EPA to take another run at TSCA CBI claims
20 December 2013 / United States
The US Environmental Protection Agency (EPA) plans to revisit by mid-2014 its efforts to tackle confidential business information (CBI) claims made under the Toxic Substances Control Act (TSCA) by chemical companies for health and safety studies.
Earlier this year, the agency withdrew a proposal that was submitted to the Office of Management and Budget (OMB) two years earlier (CW 9 September 2013).
According to the latest OMB regulatory agenda, the EPA is planning to establish regulations that would require CBI claims made under TSCA to be reasserted and re-substantiated periodically. The agency says the action would increase the transparency and availability of public health and environmental effects information on chemicals in commerce.
Details of the proposed rule have not been announced by the agency. However, industry and NGO stakeholders expect CBI claims to stand for five years before they have to reviewed and renewed.
The Chemical Safety Improvement Act pending in the Senate's Public Works committee contains complex CBI review procedures that would further strain EPA resources, says Marianne Engelman Lado, staff attorney at the NGO Earthjustice. Simpler procedures are needed, she adds.
One challenge is that ownership of trade secrets can easily change in five years, says Mark Duvall, attorney at the law firm Beveridge & Diamond. He adds new owners of existing chemicals do not necessarily have access to data supporting original CBI claims.
"Data is the new currency of this industry," says Lynn Bergeson, of the law firm Bergeson & Campbell. In addition to developing technology and the surrounding management methodologies to track CBI claims, firms will need to develop repositories of CBI data for internal management and protection of intellectual capital, she says.
Two critical details are whether chemical companies' CBI requests will be reviewed upfront and whether individual chemicals must be disclosed. Concern remains in the industry that disclosure of some chemicals is a de facto disclosure of proprietary processes and intellectual capital.
"I think the answer is they [EPA] do scrutinise some claims, but they can't scrutinise every claim" during upfront substantiation, says Mr Duval. Ms Bergeson agrees, saying it is in industry's interest to support early review of CBI and to advocate for EPA to receive the resources necessary to conduct the reviews.
Another question is whether the agency will continue with its voluntary programme which calls on industry to review CBI claims and weed out those no longer necessary, such as those for chemicals already publicly disclosed in the marketplace.
"It's conceivable they'd try to make [review of CBI requests] mandatory," says Mr Duvall. He adds that a system of generic nomenclature similar to that proposed by industry in 2010 would provide the data needed without revealing individual substances and proprietary secrets.
The American Chemical Council (ACC) questions the need for a CBI rule. "This issue of CBI might not be as great as some claim," says Scott Jensen, ACC spokesman. He says tracking errors may account for EPA's volume of CBIs. The EPA itself says it has reduced claims made on existing chemicals by 66% to 7,675 during 2013's TSCA CBI Voluntary Challenge.
Mr Jensen also says the EPA has increased upfront substantiation and chemical data reporting (CDR), further obviating the need for a new rule. "When you put all this together, why is this a priority?" he asks.