Triclosan: response to comments on the proposed notice
On November 24, 2018, we published a proposed notice requiring the preparation and implementation of pollution prevention plans with respect to triclosan (CAS RN 3380-34-5) in the Canada Gazette, Part I for a 60-day consultation period. Comments on the proposed notice were provided by:
- Canadian Consumer Specialty Products Association (CCSPA)
- Canadian Environmental Law Association (CELA)
- Ottawa Riverkeeper
- Regional Municipality of York
- 39 Canadian citizens
A summary of comments and responses are included below, organized by topic.
Comment: Several stakeholders commented that triclosan should be banned across Canada due to its toxicity to aquatic ecosystems.
Response: We undertook a rigorous scientific risk assessment and concluded that triclosan can be toxic to the environment above certain exposure levels. Risk management tools are available to effectively control levels of triclosan in the environment without the need for a complete ban. Therefore, we proposed the use of a pollution prevention planning notice (P2 notice) to reduce the amount of triclosan in products that are imported into and formulated in Canada.
A reduction target based was proposed on the lower confidence limit of the Federal Environmental Quality Guideline (FEQG) for triclosan and modelling of municipal wastewater treatment plant removal rates. The results showed that a P2 notice to reduce the amount of triclosan in products that are imported into and formulated in Canada by 30% from 2011 levels is precautionary and should protect all aquatic ecosystems in Canada from triclosan.
Canada already restricts the amount of triclosan that can be used in cosmetics, non-prescription drugs, and natural health products. In addition, since 2014, triclosan has not been registered under the Pest Controls Products Act for use in Canada as a pesticide.
Comment: Several stakeholders commented that triclosan should be banned across Canada due to its toxicity to human health.
Response: We conducted a rigorous scientific risk assessment on triclosan, which used biomonitoring data and a conservative No Observed Adverse Effect Level database. The margins of exposure for human health were acceptable and, therefore triclosan does not meet the criteria set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). Canada already restricts the amount of triclosan that can be used in cosmetics, non-prescription drugs, and natural health products.
Comment: Several stakeholders commented that triclosan should be banned across Canada due to its ability to create antibiotic resistant bacteria.
Response: During the risk assessment process, we reviewed all available information on the potential for triclosan to induce antimicrobial resistance. Although there is the potential for triclosan-resistant bacteria to exist in laboratory and clinical settings, this has not been documented outside of clinical use (e.g. toothpaste use at home).
Comment: Two stakeholders commented that triclosan should be banned except in hospital-type settings.
Response: The triclosan P2 notice does not include specific restrictions on where a product is used. It focuses on an overall reduction of triclosan from all cosmetics, natural health products, and drugs.
Comment: Some stakeholders are in agreement with the approach to reduce triclosan at its source. Another agreed with the scope of the products included, while others suggested that the triclosan P2 notice’s scope should expand to include all uses of triclosan such as cleaning products, textiles, and kitchen products.
Response: Information collected from a mandatory survey conducted under the Canadian Environmental Protection Act, 1999 (section 71) indicated that as of 2011, Canadian companies used or imported triclosan in general purpose and industrial cleaners. Limited evidence is available on the current use of triclosan in cleaning products in Canada and therefore cleaning products have been removed from the scope of the triclosan P2 notice. Antibacterial products that contain triclosan are regulated under the Food and Drugs Act as drug products and are covered under the notice. We will continue to monitor the use of triclosan in cleaning products in Canada.
Triclosan has not been registered under the Pest Control Products Act for use as a pesticide in Canada since 2014.
Comment: Stakeholders commented that manufacturers and importers should be required to provide evidence of a product’s long-term safety before it can be used, including triclosan’s alternatives.
Response: Those who are subject to the triclosan P2 notice and elect to use an alternative would be required to consider using one that reduces or minimizes harmful effects to the environment and to human health while complying with all relevant legislation. Those subject to the triclosan P2 notice should also consider conducting a hazard assessment on any alternatives.
Comment: One stakeholder stated that triclocarban should be included under the triclosan P2 notice, given it is a likely alternative to triclosan.
Response: Triclocarban is currently undergoing a risk assessment under the Chemicals Management Plan (CMP).
Those who are subject to the triclosan P2 notice must consider using an alternative that reduces or minimizes harmful effects to the environment and to human health while complying with all relevant legislation. Those subject to this notice should also consider conducting a hazard assessment on any alternatives.
Persons subject to the notice
Comment: Regulations should be set for wastewater treatment plants.
Response: Reducing the amount of triclosan in products manufactured in and imported into Canada will decrease the quantity of triclosan washed down the drain and into wastewater treatment plants. Reducing releases at the source is considered a more effective approach than end of pipe control.
Availability of plans
Comment: All pollution prevention plans should be available to the public.
Response: Information received through the completed declarations for P2 notices (in other words, schedules 1 and 5) will be publicly available on the pollution prevention planning reports website, except for the contact information and information deemed confidential in accordance with CEPA and the Access to Information Act and Privacy Protection Act. Publicly available information can include quantities of triclosan or alternatives imported or used, pollution prevention planning activities, amounts of pollution reduced, how each factor to consider is met, etc.
Comment: Interim reports should be included to show progress towards reductions. These reports should be available to the public.
Response: After considering of the short period of time between the deadlines to submit the declarations of preparation and implementation, it was decided that interim progress reports were not needed.
Alignment with other jurisdictions
Comment: Canada should align with the U.S. and ban triclosan
Response: The United States Food and Drug Administration (U.S. FDA) has taken a different approach on triclosan than Canada. After the industry did not provide the necessary evidence that certain triclosan-containing products were effective, the U.S. FDA determined that triclosan and 18 other active ingredients are not generally recognized as safe or effective (GRAS/GRAE) for use in over-the-counter (OTC) antiseptic washes, consumer hand sanitizers, and hand sanitizers in health care settings. The U.S. FDA rule is not a full ban on triclosan. Triclosan can still be used in cosmetics, toothpastes, and mouth washes at certain concentrations in the U.S.
Comment: A stakeholder requested that we continue to monitor the levels of triclosan in Canadian waterways and report to Parliament and Canadians on a yearly basis.
Response: Monitoring data showing measured concentrations of triclosan in surface water over the period 2002 to 2007 are available for numerous water bodies in both densely and lightly populated areas of Canada. We will continue to monitor triclosan in Canadian waterways to determine whether triclosan concentrations are below levels of concern, and to assess the effectiveness of the triclosan P2 notice.
More information on the CMP monitoring and surveillance program is available online.
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