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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460
May 30, 2017
MEMORANDUM
SUBJECT:
Concur with Comment
Expedited Final Agency Review . Final Rule: Procedures for Chemical Risk Evaluation
Under the Amended Toxic Substances (Tier 2; SAN 5947; RIN 2070-AK20)
FROM:
Michael Shapiro
Acting Assistant Administrator, Office of Water
TO:
Wendy Cleland-Hamnett
Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention
The Office of Water (OW) concurs with comments on the above referenced Risk Evaluation rule, in
which EPA describes a process to conduct risk evaluations on High Priority chemicals and on chemicals
whose evaluation is requested by manufacturers.
Understanding the Administrator's direction to meet the tight deadline to promulgate a final rule by June
22, 2017, OW has conducted an expedited 2-day review of the rule and preamble. If there is any
extension of time provided as a result of OMB's review process or if the rule is changed after FAR, the
OW requests that OCSPP reengage the workgroup.
The OW understands that changes have been made to the final prioritization rule (in a separate
rulemaking) and the risk evaluation rule that result in prioritization and risk evaluation for one or more
'conditions of use" of a chemical, as determined by the Administrator, rather than for a chemical
substance in its entirety for all conditions of use. OW recommends that OCSPP remove references in the
Risk Evaluation rule to evaluating single conditions of use or subsets of conditions of use and instead
adopt a chemical substance-based approach. If only a portion of conditions of use of a chemical are
included in the scope, it is not clear how a risk-based prioritization approach will be conducted and how
aggregate risk (under all conditions of use) to human health or the environment will be assessed. OW's
concern is whether a chemical may occur in drinking water or ambient water above a level of concern
for human health or the environment regardless of the condition(s) of use that led to its occurrence.
Of particular concern is the revised preamble language in the section Exclusions from the Definition of
Conditions of Use. Under this new paradigm, "legacy uses," "associated disposal (e.g., the future
disposal of insulation that contains a chemical substance that is no longer manufactured, processed, or
distributed for use in insulation)," and "legacy disposal (e.g., a chemical substance currently in a landfill
or in groundwater plumes)" may be excluded from conditions of use. These important chemical
Source: https://www.industrydocuments.ucsf.edu/docs/shcn0226

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