Minutes of the Face to Face Meeting of the Consumer Chemical Sector Working Group (CCSWG)

February 4-5th, 2008,
1800 Walkley Road Ottawa Ontario

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Members

Present

• Claude Chartrand
  Consumer Product Safety Bureau - Health Canada (Chair)
• James Hardy
  Consumer Product Safety Bureau - Health Canada
• Ann McConnell
  Soap and Detergent Association of Canada
• Stephen Rathlou
  Canadian Consumer Specialty Products Association
• Jacqui Jensky
  Canadian Consumer Specialty Products Association
• Lorraine Bennett
  Canadian Paint and Coatings Association
• Jeff Bennie
  Canadian Labour Congress
• David Pinsonnault
  Adhesives and Sealants Manufacturers Association of Canada
• Nalini Vaddapalli
  Option consommateurs
• Lyse Lefebvre
  Institut national de Santé publique du Québec
• Mae Burrows
  Labour Environmental Alliance Society
• Mel Fruitman
  Consumers Association of Canada
• Claire Checkland
  Canadian Cancer Association

Regrets

Observers

Present

• Nadira Rambritch
  Consumer Product Safety Bureau, Toronto Region - Health Canada
• Kim Headrick
  Policy and Programme Services - Health Canada
• Brenda Everson
  Policy and Programme Services - Health Canada
• Karen Kohrman
  U.S. Consumer Specialty Products Association
• Michael A. Babich
  U.S. Consumer Product Safety Commission
• Pierre Petelle
  Pest Management Regulatory Agency
• Martin Lawrence
  Pest Management Regulatory Agency
• Bruce Rebel
  Canadian Consumer Specialty Products Association
• Richard Sedlak
  U.S. Soap and Detergent Association
• Bratati Kar
  National WHMIS Office - Health Canada
• Madeleine Bird
  Option consommateurs
• Paul Chowhan
  Consumer Product Safety Bureau - Health Canada
  

Regrets

• Mary Toro
  U.S. Consumer Product Safety Commission

Agenda

February 4th, 2008

• 1. Welcome to all, general information and round-table
• 2. Introduction, history, context, objectives of the GHS
• 3. GHS global status regarding Consumer Chemicals
• 4. Break
• 5. The tools for implementation: prohibition and labelling risk/hazard
• 6. CPSC risk assessment process for consumer chemicals
• 7. Questions
• 8. Lunch
• 9. Technical Discussion - chronic hazard discussion document

February 5th

• 10. Brainstorming session on required elements of a Canadian risk-based approach
• 11. Break
• 12. Mixtures cut-off discussion document
• 13. Lunch
• 14. Transition period discussion document
• 15. Break
• 16. Round-table for comments
• 17. Next steps and concluding remarks

Meeting Summary

Item 1. Welcome to all, general information and round-table

Claude Chartrand (Chair) welcomed all participants and made everyone aware of the facilities at the member's and observer's disposal. Claude asked that only one person speak at a time and all discussions will be done in an orderly fashion.

A quick round-table ensued where each member/observer introduced themselves and their parent company or association. Finally, Claude introduced some new members to the CCSWG due to under representation of certain special interest groups.

Item 2. Introduction, history, context, objectives of the GHS

Claude gave the group a brief history of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) up to now. He also gave some background on the other sectors involved in Canada's implementation of the GHS: Transportation of Dangerous Goods (TDG), Pest Management Regulatory Agency (PMRA), and Workplace Hazardous Materials Information System (WHMIS).

Claude impressed on the group that our goal over the next two days is to discuss ways to integrate the GHS into the current CCCR, 2001 without lowering the current standards of protection. This constitutes the first major discussion of the CCSWG on the implementation of the GHS chronic criteria (apart from discussions within the Ad Hoc Expert Group for Chronic Hazards); all discussions up to this point have been on the acute criteria.

Claude stated that Health Canada will consider all options and points raised but the final decision to implement rests with Health Canada. He also briefly introduced the notion of a risk-based and hazard-based implementation strategy and stressed the importance that everyone agrees on these definitions in order for the following debates to be fruitful.

Item 3. GHS global status regarding Consumer Chemicals

Kim Headrick gave a presentation to the group regarding the current global implementation status of the GHS, specifically on consumer chemicals. She stated that most of her information for this presentation is from the European Union (EU) since they have more activity in this area than other countries.

Most recently, the EU has begun work on having their current REACH (Registration, Evaluation, Authorization and restriction of CHemical substances) system harmonized with the criteria in the GHS. Kim went on to discuss an UNSCEGHS paper (UN/SCEGHS/14/INF.18) and also presented a slideshow to facilitate the discussion. Status of other countries is as follows:

Canada: Moving past the 2008 date of implementation; waiting on action from CPSC before moving forward to finalize some of our interim decisions. We're currently in a good position to work with both EU and U.S. and come to the 'best fit' for Canadian implementation.

Asia: Been having lots of activities regarding training and research; recently held two workshops for Asian countries and have a large over-arching implementation scheme for all of them, including Japan.

China: Regularly sends delegates to the United Nations (UN) meetings and have had a large role in the debate pointing to an increased interest in the GHS.

Australia: Currently working on a code of practice.

New Zealand: GHS was introduced into their law but it's application will depend on how it's used by their trading partners.

South Africa: Held a regional workshop in 2004 and was identified as 1 of 6 areas of priority for action.

WHO and ILO: looking at updating their international control toolkit and international safety cards with GHS information.

Some discussion about whether the GHS was being implemented globally or regionally came out of this. Kim responded stating that the GHS will most likely begin as a regional implementation which will eventually feed into a global one.

The question of EU's choice to regulate on a hazard-based approach arose at this point. Kim indicated that this was in line with the EU's values at the time of their implementation. This caused some discussion about which direction Canada will choose with the U.S. already having a risk-based system in place. Claude indicated that this decision has not yet been taken and that our discussions today will feed into the decision-making.

Item 5. The tools for implementation: prohibition and labelling risk/hazard

Claude explained the general meanings behind a risk-based approach and a hazard-based one. At this point, Health Canada is open to suggestions in addition to the label elements under the GHS (i.e. a prohibition of a certain category); this regulatory approach is currently used by the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) for very hazardous substances.

Claude went on to state that the group should consider all possibilities with an open mind to ensure that all options for implementation get discussed.

Item 6. CPSC risk assessment process for consumer chemicals

Michael A. Babich of the U.S. Consumer Product Safety Commission (CPSC) led the group in a presentation regarding their risk-based model. He discussed the regulated and prohibited products under U.S. law, the 4-step risk assessment model, and a comparison of the current Canadian and U.S. methods. Michael stated that many labelling systems in the world are not solely hazard or risk based; they are mixtures of the two. He closed by stating that the point to labelling is to identify substantial risks and not the negligible ones.

Other points of interest from Mr. Babich's presentation included:

• Specification that the U.S. system is based on 'customary/reasonably foreseeable handling or use' and does not cover reasonably foreseeable misuse of a product.
• U.S. system does not require testing of products to validate acute or chronic effects; and
• U.S. system risk management options included: voluntary standards; mandatory
  labelling; mandatory performance standards; recalls; bans (last resort); information and
  education.

Item 7. Questions

The group asked Michael several questions including the threshold and non-threshold type hazards. Michael stated that risk assessments vary depending on many factors; this needs to be sorted out before the assessment process can be instituted.

Item 9. Technical Discussion - chronic hazard discussion document

Prior to discussion, Claude ensured that everyone understood what was meant by hazard-based and risk-based approaches. He then said that all parties in the Ad Hoc Expert Group for Chronic Hazards for Consumer Chemicals agreed that the five hazard categories listed below need to be implemented for consumer products. Finally, he closed his introduction saying that any addition to the CCCR, 2001 must raise the current level of protection, and not lower it.

Respiratory / Skin Sensitization

Health Canada's proposed option for this hazard class is to adopt it in a hazard-based approach. Multiple stakeholders suggested that a risk-based approach be used for this and all other chronic hazard classes (except germ cell mutagenicity) since a hazard-based label may dilute the hazard communication information on the product label.

It was suggested by another member that products be labelled in a hazard-based approach first and then be permitted to be risk-assessed where a lack of hazard can be shown. This would permit the consumer to carry out a risk assessment of their own where none was done by an expert body. The purpose of this would be to put the onus of proof on manufacturers that there are no hazardous chemicals in the product.

Some discussion ensued regarding the exposures and labelling of products in the workplace vs. household. The argument stated that the differences in these media are too different to warrant an exact replica of a WHMIS system for household products. To support this argument, the point was made that there are no controls with regard to use and exposure with consumer products, whereas in the workplace there is WHMIS labelling, mandatory OH&S training and regulations regarding the content and use of products.

It was agreed that the labelling used should be sensitive to the relative quantity of a hazardous chemical, such as a carcinogen, if there is less than 0.1% of the ingredient in the product. This will be a part of the 'cut-off' discussions tomorrow. There was then some discussion regarding the classification of a whole product and, when not possible, using data from individual ingredients. Both methods are currently accepted by the CCCR, 2001 and may be instituted in these categories when applicable.

Germ Cell Mutagenicity

Claude asked the group if anyone had comments on Health Canada's proposal to prohibit certain substances and require labelling on others. No comments were received and the group agreed to accept Health Canada's proposal; cut-off limits will be discussed tomorrow.

Carcinogenicity

Claude presented Health Canada's options to the group and asked for comments. Some members raised the point that a prohibition without qualifiers would capture products that are not necessarily dangerous - they asked for additional information to be put into the prohibition and otherwise rejected it.

It was proposed by some members to adopt all the labelling and classification information for this category in a risk-based system. This was noted as a new option #4. Another 5th option was proposed to have 'reverse' onus put on industry member to prove that their ingredients are not carcinogens.

Reproductive Toxicity

Claude presented Health Canada's options on this category, they are similar to those proposed for the Carcinogenicity category (see the 'Discussion Guide for the GHS Chronic Hazard Classes' for Health Canada's proposed options).

It was proposed by some members to adopt all the labelling and classification information for this category in a risk-based system. This was noted as a new option #6.

A question was raised about whether or not the CPSC reviews their risk assessments. Michael stated that the CPSC monitors companies at very regular intervals. At this point some members asked for this proposed risk assessment process to be policed by the government or some other enforcement body.

It was clarified that the risk assessment process would be carried out by industry members; the process itself will be developed by Health Canada and made to suit as many industry types as possible while still reporting on risk as best as possible. This will ensure government oversight over the whole process.

It was proposed that the public have access to this risk assessment information that is completed by industry members. In this fashion, consumers can have information to help them use the product correctly and safely.

Regarding the classification for 'effects on or via lactation', it was stated that there was a significant knowledge gap. There would need to be research in this area to ensure that all products/ingredients be properly assessed using the most up-to-date science.

Specific Target Organ Toxicity - Repeated Exposure

Claude again presented Health Canada's proposal on this category. After debate, the comments received on this category were consistent with those received regarding carcinogenicity and reproductive toxicity.

10. Brainstorming session on required elements of a Canadian risk-based approach

Claude introduced Kim Headrick again and stated that she will be leading a discussion on the elements required for a Canadian risk-based system to classify consumer products. Kim took the floor and asked all members to participate in the discussion. She asked everyone to share their thoughts and to be respectful of those from others.

Kim reiterated the meaning of a hazard-based approach and ensured that the group was comfortable with it. She then asked the group to take 5 minutes to write down the most important aspects they see as being part of a risk-assessment process. Kim then asked the group to share these thoughts with each other and she also wrote them down on a flip chart.

This generated a great deal of discussion and notes which were recorded and will be used in the future. These notes are available in the Appendix to these minutes.

There was some debate about the use of a risk-based system by large and small companies. Michael Babich stated that there are many businesses in the U.S. who specialize in risk assessment and help out smaller companies with this process.

12. Mixtures cut-off discussion document

Claude gave an explanation of the term 'cut-off' and spoke briefly about what is currently required under the CCCR, 2001. He also spoke about harmonizing as much as possible with the WHMIS cut-off levels.

Some members expressed concern over deciding on these arbitrary numbers for cut-off levels. Claude explained that all the chronic categories require these levels and the ones proposed were all put forward by the GHS purple book. These levels were also given in the discussion document which was forwarded to all members prior to the face-to-face meeting. In addition, the GHS purple book has sections which state that cut-offs can be modified depending on current knowledge when the exercise is done.

Some members raised the point that we need to harmonize as much as possible with trading partners on this matter, especially the United States. Other members pointed out that Asian countries including China and Japan, as well as the EU, are also important trading partners with Canada.

Respiratory / Skin Sensitizers

Claude asked if members were in support of the 0.1% cut-off limit for respiratory and skin sensitizers, which is also the limit being considered by the U.S. The limit was accepted by some and rejected by others.

Germ Cell Mutagenicity

Claude reminded the group that these products have no threshold values, as discussed previously. The group agreed that germ cell mutagens do not require a cut-off value for category 2. The group then discussed category 2 germ cell mutagens and came up with two different options: that no limit be used for category 2; or that a limit of 1% be used for category 2. There was no consensus on these two options. (The decision to prohibit all category 1 substances was accepted and can be seen under Agenda Item 9 'Germ Cell Mutagenicity'.)

Carcinogenicity

Claude stated that there are no options given for cut-offs of category 1 carcinogens under the GHS. The group then discussed the cut-off level for category 2 carcinogens; the GHS proposes 2 different levels: 1% and 0.1%. The group agreed on the 0.1% cut-off limit for category 2 carcinogens.

The group also agreed on using the GHS statement 1.3.3.2.2 as an overarching principle in the classification process. It states:

'1.3.3.2.2 Normally, the generic cut-off values/concentration limits adopted in the GHS should be applied uniformly in all jurisdictions and for all sectors. However, if the classifier has information that the hazard of an ingredient will be evident below the generic cut-off values/concentration limits, the mixture containing that ingredient should be classified accordingly.'

Reproductive Toxicity

Claude stated that this category has cut-off limits for categories 1, 2 and the effects on or via lactation. He also stated that WHMIS adopted the more stringent values for all 3 of these subclassifications. The group agreed to accept the cut-offs as proposed by Claude.

Specific Target Organ Toxicity - Repeated Exposure

Claude explained the cut-off values that were proposed for this classification category and also explained the WHMIS values chosen. There was a question regarding the arbitrary use of these values and accepting them simply on the fact that WHMIS is using them. Claude asked the group for additional comments and no one stated a position for or against the use of these values.

14. Transition period discussion document

Claude explained the concept of a 'transition period' and it's use in bringing new regulations into force. He then asked all members to consider the 3 options proposed in the transition period discussion document and to share their opinions on the best possible solution.

A suggestion was made to remove retailers from the requirements of the transition period. This is not possible due to the requirements of the HPA.

Members agreed that a progressive approach is the best route to take. No set year limits were decided upon and it was also decided that less hazardous products would be given longer transition times than more hazardous ones.

Finally, while no set year limits were decided, the possibility of hazard-labelling regulations coming in within the next three to five years was discussed.

16. Round-table for comments

Claude opened the floor to all to make comments.

Some members asked about the decision making process that will govern how GHS is implemented. Claude responded stating that this session was an information gathering one and that the final decision would be taken by the Minister of Health.

17. Next steps and concluding remarks

Members were told that they would be provided with the minutes upon their completion for comments in the near future. All were thanked for attending.

Appendix - Flip-Chart Notes for Whole Session

Session Objectives - Page 1

• To identify general elements of a risk-based model for consumer chemical products containing substances with chronic health effects

Session Objectives - Page 2

• To identify specific elements required for
  • Implementing
  • Monitoring
  • Enforcing
  • Evaluating
• A risk-based approach.

Misc - Page 1

• Risk = Hazard X Exposure
• Hazard ID --> label
  • Use GHS classification criteria
  • List

Parking Lot - Page 1

• HC definition
  • CEPA
  • Cosmetics
• Risk Characterization definition
  • HC, EC, International
• Ingredient Disclosure

Exposure Assessment - Page 1

• bioavailable
• how product used
• frequency
• likely cumulative exposure
• route of exposure
• quantities available
• where product used

Exposure Assessment - Page 2

• duration of exposure
• product used by itself or in combination
• physical form of product
• consideration on vulnerable populations √√
• safe threshold

Exposure Assessment - Page 3

• chemical properties
• immunity
• physical contours (packaging)
• precautionary measures
• amount of chemical in product
• intensity of exposure
• severity of exposure
• likeliness of misuse

Exposure Assessment - Page 4

• synergistic exposure of chemicals
  • potentiation
• does mixing affect the product
• likeliness of overuse
• time of the year

Exposure Assessment - Page 5

• Dose Response
  • Depends on substance
  • Vulnerability
  • Amount of substance and bio response observed at various exposure levels
  • Consider all available evidence
  • Threshold
  • Precautionary approach
  • Safety factors

Exposure Assessment - Page 6

• existing data on product
• existing data on ingredients
• statistical analysis
  • strength of data

Exposure Assessment - Page 7

• Risk Characterization
  • Conclusion of 1, 2, 3
  • Socio-economic consideration
  • Modelling
  • Recognized uncertainties
    • Lack of info

Exposure Assessment - Page 8

• Labelling - Hazard Based
  • GHS standardized elements and precautionary info
  • Add 'risk statement'
  • Substance ID

Exposure Assessment - Page 9

• Risk Based Labelling Options
  • "contains 'X' and may do 'Y'"
  • no label
  • "contains 'X' but safe to use under these conditions" and no GHS symbol/elements
  • GHS label elements if hazard is going to occur
  • Chem. And route of exposure
  • Ingredient disclosure
• assume products are acceptable to be marketed