Consultation Document Phenol, 4,4'-(1-Methylethylidene)bis-(Bisphenol A)

• 2.1 Final Screening Assessment Report
• 2.2 Proposed Risk Management Approach
• 2.3 Environmental Monitoring

2.1 Final Screening Assessment Report

A notice summarizing the scientific considerations of the final screening-level risk assessment report was published by the Government of Canada in the Canada Gazette, Part I, on October 18, 2008 ^[3]. The approach taken in this ecological screening assessment was to examine available scientific information and develop conclusions based on a weight-of-evidence approach and using a precautionary approach, as required under section 76.1 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). The final screening assessment report concluded that bisphenol A is entering or may be 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. It also concluded that bisphenol A 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. Therefore it was concluded that bisphenol A met the criteria in paragraph 64 (a) and 64 (c) of CEPA 1999.

Bisphenol A is acutely toxic to aquatic organisms and has been shown to adversely affect growth and development in both aquatic and terrestrial species. There is evidence that low-level exposure to bisphenol A, particularly at sensitive life cycle stages, may lead to permanent alterations in hormonal, developmental or reproductive capacity.

In laboratory testing, these effects have occurred within the range of concentrations measured in Canada, indicating that there is potential for adverse effects in populations, particularly those close to point sources.

Releases of bisphenol A may occur during production, processing, use or disposal of the substance or products containing it. Based on its moderate water solubility and low vapour pressure, wastewaters and washing residue generated during production and processing of application materials such as polycarbonates, epoxy resins and other industrial uses of bisphenol A are the most likely sources of release to the environment. However, there are potentially many other sources of releases into the Canadian environment including unintentional releases from handling and transportation.

2.2 Proposed Risk Management Approach

A proposed Risk Management Approach for bisphenol A was also published on October 18, 2008 ^[4]. It identified potential risk management actions to address both environmental and human health risks associated with bisphenol A.

Bisphenol A has shown high toxicity to aquatic organisms, with acute toxicity values falling below 13 mg/L and chronic values below 2 mg/L. The empirical and modelled data demonstrate that bisphenol A can be considered highly hazardous to the aquatic environment ^[5].

The proposed environmental objective is to prevent or minimize releases of bisphenol A into the Canadian environment. The proposed risk management objective for industrial effluent is to achieve the lowest level of release of bisphenol A to water that is technically and economically feasible. In order to achieve this objective, the Government of Canada intends to develop regulations that would limit the release of bisphenol A in industrial effluent to a maximum concentration of 1.75 µg/L. This level was calculated using a factor of 10 times the Predicted No-Effects Concentration (PNEC) as identified in the final Screening Assessment Report. The PNEC accounts for a dilution factor of bisphenol A released directly to surface water or to municipal wastewater treatment facilities.

The proposed regulation would require the implementation of an environmental management system to ensure best management practices are adopted at facilities where bisphenol A is used and to ensure that levels in the effluent are below the maximum concentration specified.

The Risk Management Approach document also recognized that releases of bisphenol A to water and wastewater can result from the disposal or recycling of products containing bisphenol A. Options outside of the current proposal will be explored to work towards the risk management objective for bisphenol A from these sources.

2.3 Environmental Monitoring

As part of the Government’s monitoring initiative, environmental monitoring of bisphenol A is being conducted nationally in the following media: wastewater effluent and wastewater sludge; landfill leachate; wildlife; fish; and receiving waters downstream of wastewater treatment plants. This monitoring will be used to inform the government on ambient levels of bisphenol A in the environment, to assess the efficacy of risk management actions and to help determine the fate of bisphenol A in waste streams. The above monitoring was initiated in 2008 and continued in 2009.

^[3] http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_80-05-7_en.pdf (PDF; 909KB)

^[4] http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_80-05-7_rm_en.pdf (PDF; 135KB)

^[5] http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_80-05-7_en.pdf (PDF; 135KB)