TSCA CBI – New Practices Adopted at EPA While Further Changes Are Debated in Congress

TSCA, TSCA Reform: 

Confidential Business Information (CBI) continues to be a focal point of the debates over improving implementation of the current version of TSCA, as well as amending the statute.  Here’s a short update on where those debates currently stand.

EPA Adopts New Practices under TSCA

On May 27, 2009, EPA announced in a Federal Register notice that the Agency will begin a “general practice” of reviewing CBI claims for chemical identities in health and safety studies and related data, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B.  According to the notice, “Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” If the chemical identity does not clearly reveal mixture portions or process information, EPA is unlikely to find the information eligible for confidential treatment.  EPA will apply its new practice to both newly submitted and existing claims, beginning August 25, 2010. 

Stakeholders supporting or opposing this new practice are likely to submit comments to the Agency in advance of the August implementation.

Congressional Debate over the Bills to Modernize TSCA

Both the Senate and House bills would revise and narrow the protections for CBI.  The bills would require all CBI claims to be justified up front.  EPA would have to review the claims within a prescribed time period.  Only those that withstood the review – applying standards that EPA would adopt within one year of enactment of the legislation – would be eligible for protection.  Approved claims would receive protection for up to five years. 

Similar to the current version of Section 14, the bills would not allow “the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Nonetheless, the chemical industry remains concerned about the negative impact the new CBI provisions would have on innovation, jobs, and the U.S. industry’s general competitiveness.   ICIS reports that the CEOs from 30 different chemical companies planned to meet this past Wednesday with 50 different members of Congress or their staff to discuss the bills, and the CBI provisions concerning chemical identities were on the top of their list of concerns. 

* * * *

Watch for future postings as the debates over CBI evolve.

 

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.”

California Non-Profit Formed to Certify the Sustainability of Products

Green Chemisty:

On May 20, 2010, Google held a public event at its headquarters in Mountain View, California to announce the launch of the non-profit, the Green Products Innovation Institute (GPII).  Governor Arnold Schwarzenegger, several top Google executives, and other notables attended the event.  The Institute was formed to help companies comply with California’s Green Chemistry Initiative, as well as to advance the safety and sustainability of consumer products generally.  The Institute will certify products meeting certain criteria and will provide a publicly-accessible database to help companies identify alternatives to chemicals of potential concern.

GPII appears to enjoy the support of California regulators and several large companies, and its work programs are responsive to current market demands, so readers of this blog may want to follow GPII and its initiatives.  Whether the Institute will succeed in accomplishing its larger goals or instead merely implement a program with niche appeal remains to be seen.  Further details about GPII are set out below.

Product Certification

GPII will use the so-called “cradle-to-cradle” (C2C) framework developed by William McDonough and Michael Braungart of McDonough Braungart Design Chemistry (MBDC) to establish a rating system. Products meeting the rating system’s criteria will receive the Institute’s C2C certification mark, indicating that the product has been designed or re-designed for sustainability.  GPII will train assessors, called “Licensed Assessment Partners (LAPs),” to assist companies in complying with protocol and meeting the ratings criteria, but also to advise on compliance with California’s Green Chemistry regulations.  LAPs will submit their product assessments to GPII for review and approval before the Institute will issue the C2C certifications.

The C2C framework is intended to reduce waste through innovative product design.  The goal is to enable product components and end-of-life products to be capable of use as raw materials for other products or as nutrients for ecosystems.  The framework has five criteria that GPII’s rating system will build upon.  Products will be evaluated for compliance with criteria in each of the following categories:  (1) safe and appropriately sourced materials; (2) material reutilization; (3) renewable energy; (4) access to and release of abundant, clean water; and (5) social responsibility.  After the GPII has rated a product and issued the C2C certification, the Institute will continue to work with a company to identify opportunities for improvement across each of the five categories.

Public Database

In addition to its product certification, GPII is developing a database that tracks product chemical data and also creates a list of “positive” alternative chemicals, materials, and processes.   According to GPII’s website, the database is intended to help companies reformulate or retool to create new products and to augment the Toxics Information Clearinghouse being developed by the California Department of Toxic Substances Control (DTSC) as part of California’s Green Chemistry Initiative.  DTSC and the California Environmental Protection Agency (CEPA) have expressed interest in using the database to help provide stakeholders with data on the toxicity characteristics of chemicals and materials used in products.

The database will be compiled from information companies share with the Institute about the chemicals and materials, along with manufacturing processes, used to produce their products.  The database will be partially proprietary, and partially collaborative and public.  The proprietary portion consists of a detailed review of the makeup of a product.  The characteristics of individual chemicals and materials, disassociated from product formulations, will become public.  It’s not clear from GPII’s website whether receipt of the C2C product certification will be conditioned on reaching an agreement to publicly share data.

* * * *

Additional information about GPII is available here.

Upcoming ABA-UM Law Conference on TSCA Reform in Baltimore, MD

TSCA Reform:

38th National Spring Conference on the Environment

Chemicals Regulation: REACHing For TSCA Reform

Date:   June 11, 2010

Enacted in 1976, the Toxic Substance Control Act (TSCA) is the primary means by which the United States regulates commercial chemicals. Although intended to be ambitious in scope, TSCA has proven to be a poor regulatory framework and generally is considered inadequate. In the 33 years since its enactment, advances in toxicology and analytical chemistry have raised new questions about the effects of certain chemicals on human health and the environment. These questions have left the public anxious and confused about the safety of myriad different products. Technology seems to have outstripped the regulatory regime.

There is a growing national consensus that the United States needs to modernize its chemical management law. In recent years, individual states have entered what they perceive to be a regulatory vacuum, raising the prospect of an inconsistent regulatory patchwork. The European Union’s recently enacted REACH initiative has dramatically expanded the regulatory compliance obligations for United States companies doing business in the EU. Moreover, the Obama Administration has identified risk-based chemical regulation as one of its environmental priorities. While affirming the Administration’s commitment to green innovation, U.S. EPA Administrator Lisa Jackson also has called on Congress to grant the Agency new enforcement authority and has proposed a new funding mechanism for generating the information necessary to assess chemical safety. Recent high-profile Congressional hearings also underscore the momentum for change. It is very likely that both Houses of Congress will take up the issue of TSCA reform in the next turn.

This 38th National Spring Conference on the Environment addresses the question of chemical management regulation. Featuring prominent federal, state, and private-sector experts at the center of the emerging proposals for TSCA reform, the day-long conference will provide a wide-ranging discussion about the unprecedented opportunities and challenges inherent in crafting a national regulatory framework capable of ensuring public and environmental safety while also promoting green-chemistry innovation. The conference will consider the legal implications of regulatory change and will focus on the key policy choices at the heart of the reform process.

Keynote presentations from the primary initiator of TSCA and the Senior U.S. EPA Policy Advisor responsible for the Agency’s current TSCA efforts will add unique and timely perspectives to this critical set of discussions.

Program Co-Chairs
Rebecca M. Bratspies • Sara K. Orr
Blake A. Biles

This conference is hosted by the University of Maryland of Maryland School of Law and takes place in the Ceremonial Moot Court Room at the Nathan Patz Law Center, 500 W. Baltimore Street, Baltimore, Maryland.

http://new.abanet.org/committees/environmental/Pages/38thNationalSpringConference.aspx

EPA Expands Public Access to Information on Chemicals

TSCA:

On May 17, EPA issued a press release, announcing that it had added more than 6,300 chemicals and 3,800 facilities, regulated under the Toxic Substances Control Act (TSCA), to the public database known as Envirofacts.   The Agency said its action further demonstrated Administrator Lisa Jackson’s commitment to increasing public access to information on chemicals.   

The Envirofacts database is available on EPA’s website.  The database is designed to provide information on facility activities that may affect air, water, and land in the United States.   Included in the database is information such as facility name and address, aerial imagery, maps, and links to other records such as those available on the Agency’s Enforcement Compliance History Online (ECHO) database, which provides inspection and compliance reports.

In the press release, EPA stated that it has conducted a series of efforts to increase public access to chemical information including reducing confidentiality claims by industry and making the public portion of the TSCA inventory available for free on its website.  EPA supposedly intends to take additional actions in the months ahead to further increase the amount of information available to the public.  Additional details regarding EPA’s plans are available here.

I plan to continue following and reporting on EPA’s public-access initiative, as well as the confidential business information (CBI) provisions in the Congressional bills proposing to modify TSCA.  Stay tuned for future postings here at The Green Chemistry Law Report!

ECHA Requests Updated Information on SVHCs to Assess Whether Their Uses Should Be Subject to Authorization

REACh:

The European Chemicals Agency (ECHA) is currently considering whether to recommend that two Substances of Very High Concern (SVHCs), which were added to the Candidate List in January 2010, should have their uses subject to the Authorization process.  For these two substances, ECHA is requesting specific information to help the Agency with its decision.  The Agency also is requesting more general information on the twelve other SVHCs that were placed on the Candidate list in January.

The two SVHCs currently under close review are 2,4-dinitrotoluene (CAS No. 121-14-2) and lead chromate (CAS No. 7758-97-6).  ECHA has indicated that it is requesting information on their uses and releases to assess whether they should be recommended for the Authorization process.  Persons holding relevant information that might be adversely affected by authorization are probably considering their response.  ECHA contracted with Risk and Policy Analysts Limited (RPA) to collect the information on ECHA’s behalf, and a questionnaire has been developed and is available for anyone interested in providing information.  The questionnaire can be downloaded at: http://www.rpaltd.co.uk/news-dnt.shtml.  The deadline for submitting responses is 28 May 2010.  For those readers less familiar with the Authorization process, additional details are available at: http://echa.europa.eu/chem_data/authorisation_process_en.asp.

For the other twelve SVHCs placed on the Candidate List in January, ECHA is requesting accurate and up-to-date information on the volumes available on the European market, as well as information on their uses, releases and exposures.  This information will help ECHA decide whether to eventually recommend some of these substances for the Authorization process.  These substances include:

  • Anthracene oil (CAS No. 90640-80-5);
  • Anthracene oil, anthracene paste, distn. lights (CAS No. 91995-17-4);
  • Anthracene oil, anthracene paste, anthracene fraction (CAS No. 91995-15-2);
  • Anthracene oil, anthracene-low (CAS No. 90640-82-7);
  • Anthracene oil, anthracene paste (CAS No. 90640-81-6);
  • Pitch, coal tar, high temp. (CAS No. 65996-93-2);
  • Aluminosilicate Refractory Ceramic Fibres;
  • Zirconia Aluminosilicate, Refractory Ceramic Fibres;
  • Diisobutyl phthalate (CAS No. 84-69-5);
  • Lead chromate molybdate sulphate red (C.I. Pigment Red 104) (CAS No. 12656-85-8);
  • Lead sulfochromate yellow (C.I. Pigment Yellow 34) (CAS No. 1344-37-2); and
  • tris(2-chloroethyl)phosphate (CAS No. 115-96-8).

Upcoming Meeting of California's Green Ribbon Science Panel

Green Chemistry – California:

For those readers interested in learning more about California’s Green Chemistry Initiative and the State’s draft regulations for safer products, you might be interested in participating via webcast in the upcoming Green Ribbon Science Panel’s meeting where the regulations will be discussed.

The California Department of Toxic Substances Control (DTSC) just circulated the following reminder to its listserv:

“DTSC will convene the Green Ribbon Science Panel (GRSP) on May 12 – 13, 2010 to receive input on the outline of the Draft Regulations for Safer Products and on concepts to expand DTSC’s pollution prevention program as addressed in the California Green Chemistry Initiative Final Report. The meeting will be held in Sacramento and be available via webcast.

May 12, 2010, from 9:30 a.m. to 5 p.m. PDT May 13, 2010, from 9 a.m. to 12 p.m. PDT

See information about the GRSP, the agenda, how to participate and provide input at:

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

. . . .

The meeting will be webcast at: http://www.dgs.ca.gov/Webcasts.htm

To view and comment on the outline of the Draft Regulations for Safer Products go to: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/safer_products_regs_outline.cfm

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

Bills to Modernize TSCA Could Advance Green Chemistry

TSCA Reform, Green Chemistry:

As many readers know, the recent Senate and House bills to modernize TSCA include provisions to advance green chemistry.  However, funding and other potential obstacles could frustrate this objective.  A short summary of each provision is set out below.

Introduction

The Senate and House bills were released on April 15.  The Senate bill was introduced while the House bill remains a discussion draft.  Both bills include a section entitled, “Safer Alternatives and Green Chemistry and Engineering.”  (See sections 32 and 36 in the Senate and House versions, respectively.)  Each would establish a Safer Alternatives Program, a Green Chemistry Research Network, and a Green Chemistry and Engineering Research Grants Program.  The Senate version goes further and would establish a Green Chemistry Workforce Education and Training Program.  A short discussion of each of these is set out below.

What is Green Chemistry?

Although neither bill defines green chemistry, EPA’s current definition would likely inform its future implementation of either proposal, if enacted into law.  According to EPA, green chemistry is “the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances.  Green chemistry applies across the life cycle of a chemical product, including its design, manufacture, and use.”  In other words, green chemistry is chemistry designed to reduce the environmental and human health impacts across a product’s lifecycle.  The Agency relies on 12 principles of green chemistry to clarify and implement its definition.  These principles were first established by Paul Anastas and John Warner in their book, Green Chemistry: Theory and Practice, Oxford University Press: New York (1998).

The Safer Alternatives Program

This program would require EPA, within one year of enactment of the law, “to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances.”  The program would include at least three components: (1) expedited review of new chemicals for which an alternatives analysis indicates that the new chemical is the safer alternative for a particular use than existing chemicals used for the same purpose; (2) recognition, such as a special designation for marketing, or an award, for a chemical or product that EPA determines to be a safer alternative, and (3) other incentives EPA considers appropriate to encourage the development, marketing, and use of safer alternatives.

Of the three components of the Safer Alternatives Program, the expedited review of new chemicals seems the most promising from a near-term commercial perspective.  However, its ”success” – measured by the number of new, safer alternatives reaching the market in an expedited manner – may depend more on the complexity of the alternatives analysis and less on how “expedited” the review is once the Agency receives the analysis in a new chemical notification.  Under its Design for the Environment (DfE) Program, EPA has developed considerable expertise with alternatives assessment, so the Agency may be inclined to follow a similar approach in the Safer Alternatives Program.  Yet participating in the DfE alternatives assessment process can be time-consuming and expensive.  Accordingly, EPA faces a considerable challenge.  Specifically, the Agency must develop a framework for the alternatives analysis that is less expensive and time-consuming in terms of the minimum data set and analysis than a standard new chemical notification, but also enables the Agency to utilize its expertise in alternatives assessment to ensure that only truly safer chemicals are approved.  If EPA instead merely shortens its review period, and does not streamline the alternatives assessment, the objectives of the program may not be accomplished.  Thus, much depends on the Agency’s implementation.

The Green Chemistry Research Network

This program would consist of at least four green chemistry and engineering research centers, located in different regions throughout the United States, that would “support the development and adoption of safer alternatives” to potentially hazardous chemicals, particularly those included on the Section 6(a) priority list.  (In the bills, this is a rolling list of 300 chemicals that EPA would prioritize for risk assessments, called “safety determinations.”)

The Green Chemistry and Engineering Research Grants Program

This program would require EPA to make grants “to promote and support the research, development and adoption of safer alternatives….”  Funding is the Achilles’ heel of this program.

The Green Chemistry Workforce Education and Training Program

This program would require EPA to “facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives to existing chemical substances.”  The goals of this program include the: (1) expansion of green chemistry; (2) development of scientific and technical leadership in green chemistry; (3) successful and safe integration of green chemistry into infrastructure projects; (4) informing communities about the benefits of green chemistry; and (5) promotion of innovation and strong public health and environmental protections.  To accomplish these objectives, EPA would be required to make grants, provide outreach, and form partnerships with educational institutions, training organizations, private sector companies, and community organizations.  Again, adequate funding is critical to success.

* * * *

All of these are laudable programs – and hopefully they will be included in some form in the final legislation – but, as noted above, there remain unanswered questions and the success of some of these programs depends on the ability and willingness of Congress to continue to provide adequate funding.

14th Annual Green Chemistry & Engineering Conference

Green Chemistry:

The American Chemical Society Green Chemistry Institute (ACS GCI) will hold the 14th Annual Green Chemistry & Engineering Conference in Washington, D.C. on June 21 – 23, 2010.  Pasted below is a summary of the conference, excerpted from the ACS GCI website.  For more information, follow the link embedded below the summary.

“The 14th Annual Green Chemistry & Engineering Conference returns to downtown Washington, DC.  With the theme “Innovation and Application” and with one of the renowned founders of green chemistry, Dr. John Warner (President and CTO, Warner Babcock Institute for Green Chemistry) as the chair, this conference is shaping up to be one you won’t want to miss! Confirmed keynote speakers include the popular environmentalist, entrepreneur and author Paul Hawken; 2005 Nobel Prize winner, Dr. Robert Grubbs; Senior Vice President of Research and Technology at 3M, Mr. Steven Webster; and US Congressman John Tierney (D-MA), co-sponsor of the “Green Jobs Act.”

Schedule

(subject to change)

Monday

  • Keynote address presented by Paul Hawken (renowned environmentalist, entrepreneur, and author who leads the Highwater Research LLC and Natural Capital Institute)
  • Technical Sessions
  • Exhibits
  • Presidential Green Chemistry Challenge Awards Ceremony (pre-registration required)

Tuesday

  • Technical Sessions
  • Luncheon with guest speaker US Congressman John Tierney (D-MA, co-sponsor of the “Green Jobs Act”)
  • Keynote address presented by Robert Grubbs, 2005 Nobel Prize winner
  • Poster Session
  • Exhibits
  • Reception

Wednesday

  • Keynote address presented by Mr. Steven Webster (Senior Vice President Research and Technology Commercialization, 3M)
  • Technical Sessions
  • Exhibits
  • Closing session keynote address presented by Dr. John Warner (President and CTO, Warner Babcock Institute for Green Chemistry)

Thursday

  • Student Workshop (pre-registration required)”

http://acswebcontent.acs.org/gcande/

Legislation to Modernize TSCA

TSCA Reform:

The U.S. Toxic Substances Control Act (TSCA) is the primary federal statute governing the safety of chemicals in U.S. commerce.  Revising the statute has been debated for many years, but there have been no substantial amendments since its enactment in 1976.  However, it now seems probable that Congress will enact new legislation modernizing TSCA.

On April 15, 2010, Frank R. Lautenberg (D-NJ), chair of the Senate Subcommittee on Superfund, Toxics and Environmental Health, introduced the “Safe Chemicals Act of 2010.” On the same date, Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) of the House Energy and Commerce Committee released a discussion draft of their legislation, the “Toxics Chemicals Safety Act of 2010.”

Senator Lautenberg’s legislation would amend TSCA to, among other things:

  • require manufacturers to develop and submit a minimum data set for each chemical that they produce;
  • provide EPA the authority to request additional data from a manufacturer when the Agency believes the information is necessary to determine the safety of a chemical;
  • require EPA to use the data to identify and prioritize chemicals by their likely risk;
  • require expedited action by EPA to reduce risk from chemicals of highest concern;
  • require that a safety threshold is met for chemicals to enter or remain in commerce, shifting the burden of proof to manufacturers to demonstrate safety;
  • establish a public database that would include chemical information submitted to EPA and the Agency’s determinations regarding safety;
  • promote green chemistry and foster the development of “safer” chemical alternatives; and
  • narrow the conditions under which data could be claimed as Confidential Business Information (CBI), expand access to CBI for certain stakeholders, and limit the duration of confidentiality.

Over the coming months, stakeholders will have an opportunity to review the proposals and discuss their various elements with key decision-makers.  It is too early to tell whether a consensus can be reached on key issues, but the outcome may well depend on the willingness of the sponsors to seek meaningful bipartisan support for the legislation.  Copies of the bills, summaries, and other related information are available at the links below: