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II. Overview of LCSA Prioritization Process Requirements
Sections 6(b)(1) and (2) of the LCSA address EPA's prioritization of chemical substances for
risk evaluations. Section 6(b)(1) directs EPA to establish - by rule - a "risk based screening
process," including criteria for designating substances as high or low priority for risk evaluations.
The language at Section 6(b)(1)(A) specifies what EPA must "consider" in this process and it lays
out criteria by which substances will be designated as high priority or low priority. These include
"consideration of the hazard and exposure potential of a chemical substance or a category of
chemical substances (including consideration of persistence and bioaccumulation, potentially
exposed or susceptible subpopulations and storage near significant sources of drinking water), the
conditions of use or significant changes in the conditions of use of the chemical substance, and the
volume or significant changes in the volume of the chemical substance manufactured or processed."
Section 6(b)(1) prescribes: a timeframe (between 9-12 months) within which final prioritization
designations must be made once EPA initiates the process; a requirement that EPA request
interested persons submit "relevant information"; a time period (90 days from initiation of the
prioritization process) for persons to submit information to EPA; a requirement that EPA propose its
priority designation "along with an identification of the information, analysis, and basis" used to
make the designation; and a 90 day public comment period on the proposed designation. There is
also an opportunity to extend the deadline for submitting information to EPA if that information is
required under Section 4, subject to certain limitations.
Section 6(b)(2)(A) makes clear that the prioritization process rule does not apply to EPA's
identification of the first 10 high priority substances. Section 6(b)(2)(D), requires EPA to give
"preference" to TSCA Work Plan chemicals that meet specific persistence and bioaccumulation
criteria, are known human carcinogens and have high acute and chronic toxicity.
EPA's proposed prioritization process rule establishes four steps or phases in prioritization: 1)
'pre- prioritization" during which EPA would narrow a pool of potential candidates for high or low
priority designation, loosely based on application of nine criteria EPA used to identify the 90 Work
Plan chemicals, and subject them to information gathering; 2) "initiation" of the prioritization
process in which EPA would announce candidates as high or low priority and provide a 90 day
public comment period; 3) EPA's "proposed" designation of chemicals as high or low priority (with
EPA's basis) with another 90 day public comment period; and 4) EPA's "finalization" of the
priority designations.
Three of EPA's proposed process steps for prioritization (initiation, proposal and finalization)
are largely recitations of the statute. The first step, pre-prioritization, in contrast, represents EPA's
attempt to create a pragmatic solution to the statute's tight timeframes that do not allow much time
to collect or develop information needed for prioritization. However, EPA's proposed pre-
prioritization step is opaque, leaving many questions unanswered about how it would work and
whether it is in fact authorized by the LCSA.
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Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

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