California DTSC Releases Draft Alternatives Analysis Guide For Comment
This article was originally published in The Rose Sheet
Executive Summary
The Department of Toxic Substances Control issued draft guidance last September on the first stage of analyses required from responsible parties to identify alternatives to Priority Product chemicals under California’s Safer Consumer Products regs. Industry groups identified weaknesses in the document, but said they were holding out for complete guidance, which is now available and open for comment.
Nail-product manufacturers in particular should take note of the California Department of Toxic Substances Control’s draft Alternatives Analysis Guide, released earlier this month, with the “toxic trio” and other nail-care chemicals floated as possible targets for selection in the agency’s second round of Priority Products.
Priority Products – which identify a chemical of concern in a specific product class (e.g., paint stripper with methylene chloride, a proposed first-round pick) – are subject to alternatives analyses and potential regulation under the state’s Safer Consumer Product program, launched in late 2013.
Signs indicate that any one of at least 21 Candidate Chemicals with recognized uses in nail care, particularly in salon settings, could be chosen by DTSC in its next wave of Priority Product proposals. (Also see "California DTSC Seeks Nail Chemical Info With Priority Product Picks Looming" - HBW Insight, 25 Nov, 2016.)
The long-maligned trio of formaldehyde, toluene and dibutyl phthalate are high in the running, though use of those substances has declined markedly in the cosmetics sector due to voluntary phase-out work and retailer pressure.
The DTSC has been actively soliciting input on candidate nail-care chemicals through workshops and online surveys. If the agency does end up naming a related Priority Product, its AA Guide will be the resource at manufacturers’ disposal to steer their compliance efforts.
“The AA Guide is designed to help responsible entities navigate the SCP AA process,” the DTSC explains. “It provides useful approaches, methods, resources, tools and examples of how to fulfill SCP's regulatory requirements.”
DTSC will conduct a webinar Jan. 10, 2017, to present and discuss the draft AA Guide.
The draft document adds six new chapters to the Stage 1 Alternatives Analysis Guide issued by DTSC in September 2015. That preliminary discussion guidance included chapters on the AA Framework, Product Requirements and Alternatives, Relevant Factors, Impact Assessments and Screening Alternatives. (Also see "California Alternatives Analysis Guide Short On Details For Compliance" - Pink Sheet, 14 Dec, 2015.)
The newly released, holistic draft retains those chapters – which DTSC said it would update based on comments received last year – and includes additional chapters on Exposure, Life Cycle Impacts, Economic Impacts, Informational Needs in AA, Selection of Alternatives and Self-Evaluation of AA.
DTSC is accepting comments on the guide through an online gateway by Jan. 20, 2017.
The Green Chemistry Alliance, which counts the Personal Care Products Council, Consumer Healthcare Products Association and Natural Products Association among its members, said in comments to the agency in December 2015 that while it appreciated the flexibility built into DTSC’s AA guide, the tool lacked the specificity needed to provide a clear path for compliance under SCP regs.
Among the industry organization’s concerns were references to the “iterative” nature of the AA process, which according to DTSC ensures that relevant information is folded into a company’s considerations as it becomes available.
The GCA urged the agency to clarify that “this iterative process is not intended to be an endless, circular and open-ended process.”
The group also asked DTSC to provide additional guidance on how hazard information should be weighed in companies’ AAs, asserting that some evidence is more robust than other “suggestive” evidence, and firms cannot be expected to take every piece of available data into account.
Further, GCA requested clarification on the evidence threshold for ruling out potential alternatives early on in the process – due to prohibitive costs or unacceptable performance characteristics, for example.
Ultimately, the AAs that DTSC receives from companies inform its regulatory responses, which can include orders for firms to provide additional information, implement additional safety measures or limit or discontinue sales.
The DTSC says it will conduct a webinar Jan. 10, 2017, to present and discuss the draft AA Guide.