In an increasing trend to regulate the chemicals found in consumer products, numerous states are enacting laws and regulations to address the presence of 1,4-dioxane in consumer products. 1,4-Dioxane is a synthetic industrial chemical found in household substances such as shampoos, soaps, household cleaners, dyes, paints and glues. 1,4-Dioxane can be a by-product of chemical reactions during manufacturing. For more background on 1,4-dioxane, see BCLP’s Client Alert, which discusses regulatory reopening issues.
This Client Alert discusses the federal government’s limited efforts to date and the broader efforts by many states to regulate 1,4-dioxane in consumer products. The perceived risks are twofold: (1) downstream disposal in wastewater; and (2) potential health risks to consumers using the product.
I. Federal landscape
Since 2016, the National Toxicology Program has classified 1,4-dioxane as “reasonably carcinogenic to humans.” In 2019, the U.S. Environmental Protection Agency (“EPA”) conducted a risk assessment for 1,4-dioxane (ie, an assessment of whether 1,4-dioxane poses an unacceptable risk to health or the environment). In December 2020, the EPA released its final risk assessment report, who determined that 1,4-dioxane may pose an unacceptable risk in certain manufacturing, processing, industrial and commercial settings. The report concluded that 1,4-dioxane does not pose an unacceptable risk to consumers using consumer products containing the chemical.
There are currently no federal regulations specifically addressing the presence of 1,4-dioxane in consumer products. The Food and Drug Administration (“FDA”) has evaluated 1,4-dioxane in cosmetics, but it has yet to issue enforceable regulations.
II. Government Laws and Regulations
New York is leading the way towards improved regulation of consumer goods.
In two acts (Household Cleaning Products and Cosmetic and Personal Care Products) effective January 1, 2022, state legislation banned 1,4-dioxane in these products except at “trace” levels. The law addresses the risks of disposing of 1,4-dioxane in wastewater and human exposure to consumer products. The phase-in timeline and legal definition of “trace levels” is as follows:
New York 1,4-dioxane requirements
California has also taken action. The California Office of Environmental Health Hazard Assessment (“OEHHA”) has identified 1,4-dioxane as a human health risk and has listed a “safe harbor” requirement of 30 µg per day. Exposures below the safe harbor level are exempt from the requirements of Proposition 65. Since 1988, OEHHA has classified 1,4-dioxane as a Proposition 65 cancer risk.
In 2017, California’s Right to Know Cleaning Products Act requires manufacturers to list 1,4-dioxane if it is present in finished products at total levels of 10 ppm or greater. The bill and an associated summary address this requirement.
Numerous states have banned the appearance of 1,4-dioxane in children’s products, usually when 1,4-dioxane is present at levels greater than 1 ppm. Typically, these laws and regulations require manufacturers to report to a governmental agency or department.
In New York, a 2020 law requires NYSDEC to consider 1,4-dioxane and a variety of other chemicals to publish a list of “Chemicals of Concern.” Additionally, the law requires a manufacturer offering a children’s product for sale or distribution in New York to file a report with NYSDEC identifying any chemicals of concern or high priority chemicals present at or above practical limits of quantification. Reports are due twelve months after a chemical of concern or high priority chemical appears on NYSDEC’s list. NYSDEC has yet to issue regulations to implement this statute.
III. Further regulatory investigations into disposal are likely to result in additional regulations
The California Department of Toxic Substances Control (“DTSC”) has identified 1,4-dioxane as a contaminant of concern, citing specifically a disposal risk rather than a direct risk to consumers. DTSC states the following: “DTSC is concerned about the potential adverse effects on Californians from exposure to 1,4-dioxane, particularly on children and environmental justice communities. Many personal care and cleaning products are flushed down the drain during or after use, leaving 1,4-dioxane in the sewage system.” DTSC is currently evaluating additional information to prepare partial 1,4-dioxane regulations.
In 2019, DTSC released a document entitled “1,4-Dioxane in Personal Care and Cleaning Products,” which was circulated at public hearings during that time. The document evaluated consumer products containing 1,4-dioxane for possible designation as priority products under California’s Safer Consumer Products Regulations, and also addressed several potential routes of human exposure to 1,4-dioxane.
To our understanding, DTSC has not taken any formal action to designate 1,4-dioxane found in beauty, personal care, hygiene and cleaning products as a priority product. DTSC is currently in a lengthy process of gathering information, evaluating public comments and evaluating an alternative analysis.
We expect regulation of 1,4-dioxane in consumer products to continue for the foreseeable future. In the absence of federal regulation, state legislators and agencies continue to focus on the presence of potentially harmful chemicals in consumer products to protect consumer health and water resources.