Pilot phase of the confidential substance identity claim review project
Purpose
The purpose of this document is to outline the results and lessons learned from the implementation of the pilot phase of the confidential substance identity claim review project.
Annex 1 provides a summary of the public comments received on the Notice of Intent for the pilot phase and their associated government responses.
Context
In October 2018, the Approach to disclose confidential information and promote transparency in chemicals management (the Approach) was published. This policy document set out several measures to help improve the transparency of the Chemicals Management Plan (CMP), including the introduction of a review of confidentiality claims for substance identity after a period of ten years. To implement this part of the Approach, a process to review confidentiality claims on substance identity that are older than ten years for substances on the Domestic Substances List (DSL) was developed, starting with a pilot phase to address 23 substances in the third phase of the CMP. The number of substances in the pilot phase increased to 24 due to the receipt of a voluntary request by a notifier to rescind the confidentiality claim on the identity of another substance. The pilot phase consisted of the substances listed in Annex 2 and Annex 3.
Results
Table 1 provides a summary of the number of substances in the pilot phase, whether they are owned by Canadian nominators, notifiers or foreign suppliers, as well as the responses received in regards to the disclosure of the substance identities.
| Owner of masked name | Number of substances | Willing to disclose | No response | Justification submitted to retain confidentiality |
|---|---|---|---|---|
| Canadian nominator or notifier | 13 | 12 | 1 | 0 |
| Foreign supplier | 11 | 6 | 1 | 4 |
| Total | 24 | 18 | 2 | 4 |
Table 2 provides an overview of the outcomes of the pilot phase. Three substances from the pilot phase were deleted from the confidential portion of the DSL and added to the non-confidential portion of the DSL by their Chemical Abstracts Service Registry Number (CAS RN) and descriptive chemical names (see Annex 2). The masked name of 4 substances were amended on the confidential portion of the DSL in accordance with the Masked Name Regulations. The disclosure of 17 substances were put on hold, as either no responses regarding the confidentiality claims were received or there are operational challenges with the administration of the DSL. The Government of Canada will consider alternative solutions to disclose the identities of substances for which no responses were received. One substance that consists of two main components will remain on the confidential portion of the DSL, but its identity will be disclosed in relevant documents to allow for a transparent risk assessment.
| Final Outcome | Number of substances |
|---|---|
| Disclose to substance name and CAS RN | 3 |
| Maintain CBI claim; update masked name on DSL listing | 4 |
| Disclosure on hold | 17* |
| Total | 24 |
*One substance (Confidential Accession Number (CAN) 11105-8) has two components, only one of which has a CAS RN.
Lessons learned and next steps
Environment and Climate Change Canada deliberately used a more extensive process for the pilot phase in order to test multiple aspects of the project. Based on the results of the pilot phase, the process for future phases will be streamlined to increase efficiency.
For example, during the targeted communication step of the pilot phase, nominators, notifiers, foreign suppliers and other companies known to have involvement with a substance were sent one letter for each substance with which they were involved. As such, certain companies received several copies of the letter, each addressing a different substance. In the future, only one letter identifying all relevant substances under review could be sent to each company during the targeted communication step rather than sending one letter per substance.
In addition, during the broad communication step of the pilot phase, a Notice of Intent (NOI) was published to inform the public of the government’s intent to disclose the identities of several substances. The substances included on the NOI were those for which the nominator, notifier or foreign supplier did not respond or indicated that the confidentiality claim was no longer necessary during the targeted communication step. In the future, the NOI may include only the substances for which no response is received from the original nominator, notifier or foreign supplier, rather than all the substances which Environment and Climate Change Canada intends to publically identify.
Updates to the text of the Approach and the process flowchart have been made in order to reflect a more streamlined process.
Annex 1: public comments and responses
On November 30, 2019, ECCC published a Notice of intent to amend the Domestic Substances List to disclose the identity of certain substances currently identified by a masked name in the Canada Gazette, Part I. Comments received in response to this Notice of Intent were considered.
| Comment summary | Response |
|---|---|
| A stakeholder requested that the government clearly define what constitutes “a reasonable attempt” on ECCC’s part to contact the nominator, notifier or foreign supplier. They expressed that in the case of imported substances, the foreign suppliers should be contacted and given the opportunity to substantiate the confidentiality claim. | This was taken into account in the pilot phase. The Government contacted nominators, foreign suppliers and other organizations known to be involved with the substances to provide them with the opportunity to substantiate the confidentiality claim on the substance identity or to provide comments. The Government plans on continuing this practice in future phases of the project. |
| A stakeholder expressed concern that the lack of response from a nominator, notifier or foreign supplier at the beginning of the process could lead to disclosure of confidential information without prior knowledge of one or more affected companies who may rely on the confidential identity. | This was taken into account in the pilot phase. One of the purposes of the Notice of Intent was to announce the intention to disclose certain substances and to allow affected companies to submit comments or justifications to maintain confidential identity claims. The Government plans on continuing this practice in future phases of the project. |
| A stakeholder requested that the government contact both the foreign supplier and nominator of a confidential substance before disclosing the substance identity in order to ensure that severe adverse impacts on foreign suppliers is avoided. | This was taken into account in the pilot phase. At least 24 hours prior to disclosing any information, the nominators and foreign suppliers will be given notice of the disclosure of the substance identity. |
Annex 2: substance identifiers for substances in the pilot phase before and after DSL amendment
| CAN - Before DSL Amendment | Masked Name - Before DSL Amendment | Outcome | CAS RN - After DSL Amendment | Substance Name - After DSL Amendment |
|---|---|---|---|---|
| 11145-3 | Alkylamine salt of complex phosphate ester | Disclose | 91745-46-9 | Amines, C12-14-alkyl, reaction products with hexanol, phosphorus oxide (P2O5), phosphorus sulfide (P2S5) and propylene oxide |
| 12208-4 | Silica gel, reaction product with chromic acid, bis(triphenylsilyl) ester and metal alkalkoxide | Disclose | 221455-10-3 | Silica gel, reaction products with chromic acid (H2CrO4) bis(triphenylsilyl) ester and ethoxydiethylaluminum |
| 17922-3 | 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-cyclohexanedimethanol and cycloalkane diol | Disclose | 261716-94-3 | 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-cyclohexanedimethanol and 2,2,4,4-Tetramethyl-1,3-cyclobutanediol |
| CAN - Before DSL Amendment | Masked Name - Before DSL Amendment | Status | CAN - After DSL Amendment | Masked Name - After DSL Amendment |
|---|---|---|---|---|
| 11053-1 | Fatty acids compounded with ethylenediamine | Maintain confidentiality claim | 11053-1 | Reaction products of alkyl carboxylic acid and hydrogenated castor oil fatty acid with alkyl diamine |
| 11555-8 | Fatty acids, reaction products with maleic anhydride and triethanolamine | Maintain confidentiality claim | 11555-8 | Amides, tall-oil fatty, tall-oil, (iminopolyalkanediyl)poly-, phosphates |
| 11556-0 | Fatty acids, reaction products with maleic anhydride | Maintain confidentiality claim | 11556-0 | Fatty acids, unsatd., maleated |
| 11557-1 | Fatty acids, reaction products with maleic anhydride and oleylamine | Maintain confidentiality claim | 11557-1 | Fatty acids, unsatd., maleated, reaction products with alkenamine |
Annex 3: list of substances for which disclosure is on hold
| CAN | Masked Name |
|---|---|
| 10001-2 | Borated reaction product of polybutenyl succinic anhydride with ethylene diamine-piperazine polymer |
| 10015-7 | Derivative of amines, polyethylenepoly-compounds with (polybutenyl) succinic anhydride |
| 10024-7 | Metal alkyldithiophosphates |
| 10026-0 | Alkenylsuccinic anhydride, product with polyethylenepolyamines and inorganic acid |
| 10680-6 | Alkenylsuccinimide, sulfurized |
| 10685-2 | Substituted dimercaptodithiazole |
| 10703-2 | Substituted alkylphenol, calcium salt |
| 11105-8 | Phosphorothioic acid, dialkyl ester, alkylamine salt |
| 11167-7 | Alkyl ester of styrene-maleic acid polymer, product with substituted heteromonocycle |
| 11200-4 | Substituted acrylate of a dimethyl, alkyl, substituted carbomonocycle, ammonium chloride derivative |
| 11482-7 | Formaldehyde, reaction product with phenol, polybutene derivs., polyethylene polyamines with alkenoic acid |
| 11483-8 | Formaldehyde, reaction product with phenol, polybutene derivs., polyethylene polyamines, alkenoic acid and metallo acid |
| 11487-3 | Fatty acids, tall-oil, reaction products with monomethyl maleate and a polyethylenepolyamine |
| 11496-3 | N,N' 2-Tris(6-isocyanatohexyl)imidodicarbonic diamide, α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene), heteromonocycle-methanol and 1-octadecanol adduct |
| 11497-4 | α-Fluoro-ω-[2-[(1-oxo-2-propenyl)oxy]ethyl]poly(difluromethylene), polymer with 2-methyl-2-propenoic acid phenylmethyl ester, (Z)-2-butenedioic acid bis(2-ethylhexyl) ester and 2-methyl-2-propenoic acid 2-(heteromonocycle) ethyl ester |
| 11498-5 | α-Fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]poly(difluoromethylene), polymer with 2-methyl-2-propenoic acid octadecyl ester and 2-methyl-2-propenoic acid 2-(heteromonocycle)ethyl ester |
| 11504-2 | α-Fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]poly(difluoro-methylene), polymer with 2-methyl-2-propenoic acid 1,1-dimethylethyl ester and 2-methyl-2-propenoic acid 2-(heteromonocycle)ethyl ester |
CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service Registry Number is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
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