333-016-3020 Requirements for Chemical Substitution (1) For purposes of this rule a "children’s product" is a children’s product as defined in OAR 333-016-3015(1) that is: (a) Mouthable; (b) A children’s cosmetic; or (c) Made for, marketed for use by or marketed to children under three years of age. (2) When a manufacturer of a children’s product that is sold or offered for sale in Oregon removes a high priority chemical of concern to children’s health ( HPCCCH) as required in ORS 431.260 and intends to sell the product in Oregon with a substitute chemical, the manufacturer must provide or submit to the Oregon Health Authority (Authority) no later than the date (January 31st) on which the requirement to remove or substitute a HPCCCH from a children’s product is triggered under ORS 431A.260: (a) A Hazard Assessment (HA) that meets the requirements in OAR 333-016-3030; and (b) The fees specified in OAR 333-016-2080.; (3) The Authority must either approve or disapprove a HA within 180 days of the receipt of a HA and the information and fees required in section (2) of this rule. (4) During its review of the HA the Authority may request additional information from the manufacturer at any time and must specify the time period by which the manufacturer must provide the requested information. (5) If the Authority does not approve or disapprove the HA within 180 days from receipt of all of the information and fees required in section (2) of this rule the HA is deemed approved and the manufacturer may continue to sell or offer for sale in Oregon the children’s product for which the manufacturer submitted a HA. (6) A HA approved or deemed approved under this rule is valid for a period of three years after the date of submittal of the HA. A manufacturer must resubmit a HA at the end of the three-year period. Any report upon which the resubmitted HA is based must contain a statement that evidence is of such a nature that it can be relied upon, based on current and credible scientific evidence, as specified by the entity conducting the HA, and that the evidence is of such a nature that it can be relied upon for a minimum of three years from the date the report was issued. A HA that has been approved or deemed approved for the same substitute chemical for a total of six years does not need to be submitted a third time. (7) If the Authority approves the HA it will notify the manufacturer of the approval, in writing. (8) If the Authority disapproves a HA it will provide written notice to the manufacturer of the disapproval and the basis for the disapproval. (9) If the Authority disapproves a HA the manufacturer may submit a revised HA within 180 days after the date of the Authority’s notice of disapproval that meets the requirements of this rule. The payment of non-refundable fees in OAR 333-016-2080 is not required for a resubmitted HA. (10) A revised HA is subject to the same requirements as an initial HA under this rule and the Authority will review and approve or disapprove a revised HA in the same manner as an initial HA. (11) If the Authority disapproves an initial HA and no revised HA is submitted, the manufacturer has 90 calendar days to comply with OAR 333-016-3010(4) through (6). (12) The Authority will not consider any additional information it did not request that has been provided by a manufacturer and received by the Authority more than seven business days after the revised HA conducted with an alternative hazard assessment methodology (OAR 333-016-3030(4)) is submitted to the Authority. (13) A manufacturer may request a HA for one or more product models or styles. (14) If a manufacturer requests a HA for more than one product model or style, the Authority may approve or disapprove a request in whole or in part, based on criteria established in these rules. (15) Trade associations may submit a HA on behalf of specified member manufacturers if the following conditions are met for each HA submitted: (a) The HA meets the requirements in OAR 333-016-3030; (b) The fees are paid as specified in OAR 333-016-2080; and (c) The products are identified on which a HA has been conducted for each participating manufacturer as specified in OAR 333-016-3010(3)(a) through (c). This list of identified products shall include the name and contact information of a representative for each specified member manufacturer. (16) It is a violation of this rule to continue to sell or offer for sale in Oregon a children’s product with a substitute chemical without an approved or deemed approved HA. Statutory/Other Authority: ORS 413.042 & ORS 431A.263 Statutes/Other Implemented: ORS 431A.263 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