Date: Jul 07, 2010
On June 23, 2010 the California Department of Toxic Substances Control (DTSC) posted a "Draft Regulation for Safer Consumer Products." Announcing the release of the draft regulations, DTSC's Acting Director said "study after study shows that consumer products are not safe," predicting that the California regulations would shift the way that government, industry and consumers think about products that end up in homes. While DTSC will accept comments on the draft regulations through July 15, DTSC says it will quickly move to formal administrative rulemaking which it expects to finalize by the end of the year.
The premise of California and other Green Chemistry initiatives is to impose reporting, labeling and other obligations on consumer product manufacturers to achieve the goal of eliminating certain substances from use in consumer products.
Key elements of the 61-page draft regulations include:
Applicability to all chemicals that exhibit a hazard trait and are reasonably expected to be contained in consumer products made available for use in California, unless 1) the chemical is regulated by another governmental entity throughout the life cycle of the chemical, or 2) there are no exposure pathways by which the chemical might pose a threat to public health or the environment in California.
Chemicals of Concern (COC) will be limited initially to those that cause cancer or reproductive toxicity and are on the Proposition 65 list, mutagens as classified under REACH, and persistent toxic and bioaccumulative materials as determined by U.S. Environmental Protection Agency (EPA).
Products of Concern will be chosen based on the relative degree of threat posed by the product due to the COC that is contained in the product, to public health or the environment based on consideration of the two page list of factors detailed in the regulation.
Priority Products will be identified from the list of Products of Concern, along with de minimis exemptions; however, the draft establishes that under no circumstances shall a de minimis exemption be allowed for chemicals, materials or substances manufactured or engineered at the nanoscale, which contain nanostructures, or are considered to be a nanomaterial.
Notification: Any manufacturer of a listed Priority Product will be required to notify retailers who sell the Priority Product in California and the Department that their consumer product is a Priority Product and include a statement as to whether the manufacturer will seek the Departments concurrence that the COC is below the de minimis level. The regulation assumes that the COC will be in the priority product and there is a requirement that the manufacturer submit either a written description of the manufacturing process to show why it would not be present or a chemical analysis that shows that it is below the de minimis level.
An alternatives assessment is required to determine whether another chemical can be substituted for the chemical of concern if the COC is above the de minimis level in a Priority Product. The alternatives assessment must be performed by an assessor who is certified by the State.
Regulatory action may include a request for additional information, a requirement that the manufacturer provide product information for consumers or provide an end of life take-back program, or result in a product sales prohibition.
The Green Chemistry initiative will ultimately require all consumer product manufacturers to be more aware of the chemical makeup of their products, necessitating the commitment of significant additional resources to support their products. The regulations, for example, include consumer labeling obligations to advise consumers of all of the following information: the manufacturer's name, the brand name, the COCs contained in the product, sensitive sub-populations who should avoid contact with the product due to the COC, safe handling procedures both during the useful life and end of life disposal, and a website address where consumers can obtain more information. The regulations also include a recall obligation under certain circumstances for products that contain COCs.
DTSC will hold workshops on July 7 and 8 to discuss the proposed regulation and will accept comments until July 15, 2010. Many questions about the regulations exist and it remains to be seen whether clear answers will be offered at the workshops.
The regulation, press release, conceptual framework behind the proposal, and related documents can be found at: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm.
Green Chemistry proposals are spreading to other states. Makers of consumer products should consider carefully the implications and obligations involved.
For more information on Green Chemistry and product safety, contact Sheila A. Millar, firstname.lastname@example.org, J.C. Walker, email@example.com, or Alisa A. Karlsons, firstname.lastname@example.org. For more information on Green Chemistry and other California requirements, contact Leslie T. Krasny, email@example.com or Diana G. Graham, firstname.lastname@example.org.