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Summary of public comments received on the draft screening assessment and risk management scope for benzophenone

Comments on the draft screening assessment (dSAR) and risk management scope for benzophenone assessed under the Chemicals Management Plan (CMP), were submitted by: 3M Company; Canadian Paint and Coatings Association (CPCA); Canadian Consumer Specialty Products Association (CCSPA); Dow Chemical Canada ULC; S.C. Johnson and Son, Limited; Saint John Citizens Coalition for Clean Air; and, a private citizen. 

Summarized public comments and responses from the are provided below, organized by topic.

Methodology

Summarized comment Summarized response
There was concern about how long the Government has known about the potential of the substance to cause harm to the public, especially vulnerable populations. Benzophenone was identified as a priority for assessment in 2006 along with 4300 other substances. Benzophenone was scheduled for assessment in CMP3 (2015-2020). The assessment takes into consideration the most sensitive life stages when assessing risk; specifically, the screening assessment for human health considers the available data and includes various conservative exposure scenarios that account for both the general population and for vulnerable populations in Canada. If information is available, that suggests a specific sub-population or age group would be particularly vulnerable, it will be considered in the assessment.
The screening assessment should clarify the difference between a screening assessment of risk and a formal or definitive risk assessment. The report does not follow the prescribed process for formal or definitive risk assessment, and therefore does not provide the level of detail described in the Federal Contaminated Sites Action Plan Ecological Risk Assessment Guidance. Substance screening assessments under CEPA are not site-specific evaluations; rather, they are based on available information that represents a range of potential exposure scenarios in Canada. While CEPA uses the term screening assessment, these are full regulatory assessments. For additional information please see the Risk assessment of chemical substances.
The draft screening assessment for benzophenone is detailed and well-documented with recent references. Noted.
The conclusion is fully supported by the preceding characterization of ecological risk and is fully justified with the current state of our knowledge. Noted.
No significant deficiencies or omissions were identified in the very comprehensive and thorough risk management document. An important part of the risk management scope is the identification of a number of information gaps and invitation for stakeholders to provide additional information.  Noted.

New information and data

Summarized comment Summarized response
Information was provided by stakeholders regarding the use activities and exposure scenarios for benzophenone. Information provided by stakeholders supports the exposure information considered in the screening assessment.
A stakeholder has identified a study with new exposure data related to preservative use in paints and has suggested updating exposure models for paint application based on the new data. The study identified was conducted to provide updated exposure parameters for assessing dermal and inhalation exposures following use of an antimicrobial treated paint product applied with a brush or a roller. According to the United States Environmental Protection Agency’s review of the study (2019), the data generated is meant for evaluating antimicrobials with vapour pressures less than ~1E-4 mmHg at 20ºC). Benzophenone is not an antimicrobial and has a vapour pressure of 2E-3 mmHg (at 25°C). Therefore, the exposure estimates for paint scenarios modeled using ConsExpo were retained in the final screening assessment.

Sources and releases

Summarized comment Summarized response
Exposure via drinking water is a concern.  Many people wash out their paint brushes in the bath tub. This needs to be studied further. In the absence of measured Canadian data, conservative approaches are applied, such as the use of models or surrogate data to ensure all sources of exposure, including from drinking water, are considered. Estimates of exposure to benzophenone in drinking water for the general population of Canada did not result in a concern for human health.
There is a real concern, especially for children, from exposures such as migration of the substance from baby bottles and food flavouring agents. Conservative exposure estimates were derived for Canadians of all age groups and are considered to be protective of both the general and vulnerable populations, including children. In Canada, these estimates address all exposure sources including exposure from food. Food-related uses (including exposure to benzophenone from baby bottles) are not a concern to human health at current levels of exposure. This determination is supported by other international food regulatory agencies.
A stakeholder noted that benzophenone might be a derivative of benzene and asked for clarity on whether this had been considered in determining risk to humans. This should be included to further support the conclusion. Specific conditions have to be present for the production of benzophenone. Benzophenone is unlikely to be produced on its own in the atmosphere. Benzene was previously assessed and was added to Schedule 1 of CEPA, and various risk management tools are in place to control its release. More information on this can be found on Toxic substances list: benzene

Risk characterization

Summarized comment Summarized response
Although the screening assessment clearly states that the human health concerns are for “‘interior consumer paint products only’”, the risk management scope document is not explicitly focused on these types of paint products. The final risk management approach should be confined to interior paint products that may be reasonably obtained by consumers.  The final screening assessment has clarified that the risks of concern are associated with “paints and stains", which includes both interior and exterior products. As such, the risk management approach document includes both interior and exterior paint and stain products available to consumers.
The frequency of dermal exposure to benzophenone should be less for exterior paint than for indoor residential painting. In the case of the paint scenario, exposure was characterized during use of the product and frequency was not factored in.
It is recommended that Health Canada review any paint scenario and initial exposure model parameter that led to the 0.1% w/w threshold in interior consumer products. These assessments are based on all the available information and the best available exposure estimation approaches and tools, including models. The assessments are peer reviewed by third party technical experts. The exposure estimates for the paint scenario are considered refined based on the following assumptions: the duration of painting is assumed to be limited to 2 hours, and the use of a dermal absorption value was based on a study using unoccluded skin. Any additional information submitted during the consultation period was taken into consideration in the finalization of the screening assessment. The Government of Canada intends to consult with implicated stakeholders, including on the derivation of the 0.1% value.
There was concern that numerous products contain benzophenone. Have the cumulative effects and long-term exposure been taken into consideration? When sufficient information is available, consideration of cumulative, synergistic and antagonistic effects may be included in a screening assessment. The screening assessment has been updated to combine exposures for dermal and inhalation exposures for relevant scenarios. Both long-term and short-term exposures are taken into consideration in determination of risk in the screening assessment for benzophenone.

Risk management

Summarized comment Summarized response
Agreement and support for the findings of the screening assessment. Noted.
Due to health concerns identified for benzophenone, it is recommended that Health Canada be the lead department moving forward with risk management. Noted.
The findings of the screening assessment are supported; however, voluntary measures are not proportional to the findings cited by the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA). There is concern with the use of benzophenone in various products and the resulting exposures that can occur on a daily basis. The most stringent regulatory options should be implemented to ensure Canadians are protected. The assessment considered evaluations of benzophenone by other jurisdictions, including IARC and EFSA. The Government of Canada follows a risk-based approach for chemicals assessment and management. A consistent instrument selection process that includes environmental, health and socio-economic considerations is followed to select the most suitable instrument (or mix of instruments) to manage risks associated with a toxic substance. Based on this process, a voluntary measure may be selected as the most appropriate risk management tool to successfully achieve the human health objective. Additional regulatory actions may be considered at a later date, if warranted.
Proposed risk management objectives are supported. The addition of benzophenone as a restricted ingredient to Health Canada’s Cosmetic Ingredient Hotlist and implementation of regulatory actions to reduce the concentration of benzophenone in paints and coatings (including stains) are also supported. Noted. Additional product exposure scenarios, such as for stains, were included in the screening assessment and the associated risk management approach to be more comprehensive.
Not all international jurisdictions have prohibited benzophenone in products and this could present challenges when such international products are imported into Canada. These challenges should be analyzed and taken into consideration when protecting Canadian consumers. International regulatory alignment has been considered as much as possible in the development of the proposed risk management. The import of international products to Canada will be considered as part of the instrument selection process when selecting the most promising instrument (or mix of instruments) to manage risks associated with benzophenone.
It is expected that risk management instruments be proposed and the substance be added to Schedule 1 of CEPA. However, there is concern about the time frame identified for the implementation of the risk management measures, approximately 3.5 years. This could allow for another long period of exposure to products of concern such as cosmetics/nail polish, and interior paints and coatings. Following the recommendation for a substance to be added to Schedule 1, risk management measures must be proposed and implemented within the timelines described under sections 91 and 92 of CEPA. These dates allow time for appropriate instrument selection, development, consultation and implementation.   
Imposing use restrictions for benzophenone would misalign Canada with risk management actions taken by the United States. Paint products are infrequently used by consumers, and use by painters are normally done under controlled conditions, adequate ventilation, and use of proper protective equipment. International regulatory alignment has been considered in the development of the proposed risk management.
In the risk management scope, a specific measure of benzophenone concentration in paints and coatings is not identified. The risk management approach provides more clarity on the Government’s plans for managing benzophenone.
In the risk management scope, it is not clear how a limit of 0.1% (w/w) or 1,000 mg/kg in paint and coating products was derived. It is recommended that Health Canada undertake dialogue with stakeholders to explain the concentration limit. This concentration was selected as an appropriate health-protective limit based on the current exposure assumptions and data in the health effects database. The Government of Canada intends to consult with implicated stakeholders, including on the derivation of the 0.1% value.
There is support for the recommended risk management options identified in the risk management scope, with the suggestion of scientifically determining a concentration limit through a collaborative effort. Noted.
Do not impose any additional labelling requirements for indoor consumer paint products. Paint, stain, and coating products available to consumers must adhere to Canada Consumer Product Safety Act (CCPSA) labelling and packaging requirements in the Consumer Chemicals and Containers Regulations (CCCR). Additional mandatory labelling is not proposed; rather, labelling that recommends measures, such as wearing personal protective equipment or using these products in well-ventilated areas, may be included in the Code of Practice proposed in the Risk Management Approach.
Canadian interior and exterior consumer paint products containing benzophenone may not require reformulating or alternatives. Noted.

Socio-economic factors

Summarized comment Summarized response
Concern was expressed that industry may use socio-economic and technical impact information gaps to leverage risk management actions, such as voluntary measures or delay required actions. Benzophenone should be added to the Cosmetic Ingredient Hotlist and Significant New Activity (SNAc) provisions should be applied. The proposed risk management actions for benzophenone are described in the risk management approach document, which is open to a 60-day public consultation period. Comments received will be taken into consideration in the selection or development of the instrument(s).
The final screening assessment and risk management approach should ensure further validation of the use of benzophenone in interior consumer paint products. Every effort should be made to prevent any indirect impact on the entire consumer paint market as a result of the addition of benzophenone to Schedule I, such as the possibility of changes to safety data sheets. A consistent instrument selection process that includes environmental, health and socio-economic considerations is followed to select the most suitable instrument (or mix of instruments) to manage risks associated with a toxic substance. The risk management approach has identified some additional information needed in order to confirm potentially implicated products.
Health Canada is encouraged to examine the potential unintended consequences of a CEPA toxic finding and adding a substance to Schedule 1. Adding benzophenone to Schedule I without accompaniment of an explanatory note to identify specific cosmetic and paint products that are being targeted will indirectly affect a larger number of consumer and commercial products that may contain benzophenone. As part of the cost-benefit analysis of regulation, the Government assesses all the economic impacts of a chemical, including the health and environmental impacts, and the economic benefits of managing that chemical, and these are compared against the costs of regulating. For transparency, this cost-benefit analysis is published along with the regulatory impact assessment statement (RIAS) for each regulation.  Further details on this analytical process are available in the Cabinet Policy on Cost-Benefit Analysis and in Treasury Board Secretariat’s Cost-Benefit Analysis Guide. The conclusion of the screening assessment, including a summary of the scenarios and/or products identified as being of concern, is summarized in the RIAS accompanying the Order adding a substance to Schedule 1 published in the Canada Gazette.
The government should promote Sustainability and the Circular Economy while creating and implementing risk management instruments, ensuring an economical product supply while delivering improvements to the environment and human health. The Government is exploring ways to advance responsible replacement of chemicals of concern, including ways to apply informed substitution to support chemicals management.
A risk management initiative to reduce exposure in the consumer paint market can be disruptive if not adequately addressed by engaging in extensive discussion with affected stakeholders. A voluntary risk management instrument is preferred, such as a Code of Practice, given the limited use of resins containing benzophenone and the significant amount of time needed for suppliers and manufacturers to reformulate their products, or to consider any substitution available. Importers need additional time to comply throughout the supply chain and for the management of international stocks. The Government of Canada intends to consult with implicated stakeholders on risk management initiatives for this substance.

Consultation and/or stakeholder engagement

Summarized comment Summarized response
The 60-day public comment periods that overlap vacation periods in August and September do not provide enough time for public responses. There should be an opportunity to provide additional information at a later date.   The 60-day public comment period on the draft screening assessment is statutory and cannot not be extended. However, the Government encourages stakeholders to contribute to the assessment process and can consider late comments in some instances. The Government of Canada works with stakeholders before, during, and after the consultation period to gather all relevant information available. The Government of Canada is committed to consulting extensively with all affected stakeholders as part of the risk management process.
Health Canada’s risk management team should work with resin producers to identify a concentration limit for benzophenone that is acceptable and achievable to the resin producers. Resin suppliers are Responsible Care adherents, which will comply with any new requirements. Consequently, reformulated paint products will become compliant. Noted.
Stakeholders remain available for further discussion on this matter and to provide additional factual data regarding paint exposure scenarios. 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.

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