On July 27, 2012, the DTSC released its latest draft version of the proposed regulation subject to a 45-day comment period, and they are soliciting public comments until September 11, 2012.
DTSC characterized the proposed regulation as a "preemptive strategy that reduces the use of toxic substances in the design of products and industrial processes with the aim of creating safer and sustainable products that do not threaten human health or persist in the environment."
There are several major changes in the latest version of the proposed regulation (http://www.dtsc.ca.gov/
a. Chemicals of Concern (COC),
b. Priority Products (PPs),
c. Alternative Analyses, and
d. Regulatory Response.
These changes are summarized as follows:
• The proposed list of Chemicals of Concern (COC) has been revised downward from ~3000 to 1200. The COC List would include those substances that exhibit a hazard trait or an environmental or toxicological endpoint identified by OEHHA 4, 5 pursuant to Health and Safety Code Section 25256.1
• DTSC will evaluate and prioritize products to develop a list of Priority Products (PP) that contain COCs for which an Alternative Assessment must be conducted. Instead of requiring information on all products sold in California, the DTSC will focus on no more than five Priority Products.
• Priority Products will be chosen based upon their risk of containing one or more COCs that exhibit a hazard trait and are on an exposure indicator list.
• The petition process has been augmented to provide for the removal of chemicals from the COC list, for the removal of Priority Products, for the addition of entire lists of existing chemicals to the COC list, and for the revising or establishing of an alternatives analysis threshold for a given COC in a Priority Product.
• Uses of the word “potential”
• Products regulated by other laws no longer receive an automatic exemption from these regulations, but these other laws are taken into account when considering the product prioritization process.
• The prioritization process itself has been streamlined.
• There is no longer a mandate for how frequently DTCS must review and revise the COC list.
How to comply?
Manufacturers (or other responsible entities such as importers and retailers) who sell products in California will be required to notify the DTSC within 60 days of a PP's listing that its product is a PP containing one or more COCs or satisfies an exemption. They will then be required to submit an alternatives analysis (AA) to determine how best to limit adverse public health and environmental impacts posed by the product. This will usually entail exploring options to remove the COC from the product, to substitute the COC with a safer alternative, to reformulate the product to avoid the COC entirely, or in the case of the COC as a contaminant, to put in place process controls to minimize its presence in the product. Failure to provide an AA, or to comply in any other way with the regulation, will result in a notice of noncompliance being sent. Failure to respond to this will place the responsible entity on the “Failure To Comply” list on the DTSC website. DTSC is authorized to initiate enforcement actions, including the imposition of fines and penalties.
Exemptions are available if the manufacturer can demonstrate that his Priority Product does not contain a COC in a quantity above the alternative analysis threshold (formerly the de minimis level). If the manufacturer meets this condition, he will be able to submit an Alternative Analysis Threshold Exemption Notification to DTSC in which he states the maximum concentration of the COC and how this number was obtained (e.g. laboratory analysis or calculation)
If the manufacturer is able to remove the COC from his product, he would submit a revised AA to DTSC informing them of this. If the manufacturer ceases to sell the product in California, he would also inform DTSC. Products made in California to be sold exclusively outside of the state are not subject to this regulation.
DTSC defines "consumer product" to include, in part, "component" and "homogeneous material" to provide it "flexibility to name any identifiable constituent or part or a homogeneous layer of material in the finished product or that makes up the finished product as a Priority Product." However neither the COC list nor the list of Priority Products has yet been created. SGS will continue to monitor this situation and issue updates as these details are finalized.
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To learn more about SGS’ services, please contact the SGS experts.
SGS Consumer Testing Services
Paul Milne, Ph.D.
Technical Manager, Restricted Substances Testing Services
SGS – North America
291 Fairfield Avenue
Fairfield, NJ 07004
t: +1 973-461-1512
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