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Multi-stakeholder Technical Consultation:

Proposed Subgrouping of aromatic azo- and benzidine-based substances

Summary Report

Environment Canada
Health Canada

July 2012


(PDF Version - 221 KB)

Table of Contents

Introduction

The Chemicals Management Plan (CMP) was announced by the Government of Canada in December, 2006. The CMP is a comprehensive program designed to enhance the protection of the health of Canadians and their environment from harmful chemicals. Detailed information on the CMP is available at the Chemical Substances Website.

Moving forward in the CMP, a key initiative is the Substances Groupings Initiative. This initiative began with a Notice of Intent for the aromatic azo- and benzidine-based substance group, published on June 5, 2010. On October 8, 2011 an announcement of planned actions to assess and manage, where appropriate, the risk posed by certain substances to the health of Canadians and the environment, that applies to this group and eight additional groups of substances, was published in the Canada Gazette, Part I: Vol 145, No. 41 - October 8, 2011.

The aromatic azo- and benzidine-based substances grouping, consists of 358 substances which were identified as priorities for action through the categorization process. To address this class of substances, the Government of Canada proposed subgroups to cluster substances based on structural similarities, common functional uses and applications and physical-chemical properties. A technical consultation on the proposed subgroups was carried out on March 20, 2012 in Ottawa, with the specific objective of obtaining stakeholder input on the proposed subgrouping approach for the 358 substances[1]. The charge questions were formulated around the specific topics (overall subgrouping approach and subgroup specific questions) and sent to the participants in advance of the meeting. Participation included individuals from industry, environmental and health non-governmental organizations and aboriginal groups, as well as academia. Representatives from Health Canada (HC) and Environment Canada (EC) attended as participants/presenters as well as observers/note takers[2]. The consultation meeting consisted of a series of presentations from HC and EC. Presentations were followed by breakout sessions with charge questions and plenary discussion periods.

This report is a summary of stakeholder feedback and commentary. Feedback and comments are presented as we have understood them and are not reported verbatim. In many cases, the comments summarized below are feedback based on information presented at the workshop. These presentations are available upon request[3].

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Presentation 1: Background & Context

Stakeholder comments/questions included:

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Presentation 2: The Proposed Approach to Subgrouping

Stakeholder comments/questions included:

Charge Question 1: What do you see as the strengths of the proposed subgrouping approach?

Charge Question 2. Are there limitations to the proposed subgrouping approach and if so, how do you recommend to address them?

Charge Question 3. Are there other subgrouping approaches that you would like to recommend?

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Presentation 3: Subgroup by Subgroup Walkthrough

This session was designed to go through Subgroups one-by-one to address charge questions 4 and 5:

Charge Question 4: Should any substance belong to a different subgroup than proposed?

If so, please provide the rationale.

Charge Question 5: Should any substances be considered within the same structurally related grouping?

If so, please provide the rationale.

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Overarching Comments

Monoazo pigments

Benzidine-based Dyes

Benzidine Acid Dyes:

Benzidine Direct Dyes:

Benzidine Basic Dyes:

Azo Solvent Dyes

Azo Acid Dyes

Azo Direct Dyes

Azo Reactive Dyes

Azo Basic Dyes

Azo Mordant Dyes

Azo Food Dyes

Aromatic Amines and Benzidine derivatives

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Wrap up Discussion on the Proposed Approach to Subgrouping

Participants, including Government representatives, had further discussions on advantages and disadvantages of the proposed approach versus an aromatic amine breakdown product-oriented approach. Government representatives indicated a difficulty with a moiety-based approach is that, of the 358 substances in the grouping, analysis indicated approximately 200-300 theoretical/potential breakdown products, which presents a large number of substances on which to organize a subgrouping approach. Government representatives indicated they recognized that several substances may release a common aromatic amine of concern and that consideration of such a common moiety needs to be taken into consideration at some point in the approach. A comment was made that perhaps one approach versus the other might not be the path forward, but rather a combination of both would be most appropriate.

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Next Steps

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Appendix A – Technical Consultation Meeting Agenda

Technical Consultation Meeting Proposed Subgrouping of the Aromatic Azo- and Benzidine-based Substances

March 20th, 2012

Minto Suites Hotel (Salon Stanley)
185 Lyon Street North, Ottawa

Agenda

Objective of the Meeting:

To solicit input on the proposed subgrouping of the Aromatic Azo- and Benzidine-based substances

Technical Consultation Meeting Agenda
TimeItem
8:30Registration and Coffee
9:00

Welcome and Objective of Meeting Christine Norman, Director, Health Canada

Review of agenda and approach Kathleen Connelly, Intersol Group

Introductions

9:15

Background and Context HC/EC Officials

Q&A Participants

10:15Health Break
10:30

The Proposed Approach to Subgrouping the Substances

Presentation HC/EC Officials
Q&A Participants
Feedback Participants

Charge Question 1. What do you see as the strengths of the proposed subgrouping approach?

Charge Question 2. Are there limitations to the proposed subgrouping approach and if so, how do you recommend to address them?

Charge Question 3. Are there other subgrouping approaches that you would like to recommend?

12:00Lunch (not provided)
13:00

Subgroup by Subgroup Walkthrough
Description and rationale of each subgroup HC/EC Officials
 Feedback on each subgroup Participants

Charge Question 4. Should any substance belong to a different subgroup than proposed? If so, please provide the rationale.

Charge Question 5. Should any substances be considered within the same structurally related grouping? If so, please provide the rationale.

(Health Break 14:30 – 14:45)

16:00Recap and Next Steps Christine Norman, Director, Health Canada
16:30Meeting Close Kathleen Connelly, Intersol Group

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Appendix B – List of Participants

List of Participants
NameAffiliation
Abel, SusanFood and Consumer Product Association
Aikawa, BioHealth Canada
Albert, TawniaHealth Canada
Borkhoff, JoyceCantox/Intertek (ETAD[1])
Bullock, NeilCantox/Intertek (ETAD)
Connelly, KathleenIntersol Group
Cran, BruceConsumers Association of Canada
de Leon, FeCanadian Environmental Law Association
Dornan, LauraEnvironment Canada
Farago, DomenicoHealth Canada
Freeman, HaroldCollege of Textiles, North Carolina State University
Griffiths, AdamHealth Canada
Helmes, TuckerETAD North America (ETAD)
Hill, JonathanEnvironment Canada
Kneen, SohaInuit Tapiriit Kanatami (ITK)
Madray, SandraChemical Sensitivities Manitoba
Manarang-Pena, GraceCanadian Paints and Coatings Association
McElgunn, BarbaraCanadian Institute of Child Health / Learning Disabilities Association of Canada
Merritt, GlennFitzpatrick & Merritt (CPMA[2])
Montemayor, BetaCanadian Cosmetic, Toiletry and Fragrance Association
Mott, RobertSun Chemical (CPMA)
Norman, ChristineHealth Canada
Okonski, SahsaEnvironment Canada
Richardson, MaryCrooked Creek Conservancy Society of Athabasca
Seenundun, ShayestaHealth Canada
Seibert, EarlFlintGroup Pigments (CPMA)
Sharp, DonaldAssembly of First Nations
Tilli, PatClariant (ETAD)
Whitall, CheriHealth Canada
Wilke, DonCanadian Consumer Specialty Products Association / Industry Coordinating Group for CEPA 1999
[1] Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers
[2] CPMA: Color Pigments Manufacturers Association, Inc.

Footnotes

[1] See Appendix A for consultation meeting agenda.
[2] See Appendix B for a list of participants.
[3] Please contact Substances@ec.gc.ca.
[4] An azo pigment lake, alternatively referred to as a “toner” or a “lake,” is a salt-type pigment formed by precipitating a water-soluble anionic monoazo substance with a metal cation.
[5] Significant New Use Rules

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