The nation's federal toxic chemicals law, the Toxic Substances Control Act (TSCA), has a number of significant shortcomings. Among other things, it does not generally require companies to test chemicals for possible health effects before using them in consumer products. And though the federal Consumer Product Safety Improvement Act limits the amount of lead and bans certain chemicals known as phthalates in children's products, it doesn’t restrict the use of other toxic substances in consumer goods. To respond to this gap in addressing the use of toxic substances in consumer products, California adopted new regulations on Oct. 1 designed to create safer substitutes for hazardous ingredients in products sold in the state.

In addition to reducing consumer exposures to toxic chemicals and thus improving health, the goal of the regulations is to also “create new business opportunities in the emerging safer consumer products economy and reduce the burden on consumers and businesses struggling to identify what’s in the products they buy for their families and customers.” The regulations are an outgrowth of California’s Green Chemistry Law, specifically Assembly Bill 1879, which mandated the Safer Consumer Products Regulations and authorized the implementation of the Safer Consumer Products Program.

Four-step Process

The regulations require a four-step process for regulating toxic chemicals in consumer products (Figure 1):

1. Development of a list of potentially harmful chemicals by California’s Department of Toxic Substances Control (DTSC) based on the work already done by other authoritative organizations.


2. Evaluation and prioritization of combinations of toxic chemicals and the products they are used in to develop a list of “Priority Products” for which analyses must be conducted to see if safer alternatives are available. A chemical that is the basis for a product being listed as a Priority Product will be designated a Chemical of Concern (COC) for that product and any alternative considered or selected to replace that product.


3. Responsible entities (i.e., manufacturers, importers, assemblers, and retailers) notify the Department of Toxic Substances Control when their product is listed as a Priority Product. Manufacturers (or other responsible entities) of a product listed as a Priority Product must then perform an alternatives analysis for the product and the Chemicals of Concern in the product to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals in the product.


4. The Department identifies and implements regulatory responses designed to protect public health and/or the environment, which maximize the use of acceptable and feasible alternatives of least concern. DTSC may require regulatory responses for a Priority Product (if the manufacturer decides to retain the Priority Product), or for an alternative product selected to replace the Priority Product.

Figure 1 (click image to enlarge)

Candidate Chemicals/Priority Product Selection

The regulations require the entities that produce consumer products to inform the DTSC that their products contain a chemical that is listed on a forthcoming list of “priority products.” On Sept. 26, the DTSC published an informational list of approximately 1,200 individual and groups of “candidate chemicals” derived by the DTSC from lists developed by other “authoritative organizations.” Manufacturers can voluntarily review whether their products contain any of the chemicals on the list to evaluate whether safer chemicals are available and to avoid substitutions in which one toxic chemical is substituted for another.

Figure 2 (click image to enlarge)

A list of 164 initial Candidate Chemicals that meet the criteria for the Initial Priority Products List was developed from this larger list of chemicals based on both the toxicity profile of the chemical and information on the potential for human exposure (Figure 2).

The DTSC will then evaluate and prioritize product/Candidate Chemical combinations to develop a list of Priority Products for which analyses of potential alternatives must be conducted. By April 1, 2014, the DTSC will make available for public review and comment up to five products proposed on an Initial Priority Products List. In evaluating a product for inclusion on this list, the DTSC will assess the potential adverse impacts of its candidate chemical(s) and adverse impacts due to potential exposures during the life cycle (i.e., from manufacture through to use and disposal) of the product by considering various factors listed in the regulations for which information is reasonably available.

The DTSC will also identify the chemical(s) from the initial candidate chemicals list included in the product for each initial priority product. A chemical that is the basis for a product being listed as a priority product will be designated a Chemical of Concern for that product and any alternative considered or selected to replace the product. By Oct. 1, 2014, the DTSC will develop a Priority Product Work Plan to identify and describe the product categories they will evaluate in the future.

Alternatives Analysis

For products categorized as Priority Products, the responsible entity must perform an alternatives analysis for the product and the chemicals of concern in the product to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by them.

A two-phase alternative analysis process is described in the rule. Safer Consumer Products Regulations requires the manufacturers to compare the existing product-chemical combination that contains a chemical of concern with a potential alternative (e.g. chemical substitution or product redesign) using 13 factors evaluated at each stage of the product’s life cycle. Based on this analysis, the manufacturer (or another responsible entity) will select an alternative chemical ingredient or alternative product design, or decide to retain the existing product-chemical combination. A DTSC guidance document on conducting an alternatives analysis is currently being developed.

Conclusion

As has been the case for a variety of environmental health concerns (e.g., air pollution, chemical hazard assessment), California is taking a national leadership role in developing a regulatory system to reduce public exposure to toxic chemicals in consumer products, a major source of public exposure to toxic hazards. As California gains experience with this new program, other states will be looking at this model to develop similar programs. However, industry is expected to challenge California’s program and concerns remain that preemption of state chemical regulations could be included in efforts to reform the Toxic Substances Control Act, the nation’s outdated and generally ineffective legislation for chemical regulation.