Summary of public comments received on the draft screening assessment for Poly(alkoxylates/ethers) Group

Comments on the draft screening assessment for the Poly(alkoxylates/ethers) Group, assessed under the Chemicals Management Plan (CMP), were submitted by Alkylphenols & Ethoxylates Research Council, Canadian Consumer Specialty Products Association, Canadian Network for Human Health and the Environment, and TTM Technologies.

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

Overarching

Comment summary 1: A stakeholder indicated that they are using products containing substances listed in this screening assessment at low quantities.

Response 1: Noted.

Comment summary 2: Assistance is offered, should additional information be required. 

Response 2: Noted.

Comment summary 3: There is a lack of questioning whether the product is needed, and the environmental and human health implications of its production.

Response 3: The screening assessment does not include product need or value but assesses hazard and exposure using the data available at the time. The conclusion is considered to be protective of both human health and the environment.

Comment summary 4: The screening assessment does not consider the precursor products/reactants and/or degradation products.

Response 4: The scope of screening assessments does not include evaluation of the chemicals used in their production, except with regard to their impact on the composition of, or residual presence in, products, which is being assessed. Degradation products can be considered when information is available.

In the case of polymers, reactants used to produce the polymers are chemically reacted into the polymers. These reactants are generally not regenerated through environmental degradation. For the substances in this screening assessment, complete environmental degradation products include carbon dioxide and water. When appropriate, the degradation products were given additional consideration, as was done for OPEs.

Comment summary 5: The stakeholder is concerned that the screening assessment does not consider exposure of Canadians and the environment located in close proximity to the pesticidal use operations.

Summary 5: In Canada, pesticides are regulated federally under the Pest Control Products Act (PCPA), which is administered by Health Canada’s Pest Management Regulatory Agency (PMRA). The PMRA’s number one priority is to protect the health and safety of Canadians and the environment.

Before a pesticide is allowed to be used or sold in Canada, it must undergo a rigorous scientific assessment process that provides reasonable certainty that no harm to human health and the environment will occur when pesticides are used according to label directions. This includes an occupational/bystander risk assessment.

In order to continue to monitor for safety after pesticides are registered, Health Canada collects pesticide incident reports from Canadians. The public may also report violations to the PCPA, including those they believe to be related to pesticide use, by completing Health Canada’s Complaint and Violation Report.

Comment summary 6: The stakeholder is concerned that the screening assessment is based on the current market use of the products, without consideration for potential growth in the market in the near future.

Response 6: Information gathering involves collecting information on a substance or group of substances from a variety of published and unpublished sources, stakeholders and various databases. The screening assessment of the substances, utilizes information available on market use.  Information on trends in use pattern or exposures can be taken into consideration when available. The Identification of Risk Assessment Priorities approach outlines the systematic collection, consolidation and analysis of new information, in order to determine appropriate action, including risk assessment, for substances with new information.

Comment summary 7: The stakeholder is concerned that the extraction of starting materials such as propylene (used in the manufacture of PPG) from petroleum products poses environmental and human health risks.

Response 7: Petroleum hydrocarbons (such as propylene) are not used in the manufacture of PPG.

Comment summary 8: The stakeholder agrees to the approach taken and the proposed risk assessment outcome for the two OPE substances.

Response 8: Noted.

Information and data gaps

Comment summary 9: The stakeholder indicates that PF produces formaldehyde, which has been shown to be toxic; therefore, PF should be regulated in the same way as formaldehyde.

Response 9: This screening assessment focuses on the exposures and risks of PF, as at room temperature the release of formaldehyde from PF is slow and results in concentration increases that are minuscule in comparison to the typical levels of formaldehyde in the environment. The hazards of and exposures to formaldehyde have been assessed previously by Health Canada and Environment and Climate Change Canada. Information on uses of PF can inform risk management activities on formaldehyde.

Comment summary 10: The stakeholder is concerned that exposure to formaldehyde when used as a disinfectant poses a health risk.

Response 10: This screening assessment focuses on the exposures and risks of PF as well as the release of formaldehyde from PF. On the basis of the slow liberation of formaldehyde from PF at room temperature, it is expected that the amount of this additional formaldehyde (such as disinfectant) would be minuscule in comparison to the typical levels of formaldehyde in the environment.

Human health assessment

Comment summary 11: The stakeholder suggests that E-FAST exposure calculations are inaccurate for children.

Response 11: E-FAST estimation for exposure calculations considers body weights, regardless of the age.

Comment summary 12: The stakeholder suggests that occupational exposure should be considered in this screening assessment.

Response 12: Human health assessments 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.

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.

Comment summary 13: The stakeholder indicates that oral exposure to PPG may occur through the use of food packaging where it has migrated into the food.

Response 13: Oral exposure to PPG from such use was considered in the assessment. Even under very conservative, worst-case assumptions (i.e., 100% migration), exposure is expected to be very low.

Comment summary 14: The stakeholder suggests that dermal and oral exposure estimates may not be sufficiently conservative.

Response 14: Toothpaste and toys were considered for dermal exposure estimation. Even assuming a theoretical worst-case scenario (i.e., based on 100% migration), the oral exposure is expected to be very low.

Comment summary 15: The stakeholder recommends that the health risks for formaldehyde also be evaluated in this screening assessment.

Response 15: This screening assessment focuses more on the exposures and risks of PF, as the hazards and exposures to formaldehyde have been assessed previously by Health Canada and Environment and Climate Change Canada. In addition, formaldehyde is subject to risk management.

Comment summary 16: The stakeholder indicates that the release of OPEs and ANEOs in the environment pose a human health risk through drinking water.

Response 16: The polymers are expected to bind to particles in the water and to be sufficiently diluted before reaching drinking water so as to not pose a human health risk as a result of indirect exposure. In addition, the indirect exposure of the general population to ANEOs through environmental media such as drinking water is expected to be minimal.

Comment summary 17: The stakeholder states that OPEs are endocrine disruptors and that risk to humans was not properly assessed.

Response 17: OPEs are not considered to pose a risk for endocrine disruption at the current exposure levels to the general population.

Ecological assessment

Comment summary 18: The stakeholder is concerned that environmental exposures resulting from use of consumer products are underestimated due to the range of wastewater treatment processes, as well as release to septic systems.

Comment summary 19: The stakeholder finds that the degradation pathway in wastewater treatment and the environment summarized in the OPEs section includes some inaccuracies. However, the summary correctly describes the degradation properties and fate of OPEs.

Response 19: The text in the screening assessment has been revised and the associated references have been updated.

Comment summary 20: The screening assessment should provide discussion on toxicity equivalency factors (TEFs), and should emphasize the critical toxicity value chosen for the two OPEs is applicable to octyl phenol. 

Response 20: Additional detail has been provided in the screening assessment on how TEFs and TEQs were obtained.

Comment Summary 21: The stakeholder agrees that the approach to considering estrogenic effects of octyl phenol in the screening assessment is conservative and appropriate. However, the stakeholder noted that several studies quoted in the screening assessment should be used with caution due to study limitations.

Response 21: The text in the screening assessment has been revised to indicate that effects on invertebrate growth and development may be the result of potential estrogenic effects.

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