WSR 16-15-037 EMERGENCY RULES LIQUOR AND CANNABIS
BOARD
[Filed July 13, 2016, 1:06 p.m., effective July 13, 2016, 1:06 p.m.] Effective Date of Rule: Immediately upon filing.
Purpose: New rules are needed to create a process to recall marijuana and marijuana products that pose a risk to consumers. This emergency rule establishes a recall process similar to the recall process used by other state and federal agencies for products that pose risks to consumers.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: Marijuana and marijuana products sold in Washington state liquor and cannabis board licensed retail stores are a consumable product and it is important that they are safe for human consumption. In the event that product posing a risk to public health is discovered, regulations and a process need to be in place to allow for affected product to be identified and removed from the marketplace in a fast and efficient manner. The emergency rules are needed to ensure the public health, and safety of the citizens of Washington. Permanent rule making is currently underway. This emergency rule is being refiled to ensure emergency rule requirements remain in place to protect public safety until permanent rules become effective.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 1, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
Date Adopted: July 13, 2016.
Jane Rushford
Chair
NEW SECTION
WAC 314-55-225 Marijuana recalls.
(1) Definitions. For the purposes of this section, the following definitions apply:
(a) "Affected product" means marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products subject to a recall.
(b) "Affected licensee" means a licensee whose marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products are subject to a recall. More than one licensee may be an affected licensee in a recall.
(2) Exempt market withdrawals.
(a) A licensee may withdraw from the market marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products by its own determination for reasons that do not pose a risk to consumers such as for aesthetic reasons or other similar deficiencies in product or packaging.
(b) If a licensee initiates a market withdrawal for a reason that does not pose a risk to consumers, the licensee must notify the WSLCB by contacting the local WSLCB enforcement officer assigned to the local area within forty-eight hours of beginning the market withdrawal. Licensees withdrawing marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products under this subsection (2), for reasons other than risk to consumers, are exempt from the remaining requirements of this section.
(3)(a) When a recall is required. A recall is required when circumstances exist that pose a risk to consumers. Factors that contribute to a determination of a recall situation include, but are not limited to, the following:
(i) Evidence that pesticides not approved by the board are present on or in marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products above the action levels prescribed by board rule;
(ii) Evidence that residual solvents are present on or in marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products at levels above the action levels prescribed by board rule; or
(iii) Evidence of another condition that poses a risk to consumers including, but not limited to, ingredients in marijuana-infused products that are unfit for human consumption.
(b) Licensee-initiated recalls.
(i) If a licensee initiates a recall due to a condition that poses a risk to consumers and would make a recall appropriate under this subsection (3), the licensee must:
(A) Immediately notify the local WSLCB enforcement officer; and
(B) Secure, isolate, and prevent the distribution of all marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products that may have been exposed to the condition warranting the recall. The licensee is prohibited from destroying any affected product prior to notifying the WSCLB and coordinating with the local WSLCB officer on destruction activities.
(ii) If the WSLCB determines the licensee fails to engage in recall efforts that meet the urgency of the risk to consumers, the WSLCB may seek a board-directed recall as provided in this section depending on the circumstances.
(c) WSLCB investigation-initiated recalls.
(i) If the WSLCB determines that a recall is not appropriate after an investigation, the WSLCB enforcement division may release administrative holds placed on marijuana, usable marijuana, marijuana concentrates, or marijuana-infused products as part of the investigation as appropriate, unless an administrative hold is necessary under a continuing investigation.
(ii) If the WSLCB determines that a recall is appropriate after an investigation, the WSLCB notifies the board and requests the board issue a recall. If the board issues a recall, the WSLCB notifies the affected licensee that is the source of the issue giving rise to a recall.
(d) Recall plans. All licensees must develop a recall plan within sixty days of the effective date of this section that sets the procedures the licensee will follow in the event of a recall of the licensee's product or products under the licensee's control. If a licensee becomes an affected licensee as part of a recall and the affected licensee distributed affected product to consumers or to retailers, the affected licensee must immediately notify all licensees that received affected product, and issue a press release and other appropriate public notification to inform consumers of the recall and identifying information about the affected product recalled.
(i) A recall plan must include, at a minimum, the following:
(A) Designation of a member of the licensee's staff who serves as the licensee's recall coordinator;
(B) Procedures for identifying and isolating product to prevent or minimize its distribution to consumers;
(C) Procedures to retrieve and destroy product; and
(D) A communications plan to notify those affected by the recall, including:
(I) How the affected licensee will notify other licensees in possession of product subject to the recall; and
(II) The use of press releases and other appropriate notifications to ensure consumers are notified of the recall and affected product information if the affected product was distributed to consumers.
(ii) A recall must follow the procedures outlined in the recall plan unless otherwise agreed by the WSLCB and the licensee. The affected licensee must ensure recall procedures are conducted to maximize recall of affected product and minimize risks to consumers.
(e) Destruction of affected product. An affected licensee must coordinate destruction of affected product with the local WSLCB enforcement officer and allow WSCLB enforcement to oversee the destruction of affected product recalled to ensure the destruction of affected product that poses risks to consumers.
(f) Recall reports and audit. The affected licensee must track the total amount of affected product and the amount of affected product returned to the affected licensee as part of the recall effort. The affected licensee must report to the WSLCB periodically on the progress of the recall efforts. The periodic reports must occur at a minimum of once a week or as otherwise specified and agreed to by the WSLCB and the affected licensee in the recall plan.
(g) Recall closure. If the WSLCB determines that the recall efforts are successful and risks to public health and safety are no longer present, the WSLCB may recommend closure of the recall to the board.
(4) Board-directed recall.
(a) Upon the recommendation by the WSLCB enforcement division, the board may issue a directed recall if:
(i) The affected licensee does not comply with a recall under subsection (3) of this section;
(ii) The affected licensee does not comply with the recall plan or recall reporting requirements under subsection (3) of this section; or
(iii) The WSLCB enforcement division determines that affected product may be diverted or is being diverted from the licensed business, or another circumstance that makes the affected licensee's destruction of the product inadvisable or a risk to consumers.
(b) If the board issues a directed recall, the WSLCB will notify consumers of the recall and all licensees that may possess product affected by the recall if notice has not yet occurred.
(c) Under a directed recall, the WSLCB enforcement division may seek an order for destruction of the affected product from the board.
(i) If the board issues an order for destruction, the WSLCB enforcement division may seize and conduct the destruction of affected product.
(ii) An order for destruction will include notice to the licensee and opportunity for hearing before destruction, unless there is evidence of an immediate danger to public health, safety, or welfare to justify an immediate order for destruction, with an opportunity for an expedited hearing after the destruction.
(d) If a destruction order is issued and the WSLCB seizes product affected by the recall and conducts the destruction of the product, the affected licensee may be responsible for reimbursing the WSLCB for costs associated with product destruction.
(e) If the board finds that an immediate danger to the public health, safety, or welfare requires immediate WSLCB action, a licensee may also be subject to summary suspension under RCW 66.08.150(4).
(5) The WSLCB will maintain a recall web page on its web site of all current and closed recalls of record.
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