Summary of public comments received on the screening assessment for the arenes group

Official title: Summary of public comments received on the screening assessment for the arenes group

Comments on the draft screening assessment for the Arenes Group to be addressed as part of the Chemicals Management Plan (CMP) were submitted by American Chemistry Council, Canadian Fuels Association, and Pultrall Inc.

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

1. Information & data updates

Summarized comment	Summarized response
Consider the data provided on the concentration of cumene found in an imported product, the quantity used annually, and its use in a manufacturer’s activities.	The data provided was evaluated and found to support data already considered in the assessment.

2. Risk characterization

Summarized comment	Summarized response
Concerns were raised regarding the description of the characterization of risk to human health in the SAR.	Assessments made under the Chemicals Management Plan (CMP) consider various sources of information to identify critical values and apply multiple lines of evidence to determine and evaluate risks to human health.
Scientific evidence indicates that the mode of action (MOA) for the tissue-specific adenomas (benign tumors) and carcinomas (groups of cancerous cells) observed in the chronic National Toxicology Program (NTP) study are not relevant to humans because of the physiological differences between rodents and humans.	The newer references were reviewed and added to the screening assessment. These review reports have no additional new evidence. Various scientific studies evaluated in this screening assessment show that this genotoxic MOA is relevant to humans.

3. Human health risks

Summarized comment	Summarized response
The statement “Available evidence suggests a possible genotoxic mode of action for cumene-induced lung cancer” on page 16 in the screening assessment report is not adequately supported by the available scientific evidence. It also contradicts an this earlier statement in in the assessment: “On the basis of the available evidence, cumene as a parent chemical is generally considered to be non-genotoxic.”	Cumene-induced lung cancer is potentially due to a genotoxic MOA from intermediate metabolites of cumene. It does not contradict the earlier statement because cumene, as a parent chemical without metabolic activation, is not genotoxic.
The general population is not exposed to high levels of cumene and there are no indications that such exposure is expected to increase. Exposures, if any, are generally through occupational exposure.	Although increased exposure to cumene among the general population is unlikely, it is still possible. This statement is precautionary.

Summarized comment

Summarized response

The statement “Available evidence suggests a possible genotoxic mode of action for cumene-induced lung cancer” on page 16 in the screening assessment report is not adequately supported by the available scientific evidence. It also contradicts an this earlier statement in in the assessment: “On the basis of the available evidence, cumene as a parent chemical is generally considered to be non-genotoxic.”

Cumene-induced lung cancer is potentially due to a genotoxic MOA from intermediate metabolites of cumene. It does not contradict the earlier statement because cumene, as a parent chemical without metabolic activation, is not genotoxic.

The general population is not exposed to high levels of cumene and there are no indications that such exposure is expected to increase. Exposures, if any, are generally through occupational exposure.

Although increased exposure to cumene among the general population is unlikely, it is still possible. This statement is precautionary.

4. Conclusion

Summarized comment	Summarized response
Stakeholders support the overall conclusion that cumene does not meet the criteria set forth under paragraph 64(c) of the Canadian Environmental Protection Act (CEPA 1999) and therefore does not constitute a danger to human life or health. The weight-of-evidence and risk-based approach is commended.	Noted.
Scientific evidence supports classification of cumene as having a low potential for ecological risk. This is presented and concluded in the screening assessment.	Noted.
Scientific evidence supports the conclusion that the development of kidney tumours in the two year inhalation study of mice and rats (NTP, 2012) is specific to rats and therefore not relevant to humans.	Noted.
The draft SAR is balanced and representative of relevant public hazard and exposure pathway information.	Noted.

5. Risk management

Summarized comment	Summarized response
The Government of Canada should continue to rely on National Pollution Release Inventory (NPRI) data for tracking levels of exposure to substances released to the environment.	Comments are noted and were taken into consideration during the analysis of post-assessment follow-up activities.

6. Consultations & stakeholder engagement

Summarized comment	Summarized response
The Government of Canada should continue to consult with those providing data to the NPRI to develop effective risk management measures that do not cause undue administrative burden.	Government of Canada is committed to consulting with all affected stakeholders to develop effective and appropriate risk management measures.

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Date modified:: 2019-03-08

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