The American Chemistry Council (ACC), one industry participant, said the objective of the initiative was a “rational, predictable, science-based regulatory environment.” But, according to the ACC, that objective would not be achieved by a proposal that “falls short of achieving the critical tests of clarity, necessity, authority, consistency, and non-duplication with California law.”
In general, the ACC believes the proposal would provide minimal benefits to public health and the environment and result in unwarranted public alarm about chemicals and products as well as great expense and lost opportunities for businesses nationwide. The ACC believes that the DTSC estimate that about 1,200 chemicals would be covered by the SCPR falls short of the 4,000, “if not more,” that would, in fact, be subject to the regulation.
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Following are some of the more general objections to the proposed SCPR made by the ACC and other industry stakeholders. (The DTSC has made all public comments on the proposal available at http://dtsc.ca.gov/SCPRegulations.cfm, along with the proposal itself and extensive related information.)
- Other laws. The ACC believes that products currently covered by multiple federal statutes should be exempted from the California program. The primary federal laws governing chemicals and products are the Toxic Substances Control Act; the Federal Food, Drug, and Cosmetic Act; the Federal Insecticide, Fungicide, and Rodenticide Act; the Consumer Product Safety Act; and the Federal Hazardous Substances Act. Three electronics manufacturing associations sent in a collective comment asserting that there should at least be consideration for exempting products that are previously regulated under other international or federal chemical regulatory regimes. “There should be a presumption that chemical risks have already been reduced in such cases,” state the organizations.
- Reliable information. The proposal depends on loosely defined reliable information to identify chemicals of concern (COC), says the ACC. The ACC believes the DTSC failed to adopt the necessary weight-of-evidence approach wherein dozens of toxicological studies of each chemical are evaluated. “Without that approach, a single study, regardless of its quality (and irrespective of other available relevant data), could be used to conclude that a chemical possesses ‘suggestive evidence’ of a specific hazard.” The American Cleaning Institute complains that the proposed definition of reliable information lacks any description or characteristics of what constitutes reliable information or studies. “Publication of a report or study, whether in a peer-reviewed journal or otherwise, is no guarantee that the underlying data and information are appropriate for regulatory decisions.”
- Risk evaluation. The ACC does not believe that DTSC’s intention to evaluate the aggregate and cumulative effects of each COC is either necessary or practical. Assessing aggregate effects and risks (the total exposure to a specific chemical from all different sources and routes) requires considerable data and information that manufacturers of individual products typically do not have and may be difficult to readily obtain, says the ACC. Assessing cumulative effects or risks (the common toxic effect from concurrent exposure to risks from other chemical and nonchemical sources) poses even greater challenges, the ACC adds.
“For all practical purposes, [for cumulative assessments] DTSC would require an encyclopedia of all substances arrayed by the adverse effects they are capable of producing and the dose levels associated with such effects, both natural substances and synthetic agents, including consumer products, industrial chemicals, and pharmaceuticals and understanding the temporal, demographic, and geographic exposures to each of these,” states the ACC. “Beyond that, DTSC would also need to know the background exposure for the chemical being evaluated. Simply, ACC believes there is no practical way to incorporate cumulative assessment as a routine component of the Safer Consumer Products Regulation. The burden of analysis on DTSC and the industry would be very high and will divert scarce resources from managing important risks.”
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The Dow Chemical Company agrees. “Cumulative risk assessment is far from settled science,” commented Dow. “Scientific bodies do not yet agree on an accepted cumulative risk assessment methodology. Individual companies cannot possibly know all of the possible sources and uses of any given chemical outside of their own control, thus rendering cumulative risk analysis impossible. In the context of the consumer product regulation, cumulative assessments would quickly become an onerous exercise with little practical meaning.”
- Eliminating exposure. The ACC says it is concerned that DTSC’s intent under the proposed SCPR is to eliminate exposures to COCs rather than minimize them. This approach, says the ACC, stands in sharp contrast to the requirement in the Green Chemistry statute, which states that DTSC’s regulations must “establish a process for evaluating chemicals of concern in consumer products, and their potential alternatives, to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern” (emphasis added). The ACC claims that a “minimum detectable concentration,” which the SCPR would require for COCs cannot function as an exemption threshold, nor can it be used to document incremental improvement in a particular product. “In practical terms, the minimum detectable concentration is zero,” states the ACC. “It is unclear how a manufacturer or importer covered by the regulation would use a minimum detectable concentration to demonstrate reductions in chemicals of concern.”
- Cost. Finally, the ACC asserts that the DTSC has significantly underestimated the costs of the SCPR—both to the DTSC and to the California chemical industry. Using knowledge of the federal EPA’s Chemical Risk Review and Reduction program, which is estimated to cost $40 million to $45 million per year, excluding new chemicals, the ACC estimates that implementing the SCPR will cost at least three times more than the $6 million budgeted for the regulation.
Also, the ACC argues that DTSC’s economic analysis does not reflect the complexity of California’s chemical industry. “The value of the chemical shipments is almost $46 billion, and the California chemical industry exports $12.5 billion worth of chemicals throughout the world,” says the ACC. “The business of chemistry directly employs 74,000 people and indirectly contributes 239,000 jobs in California. For every chemistry industry job in California, 4.2 jobs are created downstream within the state. Together these jobs generate $23 billion in earnings, which then also generate state and federal revenues through taxes.”
“The analysis prepared for the SCPR provides no quantitative estimate of costs or benefits,” adds the ACC, “and takes no account of the chemical industry and the downstream impacts in the state.”
Furthermore, the proposed regulation does not acknowledge potential compliance challenges that small- and medium-sized businesses will face as a result of the proposed regulation, asserts the ACC.