09.30.13
In 2008, the California legislature enacted a pair of statutes, Assembly Bill 1879 and Senate Bill 509, which adopted two of six recommendations of the Green Chemistry Initiative. The statutes tasked California’s Department of Toxic Substances Control (“DTSC”) to develop an on-line toxics clearinghouse and to systematically identify and prioritize chemicals of concern in consumer products; to scientifically evaluate which presented significant health and environmental risks; to provide for a rational process for manufacturers of consumer products presenting such risks to assess whether alternative chemicals could be used instead; and to specify what regulatory response the DTSC would take in response to such analysis.
DTSC was instructed to have implementing regulations in place to accomplish all of these goals no later than January 1, 2011.
Now, on October 1, 2013, nearly three years after that deadline, DTSC’s “Safer Consumer Products” regulations, will at last become effective. Here's an explanation of how we got here and what sort of program, after five years of development, has finally been put into place.
How Did We Get Here? – a Five Year Odyssey
The fundamental concept of Green Chemistry, reducing health and environmental hazards by paying closer attention to the nature of the chemicals which make up the products that we buy, had a wide range of supporters in both industry and the NGO community, an alliance which supported the passage of California’s green chemistry statutes. However, as is often proven to be the case, it turned out that the devil was in the detail.
As the process of developing regulations unfolded, manufacturers with substantial experience in evaluating safe chemical usage in their products became increasingly disappointed that none of this knowledge base seemed to matter. Interested parties outside of industry often pushed hard in the opposite direction: encouraging DTSC regulators to design their ground-breaking regulatory process from scratch, with little regard for the experience of industry or other regulatory programs as to what may worked, and what may not.
The lengthy odyssey which the DTSC took to reach the upcoming effective date of its Safer Consumer Products regulations shows the pressure of this tug and pull. It began in the spring of 2010 with the agency circulating for public comment a “Conceptual Flowchart” of regulations and an “Outline.” Then, in June, 2010 the DTSC released, for public comment its first full draft of regulations, based on the previously circulated flowchart and outline. The draft was slammed by some in industry as threatening manufacturers’ trade secrets, and imposing “burdensome costs.” From the environmental side, DTSC was attacked on several grounds, including limiting its initial definition “chemicals of concern;” allowing compliance timelines that were characterized as “open-ended,” and establishing a minimal chemical concentration level beneath which a product would be exempt from regulation (called a “de minimis level”).
In September, 2010, the DTSC responded by issuing a new draft set of regulations, further modified by amendments issued in November, which were on track for formal adoption in time to meet the January 1, 2011 deadline. Some of the concerns raised by environmentalists were addressed but others, such as the “de minimis level” were retained. In a further controversial proposal, for the first five years of the program, DTSC’s proposed regulations provided that products subject to regulation would be limited to three categories: children’s products, personal care products and household cleaning products.
Environmentalists were furious with the agency’s proposal, characterizing it as “sell-out.” In the meantime, California voters went to the polls and elected a new State political administration. A little over a month later, on December 23, 2010 Cal/EPA Secretary Linda Adams signaled that all bets were off, announcing that, at her request, the DTSC had agreed to “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”
Safer Consumer Product Regulations “Re-visited”: Round II
The process of Secretary Adam’s “re-visitation” began, for a second time, a process of “informal drafts” (10/31/2011); follow on workshops (12/5/2011); “informal comments” (1/20/2012); further “informal drafts” (5/18/2012); “proposed regulations” (7/27/2012); “revised proposed regulations” (1/29/2013); further “revised proposed regulations (4/10/2013); and, finally, the “revised text of proposed regulations,” issued on August 23, 2013, which are to become final on October 1, 2013.
Along the way, the debate which had existed from the outset only intensified. Two themes dominated the concerns expressed in the comments of impacted parties in industry and elsewhere: (1) More effective alternatives exist to better achieve the goals of Green Chemistry than the approach proposed by DTSC; and (2) the breadth and vagueness of DTSC’s proposed regulatory language, combined with the scarcity of “real world” experience with such a program, creates agonizing uncertainty, threatening innovation and thereby jeopardizing economic growth.
The DTSC, nevertheless, forged ahead.
California’s Final Safer Consumer Products Regulations: Creating A Four Stage Process
In contract law there is a concept called “an agreement to agree” – evidence that the parties intended an agreement, but provided insufficient detail to make it a binding contract. Many believe that this could also describe the Safer Consumer Products Regulations. The regulations will be final and enforceable on October 1, but in fact consist mostly of a broad regulatory program outline with multiple processes and procedures yet to come to before the substantive detail will be known. Thus, under the “still to come” category, are the following key steps:
Identifying Candidate Chemicals: Within 30 days the DTSC must identify what it calls “Candidate Chemicals;” that initial list of chemicals in consumer products which the department believes should be a candidate for further scrutiny and potential regulation later as a “Chemical of Concern.”
Identifying Priority Products: Once “Candidate Chemicals” are identified, the DTSC is required to begin, and, within 180 day complete, an evaluation of combinations of Candidate Chemicals and broadly defined “Consumer Products” to develop an initial list of no more than five (5) “Priority Products” for further regulation. This initial list will be subject to “fast track” procedures which minimize public review and comment.
Thereafter, additional “Priority Products” will be identified through a process that currently is mostly unknown, but will begin no later than October 1, 2014, with publication by the DTSC of a “Work Plan” that identifies and describes the product categories that the Department will evaluate to identify product-chemical combinations to be added to the Priority Products list during the next three years. Successive “work plans” will add to the growing list of Priority Products over time.
When Priority Products are identified, the “Candidate Chemicals” which they contain will become “Chemicals of Concern”.
Conducting “Alternative Analyses": Identification of a product as a “Priority Product” triggers a duty by the sellers of that product in California (typically the manufacturer) to notify the DTSC whether its product contains a Chemical of Concern, and, if so, to begin another complex process: a lengthy set steps called an “Alternative Analysis” to determine whether alternatives to use of a Chemical of Concern exist and, if not, why not. Reports are required to be submitted to the department but what exactly this entire process will involve as a substantive matter is not known yet because the department does not plan on publishing any “guidance” until its list of Initial Priority Products is published.
Determining a “Regulatory Response”: In the last stage of the Safer Consumer Product regulatory process, the department must determine what to do with a manufacturer’s Alternative Analysis. The array of options, the choice of which is heavily committed to the department’s discretion, ranges from no action at all, to intermediate steps such as requiring warning labels, to the ultimate sanction of banning the product from sale in California. Of all the stages, this is the most uncertain of all.
One Step Forward, or Two Back?
While California’s Safer Consumer Product regulations are largely a framework for future regulation—with most critical details still unknown—at least two things seem certain. First, the program proposed is undoubtedly an ambitious, complex and deeply discretionary regulatory process, that promises profound, and largely unknown, impacts on the design and manufacturing of consumer products. Second, regardless of the merits, California has undoubtedly taken an historic step. A state recognized as a leader in environmental law and policy, California’s Safer Consumer Product regulations continue that tradition, shifting environmental law from its traditional concerns to a new focus on the safety of chemicals in consumer products.
With the DTSC’s “framework” approach, however, it is a story still mostly unwritten. Whether the Safer Consumer Product regulations will actually advance the goals of Green Chemistry, or cause them to suffer a serious setback, will take time to know.
About the Author
Ward Benshoof, a partner at Alston & Bird, has specialized in environmental litigation for nearly 30 years and has been active in the development of environmental law in California. He can be reached at ward.benshoof@alston.com.
DTSC was instructed to have implementing regulations in place to accomplish all of these goals no later than January 1, 2011.
Now, on October 1, 2013, nearly three years after that deadline, DTSC’s “Safer Consumer Products” regulations, will at last become effective. Here's an explanation of how we got here and what sort of program, after five years of development, has finally been put into place.
How Did We Get Here? – a Five Year Odyssey
The fundamental concept of Green Chemistry, reducing health and environmental hazards by paying closer attention to the nature of the chemicals which make up the products that we buy, had a wide range of supporters in both industry and the NGO community, an alliance which supported the passage of California’s green chemistry statutes. However, as is often proven to be the case, it turned out that the devil was in the detail.
As the process of developing regulations unfolded, manufacturers with substantial experience in evaluating safe chemical usage in their products became increasingly disappointed that none of this knowledge base seemed to matter. Interested parties outside of industry often pushed hard in the opposite direction: encouraging DTSC regulators to design their ground-breaking regulatory process from scratch, with little regard for the experience of industry or other regulatory programs as to what may worked, and what may not.
The lengthy odyssey which the DTSC took to reach the upcoming effective date of its Safer Consumer Products regulations shows the pressure of this tug and pull. It began in the spring of 2010 with the agency circulating for public comment a “Conceptual Flowchart” of regulations and an “Outline.” Then, in June, 2010 the DTSC released, for public comment its first full draft of regulations, based on the previously circulated flowchart and outline. The draft was slammed by some in industry as threatening manufacturers’ trade secrets, and imposing “burdensome costs.” From the environmental side, DTSC was attacked on several grounds, including limiting its initial definition “chemicals of concern;” allowing compliance timelines that were characterized as “open-ended,” and establishing a minimal chemical concentration level beneath which a product would be exempt from regulation (called a “de minimis level”).
In September, 2010, the DTSC responded by issuing a new draft set of regulations, further modified by amendments issued in November, which were on track for formal adoption in time to meet the January 1, 2011 deadline. Some of the concerns raised by environmentalists were addressed but others, such as the “de minimis level” were retained. In a further controversial proposal, for the first five years of the program, DTSC’s proposed regulations provided that products subject to regulation would be limited to three categories: children’s products, personal care products and household cleaning products.
Environmentalists were furious with the agency’s proposal, characterizing it as “sell-out.” In the meantime, California voters went to the polls and elected a new State political administration. A little over a month later, on December 23, 2010 Cal/EPA Secretary Linda Adams signaled that all bets were off, announcing that, at her request, the DTSC had agreed to “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”
Safer Consumer Product Regulations “Re-visited”: Round II
The process of Secretary Adam’s “re-visitation” began, for a second time, a process of “informal drafts” (10/31/2011); follow on workshops (12/5/2011); “informal comments” (1/20/2012); further “informal drafts” (5/18/2012); “proposed regulations” (7/27/2012); “revised proposed regulations” (1/29/2013); further “revised proposed regulations (4/10/2013); and, finally, the “revised text of proposed regulations,” issued on August 23, 2013, which are to become final on October 1, 2013.
Along the way, the debate which had existed from the outset only intensified. Two themes dominated the concerns expressed in the comments of impacted parties in industry and elsewhere: (1) More effective alternatives exist to better achieve the goals of Green Chemistry than the approach proposed by DTSC; and (2) the breadth and vagueness of DTSC’s proposed regulatory language, combined with the scarcity of “real world” experience with such a program, creates agonizing uncertainty, threatening innovation and thereby jeopardizing economic growth.
The DTSC, nevertheless, forged ahead.
California’s Final Safer Consumer Products Regulations: Creating A Four Stage Process
In contract law there is a concept called “an agreement to agree” – evidence that the parties intended an agreement, but provided insufficient detail to make it a binding contract. Many believe that this could also describe the Safer Consumer Products Regulations. The regulations will be final and enforceable on October 1, but in fact consist mostly of a broad regulatory program outline with multiple processes and procedures yet to come to before the substantive detail will be known. Thus, under the “still to come” category, are the following key steps:
Identifying Candidate Chemicals: Within 30 days the DTSC must identify what it calls “Candidate Chemicals;” that initial list of chemicals in consumer products which the department believes should be a candidate for further scrutiny and potential regulation later as a “Chemical of Concern.”
Identifying Priority Products: Once “Candidate Chemicals” are identified, the DTSC is required to begin, and, within 180 day complete, an evaluation of combinations of Candidate Chemicals and broadly defined “Consumer Products” to develop an initial list of no more than five (5) “Priority Products” for further regulation. This initial list will be subject to “fast track” procedures which minimize public review and comment.
Thereafter, additional “Priority Products” will be identified through a process that currently is mostly unknown, but will begin no later than October 1, 2014, with publication by the DTSC of a “Work Plan” that identifies and describes the product categories that the Department will evaluate to identify product-chemical combinations to be added to the Priority Products list during the next three years. Successive “work plans” will add to the growing list of Priority Products over time.
When Priority Products are identified, the “Candidate Chemicals” which they contain will become “Chemicals of Concern”.
Conducting “Alternative Analyses": Identification of a product as a “Priority Product” triggers a duty by the sellers of that product in California (typically the manufacturer) to notify the DTSC whether its product contains a Chemical of Concern, and, if so, to begin another complex process: a lengthy set steps called an “Alternative Analysis” to determine whether alternatives to use of a Chemical of Concern exist and, if not, why not. Reports are required to be submitted to the department but what exactly this entire process will involve as a substantive matter is not known yet because the department does not plan on publishing any “guidance” until its list of Initial Priority Products is published.
Determining a “Regulatory Response”: In the last stage of the Safer Consumer Product regulatory process, the department must determine what to do with a manufacturer’s Alternative Analysis. The array of options, the choice of which is heavily committed to the department’s discretion, ranges from no action at all, to intermediate steps such as requiring warning labels, to the ultimate sanction of banning the product from sale in California. Of all the stages, this is the most uncertain of all.
One Step Forward, or Two Back?
While California’s Safer Consumer Product regulations are largely a framework for future regulation—with most critical details still unknown—at least two things seem certain. First, the program proposed is undoubtedly an ambitious, complex and deeply discretionary regulatory process, that promises profound, and largely unknown, impacts on the design and manufacturing of consumer products. Second, regardless of the merits, California has undoubtedly taken an historic step. A state recognized as a leader in environmental law and policy, California’s Safer Consumer Product regulations continue that tradition, shifting environmental law from its traditional concerns to a new focus on the safety of chemicals in consumer products.
With the DTSC’s “framework” approach, however, it is a story still mostly unwritten. Whether the Safer Consumer Product regulations will actually advance the goals of Green Chemistry, or cause them to suffer a serious setback, will take time to know.
About the Author
Ward Benshoof, a partner at Alston & Bird, has specialized in environmental litigation for nearly 30 years and has been active in the development of environmental law in California. He can be reached at ward.benshoof@alston.com.
