333-016-3080 Enforcement and Civil Penalties (1) The Oregon Health Authority (Authority) may impose a civil penalty on a manufacturer for a violation of any provision of ORS 431A.258 , 431A.260 or 431A.263, or these rules. A civil penalty may not exceed: (a) $2,500 for the first violation. (b) $5,000 for the second and each subsequent violation. (2) For purposes of assessing civil penalties under these rules a violation consists of a single course of conduct with regard to an entire children’s product line that is sold or offered for sale in Oregon. (3)(a) If a manufacturer violates the notification requirement described in ORS 431A.258 the Authority shall provide the manufacturer with written notice informing the manufacturer of the violation and stating that the manufacturer may avoid a civil penalty for the violation by providing the proper notice required under ORS 431A.258 within 90 days. (b) If the manufacturer fails to cure the violation within the first 90 days, the Authority may impose a civil penalty not to exceed $2,500. (c) For a continuing violation, each 90-day period that the violation continues after the preceding imposition of a civil penalty is considered a separate offense subject to a separate civil penalty not to exceed $5,000. The Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before imposing the separate civil penalty. (4)(a) If a manufacturer continues to sell or offers for sale a product for which a chemical was required to be removed under ORS 431A.260, and the manufacturer does not have an approved, or deemed approved waiver or hazard assessment request, the Authority shall provide the manufacturer with written notice informing the manufacturer of the violation. The notice shall state that the manufacturer may avoid a civil penalty by: (A) Ceasing to sell or offer the product for sale; and (B) Contacting any known entities who are distributing or selling the product in Oregon, advising them that the product can no longer be sold in Oregon, and providing documentation of those notifications to the Authority in accordance with OAR 333-016-3010(4) through (6); or (C) Submitting proof to the Authority that it is not in violation as alleged in the notice. (b) If the manufacturer does not submit proof that it is in compliance or fails to cure the violation within 90 days, the Authority may impose a civil penalty not to exceed $2,500. (c) For a continuing violation, each day that the violation continues after the preceding imposition of a civil penalty is considered a separate offense subject to a civil penalty not to exceed $5,000. The Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before imposing the separate civil penalty. (5) If the Authority has reason to believe that a children’s product that contains a high priority chemical of concern to children's health (HPCCCH) used in children’s products is being sold or offered for sale in Oregon in violation of ORS 431A.258, 431A.260 or 431A.263 the Authority may request that the manufacturer provide a statement of compliance on a form provided by the Authority. The manufacturer must submit the statement of compliance within 30 days after receipt of a request. To prove compliance with ORS 431A.258, 431A.260 and 431A.263, the manufacturer must provide the Authority with proof that: (a) The children’s product does not contain the HPCCCH at or above de minimis levels; or (b) The manufacturer has previously provided the Authority with notice as required by ORS 431A.258; or (c) The manufacturer is providing notice as required by ORS 431A.258; or (d) The manufacturer or trade association has provided the Authority with an exemption request approved by the Authority under ORS 431A.260; or (e) The manufacturer possesses a hazard assessment for a substitution approved by the Authority for the HPCCCH and products in question under ORS 431A.263; or (f) The manufacturer possesses a waiver for the HPCCCH and products in question approved by the Authority under ORS 431A.265. (6) Providing a notice under subsection (5)(c) of this rule does not exempt the manufacturer from compliance with the timelines for removal or substitution under ORS 431A.260, OAR 333-016-3015, ORS 431A.263, or OAR 333-016-3030. (7) In imposing a penalty under these rules the Authority must consider the following factors: (a) The past history of the manufacturer in taking all feasible steps or following all feasible procedures necessary or appropriate to correct any violation. (b) Any prior violations of statutes, rules, orders or permits pertaining to HPCCCH used in children’s products. (c) The gravity and magnitude of the violation. (d) Whether the violation was a sole event, repeated or continuous. (e) Whether the violation was a result of an unavoidable accident, negligence or an intentional act. (f) The violator’s cooperativeness and efforts to correct the violation. (g) The economic and financial conditions of the manufacturer incurring a penalty. (h) The manufacturer’s declaration that a HPCCCH used in a children’s product is present only as a contaminant, and the manufacturer is able to provide evidence that a manufacturing control program for the contaminant that meets or exceeds the minimum requirements for a manufacturing control program in OAR 333-016-2070, which was approved by the Authority, was in place prior to the violation and that the manufacturer has exercised due diligence. (i) Civil penalties will be imposed in the manner provided in ORS 183.745. (8) The Authority will enforce the reporting requirements against a manufacturer in the same order as the priority order for reporting in OAR 333-016-2060(11). Statutory/Other Authority: ORS 413.042 & ORS 431A.275 Statutes/Other Implemented: ORS 431A.275 History: PH 119-2024, amend filed 12/22/2024, effective 01/01/2025 PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021