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recognizes that the current MOE approach, similar to the HQ method, creates difficulties for the
analysis of costs and benefits; however, it provides an accurate representation of the current state
of the scientific approach for evaluating non-cancer hazards. While some have suggested a
"linear to zero" approach for non-cancer hazards, it is not a generally accepted scientific
approach, and in fact is not supported by an evaluation of biochemical networks. It can be
considered a policy decision and as such should be made on a case-by-case basis considering the
specific supporting information for an individual chemical hazard. It should not become a new
default approach.
When EPA presents MOE exposure values, consistent with EPA's 2000 Risk Characterization
Handbook * and the EPA Information Quality Guidelines, EPA should present a range of
estimates including the central tendency estimate. While EPA tends to present ranges reflecting
different exposure scenarios, the range of values presented should be informed by modifying
both the exposure and the hazard estimates.
Question 3. Systematic Review
EPA notes in its proposal that it has conducted systematic reviews in the past and that it intends
to do so in the future. The Agency has not, however, made a firm commitment to follow a
systematic review approach and seeks comment on whether such a commitment in regulatory
text is necessary. ACC strongly supports the need for regulatory text describing the systematic
review process, and EPA should commit to conduct its risk evaluations consistent with the
systematic review definition.
Systematic review is critical part of a WoE approach. As discussed above, it is part of the
definition provided in the June 7, 2016 Congressional record and the June 2015 House Report.
Congressional intent is to ensure that EPA conducts systematic reviews is clear.
ACC acknowledges that systematic review can mean different things to different groups. A
recent publication by Haddaway et al. found that while systematic review is becoming the
"widely accepted gold standard in evidence synthesis" not all users of systematic review
understand the term in the same way." In this publication, a survey of six publications that
claimed to be systematic reviews found that none met all the requirements of a true systematic
review." For instance, simply having a system to search for studies does not classify as being a
systematic review. Haddaway et al. state:
A review may include a systematic search or screening, but unless it includes all of the
aspects of a full systematic review, such as critical appraisal and full transparency, the
43 See hups:/jehp.nichs. nib.gov/1408244/.
4 See hups://www.epa.zov/sites/production/files/2015.
10/documents/osp fisk characterization handbook 2000.pdf.
See Senate Congressional Record, June 7, 2016 at $3518; House Report at 33.
to See Haddaway, NR, et al. 2016. "A Little Learning Is a Dangerous Thing": A Call for Better Understanding of the
Term 'Systematic Review,' Environ Int 99: 356-360, available at:
bup:/www.sciencedirect.com/science/article/pil/$0 160412016303634.
47 Id.
19/Page
Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

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.