Chemical name:

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 LC-PFCAs and products containing LC-PFCAs, 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 LC-PFCAs or a product containing them, if LC-PFCAs are incidentally present [subsection 6(1) of the Regulations]

·The import, manufacture, use, sale and offer for sale of LC-PFCAs 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 LC-PFCAs [subsection 6(2.2) of the Regulations]

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

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

·The use, sale or offer for sale of:

oProducts containing LC-PFCAs 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 LC-PFCAs that were manufactured or imported before January 1, 2017 [subsection 7(1) of the Regulations]

oLC-PFCAs 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 LC-PFCAs and products containing LC-PFCAs 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:

Perfluorocarboxylic acids that have the molecular formula C_nF_2n+1CO₂H in which 8 = n = 20, their salts, and their precursors (collectively referred to as LC-PFCAs) 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 LC-PFCAs, and products containing LC-PFCAs, 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 assessment was undertaken on the PFCAs with carbon chain lengths from 9 to 20 inclusive, their salts and their precursors. Precursors, i.e., substances that could transform or degrade to long-chain PFCAs, were considered on the basis of their contribution to the total presence of long-chain PFCAs in the environment. The assessment defines precursors as any substances where the perfluorinated alkyl moiety has the formula C_nF_2n+1 (where 8 = n = 20) and is directly bonded to any chemical moiety other than a fluorine, chlorine or bromine atom. While the assessment did not directly consider the potential additive effects of long-chain PFCAs and their precursors and their salts, it is recognized that the precursors and salts may contribute to the total presence of long-chain PFCAs in the environment. The expression C# is used to define the carbon chain length of the perfluorocarboxylic acid in question, e.g., C9 is a nine carbon PFCA.

In traditional toxicity studies (e.g., lethality, growth), several long-chain PFCAs were found to be low to moderately toxic, with acute toxicity values ranging from 8.8 to 285 mg/L. There are two studies on the toxicity of long-chain PFCAs in terrestrial species. In one study, no adverse effects were observed up to 1.0 mg/kg body weight for male chickens dosed with C10 PFCA three times/week for three weeks. In another study, a soil-dwelling nematode showed acute lethality at 306 mg/L and multi-generation effects (decreased fecundity) at 0.000464 mg/L when exposed to C9 PFCA.

There is the potential for long-chain PFCAs to cause the activation of the PPARa in Baikal seal livers at 35.25 - 64.26 mg/L C9-C11 PFCAs - based on data from in vitro laboratory studies. There is also the potential for long-chain PFCAs to affect endocrine function, e.g., vitellogenesis in rainbow trout at 0.0256 - 2000 µg/g diet C10 PFCA. C9-C10 PFCAs are also chemical sensitizers for the marine mussel, Mytilus californianus, by allowing normally excluded toxic substances to accumulate in the marine mussel. C12 and C14 PFCAs increased the mitochondrial membrane potential in the freshwater alga, Scenedesmus obliquus, indicating damage to the mitochondrial function.

Certain long-chain PFCAs have been measured in the Canadian aquatic environment in concentrations ranging from 0.5 ng/L to 19 ng/L. C9-C12 PFCAs were measured in sediment from the Canadian Arctic ranging in concentration from 0.5 - 3.3 ng/g. C9 to C15 PFCAs were measured in the liver of seals, foxes, fish, polar bears, Greenland shark, narwhals, beluga whales and birds either in the Canadian Arctic or the Great Lakes region. Concentrations ranged from below detection levels to 180 ng/g liver-ww with concentrations greatest for polar bears followed by Greenland shark, narwhals and beluga whales. Worldwide, levels of C9 to C15 PFCAs have been reported in ringed, fur and harbour seals, dolphins (i.e., white-sided, bottlenose, white-beaked, Franciscana, humpback), finless porpoises, glaucous gulls, sperm whale, beavers, Amur tigers, wild rats and several species of birds (little egret, little ringed plover, parrotbills, black-crowned herons). Concentrations ranged from below detection levels to 480 ng/g-ww, with concentrations highest in the white-beaked dolphin.

All long-chain PFCAs are considered to be persistent due to the strength of the carbon-fluorine bond. Furthermore, long-chain PFCAs have been detected in remote areas (e.g., the Canadian Arctic). While mechanisms of transport are not fully understood, certain precursors may undergo long-range transport to remote areas, where subsequent degradation can result in the formation of long-chain PFCAs.

For C11 (2700BCF11000), C12 (18000BCF40000), and C14 (23000BCF30000) PFCAs, there is empirical evidence that these substances are highly bioaccumulative in fish and have the potential for biomagnification in fish and marine mammals. There are no experimental or predicted bioaccumulation data available for long-chain PFCAs greater than C14. Nevertheless, there is the potential that long-chain PFCAs could accumulate or biomagnify in marine and/or terrestrial species based on chemical conformations. In addition, C14 and C15 PFCAs have been found in fish, invertebrates and polar bears.

Increasing trends of long-chain PFCA concentrations have been shown in polar bears, ringed seals and birds. From 1980 to 2000, C10 and C11 PFCAs in ringed seal livers from Greenland increased 3.3 and 6.8% per year, respectively. From 1992 to 2005, the mean concentrations of C9 and C10 PFCA in the livers of Baikal seals were 1.2 to 1.7-fold higher. From 1972 to 2002, mean doubling times for concentrations in polar bear livers from the Arctic ranged from 5.8 to 9.1 years for C9 to C11 PFCAs. From 1993 to 2004, concentrations in ringed seal liver samples increased, with a doubling time of 4 to 10 years for C9 to C12 PFCAs. In northern fulmar liver samples, C9 to C15 PFCA levels increased from 1987 to 1993 and remained steady from 1993 to 2003. Thick-billed murre liver samples showed an increase in C9 to C15 PFCAs concentrations from 1975 to 2004. Concentrations of C9 to C13 PFCAs increased significantly in whole eggs of herring gulls in Norway from 1983 to 1993. Annual temporal increases of C9-C12 PFCAs were observed in male beluga whales from Nunavut at 1.8 ng/g-ww liver from 1980-2010.

The presence of long-chain PFCAs, their salts and their precursors results from anthropogenic activity. The long-chain PFCAs and their salts are persistent. There is empirical evidence that long-chain PFCAs can accumulate to a significant extent and biomagnify in marine and terrestrial mammals. They have been found in remote regions, likely due to the long-range atmospheric or oceanic transport of volatile precursors and/or the acids themselves. Long-chain PFCAs and their precursors have been detected in biota over wide areas in Canada, including the Canadian Arctic. There is evidence that environmental concentrations are increasing with time for Canadian Arctic species such as polar bears, ringed seals, northern fulmars and thick-billed murres. Based on the above, it is concluded that long-chain PFCAs their salts and their precursors have the potential to cause ecological harm.

Based on the information presented in this screening assessment, it is concluded that long-chain (C9-C20) PFCAs, their salts and their precursors are entering or may 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. In addition, it is concluded that long-chain (C9-C20) PFCAs and their salts are extremely persistent and meet the criteria for persistence as set out in the Persistence and Bioaccumulation Regulations. Long-chain (C9-C20) PFCAs do not meet the criteria for bioaccumulation as set out in the Persistence and Bioaccumulation Regulations. Nevertheless, the weight of evidence is sufficient to conclude that long-chain (C9-C20) PFCAs and their salts accumulate and biomagnify in terrestrial and marine mammals.

It is, therefore, concluded that long-chain (C9-C20) PFCAs, their salts, and their precursors meet one or more of the criteria in section 64 of CEPA.

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

The risk management objective for LC-PFCAs 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 LC-PFCAs and certain products containing them.

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