On February 16, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS).
Lynn BergesonThe HCS is the federal-level legislation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed changes include updating the HCS to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed is one year for chemical manufacturers, importers, and distributors of substances and two years for chemical manufacturers, importers, and distributors of mixtures after the effective final rule is published. The notice is open for comments until April 19, 2021. OSHA states that it will schedule an informal public hearing on the NPRM if a request is made during the comment period. If a hearing is requested, OSHA will announce the details in the Federal Register.
The following report was prepared by Bergeson & Campbell, P.C. (B&C®) is a Washington D.C. law firm providing decades of experience in the manufacture, handling, and transport of conventional, biobased, and nanoscale industrial, agricultural, and specialty chemicals, including product approval and regulation, product defense, and associated business issues. www.lawbc.com
Background
In 2012, the first update to the HCS since 1994 was published in the Federal Register. 77 Fed. Reg. 17574. The notice revised and amended the previous HCS substantially as it introduced the GHS concepts into the regulatory framework. At the time of publication, HCS 2012 was based on Rev 3 GHS. The UN updates and revises the GHS model on a biannual basis, and at this time, the most current version is Rev 8. OSHA is proposing an update to align with Rev 7 and includes several other points of clarification and revision in the notice.
Overview of Proposed Amendments
Highlights of several major changes include the following:
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Revisions to align with Rev 7, with consideration of specific elements of Rev 8;
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Changes to labeling, including new label elements and accommodations to address small containers and bulk shipments;
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Revisions, clarifications, and additions to definitions;
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Updates to testing methods for various endpoints;
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Considerations for concentrations ranges for Trade Secrets;
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Proposed revisions to SDS content; and
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Proposal for scheduled updates to the HCS.
A more detailed discussion on a few of the more significant changes follows.
Regulatory Text
The NPRM includes new definitions to clarify various hazard endpoints, address proposed changes to labeling, and align with Rev 7. Substantial proposals for changes to labels include adding a date the chemical is released for shipment with the intent that relabeling activities could be reduced utilizing the date noted. The inclusion of this released for shipment date aligns with proposed changes that chemicals that are released for shipment and are awaiting future distribution will not need to be relabeled as long as the revised label is provided with each shipment. In addition, OSHA includes allowances for labels for bulk shipments that include providing labels with shipping papers, bills of lading, or by other electronic means. OSHA also provides two proposed amendments that consider accommodations for reduced labeling requirements for small containers. The NPRM details changes to trade secrets, including concentration ranges that are either prescribed as noted in the NPRM or use the narrowest range possible. This concept is similar to the approach currently utilized in Canada in accordance with the Hazardous Products Regulation.
Appendix A -- Health Hazard Criteria
The majority of the changes proposed to Appendix A are to align with Rev 7 and to provide additional clarity on the hazard categories in each hazard class. OSHA is also seeking comments on the addition of Rev 8 specific language related to Appendix A.2, Skin Corrosion/Irritation. The significant revisions include Rev 8 guidance on approaches to classification utilizing in vitro data. The proposed changes include more descriptive guidance for a tiered approach with this hazard class. Similar updates to the tiered approach are proposed for Appendix A.3, Serious Eye Damage/Eye Irritation.
Appendix B -- Physical Criteria
Changes that address certain physical hazard classes to align with Rev 7 include significant but necessary changes to sections on Flammable Gases and Aerosols. The revisions include the incorporation of pyrophoric gases into Appendix B.2, Flammable Gases. Currently, pyrophoric gases are addressed in a separate Appendix, but this physical hazard was added to the UN GHS model in a later revision. The revisions to Appendix B.3, Flammable Aerosols, include renaming it Aerosols, and the addition of non-flammable aerosols is necessary to align with Rev 7. In addition, a new chapter in Appendix B, B.17, Desensitized Explosives, is proposed. This addition is necessary to align with Rev 7.
Appendix C -- Allocation of Label Elements
Significant updates to precautionary phrases appear in every hazard class and category noted within Appendix C. OSHA also, with intent to align with Rev 7, removed pyrophoric gas from OSHA-defined hazards to the section on Flammable Gas. OSHA includes further clarification on Combustible Dusts, including amended hazard statements.
Appendix D -- Safety Data Sheets
OSHA proposes revisions to clarify certain required information on the SDS. In Section 1, OSHA notes that the address and telephone number listed must be in the United States. Other changes include in Section 2, Hazard(s) Identification, the addition of including “any hazards associated with a change in the chemical’s physical form under normal conditions of use” and identification of hazards that “result from a chemical reaction (changing the chemical structure of the original substance or mixture).” As noted, OSHA proposes use of concentration ranges where a trade secret is claimed in Section 3, Composition/Information on Ingredients. Section 11, Toxicological Information, includes additional details on interactive effects if relevant and available and requires that the preparer provide details on the methods used for the information presented in this section if there are no chemical data available.
Issues for Comment
OSHA included an “Issues and Options Considered” section that is intended to solicit stakeholder input on various regulatory issues and to allow for potential regulatory flexibility with respect to the content of the final rule. While OSHA invites stakeholders to comment on all aspects of the NPRM, this section identifies the specific areas of interest listed below. The section includes certain issues and questions that are intended to assist stakeholders as they review the proposal and consider the comments they plan to submit.
Timeframe for Updates to the HCS
OSHA requests public comment on whether it should adopt a schedule for updates to the HCS standard (e.g., every four years or every two revisions of the GHS) or wait until there are significant changes to the GHS before initiating rulemaking. OSHA is interested in receiving public comment about the utility, costs, or other issues that might be associated with regular updates and about specific timeframes or criteria that OSHA should consider when determining when and whether to update the HCS.
Regulatory Text
Under paragraph (f), Labels and other forms of warning, OSHA proposes changes to paragraphs (f)(5) (bulk shipments) and (f)(11) (release for shipment) and also proposes to add a new paragraph (f)(12) containing provisions specific to labeling on small containers. OSHA requests comments on the proposed additions to paragraph (f)(5), which would be newly titled Transportation. OSHA requests comments on the usefulness and effectiveness of allowing specified alternate approaches for labeling bulk shipments. OSHA proposes to update paragraph (f)(11) to provide that chemicals that have been released for shipment and are awaiting future distribution need not be relabeled to incorporate new significant information about hazards. OSHA requests comments on whether it is appropriate to use “released for shipment” as the cutoff point for relabeling requirements, as opposed to, for example, the time of shipment. OSHA proposes a new paragraph (f)(12) addressing labeling requirements for small containers. OSHA requests comments on the feasibility of, and any cost savings associated with, these proposed provisions for the labeling of small containers (both 100 mL and less and 3 mL and less).
Under paragraph (g), Safety data sheets, OSHA proposes a change to paragraph (g)(10), which addresses the form and storage of SDSs, to allow SDSs to be stored, rather than designed, in a way that covers groups of hazardous chemicals in a work area. OSHA requests comments regarding whether this proposed revision would require significant changes to current practices.
Under paragraph (i), Trade secrets, OSHA proposes two significant changes: to allow manufacturers, importers, and employers to withhold a chemical’s concentration range as a trade secret; and the use of prescriptive concentration ranges in lieu of the actual concentration or concentration range whenever the actual concentration or concentration range is claimed as a trade secret. Specifically, OSHA is interested in any experience stakeholders have had with developing SDSs using the prescribed concentration ranges and any concerns stakeholders have about using concentration ranges on the SDS. OSHA also requests comments addressing the adequacy of hazard information provided by these ranges. OSHA is also interested in receiving comments on any economic implications associated with including the prescribed concentration ranges.
Appendix B
OSHA proposes several substantive updates to Appendix B, including the addition of a new hazard class (desensitized explosives) and several new hazard categories (unstable gases and pyrophoric gases in the Flammable Gases class and nonflammable aerosols in the Aerosols class). OSHA states that it preliminarily determined that the addition of these specific hazard classes and categories would better differentiate between the hazards and better communicate hazards on labels for downstream users. OSHA requests comments on whether these changes provide improved safety through more targeted hazard statements, precautionary statements, and pictograms.
Appendix C
OSHA proposes numerous changes to Appendix C, many of which are editorial, clarifying, or organizational in nature and are designed to clarify requirements for preparing labels. OSHA also proposes some substantive changes to correspond to proposed changes to Appendix B or the regulatory text. In paragraph C.2.4.10, OSHA proposes to require prioritization of certain precautionary statements related to medical response. OSHA requests comments on the particular system of prioritization specified and on whether the proposed prioritization provisions would improve clarity on labels.
Appendix D
OSHA proposes changes to Section 2 of the SDS to emphasize that hazards identified under normal conditions of use that result from a chemical reaction must appear on the SDS, even though these hazards do not need to be listed on the label. According to OSHA, this proposed change would simply reorganize the information presented in the SDS. OSHA requests comments on whether the text OSHA is proposing for paragraph (c) in Section 2 would clarify when it is appropriate to include information on the hazards associated with a change in the chemical’s physical form or chemical reaction under normal conditions of use and the type of information that should be presented in Section 2 of the SDS.
With some conditions, the HCS currently requires Section 3 of the SDS to include the chemical name and concentration (exact percentage) or concentration ranges of all ingredients that are classified as “health hazards” in accordance with paragraph (d) of OSHA’s Section 1910.1200. OSHA notes that it is not proposing to change this requirement, but “is interested in comments on whether it should be expanded to include all classified chemicals (i.e., also physical hazards and HNOCSs [hazards not otherwise classified]).”
OSHA invites comments on the use of electronic labeling for chemical packaging. OSHA also requests comments on the types of electronic chemical labeling already in existence or under development. For employers already implementing electronic labeling programs in the United States or in other countries, OSHA asks for information on the types of electronic coding systems used in the program and the costs incurred and benefits achieved. OSHA states that it is interested in information about workers’ experiences with the use of electronic labels. OSHA also requests comments on foreseeable challenges that it should consider (e.g., worker accessibility to electronic label information).
Commentary
The proposed changes to the HCS were expected. OSHA previously stated its intent to align the HCS with more recent revisions of GHS. This item has appeared on the U.S. regulatory agenda since 2014. As the UN model is updated biannually, the update of the HCS to Rev 7 will still lag with the current UN GHS Rev 8 and expected publication of UN GHS Rev 9 this year. OSHA does address key elements of Rev 8 as an option in this proposal. This approach, if adopted, will make OSHA’s approach slightly different from multiple countries that are in the process of adopting or revising legislation to align with Rev 7. The proposed inclusion of Rev 8 elements is viewed as significantly beneficial, especially to manufacturers utilizing in vitro data for other purposes, like chemical registrations. In addition, OSHA seeks comments on an approach to regular updates to the HCS. This is necessary to align the HCS with GHS as it is revised and updated. OSHA is currently asking stakeholder questions about the impacts of updating the HCS every two or four years. As this NPRM took more than seven years to issue, stakeholders should evaluate the impact of the changes to determine if a regular update would benefit business practices and allow for more consistent approaches to changes to HCS.
OSHA includes in the proposed update several items related to labeling. These items were currently addressed in various Letters of Interpretation. OSHA is amending the HCS to include them and seeks comments from stakeholders on this approach. Chemical manufacturers, importers, and distributors should actively review the changes and issue comments to OSHA on their applicability and utility in their operations. The changes to allow concentration ranges as an approach for addressing trade secrets and inclusion of prescribed proposed ranges create better alignment with Canada and allow additional options to those wishing to disclose certain details, while allowing exact concentrations to remain protected. The use of concentration ranges and proposed ranges is a benefit interested parties should consider and provide comments to OSHA.
