Summary of public comments received on the draft screening assessment report for the Trimellitates Group

Official title: Summary of Public Comments Received on the Draft Screening Assessment Report for the Trimellitates Group

Comments on the draft Screening Assessment Report (dSAR) for the Trimellitates Group to be addressed as part of the Chemicals Management Plan (CMP) were provided by Canadian Consumer Specialty Products Association (CCSPA), Prevent Cancer Now and Chemical Sensitivities Manitoba.

A summary of comments and responses from the Government of Canada is included below, organized by topic:

1. New Information & data

Summarized Comment Summarized Response
Consider the potential increased and ubiquitous use of trimellitates in the rapidly growing chemical industry. New information regarding increased use of trimellitates can be submitted through several mechanisms defined within the Canadian Environmental Protection Act (CEPA) 1999 and other legislation. Based on large use quantities and conservative assumptions, calculated margins of exposure were considered adequate to account for uncertainties. Therefore, it was concluded that trimellitates are not entering the environment in amounts that pose a risk to human and environmental health    
There is limited toxicity data for Tris(2-ethylhexyl) trimellitate (TEHT), and no toxicity data for Branched tridecyl and isodecyl trimellitate (BTIT) and Tristridecyl trimellitate (TTDT). The hazard assessment was based on modeling and read-across from phthalate data.   The health effects characterizations for BTIT and TTDT is based on read-across from other structurally related chemicals. The approach is consistent with international best practices. Data based on phthalates was used to characterize dermal absorption.  
Identify the research regarding trimellitates remaining in the water column and that may pose hazards similar to microbeads. CMP screening assessments are based on consideration of available data at the time of publication. It should be noted that there are some key differences between trimellitates and microbeads. For example, trimellitates are liquid at room temperature, while microbeads are solid.

2. Environmental fate

Summarized Comment Summarized Response
The CMP assessment lacks complete environmental fate reporting. Environmental fate should be identified, and toxicity of the parent compound and environmental breakdown products should be considered. The Trimellitates Group is characterized in the Science Approach Document: Ecological Risk Classification of Organic Substances, which includes information such as half-life and bioaccumulation potential. There was no further investigation of environmental fate and toxicity for environmental breakdown products because these substances are identified as a low ecological concern.

3. Cumulative exposure

Summarized Comment Summarized Response
Reporting is only required when use or importation of a regulated substance by a particular company exceeds 100 kg. Consider collective or cumulative quantities in commerce from the vast number of imported plastics, cosmetics, and other products by numerous companies. Relevant information is taken into account when conducting a risk assessment. Available information on exposure from all known sources is considered during CMP assessment of substances. Conservative assumptions are used in order to account for uncertainties in the health and exposure databases.  

4. Risk characterization

Summarized Comment Summarized Response
Phthalates are noted for endocrine disruption at low concentrations. The chemical similarities between trimellitates and phthalates, and unknown endocrine disruption potential of partially degraded trimellitates pose a concern. Information on phthalates was used to characterize dermal absorption. The read across approach applied in the assessment identified substances best suited to support the risk characterization of trimellitates. Furthermore, no structural alerts were identifiedfrom the OECD QSAR Toolbox from theOrganization for Economic Cooperation & Development (OECD 2014), which identified substances in this assessment as being potential binders for endocrine receptors. For additional information on how the CMP considers endocrine-related chemicals see the fact sheet: Consideration of endocrine-related effects in risk assessment.

5. Risk management

Summarized Comment Summarized Response
The Government of Canada should continue to monitor these types of increased uses to prevent any additional exposures to toxic chemicals in the environment. This should include ongoing review of uses and substitutes to develop a more protective approach. Noted.

6. Alternatives & informed substitution

Summarized Comment Summarized Response
Considering current use patterns, trimellitates are increasingly used as a substitute for phthalates. The Government of Canada should examine the potential for substitution with similar chemicals that may be of concern, to avoid regrettable substitutions.    In developing risk management approaches for substances of concern, the CMP considers any existing information regarding substitutes and alternatives including relevant information on the economic, social, and environmental implications for Canada.
Including alternatives such as those identified through “green chemistry” would provide a more rational and protective environmental assessment. The Government of Canada is exploring ways to advance responsible replacement of chemicals of concern, including ways to apply informed substitution to support chemicals management. For additional information please see the Combined government discussion paper and science committee report on informed substitution

7. Consultation & stakeholder engagement

Summarized Comment Summarized Response
The opportunity to provide input on the draft screening assessment report is appreciated. Assistance is offered, should additional information be required.   Noted.
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