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the committee discusses the charge in a public venue and also ensures that the charge is not
unduly narrow.
C.
Comment Period on Manufacturer Requested Evaluations
Once EPA receives a manufacturer request for a risk evaluation and deems it to be valid, EPA
proposes a comment period of no less than 30 calendar days. ACC is concerned that this open-
ended comment period could potentially delay EPA's determinations. Based on EPA's proposal,
a valid manufacturer request will need to contain all the exposure and hazard information for
multiple conditions of use. The information presented will be similar to what EPA would present
in a draft scoping evaluation. As such, ACC recommends that EPA align this comment period
with the comment period provided for the draft scoping evaluation. ACC recommends that this
be 60 calendar days and that extensions of the comment period be allowed only for particularly
complex manufacturer requests.
VI. The Risk Evaluation Process
In describing what the risk evaluation process will look like under the LCSA, compared to
previous assessments, EPA notes that key differences include considerations of conditions of
use, timelines, and determinations of unreasonable risk. While these are indeed new
considerations, EPA fails to mention the importance of relying on best available science and
using a WoE approach, which should incorporate systematic review practices. ACC believes that
these requirements, from Section 26 of the LCSA, do indeed require a new risk evaluation
process-one that is much more transparent, objective and reproducible. ACC has addressed the
importance of Section 26 previously in these comments and will focus in this section on the steps
in the risk evaluation process.
When generally discussing the risk evaluation process, EPA points to specific NAS committee
reports and EPA guidance documents to describe how the Agency will follow "accepted science
policies" and approaches. As ACC has discussed previously, in responding to question 6 (see
Section IV, above) this approach is not sufficiently transparent and much more specificity will be
needed for stakeholders to understand the approach EPA intends to provide in the scoping
document.
A.
Scoping
EPA's risk evaluation process begins with the development of the scope. In the scope, EPA
intends to include the conceptual model and the analysis plan. ACC suggests that this scope also
include the literature search terms and results, and a screening level risk evaluation. Consistent
with systematic review approaches, discussed above, EPA should ensure that the analysis plan
includes the protocol for the systematic review that will be conducted in the refined risk
evaluation step.
As shown below in Figure 1, in order to ensure that the in-depth risk evaluation is focused on the
conditions of use of greatest potential concern, EPA must use a tiered approach that includes a
68 See 82 Fed. Reg. at 7565.
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Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

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