California OEHHA Proposes Drastic Reduction in Allowable Exposures to Ethylene Oxide
On April 7, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking reducing the No-Significant-Risk Level (NSRL) for ethylene oxide from 2 micrograms per day to 0.058 micrograms per day. This change would effectively reduce the allowable exposure level for ethylene oxide based on potential carcinogenicity by 97 percent, which represents one on the most drastic reductions in a Proposition 65 benchmark for any chemical addressed under California Proposition 65. The deadline for submission of comments on this proposed action is May 23, 2023.
Ethylene oxide (EtO) is present in cleaning products, including detergents, surfactants, shampoos, and some disinfectants, due to the chemistry involved in production of these products. Trace amounts of EtO can also be found in high-durability fabrics, carpets, and upholstery. Trace levels may be present in products that are fumigated with EtO, such as spices, milk powder, and cereals, and products that are sterilized with EtO, such as medical devices. The proposed change, if finalized, could have far-reaching impacts for manufacturers and distributors of these products. California Proposition 65 puts the responsibility on product manufacturers and/or distributors to conduct exposure assessments/risk assessments to determine whether a product is compliant with the relevant Proposition 65 benchmarks, and to determine whether a product should contain a Proposition 65 warning statement. The proposed new restriction in the allowable exposures to EtO will present new challenges for manufacturers and distributors of products containing trace amounts of this chemical.
With its 3 board-certified toxicologists and decades of experience in conducting California Proposition 65 exposure/risk assessments, toXcel, LLC, is uniquely positioned to provide these evaluations and accompanying Proposition 65 compliance letters, as well as to advise on the specific wording of Proposition 65 warning statements and label compliance language.