Chemical name: Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All manufacture, use, sale, offer for sale or import of SCCAs, or a product containing them, is prohibited unless the toxic substance is incidentally present. Use or uses that remain allowed: N/A The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: A person must not manufacture, use, sell, offer for sale or import SCCAs or a product containing them unless the toxic substance is incidentally present. A person must not manufacture, use, sale, offer for sale or import SCCAs or products containing them unless they are to be used in laboratory for analysis, in scientific research or as a laboratory analytical standard. A person who manufactures or imports SCCAs listed in Schedule 2, Part 4 or a product containing it whether incidentally or not, above the reporting thresholds must submit an annual report by March 31st of the following year. A person may use, sell, or offer for sale a product containing SCCAs if the product is manufactured or imported before the day on which these Regulations come into force (March 14, 2013). The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: For SCCAs, critical data relevant to both estimation of exposure of the general population in Canada and assessment of the weight of evidence for the mode of induction of specific tumours were identified following release of the first Priority Substances List (PSL1) assessment and prior to February 2001, although most of this information has been reported in incomplete published summary accounts or abstracts. These data suggest that several tumours observed in carcinogenicity bioassays in rats and mice exposed to SCCAs are induced by modes of action either not relevant to humans (kidney tumours in male rats) or for which humans are likely less sensitive (in rats, liver tumours related to peroxisome proliferation and thyroid tumours related to thyroid-pituitary disruption). Complete documentation of available studies and consideration in additional investigations of the reversibility of precursor lesions in the absence of continued exposure is lacking. However, reported data on mode of induction of tumours in addition to the weight of evidence that SCCAs are not DNA reactive are at least sufficient as a basis for consideration of a Tolerable Daily Intake (TDI) for non-cancer effects as protective for carcinogenicity for observed tumours. Upper-bounding estimates of daily intake of SCCAs approach or exceed the TDI for these compounds, which, on the basis of available information, is likely also protective for potential carcinogenicity. Expected effect of the final regulatory action in relation to human health: Prevention of potential risks of harm to the Canadian environment and, where applicable, human health by prohibiting the manufacture, use, sale, offer for sale or import of SCCAs as well as products containing these substances. Summary of known hazards and risks to the environment: The risk evaluation considered all Chlorinated Alkanes (CAs) including SCCAs, Medium-Chain Chlorinated Alkanes (MCCAs) and Long-Chain Chlorinated Alkanes (LCCAs). There are no known natural sources of CAs. The major sources of release of CAs into the Canadian environment are likely the formulation and manufacturing of products containing CAs, such as polyvinyl chloride (PVC) plastics, and use in metalworking fluids. The possible sources of releases to water from manufacturing include spills, facility wash-down and drum rinsing/disposal. CAs in metalworking/metal cutting fluids may also be released to aquatic environments from drum disposal, carry-off and spent bath. These releases are collected in sewer systems and often ultimately end up in the effluents of sewage treatment plants. When released to the environment, CAs tend to partition primarily to sediment or soil. SCCAs have been detected in the following environmental samples from Canada: in Arctic air, in sediments from remote northern lakes, in sewage treatment plant effluents from southern Ontario, in surface water, sediments and fish from Lake Ontario and in marine mammals from the Canadian Arctic and the St. Lawrence River. Maximum Canadian concentrations of SCCAs were observed in aquatic biota and sediments from the St. Lawrence River and also in sediments and fish from southwestern Ontario. Atmospheric half-lives for many CAs are estimated to be greater than 2 days. In addition, SCCAs have been detected in Arctic biota and lake sediments in the absence of significant sources of SCCAs in this region, which suggests that long-range atmospheric transport of SCCAs is occurring. SCCA residues have been detected in Canadian lake sediments dating back over 25 years, suggesting that the half-lives of SCCAs in sediment are greater than 1 year. It is therefore concluded that SCCAs are persistent as defined in the Persistence and Bioaccumulation Regulations of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Bioaccumulation factors (BAFs) of 16,440-25,650 wet weight (wet wt.) in trout from Lake Ontario indicate that SCCAs are bioaccumulating to a high degree in aquatic biota in Canada. This is supported by very high bioconcentration factors (BCFs) for SCCAs measured in mussels (5,785-138,000 wet wt.). In cases where appropriate Canadian environmental exposure data were not available, international concentration data were used for the risk quotients. Conservative risk quotients indicate that SCCAs have the potential to harm pelagic and soil organisms, that SCCAs may harm benthic organisms and that SCCAs have the potential to harm fish-eating wildlife through food chain effects. Based on the information available, it is proposed that SCCAs are entering the environment in quantities or concentrations or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Expected effect of the final regulatory action in relation to the environment: Prevention of potential risks of harm to the Canadian environment and, where applicable, human health by prohibiting the manufacture, use, sale, offer for sale or import of SCCAs as well as products containing these substances with a limited number of exemptions. Date of entry into force of the final regulatory action: 14/03/2013 |