Chapter 15A NCAC 18A

15A NCAC 18A .0183 ALTERNATIVE LABELING A durable label, such that it will not fade or deteriorate, that is permanently affixed to the container may be used to meet any labeling requirement in this Section. History Note: Authority G.S. 113-134; 113-182; 113-221.2; 143B-289.52; Ef…

15A NCAC 18A .0184 THERMAL PROCESSING CONTROLS - THERMOMETERS (a) All thermal processing equipment shall have a time-temperature recording thermometer with a temperature controller (combined or separately) and an indicating thermometer. The thermometers shall be located to give a…

15A NCAC 18A .0185 THERMAL PROCESSING OF CRUSTACEA AND CRUSTACEA MEAT (a) All thermal processing operations shall require a Process Validation Study Report approved by the Division of Marine Fisheries prior to operation based upon documentation of the ability to produce time-temp…

15A NCAC 18A .0186 LABELING OF THERMALLY PROCESSED CRUSTACEA OR CRUSTACEA MEAT Labeling of thermally processed crustacea or crustacea meat shall be in compliance with the following: (1) the label used shall legibly identify the contents of the container as thermally processed cru…

15A NCAC 18A .0187 INTERFACILITY THERMAL PROCESSING PROCEDURES Interfacility thermal processing of crustacea or crustacea meat shall be in compliance with the following: (1) crustacea or crustacea meat shall be packed, labeled, and refrigerated in compliance with Rules .0134 thro…

15A NCAC 18A .0188 HAZARD ANALYSIS Each dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of crustacea or crustacea meat product processed by that dealer and to identify the preventative measures that the…

15a ncac 18a .0189 HACCP PLAN Each dealer shall have and implement a written HACCP plan. The owner or authorized designee shall sign the plan when implemented and after any modification. The plan shall be reviewed at least annually and updated if necessary. The plan shall, at a m…

15A NCAC 18A .0190 SANITATION MONITORING REQUIREMENTS Each dealer shall monitor, at a minimum, the following sanitation items: (1) safety of water; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross contamination; (4) maintenance of hand washing, hand…

15A NCAC 18A .0191 MONITORING RECORDS Monitoring records of critical control points and the eight key sanitation items shall be recorded, as specified in the HACCP Plan, and signed and dated when recorded. The eight key sanitation items are set forth in 21 CFR 123.11 "Sanitation …

15A NCAC 18A .0231 REFERENCE RULES History Note: Authority G.S. 130A-230; Eff. February 1, 1976; Amended Eff. July 1, 1977; Readopted Eff. December 5, 1977; Amended Eff. July 1, 1985; Repealed Eff. September 1, 1990.

SECTION .0300 – sanitation of shellfish - general 15A NCAC 18A .0301 DEFINITIONS The following definitions shall apply throughout Sections .0300 through .0800 of this Subchapter: (1) "Adulterated" means: (a) any shellfish that have been harvested from polluted areas as defined in…

15A NCAC 18A .0302 PERMITS (a) It shall be unlawful to operate any of the following facilities without first obtaining a Shellfish Dealer Permit and Certificate of Compliance from the Division of Marine Fisheries: (1) depuration facilities; (2) repacking plants; (3) shellstock pl…

15A NCAC 18A .0303 RELAYING PERMITS History Note: Authority G.S. 130A-230; Eff. February 1, 1987; Amended Eff. September 1, 1990; Repealed Eff. March 15, 2023.

15A NCAC 18A .0304 DEPURATION HARVESTING PERMITS History Note: Authority G.S. 130A-230; Eff. February 1, 1987; Amended Eff. September 1, 1990; Repealed Eff. June 1, 2022.

15A NCAC 18A .0305 APPEALS PROCEDURE History Note: Authority G.S. 130A-230; Eff. February 1, 1987; Amended Eff. September 1, 1990; Repealed Eff. April 1, 2024.

SECTION .0400 – SANITATION OF SHELLFISH - GENERAL OPERATION STANDARDS Rules .0401 - .0431 of Title 15A Subchapter 18A of the North Carolina Administrative Code (T15A.18A .0401 - .0431); has been transferred and recodified from Rules .0901 - .0931 of Title 10 Subchapter 10B of the…

15A NCAC 18A .0402 GENERAL REQUIREMENTS FOR OPERATION (a) Shellfish dealers shall provide mechanical refrigeration that is capable of maintaining an ambient temperature of 45°F or less and be sized to handle one day's production. The mechanical refrigeration shall include an auto…

15A NCAC 18A .0403 SUPERVISION AND TRAINING (a) The shellfish dealer shall personally supervise or shall designate a responsible individual whose principal duty shall be to supervise and be responsible for compliance with the rules of this Subchapter. No unauthorized individuals …

15A NCAC 18A .0404 CONSTRUCTION Shellfish plants shall be sized and constructed to permit compliance with the operational provisions of Sections .0300 through .0800 of this Subchapter. History Note: Authority G.S. 113-134; 113-182; 113-221.2; 143B-289.52; Eff. February 1, 1987; R…

15A NCAC 18A .0405 FACILITY FLOODING (a) Shellfish plants shall be located so that they will not be subject to flooding by high tides. (b) If the facility floors are flooded, processing shall be discontinued until flood waters have receded and the facility and equipment are clean…

15A NCAC 18A .0406 FLOORS Floors shall be concrete or other equally impervious material, constructed so that they are easily cleanable, sloped so that water drains completely, and kept in good repair. The junction between floors and walls shall be sealed to render them impervious…

15A NCAC 18A .0407 WALLS AND CEILINGS (a) Walls and ceilings in areas where shellfish are stored, handled, processed, or packaged or where food handling equipment or packaging materials are stored shall be constructed of smooth, easily cleanable, non-corrosive, impervious materia…

15A NCAC 18A .0408 LIGHTING (a) Natural or artificial lighting shall be provided in all parts of the plant. Lighting intensities shall be a minimum of 25 foot-candles on working surfaces in packing and shucking rooms and a minimum of 10 foot-candles measured at a height of 30 inc…

15A NCAC 18A .0409 VENTILATION Ventilation shall be provided to prevent odors and condensation from contaminating shellfish, food contact surfaces, or food packaging materials. History Note: Authority G.S. 113-134; 113-182; 113-221.2; 143B-289.52; Eff. February 1, 1987; Readopted…

15A NCAC 18A .0410 PEST CONTROL (a) All exterior openings shall be screened or provided with wind curtains, or other methods to prevent the entrance of pests. All screens shall be kept in good repair. All exterior doors shall open outward and shall be self-closing. (b) The use an…

15A NCAC 18A .0411 RODENT AND ANIMAL CONTROL History Note: Authority G.S. 130A-230; Eff. February 1, 1987; Repealed Eff. April 1, 2024.

15A NCAC 18A .0412 PLUMBING AND HAND Washing Facilities (a) All plumbing shall be in compliance with applicable plumbing codes. (b) Hand washing facilities shall be provided with running water at a minimum temperature of 100°F dispensed from a hot and cold combination faucet. (c)…

15A NCAC 18A .0413 WATER SUPPLY (a) The water supply used shall be in accordance with 15A NCAC 18A .1720 through .1728, 15A NCAC 18C, or 02 NCAC 09C .0703, which are incorporated by reference, including subsequent amendments. (b) If the water supply is from a private source, samp…

15A NCAC 18A .0414 TOILET FACILITIES (a) Toilets shall be provided in the plant by the owner or responsible individual and shall be kept clean and in good repair. (b) Toilet tissue, in a holder, shall be provided by the owner or responsible individual. (c) Toilet room doors shall…

15A NCAC 18A .0415 PREMISES (a) The premises shall be maintained free from conditions that may constitute an attractant, breeding place, or harborage for pests such as unmowed weeds or grass, uncontained litter or waste, or unused equipment. (b) To prevent pests and odors, shells…

15A NCAC 18A .0416 PERSONAL HYGIENE (a) All employees shall wash their hands thoroughly with soap and running water before beginning work and again after each interruption or if their hands may have become soiled or contaminated. Hand washing signs shall be posted by the owner or…

15A NCAC 18A .0417 EMPLOYEES' PERSONAL ARTICLES Employees' street clothing, aprons, gloves, food, drink, and personal articles shall be stored in a room or locker separate from any area where shellfish are shucked or packed or any area that is used for the cleaning or storage of …

15A NCAC 18A .0418 SUPPLY STORAGE (a) Shipping containers, boxes, and other supplies shall be stored in a storage room or area. The storage room or area shall be kept clean. (b) Pesticides, rodenticides, chemical agents, sanitizers, and other toxic substances shall be stored sepa…

15A NCAC 18A .0419 HARVEST VESSELS AND VEHICLES (a) It shall be unlawful to use vessels or vehicles that are engaged in the commercial harvest, handling, or transport of shellstock in such a manner that allows contact of shellstock with bilge water, standing water, or other sourc…

15A NCAC 18A .0420 TRANSPORTING Shellfish (a) All shellfish storage areas in trucks, vessels, trailers, and other conveyances used for transporting shellfish shall be enclosed, tightly constructed to eliminate the entrance of pests, kept clean, and shall be subject to inspection …

15A NCAC 18A .0421 RECORDS (a) All shellfish dealers who conduct any business of buying, selling, or shipping shellfish shall keep an accurate, daily record that shall show the names of all persons from whom shellfish are received, the address of any shellfish dealer from whom sh…

15A NCAC 18A .0422 SHELLSTOCK CLEANING No person shall offer for sale any shellstock that have not been washed free of harvest area sediments and detritus. Water used for shellstock washing shall be obtained from a water source in accordance with Rule .0413 of this Section or fro…

15A NCAC 18A .0423 SALE OF LIVE SHELLSTOCK Only live shellstock shall be offered for sale. History Note: Authority G.S. 113-134; 113-182; 113-221.2; 143B-289.52; Eff. February 1, 1987; Readopted Eff. April 1, 2024.

15A NCAC 18A .0424 SHELLFISH RECEIVING No shellfish dealer shall receive or accept: (1) any shellstock from: (a) a licensed shellfish harvester unless: (i) the container or package bears the harvest tag as required in Rule 15A NCAC 03K .0109 and in accordance with the HACCP plan;…

15A NCAC 18A .0425 Dealer tags (a) Consistent with the rules of this Section, it shall be unlawful to possess shellstock without a dealer tag or label affixed after the shellstock is processed or shipped by the initial certified shellfish dealer. The tag shall be durable, waterpr…

15A NCAC 18A .0426 BULK SHIPMENTS BETWEEN SHELLFISH DEALERS (a) For the purpose of this Rule: (1) "bulk shipment" shall mean a shipment of a shellstock lot between shellfish dealers. (2) "shellstock lot" shall mean a single type of bulk shellstock or containers of shellstock of n…

15A NCAC 18A .0427 SHELLFISH STORAGE (a) It shall be unlawful to fail to keep shellstock and in-shell product under mechanical refrigeration at a temperature of 45°F or below unless otherwise required by proclamation issued under the authority of 15A NCAC 03K .0110 or otherwise s…

15A NCAC 18A .0428 SAMPLING AND TESTING Samples of shellfish may be taken and examined by the Division of Marine Fisheries at any time or place for routine quality control checks or to evaluate for threats of physical injury or adverse health effects to consumers. This may includ…

15A NCAC 18A .0429 embargo OR DISPOSAL OF SHELLFISH (a) When it has been determined by the Division of Marine Fisheries that shellfish have not been grown, harvested, stored, treated, transported, handled, shucked, packed, or offered for sale in compliance with Sections .0300 thr…

15A NCAC 18A .0430 BACTERIOLOGICAL and contamination STANDARDS Shellfish shucked or in the shell and intended or offered for sale shall be deemed adulterated by the Division of Marine Fisheries if: (1) the concentration of Escherichia coli exceeds a Most Probable Number (MPN), as…

15A NCAC 18A .0431 STANDARDS FOR AN APPROVED SHELLFISH GROWING AREA History Note: Authority G.S. 130A-230; Eff. February 1, 1987; Repealed Eff. May 1, 2021.

15A NCAC 18A .0432 PUBLIC DISPLAY OF CONSUMER ADVISORY All shellfish dealers permitted by Rule .0302 of this Subchapter and all other businesses and persons that sell or serve raw shellfish shall post one of the following consumer advisories or an equivalent statement in a place …

15A NCAC 18A .0433 HAZARD ANALYSIS Each shellfish dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of shellfish product processed by that dealer and to identify the preventative measures that the dealer …

15A NCAC 18A .0434 HACCP PLAN (a) Each shellfish dealer shall have and implement a written HACCP plan specific to each kind of shellfish product processed. The owner or authorized individual shall sign the plan when implemented, which shall signify that the plan has been accepted…

15A NCAC 18A .0435 SANITATION MONITORING REQUIREMENTS (a) Each shellfish dealer shall monitor the following sanitation items when the plant is operational: (1) safety of water; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination; (4) main…