OAR 333-016-3050
Quantitative Exposure Assessment

(1) A Quantitative Exposure Assessment (QEA) must demonstrate that a HPCCCH in a children’s product is not reasonably anticipated to result in exposure to a child based on an analysis of the leachability and bioavailability of the HPCCCH.
(2) A QEA may be done in two steps, as follows:
(a) A description of exposure scenario(s) that demonstrate how, if at all, a HPCCCH in the children’s product could reasonably be anticipated to be transferred to or into a child’s body through a completed exposure pathway because of leachability and bioavailability of a HPCCCH from the children’s product. Exposure scenarios must focus on the reasonably foreseeable use and abuse of the specified children’s product.
(b) If the manufacturer determines that the exposure scenarios, through reasonably foreseeable use and abuse of the specified children’s product, are reasonably anticipated to result in a completed exposure pathway to a child regardless of the amount of HPCCCH potentially transferred, the manufacturer shall submit information on the leachability and bioavailability of HPCCCH from a product, including measurements of the concentration of a HPCCCH in the simulated media such as saliva, sweat, or digestive fluid appropriate for the exposure scenarios, using analytical methods relevant to the chemical and the product. The manufacturer must also submit a copy of any analytical test results for the HPCCCH in each media tested that include:
(A) The specific analytical methods or source of information utilized to determine the concentration of the HPCCCH in media relevant for each exposure pathway.
(B) The detection limit for each HPCCCH for each analytical instrument used for the testing in each medium tested.
(c) If a manufacturer determines that, based on exposure scenarios, a HPCCCH cannot reasonably be anticipated to be transferred to or into a child’s body through a completed exposure pathway because of leachability and bioavailability and only conducts the first step of the QEA as described in subsection (2)(a) of this rule, the manufacturer shall provide a detailed report and analysis to the Authority that demonstrates to the Authority’s satisfaction, that a child would not be exposed to a HPCCCH.
(3) A QEA must include citations from scientific literature for any assertion made.
(4) Laboratory analysis done for purposes of a QEA must be conducted by a laboratory accredited to ISO/IEC 17025 as described in OAR 333-016-2070 (Exemptions from Notice Requirement)(7)(a).
(5) To enable accurate identification of children’s products on which a QEA is conducted, such products must be identified by manufacturers as specified in OAR 333-016-3010 (Removal or Substitution of High Priority Chemicals)(3)(a) through (c).
(6) In order to be approved a QEA must demonstrate that HPCCCH concentrations measured in the media are less than or equal to the Practical Quantification Limit of the HPCCCH established in OAR 333-016-2035 (Manufacturer Disclosure of High Priority Chemicals of Concern for Children’s Health Used in Children’s Products: Practical Quantification Limits)(2), Exhibit A, incorporated by reference.
(7) If the Authority determines that there are exposure scenarios for which a completed exposure pathway is possible through reasonably foreseeable use and abuse of the specified children’s product, it will deny the QEA. The manufacturer may resubmit a revised request along with a completed QEA.
(8) A QEA approved by the Authority may be used to apply to a new product if the composition of the new product is substantially similar to those specified in an approved QEA and differ only in ways that do not affect the HPCCCH’s behavior in the product. Differences may include, but are not limited to, packaging, size/volume, product name, and other minor aesthetic differences. The use of a QEA approved by the Authority in this manner is permitted if all of the following are demonstrated for the new product:
(a) The chemical composition of the new product is substantially similar to those in an approved QEA;
(b) There are not any HPCCCHs at or above de minimis in addition to those in the product specified in the approved QEA; and
(c) Neither the concentration of the HPCCCH nor its mobility from the product has increased from those in the referenced product.
(9) To substantiate a claim that a QEA approved by the Authority applies to a new product, manufacturers shall submit all of the following:
(a) A copy of the referenced QEA approved by the Authority;
(b) Documentation demonstrating compliance with section (8) of this rule, which must include the signature, on an application form provided by the Authority, of an authorized representative of the manufacturer bringing the product into Oregon, with the knowledge and authority to attest to the veracity of the information submitted under section (8) of this rule; and
(c) Identification of new affected products as specified in section (5) of this rule.

Source: Rule 333-016-3050 — Quantitative Exposure Assessment, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-3050.

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 333-016-3050’s source at or​.us