Persistence, bioaccumulation and inherent toxicity

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Canadian Environmental Protection Act, 1999
Environment Canada and Health Canada

April 2008

Introduction

The Ministers are required under the Canadian Environmental Protection Act, 1999 (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 persistence, bioaccumulation and inherent toxicity (PBiT) is to set priorities for assessment by first establishing which of these substances have a potential for release into the environment.

The Domestic Substances List (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 pursuant to paragraphs 71(1)(a) and (b) of CEPA 1999 (PDF, 690 KB, go to page 4). 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 DSL pursuant to section 71(1)(b) of CEPA 1999 published in Part I of the Canada Gazette on November 17, 2001 (PDF, 575 KB, go to page 4).

Description of survey

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.

Results of surveys

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 CASRegistry 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).

Overall survey results

For 135 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).

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.

Summary of information used as basis for this screening assessment

Based on the results of Categorization, the 145 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 also found to 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 145 substances in Canada, above the reporting threshold of 100 kg, for the specified reporting years.

The 2006 survey further invited 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, except for one company that did not gave information to the effect that uses covered under the Significant New Activity description exist. This provides further evidence that these substances are currently not of commercial interest in Canada.

Originally, 148 substances were assessed because they were categorized as having persistence, bioaccumulation and inherent toxicity properties and were not considered to be in commerce because they were not used, manufactured or imported in quantities above 100 kg per calendar year. During the public comment period on the draft screening assessment, two of these substances (Chemical Abstracts Service Registry Numbers [CAS RNs] 13080-86-9 and 71032-95-6) were reported to be used, manufactured or imported over the threshold, and it is now recommended that they be added to the Challenge program for chemicals that are a high priority for action under the Government of Canada’s Chemicals Management Plan. It has been found that a third substance (CAS RN 7832-83-2) no longer meets the categorization criteria for bioaccumulation and inherent toxicity. This substance will be assessed separately, and the conclusions of the assessment will be published later this year.

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.

Conclusion

Based on available information, the above 145 substances are currently not entering, or likely to enter, the environment as a result of commercial activity. Therefore, they do not meet any of the criteria set out in section 64 of CEPA 1999.

As substances listed on the DSL, import and manufacture of these 145 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 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 the 145 PBiT substances will 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.

References

Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33, part #, s. #. Canada Gazette. Part III. vol. 22, no. 3. PDF (1649 KB).

Canada. 2000. Canadian Environmental Protection Act: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March, 2000, SOR/2000-107, Canada Gazette. Part II, vol. 134, no. 7, p. 607-612. PDF (1975 KB).

Canada, Dept. of the Environment, Dept. of Health. 2001. Canadian Environmental Protection Act, 1999: Notice with Respect to Certain Substances on the Domestic Substances List (DSL). Canada Gazette, Part I, vol. 135, no. 46, p. 4194-4210. PDF (575 KB).

Canada, Dept. of the Environment, Dept. of Health. 2006. Canadian Environmental Protection Act, 1999: Notice with respect to selected substances identified as priority for action. Canada Gazette, Part I, vol. 140, no. 9, p. 435-459 PDF (690 KB).

Environment Canada. 2006. CEPA DSL Categorization Overview and Results [CD-ROM]. Gatineau (QC): Environment Canada, Existing Substances Division. Available on request.