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.

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. 

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Watch for future postings as the debates over CBI evolve.

 

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

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.

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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.

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: