Or. Admin. R. 333-016-3060

Current through Register Vol. 63, No. 6, June 1, 2024

Section 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.

(5) The QEA for purposes of an AA must be conducted in accordance with OAR 333-016-3050.

(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(3)(a) through (c).

Or. Admin. R. 333-016-3060

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