Section 25-B9901. DEFINITIONS

 

Acid foods - foods that have a natural pH of four and six tenths (4.6) or below.

 

Acidified foods - low-acid foods to which acid(s) or acid food(s) are added. Acidified foods include, but are not limited to beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish. Singly or in any combination they have water activity (aw) greater than eighty-five hundredths (0.85) and have a finished equilibrium pH of four and six tenths (4.6) or below. These foods may be called pickled, such as "pickled cauliflower." Acidified foods do not include carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, or foods that are stored, distributed, and retailed under refrigeration.

 

Adequate - that which is needed to accomplish the intended purpose in keeping with good public health practice.

 

Adulterated food - consists of any of the following:

 

(a)Food that:

 

(1)Has been manufactured under such conditions that it is unfit for food; or if the food has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health within the meaning of 9 CFR 331.5 - Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of products; application of regulations; or 21 CFR 114.5 - Current good manufacturing practice; and

 

(2)Is covered by specific regulations for good manufacturing practices; or

 

(b)A food, including egg or egg product, that:

 

(1)Bears or contains any poisonous or deleterious substance which may render it injurious to health; but if the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health;

 

(2)Bears or contains any added poisonous or added deleterious substance other than one which is:

 

(A)A pesticide chemical in or on a raw agricultural commodity;

 

(B)A food additive; or

 

(C)A color additive which is unsafe within the meaning of 9 CFR 301.2 - Definitions;

 

(3)Is, in whole or part, a raw agricultural commodity and bears or contains a pesticide chemical which is unsafe within the meaning of 9 CFR 301.2 - Definitions;

 

(4)Bears or contains any food additive which is unsafe within the meaning of 9 CFR 301.2 - Definitions;

 

(5)Consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human food;

 

(6)Consists in whole or in part of any damaged egg or eggs to the extent that the egg meat or white is leaking, or it has been contacted by egg meat or white leaking from other eggs;

 

(7)Has been prepared, packaged, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health within the meaning of 21 CFR 114.5 - Current good manufacturing practice;

 

(8)Is an egg or the product of any egg that has been subjected to incubation;

 

(9)Has been in a container that is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;

 

(10)Has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to 9 CFR 381.1 - Definitions; or

 

(11)Has any valuable constituent that has been in whole or in part omitted or abstracted from the egg or egg product, or has any substance substituted, wholly or in part for the egg or egg product, or has damage or inferiority that has been concealed in any manner; or has had any substance added to or mixed or packed with the egg or egg product 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.

 

Advertisement - a representation made, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of food.

 

Air gap - the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture or other device and the flood level rim of that receptacle.

 

Allergen - foods that are commonly known to cause serious allergenic responses, including, but not limited to, milk, eggs, fish, crustacea, mollusks, tree nuts, wheat, and legumes, particularly peanuts and soybeans.

 

Anicteric - not accompanied or characterized by jaundice.

 

Applicant - any person or entity that has submitted an application to the Department for a license or certification to operate a food processing operation or a shellfish operation.

 

Approved - acceptable to the Department or other regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

 

Artesian water - bottled water from a well tapping a confined aquifer in which the water level stands above the water table. "Artesian water" shall meet the requirements of "natural water."

 

Asymptomatic - without obvious symptoms and not showing or producing indications of a disease or other medical condition, such as an individual infected with a pathogen but not exhibiting or producing any signs or symptoms of vomiting, diarrhea, or jaundice. An asymptomatic individual may not be showing symptoms because symptoms have resolved or subsided, or because symptoms never manifested.

 

Backflow - the flow of water or other liquids, mixtures or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.

 

Back siphonage - the flowing back of used, contaminated or polluted water from a plumbing fixture, vessel or other source into potable water supply pipes because of negative pressure in the water supply pipes.

 

Bottled water - water that is placed in a sealed container or package and is offered for sale for human consumption or other consumer uses.

 

Capable of use as human food - applies to any egg or egg product unless it is denatured, or otherwise identified, as required by regulations prescribed by the Director, to deter its use as human food.

 

Certification - the approval issued by the Department to a Molluscan Shellfish Dealer according to the provisions of the NSSP for each location in which the dealer conducts a shellfish operation. Each certification shall contain a certification number that consists of a one to five digit Arabic number preceded by "DC" the two letter abbreviation for the District of Columbia, followed by a two letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this Code using the following terms:

 

(a)Shellstock shipper (SS);

 

(b)Shucker-packer (SP);

 

(c)Repacker (RP); and

 

(d)Reshipper (RS).

 

CFR - the Code of Federal Regulations. Citations in this Code to the CFR refer sequentially to the Title, Part, and Section numbers. For example, 40 CFR 180.194 refers to Title 40, Part 180, Section 194.

 

Color additive - has the meaning stated in 21 CFR 70.3 Definitions.

 

Commingle or commingling - the act of combining different lots of shellstock or shucked shellfish.

 

Compliance schedule - a written schedule that provides a correction time period to eliminate critical and noncritical violations.

 

Conditional employee - a potential food employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food.

 

Confirmed disease outbreak - a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness; or when two (2) or more persons experience a similar illness after ingestion of a common food and epidemiological analysis implicates the food as the source of the illness; or a single case of illness from botulism or chemical poisoning.

 

Consumer - a person, who is a member of the public, takes possession of food, does not operate a food processing operation, and does not offer the food for resale. A consumer also includes any person who purchases eggs for his or her own family use or consumption, or any restaurant, hotel, boarding house, bakery, or other institution or concern which purchases eggs for serving to guests or patrons thereof, or for its own use in cooking or baking.

 

Container - any box, can, tin, plastic, or other receptacle, wrapper, or cover or any bag, sack, tote, conveyance or other receptacle in which food is packaged.

 

Corrosion-resistant material - a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

 

Critical Control Point - a point, step or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.

 

Critical item - a provision of this Code that, if in noncompliance, is more likely than other violations to contribute to food contamination, illness, or an environmental health hazard. Critical items are denoted in this Code with an asterisk (*).

 

Critical limit - the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.

 

Critical violation - a condition or practice that violates this Code and results in the production of a product that is adulterated, decomposed, misbranded, or unwholesome; or presents a threat to the health or safety of the consumer.

 

Cross connection - an unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not or cannot be approved as safe and potable. Examples are bypass arrangements, jumper connections, removable sections, swivel or change over devices, or other devices through which backflow could occur.

 

Cull - to remove dead or unsafe shellstock from a lot of shellstock.

 

Dealer - any person who engages in, or desires to engage or continue to engage in the activities of shellstock shipper, shucker-packer, repacker, or reshipper of molluscan shellfish according to the provisions of the NSSP.

 

Department - the District of Columbia Department of Health.

 

Distilled water - bottled water that has been produced by a process of distillation and meets the definition of purified water in the most recent edition of the United States Pharmacopeia.

 

Egg - The shell egg of the domesticated chicken, turkey, duck, goose, or guinea, or any other species of fowl. The term does not include a balut, the egg of reptile such as an alligator, or an egg product.

 

Egg handler - any person who produces, contracts for, or obtains possession or control of eggs for the purpose of sale to another dealer or retailer, or for processing and sale to a dealer, retailer or consumer: The term "sell" or "sale" includes to offer for sale, expose for sale, or to have in one's possession for sale, exchange, barter, trade, or as an inducement for the sale of another product.

 

Egg product - all or a portion of the contents found inside eggs separated from the shell and pasteurized in a food processing operation, with or without added ingredients, that are intended for human consumption, such as dried, frozen or liquid eggs. Egg products do not include food which contains eggs only in a relatively small proportion such as cake mixes.

 

Employee - the licensee, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food processing operation.

 

Enterohemorrhagic Escherichia coli (EHEC) - E. coli that cause hemorrhagic colitis, meaning bleeding enterically or bleeding from the intestine. The term is typically used in association with E. coli that have the capacity to produce Shiga toxins and to cause attaching and effacing lesions in the intestine. EHEC is a subset of Shiga Toxin- producing E. coli. (STEC), whose members produce additional virulence factors which include hemorrhagic colitis and hemolytic uremic syndrome (HUS). Examples of serotypes of EHEC include: E. coli O157:117; E. coli O157:NM; E.coli O26:H11; E. coli O145:NM; E. coli O103:112; and E. coli O111:NM.

 

EPA - the United States Environmental Protection Agency.

 

Equipment - an article that is used in a food processing operation such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine The term does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, or skids.

 

Exclude - to prevent a person from working as an employee in a food processing operation.

 

FDA - the United States Food and Drug Administration.

 

Federal Safe Drinking Water Act - the Safe Drinking Water Act, approved December 16, 1974 (88 Stat. 1660; 42 U.S.C. § 300f et seq.).

 

Federal Food Act - the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (52 Stat. 1040; 21 U.S.C. § 301 et seq.).

 

Food - shall have the meaning specified in section 201 of the Federal Food Act (21 U.S.C. § 321).

 

Food-contact surface - a surface of equipment or a utensil with which food normally comes into contact or a surface of equipment or a utensil from which food may drain, drip, or splash into a food or onto a surface normally in contact with food, including equipment or a surface or utensil that normally comes into direct or indirect contact with shucked shellfish.

 

Food employee - an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces. This could include the owner, an individual having supervisory or management duties, person on payroll, family member, volunteer, person performing work under contractual agreement, or any other person working in a food processing plant.

 

Food operation - the premises, practices, and procedures associated with a specific type of activity within a food processing operation.

 

Food processing - the handling or processing of food in any manner of preparation for sale for human consumption, except that food processing does not include the handling of fresh fruits or vegetables that are merely washed or trimmed while being prepared or packaged for sale in their natural state.

 

Food processing operation - any of the following:

 

(a)Any premises, plant, establishment, building, room, area, facility and the appurtenances thereto, in whole or in part, where food is prepared, handled or processed in any manner for distribution or sale for resale by retail outlets, restaurants, and any such other facility selling or distributing to the ultimate consumer;

 

(b)A commercial operation that manufactures, processes, packages, labels, or stores food for human consumption or provides food for sale or distribution to business entities such as other food processing operations or food establishments as defined in 25 DCMR § 9901. A food processing operation includes a place used for or in connection with commercial food manufacturing, preparation, processing, packaging, canning, freezing, storing, distributing, labeling, or holding. The term includes, but is not limited to bakery plants, confectionery plants, egg processing plants, food manufacturing plants, frozen food manufacturing plants, fresh and frozen seafood processing operations, shellfish processing operations, food storage warehouses, refrigerated lockers, food distribution centers, ice manufacturing plants, soft drink manufacturing plants, bottled water manufacturing plants, breweries, wineries, distilleries, food transfer stations, and meat processing plants that are not subject to regulation by the United States Department of Agriculture; or

 

(c)Any custom cannery or processing operation where raw food products, food, or food products are processed for the owner thereof, or the food processing facilities are made available to the owners or persons in control of raw food products or food or food products for processing in any manner

 

Food safety hazard - any biological, chemical or physical property that may cause a food to be unsafe for human consumption.

 

Food storage warehouse - any premise, establishment, building, room area, facility, or place, in whole or in part, where food is stored, kept, or held for wholesale distribution to other wholesalers or to retail outlets, restaurants, and any other facility selling or distributing food to the ultimate consumer. The term does not include grain elevators or fruit and vegetable storage and packing houses that store, pack, and ship fresh fruit and vegetables.

 

HACCP - the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee on Microbiological Criteria for Foods.

 

HACCP Plan - a written document that delineates formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee on Microbiological Criteria for Foods, or that a shellfish dealer follows to implement the HACCP requirements set forth in 21 CFR 123.6 as adopted by the ISSC.

 

IgG - a class of immunoglobulins that include the most common antibodies circulating in the blood, that facilitate the phagocytic destruction of microorganisms foreign to the body, that bind to and activate complement, and that are the only immunoglobulins to cross over the placenta from mother to fetus; an immunoglobulin of the class of IgG.

 

Imminent health hazard - a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operations to prevent injury based on the number of potential injuries, and the nature, severity, and duration of the anticipated injury.

 

Inspection item - standard criteria under which single or multiple observations of specific critical or noncritical violations can be debited.

 

Interstate Certified Shellfish Shippers List (ICSSL) - a monthly FDA publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign Authority as meeting the public health control measures specified in this Code. An ICSSL Link is accessible through the ICSSL website at http://www.issc.org/

 

Interstate Shellfish Sanitation Conference (ISSC) - the organization which consists of agencies from shellfish producing and receiving States, FDA, the shellfish industry, the National Marine Fisheries Service of the U.S. Department of Commerce, and the U.S. Environmental Protection Agency. The ISSC provides the formal structure wherein State regulatory authorities, with FDA concurrence, can establish updated guidelines and procedures for sanitary control of the shellfish industry.

 

Licensee - the holder of a license to operate a food processing operation. Lot - the food produced during a period of time indicated by a specific code.

 

Low-acid food - any food, other than an alcoholic beverage, that has a finished equilibrium pH greater than four and six tenths (4.6) and a water activity (aw.) greater than eighty-five hundredths (0.85). Tomatoes and tomato products having a finished equilibrium pH less than four and seven tenths (4.7) are not classed as low-acid foods.

 

Mineral water - bottled water that contains not less than two hundred and fifty parts per million (250 ppm) total dissolved solids that originate from a geologically and physically protected underground water source. Mineral water is characterized by constant levels and relative proportions of minerals and trace elements at the source. No minerals may be added to mineral water.

 

National Shellfish Sanitation Program (NSSP) - a Federal, State, Industry voluntary cooperative program that relies on regulatory controls by the State Shellfish Authority to ensure safe molluscan shellfish. The NSSP was developed through a Memorandum of Understanding between the FDA and the ISSC, of which the District of Columbia is a member.

 

Natural water - bottled spring, mineral, artesian, or well water that is derived from an underground formation. Natural water may be derived from a public water system if that supply has a single source such as an actual spring, artesian well, or pumped well, and has not undergone any treatment that changes its original chemical makeup except ozonization or an equivalent disinfection process.

 

Person - an association, a corporation, individual, partnership, trustee, government or governmental subdivision, or other legal entity.

 

Pest - any objectionable animal or insect including, but not limited to birds, rodents, flies, and larvae.

 

Personal care items - an item or substance that may be poisonous, toxic, or a source of contamination that is used to maintain or enhance a person's health, hygiene or appearance. Personal care items include medicines, first aid supplies, cosmetics, and toiletries such as toothpaste and mouthwash.

 

pH - the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between zero (0) and seven (7) indicate acidity and values between seven (7) and fourteen (14) indicate alkalinity. The value for pure distilled water is seven (7), which is considered neutral.

 

Physical facilities - the structure and interior surfaces of a food processing operation, including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

 

Plumbing fixture - a receptacle or device that is permanently or temporarily connected to the water distribution system of the premises and demands a supply from the system or discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises.

 

Plumbing system - the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water- treating equipment.

 

Poisonous or deleterious substance - a toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in shellfish to protect public health.

 

Poisonous or toxic materials - any of the following substances that are not intended for ingestion:

 

(a)Cleaners and sanitizers, including cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

 

(b)Pesticides, except sanitizers, including insecticides and rodenticides;

 

(c)Substances necessary for the operation and maintenance of the food processing operation, such as nonfood grade lubricants and personal care items that may be deleterious to health; and

 

(d)Substances that are not necessary for the operation and maintenance of the food processing operation, including but not limited to substances on the premises for retail sale, such as petroleum products and paints.

 

Potentially hazardous food - any of the following:

 

(a)A food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation, including:

 

(1)An animal food that is raw or heat-treated; a plant FOOD that is heat- treated or consists of raw seed sprouts, cut melons, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and

 

(2)Except as specified in section (b)(4) of this definition, a food that because of the interaction of its aw and ph values is designated as Product Assessment Required (PA) in Table A or B of this definition:

 

Table A. Interaction of ph and aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged
aw values	ph values
	4.6 or less	> 4.6 — 5.6	> 5.6
< 0.92	non-PHF*/non-TCS food**	non-PHF/non-TCS food	non-PHF/non-TCS food
>0.92 - .95	non-PHF/non-TCS food food	non-PHF/non-TCS	PA* * *
*PHF means Potentially Hazardous Food **TCS food means Time/Temperature Control for Safety Food ***PA means Product Assessment required

 

Table B. Interaction of ph and aw for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged
aw values	ph values
	< 4.2	4.2 - 4.6	> 4.6 - 5.0	> 5.0
< 0.88	non-PHF*/non- TCS food**	non-PHF/ non-TCS food	non-PHF/ non-TCS food	non-PHF/ non-TCS food
0.88 - 0.90	non-PHF/ non-TCS food	non-PHF/ non-TCS food	non-PHF/non- TCS food	PA***
> 0.90 - 0.92	non-PHF/ non-TCS food	non-PHF/ non-TCS food	PA	PA
> 0.92	non-PHF/ non-TCS food	PA	PA	PA
*PHF means Potentially Hazardous Food **TCS food means Time/Temperature Control for Safety Food ***PA means Product Assessment required

(b)The term does not include:

 

(1)An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled but has been pasteurized to destroy all viable salmonellae;

 

(2)A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

 

(3)A food that because of its ph or aw value, or interaction of aw value or ph values, is designated as a non-PHF/non-TCS food in Table A or B of this definition;

 

(4)A food that is designated as Product Assessment Required (PA) in Table A or B of this definition and has undergone a Product Assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

 

(A)Intrinsic factors, including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

 

(B)Extrinsic factors, including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use; or

 

(C)A combination of intrinsic and extrinsic factors; or

 

(5)A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the sections in (b)(1) through (b)(4) of this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

 

Potable water means a water supply that meets the requirements of 40 CFR Part 141 - National Primary Drinking Water Regulations and District of Columbia drinking water quality standards.

 

Premises - the physical facility of a food processing operation, its contents, and the contiguous land or property under the control of the licensee or dealer.

 

Processing - the canning, freezing, drying, dehydrating, cooking, pressing, powdering, packaging, baking, heating, mixing, grinding, churning, separating, extracting, cutting, fermenting, eviscerating, preserving, jarring, or otherwise processing food, including:

 

(a)Manufacturing egg products, including breaking eggs or filtering, mixing, blending, pasteurizing, stabilizing, cooling, freezing, drying, or packaging egg products;

 

(b)Any operation or combination of operations, whereby poultry is slaughtered, eviscerated, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed but does not include freezing of poultry products, except when freezing is incidental to operations otherwise classed as "processing" under this paragraph;

 

(c)Activities that are directly related to the production of juice products but do not include:

 

(1)Harvesting, picking, or transporting raw agricultural ingredients of juice products, without otherwise engaging in processing; and

 

(2)The operation of a retail establishment; and

 

(d)Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding of fish or fishery products but does not include:

 

(1)Harvesting or transporting fish or fishery products, without otherwise engaging in processing;

 

(2)Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel; and

 

(3)The operation of a retail establishment.

 

Public health significance - the potential for causing diseases and symptoms, as specified in chapter 3 of this Code that include but are not limited to:

 

(a)Diarrhea;

 

(b)Fever;

 

(c)Jaundice;

 

(d)Vomiting

 

(e)Sore throat with fever;

 

(f)Boils;

 

(g)Salmonella Typhi;

 

(h)Shigella spp.;

 

(i)Enterohemorrhagic or Shiga Toxin-Producing Escherichia coli;

 

(j)Hepatitis A virus; or

 

(k)Norovirus.

 

Public water system - a system for the provision to the public of water for human consumption through pipes or, after August 5, 1998, other constructed conveyances, if such system has at least fifteen (15) service connections or regularly serves an average of at least twenty-five (25) individuals daily at least sixty (60) days out of the year including any collection, treatment, storage, and distribution facilities under the control of the operator of such system and used primarily in connection with such system; and any collection or pretreatment storage facilities not under such control which are used primarily in connection with such system.

 

Pull date - the latest date a packaged food product shall be offered for sale to the public.

 

Purified water - bottled water produced by distillation, deionization, reverse osmosis, or other suitable process and that meets the definition of purified water in the most recent edition of the United States Pharmacopeia. Water that meets this definition and is vaporized, then condensed, may be labeled "distilled water."

 

Raw shellfish - shellfish that have not been thermally processed to an internal temperature of one hundred forty-five degrees Fahrenheit (145° F) (sixty-two degrees Centigrade (62 ° C)) or greater for fifteen seconds (15 sec.); or to alter organoleptic characteristics.

 

Recall - a licensee's or dealer's removal or correction of a marketed product that the FDA or other responsible agency, such as the United States Department of Agriculture, Federal Trade Commission, or United States Customs Service considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery, as defined in 21 CFR 7.3 - Definitions. A recall may be initiated: (1) voluntarily by the firm that has primary responsibility for the manufacture or marketing of the product; or (2) at the request of the FDA or other responsible agency. Information regarding recall activities is shared with state agencies and the Department through daily faxed Recall Notices or other government reports. The state agencies and the Department monitor recall activities to ensure non-compliant products are removed from the market through recall audit checks.

 

Refrigerated locker - any place, premises or establishment where facilities for the cold storage and preservation of human food in separate and individual compartments are offered to the public upon a rental or other basis providing compensation to the person offering such services. The term includes chill rooms, sharp freeze rooms and compartments, and locker rooms.

 

Refuse - solid waste not carried by water through the sewage system.

 

Repacker - any person, other than the original certified shucker packer, who repackages shucked shellfish into other containers.

 

Represent - to hold out as or to advertise.

 

Reshipper - a person who purchases shucked shellfish or shellstock from dealers and sells the product without repacking or relabeling to other dealers, wholesalers, or retailers.

 

Restrict - to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment or utensils, food contact surfaces, or food-packaging materials.

 

Restricted egg - any check, dirty egg, incubator reject, inedible, leaker, or loss.

 

Restricted use pesticide - a pesticide product that contains the active ingredients specified in 40 CFR 152.175 - Pesticides classified for restricted use, and that is limited to use by or under the direct supervision of a certified applicator.

 

Retailer or retail establishment - an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption directly to consumers; and includes any person in intrastate commerce who sells eggs to a consumer.

 

Rework - clean, unadulterated food that has been removed from processing for reasons other than unsanitary conditions or that has been successfully reconditioned by reprocessing and is suitable for use as food.

 

Safe materials - articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of or otherwise adversely affect the characteristics of any food.

 

Sanitation control record - a record that documents the monitoring of sanitation practices and conditions during processing.

 

Sanitization - the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five (5) logs, which is equal to a ninety-nine and nine hundred, ninety-nine thousands of a percent (99.999%) reduction of representative disease microorganisms of public health importance.

 

Sanitize - the application of a bactericidal treatment which is approved as being effective in destroying microorganisms, including pathogens:

 

(a)To adequately treat food contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance substantially reducing the numbers of other undesirable microorganisms and not adversely affecting the product or its safety for the consumer; or

 

(b)To treat hands in accordance with the requirements in section 404.

 

Scheduled process - the process selected by a processor as adequate for use under food manufacturing conditions to achieve and maintain a food that will not permit the growth of microorganisms having public health significance.

 

Sealed - free of cracks or other openings that allow the entry or passage of moisture.

 

Service animal - an animal such as a guide dog, signal dog, or other animal trained to provide assistance to an individual with a disability.

 

Sewage - liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

 

Shelf life - the length of time during which a packaged food product will retain its safe consumption quality if stored under proper temperature conditions.

 

Shellfish - all aspects of:

 

(a)Oysters, clams, or mussels, whether:

 

(1)Shucked or in the shell;

 

(2)Raw, including post harvest processed;

 

(3)Fresh or frozen; or

 

(4)Whole or in part; and

 

(b)Scallops in any form, except when the final product form is the adductor muscle only.

 

Shellfish dealer - any person who engages in, or desires to engage or continue to engage in the wholesale handling, shipping, or repacking of molluscan shellfish according to the provisions of the NSSP.

 

Shellstock - live molluscan shellfish in the shell.

 

Shellstock Shipper (SS) - a dealer who grows, harvests, buys, or repacks and sells shellstock. A shellstock shipper may also ship shucked shellfish. A shellstock shipper is not authorized to shuck shellfish or to repack shucked shellfish.

 

Shiga toxin-producing Escherichia coli (STEC) - any E. coli capable of producing Shiga toxins (also called verocytotoxins or "Shiga-like" toxins). Examples of serotypes of STEC include both O157 and non-O157 E. coli.

 

Shucker-Packer (SP) - a person who shucks and packs shellfish. A shucker-packer may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.

 

Smooth -

 

(a)A food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100) grit number three (3) stainless steel;

 

(b)A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; or

 

(c)A floor, wall, or ceiling having an even or level surface with no roughness or projections that renders it difficult to clean.

 

Spring water - water derived from an underground formation from which water flows naturally to the surface of the earth. "Spring water" shall meet the requirements of "natural water."

 

Standard of Identity - a government regulation which establishes the criteria which must be met before foods can be labeled in a certain way.

 

Supervisor - a licensee or an employee of a licensee who, when present at the food processing operation, is responsible for the food processing operation or for the food processing operation's compliance with some or all of the provisions of this Code.

 

Temperature measuring device - a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

 

Transaction record - the form or forms used to document each purchase or sale of shellfish at the wholesale level, including shellfish harvest and sales records, ledgers, purchase records, invoices and bills of lading.

 

USDA - the United States Department of Agriculture.

 

Utensil - a food-contact implement or container used in the storage, preparation, transportation; dispensing; sale or service of food including kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact with food; temperature sensing probes or measuring devices; and probe-type price or identification tags used in contact with food.

 

Vehicle - a commercial vehicle or commercial vessel which has a gross weight of more than ten thousand pounds, is used to transport property, and is a motor vehicle, motor truck, trailer, railroad car, or vessel.

 

Warewashing - the cleaning and sanitizing of utensils and the food-contact surfaces of equipment.

 

source

Final Rulemaking published at 56 DCR 5245 (July 3, 2009).