AGENCY: Canadian Department of Health, Hazardous Products Act
APPROVAL DATE: April 4, 2018
PUBLICATION DATE: April 18, 2018
SUMMARY: The amendment, which was initially proposed and published in the Canada Gazette, Part I on October 21, 2017, allows for the use of prescribed concentration ranges to protect the trade secret concentrations and concentration ranges of materials or substances in hazardous products.
BACKGROUND: The Workplace Hazardous Materials Information System (WHMIS), Canada’s national hazard communication standard, came into effect on October 31, 1988. It represents tripartite consensus between regulators, industry and organized labor. It is implemented through coordinated federal, provincial and territorial (FPT) legislation using an integrated approach that avoids duplication, inefficiency, and the potential for interprovincial trade barriers by allowing the application of a single consistent hazard communication system nationwide. WHMIS is supported by the Current Issues Committee (CIC), which includes representatives of FPT regulators, suppliers, employers and organized labor. The HPA requires consultation with these representatives prior to making or amending regulations under the HPA; therefore, the CIC is the mechanism by which discussions on industry’s proposal to protect the concentrations or concentration ranges of ingredients without having the burden and cost of the HMIRA application process were undertaken.
On February 11, 2015, the HPR came into force and the Controlled Products Regulations (CPR) were repealed. This fulfilled a commitment under the Canada–United States Regulatory Cooperation Council (RCC) to implement the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals in Canada without reducing the level of safety or protection for workers. This modified WHMIS is referred to as WHMIS 2015. Regulated parties are currently in transition from the old WHMIS to WHMIS 2015. The phases of transition were set up in such a way as to allow three steps to occur in sequence. Currently, all suppliers have the option of complying with the repealed CPR or the HPR. Manufacturers and importers (those responsible for bringing products to the Canadian market) must comply with the HPR by June 1, 2018, and then distributors (those responsible for reselling products on the Canadian market) and importers who use the imported product only in their workplace must comply with the HPR by September 1, 2018. Following this, there was national agreement among all FPT jurisdictions that the final stage of transition, which allows for updating of existing information in the workplace by employers, would be completed by December 1, 2018. This final transition deadline is set by the FPT jurisdictions responsible for occupational health and safety, not by Health Canada.
Industry representatives informed Health Canada officials that under the old CPR, some companies protected their CBI ingredient concentrations by disclosing prescribed concentration ranges rather than using the CBI protection mechanism provided by the HMIRA. Prescribed concentration ranges were generic ranges set out in the repealed CPR that companies could use when the concentration of an ingredient varied from batch to batch in the manufacturing of a product. The concentration ranges prescribed in the CPR were not retained in the HPR. Instead, the HPR require the actual concentrations or concentration ranges of ingredients that present health hazards to be disclosed. In order to protect the concentrations or concentration ranges of ingredients, industry must use the CBI protection mechanism provided by the HMIRA. Therefore, the protection of actual concentrations of ingredients that used to be possible by using the prescribed ranges in the CPR is only possible by submitting an application and fee under the HMIRA. This means that the number of filings Health Canada receives is predicted to increase.
Absent any changes to these HPR requirements, industry representatives have estimated that thousands of claims will need to be filed under the HMIRA in order to protect the concentrations or concentration ranges of ingredients as CBI when they transition to HPR compliance, and that these filings will cost millions of dollars. They have stated that the HMIRA requirements for CBI protection in Canada will result in increased compliance costs compared to the United States.
Alignment of the mechanisms to protect CBI in Canada and the United States was outside the scope of the RCC commitment. In the United States, as in Canada, companies are required to identify on product labels and SDSs when information is withheld due to a CBI claim. However, unlike in Canada, the United States approach allows suppliers to self-declare information as CBI, with no application or verification process by the United States Occupational Health and Safety Administration. There is no fee related to verification of CBI claims in the United States. In Canada, there is a fee associated with the Health Canada review of CBI applications.
Currently, all suppliers have the option of complying with either the CPR or the HPR. However, in order to protect ingredient concentrations or concentration ranges as CBI once suppliers transition to compliance with the HPR, they have to use the mechanism provided by the HMIRA. Since manufacturers and importers who resell imported hazardous products are required to comply with the HPR by June 1, 2018, they would have to submit any CBI claims before that date.
In order to avoid the burden of protecting CBI under the HMIRA, industry stakeholders proposed that prescribed concentration ranges could be permitted in the HPR and used to replace the actual concentrations and concentration ranges of ingredients rather than having to use the HMIRA to protect CBI. Their proposal would allow the supplier to choose whether to disclose the actual concentration or concentration range of the ingredient or to make use of the prescribed concentration ranges. As under the old WHMIS, suppliers would continue to have the option to submit HMIRA claims to protect ingredient names or concentrations or concentration ranges, but given this option of using prescribed concentration ranges, it is not expected that the number of filings Health Canada receives under the HMIRA will increase.
ALLOWED RANGES: The amendment allows the use of prescribed concentration ranges to protect ingredient concentrations and concentration ranges that are considered CBI without having to submit claims for exemption under the HMIRA. These prescribed concentration ranges are spelled out directly in the amended HPR. The concentrations and concentration ranges of ingredients in the product that present a health hazard must be disclosed on the SDS as either the actual concentration or actual concentration range of the material or substance (i.e. the ingredient) in the hazardous product; or one of the following prescribed concentration ranges within which the actual concentration or actual concentration range of the material or substance in the hazardous product falls:
(a) from 0.1 to 1%;
(b) from 0.5 to 1.5%;
(c) from 1 to 5%;
(d) from 3 to 7%;
(e) from 5 to 10%;
(f) from 7 to 13%;
(g) from 10 to 30%;
(h) from 15 to 40%;
(i) from 30 to 60%;
(j) from 45 to 70%;
(k) from 60 to 80%;
(l) from 65 to 85%; and
(m) from 80 to 100%.
In addition, if the actual concentration range falls between 0.1 and 30% and does not fit entirely into one of the prescribed concentration ranges of (a) to (g), a single range created by the combination of two applicable consecutive ranges between (a) and (g) may be disclosed instead, provided that the combined concentration range does not include any range that falls entirely outside the actual concentration range in which the ingredient is present in the hazardous product.
The amendment also requires any supplier who uses a prescribed concentration range to protect from disclosure the actual concentration or concentration range to provide immediately following that prescribed range a statement to the effect that the actual concentration or concentration range is withheld as a trade secret.
FOR MORE INFORMATION: Call Infotrac and speak to your Sales Representative for options related to previously published WHMIS SDS and the authoring of new WHMIS SDs moving forward.
Beginning April 18, 2018, you may visit http://www.gazette.gc.ca/rp-pr/p2/2018/index-eng.html for the full amendment.