US ACC proposes principles for regulatory assessment of chemicals

25 April 2014 17:51 Source:ICIS News

WASHINGTON (ICIS)--The American Chemistry Council (ACC) on Friday issued a set of principles to guide assessment of chemicals risk, saying they are needed to improve regulators’ work across a wide range of rulemaking and policy decisions.

ACC president Cal Dooley said that the council’s four basic principles for risk assessment are needed because “getting the regulatory framework right is absolutely essential”.

He said that multiple government agencies involved in regulating chemicals “must have the appropriate scientific tools and knowledge deployed to assess accurately the risk that chemicals pose in the context of their intended use exposure”.

“It is important that EPA [Environmental Protection Agency] and other regulatory agencies are incorporating the latest in technology and the latest science to ensure the most accurate assessment of risks posed by chemicals in their applications,” he said.

He said the council’s core assessment principles are intended as a framework on which discussions and negotiations can go forward on such crucial issues as current efforts in Congress to modernise and reform the Toxic Substances Control Act (TSCA).

That 38-year-old statute has been widely criticised by industry and environmentalists as no longer adequate, and two bills are pending in Congress to update US regulation of chemicals in commerce.

But the principles “go beyond TSCA reform and are aimed at all risk assessments conducted by various federal agencies”, Dooley said, citing chemicals-related regulatory programmes at the Health and Human Services (HHS) department, the National Toxicology Program (NTP), the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and of course the EPA.

“To the extent possible,” he told reporters in a conference call, “it is incumbent on the federal government to employ the most advanced technology and scientific methodology to conduct the most accurate assessment of chemicals.”

He said that those goals reflect objectives in executive orders issued by both former President Bill Clinton and more recently by President Barack Obama, and concerns among other stakeholders such as environmental and consumer groups.

The ACC’s principles, he said, “provide a road map to ensure that the US government is really employing the gold standard in assessment of chemicals”.    

The guiding principles outlined by Dooley first address the way in which assessments are designed by regulators through engagement with stakeholders to ensure that “modern scientific policies and practices [are] utilised instead of relying on outdated assumptions and default approaches”.

Second, the council calls on regulators to develop and apply consistent criteria for evaluating data and employing all pertinent studies with emphasis on the most relevant and highest quality independent analyses.

Third, Dooley said that regulators’ chemical review processes must be transparent and provide full disclosure of underlying data and key information used to develop their assessments to ensure that “both hazards and risks [are] characterised accurately and in a manner that is relevant to actual human exposure”.

Lastly, the principles urge that “all chemical assessments must be subject to robust review by independent experts and peer review panels”.

Dooley said that ACC has been working toward the set of assessment principles for three years, since the EPA came under sharp criticism in 2011 by the National Academy of Sciences (NAS) for what NAS charged was “unsupported” scientific conclusions in the agency’s chemical assessment practices.

For example, the 2011 NAS study found that an EPA assessment of formaldehyde as a carcinogen “was not prepared in a logically consistent fashion, lacked clear links to an underlying conceptual framework and did not sufficiently document methods and criteria used to identify evidence for selecting and evaluating chemical studies”.

Dooley said that the NAS 2011 finding of “serious shortcomings” in EPA’s assessment practices “led to a constructive effort by Congress, industry and the EPA to ensure that we can take the advance made by NAS to the next level and develop and deploy it to all government agencies involved in chemical risk assessment”.

He said the council will use the four principles going forward in discussions with members of Congress, regulatory agencies, environmental groups and the broad chemicals sector supply chain as work continues on modernising TSCA and making other regulatory changes.

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

By Joe Kamalick