Oregon Health Authority
Public Health Division - Chapter 333
Division 16
HAZARDOUS SUBSTANCES
333-016-2060
Notification Requirements
(1) For purposes of this rule, "unit" has the same meaning as "component part" as that is defined in OAR 333-016-2010.
(2) A manufacturer of a children’s product sold or offered for sale in this state that contains a HPCCCH listed in OAR 333-016-2020 as an individual chemical or a member of a class or subclass of chemicals, in an amount at or above a de minimis level must submit:
(a) A notice to the Oregon Health Authority (Authority) that contains all the information required in these rules, unless the manufacturer or product is exempt; and
(b) A nonrefundable fee of $250 for the notification of each HPCCCH as specified in OAR 333-016-2080.
(3) The first manufacturer’s notice due on January 1, 2018, applies to children’s products sold or offered for sale in this state between January 1, 2017 and December 31, 2017. For the reporting years 2018, 2020, and 2022, reports are due on January 1st.
(4) On and after January 1, 2024, manufacturer reports are due on January 31st of even numbered years for the previous two-year biennial notice period. For example, for the reporting year 2024, a manufacturer must include children’s products sold or offered for sale between January 1, 2022, and December 31, 2023, that contain a HPCCCH listed in OAR 333-016-2020.
(5) The notice required in section (2) of this rule must include the following:
(a) The name and Chemical Abstracts Service Registry Number of the chemical contained in the children’s product;
(b) The product category of the children’s product that contains the chemical;
(c) A description of the function of the chemical in the children’s product;
(d) The amount of the chemical used in each unit within each product category. The amount of the chemical used in each unit of the children’s product is to be reported as a range rather than an exact amount. If there are multiple concentrations for a given unit in a particular product category, the manufacturer must use the highest concentration for reporting.
(e) The target age category for whom the children’s product is intended, either ages 0-3, 3-12 or 0-12 years-old;
(f) The number of the children’s product that contain the high priority chemical either sold or offered for sale in Oregon during the biennial notice period;
(g) The name and address of the manufacturer, and the name, address and telephone number of the contact person for the manufacturer;
(h) The name, address and contact information for the trade association submitting the notification on behalf of the affected industry; and
(i) Any other information that the manufacturer deems relevant to the appropriate use of the children’s product.
(6) No later than January 1, 2020, and every other year thereafter, notices to the Authority shall be submitted utilizing the Interstate Chemicals Clearinghouse’s High Priority Chemicals Data System (HPCDS) or alternate data system designated by the Authority. A link to the data system will be made available on the Toxic Free Kids Program website: www.healthoregon.org/toxicfreekids.
(7) If a manufacturer, required to report under ORS 431A.258, is acquired by another business entity, merges into another business entity or separates into distinct business entities, the new controlling entity must submit the required biennial notices to the Authority.
(8) If a manufacturer has included a children’s product in a notice required under these rules, and determines that there is no change to the information for the product except the number of products sold or offered for sale submitted to the Authority in the previous notice, the manufacturer may, in lieu of including the children’s product again in a subsequent notice, submit a written statement, or if available, an electronic notification indicating that the previous reported data is still valid for that children’s product. The notification shall include the number of products sold or offered for sale during the biennial notice period.
(9) A trade association may provide the notice required in these rules on behalf of a member manufacturer. If a trade association reports on a member manufacturer’s behalf, the trade association must specify which member or members the association is reporting on behalf of, including the name and contact information of a representative for each of those members, and must submit the fees for each member as required in OAR 333-016-2080.
(10) A trade association who fulfills the notice or exemption from notice requirements as well as waiver or hazard assessment requests in these rules on behalf of a member manufacturer will not be held liable for a violation or penalty as a result of the member manufacturer’s noncompliance with the requirements of these rules.
(11) A manufacturer may, during the notification process, submit to the Authority recommendations regarding technical, financial or logistical support considered necessary for the implementation of innovation and green chemistry solutions related to HPCCCH used in children’s products.
(12) Only one person or entity that falls within the definition of manufacturer is required to report with respect to a particular children’s product. The Authority will hold the following primarily responsible for ensuring that it receives a complete, accurate, and timely notice for the children's product, in the following order:
(a) Any person or entity that manufactured the children's product, unless it has no presence in the United States.
(b) Any person or entity that distributed or made available for distribution the children's product, unless it has no presence in the United States.
(c) The importer or owner of the children's product in the United States.
(13) The Authority will enforce the reporting requirements in this rule against a manufacturer in the same order as the priority order for reporting in section (12) of this rule.
(14) If a manufacturer has included a children’s product in a notice required under these rules, and removes the HPCCCH from that children’s product it shall, within 180 days of removal, submit a written statement, or if available, an electronic notification indicating the HPCCCH that was removed, whether another HPCCCH was substituted and the date the removal was effective, unless the Authority has already been notified under OAR 333-016-3010(1). Such notification will help the Authority avoid any unnecessary enforcement actions because of a failure to report or failure to comply with the other requirements of these rules.
Statutory/Other Authority: ORS 413.042 & 431A.258
Statutes/Other Implemented: ORS 431A.258
History:
PH 56-2023, amend filed 12/15/2023, effective 01/01/2024
PH 91-2021, amend filed 12/29/2021, effective 01/01/2022
PH 40-2021, temporary amend filed 08/26/2021, effective 08/26/2021 through 02/21/2022
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 253-2018, amend filed 09/11/2018, effective 10/01/2018
PH 5-2017, f. 1-31-17, cert. ef. 2-1-17
PH 34-2016, f. & cert. ef. 12-1-16