The California Department of Toxic Substances Control (DTSC) published draft guidance discussing methods for conducting Alternative Analyses (AA) under the Safer Consumer Products (SCP) regulation on December 12th, 2016. Public comments are due by February 3rd, 2017.
The DTSC is particularly interested in comments regarding the clarity and usefulness of the Draft Guide. Significantly, DTSC cannot finalize its initial Priority Products list until it “make[s] available on its website guidance materials to assist persons in performing AAs” (Title 22, California Code of Regulations, Section 69505.) Thus, finalizing this AA guidance is essential for DTSC to move forward with its first Priority Product proposed regulation, identifying children’s foam padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product.
DTSC promulgated the SCP to replace the traditional case-by-case single chemicals in consumer products bans with a comprehensive, science-based process for addressing “chemicals of concern” in consumer products. AAs are a key component of the SCP program. The AA process applies to any “businesses that manufacture, import, distribute, sell, or assemble consumer products [i.e., “responsible entities”] listed by the Department of Toxic Substance Control as Priority Products containing chemicals of concern and placed into the stream of commerce in California.” (https://dtsc.ca.gov/SCP/affectme.cfm)
Draft Alternative Analysis Guide Contents:
The Draft Guide includes resources, descriptions of the regulations, and examples of tools and approaches that businesses can take to complete the AA process. The Draft Guide is not intended as a regulation or standard and creates no new legal requirement; it is intended to function merely as an informational guide to assist responsible parties in meeting existing AA regulations.
The Guide begins with a discussion of the AA framework, emphasizing regulatory requirements. Subsequent chapters discuss more technical aspects, including the following:
• The two stages of the AA process
o During the first stage, “the responsible entity identifies the goal, scope, legal, functional, and performance requirements of the Priority Product and the Chemical of Concern,” and also identifies alternatives in lieu of the chemical of concern.
o During the second stage, the responsible entity compares the Priority Product to the identified alternatives. This stage requires an in-depth analysis considering impacts.
• Various approaches to completing the AA steps
o The Guide provides various options responsible entities may employ, but is not a comprehensive guide. For example, a full ISO-compliant Life Cycle Analyses is not required to conduct an AA; rather, it is one approach for meeting the requirement to quantify and assess impacts.
• Tools and methods that may be useful for these approaches
o According to the Draft Guide, a qualitative approach is useful for the first stage of AA. Conceptual models may be utilized to illustrate the life cycle impacts of a product and various exposure pathways.
o According to the Draft Guide, a quantitative approach is useful for the second stage of AA. Responsible entities may elect to utilize life cycle analysis (“LCA”) tools, which “consider a wide range of hazard endpoints that address most of the relevant factors specified in the regulation” (Section 7.3 of the draft guide), or they may elect to utilize their own approach for data collection and analysis.
A key – and challenging – element of AAs is the requirement that responsible entities evaluate the environmental and health impacts of a product throughout its life cycle. Assessment of a product’s life cycle impact is a resource-intensive exercise requiring consideration of the input of resources and the output of emissions and wastes along each relevant “segment” of the life cycle. Responsible entities must also consider various exposure pathways for subpopulations throughout the life cycle. DTSC defines the life cycle as beginning with raw materials extraction and ending in “end-of-life” disposal, and includes usage of the product in between. A more detailed list of segments that must be assessed during a life cycle impact is included on pages 33-34 of the Draft Guide.
The AA process also requires responsible entities to “evaluate, monetize and compare the impacts of the Priority Product and the alternatives on:
• public health and environmental costs
• costs to governmental agencies and non-profit organizations that manage wastes, oversee environmental cleanup and restoration efforts, and charged with protecting natural resources, water quality, and wildlife.”
It is far from clear that the data required for this analysis would even be available or, if it is available, that it would be of sufficient quality for analysis. Industries already have conveyed their concerns to DTSC that the external cost analysis could be virtually impossible to carry out.
Industry also has raised concerns about the what appears to be mandatory requirements in what is only a guidance document with no independent regulatory effect. It remains to be seen whether the final AA guidance document will use permissive, rather than mandatory, language.
Background – Safer Consumer Products Program
DTSC developed the SCP program in 2013 under the authority of the Green Chemistry laws, Assembly Bill 1879 and Senate Bill 507, enacted in 2008. Its goals consist of establishing a process to identify and prioritize chemicals in consumer products and establishing an AA process that evaluates safer substitutes for these “chemicals of concern” in consumer products.
The SCP regulations provide a four-step process:
1) Candidate Chemicals: The DTSC identifies “candidate chemicals,” via a list of lists, representing a potential public health or environmental concern based on scientific work done by authoritative organizations. The most recently published list can be found here.
2) Priority Products: The DTSC identifies consumer products that contain candidate chemicals; these are then identified as “Priority Products.” Priority Products must be formally adopted in regulations before the third step of the process can occur.
3) Alternative Analysis: Responsible entities are responsible for reporting Priority Products as well as performing an Alternative Analysis on those products. The AA process is intended to answer the following questions:
a. Is this chemical ingredient necessary to the product?
b. Is there a safer alternative?
c. Is that alternative feasible?
4) Regulatory Responses: Depending on the result of the Alternative Analysis, DTSC may impose restrictions such as labeling requirements, use and disposal requirements, and product bans.
This blog article was researched and written by Brown University Class of 2018 student Aisha Keown-Lang. Ms. Lang is studying biology and political science at Brown University with the goal of going into bioethics and public health. Her special interest in genetics stems from her research in the Li Lab at UCSF and the Gerbi Lab at Brown. After having worked with children in the Providence school system for nearly three years, her commitment to improving scientific literacy and expanding health services in underserved communities remains strong. Ms. Lang is currently a writer for Brown’s Science Cartoon Program (SciToons), which aims to communicate scientific research and ideas to a diverse audience.
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