June 2018

Health Canada amends the Hazardous Products Regulations

Health Canada has finally released a long-anticipated amendment to the Hazardous Products Regulation (HPR). This amendment allows industry to use prescribed concentration ranges to protect the actual concentrations of chemical ingredients as trade secret on safety data sheets (SDS) for hazardous mixtures in Canada.

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The Canadian requirements for implementation of the Globally Harmonized System (GHS) are set out in the Hazardous Products Act (HPA) and the HPR. The primary purpose of the HPR is to implement GHS without reducing the level of protection for workers offered under the repealed Controlled Products Regulations (CPR). Canadian GHS under the HPR is known as Workplace Hazardous Materials Information System (WHMIS) 2015.

On May 31, 2017, the day before the original WHMIS 2015 deadline for manufacturers and importers, Health Canada announced an extension of the first two transition milestones for WHMIS 2015 in the Canada Gazette. The extended June 1, 2018 deadline for manufactures and importers will have already passed at the time of publication of SPRAY’s June issue. The deadlines for distributors are quickly approaching. As of Sept. 1, 2018, all hazardous products sold or imported for use in a workplace in Canada must be compliant with WHMIS 2015. The final deadline for transition to WHMIS 2015 for employers in the workplace is Dec. 1, 2018.

Industry stakeholders expressed concerns about the level of protection for Confidential Business Information (CBI) under WHMIS 2015. Under the CPR, also known as WHMIS 1988, suppliers protected the concentrations of CBI ingredients with the prescribed concentration ranges set out in the regulations. However, the generic concentration ranges were not initially retained under WHMIS 2015. Originally, the HPR required the exact concentrations or true concentration ranges of hazardous ingredients to be disclosed on the SDS. To protect the concentrations of hazardous ingredients as CBI under the new regulation, a costly Hazardous Materials Information Review Act (HMIRA) claim would need to be filed to Health Canada. With the knowledge that there would be a large influx of new HMIRA claims, Health Canada agreed to examine the concerns raised by stakeholders. To allow more time to reach a consensus on the CBI issue and address other concerns raised by labor representatives, the first two deadlines for compliance with WHMIS 2015 were extended.

On April 18, 2018, the finalized HPR amendment was published in the Canada Gazette, Part II. This amendment provides industry with the option to use prescribed concentration ranges to protect the concentration of hazardous ingredients as CBI without submitting an HMIRA application. One change to the amendment that was originally proposed in October 2017 is to allow the combination of only two prescribed consecutive concentration ranges set out in the HPR. It is worth noting that the prescribed concentration ranges should only be used when ingredient concentrations are considered CBI and that a statement must be included to indicate that the prescribed concentration range(s) are being used to protect a trade secret.

Health Canada has acknowledged that many HMIRA claims relating to the protection of ingredient concentrations or concentration ranges have already been filed under WHMIS 2015. Health Canada is currently exploring options for addressing these claims and have indicated that over the coming months they will contact claimants impacted by the amendment to discuss options for their claims.

Additional issues raised by labor representatives relate to the protection of ingredients that are carcinogens, mutagens, reproductive toxins and respiratory sensitizers (CMRRs) as CBI and to the protection of product sectors excluded by WHMIS such as consumer products and manufactured articles. Labor representatives have asserted that CMRRs should not be eligible for CBI protection due to the higher risks associated with these substances. Labor representatives additionally regard the exclusion of products such as manufactured articles from the HPA as undermining workers’ “right to know.” As such, they are calling for the removal of all exclusions to the HPA due to the risk they present to workers. These additional issues remain under discussion and have not been addressed in the amendment. Health Canada has published a Notice of Intent to inform the public of its intentions to work with stakeholders to examine the issues and possible solutions to these concerns in detail.

Health Canada has developed two new fact sheets to help employers and distributors transition to WHMIS 2015. The fact sheets, which outline some good practices to consider in preparation for the transition, can be found at WHMIS.org under “resources.” Health Canada has also created a detailed Technical Guidance on the Requirements of the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR). It should be noted that this Technical Guidance has not been updated since the amendment, and therefore the option to use percent ranges to protect ingredient concentrations is not included. This Technical Guidance is a great resource for anyone with questions about the requirements of WHMIS 2015. Additional information can be found here.

 Draft Consumer Product Development Guidance Released

On March 23, 2018, Health Canada and the U.S. Consumer Product Safety Commission (CPSC) jointly released a draft Guidance on the Application of Human Factors to Consumer Products1. With a goal to help industry make safer consumer products, this document is of interest if your company is involved in the design and manufacture of consumer products sold in Canada and the U.S. The document provides recommendations to improve the utility and reduce the hazards related to the use of consumer products. By taking special consideration for the user throughout the stages of product development, it is possible to prevent product-related injuries and establish safe and effective use outcomes.

The draft guidance discusses the human factors discipline as an approach toward understanding how humans interact with other elements of a system. The human factors design principles suggest that development of products should be undertaken with the user in mind. Products can be made safer by considering under what conditions the user will interact with a product. There are four key human factors considerations when developing a new product: (1) the environment in which the product is used, (2) the product user, (3) the user interface or product design, and (4) the tasks to be accomplished by the user. By carefully considering human attributes, abilities, and limitations in the context of these factors during product development, a safe and effective use outcome may be achieved.

The draft guidance asserts that considering human factors from the early stages of product development is beneficial not only from a safety and usability perspective, but also from a cost perspective. Identifying critical human performance aspects during the early stages of product design will decrease long-term costs by reducing the need for expensive changes in design later in the process. Additionally, careful consideration of product usability will result in reduced support and help desk costs when the users find the product to be effective and easy to learn.

As in all aspects of life, when developing a new product we should expect the unexpected. It’s obvious to consider the target user and intended use of a product. However, it is also essential to consider those users and uses that fall outside the scope of what is typical. Product testing should be comprehensive, adequately sensitive and generalizable to real-world use by consumers. Test participants should represent the wide range of characteristics that end-users may possess. In this sense, it is important to account for diversity of ability and experience among users including unintended users of the product. It is also imperative to account for vulnerable users, such as children, that may not fully understand the risks of the product.

The draft guidance additionally recommends applying human factors principles to the packaging and labeling of the product, including instructions and other information. Instructions should allow the user to avoid harm caused by a product hazard that has not been eliminated. Technical documentation should be thorough, technically accurate, at an appropriate reading level and at a level of technical sophistication. All foreseeable hazards associated with use of the product should also be identified.

The draft guidance outlines the stages of the product design process and details human factors activities that can be performed during each phase. The comment period for the draft document ended on May 14, 2018. We will be sure to provide an update once the official guidance document is published. SPRAY

1Email [email protected] for a copy of the Guidance on the Application of Human Factors to Consumer Products draft.