W. Va. Code R. § 61-30-11

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 61-30-11 - Enforcement actions on products violations and related penalties

11.1. The Commissioner may assess a violation of West Virginia Code § 19-12E-7et. seq. or this rule.

11.2. Violations shall be broken into classes, dependent on the severity. Violations are classified as follows:

11.2.a. Class I violations are flagrant violations and include, but are not limited to:

11.2.a.1. Hemp products that are unsafe or adulterated or show cause for immediate human or animal health concern; and

11.2.a.2. Hemp products that contain more than the THC content authorized by law.

11.2.a.3. Third offense registration violations as defined in subsection 10.4 of this rule.

11.2.b. Class II violations are violations in which the person acted in a faulty or careless manner and include, but are not limited to:

11.2.b.1. Falsification of information on an application;

11.2.b.2. No serving size and frequency of use listed on labeling; and

11.2.b.3. Failure of the product to meet label claims.

11.2.c. Class III violations are negligent violations and include but are not limited to:

11.2.c1. Improper labeling; and

11.2.c.2. Misbranding.

11.3. Class III (Negligent) Violations.

11.3.a. Upon the first Class III violation being committed by a manufacturer:

11.3.a.1. The Commissioner shall send a written "First Notice" to the registrant. This notice shall notify the registrant that a violation of West Virginia Code § 19-12E-7et seq. of this rule and the enforcement policy established by this section of the rule has been violated.

11.3.a.2. The manufacturer shall be assessed a $100.00 penalty for the Class III violation.

11.3.a.3. The manufacturer shall be given 30 days to fix the Class III violation and must provide evidence to the Department that the violation has been corrected.

11.3.b. If a second Class III violation has been committed on the same products within a one year period, the Commissioner shall send a written "Second Notice" to the registrant. The registrant must develop a written plan to correct the violation(s) and implement it within 7 days after the Second Notice has been sent. An additional $100.00 penalty will be assessed for the second Class III violation of a product.

11.3.c. If a third Class III violation has been committed on the same product within a one year period, the Commissioner will issue an immediate "Suspension of Permit."

11.3.c.1. The "Suspension of Permit" order will give the reason for the order and the length of time the Suspension of Permit order will be in effect.

11.3.c.2. The suspension of permit order shall state the time that the suspension will be effective and give the reason for the suspension. In the case of a summary suspension, the Commissioner may give the manufacturer an opportunity to request a hearing in the matter subsequent to the notification of the suspension.

11.4. Class II (Faulty or Careless) Violations.

11.4.a. Upon the first Class II violation being committed by a manufacturer:

11.4.a.1. The Commissioner shall send a written "First Notice" to the registrant. This notice shall notify the registrant that a violation of West Virginia Code § 19-12E-7et. seq. of this rule, and the enforcement policy established by this section of the rule.

11.4.a.2. The manufacturer shall be assessed a $200.00 penalty for the Class II violation.

11.4.a.3. The manufacturer shall be given 30 days to fix the Class II violation and must provide evidence to the Department that the violation has been alleviated.

11.4.b. If a second Class II violation has been committed on the same products within a one year period, the Commissioner shall send a written "Second Notice" to the registrant. The registrant must develop a written plan to correct the violation(s) and implement it within 7 days after the Second Notice has been sent. An additional $200.00 penalty will be assessed for the second Class II violation of a product.

11.4.c. If a third Class II violation has not been resolved within a specified time frame, the will issue an immediate "Suspension of Permit".

11.4.c.1. The "Suspension of Permit" order will give the reason for the order and the length of time the "Suspension of Permit" order will be in effect.

11.4.c.2. The suspension of permit order shall state the time that the suspension will be effective and give the reason for the suspension. In the case of a summary suspension, the Commissioner may give the manufacturer the opportunity to request a hearing in this matter subsequent to the notification of the suspension.

11.5. Class I (Flagrant) Violations.

11.5.a. Upon the first Class I violation being committed by a manufacturer:

11.5.a.1. The Commissioner shall notify the registrant that the product has been embargoed. This notice shall notify the registrant that a violation of West Virginia Code § 19-12E-7et. seq. of this rule and the enforcement policy established by this section of the rule.

11.5.a.2. Embargo of products shall follow in accordance with Section 12 of this rule.

11.5.a.3. The manufacturer of a product with a Class I violation shall be assessed a penalty of $250.00.

11.5.b. The embargo notice will establish the date effective and give the reason for the.

11.6. A person who performs a recall by voluntarily removing product from sale or distribution in an effective manner, so as to limit the potential harm to the health and well-being of the public, may be eligible for exemptions from the normal enforcement policy. The Commissioner shall consider the facts of each case when making a decision on an exemption.

11.7. The Commissioner may suspend the standard enforcement policy in cases where such action is necessary to protect the public health, safety, and welfare.

W. Va. Code R. § 61-30-11