Rules and Rulemaking
The Oregon Health Authority (OHA) is currently writing rules that will govern what manufacturers must do to comply with the law. Rule writing is happening in three phases:
||Establish a list of high priority chemicals of concern for children's health and criteria by which the list can be updated in the future.
||Detail manufacturer reporting requirements. Detail required components of a Manufacturing Control Program which is an exemption request from these rule requirements and those in Phase 3. Establish penalties for noncompliance with reporting requirements.
Amend list of high priority chemicals of concern for children's health. Establish a priority order of those entities responsible for providing product notifications. [The same priority order will be used for enforcement purposes.] Clarify that only one entity meeting the definition of manufacturer is required to provide product notifications. Establish that product notifications include the number of products sold or offered for sale in Oregon during notice period. Align Exemption Request Review Fee in rule with that in statute.
Proposed changes may be found in 333-016 Notice of Rulemaking. [Note: in document, language proposed to be added is underlined while language proposed for removal is indicated by strikethrough.]
Comments on proposed changes may be provided as follows:
1) A public hearing, during which oral testimony may be presented, will be held on August 16, 2018 at
9:00 a.m. at the Portland State Office Building, 800 NE Oregon St., Room 1A,
Portland, OR 97232.
2) Written comments may be filed before 5:00 p.m. on August 22, 2018. Please see 333-016 Notice to Interested Parties for how to do this.
||Detail requirements for manufacturers to remove chemicals of concern from products or seek waiver. Detail required components of waiver request and establish approved methods for alternative assessment.
||Status: Rule development and rules advisory committee meetings begin in 2019|
Phase 1: SB 478 required OHA to post the list of high priority chemicals of concern for children's health that manufacturers will be required to report, along with health information about these chemicals, by January 1, 2016. OHA will review the list of chemicals every 3 years and may remove chemicals or add up to 5 chemicals per review cycle.
Phase 2: SB 478 requires manufacturers of children’s products to report to OHA the products they manufacture that contain chemicals on the list and identify which chemicals they contain.
- The first round of manufacturer reporting is due to OHA by January 1, 2018, unless OHA approves the successful submission of a Manufacturing Control Program exemption request.
- From then on, non-exempt manufacturers will be required to report every other year until they remove the chemicals of concern from their products, or they stop marketing the products containing those chemicals in Oregon.
Phase 3: SB 478 requires that non-exempt manufacturers either remove the chemicals on the list from their products or apply to OHA for a waiver by their third report (first deadline possible is January 1, 2022).
If a manufacturer applies for a waiver, they will be required to either demonstrate that:
- The chemical of concern does not move from the product into children’s bodies under conditions of normal use of the product, or;
- Conduct an alternatives assessment demonstrating that eliminating or substituting the chemical of concern is not financially or technically feasible.
If a manufacturer replaces a chemical of concern with another chemical in the product, SB 478 requires that they submit a chemical hazard assessment demonstrating that the substitute chemical is not as or any more toxic than the replaced chemical of concern.