Regulatory Developments

EPA Finds PCE, NMP, and 1-BP, as Whole Chemical Substances, Pose Unreasonable Risks to Human Health

December 21, 2022 PRINT

The U.S. Environmental Protection Agency (EPA) announced on December 14, 2022, the availability of the final revision to the risk determination for the perchloroethylene (PCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 76481. EPA determined that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). On December 19, 2022, EPA announced the availability of the final revision to the risk determination for the n-Methylpyrrolidone (NMP) risk evaluation and the final revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation. 87 Fed. Reg. 77596, 87 Fed. Reg. 77603. EPA determined that NMP and 1-BP, as whole chemical substances, present an unreasonable risk of injury to human health when evaluated under their COUs. In each case, EPA states that the revision to the risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law.

PCE

In its December 14, 2022, press release, EPA states that PCE is used in the production of fluorinated compounds, as a solvent for cleaning and degreasing, and in lubricants, adhesives, and sealants. According to EPA, a variety of consumer and commercial products use PCE, such as adhesives (arts and crafts, as well as light repairs), aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish, and wipe cleaners.

In its revised risk determination, EPA found that PCE presents unreasonable risk to the health of workers, occupational non-users (ONU) (workers nearby but not in direct contact with PCE), consumers, and bystanders. EPA states that it identified risks for adverse human health effects not related to cancer, including neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to PCE. EPA also identified risks for cancer from chronic inhalation and dermal exposures to PCE.

EPA determined that 60 of the 61 COUs evaluated drive the unreasonable risk determination. The one COU that does not drive the unreasonable risk is distribution in commerce. The revised risk determination supersedes the COU-specific no unreasonable risk determinations that were previously issued by order under TSCA Section 6(i) in the 2020 PCE risk evaluation.

NMP

In its December 19, 2022, press release, EPA states that NMP is widely used during the manufacture and production of electronics, polymers, agrichemicals, and petrochemical products. It has numerous industrial, commercial, and consumer applications.

In its revised risk determination, EPA found that NMP presents unreasonable risk to the health of workers and consumers. EPA states that it identified risks for adverse human health effects, including developmental post-implantation fetal loss from short-term exposure and reduced fertility and fecundity from long-term exposure. EPA found that NMP presents unreasonable risk to the health of workers for all occupational uses and to consumers from one consumer use.

EPA determined that 29 of the 37 COUs evaluated drive the unreasonable risk determination. Eight out of 37 COUs do not drive the unreasonable risk, including the consumer use in paints and coatings in lacquers, stains, varnishes, primers, and floor finishes, the consumer use in paint and coating removers, and the consumer use in automotive care products. The revised risk determination supersedes the COU-specific no unreasonable risk determinations previously issued by order under TSCA Section 6(i) in the 2020 NMP risk evaluation.

1-BP

In its December 19, 2022, press release, EPA states that 1-BP is used as a solvent in commercial and industrial applications and as a reactant in the manufacturing of other chemical substances. Consumer uses include adhesives, degreasers, cleaners, and automobile care products.

In its revised risk determination, EPA found that 1-BP presents unreasonable risk to the health of workers, ONUs, consumers, and bystanders to consumer use. EPA states that it identified risks for adverse human health effects, including developmental toxicity from short- and long-term inhalation and dermal exposure to the chemical, and cancer from long-term inhalation and dermal exposure.

EPA determined that 23 of the 25 COUs evaluated drive the unreasonable risk determination. Two out of 25 COUs do not drive the unreasonable risk: commercial and consumer use of 1-BP in insulation and building materials, and distribution in commerce. The revised risk determination supersedes the COU-specific no unreasonable risk determinations previously issued by order under TSCA Section 6(i) in the 2020 1-BP risk evaluation.

Risk Determination Approach for PCE, NMP, and 1-BP

For each chemical, EPA states that it used the whole chemical risk determination approach in part because there are benchmark exceedances for multiple COUs spanning across most aspects of the chemicals’ lifecycle (from manufacturing (including import), processing, commercial use, consumer use, and disposal) for health of workers, ONUs, consumers, and bystanders, and because the health effects associated with exposures to these chemicals are severe and potentially irreversible.

EPA notes that the revised risk determinations do not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce workers’ exposure. EPA states that this decision “should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards.” In fact, according to EPA, it received public comments from industry respondents about occupational safety practices currently in use at their facilities and will consider these comments, as well as other information on use of PPE, engineering controls, and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process.

EPA acknowledges that there could be occupational safety protections in place at some workplace locations. Not assuming use of PPE in its baseline exposure scenarios, however, reflects EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because:

  • They are not covered by OSHA standards (e.g., self-employed individuals and public sector workers who are not covered by a state plan);
     
  • Their employers are out of compliance with OSHA standards;
     
  • OSHA’s chemical-specific permissible exposure limits (PEL) (largely adopted in the 1970s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health”;
     
  • The OSHA PEL alone may be inadequate for ensuring protection of worker health, as is the case for PCE, according to EPA; or
     
  • There is no chemical-specific OSHA PEL, as is the case for both NMP and 1-BP.
     

EPA states that as it moves forward with risk management rulemakings for PCE, NMP, and 1-BP, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.” EPA will propose occupational safety measures in the risk management process that would meet TSCA’s statutory requirement to eliminate unreasonable risk of injury to health and the environment.

Next Steps for PCE, NMP, and 1-BP

EPA states that it is now moving forward on risk management to address the unreasonable risks presented by PCE, NMP, and 1-BP. EPA notes that in revising the risk determinations, it has not conducted new scientific analyses on these chemicals and the risk evaluations continue to characterize risks associated with individual COUs in the risk evaluations of PCE, NMP, and 1-BP to inform risk management.

Separately, EPA is conducting a screening-level approach to assess potential risks from the air and water pathways for several of the “first 10” chemicals, including PCE, NMP, and 1-BP. The goal of the screening-level approach is to evaluate the surface water, drinking water, and ambient air pathways for PCE that were excluded from the 2020 risk evaluation, the drinking water and ambient air pathways for NMP that were excluded from the 2020 risk evaluation, and the ambient air pathway for 1-BP that was not fully assessed in the 2020 risk determination, and to determine if there are risks that were unaccounted for in the risk evaluations. EPA states that it expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rules for PCE, NMP, and 1-BP.

Additionally, EPA expects to focus its risk management action on the COUs that drive the unreasonable risk. EPA notes that it is not limited to regulating the specific activities found to drive unreasonable risk, however, and may select from among a wide range of risk management requirements. EPA states that as a general example, it may regulate upstream activities (e.g., processing, distribution in commerce) to address downstream activities (e.g., consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk.

Commentary

Bergeson & Campbell, P.C. (B&C®) has been expecting EPA to issue its final revisions for the PCE, NMP, and 1-BP risk determinations. EPA’s revised determinations have taken roughly five to six months from issuing the draft revisions to announcing the final revisions (e.g., PCE draft: June 30, 2022, final: December 14, 2022; NMP draft: July 1, 2022, final: December 19, 2022; 1-BP draft: July 20, 2022, final: December 19, 2022), which is consistent with previous determinations (e.g., Colour Index Pigment Violet 29 draft: March 7, 2022, final: September 6, 2022).

Not surprisingly, the final revisions for the PCE, NMP, and 1-BP risk determinations did not change during the public comment periods and still present the issues we identified on these chemical substances when in draft revised form (see our memorandum dated July 12, 2022). These issues include using a faulty systematic review method that is inconsistent with the scientific standards under TSCA Section 26, making unreasonable risk determinations for the whole chemical substance, that is inconsistent with the requirement under TSCA Section 6(a) for making risk-based determinations and Section 702.47 of 40 C.F.R. Subpart B, and considering the use of PPE during risk management, that is inconsistent with TSCA Section 26(k) for reasonably available information and Section 702.33 of 40 C.F.R. Subpart B.

B&C notes that interested parties should be mindful of these issues in preparation for EPA’s forthcoming draft risk management rules. Raising these and other relevant issues during the public comment period will not change EPA’s final risk management rules. It is, however, important to provide these comments to ensure the continued development of an administrative record, especially if challenging the final risk management rule in court becomes the only viable option for urging a court to require EPA to rescind and reissue its rules in a form that is consistent with TSCA requirements.


 
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