OSHA’s hazard communication standard (HCS) is the principal federal requirement governing labels and safety data sheets (SDSs) for hazardous chemicals used in the workplace in the United States. OSHA has proposed to update its requirements in a variety of ways that, once the rule is final, will require almost all labels and SDSs to be revised.
At the international level, the United Nations (UN) has adopted the Globally Harmonized System of Classification of Labelling of Chemicals (GHS) to harmonize the elements of hazard communication across countries. OSHA last revised the HCS in 2012 to align with GHS Revision 3. U.S. manufacturers, importers, and employers have since been monitoring OSHA’s rulemaking agenda to see when OSHA would modify the HCS to conform to the GHS, which has been updated five times since 2012. As long anticipated, OSHA published a proposed rule on February 16, 2021 to update the HCS to conform with GHS Revision 7 (published in 2017) and to address issues encountered since the 2012 HCS revisions.
Key Takeaways
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Comments on the proposed HCS revisions are due by April 19, 2021. The Federal Register notice runs 256 pages, so stakeholders should invest time early to be able to evaluate the proposal and prepare comments.
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OSHA is proposing to modify the HCS to conform to GHS Revision 7 and address issues that OSHA, manufacturers, importers, and employers have encountered since implementation of the 2012 HCS revisions.
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The proposed modifications include revised criteria for classification of certain health and physical hazards, relaxed provisions for updating labels, more flexible labeling provisions for small containers, proposed amendments related to the contents of SDSs, and related revisions to definitions of terms used in the standards.
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The bottom line is that once OSHA promulgates a final rule, most labels and SDSs will need to be revised.
Background
The HCS is a comprehensive standard that requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import and to provide that information to downstream distributors and employers that use those chemicals. Those employers must in turn provide information to their employees. OSHA first issued the HCS in 1983. Subsequent amendments in 1987 and 1994 expanded its coverage and included technical changes.
Other countries have developed regulatory systems governing the evaluation of chemical hazards and the dissemination of information about those hazards. However, these regulatory systems vary with regard to the scope of chemicals covered, the definitions of hazards, and the specificity of requirements for labels and SDSs. These inconsistent requirements place additional regulatory burdens on companies selling chemicals in multiple countries and have led to the provision of inconsistent information.
In 1992, after recognizing the problems associated with these differing requirements, the UN Conference on Environment and Development issued a mandate to develop a globally harmonized chemical classification and labeling system. Pursuant to this mandate, a coordinating group comprised of countries, stakeholder representatives, and international organizations developed the GHS.
The GHS contains classification criteria for physical hazards, classification criteria for health and environmental hazards, and hazard communication elements, including requirements for labels and SDSs. The UN formally adopted the GHS in 2003 and encouraged countries to implement it as soon as possible.
The GHS has been revised on an ongoing basis, and, in 2012, OSHA updated the HCS to align with GHS Revision 3. Since that time, the GHS has been revised five times, with the most recent revisions occurring in 2017 (GHS Revision 7) and 2019 (GHS Revision 8).
Proposed Modifications
While the basic framework of the HCS will remain the same, OSHA’s proposed rule will include revised criteria for classification of certain health and physical hazards, revised provisions for updating labels, new labeling provisions for small containers, proposed amendments related to the contents of SDSs, and related revisions to definitions of terms used in the standards. These revisions are intended to conform the HCS to GHS Revision 7 and address issues that OSHA and employers have encountered since implementation of the 2012 HCS revisions. OSHA chose to align with Revision 7 instead of Revision 8 in part because the European Union, Canada, and other major U.S. trading partners have aligned or are in the process of aligning with Revision 7. However, the agency has included select provisions from Revision 8 for consideration in this rulemaking.
Revised Criteria for Classification of Certain Health and Physical Hazards
To align the HCS with GHS Revision 7, OSHA proposes several changes to HCS Appendices A and B, which set forth criteria for classification of health and physical hazards.
Among these changes are:
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revised health hazard definitions;
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extensive revisions to the sections on skin corrosion/irritation and serious eye damage/irritation;
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changes to the Flammable Gases hazard class, including separating Category 1 flammable gases into two sub-categories, classifying pyrophoric and chemically unstable gases as Category 1A flammable gases, and adding a new sub-category (Category 1B) for gases which meet the flammability criteria for Category 1A but which are neither pyrophoric nor chemically unstable, and have either a lower flammability limit of more than 6% by volume in air or a fundamental burning velocity of less than 10 cm/s;
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expansion of the Flammable Aerosol hazard class to also include non-flammable aerosols; and
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adding a new physical hazard class for desensitized explosives.
Revised Provisions for Updating Labels
OSHA proposes to modify the existing requirements for updating labels when chemical manufacturers, importers, distributors, or employers become newly aware of any significant information regarding the hazards of a chemical. Under the existing HCS, these individuals must revise labels within six months of becoming aware of this new information and ensure that any labels on containers of hazardous chemicals shipped after that time contain the new information.
Recognizing the long distribution cycles for some chemicals, OSHA proposes to increase flexibility by not requiring the relabeling of immediate containers of chemicals that have been released for shipment and are awaiting future distribution. Rather, the proposed rule would allow labels to be either placed on the immediate container or transmitted with shipping papers, bills of lading, or by other technological or electronic means so that they are immediately available to workers in printed form on the receiving end of the shipment. This change is intended to reduce the potential hazards workers could face in relabeling immediate containers of hazardous chemicals that have already been packaged and prepared for shipment.
New Labeling Provision for Small Containers
In response to concerns that have been raised to OSHA regarding the difficulty of including complete labeling information on small containers, and consistent with small packaging examples provided in the GHS, OSHA proposes to relax labeling requirements with respect to small containers, where it can be demonstrated that it is not feasible to use pull-out labels, fold-back labels, or tags containing the full label information required.
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For those containers with less than or equal to 100 ml capacity, but greater than 3 ml, the minimum information required on the label of the container would be the product identifier, pictogram(s), signal word, chemical manufacturer’s name and phone number, and a statement that the full label information is provided on the immediate outer package.
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For those containers with less than or equal to 3 ml of capacity, and where it can be demonstrated that any label would interfere with the normal use of the container, no label would be required, and instead the only information required on the container itself would be the product identifier.
The immediate outer package for these smaller containers would have to include the full label information, along with a statement that the small container(s) inside must be stored in the immediate outer package when not in use.
Proposed Amendments to the Contents of Labels
OSHA is proposing to require that all labels include an additional data element, the date that the product is released for shipment. This ties in to the six-month label update requirement, which applies when the chemical manufacturer or importer receives significant new information that must be added to the label. As discussed above, new language would provide that products that have been released for shipment and are awaiting future distribution need not be relabeled, but the manufacturer or importer would have to provide the updated label for each individual container with each shipment.
Proposed Amendments to the Contents of SDSs
OSHA proposes a number of changes to the current SDS requirements in Appendix D. For example, where the specific concentration of a component in a mixture is a trade secret or varies batch-to-batch, the current Appendix D says that a range may be used instead. The proposal would specify the allowable ranges (the ranges appear in proposed paragraph (i)(1)(iv)).
OSHA proposes to change the current requirement that “the chemical manufacturer or importer preparing the [SDS] shall ensure that it is English,” to a requirement that “the chemical manufacturer or importer shall ensure that the SDS is in English.” This change is intended to recognize that chemical manufacturers and importers may obtain, rather than prepare, SDSs.
To account for the fact that SDSs must be specific to individual hazardous chemicals and are not permitted to be designed to cover groups of hazards, OSHA proposes that the SDS requirements specify that SDSs may be stored, rather than designed, in such a way to cover groups of hazardous chemicals in a work area.
Among other changes, section 8, exposure controls, would have to include any ranges suggested by hazard banding. Section 9 would no longer need to include “odor threshold” or ‘‘evaporation rate,” but it would have to include “particle characteristics.” Section 11, toxicological information, would have to include “interactive effects.” Where information for section 11 is not based on the hazard of the individual chemical but rather on similar chemicals (such as through structure-activity relationship analysis or read across), the SDS must state that alternative information was used and the method used to derive the information. The date of preparation or latest update to the SDS would have to appear in section 16 of the SDS.
Revisions to HCS Definitions
To account for the changes being made elsewhere in the HCS, OSHA proposes to update three existing definitions and add eight new terms and definitions to the HCS. The definitions that would be updated would be “exposure or exposed,” “hazardous chemicals,” and “physical hazard.” The new terms to be defined would be “bulk shipment,” “combustible dust,” “gas,” “liquid,” “solid,” “immediate outer package,” “Physician or other licensed health care professional (PLHCP),” and “released-for-shipment.” Of these, the most significant is that for combustible dust, which OSHA proposes to define as “finely divided solid particles of a substance or mixture that are liable to catch fire or explode on ignition when dispersed in air or other oxidizing media.” OSHA also proposed to amend the required hazard statement for combustible dust in Appendix B.
Compliance Deadlines
OSHA proposes to make the final rule effective one month after publication in the Federal Register. Hazard communication for individual substances under the final rule would be mandatory a year later. Hazard communication for mixtures under the final rule would be mandatory two years after the effective date.
Next Steps
OSHA is accepting comments on the proposed rule until April 19, 2021. OSHA will also hold an informal public hearing if requested during the public comment period. The regulated community should review this extensive rulemaking notice carefully and be aware of these opportunities to comment.