27 February 2014 11:15 [Source: ICB]
After many years of waiting and wrangling, a consensus is emerging on reform of the long-standing TSCA chemicals safety legislation. But there are still issues of detail to be resolved to keep industry and politicians happy
Most of the time, development of new legislation moves at a snail’s pace, but there are occasionally periods when rapid forward movement is achieved. This seems to be the case now with US efforts to modernise the Toxic Substances Control Act (TSCA).
The Chemical Safety Improvement Act (CSIA, S.1009) introduced by Senator David Vitter (R-LA) and the late Frank Lautenberg (D-NJ) on 22 May 2013 was a turning point. The House Energy and Commerce (EC) Committee followed up with five hearings on TSCA reform, including one on the Senate bill.
Lautenberg (left) and Vitter: their bipartisan initiative gives TSCA reform a fighting chance
Copyright: US Senate
The chemical industry has been pushing for modernisation of TSCA since 2008, but most legislative efforts were, until recently, seen by SOCMA, the ACC and other industry groups as too costly, stifling innovation and reducing the competitiveness of US companies. CSIA addresses the areas where modernisation of existing TSCA legislation is most needed, but does so in a more efficient and effective way.
This latest bill is, to some degree, according to Mark Duvall, a principal with Beveridge & Diamond, a significantly shortened version of the Safe Chemicals Act, an earlier bill introduced by Senator Lautenberg that was not well-received. “Based on the testimony of numerous stakeholders at the last House hearing in 2013, it appears that there is general agreement about CSIA: although there are problems with it, they are solvable, and if TSCA reform is going to take place, the CSIA is the bill of choice,” observes Duvall.
So what drove this change in TSCA reform in the span of a year? The support of Senator Vitter and the more reasonable and practical nature of CSIA were clearly important. “In addition,” says Bill Allmond, vice president of government and public relations at SOCMA, “heightened education about the benefits of reforming TSCA has led to much more widespread support for TSCA modernisation. People are finally recognising that this important law is over 30 years old and has yet to be revised or updated in any significant way.”
Mike Walls, vice president of regulatory and technical affairs with ACC, adds that the introduction and subsequent growing interest and support for CSIA reflects a major change in the understanding of the impacts of TSCA. “With this change in perspective, we believe that for the first time in more than 20 years, there is the significant potential for revision of a major federal environmental statute.”
CSIA has been under review for several months by the Senate Environment and Public Works (EPW) Committee, chaired by Senator Barbara Boxer (D-CA). Senator Vitter and Senator Tom Udall (D-NM) (who has played an important leadership role since Senator Lautenberg’s death) have also been considering suggestions for some changes to CSIA from industry, NGOs, the US Environmental Protection Agency (EPA), and other stakeholders.
Congressman John Shimkus (R-IL) is working on a House bill that is thought will be similar to CSIA. Shimkus is chairman of the House Subcommittee on Environment and the Economy that has jurisdiction over TSCA.
Walls is hopeful that a House bill can be introduced early in 2014, and expects that it will have strong bipartisan support as well. Shimkus’ subcommittee hosted a TSCA reform hearing on 4 February.
The timing of a vote on the Senate bill will depend on the Senate calendar. “Because 2014 is an election year, there are a limited number of legislative dates, and once the campaign season begins, the likelihood of a bill passing is significantly reduced,” Duvall notes. Allmond agrees that if some action is not taken by the end of the first half of the year, it will be difficult to get a bill through both chambers and to the president for signing before the end of the year. “It will be unfortunate if the clock runs out this year before a bill is approved.”
There are, however, areas of disagreement that must also be addressed before CSIA could pass. Pre-emption of state regulations by the amended TSCA programme is perhaps the biggest issue. It is not surprising that Senator Boxer, whose state legislature recently adopted the California Safer Consumer Products regulation (see page 17), is not in favour of the pre-emption clause.
Some in industry, on the other hand, do not feel that the pre-emption protections presently included in CSIA are strong enough. Even so, Duvall feels that if the other areas of contention can be resolved, then there is a good chance that the pre-emption issue can be resolved as the last step in the process.
Those other areas of contention include the safety standard; prioritisation, safety assessment and safety determination processes; and confidential business information (CBI). The CSIA safety standard differs from the current TSCA one in that it is based only on risks to human health and the environment. Only in applying risk management measures to control the risks would EPA consider cost and benefit.
For SOCMA, one of the key issues is ensuring that the modernised version of TSCA facilitates innovation. “Protection of confidential business information (CBI) is crucial for innovation and of paramount importance to our members. We would also like to see the EPA’s new chemicals programme basically left unchanged,” says Dan Newton, SOCMA’s senior manager of government relations.
“We also want to avoid redundancy. There are some sections of the exiting TSCA legislation that are effective and working well, and we would like to see them carried over in the modernised version,” he adds.
RESOURCES AND PRIORITIES
Another area that ACC is concerned about is the availability of resources for EPA to efficiently and effectively implement a modernised version of TSCA, according to Walls. Duvall notes that user fees have been mentioned but have not been well fleshed out yet.
In the meantime, ACC is looking to the day when CSIA is passed and how it might affect programmes such as EPA’s workplan chemicals effort, according to Sarah H Brozena, senior director in ACC’s Regulatory and Technical Affairs Department. ACC sees the workplan chemical assessments as a great test case for what a revised TSCA might look like and how it might be implemented.
“We support EPA’s efforts to prioritise chemicals for risk assessment, and particularly the agency’s focus on particular use scenarios. Based on the first five assessments that have been completed, however, we still see room for improvement,” states Christina Franz, senior director in ACC’s Regulatory and Technical Affairs Department. “There is general consensus among the peer reviewers that more explanations of the prioritisation method and screening approach and the use of realistic exposure data are needed,” she explains.
SOCMA’s Newton adds that although there are issues with the programme, it is important that EPA be required to review existing chemicals, which is an issue that may be addressed in the new TSCA legislation.
ACC is also focused on addressing TSCA regulatory developments in 2014. These issues include EPA’s effort to declassify any unnecessary claims for confidential business information (CBI), preparation for the 2016 Chemical Data Reporting (CDR) requirements, and collaborations with other industry and EPA to address concerns related to the testing of challenging substances for premanufacture notifications (PMNs) and the unintended adverse impacts of significant new use rules (SNURS).
With respect to CBI, EPA previously identified nearly 22,500 cases that it believed included incorrect CBI claims. ACC and its member companies began working with EPA on these cases in 2010. As of March 2013, slightly more than 16,000 were completed, and of those, just over 12,000 did not even contain any CBI claims at all. Franz expects that a majority of the remaining 7,000 cases to be reviewed in 2014 will likely not have any CBI claims either.
ACC is also hopeful that the recent information the association provided to EPA regarding lessons learned during the 2012 Chemical Data Reporting process will be utilised by the agency to improve the CDR for 2016. “We are gratified that EPA has agreed to meet with us to discuss the issues we raised, and we have been pleased with the communications we have had with the agency regarding the CDR, Franz observes.
Along with several other associations, including SOCMA and the North American section of the International Fragrance Association, ACC has also been collaborating with EPA to develop a workshop on how to handle difficult-to-test substances when companies submit a Premanufacture Notice (PMN). “It can be very difficult for industry and the agency to manage these compounds through the PMN programme, and we believe that this workshop will help explore how to adapt current test methods beyond typical or standard approaches,” says Franz.
The same coalition of industry trade groups is also working with EPA on a project that is seeking to mitigate the potential adverse impact of SNURs. Often when a PMN is approved for a specific use and EPA places a SNUR on the chemical for an alternate use, the result is increased requirements for reporting and record-keeping by the users of that product.
“Many times, we see that downstream users therefore elect to find alternatives to products with SNURS in order to avoid this added administrative burden. As a result, approved products are put at a significant disadvantage in the marketplace unnecessarily,” Franz asserts. She is optimistic that the group will find a viable solution for shifting these reporting and record-keeping requirements away from the end-users to the manufacturers and importers of the products.
US-EU TRADE TALKS
In addition, Allmond believes the free-trade agreement being hammered out between the US and the EU – the Trans-Atlantic Trade and Investment Partnership (TTIP) – may have some impact on regulatory issues. “There are some regulatory barriers SOCMA has identified that need to be addressed between the US and EU,” with the most significant being the EU’s Registration, evaluation, authorisation and restriction of chemicals (Reach) programme, which is particularly onerous for US specialty chemical manufacturers.”
He also notes that Reach and TSCA are based on two very different philosophical approaches to legislation. Therefore, he does not expect the trade agreement will lead to any real changes in either legislation, but it remains to be seen what will come of the negotiations.
Congressional action on TSCA is likely to dominate the agenda for 2014. Both SOCMA and ACC are waiting to see what the Senate and House Committees will do on TSCA modernisation bills. “Senators Vitter and Udall and the House Subcommittee leadership are very active and engaged in developing a bill that can be passed into law, and we remain optimistic about Congress enacting TSCA reform this year,” asserts Walls.
Duvall notes that, because the elections this year are not expected to lead to any significant changes in the House or Senate, with the former remaining Republican and the latter Democratic, there is no reason to wait for the new composition of either chamber.
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