40 C.F.R. § 702.49 : Protection of Environment — ENVIRONMENTAL PROTECTION AGENCY — TOXIC SUBSTANCES CONTROL ACT — GENERAL PRACTICES AND PROCEDURES — PROCEDURES FOR CHEMICAL SUBSTANCE RISK EVALUATIONS — Risk evaluation timeframes and actions

(a) Draft risk evaluation timeframe. EPA will publish a draft risk evaluation in the Federal Register, open a docket to facilitate receipt of public comment, and provide no less than a 60-day comment period, during which time the public may submit comment on EPA's draft risk evaluation.
(b) Final risk evaluation.
(1) EPA will complete a risk evaluation for the chemical substance under the conditions of use within the scope of the risk evaluation as soon as practicable, but not later than 3 years after the date on which the Agency initiates the risk evaluation.
(2) The Agency may extend the deadline for a risk evaluation for not more than 6 months. The total time elapsed between initiation of the risk evaluation and completion of the risk evaluation may not exceed 3 and one half years.
(3) EPA will publish the final risk evaluation in the Federal Register.
(c) Final determination of unreasonable risk. Upon determination by the EPA that a chemical substance under one or more of the conditions of use within the scope of the risk evaluation presents an unreasonable risk of injury to health or the environment as described in §702.47, the Agency will initiate action as required pursuant to 15 U.S.C. 2605(a).
(d) Final determination of no unreasonable risk. A determination by EPA that the chemical substance, under one or more of the conditions of use within the scope of the risk evaluation, does not present an unreasonable risk of injury to health or the environment will be issued by order and considered to be a final Agency action, effective on the date of issuance of the order.

40 C.F.R. § 702.49

82 FR 33747, 9/18/2017