1. (a) No person shall engage in any activity requiring a certificate in §§241.50-241.67 of this title (relating to Molluscan Shellfish) without having applied for and obtained an annual numbered certificate of compliance pertaining to the particular activity from the department. No certificate will be issued without an HACCP plan in accordance with §241.60 of this title (relating to General HACCP Requirements) which is acceptable to the SSD.

2. (b) Dealer certification.

   1. (1) Shucker/packer. Any person who shucks molluscan shellfish shall be certified as a shucker/packer.

   2. (2) Repacker.

      1. (A) Any person who repacks shucked molluscan shellfish shall be certified as a shucker/packer or repacker.
      2. (B) Any person who repacks molluscan shell stock shall be certified as a shellstock shipper, shucker/packer, or repacker.
      3. (C) A repacker shall not shuck molluscan shellfish.
   3. (3) Shellstock shipper. Any person who ships and receives molluscan shell stock in interstate commerce shall be certified as a shellstock shipper, repacker, or shucker/packer.
3. (c) Each dealer shall have a Texas business address at which inspections of facilities, activities, equipment, or records can be made.
4. (d) Each dealer shall accept molluscan shellfish only if they are taken from areas approved by the department, or obtained from sources outside the State of Texas which are approved by the department. If obtained from sources outside of the State of Texas, the molluscan shellfish must be from areas approved by the appropriate state or other government authorities having jurisdiction and must be obtained from dealers currently certified by the appropriate state or other government authority. Molluscan shellfish obtained from sources other than those outlined in this section shall not be sold, offered for sale, or held for sale.
5. (e) Each dealer shall pay the oyster sales fee as assessed by the Texas Health and Safety Code, §436.103. The fee is established at $1.00 per barrel of oyster shell stock. One barrel shall be equal to three containers (sacks, bushels, boxes, etc.) of oyster shell stock. Each container of oyster shell stock shall not weigh more than 100 pounds. Any container weighing more than 100 pounds shall be counted as two containers for purposes of computing the oyster sales fee owed.
6. (f) Prior to beginning construction of a new molluscan shellfish processing plant, or major remodeling of an existing molluscan shellfish processing plant (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure) complete, legible plans showing the floor plan of the building, with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to the SSD for review and approval. Additional plans of the entire premises may be required showing all structures, as well as, all water wells and septic systems with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any inside plant construction or any other construction which has the potential to contaminate the product is occurring. A legibly written or typed application for certification on forms provided by the department must be filed with the SSD each year.
7. (g) The application for a shucker/packer or repacker certificate must be accompanied by a written statement of the procedure the applicant will use to determine the SELL BY date for molluscan shellfish packed and shipped from the location listed in the application.
8. (h) A certificate and unique number shall be issued by the department only after an inspection of the plant by an authorized agent has revealed that the plant and practices are in compliance with these sections. A certificate and unique number shall be issued to a dealer for each location at which molluscan shellfish operations are to be conducted and a certificate is required.
9. (i) The inspection of a previously certified plant which has exhibited operational problems or violations of operational requirements of these sections or had a certificate of compliance revoked shall not be conducted until written, complete operational procedures for all phases of the activity, including flow of the product, are submitted to the SSD for review and approval. An application may be rejected and a certificate of compliance denied based on a history of failure to comply with the requirements of these sections.
10. (j) Molluscan shellfish operations by the dealer shall not begin until the department has issued the certificate for that location. Each certificate shall expire automatically at 11:59 p.m. on August 31st following the date of issue. Certificates shall not be transferable.

11. (k) After a certificate is issued, unannounced inspections may be conducted at any time the SSD has reason to believe the business may be in operation or that molluscan shellfish may be stored on the premises and at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained. All molluscan shellfish at a certified location shall be the responsibility of the dealer at that location, for the purposes of these sections. A copy of the completed inspection form listing written descriptions of the violations observed along with any necessary explanation shall be provided by an authorized agent of department to the most responsible individual present at the firm at the conclusion of the inspection. Any violations of the same requirement found on a consecutive inspection may result in certificate suspension in accordance with subsection (l) of this section. Molluscan shellfish inspections and the SSD forms shall comply with the requirements established in the current National Shellfish Sanitation Program.

    1. (1) When an inspection detects a critical deficiency the violation shall be corrected during that inspection or the plant must cease production affected by the violation. If production affected by the violation does not voluntarily cease, all molluscan shellfish handled or processed while the violation exists or existed shall be detained pursuant to Health and Safety Code, §436.028.
    2. (2) When an inspection detects four or more key deficiencies, the dealer shall establish a correction schedule acceptable to the SSD. Follow-up inspection shall determine if the violations have been corrected or are being corrected in accordance with the scheduled correction dates noted on the previous inspection report.
    3. (3) When an inspection detects other deficiencies or three or less key deficiencies, the deficiencies shall be corrected prior to the next routine inspection.

12. (l) The SSD may initiate procedures to suspend or revoke a certificate of compliance as follows.

    1. (1) The procedures shall be in accordance with the Texas Health and Safety Code, §436.114 and the provisions of the Government Code, Chapter 2001, Administrative Procedure Act, and department formal hearing procedures in Chapter 1 of this title (relating to the Texas Board of Health).

    2. (2) The grounds for suspension or revocation or assessment of administrative penalties may be any one or more of the following:

       1. (A) inspection results indicate unsatisfactory conditions in the plant or the existence of a public health hazard;
       2. (B) the certificate holder or representative refuses to allow an inspection or otherwise interferes with the authorized department agent in the performance of his or her duties; or
       3. (C) the certificate holder does not have an HACCP plan, has an HACCP plan unacceptable to the SSD, or fails to comply with an HACCP plan which is acceptable to the SSD.
13. (m) A dealer whose certificate has been suspended may not process any molluscan shellfish for a period determined by the commissioner.
14. (n) A dealer whose certificate has been suspended may not process any molluscan shellfish until the SSD is satisfied that all necessary corrections have been made. A suspension will not be rescinded until an inspection establishes that the firm has corrected all violations which resulted in the suspension and is in full compliance with all applicable criteria of these sections.
15. (o) A certificate may be revoked for any of the reasons outlined in subsection (l) of this section or for either of the following: if the violations initiating a suspension fail to be corrected within the time frame established, or if a history of repeated suspensions exists. A dealer whose certificate has been revoked may not be issued a new certificate for 180 days or before the next certification period, whichever is longer, after the date of signing of the final order of revocation. When the department contemplates suspension or revocation, the certificate holder shall be afforded the opportunity for a hearing. Notice of the contemplated action shall be given to the certificate holder by personal service or certified mail, return receipt requested. If no request for a hearing is received by the director of the SSD, within 14 days of personal service or the date of receipt of the notice by the dealer, the allegations contained in the notice are admitted as true, and the department may proceed to take the action set out in the notice.
16. (p) When the department determines that administrative penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with the Texas Health and Safety Code, §436.034; the Government Code, Chapter 2001, Administrative Procedure Act; and the department formal hearing procedures in Chapter 1 of this title. When the department contemplates administrative penalties, the certificate holder or harvester shall be afforded the opportunity for a hearing. Notice of the contemplated action shall be given to the certificate holder or harvester by personal service or certified mail, return receipt requested. If no request for a hearing is received by the director of the SSD, within 14 days of personal service or the date of receipt of the notice by the dealer, the allegations contained in the notice are admitted as true, and the department may proceed to take the action set out in the notice.

17. (q) The seriousness of violations shall be categorized by one of the following severity levels. The examples following the severity levels are neither exhaustive nor controlling. They reflect only the seriousness of the violation and not the intent of the violator, the history of the violator, the amount necessary to deter future violations, or efforts to correct the violation.

    1. (1) Severity Level I--Violations that are of minor public health significance. The following are examples of severity level I violations (other deficiency):

       1. (A) failure to keep premises clean and have adequate drainage;
       2. (B) failure to clean and maintain floors, walls, or ceilings;
       3. (C) failure to provide adequate and properly shielded lighting;
       4. (D) failure to post hand washing signs at hand washing stations;
       5. (E) failure to provide blower air intake with approved filter;
       6. (F) failure to prohibit use of "dip" buckets to rinse hands or knives;
       7. (G) failure to use returnable containers only within the plant; and
       8. (H) failure to restrict shuckers from the packing room and all unauthorized persons from processing areas when operating.

    2. (2) Severity Level II--Violations that are of more than minor significance, or if left uncorrected, could result in more serious violations. The following are examples of severity level II violations (other deficiency):

       1. (A) failure to provide or use storage for employee clothing or personal articles;
       2. (B) failure to have clean, maintained, adequately drained floor;
       3. (C) failure to provide adequate heating/cooling/ventilation;
       4. (D) failure to provide adequate quantity of water to facility;
       5. (E) failure to provide hand washing stations with soap, sanitary towels, and/or waste receptacles with proper lids;
       6. (F) failure to properly construct, locate, maintain, and/or keep clean all non-food contact surfaces;
       7. (G) failure to provide detergents, approved sanitizers, brushes, and/or a sanitizer test kit to properly clean and sanitize the facility;
       8. (H) failure to properly store and/or keep clean single service containers;
       9. (I) failure to maintain frozen molluscan shellfish at 0 degrees Fahrenheit or less;
       10. (J) failure to require employees to wear clean outer garments, impermeable gloves/finger cots; to store these items properly; and/or to wear proper hair restraints;
       11. (K) failure to promptly remove empty molluscan shells or other accumulation; and
       12. (L) failure to meet plumbing code and/or install water disposal correctly or have adequate drainage where operations discharge water.

    3. (3) Severity Level III--Violations that are significant and which, if not corrected, could threaten public health. The following are examples of severity level III violations (key deficiency):

       1. (A) failure to exclude insects, rodents, vermin, and any other animals;
       2. (B) failure to provide hot and cold water at each sink and lavatory;
       3. (C) failure to protect plumbing from backflow, backsiphonage, and/or cross contamination;
       4. (D) failure to have toilets clean, repaired, and/or have self-closing doors;
       5. (E) failure to properly use, store, separate, and/or label poisonous/toxic materials;
       6. (F) failure to properly construct, locate, clean, and/or maintain food contact surfaces;
       7. (G) failure to provide a temperature measuring device in each refrigeration unit;
       8. (H) failure to wash molluscan shell stock reasonably free of bottom sediments and detritus as soon after harvesting as feasible;
       9. (I) failure of employees to wash/sanitize hands and/or exhibit good hygienic practices;
       10. (J) failure to restrict any personnel with infections that may be transmitted through the molluscan shellfish from participating in molluscan shellfish operations; and
       11. (K) failure to maintain complete and accurate records.

    4. (4) Severity Level IV--Violations that have a significant adverse impact on public health. The following are examples of severity level IV violations (key deficiency):

       1. (A) failure to separate operations by partition, space, or time;
       2. (B) failure to provide adequate refrigeration units;
       3. (C) failure to clean and sanitize food contact surfaces effectively and within required time frame;
       4. (D) failure to label molluscan shell stock or properly complete label;
       5. (E) failure to protect molluscan shell stock from contamination;
       6. (F) failure to pack into containers with a valid certificate number for that location; comply with label requirements; and/or to use proper date;
       7. (G) failure to promptly shuck, pack, and protect molluscan shellfish; and
       8. (H) failure to have responsible, effective, designated person as supervisor.

    5. (5) Severity Level V--Violations that are most significant and create an imminent hazard to public health. The following are examples of severity level V violations (critical deficiency):

       1. (A) failure to cease operations when location/plant is flooded;
       2. (B) failure to protect the water supply from contamination;
       3. (C) failure to install and/or maintain adequate sewage disposal system;
       4. (D) failure to process molluscan shellfish from only an approved source;
       5. (E) failure to maintain molluscan shell stock at the proper temperature;
       6. (F) failure to obtain approval for wet storage operation;
       7. (G) failure to keep molluscan shellfish from becoming contaminated;
       8. (H) failure to cool packed molluscan shellfish to 45 degrees Fahrenheit within two hours of delivery to the packing room;
       9. (I) failure to maintain packed molluscan shellfish at 45 degrees Fahrenheit or less during storage, repacking, and to cover in ice; and
       10. (J) failure to provide sanitary ice and/or properly protect it.

18. (r) The department may impose differing levels of penalties for different severity level violations.

    1. (1) Administrative penalties shall be imposed for Severity Level III, IV and V violations. Administrative penalties may be assessed for Severity Level I and II violations when they are combined with those of higher severity level(s) or for repeated violations which could have been prevented by corrective action and for which the dealer or harvester did not take effective corrective action.
    2. (2) Tables IA and IB show the base administrative penalties and the percentage of base amounts to be proposed based on severity level of violation.
19. (s) The department may offer a certificate holder or harvester the opportunity to attend a settlement conference to discuss with the SSD, methods and schedules for correcting the violation(s) or to show compliance with applicable provisions of the Health and Safety Code, Chapter 436, the rules in this chapter of this title (relating to Molluscan Shellfish), certificate conditions, and any orders of the department issued thereunder, or discuss all such topics. The Office of General Counsel may conduct settlement negotiations.
20. (t) Notices of any settlement conference shall be sent by personal service or certified mail, return receipt requested. A settlement conference is not a prerequisite for the action to be taken under subsections (l), (m), (n), (o), or (p) of this section.
21. (u) By acceptance of a certificate, the holder agrees to save, hold harmless, and indemnify the State of Texas, the department, and its employees against any and all liability, claims or losses for property damage or personal injury which result in whole or in part from the certificate holder's activities. The State of Texas shall not be held liable for financial losses incurred by the molluscan shellfish transplanters, gatherers, harvesters, plant supervisors, or plant owners due to failure of molluscan shellfish activity, condemnation of molluscan shellfish, loss of molluscan shellfish, or other reasons.

Source Note:The provisions of this §241.57 adopted to be effective May 10, 1998, 23 TexReg 4273.