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Will TSCA Sink or Swim?

Date: Feb 17, 2009

During Hill discussions on priorities for the coming year, the comment was reportedly made that TSCA is a "broken statute" and needs to be rewritten from the ground up. The perception of TSCA as a broken statute is likely to fuel the desire of key Members of Congress in leadership positions to enact their idea of a "fix". Despite pressing priorities regarding the stimulus package, healthcare reform and climate change, TSCA seems firmly on the radar screen for Congress to address in the next two to four years.

Will there be a revised TSCA or an entirely new chemicals management approach? Given that the statute was originally enacted in 1979 and has not substantially changed, one could conclude that we have a tried and tested method that permits effective responses to change, and that the statute simply requires some updating. Others see the length of time without a shift in approach as a fundamental flaw and think that change is overdue.

With Senator Lautenberg (D-NJ) now firmly in charge of the subcommittee with oversight of TSCA, elements of the Kid Safe Chemical Act (KSCA) remain in play as the 111th Congress gets underway. As one of the leaders behind the original version of the KSCA introduced in 2005, he reintroduced the bill as S.3040 in 2008 and is expected to do so again. The Senate Committee on Environment and Public works, which Senator Boxer (D-Ca.) chairs and on which Senator Lautenberg continues to serve, indicates that they may hold hearings on TSCA reform as early as this spring.

Last year in the House, KSCA (H.R. 6100) was introduced by Hilda Solis (D-CA) and Henry Waxman (D-CA). Congresswoman Solis has been tapped by President Obama to be his Secretary of Labor. This does not signal any let up from the House-side, however, as Congressman Waxman has taken over the chair of the House Committee on Energy and Commerce, previously held by Congressman John Dingell (D-MI). Both Congressman Waxman and Congressman Dingell were serving in Congress when TSCA was enacted, and are likely to have major roles in its reform.

It is safe to say that the 2008 version of KSCA was in the camp of an entirely new approach to US chemical management, in calling upon industry to either defend the continued use of its products or lose the legal ability to sell them. It would have added a Title V to the Act "to reduce the exposure of children, workers, and consumers to toxic chemical substances" by 2020. The KSCA would have required each manufacturer of a chemical substance to certify to EPA within one year of enactment whether it had sufficient information to determine that its substance met a safety standard of "reasonable certainty" that aggregate exposure to the chemical will present not more than a 1-in-1,000,000 risk of adverse effects in the population of concern, and, to account for potential vulnerability associated with in-utero, infant, or childhood exposure, an additional 10-fold safety factor for chemicals with threshold effects. Within 5 years, the TSCA Inventory would have categorized substances in U.S. commerce based on whether they met certain criteria (e.g., production >1 million lbs/year, detection in humans or various media, toxicity, persistence, bioaccumulation. Within 18 months, EPA would have had to publish a "priority list" of at least 300 substances for making safety determinations (and add at least 200 substances annually. These are just some of the initiatives that provide a flavor of the KSCA approach.

From industry's perspective, KSCA was and is a non-starter. Its likely re-emergence will need to be viewed in perspective with other reform proposals that we are certain to see introduced. There are many issues competing for the attention and resources of Congress, but given the pent-up demand for reform along the lines of EU REACH and the Canadian prioritization program, there likely will be considerable debate on the need to find a workable alternative to the current TSCA program.

Initially, consideration is needed on establishing the policy objectives that will frame the reform. The objectives must be distilled into conceptual phrases, not paragraphs. Bearing in mind that the affected scope of this exercise involves 80,000 chemical substances, it is imperative to establish objectives that help to focus reform efforts on only those aspects of TSCA that need fixing. Historically, TSCA was enacted as a "gap filler" statute. Clearly articulating the perceived gaps of today, together with science-based initiatives that refine the current "production level" approach for prioritizing agency resources, will improve the prospect for meaningful results.

For example, imposing substantial base set data requirements on new and emerging chemistries would make many promising innovations dead in the water, if we make the cost of testing too substantial to undertake without the revenue to support it. We think the Environmental Protection Agency's (EPA's) screening program for new chemistries has been effective to a surprising degree. When US regulatory outcomes have been compared with EU results, the parity in results has been strikingly similar. Bear in mind as well that the screening is supplemented by a requirement already in the law that available data (such as that generated under regulatory schemes elsewhere) must be submitted to EPA. For new chemicals, instead of "no data, no market", consideration should be given to a "no market, no data" approach.

To fix the current TSCA "new chemical review bias" and moderate the REACH concept of substitution, acceptable objectives may include a "new chemicals trust", "recognizing risk", "greening the market", "benign by design", and/or "pollution prevention." Fundamentally, we will see whether the U.S. track record based on the use of a "sound science" approach is enough to sustain it in the face of predicable attempts to insert a "precautionary principle" or "hazard-based" approach into reform legislation. From the outset, we need to think about how reform objectives can be used to pair the dual goals of promoting "U.S. chemical know-how" and chemical "right-to-know".

We anticipate that the legal standard of review and who bears the burden of proof for approving the continued use of chemical substances in commerce will be a pivotal aspect of reform. Currently, for new chemicals, EPA can restrict a chemical's production or use if the agency determines that insufficient information exists to permit a reasoned evaluation of the health and environmental effects of the chemical and that, in the absence of such information, the chemical may present an unreasonable risk. The "may present" finding is a low regulatory threshold; it is a predominately hazard-based approach based on lack of information or the potential for significant exposure. The burden then shifts to industry to supply sufficient information for a science-based evaluation in order for there to be a possibility for those restrictions to be lifted.

At the other end of the spectrum, for existing chemicals, EPA may regulate a chemical for which it finds a reasonable basis exists to conclude that it presents or will present an unreasonable risk. Further, TSCA requires EPA to choose the regulatory action that is least burdensome in mitigating the unreasonable risk. Historically, EPA has found it difficult to promulgate rules under this standard that restrict current uses of existing chemicals in whole or in part, and it is this aspect of TSCA that has been the lightening rod of criticism. A legal review standard that provides absolute assurance that a chemical is used safely is an unrealistic goal in a litigious society that is not practically possible to achieve. Yet, it may still be quite difficult to explain to Congress and the American public how they can find comfort with a standard that guarantees less. The role, if any, for the principle of cost/benefit analysis in environmental policy for chemicals management has yet to be fully explored. Further adding to the complex legal challenges ahead is the prospect of a state preemption debate and the need to balance the 11th amendment in relation to the turmoil that could result from Commerce Clause challenges to, for example, any emerging plethora of regional product bans.

While the NGO voice on TSCA reform is, for the moment, underwhelming, their presence is felt. For one thing, they will continue to assert that TSCA doesn't properly cover consumer products. All indications from the recently enacted changes in consumer product laws are that we could see proposed items such as Attorney General enforcement, increased consumer product labeling associated with the chemicals they contain, green claims provisos, and environmental effects hazard classification and labeling. Other perceived gaps include provisions to require the US to join the international Stockholm, Rotterdam, and LURTAP/POPS Conventions. New initiatives, such as the SIN list, GHS pushback to confidential business information protection, and promotion of the National Academy's 21st century test data criteria are other candidate areas for TSCA reform. With the heavy California influence amongst the legislators involved, the prospect of California's green chemistry initiatives emerging center stage can't be discounted.

Amidst the mix of highly complex, substantive policy concerns, procedural matters that should not be lost from sight are the need to build in a reasonable transition period for new reform programs and to recognize that the cost responsibility associated with carrying out a reform package likely involves more than doubling the current staffing and funding levels for EPA's program.

Examining other factors that may influence the pace at which reform proceeds, the continued discussion over the adequacy of environmental health and safety resources devoted to nanotechnology may be the tail that wags the dog. At a minimum, it is yet another possible free rider. Currently, there are two nano-EHS bills pending in Congress that provide a glimpse of what could be in store in this regard. H.R.554 would authorize activities for support of nanotechnology research and development and is sponsored by Rep. Gordon (D-TN). H.R.820 would ensure the development and responsible stewardship of nanotechnology and is sponsored by Rep. Honda (D-CA). See http://thomas.loc.gov/cgi-bin/thomas. Other factors that may increase reform momentum are signs of mounting demand for a green vote, alone or in combination with any deadlock that develops on climate change legislation.

It is safe to say that, once introduced, a 2009 TSCA reform vehicle will already enjoy better traction than its predecessors. The approach taken will reflect Congressman Waxman's formula for environmental legislation: multiple deadlines and specific lists mixed with numerous technology-forcing initiatives. Only time will tell, however, whether we succumb to the pressure to be REACH-like – or reach back in time for a Boston Tea Party approach to chemical reform.