DTSC Lists First Three Draft Priority Products Pursuant to Safer Consumer Products Regulations

Posted by in Green Chemistry on September 4, 2014

By Mary E. Wilke

In August 2013, after five years of joint effort among manufacturers, consumers, environmentalists, and the Department of Toxic Substances Control (DTSC), the Safer Consumer Products regulations (Regulations), previously known as the Green Chemistry Initiative regulations, were approved by the California Office of Administrative Law and went into effect on October 1, 2013.  The regulations require manufacturers or other responsible entities to seek safer alternatives to certain chemical ingredients in widely used products. The DTSC describes the Regulations as “a preventive approach to keeping dangerous chemicals out of everyday products and giving consumers greater confidence that the products they buy ultimately will be safe.…For industry, these regulations will provide a more predictable process for ensuring product safety, and offer a competitive advantage for innovators who see an opportunity in the growing market for toxic-free or toxic-reduced products.”

The Regulations call for the DTSC to develop a list of chemicals that are candidates for elimination based on a variety of hazardous traits as determined by authoritative scientific organizations, and their history of exposure potential. The most recent candidate chemicals list can be found here. The DTSC must then develop a group of product types, known as “priority products,” containing at least one of those chemicals. When a candidate chemical is a basis for a product being listed as a “priority product” it becomes designated as a “chemical of concern.” Once the priority products are identified, manufacturers of the products will have to conduct an “alternatives analysis” for the product and the chemicals of concern in the product to determine how best to limit exposures to, or the level of adverse public health and environmental impacts posed by, the chemicals of concern in the product. The alternatives analysis requires manufacturers to answer two questions: (1) is this chemical necessary; and (2) is there a safer alternative. If no other safer, nontoxic ingredient is feasible, the DTSC has the ability to apply one of several regulatory responses, ranging from product labeling to sales prohibition, which would reduce risk or phase out the chemical. The findings of each manufacturer’s alternatives analysis report will ultimately determine what regulatory response, if any, DTSC may impose.

In March 2014, the DTSC announced the first draft list of priority products to be evaluated under the Regulations. Three classes of product-chemical combinations were identified: (1) spray polyurethane foam systems containing unreacted diisocyanates; (2) children’s foam padding sleeping products containing the flame retardants Tris (1,3-dichloro-2-propyl) phosphate or TDCPP; and (3) paint and varnish strippers, and industrial-strength surface cleaners containing methylene chloride. Despite identification of the first priority products, manufacturers of these products are not yet required to conduct alternatives analyses. It is not until the draft list of priority products is finalized by DTSC and adopted into regulation that manufacturers have to notify DTSC and begin the alternatives analysis process. The adoption into regulation is done in conformance with California’s rulemaking law – the Administrative Procedure Act (APA). The APA process includes a 45-day public notice and comment period and allows DTSC up to one year from the public notice date to finalize the regulations. The March 2014 announcement is not the start of the formal rulemaking for the three listed priority products. DTSC indicates that it expects to initiate rulemaking to codify the initial priority products list into regulations in late 2014 and that this could take up to a year. DTSC updates the status of the rulemaking for these three initial priority products and any future identified priority products here.

DTSC Issues Ninth Draft of Proposed Green Chemistry Initiative Regulations

Posted by in Environmental Legislation and Regulation, Green Chemistry on March 12, 2013

By Clare Bienvenu and Mary E. Wilke

The California Department of Toxic Substances Control (“DTSC”) recently issued its ninth draft of the Green Chemistry Initiative regulations (“Regulations”) with the final rules expected later this year.  The following are six key changes set forth in the ninth draft: (1) companies are only required to make changes to ingredients included on DTSC’s list of chemicals of concern (“COC”); (2) companies are no longer required to hire a certified assessor to perform an Alternative Analysis (“AA”) but may conduct the AA themselves, while also undergoing a public notice and comment period; (3) companies from the same industry are allowed to form a nonprofit group to fund disposal of certain products as part of the end-of-life management program; (4) companies are allowed to assert “trade secret” protection over information required to be submitted; (5) the regulations will distinguish between companies that make products and those that assemble products, rather than define them all as manufacturers; and (6) an exemption is provided for products regulated by other laws that provide public health and environmental protections that are equivalent to the Green Chemistry Initiative or stricter.

With respect to the second key change, under the Regulations, Priority Products must undergo an AA, or an evaluation and comparison of the product to product alternatives.  Alternatives may include removing the COC from the product, replacing the COC with a substitute chemical, reformulating/redesigning the product to reduce or eliminate the COC, or using another material to restrict exposure to the COC.  Earlier versions of the Regulations allowed DTSC to make changes to any ingredients in their products instead of limiting DTSC’s authority to addressing ingredients on DTSC’s list of COCs.  The prior version of the Regulations also required that AAs be performed by certified assessors.  Under the latest revised version, while affected entities will be able to conduct their own AAs, those AAs must undergo a public notice and comment period of 45 days, with public comments to be sent directly to the company as well as DTSC.  In the Final AA Report, the company must summarize and address the public comments received.

With respect to the third key change, manufacturers of a Priority Product or a selected alternative that must be managed as a hazardous waste in California at the end of its useful life are required to establish “end-of-life” management programs for such products.  The new revisions allow manufacturers to join together to form and fund a non-profit third-party stewardship organization to fulfill the end-of-life management program requirements.  Under previous versions, each manufacturer was required to individually fund the program within one year of issuance of a notice of compliance for the Final AA Report.

With respect to the fourth key change, the newly revised Regulations allow companies to assert “trade secret” protection over information required to be submitted.  In doing so, the company must submit a complete copy of the documentation, including the information for which trade secret protection is claimed, and a redacted copy of that same documentation.  The revised Regulations, however, provides an exception to the submission of the complete copy where federal law or a nondisclosure agreement expressly prohibits the release of the information.  Additionally, while the regulations generally prohibit trade secret protection for hazard trait submissions, the new draft allows for companies to at least temporarily mask the precise identity of a chemical in the hazard trait submission if the chemical is an alternative considered in the AA and a patent application for the chemical or its use is pending.

With respect to the fifth key change, the Regulations now define manufacturer as “any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or has the capacity to specify the use of chemicals in, such a product.”  The definition of manufacture has also been revised and now states that “manufacture does not include acts that meet the definition of ‘assemble.’”  Assemble is defined as to “fit, join, put, or otherwise bring together components to create a consumer product.”  If the manufacturer of a Priority Product component does not comply with applicable requirements, assemblers who use that component have the same option as retailers.  The assembler can comply with the requirement themselves or cease ordering the Priority Product component.

With respect to the sixth key change, an upfront exemption has been created for products regulated by other laws that provide public health and environmental protections that are equivalent to the Green Chemistry Initiative or stricter.

While it appears that the ninth draft of the regulations provides some relief to the regulatory burden imposed on companies who use targeted materials, with public comments recently closed, it will shortly be seen how the business and environmental communities receive these changes.  The answer may come in the form of final rules, as this draft of the regulations is believed to be DTSC’s last version prior to its issuance of the final rules.  DTSC has indicated that it will identify the first five Priority Product categories to which to apply these regulations, this year, with the likely categories being articles for personal care and for children/infants.

DTSC Delays California Green Chemistry Initiative Implementation

Posted by in Green Chemistry on February 1, 2011

Implementation of California’s Green Chemistry Initiative titled “Safer Consumer Product Alternatives” has been delayed indefinitely beyond the January 1, 2011 statutory adoption deadline.  The deadline was established by California Assembly Bill 1879 (Chapter 559, Statutes of 2008).  According to Linda S. Adams, the Secretary of California’s Environmental Protection Agency, the delay is needed “to further vet the programmatic issues that have been brought to our attention via the public comment process.”  The Department of Toxic Substance Control (DTSC), the state agency that is promulgating the regulations, is taking additional time to further review the proposed regulations.  Secretary Adams also requested that the Green Ribbon Science Advisory Panel reconvene to address public comments collected from the previous drafts.  A revised third draft of the regulations was presented in November, 2010 following a public comment period.  The third draft contains substantive revisions to the earlier text, including scaled back manufacturer and retailer compliance requirements that were not well-received by the environmental community.

California Proposes To Regulate Nanomaterials as Chemical Substances

Posted by in Emerging Issues, Environmental Legislation and Regulation, Green Chemistry on October 12, 2010

Nanotechnology, the study of the controlling of matter on an atomic and molecular scale, promises a number of benefits to society.  If current trends in manufacturing are any indication, this emerging technology is here to stay.  The August 21, 2008 Project on Emerging Nanotechnologies estimated that over 800 manufacturer-identified nanotechnology products are publicly available, with 3 to 4 new products arriving in the market place per week.

Early research has established that while some types of nanomaterials are seemingly inert, others may be highly toxic.  Thus, the field of nanotechnology is ripe for regulatory intervention.  Policy makers in several jurisdictions are already establishing legal frameworks for the management of nanotechnology.  For example, the federal Toxic Substances Control Act (“TSCA”) already includes nanoscale materials within its definition of “chemical substances.”  And if recent legislative proposals to overhaul TSCA become law, the level of federal regulatory scrutiny of nanotechnology will expand, subjecting manufacturers and processors to additional notification, reporting and review procedures.

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California Releases Proposed Green Chemistry Regulation

Posted by in Emerging Issues, Environmental Legislation and Regulation, Green Chemistry on September 16, 2010

 

On September 14, 2010, California’s Department of Toxic Substances Control (“DTSC”) released the Green Chemistry Proposed Regulation for Safer Consumer Products, also known at the “Green Chemistry” regulations.  DTSC’s adoption of the regulation, required by AB 1879 (Feuer, 2008), was signed into law by Governor Schwarzenegger and establishes a process for the identification and prioritization of chemicals of concern and the performance of alternatives assessments. 

According to Linda Adams, Secretary of the California Environmental Protection Agency, “[t]his regulation propels California to the forefront of the nation and the world with the most comprehensive Green Chemistry program and will lead to safer products for consumers.”

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DTSC Releases Draft “Green Chemistry” Regulations on June 23, 2010

Posted by in Emerging Issues, Green Chemistry on August 6, 2010

 

On June 23, 2010, DTSC released its anxiously anticipated draft regulations implementing AB 1879, the 2008 Green Chemistry Initiative law intended to “accelerate the quest for safer products.”  California Health & Safety Code section 25252 (AB 1879) requires DTSC to promulgate regulations: (1) identifying and prioritizing “chemicals of concern” in consumer products; (2) establishing methods for analyzing whether safer alternatives may exist to “chemicals of concern” currently used in consumer products; and (3) developing appropriate regulatory responses based on the results of the safer alternatives analyses. The regulations are currently set to take effect Jan. 1, 2011, after being finalized.  The draft regulations are 61 pages long, include numerous definitions and cross-references to other existing regulatory programs, and are generally very complex.  Determining the potential application of these draft regulations to a specific product, and the obligations of any particular commercial entity engaged in the purchase or sale of any such product, requires a detailed review of the regulations.  Nonetheless, we summarize a few of the key provisions below.         

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