Consultation Document

Perfluorooctane Sulfonate, its Salts and Certain Other Compounds Regulations – Examination of On-going Exemptions

Environment Canada
Health Canada

January 2013


Table of Contents

1. Objective of Consultation

The objective of this consultation document and the corresponding 60 day electronic public comment period is to solicit feedback from the public and other stakeholders regarding the continued need for the on-going exemptions listed in the Perfluorooctane Sulfonate, its Salts and Certain Other Compounds Regulations. Consideration is being given to modifying the existing regulatory requirements for perfluorooctane sulfonate (PFOS), its salts and precursors, where it is technically and economically feasible to do so. Comments received will help to inform the development of proposed amendments to the regulatory controls for PFOS prior to their publication in Canada Gazette, Part I.

2. Background

2.1 Substance Information

PFOS, its salts and its precursors all belong to the larger class of fluorochemicals referred to as perfluorinated alkyl compounds which contain carbons that are completely saturated by fluorine.

2.2 Final Screening Assessment Report Conclusion for PFOS, its Salts and its Precursors

The final ecological screening assessment concluded that PFOS, its salts and its precursors meet the criteria under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) and are 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. The human health assessment concluded that current levels of PFOS exposure are below levels which might affect human health.

For further information on the final screening assessment report conclusion for PFOS, its salts and precursors, refer to the final screening assessment reports (Environment Canada, 2006a and Health Canada 2006).

Given the conclusions of the ecological screening assessment, it has been proposed to manage PFOS, its salts and precursors under the provisions of CEPA 1999 with the objective of achieving the lowest level of releases to the environment that is technically and economically feasible from all emission sources (Environment Canada, 2006b).

3. Existing Risk Management Actions

3.1 Domestic

On June 11, 2008, the Perfluorooctane Sulfonate and Its Salts and Certain Other Compounds Regulations (Canada, 2008) were published in the Canada Gazette, Part II. These Regulations prohibit the manufacture, use, sale, offer for sale and import of PFOS or products containing PFOS with a limited number of exemptions. Some of the exemptions are time-limited while others are not.

Time-limited exemptions under the Regulations include:

  • the use, sale, offer for sale and import, until May 2013, of PFOS-based fume suppressants for:
    • chromium electroplating, chromium anodizing and reverse etching;
    • electroless nickel-polytetrafluoroethylene plating; and
    • etching of plastic substrates prior to their metallization; and
  • the use, until May 2013, of aqueous film-forming foams (AFFF) containing PFOS that was manufactured or imported before May 2008, except for testing and training purposes.

On-going exemptions include:

  • the use, sale, offer for sale and import of aviation hydraulic fluid containing PFOS;
  • the manufacture, use, sale, offer for sale and import of the following products containing PFOS:
    • photo-resists or anti-reflective coatings for photolithography processes; and
    • photographic films, papers and printing plates
  • the use, sale and offer for sale of manufactured products containing PFOS that were manufactured or imported before May 2008;
  • the use of AFFF-containing PFOS in a military vessel that is deployed before May 2013 for a military operation; or
  • the use or import of AFFF-containing PFOS in a military vessel or military fire fighting vehicle that is contaminated during a foreign military operation after May 2008; and
  • the use of AFFF-containing PFOS if the concentration is less than or equal to 0.5 ppm.

3.2 International

3.2.1 Stockholm Convention on Persistent Organic Pollutants (POPs) and Protocol on POPs to the Convention on Long-range Transboundary Air Pollution

At its fourth meeting held from 4 to 8 May 2009, the Conference of the Parties to the Stockholm Convention adopted amendments to list nine new substances (SC-4/10-SC-4/18) including PFOS. Similarly, at  the 27th Session in December 2009, the Executive Body to the Convention on Long-range Transboundary Air Pollution agreed to amend the Protocol on POPs by adding a number of new substances, including PFOS.  Under both agreements there are a number of time-limited and on-going exemptions, however Parties using PFOSare encouraged to take action to phase out the exempted uses once suitable alternatives are available.  Furthermore in 2015, the Conference of the Parties to the Stockholm Convention and the Executive Body to the Protocol on POPs will evaluate the continued need for exemptions.

In order to assist with efforts to phase out the exempted uses, the Persistent Organic Pollutants Review Committee under the Stockholm Convention has developed the following documents:

  • Technical paper on the identification and assessment of alternatives to perfluorooctane sulfonic acid in open applications; and
  • Guidance on alternatives to perfluorooctane sulfonate and its derivatives

Copies of these documents are available on the website for the Stockholm Convention.

Additional information on these international agreements is provided in Annex A.

3.2.2 Other Jurisdictions

Risk management measures are underway in other jurisdictions. In the United States there are three Significant New Use Rules in place affecting 271 PFOS related chemicals. A regulation prohibiting manufacture and use of PFOS, with certain exemptions, is in place in the European Union. In Australia, a voluntary phase-out has been occurring since 2000, motivated by four alerts concerning PFOSpublished through their National Industrial Chemicals Notification and Assessment Scheme.

Additional information on these measures is provided in Annex A.

4. Request for Input

To achieve the risk management objective as outlined in the Risk Management Strategy for Perfluorooctane Sulfonate, its Salts and is Precursors (Environment Canada, 2006b) and to ensure continued alignment with its international obligations, the Government of Canada is evaluating the continued need for the on-going exemptions listed in the Perfluorooctane Sulfonate, its Salts and Certain Other Compounds Regulations. In order to inform this evaluation, the Government of Canada is seeking comments from stakeholders on the following questions related to each of the on-going exemptions:

4.1 The use, sale, offer for sale and import of aviation hydraulic fluid containing PFOS1

Is this exemption still required? Could it be phased out over a 5 year period? Are there any alternatives for all or some of the uses included in this exemption, such as specific aircrafts? Can the description of this exemption be more precise, (e.g applicable only to specific types of aircraft or specifying a maximum concentration of PFOS)?

4.2 The manufacture, use, sale, offer for sale and import of photo-resists or anti-reflective coatings for photolithography processes containing PFOS2

Is this exemption still required? Is PFOS still used in these applications in Canada? Since PFOS is used as a process chemical, do finished products imported into Canada contain PFOS? Could the description of the products or process in this exemption be refined to improve its precision?

4.3 The manufacture, use, sale, offer for sale and import of photographic films, papers and printing plates containing PFOS3

Is this exemption still required? Could it be phased out over a 5 year period? Alternatively, could the scope of the exemption be narrowed to certain application such as medical imaging only? Are there alternatives to PFOS available? For what specific products or processes is PFOS essential?

4.4 AFFF containing PFOS

  • Used in a military vessel deployed, before the day on which these Regulations came into force or within five years after that day (until May 29, 2013), for a military application.

Is this exemption still necessary?

  • Used or imported in a military vessel or military fire fighting vehicle contaminated during a foreign military operation after the coming into force of the Regulations

Is this exemption still necessary? Is there a protocol in place to decontaminate vessels or vehicles contaminated during foreign operations?

4.5 The use of AFFF containing PFOS if the concentration of the substance is inferior or equal to 0.5ppm.

Could this concentration limit be removed or replaced with a different criterion?

All input received will help to inform the development of the proposed regulations prior to their publication in Canada Gazette, Part I. Responses, comments and other materials should be sent to the contact listed below.

5. Next Steps and Timelines

Actions and dates for the next steps and timelines
Actions
Date
60-day electronic public consultation period on this Consultation DocumentJanuary 2013
Publication of the proposed regulations in Canada Gazette, Part INo later than November 2013
Publication of the final regulations in Canada Gazette, Part IINo later than 18 months following the publication of the proposed instrument

Industry and other interested stakeholders are invited to submit comments on the content of this consultation document or provide other information that would help to inform decision making. Please submit comments prior to March 5th, 2013. Comments and information submissions should be submitted to the address provided below:

Chemicals Management Division
351 boul. St Joseph, 10th floor
Gatineau Quebec  K1A 0H3
Tel: 1-888-228-0530 / 819-956-9313
Fax: 819-953-7155
Email: GR-RM@ec.gc.ca

6. References

Canada. 2008. Perfluorooctane and its Salts and Certain Other Compounds Regulation.

Canada. 2009. Regulations Adding Perfluorooctane Sulfonate and its Salts to the Virtual Elimination List.

Environment Canada. 2006a. Ecological Screening Assessment Report on Perfluorooctane Sulfonate, Its Salts and Its Precursors that Contain the C8F17SO2 or C8F17SO3, or C8F17SO2N Moiety.

Environment Canada (2006b) Perfluorooctane Sulfonate (PFOS), its Salts and its Precursors – Risk Management Strategy.

Health Canada (2006) Perfluorooctane Sulfonate, Its Salts and Its Precursors that Contain the C8F17SO2 or C8F17SO3 Moiety.

Annex A: Summary of International Risk Management Actions for Perfluorooctane Sulfonate, its Salts and its Precursors

Summary of international risk management actions for Perfluorooctane Sulfonate, its Salts and its Precursors
JURISDICTIONACTIONTIMELINE/STATUS
Stockholm Convention on Persistent Organic Pollutants
At its fourth meeting held from 4 to 8 May 2009, the Conference of the Parties adopted amendments to Annexes A, B and C to the Stockholm Convention to list nine new substances (SC-4/10-SC-4/18) including PFOS. The listing of PFOSincludes a number of time-limited and on-going exemptions as follows:
  • acceptable purposes:
    • photo-imaging;
    • photo-resist and anti-reflective coatings for semi-conductors;
    • etching agent for compound semi-conductors and ceramic filters;
    • aviation hydraulic fluids;
    • metal plating (hard metal plating) only in closed-loop systems;
    • certain medical devices (such as ethylene tetrafluoroethylene copolymer (ETFE) layers and radio-opaque ETFE production, in-vitro diagnostic medical devices, and CCD colour filters);
    • fire-fighting foam; and
    • insect baits for control of leaf-cutting ants from Atta spp. and Acromyrmex spp.; and
  • specific exemptions:
    • photo masks in the semiconductor and liquid crystal display (LCD) industries;
    • metal plating (hard metal plating);
    • metal plating (decorative plating);
    • electric and electronic parts for some colour printers and colour copy machines;
    • insecticides for control of red imported fire ants and termites;
    • chemically driven oil production;
    • carpets;
    • leather and apparel;
    • textiles and upholstery;
    • paper and packaging;
    • coatings and coating additives; and
    • rubber and plastics.
Canada ratified in 2011
United Nations Economic Commission for Europe Convention on Long Range Transboundary Air Pollution
At the 27th Session of the Executive Body, in December 2009, the Executive Body agreed to amend the Protocol to add a number of new substances, including PFOS.  The listing of PFOS includes a number of time-limited and on-going exemptions as follows:

Annex I:
  • chromium electroplating, chromium anodizing and reverse etching until 2014;
  • electroless nickel-polytetrafluoroethylene plating until 2014;
  • etching of plastic substrates prior to their metalization until 2014; and
  • fire-fighting foams, but only if they have been manufactured or were in use by December 18, 2009.
Annex II:
  • photo-resist or anti-reflective coatings for photolithography processes;
  • photographic coatings applied to films, papers or printing plates;
  • mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems;
  • hydraulic fluids for aviation;
  • certain medical devices (such as ethylene tetrafluoroethylene copolymer (ETFE) layers and radio-opaque ETFE production, in vitro diagnostic medical devices and CCD colour filters).
Canada ratified in 2011
United StatesThe United States Environmental Protection Agency (US EPA) published two significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) in 2002 to limit any future manufacture or importation of 88 PFOS-related substances.

These SNURs allowed the continuation of a few specifically limited, highly technical uses of these chemicals for which no alternatives were available, and which were characterized by very low volume, low exposure, and low releases. Another SNUR, affecting a further 183 chemicals, was published in 2007. Seven of the chemicals affected by this SNUR are exempted for specific uses.

The total number of chemicals affected by these SNURs is 271.
Published in 2002







Published in 2007
 The EPA proposed another SNUR under TSCA to add 7 PFOS-related substances to the existing SNUR and include "processing" in the definition of significant new use for these substances.Proposed August 8th2012
European Union
The European Union published Regulation No 757/2010 on August 24, 2010.  The Regulation prohibits the production, placing on the market and use of PFOS and its derivatives with some exemptions.  The regulations do not apply to:
  • PFOS occurring as an unintentional trace contaminant in substances, preparations and articles:
    • In concentrations equal to or below 0.001% when it occurs in substances or in preparations;
    • In semi-finished products or articles, or parts thereof, at a level lower than 0.1% by weight; or
    • In textiles and other coated materials if the amount of PFOS is lower than 1µg/m2.
Published in August 2010
 
Exemptions to the above mentioned restrictions include:
  • Use of articles containing PFOS that were already in use before August 25, 2010;
  • Fire fighting foams that were placed on the market before December 27, 2006 may be used until June 27, 2011;
  • Production and placing on the market:
    • Until August 26, 2015 of wetting agents for use in controlled electroplating systems;
    • photoresists or anti reflective coatings for photolithography processes;
    • photographic coatings applied to films, papers or printing plates;
    • mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems; and
    • hydraulic fluids for aviation.
 
AustraliaIn Australia, there has been a voluntary phase-out agreement for PFOS since 2000. Australia has issued four alerts concerning PFOS through its National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The alerts issued are recommendations that contain information and advice on the use and handling of PFOS and perfluorinated chemicals.

The first alert called for the phase-out of
water, oil, soil and grease repellent products containing PFOS by September 2002. As well, the use of PFOS for leather products was to be phased out by March 2003.

A report was published in 2009 on the status of PFOS and PFAS in Australia. It showed that imports of PFOS had ceased for surface treatment applications (carpet, leather floor, etc), printing, industrial coatings and curatives. Imports continued in the areas of aviation, photolithography, photography and metal plating. There were no imports but stocks were still present in the area of fire fighting foam. This report reflected data for the years 2006 and 2007.
2000
 
The second, third and fourth alerts, published in April 2003, February 2007 and December 2008, recommended that
  • PFOS (and related perfluoroalkyl sulfonate-based chemicals) be used only for essential uses for which there are no suitable and less hazardous alternatives are available;
  • existing stocks of PFOS-based AFFF not be used for training purposes;
  • PFOS not be replaced by perfluorooctanoic acid (PFOA) as an alternative, as PFOA may have the same environmental and health concerns as PFOS;
  • Importers should ensure that the alternative chemicals used are less toxic and not persistent in the environment.
  • Stocks be disposed off responsibly on expiry. For disposal options contact the relevant State and Territory environment authorities.
  • All labels and MSDSs include details of the PFOS and PFAS chemicals in the product.
  • Information on the safe use and handling of all these chemicals of concern be provided in the relevant and most recent MSDSs available from the suppliers of these chemicals.
  • Importers of these chemicals should remain vigilant of the ongoing international regulatory activities related to PFOS /PFAS compounds.
April 2003

Feb 2007

Dec 2008


Annex References

Department of Health and Ageing, Australian Government. 2012. NICNASAlerts.

European Parliament and Council of the European Union. 2010. COMMISSION REGULATION ((EU) No 757/2010 of 24 August 2010 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annexes I and III, European Commission.

Stockholm Convention. 2008. The new POPs under the Stockholm Convention.

United Nations Economic Commission for Europe. 2009. The 1998 Aarhus Protocol on Persistent Organic Pollutants (POPs).

United States Environmental Protection Agency (US EPA). 2012. Regulatory Action on PFAS/LCPFAC Compounds.

US EPA. 2012. Significant New Use Rule for adding seven perfluoroalkyl sulfonate (PFAS) chemicals to the existing PFAS SNUR (40 CFR 721.9582), and amend that SNUR to include "processing" in the definition of significant new use for PFAS chemicals.


1. PFOS has been used as an anti-erosion additive in aviation hydraulic fluids including those used in larger aircraft, both military and commercial

2. PFOS is a process chemical used in photolithography applications in semi-conductor manufacturing. Specifically PFOS is used in either photoresists or antireflective coatings in these processes.

3. PFOS can be contained in coatings applied to photographic films, papers and printing plates. PFOS-related substances provide antistatic, surfactant, friction control, and dirt repellant qualities.