ARM 42.39.312. MARIJUANA RECALLS

(1) For purposes of this rule, the following definitions apply: (a) "Affected licensee" means a licensee whose marijuana or marijuana products are subject to a recall. If more than one licensee is affected by a recall, the licensee that created the affected product shall be considered the affected licensee. (b) "Affected product" means marijuana or a marijuana product subject to a recall. (2) A recall is required when marijuana or marijuana products pose a risk to public health and safety. A product is considered to pose such a risk when, including but not limited to, any of the following events happen: (a) the licensee cannot provide proof that the product meets all required testing standards pursuant to ARM 42.39.614; (b) the product fails any testing, including research and development testing, and was not successfully remediated and retested pursuant to ARM 42.39.613 and 42.39.614; or (c) the product has been improperly or invalidly tested. (3) A licensee, other than a transporter or testing lab licensee, must develop a written recall plan that is accessible to staff and the department and is subject to audit. The recall plan must establish the procedures the licensee will follow in the event of a recall of its product or products. A recall plan must include, at a minimum: (a) a designated member of the licensee's staff who serves as the licensee's recall coordinator, identified by name, title, and contact information; (b) step-by-step procedures for identifying and immediately isolating the affected product to prevent or minimize sales, manufacturing, and distribution; (c) written procedures to either retrieve and destroy affected product or destroy affected product at all licensed locations; and (d) communication protocols that include written procedures for: (i) notifying registered cardholders, consumers, and licensees, known or reasonably believed to be in possession of the affected product, including the method and timing of communications; (ii) coordinating secure transport or return of affected product; and (iii) issuing a press release and other appropriate public notifications to ensure customers are notified of the recall and affected product information. “Other appropriate public notification” includes, but is not limited to, posting information identifying the affected product on the affected licensee’s website. (4) If the department or an affected licensee determines that a recall is required, an affected licensee shall: (a) immediately notify the department that it has initiated recall efforts; (b) segregate the affected product located at its licensed premises immediately upon being notified of the recall; (c) activate its recall plan within 24 hours of initiating a recall or being notified by the department or another affected licensee of the recall; (d) issue a press release or other appropriate public notifications identified in (3)(d)(iii) within 48 hours of being notified of the recall; (e) within 24 hours of activating the recall plan coordinate with other licensees known or believed to be in possession of the affected product for either the affected licensee’s retrieval of the affected product or the destruction of the affected product at its current location; (f) provide the department with weekly progress reports, detailing recall efforts; and (g) destroy or, if able, remediate the affected product within 30 business days of being notified of the recall. (5) An affected licensee must provide written confirmation and copies of supporting documentation to the department confirming it has fully complied with (4). (6) After a recall has been completed, the affected licensee must identify the cause for the recall and detail, in writing, the corrective actions taken to avoid a future recall. If the affected licensee’s conclusions and corrections require modification or replacement of the recall plan in (3), then the affected licensee will provide the updated plan to the department within 30 days from its implementation. (7) An affected licensee must coordinate the destruction of affected product with the department, and the department must be granted an opportunity, in advance, to oversee the destruction process. The destruction of affected product must be recorded in the seed-to-sale tracking system in compliance with ARM 42.39.310. (8) An affected licensee must track all affected product and the amount of affected product returned to the affected licensee as part of the recall effort. (9) The department shall actively maintain a publicly accessible marijuana recall page on its website of all current recalls. (10) When the department determines that a recall is successful and the risk to public health and safety is no longer present, the department shall notify the affected licensee, in writing, and close the recall. (11) An affected licensee’s failure to comply constitutes a violation of the marijuana laws and may subject the licensee to administrative action.