Comments and responses on the proposed approach for confidentiality claims

In 2017, Environment and Climate Change Canada proposed the Approach to disclose confidential information and promote transparency in Chemical Management. Comments on this approach were provided by: Canadian Fuels Association; Arkema; Chemsynergy; U.S. Borax Inc.; Chemistry Industry Association of Canada; Canadian Association of Petroleum Producers; Prevent Cancer Now; and the American Chemistry Council.

1. Support, concerns and recommendations on the proposed approach

Comment summary

Response

Two stakeholders submitted comments supporting the proposed approach and some added that providing a rationale when claiming Confidential Business Information (CBI) is reasonable and appropriate.

The Government of Canada acknowledges and notes the comments.

 

A number of stakeholders said that the articulated goal may not recognize the significant importance of CBI.

The Government recognizes the importance of protecting Canadian commercial interests by ensuring that CBI is protected from disclosure. The approach aims to provide a balance between transparency and industry’s right to protect confidential information.

One stakeholder noted concern about the publication of Confidential Accession Numbers in the Canada Gazette. The stakeholder mentioned that those numbers should be only used after all other reasonable attempts to notify the owners of CBI are made. The stakeholder indicated that CBI should be treated with the highest discretion when reproducing for internal briefing purposes and in administrative practices.

The Government of Canada will make every effort to first work with those who claimed CBI. If the Government receives the required information from CBI owners, it will not proceed with further outreach. Please refer to the Process to validate older claims of CBI for substance identity flowchart.

A stakeholder recommended that Health Canada (HC) and Environment and Climate Change Canada (ECCC) continue to check summaries of data for possible CBI, and to not assume the use of such data as inconsequential. 

The Government of Canada acknowledges and notes the comments.

 

Stakeholders appreciated the inclusion of past comments from the Chemistry Industry Association of Canada (CIAC) as well as those of the Industry Coordinating Group (ICG) Survey Subcommittee in the approach.

Past comments from stakeholders have been considered in the approach.

 

A stakeholder proposed that the Government of Canada should use the Regulatory Cooperation Council to attempt to influence the design of the United States’ (US) CBI process to closer align it with Canada’s.

There are opportunities for alignment within the two governments and through the Regulatory Cooperation Council, Canada and the US are employing efforts toward regulatory co-operation that aim to address the systemic barriers impeding more advanced forms of collaboration, in regards to sharing confidential business information among regulators in the course of risk assessment.

A stakeholder noted that the confidential status of information should be repealed when that information results in a conclusion of potential toxicity for that substance in a risk assessment.  

The approach addresses instances where the Government would wish to review and disclose CBI. Please refer to the Review and disclosure of confidential information section of the approach.                             

 

A stakeholder stated that the “submitter” is not the only party involved. They noted that the responsibilities of the party to whom the information is provided are also important, including the requirement that information be adequate to have confidence in hazard and risk assessments.  

Where required the government includes a broader outreach step to consider other perspectives. Please refer to the Process to validate older claims of CBI for substance identity flowchart.

 

2. Concerns and clarification regarding the review of a confidentiality claim


Comment summary

Response

Stakeholders expressed concerns regarding the situation where the Government would decide to publish information or data submitted without contacting and asking the submitter to substantiate their original claim.

 

A reasonable attempt will be made to contact all submitters of the original CBI claim to validate the claim. When they cannot be reached, a broader outreach will be undertaken. However, there may be instances, such as emergencies, where notification of disclosure is given after the fact. Please see the Review and disclosure of confidential information section of the approach, and refer to the Process to validate older claims of CBI for substance identity” flowchart .

Stakeholders wondered whether there will be a specific review committee under the CMP that will address the continuity of CBI information.

The Government submission review teams are trained in CBI handling and do reviews of submitted information including CBI. Please refer to the Process to validate older claims of CBI for substance identity” flowchart.

A stakeholder indicated that the Government should ensure that it has all relevant information at its disposal before making such a significant decision as disclosing CBI.

The Government will make attempts to identify all of the impacts of disclosure of CBI. Please refer to the Review and disclosure of confidential information section of the approach and the Process to validate older claims of CBI for substance identity” flowchart.

 

Stakeholders stated that guidelines are needed as to when the Government of Canada is able to disclose information claimed as confidential. Parameters that would warrant the decision to release confidential information publicly should also be listed in CEPA 1999.

Sections 313 - 317 of CEPA 1999 address disclosure of information claimed as confidential.

 

A number of stakeholders suggested that in all cases, as opposed to in most cases, the submitter of the information should be contacted and asked to provide additional information to substantiate their original claim.  

A reasonable attempt will be made to contact all submitters of the original CBI claim to validate the claim. When they cannot be reached, a broader outreach will be undertaken. Please refer to the Process to validate older claims of CBI for substance identity flowchart.

 

 

A stakeholder needed clarification regarding whether there should be an attempt to contact all submitters so that companies are aware when their CBI claim will be released. 

 

A change was added in the approach as to when submitters will be contacted so that companies are aware when their CBI claim will be released.  The Government will make a reasonable attempt to contact a submitter prior to making any decisions on releasing or publishing CBI. However, there may be instances, such as emergencies, where notification of disclosure is given after the fact. Please refer to the Review and disclosure of confidential information section of the approach.

 

Stakeholders indicated that confidentiality claims should all be respected if given appropriate rationale, regardless of the kind information claimed as confidential. 

The Claiming confidentiality section of the approach describes when information is generally expected to be CBI. Information generally not expected to be confidential is also described in the approach. The approach aims to provide clarity on information that is truly confidential and information general not expected to be confidential.

A stakeholder recommended adding in the Review of a confidentiality claim section of the approach, a description explicitly mentioning that all elements of a confidentiality claim are reviewed for applicability and accuracy.

The approach outlines the required elements that must be submitted with a CBI claim, which will be thoroughly reviewed.

 

It was recommended that once publicly reviewed, all criteria to be met for confidentiality claims should be mandatory, clearly articulated, and added to the text of CEPA, not relegated to guidance documents.

The Government of Canada acknowledges and notes the comments.

 

3. Recommendations for confidential substance identity claims

Comment summary

Response

A stakeholder strongly encouraged the identification of the types of information that are ordinarily accepted as so competitively sensitive that no substantiation is required. 

In the interest of establishing maximum transparency, the Government of Canada requires justification for all CBI claims.

 

 

A stakeholder requested that the government ensure that where other information can be linked to a trade name that the two are not both discoverable. Allowing any link between the two would compromise CBI.     

In the event that the link between a company and a substance is CBI, information identifying the company must be kept confidential, unless the link can be found in the public domain, or written consent is obtained from the submitter to disclose that link. 

A stakeholder encouraged ECCC to refrain from disclosing the names of company personnel submitting CBI claims since company personnel are not relevant to environmental and human health transparency concerns.

The approach aims to address the submission of information on substances and does not address the disclosure of personal information.

A stakeholder expressed a concern that CBI would be compromised.  In response, the stakeholder requested that the Government ensures the protection of the sensitive information included in the trade names.

The Government recognizes the importance of protecting Canadian commercial interests by ensuring that CBI is protected from disclosure. The approach aims to provide a balance between transparency and industry’s right to protect confidential information.

4. Recommendations for the duration of confidentiality claims for substances

Comment summary

Response

A stakeholder recommended that ECCC publish a Notice of Intent in the Canada Gazette listing the confidential accession number(s) that they wish to declassify when more than 10 years old.

The Government of Canada is in agreement with the comment. Please refer to the Process to validate older claims of CBI for substance identity flowchart.

 

Stakeholders strongly encouraged the Government to contact submitters prior to the expiry of the confidentiality period and suggest allowing a minimum of 30 days to develop and provide the rationale to justify an extension to the protections of CBI.

A timeline of 30 days was added in the approach for submitters to develop and provide the rationale for the continued need for confidentiality.

 

Two stakeholders noted that there is no indication in the approach in regards to the identification and tracking of the duration of CBI claims. Stakeholders believe this is an important process that should be described in the proposed approach and should be transparent to industry stakeholders.

The approach is flexible in terms of timelines. When a submitter is contacted with respect to the review of a confidentiality claim, a process and timeline is communicated at the same time. In general, CBI claims last for 10 years, and a minimum of 30 days notice will be provided to submitters if the Government wishes to disclose CBI. Please see the Duration of confidentiality claims section of the approach.

 

A stakeholder recommended that ECCC send correspondence regarding CBI claims to CBI owners by registered mail to ensure receipt.

The Government of Canada acknowledges and notes the comments.

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