Waiver and Exemptions from Removal/Substitution

Frequently Asked Questions

FAQ#	QUESTION	ANSWER
#38	What are alternatives to HPCCCH removal or substitution that a manufacturer may take by the end of the third biennial notice/reporting period of a product category/HPCCCH combination?	Instead of removal or substitution of an HPCCCH in its children’s products subject to OAR 333-016-3010, a manufacturer must take one or more of the following options on or before the due date of the third biennial notice/report for a product category/HPCCCH combination: Waiver and Exemption from Removal or Substitution Requirements Requests Instead of removing or substituting an HPCCCH from a product subject to OAR 333-016-3010, a manufacturer may submit a request for: Exemptions from Removal or Substitutions Requirements per OAR 333-016-3015; and/or Waiver from Removal or Substitution Requirements per OAR 333-016-3040. If OHA approves either one of these requests, the HPCCCH(s) in specific brand name/product models approved in the request do not need to be removed nor substituted. Manufacturers may apply for both requests.
#39	What options are available to support a Waiver Request?	Manufacturers making requests under OAR 333-016-3040 must support the request with either: A Quantitative Exposure Assessment (QEA) meeting the requirements of OAR 333-016-3050; or An Alternatives Assessment (AA) meeting the requirements of OAR 333-016-3060. The Guidance for a Quantitative Exposure Assessment (QEA) per OAR 333-016-3050 is available to assist in development of a QEA. [A QEA is a required component of an AA, so the QEA Guidance applies to both options.]
#40	HOW and WHEN must a request for a Waiver be received by OHA?	On or before the date (January 31st) on which a manufacturer of a children's product must submit the third biennial notice for a product category/HPCCCH combination, the manufacturer may submit a completed request for a complete request for a waiver (OAR 333-016-3040). Please follow in instructions in FAQ #39 above to develop a Waiver request. Then submit the waiver request on or before the reporting due date (January 31st) By the 15th of the December preceding the end of two-year biennial notice period, a secure fee payment and application upload portal will appear at healthoregon.org/toxicfreekids . This is called the TFK Fee Payment & Application Upload Portal. The $1500 application fee is paid by credit card and the documentation for a request uploaded at this secure website. In the Portal's dropdown, there are two choices for submitting a waiver request: Waiver from Removal or Substitution Requirement Request (Quantitative Exposure Requirement - QEA) and Waiver from Removal or Substitution Requirement Request (Alternatives Assessment - AA). Make sure you are selecting the correct one for the type of waiver being submitted. IMPORTANT: When paying by credit card, the address entered must be the same as the billing address known to the credit card company. If it is not, the credit card payment will be rejected and your submission will not be accepted by OHA. The State of Oregon's payment processor accepts VISA, Mastercard and Discover cards. It does not take American Express. Manufacturers are able to emailing the request and pay the application fee by check. Directions for emailing the request and paying by check are given at the Portal.
#41	HOW and WHEN must a request for Exemptions from Removal or Substitution Requirements be received by OHA?	On or before the date (January 31st) on which a manufacturer of a children's product must submit the third biennial notice for a poduct cateory/HPCCCH combination, the manufacturer may submit a completed request for an exemption from removal or substitution (OAR 333-016-3015) request. Manufacturers should know that exemption from the requirements of OAR 333-016-3010 using OAR 333-016-3015 may not be available for all HPCCCHs. Manufacturers making a request under OAR 333-016-3015 should follow the rules in OAR 333-016-3015. Guidance for Requesting Exemptions from Removal or Substitution Requirements per OAR 333-016-3015 may be of help in the development of this request. By the 15th of the December preceding the end of two-year biennial notice period, a secure fee payment and application upload portal will appear at healthoregon.org/toxicfreekids . This is called the TFK Fee Payment & Application Upload Portal. The $1500 application fee is paid by credit card and the documentation for a request uploaded at this secure website. Choose Exemptions from Substitution or Removal Requirement Request option in the dropdown. IMPORTANT: When paying by credit card, the address entered must be the same as the billing address known to the credit card company. If it is not, the credit card payment will be rejected and your submission will not be accepted by OHA. The State of Oregon's payment processor accepts VISA, Mastercard and Discover cards. It does not take American Express. Emailing the request and paying the application fee by paper check will be available. Directions for emailing the request and paying by check are given in the Portal. Already have an *exemption from removal or substitution requirement* approved by OHA? You may be able to add additional children's products to that list via email and without a fee. See OAR 333-016-3015(8) and (9) for criteria. Do not use the portal discussed above. Email a signed application form for OAR 333-016-3015(8) and (9); the spreadsheet of added product models; and the APPROVAL letter the manfucturer received from OHA to: toxicfreekids.program@odhsoha.oregon.gov. This should be done on or before the January 31st following the reporting period in which the added product models were sold or offered for sale in Oregon.
#42	My company has multiple HPCCCHs and/or multiple product models and styles for which I’d like a waiver and/or exemptions from removal or substitution requirements. Can I submit them all together under one request?	Manufacturers may include multiple HPCCCHs and/or multiple product models and styles in the same Waiver or Exemption from Removal or Substitution Requirements request. The Authority may approve or disapprove a request in whole or in part, based on criteria established in the rules.
#43	Can OHA recommend technical expertise to assist in the preparation of a QEA or AA?	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.
#44	What happens after I submit a request for a Waiver or Waiver or Exemption from Removal or Substitution Requirements?	You will receive a receipt confirming payment of the $1500 application fee. OHA will confirm receipt of the documents by email. Contact the Toxic Free Kids Program at toxicfreekids.program@odhsoha.oregon.gov if this confirmation is not received 14 days after the request’s submission. Read OAR 333-016-2080 for additional information on the OHA’s process, including fees OHA will charge for review of these requests.
#45	What are a company’s obligations for a children’s product(s) previously reported as containing HPCCCH(s), but from which the HPCCCH has been removed?	For items affected by OAR 333-016-3010(1): Manufacturers that have made two biennial notices/reports to OHA for product category/HPCCCH combination, must notify OHA of individual models/styles in that combination affected by OAR 333-016-3010(1). Product models/styles to which OAR 333-016-3010 applies are those that are: “Mouthable” products (per ORS 431.253(8)); Children’s cosmetics; or Made for, marketed for use by or marketed to children under three years of age. Manufacturers must notify OHA of those models/styles in a product category/HPCCCH combination that: Will not be offered for sale in Oregon on the next January 1st of the fourth biennial notice period and after; or Have had HPCCCHs removed and do not have a substitute chemical; or Are no longer being manufactured; or Contain substitute chemicals that are no longer being used. The notice to OHA must include details listed in OAR 333-016-3010(3). Ninety calendar days after submitting to OHA the notice in compliance with OAR 333-016-3010(3), manufacturers must comply with OAR 333-016-3010(4). Manufacturers should use this notification form and instructions for complying with OAR 333-016-3010(3) and (4). For other items reported under the Toxic Free Kids Act: If your company has provided OHA notice of children's products containing HPCCCH(s), but the HPCCCH(s) has been removed or substituted, this change must be reported to OHA per OAR 333-0160-2060(14) within 180 days of one of these changes. This reporting helps OHA avoid unnecessary enforcement actions, which may save reporters/manufacturers time and money. For products where one HPCCCH was removed or substituted, use Notice of Children's Products No Longer Sold in Oregon per OAR 333-016-2060(14)_one product category-HPCCCH combination. For products where multiple HPCCCHs were removed or substituted, use Notice of Children's Products No Longer Sold in Oregon per OAR 333-016-2060(14)_multiple product category-HPCCCH combinations. IMPORTANT: Substitute chemicals used to replace HPCCCHs in product models affected by OAR 333-015-3010(1) must be approved by OHA. See under HPCCCH Substitution in the second half of that webpage.