(a) The following activities are exempted from the requirements in this section:      
        (1) hatcheries;       
        (2) nursery products which do not exceed 10% of the market weight; and       
        (3) nursery products that are six months or more growing time from market size.       
      (b) Aquaculture encompasses both open water and land based monoculture and polyculture.     
      (c) Any person who performs open water aquaculture or operates an aquaculture facility to raise molluscan shellfish for human consumption shall obtain:      
        (1) a permit(s) or authorization from the department, GLO, TPWD, TDA, and/or TCEQ for the activity or for construction and functioning of his/her facility;       
        (2) a harvester's license; and       
        (3) certification as a dealer, where necessary.       
      (d) Molluscan shellfish aquaculture shall be practiced only in strict compliance with the provisions of the authorization issued by the department for the aquaculture activity. Authorization shall be based on the aquaculturist's written operational plan.     
      (e) Prior to beginning any activity, a department approved aquaculturist shall obtain the written permission of the department for use of the site and any construction.     
      (f) Water quality at any site used for open water or land based aquaculture shall meet the criteria for the approved, conditionally approved, restricted or conditionally restricted classification.     
      (g) Molluscan shellfish cultured in any open water or land based system meeting the criteria for the approved classification in the open status or the open status of the conditionally approved classification of a harvest area throughout the culture period may be immediately marketed.     
      (h) Any molluscan shellfish raised in aquaculture shall be subjected to relaying or depuration prior to direct marketing if the culture area or facility is located in or using water that is in:      
        (1) the closed status of the conditionally approved classification;       
        (2) the restricted classification; or       
        (3) the open status of the conditionally restricted classification.       
      (i) Only drugs sanctioned by the FDA shall be used for molluscan shellfish treatment.     
      (j) Harvesting, processing, storage, and shipping requirements for molluscan shellfish raised in aquaculture shall be the same as the requirements for wild molluscan shellfish specified in this subchapter of this title (relating to Molluscan Shellfish).     
      (k) Complete and accurate written records shall be maintained for at least two years by the aquaculturist and shall include the:      
        (1) source of molluscan shellfish, including seed if the seed is from harvest areas that are not in the approved classification;       
        (2) dates of transplanting and harvest; and       
        (3) water source, its treatment method, if necessary, and its quality in land based systems.       
      (l) Seed may come from any growing area, or from any harvest area in any classification, provided that:      
        (1) the source of the seed is approved by the department;       
        (2) seed from growing areas or harvest areas in the restricted or prohibited classification has acceptable levels of poisonous or deleterious substances; and       
        (3) seed from growing areas or harvest areas in the prohibited classification is cultured for a minimum of six months.       
     Source Note:        The provisions of this §241.54 adopted to be effective March 20, 2003, 28 TexReg 2346