U.S. EPA and Health Canada Move to Restrict PIP (3:1) and IPBC
Regulators in the United States and Canada have been revisiting exposure data for certain lubricant additives for purposes of health risk regulation. Recent actions by the U.S. EPA and Health Canada have implications for lubricant manufacturers and additive suppliers.
EPA’s Final Revisions to PIP (3:1) Regulations
On November 19, the EPA finalized revisions to its regulations for phenol, isopropylated phosphate (3:1), or PIP (3:1). The final rule introduces new occupational safety requirements and establishes phase-out timelines for the processing and distribution of PIP (3:1) in certain applications, including lubricants and greases.
The EPA first regulated the substance as a persistent, bioaccumlative and toxic chemical under TSCA in 2021. These regulations banned the processing and distribution of the chemical, including in products and articles. The regulatory framework had exclusions for several applications in lubricants and greases. However, the EPA is now narrowing the scope of these exclusions to cover only aerospace and turbine uses. The agency has established a 15-year phased prohibition for all other uses, despite its recognition that “PIP (3:1) is a crucial anti-wear component for lubricants and greases” in various applications beyond aerospace.
The rule becomes effective on January 21, the day after President-Elect Trump’s inauguration. At a minimum, it is likely that the incoming administration will freeze the rule’s effective date to allow the new management team at the EPA an opportunity to review the rule.
Health Canada’s Proposed IPBC Special Review
Last month, Health Canada proposed hazardous communication requirements and risk mitigation measures for “all products containing iodocarb used in metalworking fluids that are registered in Canada.” The agency will accept comments on the proposal until December 14.
Under subsection 17(1) of the Pest Control Products Act, Health Canada initiated a special review of registered pest control products containing iodocarb (3-iodo-2-propynyl butyl carbamate or IPBC) used in metalworking fluids. This review was prompted by post-application exposure information on workers handling iodocarb-treated metalworking fluids or involved in maintenance activities. Specifically, the agency assessed risks to mixers/loaders treating metalworking fluids with iodocarb and machinists exposed to iodocarb-treated metalworking fluids.
As a result, Health Canada is proposing labeling amendments and dose use rates. For dose rates, the agency is proposing:
- To protect workers (mixers/loaders) from exposure when open-pouring products containing iodocarb into metalworking fluid, the proposed maximum amount of iodocarb handled per day is limited to 1.25 kg active ingredient (a.i.) per person. If handling more than this, a closed transfer (injection) system is required.
- To protect secondary workers (machinists) from exposure, the proposed maximum concentration of iodocarb in metalworking fluid is 750 parts per million (ppm).
ILMA is collaborating with stakeholders to submit comments, aiming to prevent the proposal from overly restricting the biocidal use of IPBC in metalworking fluids. If you are interested in providing input, please contact Regulatory Counsel Jorge Roman.