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Response to Comments
Risk Management Strategy for Perfluorooctane Sulfonate (PFOS), its Salts and its Precursors
As part of the ongoing consultations with stakeholders on risk management actions for perfluorooctane sulfonate (PFOS), its salts and its precursors, Environment Canada has collected and assessed comments on the proposed Risk Management Strategy that was published on Environment Canada's Website and distributed to affected stakeholders on July 1, 2006. The proposed Risk Management Strategy and comments received provided the framework for the proposed Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations. The proposed Regulations were published in Part I of the Canada Gazette, on December 16, 2006.
This document has been prepared to present the comments and issues raised by stakeholders on the proposed Risk Management Strategy with Environment Canada's responses. All comments have been noted and considered, however they may not be reported verbatim as similar comments have been combined and paraphrased for brevity.
Comment #1: The proposed 5-year phase-out period for PFOS-based aqueous film forming foams (AFFFs) is too short. Additional time is required to phase-out existing stocks
Five years is considered to be an appropriate time period to phase-out existing PFOS-based AFFF stocks. Replacement products to PFOS-based AFFF are readily available and are comparable in cost and effectiveness. With the proposed 5 year exemption effective upon the coming into force of the Regulations, users will have until 2012 to complete the orderly phase-out and disposal of their existing stocks.
Comment #2: The proposed 5 year phase-out period for PFOS-based AFFFs is too long. A shorter phase-out period should be considered to reduce PFOSexposure.
A 5 year phase-out period is considered appropriate to allow facilities to replace PFOS-based AFFF with alternative fire fighting foam and to dispose of the surplus PFOS-based stocks. The Regulations will prohibit the use of PFOS-based AFFF for testing and training purposes which will address an important source of PFOS releases immediately.
Comment #3: Separate phase-out dates should be considered for concentrate and ready mix PFOS-based AFFFstocks.
Five years is considered to be an appropriate time period to phase-out both concentrate and ready mix stocks of PFOS-based AFFF. Furthermore, a single phase-out period provides users with the most operational flexibility to manage the phase-out of all existing stocks.
Comment #4: Provide support on best management practices for the storage and destruction of PFOS-based AFFF stocks, and provide financial assistance for the disposal of AFFF.
The disposal of AFFF is already well managed under existing federal and provincial hazardous waste regulations. The operational use of AFFF is also well defined by existing federal, provincial/territorial and municipal standards and protocols dealing with fire response and prevention. The disposal costs for AFFF stocks are similar to other hazardous waste material. The costs to be incurred by facilities to dispose of surplus PFOS-based AFFF stocks were taken into consideration in the cost-benefit analysis that supports the proposed Regulations. As such, additional guidance on best management practices or financial assistance are not considered necessary to support the proposed Regulations.
Comment #5: The testing of fire suppression systems with PFOS-based AFFF should be permitted.
Approved AFFF testing systems that eliminate the need to discharge PFOS during testing are available in the marketplace at a reasonable cost in relation to the costs of testing with PFOS-based AFFF.
The testing of fire suppression systems with PFOS-based AFFF may result in the repeated, direct discharge to surface water, groundwater and land. Furthermore, depending on the nature of the activity, it is not always possible to collect and pre-treat or contain the AFFF residual for proper disposal. Given the availability of alternative testing methods and the potential environmental risks with the testing of PFOS-based AFFFequipment, the proposed restriction on testing is considered appropriate.
Comment #6: The proposed regulatory approach should not provide an exemption for articles imported into Canada.
Following further consideration, Environment Canada is proposing to include a prohibition on the import of manufactured items that contain PFOS into Canada. Manufactured items include such things as rugs and carpets, furniture, fabrics, leather articles as well as paper and packaging products.
Despite the decline in global PFOS production and the current low level of PFOS imports, the potential exists for PFOS containing manufactured items to be imported into Canada as some PFOS production has been identified in other countries. Alternatives to PFOS have been developed for all applications apart from a limited number of exemptions that have been identified. Since alternatives to PFOS are readily available to global manufacturers of these items, Environment Canada considers a prohibition on the import of manufactured items containing PFOSappropriate.
Comment #7: The exemption proposed for the import of articles containing PFOS is appropriate since no action is warranted at this time.
As noted in comment #6, Environment Canada has revised the approach for manufactured items following input received on the risk management strategy and further consideration on the issue.
Comment #8: Any future exemptions to the regulatory prohibitions should be identified based on specific criteria and the exempted uses should be subject to reporting requirements and a quick phase-out schedule.
The exemptions provided in the proposed Regulations are as follows:
- the use of existing stocks of PFOS-based AFFF, other than for testing or training, for a period of 5 years;
- the import, manufacture, sale, offer for sale and use of PFOS based surfactants in the metal plating sector for a period of 5 years;
- the use, sale or offer for sale of manufactured items containing PFOS that were manufactured or imported before the coming into force of the Regulations; and
- the use, sale, offer for sale or import of semiconductor devices and photographic materials that contain PFOS.
The exemptions to the proposed Regulations are limited to these activities and the availability of other future exemptions are not provided for in the proposed Regulations. These proposed exemptions are similar to existing or proposed exemptions in other jurisdictions.
The exemptions provided for the PFOS-based AFFF stocks and the metal plating sector are subject to a 5 year phase-out period. This phase-out period is necessary for industry to deal with remaining stocks of PFOS-based AFFF and for the metal plating sector to develop alternative products. In addition, importers of PFOS for the exempted use as a fume suppressant will be subject to annual reporting requirements such that Environment Canada can monitor the use of PFOS during the 5 year exemption period.
The exemption for manufactured items imported or manufactured before the Regulations come into force allows for the continued use and sale of legacy items. In addition, exemptions for the import of semiconductor devices and photographic materials that contain PFOS are proposed given that exemptions for the use of PFOS in the process to manufacture these articles has been granted in other jurisdictions, including the United Sates and the European Union, and given that alternatives to PFOS for these uses are currently not available. These items are not manufactured in Canada however they are imported into Canada.
Comment #9: PFOS releases from landfills and from waste water treatment facilities should be addressed.
The proposed regulations address the source of PFOS in Canada; that is, the manufacture, import, sale and use. The prohibition of PFOS at the source will ultimately result in the reduction of releases at landfills and sewage treatment plants in Canada.
Comment #10: All perfluorinated substances, including all PFOS substances that have been identified internationally, should be managed as part of this initiative.
The proposed Regulations apply to a group of substances consisting of the PFOS anion, the PFOSHacid (PFOSH), the PFOS salts (PFOS potassium salt, PFOS ammonium salt, PFOSlithium salt and PFOS diethanol-amine salt) as well as any compound that contains one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N. A list of some compounds considered to be part of the group of substances targeted by the proposed Regulations was provided in an appendix to the proposed Risk Management Strategy for guidance purposes only. This list is not considered exhaustive as there may be other compounds that are also PFOS precursors not appearing on this list that would be subject to the proposed Regulations. An updated non-exhaustive list of PFOS substances will be provided as part of compliance promotion materials to support the final Regulations.
Environment Canada is also taking action on other perfluorinated substances as described in a recently published Action Plan on Perfluorocarboxylic Acids and their Precursors. Risk management action on other perfluorinated substances may be undertaken within the normal CEPA 1999 process if these substances are deemed to meet the criteria specified in Section 64 of CEPA 1999 or through other approaches, as appropriate.
Comment #11: Substances that are subject to the proposed Regulations must be clearly defined. Chemical Abstract Service (CAS) Numbers should be provided when possible.
The proposed Regulations apply to all substances meeting the criteria specified in Schedule 1 of CEPA 1999, List of Toxic Substances, for this group of substances (PFOS and its salts, and certain other compounds that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N).
As noted in the response to Comment #10, in order to provide guidance to stakeholders, Environment Canada will provide a list of compounds, with associated CAS number if available, considered to be part of the group of substances targeted by the proposed Regulations. However, this list will be non-exhaustive and does not preclude substances with CAS numbers not appearing on this list.
Comment #12: A criteria should be developed to identify safe alternatives to PFOS.
Alternatives to PFOS have already been developed for the majority of uses as a result of the phase-out in production by the major manufacturer between 2000 and 2002. Significant global effort is already being put into the development of alternatives for the limited number of applications where alternatives to PFOS have yet to be identified.
Alternatives to PFOS substances that are not already on the Domestic Substances List are subject to the New Substances Notification Regulations under CEPA 1999. These Regulations were created to ensure that no new substances were introduced into the Canadian marketplace before an assessment of whether they are potentially toxic has been completed and any appropriate or required control measures have been taken. Substances already on the Domestic Substances List have undergone categorization and work has begun on the assessment and/or management of those substances deemed to have greatest potential for human health and/or environmental effects.
Comment #13: The impact of international actions on PFOS on Canada's domestic initiatives should be taken into consideration.
The proposed Regulations are consistent with actions taken internationally and support global efforts to effectively manage and eventually phase-out worldwide PFOS uses.
Comment #14: All users of PFOS should complete pollution prevention plans outlining their plans and progress on phasing out the use of these substances.
The proposed Regulations address the remaining users of PFOS in Canada by providing a fixed 5 year phase-out schedule. In addition, the only permitted import of PFOS, for its use as a fume suppressant, will be subject to annual reporting requirements such that Environment Canada can monitor the import of PFOS during the 5 year exempted period.
Comment #15: There should be mandatory labelling for imported products containing PFOS.
The proposed Regulations will prohibit the import of products and manufactured items containing PFOS. As such, a labelling requirement is not required.
Comment #16: Thresholds for the Persistence and Bioaccumulation Regulations must be respected or clear and compelling evidence must be provided to show why the weight of evidence approach is used with respect to bioaccumulation.
While there is scientific evidence that PFOS accumulates in animals and magnifies in food chains, PFOS, its salts and its precursors do not meet the numeric criteria for bioaccumulation as defined in the Persistence and Bioaccumulation Regulationsunder CEPA 1999 and does not meet the conditions set out under subsection 77(4) of CEPA 1999 for mandatory addition to the Virtual Elimination List.
Comment #17: Provide the technical and economic information that was used as the basis for actions to achieve lowest level of releases.
The ultimate objective of Environment Canada's actions to achieve the lowest level of releases of PFOS in Canada was based on the conclusions of the ecological screening assessment report. The assessment concluded that PFOS substances are entering into 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 assessment also concluded that PFOS and its salts are persistent and a potential risk may occur through bioaccumulation and biomagnification of PFOS in wildlife. Furthermore, it was found that PFOS is present in the environment primarily as a result of human activity and has been detected in wildlife worldwide. In Canada, PFOS has been detected in species such as fish, fish-eating birds, and Arctic marine mammals far from known sources or manufacturing facilities.
Technical and economic information supporting the actions identified in the proposed Regulations is included in the Regulatory Impact Analysis Statement that accompanies the Regulations.
Comment #18: Explain why the Prohibition of Toxic Substances Regulations, 2005 was chosen as the preferred regulatory instrument.
After a detailed analysis of the regulatory instruments available to manage PFOS, it was concluded that Regulations were the most appropriate instrument. Information supporting the instrument choice for PFOS is included in the Regulatory Impact Analysis Statement that accompanies the proposed Regulations
It should be noted that following a review of the individual components of the Prohibition of Toxic Substances Regulations, 2005, Environment Canada decided that separate Regulations for PFOS were more appropriate to achieve the desired risk management objective.
Comment #19: Action on PFOS should be aligned with regulatory requirements with other jurisdictions when it makes sense to do so.
The proposed Regulations on PFOS are consistent with actions taken in other jurisdictions.
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