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 PFOS, or a product containing PFOS, unless the substance is incidentally present, with a limited number of exemptions 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 PFOS or a product containing it, if PFOS is incidentally present [subsection 6(1) of the Regulations]

·The import, manufacture, use, sale and offer for sale of PFOS or a product containing it if it is designed for use in photoresists or anti-reflective coatings for photolithography process or photographic films, papers and printing plates [paragraph 6(2)(a) of the Regulations]

·The use and import of PFOS in aqueous film forming foam present in a military vessel or military fire-fighting vehicle contaminated during a foreign military operation [subsection 6(2.1) of the Regulations]

·The use of PFOS in aqueous film forming foam at a concentration less than or equal to 10 ppm [subsection 6(2.5) of the Regulations]

·The use, sale or offer for sale of manufactured items containing PFOS if they were manufactured or imported before May 29, 2008 [subsection 7(3) of the Regulations]

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 Perfluorooctane sulfonate, its salts and its precursors. Environment and Climate Change Canada. July 2017.

http://ec.gc.ca/lcpe-cepa/default.asp?lang=En&;xml=86BBBD05-D88E-44B2-932D-1ECCDF5FE9F1

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:

Perfluorooctane sulfonate and its salts and compounds that contain one of the following groups: C₈F₁₇SO₂, C₈F₁₇SO₃ or C₈F₁₇SO₂N (collectively referred to as PFOS) and products containing it are subject to Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) as amended in 2016, made under the Canadian Environmental Protection Act, 1999 (CEPA).

The manufacture, use, sale, offer for sale or import of PFOS is prohibited with a limited number of exemptions.

The Regulations replace the former Perfluorooctane Sulfonate and Its Salts and Certain Other Compounds Regulations which were the subject of a previous Notification of Final Regulatory Action from Canada.

Regulatory controls pertaining to PFOS already existed under CEPA prior to this new regulatory action, which were maintained. The new regulatory action expanded the controls by removing certain 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 perfluorooctane sulfonate (PFOS), its salts and its precursors containing the perfluorooctylsulfonyl (C₈F₁₇SO₂, C₈F₁₇SO₃, or C₈F₁₇SO₂N) moiety.

PFOS is resistant to hydrolysis, photolysis, microbial degradation, and metabolism by vertebrates. PFOS has been detected in fish, in wildlife worldwide and in the northern hemisphere. This includes Canadian wildlife located far from known sources or manufacturing facilities indicating that PFOS and/or its precursors may undergo long-range transport. Maximum concentrations in liver of biota in remote areas of the Canadian Arctic include: mink (20 µg.kg-1), common loon (26 µg.kg-1), ringed seal (37 µg.kg-1), brook trout (50 µg.kg-1), Arctic fox (1400 µg.kg-1) and polar bear (4000 µg.kg-1).

Unlike many other persistent organic pollutants, certain perfluorinated substances, such as PFOS, are present as ions in environmental media and partition preferentially to proteins in liver and blood rather than to lipids. Therefore, the bioaccumulation potential of PFOS may not be related to the typical mechanisms associated with bioaccumulation in lipid-rich tissues. Discretion is required when applying numeric criteria for bioaccumulation such as those outlined in the Government of Canada's Toxic Substances Management Policy (TSMP) and in the Persistence and Bioaccumulation Regulations under CEPA when determining whether substances such as PFOS are bioaccumulative. These numeric criteria were derived from bioaccumulation data for aquatic species and for substances which preferentially partition to lipids.

The assessment is based on a weight of evidence approach regarding persistence, bioaccumulation, the widespread occurrence of and concentrations of PFOS in the environment and in biota (including remote areas of Canada), and risk quotient analyses. Based on available data, it is concluded that PFOS, its salts and its precursors are 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. In addition, based on available data, it is concluded that PFOS and its salts is persistent. The weight of evidence is also sufficient to conclude that PFOS and its salts are bioaccumulative.

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

This regulatory action builds upon original action taken in 2008. The continued prohibition on manufacture, use, sale, offer for sale, or import of PFOS will work towards the objective of virtual elimination of the substance. Therefore, this regulatory action will also result in a reduction of risk for Canada's environment.

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

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