| What is an Exemption from Notice Requirement/MCP? |
Per
OAR 333-016-2010, "a Manufacturing Control Program or 'MCP' means a program implemented by the manufacturer or its suppliers to control the amount of an HPCCCH present as a contaminant at or above de minimis levels through the implementation of tools, processes and oversight that support effective chemicals management at all levels to include supply chain management, quality assurance and educational programs. Control includes the minimization, reduction or elimination of contaminants when possible."
If approved, an MCP submitted with a request for Exemptions from Notice Requirement ( OAR 333-016-2070), exempts product category/HPCCCH combination(s) in the MCP from the reporting/biennial notice requirement ( OAR 333-016-2060) from that point onward.
This means that product models/styles in the product category/HPCCCH combinations in an approved MCP, which belong to one or more of the subsets of children’s products identified in
OAR 333-016-3010, are no longer subject to the HPCCCH removal or substitution requirement after their third biennial notice period.
Key Points for Exemptions from Notice Requirement/MCP:
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Under the TFK Act, requests for Exemptions from Notice Requirement/MCP
must be approved by OHA
before the product category/HPCCCP combination is considered exempt from TFK's biennial notice/reporting requirement.
- This exeption type is not available for product models affected by
OAR 333-016-3010 after the start of their fourth Biennial Notice Period. See FAQ#30
This is different than exemption from notice requirement rules for Washington State's
Children's Safe Products Act. Under CSPA, manufacturers may provide MCPs not yet reviewed by the Washington Department of Ecology to determine if product category/HPCCCH combinations must be reported under CSPA.
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Requests for Exemptions from Notice Requirement/MCP that OHA has not approved/denied may be changed to meet the requirements of
OAR 333-016-2070, and resubmitted before the end of future biennial notice periods, subject to limitations for children's products affected by OAR 333-016-3010.
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| Which children’s products are eligible for Exemption from Notice Requirement/MCP? |
Any children’s product with an HPCCCH, found as a ‘contaminant’ at 100 ppm or more in a children’s product, may be included in a supporting Manufacturing Control Program (MCP) as stipulated in OAR 333-016-2070. Per ORS 431A.253:
“Contaminant” means trace amounts of chemicals that are incidental to manufacturing and that serve no intended function in the product component, including but not limited to:
(a) Unintended by-products of chemical reactions during the manufacture of the product component; (b) Trace impurities in feedstock; (c) Incompletely reacted chemical mixtures; and (d) Degradation products.
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| Which children’s products are not eligible for Exemption from Notice Requirement/MCP? | Two groups of children's products are not eligible for Exemption from Notice Requirement/MCP:
First, children’s products with HPCCCHs that are ‘intentionally added’ and found at de minimis are not eligible for exemption from the reporting/biennial notice requirement. Per
ORS 431A.253, intentionally added chemical means a chemical in a product that serves an intended function in the product component.
Biennial notices/reports must be made for children's products with component parts containing intentionally added HPCCCP above de minimis. De minimis levels, also called practical quantification limits, for specific HPCCCHs vary. Those levels may be found at
OAR 333-016-2035(2), Exhibit A.
Second, requests for Exemption from Notice Requirement/MCP are only available for product models, affected by
OAR 333-016-3010, sold or offered for sale in their first, second or third Biennial Notice Period.
After the start of their fourth Biennial Notice Period, HPCCCHs in those product models must be removed or substituted per OAR 333-016-3020. Alternatively, requests for a waiver and/or exemption from the removal or substitution requirement may be submitted. Those request "pause" enforcement of
OAR 333-016-3010 until OHA makes a final decision on those requests.
Manufacturers requesting for Exemption from Notice Requirement/MCP for a product category/HPCCCH combination in its fourth biennial notice period (or beyond) should understand that product models affected by
OAR 333-016-3010 are not to be be considered part of the MCP request.
Instead,
OAR 333-016-3010 requires that HPCCCH in those product models be reported on the due date for the third biennial notice period for that product category/HPCCCH combination.
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| WHEN must a request for Exemption from Notice Requirement/MCP be received by OHA? | OHA will accept requests for Exemption from Notice Requirement/MCPs on or before the date (January 31st) the biennial notice/report is due for a product category/HPCCCH combination in question.
Emailing the request and paying the application fee by check will also be available. Directions for emailing the request and paying by check will be posted at the same location at that time.
IMPORTANT: Under Washington’s State’s Children’s Safe Product Act, manufacturers who are required to report their products may, instead of reporting, may provide their MCPs upon request by the Washington Department of Ecology for review. This is not possible for Oregon’s law. Please see FAQ #28 to learn more about applying for an Exemption from Notice Requirement/MCP under Oregon's law. |
| Who can apply for Exemption from Notice Requirement/MCP? |
Manufacturers of children’s products or a trade association representing manufacturers of children’s products may apply per
OAR 333-016-2070. |
| What are the requirements for an Exemption from a Reporting /MCP? | |
| What happens after I submit a request for Exemption from Notice Requirement/MCP? |
You will receive a receipt confirming payment of the $1500 application fee. OHA will confirm receipt of the MCP by email. Contact the Toxic Free Kids Program at
toxicfreekids.program@odhsoha.oregon.gov if this confirmation is not received 14 days after the MCP’s submission.
Until OHA communicates its final decision on an MCP to the manufacturer/trade association that submitted it, the biennial notice/reporting requirement for the product category/HPCCCH in the MCP is paused, as stated in
Guidance for Manufacturing Control Program per OAR 333-016-2070. OHA will not initiate enforcement action for failure to submit a biennial notice/report for the any product category/HPCCCH combinations in the submitted MCP. |
| My company has multiple HPCCCHs and/or multiple product categories/GS1 bricks for which I’d like exemption from reporting. |
a. Can I submit them all together under one request? Yes, under the TFK Act and its rules, multiple HPCCCHs and/or multiple product categories/GS1 bricks may be submitted in the same MCP.
b. Why might I not want to do this? Under
OAR 333-016-2070, OHA must approve or deny an MCP in its entirety. That means, for example, if six product categories/GS1 ‘bricks’ containing formaldehyde (CASN 50-00-0) are submitted in the same MCP, but the requirements of
OAR 333-016-2070 are met for four of them, OHA must deny the MCP.
Manufacturers are advised to ensure that each combination of product category/HPCCCH included in a submitted MCO meets the requirements of
OAR 333-016-2070. |
| Can OHA recommend technical expertise to assist in the preparation of an MCP? | No, OHA cannot recommend specific sources of technical expertise for this purpose. However, professionals and firms with experience in assisting manufacturers to comply with U.S. Consumer Product Safety Commission or European Union requirements for children’s products, are available. Trade associations for children’s products and cosmetics may be able to assist. |