Current through Register Vol. 30, No. 38, September 20, 2024
A. Plant and Processing Standards.
1. The plant area shall be clean, orderly and
free from refuse, rubbish, smoke, dust, air pollution and strong or foul odors
originating on the premises. A drainage system shall be provided for the rapid
drainage of water away from the building. If unsatisfactory conditions occur in
the plant area, with respect to smoke, dust, air pollution, or odors, provision
shall be made to protect the frozen desserts and ingredients from
contamination.
2. Sewage and
industrial waste shall be disposed in accordance with the provisions of the
state or county environmental laws. Refuse, unless in appropriate containers,
shall not accumulate on the premises.
3. Roads, driveways, yards, and parking areas
adjacent to the plant shall be paved or treated to prevent dust and shall be
smooth and well drained to prevent accumulation of stagnant liquid.
4. Buildings.
a. The building exterior and interior shall
be kept clean and in good repair.
b. In processing and packaging areas, outside
doors, windows, skylights, transoms, or other openings shall be protected and
operated to preclude the entrance of dust, insects, vermin, rodents, and other
animals. Outside doors shall be self-closing wherever practical. Window sills
on new construction shall slope inward at least 45-degrees. Outside conveyor
openings and other outside openings shall be protected by doors, screens,
flaps, fans, or tunnels. Pipes shall be sealed where they extend through
exterior walls. Outside pipe openings shall be covered when not in
use.
c. Rooms. All rooms,
compartments, coolers, freezers, and dry storage space in which any raw
material, packaging or ingredient supplies, or finished products are handled,
processed, manufactured, packaged, or stored shall be constructed to ensure
clean and orderly operations.
i. Boiler and
tool rooms shall be separate from rooms where milk products are received, where
processing and packaging is done, or where equipment, facilities, and
containers are washed and stored.
ii. Toilets and dressing rooms shall be
conveniently located and toilets shall not open directly into any room where
milk products, ingredients, or frozen desserts are handled, processed,
packaged, or stored. Toilet and dressing room doors shall be self-closing.
Toilets and dressing rooms shall be well vented to the outer air, and contain
hand-washing facilities, hot and cold running water, soap, single-service
towels or air dryers. Hand-washing signs shall be posted. Fixtures shall be
kept clean and in good repair.
iii.
Rooms for receiving milk and other raw ingredients and materials shall be
separated from the processing area to avoid contamination of frozen desserts in
the processing operations, except that products in cans or other closed
containers may be received and transferred to a cooler or other storage without
being received in a separate room.
iv. If tank truck deliveries of milk, milk
products, or frozen desserts mix are made, other than occasional deliveries, a
tank truck room large enough to accommodate the entire truck shall be provided
with equipment for cleaning. A covered outside unloading pad may be used for
truck tankers with filter dome vents, if washing and sanitizing facilities are
provided. If a tank truck room is not located on the premises of an existing
plant, facilities for washing and sanitizing tank trucks shall be provided at
another location where the washing and sanitizing facility is free from dust
and extreme weather conditions.
v.
Except for existing processing and packaging rooms, there shall be at least
three feet clearance between installations and the wall to prevent overcrowding
and to facilitate cleaning. Existing facilities not meeting this requirement
shall be permitted if cleaning can be accomplished and permission is obtained
from the Dairy Supervisor or the Dairy Supervisor's designee. All processing
and packaging rooms shall be equipped with hand-washing facilities including
hot and cold running water, soap, single-service towels, or
air-dryer.
vi. Refrigeration rooms
and units shall be constructed of impervious material and shall be kept clean
and sanitary.
vii. Separate rooms
shall be provided so that the manufacturing, processing, and packaging are
separate from the cleaning and sterilizing of utensils and
containers.
viii. No person shall
reside or sleep in a frozen desserts plant or in any room connected with it. No
animal shall be kept or permitted in a frozen desserts plant.
d. Walls and ceilings shall be
constructed of smooth, washable, impervious material. They shall be
light-colored, kept clean and sanitary, and refinished when discolored. A
darker color material may be used to a height not exceeding 60 inches from the
floor.
e. Floors shall be an
impervious, smooth-surfaced material that may be flushed clean with water.
Except for hardening rooms, floors shall slope 3/16 to 1/4 inch per foot to one
or more trapped outlets. No open channel drainage is permitted in new
construction or in extensive remodeling of existing plants. Floor drains are
not required in freezers used for storing frozen desserts or frozen
ingredients. However, the floors shall be sloped to drain to at least one exit
and shall be kept clean. Floors in new construction or extensive remodeling
shall be joined and coved with the walls to form water-tight joints. Smooth
wood floors may only be permitted in rooms where there will be no spillage of
product or ingredients, such as rooms where wrapped or packaged frozen products
are packed in multiple-pack containers. Toilets and dressing rooms shall have
impervious floors and smooth walls.
f. Plumbing shall be installed to prevent
back-up of sewage or odors into the plant.
g. All rooms and compartments, including
storage space for materials, ingredients, and packages, and toilets and
dressing rooms, shall be ventilated to maintain sanitary conditions, and to
minimize or eliminate condensation and odors.
h. Lighting, whether natural or artificial,
shall be well distributed in all rooms and compartments. Light bulbs and
fluorescent tubes shall be protected so that broken glass cannot fall into any
product or equipment.
i. Rooms where frozen
desserts are handled, processed, manufactured, or packaged, or where equipment
or utensils are washed, shall have at least 30 footcandles of light on all
working surfaces;
ii. Areas where
dairy products are examined for condition and quality shall have at least 50
footcandles of light; and
iii. All
other rooms shall have at least 20 footcandles of light 30 inches above the
floor.
i. Containers for
collecting and holding waste other than dry waste paper and other dry packaging
material shall be constructed of metal or other impervious material, covered
with tight-fitting lids or covers, and emptied or disposed of daily or at least
once during the shift. Clothing, tools, equipment, and other material not used
with the frozen desserts operations shall not accumulate in the work areas or
in the storage rooms.
j. A room or
other space separate from any room or space where milk products or frozen
desserts are received, handled, processed, packaged, or stored, shall be
provided where employees may change and store clothing. This area shall contain
hand-washing facilities, with hot and cold running water, soap or other
detergents, and single-service towels or air dryers. Self-closing containers
shall be provided for used towels and other wastes.
k. Approval of plans. Plans shall be
submitted to the Dairy Supervisor, for any new or remodeled frozen dessert
manufacturer, to be reviewed for compliance with this Section. The Dairy
Supervisor may allow variances to the requirements in this Section, if
protection from contamination is provided for all products handled.
5. Water and steam.
a. Potable hot and cold water shall be
available in sufficient quantity for all plant operations and facilities.
Non-potable water may be used for boiler feed and condenser water, if the water
lines are separated from the water lines carrying the potable water supply and
the equipment is constructed to preclude contamination of any product or
product contact surface. If water for washing frozen desserts equipment and
utensils and for use in rehydration or as an ingredient in any frozen desserts
is obtained from other than a regulated municipal supply, a bacteriological
examination shall be made of the water supply at least once every six months by
a laboratory acceptable to the Dairy regulatory program to determine
potability. If the examination indicates contamination of the water supply, a
device shall be installed to eliminate the contamination.
b. If steam is used, it shall be provided in
sufficient volume and pressure for the operation of equipment or for
sterilization, or both. Steam that comes in contact with frozen desserts,
ingredients, or with the product contact surface, shall be steam of culinary
quality as prescribed in Appendix H, Part III, Culinary Steam - Milk and Milk
Products, of the PMO.
6.
Equipment and utensils.
a. New equipment
shall meet applicable 3-A Sanitary Standards. All equipment, including
connections, coming in contact with frozen desserts or ingredients during
processing, manufacturing, handling, or packaging, shall be made of stainless
steel. No equipment shall be permitted that is rusted, corroded, or in any
other condition that may result in contamination of the frozen desserts.
Non-metallic parts with product contact surfaces shall consist of material that
meets 3-A Sanitary Standards for Plastic or Rubber and Rubber-like Materials or
shall be of plastic approved by the United States Food and Drug Administration.
Equipment, apparatus, and piping shall be easily accessible for cleaning and
shall be kept in good repair and free from cracks and corroded surfaces.
Stationary equipment, including welded sanitary lines and apparatus that permit
in-place-cleaning, may be used if prior approval from the Dairy Supervisor has
been obtained. C-I-P piping and welded sanitary pipeline systems shall be
permitted if engineered and installed according to 3-A Accepted Practices for
Permanently Installed Sanitary Product and Solution Pipelines and Cleaning
Systems. If rigid pipelines are not practical, plastic pipelines listed in the
3-A Accepted Practices may be used. Product pumps shall be sanitary and easily
dismantled for cleaning or shall be constructed to allow C-I-P procedures. All
parts of interior surfaces of equipment, pipes (except C-I-P piping), or
fittings, including valves and connections shall be accessible for inspection.
The Dairy Supervisor may require other equipment, apparatus or piping if
stationary equipment, apparatus or piping cannot or is not being effectively
cleaned-in-place.
b. Equipment for
storage and distribution of liquid sweetening agents shall be constructed of
metals, alloys, or other material that will withstand corrosive action by the
ingredient. The equipment and the ingredients shall be protected from
contamination.
c. Pasteurizing
equipment shall meet the standards prescribed in the PMO and 3-A Accepted
Practices for Sanitary Construction, Installation, Testing and Operation of
High-Temperature-Short-Time Pasteurizers and 3-A Sanitary Standards for
Non-Coiled Type Batch Pasteurizers. Batch-type pasteurizers shall be provided
with close-coupled outlet valves protected against leakage and shall be
equipped with thermometers that record the information of each day's operation
on separate charts. Air space thermometers and indicating thermometers shall be
provided to check the recording thermometers. The recording thermometer chart
shall contain the date, the identity of the pasteurizing number, the batch and
product name, and the signature of the employee responsible for this
information. The record shall be kept on file at the plant for at least six
months. The accuracy of the recording thermometer shall be checked daily using
the indicating thermometer and the time and temperature shall be documented on
the recording chart. Chart recorders and thermometers for batch pasteurizers
shall be tested and sealed by the Dairy Supervisor or the Supervisor's designee
after testing and seals shall not be removed without immediately notifying the
Dairy Supervisor or the Supervisor's designee.
d. Every plant shall contain hardening rooms,
refrigerating rooms, or refrigerated cabinets with space for storage of frozen
desserts and perishable ingredients.
e. All utensils used in the receiving,
storing, processing, manufacturing, packaging, and handling of frozen desserts
or any ingredients shall be of smooth, stainless steel, or plastic listed in
the 3-A Accepted Practices and shall have flush seams. Utensils that are badly
worn, rusted, or corroded or that cannot be rendered clean and sanitary by
washing shall not be used. Lead solder shall not come in contact with milk or
milk products or frozen desserts.
7. Cleaning and sanitizing.
a. Cleaning and sanitizing. Equipment,
sanitary piping and utensils used in receiving, storing, processing,
manufacturing, packaging, and handling frozen desserts and ingredients, and all
product contact surfaces of homogenizers, high pressure pumps, packing glands
on agitators, pumps and vats, and lines shall be kept clean. Before use, all
equipment coming in contact with milk products or frozen desserts shall have a
bactericidal or sanitizing treatment. Equipment not designed for C-I-P cleaning
shall be disassembled, thoroughly cleaned and sanitized. Biodegradable dairy
cleaners, wetting agents, detergents, sanitizing agents, or other similar
material that does not adversely affect or contaminate the frozen desserts or
ingredients may be used. Steel wool or metal sponges shall not be used to clean
any equipment or utensils with product contact surfaces. C-I-P cleaning shall
be used only on equipment and pipeline systems designed, engineered, and
installed for that type of cleaning. Other equipment and areas in the plant
shall be thoroughly cleaned with appropriate methods that prevent potential
contamination of ingredients, packaging and frozen desserts. Exhaust stacks,
elevators and elevator pits, conveyors and similar facilities shall be
inspected and cleaned regularly.
b.
Equipment shall be sanitized by using one of the following methods:
i. Using 180° F water for at least two
minutes.
ii. Using steam under
pressure for at least two minutes or until all parts of the equipment being
sanitized have reached 180° F, or the condensate off the equipment remains
at 180° F for at least two minutes.
iii. Using chlorine with a residual of at
least 50 ppm after one minute contact with equipment, or if sprayed, with a
residual of at least 100 ppm after five minutes.
iv. Using any other sanitizing substance
prescribed in Appendix F of the PMO.
8. Pasteurization and cooling.
a. All frozen desserts mix, except for
flavoring agents used in frozen desserts, shall be pasteurized.
b. Frozen desserts mix shall be pasteurized
by heating every particle as described in Table 1:
Table 1 |
Batch (Vat) Pasteurization |
Temperature
|
Time
|
69ºC (155ºF)
|
30 minutes
|
Continuous Flow (HTST)
Pasteurization
|
Temperature
|
Time
|
80ºC (175ºF)
|
25 seconds
|
83ºC (180ºF)
|
15 seconds
|
89ºC (191°F)
|
1.0 seconds
|
90ºC (194°F)
|
0.5 seconds
|
94ºC (201°F)
|
0.10 seconds
|
96ºC (204°F)
|
0.05 seconds
|
100ºC (212°F)
|
0.01 seconds
|
c.
Continuous flow pasteurizers, high-temperature-short-time and
higher-heat-shorter-time, shall have all public health controls sealed against
access and alteration. The seals shall be applied by the Dairy Supervisor or
the Supervisor's designee after testing and shall not be removed without
immediately notifying the Dairy Supervisor or the Supervisor's designee. The
system shall be designed to meet the requirements of the PMO.
d. After pasteurization all mix shall be
cooled immediately to 45° F or less and shall be maintained at that
temperature until frozen. Milk, cream, and other fluid milk products other than
sterilized, evaporated or sweetened condensed milk in hermetically sealed
containers shall be stored at 45° F or less.
i. Refrigerated vehicles or approved
insulated containers shall be used when transporting frozen desserts mix from
the manufacturing or other plant to a retail manufacturer, and
ii. Mix shall be moved from coolers or
refrigeration units in a manufacturing plant to freezers by using pipes,
tubing, or other means listed in the Permanently Installed Product and Solution
Pipelines and Cleaning Systems Used in Milk and Milk Product Processing Plants
section of the 3-A Accepted Practices.
9. Storage.
a. Utensils and equipment. Utensils and
portable equipment used in processing, handling, or packaging of frozen
desserts shall be stored above the floor in clean, dry locations and in a
self-draining position on racks constructed of impervious, corrosion-resistant
material.
b. Supplies and
containers. Whenever possible, supplies shall be kept in a room separate from
the processing, handling, and packaging of frozen desserts and under conditions
that result in keeping the materials clean and free from dust, moisture,
insects, rodents, or other possible contamination. Supplies shall be arranged
to permit cleaning of the area and easy inspection and access. Insecticides and
rodenticides shall be plainly labeled, segregated, and stored in a separate
room or cabinet away from the edible material or packaging supplies. Caps,
parchment papers, wrappers, liners, gaskets, and single-service sticks, spoons,
covers, and containers for frozen desserts or ingredients shall be stored only
in sanitary tubes, wrappings, or cartons and kept in a clean, dry place until
used and shall be handled in a sanitary manner.
c. Raw milk products. Raw products for use in
frozen desserts that are conducive to bacterial growth shall be handled and
stored to minimize bacterial growth. When stored, raw products shall be
maintained at 45° F or lower until processing commences.
d. Non-refrigerated products. Products such
as non-fat dry milk and other frozen desserts ingredients that do not require
refrigeration for proper storing shall be placed in dry storage to be easily
accessible for inspection and removal, and for adequate cleaning of the room.
Dunnage, pallets or other similar method of elevation shall be used. Frozen
desserts or ingredients shall not be stored with any product that would damage
them or impair their quality. Opened containers of ingredients shall be
protected from contamination.
e.
Refrigerated products. All products that require refrigeration shall, except as
otherwise specified, be stored under conditions of temperature and humidity
that best maintain quality and condition. Products shall not be stored directly
on wet floors or be exposed to foreign odors or conditions such as dripping or
condensation that may cause package or product damage.
10. Notification of change in products to be
manufactured. Any person manufacturing only frozen desserts with butterfat, or
only frozen desserts with fats other than butterfat, and uses the other type of
fat shall first notify the Dairy Supervisor.
11. Clearing lines and equipment. If the same
equipment is used for processing, pasteurizing, and packaging frozen desserts
made with dairy products and frozen desserts made with vegetable fats, oils, or
proteins, any remaining product shall be completely removed from the lines and
equipment and sanitized before introducing another product into the lines and
equipment. All equipment and lines shall be sanitized either at the end or
beginning of each day's operations.
12. Packaging and containers.
a. Frozen desserts shall be packaged in
commercial containers using packaging material that protects the product from
contamination. The packaging, cutting, molding, dispensing, and other handling
or preparation of frozen desserts and their ingredients shall be in a sanitary
manner. Frozen dessert containers shall be filled at the place of
pasteurization using approved mechanical equipment. Existing manual processes
may be permitted if done in a manner that prevents all contact surface
contamination and is approved by the Dairy Supervisor.
b. Multi-use containers for frozen desserts
shall be kept clean and dry. If used for transporting frozen desserts, the
containers shall be:
i. Rinsed immediately
after emptying,
ii. Cleaned upon
return to the plant, and
iii.
Protected from contamination during storage.
c. Metal cans and containers shall be free
from rust and corrosion.
d. Paper
and plastic containers, liners, covers, or other materials coming in contact
with frozen desserts shall be free from contamination.
e. Single-service containers shall not be
reused.
B.
Personnel.
1. Plant employees shall wash
their hands before beginning work and upon returning to work after using toilet
facilities, eating, smoking, or otherwise soiling their hands. Employees shall
keep their hands clean and follow good hygienic practices while on duty.
Expectorating or using tobacco in rooms or compartments where frozen desserts
or ingredients are exposed is prohibited. Clean, white, or light-colored,
washable outer garments shall be worn by all employees engaged in handling
dairy products, mix or frozen desserts. Hair coverings for head and facial hair
shall be worn by all employees engaged in the processing, pasteurizing,
packaging, handling, and storage of frozen desserts, product containers, and
utensils.
2. Frozen desserts shall
be handled so that there is no direct contact between an employee's hands and
the product.
3. A person who has a
discharging or infected wound, sore or lesion on hands, arms or other exposed
portions of the body shall not work in any plant processing or packaging room
or in any capacity resulting in contact with milk products or frozen desserts
or equipment used in the processing or handling of milk products or frozen
desserts. An employee returning to work following illness from a communicable
disease shall provide a certificate from a physician attesting to the
employee's complete recovery before processing or handling milk products or
frozen desserts.
C.
Quality standards.
1. Milk products used in
the manufacture of frozen desserts shall meet the following standards:
Product
|
Standard Plate Count Not to
Exceed
|
Raw Milk
|
500,000 per ml.
|
Pasteurized Milk
|
50,000 per ml.
|
Raw Cream
|
500,000 per ml.
|
Pasteurized Cream 100,000 per ml.
2. Butter, 80% cream, plastic cream, mixtures
of butterfat, sugar or sweetening agent, moisture and flavoring, condensed
milk, mixes and all other similar products shall meet the following standards:
Bacterial Standards
|
Not to Exceed
|
Standard Plate Count
|
50,000 per gram
|
Coliform Count
|
20 per gram
|
Yeast Count
|
50 per gram
|
Mold Count
|
50 per gram
|
3.
Powdered non-fat dry milk, dry whey, and dry buttermilk shall meet the PMO
standards.
4. Fats and oils other
than from milk shall meet the standards of the United States Food, Drug and
Cosmetic Act as amended, or those of any applicable state regulation for fats
and oils of food grade standards.
5. Frozen desserts in broken or opened
containers or in containers from which the product has been partially used may
be returned to the plant for examination but shall not be used or sold for
making frozen desserts.
6. All
reconstituted frozen desserts shall be pasteurized before packaging.