Public comments summary for the acrylates and methacrylates group draft screening assessment report

Comments on the draft Screening Assessment Report (dSAR) for the Acrylates and Methacrylates Group to be addressed as part of the Chemicals Management Plan (CMP) were submitted by Basic Acrylic Monomer Manufacturers (BAMM), Canadian Consumer Specialty Products Association (CCSPA), KAND Environmental Health & Safety Services Inc., and the Methacrylate Producers Association (MPA).

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

1. Information & data updates

Comment summary

Response

Some material safety data sheets (MSDS) cited in the draft SAR appear to be out of date, inaccurate, or not compliant with the Globally Harmonized System of Classification & Labeling of Chemicals (GHS).

Information from the most recent version of an available MSDS was used to inform the SAR. Compliance with the GHS was not considered because these MSDSs were published before or during the transition to GHS.

To improve transparency and build credibility, add a summary of the actual data and information from the Ecological Risk Classification of Organic Substances (ERC) to the draft SAR.

This information is found in the supporting document “Data used to create substance-specific hazard and exposure profiles and assign risk classifications in the Ecological Risk Classification of organic substances”. A copy of this document can be obtained from: substances@ec.gc.ca

2. Methodology

Comment summary

Response

It is not clear whether a peer review was conducted for this draft SAR.

An external peer review is not required because this is a type 3-1 assessment. However, references cited in the human health section of the dSAR were already peer-reviewed and/or endorsed by international government authorities. Also, the ecological portion of the dSAR is based on the peer-reviewed ERC that was published on July 30, 2016 for a 60-day public review.

In Section 3, add a statement to identify which chemical and physical properties were used.

This information is in Appendix B of the SAR.

New approaches are appreciated including those that apply ecological risk classification of organic substances, thresholds of toxicological concern, and rapid screening for substances with limited exposures among general populations.

Noted.

3. Sources and uses

Comment summary

Response

Revise the dSAR so that monomeric acrylates are not confused with the polymers made from these monomers; and make a clear distinction between use of acrylates for production of polymers, and the use of polymers made from acrylates.

Throughout the document, and particularly in the section on “Sources and Uses”, the final SAR was revised to distinguish between use of acrylates to produce polymers and use of polymers made from acrylates.

It is surprising that the reported quantity of acrylic acid imported into Canada is not higher.

The quantity of acrylic acid is based on responses to a Section 71 survey conducted under the Canadian environmental Protection Act, 1999 (CEPA).

It is positive that intentional uses are differentiated from incidental use in section 4 of the dSAR.

Noted.

The dSAR is a fair and reasonable representation of the potential conditions that exist in Canada for these substances.

Noted.

4. Ecological risk

Comment summary

Response

The dSAR applied the ERC to characterize 2-ethyhexyl acrylate as a low hazard, having low exposure, and therefore a low risk. However, an overall moderate risk was attributed to this substance because of the potential for exposures to increase significantly. Confirm if this change from low to moderate risk is based on a mathematical calculation or other criteria in the assessment.

Although the ERC recognized 2-ethyhexyl acrylate as having low hazard and low exposure, an additional risk-based evaluation of this substance identified an increased potential for concern near points of discharge to receiving waters. This increased the risk classification from low to moderate

The dSAR identifies butyl acrylate (n-BA) as high hazard, based on mode of action, and low exposure. The Government of Canada should also review empirical data on n-BA from the Economic Co-operation and Development (OECD) Screening Information Dataset (SIDS) Initial Assessments, or from the European Chemicals Agency (ECHA) dissemination database.

While empirical data is available in the OECD SIDS Initial Assessments, the ERC considers additional non-traditional lines of evidence when classifying hazard, exposure, and risk potential. This helps to determine if further ecological assessment is required. Through the ERC, n-BA was characterized as high hazard due to its reactive mode of action and elevated ratio for toxicity.

However, as a low exposure risk, it was determined that there is no need for additional ecological assessment, and the hazard was not further characterized.

5. Human health risks

Comment summary

Response

The high concentrations presented in the dSAR may refer to starting material rather than concentrations in the final products available on the market.

The concentration data from notifications submitted to the Government of Canada under the Cosmetic Regulations and publically available MSDSs were used as provided.

6. Conclusion

Comment summary

Response

The conclusions presented in this draft SAR are supported.

Noted.

7. Risk management

Comment summary

Response

If there is a need to monitor future exposures due to potential volume increases, these substances should be added to the Domestic Substances List (DSL) for future Inventory Update.

Follow-up actions to monitor changes in exposures are not considered at this time because increases of these substances in the environment to levels that are harmful to human and ecological health are not expected.

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