U.S. – Oregon Toxic Free Kids Act Signed into Law
Vol. 842 | 29 Jul 2015
On July 28, 2015, Oregon’s Toxic Free Kids Act (Senate bill 478) was signed into law by Governor Kate Brown; it will go into effect January 1, 2016. This bill is similar to the laws in the states of Vermont and Washington; and establishes a list of high priority chemicals, requires reporting by manufacturers for presence of these high priority chemicals in certain children’s products, and calls for phase-out of high priority chemicals in certain products. The details of this bill are outlined below:
What is covered?
Scope: Following children’s product1, accessible and inaccessible components.
- A product designed or intended by the manufacturer to facilitate sucking, teething, sleep, relaxation, feeding or drinking
- Children’s clothing and footwear
- Car seats
- Children’s cosmetics
- Children’s jewelry
- Athletic shoes with cleats or spikes,
- BB guns, pellet guns and air rifles
- Bicycles and tricycles
- Chemistry sets
- Certain consumer electronic products
- Interactive software intended for leisure and entertainment
- Model rockets
- Pocketknives and multitools
- Roller skates
- Sets of darts with metallic points
- Slings and catapults
- Snow sporting equipment
- Sporting equipment and accessories
- Video toys that can be connected to video screen and operated at nominal voltage exceeding 24 volts and
- Food and beverages and their packaging regulated by FDA
Also, exempt are the manufacturer(s) with annual worldwide gross sales of less than $ 5 million, as reported on the most recent tax return filed.
Who is covered (responsible)?
U.S. manufacturer, importer of record or domestic distributor.
What is required?
- Report chemicals of high priority contained in products at or above the “de minimis level”2 to the Oregon Health Authority (OHA) once every two years (biennially) on January 1 of each applicable year.
- The first biennial notice required for a product containing a chemical of concern needs to be within one year, on the January 1 of the following year, from when the chemical is added to the list.
- The notice shall contain:
- Name and CAS# of chemical contained in product
- Product category of children’s product
- Description of function of chemical in product
- Amount of chemical used in each unit, reported as a range rather than an exact number
- Name and address of manufacturer AND name, address and phone number for a contact person at the manufacturer
- Any other relevant information
- If the Oregon Health Authority has entered into data sharing agreements with other states and a manufacturer has reported the information required in the notice to the other state, then the manufacturer may request the other state to provide the information to the OHA, as long as it satisfies all the information requirements of the notice.
- In lieu of submitting such notice information to the OHA, the Authority may require the notice submitted to the Interstate Chemical Clearinghouse. But the specific procedures for such submissions will need to be clarified by way of a rule.
- The OHA can grant exemptions to manufacturers of children’s products containing chemicals of concern:
- If the manufacturer can confirm that the chemical is present only as a contaminant
- Has a MCP
- And the MCP meets the Authority’s minimum standards
- Approval or disapproval of exemptions shall happen with 180 days of submission. If the authority fails to act within 180 days, the exemption application is deemed approved.
Manufacturing Control Program (MCP) reporting exemption:
- On or before the third biennial notice required, the manufacturer must either remove the chemical of concern, make a substitution or apply for an exemption, if the product is:
- A children’s cosmetic, or
- Intended for use by children under 3 years of age
- Substitution of chemicals of concern
When a manufacturer removes a chemical of concern and substitute another chemicals, a hazard assessment shall be submitted to OHA to demonstrate how the children’s product, and any substitute chemical the children’s product contains, is inherently less hazardous than before the substitution was made.
- OHA will establish a methodology that a manufacturer must use and the standards that a children’s product must meet in order to comply with the hazard assessment requirements. The OHA will approve or disapprove a hazard assessment within 180 days after submission. If no action from OHA within 180 days, the hazard assessment is deemed approved. If disapproved, the manufacture may submit a revised hazard assessment within 180 days.
- Removal of chemical of concern
When a manufacturer removes a chemical of concern without substitution, a notice must be submitted to OHA that a manufacturer is no longer using the chemical or a substitute chemical.
- A manufacturer can apply a waiver by submitting one of following:
- An alternative assessment demonstrating that removal of the chemical of concern is not financially or technically feasible; or
- A quantitative exposure assessment demonstrating that the chemical of concern is not reasonably anticipated to result in exposure based upon an analysis of leachability or bioavailability.
- OHA will approve or disapprove a waiver application within 180 days after submittal. If no action within 180 days by OHA, the waiver is deemed approved. If disapproved by OHA, a manufacture can submit the revised application for consideration within 180 days.
- Assessments (Alternative assessment or quantitative exposure assessment) shall be conducted based on the guidance or frameworks as established by EPA, the Interstate Chemicals Clearinghouse, California or other states or non-governmental organizations or as developed by OHA. OHA may recommend or require a manufacture follow a particular framework or guidance. If an assessment is determined to be incomplete by OHA, OHA may seek assessment from another party and the generated assessment cost must be paid by the manufacture.
- A manufacturer can apply a waiver by submitting one of following:
High Priority Chemicals
- On the effective date of the act, the Oregon Health Authority (OHA) will establish a list of high priority chemicals which will include, but not necessarily be limited to, the Washington state 66 Chemicals of high concern to children (CHCC).
- This list of high priority chemicals will be reviewed and revised every 3 years and no more than five new chemicals maybe added during each revision.
- If any additions or modifications occur in the WA CHCC list or other federal and state lists, these shall be reviewed by Oregon and considered for similar actions.
- If a chemical on the list is no longer being used in children’s products, the OHA may consider removing it from the list.
- The list of high priority chemicals will be maintained on the OHA’s website and updated at least within a year of a chemical being added or removed from the list.
If a federal standard establishes requirements for high priority chemicals in children’s products, then the OHA will consider that product compliant and not requiring AA as long as the product is in compliance with federal requirements. Unless the OHA establishes that a lower level of the chemical is required for the safety of human health vs. the levels set by the federal authorities.
- Reporting or AA provisions:
- To be adopted by rule.
- Not to exceed $ 5,000 for first violation3.
- Not to exceed $ 10,000 for second and each subsequent violation.
- Statement of compliance may be requested by authority, if there is a reason to believe children’s product contains a high priority chemical of concern and is in violation of reporting or AA provisions of this rule.
- Fund: Separate fund is established for implementation and administration of this rule. The fees and fines collected in the rule will be part of this fund. Also, any money accepted as gifts, grants or contribution from public or private source for execution of this rule, will be part of this fund.
- Report to legislative assembly: OHA to provide report to legislative assembly, no later than September 15 of each odd-numbered year, on:
- Revision to high priority chemical list.
- # of manufacturers in compliance with reporting rule and analysis of submitted reports.
- Details about hazard assessments and waivers as part of AA.
- Surveillance testing results.
- Recommendations submitted to OHA by manufacturer under reporting rule.
- Regulation effective date: January 1, 2016.
- First biennial notices due date: no later than January 1, 2018.
For questions, please contact:
Dr. Pratik Ichhaporia
1products that are made for, marketed for use by or marketed to children under 12 years of age
2“De minimis level” means:
(a) For a chemical that is an intentionally added chemical, the practical quantification limit; or
(b) For a chemical that is a contaminant, a concentration of 100 parts per million.
3a violation consists of a single course of conduct with regard to an entire children’s product line that is sold or offered for sale in this state.