Cassandra Taylor
Regulatory Specialist,
Nexreg Compliance Inc.
Regulatory International
Influences
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.
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level of protection for workers offered under the repealed Controlled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 at http://www.whmis.gc.ca.
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
24 Spray June 2018