TITLE 12. HEALTH
STATE BOARD OF HEALTH
Proposed Regulation
REGISTRAR’S NOTICE: The State Board of Health
is claiming an exemption from the Administrative Process Act in accordance with
§ 2.2-4002 A 23 of the Code of Virginia, which excludes the State Board of
Health when promulgating regulations pursuant to § 35.1-14, which conform,
insofar as practicable, with the federal Food and Drug Administration's Food
Code. Pursuant to § 35.1-14 E of the Code of Virginia, this regulatory
action is exempt from portions of the Administrative Process Act provided the
State Board of Agriculture and Consumer Services adopts the same version and
both agency’s regulations have the same effective date. Both agencies are
working toward that goal.
Title of Regulation: 12VAC5-421. Food Regulations (amending 12VAC5-421-10, 12VAC5-421-50, 12VAC5-421-60, 12VAC5-421-70, 12VAC5-421-80, 12VAC5-421-90, 12VAC5-421-100, 12VAC5-421-140, 12VAC5-421-180, 12VAC5-421-360, 12VAC5-421-370, 12VAC5-421-400, 12VAC5-421-410, 12VAC5-421-430, 12VAC5-421-440, 12VAC5-421-450, 12VAC5-421-490, 12VAC5-421-500, 12VAC5-421-540, 12VAC5-421-570, 12VAC5-421-680, 12VAC5-421-700, 12VAC5-421-730, 12VAC5-421-740, 12VAC5-421-760, 12VAC5-421-780, 12VAC5-421-790, 12VAC5-421-800, 12VAC5-421-820, 12VAC5-421-830, 12VAC5-421-850, 12VAC5-421-860, 12VAC5-421-870, 12VAC5-421-900, 12VAC5-421-950, 12VAC5-421-980, 12VAC5-421-1200, 12VAC5-421-1230, 12VAC5-421-1260, 12VAC5-421-1310, 12VAC5-421-1420, 12VAC5-421-1550, 12VAC5-421-1560, 12VAC5-421-1690, 12VAC5-421-1890, 12VAC5-421-1980, 12VAC5-421-2040, 12VAC5-421-2190, 12VAC5-421-2230, 12VAC5-421-2280, 12VAC5-421-2310, 12VAC5-421-2520, 12VAC5-421-2600, 12VAC5-421-2630, 12VAC5-421-2790, 12VAC5-421-2810, 12VAC5-421-2920, 12VAC5-421-2950, 12VAC5-421-2960, 12VAC5-421-3020, 12VAC5-421-3030, 12VAC5-421-3040, 12VAC5-421-3045, 12VAC5-421-3080, 12VAC5-421-3130, 12VAC5-421-3180, 12VAC5-421-3240, 12VAC5-421-3460, 12VAC5-421-3750, 12VAC5-421-3815, 12VAC5-421-3860, 12VAC5-421-4040, 12VAC5-421-4050, 12VAC5-421-4070; repealing 12VAC5-421-110, 12VAC5-421-120, 12VAC5-421-150, 12VAC5-421-750, 12VAC5-421-1020, 12VAC5-421-1030, 12VAC5-421-1440, 12VAC5-421-1880, 12VAC5-421-2510, 12VAC5-421-2590, 12VAC5-421-3010, 12VAC5-421-3050, 12VAC5-421-3060, 12VAC5-421-3110, 12VAC5-421-3120, 12VAC5-421-3160).
Statutory Authority: §§ 35.1-11 and 35.1-14
of the Code of Virginia.
Public Hearing Information:
October 21, 2009 - 2 p.m. - Virginia
Department of Health, James Madison Building, 109 Governor Street, Fifth Floor
Conference Room, Richmond, VA
Public Comments: Public comments may be submitted
until 5 p.m. on October 30, 2009.
Agency Contact: Gary L. Hagy, Director of
Food and General Environmental Services, Department of Health, 109 Governor
St., Richmond, VA 23219, telephone (804) 864-7455, TTY (800) 828-1120, or email
gary.hagy@vdh.virginia.gov.
Summary:
The Food Regulations
establish minimum sanitary standards for operating restaurants. Those standards
include the safe and sanitary maintenance, storage, operation, and use of
equipment; the safe preparation, handling, protection, and preservation of
food, including necessary refrigeration or heating methods; procedures for
vector and pest control; requirements for toilet and cleansing facilities for
employees and customers; requirements for appropriate lighting and ventilation
not otherwise provided for in the Uniform Statewide Building Code; requirements
for an approved water supply and sewage disposal system; personal hygiene
standards for employees, particularly those engaged in food handling; and the
appropriate use of precautions to prevent the transmission of communicable
diseases. The regulations also inform potential restaurant owners or operators
how to obtain a permit to operate a restaurant from the department. The
regulations are being amended to be consistent with the current 2007 supplement
to the 2005 Food and Drug Administration's (FDA) Food Code. The current Food
Regulations are based on the 2003 Supplement to the 2001 FDA Food Code. These
changes are also being proposed concurrently with the Virginia Department of
Agriculture and Consumer Services (VDACS) adoption of the 2007 Supplement to
the 2005 FDA Food Code. Pursuant to § 35.1-14 C and E of the Code of Virginia,
this action is exempt from portions of the Administrative Process Act (APA),
provided VDACS adopts the same version and both agency’s regulations have the
same effective date. Both agencies are working toward that end. Both VDH and
VDACS previously adopted the 2003 supplement to the 2001 FDA Food Code with an
effective date of October 16, 2007.
Part I
Definitions, Purpose and Administration
12VAC5-421-10. Definitions.
The following words and
terms when used in this chapter shall have the following meanings unless the
context clearly indicates otherwise.
"Accredited
program" means a food protection manager certification program that has
been evaluated and listed by an accrediting agency as conforming to national
standards that certify individuals. "Accredited program" refers to
the certification process and is a designation 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, recertification, discipline and grievance
procedures; and test development and administration. "Accredited
program" does not refer to training functions or educational programs.
"Additive" means
either a (i) "food additive" having the meaning stated in the Federal
Food, Drug, and Cosmetic Act, § 201(s) and 21 CFR Part 170 or (ii) "color
additive" having the meaning stated in the Federal Food, Drug, and
Cosmetic Act, § 201(t) and 21 CFR Part 70.
"Adulterated" has
the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 402.
"Agent" means a
legally authorized representative of the owner.
"Agent of the
commissioner" means the district or local health director, unless
otherwise stipulated.
"Approved" means
acceptable to the department based on a determination of conformity with
principles, practices, and generally recognized standards that protect public
health.
"Approved water
supply" means a waterworks which has a valid waterworks operation permit
from the department or a nonpublic water supply which is evaluated, tested and
if found in reasonable compliance with the construction standards of the
Private Well Regulations (12VAC5-630) and the bacteriological water quality
standards of the Virginia Waterworks Regulations (12VAC5-590), accepted and
approved by the director or the director's designee.
"Asymptomatic"
means without obvious symptoms; not showing or producing indication 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. Asymptomatic includes not showing symptoms because
symptoms have resolved or subsided, or because symptoms never manifested.
"aw"
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
aw.
"Balut" means an
embryo inside a fertile egg that has been incubated for a period sufficient for
the embryo to reach a specific stage of development after which it is removed
from incubation before hatching.
"Bed and
breakfast" means a tourist home that serves meals.
"Beverage" means a
liquid for drinking, including water.
"Board" means the
State Board of Health.
"Bottled drinking
water" means water that is sealed in bottles, packages, or other
containers and offered for sale for human consumption.
"Building
official" means a representative of the Department of Housing and
Community Development.
"Casing" means a
tubular container for sausage products made of either natural or artificial
(synthetic) material.
"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.
"CIP" 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. 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.
"CFR" means Code
of Federal Regulations. Citations in these regulations 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.
"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:
1. Is published annually by the U.S.
Government Printing Office; and
2. Contains FDA rules in 21 CFR, USDA rules
in 7 CFR and 9 CFR, EPA rules in 40 CFR, and Wildlife and Fisheries Rules in 50
CFR.
"Commingle" means:
1. To combine shellstock harvested on
different days or from different growing areas as identified on the tag or
label; or
2. To combine shucked shellfish from
containers with different container codes or different shucking dates.
"Comminuted" means
reduced in size by methods including chopping, flaking, grinding, or mincing.
"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 two or more types of meat that have been reduced in
size and combined, such as sausages made from two or more meats.
"Commissary" means
a catering establishment, restaurant, or any other place in which food, food
containers or supplies are kept, handled, prepared, packaged or stored for
distribution to satellite operations.
"Commissioner"
means the State Health Commissioner, his duly designated officer or his agent.
"Conditional
employee" means 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 and done in compliance with Title
1 of the Americans with Disabilities Act of 1990.
"Confirmed disease
outbreak" means a foodborne disease outbreak in which laboratory analysis
of appropriate specimens identifies a causative organism or chemical and
epidemiological analysis implicates the food as the source of the illness.
"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.
"Corrosion-resistant
materials" 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.
"Counter-mounted
equipment" means equipment that is not easily movable and is designed to
be mounted off the floor on a table, counter, or shelf.
"Critical control
point" means a point or procedure in a specific food system where loss of
control may result in an unacceptable health risk.
"Critical item"
means a provision of these regulations that, if in noncompliance, is more
likely than other violations to contribute to food contamination, illness, or
environmental degradation.
"Critical limit"
means the maximum or minimum value to which a physical, biological, or chemical
parameter must be controlled at a critical control point to minimize the risk
that the identified food safety hazard may occur.
"Dealer" means a person
who is authorized by a shellfish control authority for the activities of a
shellstock shipper, shucker-packer, repacker, reshipper, or depuration
processor of molluscan shellfish according to the provisions of the National
Shellfish Sanitation Program.
"Delicatessen"
means a store where ready to eat products such as cooked meats, prepared
salads, etc. are sold for off-premises consumption.
"Department" means
the State Health Department.
"Director" means
the district or local health director.
"Disclosure" means
a written statement that clearly identifies the animal foods that are, or can
be ordered, raw, undercooked, or without otherwise being processed to eliminate
pathogens in their entirety, or items that contain an ingredient that is raw,
undercooked, or otherwise being processed to eliminate pathogens.
"Drinking water"
means water that meets the water quality standards for bacteria of the Virginia
Waterworks Regulations (12VAC5-590). Drinking water is traditionally known as
"potable water." Drinking water includes the term water except where
the term used connotes that the water is not potable, such as "boiler
water," "mop water," "rainwater,"
"wastewater," and "nondrinking" water.
"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.
"Easily cleanable"
means a characteristic of a surface that:
1. Allows effective removal of soil by normal
cleaning methods;
2. Is dependent on the material, design,
construction, and installation of the surface; and
3. Varies with the likelihood of the
surface's role in introducing pathogenic or toxigenic agents or other
contaminants into food based on the surface's approved placement, purpose, and
use.
"Easily cleanable"
includes a tiered application of the criteria that qualify the surface as
easily cleanable as specified above 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
2. 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.
"Easily movable"
means:
1. Portable (weighing 30 pounds or less);
mounted on casters, gliders, or rollers; or provided with a mechanical means to
safely tilt a unit of equipment for cleaning; and
2. 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.
"Egg" means the
shell egg of the domesticated chicken, turkey, duck, goose, or guinea. avian
species such as chicken, duck, goose, guinea, quail, ratites, or turkey. Egg
does not include a balut; egg of the reptile species such as alligator; or an
egg product.
"Egg product"
means all, or a portion of, the contents found inside eggs separated from the
shell and pasteurized in a food processing plant, with or without added
ingredients, intended for human consumption, such as dried, frozen, or liquid
eggs. Egg product does not include food that contains eggs only in a relatively
small proportion such as cake mixes.
"Employee" means
the permit holder, 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 establishment.
"Enterohemorrhagic Escherichia
coli (EHEC)" means 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 lesion in the
intestine. EHEC is a subset of STEC, whose members produce additional virulence
factors. Infections with EHEC may be asymptomatic but are classically
associated with bloody diarrhea (hemorrhagic colitis) and hemolytic uremic
syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). Examples of
serotypes of EHEC include: E.coli O157:H7; E.coli O157:NM; E.coli
O26:H11; E.coli O145:NM; E.coli O103:H2; or E.coli
O111:NM. Also see Shiga toxin-producing E.coli.
"EPA" means the
U.S. Environmental Protection Agency.
"Equipment" means
an article that is used in the operation of a food establishment. "Equipment"
includes, but is not limited to, items 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.
"Exclude" means to
prevent a person from working as a food employee in a food establishment
or entering a food establishment except for those areas open to the general
public as an employee.
"F" means degrees
Fahrenheit.
"FDA" means the
U.S. Food and Drug Administration.
"Fish" 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; all mollusks,
if such animal life is intended for human consumption; and, includes any edible
human food product derived in whole or in part from fish, including fish that
has been processed in any manner.
"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.
"Foodborne disease
outbreak" means the occurrence of two or more cases of a similar illness
resulting from the ingestion of a common food.
"Food-contact
surface" means 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.
"Food employee"
means an individual working with unpackaged food, food equipment or utensils,
or food-contact surfaces.
"Food
establishment" means an 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.
"Food establishment"
includes (a) an element of the operation such as a transportation vehicle or a
central preparation facility that supplies a vending location or satellite
feeding location; (b) 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; and (c)
a facility that does not meet the exemption criteria identified in subdivision
6 of this definition or a facility that meets the exemption requirements but
chooses to be regulated under these regulations.
"Food
establishment" does not include:
1. An establishment that offers only
prepackaged foods that are not potentially hazardous;
2. A produce stand that only offers whole,
uncut fresh fruits and vegetables;
3. A food processing plant; including
those that are located on the premises of a food establishment;
4. 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;
5. An area where food that is prepared as
specified in subdivision 4 above is sold or offered for human consumption;
6. A kitchen in a private home, such as, but
not limited to, a family day-care provider or a home for adults, serving 12 or
fewer recipients; or a bed-and-breakfast operation that prepares and offers
food only to guests if the home is owner occupied, the number of available
guest bedrooms does not exceed six, breakfast is the only meal offered, the
number of guests served does not exceed 18, and the consumer is informed by
statements contained in published advertisements, mailed brochures, and
placards posted at the registration area that the food is prepared in a kitchen
that is, by these regulations, exempt from this chapter; or
7. A private home that receives catered or
home-delivered food.
For the purpose of
implementing this chapter, the following are also exempt from the definition of
a "food establishment" in this chapter, as defined in §§ 35.1-25
and 35.1-26 of the Code of Virginia:
1. Boarding houses that do not accommodate
transients;
2. Cafeterias operated by industrial plants
for employees only;
3. Churches, fraternal, school and social
organizations and volunteer fire departments and rescue squads that hold
dinners and bazaars not more than one time per week and not in excess of two
days duration at which food prepared in homes of members or in the kitchen of
the church or organization and is offered for sale to the public;
4. Grocery stores, including the delicatessen
that is a part of a grocery store, selling exclusively for off-premises
consumption and places manufacturing or selling packaged or canned goods;
5. Churches that serve meals for their
members as a regular part of their religious observance; and
6. Convenience stores or gas stations that
are subject to the State Board of Agriculture and Consumer Services' Retail
Food Establishment Regulations (2VAC5-585) or any regulations subsequently
adopted and that (i) have 15 or fewer seats at which food is served to the
public on the premises of the convenience store or gas station and (ii) are not
associated with a national or regional restaurant chain. Notwithstanding this
exemption, such convenience stores or gas stations shall remain responsible for
collecting any applicable local meals tax.
"Food processing
plant" means a commercial operation that manufactures, packages, labels,
or stores food for human consumption and does not provide food directly to a
consumer provides food for sale or distribution to other business
entities such as food processing plants or food establishments. Food processing
plant does not include a food establishment.
"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 Part 301
Definitions, as poultry in 9 CFR Part 381 Poultry Products Inspection
Regulations, or as Fish as defined in this section.
"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.
"Game animal" does
not include ratites such as ostrich, emu, and rhea.
"General use
pesticide" means a pesticide that is not classified by EPA for restricted
use as specified in 40 CFR 152.175.
"Grade A
standards" means the requirements of the USPHS/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.
"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.
"Handwashing sink"
means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing
fixture especially placed for use in personal hygiene and designed for the
washing of hands. Handwashing sink includes an automatic handwashing
facility.
"Hazard" means a
biological, chemical, or physical property that may cause an unacceptable
consumer health risk.
"Health
practitioner" means a physician licensed to practice medicine, or if
allowed by law, a nurse practitioner, physician assistant, or similar medical
profession.
"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 of its contents after processing.
"Highly susceptible
population" means persons who are more likely than other people in the
general population to experience foodborne disease because they are:
1. Immunocompromised, preschool age children,
or older adults; and
2. 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.
"Hot water" means
water at a temperature of 100°F or higher unless otherwise stated.
"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 immediate correction
or cessation of operation to prevent injury based on the number of potential
injuries, and the nature, severity, and duration of the anticipated injury.
"Injected" means
tenderizing a meat with deep penetration or injecting the meat such as with
juices which may be referred to as "injecting," "pinning,"
or "stitch pumping." During injection infectious or toxigenic
microorganisms may be introduced from its surface to its interior.
"Juice," when
used in the context of food safety, means the aqueous liquid expressed or
extracted from one or more fruits or vegetables, puries purées of
the edible portions of one or more fruits or vegetables, purées of the
edible portions of one or more fruits or vegetables, or any concentrate of
such liquid or purée. Juice includes juice as a whole beverage, an
ingredient of a beverage and a purée as an ingredient of a beverage. Juice
does not include, for purposes of HACCP, liquids, purées, or concentrates that
are not used as beverages or ingredients of beverages.
"Kitchenware"
means food preparation and storage utensils.
"Law" means
applicable local, state, and federal statutes, regulations, and ordinances.
"Linens" means
fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths,
and work garments including cloth gloves.
"Major food
allergen" means milk, egg, fish (such as bass, flounder, cod, and
including crustacean shellfish such as crab, lobster, or shrimp), tree nuts
(such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or a food
ingredient that contains protein derived from one of these foods. Major
food allergen does not include any highly refined oil derived from a major food
allergen in this definition and any ingredient derived from such highly refined
oil; or any ingredient that is exempt under the petition or notification
process specified in the Food Allergen Labeling and Consumer Protection Act of
2004 (P. L. 108-282).
"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 12VAC5-421-330 A 3 and 4.
"mg/L" means
milligrams per liter, which is the metric equivalent of parts per million
(ppm).
"Mobile food unit"
means a food establishment that is mounted on wheels that is readily moveable
from place to place and shall include pushcarts, trailers, trucks, or vans.
There is no size limit to mobile food units but they must be mobile at all
times during operation and must be on wheels (excluding boats in the water) at
all times. The unit, all operations, and all equipment must be integral to and
be within or attached to the unit.
"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.
"Occasional" means
not more than one time per week, and not in excess of two days duration.
"Organization"
means any one of the following:
1. A volunteer fire department or rescue
squad or auxiliary unit thereof which has been recognized in accordance with §
15.2-955 of the Code of Virginia by an ordinance or resolution of the political
subdivision where the volunteer fire department or rescue squad is located as
being a part of the safety program of such political subdivision;
2. An organization operated exclusively for
religious, charitable, community or educational purposes;
3. An association of war veterans or
auxiliary units thereof organized in the United States;
4. A fraternal association or corporation
operating under the lodge system;
5. A local chamber of commerce; or
6. A nonprofit organization that raises funds
by conducting raffles which generate annual gross receipts of less than
$75,000, provided such gross receipts from the raffle, less expenses and
prizes, are used exclusively for charitable, educational, religious or
community purposes.
"Packaged" means
bottled, canned, cartoned, securely bagged, or securely wrapped, whether
packaged in a food establishment or a food processing plant.
"Permit" means a
license issued by the regulatory authority that authorizes a person to operate
a food establishment.
"Permit holder"
means the entity that is legally responsible for the operation of the food
establishment such as the owner, the owner's agent, or other person, and
possesses a valid permit to operate a food establishment.
"Person" means an
association, a corporation, individual, partnership, other legal entity,
government, or governmental subdivision or agency.
"Person in charge"
means the individual present at a food establishment who is responsible for the
operation at the time of inspection.
"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. Personal care items include items such as medicines;
first aid supplies; and other items such as cosmetics, and toiletries such as
toothpaste and mouthwash.
"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.
"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.
"Plumbing fixture"
means a receptacle or device that is permanently or temporarily connected to the
water distribution system of the premises and demands a supply of water from
the system or discharges used water, waste materials, or sewage directly or
indirectly to the drainage system of the premises.
"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.
"Poisonous or toxic
materials" means substances that are not intended for ingestion and are
included in four categories:
1. Cleaners and sanitizers, which include
cleaning and sanitizing agents and agents such as caustics, acids, drying
agents, polishes, and other chemicals;
2. Pesticides which include substances such
as insecticides and rodenticides;
3. Substances necessary for the operation and
maintenance of the establishment such as nonfood grade lubricants, paints, and
personal care items that may be deleterious to health; and
4. 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.
"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:
1. The rapid and progressive
growth of infectious or toxigenic microorganisms;
2. The growth and toxin
production of Clostridium botulinum; or
3. In raw shell eggs, the
growth of Salmonella enteritidis.
"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 acidified or
otherwise modified at a food processing plant in a way that results in mixtures
that do not support growth as specified above in this definition.
Potentially hazardous food
does not include:
1. 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;
2. A food with an aw
value of 0.85 or less;
3. A food with a pH level of
4.6 or below when measured at 24°C (75°F);
4. 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;
5. A food for which a
laboratory evidence demonstrates that the rapid and progressive growth of infectious
and toxigenic microorganisms or the growth of Salmonella enteritidis in eggs or
Clostridium botulinum cannot occur, such as a food that has an aw
and a pH that are above the levels specified in this definition and that may
contain a preservative, other barrier to the growth of microorganism, or a
combination of barriers that inhibit the growth of microorganisms; and
6. A food that does not
support the growth of microorganisms as specified above in 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.
"Potentially hazardous
food (time/temperature control for safety food)" means a food that
requires time/temperature control for safety (TCS) to limit pathogenic
microorganism growth or toxin formation:
1. Potentially hazardous
food (time/temperature control for safety food) includes 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 that results in mixtures that do not support pathogenic microorganism
growth or toxin formation; and except as specified in subdivision 2 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 |
|
> 0.92-0.95 |
non-PHF/non-TCS food |
non-PHF/non-TCS food |
PA*** |
|
>0.95 |
non-PHF/non-TCS food |
PA |
PA |
|
*PHF means Potentially Hazardous Food **TCS 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 means Time/Temperature Control for Safety Food ***PA means Product Assessment required |
2. Potentially hazardous
food (time/temperature control for safety food) does not include:
a. 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;
b. 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;
c. A food that because of
its pH or Aw value, or interaction of Aw and pH values,
is designated as a non-PHF/non-TCS food in Table A or B of this definition;
d. 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:
(1) Intrinsic factors including
added or natural characteristics of the food such as preservatives,
antimicrobials, humectants, acidulants, or nutrients,
(2) 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
(3) A combination of
intrinsic and extrinsic factors; or
e. A food that does not
support the growth or toxin formation of pathogenic microorganisms in accordance
with one of the subdivisions 2 a through 2 d 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.
"Poultry" means
any domesticated bird (chickens, turkeys, ducks, geese, or guineas), whether
live or dead, as defined in 9 CFR Part 381, Poultry Products Inspection
Regulations, and any migratory waterfowl, game bird, or squab such as pheasant,
partridge, quail, grouse, guineas, or pigeon or squab whether live or dead, as
defined in 9 CFR Part 362, Voluntary Poultry Inspection Regulations.
"Poultry" does not include ratites.
"Premises" means
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 which are under the control of the permit holder and may
impact food establishment personnel, facilities, or operations, if a food
establishment is only one component of a larger operation such as a health care
facility, hotel, motel, school, recreational camp, or prison.
"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.
"Public water system"
has the meaning stated in 40 CFR Part 141, National Primary Drinking Water
Regulations.
"Pushcart" means
any wheeled vehicle or device other than a motor vehicle or trailer that may be
moved with or without the assistance of a motor and that does not require
registration by the department of motor vehicles. A pushcart is limited to the
sale and/or service of hot dogs and frankfurter-like foods.
"Ratite" means a
flightless bird such as an emu, ostrich, or rhea.
"Ready-to-eat
food" means food that:
1. Is in a form that is edible without
additional preparation to achieve food safety, as specified under
12VAC5-421-700 A through C, 12VAC5-421-710, or 12VAC5-421-730;
2. Is a raw or partially cooked animal food
and the consumer is advised as specified under 12VAC5-421- 700 D 1 and 2; or
3. Is prepared in accordance with a variance
that is granted as specified under 12VAC5-421-700 D 1 and 2.
Ready-to-eat food may
receive additional preparation for palatability or aesthetic, epicurean,
gastronomic, or culinary purposes.
"Ready-to-eat
food" includes:
1. Raw animal food that is cooked as
specified under 12VAC5-421-700, or frozen as specified under 12VAC5-421-730;
2. Raw fruits and vegetables that are washed
as specified under 12VAC5-421-510;
3. Fruits and vegetables that are cooked for
hot holding as specified under 12VAC5-421-720;
4. All potentially hazardous food that is
cooked to the temperature and time required for the specific food under
12VAC5-421-700 and cooled as specified in 12VAC5-421-800;
5. Plant food for which further washing,
cooking, or other processing is not required for food safety, and from which
rinds, peels, husks, or shells, if naturally present, are removed;
6. Substances derived from plants such as
spices, seasonings, and sugar;
7. A bakery item such as bread, cakes, pies,
fillings, or icing for which further cooking is not required for food safety;
8. The following products that are produced
in accordance with USDA guidelines and that have received a lethality treatment
for pathogen: dry, fermented sausages, such as dry salami or pepperoni;
salt-cured meat and poultry products, such as prosciutto, country cured ham,
and Parma ham; and dried meat and poultry products, such as jerky or beef
sticks; and
9. Food manufactured according to 21 CFR Part
113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers.
"Reduced oxygen
packaging" means 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 atmosphere
(approximately 21% at sea level); and a process as specified in this
definition that involves a food for which Clostridium botulinum is
identified as a microbiological hazard in the final packaged form. the
hazards Clostridium botulinum or Listeria monocytogenes require
control in the final packaged form. Reduced oxygen packaging includes:
1. 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;
2. 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;
3. Controlled atmosphere
packaging, in which the atmosphere of a package of food is modified so that
until the package is 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 oxygen, nonrespiring food, and
impermeable packaging material;
4. Cook chill packaging, in
which cooked food is hot filled into impermeable bags that have the air
expelled and are then sealed or crimped closed. The bagged food is rapidly
chilled and refrigerated at temperatures that inhibit the growth of
psychrotrophic pathogens; or
5. Sous vide packaging, in
which raw or partially cooked food is placed in a hermetically sealed,
impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at
temperatures that inhibit the growth of psychrotrophic pathogens.
"Refuse" means
solid waste not carried by water through the sewage system.
"Regulatory authority"
means the Virginia Department of Agriculture and Consumer Services, the
Virginia Department of Health or their authorized representative having
jurisdiction over the food establishment.
"Reminder" means a
written statement concerning the health risk of consuming animal foods raw,
undercooked, or without being processed to eliminate pathogens.
"Reservice" means
the transfer of food that is unused and returned by a consumer after being
served or sold and in the possession of the consumer, to another person.
"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.
"Restricted egg"
means any check, dirty egg, incubator reject, inedible, leaker, or loss as
defined in 9 CFR Part 590.
"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.
"Risk" means the
likelihood that an adverse health effect will occur within a population as a
result of a hazard in a food.
"Safe material"
means an article manufactured from or composed of materials that shall not
reasonably be expected to result, directly or indirectly, in their becoming a
component or otherwise affecting the characteristics of any food; an additive
that is used as specified in § 409 or 706 of the Federal Food, Drug, and
Cosmetic Act; or other materials that are not additives and that are used in
conformity with applicable regulations of the Food and Drug Administration.
"Sanitization" means
the application of cumulative heat or chemicals on cleaned food contact
surfaces that, when evaluated for efficacy, yield a reduction of five logs,
which is equal to a 99.999% reduction, of representative disease microorganisms
of public health importance.
"Sealed" means
free of cracks or other openings that permit the entry or passage of moisture.
"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.
"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.
"Sewage" means
liquid waste containing animal or vegetable matter in suspension or solution
and may include liquids containing chemicals in solution.
"Shellfish control
authority" means a state, federal, foreign, or other government entity
legally responsible for administering a program that includes certification of
molluscan shellfish harvesters and dealers for interstate commerce such as the
Virginia Department of Health Division of Shellfish Sanitation.
"Shellstock" means
raw, in-shell molluscan shellfish.
"Shiga toxin-producing
Escherichia coli" (STEC) 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 O157:H-. Examples of serotypes of STEC include both O157 and
non-O157 E.coli. Also see Enterohemorrhagic Escherichia coli.
"Shucked
shellfish" means molluscan shellfish that have one or both shells removed.
"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.
"Single-use
articles" means utensils and bulk food containers designed and constructed
to be used once and discarded. 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 contained in 12VAC5-421-960, 12VAC5-421-1080, and
12VAC5-421-1100 for multiuse utensils.
"Slacking" means
the process of moderating the temperature of a food such as allowing a food to
gradually increase from a temperature of -10°F (-23°C) to 25°F (-4°C) in
preparation for deep-fat frying or to facilitate even heat penetration during
the cooking of previously block-frozen food such as spinach.
"Smooth" means 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 stainless
steel; a nonfood-contact surface of equipment having a surface equal to that of
commercial grade hot-rolled steel free of visible scale; and a floor, wall, or
ceiling having an even or level surface with no roughness or projections that
render it difficult to clean.
"Substantial
compliance" shall mean that details of equipment or structure design or
construction and/or food preparation, handling, storage, transportation and/or
cleaning procedures will not substantially affect health consideration or
performance of the facility or its employees.
"Table-mounted
equipment" means equipment that is not easily movable and is designed to
be mounted off the floor on a table, counter, or shelf.
"Tableware" means
eating, drinking, and serving utensils for table use such as flatware including
forks, knives, and spoons; hollowware including bowls, cups, serving dishes,
tumblers; and plates.
"Temperature measuring
device" means a thermometer, thermocouple, thermistor, or other device
that indicates the temperature of food, air, or water.
"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.
"USDA" means the
U.S. Department of Agriculture.
"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.
"Variance" means a
written document issued by the regulatory authority that authorizes a
modification or waiver of one or more requirements of this chapter if, in the
opinion of the regulatory authority, a health hazard or nuisance will not
result from the modification or waiver.
"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.
"Vending machine
location" means the room, enclosure, space, or area where one or more
vending machines are installed and operated and includes the storage and
servicing areas on the premises that are used in conjunction with the vending
machines.
"Warewashing"
means the cleaning and sanitizing of food-contact surfaces of equipment and
utensils.
"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.
Part II
Management and Personnel
Article 1
Supervision
12VAC5-421-50. Assignment of
responsibility.
The 1. Except as specified
in subdivision 2 of this section, 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.
2. In a food establishment
with two or more separately permitted departments that are the legal
responsibility of the same permit holder and that are located on the same
premises, the permit holder may, during specific time periods when food is not
being prepared, packaged, or served, designate a single person in charge who is
present on the premises during all hours of operation, and who is responsible
for each separately permitted food establishment on the premises.
12VAC5-421-60. Demonstration
of knowledge.
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 regulatory authority
knowledge of foodborne disease prevention, and the requirements of these
regulations. The person in charge shall demonstrate this knowledge by:
being a certified food protection manager who has shown proficiency of required
information through passing a test that is part of an accredited program, or by
responding correctly to the environmental health specialist's questions as they
relate to the specific food operation. The areas of knowledge may include:
1. Complying with the Food
Regulations by having no violations of critical items during the current
inspection;
2. Being a certified food
protection manager who has shown proficiency of required information through
passing a test that is part of an accredited program; or
3. Responding correctly to
the environmental specialist's questions as they relate to the specific food
operation. The areas of operation may include:
1. a. Describing the
relationship between the prevention of foodborne disease and the personal
hygiene of a food employee;
2. b. Explaining the
responsibility of the person in charge for preventing the transmission of
foodborne disease by a food employee who has a disease or medical condition
that may cause foodborne disease;
3. c. Describing the
symptoms associated with the diseases that are transmissible through food;
4. d. Explaining the
significance of the relationship between maintaining the time and temperature
of potentially hazardous food (time/temperature control for safety food)
and the prevention of foodborne illness;
5. e. Explaining the
hazards involved in the consumption of raw or undercooked meat, poultry, eggs,
and fish;
6. f. Stating the
required food temperatures and times for safe cooking of potentially hazardous
food (time/temperature control for safety food) including meat, poultry,
eggs, and fish;
7. g. Stating the
required temperatures and times for the safe refrigerated storage, hot holding,
cooling, and reheating of potentially hazardous food (time/temperature
control for safety food);
8. h. Describing the
relationship between the prevention of foodborne illness and the management and
control of the following:
a. (1) Cross contamination,
b. (2) Hand contact
with ready-to-eat foods,
c. (3) Handwashing, and
d. (4) Maintaining the
food establishment in a clean condition and in good repair;
i. Describing the foods
identified as major food allergens and the symptoms that a major food allergen
could cause in a sensitive individual who has an allergic reaction;
9. j. Explaining the
relationship between food safety and providing equipment that is:
a. (1) Sufficient in
number and capacity, and
b. (2) Properly
designed, constructed, located, installed, operated, maintained, and cleaned;
10. k. Explaining
correct procedures for cleaning and sanitizing utensils and food-contact
surfaces of equipment;
11. l. 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. m. Identifying
poisonous or toxic materials in the food establishment and the procedures
necessary to ensure that they are safely stored, dispensed, used, and disposed
of according to law;
13. n. Identifying
control points in the operation from purchasing through sale or service that
may contribute to the transmission of foodborne illness and explaining steps
taken to ensure that the points are controlled in accordance with the
requirements of this chapter;
14. o. Explaining the
details of how the person in charge and food employees comply with a HACCP plan
if such a plan is a voluntary agreement between the regulatory authority and
the establishment; and
15. p. Explaining the
responsibilities, rights, and authorities assigned by this chapter to the:
a. (1) Food employee,
b. (2) Person in
charge, and
c. (3) Regulatory
authority.; and
q. Explaining how the person
in charge, food employees, and conditional employees comply with reporting
responsibilities and the exclusion or restriction of food employees.
12VAC5-421-70. Person
Duties of person in charge.
The person in charge shall
ensure that:
1. Food establishment operations are not
conducted in a private home or in a room used as living or sleeping quarters as
specified under 12VAC5-421-2990;
2. Persons unnecessary to the food
establishment operation are not allowed in the food preparation, food storage,
or warewashing areas, except that 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;
3. Employees and other persons such as
delivery and maintenance persons and pesticide applicators entering the food
preparation, food storage, and warewashing areas comply with these regulations;
4. Employees are effectively cleaning their
hands, by routinely monitoring the employees' handwashing;
5. 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 employees' observations and
periodically evaluating foods upon their receipt;
6. Employees are properly cooking potentially
hazardous food, being particularly careful in cooking those foods known to
cause severe foodborne illness and death, such as eggs and comminuted meats,
through daily oversight of the employees' routine monitoring of the cooking
temperatures;
7. Employees are using proper methods to
rapidly cool potentially hazardous foods that are not held hot or are not for
consumption within four hours, through daily oversight of the employees'
routine monitoring of food temperatures during cooling;
8. (Reserved); Consumers who order
raw or partially cooked ready-to-eat foods of animal origin are informed as specified
under 12VAC5-421-930 that the food is not cooked sufficiently to ensure its
safety;
9. 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;
10. Consumers are notified that clean
tableware is to be used when they return to self-service areas such as salad
bars and buffets;
11. Employees Except when approval
is obtained from the regulatory authority as specified in 12VAC5-421-450 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
12. Employees are properly trained in food
safety as it relates to their assigned duties.; and
13. Food employees and
conditional employees are informed of their responsibility to report in accordance
with law, to the person in charge, information about their health and
activities as they relate to diseases that are transmissible through food, as
specified under 12VAC5-421-80.
Article 2
Employee Health
12VAC5-421-80.
Responsibility of the permit holder, person in charge to
require reporting by food employees and applicants, and conditional
employees.
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 shall report the information in a
manner that allows the person in charge to prevent the likelihood of foodborne
disease transmission, including the date of onset of jaundice or of an illness
specified in subdivision 2 of this section, if the food employee or applicant:
1. Is diagnosed with an
illness due to:
a. Salmonella typhi,
b. Shigella spp.,
c. Escherichia coli O157:H7,
or
d. Hepatitis A virus;
2. Has a symptom caused by
illness, infection, or other source that is:
a. Associated with an acute
gastrointestinal illness such as (i) diarrhea; (ii) fever; (iii) vomiting; (iv)
jaundice; or (v) sore throat with fever; or
b. A lesion containing pus
such as a boil or infected wound that is open or draining and is:
(1) 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;
(2) On exposed portions of
the arms, unless the lesion is protected by an impermeable cover; or
(3) On other parts of the
body, unless the lesion is covered by a dry, durable, tight-fitting bandage;
3. Had a past illness from
an infectious agent specified in subsection A of this section; or
4. Meets one or more of the
following high-risk conditions:
a. Is suspected of causing,
or being exposed to, a confirmed disease outbreak caused by S. typhi, Shigella
spp., E. coli O157:H7, 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:
(1) Prepared food implicated
in the outbreak,
(2) Consumed food implicated
in the outbreak, or
(3) Consumed food at the
event prepared by a person who is infected or ill with the infectious agent
that caused the outbreak or who is suspected of being a shedder of the
infectious agent, or
b. Lives in the same
household as a person who is diagnosed with a disease caused by S. typhi,
Shigella spp., E. coli O157:H7, or hepatitis A virus, or
c. Lives in the same
household as a person who attends or works in a setting where there is a
confirmed disease outbreak caused by S. typhi, Shigella spp., E. coli O157:H7,
or hepatitis A virus.
A. The permit holder
shall require food employees and conditional 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 conditional
employee shall report the information in a manner that allows the person
in charge to reduce the risk of foodborne disease transmission, including
providing necessary additional information, such as the date of onset of
symptoms and an illness, or of a diagnosis without symptoms, if the food
employee or conditional employee:
1. Has any of the following
symptoms:
a. Vomiting;
b. Diarrhea;
c. Jaundice;
d. Sore throat with fever;
or
e. A lesion containing pus
such as a boil or infected wound that is open or draining and is:
(1) 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;
(2) On exposed portions of
the arms, unless the lesion is protected by an impermeable cover; or
(3) On other parts of the
body, unless the lesion is covered by a dry, durable, tight-fitting bandage;
2. Has an illness diagnosed
by a health practitioner due to:
a. Norovirus;
b. Hepatitis A virus;
c. Shigella spp.;
d. Enterohemorrhagic or
Shiga-toxin producing Escherichia coli; or
e. Salmonella Typhi;
3. Had a previous illness,
diagnosed by a health practitioner, within the past three months due to
Salmonella Typhi, without having received antibiotic therapy, as determined by
a health practitioner;
4. Has been exposed to, or
is the suspected source of, a confirmed disease outbreak, because the food
employee or conditional employee consumed or prepared food implicated in the
outbreak, or consumed food at an event prepared by a person who is infected or
ill with:
a. Norovirus within the past
48 hours of the last exposure;
b. Enterohemorrhagic or
Shiga-toxin producing Escherichia coli, or Shigella spp. within the past three
days of the last exposure;
c. Salmonella Typhi within
the past 14 days of the last exposure; or
d. Hepatitis A virus within
the past 30 days of the last exposure; or
5. Has been exposed by
attending or working in a setting where there is a confirmed disease outbreak,
or living in the same household as, and has knowledge about an individual who
works or attends a setting where there is a confirmed disease outbreak, or
living in the same household as, and has knowledge about, and individual
diagnosed with an illness caused by:
a. Norovirus within the past
48 hours of exposure;
b. Enterohemorragic or
Shiga-toxin producing Escherichia coli or Shigella spp. within the past three
days of the last exposure;
c. Salmonella Typhi within
the past 14 days of the last exposure; or
d. Hepatitis A virus within
the past 30 days of the last exposure.
B. The person in
charge shall notify the regulatory authority when a food employee is:
1. Jaundiced; or
2. Diagnosed with an illness
due to a pathogen as specified under subdivision A 2 a through e of this
section.
C. The person in charge
shall ensure that a conditional employee:
1. Who exhibits or reports a
symptom, or who reports a diagnosed illness as specified under subdivision A 2
a through e of this section, is prohibited from becoming a food employee until
the conditional employee meets the criteria for the specific symptoms or
diagnosed illness as specified under 12VAC5-421-100; and
2. Who will work as a food
employee in a food establishment that serves a highly susceptible population
and reports a history of exposure as specified under subdivision A 4 through 5
of this section, is prohibited from becoming a food employee until the
conditional employee meets the criteria specified under subdivision 9 of
12VAC5-421-100.
D. The person in charge
shall ensure that a food employee who exhibits or reports a symptom, or who
reports a diagnosed illness or history of exposure as specified under
subdivision A 1 through 5 of this section is:
1. Excluded as specified
under subdivisions 1 through 3 of 12VAC5-421-90, and subdivisions D 1, E 1, F
1, or G 1 of 12VAC5-421-90 and in compliance with the provisions specified
under subdivision 1 through 7 of 12VAC5-421-100; or
2. Restricted as specified
under subdivisions 4 b, 5 b, 6 b, or 7 b of 12VAC5-421-90, or subdivisions 8 or
9 of 12VAC5-421-90 and in compliance with the provisions specified under
subdivisions 4 through 9 of 12VAC5-421-100.
E. A food employee or
conditional employee shall report to the person in charge the information as
specified under subsection A of this section.
F. A food employee shall:
1. Comply with an exclusion
as specified under subdivisions 1 through 3 of 12VAC5-421-90 and subdivisions 4
a, 5 a, 6 a, or 7 a of 12VAC5-421-90 and with the provisions specified
under subdivisions 1 through 7 of 12VAC5-421-100; or
2. Comply with a restriction
as specified under subdivisions 4 b, 5 b, 6 b, or 7 b of 12VAC5-421-90, or
subdivisions 8 or 9 of 12VAC5-421-90 and comply with the provisions specified
under subdivisions 4 through 9 of 12VAC5-421-100.
12VAC5-421-90. Exclusions
and restrictions.
A. The person in charge
shall exclude a food employee from a food establishment if the food employee is
diagnosed with an infectious agent specified in subdivision 1 of 12VAC5-421-80;
B. Except as specified under
subsection C or D of this section, the person in charge shall 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:
1. Suffering from a symptom
specified in 12VAC5-421-80 subdivision 2 a (1), (2), (3) or (5) or subdivision
2 b; or
2. Not experiencing a
symptom of acute gastroenteritis specified in subdivision 2 a of 12VAC5-421-80,
but has a stool that yields a specimen culture that is positive for Salmonella
typhi, Shigella spp., or E. coli O157:H7.
C. If the population served
is a highly susceptible population, the person in charge shall exclude a food
employee who:
1. Is experiencing a symptom
of acute gastrointestinal illness specified in 12VAC5-421-80 subdivision 2 a
(1), (2), (3) or (5) and meets a high-risk condition specified in subdivision 4
of 12VAC5-421-80;
2. Is not experiencing a
symptom of acute gastroenteritis specified in subdivision 2 a of 12VAC5-421-80,
but has a stool that yields a specimen culture that is positive for S. typhi,
Shigella spp., or E. coli O157:H7;
3. Had a past illness from
S. typhi within the last three months; or
4. Had a past illness from
Shigella spp. or E. coli O157:H7 within the last month.
D. For a food employee who
is jaundiced:
1. If the onset of jaundice
occurred within the last seven calendar days, the person in charge shall
exclude the food employee from the food establishment; or
2. If the onset of jaundice
occurred more than seven calendar days before, the person in charge shall:
a. Exclude the food employee
from a food establishment that serves a highly susceptible population; or
b. Restrict the food
employee from activities specified in subdivision 2 of 12VAC5-421-90, if the
food establishment does not serve a highly susceptible population.
The person in charge shall
exclude or restrict a food employee from a food establishment in accordance
with the following:
1. Except when the symptom
is from a noninfectious condition, exclude a food employee if the food employee
is:
a. Symptomatic with vomiting
or diarrhea; or
b. Symptomatic with vomiting
or diarrhea and diagnosed with an infection from Norovirus, Shigella spp., or
Enterohemorrhagic or Shiga-toxin producing Escherichia coli.
2. Exclude a food employee
who is:
a. Jaundiced and the onset
of jaundice occurred within the last seven calendar days, unless the food
employee provides to the person in charge written medical documentation from a
health practitioner specifying that the jaundice is not caused by Hepatitis A
virus or other fecal-orally transmitted infection;
b. Diagnosed with an
infection from Hepatitis A virus within 14 calendar days from the onset of any
illness symptoms, or within seven calendar days of the onset of jaundice; or
c. Diagnosed with an
infection from Hepatitis A virus without developing symptoms.
3. Exclude a food employee
who is diagnosed with an infection from Salmonella Typhi, or reports a previous
infection with Salmonella Typhi within the past three months as specified in
12VAC5-421-80 A 3.
4. If a food employee is
diagnosed with an infection from Norovirus and is asymptomatic:
a. Exclude the food employee
who works in a food establishment serving a highly susceptible population; or
b. Restrict the food
employee who works in a food establishment not serving a highly susceptible
population.
5. If a food employee is
diagnosed with an infection from Shigella spp. and is asymptomatic:
a. Exclude the food employee
who works in a food establishment serving a highly susceptible population; or
b. Restrict the food
employee who works in a food establishment not serving a highly susceptible
population.
6. If a food employee is
diagnosed with an infection from Enterohemorrhagic or Shiga-toxin producing
E.coli, and is asymptomatic:
a. Exclude the food employee
who works in a food establishment serving a highly susceptible population; or
b. Restrict the food
employee who works in a food establishment not serving a highly susceptible
population.
7. If a food employee is ill
with symptoms of acute onset of sore throat with fever:
a. Exclude the food employee
who works in a food establishment serving a highly susceptible population; or
b. Restrict the food
employee who works in a food establishment not serving a highly susceptible
population.
8. If a food employee is
infected with a skin lesion containing pus such as a boil or infected wound
that is open or draining and not properly covered as specified under
12VAC5-421-80 A 1 e, restrict the food employee.
9. If a food employee is
exposed to a foodborne pathogen as specified under 12VAC5-421-80 A 4 or 5,
restrict the food employee who works in a food establishment serving a highly
susceptible population.
12VAC5-421-100. Removal,
adjustment, or retention of exclusions and restrictions.
A. The person in charge may
remove an exclusion specified under 12VAC5-421-90 A if:
1. The person in charge
obtains approval from the regulatory authority; and
2. The person excluded as
specified under 12VAC5-421-90 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 in an unrestricted capacity in a food establishment,
including an establishment that serves a highly susceptible population, because
the person is free of the infectious agent of concern as specified in
12VAC5-421-4070.
B. The person in charge may
remove a restriction specified under:
1. 12VAC5-421-90 B 1 if the
restricted person:
a. Is free of the symptoms
specified under 12VAC5-421-80 subdivision 2 a (1), (2), (3) or (5) and no
foodborne illness occurs that may have been caused by the restricted person;
b. Is suspected of causing
foodborne illness but (i) is free of the symptoms specified under 12VAC5-421-80
subdivision 2 a (1), (2), (3) or (5) and (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 is suspected of causing the
person's symptoms or causing foodborne illness, as specified in
12VAC5-421-4070; or
c. 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 symptoms
experienced result from a chronic noninfectious condition such as Crohn's
disease, irritable bowel syndrome, or ulcerative colitis; or
2. 12VAC5-421-90 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 12VAC5-421-4070
that indicates the stools are free of Salmonella typhi, Shigella spp., or E.
coli O157:H7, whichever is the infectious agent of concern.
C. The person in charge may
remove an exclusion specified under 12VAC5-421-90 C if the excluded person
provides written medical documentation from a physician licensed to 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
12VAC5-421-4070.
2. If the person is excluded
under 12VAC5-421-90 C 1, that the symptoms experienced result from a chronic
noninfectious condition such as Crohn's disease, irritable bowel syndrome, or
ulcerative colitis.
D. The person in charge may
remove an exclusion specified under 12VAC5-421-90 D 1 and 12VAC5-421-90 D 2 a
and a restriction specified in 12VAC5-421-90 D 2 b if:
1. No foodborne 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 stating that specifies that the person is free of hepatitis A
virus as specified in subdivision 4 a of 12VAC5-421-4070; or
2. The excluded or
restricted person is suspected of causing foodborne illness and complies with
subdivision 4 a and 4 b of 12VAC5-421-4070.
The person in charge shall
adhere to the following conditions when removing, adjusting, or retaining the
exclusion or restriction of a food employee:
1. Except when a food
employee is diagnosed with an infection from Hepatitis A virus or Salmonella
Typhi:
a. Reinstate a food employee
who was excluded as specified under subdivision 1 a of 12VAC5-421-90 if the
food employee:
(1) Is asymptomatic for at
least 24 hours; or
(2) Provides to the person
in charge written medical documentation from a health practitioner that states
the symptom is from a noninfectious condition.
b. If a food employee was
diagnosed with an infection from Norovirus and excluded as specified under
subdivision 1 b of 12VAC5-421-90:
(1) Restrict the food
employee, who is asymptomatic for at least 24 hours and works in a food
establishment not serving a highly susceptible population until the conditions
for reinstatement as specified in subdivision 4 a or b of this section are met;
or
(2) Retain the exclusion for
the food employee, who is asymptomatic for at least 24 hours and works in a
food establishment that serves a highly susceptible population, until the
conditions for reinstatement as specified in subdivision 4 a or b of this
section are met.
c. If a food employee was diagnosed
with an infection from Shigella spp. and excluded as specified under
subdivision 1 b of 12VAC5-421-90:
(1) Restrict the food
employee, who is asymptomatic, for at least 24 hours and works in a food
establishment not serving a highly susceptible population, until the conditions
for reinstatement as specified in subdivision 5 a or b of this section are met;
or
(2) Retain the exclusion for
the food employee, who is asymptomatic for at least 24 hours and works in a
food establishment that serves a highly susceptible population, until the
conditions for reinstatement as specified in subdivision 5 a or b, or 5 a and 1
c (1) of this section are met.
d. If a food employee was
diagnosed with an infection from Enterohemorrhagic or Shiga-toxin producing
Escherichia coli and excluded as specified under subdivision 1 b of
12VAC5-421-90:
(1) Restrict the food
employee, who is asymptomatic for at least 24 hours and works in a food
establishment not serving a highly susceptible population, until the conditions
for reinstatement as specified in subdivision 6 a or b of this section are met;
or
(2) Retain the exclusion for
the food employee, who is asymptomatic for at least 24 hours and works in a
food establishment that serves a highly susceptible population, until the conditions
for reinstatement as specified in subdivision 6 a or b are met.
2. Reinstate a food employee
who was excluded as specified under subdivision 2 of 12VAC5-421-90 if the
person in charge obtains approval from the regulatory authority and one of the
following conditions is met:
a. The food employee has
been jaundiced for more than seven calendar days;
b. The anicteric food
employee has been symptomatic with symptoms other than jaundice for more than
14 calendar days; or
c. The food employee
provides to the person in charge written medical documentation from a health
practitioner stating that the food employee is free of a Hepatitis A virus
infection.
3. Reinstate a food employee
who was excluded as specified under subdivision 3 of 12VAC5-421-90 if:
a. The person in charge
obtains approval from the regulatory authority; and
b. The food employee
provides to the person in charge written medical documentation from a health
practitioner that states the employee is free from S. Typhi infection.
4. Reinstate a food employee
who was excluded as specified under subdivision 1 b or 4 a of 12VAC5-421-90,
who was restricted under subdivision 4 b of 12VAC5-421-90 if the person in
charge obtains approval from the regulatory authority and one of the following
conditions is met:
a. The excluded or
restricted food employee provides to the person in charge written medical
documentation from a health practitioner stating that the food employee is free
of a Norovirus infection;
b. The food employee was
excluded or restricted after symptoms of vomiting or diarrhea resolved, and
more than 48 hours have passed since the food employee became symptomatic; or
c. The food employee was
excluded or restricted and did not develop symptoms and more than 48 hours have
passed since the food employee was diagnosed.
5. Reinstate a food employee
who was excluded as specified under subdivision 1 b or 5 a of 12VAC5-421-90 or
who was restricted under subdivision 5 b of 12VAC5-421-90 if the person in
charge obtains approval from the regulatory authority and one of the following
conditions is met:
a. The excluded or
restricted food employee provides to the person in charge written medical
documentation from a health practitioner stating that the food employee is free
of a Shigella spp. infection based on test results showing two consecutive
negative stool specimen cultures that are taken:
(1) Not earlier than 48
hours after discontinuance of antibiotics, and
(2) At least 24 hours apart;
b. The food employee was
excluded or restricted after symptoms of vomiting or diarrhea resolved, and
more than seven calendar days have passed since the food employee became
asymptomatic; or
c. The food employee was
excluded or restricted and did not develop symptoms and more than seven
calendar days have passed since the food employee was diagnosed.
6. Reinstate a food employee
who was excluded or restricted as specified under subdivision 1 b or 6 a of
12VAC5-421-90 or who was restricted under subdivision 6 b of 12VAC5-421-90 if
the person in charge obtains approval from the regulatory authority and one of
the following conditions is met:
a. The excluded or
restricted food employee provides to the person in charge written medical
documentation from a health practitioner stating that the food employee is free
of an infection from Enterohemorrhagic or Shiga-toxin producing Escherichia
coli based on test results that show two consecutive negative stool specimen
cultures that are taken:
(1) Not earlier than 48
hours after the discontinuance of antibiotics; and
(2) At least 24 hours apart;
b. The food employee was
excluded or restricted after symptoms of vomiting or diarrhea resolved and more
than seven calendar days have passed since the employee became asymptomatic; or
c. The food employee was
excluded or restricted and did not develop symptoms and more than seven days
have passed since the employee was diagnosed.
7. Reinstate a food employee
who was excluded or restricted as specified under subdivision 7 a or b of
12VAC5-421-90 if the food employee provides to the person in charge written
medical documentation from a health practitioner stating that the food employee
meets one of the following conditions:
a. Has received antibiotic
therapy for Streptococcus pyogenes infection for more than 24 hours;
b. Has at least one negative
throat specimen culture for Streptococcus pyogenes infection; or
c. Is otherwise determined
by a health practitioner to be free of Streptococcus pyogenes infection.
8. Reinstate a food employee
who was restricted as specified under subdivision 8 of 12VAC5-421-90 if the
skin, infected wound, cut, or pustular boil is properly covered with one of the
following:
a. An impermeable cover such
as a finger cot or stall and a single-use glove over the impermeable cover if
the infected wound or pustular boil is on the hand, finger, or wrist;
b. An impermeable cover on
the arm if the infected wound or pustular boil is on the arm; or
c. A dry, durable,
tight-fitting bandage if the infected wound or pustular boil is on another part
of the body.
9. Reinstate a food employee
who was restricted as specified under subdivision 9 of 12VAC5-421-90 and was
exposed to one of the following pathogens as specified under 12VAC5-421-80 A 4
or 5:
a. Norovirus and one of the
following conditions is met:
(1) More than 48 hours have
passed since the last day the food employee was potentially exposed; or
(2) More than 48 hours have
passed since the food employee's household contact became asymptomatic.
b. Shigella spp. or
Enterohemorrhagic or Shiga-toxin producing Escherichia coli and one of the
following conditions is met:
(1) More than three calendar
days have passed since the last day the food employee was potentially exposed;
or
(2) More than three calendar
days have passed since the food employee's household contact became asymptomatic.
c. S. Typhi and one of the
following conditions is met:
(1) More than 14 calendar
days have passed since the last day the food employee was potentially exposed;
or
(2) More than 14 calendar
days have passed since the food employee's household contact became
asymptomatic.
d. Hepatitis A virus and one
of the following conditions is met:
(1) The food employee is
immune to Hepatitis A virus infection because of prior illness from Hepatitis
A;
(2) The food employee is
immune to Hepatitis A virus infection because of vaccination against Hepatitis
A;
(3) The food employee is
immune to Hepatitis A virus infection because of IgG administration;
(4) More than 30 calendar
days have passed since the last the food employee was potentially exposed;
(5) More than 30 calendar
days have passed since the food employee's household contact became jaundiced;
or
(6) The food employee does
not use an alternative procedure that allows bare hand contact with
ready-to-eat food until at least 30 days after the potential exposure, as
specified in subdivisions 9 d (4) and (5) of this section, and the food
employee receives additional training about:
(a) Hepatitis A symptoms and
preventing the transmission of infection;
(b) Proper handwashing
procedures; and
(c) Protecting ready-to-eat
food from contamination introduced by bare hand contact.
12VAC5-421-110. Responsibility
of a food employee or an applicant to report to the person in charge. (Repealed.)
A food employee or a person
who applies for a job as a food employee shall:
1. In a manner specified in
12VAC5-421-80, report to the person in charge the information specified in
12VAC5-421-80; and
2. Comply with exclusions
and restrictions that are specified in 12VAC5-421-90.
12VAC5-421-120. Reporting
by the person in charge. (Repealed.)
The person in charge shall
notify the regulatory authority that a food employee is diagnosed with, an
illness due to Salmonella typhi, Shigella spp., Shiga toxin-producing
Escherichia coli , or hepatitis A virus.
12VAC5-421-140. Cleaning
procedure of hands and arms.
A. Except as specified in
subsection B D 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 12VAC5-421-2190 A.
B. Food employees shall use
the following cleaning procedure:
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 thorough rinsing under
clean, running warm water; and
2. Immediately follow the
cleaning procedure, thorough drying of cleaned hands and arms (or surrogate
prosthetic devices) using a method as specified under 12VAC5-421-3030.
B. Food employees
shall use the following cleaning procedure in the order stated to clean their
hands and exposed portions of their arms, including surrogate prosthetic
devices for hands and arms:
1. Rinse under clean,
running warm water;
2. Apply an amount of
cleaning compound recommended by the cleaning compound manufacturer;
3. Rub together vigorously
for at least 10 to 15 seconds while:
a. Paying particular
attention to removing soil from underneath the fingernails during the cleaning
procedure; and
b. Creating friction on the
surfaces of the hands and arms or surrogate prosthetic devices for hands and
arms, finger tips, and areas between the fingers;
4. Thoroughly rinsing under
clean, running warm water; and
5. Immediately follow the
cleaning procedure with thorough drying using a method as specified under
12VAC5-421-3030.
C. Food employees shall pay
particular attention to the areas underneath the fingernails during the cleaning
procedure.
C. To avoid recontaminating
their hands or surrogate prosthetic devices, food employees may use disposable
paper towels or similar clean barriers when touching surfaces such as manually
operated faucet handles on a handwashing sink or the handle of a restroom door.
D. If approved 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.
12VAC5-421-150. [Reserved]
(Repealed.)
12VAC5-421-180. Hand sanitizers
Antiseptics.
A. A hand sanitizer and a
chemical hand sanitizing solution used as a hand dip shall antiseptic
used as a topical application, a hand antiseptic solution used as a hand dip,
or a hand antiseptic soap shall:
1. Comply with one of the following:
a. Be an FDA approved drug based on safety
and effectiveness 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
b. Have active antimicrobial ingredients that
are approved by FDA as an OTC (over-the-counter) health-care antiseptic drug
product that is safe and effective for application to human skin listed
in the FDA monograph for OTC (over the counter) Health-Care Antiseptic Drug
Products as an antiseptic handwash; and
2. Consist of components that are Comply
with one of the following:
a. Listed for such use in
contact with food in 21 CFR Part 178 - Indirect Food Additives: Adjuvants,
Production Aids, and Sanitizer;
b. Exempt from regulation as
food additives under 21 CFR 170.39 - Threshold of regulation for substances
used in food-contact articles;
c. Generally recognized as
safe (GRAS) for the intended use in contact with food within the meaning of the
Federal Food, Drug and Cosmetic Act (FFDCA); or
d. Permitted for such use by
an effective Food Contact Substance Notification as defined by paragraph 409(h)
of the FFDCA and listed in the FDA's Inventory of Effective Premarket
Notifications for Food Contact Substances; and
a. Have components that are
exempted from the requirement of being listed in the 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
(ii) 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 12VAC5-421-140.
B. If a hand sanitizer or
a chemical hand sanitizing solution used as a hand dip does not meet the
criteria specified under subdivision A 2 of this section, use shall be:
If a hand antiseptic or a hand antiseptic solution used as a hand dip does not
meet the criteria specified in subdivision 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 hand antiseptic solution used as a hand dip
shall be maintained clean and at a strength equivalent to 100 ppm (mg/l)
chlorine or above.
12VAC5-421-360. Shell eggs.
Shell eggs shall be received
clean and sound and shall not exceed the restricted egg tolerances for U.S.
Consumer Grade B as specified in 7 CFR Part 56 - Regulations Governing the
Grading of Shell Eggs and U.S. Standards, Grades, and Weight Classes for Shell
Eggs, and 7 CFR Part 59 - Regulations Governing the Inspection of Eggs and Egg
Products as specified in United States Standards, Grades, and Weight
Classes for Shell Eggs, AMS 56.200 et seq., administered by the Agricultural
Marketing Service of USDA.
12VAC5-421-370. Eggs and
milk products, pasteurized.
A. Liquid, frozen, and
dry eggs and egg 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. shall:
1. Be obtained pasteurized;
and
2. Comply with Grade A
standards as specified in law.
C. Frozen milk products,
such as ice cream, shall be obtained pasteurized in accordance with 21 CFR Part
135, Frozen Desserts.
D. Cheese shall be obtained
pasteurized unless alternative procedures to pasteurization are provided for in
the Code of Federal Regulations, such as 21 CFR Part 133, Cheeses and Related
Cheese Products, for curing certain cheese varieties.
12VAC5-421-400. Shucked
shellfish, packaging and identification.
A. Raw shucked shellfish
shall be obtained in nonreturnable packages that bear a legible label that
identifies the:
1. Name, address, and certification number of
the shucker-packer shucker, packer, or repacker of the molluscan
shellfish; and
2. The "sell by" or "best
if used by" date for packages with a capacity of less than one-half
gallon (1.87 L) or the date shucked for packages with a capacity of one-half
gallon (1.87 L) or more.
B. A package of raw shucked
shellfish that does not bear a label or which bears a label which does not
contain all the information as specified under subsection A of this section
shall be subject to a hold order, as allowed by law, or seizure and destruction
in accordance with 21 CFR 1240.60(d), Subpart D, Specific Administrative
Decisions Regarding Interstate Shipments.
12VAC5-421-410. Shellstock
identification.
A. 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 Manual of Operations Guide for the Control of Molluscan
Shellfish, Part II Sanitation of the Harvesting, Processing and
Distribution of Shellfish, 1995 Revision, and that list:
1. Except as specified under subsection C of
this section, on the harvester's tag or label, the following information in the
following order:
a. The harvester's identification number that
is assigned by the shellfish control authority,
b. The date of harvesting,
c. 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 control authority and
including the abbreviation of the name of the state or country in which the
shellfish are harvested,
d. The type and quantity of shellfish, and
e. 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 under subsection D of
this section, on each dealer's tag or label, the following information in the
following order:
a. The dealer's name and address, and the
certification number assigned by the shellfish control authority,
b. The original shipper's certification
number including the abbreviation of the name of the state or country in which
the shellfish are harvested,
c. The same information as specified for a
harvester's tag under subdivisions 1 b through d of this subsection, and
d. 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."
B. 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 subsection A of this section
shall be subject to a hold order, as allowed by law, or seizure and destruction
in accordance with 21 CFR 1240.60(d), Subpart D, Specific Administrative
Decisions Regarding Interstate Shipments.
C. 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.
D. If the harvester's tag or
label is designed to accommodate each dealer's identification as specified
under subdivisions A 2 a and b of this section, individual dealer tags or
labels need not be provided.
12VAC5-421-430. Molluscan
shellfish; original container.
A. Except as specified in
subsections B and C of this section, molluscan shellfish shall not be removed
from the container in which they were 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 12VAC5-421-410 and recorded as specified under
12VAC5-421-440; 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 information for the shellfish
on display as specified under 12VAC5-421-400 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.
D. Shucked shellfish may be
removed from the container in which they were received and repacked in consumer
self-service containers where allowed by law if:
1. The labeling information
for the shellfish is on each consumer self-service container as specified under
12VAC5-421-400 and 12VAC5-421-900 A and B 1 through 5;
2. The labeling information
as specified under 12VAC5-421-400 is retained and correlated with the date
when, or dates during which, the shellfish are sold or served;
3. The labeling information
and dates specified under subdivision D 2 of this section are maintained for 90
days; and
4. The shellfish are
protected from contamination.
12VAC5-421-440. Shellstock;
maintaining identification.
A. Except as specified under
subdivision B C 2 of this section, shellstock tags or labels
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
recordkeeping 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. If shellstock are removed
from their tagged or labeled container:
a. Preserving source
identification by using a recordkeeping system as specified under subdivision 1
of this subsection;
b. Ensuring that shellstock
from one tagged or labeled container are not commingled with shellstock from
another container being ordered by the consumer.
B. The date when the last
shellstock from the container is sold or served shall be recorded on the tag or
label.
C. The identity of the
source of shellfish that are sold or served shall be maintained by retaining
shellstock tags or labels for 90 calendar days from the date that is recorded
on the tag or label as specified in subsection B of this section, by:
1. Using an approved
recordkeeping system that keeps the tags or labels in chronological order
correlated to the date that is recorded on the tag or label, as specified under
subsection B of this section; and
2. If shellstock are removed
from its tagged or labeled container:
a. Preserving source
identification by using a recordkeeping system as specified under subdivision C
1 of this section, and
b. Ensuring that shellstock
from one tagged or labeled container are not commingled with shellstock from
another container with certification numbers, different harvest dates, or
different growing areas as identified on the tag or label before being ordered
by the consumer.
Article 3
Protection from Contamination after Receiving
12VAC5-421-450. Preventing
contamination.
A. Food employees shall wash
their hands as specified under 12VAC5-421-140.
B. Except when washing
fruits and vegetables as specified under 12VAC5-421-510 or as specified in
subsection C D of this section, food employees shall not contact
exposed, ready-to-eat food with their bare hands and shall use suitable
utensils such as deli tissue, spatulas, tongs, single-use gloves or dispensing
equipment.
C. When otherwise approved,
food employees not serving a highly susceptible population may contact exposed,
ready-to-eat food with their bare hands.
D. Food employees shall
minimize bare hand and arm contact with exposed food that is not in a
ready-to-eat form.
C. Food employees shall
minimize bare hand and arm contact with exposed food that is not in a ready-to-eat
form.
D. Food employees not
serving a highly susceptible population may contact exposed, ready-to-eat food
with their bare hands if:
1. The permit holder obtains
prior approval from the regulatory authority;
2. Written procedures are
maintained in the food establishment and made available to the regulatory
authority upon request that include:
a. For each bare hand
contact procedure, a listing of the specific ready-to-eat foods that are
touched by bare hands.
b. Diagrams and other
information showing that handwashing facilities, installed, located, equipped,
and maintained as specified under 12VAC5-421-2230, 12VAC5-421-2280,
12VAC5-421-2310, 12VAC5-421-3020, 12VAC5-421-3030, and 12VAC5-421-3045 are in
an easily accessible location and in close proximity to the work station where
the bare hand contact procedure is conducted;
3. A written employee health
policy that details how the food establishment complies with 12VAC5-421-80,
12VAC5-421-90, and 12VAC5-421-100 including:
a. Documentation that the
food employees and conditional employees acknowledge that they are informed to
report information about their health and activities as they relate to
gastrointestinal symptoms and diseases that are transmittable through food as
specified under 12VAC5-421-80 A,
b. Documentation that food
employees and conditional employees acknowledge their responsibilities as
specified under 12VAC5-421-80 E and F, and
c. Documentation that the
person in charge acknowledges the responsibilities as specified under
12VAC5-421-80 B, C, and D, and 12VAC5-421-90 and 12VAC5-421-100;
4. Documentation that the
food employees acknowledge that they have received training in:
a. The risks of contacting
the specific ready-to-eat foods with their bare hands,
b. Proper handwashing as
specified under 12VAC5-421-140,
c. When to wash their hands
as specified under 12VAC5-421-160,
d. Where to wash their hands
as specified under 12VAC5-421-170,
e. Proper fingernail
maintenance as specified under 12VAC5-421-190,
f. Prohibition of jewelry as
specified under 12VAC5-421-200, and
g. Good hygienic practices
as specified under 12VAC5-421-220 and 12VAC5-421-230;
5. Documentation that hands
are washed before food preparation and as necessary to prevent
cross-contamination by food employees as specified under 12VAC5-421-130,
12VAC5-421-140, 12VAC5-421-160, and 12VAC5-421-170 during all hours of
operation when the specific ready-to-eat foods are prepared;
6. Documentation that food
employees contacting ready-to-eat food with bare hands use two or more of the
following control measures to provide additional safeguards to hazards
associated with bare hand contact:
a. Double handwashing,
b. Nail brushes,
c. A hand antiseptic after
handwashing as specified under 12VAC5-421-180,
d. Incentive programs such
as paid sick leave that assist or encourage food employees not to work when
they are ill, or
e. Other control measures
approved by the regulatory authority; and
7. Documentation that
corrective action is taken when subdivision D 1 through 6 of this section are
not followed.
12VAC5-421-490. Pasteurized
eggs; substitute for shell eggs for certain recipes and populations.
Pasteurized eggs or egg
products shall be substituted for raw shell eggs in the preparation of foods
such as Caesar salad, hollandaise or bearnaise sauce, mayonnaise, meringue,
and egg-fortified beverages that are not:
1. Cooked as specified in 12VAC5-421-700 A 1
or 2; or
2. Included in 12VAC5-421-700 D. The eggs
are held before service following cooking.
12VAC5-421-500. Protection
from unapproved additives.
A. As Food, as
specified in 12VAC5-421-350, food shall be protected from contamination
that may result from the addition of:
1. Unsafe or unapproved food or color
additives; and
2. Unsafe or unapproved levels of approved
food and color additives.
B. A food employee shall
not:
1. Apply sulfiting agents to fresh fruits and
vegetables intended for raw consumption or to a food considered to be a good
source of vitamin B1; or
2. Serve or sell food
specified in subdivision 1 of this subsection that is treated with sulfiting
agents before receipt by the food establishment, except that grapes need not
meet the provisions of this subsection.
2. Except for grapes, serve
or sell food specified under subdivision B 1 of this section that is treated
with sulfiting agents before receipt by the food establishment.
12VAC5-421-540. Food contact
with equipment and utensils.
Food shall only contact
surfaces of equipment and utensils that are cleaned as specified under
12VAC5-421-1770 through 12VAC5-421-1870 and sanitized as specified under
12VAC5-421-1880 through 12VAC5-421-1900. :
1. Equipment and utensils
that are cleaned as specified under 12VAC5-421-1770 through 12VAC5-421-1870,
and sanitized as specified under 12VAC5-421-1880 through 12VAC5-421-1900; or
2. Single-service and
single-use articles.
12VAC5-421-570. Wiping
cloths; used for one purpose.
A. Cloths that are in use
for wiping food spills shall be used for no other purpose. in-use for
wiping food spills from tableware and carry-out containers that occur as food is
being served shall be:
1. Maintained dry; and
2. Used for no other
purpose.
B. Cloths used for wiping
food spills shall be:
1. Dry and used for wiping
food spills from tableware and carry-out containers; or
2. Wet and cleaned as
specified under 12VAC5-421-1920 D, stored in a chemical sanitizer at a
concentration specified in 12VAC5-421-3380, and used for wiping spills from
food-contact and nonfood-contact surfaces of equipment.
C. Dry or wet cloths that
are used with raw animal foods shall be kept separate from cloths used for
other purposes, and moist cloths used with raw animal foods shall be kept in a
separate sanitizing solution.
D. Wet wiping cloths used
with a freshly made sanitizing solution and dry wiping cloths shall be free of
food debris and visible soil.
E. Working containers of
sanitizing solutions for storage of in-use wiping cloths shall be placed above
the floor and used in a manner to prevent contamination of food, equipment,
utensils, linens, single-service or single-use articles.
B. Cloths in-use for wiping
counters and other equipment surfaces shall be:
1. Held between uses in a
chemical sanitizer solution at a concentration specified in 12VAC5-421-3380;
and
2. Laundered daily as
specified under 12VAC5-421-1920 D.
C. Cloths in-use for wiping
surfaces in contact with raw animal foods shall be kept separate from other
cloths used for other purposes.
D. Dry wiping cloths and the
chemical sanitizing solutions specified in subdivision B 1 of this section in
which wet wiping cloths are held between uses shall be free of food debris and
visible soil.
E. Containers of chemical
sanitizing solutions specified in subdivision B 1 of this section in which wet
wiping cloths are held between uses shall be stored off the floor and used in a
manner that prevents contamination of food, equipment, utensils, linens,
single-service, or single-use articles.
F. Single-use disposable
sanitizer wipes shall be used in accordance with EPA-approved manufacturer's
label use instructions.
12VAC5-421-680. Returned food
and reservice of food.
A. Except as specified under
subsection B of this section, after being served or sold and in the possession
of a consumer, food that is unused or returned by the consumer shall not be
offered as food for human consumption.
B. A Except as
specified in subdivision 8 of 12VAC5-421-950, a container of food that is
not potentially hazardous (time/temperature control for safety food) may
be transferred reserved from one consumer to another if:
1. The food is dispensed so that it is protected
from contamination and the container is closed between uses such as a
narrow-neck bottle containing catsup, steak sauce, or wine; or
2. The food, such as crackers, salt or
pepper, is in an unopened original package and maintained in sound condition.
Article 4
Destruction of Organisms of Public Health Concern
12VAC5-421-700. Raw animal
foods.
A. Except as specified in
subsections B, C, and D of this section, raw animal foods such as eggs, fish,
meat, poultry, and foods containing these raw animal foods shall be cooked to
heat all parts of the food to a temperature and for a time that complies with
one of the following methods based on the food that is being cooked:
1. 145°F (63°C) or above for 15 seconds for:
a. Raw shell eggs that are broken and
prepared in response to a consumer's order and for immediate service; and
b. Except as specified under subdivisions A 2
and 3 and subsection B and C of this section, fish, and
meat, and pork including game animals commercially raised for food as
specified under 12VAC5-421-330 A 1 and game animals under a voluntary
inspection program as specified under 12VAC5-421-330 A 2;
2. 155°F (68°C) for 15 seconds or the
temperature specified in the following chart that corresponds to the holding
time for ratites and injected meats; the following if they are comminuted:
fish, meat, game animals commercially raised for food as specified under
12VAC5-421-330 A 1, and game animals under a voluntary inspection program as
specified under 12VAC5-421-330 A 2; and raw eggs that are not prepared as
specified under subdivision 1 a of this subsection:
|
Minimum |
|
|
Temperature |
Time |
|
145 (63) |
3 minutes |
|
150 (66) |
1 minute |
|
158 (70) |
<1 second
(instantaneous) |
3. 165°F (74°C) or above for 15 seconds for
poultry, wild game animals as specified under 12VAC5-421-330 A 3, stuffed fish,
stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites, or stuffing
containing fish, meat, or poultry.
B. Whole beef roasts and
corned beef roasts, pork roasts, meat roasts including beef, corned
beef, lamb, pork, and cured pork roasts such as ham shall be cooked:
1. In an oven that is preheated to the
temperature specified for the roast's weight in the following chart and that is
held at that temperature; and
|
Oven Type |
Oven Temperature Based on
Roast Weight |
|
|
|
Less
than 10 lbs (4.5 kg) |
10
lbs (4.5 kg) or more |
|
Still Dry |
350°F (177°C) or more |
250°F (121°C) or more |
|
Convection |
325°F (163°C) or more |
250°F (121°C) or more |
|
High Humidity1 |
250°F (121°C) or less |
250°F (121°C) or less |
|
1 Relative humidity greater
than 90% for at least 1 hour as measured in the cooking chamber or exit of
the oven; or in a moisture-impermeable bag that provides 100% humidity. |
2. As specified in the following chart, to
heat all parts of the food to a temperature and for the holding time that
corresponds to that temperature.
|
Temperature |
Time1 in
Minutes |
Temperature |
Time1 in
Seconds |
|
130 (54.4) |
112 |
147 (63.9) |
134 |
|
131 (55.0) |
89 |
149 (65.0) |
85 |
|
133 (56.1) |
56 |
151 (66.1) |
54 |
|
135 (57.2) |
36 |
153 (67.2) |
34 |
|
136 (57.8) |
28 |
155 (68.3) |
22 |
|
138 (58.9) |
18 |
157 (69.4) |
14 |
|
140 (60.0) |
12 |
158 (70.0) |
0 |
|
142 (61.1) |
8 |
|
|
|
144 (62.2) |
5 |
|
|
|
145 (62.8) |
4 |
|
|
|
1 Holding time may include
postoven heat rise |
C. A raw or undercooked
whole-muscle, intact beef steak may be served or offered for sale in a
ready-to-eat form if:
1. The food establishment serves a population
that is not a highly susceptible population;
2. The steak is labeled, as specified under
12VAC5-421-270 E, to indicate that it meets the definition of
"whole-muscle, intact beef"; and
3. The steak is cooked on both the top and
bottom to a surface temperature of 145°F (63°C) or above and a cooked color
change is achieved on all external surfaces.
D. A raw animal food such as
raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak
tartare, or a partially cooked food such as lightly cooked fish, soft cooked
eggs, or rare meat other than whole-muscle, intact beef steaks as specified in
subsection C of this section, may be served or offered for sale in a
ready-to-eat form if:
1. (i) As specified under subdivisions 3 a
and b of 12VAC5-421-950 the food establishment serves a population that is not
a highly susceptible population and (ii) the consumer is informed as specified
under 12VAC5-421-930 that to ensure its safety, the food should be cooked as
specified under subsections A or B of this section; or
2. The regulatory authority grants a variance
from subsection A or B of this section as specified in 12VAC5-421-3570 based on
a HACCP plan that:
a. Is submitted by the permit holder and
approved as specified under 12VAC5-421-3570;
b. Documents scientific data or other
information that shows that a lesser time and temperature regimen results in a
safe food; and
c. Verifies that equipment and procedures for
food preparation and training of food employees at the food establishment meet
the conditions.
12VAC5-421-730. Parasite
destruction.
A. Except as specified in
subsection B of this section, before service or sale in ready-to-eat form, raw,
marinated raw-marinated, partially cooked or marinated-partially
cooked fish other than molluscan shellfish shall be frozen throughout to a
temperature of shall be:
1. -4°F (-20°C) or below for
168 hours (seven days) in a freezer; or
2. -35°C (-31°F) or below
for 15 hours in a blast freezer.
1. Frozen and stored at a
temperature of -4°F (-20°C) or below for a minimum of 168 hours (seven days) in
a freezer;
2. Frozen at -31°F (-35°C)
or below until solid and stored at -31°F (-35°C) or below for a minimum of 15
hours; or
3. Frozen at -31°F (-35°C)
or below until solid and stored at -4°F (-20°C) or below for a minimum of 24
hours.
B. If the fish are tuna of
the species Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus,
Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or
Thunnus thynnus (Bluefin tuna, Northern), the fish may be served or sold in a
raw, raw-marinated, or partially cooked ready-to-eat form without freezing as
specified under subsection A of the section.
B. Subsection A of this
section does not apply to:
1. Molluscan shellfish;
2. Tuna of the species
Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus,
Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or
Thunnus thynnus (Bluefin, Northern); or
3. Aquacultured fish, such
as salmon, that:
a. If raised in open water,
are raised in net-pens; or
b. Are raised in land-based
operations such as ponds or tanks; and
c. Are fed formulated feed,
such as pellets, that contains no live parasites infective to the aquacultured
fish.
12VAC5-421-740. Records,
creation and retention.
A. Except as specified in
12VAC5-421-730 B and subsection B of this section, if raw, marinated,
raw-marinated, partially cooked, or marinated-partially cooked fish are served
or sold in ready-to-eat form, the person in charge shall record the freezing
temperature and time to which the fish are subjected and shall retain the
records at the food establishment for 90 calendar days beyond the time of
service or sale of the fish.
B. If the fish are frozen by
a supplier, a written agreement or statement from the supplier stipulating that
the fish supplied are frozen to a temperature and for a time specified under
12VAC5-421-730 may substitute for the records specified under subsection A of
this section.
C. If raw, raw-marinated,
partially cooked, or marinated-partially cooked fish are served or sold in
ready-to-eat form, and the fish are raised and fed as specified in 12VAC5-421-730
B 3, a written agreement or statement from the supplier or aquaculturist
stipulating that the fish were raised and fed as specified in 12VAC5-421-730 B
3 shall be obtained by the person in charge and retained in the records of the
food establishment for 90 calendar days beyond the time of service or sale of
the fish.
12VAC5-421-750. Reheating
for immediate service. (Repealed.)
Cooked and refrigerated food
that is prepared for immediate service in response to an individual consumer
order, such as a roast beef sandwich au jus, may be served at any temperature.
12VAC5-421-760. Reheating
for hot holding.
A. Except as specified under
subsections B, C and E of this section, potentially hazardous food (time/temperature
control for safety food) that is cooked, cooled, and reheated for hot
holding shall be reheated so that all parts of the food reach at least 165°F
(74°C) for 15 seconds.
B. Except as specified under
subsection C of this section, potentially hazardous food (time/temperature
control for safety food) reheated in a microwave oven for hot holding shall
be reheated so that all parts of the food reach a temperature of at least 165°F
(74°C) and the food is rotated or stirred, covered, and allowed to stand
covered two minutes after reheating.
C. Ready-to-eat food taken
from a commercially processed, hermetically sealed container, or from an intact
package from a food processing plant that is inspected by the food regulatory
authority that has jurisdiction over the plant, shall be heated to a
temperature of at least 135°F (57°C) for hot holding.
D. Reheating for hot holding
shall be done rapidly and the time the food is between the temperature
specified under subdivision 2 of 12VAC5-421-820 and 165°F (74°C) shall not
exceed two hours as specified under subsections A through C of this
section shall be done rapidly and the time the food is between 41°F (5°C) and
the temperatures specified under subsections A through C of this section may
not exceed two hours.
E. Remaining unsliced
portions of meat roasts that are cooked as specified under
12VAC5-421-700 B may be reheated for hot holding using the oven parameters and
minimum time and temperature conditions specified under 12VAC5-421-700 B.
12VAC5-421-780. Potentially
hazardous food, slacking.
Frozen potentially hazardous
food (time/temperature control for safety food) that is slacked to
moderate the temperature shall be held:
1. Under refrigeration that maintains the
food temperature at 41°F (5°C) or less; or
2. At any temperature if the food remains
frozen.
12VAC5-421-790. Thawing.
Except as specified in
subdivision 4 of this section, potentially hazardous food (time/temperature
control for safety food) shall be thawed:
1. Under refrigeration that maintains the
food temperature at 41°F (5°C) or less; or
2. Completely submerged under running water:
a. At a water temperature of 70°F (21°C) or
below;
b. With sufficient water velocity to agitate
and float off loose particles in an overflow; and
c. For a period of time that does not allow
thawed portions of ready-to-eat food to rise above 41°F (5°C); or
d. For a period of time that does not allow
thawed portions of a raw animal food requiring cooking as specified under
12VAC5-421-700 A or B to be above 41°F (5°C) for more than four hours
including:
(1) The time the food is exposed to the
running water and the time needed for preparation for cooking; or
(2) The time it takes under refrigeration to
lower the food temperature to 41°F (5°C);
3. As part of a cooking process if the food
that is frozen is:
a. Cooked as specified under 12VAC5-421-700 A
or B or 12VAC5-421-710; or
b. Thawed in a microwave oven and immediately
transferred to conventional cooking equipment, with no interruption in the
process; or
4. Using any procedure if a portion of frozen
ready-to-eat food is thawed and prepared for immediate service in response to
an individual consumer's order.
12VAC5-421-800. Cooling.
A. Cooked potentially
hazardous food (time/temperature controlled for safety food) shall be
cooled:
1. Within two hours, from 135°F (57°C) to 70°F
(21°C); and
2. Within an additional four
hours, from 70°F (21°C) to 41°F (5°C) or less.
2. Within a total of six
hours from 135°F (57°C) to 41°F (5°C) or less.
B. Potentially hazardous
food (time/temperature control for safety food) shall be cooled within
four hours to 41°F (5°C) or less if prepared from ingredients at ambient
temperature, such as reconstituted foods and canned tuna.
C. Except as specified in
subsection D of this section, a potentially hazardous food (time/temperature
control for safety food) received in compliance with laws allowing a
temperature above 41°F (5°C) during shipment from the supplier as specified in
12VAC5-421-340 B, shall be cooled within four hours to 41°F (5°C) or less.
D. Raw shell eggs shall be
received as specified under 12VAC5-421-340 C and immediately placed in
refrigerated equipment that maintains an ambient air temperature of 45°F (7°C)
or less.
12VAC5-421-820. Potentially
hazardous food; hot and cold holding.
A. Except during
preparation, cooking, or cooling, or when time is used as the public health
control as specified under 12VAC5-421-850, potentially hazardous food (time/temperature
control for safety food) shall be maintained:
1. At 135°F (57°C) or above, except that
roasts cooked to a temperature and for a time specified under 12VAC5-421-700 B
or reheated as specified in 12VAC5-421-760 E may be held at a temperature of
130°F (54°C) or above; or
2. At 41°F (5°C) or less.
B. Shell eggs that have not
been treated to destroy all viable Salmonellae shall be stored in refrigerated
equipment that maintains an ambient air temperature of 45°F (7°C) or less.
C. Potentially hazardous
food (time/temperature control for safety food) in a homogenous liquid form may
be maintained outside the temperature control requirements, as specified in
subsection A of this section, while contained within specially designed
equipment that complies with the design and construction requirements as
specified under subdivision 5 of 12VAC5-421-1230.
12VAC5-421-830.
Ready-to-eat, potentially hazardous food, date marking.
A. Except as specified in
subsection D of this section, refrigerated, ready-to-eat, potentially hazardous
food prepared and held in a food establishment for more than 24 hours shall be
clearly marked to indicate the food shall be consumed on the premises, sold, or
discarded within seven calendar days or less from the day the food is prepared.
The day of preparation shall be counted as day 1 when packaging food
using a reduced oxygen packaging method as specified under 12VAC5-421-870, and
except as specified in subsections D and E of this section, refrigerated
ready-to-eat potentially hazardous food (time/temperature control for safety
food) prepared and held in a food establishment for more than 24 hours shall be
clearly marked to indicate the date or day by which the food shall be consumed
on the premises, sold, or discarded when held at a temperature of 41°F (5°C) or
less for a maximum of seven days.
B. Except as specified in
subsections D and E D through F of this section, refrigerated
ready-to-eat, potentially hazardous food (time/temperature control for
safety food) prepared and packaged by a food processing plant shall be
clearly marked at the time the original container is opened in a food
establishment and if the food is held for more than 24 hours, to indicate the
date or day by which the food shall be consumed on the premises, sold, or
discarded, based on the temperature and time combinations specified in
subsection A of this section and:
1. The day the original container is opened
in the food establishment shall be counted as day 1; and
2. The day or date marked by the food
establishment shall not exceed a manufacturer's use-by date if the manufacturer
determined the use-by date based on food safety.
C. A refrigerated, ready-to-eat
potentially hazardous food that is frequently rewrapped, such as lunchmeat or a
roast, or for which date marking is impractical, such as soft serve mix or milk
in a dispensing machine, may be marked as specified in subsection A or B of
this section, or by an alternative method acceptable to the regulatory
authority.
D. Subsections A and B of
this section do not apply to individual meal portions served or repackaged for
sale from a bulk container upon a consumer's request.
E. Subsection B of this section
does not apply to the following when the face has been cut, but the remaining
portion is whole and intact.
1. Fermented sausages
produced in a federally inspected food processing plant that are not labeled
"Keep Refrigerated" and that retain the original casing on the
product;
2. Shelf stable, dry,
fermented sausages; and
3. Shelf stable salt-cured
products such as prosciutto and Parma (ham) produced in a federally inspected
food processing plant that are not labeled "Keep Refrigerated."
F. A refrigerated,
ready-to-eat, potentially hazardous food ingredient or a portion of a
refrigerated, ready-to-eat, potentially hazardous food that is subsequently
combined with additional ingredients or portions of food shall retain the date
marking of the earliest-prepared or first-prepared ingredient.
C. A refrigerated,
ready-to-eat, potentially hazardous food (time/temperature control for safety
food) ingredient or a portion of a refrigerated, ready-to-eat, potentially
hazardous food (time/temperature control for safety food) that is subsequently
combined with additional ingredients or portions of food shall retain the date
marking of the earliest-prepared or first-prepared ingredient.
D. A date marking system
that meets the criteria specified in subsections A and B of this section may
include:
1. Using a method approved
by the regulatory authority for refrigerated, ready-to-eat potentially
hazardous food (time/temperature control for safety food) that is frequently
rewrapped, such as lunchmeat or a roast, or for which date marking is
impractical, such as soft-serve mix or milk in a dispensing machine;
2. Marking the date or day
of preparation, with a procedure to discard the food on or before the last date
or day by which the food must be consumed on the premises, sold, or discarded
as specified in subsection A of this section;
3. Marking the date or day
the original container is opened in a food establishment, with a procedure to
discard the food on or before the last date of day by which the food must be
consumed on the premises, sold, or discarded as specified under subsection B of
this section; or
4. Using calendar dates,
days of the week, color-coded marks, or other effective marking methods,
provided that the marking system is disclosed to the regulatory authority upon
request.
E. Subsections A and B of
this section do not apply to individual meal portions served or repackaged for
sale from a bulk container upon a consumer's request.
F. Subsection B of this
section does not apply to the following foods prepared and packaged by a food
processing plant inspected by a regulatory authority:
1. Deli salads, such as ham
salad, seafood salad, chicken salad, egg salad, pasta salad, potato salad, and
macaroni salad, manufactured in accordance with 21 CFR Part 110 Current good
manufacturing practice in manufacturing, packing or holding food;
2. Hard cheeses containing
not more than 39% moisture as defined in 21 CFR Part 133 Cheeses and related
cheese products, such as cheddar, gruyere, parmesan and reggiano, and romano;
3. Semi-soft cheese
containing more than 39% moisture, but not more than 50% moisture, as defined
in 21 CFR Part 133 Cheeses and cheese related products, such as blue, edam,
gorgonzola, gouda, and monterey jack;
4. Cultured dairy products
as defined in 21 CFR Part 131 Milk and cream, such as yogurt, sour cream, and
buttermilk;
5. Preserved fish products,
such as pickled herring and dried or salted cod, and other acidified fish
products as defined in 21 CFR Part 114 Acidified foods;
6. Shelf stable, dry
fermented sausages, such as pepperoni and Genoa salami that are not labeled
"Keep Refrigerated" as specified in 9 CFR Part 317 Labeling, marking
devices, and containers, and that retain the original casing on the product;
and
7. Shelf stable salt-cured
products such as prosciutto and Parma (ham) that are not labeled "Keep
Refrigerated" as specified in 9 CFR Part 317 Labeling, marking devices,
and containers.
12VAC5-421-850. Time as a
public health control.
A. Except as specified under
subsection B of this section, if time only, rather than time in conjunction
with temperature, is used as the public health control for a working supply of
potentially hazardous food before cooking, or for ready-to-eat potentially
hazardous food that is displayed or held for service for immediate consumption:
1. The food shall be marked
or otherwise identified to indicate the time that is four hours past the point
in time when the food is removed from temperature control;
2. The food shall be cooked
and served, served if ready-to-eat, or discarded, within four hours from the
point in time when the food is removed from temperature control;
3. The food in unmarked
containers or packages or marked to exceed a four-hour limit shall be
discarded; and
4. Written procedures shall
be maintained in the food establishment and made available to the regulatory
authority upon request, that ensure compliance with:
a. Subdivisions 1, 2 and 3
of this section; and
b. 12VAC5-421-800 for food
that is prepared, cooked, and refrigerated before time is used as a public
health control.
B. In a food establishment
that serves a highly susceptible population, time only, rather than time in
conjunction with temperature, shall not be used as the public health control
for raw eggs.
A. Except as specified under
subsection D of this section, if time without temperature control is used as
the public health control for a working supply of potentially hazardous food
(time/temperature control for safety food) before cooking or for ready-to-eat
potentially hazardous food (time/temperature control for safety food) that is
displayed or held for sale or service, written procedures shall be prepared in
advance, maintained in the food establishment, and made available to the
regulatory authority upon request that specify:
1. Methods of compliance
with subdivisions B 1 through 3 or C 1 through 5 of this section; and
2. Methods of compliance
with 12VAC5-421-800 for food that is prepared, cooked, and refrigerated before
time is used as a public health control.
B. If time without temperature
control is used as the public health control up to a maximum of four hours:
1. The food shall be marked
or otherwise identified to indicate the time that is four hours past the point
in time when the food is removed from temperature control;
2. The food shall be cooked
and served, served at any temperature if ready-to-eat, or discarded, within
four hours from the point in time when the food is removed from temperature
control; and
3. The food in unmarked
containers or packages, or marked to exceed a four-hour limit shall be
discarded.
C. If time without
temperature control is used as the public health control up to a maximum of six
hours:
1. The food shall have an
initial temperature of 41ºF (5ºC) or less when removed from temperature control
and the food temperature may not exceed 70ºF (21ºC) within a maximum time
period of six hours;
2. The food shall be
monitored to ensure the warmest portion of the food does not exceed 70ºF (21ºC)
during the six-hour period, unless an ambient air temperature is maintained
that ensures the food does not exceed 70ºF (21ºC) during the six-hour holding
period;
3. The food shall be marked
or otherwise identified to indicate:
a. The time when the food is
removed from 41ºF (5ºC) or less cold-holding temperature control, and
b. The time that is six
hours past the point in time when the food is removed from 41ºF (5ºC) or less
cold-holding temperature control;
4. The food shall be:
a. Discarded if the
temperature of the foods exceeds 70ºF (21ºC), or
b. Cooked and served, served
at any temperature if ready-to-eat, or discarded within a maximum of six hours
from the point in time when the food is removed from 41ºF (5ºC) or less
cold-holding temperature control; and
5. The food in unmarked
containers or packages, or marked with a time that exceeds the six-hour limit
shall be discarded.
D. A food establishment that
serves a highly susceptible population may not use time as specified under
subsections A, B, or C of this section as the public health control for raw
eggs.
12VAC5-421-860. Variance
requirement.
A food establishment shall
obtain a variance from the regulatory authority as specified in 12VAC5-421-3570
and 12VAC5-421-3580 before:
1. Smoking food as a method of food
preservation rather than as a method of flavor enhancement;
2. Curing food;
3. Using food additives or adding components
such as vinegar:
a. As a method of food preservation rather
than as a method of flavor enhancement; or
b. To render a food so that it is not
potentially hazardous;
4. Packaging food using a reduced oxygen
packaging method except as specified under 12VAC5-421-870 where a barrier to
Clostridium botulinum in addition to refrigeration exists;
5. Operating a molluscan shellfish
life-support system display tank used to store and display shellfish that are
offered for human consumption;
6. Custom processing animals that are for
personal use as food and not for sale or service in a food establishment; or
7. Preparing food by another method that
is determined by the regulatory authority to require a variance. Sprouting
seeds or beans; or
8. Preparing food by another
method that is determined by the regulatory authority to require a variance.
12VAC5-421-870. Reduced
oxygen packaging; criteria.
A. Except for a food
establishment that obtains a variance as specified under 12VAC5-421-860, a food
establishment that packages food using a reduced oxygen packaging method and
Clostridium botulinum is identified as a microbiological hazard in the final
packaged form shall ensure that there are at least two barriers in place to
control the growth and toxin formation of Clostridium botulinum.
B. A food establishment that
packages food using a reduced oxygen packaging method and Clostridium botulinum
is identified as a microbiological hazard in the final packaged form shall have
a HACCP plan that contains the information specified under subdivision 4 of
12VAC5-421-3630 and that:
1. Identifies the food to be
packaged;
2. Limits the food packaged
to a food that does not support the growth of Clostridium botulinum because it
complies with one of the following:
a. Has an aw of
0.91 or less;
b. Has a pH of 4.6 or less;
c. Is a meat or poultry
product cured at a food processing plant regulated by the USDA using substances
specified in 9 CFR 424.21, Use of food ingredients and sources of radiation,
and is received in an intact package; or
d. Is a food with a high
level of competing organisms such as raw meat or raw poultry;
3. Specifies methods for
maintaining food at 41°F (5°C) or below;
4. Describes how the
packages shall be prominently and conspicuously labeled on the principal
display panel in bold type on a contrasting background, with instructions to:
a. Maintain the food at 41°F
(5°C) or below; and
b. Discard the food if
within 14 calendar days of its packaging it is not served for on-premises
consumption, or consumed if served or sold for off-premises consumption;
5. Limits the refrigerated
shelf life to no more than 14 calendar days from packaging to consumption,
except the time the product is maintained frozen, or the original
manufacturer's "sell by" or "use by" date, whichever occurs
first;
6. Includes operational
procedures that:
a. Prohibit contacting food
with bare hands;
b. Identify a designated
area and the method by which:
(1) Physical barriers or
methods of separation of raw foods and ready-to-eat foods minimize cross
contamination; and
(2) Access to the processing
equipment is restricted to responsible trained personnel familiar with the
potential hazards of the operation, and
c. Delineate cleaning and
sanitization procedures for food-contact surfaces; and
7. Describes the training
program that ensures that the individual responsible for the reduced oxygen
packaging operation understands the:
a. Concepts required for a
safe operation;
b. Equipment and facilities;
and
c. Procedures specified
under subdivision 6 of this subsection and subdivision 4 of 12VAC5-421-3630.
C. Except for fish that is
frozen before, during, and after packaging, a food establishment shall not
package fish using a reduced oxygen packaging method.
A. Except for a food
establishment that obtains a variance as specified under 12VAC5-421-860 and
except as specified under subsections C and E of this section, a food
establishment that packages potentially hazardous food (time/temperature
control for safety food) using a reduced oxygen packaging method shall ensure
that there are at least two barriers in place to control the growth and toxin
formation of Clostridium botulinum and the growth of Listeria monocytogenes.
B. A food establishment that
packages potentially hazardous food (time/temperature control for safety food)
using a reduced oxygen method shall have a HACCP plan that contains the
following information specified under 12VAC5-421-3630 D:
1. Identifies food to be
packaged;
2. Except as specified in
subsections C and E and as specified in subsection D of this section, requires
that the packaged food shall be maintained at 41°F (5°C) or less and meet at
least one of the following criteria:
a. Has an Aw of
0.91 or less,
b. Has a pH of 4.6 or less,
c. Is a meat or poultry
product cured as a food processing plant regulated by the USDA using substances
specified in 9 CFR 424.21, Use of food ingredients and sources of radiation,
and is received in an intact package, or
d. Is a food with a high level
of competing organisms such as raw meat or raw poultry;
3. Describes how the package
shall be prominently and conspicuously labeled on the principal display panel
in bold type on a contrasting background, with instructions to:
a. Maintain food at 41°F (5°C)
or below, and
b. Discard the food within
14 calendar days of its packaging if it not served for on-premises consumption,
or consumed if served or sold for off-premises consumption;
4. Limits the refrigerated
shelf life to no more than 14 calendar days from packaging to consumption,
except the time the product is maintained frozen, or the original
manufacturer's "sell by" or "use by" date, whichever occurs
first;
5. Includes operational
procedures that:
a. Prohibit contacting food
with bare hands,
b. Identify a designated
work area and the method by which:
(1) Physical barriers or
methods of separation of raw foods and ready-to-eat foods minimize cross
contamination, and
(2) Access to the processing
equipment is limited to responsible trained personnel familiar with the
potential hazards of the operation, and
c. Delineate cleaning and
sanitization procedures for food contact surfaces; and
6. Describes the training
program that ensures that the individual responsible for the reduced oxygen
packaging operation understands the:
a. Concepts required for
safe operation,
b. Equipment and facilities,
and
c. Procedures specified
under subdivision B 5 of this section and 12VAC5-421-3630 D.
C. Except for fish that is
frozen before, during, and after packaging, a food establishment may not
package fish using a reduced oxygen packaging method.
D. Except as specified in
subsection C of this section, a food establishment may package food using a
cook-chill or sous-vide process without obtaining a variance if:
1. The food establishment
implements a HACCP plan that contains the information as specified under
12VAC5-421-3630 D:
2. The food is:
a. Prepared and consumed on
the premises, or prepared and consumed off the premises but within the same
business entity with no distribution or sale of the bagged product to another
business entity or the consumer,
b. Cooked to heat all parts
of the food to a temperature and for a time as specified under 12VAC5-421-700,
c. Protected from
contamination after cooking as specified in 12VAC5-421-450 through
12VAC5-421-690,
d. Placed in a package or
bag with an oxygen barrier and sealed before cooking, or placed in a package or
bag and sealed immediately after cooking, and before reaching a temperature
below 135°F (57°C),
e. Cooled to 41°F (5°C) in
the sealed package or bag as specified under 12VAC5-421-800, and subsequently:
(1) Cooled to 34°F (1°C)
within 48 hours of reaching 41°F (5°C) and held at that temperature until
consumed or discarded within 30 days after the date of preparation;
(2) Cooled to 34°F (1°C)
within 48 hours of reaching 41°F (5°C), removed from refrigeration equipment
that maintains a 34°F (1°C) food temperature and then held at 41°F (5°C) or
less for no more than 72 hours, at which time the food must be consumed or discarded;
(3) Cooled to 38°F (3°C) or
less within 24 hours of reaching 41°F (5°C) and held there for no more than 72
hours from packaging, at which time the food must be consumed or discarded; or
(4) Held frozen with no
shelf-life restriction while frozen until consumed or used.
f. Held in a refrigeration
unit that is equipped with an electronic system that continuously monitors
time and temperature and is visually examined for proper operation twice
daily,
g. If transported off-site
to a satellite location of the same business entity, equipped with verifiable
electronic monitoring devices to ensure that times and temperatures are
monitored during transportation, and
h. Labeled with the product
name and the date packaged; and
3. The records required to
confirm that cooling and cold holding refrigeration time/temperature parameters
are required as part of the HACCP plan, are maintained and are:
a. Made available to the
regulatory authority upon request, and
b. Held for six months; and
4. Written operational procedures
as specified under subdivision B 5 of this section and a training program as
specified under subdivision B 6 of this section are implemented.
E. A food establishment may
package cheese using a reduced oxygen packaging method without obtaining a variance
if it:
1. Limits the cheeses
packaged to those that are commercially manufactured in a food processing plant
with no ingredients added in the food establishment and that meet the Standards
of Identity as specified in 21 CFR 133.150 Hard Cheeses, 21 CFR 133.169
Pasteurized process cheese, or 21 CFR 133.187 Semi-soft cheeses;
2. Has a HACCP plan that
contains the information specified in 12VAC5-421-3630 D;
3. Except as specified under
subdivision B 2 , B 3 b, and B 4, complies with subsection B of this section;
4. Labels the package on the
principal display panel with a "use by" date that does not exceed 30
days or the original manufacturer's "sell by" or "use by"
date, whichever comes first; and
5. Discards the reduced
oxygen packaged cheese if it is not sold for off-premises consumption or
consumed within 30 calendar days of its packaging.
12VAC5-421-900. Food labels.
A. Food packaged in a food
establishment, shall be labeled as specified in accordance with all applicable
laws and regulations, including 21 CFR Part 101 - Food Labeling, and 9 CFR Part
317 - Labeling, Marking Devices, and Containers.
B. Label information shall
include:
1. The common name of the food, or absent a
common name, an adequately descriptive identity statement;
2. If made from two or more ingredients, a
list of ingredients in descending order of predominance by weight, including a
declaration of artificial color or flavor and chemical preservatives, if
contained in the food;
3. An accurate declaration of the quantity of
contents;
4. The name and place of business of the
manufacturer, packer, or distributor; and
5. Except as exempted in the
Federal Food, Drug, and Cosmetic Act § 403(Q)(3) - (5), nutrition labeling as
specified in 21 CFR Part 101 - Food Labeling, and 9 CFR Part 317 Subpart B -
Nutrition Labeling.
6. For any salmonid fish
containing canthaxanthin as a color additive, the labeling of the bulk fish
container, including a list of ingredients, displayed on the retail container
or by other written means, such as a counter card, that discloses the use of
canthaxanthin.
5. The name of the food
source for each major food allergen contained in the food unless the food
source is already part of the common or usual name of the respective
ingredient;
6. Except as exempted in the
Federal Food, Drug, and Cosmetic Act § 403(Q)(3) - (5), nutrition labeling as
specified in 21 CFR Part 101 - Food Labeling, and 9 CFR Part 317 Subpart B -
Nutrition Labeling; and
7. For any salmonid fish
containing canthaxanthin as a color additive, the labeling of the bulk fish
container, including a list of ingredients, displayed on the retail container
or by other written means, such as a counter card, that discloses the use of
canthaxanthin.
C. Bulk food that is
available for consumer self-dispensing shall be prominently labeled with the
following information in plain view of the consumer:
1. The manufacturer's or processor's label
that was provided with the food; or
2. A card, sign, or other method of
notification that includes the information specified under subdivisions B 1, 2
and 5 of this section.
D. Bulk, unpackaged foods
such as bakery products and unpackaged foods that are portioned to consumer
specification need not be labeled if:
1. A health, nutrient content, or other claim
is not made;
2. There are no state or local laws requiring
labeling; and
3. The food is manufactured or prepared on
the premises of the food establishment or at another food establishment or a
food processing plant that is owned by the same person and is regulated by the
food regulatory agency that has jurisdiction.
Article 8
Special Requirements for Highly Susceptible Populations
12VAC5-421-950. Pasteurized
foods, prohibited reservice, and prohibited food.
In a food establishment that
serves a highly susceptible population:
1. The following criteria apply to juice:
a. For the purposes of this paragraph only,
children who are age nine or less and receive food in a school, day care
setting, or similar facility that provides custodial care are included as
highly susceptible populations;
b. Prepackaged juice or a prepackaged
beverage containing juice, that bears a warning label as specified in 21 CFR
101.17(g) Food Labeling, or packaged juice or beverage containing juice, that
bears a warning label as specified under subdivision 2 of 12VAC5-421-765 shall
not be served or offered for sale; and
c. Unpackaged juice that is prepared on the
premises for service or sale in a ready-to-eat form shall be processed under a
HACCP plan that contains the information specified in subdivisions 2 through 5
of 12VAC5-421-3630 and as specified under 21 CFR 120.24, Process controls.
2. Pasteurized shell eggs or pasteurized
liquid, frozen, or dry eggs or egg products shall be substituted for raw
shell eggs in the preparation of:
a. Foods such as Caesar salad, hollandaise or
biarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and
egg-fortified beverages; and
b. Except as specified in subdivision 5
6 of this section, recipes in which more than one egg is broken and the
eggs are combined.
3. The following foods shall not be served or
offered for sale in a ready-to-eat form:
a. Raw animal foods such as raw fish,
raw-marinated fish, raw molluscan shellfish, and steak tartare;
b. A partially cooked animal food such as
lightly cooked fish, rare meat, soft-cooked eggs that are made from raw shell
eggs, and meringue; and
c. Raw seed sprouts.
4. Food employees shall not contact
ready-to-eat food as specified in 12VAC5-421-450 B.
5. Subdivision 2 b of this
section does not apply if:
a. The raw eggs are combined
immediately before cooking for one consumer's serving at a single meal, cooked
as specified under 12VAC5-421-700 A 1, and served immediately, such as an
omelet, soufflé, or scrambled eggs;
b. The raw eggs are combined
as an ingredient immediately before baking and the eggs are thoroughly cooked
to a ready-to-eat form, such as a cake, muffin, or bread; or
c. The preparation of the
food is conducted under a HACCP plan that:
(1) Identifies the food to
be prepared;
(2) Prohibits contacting
ready-to-eat food with bare hands;
(3) Includes specifications
and practices that ensure:
(a) Salmonella Enteritidis
growth is controlled before and after cooking; and
(b) Salmonella Enteritidis
is destroyed by cooking the eggs according to the temperature and time
specified in 12VAC5-421-700 A 2;
d. Contains the information
specified under subdivision 4 of 12VAC5-421-3630 including procedures that:
(1) Control cross
contamination of ready-to-eat food with raw eggs; and
(2) Delineate cleaning and
sanitization procedures for food-contact surfaces; and
e. Describes the training
program that ensures that the food employee responsible for the preparation of
the food understands the procedures to be used.
5. Time only, as the public
health control as specified under 12VAC5-421-850, may not be used for raw eggs.
6. Subdivision 2 b of this
section does not apply if:
a. The raw eggs are combined
immediately before cooking for one consumer's serving at a single meal, cooked
as specified under 12VAC5-421-700 A 1, and served immediately, such as an
omelet, soufflé, or scrambled eggs;
b. The raw eggs are combined
as an ingredient immediately before baking and the eggs are thoroughly cooked
to a ready-to-eat form, such as a cake, muffin, or bread; or
c. The preparation of the food
is conducted under a HACCP plan that:
(1) Identifies the food to
be prepared;
(2) Prohibits contacting
ready-to-eat food with bare hands;
(3) Includes specifications
and practices that ensure:
(a) Salmonella Enteritidis
growth is controlled before and after cooking; and
(b) Salmonella Enteritidis
is destroyed by cooking the eggs according to the temperature and time
specified in 12VAC5-421-700 A 2;
d. Contains the information
specified under subdivision 4 of 12VAC5-421-3630 including procedures that:
(1) Control cross
contamination of ready-to-eat food with raw eggs; and
(2) Delineate cleaning and
sanitization procedures for food-contact surfaces; and
e. Describes the training
program that ensures that the food employee responsible for the preparation of the
food understands the procedures to be used.
7. Except as specified in
subdivision 8 of this section, food may be reserved as specified under
12VAC5-421-680 B 1 and 2.
8. Foods may not be reserved
under the following conditions:
1. Any food served to patients
or clients who are under contact precautions in medical isolation or
quarantine, or protective environment isolation may not be reserved to others
outside.
2. Packages of food from any
patients, clients, or other consumers should not be reserved to persons in
protective environment isolation
12VAC5-421-980. Lead in
ceramic, china, and crystal utensils, use limitation.
A. Ceramic, china, crystal
utensils, and decorative utensils such as hand-painted ceramic or china that
are used in contact with food shall be lead-free or contain levels of lead not
exceeding the limits of the following utensil categories:
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Utensil Category |
Ceramic Article Description |
Maximum Lead |
Beverage Mugs, Cups, Pitchers |
Coffee Mugs |
0.5 |
Large Hollowware |
Bowls > 1.1 Liter |
1.0 |
Small Hollowware |
Bowls <1.1 Liter |
2.0 |
Flat tableware |
Plates, Saucers |
3.0 |
B. Pewter alloys containing
lead in excess of 0.05% may not be used as a food contact surface.
C. Solder and flux
containing lead in excess of 0.2% may not be used as a food contact surface.
12VAC5-421-1020. Lead in
pewter alloys, use limitation. (Repealed.)
Pewter alloys containing
lead in excess of 0.05% shall not be used as a food-contact surface.
12VAC5-421-1030. Lead in
solder and flux, use limitation. (Repealed.)
Solder and flux containing
lead in excess of 0.2% shall not be used as a food-contact surface.
12VAC5-421-1200. Pressure
measuring devices, mechanical warewashing equipment.
Pressure measuring devices
that display the pressures in the water supply line for the fresh hot water
sanitizing rinse shall have increments of 1 pounds per square inch (7
kilopascals) or smaller and shall be accurate to ±2 pounds per square inch (±14
kilopascals) in the 1525 pounds per square inch (100170 kilopascals) range
in the range indicated on the manufacturer's data plate.
12VAC5-421-1230. Dispensing
equipment, protection of equipment and food.
In equipment that dispenses
or vends liquid food or ice in unpackaged form:
1. The delivery tube, chute, orifice, and
splash surfaces directly above the container receiving the food shall be
designed in a manner, such as with barriers, baffles, or drip aprons, so that
drips from condensation and splash are diverted from the opening of the
container receiving the food;
2. The delivery tube, chute, and orifice
shall be protected from manual contact such as by being recessed;
3. The delivery tube or chute and orifice of
equipment used to vend liquid food or ice in unpackaged form to self-service
consumers shall be designed so that the delivery tube or chute and orifice are
protected from dust, insects, rodents, and other contamination by a
self-closing door if the equipment is:
a. Located in an outside area that does not
otherwise afford the protection of an enclosure against the rain, windblown
debris, insects, rodents, and other contaminants that are present in the
environment, or
b. Available for self-service during hours
when it is not under the full-time supervision of a food employee; and
4. The dispensing equipment actuating lever
or mechanism and filling device of consumer self-service beverage dispensing
equipment shall be designed to prevent contact with the lip-contact surface of
glasses or cups that are refilled.
5. Dispensing
equipment in which potentially hazardous food (time/temperature control for
safety food) in homogenous liquid form is maintained outside of the temperature
control requirements as specified in 12VAC5-421-820 C shall:
a. Be specifically designed
and equipped to maintain the commercial sterility of aseptically packaged food
in a homogenous liquid form for a specified duration from the time of opening
the packaging within the equipment; and
b. Conform to the
requirements for this equipment as specified in NSF/ANSI 18-2006 Manual Food
and Beverage Dispensing Equipment.
12VAC5-421-1260. Beverage
tubing, separation.
Beverage tubing and
cold-plate beverage cooling devices shall not be installed in contact with
stored ice. This section does not apply to cold plates that are constructed
integrally with an ice storage bin.
Except for cold plates that
are constructed integrally with an ice storage bin, beverage tubing and
cold-plate beverage cooling devices may not be installed in contact with stored
ice.
12VAC5-421-1310. Vending machines,
automatic shutoff.
A. A machine vending
potentially hazardous food (time/temperature control for safety food)
shall have an automatic control that prevents the machine from vending food:
1. If there is a power failure, mechanical
failure, or other condition that results in an internal machine temperature
that can not maintain food temperatures as specified under Part III
(12VAC5-421-260 et seq.) of this chapter; and
2. If a condition specified under subdivision
1 of this subsection occurs, until the machine is serviced and restocked with
food that has been maintained at temperatures specified under Part III.
B. When the automatic
shutoff within a machine vending potentially hazardous food (time/temperature
control for safety food) is activated:
1. In a refrigerated vending machine, the
ambient temperature shall not exceed 41°F (5°C) for more than 30 minutes
immediately after the machine is filled, serviced, or restocked; or
2. In a hot holding vending machine, the
ambient temperature shall not be less than 135°F (57°C) for more than 120
minutes immediately after the machine is filled, serviced, or restocked.
12VAC5-421-1420. Case lot
handling equipment apparatuses, movability.
Equipment Apparatuses, such as
dollies, pallets, racks, and skids used to store and transport large quantities
of packaged foods received from a supplier in a cased or overwrapped lot, shall
be designed to be moved by hand or by conveniently available equipment such as
hand trucks and forklifts.
12VAC5-421-1440. Food
equipment, certification and classification. (Repealed.)
Food equipment that is
certified or classified for sanitation by an American National Standards
Institute (ANSI)-accredited certification program will be deemed to comply with
Articles 1 (12VAC5-421-960 et seq.) and 2 (12VAC5-421-1080 et seq.) of this
part.
12VAC5-421-1550. Fixed
equipment, spacing or sealing.
A. Equipment that is fixed
because it is not easily movable shall be installed so that it is:
1. Spaced to allow access for cleaning along
the sides, behind, and above the equipment;
2. Spaced from adjoining equipment, walls,
and ceilings a distance of not more than 1/32 inch or 1 millimeter; or
3. Sealed to adjoining equipment or walls, if
the equipment is exposed to spillage or seepage.
B. Table-mounted Counter-mounted
equipment that is not easily movable shall be installed to allow cleaning of
the equipment and areas underneath and around the equipment by being:
1. Sealed to the table; or
2. Elevated on legs as specified under
12VAC5-421-1560 D.
12VAC5-421-1560. Fixed
equipment, elevation or sealing.
A. Except as specified in
subsections B and C of this section, floor-mounted equipment that is not easily
movable shall be sealed to the floor or elevated on legs that provide at least
a 6 inch (15 centimeter) clearance between the floor and the equipment.
B. If no part of the floor
under the floor-mounted equipment is more than 6 inches (15 centimeters) from
the point of cleaning access, the clearance space may be only 4 inches (10
centimeters).
C. This section does not
apply to display shelving units, display refrigeration units, and display
freezer units located in the consumer shopping areas of a retail food store, if
the floor under the units is maintained clean.
D. Except as specified in
subsection E of this section, table-mounted counter-mounted
equipment that is not easily movable shall be elevated on legs that provide at
least a 4-inch (10 centimeter) clearance between the table and the equipment.
E. The clearance space
between the table and table-mounted counter-mounted equipment may
be:
1. Three inches (7.5 centimeters) if the
horizontal distance of the table top under the equipment is no more than 20
inches (50 centimeters) from the point of access for cleaning; or
2. Two inches (5 centimeters) if the
horizontal distance of the table top under the equipment is no more than 3
inches (7.5 centimeters) from the point of access for cleaning.
12VAC5-421-1690. Mechanical
warewashing equipment, sanitization pressure.
The flow pressure of the fresh
hot water sanitizing rinse in a warewashing machine shall not be less than 15
pounds per square inch (100 kilopascals) or more than 25 pounds per square inch
(170 kilopascals) as measured in the water line immediately downstream or
upstream from the fresh hot water sanitizing rinse control valve.
The flow pressure of the
fresh hot water sanitizing rinse in a warewashing machine, as measured in the
water line immediately downstream or upstream from the fresh hot water
sanitizing rinse control valve, shall be within the range specified on the
machine manufacturer's data plate and may not be less than five pounds per
square inch (35 kilopascals) or more than 30 pounds per square inch (200
kilopascals).
Article 7
Sanitization of Equipment and Utensils
12VAC5-421-1880. Food-contact
surfaces and utensils. (Repealed.)
Equipment food-contact
surfaces and utensils shall be sanitized.
Article 7
Sanitization of Equipment and Utensils
12VAC5-421-1890. Before use
after cleaning.
Utensils and food-contact
surfaces of equipment shall be sanitized before use after cleaning.
12VAC5-421-1980.
Food-contact surfaces.
Lubricants as specified
in 12VAC5-421-3420 shall be applied to food-contact surfaces that require
lubrication in a manner that does not contaminate food-contact surfaces.
12VAC5-421-2040. Preset
tableware.
If tableware is preset:
1. It shall be protected
from contamination by being wrapped, covered, or inverted;
2. Exposed, unused settings
shall be removed when a consumer is seated; or
3. Exposed, unused settings
shall be cleaned and sanitized before further use if the settings are not
removed when a consumer is seated.
A. Tableware that is
preset shall be protected from contamination by being wrapped, covered, or
inverted.
B. When tableware is
preset, exposed, unused settings shall be:
1. Removed when a
consumer is seated; or
2. Cleaned and
sanitized before further use if the settings are not removed when a consumer is
seated.
12VAC5-421-2190. Handwashing
lavatory sink, water temperature, and flow.
A. A handwashing lavatory
sink shall be equipped to provide water at a temperature of at least
100°F (38°C) through a mixing valve or combination faucet.
B. A steam mixing valve
shall not be used at a handwashing lavatory sink.
C. A self-closing,
slow-closing, or metering faucet shall provide a flow of water for at least 15
seconds without the need to reactivate the faucet.
12VAC5-421-2230. Handwashing
lavatory sinks, numbers, and capacities.
A. Except as specified in
subsection B of this section, at least one handwashing lavatory sink,
or the number of handwashing lavatories sinks necessary for their
convenient use by employees in areas specified under 12VAC5-421-2280, and not
fewer than the number of handwashing lavatories sinks required by
law shall be provided.
B. If approved, when food
exposure is limited and handwashing lavatories sinks are not
conveniently available, such as in some mobile or temporary food establishments
or at some vending machine locations, employees may use chemically treated
towelettes for handwashing.
12VAC5-421-2280. Handwashing
lavatory sinks, location.
A handwashing lavatory
sink shall be located:
1. To be readily accessible for use by
employees in food preparation, food dispensing, and warewashing areas; and
2. In, or immediately adjacent to, toilet
rooms.
12VAC5-421-2310. Using a
handwashing lavatory sink.
A. A handwashing lavatory
sink shall be maintained so that it is accessible at all times for
employee use.
B. A handwashing lavatory
sink shall not be used for purposes other than handwashing.
12VAC5-421-2510. Establishment
drainage system. (Repealed.)
Food establishment drainage
systems, including grease traps, that convey sewage shall be designed and
installed as specified under 12VAC5-421-2180 A.
12VAC5-421-2520. Backflow
prevention.
A. Except as specified in
subsections B and C of this section, a direct connection shall not exist
between the sewage system and a drain originating from equipment in which food,
portable equipment, or utensils are placed.
B. If allowed by law, a
warewashing machine may have a direct connection between its waste outlet and a
floor drain when the machine is located within 5 feet (1.5 m) of a trapped
floor drain and the machine outlet is connected to the inlet side of a properly
vented floor drain trap.
C. If allowed by law, a
warewashing or culinary sink may have a direct connection.
A. Except as specified in
subsections B, C, and D of this section, a direct connection may not exist
between the sewage system and a drain originating from equipment in which food,
portable equipment, or utensils are placed.
B. Subsection A of this
section does not apply to floor drains that originate in refrigerated spaces
that are constructed as an integral part of the building.
C. If allowed by law, a
warewashing machine may have a direct connection between its waste outlet and a
floor drain when the machine is located within five feet (1.5 meters) of a
trapped floor drain and the machine outlet is connected to the inlet side of a
properly vented floor drain trap.
D. If allowed by law, a
warewashing or culinary sink may have a direct connection.
Article 5
Refuse, Recyclables, and Returnables
12VAC5-421-2590. Indoor
storage area. (Repealed.)
If located within the food
establishment, a storage area for refuse, recyclables, and returnables shall
meet the requirements specified under 12VAC5-421-2790, 12VAC5-421-2810 through
12VAC5-421-2880, 12VAC5-421-2930, and 12VAC5-421-2940.
Article 5
Refuse, Recyclables, and Returnables
12VAC5-421-2600. Outdoor
storage surface.
An outdoor storage surface
for refuse, recyclables, and returnables shall be constructed of nonabsorbent
material such as concrete or asphalt and shall be smooth, durable, and sloped
to drain.
12VAC5-421-2630. Receptacles
in vending machines.
A refuse receptacle shall
not be located within a vending machine, except that a receptacle for beverage
bottle crown closures may be located within a vending machine.
Except for a receptacle for
a beverage bottle crown closures, a refuse receptacle may not be located within
a vending machine.
Part VI
Physical Facilities
Article 1
Materials for Construction and Repair
12VAC5-421-2790. Indoor
areas; surface characteristics.
A. Except as specified in
subsection B of this section, materials for indoor floor, wall, and ceiling
surfaces under conditions of normal use shall be:
1. Smooth, durable, and easily cleanable for
areas where food establishment operations are conducted;
2. Closely woven and easily cleanable carpet
for carpeted areas; and
3. Nonabsorbent for areas subject to moisture
such as food preparation areas, walk-in refrigerators, warewashing areas,
toilet rooms, mobile food establishment servicing areas, and areas subject to
flushing or spray cleaning methods.
B. In a temporary food
establishment:
1. A floor may be concrete, if graded to
drain, machine-laid asphalt, or dirt or gravel if it is covered with mats,
removable platforms, duckboards, or other suitable approved materials
that are effectively treated to control dust and mud; and
2. Walls and ceilings may be constructed of a
material that protects the interior from the weather and windblown dust and
debris.
Article 2
Design, Construction, and Installation
12VAC5-421-2810. Floors,
walls, and ceilings -- cleanability.
Except as specified under
12VAC5-421-2840, the floors, floor coverings, walls, wall coverings, and
ceilings shall be designed, constructed, and installed so they are smooth and
easily cleanable, except that antislip floor coverings or applications may be
used for safety reasons.
Except as specified under
12VAC5-421-2840 and except for anti-slip floor coverings or applications that
may be used for safety reasons, floors, floor coverings, walls, wall coverings,
and ceilings shall be designed, constructed, and installed so they are smooth and
easily cleanable.
12VAC5-421-2920. Toilet
rooms, enclosed.
A toilet room located on the
premises shall be completely enclosed and provided with a tight-fitting and
self-closing door except that this requirement does not apply to a toilet room
that is located outside a food establishment and does not open directly into
the food establishment such as a toilet room that is provided by the management
of a shopping mall.
Except where a toilet room
is located outside a food establishment and does not open directly into the
food establishment such as a toilet room that is provided by the management of
a shopping mall, a toilet room located on the premises shall be completely
enclosed and provided with a tight-fitting and self-closing door.
12VAC5-421-2950. Outdoor
food vending areas, overhead protection.
If located outside, a
machine used to vend food shall be provided with overhead protection except
that machines vending canned beverages need not meet this requirement.
Except for machines that
vend canned beverages, if located outside, a machine used to vend food shall be
provided with overhead protection.
12VAC5-421-2960. Outdoor
servicing areas, overhead protection.
Servicing areas shall be
provided with overhead protection except that areas used only for the loading
of water or the discharge of sewage and other liquid waste, through the use of
a closed system of hoses, need not be provided with overhead protection.
Except for areas used only
for the loading of water or the discharge of sewage or other liquid waste,
through the use of a closed system of hoses, servicing areas shall be provided
with overhead protection.
Article 3
Numbers and Capacities
12VAC5-421-3010. Handwashing
lavatories, minimum number. (Repealed.)
Handwashing lavatories shall
be provided as specified under 12VAC5-421-2230.
Article 3
Numbers and Capacities
12VAC5-421-3020. Handwashing
cleanser, availability.
Each handwashing lavatory
sink or group of two adjacent lavatories handwashing sinks
shall be provided with a supply of hand cleaning liquid, powder, or bar soap.
12VAC5-421-3030. Hand drying
provision.
Each handwashing lavatory
sink or group of adjacent lavatories handwashing sinks
shall be provided with:
1. Individual, disposable towels;
2. A continuous towel system that supplies
the user with a clean towel; or
3. A heated-air hand drying device.
12VAC5-421-3040. Handwashing
aids and devices, use restrictions.
A sink used for food
preparation or utensil washing shall not be provided with the handwashing aids
and devices required for a handwashing lavatory sink as specified
under 12VAC5-421-3020 and 12VAC5-421-3030 and 12VAC5-421-2650 C.
12VAC5-421-3045. Handwashing
signage.
A sign or poster that
notifies food employees to wash their hands shall be provided at all
handwashing lavatories sinks used by food employees and shall be
clearly visible to food employees.
12VAC5-421-3050. Disposable
towels, waste receptacle. (Repealed.)
A handwashing lavatory or
group of adjacent lavatories that is provided with disposable towels shall be
provided with a waste receptacle as specified under 12VAC5-421-2650 C.
12VAC5-421-3060. Toilets
and urinals, minimum number. (Repealed.)
Toilets and urinals shall be
provided as specified under 12VAC5-421-2240.
12VAC5-421-3080. Lighting,
intensity.
The light intensity shall
be:
1. At least 10 foot candles (110 lux) (108
lux) at a distance of 30 inches (75 cm) above the floor, in walk-in
refrigeration units and dry food storage areas and in other areas and rooms
during periods of cleaning;
2. At least 20 foot candles (220 lux):
(215 lux):
a. At a surface where food is provided for
consumer self-service such as buffets and salad bars or where fresh produce or
packaged foods are sold or offered for consumption;
b. Inside equipment such as reach-in and under-counter
refrigerators;
c. At a distance of 30 inches (75 cm) above
the floor in areas used for handwashing, warewashing, and equipment and utensil
storage, and in toilet rooms; and
3. At least 50 foot candles (540 lux) at a
surface where a food employee is working with food or working with utensils or
equipment such as knives, slicers, grinders, or saws where employee safety is a
factor.
12VAC5-421-3110. Service
sinks, availability. (Repealed.)
A service sink or curbed
cleaning facility shall be provided as specified under 12VAC5-421-2250.
Article 4
Location and Placement
12VAC5-421-3120. Handwashing
lavatories, conveniently located. (Repealed.)
Handwashing lavatories shall
be conveniently located as specified under 12VAC5-421-2280.
Article 4
Location and Placement
12VAC5-421-3130. Toilet
rooms, convenience and accessibility.
Toilet rooms shall be
conveniently located and accessible to employees during all hours of operation.
Toilet rooms intended for use by customers shall not necessitate travel through
food preparation or handling areas.
12VAC5-421-3160. Refuse,
recyclables, and returnables -- receptacles, waste handling units, and
designated storage areas. (Repealed.)
Units, receptacles, and
areas designated for storage of refuse and recyclable and returnable containers
shall be located as specified under 12VAC5-421-2680.
12VAC5-421-3180. Cleaning,
frequency and restrictions.
A. The physical facilities
shall be cleaned as often as necessary to keep them clean.
B. Cleaning shall be done
during periods when the least amount of food is exposed such as after closing.
This requirement does not apply to cleaning that is necessary due to a spill or
other accident.
B. Except for cleaning that
is necessary due to a spill or other accident, cleaning shall be done during
periods when the least amount of food is exposed such as after closing.
12VAC5-421-3240. Maintaining
and using handwashing lavatories Cleaning of Plumbing Fixtures.
Handwashing lavatories shall
be kept clean, and maintained and used as specified under 12VAC5-421-2310. Plumbing fixtures such as
handwashing sinks, toilets, and urinals shall be cleaned as often as necessary
to keep them clean and maintained and used as specified under 12VAC5-421-2310.
12VAC5-421-3460. Medicines
-- restriction and storage.
A. Only those medicines that
are necessary for the health of employees shall be allowed in a food
establishment. This section does not apply to medicines that are stored or
displayed for retail sale.
B. Medicines that are in a
food establishment for the employees' use shall be labeled as specified under
12VAC5-421-3320 and located to prevent the contamination of food, equipment,
utensils, linens, and single-service and single-use articles.
A. Except for medicines that
are stored or displayed for retail sale, only those medicines that are
necessary for the health of employees shall be allowed in a food establishment.
B. Medicines that are in a
food establishment for the employees' use shall be labeled as specified under
12VAC5-421-3320 and located to prevent the contamination of food, equipment,
utensils, linens, and single-service and single-use articles.
12VAC5-421-3750.
Responsibilities of the permit holder.
Upon acceptance of the
permit issued by the regulatory authority, the permit holder in order to retain
the permit shall:
1. Post the permit in a location in the food
establishment that is conspicuous to consumers;
2. Comply with the provisions of this chapter
including the conditions of a granted variance as specified under 12VAC5-421-3590,
and approved plans as specified under 12VAC5-421-3610;
3. If a food establishment is required under
12VAC5-421-3620 to operate under a HACCP plan, comply with the plan as
specified under 12VAC5-421-3590;
4. Immediately contact the regulatory
authority to report an illness of a food employee as specified under 12VAC5-421-120
12VAC5-421-80 B;
5. Immediately discontinue operations and
notify the regulatory authority if an imminent health hazard may exist as
specified under 12VAC5-421-3910;
6. Allow representatives of the regulatory
authority access to the food establishment as specified under 12VAC5-421-3820;
7. Replace existing facilities and equipment
specified in 12VAC5-421-3510 with facilities and equipment that comply with
this chapter if:
a. The regulatory authority directs the
replacement because the facilities and equipment constitute a public health
hazard or nuisance or no longer comply with the criteria upon which the
facilities and equipment were accepted;
b. The regulatory authority directs the replacement
of the facilities and equipment because of a change of ownership; or
c. The facilities and equipment are replaced
in the normal course of operation;
8. Comply with directives of the regulatory
authority including time frames for corrective actions specified in inspection
reports, notices, orders, warnings, and other directives issued by the
regulatory authority in regard to the permit holder's food establishment or in
response to community emergencies;
9. Accept notices issued and served by the regulatory
authority according to law; and
10. Be subject to the administrative, civil,
injunctive, and criminal remedies authorized in law for failure to comply with
this chapter or a directive of the regulatory authority, including time frames
for corrective actions specified in inspection reports, notices, orders,
warnings, and other directives.
12VAC5-421-3815. Competency
of environmental health specialists.
An authorized representative
of the commissioner who inspects a food establishment or conducts plan review
for compliance with this chapter shall have the knowledge, skills, and ability
to adequately perform the required duties.
12VAC5-421-3860. Documenting
information and observations.
The regulatory authority
shall document on an inspection report form:
1. Administrative information about the food
establishment's legal identity, street and mailing addresses, type of
establishment and operation as specified under 12VAC5-421-3700, inspection
date, and other information such as type of water supply and sewage disposal,
status of the permit, and personnel certificates that may be required; and
2. Specific factual observations of violative
conditions or other deviations from this chapter that require correction by the
permit holder including:
a. Failure of the person in charge to
demonstrate the knowledge of foodborne illness prevention, application of HACCP
principles, and the requirements of this chapter specified under 12VAC5-421-60;
b. Failure of food employees and the person
in charge to demonstrate their knowledge of their responsibility to report a
disease or medical condition as specified under 12VAC5-421-110 and
12VAC5-421-120 12VAC5-421-80 B and D;
c. Nonconformance with critical items of this
chapter;
d. Failure of the appropriate food employees to
demonstrate their knowledge of, and ability to perform in accordance with, the
procedural, monitoring, verification, and corrective action practices required
by the regulatory authority as specified under 12VAC5-421-60;
e. Failure of the person in charge to provide
records required by the regulatory authority for determining conformance with a
HACCP plan as specified under subdivision 4 f of 12VAC5-421-3630; and
f. Nonconformance with critical limits of a
HACCP plan.
12VAC5-421-4040.
Investigation and control, obtaining information: personal history of illness,
medical examination, and specimen analysis.
The regulatory authority
shall act when it has reasonable cause to believe that a food employee has
possibly transmitted disease; may be infected with a disease in a communicable
form that is transmissible through food; may be a carrier of infectious agents
that cause a disease that is transmissible through food; or is affected with a
boil, an infected wound, or acute respiratory infection, by:
The regulatory authority
shall act when it has reasonable cause to believe that a food employee or
conditional employee has possibly transmitted disease; may be infected with a
disease in a communicable form that is transmissible through food; may be a
carrier of infectious agents that cause a disease that is transmissible through
food; or is affected with a boil, an infected wound, or acute respiratory
infection, by:
1. Securing a confidential medical history of
the employee suspected of transmitting disease or making other investigations
as deemed appropriate; and
2. Requiring appropriate medical
examinations, including collection of specimens for laboratory analysis, of a
suspected employee and other employees.
12VAC5-421-4050. Restriction
or exclusion of food employee, or summary suspension of permit.
Based on the findings of an
investigation related to a food employee or conditional employee who is
suspected of being infected or diseased, the regulatory authority may issue an
order to the suspected food employee, conditional employee, or permit
holder instituting one or more of the following control measures:
1. Restricting the food employee or
conditional employee;
2. Excluding the food employee or
conditional employee; or
3. Closing the food establishment by summarily
suspending a permit to operate in accordance with law.
12VAC5-421-4070. Release of
food employee from restriction or exclusion.
The regulatory authority
shall release a food employee from restriction or exclusion according to law
and the following conditions:
1. A food employee who was
infected with Salmonella typhi if the food employee's stools are negative for
S. typhi based on testing of at least three consecutive stool specimen cultures
that are taken:
a. Not earlier than one
month after onset ;
b. At least 48 hours after
discontinuance of antibiotics ; and
c. At least 24 hours apart;
and
2. If one of the cultures
taken as specified in subdivision 1 of this section is positive, repeat
cultures are taken at intervals of one month until at least three consecutive
negative stool specimen cultures are obtained.
3. A food employee who was
infected with Shigella spp. or Shiga toxin-producing Escherichia coli if the
employee's stools are negative for Shigella spp. or Shiga toxin-producing
Escherichia coli based on testing of two consecutive stool specimen cultures
that are taken:
a. Not earlier than 48 hours
after discontinuance of antibiotics; and
b. At least 24 hours apart.
4. A food employee who was
infected with hepatitis A virus if:
a. Symptoms cease; or
b. At least two blood tests
show falling liver enzymes.
The regulatory authority
shall release a food employee, or conditional employee from restriction or
exclusion according to law and the conditions specified under 12VAC5-421-100.
VA.R. Doc. No. R09-1079;
Filed July 31, 2009, 9:58 a.m.