Wednesday, July 23, 2014

EPA Releases First TSCA Assessments

Posted: January 4, 2013

EPA has released drafts of the first five of 83 chemical risk assessments it is planning to conduct to determine whether it should regulate the substances under Toxic Substances Control Act (TSCA), part of a major agency effort to step up use of existing TSCA authority absent congressional reforms.

Agency staff promised to release assessments of seven chemicals by the end of 2012, when they announced last March the list of 83 substances they said they would begin assessing over the next several years.

But the agency Jan. 4 released for comment draft summaries of five of those assessments, saying the remaining two – medium- and long-chain chlorinated paraffins -- are on "a different schedule for completion and will be made available for public comment through another Federal Register notice issued on a later date," according to a draft Federal Register (FR) notice.

The draft summaries explain that EPA considers three of the chemicals to be potential concerns to human health, while the other two are of low ecological risk concern. The assessments categorize exposures to dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint strippers, trichloroethylene (TCE) as a degreaser and a spray-on protective coating to be of "potential concern for human health under specific exposure scenarios for particular uses," according to the agency's Jan. 4 press statement.

The drafts of the other two chemicals categorize antimony trioxide (ATO) use in halogenated flame retardants and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) use as a fragrance ingredient in products as "a low concern for ecological health."

The agency will take public comment on the draft summaries through March 15, according to a Jan. 3 agency memo.

The effort is one of a number of ways in which the Obama EPA is seeking to more strictly regulate existing chemicals, absent TSCA reform by Congress. TSCA defines existing chemicals as those that entered commerce before the statute's 1976 enactment. Senior EPA officials, including Administrator Lisa Jackson and acting toxics chief Jim Jones, have said TSCA currently gives the agency limited ability to regulate existing chemicals.

The agency's statement adds that "[i]f EPA concludes in finalizing the risk assessments that there is a potential for concern, the agency will take action as appropriate to address possible risks." EPA does not provide further details, but the project has already concerned the chemical industry, which in September pressed the agency to increase the scrutiny in the peer reviews of the assessments by elevating them to the status of highly influential scientific assessments (HISAs).

Four Republican senators reiterated that call in a Dec. 21 letter. Sens. James Inhofe (OK), David Vitter (LA), Mike Crapo (ID) and Lamar Alexander (TN) write to Jones "to express our serious concerns regarding" the peer review plans for the assessments, which indicate EPA considers the assessments "merely 'influential' as opposed to '[HISAs].' The 'influential' characterization and EPA's current peer review plans are insufficient to ensuring that a rigorous and robust peer review of the risk assessments occurs."

EPA in August released brief plans outlining how it intends to seek peer review of the first seven work plan risk assessments. Each review plan indicates the draft assessments will undergo peer review by contractor-managed panels. EPA uses these contractor run panels for assessments it deems to be below the status of a HISA.

HISAs undergo a higher level of peer review, so they are referred to the agency's Science Advisory Board (SAB) or, in some cases, the National Academies (NA). One key difference between the contractor-managed reviews and those of SAB or NA is that the panelists do not have to reach consensus; instead, each panelist prepares individual comments for the agency.

EPA's new draft FR notice, however, indicates that agency staff still plans to have a contractor manage the peer review panels, implying that staff will not elevate the assessments' status. "EPA is also asking the public for nominations of expert peer reviewers . . . by February 13, 2013. The nominations of expert peer reviewers from the public will be relayed to the independent peer review contractor setting up the individual peer review panels," according to the agency's Jan. 3 memo.

However, the request for public nominations does fulfill one of the senators' and industry's requests, that the public be allowed to nominate experts for the panels, which are usually chosen by the contractor.

The chemical industry association the American Chemistry Council released a statement Jan. 4 saying that it "commends EPA for seeking public comment on its draft work plan risk assessments prior to conducting scientific peer review. Seeking stakeholder input is an important and necessary step toward achieving effective, transparent and credible risk assessments."

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