Toxic to Humans, as described below:

1. Greatest Potential for Exposure (GPE): when assessing human exposure to chemical substances, scientists look at more than persistence and bioaccumulation. Some shorter-lived substances might affect humans just as much as persistent ones. To get the complete picture, scientists look at how a substance is used. Health Canada identified those chemical substances on the DSL to which people are expected most likely to be exposed.
   
2. Inherently Toxic to Humans (iTH): these are chemical substances that are known or suspected of having harmful effects on humans. Substances were examined for a number of human health effects, including cancer, birth defects and damage to genetic material.

More information on the human health aspects of categorization can be found at: https://www.canada.ca/en/health-canada/services/environmental-workplace-health/environmental-contaminants/existing-substances.html.

The results of Categorization indicate that there are 397 substances on the DSL that are Persistent, Bioaccumulative and inherently Toxic (PBiT) to non-human organisms, according to the Categorization criteria (EC, 2003, 2005a, 2005b, 2006a). Of these 397 PBiT substances, 36 were also identified as being inherently toxic to humans or presenting to individuals in Canada the greatest potential for exposure. The results of Categorization are available on the CEPA Environmental Registry. Detailed information on the results of Categorization is available upon request by submitting an e-mail to ESB.DSE@ec.gc.ca.

The Ministers are required under CEPA 1999 to conduct screening assessments of substances that meet the Categorization criteria. A screening assessment involves an analysis of a substance using available information to determine whether the substance is “toxic” or capable of becoming “toxic” as defined in CEPA 1999.

The Ministers consider that evidence that a substance is both Persistent and Bioaccumulative (according to the Persistence and Bioaccumulation Regulations), when combined with evidence of toxicity and release into the environment provides a compelling indication that the substance can lead to harmful impacts and therefore meets the criteria set out in section 64 of CEPA 1999.

The approach taken by the Government of Canada for the 397 substances that meet the Categorization criteria for PBiT is to set priorities for assessment by first establishing which of these substances have a potential for release into the environment.

The DSL includes substances manufactured in or imported into Canada in quantities greater than or equal to 100 kg/yr or found in Canadian commerce, between January 1, 1984 and December 31, 1986. However, preliminary research has indicated that a high percentage of these substances may no longer be manufactured in or imported into Canada.

To establish whether certain high priority substances, including PBiT substances, are currently being manufactured in or imported into Canada, a survey was conducted by issuing a Notice with respect to Selected Substances identified as Priority for Action (PDF 689 kB) pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999. The Notice was published in Part I of the Canada Gazette on March 4, 2006.

Several of these 397 PBiT substances were among a number of substances that were previously surveyed in 2001 under a Notice with Respect to Certain Substances on the Domestic Substances List (DSL) (PDF 575 kB) pursuant to section 71(1)(b) of CEPA 1999 published in Part I of the Canada Gazette on November 17, 2001.

The purpose of the 2006 Notice with respect to Selected Substances identified as Priority for Action was to identify:

1. whether the substances covered under the Notice were manufactured or imported into Canada in 2005 in quantities greater than 100 kg,
2. the quantity range of these substances manufactured or imported; and
3. the organizations and industrial sectors involved with the manufacture or import of these substances.

The Notice applied to any person (in Canada) who, during the 2005 calendar year, manufactured or imported greater than 100 kg of a substance (whether alone, in a product or in a mixture) listed in the Notice.

The Notice was designed with two major goals:

• To identify substances which were not in commerce during the 2005 calendar year.
  • Confirmation of substances not currently in commerce in Canada will allow government to ensure that post-categorization efforts are focused on substances with potential for release into the Canadian environment as a result of commercial activity;
    
• To identify companies having current activity with any of these substances, to allow for follow-up, where necessary, to gather more detailed information including use-pattern information which will allow for the prioritization of future assessment and/or risk management activities.
  • Future detailed data collection regarding these substances will be designed taking into consideration the level of activity and sectors identified in the responses to the Notice.
    

Companies were also invited to identify a “stakeholder” interest in the surveyed substances. Some examples of “stakeholders” include companies that manufactured or imported a listed substance below threshold (100 kg), those who domestically sourced the substance from within Canada, foreign companies that exported the substance to Canada, or companies that dealt with the substance in a year other than 2005.

For each substance (whether alone, in a product or in a mixture) listed in the Notice that was manufactured or imported during the 2005 calendar year, reporting of the following information was required:

• the Chemical Abstracts Service Registry Number of the substance (CAS);
• the name of the substance;
• the activity, whether the substance was manufactured or imported (whether alone, in a product or in a mixture);
• the total quantity range of the substance manufactured and/or imported, given ranges of i) “100-1,000 kg/yr”, ii) “1,001-100,000 kg/yr” and iii) “>100,000 kg/yr” (except for substances identified as hazards to human health, for which reporting of quantity range was not required);
• the six-digit North American Industry Classification System (NAICS) code or codes that applied to the manufacture or import of the substance;
• whether the company’s manufacture or import of the substance, quantity range or NAICS codes are confidential pursuant to section 313 of the Canadian Environmental Protection Act, 1999.

Survey information was reviewed, including:

• The number of reporters for the CAS Registry Number (for each “activity”, i.e. manufacture (>100 kg), import (>100 kg) and “stakeholder”, the number of Canadian companies and the number of foreign companies reporting the activity was recorded);
• A summary of the quantity ranges reported for the manufacture and import (whether alone, in a product or in a mixture) into Canada of the CAS Registry Number (the number of respondents, both Canadian and foreign, that reported either of these activities in the given ranges of i) “100-1,000 kg/yr”, ii) “1,001-100,000 kg/yr” and iii) “>100,000 kg/yr”);
• A summary of companies who identified themselves as stakeholders with an interest in the CAS Registry Number (Canadian companies, foreign companies or industry associations);
• The North American Industry Classification System (NAICS) code or codes that were reported for the CAS Number (which provides a general indication of the number and types of sectors involved with the substance).

For 138 PBiT substances, listed in Table 1, no reports were received of manufacture in or import into Canada, or of stakeholder interest, in the 2005 calendar year (EC 2006b).

Table 1 PBiT substances with no reported manufacture or import in Canada in 2005, at the reporting threshold of 100 kg/year

One of these PBiT substances, CAS No. 64742-66-1 (Naphtha (petroleum), catalytic dewaxed,) had also been identified as meeting the human health criteria for Categorization.

For 10 of the PBiT substances surveyed in the 2001 Notice, listed in Table 2 below, no reports were received of manufacture in or import into Canada in quantities greater than 100 kg for the 2000 calendar year (EC 2001). These substances were not included in the list of substances in the 2006 Notice with respect to Selected Substances identified as Priority for Action.

Table 2 PBiT substances with no reported manufacture or import in Canada in 2000 at the reporting threshold of 100 kg/year

Based on the results of Categorization, the 148 substances listed in this report have been found to meet the criteria for Persistence, Bioaccumulation and inherent Toxicity to non-human organisms (PBiT). One of these substances, CAS No. 64742-66-1 was found to also meet the human health criteria for Categorization.

Based on the results of Notices issued pursuant to paragraph 71(1)(b) of CEPA 1999 and published in Part I of the Canada Gazette on November 17, 2001 and on March 4, 2006, there are no reports of industrial activity (import or manufacture) with respect to these 148 substances in Canada, above the reporting threshold of 100 kg, for the specified reporting years.

These results suggest that currently these substances are not in use above the specified reporting threshold, and therefore the likelihood of exposure to these substances in Canada resulting from commercial activity is low.

The 2006 survey further invited any companies to identify themselves as stakeholders if they had an interest in any of the listed CAS Registry Numbers. No stakeholders identified themselves as having an interest in any of the substances listed on in Table 1 above. This provides further evidence that these substances are currently not of commercial interest in Canada.

Based on available information, and until new information is received indicating that any of the substances is entering, or may enter the environment, it is proposed that the above 148 substances are currently not entering, or likely to enter, the environment as a result of commercial activity. Therefore it is proposed that they do not meet the criteria set out in section 64 of CEPA 1999.

As substances listed on the DSL, import and manufacture of these 148 substances in Canada are not subject to notification under subsection 81(1). Given the hazardous PBiT properties of these substances, there is concern that new activities for the above 148 substances which have not been identified or assessed under CEPA 1999 could lead to the substances meeting the criteria set out in section 64 of the Act. Therefore it is recommended that the above 148 substances be subject to the Significant New Activity provisions specified under subsection 81(3) of the Act, to ensure that any new manufacture, import or use of any of these substances in quantities greater than 100 kg/year is notified and will undergo ecological and human health risk assessments as specified in section 83 of the Act prior to the substance being introduced into Canada.

EC (Environment Canada). 2001. Data collected pursuant to Section 71 (Canadian Environmental Protection Act, 1999) and in accordance with the published notice “Notice with Respect to Certain Substances on the Domestic Substances List (DSL)", Canada Gazette, Vol. 135, No. 46.

EC (Environment Canada). 2003. Guidance Manual for the Categorization of Organic and Inorganic Substances on Canada’s Domestic Substances List. Existing Substances Branch, Environment Canada, Gatineau, Quebec.

EC (Environment Canada). 2005a. Approach for the Ecological Categorization of Substances on the Domestic Substances List - Organometallics. Existing Substances Branch, Environment Canada, Gatineau, Quebec.

EC (Environment Canada). 2005b. Approach for the Ecological Categorization of Substances on the Domestic Substances List – Unknown or Variable Composition Complex Reaction Products and Biological Materials (UVCBs). Existing Substances Branch, Environment Canada, Gatineau, Quebec.

EC (Environment Canada). 2006a. Spreadsheets of Decisions for Ecological Categorization of Substances on the Domestic Substances List under the Existing Substances Program at Environment Canada. CD-ROM released September 2006. Existing Substances Division, Environment Canada, Gatineau, Quebec.

EC (Environment Canada). 2006b. Data collected pursuant to Section 71 (Canadian Environmental Protection Act, 1999) and in accordance with the published notice “Notice with respect to selected substances identified as priority for action", Canada Gazette, Vol. 140, No. 9.