Amendments to SNUR Requirements

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On July 5, 2022, EPA finalized the rule Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (87 FR 39756).  EPA made changes to SNUR requirements in the following sections 40 CFR §§ 721.11, 721.63, 721.72, and 721.91. In addition, the Agency has changed when 40 CFR 721.80(j) will be used.  Most amendments only apply to SNURs issued after the rule’s effective date, September 6, 2022. However, retrospective changes are flagged throughout this report.  The amendments in this Federal Register notice will also require the submission of SDS(s) with PMNs, SNUNs, and Low Volume Exemptions (LVEs).

Changes to 40 CFR § 721.63, Protection in the Workplace

EPA updated this regulation so that it will be consistent with NIOSH and OSHA requirements.  For example, the amendment to 40 CFR § 721.63(a)(4) references the updated NIOSH regulations for respirator use, testing, and certification.  EPA believes that most manufacturers and processors are already subject to and complying with the NIOSH regulations. This change will be retroactive and thus will apply to all previously issued SNURs that contain significant new use requirements pertaining to respiratory protection. The amended rule allows manufacturers and processors that are subject to SNURs to follow updated respiratory protection requirements without triggering a SNUN requirement.

EPA has also updated to the NIOSH-certified respirator language in 40 CFR § 721.63(a)(5). Notably, individuals will be allowed to continue using any of the fifteen older-style respirators listed under 40 CFR § 721.63(a)(5)(i-xv) to avoid triggering a SNUN requirement.  In addition, EPA amended 40 CFR § 721.63(a)(6) to update the language for when the airborne form of a chemical substance implicates the respiratory requirements in 40 CFR § 721.63(a)(4).

The amendments to the SNUR regulations also include new paragraphs 40 CFR § 721.63(a)(7) and 40 CFR § 721.63(a)(8).  When implicated by a SNUR, these new requirements make it a significant new use not to implement a hierarchy of controls to protect workers. These changes will require any person subject to a SNUR that calls out these requirements to identify and implement appropriate engineering and administrative controls for respiratory protection before using PPE for workers protection.

Changes to 40 CFR § 721.72, Hazard Communication Program

EPA updated the language in 40 CFR § 721.72(a) through (h) to be consistent with current OHSA requirements and the United Nations’ Globally Harmonized System of Classification and Labeling (GHS). The amendments will apply retroactively to previously issued SNURs that cite 40 CFR § 721.72(a), (c), or (d).

Paragraphs (g) and (h) were amended to include new hazard and precautionary statements to make these provisions consistent with OSHA requirements and GHS recommendations.  EPA also added two new paragraphs to 40 CFR § 721.72, (i) and (j).  These new paragraphs impose new hazard communication requirements. Paragraph (i) requires a written hazard communication program to be developed and implemented for the SNUR substance in each workplace. The written hazard communication program would need to meet OSHA requirements in 29 CFR 1910.1200, OSHA’s Hazard Communication Standard (HCS). Paragraph (j) provides specific statements and warnings that could be incorporated in hazard communications.

Under the revisions to § 721.72, whenever the statements in paragraphs (g), (h), and (j) are required, manufacturers and processors subject to the SNUR will also need to consider if they trigger any other corresponding hazard communication under the OSHA HCS.  Any hazard and/or precautionary statements required by the SNUR would need to include a minimum set of hazard warnings.

Changes to 40 CFR § 721.80, Industrial Commercial and Consumer Activities

EPA has changed the circumstance in which it will cite 40 CFR § 721.80(j) which defines a significant new use as, “[u]se other than as described in the premanufacture notice references in subpart E of this part for the substance.” No language would be changed.  Instead, the Agency is clarifying when it will identify a new use using this verbiage.  The Federal Register notice explains that “To better identify the significant new use, EPA has changed this procedure to only cite 40 CFR 721.80(j) when the use described in the PMN is confidential.”

 Changes to 40 CFR § 721.91, Computation of Estimated Surface Water Concentrations: Instructions

EPA has modified the instructions in 40 CFR § 721.91 for computation of estimated surface water concentrations to allow for a certain percentage of removal of a chemical substance from wastewater after undergoing control technology in accordance with the requirements in 40 CFR § 721.90.

Changes to 40 CFR § 721.11, Applicability Determination When a Specific Chemical Identity is Confidential

The amendments to 40 CFR § 721.11 subpart A modify the bona fide procedure so that it applies to all SNURs containing any CBI, including the significant new use.

Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVEs), Low Release, and Exposure Exemptions (LoREXs), and Test Marketing Exemption (TME) Applications

EPA has amended sections 40 CFR § 720.38, 40 CFR § 720.45, and 40 CFR § 723.50 to require that any safety data sheets (SDSs) that has been developed, even if it is in draft form, be submitted as part of any notification or exemption application (PMN, SNUN, LVE, LoREX, or TME).  Submitters are not required to develop an SDS if one does not already exist.

 

OSHA Proposes Revisions to Hazard Communication Standard

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On February 15, 2021, OSHA posted a notice of proposed rulemaking to make changes to the Hazard Communication Standard.  The proposed changes include updates the criteria for classification on health and physical hazard, updating labels, new labeling provisions for small containers, technical amendments for the contents of safety data sheets, and revisions to definitions of certain terms.

The revised criteria for classification of certain health and physical hazards now includes any hazards associated with a change in the chemical’s physical form or from a reaction with other chemicals. The revised provisions for updating labels now includes the date the chemical is released for shipment.  Labels for bulk shipments can be on the immediate container or with the shipping papers, bills of lading or other electronic means that makes it immediately available to workers “in printed form on the receiving end of shipment”.

The proposed changes also state that chemical manufacturers or importers need to update the label for each individual container with each shipment, but do not need to relabel chemicals that have been released for shipment and are awaiting future distribution. For the new labeling provisions for small containers, additional options are available in situations where it is not feasible to use the full label information.  This includes putting the full label information on an outer package, a statement on the outer package that the smaller container needs to remain in the outer package when not in use, and at least has the product identifier on containers less than or equal to 3 ml.

OSHA is taking public comments on all of the proposed changes and the use of electronic template files to create safety data sheets and labels.  The comment period is open until May 19, 2021.

EPA proposes updates to SNUR regulations on workplace protection and hazard communication.

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On July 28, EPA published a proposed rule updating the Significant New Use Rule (SNUR) regulations, which implement section 5(a)(2) of the Toxic Substances Control Act (TSCA). In announcing the proposal, EPA emphasized the need to harmonize regulations based on Occupational Safety and Health Administration (OSHA) standards for respiratory protection and hazard communication, which have both been updated since the SNUR regulations were last revised in 1989.

The proposed rule also contains several other changes meant to address “issues identified through EPA’s experience issuing and administering SNURs,” including changes to the bona fide intent to manufacture procedure. Additional, minor changes include correcting typographical errors, updating “material safety data sheet” or “MSDS” to “safety data sheet” or “SDS,” and revising language to “more accurately use the terms manufacture, manufacturer, and manufacturing.”

Notably, many of the proposed changes to the SNUR regulations will affect previously-issued SNURs.

EPA notes that, due to regulatory updates from both the National Institute for Occupational Safety and Health (NIOSH) and OSHA, the current regulatory language for protection in the workplace, concerning respiratory protection, is inconsistent with NIOSH and OSHA requirements. Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of NIOSH-certified respirators to the list of approved respirators. According to the proposed rule, companies subject to previously-issued SNURs containing respirator requirements can either follow the updated requirements or continue using the older respirators, if they are still available, without triggering a Significant New Use Notification (SNUN) requirement.

EPA also proposes to modify a subsection on airborne forms of chemicals by adding “particulate or aerosol,” “gas/vapor,” and combinations thereof.

The proposed rule further revises the workplace protection section by inserting the requirement that a hierarchy of controls – such as enclosure of operations, ventilation, and workplace policies and procedures – must be “considered and implemented to prevent exposure, where feasible” before using personal protective equipment (PPE) for worker protection. This change is reportedly in response to previous comments criticizing “EPA’s approach of exclusively identifying the absence of adequate personal protective equipment as a significant new use” as out of step with best practices in industrial hygiene. EPA notes that the new language has been incorporated in all new chemical SNURs issued since June 26, 2013 and is consistent with OSHA requirements.

The agency’s proposed updates on hazard communication are based on OSHA’s updates to its Hazard Communication Standard (HCS), which was itself modified, in 2012, to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). EPA also proposes adding a new requirement which could be used in new SNURs for a written hazard communication program in each workplace in accordance with the OSHA HCS. Another proposed addition provides specific statements and warnings that could be required under a SNUR and “would be based on EPA’s risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.”

In addition to the changes to the workplace protection and hazard communication revisions, EPA proposes various other modifications, including:

  • Bona fide procedure: Currently, when EPA issues a SNUR in which the chemical identity is withheld as confidential business information (CBI), manufacturers and processors may submit information to EPA to “determine whether their substance is subject to the SNUR.” EPA now proposes to amend the process to apply to other kinds of CBI, such as production volume limits, so EPA may inform bona fide submitters whether and how the SNUR applies to them, including any confidential significant new use designations.
  • Notice submission requirements: EPA proposes that notification submissions such as premanufacture notifications or low volume exemptions, among others, must include any SDS that has already been developed for the relevant chemical.

EPA has specifically requested comments on the following issues:

  • the use of “next generation” respirators;
  • the incorporation of the hierarchy of controls approach to worker protection in the SNUR requirements; and
  • “any suggested methods for minimizing respondent burden, including revisions to the automated collection techniques being used for submissions to EPA under TSCA, …the Agency’s Central Data Exchange (CDX) portal.”

The deadline for comments on the proposed rule is September 26, 2016.

OSHA releases Hazard Communication Standard inspection procedures.

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The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has released a new Directive outlining the changes in enforcement caused by the modification of the Hazard Communication Standard (HCS 2012) to harmonize with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new Directive, titled Inspection Procedures for the Hazard Communication Standard (HCS 2012), describes how to determine if a violation has occurred under the revised standard as well as how it will be enforced both during its transition period and after full implementation.

The Inspection Procedures note that HCS 2012 is based on GHS Revision 3 (2009), not the more recent Revisions 4 or 5 issued by the UN in 2011 and 2013, respectively. The Directive notes that using a more recent version of GHS may result in noncompliance with HCS 2012 “if it contradicts or casts doubt on OSHA required information.” Notably, OSHA requires that precautionary and hazard statements incorporated from GHS be changed to mandatory, e.g., “should” must be replaced with “shall.”

The Directive provides significant discussion on hazard classification under the revised standard. Classification must be based on criteria specific to each hazard class, and evaluations must “consider all available data on the hazards.” Other considerations include quality and quantity of data and positive and negative results in a single weight-of-evidence determination. Detailed evaluation procedures are included in the Directive’s appendices. In terms of inspection guidelines, the Directive notes that “[t]he adequacy of a company’s hazard classification should be assessed primarily by examining the outcome of that classification.”

The HCS 2012 labeling and SDS requirements went into effect on June 1, 2015 (except for distributors, for whom labeling requirements do not apply until December 1, 2015). However, where a company has “exercised ‘reasonable diligence’ and ‘good faith’ to obtain HCS 2012-compliant SDSs from upstream suppliers but have not received them, they will be allowed limited continued use of HCS 1994-compliant MSDSs and labels.”

OSHA unveils web-based tools to protect workers from toxic chemical exposure.

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Last week, the U.S. Occupational Safety and Health Administration (OSHA) announced two new web-based resources to help employers better protect workers from hazardous chemical exposures, even as the agency said its current mandatory workplace exposure limits are “dangerously out of date.” According to OSHA, hazardous chemicals are estimated to be the cause of more than 190,000 illnesses and 50,000 deaths suffered by workers each year.

The first resource is a toolkit for identifying less-hazardous chemical substitutes. It provides information, methods, tools and guidance to “either eliminate hazardous chemicals or make informed substitution decisions in the workplace by finding a safer chemical, material, product or process.” The second resource includes three annotated Permissible Exposure Limit tables (PELs) that provide side by side comparisons of OSHA PELs with recommended exposure limits from the National Institute of Occupational Safety and Health (NIOSH), the American Conference of Governmental Industrial Hygienists and the required PELs of California’s Division of Occupational Safety and Health.

Most of OSHA’s PELs were adopted in the early 1970s and based on scientific research from the 1940s through 1960s. Since then, OSHA has initiated and finalized just one new PEL [PDF] in 2006 as part of a comprehensive standard for hexavalent chromium exposure. In the meantime, non-governmental organizations have continued to update their own occupational exposure limits (OELs) for chemicals found in the workplace, which many employers implement voluntarily. Dr. David Michaels, assistant secretary of labor for OSHA, said that “the complexity of OSHA’s current rulemaking process makes it extremely difficult for us to update our chemical standards and issue new standards in a reasonable period of time.” However, the agency said it plans to start work on updating [PDF] its PELs with a request for information (RFI). These plans were delayed due to the recent federal government shutdown, but the agency expects the RFI to be published in the next couple of months.

OSHA is working closely with the U.S. Environmental Protection Agency (EPA) to ensure that when the EPA processes applications for new use of chemicals (SNUNs), they consider worker exposure. However, the agency made clear that the contents of the web resources were informational in nature and will not be used by OSHA in the enforcement process.

Final OSHA Rule Published on Globally Harmonized System of Classification and Labeling of Chemicals

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GHS/HazCom:

March 26, 2012, the Federal Register published OSHA’s final Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  With this rule OSHA has modified its Hazard Communication Standard (HCS) to be consistent with to the United Nations’ System. 

GHS Requirements

OSHA estimates that 880,000 hazardous chemicals are currently used in the U.S., and over 40 million employees are now potentially exposed to hazardous chemicals in over 5 million workplaces.  Approximately 75,000 firms create hazardous chemicals (i.e., products, substances, or mixtures) for which new labels and ‘safety data sheets’ (formerly material safety data sheets) will be required.

OSHA explains that implementation of the GHS will improve HCS by changing the performance requirements for labels to the GHS-specific requirements that labels include four standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s).  The appropriate label elements for a chemical are to be determined by the hazard classification.  Standardized label elements will better convey critically important hazard warnings, and provide useful information regarding precautionary measures that will serve to better protect employees than the performance-oriented approach of the current rule. 

Chemical manufacturers and importers will be required to re-evaluate chemicals according to the GHS criteria.  Chemicals must be classified based on the type and degree of hazards posed.  For health hazards, this will involve assigning the chemical both to the appropriate hazard category and subcategory (called hazard class).  For physical hazards new criteria are generally consistent with current DOT transportation requirements.  Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers will also be required. 

Jurisdiction

The rule adopts only sections of the GHS within the scope of OSHA jurisdiction.  DOT, CPSC and EPA will implement GHS at a later date.  EPA and OSHA have worked together to develop a common position on coverage of pesticides and chemicals.  The GHS will not require additional labels on pesticides labeled under EPA requirements; that is, the final products that enter into commerce.  However, OSHA GHS requirements will apply to the other chemical ingredients of pesticides; the ‘inactive’ ingredients or cleaning products that are hazardous.  This is a continuation of current OSHA HCS worker protection requirements.  OSHA anticipates that EPA will provide guidance to their regulated community on how to develop an OSHA GHS-compliant SDS to avoid conflict with pesticide labeling requirements. 

Key GHS Elements

Hazard communication.  A key goal of the final GHS is to better communicate hazard information to those most at risk—the workers exposed to hazardous chemicals Hazard communication requirements are provided in 29 CFR § 1910.1200.  Appendix C, Allocation of Label Elements, details how specified label elements apply to each hazard class and hazard category.  Appendix D, Safety Data Sheets, specifies requirements for the 16 SDS elements.

Concentration limits.  OSHA announced it will require the most protective GHS concentration limits for hazard classifications.  For example, for sensitizers and reproductive toxins, the final rule requires information to be provided on labels and safety data sheets at concentrations above 0.1%.  (See e.g., Appendix C, Allocation of Label Elements.)

Precautionary statements.  In addition to hazard statements, the GHS requires precautionary statements that describe recommended measures that should be taken to protect against hazardous exposures, or improper storage or handling of a chemical.  (See Appendix D, Safety Data Sheets).  Precautionary statements must also address hazard information necessary to protect workers from “hazards not otherwise classified that have been identified during the classification process.” (See Table D.1.)

Mixtures.  Health hazards posed by mixtures should be addressed based on the risks posed by the mixture itself, rather than by the hazards posed by the component chemicals individually.  The GHS does allow alternative classification methodologies where primary data are unavailable, including extrapolation and bridging.  The rule specifies procedures for determining whether mixtures are covered by the Standard. 

Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information.  New information about hazards and ways to protect against hazards must be added to the SDS within three months. 

OSHA has modified General Industry Standards containing hazard classification and communication provisions so that they will be internally consistent and aligned with the GHS modifications to the HCS. 

Implementation

Timeline.  Compliance with all of the provisions for preparation of new labels and safety data sheets is required by June 1, 2015.  Distributors will be allowed an additional six months to distribute containers received from chemical manufacturers and importers with the old labels and MSDSs in order to accommodate those they receive very close to the compliance date.  Workplace labels and training programs must be updated by June 1, 2016. 

State implementation.  OSHA intends to closely scrutinize amendments to previously approved State hazard communication standards to ensure equal or greater effectiveness, including assurance that any additional requirements do not conflict with, or adversely affect, the effectiveness of the national application of OSHA’s standard.

Guidance.  OSHA will be offering guidance materials such as quick cards and fact sheets to aid firms in developing and implementing the training requirements of this rule.  OSHA will also be releasing a small business compliance guide to provide additional guidance to small businesses, which will ease the economic impact and compliance burden. 

Next Steps

OSHA notes that the GHS is a living document, and the UN actively reviews it and considers possible changes based on implementation experiences and other information.  These changes are made on a two-year cycle, referred to as a biennium.  The OSHA proposal and the final rule are based on Revision 3 of the GHS.  OSHA will undertake future rulemaking as necessary to reflect new technological and scientific developments and UN revisions to GHS requirements.

Although not addressed in the rule, OSHA discusses interest in the development of a common classification database.  The European Union plan to deploy one.  Japan, Taiwan, South Korea, and New Zealand have already done so.  However, classifications in these databases are not necessarily the same for the same chemical.  OSHA would like an international database of classifications developed and maintained.  A UN Sub-committee has been established to explore the issue further. 

 

OSHA Requests Public Comment on Extending the Information Collection Requirements in the Cadmium in General Industry Standard

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OSHA:

On March 6, 2010, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice (77 FR 13359), requesting public comments concerning its proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements set out in the Cadmium in General Industry Standard (29 CFR 1910.1027).  The proposal would extend current requirements into 2015.  According to OSHA, the industries likely to be effected include chemical mixers, utilities, and electroplaters.  OSHA estimates that nearly 50,000 facilities are covered by the rule.  The agency is requesting public comments to ensure that information collection occurs in a way that minimizes paperwork and related burdens on employers.  The docket includes both the FR notice and OSHA’s Information Collection Supporting Statement.  

Requirements Proposed for Extension

According to OSHA, the information collection requirements in the Cadmium General Industry Standard  protect workers from the adverse health effects that result from their exposure to cadmium.  The major information collection requirements of the Standard include:  

  • conducting worker exposure monoring,
  • notifying workers of their cadmium exposures,
  • implementing a written compliance program,
  • implementing medical surveillance of workers,
  • providing examining physicians with specific information,
  • ensuring that workers receive a copy of their medical surveillance results,
  • maintaining workers’ exposure monitoring and medical surveillance records for specific periods, and
  • providing access to these records by OSHA, the National Institute for Occupational Safety and Health, the worker who is the subject of the records, the worker’s representative, and other designated parties.

Topics for Public Comment

OSHA is particularly interested in public comments on the following topics:

  • whether the proposed information collection requirements are necessary for the proper performance of the agency’s functions, including whether the information is useful;
  • the accuracy of OSHA’s estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
  • the quality, utility, and clarity of the information collected; and
  • ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

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Additional information on OSHA general industry requirements and guidance materials may be found on OSHA’s website.