COMPREHENSIVE BUSINESS CODES

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COMPREHENSIVE BUSINESS CODES

OF THE

HOOPA VALLEY TRIBE

HOOPA FOOD CODE

TITLE 56.402 SUPPLEMENT

IMPLEMENTING REGULATIONS

C)

Effective: November 24, 2003

CONTENTS

CHAPTER 1 PURPOSE AND DEFINITIONS

_ CHAPTER 2 MANAGEMENT AND PERSONNEL

CHAPTER3FOOD | |

CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS

CHAPTER 5 WATER, PLUMBING, AND WASTE _

CHAPTER 6 PHYSICAL FACILITIES

CHAPTER 7 POISONOUS OR TOXIC MATERIALS

CHAPTER 8 COMPLIANCE AND ENFORCEMENT

APPENDIX NO. 1 - HACCP GUIDELINES

Chapter] Purpose and Definitions

Parts-1 TITLE, INTENT, SCOPE

1-2 DEFINITIONS

1-1 TITLE, INTENT, SCOPE

Subpart

1-101 Title

1-102 Intent

1-103 Scope

4-104 Authority

Title

1-101.10 Food Code.

This supplement shall be known as the Food Code, hereinafter referred to as "this Code."

Intent :

1-102.10 Food Safety, Iliness Prevention, and Honest Presentation.

The purpose of this Code is to safeguard public health and provide to consumers food that is:safe,

unadulterated, and honestly presented, to establish the formal standards for food establishments

licensed by the Tribe, to ensure that Tribally-licensed food establishments and others are aware

of the Tribe’s food code standards, and to provide written information for use as training,

informational, legal and enforcement, and other purposes relating to the activities of food

establishments.

Scope

1-103.10 Statement.

(A) This supplement is enacted pursuant to authority set forth in section 51.105 (b)(9) of the

Hoopa Tribal Code and serves as a supplement to and interpretative application of 56.402

(1) and (2) of the Tribal Code.

(B) This Code establishes definitions; sets standards for management and personnel, food

operations, and equipment and facilities; and provides for food establishment plan

review, permit issuance, inspection, employee restriction, and permit suspension.

(C) While the provisions of this Code may not directly apply to food related activities by

virtue of issuance of a license or permit, the provisions of this Code shall be utilized for

monitoring and responding to inquiries of any non-licensed public and private foodrelated activities identified in Chapter 1, 1-201.10(B)(37)(c) of this Code which are

conducted within the Reservation.

(D) ‘The issuance of a license or permit by the Tribe and the acceptance of such license or

permit by an individual for conducting activities in a private home, or portion thereof,

that are authorized under this Code shall be deemed consent by the licensee or permittee

\

. - and the home owner for the regulatory authority to conduct inspections, take enforcement

actions, monitor and take other actions relating to such licensed or permitted activities.

1-2 DEFINITIONS

Subpart

1-201 Applicability and Terms Defined

1-201.10 Statement of Application and Listing of Terms.

(A) The following definitions apply in the interpretation and application of this Code.

(B) Terms Defined.

(1) Accredited program.

(11 " Accredited program" means a food protection manager certification. program

that has been evaluated and listed by an accrediting agency approved by the Tribe

as conforming to national standards for organizations that certify individuals.

(ii "Accredited program" refers to the certification process approved by the Tribe

based upon an independent evaluation of factors such as the sponsor's mission;

organizational structure; staff resources; revenue sources; policies; public:

information regarding program scope, eligibility requirements, re-certification,

discipline and grievance procedures; and test development and administration.

~ (ii " Accredited program" does not refer to training functions or educational

C ! programs, except where such activities are associated with the issuance of

: certificates of completion in an accredited program. . |

(2) Additive.

(a) "Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic

Act, § 201(s) and 21 CFR 170.

~ (b) "Color additive” has the meaning stated in the Federal Food, Drug, and

Cosmetic Act, § 201(t) and 21 CFR 70.

(3) "Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 402.

(4) "Approved" means acceptable to the regulatory authority based on a determination of

conformity with principles, practices, and generally recognized standards that protect public

health.

(5) "a,"' means water activity which is a measure of the free moisture in a food, is the quotient of

the water vapor pressure of the substance divided by the vapor pressure of pure water at the same

temperature, and is indicated by the symbol a,.

(6) "Beverage" means a liquid for drinking, including water.

(7) "Bottled drinking water" means water that is sealed in bottles, packages, or other

containers and offered for sale for human consumption, including bottled mineral water.

(8) Casing" means a tubular container for sausage products made of either natural or artificial

(synthetic) material.

(9) "Certification number" means a unique combination of letters and numbers assigned by a

shellfish control authority to a molluscan shellfish dealer according to the provisions of the

( National Shellfish Sanitation Program.

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(10) CIP. |

(a) "CTP" means cleaned in place by the circulation or flowing by mechanical means

through a piping system of a detergent solution, water rinse, and sanitizing solution onto

or over equipment surfaces that require cleaning, such as the method used, in part, to

clean and sanitize a frozen dessert machine.

(b) "“CIP" does not include the cleaning of equipment such as band saws, slicers, or mixers

that are subjected to in-place manual cleaning without the use of a CIP system.

(11) "CFR" means Code of Federal Regulations. Citations in this Code to the CFR refer

sequentially to the Title, Part, and Section numbers, such as 21 CFR 178.1010 refers to Title 21,

Part 178, Section 1010.

(12) "Code of Federal Regulations" means the compilation of the general and permanent rules

published in the Federal Register by the executive departments and agencies of the federal

government which: — 7

(a) Is published annually by the U.S. Government Printing Office; and

(b) Contains FDA rules in 21 CFR, USDA rules in 7 CFR and 9 CFR, and EPA rules in

40 CFR.

(13) "Commingle" means:

(a) To combine shellstock harvested on different days or from different growing areas as

identified on the tag or label, or . |

(b) Tocombine shucked shellfish from containers with different container codes or different

shucking dates.

(14) Comminuted. | |

(a) "Comminuted" means reduced in size by methods including chopping, flaking,

grinding, or mincing.

(b) “Comminuted" includes fish or meat products that are reduced in size and restructured

or reformulated such as gefilte fish, gyros, ground beef, and sausage, and a mixture of 2

or more types of meat that have been reduced in size and combined, such as sausages

made from 2 or more meats.

(15) “Comprehensive Business Codes” means the Comprehensive Business Codes of the

Hoopa Tribe which are enacted as Titles 50 through 60 of the Tribal Code.

(16) "Confirmed disease outbreak" means 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. |

(17) "Consumer" means a person who is a member of the public, takes possession of food, is

not functioning in the capacity of an operator of a food establishment or food processing plant,

and does not offer the food for resale.

(18) "Corrosion-resistant material" means 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.

(19) "Critical control point" means a point or procedure in a specific food system where loss of

control may result in an unacceptable health risk.

(20) Critical Item.

(a) "Critical item" means a provision of this Code, that, if in noncompliance, is more likely

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than other violations to contribute to food contamination, illness, or environmental health

hazard.

(b) "Critical item" is an item that is denoted in this Code with an asterisk *.

(21) "Critical limit" means the maximum or minimum value to which a physical, biological, or

chemical parameter must be controlled at a critical contro] point to minimize the risk that the

identified food safety hazard may occur.

(22) Drinking Water.

(a) "Drinking water" means water that meets 40 CFR 141 National Primary Drinking

Water Regulations.

(b) "Drinking water" is traditionally known as "potable water."

(c) "Drinking water" includes the term "water" except where the term used connotes that

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the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater,"

and "nondrinking” water.

(23) "Dry storage area" means a room or area designated for the storage of packaged or

containerized bulk food that is not potentially hazardous and dry goods such as single-service

items.

(24) Easily Cleanable.

(a) "Fasily cleanable" means a characteristic of a surface that:

(i) Allows effective removal of soil by normal cleaning methods;

(ii) Is dependent on the material, design, construction, and installation of the surface;

and

(iii) Varies with the likelihood of the surface's role in introducing pathogenic or

toxigenic agents or other contaminants into food based on the suriace’ S approved

placement, purpose, and use.

(b) "Kasily cleanable" includes a tiered application of the criteria that qualify the surface as

easily cleanable as specified under Subparagraph (a) of this definition to different

situations in which varying degrees of cleanability are required such as:

(1) The appropriateness of stainless steel for a food preparation surface as opposed to

the lack of need for stainless steel to be used for floors or for tables used for

consumer dining; or

(ii) The need for a different degree of cleanability for a utilitarian attachment or

accessory in the kitchen as opposed to a decorative attachment or accessory in the

consumer dining area. 7

(25) "Easily movable" means:

(a) Portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to

safely tilt a unit of equipment for cleaning; and

(b) Having no utility connection, a utility connection that disconnects quickly, or a flexible

utility connection line of sufficient length to allow the equipment to be moved for

cleaning of the equipment and adjacent area.

(26) "Egg" means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea.

(27) "Employee" means the permit holder, person in charge, 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 establishment.

C)

—

(28) "EPA" means the U.S. Environmental Protection Agency.

(29) Equipment.

(a) "Equipment" means an article that is used in the operation of a food establishment 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. |

(b) "Equipment" does not include items 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, and skids.

(30) "Exclude" means to prevent a person from working as a food employee or entering a food

establishment except for those areas open to the general public. © |

(31) "FDA" means the U.S. Food and Drug Administration.

32) Fish. |

(a) "Bish" means fresh or saltwater finfish, crustaceans and other forms of aquatic life

(including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the

roe of such animals) other than birds or mammals, and all mollusks, if such animal life is

intended for human consumption. |

(b) "Fish" includes an edible human food product derived in whole or in part from fish,

including fish that have been processed in any manner. |

(33) "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient

used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(34) "Foodborne disease outbreak" means the occurrence of two or more cases of a similar

illness resulting from the ingestion of a common food.

(35) "Food-contact surface" means:

(a) Asurface of equipment or a utensil with which food normally comes into contact; or

(b) Asurface of equipment or a utensil from which food may drain, drip, or splash:

(1) Into a food, or :

(i) Onto a surface normally in contact with food.

(36) "Food employee" means an individual working with unpackaged food, food equipment or

utensils, or food-contact surfaces.

(37) Food Establishment.

(a) "ood establishment" means a licensed or permitted operation that stores, prepares,

packages, serves, vends, or otherwise provides food for human consumption:

(i) Such as a restaurant; satellite or catered feeding location; catering operation if the

operation provides food directly to a consumer or to a conveyance used to

transport people; market; vending location; conveyance used to transport people;

‘institution; or food bank; and

(ii) That relinquishes possession of food to a consumer directly, or indirectly through

a delivery service such as home delivery of grocery orders or restaurant takeout

orders, or delivery service that is provided by common carriers.

(iii) A food processing plant; and

(iv) That portion of a private home that is licensed by as a food establishment.

(b) "Food establishment" includes:

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(1) An element of the operation such as a transportation vehicle or a central

preparation facility that supplies a vending location or satellite feeding location

unless the vending or feeding location is permitted by the regulatory authority;

and

(i) | An operation that is conducted in a mobile, stationary, temporary, or permanent

_ facility or location; where consumption is on or off the premises; and regardless of

whether there is a charge for the food.

(c) "Food establishment" does not include:

(i) An establishment that offers only prepackaged foods that are not potentially

hazardous; |

(i) | A produce stand that only offers whole, uncut fresh fruits and vegetables;

(ii) A kitchen in a private home if only food that is not potentially hazardous is

prepared for sale or service at a function such as a religious or charitable

organization's bake sale if allowed by law and if the consumer is informed by a

clearly visible placard at the sales or service location that the food is prepared in a

kitchen that is not subject to regulation and inspection by the regulatory authority;

(iv) | An area where food that is prepared as specified in Subparagraph (C)(ii1) of this

definition is sold or offered for human consumption;

(v) | Akitchen or other areas in a private home that is not licensed as a food

establishment; | )

(vi) Avprivate home that receives catered or home-delivered food, or

(vii) An unlicensed portion of a private home.

(38) "Food processing plant" means a commercial operation that manufactures, packages,

labels, or stores food for human consumption whether or not it provides food directly to a

consumer. |

(39) Game Animal.

(a) "Game animal" means an animal, the products of which are food, that is not classified

as cattle, sheep, swine, goat, horse, mule, or other equine in 9 CFR Subchapter A -

Mandatory Meat Inspection, Part 301, as Poultry in 9 CFR Subchapter C - Mandatory

Poultry Products Inspection, Part 381, or as fish as defined under Subparagraph

1-201.10(B)(26).

(b) "Game animal" includes mammals such as reindeer, elk, deer, antelope, water buffalo,

bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat, and nonaquatic reptiles such

as land snakes, |

(c) "Game animal" does not include ratites such as ostrich, emu, and rhea.

(40) "General use pesticide" means a pesticide that is not classified by EPA for restricted use as

specified in 40 CFR 152.175. |

(41) "Grade A standards" means the requirements of the United States Public Health

Service/FDA "Grade A Pasteurized Milk Ordinance" and "Grade A Condensed and Dry Milk

Ordinance" with which certain fluid and dry milk and milk products comply.

(42) "HACCP plan" means a written document that delineates the formal procedures for

following the Hazard Analysis Critical Control Point principles developed by The National

Advisory Committee on Microbiological Criteria for Foods, and as further defined in Appendix

i 4

No. 1 to this Code.

(43) "Hazard" means 2 biological, chemical, or physical property that may cause an

unacceptable consumer health risk.

(44) "Hermetically sealed container" means a container that is designed and intended to be

secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain

the commercial sterility ofits contents after processing.

(45) "Highly susceptible population" means persons who are more likely than other people in

the general population to experience foodborne disease because they are:

(i) Immunocompromised; preschool age children, or older adults; and

(ii) Obtaining food at a facility that provides services such as custodial care, health

care, or assisted living, such as a child or adult day care center, kidney dialysis

center, hospital or nursing home, or nutritional or socialization services such as a

senior center. | |

(46) "Imminent health hazard" means 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 ; mmediate correction or cessation of operation to prevent injury

based on: :

(i) The number of potential injuries, and |

(ii) The nature, severity, and duration of the anticipated injury.

(47) "Injected" means manipulating a meat so that infectious or toxigenic microorganisms may

be introduced from its surface to its interior through tenderizing with deep penetration or

injecting the meat such as by processes which may be referred to as “injecting,” “pinning,” or

"stitch pumping." | | |

(48) "Juice" means, when used in the context of food safety, the aqueous liquid expressed or |

extracted from one or more fruits or vegetables, purées of the edible portions of one or more

fruits or vegetables, or any concentrates of such liquid or puree. Juice includes juice as a whole

beverage, an ingredient of a beverage and a puree as an ingredient of a beverage.

(49) "Kitchenware" means food preparation and storage utensils.

(50) "Law" means applicable tribal, local, state, and federal statutes, regulations, and

ordinances. . |

(51) “License” means a business license issued pursuant to the Comprehensive Business Codes

of the Hoopa Valley Tribe.

(52) "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping

cloths, and work garments including cloth gloves.

(53) "Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine,

sheep, or goats and other edible animals, except fish, poultry, and wild game animals as specified

under Subparagraphs 3-201.17(A)(3) and (4).

(54) "mg/L" means milligrams per liter, which is the metric equivalent of parts per million

(ppm). |

(55) "Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels,

and scallops or edible portions thereof, except when the scallop product consists only of the

shucked adductor muscle.

(56) Packaged.

C)

(a) "Packaged" means bottled, canned, cartoned, securely bagged, or securely wrapped,

whether packaged in a food establishment or a food processing plant.

(b) Packaged" does not include a wrapper, carry-out box, or other nondurable container

used to containerize food with the purpose of facilitating food protection during service

and receipt of the food by the consumer.

(57) "Permit" means permit or license issued by the Tribe that authorizes a person to operate a

food establishment.

(58) "Permit holder" means the entity that:

(a) Is legally responsible for the operation of the food establishment such as the owner, the

owner's agent, or other person; and |

(b) Possesses a valid permit or license to operate a food establishment.

(59) "Person" means an association, a corporation, individual, partnership, other legal entity,

government, or governmental subdivision or agency.

(60) "Person in charge" means the individual present at a food establishment who is

responsible for the operation at the time of inspection.

(61) Personal Care Items.

(a) "Personal care items" means items or substances that may be poisonous, toxic, or a

source of contamination and are used to maintain or enhance a person's health, hygiene,

or appearance.

(b) "Personal care items" include items such as medicines; first aid supplies; and other

items such as cosmetics, and toiletries such as toothpaste and mouthwash.

(62) "pH" means 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 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity. The

value for pure distilled water is 7, which is considered neutral.

(63) "Physical facilities" means the structure and interior surfaces of a food establishment

including accessories such as soap and towel dispensers and attachments such as light fixtures

and heating or air conditioning system vents. |

(64) "Plumbing fixture" means a receptacle or device that:

(a) Is permanently or temporarily connected to the water distribution system of the premises

and demands a supply of water from the system, or

(b) Discharges used water, waste materials, or sewage directly or indirectly to the drainage

system of the premises.

(65) "Plumbing system" means 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.

(66) "Poisonous or toxic materials" means substances that are not intended for ingestion and

are included in 4 categories:

(a) Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as

caustics, acids, drying agents, polishes, and other chemicals;

(b) Pesticides, except sanitizers, which include substances such as insecticides and

rodenticides;

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(c) Substances necessary for the operation and maintenance of the establishment 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 establishment

and are on the premises for retail sale, such as petroleum products and paints.

(67) Potentially Hazardous Food.

(a) "Potentially hazardous food" means a food that is natural or synthetic and that requires

temperature control because it is in a form capable of supporting:

(i) The rapid and progressive growth of infectious or toxigenic microorganisms;

(ii) | The growth and toxin production of Clostridium botulinum, or

(iii) | In raw shell eggs, the growth of Salmonella Enteritidis.

(b) "Potentially hazardous food" includes an animal food (a food of animal origin) that is

raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed

sprouts; cut melons; and garlic-in-oil mixtures that are not modified in a way that results

in mixtures that do not support growth as specified under Subparagraph (a) of this

definition.

(c) "Potentially hazardous food" does not include:

(i) An air-cooled hard-boiled egg with shell intact, or a shell egg that is not

hard-boiled, but has been treated to destroy all viable Salmonellae;

Gi) A food with an a, value of 0.85 or less; |

Gii) A food with a pH level of 4.6 or below when measured at 24°C (75°F);

(iv) A food, in an unopened hermetically sealed container, that is commercially

processed to achieve and maintain commercial sterility under conditions of

nonrefrigerated storage and distribution,

(v) A food for which laboratory evidence demonstrates that the rapid and progressive

erowth of infectious or toxigenic microorganisms Or the growth of S. Enteritidis

in eggs or C. botulinum can not occur, such as a food that has an a,, and a pH that

are above the levels specified under Subparagraphs (c)(ii) and (ii1).of this

definition and that may contain a preservative, other barrier to the growth of .

microorganisms, or a combination of barriers that inhibit the growth of

microorganisms; Or

(vi) A food that does not support the growth of microorganisms as specified under

Subparagraph (a) of this definition even though the food may contain an

infectious or toxigenic microorganism or chemical or physical contaminant at a

level sufficient to cause illness.

(68) Poultry.

(a) "Poultry" means:

(i) Any domesticated bird (chickens, turkeys, ducks, geese, or guineas), whether live

or dead, as defined in 9 CFR 381 Poultry Products Inspection Regulations; and

Gi) Any migratory waterfowl, game bird, such as pheasant, partridge, quail, grouse, or

guinea, or pigeon or squab, whether live or dead, as defined in 9 CFR 362.

Voluntary Poultry Inspection Program.

(b) "Poultry" does not include ratites.

(69) "Premises" means:

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(b)

(c)

(a)

The physical facility, its contents, and the contiguous land or property under the control

of the permit holder; or

The physical facility, its contents, and the land or property not described under

Subparagraph (a) of this definition if its facilities and contents are under the control of the

permit holder and may impact food establishment personnel, facilities, or operations, and

a food establishment is only one component of a larger operation such as a health care

facility, hotel, motel, school, recreational camp, or prison.

That area of a private home that is licensed as a food establishment that is subject to the

requirements of this Code and which is subject to the inspection by the Tribe as a food

establishment.

(70) "Primal cut" means a basic major cut into which carcasses and sides of meat are separated,

such as a beef round, pork loin, lamb flank, or veal breast.

(71) "Public water system" has the meaning stated in 40 CFR 141 National Primary Drinking

Water Regulations. |

(72) Ready-to-Eat Food.

"Ready-to-eat food" means food that:

(1)

(ii

(iii)

(iv)

Is in a form that is edible without additional preparation to achieve food safety, as

specified under paragraph 3-401.11(A) (C) or § 3-401.12 or 3-402.11; or

Is a raw or partially cooked animal food and the consumer is advised as specified

under Subparagraphs 3-401. 11@)(1) and (2); or

Is prepared in accordance with a variance that is granted as specified under

Subparagraphs 3-401.11(D)(1) and (3); and

May receive additional preparation for palatability or aesthetic, epicurean,

gastronomic, or culinary purposes.

(b) 'Ready-to-eat food" includes:

(i)

(ii)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

Raw animal food that is cooked as specified under § 3-401.11 or 31401.12, or

frozen as specified under § 3-402.11;

Raw fruits and vegetables that are washed as specified under § 3-302.15;

Fruits and vegetables that are cooked for hot holding, as specified under §

3-401.13;

All potentially hazardous food that is cooked to the temperature and time required

for the specific food under Subpart 3-401 and cooled as specified in § 3-501.14;

Plant food for which further washing, cooking, or other processing is not required

for food safety, and from which rinds, peels, husks, or shells, 1f naturally present

are removed;

Substances derived from plants such as spices, seasonings, and sugar;

A bakery item such as bread, cakes, pies, fillings, or icing for which further

cooking is not required for food safety;

The following products that are produced in accordance with USDA guidelines

and that have received a lethality treatment for pathogens: dry, fermented

sausages, such as dry salami or pepperoni; salt-cured meat and poultry products,

such as prosciutto ham, country cured ham, and Parma ham; and dried meat and

poultry products, such as jerky or beef sticks; and

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(ix) Foods manufactured according to 21 CFR Part 113, Thermally Processed

Low-Acid Foods Packaged in Hermetically Sealed Containers.

(73) Reduced Oxygen Packaging.

(a) "Reduced oxygen packaging" means:

(i) The reduction of the amount of oxygen in a package by removing oxygen; —

displacing oxygen and replacing it with another gas or combination of gases; or

otherwise controlling the oxygen content to a level below that normally found in

the surrounding, 21% oxygen atmosphere, and

(ii) | A process as specified in Subparagraph (a)(1) of this definition that involves a

food for which Clostridium botulinum is identified as a microbiological hazard

in the final packaged form.

(b) "Reduced oxygen packaging" includes:

@ Vacuum packaging, in which air is removed from a package of food and the

package is hermetically sealed so that a vacuum remains inside the package, such

as sous vide;

(ii) | Modified atmosphere packaging, in which the atmosphere of a package of food is

modified so that its composition is different from air but the atmosphere may

change over time due to the permeability of the packaging material or the

respiration of the food. Modified atmosphere packaging includes: reduction:in the

proportion of oxygen, total replacement of oxygen, Or an increase in the

proportion of other gases such as carbon dioxide or nitrogen, and.

(iii) Controlled atmosphere packaging, in which the atmosphere of a package of food

is modified so that until the package 1s opened, its composition is different from

air, and continuous control of that atmosphere is maintained, such as by using

oxygen scavengers or a combination of total replacement of oxygen, nonrespiring

food, and impermeable packaging material.

(74) "Refuse" means solid waste not carried by water through the sewage system.

(75) "Regulatory authority" means the Tribe or federal enforcement body or authorized

representative having jurisdiction over the food establishment.

(76) “Reservation” means the Hoopa Valley Indian Reservation.

(77) "Restrict" means 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, utensils, linens; and unwrapped single-service or single-use

articles.

(78) "Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as

defined in 9 CFR 590.

(79) "Restricted use pesticide" means 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.

(80) Risk" means the likelihood that an adverse health effect will occur within a population as

a result of a hazard in a food. |

(81) "Safe material" means: |

(a) Anarticle manufactured from or composed of materials that may not reasonably be

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expected to result, directly or indirectly, in their becoming a component or otherwise

affecting the characteristics of any food;

(b) An additive that is used as specified in § 409 or 706 of the Federal Food, Drug, and

Cosmetic Act; or

(c) Other materials that are not additives and that are used in conformity with applicable

regulations of the Food and Drug Administration.

(82) "Sanitization" means the application of cumulative heat or chemicals on cleaned

food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of 5 logs,

which is equal to a 99.999% reduction, of representative disease microorganisms of public health

importance.

(83) "Sealed" means free of cracks or other openings that allow the entry or passage of moisture.

(84) "Service animal" means an animal such as a guide dog, signal dog, or other animal

individually trained to provide assistance to an individual with a disability.

(85) "Servicing area" means an operating base location to which a mobile food establishment or

transportation vehicle returns regularly for such things as vehicle and equipment cleaning,

discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

(86) "Sewage" means liquid waste containing animal or vegetable matter in suspension or

solution and may include liquids containing chemicals in solution.

(87) "Shellfish contro] authority" means a state, federal, foreign, tribal, or other government

entity legally responsible for administering a program that includes certification of molluscan

shellfish harvesters and dealers for interstate commerce.

(88) "Shellstock" means raw, in-shell molluscan shellfish.

(89)."Shiga toxin-producing Escherichia coli " means any E. coli capable of producing Shiga

toxins (also called verocytotoxins or "Shiga-like" toxins). This includes, but is not limited to, E.

coli reported as serotype O157:H7, O157:NM, and 0157:H-."

(90) "Shucked shellfish" means molluscan shellfish that have one or - both shells removed.

(91) "Single-service articles" means tableware, carry-out utensils, and other items such as bags,

containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed

for one time, one person use after which they are intended for discard. |

(92) Single-Use Articles. |

(a) "Single-use articles" means utensils and bulk food containers designed and constructed

to be used once and discarded.

(b) "Single-use articles" includes items such as wax paper, butcher paper, plastic wrap,

formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle

barrels, ketchup bottles, and number 10 cans which do not meet the materials, durability,

strength, and cleanability specifications under §§ 4-101.11, 4-201.11, and 4-202.11 for

multiuse utensils.

(93) "Slacking" means the process of moderating the temperature of a food such as allowing a

food to gradually increase from a temperature of -23°C (-10°F) to -4°C (25°F) in preparation for

deep-fat frying or to facilitate even heat penetration during the cooking of previously

block-frozen food such as spinach. |

(94) "Smooth" means:

(a) . A food-contact surface having a surface free of pits and inclusions with a cleanability

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equal to or exceeding that of (100 grit) number 3 stainless steel;

(b) | Anonfood-contact surface of equipment having a surface equal to that of commercial

grade hot-rolled steel free of visible scale; and .

(c) A floor, wall, or ceiling having an even or level surface with no roughness or projections

that render it difficult to clean. |

(95) "Table-mounted equipment" means equipment that is not portable and is designed to be

mounted off the floor on a table, counter, or shelf.

(96) "Tableware" means eating, drinking, and serving utensils for table use such as flatware

including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, and

tumblers; and plates.

(97) "Temperature measuring device" means a thermometer, thermocouple, thermistor, or

other-device that indicates the temperature of food, air, or water.

(98) '' Temporary food establishment" means a food establishment that operates for a period of

no more than 14 consecutive days in conjunction with a single event or celebration.

(99) “Tribe” means the Hoopa Tribe or the Hoopa Tribal Department of Commerce and any of

their authorized officials and representatives.

(100) "USDA" means the U.S. Department of Agriculture.

(101) "Utensil" means a food-contact implement or container used in the storage, preparation,

transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is”

multiuse, single-service, or single-use; gloves used in contact with food; temperature sensing

probes of food temperature measuring devices; and probe-type price or identification tags used in

contact with food.

(102) "Variance" means a written document issued by the Tribe that authorizes a modification

or waiver of one or more requirements of this Code if, in the opinion of the regulatory authority,

a health hazard or nuisance will not result from the modification or waiver.

(103) "Vending machine" means a self-service device that, upon insertion of a coin, paper

currency, token, card, or key, or by optional manual operation, dispenses unit servings of food in

bulk or in packages without the necessity of replenishing the device between each vending

operation. a

(104) "Vending machine location" means the room, enclosure, space, or area where one or

more vending machines are installed and operated and includes the storage areas and areas on the

premises that are used to service and maintain the vending machines.

(105) '"Warewashing” means the cleaning and sanitizing of utensils and food-contact surfaces

of equipment. |

(106) " Whole-muscle, intact beef" means whole muscle beef that is not injected, mechanically

tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

Chapter2 Management and Personnel

Parts

2-1 SUPERVISION

2-2 EMPLOYEE HEALTH

2-3 PERSONAL CLEANLINESS

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2-4 HYGIENIC PRACTICES

2-1 SUPERVISION

Subpart

2-101 Responsibility

2-102 Knowledge

2-103 Duties

Responsibility

2-101.11 Assignment.*

The permit holder shall be the person in charge or shall designate a person in charge and shall

ensure that a person in charge is present at the food establishment during all hours of operation.

Knowledge

2-102.11 Demonstration.*

Based on the risks of foodborne illness inherent to the food operation, during inspections and

upon request the person in charge shall demonstrate to the Tribe knowledge of foodborne disease

prevention, application of the Hazard Analysis Critical Control Point principles, and the

requirements of this Code. The person in charge shall demonstrate this knowledge by:

(A) Complying with this Code; and

(B) Responding correctly to the inspector's questions as they relate to the specific food

operation. The areas of knowledge include:

(1) Describing the relationship between the prevention of food borne disease and the

personal hygiene of a food employee;

(2) Explaining the responsibility of the person in charge for preventing the

transmission of food bome disease by a food employee who has a disease or

_ medical condition that may cause food borne disease;

(3) Describing the symptoms associated with the diseases that are transmissible

through food;

(4) Explaining the significance of the relationship between maintaining the time and

temperature of potentially hazardous food and the prevention of food borne

illness;

(5) If relevant, explaining the hazards involved in the consumption of raw or

undercooked meat, poultry, eggs, and fish;

(6) Stating the required food temperatures and times for safe cooking of potentially

hazardous food including meat, poultry, eggs, or fish;

(7) Stating the required temperatures and times for the safe refrigerated storage, hot

holding, cooling, and reheating of potentially hazardous food;

(8) | Descnbing the relationship between the prevention of food borne illness and the

management and control of the following:

(a) Cross contamination,

(b) Hand contact with ready-to-eat foods,

(c) Handwashing, and

(d) Maintaining the food establishment in a clean condition and in good

15

repair;

(9) Explaining the relationship between food safety and providing equipment that is:

(a) Sufficient in number and capacity; and

(b) Properly designed, constructed, located, installed, operated, maintained,

and cleaned;

(10) Explaining correct procedures for cleaning and sanitizing utensils and

food-contact surfaces of equipment;

(11) Identifying the source of water used and measures taken to ensure that it remains

protected from contamination such as providing protection from backflow and.

precluding the creation of cross connections;

(12) Identifying poisonous or toxic materials in the food establishment and the

procedures necessaty to ensure that they are safely stored, dispensed, used, and

disposed of according to law,

(13) Identifying critical control points in the op eration from purchasing through sale or

service that when not controlled may contribute to the transmission of food borne

illness and explaining steps taken to ensure that the points are controlled in

accordance with the requirements of this Code;

(14) Explaining the details of how the person in charge and food employees comply

with the HACCP plan if a plan 1s required by the law, this Code, or an agreement

between the Regulatory authority and the establishment; and

(15) Explaining the responsibilities, rights, and authorities assigned by this Code to

the:

(a) food employee,

(b) person in charge, and

(c) Regulatory authority.

Duties

2-103.11 Person in Charge.

The person in charge shall ensure that:

(A) Food establishment operations are not conducted in an unlicensed area of a private home,

or jn aroom used as living or sleeping quarters as specified under § 6-202.1 11; |

(B) Persons unnecessary to the food establishment operation are not allowed in the food

preparation, food storage, or warewashing areas, except ihat brief visits and tours may be

authorized by the person in charge if steps are taken to ensure that exposed food; clean

equipment, utensils, and linens; and unwrapped single-service and single-use articles are

protected from contamination;

(C) Employees and other persons such as delivery and maintenance persons and pesticide

applicators entering the food preparation, food storage, and warewashing areas comply

with this Code;

(D) Employees are effectively cleaning their hands, by routinely monitoring the employees’

handwashing;

(E) Employees are visibly observing foods as they are received to determine that they are

from approved sources, delivered at the required temperatures, protected from

contamination, unadulterated, and accurately presented, by routinely monitoring the

16

employees’ observations and periodically evaluating foods upon their receipt;

(F) Employees are properly cooking potentially hazardous food, being particularly careful in

cooking those foods known to cause severe food borne illness and death, such as eggs and

comminuted meats, through daily oversight of the employees' routine monitoring of the

- cooking temperatures using appropriate temperature measuring devices properly scaled

and calibrated as specified under § 4-203.11 and paragraph 4-502.11(B);

(G) Employees are using proper methods to rapidly cool potentially hazardous foods that are

not held hot or are not for consumption within 4 hours, through daily oversight of the

employees' routine monitoring of food temperatures during cooling;

(H) Consumers who order raw or partially cooked ready-to-eat foods of animal origin are

informed as specified under § 3-603.11 that the food is not cooked sufficiently to ensure

its safety;

(1) Employees are properly sanitizing cleaned multiuse equipment and utensils before they

are reused, through routine monitoring of solution temperature and exposure time for hot

water sanitizing, and chemical concentration, pH, temperature, and exposure time for

chemical sanitizing;

(J) Consumers are notified that clean tableware is to be used when they return to self-service

areas such as salad bars and buffets as specified under § 3-304.16;

(K) Except when otherwise approved as specified in paragraph 3-301.11(B), employees:are

preventing cross-contamination of ready-to-eat food with bare hands by properly using

suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing

equipment; and

(L) Employees are properly trained in food safety as it relates to their assigned duties.

2-2 EMPLOYEE HEALTH

Subpart |

2-201 Disease or Medical Condition

Disease or Medica] Condition

2-201.11 Responsibility of the Person in Charge to Require Reporting by Food Employees

and Applicants.* |

Employer requires employee reporting of.

The permit holder shall require food employee applicants to whom a conditional offer of

employment is made and food employees to report to the person in charge, information about

their health and activities as they relate to diseases that are transmissible through food. A food

employee or applicant shal! report the information in a manner that allows the person in charge to

prevent the likelihood of food borne disease transmission, including the date of onset of jaundice

or of an illness specified under paragraph (C) of this section, if the food employee or applicant:

health status

employee is ill:

(A) Is diagnosed with an illness due to:

(1) Salmonella Typha,

(2) Shigella spp.,

(3) Shiga toxin-producing Escherichia coli, or

(4) Hepatitis A virus;

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employee has symptom of:

(B) Has a symptom caused by illness, infection, or other source that is:

intestinal illness

(1) Associated with an acute gastrointestinal illness such as:

(a) Diarrhea,

(b) ‘Fever,

(c) Vomiting,

(d) Jaundice, or

(ce) Sore throat with fever, or

(f) Boil or infected wound.

(2) A lesion containing pus such as a boil or infected wound that is open or draining

and is:

(a) On the hands or wrists, unless an impermeable cover such as a finger cot

or stall protects the lesion and a single-use glove is worn over the

impermeable cover,

(b) | Onexposed portions of the arms, unless the lesion is protected by an impermeable

cover, Or . |

(c) On other parts of the body, unless the lesion is covered by a dry, durable,

tight-fitting bandage;

employee previously ill

(C) Had a past illness from:

(1) 8. Typha within the past three months,

(2) Shigella spp. within the past month,

(3) Shiga toxin-producing Escherichia coli, within the past month; or

(4) Hepatitis A virus;

activities

(D) Meets one or more of the following high-risk conditions:

employee at high risk of becoming ill: _

prepared or consumed food that caused disease

(1) Is suspected of causing, or being exposed to, a confirmed disease outbreak caused

by S. Typha, Shigella spp., Shiga toxin-producing Escherichia coli, or hepatitis

A virus including an outbreak at an event such as a family meal, church supper, or

festival because the food employee or applicant:

(a) food implicated in the outbreak,

(b) Consumed food implicated in the outbreak, or

(c) Consumed food at the event prepared by a person who is infected or 111

with the infectious agent that caused the outbreak or who is suspected of

being a shedder of the infectious agent, lives with ill person.

(2) Lives in the same household as, and has knowledge about, a person who is

diagnosed with a disease caused by S. Typha, Shigella spp., Shiga

toxin-producing Es cherichia coli, or hepatitis A virus, or lives with person

involved in disease outbreak.

(3) Lives in the same household as, and has knowledge about, a person who attends

18

or works in a setting where there is a confirmed disease outbreak caused by S.

Typha, Shigella spp., Shiga toxin-producing Escherichia coli, or hepatitis A

Virus.

2-201.12 Exclusions and Restrictions.*

The person in charge shall:

excluding ill employees

(A) Exclude a food employee from a food establishment if the food employee is

diagnosed with an infectious agent specified under paragraph 2-201.11(A);

_ restricting employees: (serving general population)

(B) Except as specified under paragraph (C) or (D) of this section, restrict a food

employee from working with exposed food; clean equipment, utensils, and linens;

and unwrapped single-service and single-use articles, in a food establishment if

the food employee is: |

with symptom of illness or of past illness

(1) Suffering from a symptom specified under paragraph 2-201.11(B)(1)(a), (b), (c),

and (e), or

(2) Not experiencing a symptom of acute gastro enteritis specified under

Subparagraph 2-201.11(B)(1) but has a stool that yields a specimen culture that is

positive for Salmonella Typha, Shigella spp., or Shiga toxin-producing

Escherichia coli;

excluding employees:

(serving high-risk population)

with symptom of ilJness or of past iliness

(C) If the population served is a highly susceptible population, Exclude a food

employee who:

(1) Is experiencing a symptom of acute gastrointestinal illness specified under

Subparagraph 2-201.11(B)(1)(a), (b), (c), or (€) and meets a high-risk condition

specified under Subparagraphs 2-201.11(D)(1)-@3),

(2) Is not experiencing a symptom of acute gastroenteritis specified under

Subparagraph 2-201.11(B)(1) but has a stool that yields a specimen culture that is

positive for S. Typha, Shigella spp., or Shiga toxin-producing Escherichia coli,

(3) Hadapast illness from 8S. Typha within the last 3 months, or

(4) Hadapast illness from Shigella spp. or Shiga toxin-producing Escherichia coli

within the last month; and excluding and restricting jaundiced employees.

(D) Fora food employee who is jaundiced: :; |

(1) Ifthe onset of jaundice occurred within the last 7 calendar days, Exclude the food

employee from the food establishment, or

(2) If the onset of jaundice occurred more than 7 calendar days before:

(a) Exclude the food employee from a food establishment that serves a highly

susceptible population, or

(b) restrict the food employee from activities specified under

paragraph 2-201.12(B), if the food establishment does not serve a highly

susceptible population.

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©) 4-201.13 Removal of Exclusions and Restrictions.

reinstating an excluded employee who is:

(i) no longer ill; or

(ii) free of jaundice |

(A) The person in charge may remove an exclusion specified under paragraph 2-201.12(A) if

(1) The person in charge obtains approval from the regulatory authority; and

(2) The person excluded as specified under paragraph 2-201.12(A) provides to the

person in charge written medical documentation from a physician licensed to

practice medicine or, if allowed by law, a nurse practitioner or physician assistant,

that specifies that the excluded person may work as a food employee in a food

establishment, including an establishment that serves a highly susceptible

population, because the person is free of the infectious agent of concer as

specified in § 8-501.40.

reinstating a restricted employee who is free of symptoms

(B) The person in charge may remove a restriction specified under:

(1) Subparagraph 2-201.12(B)(1) if the restricted person:

(a) Is free of the symptoms specified under paragraph 2-201.11 (B)(1)(a), (b),

(c), or (e) or (2) and no food bome illness occurs that may have been

caused by the restricted person, |

(b) Is suspected of causing food bome illness but:

(1) Is free of the symptoms specified under

O paragraph 9-201.11(B)(1){a), (b), (©), oF (e) or (2), and free of

suspected infectious agent; |

(ii) Provides written medical documentation from a physician licensed

to practice medicine or, if allowed by law, a nurse practitioner or

physician assistant, stating that the restricted person is free of the

infectious agent that 1s susp ected of causing the person's symptoms

or causing food borne illness, as specified in § 8-501.40, or has

symptoms that are not caused by an infectious agent.

(c) Provides written medical documentation from a physician licensed to

practice medicine or, 1f allowed by law, a nurse practitioner or physician

assistant, stating that the symptoms experienced result from a chronic

noninfectious condition such as Crohn's disease, irritable bowel syndrome,

or ulcerative colitis; or no longer a shedder.

(2) Subparagraph 2-201.12(B)(2) if the restricted person provides written medical

documentation from a physician, licensed to practice medicine, or, if allowed by

law, a nurse practitioner or physician assistant, according to the criteria specified

in § 8-501.40 that indicates the stools are free of Salmonella Typha, Shigella

spp., or Shiga toxin-producing Escherichia coli, whichever is the infectious agent

of concem.

reinstating an excluded employee serving: high-risk population |

(C) The person in charge may remove an exclusion specified under paragraph 2-201.12(C) if

the excluded person provides written medical documentation from a physician licensed to

20

practice medicine or, if allowed by law, a nurse practitioner or physician assistant:

(1) That specifies that the person is free of the infectious agent of concern as specified

in § 8-501.40, or

(2) Ifthe person is excluded under Subparagraph 2-201.12(C)(1), stating that the

symptoms experienced result from a chronic noninfectious condition such as

_ Crohn's disease, irritable bowel syndrome, or ulcerative colitis.

reinstating an employee who is: not suspect source of illness

(D) The person in charge may remove an exclusion specified under Subparagraph

2-201.12(D)(1) and Subparagraph 2-201.12(D){2)(a) and a restriction specified under

Subparagraph 2-201.12(D)(2)(b) if:

(1) No food borne illness occurs that may have been caused by the excluded or

restricted person and the person provides written medical documentation from a

physician licensed to practice medicine or, if allowed by law, a nurse practitioner

or physician assistant, that specifies that the person is free of hepatitis A virus as

specified in Subparagraph 8-501.40(D)(1); or suspect source of illness .

(2) The excluded or restricted person is suspected of causing food borne illness and

complies with the requirements in Subparagraphs 8-501.40(D)(1) and (D)(2).

2-201.14 Responsibility of a Food Employee or an Applicant to Report to the Person in

Charge.*

A food employee or a person who applies for a job as a food employee shall:

(A) Inamanner specified under § 2-201.11, report to the person in charge the information

specified under paragraphs 2-201.11(A)-(D); and

(B) | Comply with exclusions and restrictions that are specified under

paragraphs 2-201.12(A)-(D).

2-201.15 Reporting by the Person in Charge.*

The person in charge shall notify the regulatory authority that a food employee is diagnosed with

an illness due to Salmonella Typha, Shigella spp., Shiga toxin-producing Escherichia coli, or

hepatitis A virus.

2-3 PERSONAL CLEANLINESS

Subparts

2-301 Hands and Arms

2-302 Fingernails

2-303 Jewelry

2-304 Outer Clothing

Hands and Arms

2-301.11 Clean Condition.*

Food Employees shall keep their hands and exposed portions of their arms clean.

2-301.12 Cleaning Procedure.*

(A) | Except as specified in paragraph (B) of this section, food employees shall clean their

hands and exposed portions of their arms (or surrogate prosthetic devices for hands or

arms) for at least 20 seconds, using a cleaning compound in a lavatory that is equipped as

specified under § 5-202.12.

(B) Food employees shall use the following cleaning procedure:

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(1) Vigorous friction on the surfaces of the lathered fingers, finger tips, areas between

the fingers, hands and arms (or by vigorously rubbing the surrogate prosthetic —

| devices for hands or arms) for at least 10 to 15 seconds, followed by;

(2) Thorough rinsing under clean, running warm water; and

(3) Immediately follow the cleaning procedure with thorough drying of cleaned hands

and arms (or surrogate prosthetic devices) using a method as specified under §

6-301.12.

(C) Food Employees shall pay particular attention to the areas underneath the fingernails

during the cleaning procedure. -_

(D) Ifapproved and capable of removing the types of soils encountered in the food operations

involved, an automatic handwashing facility may be used by food employees to clean

their hands. | .

2-301.13 Special Handwash Procedures.*

Reserved. |

2-301.14 When to Wash.*

Food Employees shall clean their hands and exposed portions of their arms as specified under §

9-301.12 immediately before engaging in food preparation including working with exposed food,

clean equipment and utensils, and unwrapped single-service and single-use articles and:

(A) After touching bare human body parts other than clean hands and clean, exposed portions

of arms;

(B) After using the toilet room;

(C) After caring for or handling service animals or aquatic animals as specified in paragraph

2-403.11(8); |

(D) Except as specified in paragraph 2-401.11(B), after coughing, sneezing, using a

handkerchief or disposable tissue, using tobacco, eating, or drinking;

(E) After handling soiled equipment or utensils;

(F) During food preparation, as often as necessary to remove soil and contamination and to

prevent cross contamination when changing tasks; _

(G) © When switching between working with raw food and working with ready-to-eat food;

(H) When working with or switching to different raw foods,

(1) Before donning gloves for working with food; and

(3) After engaging in other activities that contaminate the hands.

4-301.15 Where to Wash.

Food Employees shall clean their hands in a handwashing lavatory or approved automatic

handwashing facility and may not clean their hands in a sink used for food preparation or

warewashing, or in a service sink or a curbed cleaning facility used for the disposal of mop water

and similar liquid waste.

2-301.16 Hand Sanitizers. |

(A) Ahand sanitizer and a chemical hand sanitizing solution used as a hand dip shall:

(1) Comply with one of the following:

(a) Bean approved drug that is listed in the FDA publication Approved Drug

Products with Therapeutic Equivalence Evaluations as an approved

drug based on safety and effectiveness; Or

22

(b) Have active antimicrobial ingredients that are listed in the FDA

monograph for OTC Health-Care Antiseptic Drug Products as an

antiseptic handwash, or

(2) Comply with one of the following:

(a) | Have components that are exempted from the requirement of being listed

in federal food additive regulations as specified in 21 CFR 170.39 - |

Threshold of regulation for substances used in food-contact articles; or

(b) | Comply with and be listed in:

(i) 21 CFR 178 - Indirect Food Additives: Adjuvants, Production

Aids, and Sanitizers as regulated for use as a food additive with

conditions of safe use, or

(11) 21 CFR 182 - Substances Generally Recognized as Safe, 21 CFR

184 - Direct Food Substances Affirmed as Generally Recognized

as Safe, or 21 CFR 186 - Indirect Food Substances Affirmed as.

Generally Recognized as Safe for use in contact with food; and

(3) Be applied only to hands that are cleaned as specified under § 2-301.12.

(B) If a hand sanitizer or a chemical hand sanitizing solution used as a hand dip does not meet the

criteria specified under Subparagraph (A)(2) of this section, use shall be:

(1) Followed by thorough hand rinsing in clean water before hand contact with food |

or by the use of gloves; or

(2) Limited to situations that involve no direct contact with food by the bare hands.

(C) A chemical hand sanitizing solution used as a hand dip shall be maintained clean and at a

strength equivalent to at least 100 mg/L chlorine.

Fingernails

2-302.11 Maintenance. 7

(A) Food employees shall keep their fingernails trimmed, filed, and maintained so the edges

and surfaces are cleanable and not rough.

(B) Unless wearing intact gloves in good repair, a food employee may not wear fingernail

polish or artificial fingernails when working with exposed food.

Jewelry

2-303.11 Prohibition.

While preparing food, food employees may not wear jewelry including medical information

jewelry on their arms and hands. This section does not apply to a plain ring such as a wedding

band.

Outer Clothing

2-304.11 Clean Condition.

Food Employees shall wear clean outer clothing to prevent contamination of food, equipment,

utensils, linens, and single-service and single-use articles.

2-4 HYGIENIC PRACTICES

Subparts

2-401 Food Contamination Prevention

2-402 Hair Restraints

2-403 Animals

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Food Contamination Prevention

2-01.11 Eating, Drinking, or Using Tobacco.*

(A) Except as specified in paragraph (B) of this section, an employee shall eat, drink, or use

any form paragraph of tobacco only in designated areas where the contamination of

exposed food; clean equipment, utensils, and.linens; unwrapped single-service and

single-use articles; or other items needing protection can not result.

(B) A food employee may drink from a closed beverage container if the container is handled

to prevent contamination of:

(1) The employee's hands;

(2) The container; and

(3) Exposed food; clean equipment, utensils, and linens; and unwrapped

single-service and single-use articles.

2.401.12 Discharges from the Eyes, Nose, and Mouth.*

Food employees experiencing persistent sneezing, coughing, or a runny nose that causes

discharges from the eyes, nose, or mouth may not work with exposed food; clean equipment,

utensils, and linens; or unwrapped single-service or single-use articles.

Hair Restraints .

2-402.11 Effectiveness. |

(A) Except as provided in paragraph (B) of this section, food employees shall wear hair’

restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers

body hair, that are designed and worn to effectively keep their hair from contacting

exposed food; clean equipment, utensils, and linens; and unwrapped single-service and

single-use articles. |

(B) This section does not apply to food employees such as counter staff who only serve

beverages and wrapped or packaged foods, hostesses, and wait staff if they present a

minimal risk of contaminating exposed food; clean equipment, utensils, and linens; and

unwrapped single-service and single-use articles. .

2-403.11 Handling Prohibition.* |

(A) Except as specified in paragraph (B) of this section, food employees may not care for or

handle animals that may be present such as patrol dogs, service animals, or pets that are

allowed as specified in Subparagraphs 6-501.115(B)(2)-(5).

(B) Food Employees with service animals may handle or care for their service animals and

food employees may handle or care for fish in aquariums or molluscan shellfish or

crustacea in display tanks if they wash their hands as specified under § 2-301.12 and

paragraph 2-301.14(C). .

Chapter 3 Food

Parts

3-1 CHARACTERISTICS

3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS

3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING

3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

3.5 LIMITATION OF GROWTH. OF ORGANISMS OF PUBLIC HEALTH CONCERN

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3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING

3-7 CONTAMINATED FOOD ©

3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS

3-1 CHARACTERISTICS

Subparts

3-101 Condition

Condition

3-101.11 Safe, Unadulterated, and Honestly Presented.*

Food shall be safe, unadulterated, and, as specified under § 3-601.12, honestly presented.

3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS

Subparts

3-201 Sources

3-202 Specifications for Receiving

3-203 Original Containers and Records

Sources

3-201.11 Compliance with Food Law.*

(A) Food shall be obtained from sources that comply with law.

(B) Food prepared in an unlicensed area of a private home may not be used or offered for

human consumption in a food establishment.

(C) Packaged food shall be labeled as specified in law, including 21 CFR 101 Food Labeling,

9 CFR 317 Labeling, Marking Devices, and Containers, and 9 CFR 381 Subpart N

Labeling and Containers, and as specified under §§ 3-202.17 and 3-202.18.

(D) Fish, other than molluscan shellfish, that are intended for consumption in their raw form

and allowed as specified in Subparagraph 3-401.11(C)(1) may be offered for sale or

service if they are obtained from a supplier that freezes the fish as specified under §

3-402.11; or frozen on the premises as specified under § 3-402.11 and records are

retained as specified under § 3-402.12.

(E) Whole-muscle, intact beef steaks that are intended for consumption in an undercooked

form without a consumer advisory as specified in paragraph 3-401.11(C) shall be:

(1) Obtained from a food processing plant that, upon request by the purchaser,

packages the steaks and labels them, to indicate that the steaks meet the definition

of whole-muscle, intact beef, or

(2) Deemed acceptable by the regulatory authority based on other evidence, such as

written buyer specifications or invoices, that indicates that the steaks meet the

definition of whole-muscle, intact beef, and

(3) Ifindividually cut in a food establishment:

(a) Cut from whole-muscle intact beef that is labeled by a food processing

plant as specified in Subparagraph (1) or identified as specified in

Subparagraph (2) of this section,

(b) . Prepared so they remain intact, and

(c) If packaged for undercooking in a food establishment, labeled as specified

in Subparagraph (1) or identified as specified in (2) of this section.

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(F) Meat and poultry that is not a ready-to-eat food and is in a packaged form when it is

offered for sale or otherwise offered for consumption, shall be labeled to include safe

handling instructions as specified in law, including 9 CFR 317.2(1) and 9 CFR

381.125(b).

(G) Shell eggs that have not been specifically treated to destroy all viable Salmonellae shall

be labeled to include safe handling instructions as specified in law, including 21 CFR

101.17(h).

3-201.12 Food in a Hermetically Sealed Container.*

Food in a’hermetically sealed container shall be obtained from a food processing plant that is

regulated by the food regulatory agency that has jurisdiction over the plant.

3-201.13 Fluid Milk and Milk Products.*

‘Fluid milk and milk products shall be obtained from sources that comply with grade a standards

as specified in law.

3-201.14 Fish.*

(A) _ Fish that are received for sale or service shall be:

(1) Legally caught or harvested; or

(2) Approved for sale or Service.

(B) Molluscan shellfish that are recreationally caught may not be received for sale or service.

3-201.15 Molluscan Shellfish.*

(A) Molluscan shellfish shall be obtained from sources according to law and the requirements

specified in the U.S. Department of Health and Human Services, Public Health Service,

Food and Drug Administration, National Shellfish Sanitation Program Guide for the

Control of Molluscan Shellfish.

(B) Molluscan shellfish received in interstate commerce shall be from sources that are listed

in the Interstate Certified Shellfish Shippers List.

3-201.16 Wild Mushrooms.* | |

(A) Except as specified in paragraph (B) of this section, mushroom species picked in the wild

shall be obtained from sources where each mushroom is individually inspected and found

to be safe by an approved mushroom identification expert.

(B) This section does not apply to:

(1) Cultivated wild mushroom species that are grown, harvested, and processed in an

operation that is regulated by the food regulatory agency that has jurisdiction over

the operation; or a

(2) Wild mushroom species if they are in packaged form and are the product of a food

processing plant that is regulated by the food regulatory agency that has

jurisdiction over the plant.

3-201.17 Game Animals.*

If game animals are received for sale or service they shall be:

(1) Commercially raised for food and:

(a) Raised slaughtered, and processed under a voluntary inspection program

that is conducted by the agency that has animal health jurisdiction, or

(b) Under a routine inspection program conducted by a regulatory agency

| other than the agency that has animal health jurisdiction, and

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(c) Raised, slaughtered, and processed according to:

(1) Laws governing meat and poultry as determined by the agency that

has animal health jurisdiction and the agency that conducts the

inspection program, and

(ii) | Requirements which are developed by the agency that has animal

health jurisdiction and the agency that conducts the inspection

program with consideration of factors such as the need for

antemortem and postmortem examination by an approved

veterinarian or veterinarian's designee;

(2) Under a voluntary inspection program administered by the USDA for game

animals such as exotic animals (reindeer, elk, deer, antelope, water buffalo, or

bison) that are "Inspected and approved" in accordance with 9 CFR 352 Voluntary

Exotic Anima! Program or rabbits that are "inspected and certified" in accordance

with 9 CFR 354 Rabbit Inspection Program;

(3) As allowed by law, for wild game animals that are live-caught:

(a) Under a routine inspection program conducted by a regulatory agency such

as the agency that has animal health jurisdiction, and

(b) Slaughtered and processed according to:

(1) Laws governing meat and poultry as determined by the agency that

has animal health jurisdiction and the agency that conducts the

inspection program, and

(ii) | Requirements which are developed by the agency that has animal

health jurisdiction and the agency that conducts the inspection

program with consideration of factors such as the need for

antemortem and postmortem examination by an approved

veterinarian or veterinarian's designee; or

(4) As allowed by law, for field-dressed wild game animals under a routine inspection

program that ensures the animals:

(a) Receive a postmortem examination by an approved veterinarian or

veterinarian's designee, or

(b) Are field-dressed and transported according to requirements specified by

the agency that has animal health jurisdiction and the agency that conducts

the inspection program, and

(c) Are processed according to laws governing meat and poultry as

determined by the agency that has animal health jurisdiction and the

agency that conducts the inspection program.

Specifications for Receiving

3-202.11 Temperature.*

(A)

(B)

Except as specified in paragraph (B) of this section, refrigerated, potentially hazardous

food shall be at a temperature of 5°C (41°F) or below when received.

If a temperature other than 5°C (41°F) for a potentially hazardous food is specified in law

governing its distribution, such as laws governing milk and molluscan shellfish, the food

may be received at the specified temperature.

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(C) Raw shell eggs shall be received in refrigerated equipment that maintains an ambient air

temperature of 7°C (45°F) or less.

(D) Potentially hazardous food that is cooked to a temperature and for a time specified under

§ 3-401.11 - 3-401.13 and received hot shall be at a temperature of 60°C (140°F) or

above. | |

(ZE) A food that is labeled frozen and shipped frozen by a food processing plant shall be

received frozen. so

(F) Upon receipt, potentially hazardous food shall be free of evidence of previous

temperature abuse.

3-202.12 Additives.” |

Food may not contain unapproved food additives or additives that exceed amounts specified in

21 CFR 170-180 relating to food additives, generally recognized as safe or prior sanctioned

substances that exceed amounts specified in 21 CFR 181-186, substances that exceed amounts

specified in 9 CFR Subpart C Section 424.21(b) Food ingredients and sources of radiation, or

pesticide residues that exceed provisions specified in AQ CFR 185 Tolerances for Pesticides in

Food. .

3-202.13 Shell Eggs.*

Shell eggs shall be received clean and sound and may not exceed the restricted egg tolerances for

U.S. Consumer Grade B as specified in 7 CFR Part 56 " Voluntary Grading of Shell Eggs and.

United States Standards, Grades, and Weight Classes for Shell Eggs, and 9 CFR Part 590 "

Inspection of Eggs and Egg Products. |

3-202.14 Eggs and Milk Products, Pasteurized.*

(A) Liquid, frozen, and dry eggs and egg products shall be obtained pasteurized.

(B) Fluid and dry milk and milk products complying with grade A standards as specified in

law shall be obtained pasteurized.

(C) Frozen milk products, such as ice cream, shall be obtained pasteurized as specified in 21

CFR 135 - Frozen Desserts. :

(D) Cheese shall be obtained pasteurized unless alternative procedures to pasteurization are

specified in the CFR, such as 21 CFR 133 - Cheeses and Related Cheese Products, for

curing certain cheese varieties. |

3-202.15 Package Integrity.” |

Food packages shall be in good condition and protect the integrity of the contents so that the food

is not exposed to adulteration or potential contaminants.

3-202.16 Ice.*

Ice for use as a food or a cooling medium shall be made from drinking water.

3-202.17 Shucked Shellfish, Packaging and Identification.

(A) Raw shucked shellfish shall be obtained in nonretumable packages which bear a legible

label that identifies the: |

(1) Name, address, and certification number of the shucker-packer or repacker of the

molluscan shellfish; and

(2) The "sell by" date for packages with a capacity of less than 1.87 L (one-haif

gallon) or the date shucked for packages with a capacity of 1.87 L (one-half

gallon) or more. |

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(B)

(A)

(B)

A package of raw shucked shellfish that does not bear a label or which bears a Jabel

which does not contain all the information as specified under paragraph (A) of this

. section shal] be subject to a hold order, as allowed by law, or seizure and destruction in

accordance with 21 CFR Subpart D - Specific Administrative Decisions Regarding

Interstate Shipments, Section 1240.60(d).

3-202.18 Shellstock Identification.*

Shellstock shall be obtained in containers bearing legible source identification tags or

labels that are affixed by the harvester and each dealer that depurates, ships, or reships the

shellstock, as specified in the National Shellfish Sanitation Program Guide for the

Control of Molluscan Shellfish, and that list:

(1) Except as specified under paragraph (C) of this section, on the harvester's tag or

label, the following information in the following order:

(a)

(b)

(c)

(d)

(e)

The harvester's identification number that is assigned by the shellfish

control authority,

The date of harvesting,

The most precise identification of the harvest location or aquaculture site

that is practicable based on the system of harvest area designations that is

in use by the shellfish contro] authority and including the abbreviation of

the name of the state or country in which the shellfish are harvested,

The type and quantity of shellfish, and

The following statement in bold, capitalized type: "This tag is required to

be attached until container is empty or retagged and thereafter kept on file

for 90 days;" and —

(2) Except as specified in paragraph (D) of this section, on each dealer's tag or label,

the following information in the following order:

(a)

(b)

(c)

(d)

The dealer's name and address, and the certification number assigned by

the shellfish control authority,

The original shipper's certification number including the abbreviation of

the name of the state or country in which the shellfish are harvested,

The same information as specified for a harvester's tag under

Subparagraphs (A)(1)(b)-(d) of this section, and

The following statement in bold, capitalized type: "This tag is required to

be attached until container is empty and thereafter kept on file for 90

days."

A container of shellstock that does not bear a tag or label or that bears a tag or label that

does not contain all the information as specified under paragraph (A) of this section shall

be subject to a hold order, as allowed by law, or seizure and destruction in accordance

with 21 CFR Subpart D - Specific Administrative Decisions Regarding Interstate

Shipments, Section 1240.60(d).

If a place is provided on the harvester's tag or label for a dealer's name, address, and

certification number, the dealer's information shall be listed first.

If the harvester's tag or label is designed to accommodate each dealer's identification as

specified under Subparagraphs (A)(2)(a) and (b) of this section, individual dealer tags or

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labels need not be provided.

3-202.19 Shellstock, Condition.

When received by a food establishment, shellstock shall be reasonably free of mud, dead

shellfish, and shellfish with broken shells. Dead shellfish or shellstock with badly broken shells

shall be discarded. |

3-202.110 Juice Treated.

Pre-packaged juice shall:

(A) Be obtained from a processor with a HACCP system as specified in 21 CFR Part 120;

(B) Be obtained pasteurized or otherwise treated to attain a 5-log reduction of the most

resistant microorganism of public health significance as specified in 21 CFR Part 120.24;

or

(C) Bear a warning label as specified in 21 CFR Section 101.17(g).

Original Containers and Records

3-203.11 Molluscan Shellfish, Original Container.

(A) Exceptas specified in paragraphs (B) and (C) of this section, molluscan shellfish may not

be removed from the container in which they are received other than immediately before

sale or preparation for service.

(B) For display purposes, shellstock may be removed from the container in which they are

received, displayed on drained ice, or held in a display container, and a quantity specified

by a consumer may be removed from the display or display container and provided to the

consumer if: ; |

(1) The source of the shellstock on display is identified as specified under § 3-202.18

and recorded as specified under § 3-203.12; and

(2) The shellstock are protected from contamination.

(C) Shucked shellfish may be removed from the container in which they were received and

held in a display container from which individual servings are dispensed upon a

consumer's request if: |

(1) The labeling :nformation for the shellfish on display as specified under § 3-202.17

is retained and correlated to the date when, or dates during which, the shellfish are

sold or served; and

(2) The shellfish are protected from contamination.

3-203.12 Shellstock, Maintaining Jdentification.*

(A) | Except as specified under Subparagraph (B)(2) of this section, shellstock tags shall

remain attached to the container in which the shellstock are received until the container is

empty.

(B) The identity of the source of shellstock that are sold or served shall be maintained by

retaining shellstock tags or labels for 90 calendar days from the date the container is

emptied by:

(1) Using an approved record keeping system that keeps the tags or labels in

chronological order correlated to the date when, or dates during which, the

shellstock are sold or served; and |

(2) Ifshelistock are removed from their tagged or labeled container:

(a) Preserving source identification by using a record keeping system as

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