Global Harmonization: Achieving compliance on both sides of the U.S./Canada Border

Written on: June 1, 2015 by Mike Moffatt

CaptureWith the release the final version of the Hazardous Products Regulations, Canada has finally followed the lead of the U.S. and entered the globally harmonized-era. However, do not let the term “globally harmonized” fool you, as there are still significant differences between the U.S. and Canadian regulations. These differences are already causing headaches for aerosol companies that sell products on both sides of the border.

We will devote future pieces to strategies aerosol companies can use in dealing with the differences in the two regulations, as we know the goal for many aerosol companies is to have documents that are jointly compliant with both U.S. and Canadian regulations. For the moment, we are advising our clients to postpone their plans to create jointly compliant documents, if possible, until the Canadian government releases advice on best practices for harmonization. We are also advising our clients to have a strategy for protecting confidential data, as well as to ensure their safety data sheets (SDS) and labels contain a Canadian contact address. Here is what we know about these issues so far:

Canadian Ingredient Disclosure Rules Are Relatively Restrictive
The U.S. Hazcom 2015 rules around ingredient disclosure (and concentration disclosure) are relatively forgiving. The authors of the SDS can make the determination for themselves on whether or not an ingredient (and/or its exact concentration) is a trade secret. That does not suggest that all trade secret claims are legitimate; there is a six-point test that must be followed. However, the initial determination of whether or not a trade secret claim is legitimate is left to the company in question.

In Canada, however, all trade secret claims must be made through the government, by applying for an HMIRA#. Documentation (along with an application fee) is required, so the Canadian government can make the determination if an ingredient (or an ingredient concentration) is a legitimate trade secret. Fortunately, companies are permitted to mask the confidential information while awaiting a determination.

Canada’s requirement of obtaining an HMIRA# to keep ingredients confidential on a SDS is a hold-over from the existing Controlled Products Regulations. However, the system did allow companies to mask the exact quantities of ingredients through the use of ingredient ranges, better known as WHMIS ranges. The new Hazardous Products Regulations, however, requires companies to use exact percentages, unless there are batch-to-batch variations or the like, in which case ranges are allowed. Due to this, we expect to see the number of HMIRA applications skyrocket as companies use HMIRA#s as a way to mask the exact concentrations of their ingredients on their SDS.

U.S.–Canada Disharmonization: Difficulty in Making Jointly Compliant Documents
An unexpected source of disharmonization exists between the Canadian and U.S. rules concerning required statements. Canada requires the use of Precautionary Statements as they are laid out in the U.N.’s “Purple Book”. The U.S. Occupational Safety & Health Administration’s (OSHA) Hazcom 2015, however, lays out specific Precautionary Statements that must be used. In many cases, these differ, as shown by the following example:

  • S.: Contaminated work clothing must not be allowed out of the workplace.
  • Canada: Contaminated work clothing should not be allowed out of the workplace.

[Emphasis added]

These and many other small discrepancies make it difficult to make documents that are compliant in both Canada and the U.S. Both governments are aware of the issue and we are told the Regulatory Cooperation Council between the two countries is looking into the issue. We expect to see guidance issued by the Canadian government on how to create jointly compliant documents between the two countries, although we are unsure when this will happen.

Requirement for a Canadian Address on Workplace Labels on SDS
Canada’s new Hazardous Products Regulations require an “initial supplier identifier,” defined as the “name, address and telephone number” to be placed on labels and SDS. This initial supplier identifier can either be:

  • The “manufacturer” defined as “a supplier who, in the course of business in Canada, manufactures, produces, processes, packages or labels a hazardous product and sells it.”
  • “The importer of the hazardous product who operates in Canada.”

[Emphasis added]

Put together, it is clear that the Hazardous Products Regulations creates the requirement of a Canadian address on SDS and workplace labels. The address itself could be anything from a factory to the home address of the importer, but the address must physically be in Canada.

Timelines to Act
Manufacturers have only two years to create compliant workplace labels and SDS for their products, so work is needed today if the timelines are to be met. While we are urging companies take a cautious approach in creating jointly compliant documents for the U.S. and Canada, there is still much they can be doing now. The first step is in ensuring that they have the necessary information to author those documents when the time comes. That could include, but is not limited to, product information from suppliers and ingredient information from regulatory databases. May 2017 will arrive quicker than we think, so it helps to be prepared.

In the next column, we hope to have guidance from the Canadian government on strategies aerosol manufacturers can use to ensure their labels and SDS are compliant in both countries. We will also inform you of additional GHS-related issues, as our experience with the first few months of GHS in the U.S. is that the initial launch of a regulation creates pitfalls the government had not anticipated. Until then!