Chemical name: 1-Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro- PFOA, its salts and esters, and PFOA-related substances, 1-Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-, and its salts and esters

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

N/A

The Regulations prohibit the manufacture, use, sale, offer for sale or import of PFOA and products containing PFOA, unless the substance is incidentally present. A limited number of exemptions are listed below.

Use or uses that remain allowed:

The Regulations do not apply to any toxic substance that is:

a)contained in a hazardous waste, hazardous recyclable material or non-hazardous waste to which Division 8 of Part 7 of CEPA applies;

b)contained in a pest control product as defined in subsection 2(1) of the Pest Control Products Act;

c)present as a contaminant in a chemical feedstock that is used in a process from which there are no releases of the toxic substance and on the condition that the toxic substance is destroyed or completely converted in that process to a substance that is not a toxic substance set out in either Schedule 1 or 2 of the regulations; or

d)to be used in a laboratory for analysis, in scientific research or as a laboratory analytical standard.

The Regulations do not prohibit:

·The import, manufacture, use, sale and offer for sale of PFOA or a product containing them, if PFOA are incidentally present [subsection 6(1) of the Regulations]

·The import, manufacture, use, sale and offer for sale of PFOA or a product containing them, before January 1, 2017, if it is designed for use in water-based inks or in photo media coatings, [paragraph 6(2)(b) of the Regulations]

·The import, use, sale and offer for sale of aqueous film forming foam for fire-fighting operations that contain PFOA [subsection 6(2.2) of the Regulations]

·The import, use, sale or offer for sale of manufactured items containing PFOA [subsection 6(2.4) of the Regulations]

·The use or import of products containing PFOA, if the product is for personal use [subsection 6(4) of the Regulations].

·The use, sale or offer for sale of:

oProducts containing PFOA if manufactured or imported before the Regulations come into force [paragraph 7(2)(a) of the Regulations]

oWater-based inks and photo media coatings containing PFOA that were manufactured or imported before January 1, 2017 [subsection 7(1) of the Regulations]

oPFOA or products containing them if they were manufactured or imported in accordance with a permit (section 8 of the Regulations).

The Regulations allow manufacturers and importers of PFOA and products containing PFOA to apply for a permit to continue their activities after the coming into force of the amendments or after expiry of a temporary exemption. Permits are valid for one year and can potentially be renewed twice allowing manufacturers and importers to continue their activities for an additional three years.

REFERENCES

Prohibition of Certain Toxic Substances Regulations, 2012 (SOR/2012-285) under CEPA, as amended 2016 (SOR/2016-252).

http://www.gazette.gc.ca/rp-pr/p2/2016/2016-10-05/html/sor-dors252-eng.html

Substance Prohibition Summary for Perfluorooctanoic acid, its salts, and its precursors and Long-Chain Perfluorocarboxylic acids, their salts, and their precursors. Environment and Climate Change Canada. July 2017.

http://ec.gc.ca/lcpe-cepa/default.asp?lang=En&;xml=3E603995-6012-4D22-993B-0ADEA222C2C4

Pesticide 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:

Perfluorooctanoic acid, which has the molecular formula C₇F₁₅CO₂H, its salts, and its precursors (collectively referred to as PFOA) and products containing them are subject to the Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) as amended in 2016, under the Canadian Environmental Protection Act, 1999 (CEPA).

The Prohibition of Certain Toxic Substances Regulations, 2012 prohibit the import, manufacture, use, sale and offer for sale of PFOA, and products containing PFOA, with a limited number of exemptions.

The reasons for the final regulatory action were relevant to: Environment

Summary of known hazards and risks to human health:

N/A

Expected effect of the final regulatory action in relation to human health:

N/A

Summary of known hazards and risks to the environment:

An ecological screening assessment was undertaken on perfluorooctanoic acid (PFOA), its salts and its precursors containing the perfluorinated alkyl moiety (C₇H₁₅, C₈H₁₇) and is directly bound to any chemical moiety other than a fluorine, chlorine or bromine atom.

Once in the environment, PFOA is extremely persistent and not known to undergo significant abiotic or biotic degradation under relevant environmental conditions. PFOA is highly soluble in water and typically present as an anion (conjugate base) in solution. It has low vapour pressure; therefore, the aquatic environment is expected to be its primary sink, with some additional partitioning to sediment. The presence of PFOA in the Canadian Arctic is likely attributable to the long-range transport of PFOA (e.g., via ocean currents) and/or volatile precursors to PFOA (e.g., via atmospheric transport).

PFOA has been detected at trace levels in the northern hemisphere. In North America, higher levels were measured in surface waters in the vicinity of US fluoropolymer manufacturing facilities (0.025-1900 µg/L) and in groundwater near US military bases (not detected [ND] to 6570 µg/L). PFOA was detected in effluent from Canadian wastewater treatment facilities at concentrations ranging from 0.007 to 0.055 µg/L. PFOA was also detected in the influent at US wastewater treatment facilities at concentrations ranging from 0.0074-0.089 µg/L.

Trace levels of PFOA have been measured in Canadian freshwater (ND-11.3 µg/L) and freshwater sediments (0.3-7.5 µg/kg). PFOA has also been detected in a variety of Canadian biota (ND-90 µg/kg wet weight [kg-ww] tissue) in southern Ontario and the Canadian Arctic. The highest concentration of PFOA in Canadian organisms was found in the benthic invertebrate Diporeia hoyi at 90 µg/kg-ww, followed by turbot liver at 26.5 µg/kg-ww, polar bear liver at 13 µg/kg-ww, caribou liver at 12.2 µg/kg-ww, ringed seal liver at 8.7 µg/kg-ww and walrus liver at 5.8 µg/kg-ww. Following an accidental release of fire-fighting foam in Etobicoke Creek (Ontario), PFOA was measured in common shiner liver at a maximum concentration of 91 µg/kg-ww. However, current PFOA concentrations in Canadian biota (tissue specific and whole body) are below the highest concentration found in US biota (up to 1934.5 µg/kg-ww in gar liver).

Temporal or spatial trends in PFOA concentrations in guillemot eggs, lake trout, thick-billed murres, northern fulmars or ringed seals could not be determined. However, temporal trends were found for PFOA concentrations in polar bears (1972 - 2002 and 1984 - 2006) and sea otters (1992 - 2002). PFOA doubling time in liver tissue was calculated to be 7.3 ± 2.8 years for Baffin Island polar bears and 13.9 ± 14.2 years for Barrow, Alaska, polar bears; central East Greenland polar bears showed an annual increase of 2.3% in PFOA concentrations. Concentrations of PFOA also increased significantly over a 10-year period for adult female sea otters.

Due to the perfluorination, the perfluorinated chains are both oleophobic and hydrophobic. PFOA primarily binds to albumin proteins in the blood of biota and, as a result, is present in blood and highly perfused tissues such as liver and kidney, rather than lipid tissue. There is experimental evidence indicating that PFOA is not highly bioaccumulative in fish. However, these results should not be extrapolated to non-aquatic species, since gills provide an additional mode of elimination for PFOA that air-breathing organisms, such as terrestrial and marine mammals, do not possess. Field studies indicating biomagnification factors greater than 1 for Arctic and other mammals (such as narwhal, beluga, polar bear, walrus, bottlenose dolphins, and harbour seals) suggest that PFOA may bioaccumulate and biomagnify in terrestrial and marine mammals. Reported field biomagnification factors for terrestrial and marine mammals ranged from 0.03-31. Polar bears, as the apex predator in the Arctic marine food web, have been shown to be the most contaminated with PFOA relative to other Arctic terrestrial organisms.

The risk quotients for pelagic organisms indicate a low likelihood of risk from exposures at current concentrations in the aquatic environment. The risk quotient for Canadian mammalian wildlife (i.e., polar bears) is less than 1; however, due to the persistence of the substance, its tendency to accumulate and biomagnify in a variety of terrestrial and marine mammals, its hepatotoxicity, and the upward temporal trend of PFOA concentrations in polar bears and some other species, PFOA concentrations in polar bears may approach exposures resulting in harm.

The assessment is based on a weight of evidence approach regarding persistence, bioaccumulation, temporal trends in some species (i.e. the polar bear), long-range transport and the widespread occurrence and concentrations of PFOA in the environment and in biota (including remote areas of Canada). Based on the information presented in the screening assessment, it is concluded that PFOA, its salts and its precursors are 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.

Expected effect of the final regulatory action in relation to the environment:

The risk management objective for PFOA is to achieve the lowest level of releases into the Canadian environment which is technically or economically feasible.

The final regulatory action protects the Canadian environment from risks associated with the manufacture, use, sale, offer for sale or import of PFOA and certain products containing PFOA.

REFERENCE

Regulatory Impact Analysis Statement, Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012. Environment Canada and Health Canada. October 2016.

http://www.gazette.gc.ca/rp-pr/p2/2016/2016-10-05/html/sor-dors252-eng.html

Date of entry into force of the final regulatory action: 23/12/2016