Summary of public comments received on the draft screening assessment and risk management scope for organic flame retardants (TCPP & TDCPP)

Expertise and information are offered, should they be of assistance to the assessment process.

Noted.

The Government of Canada should request dialogue with stakeholders that are likely to be affected by the risk management of TCPP and TDCPP.

Dialogue with stakeholders will continue throughout the risk management process.

Instead of responding to the information data gaps identified in the risk management scope, there should be targeted dialogue with stakeholders.

The Government of Canada is committed to consulting extensively with all affected stakeholders when developing risk management measures. New information can be submitted through several mechanisms defined under specific sections of CEPA and other legislation including responses to mandatory or voluntary surveys, targeted dialogue, and voluntary information submissions. All substances assessed under the CMP are subject to future evaluation if new, significant information is received that indicates a need for further consideration.

Various editorial comments were received requiring clarification and revision of text and referencing.

Editorial corrections were made to the updated dSAR and the risk management scope.

Some TCPP isomers were not included in the SAR. If applicable, these isomers should be considered in the conclusion for TCPP.

The TCPP isomers are on the Domestic Substances List (DSL) but were not identified as a priority for assessment because they did not meet the human health or environmental categorization criteria. The commercial products of TCPP contain low concentrations of these isomers which are not produced individually nor are they expected to be separated or marketed individually.  

The parameters and calculations used in models to estimate predicted environmental concentrations in the surface waters, sediments and soil should be disclosed and verified to ensure credibility.

Data considered in exposure modeling is determined based on the available information.  In the interest of the protection of the environment, the Government of Canada continually works with stakeholders to ensure a balance between protecting proprietary information and presenting information in the most transparent manner possible. The assessment discloses assumptions, and summarizes calculations for exposure, with further elaboration available on request in supporting documentation.

The process of critically evaluating key studies using robust scoring sheets is an overall strength of the Canadian assessment process; however, these should be disclosed as an appendix to the assessments.

This information is available upon request at substances@ec.gc.ca.

One value was selected for characterizing each physical and chemical property. Although it is agreed that only one value needs to be selected, the selection criteria for this value should be disclosed.

The updated dSAR was revised to reflect the comment.

Remove information for physical and chemical properties of TCPP and TDCPP found in Alibaba (2013) because the scientific information may not be compatible with the Canadian research context.

The updated dSAR was revised to reflect the comment and to remove information that is not compatible with the Canadian research context.

The SAR indicates that most TCPP and TDCPP enter Canada as imported neat material; only a small portion is contained in products. This statement is surprising: the opposite was expected.

The updated dSAR was revised to note that quantities of TCPP and TDCPP imported in manufactured items and products were potentially underestimated.

Supplemental information was provided regarding uses of TCPP and TDPPP.

The information provided was considered in the updated dSAR.

Additional information was provided to specify the role of TCPP and TDCPP as additives in the manufacturing process for polyurethane foams. 

The updated dSAR was revised to take into consideration the information provided.

In Appendix A, table A1.1, dust samples are identified as Vacuum or Fresh. An explanation of these sample types should be included as a footnote.

Footnotes were added to the table.

Reconsider the proposed conclusion regarding the presence of TCPP in the environment based on information provided on TCPP levels in Canadian surface waters and in effluents from Canadian wastewater treatment facilities.

The updated dSAR was revised to consider information on TCPP levels in Canadian surface waters and effluents.

Consider new references provided on TCPP released to laundry wastewater from clothing, along with the compilation of studies and data on TCPP and TDCPP that were submitted.

The additional studies, references and data on TCPP and TDCPP applicable to the Canadian environment were considered.

There was concern that the data presented in the assessment might not reflect the current availability and concentration of TCPP and TDCPP in manufactured items used in particular by adults. Margins of exposure (MOEs) for adults would increase if actual data from adult products currently on the market were used. In addition, many children’s products were recently tested by the Government of Canada and found to contain very little TDCPP and no TCPP. The results of these tests should be given a greater profile in the SAR. For example, this information could be noted in the synopsis and the conclusions. 

The screening assessment was revised to include additional information on product testing, including products used by both children and adults. Estimating the exposure of children and adults to TCPP and TDCPP due to dermal transfer from foam mattresses is considered a realistic and representative scenario for exposure to TCPP from contact with furniture.

The U.S. National Toxicology Program (NTP) TCPP study currently underway may affect the outcome of this screening assessment.

The updated dSAR was revised to include critical and relevant information from toxicology studies currently being conducted by the U.S. NTP. Note that TCPP is proposed harmful to human health on the basis of the non-cancer effects.

Information was provided on the distribution of TDCPP in Canadian indoor environments and the potential for exposure.

The information provided was considered in the updated dSAR. 

Information was provided on indoor levels of TCPP which appear to have multiple sources, including building insulation.

The updated dSAR was revised to include the provided dust data (TDCPP) and indoor air data (TDCPP and TCPP).

A statement on page 68 which indicates that “TCPP and TDCPP are non-volatile substances; therefore, they are not expected to appear in the gaseous form under normal conditions” is incorrect.

This statement was revised to reflect that TCPP and TDCPP are semi-volatile organic compounds (sVOCs).

The Sprague et al. (1981) study did not conform to good practices, so its inclusion in the SAR should be justified.

The updated dSAR was revised to explain how this study was used in the assessment.

Include verified data to support the claim in the SAR that there is potential for TCPP and/or TDCPP to be released from a product to the environment over the service lifetime because they are additive flame retardants.

The updated dSAR includes information to support the statement and revisions were made to reflect the comment.

The dermal exposure estimates for foam mattresses are missing from Appendix E.

The foam mattress scenario was in Appendix D of the dSAR, and the reference for this scenario was modified in the updated dSAR accordingly.

It is requested that the Government of Canada make available to the public the information collected in the 2014-2015 CMP survey of flame retardants in consumer products that is referenced in the assessment.

Relevant information from the 2014-2015 CMP survey was included in the dSAR, and a summary of the information received in response to the Section 71 Notice for certain OFRs is available on the Government of Canada Open Data portal.

The SAR cites many sources that mention TCPP and TDCPP being present in manufactured items at concentrations up to 9% weight per weight (w/w). An upper bound of 10% is recommended, to reduce uncertainty.

No changes were made to the updated dSAR because the studies cited include values up to 9% w/w of TCPP and TDCPP in foam furniture.

A more thorough assessment may be warranted, such as conducting a detailed assessment with in depth scenarios instead of a screening assessment.

The Government of Canada’s CMP substance screening assessments are science-based evaluations that apply a weight of evidence approach and are conducted under CEPA. This approach considers various sources of information to identify critical values used in the assessment, and consults multiple lines of evidence to determine if a substance may pose a risk. When sufficient and reliable data are not available, the best available estimation approaches, models, and tools are applied. This supports the use of conservative exposure scenarios that consider both the general population and vulnerable populations in Canada.

Ensure units of measurement for TCPP and TDCPP quantities are consistent across different jurisdictions.

The updated dSAR was revised to use the same unit of measurement for TCPP and TDCPP quantities.

The SAR presents the Long-range Transport Potential (LRTP) screening tool, a spreadsheet developed by the Organisation for Economic Co-operation and Development (OECD). Most regulatory authorities acknowledge that this tool is not used for decision making purposes. It is suggested that the OECD tool be omitted from the discussion in the SAR.

The OECD tool and other available models for determining LRTP were omitted from the updated draft assessment. The limitations associated with using these tools to estimate particle phase adsorption and related atmospheric fate are identified in the updated dSAR.

The SAR cites the model outcomes, suggesting no releases of TCPP and TDCPP to air. However, another section cites a reference that suggests the possibility for some releases from consumer products to air.

The limitations of the model are discussed in the dSAR to explain why aspects of outdoor air quality are not considered in the assessment.

The Critical Toxicity Value (CTV) should be within the ranges of key toxicity data, not the lowest one. A Species Sensitivity Distribution should be used to estimate a more representative effect threshold.  

Selecting the most sensitive endpoint is considered suitable because risk to the environment is not identified, even with this conservative approach. Also, a Species Sensitivity Distribution cannot be performed due to an insufficient variety of species represented in the available effects dataset.

An assessment factor of 30 should be used instead of 50 for extrapolating the soil predicted no effect concentration (PNEC) in Table 8.9.

The updated dSAR was revised to clarify that the assessment factor of 50 is used to determine the TCPP soil PNEC based on the available data points.

Losses and exposure of TCPP and TDCPP from consumer products appear overestimated and should be validated.

EU RAR 2008a and 2008b cite losses of TCPP and TDCPP from consumer products at 0.25% and 0.75%, respectively. No other reference is available to validate these values. The scenario estimating exposure in the environment from consumer products considers measured concentrations of TCPP and TDCPP in laundry wastewater. Resulting environmental concentrations were calculated using empirically determined removal efficiencies for wastewater treatment systems that are consistent with other exposure estimates.

Suggest using a term such as “notable” or “significant” instead of “high” to describe products that include greater levels of TCPP and TDCPP compared to other products.

The Government of Canada should consider refining the MOEs for adults.

The MOEs for dermal exposure from contact with covered foam (in mattresses or furniture) have been updated following the receipt of new information and subsequent adjustments of the exposure estimate. The updated MOEs for both TCPP and TDCPP from this exposure are considered potentially inadequate for infants and for adults, based on uncertainties in the exposure and health effects databases.

The Government of Canada should re-examine the infant mattress exposure scenario to account for the typical use of an additional bed wetting barrier as well as a re-examination of the migration rates and MOEs associated with children's mattresses.

 The MOEs for dermal exposure from contact with foam-containing mattresses or furniture have been updated following the receipt of new information and subsequent adjustment of the exposure estimate.

Not all exposure estimates are calculated based on Canadian data. Are the foreign data valid in Canada, and what is the rationale to use/apply the non-Canadian data?

In cases where appropriate data from Canada are not available, relevant, high-quality data from other jurisdictions are considered. Other factors included in exposure estimates, such as assumptions made, are included in the discussion of the dSAR and as footnotes to tables summarizing exposure.

The Government of Canada should re-examine the MOEs for environmental media and food, consider studies where substances were below the detection limit, and consider alternate drinking water data.

The MOEs for exposure to environmental media and food are considered adequate. The updated dSAR was not modified.

The information in Section 9.1.1.4 Soil and sediment is based on one set of data points. In principle, it is best to use more than a single set of data points to generate inputs or conclusions.

An additional study was identified and added to the updated dSAR; however, limited data in this area did not allow an in-depth discussion and MOEs were considered adequate based on available data.

Why is the Jantunen (2014) study presented in Section 9.1.1.5, considering the wealth of other information and data available in the SAR?

The Jantunen (2014) study is presented because it is directly relevant to drinking water in Canada compared to other studies.

It is recommended that the applicability of the U.S. Consumer Product Safety Commission factor for skin contact be evaluated for use in Canada and with TCPP and TDCPP.

Additional consideration was given to the applicability of the value of the skin contact factor for TCPP and TDCPP used by the US Consumer Product Safety Commission (0.13); however, the information available on this factor is limited, and it was considered more appropriate to use a value of 1.

The fact that most biomonitoring data relates to TDCPP should be clearly noted in the assessment. It is also questioned whether BDCPP is a valid or appropriate biomarker for TDCPP, since the correlation between the two should not be limited to the selected media, such as office dust.

The biomonitoring data and reverse dosimetry results discussed in the dSAR are used to support estimated exposures from environmental media and the use of consumer products. The possibility that BDCPP could be an environmental breakdown product of TDCPP is acknowledged in the updated dSAR, along with other uncertainties related to the biomonitoring data for TDCPP.

If using reverse dosimetry from biomonitoring studies to estimate daily exposure, the analysis should be presented to justify the conclusions.

Details on the reverse dosimetry calculations are included in Appendix F.

TCEP was presented as a valid analogue to characterize the carcinogenic potential of TCPP. However, additional analogues should be identified and the Government of Canada should re-evaluate the use of the analogues chosen for this SAR.

A supporting document (Health Canada, 2015a) explains in detail several lines of evidence, including the analogue approach, the quantitative structure-activity relationship (QSAR) approach, and the structural alerts approach. Analogues selected for the SAR align with those selected in the European Union’s assessment of TCPP in 2008, and are consistent with other read-across approaches from previous CMP assessments.

The endpoints presented in Tables 9.5 and 9.6 should not be the threshold presented in the Freudenthal and Henrich (1999) study. Rather, the endpoints should be between the dose levels presented in the study.

The lowest observed adverse effect level (LOAEL) of 800 ppm is considered more appropriate for risk characterization – this is based on significant increases in absolute and relative liver weights.

To improve the accuracy of the model inputs in Appendix D, consider a factor of 0.20 or 0.25 for the surface area of the head instead of 0.5; this would still be expected to have a built-in degree of safety.

In this scenario, using a factor of 0.50 for the surface area of the head is considered appropriate to account for movement.

In Table E2, the weight fraction of TCPP for large scale polyurethane spray foams is represented as 45%. This is incorrect: the product does not typically contain more than 10% TCPP. It is strongly suggested the polyurethane spray foam scenario be recalculated with a TCPP weight fraction that accurately represents products on the Canadian market.

The scenario summarized in Table E2 is supported by a Safety Data Sheet for foam sealant available in Canada with a percent composition in the range of 15 to 45%.

The SAR presents literature on the occurrence of TDCPP in foam products and textile backing. However, data shows that TDCPP is also in electronics, providing the opportunity for direct product-hand transfer.

Contributions of TDCPP from electronics to overall exposures from the indoor environment were included in the SAR by considering TDCPP levels in indoor air and dust.

The SAR estimates exposures from mattresses based on chemical migration rates cited in EU RAR (2008) for TCPP and in CPSC (2005) for TDCPP. Each study used a different methodology to determine migration rates, so results should be compared cautiously. Regional differences in foam composition may also distort the report conclusions.

The EU RAR (2008) data for TCPP and CPSC (2005) data for TDCPP were considered in the dSAR because these are the best available data on surface migration (release) of these substances from certain products.  The limitations of these migration studies are clarified in the SAR.

There is an inconsistency in the value reported for the TDCPP migration. The assessment report lists a value of 5.6 x 10^-5 mg/cm²/hr for the TDCPP migration rate based on U.S. CPSC (2005a). However, upon reviewing the referenced document, a different value was noted, 1.5 x 10⁴ mg/cm²/hr.

The value 1.5×10⁴ mg/cm²/hr is referenced in U.S. CPSC (2006), “CPSC Staff Preliminary Risk Assessment of Flame Retardant (FR) Chemicals in Upholstered Furniture Foam”, not U.S. CPSC (2005a). This migration value is reported as 0.15 µg/cm². The U.S. CPSC (2005b) memorandum entitled “Migration of Flame Retardant Chemicals in Upholstered Furniture Foams” was used to determine the TDCPP migration rate data. The table in Appendix D contains footnotes to describe how the migration rate is used in the SAR.

The rationale for the addition of adult mattresses and upholstered furniture should be presented in the risk management documents, since the SAR only presented the risk associated with children’s mattresses.

The screening assessment has been revised and a concern for infants, children, and adults from dermal exposure to TCPP and TDCPP in foam-containing mattresses and furniture has been identified. The risk management documents were revised to reflect this.

The adjusted 30% absorption value appears excessive for TDCPP. It is suggested to include the technical reasoning for using this value, instead of using the 15% absorption rate.

The SAR was revised to clarify the use of a 30% dermal absorption rate for TDCPP.

What is the difference between the substance in air and the substance on dust as a particle? Are the data/results interchangeable?

The data/results are not interchangeable because the exposure pathways are considered to be different. Exposure from indoor air is through inhalation while exposure to substances in dust is through ingestion. 

The low vapour pressure should have been given a greater profile throughout the assessment because this physical property could reduce air emission from industrial uses and binding to dust particles.

Although air emissions of TCPP and TDCPP are discussed in the dSAR, they are not quantified for exposure scenarios in industrial settings. These flame retardants are semi-volatile and volatilization is likely to be one of many routes by which they migrate to dust.

Consider discussing the uncertainty of the influence of adsorption to atmospheric particles when characterizing the environmental fate of TCPP and TDCPP.

The limitations of available models for estimating adsorption to atmospheric particles are identified in the assessment.

Is the TCPP dermal absorption rate of 40% in adults the most representative?

The dermal absorption rate of 40% was reported in the European Union Risk Assessment for TCPP (EU RAR, 2008) as most applicable for foam products that release TCPP.

Persistence should be assessed by focusing on substances in a pure and isolated state, instead of in the particle formation.

Persistence is assessed based on substance fate under environmental conditions. Atmospheric monitoring data show that TCPP and TDCPP are found in air particulates, and that due to their slow degradation, they could persist in the environment.

It is noted that the SAR only concludes that TCPP and not TDCPP meets the persistence criteria in the assessment. However, both substances seem to have demonstrated slow degradation in the environment.

The initial draft SAR did not conclude on whether TDCPP meets criteria under the Persistence and Bioaccumulation Regulations because it did not meet the criteria for risk, as defined under paragraph 64 of CEPA. The updated draft SAR proposes that TDCPP meets the criteria for risk, as defined under paragraph 64 of CEPA, so text has been added to this updated draft to propose that both TDCPP and TCPP meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations.

The SAR does not clearly explain whether organisms were exposed to one or more organophosphate flame retardants at the same time in the Fernie et al. (2015) toxicity study.

The updated dSAR was revised to clarify that groups of organisms were exposed to individual organophosphate flame retardants.

The Government of Canada should provide a rationale positively linking TCPP and TDCPP with the products presented in the studies cited in Section 9.1.1.2.

The studies cited do not definitively state that the measured TCPP and/or TDCPP strictly come from select listed products. Instead, the authors discuss potential sources that may release these chemicals to indoor air and suggest why higher concentrations of these flame retardants may be found in some of the environments tested and not in others.

Can the Ali et al. (2012) study listed in Table A2.2 be examined to validate the exposure to flame retardants from mattresses?

The Ali et al. (2012) study includes uncertainties related to the collection of dust found on mattresses and this type of data would be difficult to use to support dermal exposure estimates.

The wastewater treatment system removal rates used in the assessment are too conservative and should consider available empirical data.

Several studies referenced in the dSAR suggested inefficiency in removing TCPP and TDCPP at wastewater treatment facilities. Removal rates in the dSAR are considered to be realistic because they are based on influent and effluent monitoring data collected from Canadian wastewater treatment facilities.

The SAR includes do-it-yourself scenario analyses that do not consider the use of personal protective equipment (PPE), resulting in very conservative worst-case scenarios.

The approaches in the dSAR for do-it-yourself scenarios are considered appropriate. It is acknowledged that the use of PPE can reduce exposure to do-it-yourself products and this is noted in the Uncertainties section.

The SAR states that a few major manufacturers will discontinue production of TDCPP, which will reduce the availability of the product in the long term and therefore reduce chances of exposure. This should inform any action taken on this substance in the future. Additionally, the SAR should document the reason for discontinuing production.

The exposure assessment in the dSAR considers the recent discontinuation of TDCPP production in Canada. The discontinuation of TDCPP production by some manufacturers will reduce availability of the product. Thus, there remains moderate confidence that quantities imported and used in Canada will not increase. It is not within the scope of the SAR to document the reason for discontinuing production.

The SAR states that more TCPP is released from laundry water and from industrial sites than TDCPP. However, based on applications in the Canadian market, both substances are expected to cause similar releases or be lower than reported.

Releases of TCPP and TDCPP in the laundry wastewater scenario were estimated based on an environmental study in the United States (U.S.). Data in this study are assumed to be similar in the U.S. and Canada, such as the ratio of TCPP/TDCPP in products and the release of TCPP and TDCPP from products. Some factors specific to the Canadian market may account for the higher environmental releases of TCPP such as higher import and usage quantities, and lower removal rates at wastewater treatment facilities.

The no observed effect concentration (NOEC) and predicted no effect concentration (PNEC) for TCPP do not include endocrine disruption effects investigated for TDCPP.

Results of scientific tests show that high concentrations of TCPP will have weak endocrine (hormonal) disruption effects. The PNEC for TCPP was taken from the lowest toxicity value for aquatic organisms. Levels of TCPP in the Canadian environment are not expected to have an effect on organisms. Available scientific data suggests that TDCPP has a stronger effect on hormonal systems when compared to TCPP.

Information has been provided regarding the distribution of TDCPP in Canadian indoor environments and potential for exposure. The Government of Canada should reconsider the conclusion of TDCPP as a hazardous substance despite the current, low exposure and thus risk for human health.

The information provided by the stakeholder has been considered in the screening assessment.  The updated draft screening assessment proposes that both TCPP and TDCPP are harmful to human health based on the receipt of new information and adjustments were made to estimated exposure to these substances through dermal contact with foam-containing mattresses and furniture.

Updated risk management documents have been prepared to accompany the updated dSAR. Consideration will be given to whether or not a concentration threshold for TCPP and TDCPP in products targeted for risk management is needed.

The Government of Canada should present any risk management action on TCPP with a Sustainable Development Objective.

TCPP is included in the Federal Sustainable Development Strategy for 2016-2019 [PDF]. This strategy proposes that risk management controls be in place within 42 months for all substances assessed as posing a risk to the environment or human health.

If a Significant New Activity condition (SNAc) is considered for TDCPP, it should focus on TDCPP, omit TCPP, and be based on assessment outcomes. The SNAc should only consider applications where there may be unacceptable risks.

TDCPP is proposed to be harmful to human health, as defined under paragraph 64 of CEPA, in the updated draft screening assessment. Risk management measures under consideration for TDCPP are included in updated risk management documents.

To address the identified unacceptable risks, the Hazardous Products (Mattress) Regulation under the Canadian Consumer Products Safety Act should be amended because it would build on an existing known regulation.

Action under the Canada Consumer Product Safety Act is among the risk management options under consideration for TCPP and TDCPP.  The development of risk management will take into consideration the need to address the range of sources of exposure identified as a concern.

For the purposes of risk management, the Government of Canada should group flame retardants to minimize effects on the regulated community and the government, even if this means a delay.

Flame retardants are considered as a group in Phase 2 of the CMP. An additional group of flame retardants are being assessed in Phase 3. The hazard for each substance is presented in the updated dSARs which are expected to facilitate informed substitution. 

The presence of a CEPA toxic substance may cause concern for stakeholders, the regulated community, or the marketplace. The Government of Canada should mitigate the concerns that a CEPA toxic conclusion may raise, especially when no unacceptable risks were identified.

Products that may require risk management actions are identified in the updated dSAR.  Sources of exposure to substances listed in Schedule 1 are also identified on the CMP website. This information identifies substances of concern.

To prevent increased human and environmental exposure risks, reconsider the status of TDCPP in order to prevent the possibility of continued use and inventory stockpiling of products containing TDCPP in Canada.

 TDCPP is proposed to be harmful to human health, as defined under paragraph 64 of CEPA, in the updated dSAR. Risk management measures under consideration for TDCPP are included in updated risk management documents.

Risk management should be based on science, avoid market disruption, and consider consistency in North America so that fire and safety requirements can be maintained.

Screening assessments are based on the best available data which enables Ministers to issue decisions that safeguard human health and the environment. This includes the economic, social, health and environmental implications, all of which are considered when developing risk management tools.

Risk management should address the specific risks identified and should not extend beyond what is currently proposed.

Risk management proposals may evolve due to new information. However, each step in the process (e.g., publication of the risk management scope, risk management approach, proposed instrument, and final instrument) provides an opportunity for stakeholder input. 

TCPP is a critical flame retardant in insulation foams.

Insulation was not identified as a source of exposure of concern; therefore, risk management is not being proposed for this product type.

The assessment of TDCPP presents a case where a precautionary approach is needed. Designating TCPP as “CEPA toxic” (e.g., on CEPA’s Priority Substances List) seems likely to increase the use of TDCPP. Given that TDCPP is known to have hazardous properties, this increase should be prevented.

 The updated dSAR proposes that both TCPP and TDCPP are harmful to human health.