22 April 2010 21:01 [Source: ICIS news]
By Joe Kamalick
In the week since Senator Frank Lautenberg (Democrat-New Jersey) introduced his 169-page "Safe Chemicals Act" to update and expand the 34-year-old Toxic Substances Control Act (TSCA), chemical industry officials have been drilling down into the legislative language, and they’re having deepening concerns.
Even the former long-time head of toxics controls at the Environmental Protection Agency (EPA) said the Lautenberg bill and a parallel measure in the House “pose great risk of putting chains around the
Charles Auer, until 2009 director of the EPA’s Office of Pollution Prevention and Toxics, said the TSCA reform bills as now drafted would have a significant negative impact on innovation in the chemicals industry and beyond.
“This could be a huge hit on the future competitiveness of the
That sentiment is shared by many in the chemicals industry.
“This goes well beyond Reach,” said National Petrochemical & Refiners Association (NPRA) vice president Jim Cooper, who heads the trade group’s petrochemicals wing.
He was referring to the EU’s controversial and still developing programme for the registration, evaluation and authorisation of chemicals (Reach), which the
Lautenberg, chairman of the Senate Subcommittee on Superfund, Toxics and Environmental Health, said his bill “requires safety testing of all industrial chemicals and puts the burden on industry to prove that chemicals are safe in order to stay on the market”.
He said the bill also would give the EPA “more power to regulate the use of dangerous chemicals and require manufacturers to submit information proving the safety of every chemical in production and any new chemical seeking to enter the market”.
The agency also would be given authority under the bill to demand additional information from manufacturers on any chemicals they produced.
All downstream uses of a specific chemical would have to be identified and proven to be safe if a chemical was to remain in commerce and for those new substances that producers wanted to market.
Cooper argues that such an exhaustive requirement to identify and demonstrate the safety of perhaps thousands of downstream uses and applications of chemicals and polymers closely parallels the registration process in Reach.
The Lautenberg bill’s requirement that existing chemicals, new substances and new uses of existing products meet a safety standard of “reasonable certainty of no harm” to human health or the environment more or less parallels the precautionary authorisation criteria of Reach, in the eyes of some.
“The requirement in both the Lautenberg bill and the House discussion draft for declarations [of all downstream uses] by manufacturers and processors of chemicals is Reach registration in all but name,” said Auer.
“In the EU’s Reach, you are required to register chemicals down through the chain of commerce, and each entity has to account for its uses,” Auer said. “The declaration provision has essentially the same effect.”
Mike Walls, vice president for regulatory and technical affairs at the American Chemistry Council (ACC), said he is particularly concerned about the proposed legislation’s requirement for minimum data sets on all existing and new chemicals and “the significant expansion and scope of EPA authority under TSCA, especially that the bills give EPA authority to regulate mixtures and articles containing chemicals”.
Articles can mean any manufactured or assembled end-user product or substance.
“Chemicals touch 96% of all goods manufactured in the
Walls said that the council’s overriding concern about the TSCA reform bills “is their potential impact on innovation”.
The bills would require that any new chemical or new use of an existing chemical be subject to the minimum data set rules and that the manufacturer demonstrate that the safety standard - reasonable certainty of no harm - has been met.
“In our view that would be technically a very difficult standard to meet,” said Walls. “We don’t think that even a new ‘green’ chemical could meet that standard.”
Noting that the proposed legislation also would limit to five years protections given to manufacturers’ confidential business information (CBI) about their chemical products, Walls said the three requirements - minimum data sets, proven safety and limited CBI protections - “effectively puts the brakes on any technical innovation in this industry”.
NPRA’s Cooper shares those concerns, noting that the costs of testing that would be required of new chemicals before a pound is produced for market would sharply alter the business case for many innovative but low-volume products.
“If you raise more and more barriers to innovation, you induce people to go elsewhere, to other countries where the introduction to market is not so painful or costly,” he said.
“If this whole legislative package is passed, it is going to have sway over everything to do with innovation, and it is going to have impact throughout the value chain,” Cooper said.
“The language of the bills, including mixtures and articles within TSCA, gives EPA carte blanche over US manufacturing in general,” Cooper said.
“I really think this is going beyond Reach,” he added.
Perhaps no sector of the
Lawrence Sloan, president and chief executive of the society, also said the bills’ tough requirements for new chemicals would stifle chemistry research and development (R&D) and new products.
Citing the bills’ requirement for detailed minimum data on any new substance before it is produced for market, Sloan noted that “manufacturers do not have definite information regarding volume, specifications, markets or pricing”.
“This would stifle innovation and negatively affect SOCMA members,” he said, “especially given the nature of our sector.”
“Mandatory upfront data on new chemicals could pose a huge problem for our members,” he said.
“Another issue is with new uses of existing chemicals,” he added. “It is unrealistic to think that every single new use can be identified, which is what the bill seems to suggest.”
The definition of uses includes significant changes in production volume, and “this could be impossible to meet, given that it is difficult to track uses down the chain of commerce”.
Sloan also sees major problems with the legislation’s inclusion of mixtures of chemicals as separate products. “This would immensely broaden the scope of TSCA,” he said, because “given the complexities of mixtures, even a slight change could theoretically be a new substance.”
Here too, “implementation could be literally impossible and negatively impact innovation”, he said.
Every industry official commenting on the new TSCA legislation also raised the issue of federal pre-emption of state-level regulation of chemicals in commerce.
“There are no restrictions in the bills against state regulations,” Sloan said. “States will always have the option of going beyond the federal rules and some states will assuredly do more -
“A patchwork of state laws increases the burden of doing business,” he said.
Walls said that executives and staff at the American Chemistry Council are still digging through the detailed language of the 169-page Lautenberg bill, a process complicated by the fact that each provision of the proposed law has to be laid over pertinent provisions in the existing TSCA to tease out the changes.
“We want to be, and it is our intent to be constructively engaged with Congress on this,” Walls said. “But the deeper we dive, the more concerns we have.”
He noted that chemistry and chemicals innovations are essential to advances being made on worldwide issues, including global climate change for example. Chemical and polymers innovations have advanced energy efficiencies, and led to better windmill blades, photovoltaic collectors and the like.
“All of these could be impacted by these bills,” he said.
“We hope we can work to get to a legislative solution that will protect human health and the environment - but also protect the chemicals industry and commerce,” Walls said.
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