OAR 333-016-3060
Alternatives Assessment


(1) An Alternatives Assessment (AA) must evaluate the possibility of replacing chemicals in products or processes with an inherently safer alternative, in order to better protect and enhance human health.
(2) A manufacturer must conduct an AA by doing a Hazard Assessment (HA), Quantitative Exposure Assessment (QEA), technical feasibility assessment, and financial feasibility assessment, starting with an HA, except as specified in section (3) of this rule. The three remaining assessments may be conducted in any order.
(3) If, after HA and technical feasibility assessments are conducted, an alternate chemical substitute or substitutes is not found to be technically feasible, the financial feasibility assessment is not required.
(4) The HA for purposes of an AA must be conducted in accordance with OAR 333-016-3030 (Hazard Assessment for Substitute Chemicals).
(5) The QEA for purposes of an AA must be conducted in accordance with OAR 333-016-3050 (Quantitative Exposure Assessment).
(6) To substantiate a claim that removal of a HPCCCH or substitution of a HPCCCH in a children’s product with a less hazardous chemical is not technically feasible, a manufacturer must provide to the Authority the following for each HPCCCH in a children’s product:
(a) A detailed analysis of the role of each HPCCCH in the product specified by function, its application in the product (in a material, component, or manufacturing process) and whether the HPCCCH or function is non-essential, substitutable, essential, or a contaminant;
(b) For HPCCCH roles labeled as substitutable or non-essential, an explanation with supporting evidence shall be provided that justifies retaining the HPCCCH in the children’s product;
(c) A detailed analysis of the role played by each HPCCCH if labeled as non-essential, substitutable, or essential in the product for the reliability, quality, useful life and acceptability to consumers of the product; and
(d) After an AA is conducted, a detailed explanation of why it not technically feasible for any identified alternate chemical substitutes to fulfill the roles specified in subsections (a) through (c) of this section.
(7) To substantiate a claim that removal or substitution of a HPCCCH is not financially feasible, a manufacturer must provide to the Authority a price comparison of the cost to produce the children’s product with an alternative chemical to the current cost to produce the product. The comparison must include:
(a) Direct costs along the value-chain, such as product reformulation;
(b) Retooling;
(c) Research or other capital investment costs;
(d) An evaluation of adequate supply to meet demand; and
(e) An evaluation of the potential reduction in price of the alternative chemical if the volume of the alternative chemical being purchased increases.
(8) An AA 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 AA 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 an AA 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 AA;
(b) There are not any HPCCCHs at or above de minimis in addition to those in a product specified in the approved AA; and
(c) Neither the concentration of the HPCCCH nor its mobility from the product has increased from those in the referenced products.
(9) To substantiate a claim that an AA approved by the Authority applies to a new product, manufacturers shall submit all of the following:
(a) A copy of the referenced AA 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 the new affected products as specified in OAR 333-016-3010 (Removal or Substitution of High Priority Chemicals)(3)(a) through (c).

Source: Rule 333-016-3060 — Alternatives Assessment, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-016-3060.

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 333-016-3060’s source at or​.us