S.C. Code Regs. § § 61-32.III

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

Section 61-32.III - DEFINITIONS

A. ADEQUATE - substantial compliance with acceptable health standards, procedures, and practices.

B. ADULTERATED or ADULTERATION - BOTTLED WATER, SOFT DRINKS, or ICE are deemed to be ADULTERATED if the product:

1. Bears or contains any poisonous or deleterious substance in a quantity that may render it injurious to health;

2. Bears or contains any added poisonous or deleterious substance for which no state or federal regulation has established a safe tolerance, or in excess of such tolerance if one has been established;

3. Consists, in whole or in part, of any substance unfit for human consumption;

4. Has been produced, processed, prepared, packaged, or held under unsanitary conditions;

5. Is packaged in a container which is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

6. Has any substance added thereto, or mixed or packaged therewith, so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or

7. Is in violation of Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. Section 342) .

C. APPROVED - acceptable to the Department based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

D. APPROVED LABORATORY - a laboratory APPROVED by the Department or certified by the U.S. Environmental Protection Agency (EPA), or certified (accredited) by a third-party organization acceptable to the Department.

E. APPROVED SOURCE - the source of the water used in a plant's operations or a bottled water plant's product water, whether it be from a spring, artesian well, drilled well, public or community water system, or any other source that has been inspected and the water sampled, analyzed, and found of a safe and sanitary quality with or without treatment, and APPROVED by the Department in accordance with Regulation 61-58, State Primary Drinking Water Regulations.

F. ARTESIAN WATER - BOTTLED WATER from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer. ARTESIAN WATER may be collected with the assistance of external force to enhance the natural underground pressure. On request, plants shall demonstrate to the Department that the water level stands at some height above the top of the aquifer.

G. BOTTLED WATER - water that is intended for human consumption and that is sealed in bottles or other CONTAINERS with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents. It does not include those FOOD ingredients that are declared in ingredient labeling as "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "SPARKLING WATER," and "tonic water."

H. BOTTLING - filling, capping, packaging, or enclosing in CONTAINERS.

I. BOTTLING PLANT - any establishment involved in the manufacturing or packaging of SOFT DRINKS and/or BOTTLED WATERS.

J. BUSINESS DAY - every official work day of the week excluding weekends and state holidays.

K. BULK WATER - source water collected at an APPROVED site remote from the BOTTLING PLANT and transported to the BOTTLING PLANT for further processing and BOTTLING.

L. CODE OF FEDERAL REGULATION (CFR) - a codification of the general and permanent rules and regulations (administrative LAW) published in the Federal Register by the executive departments and agencies of the federal government of the United States. Citations to the CFR in this regulation refer sequentially to the Title, Part, and Section numbers. For example, the citation 21 CFR 117.10 refers to Title 21, Part 117, Section 117.10.

M. CONTAINER - any material used for the packaging of SOFT DRINKS, BOTTLED WATERS, and ICE, whether of glass, plastic, metal, paper, or any combination thereof.

N. DEMINERALIZED WATER - BOTTLED WATER that is produced by distillation, deionization, reverse osmosis, or other suitable process, that meets the definition of PURIFIED WATER in the United States Pharmacopoeia, and is specified by the U. S. Food and Drug Administration (FDA) in 21 CFR 165.110.

O. DEIONIZED WATER - BOTTLED WATER that has been produced by a process of deionization, that meets the definition of PURIFIED WATER in the United States Pharmacopoeia, and is specified by the FDA in 21 CFR 165.110.

P. DEPARTMENT - the South Carolina Department of Health and Environmental Control and its authorized representatives.

Q. DISTILLED WATER - BOTTLED WATER that has been produced by a process of distillation, meets the definition of PURIFIED WATER in the United States Pharmacopoeia, and is specified by FDA in 21 CFR Section 165.110.

R. DRINKING WATER - water that is intended for human consumption and that is sealed in bottles or other CONTAINERS with no added ingredients, except that it may optionally contain safe and suitable antimicrobial agents.

S. EMPLOYEE - a permit holder, PERSON in charge, PERSON having supervisory or managerial duties, PERSON on the payroll, family member, volunteer, PERSON performing work under a contractual agreement, or any other PERSON working in a BOTTLED WATER, SOFT DRINK, or ICE plant or distribution station.

T. EQUIPMENT - all machinery, utensils, conveyors, CONTAINERS, cases, and other articles used in the manufacturing of BOTTLED WATER, SOFT DRINKS, or ICE.

U. EXCLUSION - prevention of a PERSON from working as an EMPLOYEE in a BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station, or entering a BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station as an EMPLOYEE.

V. FDA - United States Food and Drug Administration.

W. FOOD - means FOOD as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act ("FD&C") and includes raw materials and ingredients.

X. GROUND WATER - water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure. GROUND WATER must not be under the direct influence of surface water.

Y. ICE - the product, in any form, obtained as a result of freezing water by mechanical or artificial means.

Z. ICE VENDING MACHINES - any self-service machines that act as stand-alone units and may operate without full-time service personnel. These units are activated by the insertion of money; the ICE is bagged automatically or dispensed in bulk to the customer.

AA. IMMINENT HEALTH HAZARD - a significant threat or danger to health that is considered to exist when there is sufficient evidence to show that a product, practice, circumstance, or event creates a situation requiring immediate correction or cessation of operation to prevent illness or injury based on the number of potential illnesses or injuries, and the nature, severity, and duration of the anticipated illness or injury.

BB. LAW - applicable local, state, and federal statues, regulations, and ordinances.

CC. MANUFACTURED BOTTLED WATER, SOFT DRINKS, AND/OR ICE PRODUCTS DISTRIBUTION STATION - any place or PREMISES, except RETAILERS, where manufactured BOTTLED WATER, SOFT DRINKS, and ICE products are received, stored, and dispensed to RETAILERS (may also be referred to as "Distribution Station").

DD. MANUFACTURED BOTTLED WATER, SOFT DRINKS, AND/OR ICE PRODUCTS DISTRIBUTOR - any PERSON, except a RETAILER, who receives, stores, and dispenses manufactured BOTTLED WATER, SOFT DRINKS, and ICE products to RETAILERS (may also be referred to as "Distributor").

EE. MANUFACTURED BOTTLED WATER, SOFT DRINKS, AND/OR ICE PRODUCTS MANUFACTURER - any PERSON, except a RETAILER, who manufactures, processes, or freezes manufactured BOTTLED WATER, SOFT DRINKS, and ICE products for distribution or sale.

FF. MANUFACTURED BOTTLED WATER, SOFT DRINKS, AND/OR ICE PRODUCTS PLANT - any place or PREMISES, except RETAILERS, where manufactured BOTTLED WATER, SOFT DRINKS, and ICE products are manufactured, processed, or frozen for distribution or sale.

GG. MICROORGANISMS - means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are PATHOGENS. The term "undesirable MICROORGANISMS" includes those MICROORGANISMS that are PATHOGENS, that subject FOOD to decomposition, that indicate that FOOD is contaminated with filth, or that otherwise may cause FOOD to be ADULTERATED.

HH. MINERAL WATER - BOTTLED WATER containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more boreholes or springs, originating from a geologically and physically protected underground water source. MINERAL WATER is distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source, with consideration given to the cycles of natural fluctuations. No minerals may be added to this water.

II. NATURAL WATER - bottled spring, mineral, artesian, or WELL WATER that is derived from an underground formation or water from surface water that only requires minimal processing, is not derived from a municipal system or public water supply, and is unmodified except for limited treatment (e.g., filtration, ozonation, or equivalent disinfection process).

JJ. PACKAGED ICE - ICE products packaged by APPROVED manufacturers and sold through retail outlets.

KK. PATHOGEN - a microorganism of public health significance.

LL. PERMIT - the document issued by the DEPARTMENT that authorizes a PERSON or entity to operate a BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station.

MM. PERMIT HOLDER - the entity, such as the owner, the owner's agent, or other PERSON, that possesses a valid PERMIT to operate a BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station and is legally responsible for its operation.

NN. PERSON - an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

OO. PEST - any objectionable animals or insects including, but not limited to, birds, rodents, flies and larvae.

PP. PURIFIED WATER - BOTTLED WATER produced by distillation, deionization, reverse osmosis, or other suitable process, that meets the definition of PURIFIED WATER in the United States Pharmacopoeia, and is specified by the FDA in 21 CFR 165.110.

QQ. PREMISES -

1. The physical facility, its contents, its land, and any adjacent or bordering contiguous land or property under the control of the PERMIT HOLDER; or

2. The physical facility, its contents, and land or property not described in (a) of this definition if the facilities and contents are under the control of the PERMIT HOLDER and may impact the BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station personnel, facilities, or operations, and the BOTTLED WATER, SOFT DRINKS, or ICE plant or distribution station is only one component of a larger operation, such as a healthcare facility, hotel, motel, school, recreational camp, or prison.

RR. RESTRICTION - limitation of the activities of an EMPLOYEE so that there is no risk of transmitting a disease that is transmissible through BOTTLED WATER, SOFT DRINKS, or ICE or their ingredients and the EMPLOYEE does not work with exposed BOTTLED WATER, SOFT DRINKS, or ICE or their ingredients, clean EQUIPMENT, utensils, linens, or unwrapped single-service or single-use articles.

SS. RETAIL FOOD ESTABLISHMENT - an establishment that sells FOOD products directly to consumers as its primary function. RETAIL FOOD ESTABLISHMENTS include, but are not limited to, grocery stores, convenience stores, roadside stands, farmers markets, and community supported agriculture (CSA) operations. Any business making FOOD (including a farm business) with at least 50.1 percent in direct to individual consumer FOOD sales satisfies the definition of a RETAIL FOOD ESTABLISHMENT and is exempt from the Bioterrorism Act registration regulations under the 2002 Bioterrorism Act ( 21 CFR 1.225) as a RETAIL FOOD ESTABLISHMENT. The term "consumers" does not include businesses. A RETAIL FOOD ESTABLISHMENT also includes certain farm-operated businesses selling FOOD directly to consumers as their primary function.

TT. RETAILER - any PERSON who sells, serves, or dispenses at retail manufactured BOTTLED WATER, SOFT DRINKS, or ICE products that have been processed in an APPROVED manufactured BOTTLED WATER, SOFT DRINKS, or ICE products plant.

UU. REMODELED - any enlarging, replacing of floors, walls, or ceilings, or changing in any respect the structure at which a SOFT DRINK, BOTTLED WATER, or ICE plant is housed. This does not apply to repainting or refinishing of floors or walls.

VV. REVERSE OSMOSIS WATER - BOTTLED WATER that is produced by a process of reverse osmosis, that meets the definition of "PURIFIED WATER" in the United States Pharmacopoeia, and is specified by the FDA in 21 CFR 165.110.

WW. RISK - the likelihood that an adverse health effect will occur within a population as a result of a hazard in a FOOD.

XX. SANITIZE - to ADEQUATELY treat cleaned surfaces by a DEPARTMENT -accepted process that is effective in destroying vegetative cells of PATHOGENS, and in substantially reducing numbers of other undesirable MICROORGANISMS, but without adversely affecting the product or its safety for the consumer.

YY. SOFT DRINK - any nonalcoholic, flavored carbonated beverage, including but not limited to soda or soda water, fruit flavored drink, nonalcoholic still beverage, and seltzer or club soda.

ZZ. SPARKLING BOTTLED WATER - BOTTLED WATER that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide that it had at the emergence from the source. Manufacturers may add carbonation to previously noncarbonated BOTTLED WATER products and label such water appropriately (e.g. sparkling SPRING WATER).

AAA. SPRING WATER - BOTTLED WATER derived from an underground formation from which water flows naturally to the surface of the earth. SPRING WATER must comply with the FDA standard of identity in 21 CFR 165.110.

BBB. STERILE WATER - BOTTLED WATER that meets the requirements under "Sterility Tests" <71> in the current United States Pharmacopoeia and specified by the FDA in 21 CFR 165.110.

CCC. UNEXPOSED PACKAGED FOOD - packaged FOOD that is not exposed to the environment.

DDD. WELL WATER - BOTTLED WATER from a hole bored, drilled, or otherwise constructed in the ground that taps the water of an aquifer.

S.C. Code Regs. § 61-32.III

Replaced and amended by State Register Volume 44, Issue No. 06, eff. 6/26/2020.