OAR 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 (Requirement to remove or substitute high priority chemicals of concern) “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 (Requirement to remove or substitute high priority chemicals of concern) 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 (Quantitative Exposure Assessment); or
(b) An Alternatives Assessment (AA) that meets the requirements of OAR 333-016-3060 (Alternatives Assessment).
(3) An application for a waiver under this rule must be accompanied by the fees specified in OAR 333-016-2080 (Fees) 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 (Notification Requirements)(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 (Fees) 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 (Removal or Substitution of High Priority Chemicals)(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 (Disclosure by manufacturers) 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 (Fees).
(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 (Removal or Substitution of High Priority Chemicals)(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.

Source: Rule 333-016-3040 — Waiver from Removal or Substitution Requirement, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-3040.

333‑016‑0005
Definitions 333‑016‑0010
Human Experience with Hazardous Substances 333‑016‑0015
Hazardous Mixtures 333‑016‑0020
Testing Procedures for Hazardous Substances 333‑016‑0025
Method of Testing Primary Irritant Substances 333‑016‑0030
Test for Eye Irritants 333‑016‑0035
Tentative Method of Test for Flashpoint of Volatile Flammable Materials by Tagliabue Open-Cup Apparatus 333‑016‑0040
Method for Determining Extremely Flammable and Flammable Solids 333‑016‑0045
Method for Determining Extremely Flammable and Flammable Contents of Self-Pressurized Containers 333‑016‑0050
Method for Determining Flashpoint of Extremely Flammable Contents of Self-Pressurized Containers 333‑016‑0055
Method for Determining the Sound Pressure Level Produced by Toy Caps 333‑016‑0056
Test Methods for Simulating Use and Abuse, Toys, Games, and Other Articles Intended for Use by Children 333‑016‑0057
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children 18 Months of Age or Less 333‑016‑0058
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 18 But not Over 36 Months of Age 333‑016‑0059
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 36 But Not Over 96 Months of Age 333‑016‑0060
Products Declared to be Hazardous Substances Under ORS 453.055(1) 333‑016‑0065
Products Requiring Special Labeling Under ORS 453.055(2) 333‑016‑0070
Labeling of Fire Extinguishers 333‑016‑0075
Banned Hazardous Substances 333‑016‑0077
Pointed Objects in Food Items of Particular Appeal to Children 333‑016‑0080
Toys and Other Articles Intended for Use by Children 333‑016‑0082
Repurchase of Banned Hazardous Substances 333‑016‑0085
Exemptions for Foods, Drugs, Cosmetics, and Fuels 333‑016‑0090
Exemption from Full Labeling and Other Requirements 333‑016‑0095
Exemptions for Small Packages, Minor Hazards, and Special Circumstances 333‑016‑0100
Exemption for Unlabeled Containers 333‑016‑0105
Exemptions from Classification as Banned Hazardous Substances 333‑016‑0110
Labeling of Toys, Including Games 333‑016‑0115
Labeling Requirements, Placement, Conspicuousness, Contrast 333‑016‑0120
Deceptive Use of Disclaimers 333‑016‑0125
Condensation of Label Information 333‑016‑0130
Labeling Requirements for Accompanying Literature 333‑016‑0135
Substances Determined to be “Special Hazards” (e.g., to children) 333‑016‑0140
Substances with Multiple Hazards or Other Special Hazards 333‑016‑0145
For the Following Substances and at the Following Concentrations, the Word “Poison” Is Necessary Instead of Any Signal Word 333‑016‑0150
Self-Pressurized Containers 333‑016‑0155
Methyl Alcohol-Base Radiator Antifreeze 333‑016‑0160
Ethylene Glycol-Base Radiator Antifreeze 333‑016‑0165
Extremely Flammable Contact Adhesives 333‑016‑0170
Procedural Rules 333‑016‑0175
Prohibited Acts and Penalties 333‑016‑0180
Guaranty 333‑016‑0185
Examinations and Investigations 333‑016‑0190
“Administrator” Intended to Include “State Public Health Officer” 333‑016‑2001
Toxic Free Kids Program 333‑016‑2010
Definitions 333‑016‑2020
Chemicals of High Concern to Children 333‑016‑2030
Modifications to the List of High Priority Chemicals of Concern for Children’s Health 333‑016‑2035
Manufacturer Disclosure of High Priority Chemicals of Concern for Children’s Health Used in Children’s Products: Practical Quantification Limits 333‑016‑2060
Notification Requirements 333‑016‑2065
Formal Communications Regarding Toxic Free Kids 333‑016‑2070
Exemptions from Notice Requirement 333‑016‑2080
Fees 333‑016‑3010
Removal or Substitution of High Priority Chemicals 333‑016‑3015
Exemptions from Removal or Substitution Requirements 333‑016‑3020
Requirements for Chemical Substitution 333‑016‑3030
Hazard Assessment for Substitute Chemicals 333‑016‑3040
Waiver from Removal or Substitution Requirement 333‑016‑3050
Quantitative Exposure Assessment 333‑016‑3060
Alternatives Assessment 333‑016‑3070
Trade Secrets 333‑016‑3080
Enforcement and Civil Penalties
Last Updated

Jun. 8, 2021

Rule 333-016-3040’s source at or​.us