333-016-3015 Exemptions from Removal or Substitution Requirements (1) For purposes of this rule "children’s product" is a children’s product as defined in ORS 431A.253 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) A manufacturer is exempt from meeting the requirement of removal or substitution of a high priority chemical of concern to children's health (HPCCCH) in a children’s product under ORS 431A.260 if one or more of the following is met: (a) The children’s product contains a HPCCCH used in children’s products at levels that are at or below allowable levels for children’s products as established by the Consumer Product Safety Improvement Act of 2008, P.L. 110-314, 122 Stat. 3016, as in effect on July 27, 2015. (b) A manufacturer is in compliance with a federal consumer product safety standard adopted under federal law that establishes allowable levels for children’s products of a high priority chemical of concern for children’s health used in children’s products. (c) The State of Washington has granted an exemption for the removal or substitution of a HPCCCH in the same children’s product model for which the exemption is requested under OAR 333-016-3015. (d) A children’s product has been tested under applicable EN-71 standards, by a laboratory that is accredited to conduct such testing under the current edition of ISO/IEC 17025 by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation mutual recognition arrangement. (3) More than one product model may be submitted in a single exemption request. (4) In order to be exempt under one or more of the categories in section (2) of this rule a manufacturer must submit: (a) An exemption request on a form prescribed by the Oregon Health Authority ( Authority) ; (b) The fees specified in OAR 333-016- 2080(1)(e); (c) The information required in OAR 333-016-3010(3)(a) through (c), for the product models as they are sold in Oregon for which exemption is being requested; and (d) Written documentation supporting the exemption request, including but not limited to an electronic copy of the certificate of conformity issued by the applicable authority or an authorized designate, if available, and evidence that the children’s product meets the standards described in the applicable exemption category including: (A) For an exemption request under subsection (2)(a) of this rule, the citation for the section of the Consumer Product Safety Improvement Act of 2008, P.L. 110-314, 122 Stat. 3016, in effect on July 27, 2015, naming the HPCCCH. (B) For an exemption request under subsection (2)(b) of this rule, a citation to the federal consumer product safety standard adopted under federal law that establishes an allowable level of a HPCCCH in children’s products, specific to allowable levels of the HPCCCH in children’s products. (C) For an exemption request under subsection (2)(c) of this rule, a copy of the manufacturer’s request for exemption under the applicable State of Washington law and the exemption approval from that state. (D) For an exemption request under subsection (2)(d) of this rule, an electronic copy of an actual European Community/European Union Declaration of Conformity issued for the product or products for which exemption is being requested, establishing that the product or products meets current EN-71 standards applicable to the HPCCCH and product type for which an exemption is being sought. (5) This written documentation must be submitted in its entirety to the Authority on or before the date on which the manufacturer is required to submit the third biennial notice under ORS 431A.258 and OAR 333-016-2060. (6) The Authority will approve or disapprove an exemption request made under section (2) of this rule in writing within 180 days from receipt of all of the documentation required in the rule, explaining the basis of the approval or denial. (a) If the Authority does not approve or disapprove the exemption request made under section (2) of this rule within 180 days of its submission, the exemption is deemed approved. (b) If disapproved, a manufacturer may not resubmit an exemption request. (7) If a manufacturer is granted an exemption under subsection (2)(c) of this rule and subsequently the State of Washington withdraws the approval for the exemption, the manufacturer must immediately notify the Authority and come into compliance with ORS 431A.260 and these rules. (8) A manufacturer may request to add additional children’s products to an approved list of exempted products if the following apply: (a) The chemical composition of the new product is uniform in composition and chemically identical to those specified in the approved request and differ only in ways that do not affect the HPCCCH's behavior in the product; (b) There are not any HPCCCHs at or above de minimis in the new product in addition to those in the approved list of exempted product(s); and (c) Neither the concentration of the HPCCCH nor its mobility from the product has increased from those products in the approved list of exempted product(s). (9) To request an addition to an approved list of exempted products, manufacturers shall submit the following to the Authority: (a) A copy of the current Oregon Health Authority approved list of exempted products; (b) An application form, provided by the Authority, with the signature of an authorized representative of the manufacturer, with the knowledge and authority to attest to the veracity of the information submitted under section (9) of this rule; and (c) Identification of products proposed to be added, consistent with section (4)(c) of this rule Statutory/Other Authority: ORS 413.042 & ORS 431A.260 Statutes/Other Implemented: ORS 431A.260 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