Output Explorer

corresponding BEs. Since data from NHANES is largely considered indicative of general population
exposures, this approach can be a useful tool to determine whether general population exposures
exceed EPA's reference concentrations (RfCs), reference doses (RfDs), or unit cancer risks.
Although biomonitoring results can be an important component of prioritization, when BEs are
available for substances under consideration by the Agency, they should be used to place
biomonitoring concentrations into a health risk context. Such use is consistent with the LCSA
mandate for EPA to employ best available science in a risk-based framework for priority setting
under TSCA.
EPA should establish a criteria-based approach to narrowing the pools of candidate chemicals
for prioritization that is representative of the current state of knowledge with the opportunity to
update this approach to reflect new science developments. Nowhere in EPA's proposal does it
reference any of the 21" Century hazard and exposure based tools that EPA might use to identify
either the pools for the prioritization process or to narrow the candidates in the prioritization pool.
Tools developed by EPA's Office of Research and Development - such as ToxCast, ExpoCast,
SHEDS-HT,etc. - hold particular promise in the near term for prioritization screening activities.
Further, EPA should make certain that the databases underpinning some of its qualitative criteria are
current, e.g. the Household Products Database as a source of information about presence of
chemicals in consumer products. Finally, EPA should consider and review the details of risk
assessment developed for other regulatory regions, such as Canada and the EU as source for
designating high and low priority chemicals.
RECOMMENDATION: EPA should update and fine-tune its current TSCA Work Plan
criteria (e.g. persistence and bioaccumulation; biomonitoring) and databases before
implementing its prioritization process. In addition, EPA should consider the applying 21st
Century tools and begin the planning needed for OCSPP to integrate these into the prioritization
process when they are ready to be used for these purposes. EPA should also consider the risk
assessments developed for other regulatory regions such as Canada and the EU as sources for
designating high and low priority chemicals.
B. EPA's Proposed Use of the Pre-Prioritization Step to Gather Information for Risk
Evaluations Needs to Be Better Supported and Articulated
One of the most surprising elements of EPA's proposed prioritization process rule was the
discussion of its plans to use a pre-prioritization step to gather information for risk evaluations on
substances with "insufficient information" for risk evaluation. " EPA has authority under Section 8
of TSCA to gather existing information about chemicals and under Section 4 to develop new
information when needed for risk evaluations. EPA's plan to address risk evaluation information
needs, even before a chemical is prioritized, raises several significant concerns, however. First, the
proposal has the potential to create "fishing expeditions" for data. Second, it is an unrealistic
expectation for EPA to think it could know at the pre- prioritization stage what information it might
need to begin gathering/requiring for risk evaluation - well before it has even designated the
chemical as a high priority. Finally, EPA has failed to discuss the limitations in Section 4 on EPA's
authority to require industry to develop new information for risk evaluations (e.g. EPA must issue
statements of need). ACC's concerns are exacerbated by the fact that EPA's discussion of this
proposed activity during the pre-prioritization step is vague.
""For chemicals with insufficient information to conduct a risk evaluation, EPA generally expects to pursue a significant amount of data gathering before
initiating prioritization." 82 Fed. Reg. at 4828.
12
Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

Answer the question using only the OCR text from a single document page. Return only the answer, with no explanation. Preserve the answer wording from the OCR text when possible.