Section 25-B3501. CRITERIA FOR SEEKING REMEDIES - CONDITIONS WARRANTING REMEDY, SHELLFISH-PROCESSING OPERATIONS  


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    3501.1The Department may seek an administrative or judicial remedy, or any combination thereof, to achieve compliance with the provisions of this Code if a person operating a shellfish-processing operation or employee fails to comply with sections 3500 or 3501.2 through 3501.4.

     

    3501.2When a dealer has failed to meet a compliance schedule as specified in sections 3212 and 3214, the Department shall determine whether it is appropriate to:

     

    (a)Revise an existing compliance schedule;

     

    (b)Close the shellfish-processing operation by summarily suspending a dealer's certification; or

     

    (c)Take action to revoke or suspend a dealer's certification.

     

    3501.3When any inspection detects a critical violation:

     

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

     

    (b)The dealer shall cease production of the contaminated or adulterated product affected by the violation.

     

    3501.4When a dealer fails to comply with section 3501.3, the Department shall summarily suspend the dealer's certification and immediately begin action to suspend or revoke the dealer's certification.

     

    3501.5The Department shall prevent the release of contaminated or adulterated products affected by a critical violation by:

     

    (a)Detaining or seizing any undistributed lots of shellfish that may have been adulterated in accordance with section 3503;

     

    (b)Requiring the dealer to initiate a recall of any distributed shellfish in accordance with section 1100.2; and

     

    (c)Notifying immediately the enforcement officials for FDA and any other jurisdiction where the product was distributed.

     

    3501.6Except for critical violations described in section 3501.3, when new violations that were not included in a compliance schedule are observed during an inspection, the Department shall work with the dealer to develop a compliance schedule to correct the new violations.

     

    3501.7When four (4) or more new critical violations are observed during an inspection, the Department may:

     

    (a)Revise an existing compliance schedule;

     

    (b)Close the shellfish-processing operation by summarily suspending a dealer's certification; or

     

    (c)Take action to revoke or suspend a dealer's certification.

     

    3501.8The Department shall document its reasons for revising a compliance schedule or imposing other administrative remedies.

     

source

Final Rulemaking published at 56 DCR 5245 (July 3, 2009).