What is California Alternatives Assessment?

California Health & Safety Code § 25251
 California Code of Regulations § 69301 (proposed) 
Green Screen for Safer Chemicals

Alternatives Assessment (AA) is a requirement in California's Green Chemistry Initiative. In September 2010, the Department of Toxic Substances Control (DTSC) issued "Proposed Regulations for Safer Consumer Product Alternatives" which were scheduled to become January 1, 2011.

However, following the public comment period, a second set of "Proposed Regulations" were issued in November 2010 that were a substantive rewrite and simplification of the earlier text.  Implementation has been delayed indefinitely while the Green Ribbon Science Panel is reconvened to address the programmatic issues that have been raised.

Summary of the "Proposed Regulations" as issued in September 2010:
What is Alternatives Assessment (AA)?

Performed for products that contain a Chemical Under Consideration (CUC) or a Priority Chemical
Undertaken to evaluate "greener" alternatives to the existing product
Compares a currently used substance, material or chemical process with a proposed alternative developed according to the twelve Principles of Green Chemistry
Assesses public health and environmental impacts across the entire life cycle of the existing product and proposed alternative using "life cycle assessment tools"
Used to decide whether to redesign or reformulate the existing product, replace it with a different product, or leave it "as is" until better alternatives become available
What is Tier I AA?
Applies to products that contain Chemicals of Concern (COC) i.e. listed on the Chemicals Under Consideration List or the Priority Chemicals List
Required when product is reformulated/redesigned to remove/reduce the COC or when it is replaced with an alternative product
  Not required when product is reformulated without addition of another chemical; use Chemical Removal Confirmation Notification instead
  Not required when product is withdrawn without being replaced with another product; use Product Removal Confirmation Notification instead
AA Notification must be submitted before placing the reformulated, redesigned, or replacement product in California stream of commerce
Tier I AA Report is substantially equivalent to the "Green Screen For Safer Chemicals", an open source, chemical hazard screening assessment tool developed by Clean Production Action (nonprofit organization) in consultation with US EPA and industry groups
Evaluates the parent chemical and all its feasible transformation products for "hazard endpoints" (e.g. carcinogenicity, acute aquatic toxicity, persistence, flammability) based upon measurable thresholds (e.g. soil or sediment > 180 days) or regulatory categories (from Prop 65, US EPA, EU, GHS)
Ranks chemicals by "Benchmark" (1 - Avoid,  2 - Use but Search for Safer Substitutes, 3 - Use but Opportunity for Improvement,  4 - Prefer) by rating hazard endpoints (very high, high, moderate or low) and deriving aggregate score
What is Tier II AA?
Required when product is listed as a Priority Product
  Not required if your product does not contain the Priority Chemical
  Not required if product meets DTSC-specified "de minimis" level; use De Minimis Exemption Request instead
  Not required if Priority Chemical is removed from product without the addition of another chemical; use Chemical Removal Intent/Confirmation Notifications instead
  Not required if product is withdrawn without being replaced with another product; use Product Removal Intent/Confirmation Notifications instead
Must be performed by a Qualified Assessment Entity (may be third-party or in-house) approved by the DTSC. An accredited Lead Assessor must lead the assessment. Assessments performed in-house must be verified by a second Lead Assessor who was not a participant.
Reported in three sequential documents: the Tier II AA Work Plan, the Tier II-A AA Report, and finally, the Tier II-B AA Report.

What is the Tier II AA Work Plan?
Must be submitted within 180 days of listing as a Priority Product

Includes preparer information such as names of those submitting, funding, directing, preparing, and reviewing the AA; organizations providing expert guidance; and the entire supply chain

Provides product information such as brand name, description of product, and component that is the focus of the AA
Specifies goal of the AA, alternatives to be evaluated (e.g. different chemical, different materials, product/process redesign), and life cycle segments to be evaluated (e.g. raw materials, manufacturing, transport, use, end-of-life, recycling)
Describes assessment tools, models, software, and methodology to be used; includes schedule for completion, interim milestones, and list of deliverables
After approving the Work Plan, DTSC will assign due dates for the Tier II-A AA Report and the Tier II-B AA Report
What is Tier II-A AA?    
Priority Chemical and the alternatives identified in the Work Plan are evaluated and then compared for chemical hazard traits and potential public and environmental exposure.
Chemical Hazard Assessment factors include chemical and physical properties, public health impacts, ecological impacts, and chemical traits related to environmental impacts.
If any of the alternatives contain a chemical that exhibits a hazard trait, the Exposure Potential Assessment is also required.
Exposure Potential Assessment factors include quantity, concentration and dispersive volume of the chemical; consumer uses leading to human exposure; product uses and disposal practices leading to environmental releases.
Alternatives that pose a greater chemical hazard than the Priority Chemical do not need to be evaluated under Tier II-B, provided that the potential for exposure is the same or greater.

 

 Tier II-A AA Report must include a comparative matrix with easily understood visuals, an executive summary geared to the public, a description of manufacturing facilities and full supply chain information.
Report must specify any adjustments to the Tier II-B AA Work Plan, such as changes in alternatives or life cycle segments to be evaluated, made as a result of the hazard and exposure assessments
What is Tier II-B AA?    
Priority Chemical and alternatives identified in the Tier II-A AA Report are evaluated and then compared for product performance and life cycle outcomes.
Multimedia Life Cycle Evaluation factors include product performance and technological feasibility; recyclability and renewable materials; consumption of energy and water; environmental impact on air, water, soil and wastes; economic costs and impact on jobs
Alternatives that increase adverse impacts to public health and the environment are rejected.
The selected alternative must be functionally equivalent (performance and functionality); technologically feasible (knowledge, equipment and materials are available); and economically feasible (comparable rate of return for manufacturer, consumer cost not significantly increased).
Tier II-B AA Report must include a comparative matrix with easily understood visuals, an executive summary geared to the public, a description of manufacturing facilities and full supply chain information.
Report must provide a detailed implementation plan for the selected alternative, including key milestones and dates.
If the selected alternative contains a Priority Chemical, report must specify the DTSC regulatory response needed to limit exposure and reduce level of hazard.

This summary of Alternatives Assessment (AA) is designed to provide you with an accurate, easy-to-understand overview of the topic and does not constitute legal advice. The actual standard in the original language should be reviewed and used for all business, legal, and product compliance purposes.

RSJ's awareness training is an excellent "first step" for those just learning about a regulation. Our customized training helps you understand your current responsibilities and business risks, as well as the "big picture" of where the legislation is going so that you can make better business decisions. We are here to help you!
 
 

 

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