OAR 333-016-3030
Hazard Assessment for Substitute Chemicals

(1) A manufacturer must conduct a Hazard Assessment (HA) of the substitute chemical that includes:
(a) A report:
(A) By a Licensed GreenScreen Profiler using GreenScreen® for Safer Chemicals Hazard Assessment Guidance (GreenScreen methodology) that assesses the hazard level of the substitute chemical or chemicals; or
(B) Using an Authority approved methodology as described in section (4) of this rule.
(b) Information about each product model containing the HPCCCH and each final product model containing the substitute chemical that will enable the Authority to determine if the final children’s product is inherently less hazardous than before. The information provided shall include but is not limited to:
(A) A high-resolution image of the product model in JPEG or PDF form.
(B) Identification of products on which a HA is conducted by manufacturers as specified in OAR 333-016-3010 (Removal or Substitution of High Priority Chemicals)(3)(a) through (c).
(C) A complete list of the product model’s components containing a HPCCCH at or above de minimis levels. For each component, the amount of HPCCCH in the component should be expressed as parts per million. The substitute chemical in each component of final product model should be expressed as parts per million. The HPCCCH and substitute chemical(s) shall be listed with their Chemical Abstract Numbers.
(2) The Authority will not approve a HA for a substitute chemical that has a hazard level score of ’high’ or greater as determined by the GreenScreen methodology or Authority approved methodology for any of the following human health endpoints:
(a) Reproductive toxicity;
(b) Developmental toxicity;
(c) Endocrine activity; or
(d) Skin sensitization.
(3) For a HA submitted with an assessment from a Licensed GreenScreen Profiler:
(a) A HPCCCH is considered by the Authority to be comparable to a chemical that has a GreenScreen Benchmark score of 1.
(b) A substitute chemical is considered to be inherently less hazardous if it is assigned a GreenScreen Benchmark score of 2, 3 or 4, and is in compliance with section (2) of this rule.
(4) A manufacturer may request that the Authority approve an alternative methodology for conducting a HA that exists in the public domain, is hazard-focused, considers the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) categorization method of health hazard, and is comparable to the GreenScreen Guidance methodology of this rule, including having an equivalent or stricter health hazard criteria for the human health endpoints described below:
(a) Carcinogenicity;
(b) Genotoxicity and mutagenicity;
(c) Reproductive toxicity;
(d) Developmental toxicity;
(e) Endocrine activity;
(f) Acute toxicity;
(g) Systemic toxicity;
(h) Neurotoxicity;
(i) Skin sensitization;
(j) Respiratory sensitization;
(k) Skin irritation; or
(l) Eye irritation.
(5) Prior to conducting a HA using a methodology other than the GreenScreen methodology a manufacturer must submit detailed information about the methodology it proposes to use and a detailed analysis comparing the methodology to the GreenScreen Guidance methodology.
(a) Requests to use a HA methodology other than the GreenScreen methodology must be made at least 90 business days before the date the manufacturer submits the Hazard Assessment.
(b) The Authority will review the request and within 60 business days respond in writing to the manufacturer either approving or denying the request.
(6) The Authority will accept a HA that demonstrates with scientifically supported objective data that the children’s product and any substituted chemical is inherently less hazardous than before the substitution was made.
(7) For purposes of this rule and OAR 333-016-3060 (Alternatives Assessment), the Authority:
(a) Finds that the GreenScreen methodology is scientifically supported by objective data;
(b) Finds that an assessment by a licensed GreenScreen Profiler contains sufficient protocols and safeguards to ensure that the assessment is reliable; and
(c) Will consider an assessment conducted by a licensed GreenScreen Profiler using the GreenScreen methodology that shows a children’s product and any substitute chemical is inherently less hazardous than before the substitution was made, to be sufficient to approve a HA, assuming all other provisions of this rule and OAR 333-016-3030 (Hazard Assessment for Substitute Chemicals) have been met.
(8) A HA approved by the Authority may be used to apply to a new product if the composition of the new product is substantially similar to that specified in an approved HA and differs 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, and 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 HA;
(b) There are not any HPCCCHs at or above de minimis levels in addition to those in a product that has an approved HA; and
(c) Neither the concentration of the HPCCCH nor its mobility from the new product has increased from those in the referenced product.
(9) To substantiate a claim that an HA approved by the Authority applies to a new product, manufacturers shall submit all of the following:
(a) A copy of the reference HA 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 products into Oregon, with 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 subsection (1)(b) of this rule.

Source: Rule 333-016-3030 — Hazard Assessment for Substitute Chemicals, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-3030.

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 333-016-3030’s source at or​.us