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EPA Amends Regulations Governing Significant New Uses of Chemical Substances

On July 5, 2022, the U.S. Environmental Protection Agency (EPA) finalized amendments to its general rules for Significant New Use Rules (SNURs) appearing at 40 C.F.R. Part 721. A SNUR is a rule issued by EPA under the authority of Section 5(a) of the Toxic Substances Control Act (TSCA). Among other things, a SNUR requires notice to EPA (via a Significant New Use Notice (SNUN)) before engaging in a use of a chemical substance or mixture that EPA has designated as a “significant new use.” EPA also made some minor changes to the TSCA Section 5 premanufacture notification (PMN) provisions at Part 720 as well as certain exemptions to Part 720 appearing in Part 723. The amendments are scheduled to become effective on September 2, 2022.

EPA’s stated goal in amending 40 C.F.R. Part 721 was to better ensure worker safety and access to clear and consistent information about hazardous chemicals in the workplace. The amendments implemented by the final rule were first proposed on July 28, 2016. The rule was finalized some six years later as a part of the Agency’s efforts to implement policies and regulations that better align EPA’s new chemicals program with the Biden administration’s views of the 2016 Lautenberg Chemical Safety Act (LCSA) that overhauled TSCA. EPA asserts that the changes implemented by the final rule will have minimal impact on the costs and burdens of compliance while updating the SNUR requirements to better address potential risks to human health and the environment.

The most important changes made by the July 5th amendments are:

  1. Updating the generic SNUR regulations to align with the current Occupational Safety and Health Administration (OSHA)/National Institute for Occupational Safety & Health (NIOSH) regulations for ensuring worker safety;
  2. Adopting a Hierarchy of Controls-based approach for requirements aimed at minimizing occupational exposure;
  3. Amending EPA Hazard Communication Program rules for hazardous substance labeling, Safety Data Sheets (SDS) and other forms of warning to conform with OSHA “HazCom” requirements; and, 
  4. Altering the requirements for computation of discharges of chemicals to surface water when assessing compliance with SNUR water release requirements.

EPA Updates Regulations for Respiratory Protection in the Workplace to Align with New OSHA and NIOSH Regulations

EPA’s SNUR rule provisions on respiratory protection were adopted in 1989. Since then, OSHA and NIOSH have updated certification requirements for respirators.[1] The latest NIOSH regulations (as of June 1995) include regulations for testing and certifying non-powered, air-purifying, and particulate-filter respirators. Respirators certified under these updated provisions provide increased worker protection compared to respirators previously certified under the old standard.[2] The last amendment to OSHA’s Respiratory Protection Standard also added a requirement that employers establish a maximum use concentration (MUC) based on the occupational exposure limit for the hazardous substance and the assigned protection factor (APF) for the respirator. Due to these changes, the respirators currently listed under EPA’s SNUR provisions for protection in the workplace may no longer meet the current NIOSH/OSHA criteria for respirator selection and use.[3]

To conform its regulations for respiratory protection with the latest NIOSH/OSHA standards, EPA made the following changes to 40 C.F.R. 721.63:

  • EPA has replaced its cross-references to the old NIOSH and OSHA regulations for respirator selection and use with references to the current NIOSH and OSHA regulations.[4]
    • This change will apply to all previously issued and future SNURs that contain significant new use requirements pertaining to respiratory protection.
  • By updating section 721.63(a)(5), EPA can now cross-reference the current NIOSH certification language rather than including it in each individual SNUR.
    • This change will apply to future new chemical SNURs.
  • EPA has included language that allows any person who is (1) subject to SNURs with older respirator requirements and (2) using one of the fifteen older respirators listed in 40 C.F.R. 721.63(a)(5)(i)-(xv) to continue using those older-style respirators in order to avoid triggering a SNUN requirement. Any person subject to older respirator requirements may also choose to use an equivalent respirator under the new requirement, as long as the Assigned Protection Factor (APF) of that respirator is greater than or equal to the older respirator cited in Section E.
    • This change applies to SNURs previously issued under the old respirator requirements.
  • EPA has expanded the language in 40 C.F.R. 721.63(a)(6) describing the airborne form of a substance applicable to the updated respiratory protection requirements by adding the following categories: (1) Particulate or aerosol (solids or liquid droplets suspended in a gas, e.g., dust, fume, mist, smoke); (2) Gas/vapor; and (3) Combination particulate and gas/vapor (gas and liquid/solid physical forms are both present, e.g., particulates and acid gases or particulates and organic vapors).
    • This change will apply to future SNURs, as EPA will cite this language when issuing new SNURs.

EPA Implements a Hierarchy of Controls Requirement

EPA has also added language to 40 C.F.R. 721.63 making it a significant new use not to implement the hierarchy of controls requirements to protect workers from exposure to SNUR’d chemicals.[5] EPA imposed this requirement based on its determination that OSHA’s application of the “hierarchy of controls” approach to airborne exposures is more effective than sole reliance on personal protective equipment (PPE) in promoting workplace health and safety. EPA went beyond the OSHA scheme in apparently applying this requirement to dermal exposure. EPA’s new language requires any person subject to an applicable SNUR to identify and use all feasible engineering and administrative controls (a/k/a work practices) before requiring employees to use PPE to eliminate or reduce unreasonable risks to workers. Where engineering and administrative controls are not feasible or are insufficient to protect exposed workers, persons subject to a SNUR must follow any applicable PPE requirements or submit a SNUN to EPA. In other words, if dermal exposure, eye exposure, or inhalation by workers is still reasonably likely, then each person who is reasonably likely to be exposed to the substance in these ways must be provided with and must wear PPE.[6] This requirement will only apply to SNURs issued or amended after July 5, 2022.

EPA did not, however, provide any guidance in the preamble to the rule to clarify how to document when engineering controls are not feasible. In EPA’s Response to Comments document, however, the Agency responded to commenters’ requests for clarification of the use of “where feasible” with regards to the implementation of a hierarchy of controls by explaining that the term is meant to permit manufacturers and processors to consider cost (although they cannot reject implementing a hierarchy of controls on the basis of cost alone).[7] Because the amended part 721.63(a)(1) where this phrase appears is based on and consistent with OSHA 1910.134(a)(1), “where feasible” presumably carries largely the same meaning as it does in the OSHA regulations.[8] OSHA interprets the phrase “where feasible” to mean technically and economically feasible. However, the “where feasible” requirement under 40 C.F.R. 721.63 does not require product substitution.[9] If EPA determines a product cannot be manufactured, processed, distributed, or used without unreasonable risk, it will prohibit the activity. Finally, EPA can be expected to interpret the recordkeeping requirements in 721.40 and 721.125 to require documentation of how a person implemented the hierarchy of controls requirements, including feasibility evaluations.

EPA Amends Rules for Hazardous Substance Labeling to Align with OSHA’s HazCom Standard.

EPA’s July 5th rule updates the Hazard Communication Program requirements at 40 C.F.R. 721.72 to align EPA’s rules with the OSHA HazCom rules. In order to conform with OSHA labeling and SDS rules, EPA has updated the language of its regulations at 40 C.F.R. 721.72(a)-(h) and has also added two new paragraphs: (i) and (j).  

Previously, Section 721.72 provided in paragraphs (a) through (h) that manufacturers and processors of a subject to a SNUR could rely on an existing hazard communication program established under OSHA’s Hazard Communication Standard (HCS)[10] or one consistent with the UN’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS)[11] criteria for hazard communication.  

In the July 5th rule, EPA updates the language of paragraphs (a) through (h) to conform with OSHA HazCom labeling and safety data sheet rules in the following ways:

  • Paragraphs (a), (c), and (d): EPA changes the term “material safety data sheet” (MSDS) to “safety data sheet” (SDS), and allows for easily accessible electronic versions or other alternatives to maintaining paper copies of the SDS.
    • These changes apply to any previously issued SNUR that cites these paragraphs.
    • EPA has also recommended using a Chemical Abstracts Service (CAS) number to identify the substance in an SDS wherever possible. Alternative numerical identifiers should be used only when CAS numbers are not available.
  • Paragraphs (g) and (h): EPA adds new hazard and precautionary statements to make these provisions consistent with OSHA HCS requirements and the GHS recommendations.
    • These new hazard and precautionary statements do not apply to previously issued SNURs. However, manufacturers and processors subject to a previously issued SNUR will have the option to use the prior hazard and precautionary statements or to use the new alternative statements to comply with the SNUR. EPA has specifically identified in paragraphs (g) and (h) which of the new statements can be used as alternatives for the previously issued statements.

New paragraphs (i) and (j) will establish requirements that a written hazard communication program be developed and implemented for the substance in each workplace in accordance with OSHA’s HCS[12] and will provide example statements and warnings that are consistent with OSHA HCS and GHS recommendations that could be incorporated in SNURs for substances identified in subpart E.[13] This cross-reference to OSHA HCS will automatically incorporate any future amendments to the HCS. New paragraphs (i) and (j) do not apply retroactively, and will only apply to SNURs issued after July 5, 2022. However, any person subject to a previously issued SNUR containing requirements for paragraphs (a) through (h) may now comply with those requirements by following the requirements of paragraph (i) and using any statements specified for that particular substance in paragraphs (g) or (h).

In sum, EPA’s new Hazard Communication Program provisions require all future notice provisions to take the form of OSHA “HazCom” statements. Additionally, EPA specifically identifies which OSHA statements must be on the label and the SDS. In explicitly making this change to its SNUR Regulations, EPA implicitly confirms that it did not require this level of labeling in the past. Failure to implement the required hazard communication program, with the required label and SDS statements, will be deemed a significant new use.

EPA Alters Requirements for Release to Water Discharge Limit Computation 

When EPA issues a SNUR that cites the specific significant new uses described in 40 C.F.R. sections 721.90(a)(4), (b)(4), and (c)(4),[14] the SNUR requires that a SNUN be submitted whenever the estimated surface water concentrations of the substance covered by the SNUR arising from releases to surface water exceed the level specified for that SNUR. For purposes of SNURs, surface water concentrations are established according to the methodology set out in the equation described at 40 C.F.R. 721.91.  

Historically, this equation did not allow consideration of use of control technology to reduce releases to surface water (e.g., wastewater treatment). In other words, even if wastewater treatment processes were able to reduce the concentration of a chemical that enters surface water, that treatment could not be considered when the surface water concentration of the chemical was calculated for comparison to the concentration limit specified for the SNUR.

EPA’s July 5th rule, however, revises 40 C.F.R. 721.91 to allow manufacturers and processors to account for reductions in surface water concentrations resulting from control technology. As a result of this change, any control technology used to reduce surface water concentrations can be considered in the calculation under 40 C.F.R. 721.90.  

However, reduction in estimated surface water concentration via removal by control technology is permissible only when a removal percentage is specifically identified in a specific SNUR. If no removal percentage is identified, this change does not apply to that SNUR. Therefore, this provision does not apply to existing SNURs. In addition, in instances in which this provision does apply, EPA will specify the type of control technology that it will consider (e.g., wastewater treatment) and the percentage of chemical removal it will consider for each SNUR according to EPA’s assessment of the effectiveness of the control technology for the specific substance. It remains to be seen how often EPA will specify a removal percentage in a SNUR such that this provision would apply.

Other Changes Made by the July 5th Rule

  • EPA clarifies that the provision in 40 C.F.R. 721.80(j), which describes a significant new use for new chemical SNURs as “use other than as described in the premanufacture notice referenced in subpart E of this part for the substance,” applies only when the use described in the PMN is confidential. Going forward, EPA states that it will only cite to this provision when the use described in the PMN is confidential. When the use described in the PMN is not confidential, EPA will instead identify the significant new use in a new chemical SNUR by specifically describing that use. 
  • In the context of release to surface water EPA clarifies the meaning of the phrase “predictable or purposeful release,” explaining that the term does not include releases where emergency conditions exist, and significant new use notification is not possible. Therefore, this term covers routine or repeated activity that results in releases to water and to non-routine releases to water that are not due to emergency conditions. However, this term does not limit EPA’s ability to pursue civil penalties on the basis of strict liability under the statute.
  • EPA modifies the bona fide procedures in 40 C.F.R. 721.11 for determining confidential significant new uses by adding this procedure to subpart A rather than referencing 40 C.F.R. 721.1725(b)(1) each time EPA issues a SNUR containing a significant new use designation that contains confidential business information (CBI). Accordingly, EPA also modifies the bona fide procedure that allows EPA to disclose the confidential significant new use designations to a manufacturer or processor who has established a bona fide intent to manufacture, import, or process that substance. EPA’s changes to subpart A will affect all SNURs.
  • EPA revises the provisions in 40 C.F.R. Parts 720.38, 720.45, and 723.50 to require that submitters of any TSCA Section 5 notification or exemption application (i.e., PMN, SNUN, LVE, LoREX, or TME) also include any safety data sheet (SDS) that has already been developed as part of the submission. This revision does not require submitters to develop an SDS, only to submit any already-developed SDSs to the extent that the SDS is known or reasonably ascertainable by the submitter. 
  • EPA corrects typographical errors and more accurately applies the terms manufacture, manufacturer, and manufacturing in 40 C.F.R. Parts 720, 721, and 723.

We would like to acknowledge Summer Associate Catarina Conran who assisted in drafting this article.

[1] The updated NIOSH regulations are codified at 42 C.F.R. part 84 and the updated OSHA regulations at 29 C.F.R. 1910.134.

[2] See Respiratory Protection FAQ (page 2). "On July 10, 1995, 30 CFR Part 11 certification procedures were replaced by 42 CFR Part 84 procedures. Under the 30 CFR Part 11 approval system, manufacturers were required to mark cartridges and filters with an abbreviated label that included a NIOSH/MSHA approval number (“TC number”). Under the 40 CFR Part 84 approval system, cartridges and filters are no longer marked with a “TC number”. Instead, they are marked with “NIOSH”, the manufacturer’s name and part number, and an abbreviation to indicate the cartridge (e.g., OV, CL) or filter (e.g., N95, P100) type."

[3] 40 C.F.R. 721.63.

[4] 40 C.F.R. parts 721.63(a)(4), (a)(5), and (a)(6)40 C.F.R. 721.63.

[5] 40 C.F.R. 721.63(a)(7)-(8) (as amended July 5, 2022).

[6] 40 C.F.R. 721.63(a)(7)-(8) (as amended July 5, 2022).

[7] EPA. Response to Comments on the Proposed Rule Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices. May 2022 at 28.

[8] Id. at 15.

[9] Id.

[10] 29 C.F.R. 1910.1200.

[11] GHS Rev. 9, 2021.

[12] 40 C.F.R. 721.72(i).

[13] 40 C.F.R. 721.72(j).

[14] 40 C.F.R. sections 721.90(a)(4), (b)(4), and (c)(4) read: “Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is: 
    (a) Any predictable or purposeful release of a manufacturing stream associated with any use of the substance, from any site:
        (4) Into the waters of the United States if the quotient from the following formula:
         number of kilograms/day/site released
         ------------------------------------------------------- x 1000 = N ppb
         receiving stream flow (million liters/day)

exceeds the level specified in subpart E of this part when calculated using the methods described in § 721.91…”