333-016-2070 Exemptions from Notice Requirement (1) A manufacturer of children’s products with annual worldwide gross sales of less than $5 million, as reported on the most recent tax return filed by the manufacturer before the notification required under OAR 333-016-2060, is exempt from all the requirements of these rules. (2) If, following the filing of the most recent tax return, a manufacturer’s annual worldwide gross sales are $5 million or more, the manufacturer must submit a notice as required under OAR 333-016-2060. The notice must be submitted during the next applicable reporting period or within 180 days of the filing, whichever is later. (3) A manufacturer or trade association may submit to the Oregon Health Authority ( Authority) a request for an exemption from these rules if the high priority chemical of concern to children’s health ( HPCCCH) in a children’s product is present only as a contaminant at or above the de minimis level, and a manufacturing control program (MCP) is in place. A request for an exemption must be accompanied by any applicable fees in OAR 333-016-2080. (a) An exemption request submitted by a trade association on behalf of its members must identify each member for which the exemption is being requested, including the name and contact information of a representative for each of those members. (b) A request for an exemption from these rules by any entity must be received by the Authorit y on or before January 31st of even numbered years for the previous two-year biennial notice period. (4) In order to meet the standards for an exemption an MCP must be structured using at least one of the following categories: (a) Manufacturing processes, for example polymerization of plastic resin, injection-molding of plastic, pad-transfer printing, silk screening; (b) Materials or group of materials, for example multiple styrenic plastics; (c) Component parts; (d) A HPCCCH present as a contaminant at or above the de minimis level; or (e) Finished products. (5) In addition to the information provided in section (4) of this rule a manufacturer or a trade association must document in its exemption request the specific HPCCCH present as a contaminant at or above the de minimis level that the MCP is intended to address and the product categories where the HPCCCH are found . MCPs submitted in support of an exemption request by a trade association on behalf of a member or members must include the product categories for which each member is seeking an exemption. (6) In order for the manufacturer to demonstrate that an MCP meets the minimum standards for an exemption, the MCP must meet generally-recognized industry best manufacturing practices and processes for the control of a HPCCCH, such as but not limited to : (a) The most current and appropriate International Standards Organization (ISO) requirements for a specific manufacturing process or facility. The manufacturer must demonstrate how the ISO certification held by the manufacturer or supplier is controlling the contaminant in a component part or in the finished children’s product . (b) Another established certification or standards manufacturing control program such as, but not limited to, Sony Corporations Green Partners Standards, the European ROHS (Restriction of Hazardous Substances in Electronic Parts), and EN-71. (c) The most current American Society for Testing and Materials (ASTM) International standards that provide the recommended industry standards for materials used or produced in the manufacturing process; (d) Any proven alternative methodology that will enable the manufacturer to demonstrate: (A) That the methodology controls the contaminant to the lowest practicable levels in the finished children’s product; and (B) That the alternative methodology is as or more effective at controlling the contaminant than the standards in subsections (a) through (c) of this section. (7) For any category described in section (4) of this rule a manufacturer must provide adequate evidence that the contaminant is being controlled, including but not limited to: (a) Periodic laboratory test reports from a third-party laboratory accredited to the current ISO/IEC 17025 standards by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement. The laboratory must be accredited for the method used to conduct the testing. The testing must show the presence, if quantifiable, and the amount of a HPCCCH, including documentation that characterizes the test methodology. (b) A supplier’s certificate of analysis documenting the maximum levels of contaminant in any category described in section (4) of this rule for which the exemption is being requested. A certificate of analysis must include: (A) The name and address of the laboratory that performed the tests; (B) The name and description of the product or material being tested, including, if known, the batch number used by the original manufacturer; (C) The date of the batch’s manufacture; (D) A description of methodology employed to take samples from the batch to ensure that samples are representative of the product or material being tested; (E) A reference to the analytical laboratory test method used, including the data quality assurance criteria and reporting limits; (F) The results of all analytical laboratory tests performed on the batch for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits); (G) The date or dates on which the test or tests were performed; and (H) The signature of an authorized representative of the laboratory, and the contact information for that individual. (c) Documentation demonstrating that the instituted control measures are able to control the contaminant, as appropriate for the category described in section (4) of this rule, including but not limited to, the quantification of the degree of contaminant control occurring because of contaminant control measures instituted. (8) In addition to meeting one of the requirements of section (6) of this rule a manufacturer must document and describe, in its exemption request, whether the manufacturer’s or the manufacturer’s supplier’s manufacturing control process, include any of the following : (a) Procedures to ensure the quality and purity of feedstock, whether raw or recycled; (b) Contract specifications for manufacturing process parameters, for example material purity, drying and curing times when relevant to the presence of high priority chemicals in the finished children’s product components; (c) Periodic testing that is for the presence and amount of HPCCCH in the finished children's product, including documentation of how tests were conducted and applicable lab results from an accredited third-party laboratory that meets the standards in subsection (7)(a) of this rule; (d) Procedures and approaches to audit the methods used by contractors or suppliers to control a HPCCCP present as a contaminant in a children’s product; and (e) Education and outreach to members of a supply chain about the importance to the manufacturer of controlling the amount of HPCCCH in supplied materials through activities such as discussions with suppliers, oral presentations, written materials or webinars. (9) The Authority, upon receipt of an exemption request will date stamp the document. Once date stamped the Authority must approve or deny an exemption request within 180 days. (a) If the Authority does not approve or disapprove the exemption request within 180 days the manufacturing control program exemption is deemed approved. (b) If the Authority approves the exemption the Authority will notify the manufacturer of the approval, in writing. (c) If an exemption request is disapproved, the Authority will provide written notice to the manufacturer of the disapproval and the reason for the disapproval. (10) If the Authority disapproves an exemption request, the manufacturer may submit a revised exemption request for consideration within 180 days after the Authority’s notice of disapproval. (11) If the exemption request is denied a second time, the manufacturer will have 90 days from the date of the written notification of disapproval to submit a notification in accordance with OAR 333-016-2060. (12) A manufacturer who has been denied an exemption request a second time may submit a new exemption request under section (3) of this rule during future biennial notice periods. (13) At any time the Authority may request additional information from a manufacturer requesting an exemption , and may specify the time period by which the manufacturer must provide the requested information (14) A manufacturer or trade association may request an amendment of an MCP previously approved by the Authority. A request must be made at least 30 days before the next biennial notice period. Such amendments are limited to the following: (a) The addition of product categories to an MCP provided that the HPCCCH in the manufacturing of products in these added categories is monitored and controlled, at all stages, with the specific mechanisms, tests and processes itemized in the approved MCP. (b) Changes in the specific mechanisms, tests and processes identified in an approved MCP that are used to control an HPCCCH. (c) The inclusion of additional members for specific product categories on an MCP approved by the Authority provided those members use all specific mechanisms, tests and processes itemized on the approved MCP for those product categories. (15) The Authority may impose an MCP review fee under OAR 333-016-2080(1)(b)(B) for review of a request to amend an approved MCP. (16) Within 90 days the Authority will inform the holder of the approved exemption request if the proposed amendment to the MCP still meets the standards for exemption as described in these rules. (17) Trade associations seeking to include additional members on an MCP approved by the Authority in accordance with subsection (14)(c) of this rule shall submit a new exemption request as specified in section (3) of this rule. A request to add a member manufacturer to an approved MCP must include the product categories for which each member manufacturer is seeking exemption from these rules. (18) A trade association must notify the Authority within 90 days of the date it determines a manufacturer member listed on an approved MCP is no longer party to an approved MCP. (19) An approved MCP is only valid for the manufacturer that submitted it for approval. If a manufacturer with an approved MCP merges with or is acquired by another business entity the new controlling entity must send a notice to the Authority within 90 days confirming that the specific mechanisms, tests and processes itemized in the previously approved MCP will continue to be utilized, or the exemption will be considered by the Authority to be invalid. Statutory/Other Authority: ORS 413.042, 431A.258 & 431A.268 Statutes/Other Implemented: ORS 431A.258 & 431A.268 History: PH 119-2024, amend filed 12/22/2024, effective 01/01/2025 PH 9-2021, amend filed 02/28/2021, effective 03/01/2021 PH 5-2017, f. 1-31-17, cert. ef. 2-1-17 PH 34-2016, f. & cert. ef. 12-1-16