Rules and Rulemaking
The Oregon Health Authority (OHA) is currently writing rules (Oregon Administrative Rules - OARs) that will govern what manufacturers must do to comply with the law. Rule writing is happening in phases as described below.
If you are unable to access the rules in the links below, current TFK rules are
here. Current PQLs (OAR 333-016-2035) are
Phase 1||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.|
Phase 2||Detail manufacturer reporting requirements. Detail required components of a Manufacturing Control Program (MCP) required for an exemption request from reporting requirements. HPCCCHs and products in approved MCPs are also exempt from removal/substitution requirements specified in
OAR 333-016-3010(1). Establish penalties for noncompliance with reporting requirements.|
Phase 2.1 |
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 an alternative to make the product less hazardous or have a waiver approved by the Authority. Established rules so that manufacturers may comply with removal/substitution obligations
OAR 333-016-3010(1) by the third Biennial Notice Period for HPCCH/product category combinations. [January 1, 2022 is the third Biennial Notice Period for HPCCH/product category combinations reported in 2018 and 2020.] Established rules for manufacturers to apply for exemptions from removal or substitution requirements. Modify previously established rules to clarify them, including harmonizing spelling of HPCCCHs (AKA
Chemicals of High Concern to Children) with that of counterparts on State of Washington's Children's Safe Product Act list. [No HPCCCHs were added or removed in this rulemaking.]
A number of previously written OARs for the Toxic Free Kids Act were affected by Phase 3 rulemaking. All OARs to the right are current and in effect from
March 1, 2021.
OARs for the Toxic Free Kids Act may also be accessed at
OAR 333-016, starting at 333-016-2001.
Manufacturer Disclosure of HPCCCH Used in Children’s Products: Practical Quantification Limits
Temporary Rule for Biennial Notifications
333-016-2060 Notification Requirements by stipulating that concentrations of HPCCCH (expressed as parts per million) in a unit/component part are to be reported as that HPCCCH's proportion of the mass of that unit/component part. If there are multiple concentrations for a given unit/component part in a particular product category, the manufacturer must report the highest concentration. This clarification applies to
January 1, 2022 biennial notifications (for children's products sold/offered for sale in Oregon in 2020 thru 2021).
Rulemaking to make these changes permanent took place in September 2021.
Status: Temporary Rulemaking
Permanent Rule Revision to Clarify Reporting|
and Revise Reportable Chemical List
| Add five chemicals to list of high priority chemicals of concern for children's health (HPCCCH). Amend Exhibit A referenced in OAR 333-016-2035 practical quantification limits (PQLs).
Make permanent temporary rule
|Phase 4||Amend OAR 333-016-2010; 333-016-2030; and |
333-016-3050 per the 2023 Toxic Free Kids Modernization Act (HB 3043)
| Status: Proposed|
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.