845-025-5790 Product Recalls (1) The Commission may request or require a licensee to recall any marijuana item, hemp item, or industrial hemp that the licensee has sold or transferred that does not meet the minimum standards established by these rules, including but not limited to when there is evidence that: (a) Pesticides were used in the production of marijuana or industrial hemp in violation of ORS chapter 634 or OAR chapter 603, division 57; (b) A marijuana item, hemp item, or industrial hemp is adulterated, contaminated, may pose a risk to public health and safety, or is otherwise unfit for human use, consumption, or application; (c) A marijuana item was not produced or processed by a licensee or was processed using a marijuana item that was not produced or processed by a licensee, except as explicitly allowed by these rules; or (d) A marijuana item, hemp item, or industrial hemp is labeled or packaged in a manner that poses a risk to public health and safety. (2) If a product is being recalled, the Commission: (a) May notify, or require the licensee to notify, the public and licensees of the recall; (b) May require a licensee to notify a person to whom a marijuana item, industrial hemp, or a hemp item was sold; and (c) May require that the licensee destroy the recalled product. (3) If the Commission requests or requires a licensee to initiate a recall pursuant to this rule, the Commission must provide to the licensee the reason for the recall and any other information necessary for the licensee to initiate a recall. (4) A licensee conducting a voluntary or required recall must: (a) Have a product removal strategy appropriate to the threat and location of the recalled product. (b) Identify the scope of impacted product and establish a process for identifying affected product subject to a recall, which must include the following: (A) Distribution list. When identifying products subject to a recall, the licensee must create a distribution list that includes the following information: (i) The name, license number, and address of the licensees, hemp certificate holders, and unlicensed persons that a processor transferred to under OAR 845-025-3320 that received the product subject to the recall; (ii) Manifest or transfer date for each product subject to the recall; and (iii) Business contact information for each person that received product subject to the recall, including names and telephone numbers. (B) Product information. When identifying each product subject to a recall, the licensee must document the following product information: (i) Product description; (ii) If applicable, a photograph of the principle display panel; (iii) If applicable, the label identification number required by OAR 845-025-7030; (iv) The license number of the licensee that produced or manufactured the product subject to the recall; and (v) Date or date range of the manufacture or harvest of the product subject to the recall. (c) Provide notification to the following: (A) The Commission, within 24 hours of initiating the recall. (B) Each business identified on the licensee’s distribution list under paragraph (4)(b)(A) of this rule that includes the following information: (i) Product description for the product subject to the recall; (ii) The reason for recall and related hazards, if any. If the product is being removed for quality rather than public health and safety reasons, the notice may state that the product does not meet internal company specifications and is being removed from distribution; (iii) The license number, name, and trade name of the licensee that produced or manufactured the product subject to the recall; (iv) Expiration date(s) for the product subject to the recall, if applicable; (v) Date or date range of the manufacture or harvest of the product subject to the recall; and (vi) Instructions regarding the disposition of the affected product subject to the recall. (C) No later than 48 hours from issuing a recall notice under paragraph (B) of this subsection, notify consumers of the recall using the most effective method available, which may include any of the following methods or combination of methods: (i) An e-mail to a customer e-mail list. (ii) An alert on the licensee’s website. (iii) A warning that is clearly and visibly posted on the licensed premises at locations that are open to the public. (iv) A press release to notify consumers. (d) Make all reasonable efforts to remove the affected products from commerce. Affected products that are either still in control of the originating licensee or in commerce must be secured, segregated, clearly labeled not for sale or distribution, and separated from any other non-affected products. (e) Complete recall effectiveness checks to verify that all receiving business have been notified and have taken the appropriate action, including: (A) Confirming the receiving business received the recall notification; (B) Determining whether the recalled marijuana item, hemp item, or industrial hemp was handled as instructed in the recall notification; and (C) If the product was further distributed or sold by the receiving business before receipt of the recall notification, and if so, were these additional businesses notified. (5) Prior to the recall being initiated, the Commission may require the licensee to submit any information required by this rule. (6) Business records created as part of a recall should be maintained in accordance with OAR 845-025-1200. (7) Violations. A violation of this rule is a Category I violation. Statutory/Other Authority: ORS 475C.017, 571.337, 571.275 & 475C.237 Statutes/Other Implemented: ORS 475C.021 & 571.337 History: OLCC 202-2022, amend filed 11/21/2022, effective 01/01/2023 OLCC 142-2022, minor correction filed 03/25/2022, effective 03/25/2022 OLCC 21-2021, amend filed 12/30/2021, effective 01/01/2022 OLCC 6-2016, f. 6-28-16, cert. ef. 6-29-16