The California Department of Toxic Substances Control (DTSC) in July 2012 released the eighth draft of California’s Safer Chemical Products Regulation in the last four years. The agency has targeted the end of the year as its goal for actual finalization. The last version of the regulations created a large industry backlash and the new regulations reflect some of that reaction. Most significantly the DTSC has reduced the quantify of chemicals of concern (“COC”) from 3000 to 1200 chemicals and proposed to further limit the initial list of priority products to five product/chemical combinations. They have also extended the comment period to October 11, 2012.
The new version of the regulations continues to require manufacturers to seek “safer” alternative ingredients from the those are contained in the State’s list of COC’s. The Prop 65 list of chemicals as well as other agency lists are used as the starting point in the selection of chemicals; although certain pesticides are expressly exempted under the proposed regulations. The proposed regulation requires manufacturers who are using a listed chemical to identify and examine the viability of safer ingredients. If an alternative is not feasible, DTSC will identify additional steps the manufacturer must take to ensure the product is safely used, disposed of, or phased out. The regulation provides consumers with enhanced information about product ingredients and includes an enforcement mechanism that would penalize manufacturers who fail to conduct an alternatives analysis by including them on a non-compliant list.
The following are the most significant new changes to the regulations:
- Revisions have been made to make the list less inclusive;
- Prior to 2016 DTSC will only list COC’s that meet two criteria – the chemical is on a list identifying one or more hazard characteristics, and its listed on one of the exposure indicator lists identified in the regulations;
- The petition process has been augmented to allow petitions for removal from the COC list and the Priority Products List requesting that an entire existing list be added to COC’s requesting to exempt/or revise an Alternative Analysis Threshold for COC in a Priority Product;
- There are several changes regarding the threshold for an exemption from doing an Alternative Analysis threshold. Each chemical will have its own Alternative Analysis threshold as determined during the Priority Product listing procedure;
- With respect to the Alternative Analysis, there is no longer a distinction between assembled and formulated chemicals;
- Inventory recall requirements have been removed;
- Consideration of chemical’s ability to degrade has been included;
- The concentration based trigger that determines whether a manufacturer qualified for an exemption from the Alternative Analysis requirement has been renamed from diminimis to Alternative Analysis Threshold;
- The regulation is no longer specified an “AA Threshold” instead the threshold for each chemical concern in a priority product will be listed as part of that listing process;
- Will look at the ability to contribute to or cause adverse impacts rather than the potential adverse impacts;
- The AA Threshold has been revised. The AA Threshold notifications have been revised to eliminate requirements for information that would be difficult to collect, or manufacturers to require manufactures will to provide information describing attempts to eliminate or reduce the concentration of the COC in the priority product or a demonstration that the COC in a priority product will not incur adverse impacts;
- Once a product has been listed as a priority product the manufacturer will be able to submit a chemical of concern removal notification if the only change to the product is the removal of the COC;
- Manufacturers wishing to work with a consortium to conduct an AA will have the option of doing so;
- The DTSC will have the option of allowing the manufacturer up to 3 years to complete an AA in a showing of good faith;
- The regulations are clear that AA due dates apply to the submission of the AA report and there is no due date for actual implementation of the AA decision;
- The economic impact analysis requires as part of an AA have been revised to significantly reduce the scope of externalized costs impacts that must be assessed;
- The requirements for identification of the manufacturing facility location in the AA has been removed;
- Regulations provide the circumstances under which specified regulatory responses such as use: restrictions or sale restrictions engineering or administrative control of the research and development project will be required as well as the principals and factors the DTSC to consider and select in regulatory responses;
- The requirement to post information at the point of sale is now an option not a requirement;
- Historic products and second hand products are excluded from the definition of consumer for product. The exclusion for bulk materials has been eliminated;
- The definition of functionally acceptable has been revised to ensure the alternative would meet the legal requirements and be accepted by consumers;
- The definition of diverse held impacts and sensitive has been revised to make it clear that occupational health impacts are considered as part public health impacts;
- Excedance of enforceable California or federal regulatory public health environmental standards has been added to the definition of adverse public health and environmental impact;
- Consideration of the chemical ability to degrade or form reaction products or metabolize into other chemicals have been incorporated into the regulations;
- The administrative dispute procedure will not be available for actions taken by DTSC for list chemicals, opt out petitions, or to respond to requirements for trade secrets;
- The amount of time for requesting internal dispute resolution has been increased from 15 to 30 days;
- The DTSC will be giving the option to establish a public comment period longer than 45 days;
- The DTSC is unable to complete the review report of AA or issue a notice of compliance or deficiencies in 60 days, DTSC will issue a notice of ongoing review specifying the estimated date by which they can complete their review.