Senator Lautenberg Continues in His Quest to Reform TSCA

TSCA Reform:

Guest Columnist: 
Irene Hantman
University of Maryland Law Fellow
US EPA Office of Civil Enforcement
Waste and Chemical Enforcement Division

On April 14, 2011, Senator Lautenberg of New Jersey introduced the 2011 Safe Chemicals Act (2011 SCA), almost a year after he introduced a similar bill (S. 3209) that failed to garner sufficient Congressional support.  Senator Barbara Boxer of California, Senators Amy Klobuchar and Al Franken of Minnesota, and Senator Charles Schumer of New York co-sponsored the bill.  The 2011SCA is intended “to modernize the ‘Toxic Substances Control Act of 1976’ (TSCA) and protect Americans from exposure to dangerous toxins.”  Readers familiar with the bill introduced in 2010, S. 3209, will find many of the same concepts and requirements in the 2011 SCA.  Whether this latest bill will progress further than its predecessor is unknown, but there are many reasons to believe that it will not, despite support from the high-ranking Democratic Senators Boxer and Schumer.

According to Senator Lautenberg, the 2011 SCA addresses many of TSCA’s weaknesses identified by the US Government Accountability Office in its 2005 Report to Congress, Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program.  It also adopts many of the recommendations for US Chemicals Management Policy advocated by the American Academy of Pediatrics, former EPA Associate Administrators for the Office of Prevention, Pesticides, and Toxic Substances, and National Institutes of Health officials.  Readers unfamiliar with those recommendations should know that they stressed that efforts to modernize TSCA must: (1) ensure that chemicals in commerce demonstrate reasonable certainty of no harm, at all stages of human development, and through all possible exposure routes; (2) provide EPA practical tools to assess the safety of chemicals currently in use; and (3) establish public access to chemical safety information.  Senator Lautenberg also emphasized that the 2011 SCA would require safety testing of all industrial chemicals, and put the burden on industry to prove that chemicals are safe in order to get on, or remain on, the market.  In contrast, current TSCA parameters generally do not require chemical companies to test new chemicals for toxicity or to gauge exposure levels before they are submitted for EPA’s review.

Again, the 2011 SCA has many conceptual similarities to legislation the Senator sponsored in 2010 (S. 3209), but there are differences in some of the details of implementation.   The 2011 SCA would:

  • require manufacturers to submit minimum data sets to allow the EPA to conduct screening-level risk assessments for new and existing chemical substances (see amended §4(a));
  • facilitate data sharing across federal agencies (see amended §4(f));
  • require manufacturers and processors to submit new chemical notifications for chemical substances (and mixtures upon certain EPA findings) that EPA could approve upon a finding that the substance meets the Section 6 safety standard or that the substance does not meet other criteria concerning production volume, release, toxicity, etc. (see amended §5);
  • require manufacturers to submit reports describing current manufacturing or processing (see amended §8(a)), including
    • chemical identity,
    • manufacturing and processing facility location,
    • known uses of, exposure to, and fate information, and
    • health and safety studies not previously filed with the Administrator;
  • allow the Administrator to order manufacturers to make supplemental information submissions (see amended §8(b)) to assist
    • in making safety determinations, and
    • any aspect of administering TSCA; and
  • establish an Internet-accessible database to provide public access to significant chemical safety information (see amended §§5(b)(2), 8(d)), including
    • premanufacture notices (PMNs),
    • safety testing, and
    • Agency decisions.

In addition to maintaining a number of the conceptual changes to TSCA proposed in 2010, the 2011SCA includes new authorities regarding safety standard determinations and confidential information.   For example, the amended Section 6 would establish a risk classification scheme for chemical substances currently in use.

  • Priority Class 1 would comprise chemical substances that are assessed by the Administrator as requiring immediate risk management.  Substances in Class 1 would be those that are degraded and metabolized into persistent, bioaccumulative, and toxic substances with the potential for widespread exposure to humans or other organisms. Within 18 months of assignment to this priority class, the Administrator would be required to impose conditions on the manufacturing, processing, use, distribution in commerce, and disposal of the substance to achieve the greatest practicable reductions in human and environmental exposure.  
  • Priority Class 2 would include chemical substances, presently in commerce, for which the Administrator found a more-than-theoretical concern of uncertainty that they could meet the safety standard required for new chemicals.  Assignment to Class 2 would be conducted in order of risk presented to human health and the environment.  
  • Priority Class 3 would include only those chemical substances for which the Administrator determined no immediate action was required because the substance did not and would not, at any stage of the lifecycle, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

No judicial review would be available for assignment to any priority class.

The 2011 SCA also specifies minimum considerations for safety standard determinations of both new and existing chemicals (see amended §6(b)).  The legislation would require the Administrator’s risk assessment to include consideration of scientific literature relating to the effect of cumulative exposure to chemical substances.  The Administrator would be permitted to find that a substance meets the safety standard only when there is a reasonable certainty that neither human health nor the environment would be harmed from aggregate exposure.  Judicial review would not available for determinations that manufacturers have not established that chemical substances meet applicable safety standards.

The 2011 SCA would limit protections for confidential business information.  Section 14 would also allow the Administrator to determine that particular information previously considered eligible for confidential treatment is no longer entitled to such treatment.

Lastly, 2011 SCA would have limited preemptive effect.  States and their subdivisions would remain free to adopt or enforce any regulation, requirement, or standard of performance that was different from, or in addition to, a regulation, requirement, liability, or standard of performance established under TSCA, unless it was impossible to comply with both, in which case the TSCA requirement would control.  Although the preemption provision was revised from the 2010 bill, Senator Lautenberg continues to prefer robust state involvement in chemicals management.

The website for Senator Lautenberg’s office provides summaries of and the text of the Safe Chemicals Act of 2010 and 2011 (2010 bill, 2010 summary, 2011 bill, 2011 summary).

* * * *

DISCLAIMER:  This work is not a product of the United States Government or the United States Environmental Protection Agency, and the author is not doing this work in any governmental capacity.  The views expressed are those of the author only and do not necessarily represent those of the United States or the US EPA.                       

Chemical Heritage Foundation Posts the Video from its TSCA Reform Event


The Chemical Heritage Foundation (CHF) posted the video from its recent event on the federal Toxic Substances Control Act (TSCA), the primary federal statute governing the safety of chemicals in U.S. commerce.  Readers less familiar with CHF should know that it is a Philadelphia-based non-profit that aims to foster an understanding of chemistry’s impact on society.  CHF is currently completing an oral history project on the statute’s evolution from legislative proposal through implementation and now reform.  The project has required CHF to interview various persons, including former EPA officials, responsible for key aspects of that evolution.  The March 3 event, entitled “TSCA: From Inception to Reform, a Public Dialogue,” was an outgrowth of the oral history project.

The event featured a panel of five former administrators in the EPA office responsible for implementing the statute at various times since its enactment in 1976. They included James V. Aidala, Charles M. Auer, Charles L. Elkins, Mark A. Greenwood, and Glenn E. Schweitzer.  Each panelist discussed the statute’s perceived strengths and weaknesses, major accomplishments achieved under it, and some of the ways in which Congress could address the perceived weaknesses in future legislative amendments.  Afterward, they answered questions from the audience.

The event was a terrific success.  For readers unable to attend, more information about CHF, its oral history project, and the video recording are available here.

Senate Subcommittee Holds Hearing on TSCA Reform

TSCA Reform:

On Thursday, February 3, 2010, the Senate Committee on Environment and Public Works, Subcommittee on Superfund, Toxics, and Environmental Health held a hearing titled “Assessing the Effectiveness of U.S. Chemical Safety Laws.”  Although the hearing’s title suggests that a broader discussion of US chemical control laws occurred, reforming the federal TSCA statute was the primary focus.  Representatives from industry, academia, the environmental community, and EPA testified on two different panels, and all witnesses supported TSCA reform.  The level of interest in the hearing seems to have surprised Subcommittee staff – the chamber was completely full, and with no room made available for overflow, the hall outside remained crowded for nearly the entire hearing. 

Readers will recall that the Subcommittee Chair, Senator Frank Lautenberg (D-NJ), introduced a bill last year – the “Safe Chemicals Act of 2010” – that would have substantially revised TSCA.   Thursday’s hearing undoubtedly served to demonstrate the importance that Senator Lautenberg places on revising TSCA and his commitment to maintaining active debate on the topic.  Whether his commitment will enable the parties in both houses to reach consensus and pass legislation in 2011, or even 2012, remains to be seen.  There are plenty of reasons for skepticism; however, passage of a revised TSCA is likely to occur in the next few years. 

Senator Lautenberg began the hearing with a review of the testimony the Subcommittee received during the 111th Congress.  Other Subcommittee members, including Senator James Inhofe (R-Okla.) and Senator David Vitter (R-LA) also provided statements. 

In his statement, Senator Inhofe expressed hope that the parties could “reach an agreement to develop a workable bill, one based on the best available science, one that protects human health, and one that balances the need to protect jobs and economic growth.”  Senator Inhofe alluded to concerns in the House of Representatives about the potential impact on jobs and innovation that might result from a revised TSCA statute, concerns that could very well make passage of a revised statute difficult while fears of a double-dip recession still linger.  He also stated that modernization of TSCA should (1) be based on the best available science, (2) use a risk-based standard for chemical reviews, (3) include more rigorous cost-benefit requirements, (4) protect proprietary information, (5) reduce the likelihood of litigation, (6) avoid compelling product substitution, and (7) prioritize reviews for existing chemicals.

Senator Vitter offered six broad principles for the upcoming debate: (1) the need for EPA to update the TSCA Inventory to remove those chemicals which are no longer in commerce, which he estimated to be nearly three-quarters of the approximately 80,000 currently listed, (2) the unacceptability of adopting a program modeled after the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation since it would threaten innovation and US competitiveness, (3) the mistake of prematurely assuming REACH will become the global standard for chemicals regulation, (4) the need for any scientific studies to be repeatable when used by EPA to restrict or prohibit use of a chemical, (5) the need for peer review processes to be truly independent; and (6) the need for sound science, and not media attention, to provide the basis for any EPA decision to re-review a chemical prior to an established schedule. 

A total of six witnesses testified on the two panels, with EPA testifying exclusively on the first.  Again, all witnesses supported reforming or “modernizing” the TSCA statute.  They included:

  • The Honorable Steve Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA;
  • Ms. Kelly M. Semrau, Senior Vice President for Global Corporate Affairs, Communication, and Sustainability, S.C. Johnson & Son, Inc.;
  • Mr. Steven J. Goldberg, Vice President and Associate General Counsel, BASF Corporation;
  • Ms. Frances Beinecke, President, Natural Resources Defense Council (NRDC);
  • Mr. Cal Dooley, President, American Chemistry Council (ACC); and
  • Dr. Lynn Goldman, MD, MPH, Dean, George Washington University School of Public Health and Health Services.

Mr. Owens summarized the Obama Administration’s principles for TSCA reform, first articulated in 2009.   In response to questions, Mr. Owens also expressed concern about the potential over-use of claims of confidentiality – i.e., confidential business information (CBI) – to protect the identity of chemicals listed on the TSCA Inventory.  According to Mr. Owens, approximately 17,ooo of the 84,000 listed chemicals have their identities claimed as CBI, affecting the ability to study and understand their potential effects. 

Ms. Semrau testified that S.C. Johnson supports the modernization of TSCA, but stressed the need to protect product innovation. She observed that although S.C. Johnson evaluates all chemicals used in its products, data gaps remain and revising TSCA would provide an opportunity to examine where data gaps occur and how they could be filled. She also expressed the company’s concern about chemicals being regulated on a state-by-state basis, noting the potential for the states to adopt different, and potentially conflicting, chemical management requirements.

Mr. Goldberg emphasized the need for Congress to act, so that chemicals are managed at the federal level rather than on a state-by-state basis. He noted that American Chemistry Council, the Consumer Specialty Products Association, and the American Cleaning Institute have circulated principles for TSCA modernization, which BASF supports. Interestingly, he also stated that he believed, after reviewing the principles articulated by the various stakeholders, that industry and the environmental community had more in common than is often assumed. 

Ms. Beinecke expressed appreciation for the Subcommittee’s decision to convene a hearing on TSCA reform early in the 112th Congress. She, like the other witnesses, noted that the states are adopting their own chemical regulations due to federal inaction. She observed that, in the last eight years, 18 states have adopted 71 measures concerning controls on the use of specific chemicals or classes of chemicals, and that some have adopted broader reform initiatives, most of which received strong bipartisan support.  She also noted that legislators in more than 30 states introduced or announced plans to introduce chemical control legislation this year, and that various industrialized countries around the globe are also undertaking efforts to reform or adopt chemical management programs.

Mr. Dooley agreed on the need for TSCA modernization.  He urged Congressional action so that the U.S. would remain competitive globally, seemingly anticipating objections that may come from some in the House of Representatives.  He also urged action to discourage states from passing their own laws. Mr. Dooley stated that ACC and a broad coalition of its “value chain partners” are calling for “good TSCA modernization.” According to Mr. Dooley, a revised TSCA should require scientific objectivity, prioritize to identify data needs, and use a risk-based safety standard that considers a chemical’s use when taking regulatory actions.

Dr. Goldman, a former Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) — currently called the Office of Chemical Safety and Pollution Prevention — reviewed a paper recently prepared by an American Bar Association Section of Environment, Energy, and Resources Special Committee on TSCA Reform.  The Special Committee includes a bipartisan group of former EPA officials.  According to Dr. Goldman, the officials agreed on several points, including: (1) the necessity of a practical approach to amending TSCA because of the need for a flexible and a prioritized system to regulate chemicals, (2) the limited organizational capacity and resources currently available to EPA’s TSCA program, (3) the understanding that all chemicals are not created equal and therefore TSCA modernization should not become a “numbers game” where EPA is required to review a certain number of chemicals each year instead of first determining priorities for regulatory attention, (4) the need to preserve, but strengthen, much of the current chemical management system, (5) the availability and usefulness of other regulatory systems, in addition to REACH, that should be evaluated and potentially have elements incorporated into a revised TSCA, and (6) the need for Congress not to legislate how EPA should do the science since it can evolve quickly.

Whether Senator Lautenberg’s enthusiasm for reform will enable him to achieve a bipartisan and bicameral consensus remains to be seen.  Certainly, the calls for reforming TSCA are increasing among the various stakeholders.  However, as noted elsewhere, economic considerations are certain to affect the extent of any near-term progress.  Those considerations will influence not only the Congressional resources devoted to TSCA reform, but also the details of any legislative proposals.

TSCA Reform Likely to Be a Lower Priority in 2011

TSCA Reform:

Chemical and Engineering News reports that representatives from several major US trade associations have stated publicly that they don’t expect modernization of the federal Toxic Substances Control Act (TSCA) to be a high priority for Congress in early 2011. Their statements are not surprising.  With fears of a double-dip recession still lingering, passage of a substantially revised TSCA seems unlikely in 2011, but with continued industry support, an improved economy, and a little bipartisan cooperation, it might occur in 2012.  (Assuming, of course, that the election doesn’t get in the way.  A big “if.”)

The Republican party controls the House of Representatives and it’s clearly stated its intentions.  Among other things, Republicans are determined to reduce the impacts on the deficit, national debt, and jobs that are associated with government regulation, including some forms of environmental regulation.  Adopting a more robust chemical control statute would likely require a substantial increase in EPA’s budget and it could have a significant ripple effect throughout the economy as downstream companies that don’t manufacture, but “process,” chemicals faced new requirements.  Also, at least some chemical manufacturers would need to generate expensive new health and environmental data.  And finally, there’s the risk that a new program could stifle innovation and affect the global competitiveness of the United States.

Notwithstanding support for reform coming from the American Chemistry Council (ACC), a trade association comprised primarily of chemical manufacturers, economic concerns – real or stated – could prove dissuasive in 2011 to a majority of Republicans in the House.  The Democratically-controlled Senate may be more inclined towards major near-term reform, but in the absence of sufficient support in the House, and with any Senate proposal likely less palatable to the chemical industry, such a goal seems unattainable.  At a minimum, the delay will give key members of the 112th Congress time to try to reach consensus on important points in the reform debate.

So, what will 2011 look like?  Unless there’s another crisis, such as tainted imported consumer products or an oil spill requiring the use of chemicals for which little safety information is publicly available, readers will probably see limited progress through 2011.  Closed-door meetings are certain to occur, a few hearings will take place and a bill may be introduced in the Senate – a bill may even be introduced in the House – but proposals are unlikely to advance significantly in the near-term.  Economic considerations will affect both the resources committed to the TSCA reform debate, as well as the details of any legislative proposals.  Efforts occurring in 2011 will be undertaken in the name of trying to adopt “sensible” reform that protects the environment and health without damaging the economy. 

With the Administration already taking steps to reconcile past differences with business leaders in preparation for the 2012 election, it seems unlikely that the White House will push for robust new legislation either.  So, don’t look for major legislative proposals coming from EPA anytime soon.  However, expect the ACC and others to try to persuade the Administration that TSCA Reform is a potential opportunity for bipartisanship. 

But what about the public’s and the states’ outcry for a more robust federal chemical regulatory program?  And what about the consensus among the chemicals industry, EPA, and environmental groups on the need for reform?  The outcry and the consensus are important and should not be dismissed for ultimately they will help ensure passage of a revised TSCA.  However, for the next year (and possibly longer), jobs creation, debt reduction, election politics, and efforts to reach consensus, are likely to delay reform.  In the interim, EPA will probably continue with its attempts to use existing authority to address chemical risks, despite promises of increasing Congressional oversight.  

House of Representatives Introduces Bill to Modernize TSCA

TSCA Reform:

On July 22, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (“TCSA,” confusingly similar to the acronym of the current statute).  The bill is intended to modernize the current Toxic Substances Control Act (“TSCA”).  The introduced bill is different in many respects from the discussion draft the Representatives circulated back in April.  In some instances the introduced bill is better and in others it is worse.   A short summary of the bill, provided by the House Committee on Energy and Commerce, is set out below.   A more detailed analysis will be available in a future posting on the Green Chemistry Law Report.

According to the House Committee, the bill would:

  • Establish a framework to ensure that all chemical substances to which the American people are exposed will be reviewed for safety and restricted where necessary to protect public health and the environment;
  • Require the chemical industry to develop and provide to the U.S. Environmental Protection Agency (EPA) essential data, and improve EPA’s authority to compel testing where necessary;
  • Ensure that non-confidential information submitted to EPA is shared with the public and that critical confidential information is shared among regulators, with states, and with workers in the chemical industry;
  • Establish an expedited process for EPA to reduce exposure to chemical substances that are known to be persistent, bioaccumulative, and toxic;
  • Create incentives and a review process for safer alternatives to existing chemicals, promoting innovation and investment in green chemistry;
  • Create a workforce education and training program in green chemistry, promoting and ensuring long-term viability of American jobs;
  • Encourage the reduction of the use of animals in chemical testing;
  • Allow EPA to exempt chemicals already known to be safe from requirements of the TCSA;
  • Promote research to advance understanding of children’s vulnerability to the harms of chemicals;
  • Direct EPA to address community exposures to toxic chemicals in certain “hot spot” locations;
  • Require EPA to engage in international efforts to control dangerous chemicals;
  • Ensure that EPA actions are transparent, open to public comment, and subject to judicial review, without unreasonable procedural burdens; and
  • Give EPA the resources needed to carry out the TCSA.

Key documents, including a copy of the bill, are available here.

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. 

* * * *

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.

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.


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.

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: