['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA']
10/30/2023
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(a) Screening review. Following the close of the comment period described in §702.7(d), including any extension pursuant to paragraph (e) of that section, EPA will generally use reasonably available information to screen the candidate chemical substance against the following criteria and considerations:
(1) The chemical substance's hazard and exposure potential;
(2) The chemical substance's persistence and bioaccumulation;
(3) Potentially exposed or susceptible subpopulations;
(4) Storage of the chemical substance near significant sources of drinking water;
(5) The chemical substance's conditions of use or significant changes in conditions of use;
(6) The chemical substance's production volume or significant changes in production volume; and
(7) Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority.
(b) Information sources. In conducting the screening review in paragraph (a) of this section, EPA expects to consider sources of information relevant to the listed criteria and consistent with the scientific standards provision in 15 U.S.C. 2625(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012).
(c) Proposed designation. Based on the results of the screening review in paragraph (a) of this section, relevant information received from the public as described in §702.7(d), and other information as appropriate and consistent with 15 U.S.C. 2625(h) and (i), EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance, along with an identification of the information, analysis, and basis used to support the proposed designation.
(d) Costs and non-risk factors. EPA will not consider costs or other non-risk factors in making a proposed priority designation.
(e) Insufficient information. If information remains insufficient to enable the proposed designation of the chemical substance as a Low-Priority Substance after any extension of the initial public comment period pursuant to §702.7(e), EPA will propose to designate the chemical substance as a High-Priority Substance.
(f) Conditions of use. EPA will propose to designate a chemical substance as a High-Priority Substance based on the proposed conclusion that the chemical substance satisfies the definition of High-Priority Substance in §702.3 under one or more activities that the Agency determines constitute conditions of use. EPA will propose to designate a chemical substance as a Low-Priority Substance based on the proposed conclusion that the chemical substance meets the definition of Low-Priority Substance in §702.3 under the activities that the Agency determines constitute conditions of use.
(g) Publication. EPA will publish the proposed designation in the Federal Register, along with an identification of the information, analysis and basis used to support a proposed designation, in a form and manner that EPA deems appropriate, and provide a comment period of 90 days, during which time the public may submit comment on EPA's proposed designation. EPA will open a docket to facilitate receipt of public comment.
[82 FR 33763, July 20, 2017]
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