REGULATORY MEMORANDUM

Proposed Amendments to the Hazardous Products Regulations in Canada

On December 19, 2020, the Department of Health in Canada published in the Canada Gazette, Part I a notice of its intent to amend the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the classification, labeling, and Safety Data Sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The HPR is based on the fifth revised edition (Rev 5) of the United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The proposed changes include updating the HPR to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed is two years. The notice is open for comments for 70 days from the date of publication.

Background

On February 11, 2015, the HPR was published in the Canada Gazette, Part II. The HPR revised and amended the previous Hazardous Products Act substantially, as it introduced the GHS concepts into the regulatory framework. In addition, it modified the Workplace Hazardous Materials Information System (WHMIS), which had not been updated since it first became law in 1988. The new system is referred to as WHMIS 2015. At the time of publication, the HPR was based on Rev 5 GHS. The UN updates and revises the GHS model on a bi-annual basis, and at this time, the most current version is Rev 8. Canada is proposing an update to align with Rev 7 and includes other points of clarification and revision in the Gazette, Part I notice.

Highlights of the major changes include the following:

  • Updates and amendments to terminology to align with Rev 7. This includes updates to several health and physical hazard class definitions;
  • Revisions and amendments to the HPR Subpart that includes Flammable Gases. These changes include revised definitions and the incorporation of pyrophoric gases;
  • Revisions and amendments to the HPR Subpart that is now Flammable Aerosols. These changes include adding non-flammable aerosols, revising the definitions, and renaming the Subpart Aerosols;
  • Clarifications on approaches to classification for Aerosols versus Gases Under Pressure;
  • Expansion of the criteria and methods for the HPR Subpart for Oxidizing Solids;
  • Amendments to the criteria for classification as a skin corrosive in the HPR Subpart for Skin Corrosion/Irritation;
  • Corrections to the HPR Subpart for Combustible Dusts; and
  • Changes to Section 14 Transport information in the HPR Schedule I Information Elements on the Safety Data Sheet.

A more detailed discussion on a few of the more significant changes follows.

Changes to HPR Subparts that address certain physical hazard classes to align to Rev 7 include significant but necessary changes to Flammable Gases and Aerosols. The revisions include the incorporation of pyrophoric gases into the Flammable Gases Subpart. Currently, pyrophoric gases are addressed in a separate HPR Subpart, as this physical hazard was not part of Rev 5, but was added to the UN GHS model in a later revision. In addition, the intention originally to include pyrophoric gases as a separate Subpart helped to align the HPR with the additional labeling elements the United States added when the U.S. Occupational Safety and Health Administration (OSHA) updated the Hazard Communications Standard (HCS) in 2012. The revisions to the Flammable Aerosols Subpart to rename to Aerosols and add non-flammable aerosols is necessary to align with Rev 7.

The changes to terminology have a broader impact, and as noted in the Gazette, Part I, include amendments to several health hazard classes, acute toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory and skin sensitization, and reproductive toxicity. In addition, new definitions are noted for germ cell mutagenicity and carcinogenicity.

A comparison of the definitions from the relevant Subpart in the current HPR, the proposed changes to the HPR, and the definitions in Rev 7 are provided below for germ cell mutagenicity and carcinogenicity.

Hazard Class

Subpart Definition with Proposed Changes

Rev 7 GHS Definition

Germ Cell Mutagenicity

Genotoxicity means the alteration of the structure, information content or segregation of DNA by an agent or process, including those agents or processes that cause DNA damage by interfering with normal replication processes or that in a non-physiological manner temporarily alter its replication.

Germ cell mutagen means a mixture or substance that is liable to lead to an increased occurrence of mutations in the germ cells of a population.

Mutagenic means, in relation to a mixture or substance, liable to lead to an increased occurrence of mutations in populations of cells or organisms.

Mutagenicity means an increased occurrence of mutations in populations of cells or organisms.

Mutation means a permanent change in the amount or structure of the genetic material in a cell and includes

  • (a) the heritable genetic changes that may be manifested at the phenotypic level; and
  • (b) the underlying DNA modifications when known, including specific base pair changes and chromosomal translocations.

Proposed HPR changes from Canada Gazette, Part I

Germ cell mutagenicity means an increased occurrence of heritable gene mutations, including heritable structural and numerical chromosome aberrations in germ cells, occurring after exposure to a mixture or substance.

Germ cell mutagenicity refers to heritable gene mutations, including heritable structural and numerical chromosome aberrations in germ cells occurring after exposure to a substance or mixture.

The term mutation applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including, for example, specific base pair changes and chromosomal translocations).

The term mutagenic and mutagen will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms.

The more general terms genotoxic and genotoxicity apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non-physiological manner (temporarily) alter its replication.

Carcinogenicity

Carcinogenic means, in relation to a mixture or substance, liable to lead to cancer or increase the incidence of cancer.

Proposed HPR changes from Canada Gazette, Part I:

Carcinogenicity means the production of cancer or an increase in the incidence of cancer occurring after exposure to a mixture or substance.

Carcinogenicity refers to the induction of cancer or an increase in the incidence of cancer occurring after exposure to a substance or mixture. Substances and mixtures which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans.

The proposed changes to the SDS in Schedule I of the HPR are specific to Section 14 and are meant to address those noted in Rev 7. Health Canada proposes to remove paragraph 14(f) completely from the Section. Paragraph 14(f) currently is “transport in bulk (according to Annex II of the International Convention for the Prevention of Pollution From Ships, 1973, as modified by the Protocol of 1978 (MARPOL 73/78), and the International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk (IBC Code)).” Annex 4 of Rev 7 of GHS includes details on shipping cargoes in bulk according to the International Maritime Organization instruments. The Annex also notes that cargoes are subdivided by physical state (i.e., liquid, solid, or liquefied gas). These changes are not being incorporated into the HPR; Health Canada is instead proposing repealing this item completely as it states, “the updated wording does not clearly specify which International Maritime Organization instruments must be complied with, and information relating to transport in bulk is optional information.”

Commentary

The proposed changes to the HPR published in the Canada Gazette, Part I were expected. Health Canada previously stated its intent to align the HPR with more recent revisions of GHS. What is unexpected is the timing of this notice. The publication indicates multiple times that the United States is currently making similar amendments to HCS 2012. It states, in part: “The main objective of this proposal is to meet an international commitment under the Canada–United States Regulatory Cooperation Council to align with the United States in the adoption of the seventh revised edition of the GHS. These proposed amendments would help to ensure continued alignment with the United States, thereby facilitating trade through common hazard communication requirements, while increasing the benefits to Canadian workers with respect to health and safety.” It also states, “In addition, Canada and the United States are working together to coordinate and synchronize, to the extent possible, the coming into force of the amended Hazardous Products Regulations with the coming into force of the updates to the U.S. Hazard Communication Standard.” At the time of publication, there was no official indication that the United States had issued a Notice of Proposed Rule Making (NPRM) to update the HCS 2012. This item has appeared on the U.S. regulatory agenda since 2014. OSHA has implied it was close to completing the NPRM, but it has yet to publish in the Federal Register. If OSHA were to publish, it is highly unlikely the timing will be synchronized, as the legislative processes are inherently different. Readers may recall that the initial GHS adaptations between the United States and Canada occurred several years apart. The two systems, WHMIS 2015 and HCS 2012, do remain closely aligned at this time; the proposed updates would create some misalignment, but it is not viewed as substantial. The benefits of the proposed updates to the HPR are clear and necessary to align with GHS. As the UN model is updated bi-annually, the update of the HPR to Rev 7 will still lag with the current UN GHS Rev 8 and expected publication of UN GHS Rev 9 this year. It is difficult to imagine how both the United States and Canada will continue to align with the latest revisions of GHS within the burdensome regulatory processes that currently exist.

 
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