Current through August 26, 2024
(1) CONSTRUCTION AND MAINTENANCE.
(a) Equipment and utensils, including C-I-P
systems, shall be of sanitary design and construction. Equipment and utensils,
including C-I-P systems installed after the effective date of this chapter,
shall comply with applicable "3-A Sanitary Standards" and "3-A Accepted
Practices" listed in ch. ATCP 65 Appendix A.
Note: The "3-A Sanitary Standards" and "3-A
Accepted Practices" listed in Appendix A are published by 3-A Sanitary
Standards, Inc., 1451 Dolley Madison Boulevard, Suite 210, McLean, VA
22101-3850, telephone (703) 790-0295, website www.3-a.org. Copies are on file with the division and
the legislative reference bureau and may be obtained from the "3-A Sanitary
Standards, Inc. Online Store" at http://www.techstreet.com.
(b) Equipment and utensils shall be readily
accessible for cleaning and inspection and shall be designed and constructed so
that they can be easily cleaned. Equipment and utensils shall be kept clean and
in good repair.
(c) Tanks, vats,
separators, and other containers used to store or process dairy products shall
be designed or equipped with appropriate devices to prevent surface
condensation and drainage from entering the container.
(d) Pipeline systems used to convey dairy
products shall contain no dead ends in which dairy products may collect.
Pipelines and other equipment shall be designed and constructed to prevent
cross-contamination between pasteurized dairy products, unpasteurized dairy
products, and cleaning and sanitizing solutions.
(e) If it is necessary to disassemble any
equipment or utensil to inspect a product contact surface, all tools needed for
the disassembly shall be readily available at the dairy plant.
(f) Water hoses used to wash dairy products
or add ingredient water to dairy products shall be constructed of approved food
grade materials and shall be used and stored in a sanitary manner.
(g) A dairy plant operator may use sanitary
flexible pipelines to transfer partially processed products in the intermediate
stages of production or to load and unload bulk loads of milk from transport
vehicles, if all the following apply:
1. The
use of rigid pipelines for that purpose in a sanitary manner is not possible
due to the location of walls, floors, ceiling or other equipment.
2. The dairy plant operator properly cleans
and sanitizes the flexible pipeline after completing the transfer of product,
or at least once during each day of use.
3. The operator uses only a length of
flexible pipeline necessary to conduct the transfer operation.
(2) PRODUCT CONTACT
SURFACES.
(a) Product contact surfaces of
equipment and utensils shall be made of materials that are smooth, impervious,
nontoxic, noncorrosive, nonabsorbent, and durable under foreseeable use
conditions. A product contact surface shall be constructed of one or more of
the following materials unless the division specifically authorizes another
material in writing:
1. Stainless steel of
the American Iron and Steel Institute 300 series, or an equally corrosion
resistant metal.
2. Heat resistant
glass.
3. Plastic, rubber, or
rubber-like materials that are fat resistant and insoluble; that are resistant
to scratching, scoring, decomposition, crazing, chipping, and distortion under
normal use conditions; that do not impart chemicals, flavor, or odor to milk;
and that maintain their original properties under conditions of repeated
use.
(b) Product contact
surfaces shall be easily cleanable and shall be free of breaks, open seams,
cracks, or similar defects. Product contact surfaces shall not impart any odor,
color, taste, or adulterating substance to food. Product contact surfaces,
other than product contact surfaces of approved C-I-P systems, shall be readily
accessible for manual cleaning. Joints and fittings shall be of sanitary design
and construction.
(3)
LOCATION AND INSTALLATION OF DAIRY PROCESSING EQUIPMENT.
(a) Dairy processing equipment shall be
located and installed to prevent overcrowding and to prevent contamination of
dairy products or product contact surfaces by splash, condensation, or manual
contact.
(b) Dairy processing
equipment that cannot be easily moved shall be installed in a manner that
prevents liquid or debris from accumulating under or around the
equipment.
(c) Dairy processing
equipment shall be installed so that there is adequate clearance on all sides
for cleaning and maintenance. This does not apply to that portion of a tank or
container that is designed to protrude into or through a wall or the ceiling of
a dairy plant.
(4) BULK
STORAGE TANKS; VENTING. A tank used for the bulk storage of milk, whey, or
liquid food products shall be equipped with an air filter to prevent
contamination of tank contents, or shall be vented only to one of the
following:
(a) A processing area.
(b) A tank gallery room that complies with
processing area sanitation standards under this chapter.
(5) MEASURING DEVICES AND CONTROLS.
(a) Every storage tank, freezer, and cold
storage compartment used to hold milk or dairy products shall be equipped with
a thermometer or other device that accurately indicates the temperature in the
storage tank, freezer, or compartment.
(b) Each of the following bulk storage tanks
shall be equipped with a 7-day temperature recording device that shows the
temperature of dairy products stored in that bulk storage tank:
1. Every bulk storage tank used to store
grade A milk or grade A dairy products for longer than 24 hours.
2. A silo tank installed after December 1,
1994.
(c) Instruments
and controls used for measuring, regulating, and recording temperature, pH,
acidity, water activity, or other conditions that control or prevent the growth
of undesirable microorganisms in milk or dairy products shall be accurate,
fully functional, and adequate for their intended use.
(6) LUBRICATION. Equipment shall be designed
and constructed so that gear and bearing lubricants do not come in contact with
milk or dairy products, ingredients, or product contact surfaces. Food grade
lubricants shall be used if there is any chance that lubricants may come in
contact with milk or dairy products, ingredients or product contact
surfaces.
(7) CLEANING AND
SANITIZING EQUIPMENT AND UTENSILS.
(a) A
dairy plant operator shall clean and sanitize product contact surfaces of
equipment and utensils to keep them at all times in sanitary condition.
Sanitizing methods shall comply with s.
ATCP 65.34.
(b)
Except as provided in pars. (c) to (f), a dairy plant operator shall at a
minimum clean all product contact surfaces of equipment and utensils after each
day's use, sanitize those surfaces before each day's use, and clean and
sanitize those surfaces before any change in use that may cross-contaminate
dairy products with major food allergens, as defined in s.
ATCP 70.02(29), or other
contaminants.
(c) A dairy plant
operator shall clean and sanitize tanks used to store liquid dairy products
whenever the dairy plant operator empties those tanks. Tanks used to store raw
milk or grade A dairy products shall be emptied at least once every 72
hours.
(d) A dairy plant operator
shall clean evaporators at the end of a continuous operation, not to exceed 44
hours.
(e) Paragraph (b) does not
apply to any of the following equipment, provided that the dairy plant operator
cleans and sanitizes the equipment according to manufacturer specifications or
a cleaning and sanitizing process approved under par. (f), and complying with
par. (a):
1. Drying equipment.
2. Cloth collector systems.
3. Dry product packaging equipment and
storage containers.
4. Equipment
used in brining, aging, curing, and dry product blending processes.
5. Reverse osmosis equipment that utilizes a
permeate stream from a previously pasteurized product that has passed through a
nanofiltration system achieving an efficiency of not more than 1,000
daltons.
6. Food contact surfaces
of equipment used only to process foods or food ingredients with water activity
not exceeding 0.85, or foods that are not potentially hazardous
foods.
7. Food contact surfaces
located downstream from the sterilization step in an aseptic processing and
packaging system, provided that system sterility is maintained. If system
sterility is not maintained, the surfaces shall be cleaned, sanitized, and
sterilized before processing.
(f) The division may authorize an alternative
cleaning and sanitizing schedule for continuously-operated equipment, in lieu
of the schedule under par. (b), based on a proposal under par. (g). The
division's authorization of a proposal for cleaning and sanitizing of equipment
in contact with grade A dairy products is contingent upon consultation with,
and acceptance of the proposal by, the US food and drug administration, and
shall be valid for 5 years. The division's authorization may be renewed after a
review requested in writing by the dairy plant operator. A dairy plant operator
shall adhere to the practices described in an approved proposal. A dairy plant
operator may not alter practices described in an approved proposal without
division approval. Division approval of a proposed changes for cleaning and
sanitizing of equipment in contact with grade A dairy products is contingent
upon consultation with, and acceptance of the changes by, the US food and drug
administration, and shall be valid for 5 years.
(g) A dairy plant operator's proposal, under
par. (f), shall include all of the following:
1. A complete description of the
continuously-operated equipment covered by the proposal, including relevant
design and sanitation features.
2.
A complete description of the processing, handling, or storage operations for
which the continuously-operated equipment is used. The description shall
identify the types of dairy products involved, and the type and duration of
continuous operations conducted.
3.
A complete description of the cleaning and sanitizing procedure proposed by the
dairy plant operator. The description shall include cleaning and sanitizing
frequency, cleaning and sanitizing methods and materials, and other relevant
process parameters such as time, temperature, and concentration. The
description shall include relevant process diagrams and
specifications.
4. A certification,
by the dairy plant operator, that the proposed cleaning and sanitizing
procedure complies with par. (a). The certification shall be based on a
thorough hazard analysis and safety assessment by qualified
personnel.
(h) A dairy
plant operator shall keep records to document, on an ongoing basis, the
operator's compliance with this subsection.
(8) STORING CLEAN EQUIPMENT AND UTENSILS.
Clean equipment and utensils, unless stored in an approved sanitizing solution,
shall be stored so that they drain dry. Utensils and equipment components
disassembled for cleaning shall be stored above the floor in metal racks or
other storage facilities which allow drainage. Clean equipment and utensils
shall be protected from contamination prior to use.
(9) SINGLE-SERVICE UTENSILS. Single-service
utensils shall be stored in the original containers in which they were
received, or in other closed containers that will protect them from
contamination until they are used. Single-service utensils shall not be
reused.
(10) CLEANING COMPOUNDS,
DETERGENTS, AND SANITIZERS; STORAGE AND LABELING. Cleaning compounds,
detergents, and sanitizers used in a dairy plant shall be clearly labeled. When
they are not being used, they shall be stored in designated areas and in an
appropriate manner so that they do not contaminate dairy products, ingredients,
equipment, or utensils.
