W. Va. Code R. § 61-4B-14

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

Section 61-4B-14 - Enforcement Policy for Mix Manufacturers or Distributors

14.1. The commissioner may assess a fee as set forth by W. Va. Code §§ 19-11B-1 et seq. or by this rule against the manufacturer of mix(es) and/or the distributor of the mix used to manufacture the product.

14.2. The commissioner will assess any violations of W. Va. Code §§ 19-11B-1 et seq. or of this rule to the mix manufacturer and/or distributor for mix sampled from unopened containers. The company will not be assessed additional cumulative notices of violations until the commissioner has determined that the mix manufacturer or distributor has had adequate notice of the previous notice.

14.3. Whenever one of the last five consecutive official product samples taken on separate days are found to be adulterated or misbranded, the commissioner shall send a written "First Notice" to the mix manufacturer or distributor whichever is appropriate. This notice shall notify the mix manufacturer or distributor of the violation of W. Va. Code §§ 19-11B-1 et seq. or of this rule and the enforcement policy established by this section of the rule.

14.4. Whenever two of the last five consecutive official product samples taken on separate days are found to be adulterated or misbranded, the commissioner shall send a written "Second Notice" to the mix manufacturer or distributor whichever is appropriate.

14.4.a. The commissioner may collect additional official mix samples after the Second Notice has been sent to the manufacturer or distributor.

14.5. Whenever three of the last five consecutive official mix samples taken on separate days are found to be adulterated or misbranded the commissioner shall send a written "Third Notice" to the mix manufacturer or distributor whichever is appropriate.

14.5.a. The commissioner may collect additional official mix samples after 15 business days of the sending of the Third Notice to the manufacturer or distributor.

14.6 A mix manufacturer or distributor will be assessed a fee of $100 with the issuance of a "Third Notice." All fees will be paid to the department.

14.6.a. The commissioner will issue an Immediate Shut-Down Order without giving the manufacturer or distributor the opportunity to be heard where there is a hazard to the public health, safety, or welfare. In these cases, the mix manufacturer or distributor will be given the opportunity to request an informal hearing before the commissioner after the notification of the Order is received by the mix manufacturer or distributor. All Shut-Down Orders issued due to non-compliance with subdivisions 8.1.c., 8.1.d. or 8.1.f. of this rule are considered to involve a risk to the public health, safety or welfare.

14.6.b. The mix manufacturer or distributor are responsible for causing all operations covered by the Shut-Down Order to cease and for following all other conditions of the Order. At the end of the period of the order, the mix manufacturer or distributor may resume operations without further action by the commissioner.

14.7. If after a Shut-Down Order has been issued the commissioner finds that effective corrective action has not been taken, the commissioner may issue a suspension of the Dairy Distributor Permit. The suspension shall state the time that the suspension will become effective, give the reasons for the suspension, and specify a time and place for a hearing to be held in this matter. Except that in the case of a summary suspension, the commissioner will give the mix manufacturer or distributor the opportunity to request a hearing in this matter after the notification of the suspension.

14.7.a. All suspensions due to non-conformance to subdivisions 8.1.c., 8.1.d. or 8.1.f. of this rule are summary suspensions.

14.7.b. A suspension of the Dairy Distributors Permit remains in effect until the mix manufacturer or distributor submits and the commissioner accepts a written plan of correction and a request for a reinstatement of the permit. A mandatory course on cleaning and sanitation must be completed, as determined by the commissioner, before the suspension will be lifted.

14.7.c. The commissioner has 10 business days from the date of receipt of a written plan of correction and a request for the reinstatement of the permit to respond to a suspension in the case of violations of subdivisions 8.1.c., 8.1.d. or 8.1.f. of this rule and 15 business days to respond for all other violations of W. Va. Code §§ 19-11B-1 et seq. of this rule. The commissioner shall accept or deny the application for a reinstatement of the permit and shall give the terms and conditions under which the permit will be reinstated.

14.8. Whenever an antibiotic or pesticide residue test is found to be above tolerance, the commissioner shall notify the mix manufacturer and/or distributor immediately of this fact and shall begin an investigation to determine the cause of the residue. The commissioner shall require that any person found to be responsible for the residue shall correct the cause of the residue prior to the resumption of the manufacturing or· distribution of the product.

14.9. A person who performs a recall by voluntarily removing product from sale and distribution in an effective manner, 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 deciding on an exemption.

14.10. The commissioner may apply the enforcement policy in a liberal manner in cases where all mix sample results that involve a product in the form actually sold to the public have been found to be in conformance with W. Va. Code §§ 19-11B-1 et seq. or this rule.

14.11. The commissioner may suspend the standard enforcement policy in cases where such action is necessary to protect the public health, safety, or welfare.

14.12. Hearings.

14.12.a. Informal Hearing Procedures. An informal hearing, as provided in this subsection, is intended to be an informal discussion of the facts which gave rise to the issuance of a notice of violation. A hearing can be requested at any time by the commissioner or by the permittee.

14.12.b. A party seeking to challenge the suspension, revocation, or denial order of a permit may appeal within sixty (60) days to the West Virginia Intermediate Court of Appeals.

14.12.c. At any formal review proceedings which may occur later, any evidence, as to any statement made by one party at the informal hearing, may not be introduced as evidence by another party, nor may any statement be used to impeach a witness, unless the statement is or was available as competent evidence independent of its introduction during the informal hearing.

14.12.d. A hearing (other than an informal hearing) may take place at the request of the commissioner in instances of extenuating circumstance. The commissioner will state the cause for this hearing, set a time and date, and will set forth the responsibilities of each party. Notice of such hearings will be provided 15 business days in advance of the date set by the commissioner.

W. Va. Code R. § 61-4B-14