Summary of public comments received on the draft screening assessment for triclocarban

Comments on the Draft Screening Assessment for Triclocarban, assessed under the Chemicals Management Plan (CMP), were submitted by Ecojustice and Environmental Defence, and an individual.

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

Human health risk characterization and risk management

Comment summary 1: Based on review of additional research articles, including data on endocrine disruption and effects on the gut microbiome, triclocarban and its intermediates are highly toxic to human health.

The additional research studies for triclocarban cited in the submitted comments should be considered in the screening assessment.

Additional research should be conducted on developmental, reproductive and endocrine endpoints to confirm previous results.

Response 1: Additional information submitted / cited was considered; however, no changes to the screening assessment were needed. Most of the references / information cited in the public comments were already cited in the draft screening assessment and others were not specific to triclocarban.

In conducting a risk assessment, the potential effects of the substance on humans and the environment are evaluated (hazard characterization). 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, and carcinogenicity) are identified. Information on endocrine-related effects is also considered, when available and relevant. For more information, please refer to the RA Series Fact sheet: Consideration of endocrine-related effects in risk assessment.

Screening assessments are based on the best available data. New information can be submitted through several mechanisms defined under specific sections of the Canadian Environmental Protection Act, 1999 (CEPA) and other legislation. When appropriate, the Ministers may conduct additional evaluations of substances assessed under the CMP.

Comment summary 2: Given the toxicity of triclocarban, its use in Canada should be limited to automotive care products, outdoor use, and adhesives only. Use of triclocarban in foods, pharmaceuticals and cosmetics should be banned.

Safer alternatives or natural substitutes of triclocarban should be used.

Products containing triclocarban should have a proper label containing a “WARNING” section for pregnant women and children younger than 5 years old.

Response 2: Triclocarban is not a permitted food additive in Canada, nor has it been identified as a component in incidental additives, or in the manufacture of food packaging materials.

When developing risk management approaches, the CMP considers substitutes and alternatives whenever possible and when adequate and relevant information is available on the economic, social and environmental implications for Canada. However, risk management approaches are only developed for substances concluded to be toxic. This is not the case for triclocarban as the screening assessment concluded that current levels of exposure do not pose a risk to the general population or to the environment.

Occupational exposure

Comment summary 3: Given the health effects of triclocarban, manufacturers and industries using triclocarban should take proper precautions to protect workers who are exposed repeatedly.

Response 3: Screening assessments conducted under the CEPA 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 (WHMIS).

The Government of Canada is working with the provinces and territories to explore ways to enhance the protection of workers from exposure to chemicals by integrating and leveraging the information, tools, and/or technical expertise of the CMP and Health Canada’s Workplace Hazardous Products Program.

Environmental fate and ecological risk characterization and risk management

Comment summary 4: The Government should revisit the ecological risk classification for triclocarban, determined using the ecological risk classification of organic substances (ERC) approach, and as such the proposed conclusion with respect to the toxicity of triclocarban, as defined under section 64 of CEPA.

Given triclocarban’s inherent high toxicity to aquatic species and its high potential for bioaccumulation, in addition to its wide-spread use in products available to consumers, this substance presents a moderate risk, if not high risk based on evidence of high persistence in soils.

Based on a review of research articles, including data on aquatic toxicity, metabolism, and bioaccumulation, triclocarban and its intermediates are highly toxic to the environment.

Response 4: The screening assessment of triclocarban concludes that there is low risk of harm to the environment at current exposure levels. Available use pattern and environmental monitoring data support the ERC low exposure potential classification for triclocarban. There is a limited number of uses of triclocarban in products available to consumers in Canada. Available measured Canadian surface water data indicate that triclocarban concentrations are below the reported detection limit of 0.006 µg/L.

Triclocarban can be released onto Canadian agricultural soils where biosolids are applied. Some studies indicate that triclocarban can degrade although the degradation of biosolids-borne triclocarban can be slow. However, available studies show that triclocarban has low bioavailability with low food-web bioaccumulation in terrestrial organisms (for example, earthworms and birds).

While current exposures of triclocarban to the Canadian environment are not considered to be of concern, triclocarban is considered to have a high hazard based on its inherent toxicity to aquatic species. As such, there may be a concern should exposures increase. Follow-up activities being considered may include environmental monitoring, and Federal Environmental Quality Guidelines in water and sediment have been developed.

Comment summary 5: Future studies should investigate triclocarban releases throughout the entire product life cycle, including manufacture, long-term use, disposal, and environmental release.

Facilities using triclocarban should dispose of triclocarban containers through an approved waste disposal plant.

Response 5: Risk assessment conclusions under CEPA take into consideration activities resulting in potential releases to the Canadian environment. According to information submitted in response to CEPA section 71 surveys, there is no manufacturing of triclocarban in Canada and there is a limited number of uses of triclocarban in products available to consumers. Therefore, releases of triclocarban from products available to consumers via wastewater into Canadian freshwater aquatic ecosystems is expected to be dispersive resulting in low exposure to aquatic organisms. Available use pattern and environmental monitoring data support the ERC exposure classification of low for triclocarban.

Given that triclocarban is not identified to be of concern to human health or the environment at current levels of exposure, the Government of Canada is not proposing any risk management measures.