Summary of public comments received on the draft screening assessment and risk management scope for the ketones group
Comments on the Draft Screening Assessment and Risk Management Scope for the Ketones Group, assessed under the Chemicals Management Plan (CMP), were submitted by: American Chemistry Council, ArcelorMittal Dofasco, BASF Canada Inc., Canadian Consumer Specialty Products Association, Canadian Network for Human Health and the Environment, Canadian Paints and Coatings Association, Canadian Vehicle Manufacturers’ Association, Electronics Product Stewardship Canada, IBM Bromont, S.C. Johnson and Son Limited, and Wacker Chemical Corporation.
Summarized public comments and responses from the Government of Canada are provided below, organized by topic.
Overarching comments
Comment Summary 1: The opportunity to provide comments on the draft assessment and risk management scope for the Ketones Group is appreciated. These documents provide a lot of information, including insights about the tools and information sources used.
Stakeholders are offering assistance if additional information is required to inform the risk assessment or risk management.
Response 1: The Government of Canada is committed to consulting with all affected stakeholders and the public.
Comment Summary 2: Precautionary approaches not taken.
Response 2: Assessments conducted under the Canadian Environmental Protection Act, 1999 (CEPA) are based on the best available data.
Information gathering encompasses a wide variety of published and unpublished sources. Conclusions from the assessments reflect a weight of evidence and a precautionary approach. For example, the most susceptible populations (such as children) or receptors (such as early life stages of fish) as well as critical effects (such as mortality, reproductive impairment, endocrine effects, and carcinogenicity) are identified and evaluated. Moreover, conservative approaches are taken in exposure characterization including exposure scenarios for vulnerable populations. Together, these approaches are used to inform decisions about the adequacy of the achieved margins of exposure. While the database for the ketones substances was considered generally data-rich, in some cases, read-across to structurally related analogue substances was used to fill data gaps.
Additionally, all substances that have undergone assessment remain subject to future activity if new information indicates that further consideration is warranted.
Comment Summary 3: Assessing chemicals individually misses the additive and/or synergistic effects of mixtures and real-life exposures. For example, diacetyl, 2,3-pentanedione (2,3-PD) and acetoin may co-exist in consumer products such as cigarettes, e-cigarettes and microwave popcorn.
Response 3: Consideration of cumulative, synergistic and antagonistic effects is not precluded from an assessment. However, sufficient information to undertake such analyses was not available. Nonetheless, a conservative approach, with considerations of sufficient margins of exposure, was used.
Comment Summary 4: There is concern over the potential presence of ketones in vaping products and that the assessment of risk from the use of these products will be addressed through a separate legislative and regulatory framework.
Response 4: The separate legislative and regulatory framework for vaping products that is being referred to is the new framework enabled by An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts that received Royal Assent on May 23, 2018.
Health Canada has been working actively towards establishing a number of regulations under this new framework to address public health concerns, and health and safety risks associated with vaping products. The Vaping Products Reporting Regulations, the Vaping Products Labelling and Packaging Regulations and the Vaping Products Promotion Regulations are examples of regulations developed under this framework to set out specific requirements for vaping products.
More work is underway to assess the need for future regulatory measures for vaping products in the Canadian market. Human health risk information from CMP assessments of chemicals such as diacetyl, 2,3-PD and acetoin will be used to identify appropriate actions where applicable under this framework. In the meantime, Health Canada has prepared information for consumers to inform them of the risks of vaping and for the vaping industry to inform them of mandatory requirements as well as important considerations when manufacturing, importing, advertising or selling vaping products in Canada that are not marketed for a therapeutic use, in addition to other information.
Comment Summary 5: The draft assessment ignores risks to workers, in particular those using consumer products in occupational settings, such as in nail salons.
Response 5: Assessments conducted under CEPA focus on risks of exposure of the general population, including populations who may be disproportionately impacted. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and/or technical expertise of the CMP and Health Canada's Workplace Hazardous Products Program.
Comment Summary 6: A gender lens is missing from the assessment, and is needed.
Response 6: The assessments are based on consideration of the available data, including reproductive and developmental studies, and include various conservative exposure scenarios that account for both the general population and for subpopulations who may be more susceptible or highly exposed in Canada. If information is available that suggests a specific subpopulation would be particularly vulnerable, it will be considered in the assessment.
During the review of the available toxicological information, including reproductive and developmental studies, no data were identified that suggested that sex differences are associated with increased biological susceptibility for effects considered relevant to the assessment.
Comment Summary 7: Consideration should be given to the recent paper "Retire statistical significance" (Amrhein et al. 2019) and how it could inform assessments, such as the assessment of the Ketones Group.
Response 7: Noted.
References: Amrhein, V., Greenland, S. & McShane, B. (2019) "Retire statistical significance", Nature, 567: 305 - 307.
Sources and uses
Comment Summary 8: Additional product use and concentration information was provided for various substances in the Ketones Group.
Response 8: Additional use and concentration information submitted was considered and non-confidential information was incorporated, as appropriate, into the assessment.
Exposure assessment
Comment Summary 9: As models may overestimate exposures for certain end uses, the Government of Canada should consider measured data to ensure a listing proposal is based on the most reliable available exposure information.
Response 9: When available, measured data is considered in the assessment. Measured data from the literature relevant to consumer exposures from use of products were not identified nor were any measured data provided by stakeholders.
Comment Summary 10: The reliability and comprehensiveness of the CEPA section 71 surveys are questionable, likely leading to serious underestimation about the chemicals' use and presence in Canada.
Response 10: The Government collects information through a variety of sources and mechanisms. In addition to the data collected under the section 71 surveys, the assessments use the available scientific data from a wide range of other sources including published literature in scientific journals, other international reviews, monitoring data, information from Health Canada partners (for example, Natural Health Products Ingredients Database, Licensed Natural Health Products Database), and from exposure databases.
Comment Summary 11: Health Canada's "SDS Search Tool [in house database]" is referenced in the assessment without explaining what is in it or how it is used. The difference between the search tool and the database maintained by the Canadian Centre for Occupational Health and Safety (CCOHS) is unclear.
Response 11: The “SDS Search Tool” is an automated search of safety data sheets from a variety of publicly available online retailor websites to support risk assessment initiatives. The database compiled and maintained by CCOHS contains safety data sheets that are obtained directly from the manufacturer. The focus of the CCOHS is mainly for industrial use of chemicals and chemical products whereas the SDS Search Tool focuses on products that are available to consumers. The references have been updated and clarified in the assessment (that is, the reference to the in house SDS Search Tool has been replaced with publicly available sources).
Comment Summary 12: A stakeholder had issues replicating one of the exposure scenarios using the available parameters in the appendix of the assessment.
Response 12: The appendix contained an error which was corrected.
Comment Summary 13: A stakeholder requests that Health Canada consider using more well-validated models from the United States (US) Environmental Protection Agency (EPA) such as the Wall Paint Exposure Model (WPEM), Exposure and Fate Assessment Screening Tool (E-FAST) or Consumer Exposure Model (CEM) for their evaluation of painting scenarios.
Response 13: All models have limitations. Uncertainties in the use of models are recognized.
The WPEM was not applicable to any of the scenarios in the assessment (that is, no interior wall paint scenarios).
The CEM, which includes CEM within the E-FAST program, was also considered. The results from CEM, using a range of default parameters in the model, were within the range of values derived from ConsExpo. As a result, only the modelled results using ConsExpo are presented in the assessment.
Human health assessment
Comment Summary 14: For MIBK, risk assessors should consider the extensive and scientifically relevant literature on the lack of human relevance in MIBK-mediated tumors in rats and mice.
Response 14: For MIBK, the relevance of cancer-based effects to humans was carefully considered and included reviewing toxicological literature and examining mechanistic information as well as conclusions made by various international jurisdictions. While the overall weight of evidence supports that liver tumours in mice arising from activation of the constitutive androstane receptor (CAR) are not relevant to humans, a mechanism other than that involving α2u-globulin may be responsible for the renal tumours in rats. Additionally, the available mechanistic data was considered insufficient to reliably characterize the modes of action of MIBK-mediated carcinogenesis. These conclusions are supported by the reviews by the International Agency for Research on Cancer (IARC), National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and European Chemicals Agency (ECHA). Taken together, the available data was considered insufficient to consider the observed kidney tumours in rats as being not biologically relevant to humans and was considered as a critical effect in the risk characterization of chronic inhalation exposures.
Comment Summary 15: The stakeholders disagreed with the use of misaligned sternabrae as a point of departure in the risk characterization of MEK.
While it may be considered “health protective” to use the finding that produces the lowest benchmark dose (as was rationalized previously by the US EPA in 2003 during the development of the Reference Concentration (RfC) for MEK), sound scientific judgment concerning its biological significance should not be set aside simply because one number is lower than another. In this case, the submitters highlighted that the anomalous skeletal variation was not common in other studies and no dose-response relationship was observed. Instead, the stakeholders propose using decreased fetal birth weight as a more scientifically sound effect.
Response 15: In the range of adverse effects observed in animals resulting from repeated inhalation exposure to MEK, there is consistent evidence from studies in rats and mice that developmental effects represent the most sensitive health effects, which occurred mostly in the presence of slight maternal toxicity. The relevance of misaligned sternebrae was carefully examined and was considered alongside the observation of other skeletal variations and defects occurring across doses and studies. Using a weight of evidence and precautionary approach, this effect was considered to represent a health protective point of departure for developmental effects, including decreased fetal weight, and was therefore maintained in the assessment as the critical effect for acute exposures by inhalation.
Comment Summary 16: Additional hazard studies and hazard summaries were submitted for all of the substances in the Ketones Group.
Response 16: Additional information submitted was considered; however, it did not result in any changes to the assessment conclusion.
Comment Summary 17: Methyl isoamyl ketone (MIAK) is "suspected of damaging the unborn child" and is classified and labelled as Repro Cat. 2 by the ECHA. Given such serious effects, the action taken by the ECHA and the uncertainties about the other outcomes, the hazards of this ketone should not be ignored.
Response 17: For the MIAK hazard characterization, the available studies describing effects after acute and repeated exposures were carefully considered including the studies investigating potential reproductive and developmental toxicity of MIAK.
Based on the available toxicological data, MIAK is associated with developmental toxicity, but not adverse reproductive effects. MIAK is currently not classified as Repro. 2 by the ECHA, but rather a notifier has classified it as such. Additionally, this proposed classification as Repro. 2 is based on results of the potential for developmental toxicity and not due to reproductive toxicity.
For risk characterization, the most relevant and sensitive effect was considered to be decreased fetal weight observed in pups exposed to MIAK in utero. This endpoint was used in the characterization of risk from exposure to MIAK, was considered a sensitive marker of developmental toxicity and was considered to be protective of other adverse effects observed at higher concentrations.
When predicted human exposure concentrations were compared to levels at which this effect could occur, the potential risk to human health was low.
Comment Summary 18: Endocrine disruption was not considered, although MEK is suspected of having endocrine effects according to ECHA materials.
Response 18: In conducting a risk assessment, the potential effects of the substance on humans and the environment are evaluated (hazard characterization). The most susceptible subpopulations (such as children) or receptors (such as early life stages of fish) as well as critical effects (such as mortality, reproductive impairment, and carcinogenicity) are identified. Information on endocrine-related effects is also considered, when available and relevant.
For the ketone substances assessed, no relevant data (including data from the ECHA databases) suggesting the potential for endocrine disruption was identified.
For more information, please refer to the RA Series Fact sheet: Consideration of endocrine-related effects in risk assessment.
All substances that have undergone assessment remain subject to future activity if new information is identified that indicates further consideration is warranted.
Ecological assessment
Comment Summary 19: 2,4-pentanedione (2,4-PD) should not be regarded as persistent in air.
Response 19: Additional persistence information submitted was considered and incorporated into the assessment.
Conclusion
Comment Summary 20: Stakeholder disagrees with the assessment conclusion for diacetyl and 2,3-PD given their presence in consumer products, hazard properties and potential occupational exposure.
The stakeholder also disagrees with the assessment conclusion for MIAK and with the proposed human health conclusion for diacetyl.
Response 20: Conclusions from the assessments reflect a weight of evidence. This approach weighs various sources of information to identify critical values used in the assessment. It evaluates multiple lines of evidence to determine if a substance may pose a risk to human health or to the environment. When predicted human exposure concentrations were compared to levels at which this effect could occur, the potential risk to human health was low for MIAK, diacetyl, and 2,3-PD.
Risk management
Comment Summary 21: MEK has many applications in internal electronic information technology (IT) components (for example, converters, power supplies). The stakeholder requests that any risk management exempts the semiconductor manufacturing sector as exposure to MEK from these internal components is expected to be limited and Canada’s robust e-recycling program can ensure safe disposal of these components.
Response 21: Electronic components are not identified as an exposure source of concern for MEK in the assessment. No risk management is being proposed for electronic components. The proposed risk management is focused on addressing health concerns posed by MEK in certain products available to consumers including paint or coating removers or strippers (for example, lacquer removers), adhesive removers, degreasers, paint or coating thinners, liquid paints, and spray products (for example, spray paints).
Comment Summary 22: Should the assessment retain the proposed conclusion that MEK, MIBK and 2,4-PD meet section 64(c) of CEPA, one stakeholder association wishes to engage with Environment and Climate Change Canada and Health Canada as aftermarket vehicle products have been identified that contain these substances. Risk management activities should focus on indoor use of do-it-yourself (DIY) products and avoid unique-to-Canada labelling requirements.
Response 22: Comments received on the Risk Management Approach document will be taken into consideration in the selection of the risk management instrument(s). Consultation with stakeholders will also take place as instrument(s) are developed.
Comment Summary 23: The North American Master Painters Institute (MPI) standards are increasingly being used for the certification of architectural, industrial maintenance and consumer paint products sold in Canada. MPI does not assess products with respect to Canadian regulations and is reliant upon manufacturers to disclose ingredient information. It is expected that the number of products adhering to the MPI standards, which prohibit the use of MEK and MIBK, will increase and this will act as a driver to reduce the use of MIBK and MEK regardless of Canadian risk management actions taken.
Response 23: Noted. Input regarding usage trends of MIBK and MEK in paint products is welcomed.
Comment Summary 24: The proposed VOC Concentration Limits for Certain Products Regulations will impose total VOC content limits in paint thinners and multipurpose solvents as well as in paint removers/strippers in DIY products. Reducing MEK and MIBK concentrations in consumer products while adhering to the proposed total VOC limits and maintaining or improving product performance in a cost-effective manner presents technical challenges for Coatings, Adhesives, Sealants and Elastomers (CASE) manufacturers in finding appropriate formulations. This could result in a loss of competitiveness for Canadian products.
Response 24: Stakeholders are encouraged to provide input with respect to technical considerations following publication of the Risk Management Approach document, which will be taken into consideration in the selection and development of the risk management instrument(s). Consultation with stakeholders will also take place as instrument(s) are developed.
Comment Summary 25: The development of paint and coating products without MEK will present significant technical challenges and the development of suitable alternative formulations will require significant effort and research by manufacturers. The question of alternatives to MEK needs special consideration and should be examined with expert CASE formulators.
Response 25: Consultation with stakeholders will take place as instrument(s) are developed and feasibility of alternatives is considered as part of the risk management process.
Comment Summary 26: There are no specific use restrictions existing for the concentration of MEK and MIBK in consumer products in the US, other than general or state-specific rules and control technical guidelines. It is anticipated that misalignment between policies in the US and Canada could cause trade disruptions and introduce a competitive disadvantage for Canadian companies, as well as stock management difficulties for products intended for markets with differing formulation requirements. Substitution of ingredients in formulations is a very complex process for manufacturers.
Response 26:certain products available to consumers including paint or coating removers or strippers (for example, lacquer removers), adhesive removers, degreasers, paint or coating thinners, liquid paints, spray products (for example, spray paints) and wood lacquers
Comment Summary 27: Environment and Climate Change Canada and Health Canada are encouraged to carry out a survey regarding the actual content of MEK, MIBK and 2,4-PD in consumer CASE and DIY products and also investigate the availability of viable alternatives to these substances. In addition, the cost impact of the remaining reformulation of products still containing MEK and MIBK should be further analyzed.
It is also important to remain aligned with the US regarding the use of MEK and MIBK in targeted consumer paint and DIY products.
Response 27: The Government of Canada is committed to engaging with stakeholders throughout the risk assessment and risk management process for the Ketones Group. Information provided by stakeholders is welcomed as part of this engagement.
Socio-economic factors and availability of alternatives, which may include consideration of cost-benefit analysis, are considered as part of the risk management process.
Comment Summary 28: One stakeholder association recommends: If thresholds for MEK and MIBK are to be established, the government should consider targeting MEK reductions to 10% w/w for aerosol paints. Any specific threshold to be imposed for CASE and all targeted DIY products should carefully consider the impact of the pending VOC content limit regulations prior to determining a threshold or limit for MEK, MIBK and 2,4-PD. To the extent possible, any imposed reductions in MEK and MIBK content should focus on indoor use of all paint products targeted, including spray paint. Sufficient transition time must be provided for paint manufacturers to achieve any MEK or MIBK reductions. A Code of Practice rather than Significant New Activity (SNAc) requirements should be considered to achieve the risk management objectives for ketones.
Response 28: Noted. The Government of Canada is committed to engaging with stakeholders throughout all regulatory development, including the risk assessment and risk management process for the Ketones Group. Stakeholders are encouraged to provide input with respect to technical considerations during all consultations. The proposed risk management for ketones is intended to address the specific health risks identified in the assessment. Where relevant, transition time will be considered as part of the development of the risk management instrument. As outlined in the Risk Management Approach for MEK and MIBK, to achieve the proposed risk management objective and to work towards achieving the proposed human health objective, the Government of Canada is considering developing regulations under CEPA to help reduce consumer inhalation exposure to MEK and MIBK from certain products available to consumers including paint or coating removers or strippers (for example, lacquer removers), adhesive removers, degreasers, paint or coating thinners, liquid paints, spray products (for example, spray paints) and wood lacquers.
Comment Summary 29: The Risk Management Scope ignores the possibility of options and potential benefits for products other than solvent-based paints and coatings.The proposed risk management options are inadequate.
Response 29: Noted. The Risk Management Approach for MEK and MIBK notes that there are several alternatives and alternative technologies to solvent-based paints and coatings available.
Comment Summary 30: The risk management options should introduce informed substitution as a goal and recognize occupational exposure to ketones. MEK, MIBK and methyl n-butylketone are substances of concern in other jurisdictions.
Setting concentration limits could be a good first step, but labelling is not sufficient, particularly for DIY users. Detailed usage instructions, including personal protective equipment requirements, should be included with products.
Response 30: The Government is exploring ways to advance responsible replacement of chemicals of concern, including ways to apply informed substitution to support chemicals management. Assessments focus on risks of exposure to the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System.
Paint, stain and coating products available to consumers must meet the labelling and packaging requirements set out in the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), made under the Canada Consumer Product Safety Act (CCPSA). Specifically, they must display labelling in both official languages in the form of hazard symbols, warning statements, instructions and a first-aid statement including a list of hazardous ingredients. Child-resistant packaging is required for products classified as "toxic". The requirements set out in the CCCR, 2001 are minimum requirements, and manufacturers and importers are encouraged to add any further information they consider necessary.
Comment Summary 31: Socio-economic analysis of chemical management actions by the ECHA has been criticized as one-dimensional, focused on benefits to the chemical manufacturer and not transparent. In particular, one point regarding the ECHA process for socio-economic analysis review that is relevant to the CMP is: The way ECHA opinions are formed today do not provide policymakers with accurate information regarding uncertainties in the assessment of the application for authorisation, and hence do not give policymakers all relevant information. So far, [the Committee for Socio-economic Analysis] has concluded for almost all applications for authorisation received that the benefits outweigh the risks and that no alternatives were available -- even when an alternative was available, when the benefits are questionable, and when the risks are clear.
Response 31: Socio-economic factors and availability of alternatives, which may include consideration of cost-benefit analysis, are considered as part of the risk management process.
Comment Summary 32: There are many reasons to protect the health of consumers and workers by taking a precautionary approach to the regulation of ketones. All ketones should be managed, especially those used in flavourings.
Response 32: The proposed risk management for ketones is focused on addressing the specific health concerns identified in the assessment; exposure to food flavouring agents were not identified as a concern for human health. Assessments focus on risks of exposure to the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System.
Comment Summary 33: Specific to spray paint, some stakeholders could accept a 5%-10% MEK concentration limit. MIBK is being used much less frequently than MEK in consumer aerosol paint products and some DIY products.
Response 33: Noted.
Comment Summary 34: One stakeholder association has gathered some information on reformulation costs for consumer spray paints to reduce MEK concentration. To achieve a 1%-2% MEK reduction, reformulation costs could be as high as $1.20/unit.
Response 34: Noted.
Comment Summary 35: Some stakeholders have confirmed using the normal ventilation statements in labelling on aerosol and liquid paint products, such as: ‘’Use in a well ventilated area”, “Use only in a well ventilated area” or ‘’Do not breath fumes’’.
Response 35: Noted.
Comment Summary 36: Preventive action for diacetyl and 2,3-PD should not be delayed due to economic interests, data gaps or due to their natural presence.
Response 36: The Government of Canada is not proposing risk management on diacetyl and 2,3-PD at this time as the assessment has concluded that they do not meet any of the criteria set out in section 64 of CEPA.