S.C. Code Regs. § § 61-47.H

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-47.H - INSPECTION AND COMPLIANCE

1. Inspections.

(a) Access. For the purpose of determining compliance with this Regulation, authorized representatives of the Department shall, upon display of proper identification, be permitted to enter at any reasonable time any facility, establishment, market, vessel, or vehicle used to harvest, handle, process, store, sell, or transport shellfish.

(b) Inspection Frequency.

(1) Certified Shippers. Following issuance of a certified shipper certificate, unannounced performance-based inspections shall be made during periods of activity. Inspections and re-inspections shall be made, as determined necessary by the Department, for the effective enforcement of this Regulation. At a minimum, certified shipper facilities shall be inspected in accordance with the following frequencies:

(a) monthly for Depuration Processors;

(b) quarterly for Shucker-Packers or Repackers;

(c) semi-annually for Shellstock Shippers or Reshippers.

(2) Permits. Following issuance of any permit, inspections shall be made during periods of activity as necessary for the effective enforcement of this Regulation.

(c) Records. Authorized representatives of the Department shall, upon display of proper identification, be permitted to examine the records of any facility, establishment, or operation certified or permitted by the Department in accordance with this Regulation, for the purpose of obtaining information pertaining to shellfish grown or harvested, purchased, received, sold, shipped, distributed, shucked, packed, depurated or processed in any manner.

2. Compliance.

(a) National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish Model Ordinance (chapter) X. General Requirements For Dealers shall be used in establishing and determining Hazard Analysis Critical Control Point (HACCP) and general sanitation requirements.

(b) National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish Model Ordinance (chapters) XI. Shucking and Packing, XII. Repacking Of Shucked Shellfish, XIII. Shellstock Shipping, XIV. Reshipping, and XV. Depuration shall be utilized in determining certified shipper inspection item deficiency levels. Deficiencies documented during the inspection of certified shipper facilities shall be corrected in accordance with the following procedures:

(1) When any inspection detects a critical deficiency:

(a) The deficiency shall be corrected during that inspection; or

(b) The certified shipper shall immediately cease production affected by the deficiency.

(c) If the certified shipper facility fails to correct the critical deficiency during the inspection, the Department shall provide notice of intent to suspend or revoke the certificate.

(2) Shellfish products affected by a critical deficiency shall be controlled to prevent contamination or adulterated product from reaching consumers. The Department shall:

(a) Condemn and destroy adulterated shellfish;

(b) Initiate a recall of adulterated shellfish;

(c) Notify enforcement officials for the United States Food and Drug Administration, as well as shellfish control authorities in states that are known to have received adulterated shellfish.

(3) When any inspection detects key or other deficiencies not currently covered in a compliance schedule, the Department, working with the certified shipper, shall develop a compliance and correction schedule.

(4) When any inspection detects four or more new key deficiencies, the Department shall consider the following options and document the reasons for selection of one of the following options:

(a) Revise the existing compliance schedule;

(b) Commence action to suspend or revoke certification; or

(c) Seek other administrative remedies.

(c) Nothing in sub-section H.2 shall be construed to limit or make null any option for remedy as provided for in Section P. of this Regulation.

(d) Stop Sale or Disposal of Shellfish.

(1) If it has been determined by the Department that shellfish have not been grown, harvested, stored, treated, transported, handled, shucked, packed, processed, sold, or offered for sale in compliance with this Regulation, those shellfish shall be deemed adulterated.

(2) Shellfish or shellfish products determined to be adulterated shall be subject to stop sale or disposal by the Department. The Department may temporarily or permanently issue an order to stop sale, condemn, destroy, recall, or otherwise dispose of all shellfish or shellfish containers found to be adulterated.

(3) Adulterated shellfish shall be disposed of at the discretion of the Department.

(e) Suspension or Revocation of Permits or Certificates.

(1) If the Department has evidence that an operator of a shellfish activity or facility has created or is responsible for conditions that may cause shellfish to become adulterated, the permit or certificate may be suspended or revoked.

(2) Serious or repeated violations of any of the requirements of this Regulation, failure to cooperate, or interference with Department personnel in the performance of their duties shall be cause for a permit or certificate to be revoked.

(3) Decisions involving the issuance, denial, renewal, modification, suspension, or revocation of permits, licenses, certification, or other actions of the Department shall be in accordance with the provisions of S.C. Code Section 44-1-60, 1976 Code of Laws, as amended.

(f) Appeal. A Department decision involving the issuance, denial, renewal, modification, suspension, or revocation of permits, licenses, certification, or other actions of the Department may be appealed by the affected person with standing pursuant to applicable law, including S.C. Code Title 44, Chapter 1; and Title 1, Chapter 23.

S.C. Code Regs. § 61-47.H