California Publishes New Draft of Informal Green Chemistry Regulations

Yesterday the California Department of Toxic Substances Control (DTSC) convened a Green Ribbon Science Panel (GRSP) to continue work on the state's Green Chemistry initiative.

Readers may recall from previous posts that the GRSP was established with the passage of two "green chemistry laws" in 2008, and is charged with providing advice and serving as a resource to DTSC and the public regarding the California Green Chemistry Initiative. On the agenda for the meeting this week was input from the GRSP on the recently-posted “Safer Consumer Products Informal Draft Regulations”, which were published late last month.  An earlier draft of those regulations, released by the DTSC last November, drew strong commentary from both industry and environmental groups. According to DTSC, a wide range of stakeholders, including those from industry, environmental groups, scientists, and legislative leaders, raised "substantive and valid concerns" about the prior draft of the regulations. DTSC  eventually withdrew the draft regulations.

The latest draft regulations provide for a four-step process to identify safer consumer product alternatives: 1) create an immediate list of Chemicals of Concern (~3,000) based on the work already done by other organizations, and specify a process for DTSC to identify additional  chemicals as Chemicals of Concern (COCs); 2) require DTSC to evaluate and prioritize product/COC combinations to develop a list of “Priority Products” for which an alternatives assessment must be conducted; 3) require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product.  Manufacturers (or other responsible entities) must perform an "alternatives assessment" for the product and the Chemicals of Concern in the product to determine how best to limit potential exposures to, or the level of potential adverse public health and environmental impacts posed by, the Chemicals of Concern in the product; 4) require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts, if any, posed by the Priority Product/Chemical of Concern.

The draft regulations note that they would not apply to prescription drugs and devices; dental restorative materials; medical devices, and some other categories. But it is clear that they will impose significant new burdens on many product manufacturers, importers and sellers. The new regulations require risk assessments and life cycle analyses for prioritized products, which may lead to use limits for chemicals, reformulation requirements to eliminate targeted chemicals, or even a ban on sales of certain products in California.

And, of course, varying state regulations (in approach and content) frustrate the ability of those companies to design and market products in a global supply chain.

DTSC labels the new draft "informal," perhaps because they make substantial changes to the withdrawn set, which drew such intense scrutiny.   The initial list of “Chemicals of Concern” would be far broader than previously expected; the product prioritization criteria is revised, although it still appears likely to impact children's products, personal health, and other consumer products. But worker exposure has been added to the priority criteria as well. The regulations would also expand the list of hazards to include a wider range of hazard traits and environmental and toxicological testing endpoints. The previous exemption for unintentionally added chemicals would be eliminated, and, significantly, the “no exposure pathway” exemption would also be dropped.  

The regulations would require an alternatives assessment, conducted in two stages, with a report to DTSC regarding each stage. The first stage focuses on product criteria (function, performance, technical, and legal requirements), identification of alternatives to the COC, and screening of the alternatives.  The second stage would involve a detailed assessment of alternatives, focusing on exposure pathways and life cycle segments.

After evaluating the reports of the alternatives assessment, DTSC would then consider the appropriate regulatory response, which could involve a requirement of information disclosure, or more assessment, or limitation of certain uses, up to a ban.

The draft regulations would also require responsible entities to establish and pay for an end-of-life product stewardship program for any product that is to treated as a hazardous waste in California.

Materials for the meeting are here and here. On December 5, 2011, DTSC will hold a workshop on the informal draft regulations. The informal public comment period ends December 30, 2011.  DTSC apparently will then develop a formal new set of proposed regulations.   

California Postpones Green Chemistry Regulations

California has postponed final adoption of its green chemistry rules pending further review to address a variety of stakeholder concerns. As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."

Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals. The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

Now, the state environmental head, Secretary Linda Adams, has announced that the California Department of Toxic Substances Control will reconvene the Green Ribbon Science Panel to take another look at the proposed regulations. Those regulations, released by the DTSC last November, drew strong commentary  from both industry and environmental groups.  According to Adams, a wide range of stakeholders, including those from industry, environmental groups, scientists, and legislative leaders, have raised "substantive and valid concerns" about the most recent draft of the regulations. 

 


 

DTSC Green Chemistry Symposium

The California Department of Toxic Substances Control (DTSC) and the state's Department of Public Health (DPH) are hosting a brown-bag symposium, "Green Chemistry through the Lens of Public Health," next week.  The program will examine the potential and intended effects of Green Chemistry on public health. It is set for Monday, October 18, 2010, 10 a.m. – 3 p.m.
 

We have posted on the California Green Chemistry Initiative, from the introduction of legislation for the program, to the proposal of draft regulations, to the final rule making stages.  As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals. The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

The symposium is scheduled to feature interactive discussions with physicians, scientists and some stakeholders on the impact of the new chemicals policy on public health. The keynote speakers are Dr. Margaret Kripke, Ph.D., immunologist, and Steve Owens from the U.S. Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention.

The event is open to the public and is supposed to be accessible via a live webcast at www.dtsc.ca.gov/greenchemistry.
 

 

California's Proposed "Green Chemistry" Regulations Move Forward

California's proposed "green chemistry" regulation took another step closer to completion last week, as the state Department of Toxic Substance Control (DTSC) submitted the draft regulations to begin the final official rulemaking process.  The public has until Nov. 1, 2010 to make comments.  Under state law passed in 2008, the regulations must be finalized before 2011.

As readers know from previous posts, "green chemistry" is the state's effort to require that chemical products be designed in such a way as to reduce the use or generation of hazardous substances and reduce health and environmental risks, with a clear emphasis on finding alternatives to "chemicals of concern."  Two bills passed in 2008 by the legislature mandated that DTSC develop regulations for identifying and prioritizing chemicals of concern, to create methods for analyzing alternatives to existing chemicals, and to create a mechanism for regulatory response, including possible restrictions or bans on certain chemicals.  The laws also created a Green Ribbon Science Panel to advise DTSC, and provided for a Chemical Information Clearinghouse that will make chemical risk information more accessible to the public.

Earlier in 2010, the agency released a draft Safer Consumer Product Alternatives regulation, then held public meetings and workshops and took written comments.  Last week, the final, slightly revised draft, was issued. DTSC’s regulations call for identifying and prioritizing chemicals in consumer products, for conducting an alternatives assessment, and then an appropriate  regulatory response.

The proposed regulations call for creation of a proposed initial list of Chemicals under Consideration by June 1, 2012, and, from that an eventual list of Priority Chemicals by July 1, 2012. Similarly, the agency is to create a proposed initial list of Products under Consideration (because they contain the relevant chemicals) by March 1, 2013, and eventually a final list of Priority Products by December 1, 2013. In making this determination, the regulations offer a long list of relevant factors, including usage, distribution, disposal and life cycle issues, use by sensitive sub-populations, and a host of toxicity parameters.  One thing for manufacturers to watch: it is unclear how the DTSC will weigh and balance these and other factors. Especially important will be the relative emphasis on realistic, feasible exposure scenarios and dose, as opposed to theoretical risks in the lab.  A second area of potential concern here is that while the proposed regulations include a fairly detailed (and likely lengthy) petition process to challenge regulatory response decisions, they apparently do not include a similar ready process to seek removal of a chemical or product from the priority lists.  Thus, manufacturers and relevant trade associations will have to closely monitor the draft/proposed lists and jump into the comment period before the lists are finalized. Food, drugs, and a few other products are exempt, but the potential list of "consumer products" is quite large.

In the second phase involving Alternative Assessments, product makers will have to provide what may become a quite complex and expensive assessment of potential alternatives to the chemical/product, including a look at hazards, potential exposures, and life cycle.  For example, if the lead of the assessment team works for the manufacturer, the Assessment must be reviewed and verified by an independent third-party consultant.  It is unclear what data DTSC will want to see here, including whether the agency will require additional, new toxicity testing of a product or an alternative.  This may be especially onerous for smaller companies, and for newer technologies (think nano?) in which the existing body of data may not be as robust. One area for companies to watch here is the protection, or lack thereof, of trade secret information.  Ingredients in a product, and possible alternatives that make the product safer, are often a key part of intellectual property, a competitive advantage.  The regulations purport to offer some trade secret protection, but it s not crystal clear how the DTSC will apply this principle.

After receiving the Alternative Assessment, the DTSC is to decide on the best method, if any, to mitigate paternal risks with the product, ranging from no further action to recalls and bans.

The regulations offer a good reminder to double-check company knowledge and comfort with the supply chain, components and agreements, risk sharing provisions, insurance coverage, etc.

California Right To Know Bill Strikes the Wrong Balance

Last week, the California Assembly’s Committee on Environmental Safety and Toxic Materials approved the Consumer Right to Know Act, S.B. 928.  The bill passed the California State Senate last April, and is currently pending in the California Assembly’s Committee on Appropriations.

This bill would ban the manufacture, sale, or distribution of certain consumer products unless the manufacturer publishes a comprehensive list of ingredients on a publicly available website and directs consumers to a web address on the product’s label. The ingredients would have to be identified with a Chemical Abstract Service (CAS) number. Additionally, they should be identified by either the Consumer Specialty Products Association Consumer Product Ingredients Dictionary (CSPA dictionary) name or the International Nomenclature Cosmetic Ingredient (INCI) name.

As originally drafted, the bill applied to all consumer products as defined by the federal Consumer Product Safety Act. As amended, the current bill applies only to “designated consumer products.” So far, those products include: air care products, automotive products, cleaning products, and polish or floor maintenance products. But, according to observers, the scope of products is under review and could be changed by the legislature before enactment.

One huge issue with the bill is its inadequate protection for legitimate intellectual property, including trade secret information.

As it is currently drafted, S.B. 928 purports to protect trade secrets from disclosure, but it also restricts this ostensible protection in several problematic ways.

  • First, “hazardous” ingredients cannot be trade secrets for purposes of the bill. And the bill has an overbroad broad definition of “hazardous.” That is, a “hazardous substance” is defined as a chemical, or chemical compound, including breakdown products, identified by any state or federal agency or other governmental body or the World Health Organization as potentially having properties of eye and skin irritation, sensitization, acute or chronic toxicity, carcinogenicity, cytotoxicity, neurotoxicity, developmental or reproductive toxicity, or both, endocrine disruption or ecotoxicity.  Any chemical has the "potential" to be toxic at the wrong dose. Even substances universally regarded as safe can cause sensitization in a few hyper-allergic persons.

 

  • Second, hazardous incidental ingredients—those without a technical or functional effect, which, for example, can be present in very small quantities from processing or the production of other products—cannot be protected as trade secrets.

 

  • Third, if a product or its ingredients or incidental ingredients can be reverse engineered, it should not receive trade secret protection. Of course, it is impossible for manufacturers to know in advance what is capable of being reversed engineered for the purposes of disclosing ingredients.

Such disclosure of all chemical ingredients in products may lead to final product manufacturers being placed in the awkward situation of asking suppliers to divulge ingredient information, unique combinations of ingredients, and/or formulas that are patented, proprietary, or considered trade secrets. Many times these formulas are provided to final product manufacturers only under confidentiality agreements. The legislation, in those cases, would appear to require manufacturers to violate those confidentiality agreements by disclosing chemical ingredient information.


In addition, the bill requires that a manufacturer complete a complicated and unworkable formal process to have product information protected as a trade secret. This includes a showing of how secrecy leads to value, the ease of duplication if disclosure is made, how the chemical identity relates to how the chemical is made, how the manufacturer maintains secrecy, and how hard it is to reverse engineer the product. Most importantly, this includes disclosure of the basis for the manufacturer’s determination that its ingredients are not hazardous. That is, prove the negative. 

Finally, if the state Department of Toxic Substances Control (DTSC) determines that the product is not deserving of trade secret protection for any number of listed reasons, including request from the public, the government can affirmatively disclose the product information. In order to prevent disclosure, the manufacturer will have 30 days to file for an injunction. That is an unfair and unworkable time frame.

A coalition of business interests led by the California Chamber of Commerce is opposing the bill on the grounds it increases costs to consumers and will expose confidential business information.  It fears that the definition of product will be expanded "to include everything under the California sun."

The bill would also eliminate trade secret protection after six years unless the manufacturer renews its claim. There is no apparent purpose for such a sunset provision on a trade secret claim other than to burden and place additional expense on the manufacturer. Finally, the bill provides no protections against private rights of action, including actions that may arise under California consumer fraud laws.

We could go on, but isn't that enough reason to conclude the bill strikes the wrong balance?