Summary of Public Comments received on Proposed Approach Document for Domestic Substances List Polymers

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Comments on the consultation document for the Proposed approach under the Canadian EnvironmentalProtection Act, 1999 to address polymers on the Domestic Substances List that were identified as priorities during Categorization were provided by: Industry Coordinating Group for CEPA, Canadian Plastics Industry Association, Canadian Cosmetic, Toiletry and Fragrance Association, Canadian Paint and Coatings Association, Silicones Environmental, Health and Safety Council of North America, Nalco Canada Co, Canadian Vehicle Manufacturers’ Association, Dow Chemical Canada ULC, and Precept International Inc..

Domestic Substances List
TopicCommentResponse
MethodologyUse a group/class assessment approach based on use/exposure data when appropriate. How will the polymer approach address the issue of variability (e.g., different molecular weights, Reduced Regulatory Requirement (RRR) and non-RRR forms, polymeric and non-polymeric forms)?  Polymers may be treated as UVCBs. A Canadian and global move toward a Chemical Abstracts Service (CAS)# scheme would end the practice of one CAS# representing many individual polymers.A group/class approach for assessment will be considered, if appropriate. Many polymers have variable composition, or are intentionally manufactured in that manner. As such, it is possible that the properties for one polymer may vary due to the overall molecular weight. For polymers that have various molecular weight ranges under the same Chemical Abstracts Service registry number (CAS RN), it may be considered appropriate to use information on the version with the lowest expected molecular weight as a conservative approach to facilitate the characterization of its properties. The polymer approach document has been updated to address this aspect of the approach.
MethodologyNo mention of polymers designed to degrade, decompose or depolymerize.The potential for polymers to degrade, decompose, or depolymerize will be considered during the assessment process, along with the potential effects of any resulting products from these processes, where appropriate.
MethodologyThere is general support on the tiered approach, two-staged information gathering and use of RRR considerations. Changes to the flowchart, text and appendices were suggested, in addition to rearrangement of certain sections. More details, definitions and clarity are needed on certain design elements.The document has been updated based on public comments as well as input from consultations with industry, and input from the Chemicals Management Plan (CMP) Stakeholder Advisory Council (SAC). The approach document and accompanying flowchart have been revised to clarify technical aspects noted.
MethodologyNot in commerce (NIC) is currently limited to no indication of "industrial" activity. Other commercial activities may require exposure assessment.There is generally little information available for polymers that are not reported to be in commerce. However, searches for information regarding other uses will be conducted for each candidate polymer and will be considered for assessment.
Confidential business information (CBI)Schedule 9 information is likely proprietary, may require cooperation from foreign suppliers / manufacturers, and may not be available to the importer. Schedule 10 information is unlikely to be readily available.

Assessments are based upon available data and may result in use of conservative assumptions where data is limited.

Where composition of an imported product is unknown, Canadian companies are encouraged to forward the survey to the foreign supplier/manufacturer to verify if surveyed polymers are present. Foreign submitters may submit data directly to the Government of Canada and claim CBI as appropriate.

Reduced Regulatory Requirement (RRR) and Significant New Activity (SNAc) provisions

Application of SNAc/RRR flag to an existing polymer may result in “instant non-compliance”. Is it possible for a submitter to "opt-in" for a full assessment to avoid the RRR designation?

More detail is needed in SNAc conditions and should narrowly address the identified hazard.  SNAc should also reflect New Substances Notification (NSN) trigger volumes to prevent "instant non-compliance".  Advance warning should be provided before implementation of SNAc. SNAc should not be applied to existing activities.

A customized SNAc may be applied on a case-by-case basis as appropriate. Prior to a SNAc/RRR flag being applied to an existing polymer a Notice of Intent would be published in the Canada Gazette and a 60 day public comment period would allow for users of the polymer to notify the Government of potential compliance issues. If a submitter has information that they wish the Government to consider during the assessment they should submit that information through the survey or as voluntary submissions.
Reduced Regulatory Requirement (RRR) and Significant New Activity (SNAc) provisions

Downstream users and importers may have difficulty in obtaining data to support RRR determination, which typically resides with manufactures and is often CBI. How much detail is required in S.71 data to support RRR? This information may need to come from a 3rd party, hence the process should allow for 3rd party submission.

Other cutoffs or properties to determine RRR equivalency should be applied and S.71 should indicate if a molecular weight (MW) declaration is sufficient.

RRR polymers should be exempt from further data requirements of supporting information and submission of Schedule 10 data. "No further action" is recommended to follow RRR polymers that do not meet s64.

The approach document does not focus specifically on RRR criteria. It is recommended that companies submit any available information to inform the assessment for the polymers, either through the survey or a voluntary submission. Foreign suppliers/manufacturers may also submit the data directly to the Government and claim CBI when appropriate.

Information about the surveys and data requirements will be available at a later date.

Reduced Regulatory Requirement (RRR) and Significant New Activity (SNAc) provisions

Businesses should be allowed several years to change products or nominate non-RRR polymer through the New Substances Notification (NSN) Domestic Substances List (DSL) listing process.

New Substance Notifications for non-RRR polymers should specify what is required for the various submitters by breaking down the non-RRR category further in terms of chemistry that is of actual concern to industry.

Appropriate regulatory measures may be considered for RRR polymers that do not meet s64 under Canadian Environmental Protection Act (CEPA).

A customized SNAc may be applied on a case-by-case basis as appropriate.

CategorizationCEPA does not specify categorization criteria, but authorizes categorization and screening. Technical decisions reside with departments that can use professional judgment to determine criteria used in categorization and screening.Criteria to be used for categorization are specified in S.73, 1(a) and 1(b) of Canadian Environmental Protection Act, 1999 (CEPA 1999). The categorization exercise was completed in 2006 and the substances identified as priorities from that exercise are now being addressed under the Chemicals Management Plan.
CategorizationAn Excel spreadsheet with CAS RNs and categorization status should be made available on the Chemical Substances website for information gathering initiatives and to accompany surveys. Common names for polymers should be provided when possible.Common names, if available, will be used in the draft assessment as appropriate. Providing an Excel file with CAS RNs to accompany future surveys will be explored. The Categorization status of candidate polymers is included in the Appendix of the polymer approach document. This information may also be found through the Search Engine for the Results of DSL Categorization.
Categorization

A list of 20 substances meeting eco categorization criteria was provided by one commentator. However according to best available scientific information these substances do not pose a risk to the environment.

Several widely used major polymers in commerce are not listed in the appendix of approach, in addition to other polymers similar to a listed polymer.

To inform the assessment, companies are encouraged to submit additional information on polymers through the survey or as voluntary submissions.

The final polymer approach document contains a list of candidate polymers falling within the scope of this approach. These polymers were identified as priorities for assessment through the categorization process.

CategorizationBased on best available scientific data, some of the identified candidate substances would not meet eco categorization criteria and should not be included in the approach. The polymer approach should not include polymers that were not identified as priorities at Categorization.Although some of the identified candidate substances did not meet eco categorization criteria, they are considered to be priorities for assessment as identified by "other health criteria". 
Categorization68082-23-5 and 69430-24-6 do not fit in the polymer approachThese two CAS RNs are currently part of the posted approach. If further analysis shows that they do not meet the criteria for inclusion, they will be removed.
ConsultationsFurther consultations are needed for subject matters such as grouping, high hazard, multiple versions represented by one CAS RN. The Government should collaborate with competent organizations in assessment, not just governments.There may be further consultation for various aspects of this activity and issues as they arise.
Information Gathering

There were suggestions on the process and specifics of information gathering, such as the reporting threshold and special considerations for commodity polymers. The stage two survey should not just be limited to >1000 kg/year, but should consider other substances when volumes are close or if exposure/hazard properties show a concern.

For users and importers that have limited available information due to proprietary constraints, create a legislative requirement for CAS RN disclosure of polymers imported at or above 0.1 w/w%.

Required information and the volume threshold will be clearly stated in the surveys. In the polymer approach, candidate polymers that are not in commerce above the reporting threshold (based on DSL Inventory Update submissions) are screened for potential exposure/hazard properties. Those that are likely low hazard will be concluded as not meeting S.64 criteria. Remaining candidate polymers may be subject to the second survey.

There is no definition for "commodity polymers" under the Chemicals Management Plan and New Substances Notifications.

Companies in Canada are encouraged to share the survey with the foreign supplier/ manufacturer to verify the presence of surveyed polymers. Foreign submitters may also submit the data directly to the Government and claim CBI when appropriate. Creating additional legislation to enforce listing of polymers or chemicals at > 0.1 w/w% could not occur in the timeframe required for assessing polymers under the CMP.


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