On August 28, the California Office of Administrative Law
approved the "Safer Chemical Products" regulations
developed by the California Department of Toxic Substances Control
("DTSC"). The regulations will take effect on October
1.
The regulations implement California's "Green
Chemistry" law adopted by the Legislature in 2008 (Cal. Health
& Safety Code §§ 25215–25257.1). The statute
directs DTSC to identify and prioritize chemical ingredients in
consumer products that may be chemicals of concern, and to
determine how best to limit or reduce the potential hazards posed
by such chemicals. The final regulations are the culmination of
several prior drafts and public comment periods.
The final regulations apply to consumer products that are placed
into the stream of commerce in California. They establish a
three-step process. Under the first step, DTSC will identify
"candidate" chemicals of concern and identify and
prioritize products containing candidate chemicals. Under the
second step, responsible entities, usually the manufacturer, of
priority products identified by DTSC must analyze alternatives to
eliminate or reduce potential exposure to chemicals of concern in
priority products. In the third step, DTSC will respond to the
manufacturer's analysis based on criteria set out in the
regulations. DTSC's response can include prohibiting the sale
and distribution of the product in California.
The following is a brief summary of key provisions of the new
regulations. The full text of the regulations can be found at
www.dtsc.ca.gov/SCPregulations.cfm.
Chemicals of Concern and Priority Products
The regulations define candidate chemicals of concern by
reference to lists of potentially hazardous chemicals that have
been developed by international, federal, and California agencies.
The lists contain approximately 1,200 chemicals. By November 1,
DTSC will post on its website a list of the candidate chemicals
from these combined lists. Subsequent to this initial posting, DTSC
may add or delete listed chemicals using normal rulemaking
procedures (including public notice and comment).
After the initial candidate chemicals have been listed, DTSC must
identify and evaluate products that contain candidate chemicals and
determine whether additional evaluation of the products is
warranted. In evaluating what product-chemical combinations to
propose as priority products, DTSC will consider the potential for
exposure to the candidate chemical in the product, the potential
for that exposure to contribute to or cause adverse health or
environmental impacts, and potential adverse effects from disposal
of the product. DTSC must propose a list of priority
product-chemical combinations for public review and comment no
later than 180 days after the effective date of the regulations
(April 1, 2014). This initial list may include no more than five
priority products.
Within one year after the effective date of the regulations
(October 1, 2014), DTSC must issue a priority product work plan
identifying the product categories from which DTSC will select
additional product-candidate chemical of concern combinations to be
added to the priority products list during the three years
following issuance of the work plan. Subsequent work plans are to
be issued by DTSC no later than one year before the end of the
three-year expiration date of the current work plan.
Obligations of Responsible Entities
The manufacturer has the principal duty to comply with the
regulations governing its listed priority products. If the
manufacturer does not comply, the duty falls on the importer, if
any, upon DTSC issuance of a notice of noncompliance to the
manufacturer and importer. If neither complies, the duty rests with
the assembler or retailer if DTSC provides notice through the
Failure to Comply List posted on its website. The retailer or
assembler can avoid assuming manufacturer obligations by ceasing to
order the product.
Within 60 days after a product-chemical combination has been listed
as a priority product, the responsible entity must notify DTSC that
its product is on the list. It must then submit to DTSC a
Preliminary Alternatives Analysis report no later than 180 days
after the date of the product's listing, and a Final
Alternatives Analysis report no later than 12 months after the date
DTSC approves the preliminary report, subject to potential
extensions. A responsible entity can avoid having to prepare an
Alternatives Analysis if (i) the chemicals of concern have been
removed from the product without the use of any replacement
chemicals; (ii) the manufacturer has ceased fulfilling orders for
the product from persons selling or distributing the product in
California; or (iii) the chemicals of concern have been removed
from the product and the replacement chemical is either not on the
candidate chemicals list or is a candidate chemical that is already
in use to manufacture the same product in lieu of the chemicals of
concern by the same or different manufacturer.
Consequences Flowing from Alternatives Analysis Reports
DTSC will review the Final Alternatives Analysis Report to determine if the responsible entity considered and addressed the regulatory requirements and whether the conclusions in the report are based on reliable information. If DTSC accepts the Report, it will determine if additional actions are necessary to protect public health and/or the environment. DTSC will maximize the use of alternatives posing the least concern and will prefer alternatives that avoid or reduce adverse impacts through redesign of a product or process rather than through administrative or engineering controls. Additional factors DTSC must consider include the degree to which the actions can address the product's potential adverse impacts, the ability of end users to understand and act upon information or directions provided by the responsible entity, and the cost of the action to the responsible entity relative to the cost of other possible actions. The regulations identify a number of actions that can be required by DTSC. DTSC can require the responsible entity to provide product information to consumers, it can restrict use of the chemicals of concern or the product itself, it can require safety measures to contain or control access to chemicals of concern in the product, and it can prohibit the sale of the product in California.
Conclusion
While the regulations start out with a maximum of only five
products on the initial priority product list, the list has the
potential to expand over time to cover a substantially greater
number of products. Manufacturers of priority products may decide
to either withdraw their product from the California market or find
ways to avoid use of the chemicals that resulted in the listing.
For those manufacturers that proceed with the alternatives
analysis, the result of DTSC review could be a requirement to
reformulate the product or a ban on the sale of the product in
California.
It will be important for companies to track DTSC's listing of
specific candidate chemicals of concern and the development of the
priority products list, both of which are required to be posted on
DTSC's website. The website will also include other important
information, such as notices from manufacturers that their product
is a priority product, priority product work plans, alternatives
analysis report notices, and proposed and final regulatory response
determinations. Retailers should pay particular attention to the
Failure to Comply list, which will include the manufacturers and
importers that have failed to comply with the regulations
(including the brand names of their products).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.