Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

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SECTION 7 - Confidential Information

• 7.1 Claiming Confidentiality
• 7.2 Information Supplemental to a Confidentiality Claim
  • 7.2.1 General Confidentiality Claims
  • 7.2.2 Confidential Substance Identity Claims
    • 7.2.2.1 Masking Substance Identity
• 7.3 Determining Presence of Confidential Substances on Lists

Under section 313 of the Act, any notifier who provides information to the government may, at the same time, submit a written request that the information be treated as confidential. This feature ensures that genuine Confidential Business Information (CBI) is protected from public disclosure. The degree of protection given to information claimed to be confidential will be consistent with sections 314-321 of the Act and the provisions of the Access to Information Act.

7.1 Claiming Confidentiality

The confidentiality privileges described in section 313 of the Act can be satisfied by:

1. indicating which particular information is confidential using the appropriate column in the NSN reporting form; and
2. providing the information described in section 7.2 below.

7.2 Information Supplemental to a Confidentiality Claim

Each claim for confidentiality in an NSN package must be accompanied by the supplementary information detailed in sections 7.2.1 and 7.2.2 below. The NS program will review each confidentiality claim to determine whether or not it is valid. Notifiers will be advised if their request for confidentiality is unacceptable and given an opportunity to review and provide additional substantiation for their claim. If the supplementary information is not supplied, the confidentiality claim may be rejected, or, alternatively, the notifier may choose to withdraw the confidentiality claim on the substance.

7.2.1 General Confidentiality Claims

Information supplemental to any request for confidentiality includes a substantiation that the information meets each of the following criteria:

1. the information is confidential to the notifier;
2. the notifier has taken, and intends to continue to take, measures that are reasonable in the circumstances to maintain the confidentiality of the information;
3. the information is not, and has not been, reasonably obtainable by third persons by use of legitimate means except with the consent of the company;
4. the information is not available to the public;
5. disclosure of the information may reasonably be expected to cause substantial harm to the competitive position of the notifier; and
6. disclosure of the information may reasonably be expected to result in a material financial loss to the company or a material financial gain to its competitors.

If these six criteria are met, a claim may be indicated in the appropriate column of the NSN reporting form, and the Certification Statement appearing on the front of the NSN reporting form must be signed (see section 6.2.1.1 of these Guidelines).

7.2.2 Confidential Substance Identity Claims

Publication of an acceptable masked name is required under section 88 of the Act if publication of the actual identity of a substance would result in the release of CBI. Therefore, when claiming confidentiality for substance identity, the notifier must, in addition to the certification described in section 7.2.1 and 7.2.2c) of these Guidelines, provide the information, per the Masked Name Regulations, described in a) and b):

1. a proposed masked name developed in accordance with the prescribed masking procedure (see Appendix 7 of these Guidelines);
2. justification for masking more than one descriptive segment (see Appendix 7 of these Guidelines); and
3. the following information:
   1. the detrimental effects to the competitive position of the notifier's company that would result from the identity of the substance appearing on the DSL or in any other publication;
   2. the manner in which a competitor could use the identity of the substance;
   3. an indication of whether the identity of the substance has been kept confidential to the extent that competitors do not know it is being manufactured, imported or used;
   4. an indication of whether the substance has been patented and, consequently, disclosed through the patent;
   5. an indication of whether it is public knowledge (e.g., publications in technical journals or trade publications) that the substance is being manufactured, imported or used;
   6. the measures that have been taken to prevent undesired disclosure of the substance identity and the extent of any disclosures to date;
   7. an indication of whether the substance is, or will be, in an effluent, emission or waste entering the environment;
   8. an indication of whether the substance is, or will be, in a product available to the public, and whether the substance can be identified by analysis of the product;
   9. the purpose for which the substance is being, or will be, manufactured, imported or used; and
   10. an indication, to the best of the notifier's knowledge, of whether the NS program, another federal agency, a provincial or territorial agency or the agency of a foreign government has ever made a determination that this substance 1) has an immediate or long-term effect on the environment; 2) constitutes, or may constitute, a danger to the environment; or 3) constitutes, or may constitute, a danger to human life or health (if such a determination has been made, provide details).

7.2.2.1 Masking Substance Identity

The procedures for generating a masked name are also prescribed in the Masked Name Regulations. These procedures are the same as those used in developing the DSL and are described in Appendix 7 of these Guidelines.

Masking a substance name will be acceptable only to the extent necessary to disguise the identity of the substance, while retaining the generic molecular structure. In most cases, masking a single structural feature should be sufficient, although multiple masking will be acceptable if it can be justified (see section 4 of Appendix 7 of these Guidelines).

If the claim for confidentiality of substance identity is acceptable, the proposed masked name will be evaluated to determine whether or not it is consistent with the Masked Name Regulations. If judged consistent with the Masked Name Regulations, the masked name will be available for use in publications such as the DSL. If not, inconsistencies will be indicated to the notifier and an alternative name requested. The NS program will try to reach a consensus with the company on a masked name. If a consensus is not reached, the NS program will publish a masked name that, in its opinion, will respect the confidentiality claim of the company while retaining the generic molecular structure of the substance. Once a masked name has been accepted by the NS program, a confidential accession number will be assigned to the substance and given to the notifier only once the substance is eligible for addition on the confidential portion of the DSL or the NDSL.

There are additional fees associated with masked name applications, although the fee needs to be paid only once for a specific substance, not for each notification Schedule (see Appendix 3 of these Guidelines).

7.3 Determining Presence of Confidential Substances on Lists

Substances listed on the confidential portion of the DSL or NDSL are published with confidential accession numbers using masked identities that are named in a manner prescribed by the Masked Name Regulations as specified above. Any notifier who intends to manufacture or import a substance that he or she believes to be listed on the confidential portion of either of these lists may seek confirmation from the NS program. The NS program will respond to such an inquiry only if the notifier provides the NS program with a Notice of Bona Fide Intent to Manufacture or Import the substance. For more information on this, see section 2.3.1 of these Guidelines.