22 February 2013 10:30 [Source: ICB]
While it has been slow, progress on the development of legislation to modernise the Toxic Substances Control Act (TSCA) has been achieved in the past several years. Many stakeholders are hopeful that 2013 will be the year when measurable forward movement on this issue occurs.
When dealing with TSCA modernisation, it is important to maintain perspective, according to Mark Duvall, a principal with law firm Beveridge & Diamond. "It took six years to get the first TSCA legislation passed by Congress in 1976, so it is no surprise that efforts to update the programme are taking multiple years as well," he says.
Since the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA) began pushing for the idea of TSCA modernisation in 2008, a lot has been accomplished: the basic issues have been identified, different approaches have been discussed with the various stakeholders, and members of Congress have been educated about the issues. "As a result, the overall understanding of the problems and possibilities related to TSCA modernisation has increased dramatically," Duvall notes.
CHEMISTRY DRIVES US ECONOMY
Both the ACC and SOCMA strongly support modernisation of the 37-year-old TSCA law. ACC established its 10 Principles for Modernising TSCA in 2009. It is committed to developing a new national chemical management system that has protection of the public health as its highest priority and includes strict government oversight, but does so in a way that continues to encourage the innovative strength of the business of chemistry.
"Chemistry is the engine that drives the US economy," states Mike Walls, vice president of regulatory and technical affairs for ACC. "We need a chemical management system that allows chemical manufacturers and users to leverage the benefits of chemistry and be globally competitive, but at the same time enhances public confidence in our regulatory process and our ability to safely use chemicals and protect the public and the environment."
The trade group's president and CEO Cal Dooley also underscores that a balanced, science-based approach that is efficient, transparent and focuses on chemicals of the highest concern and their intended uses is critical for a successful and effective modern TSCA.
SOCMA wants Congress to take a pragmatic approach to TSCA modernisation, including resetting the TSCA inventory to reflect the chemicals actually in commerce, prioritising the inventory based on risk (determined by a consideration of both hazard and exposure) and leveraging existing programs that have been effective, while learning from those that have not been successful.
"TSCA modernisation is clearly needed, but the end result must be a workable solution, and not one that is overreaching and involves an unachievable regulatory framework," says Bill Allmond, SOCMA's vice president of government and public relations. "It is also critical that a 'one-size-fits-all' approach be avoided, because it could devastate small to medium-sized companies that are already dealing with very challenging economic conditions.
"There has been a lot of public attention paid to the safety of chemicals recently, and it is time that TSCA be updated to address the concerns being raised," he adds. "SOCMA believes that the safety of chemicals is important and must always remain a shared responsibility between industry and government. To address the shortcomings of the existing legislation, carefully tailored enhancements to TSCA that focus on areas where various stakeholders can reach a compromise and lead to real improvements in our chemical management system should be the goal."
Achieving compromise has been and will continue to be a major challenge to TSCA modernisation. The only bill introduced in the 112th Congress, which recently ended, was Democratic Senator for New Jersey Frank Lautenberg's Safe Chemicals Act of 2011, which was approved in July 2012 by the Senate Environment and Public Works (EPW) Committee in a straight party-line vote.
The bill did not have the support of industry or Republicans, and has therefore died at the end of that Congress. SOCMA believes that such sweeping reform of TSCA is not possible given the partisan nature of Congress, and any comprehensive approach will fail.
However, Duvall believes it is important to recognise that the bill introduced in 2012 was significantly different to those first introduced in 2010, and that some industry concerns were considered. ACC's Walls also notes that the EPW approval of the Safe Chemicals Act was a high-water mark for that proposal, and now the door has been opened for development of legislation that can get some bipartisan support.
BIPARTISAN SUPPORT NEEDED
"All parties acknowledge that bipartisan support is necessary if movement on TSCA modernisation is to be achieved," Walls says. "Everyone also agrees that there is a real need to modify TSCA in order to regain public confidence in our chemical regulatory system. Therefore, we at ACC believe that we are at an important crossroads on TSCA reform."
While Senator Lautenberg is expected to reintroduce the Safe Chemicals Act in 2013, an anticipated bill from Senate Republicans under the leadership of Republican Senator for Louisiana David Vitter, who also sits on the EPW Committee, is the basis for hope for meaningful discussions on TSCA reform.
"We don't know when the new bill will be introduced, but Senator Vitter has publicly committed to developing a proposal, and we expect that it will be a more reasonable approach that can gain bipartisan support," Allmond says.
Duvall adds: "For the first time, we will have the opportunity to see contrasting legislative language and offer constructive criticism, which is the basis on which real progress can be made."
According to Walls, ACC is also anticipating intense discussions that may lead to a bill with bipartisan support that can get out of committee and through the Senate. Duvall believes that, while it is unlikely that any legislation would actually pass the Senate in 2013, particularly given other major issues that Washington must tackle in the first several months of the year, it is conceivable.
OPPORTUNITY FOR DEBATE
"We definitely want to be hopeful about 2013," Allmond says. "We have a good opportunity for good debate. Most importantly, we would like to see both the Democrats and Republicans working together on areas of TSCA where there is common ground and solutions can be developed that are workable for everyone."
In fact, there are several specific areas of the current TSCA legislation that SOCMA would like to see amended. In particular, Allmond points to Section 4 - on existing chemicals - as one of the shortcomings of TSCA. "We would like to see a modernised TSCA that uses a risk-based approach to reviewing chemicals," he says. "The way Canada has effectively and openly reviewed its chemical inventory is a good example of what can be done."
ACC's Walls also emphasises the importance of effectively prioritising chemicals in commerce for review using existing data wherever possible, and having rational rules for generating new data. "With such an approach, we have the opportunity to develop a meaningful standard that works to protect health and the environment, as well as commercial interests, so that everyone can benefit from chemistry," he remarks.
Section 6, which deals with the restriction of chemicals, can also be improved, according to Allmond. "The current law places excessive burdens on EPA [the US Environmental Protection Agency], and this section is in great need of streamlining," he notes.
With regard to the collection of exposure information (Section 8), however, SOCMA would like to see requirements for the EPA expanded. Currently, the EPA only has to gather exposure information from manufacturers and processors, while the association believes that downstream users have a much larger and more valuable dataset, because they are actually using the chemicals.
Finally, both SOCMA and ACC believe that confidential business information (CBI) should be addressed. In the past, industry has tended to over-claim CBI, and the EPA did not exercise its authority to challenge claims it deemed inappropriate. To avoid this issue in the future, both associations support requirements for upfront substantiation of the need for CBI claims and clear guidance on how to effectively derive generic names.
"The chemical industry is an innovation-driven industry, and we need strong CBI rules to protect proprietary information such as critical chemical substance identities, while still providing transparency when it comes to safety and hazard information," says Walls.
Other aspects of the management of new chemicals as they exist in the current TSCA Section 5 are effective and enable companies to introduce new products efficiently to the marketplace, according to Allmond. This area should be left, in large part, as is, he says.
ACC would also like to see modernised TSCA legislation that contains rules to protect public health and the environment on a national level. "In the absence of a modernised TSCA, public confidence in the EPA's ability to regulate chemicals has been eroded," says Walls.
"Activists have exploited that diminished public confidence in TSCA to pressure retailers to pull products from the shelves and state legislatures to restrict the sale of certain products or create their own chemical management systems, despite a lack of scientific evidence or expertise.
"As a result, compliance with so many disparate and questionable requirements has become very challenging and very costly for our members," he adds. "We have a national economy, and we need a national, modern TSCA with a strong federal pre-emption that prevents the implementation of potentially conflicting and duplicative state regulations."
It should be noted that ACC and SOCMA are far from being alone in their efforts to achieve TSCA modernisation. More than 100 trade associations are working together in the American Alliance for Innovation to advocate for effective and practical TSCA modernisation.
Leaders of individual companies are also speaking out about the need for improvements to the current national chemical management system. For example, Beth Bosley, president of SOCMA member company Boron Specialties, has testified before both the House of Representatives and Senate on many issues related to TSCA modernisation. "We would like to see improvements to legislation that make TSCA more workable for the EPA," she says. "The agency has real difficulties implementing certain sections of the law, and these issues should be addressed. On the other hand, certain areas work very well - such as Section 5 on new chemicals - and we don't believe that substantive changes to those sections are either practical or necessary."
She adds that TSCA is currently not well funded, and that unless this issue is addressed, a modernised TSCA will still face many challenges. Overall, she has a very good relationship with the EPA and believes that the agency wants to help companies comply with TSCA. As a small business owner, Bosley says she wears multiple hats ranging from overseeing day-to-day operations to managing the company's regulatory obligations.
"I am not afraid to call and ask for help on TSCA issues, whether through the TSCA hotline or a PMN (premanufacture notice) case manager," she says. "I find that EPA is staffed with talented scientists and engineers, and they really do want to help." Bosley also notes that changes to TSCA should avoid disproportionate impact on small businesses, which are often innovation drivers.
She and everyone at SOCMA and ACC are eagerly waiting to see if the new bill from Senator Vitter and other Senate Republicans will tackle some of these important issues, and whether or not it can serve as a foundation for enabling meaningful dialogue and progress on TSCA modernisation in 2013.
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