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California 'Alternatives Assessment' Delayed

California Code of Regulations 69301 - Sept 2010
California Code of Regulations 69301 - Nov 2010
California EPA Letter - Dec 2010

The California Green Chemistry Initiative was scheduled to take effect on January 1, 2011 following the publication of the Proposed Regulations for "Safer Consumer Product Alternatives" in September 2010.

During the public comment period, stakeholders raised a number of concerns about programmatic issues. As a result, in November 2010 the DTSC issued a substantially revised and simplified draft of the Proposed Regulations.  Implementation has been delayed indefinitely while the Green Ribbon Science Panel meets to address these programmatic issues.

CHANGES to the "Proposed Regulations" issued in November 2010:

"Chemical" means either a chemical substance or a chemical mixture, but it no longer includes a nanomaterial. This is a major change in scope.

The DTSC will prepare only one list of chemicals (instead of two) which will be known as Chemicals of Concern (COC). The terms "chemicals under consideration" and "priority chemicals" are no longer used. The initial COC list must be finalized by December 31, 2011 (instead of March 2012).

Chemicals of Concern are chemicals that exhibit a "hazard trait". All information used in the evaluation must now meet the definition of "reliable information". A three-step sequence for prioritizing the chemicals is now provided (instead of one undifferentiated list of factors):
#1 Relative degree of threat: assessment based upon physical chemical hazards and adverse public health, ecological, air quality, water quality and/or soil quality impacts
  "Chemical and physical properties" has been divided into physical chemical hazards (which are part of the threat assessment) and physico-chemical properties (which are part of the chemical ID and description)
  "Adverse public health impacts" has been reduced from 26 items to 7 and no longer includes bioaccumulation or electromagnetic radiation
  "Environmental impacts" (not the same as ecological impacts) has been divided into four stand-alone categories: air quality, water quality and soil quality (which are part of the threat assessment) and environmental fate properties (which are part of the chemical ID and description)
  "Release of heat, odor or radiation" is no longer an adverse impact, with the exception that thermal pollution is still considered an adverse water quality impact
#2 Potential for exposure: assessment based upon evidence of human or environmental exposure, use in household products, and quantity in CA stream of commerce
#3 Other federal or state programs or international trade agreements that regulate the chemical
  Availability of DTSC resources will be a limiting factor
  Public comment periods must include "workshops" for oral comments (instead of written comments only)
Similarly, the DTSC will prepare only one list of products (instead of two) which will be known as Priority Products. The term "products under consideration" is no longer used. The initial Priority Products list must be finalized by December 31, 2012 (instead of December 1, 2013).       
Priority Products are products that contain a Chemical of Concern. Until January 1, 2016, only children's products, personal care products or household cleaning products will be considered. This is a major change in scope (albeit temporary).
A two-step sequence for prioritizing products is now provided:
#1 Relative degree of threat: assessment based upon likelihood of human or environmental exposure
  "Volume in stream of commerce" has been reduced from 7 items to 2 (statewide sales by volume and number of units)
  "Types and extent of consumer uses" now excludes workers (but not customers, clients and general public) who are exposed at a workplace
#2 Other federal or state programs or international trade agreements that regulate the chemical
  Availability of DTSC resources will be a limiting factor
For each Priority Product, the DTSC must now specify the Chemical of Concern and the component(s) that are the basis for the product listing and a de minimis concentration for that component.
Manufacturers must still submit the "Priority Product Notification" within 60 days of its listing as a Priority Product (unless de minimis applies).
The de minimis exemption for products listed on the Priority Products List has been streamlined:
The default level is 0.1% by weight, except when this conflicts with DTSC's "hazardous waste regulatory threshold" set for the chemical; all other regulatory thresholds have been deleted
A de minimis level will be specified for all products (the DTSC may not issue a determination that it is not allowed for a particular product)
De minimis concentrations apply at the product level for "formulated" products and at the component level for "assembled" products (new)
De minimis applies to the maximum total concentration of all COCs that are the basis for the Priority Product listing (new)
Manufacturers only need to submit a De Minimis Exemption Notification (instead of submitting a "request" that must be approved by the DTSC)
There is now only one type of Alternatives Assessment (instead of two). The terms "Tier I AA" and "Tier II AA" are no longer used.
"Tier I AA" (required when a product containing a Chemical of Concern is reformulated, redesigned or replaced with an alternative product) has been deleted
"Tier II AA" (required when a product is listed as a Priority Product) is now simply "AA"
AA must only be performed for the component that is the basis for the Priority Product listing (not the entire product)
Manufacturers must still submit the "AA Work Plan" within 180 days of its listing as a Priority Product, with the following exceptions:
If the COC is removed from the Priority Product without adding or increasing the concentration of another chemical, submit the "Chemical Removal Notice" instead; only one notice is required (instead of two); the "Chemical Removal Intent" and "Chemical Removal Confirmation" are no longer used
If the Priority Product is no longer placed in the California stream of commerce, submit "documentation" to the DTSC; the terms "Product Removal Intent" and "Product Removal Confirmation" are no longer used
If the Priority Product does not exceed the de minimis concentration, a "De Minimis Exemption Notification" should have already been sent
AAs are no longer divided into "Tier II-A" or "Tier II-B". Only one report is required (instead of two). AAs must include five assessments of the COC and selected alternative(s):
1. Chemical Hazard Assessment includes physical chemical hazards and adverse public health, ecological, air quality, water quality and soil quality impacts (these are the factors used to prioritize chemicals); formerly Tier II-A
2. Exposure Potential Assessment includes chemical quantity info, exposure limitation factors, consumer uses and environmental releases (these are the factors used to prioritize products); formerly Tier II-A
  Also includes quantities used to manufacture the product, but no longer includes concentration of COC in the product
3. Multimedia Life Cycle Evaluation includes materials/resource consumption, air quality, water quality, soil quality and waste/end-of-life impacts over the entire life cycle of the product; however, it no longer includes the release of heat, odor or radiation; formerly Tier II-B
4. Product Function and Performance Analysis is now a stand-alone assessment (formerly part of Multimedia Life Cycle, Tier II-B)
5. Economic Impact Analysis is now a stand-alone assessment (formerly part of Multimedia Life Cycle, Tier II-B); additions include impact on jobs or businesses, costs of doing business (other than operations and maintenance), and cost of goods to consumers; however, non-compliance liability has been deleted
Accreditation is no longer a requirement for performing an AA; in fact, all mention of accreditation has been deleted; the terms "qualified assessment entity" and "lead assessor" are no longer used.
AAs may now be performed by a consortium, trade association or public-private partnership with which the manufacturer is affiliated
AAs must still be reviewed by a "third-party verifier" without an economic interest
Responsible entity now includes only the "manufacturer" who produces the product and the "retailer" who sells the product directly to the consumer. The importer and the distributor are no longer listed as responsible entities.
"Duty to comply" now lies principally with the manufacturer; the retailer is required to comply only when the manufacturer has been placed on the Failure to Comply List
Information may also be requested directly from chemical manufacturer, who can be placed on the Failure to Respond List for not complying
Summary of the "Proposed Regulations" as issued in September 2010 (link)

This summary of the California Green Chemistry Initiative (GCI) 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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