Screening Assessment for the Challenge

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Resin acids and rosin acids, fumarated, barium salts

Chemical Abstracts Service Registry Number
124751-15-1

Environment Canada
Health Canada

January 2011

Table of Contents

• Introduction
• Summary of Information Used as Basis for this Screening Assessment
• Conclusion
• References

Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances that have met the categorization criteria set out in the Act to determine whether these substances present or may present a risk to the environment or human health.

Based on the information obtained through the categorization process, the Ministers identified a number of substances as high priorities for action. These include substances that

• met all of the ecological categorization criteria, including persistence (P), bioaccumulation potential (B) and inherent toxicity to aquatic organisms (iT), and were believed to be in commerce in Canada; and/or
• met the categorization criteria for greatest potential for exposure (GPE) or presented an intermediate potential for exposure (IPE), and had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity.

The Ministers therefore published a notice of intent in the Canada Gazette, Part I, on December 9, 2006 (Canada 2006), that challenged industry and other interested stakeholders to submit, within specified timelines, specific information that may be used to inform risk assessment, and to develop and benchmark best practices for the risk management and product stewardship of these substances identified as high priorities.

The substance listed below was identified as a high priority for screening assessment and was included in the Challenge initiative under the Chemicals Management Plan because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms and was believed to be in commerce in Canada. This substance was not considered to be a high priority for assessment of potential risks to human health, based upon application of the simple exposure and hazard tools developed for categorization of substances on the Domestic Substances List (DSL).

Screening assessments focus on information critical to determining whether a substance meets the criteria as set out in section 64 of CEPA 1999. Screening assessments examine scientific information and develop conclusions by incorporating a weight-of-evidence approach and precaution.

The Notice for the Challenge for the above substance was published in the Canada Gazette on June 20, 2009 (Canada 2009). The Substance Profile was released at the same time. The Substance Profile presented the technical information available prior to December 2005 that formed the basis for categorization of this substance. Based on the outcome of the Challenge, the Ministers of the Environment and of Health have conducted this screening assessment for this substance. The critical information and considerations upon which the assessment is based are summarized below.

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Summary of Information Used as Basis for this Screening Assessment

Based on categorization results, the substance listed in this report has been found to meet the ecological criteria for persistence, bioaccumulation and inherent toxicity to non-human organisms (PBiT). This substance was not found to meet the human health categorization criteria (Environment Canada, 2006).

To establish whether certain high priority substances, including PBiT substances, were 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. The Notice was published in Part I of the Canada Gazette on March 4, 2006 (Canada, 2006a).

In response to this notice, there were no reports of industrial activity (import or manufacture) with respect to this substance in Canada, above the reporting threshold of 100 kg, for the specified reporting year of 2005. However, some companies did identify themselves as having a stakeholder interest in this substance. Therefore, this substance was believed to be potentially in commerce in Canada and was included in the Challenge.

Results from a similar notice issued under paragraph 71(1)(b) of CEPA 1999 on June 20, 2009, as part of the Challenge (Canada 2009) also revealed no reports of industrial activity (import or manufacture) with respect to this substance in Canada, above the reporting threshold of 100 kg, for the specified reporting year of 2006. These results indicate that in 2005 and 2006, this substance is not in use above the specified reporting threshold, and therefore the likelihood of exposure to this substance in Canada resulting from commercial activity is low. Other sources of entry into the environment have not been identified at this time.

Responses to the above notices and the accompanying questionnaire of June 20, 2009 (Canada 2006a; Canada 2009) also revealed no new information relevant to the PBiT properties of this substance. Given the lack of import or manufacture activity above the reporting threshold for this substance, no further collection or analysis relevant to the persistence, bioaccumulation and ecological effects of this substance, beyond what was done for categorization, has been conducted. Therefore, the decisions on PBiT properties made during categorization remain unchanged and accordingly this substance is considered to be highly hazardous to non-human organisms. It is also considered to meet the criteria for both persistence and bioaccumulation as set out in the Persistence and Bioaccumulation Regulations (Canada, 2000).

As mentioned above, since the results from notices issued under paragraph 71(1)(b) of CEPA 1999 on June 20, 2009 indicate that this substance is not in use above the specified reporting threshold, the likelihood of exposure to the general population in Canada is considered to be low; hence the potential risk to human health is considered to be low. Furthermore, this substance was not identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Also, it is not on the European Union’s Candidate List of Substances of Very High Concern for Authorisation (EU 2009).

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Conclusion

Based on available information, and until new information is received indicating that this substance is entering, or may enter the environment, from commercial activity or from other sources, it is concluded that the above substance is currently not entering or likely to enter 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 or constitute a danger to the environment on which life depends or that constitute a danger in Canada to human life or health. Therefore, it is concluded that it does not meet any of the criteria as set out in section 64 of CEPA 1999.

As a substance listed on the DSL, import and manufacture of this substance in Canada is not currently subject to notification under subsection 81(1). Given its hazardous PBiT properties, there is concern that new activities for the above substance which have not been identified or assessed under CEPA 1999 could lead to the substance meeting the criteria as set out in section 64 of the Act. Therefore, it is recommended to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that above substance 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 this substance 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 considered for introduction into Canada.

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References

Canada. 1999. Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33, Canada Gazette. Part III. vol. 22, no. 3. Available from: http://canadagazette.gc.ca/partIII/1999/g3-02203.pdf

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. Available from: http://canadagazette.gc.ca/partII/2000/20000329/pdf/g2-13407.pdf

Canada, Dept. of the Environment, Dept. of Health. 2006. Canadian Environmental Protection Act, 1999: Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment. Canada Gazette, Part I, vol. 140, no. 49, p. 4109–4117. Available from: http://canadagazette.gc.ca/partI/2006/20061209/pdf/g1-14049.pdf.

Canada, Dept. of the Environment, Dept. of Health. 2006a. 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. Available from: http://canadagazette.gc.ca/partI/2006/20060304/pdf/g1-14009.pdf

Canada, Dept. of Environment. 2009. Canadian Environmental Protection Act, 1999: Notice with respect to certain Batch 10 substances. Canada Gazette, Part I, vol. 143, no. 25, p1791-1814. Available from: http://gazette.gc.ca/rp-pr/p1/2009/2009-06-20/pdf/g1-14325.pdf#page=7

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

EU. 2009. Candidate List of Substances of Very High Concern for Authorisation. European Chemicals Agency. Available from: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp(accessed November 2009)

Footnote

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