Or. Admin. Code § 333-016-3040 - Waiver from Removal or Substitution Requirement

(1) For purposes of applying for a waiver from the removal or substitution requirement in ORS 431A.260"children's product" is a children's product 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 may request a waiver from the requirement to remove or substitute a chemical under ORS 431A.260 for one or more product models or styles. An application for a waiver must include:

(a) A Quantitative Exposure Assessment (QEA) that meets the requirements of OAR 333-016-3050; or

(b) An Alternatives Assessment (AA) that meets the requirements of OAR 333-016-3060.

(3) An application for a waiver under this rule must be accompanied by the fees specified in OAR 333-016-2080 and the following information:

(a) The name, address, telephone number and other contact information for the manufacturer; and

(b) The information required in OAR 333-016-2060(4)(a) through (i) for each children's product category or children's cosmetics for which a waiver is being requested, based on the information reported in the most recent Biennial Notice Period.

(4) The Authority will not consider any additional information from the manufacturer it did not request, that is received by the Authority more than seven business days after a manufacturer submits a QEA, AA or an HA to the Authority.

(5) The Authority must either approve or disapprove a waiver request within 180 days of the receipt of a request and the fees required in sections (2) and (3) of this rule.

(6) During its review of the waiver request the Authority may request additional information from the manufacturer that submitted the request at any time and must specify the time period by which the manufacturer must provide the requested information.

(7) If the Authority does not approve or disapprove the waiver request within 180 days from receipt of the information and fees required in sections (2) and (3) of this rule the request 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 an AA or QEA.

(8) If the Authority approves a waiver request the Authority will notify the manufacturer of the approval, in writing.

(9) If the Authority disapproves a waiver request it will provide written notice to the manufacturer of the disapproval and the basis for the disapproval.

(10) If the Authority disapproves a waiver request the manufacturer may submit a revised waiver request that meets the requirements of this rule within 180 days after the date of the Authority's notice of disapproval. The payment of non-refundable fees in OAR 333-016-2080 is not required for a resubmitted waiver request.

(11) A revised waiver request is subject to the same requirements as an initial waiver request under this rule and the Authority will review and approve or disapprove a revised waiver request in the same manner as an initial request.

(12) If the Authority disapproves a revised waiver request, or the Authority disapproves an initial request and the manufacturer does not submit a revised waiver request, the manufacturer has 90 calendar days to comply with OAR 333-016-3010(4) through (6).

(13) A manufacturer who has had an initial or revised waiver request disapproved who intends to remove the chemical or substitute a chemical may do so in compliance with these rules but may not sell or offer to sell the children's products unless and until the HPCCCH that is the subject of a the notice requirement in ORS 431A.258 is removed and notice is given to the Authority or the Hazard Assessment for a substitute chemical has been approved by the Authority.

(14) The Authority will disapprove any waiver request from a manufacturer that submits fraudulent information.

(15) Trade associations may submit an application for a waiver on behalf of specified member manufacturers if the following conditions are met for each waiver submitted:

(a) The waiver application follows the requirements of section (2) of this rule.

(b) The fees are submitted as specified in OAR 333-016-2080.

(c) The products are identified on which a QEA or AA has been conducted for each participating manufacturer as specified in OAR 333-016-3010(3)(a) through (c). This list of identified products shall be listed by manufacturer and shall include the name and contact information of a representative for each specified member manufacturer.

(16) If a manufacturer requests a waiver 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.

Notes

Or. Admin. Code § 333-016-3040

PH 9-2021, adopt filed 02/28/2021, effective 3/1/2021

Statutory/Other Authority: ORS 413.042, ORS 431A.263 & ORS 431A.265

Statutes/Other Implemented: ORS 431A.263 & ORS 431A.265