S.C. Code Regs. § § 61-32.IX

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-32.IX - BOTTLED WATER, SOFT DRINK, AND ICE PLANTS AND DISTRIBUTION STATIONS

A. Water supply for BOTTLED WATER, SOFT DRINK, and ICE plants and ICE and water vending.

1. The water supply shall be from an APPROVED public water system as defined in R.61-58, State Primary Drinking Water Regulations.

2. The design, operation, and maintenance of water purification systems used to further treat potable water shall be certified as meeting the specifications of the American National Standard Institute/National Sanitation Foundation (ANSI/NSF). All chemicals and products added to the potable water shall meet ANSI/NSF Standard 60. All materials and products installed that come into contact with the potable water shall meet ANSI/NSF Standard 61. The certifying party shall be accredited by the American National Standards Institute. They shall not be operated beyond their rated capacity and shall be maintained in a clean, sanitary condition at all times. This shall include dispensed water and ICE VENDING MACHINES.

3. Potable running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of SOFT DRINKS, BOTTLED WATER, and ICE; for the cleaning of EQUIPMENT, utensils, and CONTAINERS; and for EMPLOYEE sanitary facilities.

4. Carbonated water shall be conveyed in APPROVED stainless steel or equal FOOD-grade piping and not in piping of galvanized iron, lead, zinc, or other deleterious materials.

5. All water storage and cooling tanks shall be of noncorrosive material, properly covered; air vents properly filtered, clean, and free from dust both inside and outside; and the inlet and outlet so arranged as to prevent contamination during filling and emptying.

B. Required rooms.

1. Except as APPROVED by the DEPARTMENT under paragraph B.2 below, each BOTTLED WATER and SOFT DRINK plant shall have a separate room (commonly called a syrup or blend room) or separate area of the filling room for mixing ingredients for BOTTLED WATER or SOFT DRINKS. This room or separate area of the filling room shall be used only for mixing ingredients and storage of mixed batches.

2. Each BOTTLED WATER and SOFT DRINK plant shall have a separate room for filling and sealing CONTAINERS (commonly called a filling or BOTTLING room). This room shall contain only necessary filling, sealing, electronic inspection, coding, and labeling EQUIPMENT. Only the exit end of the bottle washing machine shall open into this room through a tight-fitting wall. If APPROVED by the DEPARTMENT, the mixing of ingredients and storage of mixed batches may be conducted in this room.

3. ICE for human consumption shall be processed and packaged only in rooms used exclusively for processing and packaging ICE for human consumption. ICE for human consumption shall not be processed or packaged on open platforms or on trucks or delivery vehicles, or in any manner which would allow contamination from overhead drip, condensation, dirt, or other contaminants.

C. Transportation of BULK WATER for BOTTLED WATER plants.

1. BULK WATER shall be from a public water system as APPROVED and defined in R.61-58 by the DEPARTMENT.

2. The means and methods of transporting BULK WATER shall be APPROVED by the DEPARTMENT. Bulk tanks, hoses, pumps, and connections used for loading, transporting, and unloading water shall be SANITIZED. Source water for transport shall be treated with an effective disinfectant APPROVED by the DEPARTMENT at an APPROVED concentration prior to being transported.

3. Tank filling and delivery hose connections shall be cleaned and SANITIZED on a regular basis. The tank shall be sealed at all times except when being filled, being cleaned and SANITIZED, and when the water is being unloaded. A record of such cleaning and SANITIZING shall be maintained with the vehicle and shall be available upon request by the DEPARTMENT. Pumps, hoses, connections, and fittings shall be capped and protected from contamination when not in use. The tank manhole shall not be used as a means of filling the tank. To prevent collapse of the tank during delivery of BULK WATER, the manhole may be opened but shall be provided with an air filter to prevent contamination.

4. All surfaces which come into contact with water during storage prior to transport shall be of smooth, impervious, nonabsorbent, corrosion resistant, and nontoxic material such as stainless steel of the American Iron and Steel Institute 300 Series, or equally corrosion resistant, nontoxic material. All water contact surfaces shall be free of substances that may render the water hazardous to health or may adversely affect the flavor, color, turbidity, odor, radiological, microbiological, or chemical quality of the water.

5. BULK WATER transport is intended to move source water from one area to another for the purpose of treatment, packaging, and human consumption. Such water shall not be dispensed directly to consumers from a BULK WATER transport tank or indirectly through some other vending device, unless otherwise APPROVED by the DEPARTMENT. In case of an emergency, such as a DRINKING WATER shortage or outage, or a contaminated water supply, treated water may be dispensed directly from a properly SANITIZED water transport tank.

D. Returnable CONTAINER cleaning.

1. All returnable CONTAINERS shall be ADEQUATELY, mechanically washed and SANITIZED prior to filling. Unless the CONTAINERS are sealed after washing, they shall be washed immediately prior to filling. Hand cleaning of CONTAINERS is prohibited except as a preliminary to subsequent mechanical washing.

2. Metal and glass CONTAINERS.

(a) All metal and glass CONTAINERS shall be exposed to a minimum three percent (3%) alkali solution of which not less than sixty percent (60%) is caustic soda (sodium hydroxide) by an APPROVED automatic mechanical method for a period of not less than five (5) minutes at a temperature of not less than 130ºF, or to an equivalent cleaning and sanitizing process APPROVED by the DEPARTMENT.

(b) CONTAINERS shall be rinsed of all caustic soda with potable water.

3. Polycarbonate CONTAINERS.

(a) Polycarbonate CONTAINERS shall be cleaned with APPROVED non-caustic detergents at their required concentrations by an APPROVED mechanical method.

(b) An APPROVED sanitizing rinse consisting of chlorine, bromine, iodine, quaternary ammonia, or ozonated water at the proper APPROVED temperature/time/concentration must follow the cleaning cycle.

4. A permanent record of key operating parameters of the CONTAINER washer should be maintained. These records or logs should include, but are not limited to, wash temperatures, concentrations of cleaners, concentrations of SANITIZERS, lack of carryover of cleaners or caustic in bottles, and maintenance on the washer. Tests on cleaner/SANITIZER concentrations and carryover should be carried out at start-up and regularly thereafter throughout the shift. All maintenance on the washer should be recorded, such as cleaning or aligning spray jets. All records shall be kept on file at least two (2) years for regulatory inspection. Each washer shall be equipped with an indicating thermometer.

E. Single-service CONTAINERS.

1. Single-service CONTAINERS shall be manufactured from FOOD-grade materials that do not impart odors or tastes to the product, nor contaminate the product with MICROORGANISMS, or toxic or injurious substances.

2. Single-service CONTAINERS shall be packaged and stored in a manner APPROVED by the DEPARTMENT prior to filling.

3. Unless otherwise APPROVED by the DEPARTMENT, all single-service CONTAINERS shall be inverted and rinsed with potable water, then treated by filtered compressed air or vacuumed to remove dust prior to filling.

F. Inspection of returnable CONTAINERS.

1. Bottles.

(a) All empty bottles shall be visually inspected immediately after the final rinse of the washing operation for defects, chips, foreign objects, and unclean product contact surfaces as the bottles pass on a conveyor before a well-illuminated background at a speed slow enough for the inspector to achieve high efficiency.

(b) Dirty bottles shall be removed from the production line and either destroyed or rewashed. Defective bottles shall be removed from the production line and destroyed. When inspectors break bottles for cullet, ADEQUATE protection shall be provided for exposed bottles in the immediate area to prevent glass fragments from entering them.

(c) Electronic inspection devices can be used in addition to visual inspection; however, electronic inspection devices shall not be substituted for visual inspection of returnable bottles without the approval of the DEPARTMENT. Inspectors shall have good eyesight, with or without corrective lenses, and shall be rotated to non-inspection work as often as is necessary to maintain high efficiency.

(d) Returnable bottles shall not be used where their condition or design may prevent proper inspection of the contents thereof.

2. Metal canisters.

(a) All metal canisters shall be visually inspected immediately after the final rinse of the washing operation for the presence of foreign objects or unclean product contact surfaces.

(b) Unclean canisters shall be either immediately returned to the washer or removed to the storage area for unclean canisters.

G. CONTAINER closures.

1. CONTAINER closures shall be manufactured from FOOD-grade materials which do not impart odors or tastes to the product, nor contaminate the product with MICROORGANISMS, or toxic or injurious substances.

2. CONTAINER closures shall be received by the BOTTLING PLANT in an undamaged package sealed by the manufacturer.

3. All CONTAINER closures shall be stored in a clean, dry place protected from insects, rodents, dust, splash, or other contamination. Closures which have been touched on the inner side by the operator, as may occur while adjusting EQUIPMENT, shall be discarded.

4. CONTAINER closures not used during the period of processing operations shall be resealed in their original CONTAINER or stored in an APPROVED tightly covered CONTAINER.

5. Only new CONTAINER closures shall be used.

H. Filling and sealing.

1. CONTAINERS shall be filled and sealed with APPROVED mechanical EQUIPMENT. Manual filling and sealing shall be prohibited, except when otherwise APPROVED by the DEPARTMENT for package sizes in which mechanical sealing EQUIPMENT is not yet readily available.

2. Filling EQUIPMENT which fills glass CONTAINERS under pressure should be provided with an ADEQUATE shield to protect against broken glass entering unsealed CONTAINERS. Whenever a glass bottle breaks while being filled or sealed, the machinery involved shall be stopped and all broken glass shall be removed from parts that touch the opening of bottles or contact the product. This shall be performed in such a manner to protect against transferring broken glass into nearby bottles that have exposed openings.

3. No PERSON or his clothing shall come in contact with any portion of the CONTAINER or EQUIPMENT that might result in contamination of the product.

4. The contents of all imperfectly sealed CONTAINERS shall be discarded.

I. SANITATION OF BOTTLED WATER, SOFT DRINK, AND ICE PLANTS AND DISTRIBUTION STATIONS

1. All BOTTLED WATER, SOFT DRINK, and ICE manufacturers and distributors, regardless of exemption status, shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, and Subpart F - Requirements Applying to Records That Must Be Established and Maintained, as amended.

2. All BOTTLED WATER, SOFT DRINK, and ICE plants and distribution stations that have been granted a Qualified Facility Exemption by the FDA or that are solely engaged in the storage of refrigerated UNEXPOSED PACKAGED FOODS when temperature controls are necessary to prevent PATHOGEN growth shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, Subpart D - Modified Requirements, and Subpart F - Requirements Applying to Records That Must Be Established and Maintained, and be familiar with Subpart E - Withdrawal of a Qualified Facility Exemption, as amended.

3. All BOTTLED WATER, SOFT DRINK, and ICE plants and distribution stations that have not been granted a Qualified Facility Exemption by the FDA shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, Subpart C - Hazard Analysis and Risk -Based Preventive Controls, and Subpart F- Requirements Applying to Records That Must Be Established and Maintained, as amended.

4. All BOTTLED WATER, SOFT DRINK, and ICE plants and distribution stations under an FDA order to withdraw their Qualified Facility Exemption are subject to the requirements of 21 CFR Part 117, Subpart E - Withdrawal of a Qualified Facility Exemption, as amended.

5. BOTTLED WATER, SOFT DRINK, and ICE plants and distribution stations that have not been granted a Qualified Facility Exemption by the FDA and have identified a hazard requiring a supply-chain applied control shall comply with the requirements of 21 CFR Part 117, Subpart G - Supply-Chain Program, as amended.

S.C. Code Regs. § 61-32.IX

Amended by State Register Volume 16, Issue No. 6, eff June 26, 1992; State Register Volume 28, Issue No. 5, eff May 28, 2004; State Register Volume 44, Issue No. 06, eff. 6/26/2020.