La. Admin. Code tit. 49 § I-1253

Current through Register Vol. 50, No. 9, September 20, 2024
Section I-1253 - Certification Requirements for Resident Shellfish Shippers [Formerly 49:6.2020]
A. Resident shellfish shippers shall be certified annually and shall file an application for recertification each year with the Office of Public Health. An application for certification shall not be accepted from any individual or corporation previously found guilty within the past five years in a civil or criminal proceeding of knowingly selling shellfish that were harvested from waters not approved for shellfish harvesting by the state health officer. The Office of Public Health shall certify dealers for interstate shipment in accordance with the sanitation and administrative criteria contained in the 1994 edition of the National Shellfish Sanitation Program Manual of Operations, Parts I and II.
B. All applicants for certification or certification renewal shall undergo a comprehensive on-site inspection prior to being certified. The certification period shall not exceed 12 months. This comprehensive on-site inspection shall be conducted by an Office of Public Health standardized inspector within 30 days of the application for certification or renewal of certification, show the date of the on-site inspection, the inspector's full name and date of expiration of the inspector's standardization.
C. Only one certification number shall be issued to a dealer per location.
D.
1 Certification shall be granted only to resident shippers who meet the following inspection requirements:
a. No critical deficiencies;
b. not more than two key item deficiencies; and
c. not more than three OTHER item deficiencies.
2. After a dealer is certified, unannounced inspections using an NSSP approved Office of Public Health inspection form shall be conducted during periods of operation and at such frequency as necessary to assure that adequate operational and sanitary conditions are maintained. A copy of the completed inspection form and a list of observations for items of noncompliance shall be provided to the most responsible individual at the firm.
E. The minimum frequency of inspection shall be:
1. within 30 days of beginning operation for any dealer certified on the basis of a preoperational inspection;
2. at least monthly for a depuration plant;
3. at least quarterly for shucker-packer and repacker;
4. at least semi-annually for other certified dealers.
F. Enforcement actions shall be taken as follows.
1. When a routine inspection detects a critical deficiency, the deficiency shall be corrected during the inspection or the plant must cease production affected by the deficiency. If the item is not corrected within the specified time, the Office of Public Health shall immediately begin actions to withdraw dealer certification. Further, product affected by the critical deficiency shall be controlled to prevent contaminated or adulterated product from reaching consumers.
2. When a routine inspection detects four or more key item deficiencies, a follow-up inspection shall be conducted as soon as possible but within 30 days. The follow-up inspection shall determine if the deficiencies have been corrected or are being corrected per the scheduled correction dates noted on the previous inspection report.
3. When the follow-up inspection of the key item deficiencies indicate a failure to comply with the correction schedule, the Office of Public Health shall immediately bring actions to suspend operations and withdraw dealer certification.
4. When a routine inspection detects other item deficiencies or three or less key item deficiencies, the deficiencies shall be corrected prior to the next routine inspection.
5. All specific deficiencies, as noted in the narrative section of the inspection report, which are repeated consecutively and are not corrected as scheduled shall be corrected prior to the annual certification. Dealers which fail to correct such deficiencies shall not be certified.
6. When inspections are made of certified shellfish shippers where the Office of Public Health finds nonconformities that present an imminent threat to public health, actions shall be initiated immediately by the Office of Public Health to suspend operations and withdraw certification until a reinspection confirms that appropriate corrections have been made. The Office of Public Health shall also seize any undistributed lots of shellfish that may have been adulterated, initiate a recall of shellfish distributed intrastate, and notify FDA and receiving state enforcement agencies of interstate product distributions.
7. When inspections are made of certified shellfish shippers where the Office of Public Health finds major public health deficiencies, action shall be initiated by the Office of Public Health to suspend or withdraw certification until a reinspection confirms that appropriate corrections have been made.
8. When a certificate is removed for cause, the Office of Public Health shall immediately notify FDA and shellfish control personnel in known receiving states.
G A certified shellfish dealer whose certificate has been removed for cause may not ship shellfish in intrastate or interstate commerce until the Office of Public Health is satisfied that corrections have been made. A recertification shall not be issued until an inspection by the officer of public health establishes that the firm is in substantial compliance with all applicable criteria of the latest edition of the National Shellfish Sanitation Program Manual of Operations, Parts I and II. Upon recertification, the Office of Public Health shall notify FDA and known receiving states immediately. These changes shall become effective April 20, 1994.

La. Admin. Code tit. 49, § I-1253

Promulgated by the Department of Health and Human Resources, Office of Preventive and Public Health Services, LR 11:775 (August 1985), amended by the Department of Health and Hospitals, Office of Public Health, LR 20:548 (May 1994).
AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.