(October 28, 2010) State regulators are moving to formally adopt new rules that have the potential to affect nearly all firms that manufacture or sell consumer products in California.
On September 14, the Department of Toxic Substances Control (DTSC) released its proposed “Safer Consumer Product Alternatives” regulation, which seeks to implement California’s new green chemistry program.
The program was authorized by the enactment of 2008 legislation, AB 1879 (Feuer; D-Los Angeles) and SB 509 (Simitian; D-Palo Alto).
These bills provide DTSC with authority to identify chemicals of concern, study them, prioritize chemicals of concern, and regulate certain products that contain these chemicals.
According to the statute, DTSC can require labels, reformulation of products, producer take back programs, outright bans of products, and much more.
Complex Approach
The 92-page document released by DTSC establishes a highly complex approach to identifying and prioritizing chemicals of concern in consumer products and regulating their future use based on exposure to consumers and the environment.
Products DTSC declares to be a priority would require extensive research and analysis by the manufacturer to determine whether safer alternatives exist that limit exposure or reduce the level of hazard posed by chemicals in the product. Failure to find safer alternatives could lead to a ban of the consumer product.
Ambiguous Scope
The department will be looking to a vast list of toxic traits when determining whether a substance is to be regulated as a “chemical of concern.”
Every chemical known—including ones needed to survive—exhibits at least one of these hazard traits at some level of exposure. Thus, the department could conceivably regulate virtually any chemical and any product.
Meanwhile, the regulations are written in a way that gives the department near-limitless discretion over the process that will be used to regulate consumer products. This amounts to a regulation in which it is nearly impossible to ascertain whether a given product or material will be subject to the long and expensive approval process.
Lengthy Compliance Process
The first step for DTSC will be to identify and prioritize the chemicals and products of concern in California commerce. During this phase, DTSC will collect chemical information from a variety of sources, including businesses that manufacture or sell a given chemical or product. This information is likely to include a large amount of technical data, information related to marketing and sales of related products, and chemical data.
With this information, DTSC will begin the process of identifying chemical and product combinations that pose the greatest public health and environmental threats as a result of exposure to the chemical at levels that can result in human or environmental harm.
The regulations would label chemicals that DTSC is simply considering as “chemicals of concern,” however, and thus expose those chemicals and their products to regulatory obligations. This approach blurs the line of prioritization and, together with other provisions and requirements, leads to the potential for a massive regulatory burden on every physical item in California commerce.
Other issues within the regulations add to the enlarged scope of the green chemistry process.
For example, an exemption is available for products containing such trace amounts of a chemical of concern that they do not pose a risk of exposure to consumers or the environment, but DTSC may determine that no such exemption is available on a case-by-case basis.
Also, the rules seek to avoid regulatory duplication for products and chemicals that are already regulated by other laws, but again give DTSC the ability to override this consideration at its choosing.
Finally, the burden of proof is so high for a manufacturer to show that there is no exposure risk for a given chemical in a product, that it is unlikely that products will avoid the regulatory process on an exposure basis.
Analysis of Alternatives
The heart of the Green Chemistry Initiative is the Alternative Assessment (AA) process, intended to promote the development of safer, alternative products.
Following chemical listing and submission of chemical information, a responsible party could take early action by reformulating or redesigning a product containing a listed chemical or by reducing the concentration of the listed chemical. A full report to DTSC is required, detailing the changes and noting the reduction of adverse public health or environmental impacts achieved by the reformulation, redesign or substitution.
For products for which no alternative can be quickly substituted, businesses must develop an AA Work Plan for developing alternative designs and report to DTSC within 180 days.
The work plan must detail the evaluation methods and process for selecting a product alternative designed to reduce health and environmental hazards.
The actual work of developing safer alternative consumer products is likely to be both costly and tedious. Manufacturers must submit reports for each alternative variant evaluation. These AA reports must include chemical hazard and exposure assessment information and a “Multimedia Life Cycle Evaluation.”
Using criteria developed by DTSC, manufacturers must work with evaluators to develop safer consumer products that meet the health and environmental standards established.
If the work plan is rejected at the onset or if no satisfactory alternative can be found, DTSC can take other action, including imposing extended producer responsibilities on manufacturers or imposing a ban on the product or chemical in question.
Confidential Information
Ensuring that confidential business information and trade secrets are protected throughout the process is vital to the success of the program.
Critical confidential business information would not necessarily be protected in the process. Instead, a lengthy claim of confidentiality must be asserted for each chemical, based upon a set of criteria, leaving the final determination with DTSC.
Lack of security of proprietary information is one of many features of the draft regulation that could stifle innovation in the market for consumer products in California.
Economic Impact
At a time when California needs to kick-start its economy by creating jobs, the proposed regulations impose layer upon layer of additional costs on companies, impede innovation and technology transfer, and ultimately will drive product development out of the state when California can least afford it.
Investors and innovators will face a regulatory regime in California that has substantial power over, not just the existing marketplace of products, but the developed alternatives, which presumably are safer. The regulatory obstacles and expense associated with bringing “safer alternatives” to market will be a disincentive to investment.
Add to this the potential for exposure of trade secrets and confidential business information, and entrepreneurs are left with a green chemistry program where costs far outweigh benefits.
Business Response
The California Chamber of Commerce and partners in the Green Chemistry Alliance continue to express concerns with the draft regulation and urge DTSC to work toward a process that creates certainty for manufacturers of consumer products without jeopardizing health and environmental quality or creating greater burdens to the state’s economic vitality.
Continuing down the present path would achieve few of the intended results at a high cost, including the potential for forced withdrawal of a substantial number of products across industry in the California market.
DTSC is accepting public comments until November 1, and has scheduled a public hearing on that date. Public comments may be submitted online at the DTSC website, www.dtsc.ca.gov, or at the public hearing.
Staff Contact: Robert Callahan