Tag Archive for: Green Chemistry

DTSC Delays Adoption of its Green Chemistry Regulations for Safer Consumer Product Alternatives

Green Chemistry Regulations:

After nearly two years of multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) failed to timely adopt its Safer Consumer Product Alternatives Regulations (SCPA Regulations), a key component of California’s Green Chemistry Initiative.  The regulations would have represented a new paradigm in chemicals and products regulation, providing a strong incentive for manufacturers to market products that are “benign by design” through the use of “safer” chemicals and other techniques.  The enabling legislation, AB 1879, required DTSC to complete the rulemaking by January 1, 2011, but that did not happen.  The Department’s parent agency, the California Environmental Protection Agency (Cal-EPA), decided to have DTSC delay adoption in the face of substantial criticism of last-minute changes the Department proposed in November.   No deadline for completing the rulemaking has been announced publicly.

After receiving comments on its first regulatory proposal, released in September, DTSC made substantial changes in November and released them for a 15-day comment period extending over the Thanksgiving holiday.  The changes largely streamlined and clarified the requirements and removed potential impediments to innovation.  However, critics accused DTSC of employing “bait-and-switch” tactics, caving to industry pressure, and violating the California Administrative Procedures Act.   In the face of such criticism, Cal-EPA’s Secretary for Environmental Proection, Linda S. Adams, decided — in consultation with key legislators and the Governor’s Office — to violate the statutory deadline.   She announced her decision in a December 23, 2010 letter to Assembly Member Mike Feuer, the primary author of AB 1879.  The letter states that DTSC will reconvene its Green Ribbon Science Panel — a multidisciplinary advisory body — and revisit the issues raised in the last round of comments. 

The two most controversial changes concern (1) a five-year limitation on the categories of products subject to regulation and (2) the removal of a provision that would have affected manufacturers’ ability to redesign products.  Readers will recall that both the September and November proposals set out a three-step process – (1) identification of chemicals of concern and the priority products containing them, (2) assessment of alternatives to determine whether a viable, safer alternative is available, and (3) imposition of a regulatory response to protect health and the environment from the alternative selected.  In recognition of the challenges of implementing an entirely new regulatory scheme, the Department’s November proposal would have limited (until January 1, 2016) the categories of products from which priority products could be identified.  Only children’s products, personal care products, and household cleaning products would be eligible.   To avoid stifling innovation, the November proposal also would have removed the so-called “Tier I” notification, a streamlined alternatives assessment for a product voluntarily redesigned or reformulated to reduce or remove chemicals of concern prior to the product being identified as a priority product.  Avoidance of “regrettable substitutions” was the goal of the Tier I notification, but the potential cost to innovation convinced DTSC to remove the requirement.

These eleventh-hour developments create considerable uncertainty for the regulated community and others, which have been struggling to understand the full import of the regulations and prepare for their implementation.  The impending debate over November’s changes is certain to be contentious.  Although the changes seem meritorious, they were proposed in a manner that appears to have eroded trust and damaged the spirit of cooperation.  Whether the various stakeholders can reach consensus on the most controversial issues remains to be seen.   

 

Reminder: Upcoming DTSC Symposium on Green Chemistry and Public Health

Green Chemistry:

Yesterday, the California Department of Toxic Substances Control (DTSC) circulated the following announcement regarding an upcoming symposium on Green Chemistry and public health.  The event will be held on October 18.  DTSC and the Department of Public Health are co-sponsoring the event.  More details, including a copy of the agenda, are provided in the excerpt below.

“DTSC and the California Department of Public Health will host a brown-bag symposium on October 18 to explore impacts of Green Chemistry on public health. Keynote Speaker is Margaret L. Kripke, Ph.D., a member of the President’s Cancer Panel which recently advocated expanded research into Green Chemistry.  Kripke is a professor of immunology at the University of Texas, MD Anderson Cancer Center. Our afternoon keynote speaker is Steve Owens, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention at the U.S. Environmental Protection Agency.  Owens oversees regulatory and scientific programs on pesticides and industrial chemicals along with numerous collaborative pollution prevention programs.

The symposium will be held on October 18, 2010 from 10 a.m. to 3 p.m. at the California Department of Public Health East End Complex, 1500 Capitol Ave., Sacramento, CA. It is free, open to the public and to all interested stakeholders in Green Chemistry and Public Health.

For more information or to register for in person or live webcast attendance, please visit: http://www.dtsc.ca.gov/upload/GreenChemPublicHealthBrownBagFlyer.pdf

To view the agenda, visit: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/PHAgenda.pdf

Instructions on how to view the webcast will be provided a few days before the event.

To subscribe to or unsubscribe from the DTSC Green Chemistry Initiative Listserv or other Listservs, please go to http://www.calepa.ca.gov/listservs/dtsc.  For information on DTSC`s Green Chemistry Initiative, go to http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm

California DTSC Requests Comment on Proposed Green Chemistry Regulations for Safer Consumer Product Alternatives

Green Chemistry Regulations:

After nearly two years of public meetings, informal comment periods and other multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) released on September 15, 2010 its proposed Safer Consumer Product Alternatives regulations, a key component of California’s Green Chemistry Initiative.  The proposed regulations would require DTSC to create a list of chemicals identified as posing the greatest threats to human health or the environment, the so-called “Priority Chemicals.”  Using a number of factors such as volume in commerce and extent of public exposure, DTSC would then prioritize products containing those chemicals.  Entities responsible for commercial introduction of the highest priority products, the so-called “Priority Products,” would be required to perform an alternatives assessment to determine whether a viable safer alternative is available.  The alternative ultimately selected would inform DTSC’s regulatory response, which could range from no action to sales prohibitions.

The proposed regulations represent a paradigm shift in the regulation of chemicals and products, having significant implications for all members of a product’s value chain.  The process for identifying Priority Chemicals and Priority Products is complicated and information-intensive.  Products undergoing an alternatives assessment will require a substantial resource commitment.  To help ensure compliance, reduce the risk of reputational harm, maintain market presence, and potentially identify new opportunities, companies will need to understand the process, closely monitor future DTSC pronouncements and be prepared to respond appropriately.

Companies placing products into the stream of commerce in California that have not yet reviewed the proposed regulations are probably doing so now.  Although many industry representatives actively participated in the collaborative drafting process, many more did not, mistakenly believing that their products were not “consumer products” and therefore would not be affected.  The reality is that only a limited universe of products is excluded from the definition of consumer product or otherwise eligible for some type of exemption.

Public comments on the proposed regulations are due on November 1, 2010, the same date as the public hearing on them.  DTSC intends to complete the formal rulemaking process by the end of 2010, as required by statute.  A copy of the proposed regulations, a set of Frequently Asked Questions, a conceptual flowchart, and other information is available here.

Readers that are familiar with the previous draft of the regulations may be interested in the type of changes that DTSC incorporated into the current proposal.  DTSC claims that the changes:

  • Address criticism that the initial scope of chemicals list was too narrow.  DTSC has significantly broadened the proposed scope by expanding the lists of authoritative bodies that could be consulted for establishing the Priority Chemicals list.
  • Respond to concerns that the previous draft regulation’s lack of deadlines could cause unintended delays.  Proposed deadlines are now included for both chemicals and products lists along with specific timelines for various regulatory steps.  (These are set out in more detail below.)
  • Additionally, DTSC has added a tiered process for alternative assessments intended to reduce the time for identifying safer alternatives and provide more specific performance targets to move manufacturers through the regulatory process.
  • Address comments regarding the complexity of the process.  DTSC has simplified the process somewhat and clarified what information would be required and how it would be submitted.
  • Respond to requests to have public comments on regulatory actions.  DTSC now proposes to allow public comment on any regulatory responses that are triggered by a DTSC ruling or determination.

The proposed regulations include the following deadlines:

  • The proposed initial list of Chemicals under Consideration must be issued for public review and comment no later than June 1, 2011;
  • The final initial list of Chemicals under Consideration must be issued no later than March 1, 2012;
  • The proposed initial list of Priority Chemicals must be issued for public review and comment no later than July 1, 2012;
  • The proposed initial list of Products under Consideration must be issued for public review and comment no later than March 1, 2013;
  • The proposed initial list of Priority Products must be issued for public review and comment no later than September 1, 2013;
  • The final initial list of Priority Products must be issued no later than December 1, 2013.

Future postings may delve further into various aspects of the proposed regulations, as well as review public comments that are submitted to DTSC.

Reminder: Upcoming California DTSC Symposium on Life Cycle Analysis

Green Chemistry:

This evening the California Department of Toxic Substances Control (DTSC) circulated the following announcement, reminding interested persons about the upcoming symposium on life cycle analysis.

“DTSC invites you to the Life Cycle Analysis: 101 Brown-Bag Symposium, taking place on Thursday, Sept. 23, 2010. This session looks at real-world examples of life cycle analysis (LCA) and how it affects product formulation, decision analysis and business practices. Presenters from HP, P&G, PE Americas and UCLA will share their front-line experiences of developing protocol and collaboration to successfully complete LCAs.

The symposium takes place in the Elihu M. Harris Building in Oakland, from 10:30 a.m. to 3 p.m. Bring a lunch and plenty of questions for our presenters. Register (http://www.dtsc.ca.gov/LCA_symposium.cfm) to attend in person or participate via webcast.”

DTSC Posts Public Comments on Draft Green Chemistry Regulation for Safer Consumer Products

Green Chemistry Regulations:

The California Department of Toxic Substances Control (DTSC) circulated the following announcement, informing stakeholders that the agency published all public comments received to date on the draft Green Chemistry Regulation for Safer Consumer Products.  The comments should make interesting reading.  Those of potential importance may be featured in future postings on the Green Chemistry Law Report, so stay tuned!

“DTSC: Green Chemistry Initiative

As part of DTSC’s commitment to transparency and public participation, we have posted, in the order received, all public comments on the Green Chemistry Initiative draft Regulation for Safer Consumer Products  http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm.

The regulation reflects nearly 16 months of collaboration with stakeholders, including numerous formal and informal meetings and workshops; input from the Green Ribbon Science Panel; and comments on the conceptual process flowchart, earlier drafts and the draft regulation outline released in the spring of 2010.

DTSC requested public comments during this informal comment period be received by July 15. This posting includes the comments received to date. Additional comments are expected and will be posted when received.

DTSC will now evaluate all comments and consider changes to the regulation. DTSC expects to move into the formal Administrative Procedure Act (APA) rulemaking process in late summer.”

Reminder: Upcoming DTSC Workshops on Draft Green Chemistry Regulation for Safer Consumer Products

Green Chemistry:

This evening, the California DTSC circulated the following reminder about its upcoming workshops seeking public comment on the Draft Green Chemistry Regulation for Safer Consumer Products.   These should be interesting events, which I plan to report on in a future post.  Stay tuned!

“DTSC: Green Chemistry Initiative 

Your Input is invited on the Draft Regulation for Safer Consumer Products at 2 workshops scheduled for July 7 and July 8, 2010 in Sacramento and via webcast.  Both workshops will be held in the Cal/EPA Building, 1001 I Street, Sacramento, Byron Sher Auditorium during the following times:

July 7, 2010, 8:30 – 12:00 PDT

July 8, 2010, 1:30 – 5 PDT

Participants are also invited to join via webcast at: http://www.calepa.ca.gov/Broadcast/

The workshop agenda, draft regulation and information on additional opportunities for public input are available at:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm

California Releases a Draft of the Green Chemistry Regulation for Safer Consumer Products

Green Chemistry Regulation:

On June 23, the lead agency implementing California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC), published on its website a draft of the Regulation for Safer Consumer Products.  According to the DTSC announcement, the draft will be the subject of two additional informal, half-day public workshops on July 7 from 8:30 a.m. to 11:30 a.m. and July 8 from 1:30 p.m. to 5 p.m.  Both workshops will be held in the Cal/EPA Building, 1001 I Street, Sacramento, Byron Sher Auditorium.  Public comments are due by July 15, 2010.

Under the draft regulation, DTSC would create a list of chemicals that are “toxic” and can harm people or the environment. Products containing those chemicals would be prioritized based upon such factors as the volume in commerce, the extent of public exposure and how the product is eventually disposed. Manufacturers of those products would perform an “alternatives assessment” to determine if a viable safer alternative is available.  The draft currently calls for three phases: (1) the prioritization process, during which DTSC would identify and prioritize chemicals of concern and products that contain them; (2) an alternatives assessment conducted by the product manufacturers to identify safer alternatives for those priority products identified in first phase; and (3) DTSC adoption of regulatory measures to address concerns raised by the alternatives selected by manufacturers for implementation and to encourage manufacturers to design safer products.

DTSC has stated that it may revise the draft based on comments received. It would release the revised draft following the July 15 comment deadline. The formal Administrative Procedures Act (APA) rulemaking process will begin with the release of that draft. The APA process calls for public hearings and a 45-day public comment period. DTSC will release specific information about the APA process when the final draft regulation is available for review.

According to DTSC’s announcement, the draft regulation and related documents can be found at:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm

I plan to review the draft regulation in further detail and provide additional posts on the draft for interested readers.

EPA Recognizes Recipients of 2010 Presidential Green Chemistry Challenge Awards

Green Chemistry:

This past Monday, June 21, at the Ronald Reagan Center in Washington, DC, EPA held the 2010 Presidential Green Chemistry Challenge Awards ceremony.   This year’s winners include BASF; The Dow Chemical Company; Merck & Co., Inc.; Codexis, Inc.; Clarke; LS9, Inc.; and James C. Liao, Ph.D.  Additional details regarding the Challenge Awards Program and this year’s winners are provided below.

Background on the Presidential Green Chemistry Challenge Awards Program

For those readers that are less familiar with the Challenge Awards Program, EPA offers the following description on its website:

“The Presidential Green Chemistry Challenge Awards Program is an opportunity for individuals, groups, and organizations to compete for annual awards in recognition of innovations in cleaner, cheaper, smarter chemistry. The Presidential Green Chemistry Challenge Awards Program provides national recognition of outstanding chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use, and that have been or can be utilized by industry in achieving their pollution prevention goals.

The Presidential Green Chemistry Challenge Awards Program invites nominations that describe the technical benefits of a green chemistry technology as well as human health and environmental benefits. The Awards Program is open to individuals, groups, and nongovernmental organizations, both nonprofit and for profit. The nominated green chemistry technology must have reached a significant milestone within the past five years in the United States (e.g., been researched, demonstrated, implemented, applied, patented, etc.).

Nominations received for the awards are judged by an independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute. Typically five awards are given annually to industry and government sponsors, an academic investigator, and a small business.”

According to EPA, the awards are typically granted in the following five categories:

  • Small Business: A small business* for a green chemistry technology in any of the three focus areas.
  • Academic: An academic investigator for a technology in any of the three focus areas.
  • Focus Area 1: An industry sponsor for a technology that uses greener synthetic pathways.
  • Focus Area 2: An industry sponsor for a technology that uses greener reaction conditions.
  • Focus Area 3: An industry sponsor for a technology that includes the design of greener chemicals.

* A small business is defined here as one with annual sales of less than $40 million, including all domestic and foreign sales by the company, its subsidiaries, and its parent company.

This Year’s Winners by Category

EPA’s website list this year’s winners, a summary of their innovations and their benefits, as well as a podcast overview of each innovation that is narrated by Dr. Richard Engler of EPA’s Office of Pollution Prevention and Toxics.  The winners include:

  • Greener Synthetic Pathways Award
    The Dow Chemical Company
    BASF
    Innovative, Environmentally Benign Production of Propylene Oxide via Hydrogen Peroxide (summary / podcast)
  • Greener Reaction Conditions Award
    Merck & Co., Inc.
    Codexis, Inc.
    Greener Manufacturing of Sitagliptin Enabled by an Evolved Transaminase (summary / podcast)
  • Designing Greener Chemicals Award
    Clarke
    NatularTM Larvicide: Adapting Spinosad for Next-Generation Mosquito Control (summary / podcast)
  • Small Business Award
    LS9, Inc.
    Microbial Production of Renewable PetroleumTM Fuels and Chemicals (summary / podcast)
  • Academic Award
    James C. Liao, Ph.D.
    Easel Biotechnologies, LLC
    University of California, Los Angeles
    Recycling Carbon Dioxide to Biosynthesize Higher Alcohols (summary / podcast)

Review of the ABA Conference: "Chemicals Regulation: REACHing for TSCA Reform"

TSCA Reform, Green Chemistry:

Last week, on Friday, June 11, I attended the ABA conference: “Chemicals Regulation:  REACHing for TSCA Reform.”  In my opinion, the conference was a success.  It was well-attended by a range of stakeholders and the speakers’ topics were generally interesting.  Blake Biles did a fantastic job in his opening remarks setting the context in which TSCA was passed in 1976 and the challenges that EPA has faced implementing the statue.  All in all, I think the conference was worth the investment.

The conference provided a brief overview of the Congressional bills to modify TSCA and more detail regarding the role of states in chemicals regulation, the recent green chemistry initiatives, and some of the legal issues that go beyond regulatory compliance.  If anyone would like a copy of the agenda, which includes a biography (of sorts) of supplementary reading material, please let me know.  The suite of conference materials is probably available from the ABA.

I was a little disappointed that the speakers did not cover the mechanics of the new bills in any detail, however.  Presumably this was because they felt that it was premature to do so. In other words, they probably expect the final legislation to differ from what’s currently proposed. Based on what I’m hearing, I would generally agree with that conclusion. However, the recent convergence of chemical industry executives on Capitol Hill suggests that there may be some residual concern about the bills passing this session in something similar to their present form, so more discussion of the mechanics would have been helpful to some attendees, I’m sure.

Reminder: June 9 California DTSC Symposium on Alternatives Analysis

Green Chemistry:

The California Department of Toxic Substances Control (DTSC) is convening a symposium tomorrow on alternatives analysis in Sacramento and via webcast.  The DTSC reminder for the symposium is set out below.

“DTSC: Green Chemistry Initiative

There is still time to join the Department of Toxic Substances Control and the outstanding slate of speakers gathered for Alternatives Analysis Symposium I: Issues and Evolution, Capitalizing on Success tomorrow, June 9, 2010, in Sacramento and via web cast. We will expand the dialogue on the alternatives analysis process for chemicals used in consumer products – a core element of the California Green Chemistry Initiative – and identify opportunities for chemical alternatives analysis through the lens of organizations implementing successful policies and programs.

Presenters include:

Jay Bolus – McDonough Braungart Design Chemistry (MBDC); Clive Davies – U.S. Environmental Protection Agency, Design for the Environment (DfE) program Lauren Heine, Ph.D. – Clean Production; Action Libby Sommer – U.S. Environmental Protection Agency, DfE program; Alex Stone, Sc.D. – Washington State Department of Ecology; Donald J. Versteeg, Ph.D. – Procter & Gamble.

Join us for any or all in the Byron Sher Auditorium inside the Cal/EPA Headquarters Building or via web cast.  See the agenda, download presentations, register and find web cast information at: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/Alternative-Analysis-1-Symposium.cfm.”