W. Va. Code R. § 61-4B-15
Current through Register Vol. XLI, No. 45, November 8, 2024
Section 61-4B-15 - Enforcement Policy for Frozen Dessert or Imitation Frozen Dessert Manufacturers15.1. The commissioner may assess a violation or fee as set forth by W. Va. Code §§ 19-11B-1 et seq., or as provided by this rule, against the manufacturer of product made in the state. 15.1.a. A resample fee of $45 will be collected for each collection day after the issuance of a "First Notice".15.2. Whenever official product samples taken are found to be adulterated or misbranded, the commissioner shall send a written "First Notice" to the manufacturer. This notice shall notify the manufacturer 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. Resamples may be taken after 20 business days of the sending of the "First Notice".15.3. Whenever official product samples taken are found to be adulterated or misbranded after the issuance of a "First Notice", the commissioner shall send a written "Second Notice" to the manufacturer. This notice shall notify the manufacturer 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. Resamples may be taken after 20 business days of the sending of the "Second Notice".15.4. Whenever official product samples taken are found to be adulterated or misbranded after the issuance of a "Second Notice", the commissioner shall send a written "Third Notice" to the manufacturer. This notice shall notify the manufacturer 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. Resamples may be taken after 20 business days of the sending of the "Third Notice". A manufacturer will be assessed a fee of $100 with the issuance of a "Third Notice". All fees will be paid to the department.15.5. The commissioner will issue a "Shut-Down Order" for a period of twenty-four (24) hours to a manufacturer when the record of the manufacturer indicates that effective action has not been taken to correct the causes of the violation. All violations will be assessed when the same machine(s) are violative. The commissioner may issue a "Shut-Down Order" with the "Third Notice". The "Shut-Down Order'' will give the reasons for the Order, state the portion of the manufacturing operation that is prohibited from operating while the Order is in effect, give conditions of the Order, state the length of time that the Shut-Down Order will be in effect. Except that in the case where the public health, safety or welfare is at risk, the commissioner will issue an Immediate Shut-Down Order and give notice to the manufacturer under the provisions of subdivision 15.5.a. of this rule. 15.5.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 manufacturer or distributor will be given the opportunity to request a hearing before the commissioner after the notification of the Order is received by the 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.15.5.b. The manufacturer is 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 manufacturer may resume operations without further action by the commissioner.15.6. If after a "24 Hour Shut-Down Order" has been issued and the commissioner finds that the manufacturer has not complied with the Shut-Down Order, the commissioner may issue a suspension of the Frozen Desserts Manufacturer 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 an informal hearing to be held in this matter. Except that in the case of a summary suspension, the commissioner will give the manufacturer the opportunity to request an informal hearing in this matter after the notification of the suspension to explain the failure to follow the Shut-Down Order.15.7. Whenever official product samples taken are found to be adulterated or misbranded after the issuance of a "Third Notice", the commissioner shall send a written "Fourth Notice" to the manufacturer. This notice shall notify the manufacturer 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. A manufacturer will be assessed a fee of $200 with the issuance of a "Fourth Notice". All fees will be paid to the department. A suspension of the Frozen Desserts Manufacture Permit will be issued at this time of the "Fourth Notice", and all manufacturing operation is prohibited from operating while the suspension is in effect. After the issuance of a "Fourth Notice" the manufacturer must submit, and the commissioner accepts a written plan of correction. The manufacturer must state the actions to be taken to correct the problem. A mandatory course on cleaning and sanitation must be completed, as determined by the commissioner before the suspension will be released.15.8. The commissioner has 10 business days from the date of receipt of a written plan of correction, a completed notice of the mandatory cleaning and sanitation course 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. or this rule. The commissioner shall accept or deny the request for a reinstatement of the permit and shall give the terms and conditions under which the permit will be reinstated.15.9. Whenever official product samples taken are found to be adulterated or misbranded after the issuance of a "Fourth Notice", the commissioner shall issue a Suspension of the Frozen Desserts Manufacturer Permit. This notice shall notify the manufacturer of the violation of W. Va. Code §§ 19-11B-1 et seq. of this rule and the enforcement policy established by this section of the rule. The manufacture is to stop all production at the place of business. 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.15.10. The failure to comply with the Suspension will result with the Frozen Desserts Permit being revoked for one (1) calendar year.15.11. A hearing as determined by the commissioner will be scheduled by the commissioner. The hearing will determine the status of the Frozen Desserts Manufacturer Permit and how the manufacturer can have the Frozen Desserts Manufacturer Permit reinstated. The commissioner will determine all conditions necessary to reinstate the Frozen Desserts Manufacturer Permit.15.12. All suspensions due to non-conformance to subdivisions 8.1.c., 8.1.d. or 8.1.f. of this rule are summary suspensions.15.13. If the commissioner finds that after the manufacturer has resumed production following a suspension of their Frozen Desserts Manufacturer Permit that effective corrective action has not been taken, then the commissioner may determine if the Frozen Desserts Manufacturer Permit should be revoked. Any actions taken will be determined by the commissioner and the place of business will be notified in writing. The manufacturer may request a hearing with the commissioner.15.14. Persons who manufacture a product on an intermittent or infrequent basis, so that the standard enforcement policy cannot apply, shall enter into a consent agreement with the commissioner for correction of all items found to be not in conformance with W. Va. Code §§ 19-11B-1 et seq. or this rule.15.15. Whenever an antibiotic or pesticide residue test is found to be above tolerance, the commissioner shall notify the 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.15.16. 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.15.17. The commissioner may apply the enforcement policy in a liberal manner in cases where all official product 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.15.18. The commissioner may suspend the standard enforcement policy in cases where such action is necessary to protect the public health, safety, or welfare.15.19. The commissioner will only collect resamples from machines that were shown to be producing violative product during the previous visit, except for resamples needed to check that the non-violative status is being maintained according to the following schedule: 15.19.a. After a First Notice and one non-violative sample, resamples may be taken six (6) to twelve (12) months after the non-violative sample.15.19.b. After a Second Notice and one non-violative sample, resamples may be taken three (3) to six (6) months after the non-violative sample.15.19.c. After a Third Notice and one non-violative sample, resamples may be taken two (2) to four (4) months after the non-violative sample.15.19.d. After a Fourth Notice and one non-violative sample, resamples may be taken one (1) to two (2) months after the non-violative sample.15.19.e. Other resamples may be considered necessary to determine that the non-violative status is being maintained.15.20. Hearings 15.20.a The commissioner will schedule all hearings. The department shall notify any authorized representative of the non-violative samples. The department shall set the location of the hearing and determine what representatives of each party shall be in attendance. This is to be an informal hearing between the parties. 15.20.b. The department shall notify the parties at least 15 business days prior to the time of the hearing.15.20.c. The department may continue the informal hearing only for good cause shown.15.20.d. All decisions as determined by the commissioner shall be final, and all parties must comply with those decisions.15.20.e. At any formal review proceeding(s) (a hearing other than an informal hearing) 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.W. Va. Code R. § 61-4B-15