Triclosan: response to comments on the consultation document

On December 13, 2017, Environment and Climate Change Canada (ECCC) published a consultation document outlining the key elements of a proposed Pollution Prevention Planning Notice for triclosan (CAS RN 3380-34-5) for a 60-day consultation period. Comments on the consultation document were provided by:

• Canadian Consumer Specialty Products Association
• Canadian Environmental Law Association
• Chemical Sensitivities Manitoba
• Colgate Palmolive Canada Inc.
• Cosmetics Alliance Canada
• Council of Canadians
• Ecojustice
• Environmental Defence
• Learning Disabilities Association of Canada
• Ottawa Riverkeeper
• Prevent Cancer Now
• Various Canadian citizens

A summary of comments and responses is included below, organized by topic:

Risk assessment

Comment: Some stakeholders are in disagreement with the conclusion of the final assessment that triclosan is not toxic to human health and state that the Government of Canada is missing an opportunity to address the impact of triclosan on human health.

Response: The Government of Canada conducted a human health assessment on triclosan which used recent biomonitoring data and a conservative No Observed Adverse Effect Level (NOAEL) database. The margins of exposure for human health were deemed adequate and, therefore, triclosan does not meet the criteria set out in paragraph 64(c) of CEPA.

Comment: The Government of Canada should conduct a systematic scientific review of all recent studies on the impacts to health and environment associated with triclosan. The results of this review should be reported through an updated State of the Science Report before publishing the proposed instrument.

Response: The Minister of Health and the Minister of Environment and Climate Change conduct risk assessments of substances to determine whether these substances present or may present a risk to the environment or to human health. Decisions are based on a scientific evaluation of the risk posed by a substance, which considers both the hazardous properties of the substance (such as toxicity to aquatic organisms or carcinogenic properties) and the nature of the exposure of Canadians or the environment to the substance. This allows the Government of Canada to identify whether or not a control is needed, and if so, what type of control is best suited for reducing or preventing the potential harm.

The Government of Canada has developed a cyclical process known as the identification of risk assessment priorities where new information on all substances is compiled. This information is evaluated to determine if further action on the substance(s) may be warranted.

Comment: No rationale or supporting documentation explaining the increase of the Predicted No Effect Concentration (PNEC) from the draft to final risk assessment for triclosan have been provided.

Response: The PNEC, based on the  Species Sensitivity Distribution, was modified according to:

• the Canadian Council of Ministers of the Environment (2007) protocol for the derivation of water quality guidelines for the protection of aquatic life
• studies previously included
• new studies available since the publication of the draft screening assessment in 2012

All studies were evaluated for robustness, quality, and relevance using Robust Study Summaries. These summaries are available upon request. The final screening assessment included descriptions of the newly considered studies for the PNEC and an updated bibliography.

Further information on the rationale for the update to the PNEC from the draft to the final screening assessment was addressed throughout the final assessment and in the Summary of Public Comments Received on the Preliminary Assessment and Proposed Risk Management Scope for Triclosan.

Monitoring

Comment: The risk management instrument should take into consideration the fact that the average concentration of triclosan in surface water from waterbodies across Canada from 2002 to 2017 were below the level of concern and that in sampling campaigns since 2012, exceedances were reported in only one site.

Response: Measured concentrations of triclosan in surface water are available for numerous water bodies in both densely and lightly populated areas of Canada from 2002 to 2014. Even though the majority of these measured triclosan concentrations in surface water below the level determined to be protective of toxic effects, there are a few instances where this level was exceeded.

In the absence of comprehensive monitoring datasets, and considering that existing monitoring data indicates that there are exceedances, the Government is taking a precautionary approach to help protect all aquatic ecosystems in Canada from triclosan.

Federal Environmental Quality Guideline

Comment: Did Environment and Climate Change Canada (ECCC) consider the entire body of scientific data provided in the studies submitted during the comment period for the triclosan Federal Environmental Quality Guideline (FEQG)?

Response: Following a scientific review, three of the nine proposed data revisions were accepted and considered for inclusion in the Species Sensitivity Distribution (SSD) in accordance with the Canadian Council of Ministers of the Environment (2007) protocol for the derivation of water quality guidelines for the protection of aquatic life. Consideration of the three proposed revisions resulted in a slightly higher FEQG. The studies supporting these revisions meet ECCC’s robust criteria for use in a FEQG.

The other six studies did not meet ECCC’s criteria for various reasons, including: use of an outdated Organisation for Economic Co-operation and Development test protocol; species referred to within the studies not relevant to the Canadian ecosystem; inappropriate selection of endpoints; and disagreement on an endpoint pertaining to endocrine disruption.

Risk management: reduction target

Comment: Stakeholders had mixed perspectives on the reduction target. Some noting that the 30% reduction target, chosen based on the lower confidence limit of the Federal Environmental Quality Guideline (FEQG) for triclosan, is not warranted as concentrations of triclosan in surface waters have steadily decreased and conservatism is built into the development of the FEQG.

Others did not support the 30% reduction target as it was too low.

Response: Triclosan was determined to be toxic to the environment because it can reach levels where there is a potential for harmful effects in aquatic ecosystems.

Measured concentrations of triclosan in surface water are available for numerous water bodies in both densely and lightly populated areas of Canada from 2002 to 2017. Even though the majority of these measured triclosan concentrations in surface water below the level determined to be protective of toxic effects, there are a few instances where this level was exceeded.

Selecting the lower confidence limit of the FEQG will help protect all aquatic ecosystems throughout Canada.

Risk management: selection of 30% reduction target

Comment: The Federal Environmental Quality Guideline (FEQG) was revised and there was no corresponding change in the reduction target. How was the 30% reduction determined, given the increase to the FEQG?

Response: Initially, ECCC had suggested a reduction target of 30% using previous versions of the Consumer Release Aquatic Model (CRAM).

ECCC recalculated the reduction target based on the lower confidence limit of the revised FEQG using a refined peer-reviewed CRAM, which includes real-life municipal wastewater treatment plant removal rates. The input value for the amount of triclosan flushed down the drain by consumers on a daily basis was also revised using the s.71 survey data.

This resulted in the 30% reduction target that will help reduce the amount of triclosan that enters waterways to a level that is unlikely to cause harm to the aquatic environment in all water bodies.

Risk management: product inclusion

Comment: The Notice should provide a means to permit the continued use of certain products, including those with proven health benefits.

Response: Triclosan has been used in consumer products for a variety of purposes. The Notice does not include product specific restrictions. It does not differentiate based on the role of the substance in specific products. However, the Notice would provide regulatees the flexibility to develop and implement a range of actions that are best suited for their specific situation and product lines. Implicated companies would be required to develop and implement a P2 Plan describing how they addressed each factor to consider.

Comment: The Triclosan Pollution Prevention Planning Notice (Triclosan P2 Notice) should only apply to Food and Drug Act regulated cosmetics, drugs, natural health products and cleaning products.

Response: The proposed Triclosan P2 Notice applies to triclosan-containing cosmetics, drugs, and natural health products, all of which are regulated under the Food and Drugs Act.

Comment: General consumer cleaning products and detergents have never contained triclosan and these products should not be included in the Notice.

Response: Information collected from a mandatory section 71 survey 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 Notice. Antibacterial products that use triclosan would be regulated under the Food and Drugs Act as drug products and are covered under the Notice. ECCC will continue to monitor the use of triclosan in cleaning products in Canada.

Comment: Some stakeholders are in agreement with the Government of Canada’s approach as it is good to reduce the chemical at its source.

Response: Noted

Comment: Triclosan should be banned across Canada by applying a regulatory approach to prohibit the use of triclosan in consumer and personal care products.

Response: Canada undertook a rigorous scientific assessment and found that triclosan can be toxic to the environment above certain levels. Data from this scientific assessment did not justify a ban and therefore the Government has 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 by 30% from 2011 levels. This level is precautionary and should help protect all aquatic ecosystems in Canada from triclosan.

In addition, Canada already restricts the amount of triclosan that can be used in cosmetics, non-prescription drugs, and natural health products. Since 2014, triclosan has not been registered for use in plastics, polymers, or textiles in Canada.

Risk management: alternatives

Comment: Substances that are less harmful than triclosan should be used in products.

Response: Those who would be subject to the Triclosan Pollution Prevention Planning 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 health while complying with all relevant legislation. Those subject to the P2 Notice should also consider conducting a hazard assessment on any alternatives.

Comment: Assessments on alternative substances should be a legal requirement under CEPA. This process should recognize that some substitutes are unnecessary.

Response: The House of Commons Standing Committee on Environment and Sustainable Development (Committee) made several recommendations related to informed substitution (Recommendations 57-60) in its 2017 report following its review of CEPA, including Recommendation 57 to amend CEPA to “[…] add a mandatory duty to assess alternatives as part of all screening assessments of existing substances”. On June 29, 2018, the Government of Canada published a follow-up report responding to each of the Committee’s recommendations. The Government’s response to Recommendations 57-60 can be found in section 3.5.4 on informed substitution.

• Standing Committee on Environment and Sustainable Development
• Canadian Environmental Protection Act review

Risk management: persons subject to the notice

Comment: Retailers should be subject to the Triclosan Pollution Prevention Planning Notice (Triclosan P2 Notice).

Response: The proposed Triclosan P2 Notice addresses reductions of triclosan in products that are manufactured or imported into Canada. This should result in retailers receiving fewer triclosan-containing products and not put the burden on small business. Retailers who import triclosan-containing products with triclosan totalling a quantity of 100 kg or more would be subject to the Notice.

Comment: Compliance with the Triclosan Pollution Prevention Planning Notice (Triclosan P2 Notice) may be challenging for importers based outside of Canada.

Response: ECCC will develop and implement compliance promotion activities for the Triclosan P2 Notice to increase importer knowledge and compliance.

The sender or foreign supplier (i.e. exporting to Canada) is not required to respond to the Notice. The receiver (who imports into Canada) is subject to the Notice if the 100 kilogram threshold is met. Companies located outside of Canada are encouraged to inform their customers if their products contain triclosan.

Comment: Wastewater treatment facilities should be subject to the Triclosan Pollution Prevention Planning Notice (Triclosan P2 Notice) as they remain a significant source of release of triclosan to soil and the aquatic environment.

Response: Reducing the amounts of triclosan in products manufactured 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 treatment.

Risk management: removal from wastewater

Comment: Is triclosan effectively removed from wastewater when processed at municipal wastewater treatment plant?

Response: Municipal wastewater treatment plants have a high removal efficiency for triclosan, ranging from 74-98%. For more information on the removal efficiency of triclosan from wastewater treatment plants in Canada , please refer to section 4.1.1 of the final assessment.

Risk management: time to develop and implement

Comment: The proposed timeframe to develop and implement a Pollution Prevention Plan (P2 Plan) is too long.

Response: Environment and Climate Change Canada (ECCC) proposes this timeframe to provide regulatees sufficient time to change their processes, apply pollution prevention techniques, reformulate their products, and conduct the necessary registration process with Health Canada, if applicable.

Comment: Recognition should be given to regulatees who are proactive in reducing their triclosan use or import.

Response: The proposed Triclosan Pollution Prevention Planning Notice provides regulatees the flexibility to choose a base year from 2011 onward, which would provide recognition for early reductions.

Risk management: end date following implementation

Comment: The Notice should include an end date of no more than 5 years following implementation.

Response: The Notice does not have an end date in order to discourage the manufacture or import of new triclosan-containing products in the Canadian market. At any time after the publication of the Final Notice, anyone subject to the Notice will have to achieve and maintain a target of a minimum of 95% from the amount of triclosan used or imported in the year they became subject to the Notice.

Risk management: pesticide products

Comment: What data are collected and released publicly by Pest Management Regulatory Agency (PMRA) to demonstrate compliance with the deregistration of triclosan?

Response: Health Canada uses a risk-based approach to identify priorities for follow up compliance and enforcement activities. This compliance data has not been collected to date.