Chemical name: 2-Propen-1-ol, reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine 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: The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items. 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: The Prohibition of Certain Toxic Substances Regulations, 2012 prohibit the manufacture, use, sale, offer for sale and import of toxic substances listed in Schedules 1 and 2. This notified substance is found in Part 2 of Schedule 1, which lists prohibited toxic substances subject to total prohibition, unless present in manufactured items. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Based on the available information on the physical and chemical properties of the fluorotelomer-based polymer, direct and indirect exposure of the general population to the fluorotelomer-based polymer and the hazardous degradation products is expected to be low at the currently intended annual import quantities. Based on available data, as well as surrogate data, the fluorotelomer-based polymer is expected to show low acute oral toxicity and low skin and eye irritation potential, and low reproductive and developmental toxicity; however it is likely to display moderate subchronic oral toxicity, with possible effects on the thyroid, liver, and kidney. The toxicological profile of the anticipated ultimate degradation products of the fluorotelomer-based polymer (i.e. perfluorocarboxylic acids (PFCAs)) is not expected to differ significantly from that of perfluorooctanoic acid (PFOA) and its salts. Based on available data, PFOA and its salts are not genotoxic but are tumourigenic and immunotoxic in rodents, and display moderate reproductive and developmental toxicity in rodents and moderate to high subchronic oral toxicity in rodents and monkeys. As a result, there is reason to suspect that the degradation products of the fluorotelomer-based polymer, and in particular the PFCAs, may have the potential to cause adverse health effects in humans. Direct Exposure to Humans: The fluorotelomer-based polymer is expected to react almost completely with paper fibres during the paper sizing process and prior to the sheet forming operation in the manufacture of single-use household paper containers. Supplementary information provided in the Food Contact Notification for the United States Food and Drug Administration (US FDA) gave typical levels of residual fluorinated starting materials and intermediates present in the fluorotelomer-based polymer. Residual fluorinated starting materials and intermediates are on the order of 300 ppm (total) on a dry weight basis of fluorotelomer-based polymer; whereas, fluorinated propenol byproducts are approximately 3000 ppm. It is predicted that these byproducts would be released to the environment during the paper product manufacturing process and they would be converted quickly in the environment to the corresponding PFCAs. At the projected import quantity of 17 000 kg/yr, the amount of fluorinated alcohol byproducts entering the environment would represent approximately 50 kg/yr. Expected effect of the final regulatory action in relation to human health: The Regulations prevent the introduction of new sources of PFCAs into Canada, thereby protecting the environment and human health. The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items. Summary of known hazards and risks to the environment: The fluorotelomer-based polymer, in its undegraded form, is expected to have limited exposure to the aquatic environment. Based on the exposure scenarios for paper product manufacture and general blending release, an environmental risk quotient of 6.1 x 10-5 is calculated from the lowest predicted environmental concentration (PEC) (Merickville) and the predicted no effects concentration (PNEC). This risk quotient is much less than one, so there is little immediate concern from aquatic exposure of the fluorotelomer-based polymer to aquatic organisms. It is important to note, that because the substance would tend to partition to the sediment, toxicity to sediment dwelling organisms would be more appropriate; however, based on the toxicity results for aquatic organisms, the PEC/PNECs for sediment dwelling organisms would not be expected to exceed 1. Based on these results, the fluorotelomer-based polymer, in its undegraded form, is not expected to induce adverse effects to the environment and would not be considered "toxic" under the Canadian Environmental Protection Act, 1999; however, the fluorotelomer-based polymer is expected to degrade and release substances of higher concern. The assessment has concluded that PFCA precursors are released from the fluorotelomer-based polymer as unreacted residuals or as degradation products, and are expected to further degrade to the highly persistent PFCAs. All of the PFCAs formed are expected to remain in the environment as there are no known environmental degradation mechanisms. Although the experimental evidence is not available demonstrating the occurrence, mechanism or rate of degradation from the fluorotelomer-based polymer, the release of PFCA precursors can be expected based on the chemistry of the notified substance and the available evidence suggesting susceptibility of this chemistry to degradation The rate of release may be faster or slower than rates observed in surrogate chemicals due to such factors as steric hindrance, however the rate is not considered of significant environmental importance given the exceptional stability of the ultimate degradation product, PFCAs. Atmospheric long range transport of some PFCA precursors can be used to explain the presence of the longer chain PFCAs in biota in remote regions of Canada. The measurements of longer chain PFCAs in remote regions of Canada give support to this transport mechanism and provide a scientifically defensible explanation of their presence. It is important to emphasise that the presence of PFCAs in remote regions should not be solely attributed to the notified substance or any single fluorinated substance, single source or single mechanism of transport, as local sources of contaminants and emissions from other jurisdictions may also contribute. Although acute toxicity to aquatic organisms following exposure to the degradation products appears to be low, evidence for chronic effects remains unknown. Toxicity studies to laboratory mammals indicate the potential to cause adverse health effects in wildlife. In summary, the fluorotelomer-based polymer is expected to degrade, release polyfluorinated substances, undergo long range atmospheric transport and/or degrade further to PFCAs. Available evidence indicates that the longer chain PFCAs (?C9) are susceptible to bioaccumulation and biomagnification, have been found in remote regions, and notably exhibit characteristics of persistent organic pollutants (POPs). These unique characteristics combined with the potential for long term adverse effects, warrant concern for the environment. Expected effect of the final regulatory action in relation to the environment: The Regulations prevent the introduction of new sources of PFCAs into Canada, thereby protecting the environment and human health. The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items. Date of entry into force of the final regulatory action: 13/10/2010 |