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 phases as described below. Complete rules are found at: OAR 333-016, starting at 333-016-2000.
||Establish a list of high priority chemicals of concern for children's health (HPCCCH) 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.
Part A: 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.
Part B: Amend list of HPCCCH.
||Amend Exhibit A referenced in OAR 333-016-2035 practical quantification limits (PQLs). Five PQLs corresponding to the HPCCCH added during permanent rulemaking are added to Exhibit A. Three PQLs for the three HPCCCH delisted in the same rulemaking are removal. (See Phase 2.1 for chemical changes.)
PQLs for manufacturer disclosure of HPCCCH in children's products
Detail requirements for manufacturers of three specific categories of
children's products (those for children under three years-old;
"mouthable" items, per ORS 431A.253(8); and children's cosmetics) to
remove HPCCCH from product models in these categories or substitute HPCCCH with
a less-hazardous alternative or have a waiver approved by the Authority.
Establish rules so that manufacturers may comply with their obligations under
the law by January 1, 2022. Establish rules for manufacturers to apply for exemptions from removal or substitution requirements. Modify previously established rules to clarify
Proposed rules and changes to existing rules may be found in 333-016 Notice
of Proposed 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 on July 16, 2020 at 9:00 a.m. Due to COVID-19, public hearings are via conference call only. To provide oral testimony during this hearing, please dial 1-877-848-7030. Use access code: 2030826#.
2) Written comments may be filed before 5:00 p.m. on July 23, 2020. Please see 333-016 Notice to Interested Parties for how to do this.
Phase 1: ORS 431A.255 requires 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 is to review the list of chemicals every 3 years and may remove chemicals or add up to 5 chemicals per review cycle.
Phase 2: ORS 431A.258 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: ORS 431A.260 requires that non-exempt manufacturers either remove the chemicals on the list from specific product categories or apply to OHA for a waiver by their third report (first deadline possible is January 1, 2022).
Per ORS 431A.260, those categories are:
(b) A children's cosmetic; or
(c) Made for, marketed for use by or marketed to children under three years of age.
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, ORS 431A.263 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.