Summary of public comments received on the draft screening assessment and risk management scope for the Resins and Rosins Group

Comments on the Draft Screening Assessment and Risk Management Scope for the Resins and Rosins Group, assessed under the Chemicals Management Plan (CMP), were submitted by Pine Chemistry Panel of the American Chemistry Council (ACC), Pine Chemicals Association International, Inc. (PCA), Forest Products Association of Canada (FPAC) together with National Council for Air and Stream Improvement (NCASI), Canadian Consumer Specialty Products Association (CCSPA), Canadian Paints and Coatings Association (CPCA), and a private citizen.

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

Chemical composition

Summarized comment Summarized response
Crude tall oil (CTO) and distilled tall oil (DTO) are different substances and should be clearly distinguished. Changes in the screening assessment have been made to further distinguish between CTO and DTO, where possible.
Section 64 conclusions should be revised to remove the implication that DTO and CTO are the same substance. DTO should not be included in any conclusions related to CTO because they are completely different substances. Distinctions between CTO and DTO were made in the assessment where possible; however, final s.64 conclusions were based on the CAS RN and DSL name provided in the DSL.
Substance compositional data used in the draft assessment are inaccurate. Additional information was submitted. The additional compositional data were considered in the screening assessment. A conservative approach was applied when allocating proportions of representative chemicals based on information obtained from the published literature and from stakeholders. When appropriate, a higher proportion of those representative chemicals that are considered more hazardous was selected in order to ensure the protective nature of the ecological assessment.
Information regarding the production of tall oil distillation products and rosin derivatives should be corrected. Additional information was submitted. Noted. Changes were made to the screening assessment based on additional information, where appropriate.
Hydrogenated rosin methyl esters (RHME) is not manufactured in Canada. Noted. After follow-up with stakeholders, changes were made to the screening assessment indicating that RHME is not manufactured in Canada.
The 2011 Screening Assessment for hydrogenated rosin and its esters should be emphasized in this risk assessment. Reference to the 2011 assessment for hydrogenated rosins was relevant and applied to two of the twelve substances assessed in the Resins and Rosins Group.

Ecological exposure

Summarized comment Summarized response
CTO releases from Canadian pulp mills should be based on actual [empirical] data. A site visit to a few Canadian facilities was conducted in December 2019. The findings from the site visit, as well as information submitted in response to a Canadian Environmental Protection Act (CEPA) Section 71 survey and voluntary industry follow-ups, provided the basis for CTO release and surface water exposure estimates.
The amount of CTO co-produced every year at pulp and paper facilities is highly variable. Noted. Additional information submitted by stakeholders was considered and the final Screening Assessment was revised to reflect the CTO yield. The yield is highly variable and an average was taken to obtain central tendency release estimates.
Crude tall oil losses from Canadian pulp mills to the environment may be overestimated. Additional information was submitted. The additional information was considered; however, site visits to a few facilities confirmed a release pathway for CTO (loss via evaporators’ condensates). This, along with an extensive literature search formed the basis for the re-estimates of CTO loss to wastewater and to the receiving surface water.
Relying on dated information from 1982 to estimate the number of CTO production sites should be reviewed. Recent responses to the 2016 CEPA section 71 survey and subsequent voluntary follow-up with the relevant industry in Canada will provide more accurate information. The assessment is focused on Canadian kraft pulp mills whose production of CTO has been confirmed using information submitted in response to a CEPA section 71 survey, voluntary industry follow-up, and also by FPAC and NCASI based on their membership knowledge. While the assessment is focused on the kraft pulping mills confirmed to produce CTO, there is recognition that other CTO producing mills may currently exist in Canada.
Rosin, calcium salt (RCa) is not very soluble in water and would not be expected to be 99% available to water. While information on the dissociation rate of RCa is not available, whole substance empirical values indicate moderate to high water solubility. Thus, equilibrium-partitioning estimates showing partitioning to water phase are considered appropriate.
The concern over toxicity of some of the resin acid components of CTO and DTO is mitigated in part via biodegradation. Additional information was submitted. Biodegradation data determined on the whole substance, and based on their components were considered in both the exposure and environmental persistence analyses of the risk assessment.
Additional information on resin acid releases into the environment from different sources was submitted for consideration for the assessment. While the additional submitted information was considered, no changes were made to the assessment since the current characterization of CTO-related resin acids was considered appropriate, and the additional information would have no impact the outcome of the assessment.
Additional information was submitted regarding the use of CTO, including a request for consideration of the indirect impact of CTO production on the use of land for different purposes (forest, crops, and others). Information submitted on potential additional CTO uses were considered; however, these did not impact the characterization of exposures of concern in the assessment, and were not found to be significant based on available information. Thus, these were not added to the assessment. Information on the impact of CTO production on land uses is beyond the scope of this assessment.

Ecological hazard and risk

Summarized comment Summarized response
The methodology used to calculate risk involving QSAR data for some representative chemicals is not optimal. Hazard determinations should include the use of actual test data derived using the whole substance. Additional information was submitted. Available whole substance information was evaluated and it was determined that some of the available information lacked detail regarding component contributions to the observed result, which limited the utility of these data in an environmental context. Thus, a weight of evidence (WoE) approach that considered both component-based and whole substance information was used to characterize risk.
The environmental fate, toxicity of resin acids and their intermediate products should be studied The environmental fate of representative resin acid components along with a well known and stable intermediate of resin acids (retene) were considered in the screening assessment.
Tall oil is not soluble in water and is not a dangerous substance to contaminate groundwater sources. Additional information was submitted. CTO is a complex material and contains some water soluble and poorly water soluble components, indicating its potential to enter the environment (e.g. ground water) and elicit harmful effects.
Modelled abietinal toxicity data is deficient. Experimental testing of abietinal is currently being conducted in Europe, and final assessment conclusions should wait until these experimental data are available. Additional information was submitted. While new data for abietinal are expected in the future, for the purpose of this screening risk assessment, it is considered that these data would not affect the overall conclusion respecting CTO because its presence in CTO is considered insignificant (2%).
Fatty acids in CTO can be metabolized and are not toxins. Toxicity values for fatty acids are irrelevant. Experimental and modelled aquatic toxicity data for fatty acids such as linoleic acid indicates various concentration dependent toxicological effects. The high biodegradability of fatty acids is indicated by the representative chemical linoleic acid in this assessment.
Although CTO has been proposed as toxic under section 64(a) of CEPA, many studies indicate that several physical and chemical properties of CTO make it a less harmful environmental pollutant. A WoE approach evaluating multiple lines of evidence to determine if a substance may pose a risk to human health or to the environment formed the basis for this screening assessment. Relevant data respecting physical, chemical, and other properties of CTO were weighed accordingly in this assessment when making the final determination of CTO’s potential harm to the environment.

Human health hazard

Summarized comment Summarized response
The screening assessment should provide more information on the related substances, glycerol esters of wood rosins. Additional information was submitted. These substances are not covered under the scope of this assessment. No changes were made to the screening assessment.
Human exposure to resin acids should be reduced to lowest feasible concentrations. The screening assessment concludes that current levels of exposure to resin acids do not pose a risk to the general population.
The dermal absorption used for linoleic acid is unrealistically high; what is the basis for this? The dermal absorption of 11% was based off a study cited in the screening assessment and was adjusted by the standard deviation and rounded to a whole number. Further details have been added to the screening assessment for clarity.
Additional information on rosin (CAS RN 8050-09-7) regarding dermal sensitization was submitted. Further details have been added to the screening assessment for clarity.
Human health effects of resin acids and their intermediate products should be studied. Information that was available on human health effects of resin acid components was considered in the screening assessment.

RM scope

Summarized comment Summarized response
Stakeholders have indicated they wish to be engaged with decisions on risk management for substances in the Resins and Rosins Group. The Government of Canada is committed to consulting with all affected stakeholders when developing risk management measures.
One stakeholder provided information on CTO use in products on the Canadian market. Noted.
One commenter sought confirmation that risk management actions will apply solely to CTO. Proposed risk management actions in the Risk Management Approach apply to CTO and address exposure scenarios of concern outlined in the screening assessment (i.e., CTO co-production process at kraft pulping or stand-alone facilities in Canada).
One stakeholder wondered why Canada is concerned with CTO while other jurisdictions (the European Union and the United States) are not. Based on the conclusions of the screening assessment, there is a risk of harm to the environment from the production of CTO in Canada. As such, the Government of Canada intends to implement risk management actions (as outlined in the Risk Management Approach) to reduce the risk to the environment.
One stakeholder encouraged aligning risk management actions with other jurisdictions to reduce additional regulatory burden. They also encouraged risk management to be applicable for significant releases to the environment only. Proposed risk management actions address the exposure sources of concern outlined in the screening assessment (i.e., CTO co-production process at kraft pulping or stand-alone facilities in Canada). Regulatory burden on affected stakeholders and alignment with other jurisdictions are factors considered in the selection and development of risk management measures.
Risk management should focus on improving CTO removal via wastewater treatment. Noted.
Alternatives to CTO in products were provided. The exposure scenario of concern outlined in the screening assessment is the co-production of CTO. The use of products that contain CTO was not identified as a concern.
Information about clean-up methods for CTO in wastewater were provided. Noted.
One party encourages the proper use of effluent limits and pollutant guidelines and recommends monitoring CTO-generating industrial releases. Noted.
Alternative agricultural methods such as crop rotation and the use of beneficial insects would make the use of DTO in organic pesticide products unnecessary. The exposure scenario of concern outlined in the screening assessment is the co-production of CTO. No activities related to DTO were identified as a concern at current levels of exposure.

Public comment period process

Summarized comment Summarized response
The public comment period should be extended. Specifications regarding the public comment period are described under subsection 77(5) of CEPA.
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