INSIGHT: US study advises against Reach for TSCA reform

01 March 2012 15:43  [Source: ICIS news]

By Joe Kamalick

WASHINGTON (ICIS)--A US university study of Europe’s Reach programme says that the EU approach to regulating chemicals in commerce is too complex and burdensome, although reform of US chemicals regulation could benefit from lessons learned in Reach.

A new analysis of Reach by public affairs and environmental specialists at Indiana University at Bloomington, Indiana, notes that Reach – the registration, evaluation, authorisation and restriction of chemicals – is still too new to say whether it has produced “measurable improvements in public health or the environment”.

Nor is it yet possible to grasp what the total costs of Reach will be, according to the 60-page study, titled Regulating Industrial Chemicals; Lessons for US lawmakers from the EU Reach program.

“It is nonetheless feasible to assess the workability of the Reach system and brainstorm potential applications to the USA,” said the study’s principal authors, Lois Wise and John Graham of the university’s top-ranked School of Public and Environmental Affairs (SPEA).

The Indiana University study comes as the US Congress has only begun what many expect will be a years-long effort to craft a major reform of the principal US regulatory system for chemicals in commerce, the 36-year-old Toxic Substances Control Act (TSCA).

Environmental proponents of a broadly expanded and tougher TSCA have urged Congress to essentially create a “US Reach” in place of TSCA.

US chemical industry interests have long opposed a Reach-like approach to TSCA reform, with particular dread of Reach’s underlying precautionary principle.

Under the Reach precautionary principle, a chemical product may not enter (or remain in) commerce unless it is proven to be safe. The "no data, no market" rule applies.

In contrast, TSCA is built on a risk-based approach, which considers a substance’s chemical composition, its uses and the potential for human exposure and harm for its prescribed uses.

Environmentalists and many in Congress argue that TSCA has been inadequate to the task, noting that the Environmental Protection Agency (EPA), which enforces TSCA, has only rarely restricted a chemical substance.

US chemical producers generally agree that TSCA is badly in need of a complete overhaul, but they warn policymakers that what they consider a draconian Reach-like approach could choke off the crucial US process industries sector.

The Indiana University study in part agrees with US chemical makers, finding that “Reach is much more complex and burdensome than the programme needs to be to accomplish its objectives”.

In one of its primary findings, the study suggests that US policymakers should be wary of mimicking so complex a system as Reach.

“Reach is quite complex, both in how regulatory power is distributed in the EU governance structure and in the multiplicity of burdens placed on the chemicals industry,” the analysis said.

“Much of this complexity may not be necessary in the US governmental system,” the authors conclude, suggesting that reform of TSCA could end with a structure only half the size of Reach.

The study holds that a reformed TSCA should, like Reach, provide for much more public access to information about chemical products, a goal that both the EPA and US chemical industry leaders have generally endorsed, although producers want to ensure solid protections for proprietary or confidential business information (CBI).

Indeed, a set of industry-favoured TSCA reform principles issued by the American Chemistry Council (ACC) is not widely at variance, according to the council, with a TSCA reform outline published by the EPA.

The Indiana University study also finds Reach overly broad and unfocused, and that a new US TSCA should instead use a priority chemicals approach.

“We suggest that reforms to Reach [should] allow priorities for government and industry attention to be less focused on warehousing of data and more focused on protecting human health and the environment,” the authors said.

“For example, the universe of substances covered by registration could be targeted more effectively… directed more at specific, potential risky uses of substances rather than the substances themselves,” the study advised.

This recommendation is in line with US producers’ call for a risk-based approach that focuses on substances with the greatest likelihood of potentially harmful human exposure.

A reform of TSCA, says the study, should provide “more clarity from the outset in the form of a clear and consistent standard of safety throughout the programme, more specific direction for dispute resolution… and early guidance on how information-technology challenges will be met”. The Indiana University study said that the lack of such clarity in multiple areas of Reach has been the cause of frustration and burdens in the EU.

Lastly, the study urges US policymakers to ensure the maximum use of existing testing and analysis data, including that already produced under Reach. And, as far as is possible, US registration forms under a new TSCA could parallel Reach registrations.

“For example, new formats for data submission in the US would create administrative burdens for companies doing business on both sides of the Atlantic without adding any human health or environmental protection,” the study concludes.

Although a TSCA reform bill has been introduced in Congress, it is widely opposed by industry.

It is generally agreed that it is unlikely that the many congressional committees with jurisdiction in the matter can possibly complete work on one and possibly more TSCA reform bills before the end of 2012, especially given that it is an election year.

No serious and substantive progress toward an overall and comprehensive TSCA reform is expected before 2013, perhaps even later.

However, the Indiana University study may, as its authors hope, “be worthy of consideration by US policymakers”.

Paul Hodges studies key influences shaping the chemical industry in Chemicals and the Economy

By: Joe Kamalick
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