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EPA Draws Criticism On Planning of New TSCA Risk Assessment Program

Industry argue that EPA failed to properly plan the new program, its analyses are unfit bases for regulation, and that peer review charge questions fail to follow Information Quality Act guidelines.

According to InsideEPA.com, the renewed criticism came Sept. 26 during industry comments to panelists reviewing EPA's assessments for two chemicals commonly used in paint-stripping -- methylene chloride (DCM) and N-methylpyrrolidone (NMP). The draft assessments are among a handful the agency has conducted as part of the Obama EPA's effort to more strictly regulate existing chemicals through the Toxic Substances Control Act, or TSCA.1

The draft assessments of DCM and NMP were the second assessments in the program, run by EPA's toxics office, to undergo peer review. Much of the criticism industry levied during the public comment period mirrored attacks on EPA's draft "workplan" assessment of TCE, the first of the assessments in the novel program to undergo peer review.

During the review of the draft assessment for TCE this past summer, several reviewers backed industry claims that the document is merely a screening level review that fails to evaluate actual exposures and that it should not be used in regulation without further refinement. Panelists urged the agency to add additional data or set the assessment aside in favor of a more thorough review.
 
During the Sept. 26 meeting, the first of three peer review meetings, officials with the NMP Producers Group, an affiliate of the law firm Bergeson & Campbell, told the panelists reviewing DCM and NMP that similarities between industry criticism of those draft assessments and the ones for TCE shows EPA has failed to adequately plan the new program.
 
"What is missing from this whole exercise, for the risk assessments in general, is that there is not guidance from EPA about the [exposure data] and risk assessment methodologies that these risk assessments are supposed to follow," a representative of the NMP Producers Group said. "EPA should identify what it's targeting, what are the goals?"
 
Members of the NMP Producers Group said EPA's draft assessment of NMP relies on inconsistent assumptions and unrealistic scenarios. EPA also used modeling to estimate certain exposures when agency contractors and industry have data representing actual exposures, the producers' representatives said.
"We see no benefit of a model that uses unrealistic assumptions and that gives results that are uncertain and unrealistic," Kathleen Roberts of the NMP Producers Group said.

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REFERENCES
  1. The Environmental Protection Agency intends to use the novel program to evaluate as many as 83 chemicals for possible regulation. Relevant documents are available on InsideEPA.com.

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