This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 901:11-2-01 | Definitions.
Effective:
February 21, 2016
As used in rules 901:11-2-01 to 901:11-2-44 of the
Administrative Code: (A) "Cleaned-in-place" and its
acronym "CIP" means the procedure by which sanitary pipelines or
pieces of dairy equipment are mechanically cleaned in place by
circulation. (B) "Dairy farm" and
"farm" means a place or premise where one or more lactating animals
(cows, goats, sheep, water buffalo, or other hooved mammals) are kept for
milking purposes and from which a part of all of the milk or milk products are
provided, sold, or offered for sale to a manufacturing plant, receiving
station, or transfer station. (C) "Dairy plant" and
"plant" means any place, premise, or establishment where milk or
dairy products are received or handled for processing or manufacturing and/or
prepared for distribution. When "plant" is used in connection with
the production, transportation, grading, or use of milk, it means any plant
that handles or purchases milk for manufacturing purposes; when used in
connection with requirements for plants or licensing or registration of plants,
it means only those plants that manufacture dairy products. (D) "Dairy product" means
butter, natural cheese, processed cheese, dry whole milk, nonfat dry milk, dry
buttermilk, dry whey, evaporated whole milk evaporated skim milk, condensed
whole milk and plain condensed skim milk, sweetened condensed skim milk, and
such other products, for human consumption, as may be otherwise
designated. (E) "Director" means the
director of the Ohio department of agriculture or official, employee, or
contractor of the department designated by the director of
agriculture. (F) "Drug" means: (1) Articles recognized
in the official United States pharmacopoeia, official homeopathic pharmacopoeia
of the United States, or official national formulary; (2) Articles intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
man or other animals; (3) Articles (other than
food) intended to affect the structure or any function of the body of man or
other animals; and (4) Articles intended for
use as a component of any articles specified in paragraph (F)(1), (F)(2) or
(F)(3) of this rule, but does not include devices or their components, parts or
accessories. (G) "Excluded milk" means all
of a producer's milk excluded from the market by the provisions of rule
901:11-2-02 of the Administrative Code. (H) "License" or
"registration" means a license or registration issued by the director
as provided in section 917.09 of the Revised Code. (I) "Milk" means the lacteal
secretion practically free of colostrum obtained by the complete milking of one
or more lactating animals (cows, goats, sheep, water buffalo, or other hooved
mammals). The milk shall only be used to manufacture dairy products, as defined
in this rule, or recognized as non-standardized traditional products normally
manufactured from a specific breed's milk. (J) "Milk for manufacturing
purposes" means milk produced for processing and intended for
manufacturing into products for human consumption and is not subject to grade A
requirements. (K) "Official Methods" means
the "Official Methods of Analysis of the AOAC International (OMA)"
18th edition, Dr. William Horsitz, editor, published by AOAC International,
Suite 500, 481 North Frederick Ave., Gaithersburg, Maryland 20877-2417 USA
which can be found at http://www.aoac org/. (L) "PMO" means the grade A
pasteurized milk ordinance as adopted in rules 901:11-1-01 to 901:11-1-05 of
the Administrative Code. (M) "Producer" means the person who holds a license
from the Ohio department of agriculture to produce milk for manufacturing
purposes. (N) "Standard Methods" means
the "Standard Methods for the Examination of Dairy Products (SMEDP),"
17th edition, 2004, edited by H. Michael Wehr, PhD and Joseph F. Frank, PhD,
American public health association, 800 I Street, N.W. Washington, DC 02001
which can be found at http://www.apha.org/.
Last updated February 6, 2024 at 9:38 AM
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Rule 901:11-2-02 | Quality requirements.
(A) Acceptability of raw milk from each
producer shall be based on a visual examination for appearance and odor or by
an acceptable test procedure for bacterial count, somatic cell count, and drug
residue test as specified in rules 901:11-2-03 to 901:11-2-05 of the
Administrative Code. (B) The appearance of acceptable raw milk
shall be normal and free of excessive coarse sediment. The milk shall not show
any abnormal condition including but not limited to: curdled, ropy, bloody, or
mastitic. When milk is tested for sediment and the sediment exceeds the
following United States department of agriculture standards, the milk shall be
considered as adulterated: (1) No. 1 acceptable -
not to exceed 0.50 mg. or equivalent. (2) No. 2 acceptable -
not to exceed 1.50 mg. or equivalent. (3) No. 3 probational,
not over a ten day period - not to exceed 2.50 mg. or equivalent. (4) No. 4 reject,
considered to be adulterated - over 2.50 mg. or equivalent. (C) Adulterated milk may be embargoed by
the director and disposed of in accordance with section 917.02 of the Revised
Code. (D) Methods for determining the sediment
content of the milk of individual producers shall be those described in the
standard methods. Sediment content shall be based on comparison with applicable
charts of the United States sediment standards for milk and milk products which
are found in Title 7 C.F.R. parts 58-134 (2011). (E) The odor shall be fresh and sweet. The milk shall be free
from objectionable feed and other off-odors that would adversely affect the
finished product. (F) Lactating animals which show evidence of the secretion of
abnormal milk in one or more quarters based upon bacteriological, chemical, or
physical examination shall be milked last or with separate equipment, and the
milk shall be discarded. Lactating animals treated with, or lactating animals
which have consumed chemical, medicinal, or radioactive agents which are
capable of being secreted in the milk and which in the judgement of the
director, may be deleterious to human health, shall be milked last or with
separate equipment, and the milk disposed of as the director may direct. In
making determinations regarding the impact of radioactive agents on human
health, the director may consult with the director of health. (G) A plant, hauler, or weigher, sampler, or tester shall reject
specific producer raw milk if the milk fails to meet the requirements for
appearance and odor or if the milk tests positive for drug
residue. (H) All rejected milk shall be identified either with a reject
tag or colored with harmless food coloring. (I) A plant shall not accept milk from a producer
if: (1) Three of the last
five milk samples have exceeded the maximum bacterial count as specified in
rule 901:11-2-03 of the Administrative Code; (2) Three of the last
five milk samples have exceeded the maximum somatic cell count as specified in
rule 901:11-2-04 of the Administrative Code; or (3) The producer's
last milk sample was positive on a drug residue test as specified in rule
901:11-2-05 of the Administrative Code. (J) Quality testing of milk from new producers, producers whose
license or registration has been suspended, or transfer producers shall meet
the requirements in this rule for the items listed in paragraphs (J)(1) to
(J)(4) of this rule. Thereafter, each milk shipment shall meet the requirements
of acceptable milk, and be tested in accordance with the provisions of rules
901:11-2-03 to 901:11-2-05 of the Administrative Code. (1) Acceptable raw
milk; (2) Bacterial
count; (3) Somatic cell count;
and, (4) Drug residue
level. (K) Prior to receipt of the first shipment of milk from a
producer whose milk shipment is shifted from one plant to another plant, the
processor shall make a request to the director for the following information
and may receive the producer's milk if: (1) The producer holds a
valid, active license or registration as set forth in rule 901:11-1-04 of the
Administrative Code; and (2) The last shipment of
milk received from the producer by the former plant meets the requirements
for: (a) Acceptable milk; (b) Bacterial count; (c) Somatic cell count; and (d) Drug residue level.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-03 | Bacterial count.
Effective:
February 21, 2016
(A) During at least four separate months
within any consecutive six month period, each dairy plant or co-operative
association shall collect and submit individual producer raw milk samples to a
laboratory for examination to determine the bacterial count of the samples.
Samples shall be representative of all raw milk shipped from bulk tanks and all
raw milk received in cans. (B) Samples shall be analyzed at a
laboratory approved by the director, and the laboratory results shall be
transmitted to the department as requested by the director. Each
producer's raw milk sample shall be tested for bacterial count using one
of the following methods: (1) Direct microscopic
clump count; (2) Standard plate
count; (3) Plate loop
count; (4) Pectin gel plate
count; (5) Petrifilm
aerobic count; (6) Spiral plate
count; (7) Hydrophobic grid
membrane filter count; (8) Impedance/conductance
count; (9) Any method listed in
the standard methods, as defined in rule 901:11-2-01 of the Administrative
Code; or (10) Any equivalent
method approved by the director. (C) Milk shall not exceed the following
bacterial standards: (1) Milk shipped from the
farm in a bulk milk tank shall not have a raw milk bacteria count of more than
five hundred thousand bacteria per mL. (2) Milk shipped from the
farm in cans shall not have a raw milk bacteria count of more than one million
bacteria per mL. (D) Whenever the producer's raw milk bacteria count
exceeds the standards in paragraph (C) of this rule, the producer shall be
notified of the excessive bacteria count. (E) Whenever two of the last four
bacteria counts exceed the bacteria standard as stated in paragraph (C) of this
rule, the director shall send a written warning notice to the producer. The
notice shall be in effect so long as two of the last four consecutive samples
exceed the bacterial standard. (F) An additional sample shall be taken no sooner than
three days and no later than twenty-one days after sending of the warning
notice required in paragraph (E) of this rule. If this sample also exceeds the
bacteria standard as established in paragraph (C) of this rule, the producer
license or registration shall be suspended until satisfactory compliance is
obtained. Shipment may be resumed and the producer license or registration
reinstated by the director when an additional sample of the producer raw milk
is tested and found satisfactory. The producer license or registration shall
remain in a warning status as long as two of the last four bacteria counts
exceed the standard. The director shall suspend the producer license or
registration immediately for at least seven days, in accordance with section
917.22 of the Revised Code, whenever three of the last five bacteria counts
within any twelve month period exceed the standard. (1) The director shall
suspend the producer license or producer registration for at least fourteen
consecutive days, in accordance with section 917.22 of the Revised Code,
whenever a second suspension occurs within any twelve month
period. (2) The director shall
suspend the producer license or producer registration for at least thirty
consecutive days, in accordance with section 917.22 of the Revised Code,
whenever three or more suspensions occur within any twelve month
period. (3) Somatic cell limit
violations shall not be included in paragraph (D) of rule 901:11-2-03 of the
Administrative Code.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-04 | Somatic cell count.
Effective:
February 21, 2016
(A) During at least four separate months
within any consecutive six month period, each dairy plant or co-operative
association shall collect and submit producer raw milk samples to a laboratory
for examination to determine the somatic cell count of the samples. Samples
shall be representative of all raw milk shipped from bulk tanks and received in
cans. (B) The somatic cell standard for
acceptable raw milk shall be the lesser of one million or two hundred fifty
thousand per mL. more than the standard adopted in the PMO. Goat milk shall
remain at the same level as adopted in the PMO. (C) A screening test may be conducted on
goat herd milk. When a goat herd screening sample exceeds either of the
following screening test results, a confirmatory test shall be conducted using
either: (1) The California
mastitis test - weak positive CMT 1; or (2) The Wisconsin
mastitis test - WMT value of 18 mm. (D) Samples shall be analyzed at a
laboratory approved by the director and the laboratory results shall be
transmitted to the department as requested by the director. Each
producer's raw milk sample shall be tested for somatic cell count using
one of the following methods, any other method listed in the standard methods,
or by any other equivalent method approved by the director: (1) Direct microscopic
somatic cell count (single strip procedure). Pyronin Y-methyl green stain or
"New York" modification shall be used for goat milk; (2) Electronic somatic
cell count; (3) Flow
cytometry/opto-electronic somatic cell count; or (4) Membrane filter DNA
somatic cell count. (E) The results of the confirmatory test
on goat milk for somatic cells shall be the official results. (F) Whenever the producer raw milk
somatic cell count exceeds the standard established in paragraph (B) of this
rule, the following procedures shall be applied: (1) The producer shall be
notified of an excessive somatic cell count; and, (2) Whenever two of the
last four somatic cell counts exceed the somatic cell standard as stated in
paragraph (B) of this rule, the director shall send a written warning notice to
the producer. The notice shall be in effect so long as two of the last four
consecutive samples exceed the somatic cell standard. (G) An additional sample shall be taken
no sooner than three days and no later than twenty-one days after sending of
the warning notice. If this sample also exceeds the somatic cell standard, the
producer license or registration shall be suspended until satisfactory
compliance is obtained. Shipment may be resumed and the producer license or
registration reinstated by the director when an additional sample of the
producer raw milk is tested and found satisfactory. The producer license or
registration shall remain in a warning status as long as two of the last four
somatic cell counts exceed the standard. The director shall suspend the
producer license or registration immediately for at least one day, in
accordance with section 917.22 of the Revised Code, whenever three of the last
five somatic cell counts within any twelve month period exceed the
standard. (1) The director shall
suspend the producer license or producer registration for at least seven
consecutive days, in accordance with section 917.22 of the Revised Code,
whenever a second suspension occurs within any twelve month
period. (2) The director shall
suspend the producer license or producer registration for at least fourteen
consecutive days, in accordance with section 917.22 of the Revised Code,
whenever a third suspension occurs within any twelve month period. (3) The director shall
suspend the producer license or producer registration for at least thirty
consecutive days, in accordance with section 917.22 of the Revised Code,
whenever four or more suspensions occur within any twelve month
period. (4) Bacteria limit
violations shall not be included in paragraph (G) of rule 901:11-2-04 of the
Administrative Code.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-05 | Drug residue level.
Effective:
February 21, 2016
(A) Dairy plant responsibilities. (1) Sampling and testing
program: (a) All raw milk shipped for processing or intended to be
processed on the farm where it was produced shall be sampled and tested, prior
to processing, and all individual producer raw milk samples submitted to an
approved laboratory for examination to determine bacteria and somatic cell
counts shall also be tested for beta lactam drug residue. Collecting, handling
and testing of samples shall be done according to procedures approved by the
director, and the laboratory results shall be transmitted to the department as
requested by the director; (b) When so specified by the director, all raw milk shipped for
processing, or intended to be processed on the farm where it was produced,
shall be sampled and tested, prior to processing, and all individual producer
raw milk samples submitted to an approved laboratory for examination to
determine bacteria and somatic cell counts shall also be tested for other drug
residues. Collecting, handling and testing of samples shall be done according
to procedures approved by the director, and the laboratory results shall be
transmitted to the department as requested by the director; (c) When the director determines that a potential problem exists
with an animal drug residue or other contaminant in the milk supply, additional
sampling and additional testing shall be conducted, as ordered by the director.
The testing shall continue until such time that the director determines with
reasonable assurance that the potential problem has been remedied;
and (d) The dairy plant shall analyze samples for beta lactams and
other drug residues by methods evaluated by the association of official
analytical chemists, which can be found at http://www.aoac.org/, and accepted
by the director as effective in determining compliance with established
"safe levels" or tolerances as established and amended by the United
States food and drug administration. The dairy plant may employ on a temporary
basis other test methods determined to demonstrate accurate compliance results.
These test methods may be used until they are evaluated by the AOAC and
accepted or rejected by the director. (2) Individual producer
sampling: (a) For bulk milk a milk sample for beta lactam drug residue
testing shall be taken at each farm and shall include milk from each farm bulk
tank; (b) For can milk a milk sample for beta lactam drug residue
testing shall be formed separately at the receiving plant for each can milk
producer included in a delivery, and shall be representative of all milk
received from the producer; or (c) For producer/processor a milk sample for beta lactam drug
residue testing shall be formed separately according to paragraphs (A)(2)(a)
and (A)(2)(b) of this rule for milk produced or received by a
producer/processor. (3) Load sampling and
testing: (a) For bulk milk a load sample shall be taken from the bulk
milk pickup tanker after its arrival at the plant and prior to further
commingling; (b) For can milk a load sample representing all of the milk
received on a shipment shall be formed at the plant, using a sampling procedure
that includes milk from every can on the vehicle; or (c) For producer/processor a load sample shall be formed at the
plant using a sampling procedure that includes all milk produced and
received. (4) Sample and record retention. A load
sample that tests positive for drug residue shall be retained according to
guidelines established by the appropriate state regulatory agency. The records
of all sample test results shall be retained for a period of not less than
twelve months. (5) Dairy plant follow-up: (a) When a load sample tests positive for drug residue, dairy
plant personnel shall notify the director immediately, in accordance with state
policy, of the positive test result and of the intended disposition of the
shipment of milk containing the drug residue. All milk testing positive for
drug residue shall be disposed of in a manner that removes it from the human or
animal food chain, except when acceptably reconditioned under United States
food and drug administration compliance policy guidelines; (b) Each individual producer sample represented in the
positive-testing load sample shall be individually tested in a laboratory
approved by the director to determine the producer of the milk sample testing
positive for drug residue. Identification of the producer responsible for
producing the milk testing positive for drug residue, and details of the final
disposition of the shipment of milk containing the drug residue, shall be
reported immediately to the director, according to state policy;
and (c) Milk shipment from the producer identified as the source of
milk testing positive for drug residue shall cease immediately and may resume
only after a sample from a subsequent milking does not test positive for drug
residue. (B) Regulatory agency responsibilities. (1) Monitoring and surveillance. The
director shall monitor the milk industry's drug residue program by
conducting unannounced on-site inspections to observe testing and sampling
procedures and to collect samples for comparison drug residue testing. In
addition, the director shall review industry records for compliance with state
policy. The review shall seek to determine that: (a) Each producer is included in an effective routine drug
residue milk monitoring program utilizing the official methods and federal drug
administration approved methods to test samples for the presence of drug
residue; (b) The director receives prompt notification from industry
personnel of each occurrence of a sample testing positive for drug residue, and
of the identity of each producer identified as a source of milk testing
positive for drug residue; (c) The director receives prompt notification from industry
personnel of the intended and final disposition of milk testing positive for
drug residue, and that disposal of the load is conducted in a manner that
removes it from the human or animal food chain, except when acceptably
reconditioned under federal drug administration compliance policy guidelines;
and, (d) Milk shipment from a producer identified as a source of milk
testing positive for drug residue completely and immediately ceases until a
milk sample taken from the dairy herd does not test positive for drug
residue. (2) Enforcement: (a) The director may deny, suspend or revoke the producer's
license or registration for violation of this rule; (b) The producer shall review the "Milk and Dairy Beef Drug
Residue Prevention" manual with a licensed veterinarian within thirty days
after each occurrence of shipped milk testing positive for drug residue. A
validation form confirming that the "Milk and Dairy Beef Drug Residue
Prevention" manual has been reviewed and that a valid veterinary
client-patient relationship exists shall be signed by the responsible producer
and a licensed veterinarian. The validation form shall be submitted to the
director after the manual has been reviewed; and (c) If a producer ships milk testing positive for drug residue
three times within a twelve month period, the director may revoke the
producer's license or registration.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-06 | Radionuclides.
Effective:
February 21, 2016
Composite milk samples from selected areas in the
state should be tested for biologically significant radionuclides at a
frequency which the director determines to be adequate to protect the
consumer.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-07 | Pesticide and herbicide.
Effective:
February 21, 2016
Composite milk samples should be tested for
pesticides and herbicides at a frequency which the director determines is
adequate to protect the consumer. The test results from the samples shall not
exceed established food and drug administration limits.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-08 | Added water.
Effective:
February 21, 2016
(A) Added water is considered to be an
adulteration of the product. Producer milk samples may be tested for added
water to establish a cryoscope herd history for the producer. The director
shall send the producer a written warning when the cryoscope reading exceeds
five per cent added water above the established herd history. The warning shall
be in effect for one year from the date of the warning letter. The director
shall immediately suspend the producer license or registration for adulteration
with added water when the cryoscope reading exceeds five per cent above the
established herd history on the second occasion. (B) If the director determines that a
producer, processor, or hauler has purposefully caused the milk or milk product
to be adulterated, the director may immediately suspend the license or
registration of the producer, processor, or hauler pursuant to section 917.22
of the Revised Code.
Last updated February 6, 2024 at 9:39 AM
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Rule 901:11-2-09 | Health of herd.
Effective:
February 21, 2016
(A) All animals in the herd shall be
maintained in a healthy condition. (B) All milk for manufacturing shall be
from herds which are located in an accredited free state or modified accredited
tuberculosis area, as determined by the United States department of
agriculture. Herds located in an area that fails to maintain accredited status
shall have passed an annual tuberculosis test. (C) All milk for manufacturing shall be
from herds under a brucellosis eradication program which meets one of the
following conditions: (1) The herd is located
in a certified brucellosis-free area as defined by the United States department
of agriculture and is enrolled in the testing program for the
area; (2) The herd meets United
States department of agriculture requirements for an individually certified
herd; (3) The herd participates
in a milk ring testing program at least two times per year at approximately one
hundred eighty day intervals and all herds with positive milk ring results
shall have the entire herd blood tested within thirty days from the date of the
laboratory ring test; or (4) The herd has an
individual blood agglutination test annually with an allowable maximum grace
period not exceeding two months. (D) Goat, sheep, water buffalo, or any
other hooved mammal milk for pasteurization, ultrapasteurization, or aseptic
processing shall be from a herd or flock that: (1) Has passed an annual
whole herd or flock brucellosis test as recommended by the state veterinarian
or United States department of agriculture area veterinarian in
charge; (2) Has passed an initial
whole herd brucellosis test, followed only by testing replacement animals or
any animals entering the milking group or sold as dairy animals; (3) Has passed an annual
random blood testing program sufficient to provide a confidence level of
ninety-nine per cent with a P value of 0.05. Any herd or flock with one or more
confirmed positive animals shall go to one hundred percent testing until the
whole herd tests shows no positive animals are found; or (4) Has passed a United
States department of agriculture approved bulk milk test at the recommended
frequency with implementation date based on availability of the
test. (E) Regardless of location or other herd status, a milk producer
whose herd: (1) Has a suspicious milk
ring test result shall have the entire herd blood tested within thirty days
after the date of the laboratory test. (2) Is identified as the
origin of a brucellosis reactor animal shall have the entire herd blood tested
within thirty days after the laboratory tests, unless the test requirement has
been waived by an epidemiological investigation conducted by the
director. (3) Is identified as the
origin of a tuberculosis reactor or suspect, shall follow all statutes, rules,
and recommendations of the Ohio department of agriculture concerning the
testing and disposition of animals in the herd. (F) For diseases other than brucellosis and tuberculosis,
the director may require appropriate physical, chemical, or bacteriological
tests. The diagnosis of other diseases in dairy cattle shall be based upon test
results and the diagnosis of a licensed veterinarian or a veterinarian in the
employ of a governmental agency. The milk producer shall dispose of any animal
diagnosed as being diseased in accordance with applicable laws and
rules.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-10 | Milking facility and housing.
Effective:
February 21, 2016
(A) The milking barn, stable, or parlor
shall be of a size and arrangement that will promote a sanitary milking
operation. It shall be provided with natural or artificial light, well
distributed for day or night milking and have sufficient air space and air
circulation to prevent condensate and excessive odors. The floors and gutters
shall be in good repair and constructed of concrete or other impervious
material. Concentrates and feed, when stored in the milking facility, shall be
kept in a tightly covered box or bin. The facility shall be kept clean, the
manure removed daily and no swine or fowl shall be permitted in any part of the
milking facility. (B) If milk is exposed in the milking
facility, it shall be protected in a manner that prevents any contamination of
the milk, equipment, containers, or utensils. No milk shall be strained,
poured, transferred, or stored unless it is properly protected from
contamination. (C) Milk stools, surcingles and
antikickers shall be kept clean and stored off the floor. (D) The cowyard, housing area or loafing
area shall be of ample size to prevent overcrowding, shall be kept clean and
drained to prevent forming of standing water pools, insofar as practicable. The
dairy animals shall be prevented from having any access to stored or
accumulated manure.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-11 | Milking procedure.
Effective:
February 21, 2016
(A) The milk producer shall ensure that
milking is done only in the milking barn, stable, or parlor. The flanks,
udders, bellies, and tails of all milking animals shall be free from visible
dirt. All brushing shall be completed prior to milking. The udders and teats of
all milking animals shall be clean and dry before milking. The milk producer
shall ensure that the animals' teats are treated with a sanitizing
solution just prior to the time of milking and shall be dry before milking.
Wet-hand milking is prohibited. (B) The milker's outer clothing
shall be clean. Hands shall be clean and dry immediately before milking and
performing any milkhouse function, and prior to resuming any of these
activities if interrupted. No person with an infected cut or open sore on their
hands or arms shall milk dairy animals, or handle milk, milk containers,
utensils or equipment. (C) Dairy animals which secrete abnormal
milk, shall be milked last or with separate equipment. (D) Dusty operations should not be
conducted immediately before or during milking. Strong flavored feeds should
only be fed after milking.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-12 | Cooling.
Effective:
February 21, 2016
(A) A manufacture milk producer shall do
one of the following: (1) In the case of
manufacture milk that is stored in cans on a manufacture milk producer's
farm, cool the milk to and store it at a temperature of sixty degrees
Fahrenheit (sixteen degrees Celsius) or lower within two hours after completion
of the milking; or (2) In the case of
manufacture milk that is stored in a bulk tank on the manufacture milk
producer's farm, cool the milk to and store it at a temperature of fifty
degrees Fahrenheit (ten degrees Celsius) or lower within two hours after
completion of the milking. (B) Manufacture milk stored in accordance
with paragraph (A)(1) of this rule shall be used exclusively in the manufacture
of cheese. (C) This rule does not apply to raw milk
that is delivered to a manufacture milk plant not later than two hours after
completion of milking.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-13 | Milkhouse or milkroom.
Effective:
February 21, 2016
(A) A milkhouse or milkroom shall be
provided for handling and cooling milk and for washing, handling, and storing
the utensils and equipment. Other products shall not be handled or other
activities performed in the milkroom which would be likely to contaminate milk
or otherwise create a public health hazard. (B) The milkhouse or milkroom that is a
part of the barn or other building shall be partitioned and sealed to prevent
the entrance of dust, flies, or other contamination. The floor of the milkhouse
or milkroom shall be of concrete or other impervious material and graded to
drain so that there are no pools of standing water. The walls and ceilings
shall be constructed of smooth easily cleaned material. All newly constructed
milkhouses shall have walls and ceilings constructed of smooth material kept in
good repair and well painted with a light-colored washable paint or finished in
an equally suitable manner. All outside doors shall open outward and be
self-closing, unless they are provided with tight-fitting, self-closing, screen
doors that open outward or unless other effective means are provided to prevent
the entrance of flies or insects. A direct opening between the milkhouse or
milkroom and the milking barn, stable, or parlor is permitted when the opening
has a tight fitting, self-closing, solid door. The milkhouse or milkroom shall
have sufficient air space and air circulation to prevent condensate and
excessive odors. It shall be provided with natural or artificial light well
distributed for day or night milkhouse activities. (C) The milkhouse or milkroom shall be
equipped with a two-compartment wash vat, utensil rack, milk cooling facilities
and have an adequate supply of hot water available for cleaning milking
equipment. If a farm bulk milk tank is used, it shall be situated in the
milkhouse or milkroom to allow access to all areas of the milkhouse or milkroom
and to the exterior of the bulk milk tank for cleaning and servicing. The farm
bulk milk tank shall not be located over a floor drain or under a
ventilator. (D) The truck approach to the milkhouse
or milkroom shall be properly graded and surfaced to prevent mud or pooling of
water at point of loading. The transferring of milk from a farm bulk milk tank
to a transport tank is through a hose port located in the milkhouse wall. The
port shall be fitted with a tight door which shall be in good repair. It shall
be kept closed when the port is not in use. An easily cleanable surface shall
be constructed under the hose port, adjacent to the outside wall, and
sufficiently large to protect the milk hose from contamination. (E) The milkhouse or milkroom shall be
kept clean and free of trash. Animals and fowl shall not be allowed access to
the milkhouse or milkroom at any time.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-14 | Farm chemicals and animal drugs.
Effective:
February 21, 2016
(A) Animal biologics and other drugs
intended for treatment of animals, and insecticides approved for use in dairy
operations, shall be clearly labeled and used in accordance with label
instructions. (B) Only drugs that are approved by the
food and drug administration or biologics approved by the United States
department of agriculture for use in dairy animals that are properly labeled
according to the food and drug administration or the United States department
of agriculture regulations shall be administered to such animals. (C) When drug storage is located in the
milkroom, milkhouse, or milking area, the drugs shall be stored on a shelf or
in a storage unit and shall be stored in a manner which will prevent accidental
contact with milk and milk contact surfaces. Such drugs shall further be
segregated in such a way so that drugs labeled for use in lactating dairy
animals are separated from drugs labeled for use in non-lactating dairy
animals. (D) Drugs labeled for use in non-dairy
animals shall not be stored with drugs labeled for use in dairy animals. When
drugs labeled for use in non-dairy animals are stored in the barn, the drugs
shall be located in an area of the barn separate from the milking
area. (E) Herbicides, fertilizers, pesticides,
and insecticides that are not approved for use in dairy operations shall not be
stored in the milkhouse, milkroom, or milking area.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-15 | Utensils and equipment.
Effective:
February 21, 2016
(A) Utensils, milk cans, milking
machines, pipeline systems, and other equipment used in the handling of milk
shall be maintained in good condition, shall be free from rust, open seams,
milkstone, or any unsanitary condition, and shall be washed, rinsed, and
drained after each milking, stored in suitable facilities, and sanitized
immediately before use with at least fifty parts per million chlorine solution
or a sanitizing solution listed in 21 C.F.R. 178.1010 (2014) that is used in
accordance with label directions. New or replacement can lids shall be umbrella
type. All new utensils and equipment shall comply with applicable 3-A sanitary
standards. (B) Farm bulk milk tanks shall meet 3-A
sanitary standards for construction at the time of installation and shall be
installed in accordance with rule 901:11-2-13 of the Administrative
Code. (C) Single service articles shall be
properly stored and shall not be reused.
Last updated February 6, 2024 at 9:40 AM
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Rule 901:11-2-16 | Water supply.
Effective:
February 21, 2016
The dairy farm water supply shall be properly
located, protected, and operated, and shall be easily accessible, ample, and of
safe, sanitary quality for the cleaning of dairy utensils and equipment. The
water supply shall come from a source which is approved by the state regulatory
authority; or from a spring, dug well, driven well, bored well, or drilled
well, the water from which complies with Chapter 3701-28 of the Administrative
Code. A source that does not conform with the construction requirements of the
state regulatory authority, but is tested annually by a laboratory approved by
the director and found to be safe and of sanitary quality, as outlined in
Chapter 3701-28 of the Administrative Code, shall be satisfactory. Provided,
that after adoption of this regulation any new sources of water supply or any
farm water supply requiring repairs or reconstruction or any source from which
tested samples have been found unsatisfactory shall meet the construction
requirements of Chapter 3701-28 of the Administrative Code.
Last updated February 6, 2024 at 9:41 AM
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Rule 901:11-2-17 | Sewage disposal.
Effective:
February 21, 2016
House, milkhouse, milkroom, and toilet wastes shall
be disposed of in a manner that will not pollute the soil surface, contaminate
any water supply, or be exposed to insects.
Last updated February 6, 2024 at 9:41 AM
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Rule 901:11-2-18 | Qualifications for license or registration.
Effective:
February 21, 2016
(A) No person shall be issued a producer
or processor license or registration unless they are in compliance with rules
901:11-2-01 to 901:11-2-44 of the Administrative Code. (B) The licensed dairy farm or dairy
plant shall be inspected annually after the initial licensing
inspection. (C) Any license or registration issued
under this rule may be denied, suspended, or revoked as specified in paragraph
(J) of rule 901:11-1-04 of the Administrative Code. All proceedings under
Chapter 917. of the Revised Code are subject to Chapter 119. of the Revised
Code.
Last updated February 6, 2024 at 9:41 AM
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Rule 901:11-2-19 | Premises of milk plants.
Effective:
February 21, 2016
(A) The premises shall be kept in a clean
and orderly condition, and shall be free from strong or foul odors, smoke, or
excessive air pollution. Driveways and adjacent plant traffic areas shall be
constructed of concrete, asphalt, or similar material and maintained to keep
dust and mud to a minimum. (B) The adjacent plant surroundings shall
be free from refuse, rubbish, and waste materials to prevent the harborage of
rodents, insects, and other vermin. (C) A suitable drainage system shall be
provided which will allow rapid drainage of all water from plant buildings and
driveways, including surface water around the plant and on the premises. All
water shall be disposed of in a manner as to prevent a nuisance or health
hazard.
Last updated February 6, 2024 at 9:41 AM
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Rule 901:11-2-20 | Buildings.
Effective:
February 21, 2016
The building or buildings shall be of sound
construction and shall be kept in good repair to prevent the entrance or
harborage of rodents, birds, insects, vermin, and other animals. Any openings
around service pipes through outside walls shall be effectively sealed around
the openings or sealed with tight metal collars. (A) All openings to the outer air
including doors, windows, skylights, and transoms shall be effectively
protected or screened to prevent the entrance of flies and other insects,
rodents, birds, dust, and dirt. All outside doors opening into processing rooms
shall be in good condition and fit properly. All hinged, outside screen doors
shall open outward. All doors shall be tight-fitting and self-closing. All
doors and windows shall be kept clean and in good repair. Outside conveyor
openings and other special-type outside openings shall be effectively protected
to prevent the entrance of flies and rodents by means of doors, screens, flaps,
fans, or tunnels. Outside openings for sanitary pipelines shall be covered when
not in use. On new construction, window sills should be slanted downward at an
angle of forty-five degrees. (B) The walls, ceilings, partitions,
posts of rooms in which milk or dairy products are processed, manufactured,
handled, packaged, or stored (except dry storage of packaged finished products
and supplies) or in which utensils are washed and stored, shall have a smooth
finish with a suitable material of light color, which is substantially
impervious to moisture and shall be kept clean. These surfaces shall be
refinished as often as necessary to maintain a neat, clean
surface. (C) Floors: (1) The floors of all
rooms in which milk or dairy products are processed, manufactured, packaged, or
stored or in which utensils are washed shall be constructed of tile properly
laid with impervious joint material, concrete, or other equally impervious
material. The floors shall be smooth, kept in good repair, and graded so that
there will be no pools of standing water or milk products after flushing.
Drains shall be equipped with traps properly constructed and shall be kept in
good repair. On new construction, bell-type traps shall not be used. The
plumbing shall be installed to prevent the backup of sewage into the drain
lines and onto the floor of the plant. (2) Sound, smooth wood
floors which can be kept clean may be used in rooms where new containers,
supplies and designated packaged finished products are stored. (D) Lighting and
ventilation: (1) Light shall be ample
and well distributed. All rooms in which dairy products are manufactured or
packaged or where utensils are washed shall have at least thirty foot-candles
of light intensity on all working surfaces and at least fifty foot-candles of
light intensity in areas where dairy products are graded or examined for
condition and quality. In all other rooms, there shall be at least five
foot-candles of light intensity when measured at a distance of thirty inches
from the floor. Where contamination of product by broken glass is possible,
light bulbs, fluorescent tubes, skylights, or other fixtures over the product
shall be protected against breakage. (2) There shall be
adequate heating, ventilation, or air conditioning in all to facilitate
maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods, or
temperature and humidity control facilities shall be provided as needed to
minimize or eliminate undesirable room temperatures, objectionable odors,
moisture condensation, or have an atmosphere relatively free from mold (not
exceeding ten mold colonies per cubic foot of air). Inlet fans shall be
screened and should be provided with an adequate air filtering device to
eliminate dirt and dust from incoming air. Ventilation systems shall be cleaned
periodically and shall be maintained in good repair. Exhaust outlets shall be
screened or be provided with self-closing louvers to prevent the entrance of
insects when not in use. (E) Rooms in which any raw materials,
packaging materials, ingredient supplies, or dairy products are handled,
manufactured, packaged, or stored shall be designed, constructed, and
maintained to assure desirable room temperatures and enhance clean, orderly
operating conditions free from objectionable odors and vapors. Enclosed bulk
milk receiving rooms when present shall be separated from the processing rooms
by a partition. Rooms for receiving can milk shall be separated from processing
rooms by a partition (partial or complete), by suitable arrangement of
equipment, or by allowing enough distance between receiving and processing
operations to avoid possible contamination of milk or dairy products during
manufacturing and handling. Processing rooms shall be kept free from equipment
and materials which are not routinely used. (1) Coolers and freezers
used for storage of dairy products shall be clean, reasonably dry and
maintained at proper uniform temperature and humidity levels by providing
adequate circulation of air at all times to protect the product and minimize
mold growth. Coolers and freezers shall be free from rodents, insects and
pests. Shelves shall be kept clean and dry. Refrigeration units shall have
provisions for the collection and disposal of condensate. (2) Supply rooms used for
the storage of packaging materials, containers, and miscellaneous ingredients
shall be kept clean, dry, orderly, free from insects, rodents, and mold and
maintained in good repair. Such items stored therein shall be adequately
protected from dust, dirt, or other extraneous matter and so arranged on racks,
shelves, or pallets to permit access to the supplies and to permit cleaning and
inspection of the room. Insecticides, rodenticides, cleaning compounds, and
other nonfood products shall be properly labeled and segregated, and stored in
a separate room or cabinet away from milk, dairy products, ingredients, or
packaging supplies. (3) Boiler and tool rooms
shall be separated from other rooms where milk and dairy products are
processed, manufactured, packaged, handled, or stored. Such rooms shall be kept
orderly and reasonably free from dust and dirt. (4) Toilet and dressing
room facilities shall be conveniently located to all processing
operations. (a) Toilet rooms shall not open directly into any room in which
milk or dairy products are processed, manufactured, packaged or stored. Doors
shall be self-closing. Ventilation shall be provided by mechanical means or by
screened openings to the outer air. Fixtures including but not limited to
toilet stools, sinks, lights and lockers, shall be kept clean and in good
repair. (b) If employees are furnished with a locker or other storage
facility, the lockers or other storage facilities shall be kept clean and
orderly. Adequate hand-washing facilities shall be provided as specified in
paragraph (B) of rule 901:11-2-21 of the Administrative Code. Durable, legible
signs shall be posted conspicuously in each toilet or locker room directing
employees to wash their hands before returning to work. (5) Adequate sanitary
facilities shall be provided for the handling of starter cultures.
Last updated February 6, 2024 at 9:58 AM
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Rule 901:11-2-21 | Facilities.
Effective:
February 21, 2016
(A) The water supply for the plant shall
be properly located, protected, and operated and shall be easily accessible,
ample, and of safe, sanitary quality for the cleaning of utensils and
equipment: (1) There shall be an
ample supply of safe hot and cold water. Adequate facilities shall be provided
for proper distribution of water throughout the plant and the water shall be
protected against contamination. Water from other facilities, when officially
approved, may be used for boiler feed water and condenser water provided that
such waterlines are completely separated from the waterlines carrying the
sanitary water supply, and the equipment is constructed and controlled as to
preclude contamination of product contact surfaces. There shall be no cross
connection between the safe water supply and any unsafe or questionable water
supply, or any other source of pollution through which contamination of the
safe water supply is possible. The director shall make bacteriological
examinations of the sanitary water supply and the recirculated water supply at
least twice a year, or as often as necessary to determine purity and
suitability for use in manufacturing dairy products. The processor shall keep
on file a copy of all water test results for a period of one year;
and (2) The location,
construction and operation of the water supply shall come from a source which
is approved by the state regulatory authority; or from a spring, dug well,
driven well, bored well, or drilled well, the water must comply with the
requirements found in appendices D and G of the PMO. (B) Convenient hand-washing facilities
shall be provided, including hot and cold running water, soap or other
detergents, and sanitary single-service towels or air dryers. Such facilities
shall be located in or adjacent to toilet and dressing rooms and also at other
places in the plant convenient to all personnel handling dairy products. Vats
for washing equipment or utensils shall not be used as hand-washing facilities.
Metal or plastic containers shall be provided for used towels and other wastes.
Waste containers located in the plant shall be covered. (C) Steam shall be supplied in sufficient
volume and pressure for the satisfactory operation of each applicable piece of
equipment. Culinary steam used in direct contact with milk or dairy products
shall be free from harmful substances or extraneous material, only nontoxic
boiler compounds shall be used, or a secondary steam generator shall be used in
which soft water is converted to steam and no boiler compounds are used. Steam
traps, strainers, and condensate traps shall be used wherever applicable to
insure a satisfactory and safe steam supply. Culinary steam shall comply with
appendix H of the PMO. (D) The method for supplying air under
pressure which comes in contact with milk or dairy products or any product
contact surface shall comply with the 3-A accepted practices for supplying air
under pressure. The air used at the point of application shall be free from
volatile substances, which may impart any flavor or odor to the products, and
extraneous or harmful substances. (E) Dairy wastes shall be properly
disposed of from the plant and premises. Waste containers located outside the
plant shall be covered. The sewer system shall have sufficient slope and
capacity to readily remove all liquid waste from the processing operations.
Where a public sewer is not available, all liquid wastes shall be properly
disposed of in a manner not to contaminate milk equipment or to create a
nuisance or public health hazard. Containers used for the collection and
holding of solid wastes shall be constructed of metal, plastic, or other
equally impervious material and shall be kept covered with tight fitting lids.
These containers shall be placed outside the plant on a concrete slab or on a
rack raised at least twelve inches above the ground. Alternatively waste
containers may be kept inside a suitably enclosed, clean and fly proof room.
Solid wastes shall be disposed of regularly and the containers shall be cleaned
before reuse. Accumulation of dry wastepaper and cardboard shall be kept to a
minimum. Paper burned at the plant shall be done in a properly constructed
incinerator. The waste paper and cardboard may also be compressed or bagged and
hauled away. (F) Water reclaimed from the condensing
of milk and dairy products shall comply with the specifications outlined in
appendix D of the PMO. Reclaimed water which meets category I requirements may
be used for the purposes of sanitizing product contact surfaces and
equipment.
Last updated February 6, 2024 at 9:58 AM
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Rule 901:11-2-22 | Equipment and utensils.
Effective:
February 21, 2016
(A) All equipment and utensils used for
the processing of milk and manufacturing of dairy products shall be constructed
in a manner to be readily demountable when necessary for cleaning, sanitizing,
and inspection. The product contact surfaces of all utensils and equipment
shall be constructed of stainless steal or of other equally corrosion-resistant
material. Nonmetallic parts, other than glass, having product contact surfaces
shall meet the 3-A sanitary standards for plastic or rubber and rubberlike
materials. (B) All equipment and piping shall be
designed and installed to be easily accessible for cleaning and shall be kept
in good repair, free from cracks and corroded surfaces. New or rearranged
equipment shall be set away from walls or spaced in such a manner to facilitate
proper cleaning. All parts or interior surfaces of equipment, pipes (except
certain piping cleaned in place) or fittings, including valves and connections,
shall be accessible for inspection. Milk and dairy product pumps shall be of
sanitary design and easily dismantled for cleaning or shall be of specially
approved construction to allow effective cleaning-in-place. (C) All CIP systems shall comply with the
3-A sanitary practices for permanently installed sanitary product, pipelines,
and cleaning systems for those CIP circuits that can not be readily
inspected. (D) Weigh cans and receiving tanks shall
meet the 3-A sanitary standards and be protected sufficiently with the
necessary covers or baffles to prevent contamination from splash, condensate,
and drippage. The cans and tanks shall be easily accessible for cleaning and
shall be elevated above the floor to provide easy access for the cleaning of
floors and adjacent wall areas. (E) Can rinsers shall have sufficient
capacity and ability to provide thoroughly rinsed, dry cans and covers. Rinsers
shall be maintained in a clean and satisfactory operating condition and shall
be kept free from accumulation of scale or debris which adversely affects the
efficiency of the rinser. (F) Product storage tanks shall be fully
enclosed or tightly covered and be well insulated. The entire interior surface,
agitator and all appurtenances shall be accessible for thorough cleaning and
inspection. Any opening or vent at the top of the tank including the entrance
of the agitator shaft shall be suitably protected against the entrance of dust,
moisture, insects, oil, or grease. Sight glasses, if used, shall be clean, and
in good repair. Tanks which have hinged covers shall be so designed that
moisture or dust on the surface cannot enter the tank when the covers are
raised. (1) If the storage tanks
are equipped with air agitation, the system shall be of an approved type and
properly installed in accordance with the 3-A accepted practices for supplying
air under pressure. (2) Storage tanks
intended to hold product for longer than eight hours shall be equipped with
refrigeration and/or be insulated in order to hold the product at the required
product temperature. (3) All new storage tanks
shall meet the appropriate 3-A sanitary standards and shall be equipped with
thermometers in good repair. (G) Surface coolers shall be equipped
with hinged or removable covers for the protection of the product. The edges of
the fins shall be so designed as to divert condensate on non-product contact
surfaces away from product contact surfaces. All gaskets or swivel connections
shall be leak proof. (H) Vacuum chambers shall be constructed
in a manner to facilitate cleaning and all product contact surfaces shall be
accessible for inspection. A vacuum chamber shall be equipped with a vacuum
breaker and a check valve on the product discharge line. Only steam which meets
the requirements of culinary steam shall be used. The incoming steam supply
shall be regulated by an automatic solenoid valve which will cut off the steam
supply in the event the flow diversion device of the high-temperature,
short-time (HTST) pasteurizer is not in the forward flow position. When
condensers are used they shall be equipped with a water level control and an
automatic safety shutoff valve. (I) Hot wells shall be enclosed or
covered and shall be equipped with an indicating thermometer either in the hot
well or in the hot milk inlet line to the hotwell. If used for holding high
heat products, a hot well shall also have a temperature recorder. (J) Open-type evaporators and/or vacuum
pans shall be equipped with an automatic condenser water level control,
barometric leg, or so constructed so as to prevent water from entering the
product, and shall meet the applicable 3-A sanitary standards. When
enclosed-type condensers are used, no special controls are necessary to prevent
water from entering the product. (K) If product, including foam, held in
the surge tank is not maintained at a minimum of one hundred fifty degrees
Fahrenheit, then two or more surge tanks shall be installed to permit flushing
and cleaning during processing. Such tanks shall be completely emptied and
washed after each four hours of operation or less. Covers easily removable for
cleaning shall be provided and used at all times. (L) High pressure lines may be
cleaned-in-place and shall be of such construction that dead ends, valves, and
high pressure pumps can be disassembled for manual cleaning. New high pressure
pumps shall meet the 3-A sanitary standards regarding homogenizers and high
pressure pumps of the plunger type. (M) Spray dryers shall be of continuous
discharge type construction. All joints and seams in the product contact
surfaces shall be welded and ground to a smooth finish. All dryers shall be
constructed to facilitate ease in cleaning and inspection. Sight glasses of
sufficient size shall be located at strategic positions. Dryers shall be
equipped with air intake and exhaust recording thermometers. In gas-fired
dryers, precautions shall be taken to assure complete combustion. (N) Air filter system intake media shall
consist of fiberglass with a downstream backing dense enough to prevent
fiberglass break off from passing through, or cotton flannel, wool flannel,
spun metal, activated carbon, activated alumina, non-woven fabric, absorbent
cotton fiber, electrostatic or other materials which under conditions of
intended use are non-toxic, non-shedding and which do not release to the
atmosphere, toxic volatiles, or volatiles which may impart any flavor or odor
to the product. Filtering media or devices shall prevent the entrance of
foreign substances into the drying chamber. The filtering system shall be
cleaned or the component parts shall be replaced as often as necessary to
maintain a clean air supply. Air shall be drawn into the dryer from sources
free from objectionable odors, smoke, dust, or dirt. (O) The drums of a roller dryer shall be
smooth, readily cleanable, and free of pits and corrosion. The knives shall be
maintained in a condition not to cause scoring of the drums. The end boards
shall have an impervious surface and be readily cleanable. They shall be
provided with a means of adjustment to prevent leakage and accumulation of milk
solids. The stack, the hood, the drip pan inside of the hood, and related
shields shall be constructed of stainless steel and shall be readily cleanable.
The lower edge of the hood shall be constructed to prevent condensate from
entering the product zone. The hood shall be properly located and the stack
shall be of adequate capacity to remove the vapors. The stack shall be closed
when the dryer is not in operation. The augers shall be of stainless steel
construction or be properly plated, and shall be readily cleanable. The auger
troughs and related shields shall be constructed of stainless steel and be
readily cleanable. All air entering the dryer room shall be filtered to
eliminate dust and dirt. The filter system shall consist of filtering media or
a device that will effectively, and in accordance with good manufacturing
practices, prevent the entrance of foreign substances into the drying room. The
filtering system shall be cleaned and component parts replaced as often as
necessary to maintain a clean and adequate air supply. All dryer adjustments
shall be made and the dryer shall be operating normally before food grade
powder can be collected from the dryer. (P) Collectors and conveyors shall be
constructed of stainless steel or equally noncorrosive material and be
constructed to facilitate cleaning and inspection. Filter sack collectors, if
used, shall be in good condition and the system shall be of such construction
that all parts are accessible for cleaning and inspection. (Q) Dry dairy product cooling equipment
shall be provided with sufficient capacity to cool the product to one hundred
twenty degrees Fahrenheit or lower immediately after removal from dryer and
prior to packaging. If bulk bins are used, the product should be cooled to
approximately ninety degrees Fahrenheit but shall not be more than one hundred
twenty degrees Fahrenheit. A dry air supply, that meets the requirements of
paragraph (N) of this rule, shall be provided where air cooling and conveying
is used. (R) Each plant handling dry milk products
shall be equipped with a heavy duty industrial vacuum cleaner. A regular
schedule shall be established for its use in vacuuming applicable
areas. (S) Brine tanks used for the treating of
parchment liners shall be constructed of noncorrosive material, have a safe
means of heating the salt solution for the treatment of the liners, and shall
be provided with a satisfactory drainage outlet. (T) Churn salt brine vats shall be
constructed of stainless steel or equally corrosion-resistant metal and shall
be constructed according to applicable 3-A sanitary standards. The vats shall
be in good repair and equipped with tight-fitting lids.
Last updated February 6, 2024 at 9:58 AM
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Rule 901:11-2-23 | Protection and transport of raw milk and cream.
Effective:
February 21, 2016
(A) Equipment and
facilities: (1) Milk cans used in
transporting milk from the dairy farm to the plant shall meet the requirements
of utensils and equipment as specified in rule 901:11-2-15 of the
Administrative Code. (2) New farm bulk tanks
shall meet the 3-A sanitary standards for construction and shall be installed
in accordance with the requirements of the director. (B) Transporting milk or
cream: (1) Vehicles used for the
transportation of can milk or cream shall be of the enclosed type, constructed
and operated to protect the product from extreme temperature, dust, or other
adverse conditions and shall be kept clean. Cans or bulk tanks on vehicles
which are used for the transportation of milk from the farm to the plant shall
not be used for any other purpose. (2) The exterior shell of
the farm bulk milk transport tanks shall be clean and free from open seams or
cracks which would permit liquid to enter the jacket. The interior shell shall
consist of stainless steel and constructed so that it will not buckle, sag, or
prevent complete drainage. All product contact surfaces shall be smooth, easily
cleaned, and maintained in good repair. The pump and hose cabinet shall be
fully enclosed with tight-fitting doors and the inlet and outlet shall be
provided with dust covers to provide adequate protection from road dust. New
and replacement farm bulk milk transport tanks shall meet the 3-A sanitary
standards for milk transport tanks. (C) Enclosed or covered facilities shall
be available for cleaning and sanitizing of farm bulk milk transport tanks,
piping and accessories, at central locations or at all plants that receive or
ship milk or dairy products in transport tanks. (D) Transfer of milk to transport tanks
shall be transferred under sanitary conditions from farm bulk tanks through
stainless steel piping or approved tubing. The ends of the sanitary piping and
tubing shall be capped when not in use.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-24 | Raw product storage.
Effective:
February 21, 2016
(A) All milk shall be held and processed
under conditions and at temperatures that will prevent contamination and rapid
deterioration. Drip milk from can washers or any other sources shall not be
used for the manufacture of dairy products. Bulk milk in storage tanks within
the dairy plant shall be handled in such a manner as to minimize bacterial
levels and shall be maintained at fifty degrees Fahrenheit or lower until
processing begins. This does not preclude holding milk or whey at higher
temperatures for a period of time, where applicable, for specific manufacturing
or processing practices. (B) The bacteriological level of raw
commingled milk in storage tanks shall be one million per mL or
lower. (C) Whenever the commingled raw milk
bacterial count indicates the presence of more than one million per mL, the
following procedures shall be applied: (1) The processor shall
be notified in writing of an excessive bacterial count and the director may
initiate an investigation to determine the cause; (2) Processor license
action shall be taken only if the investigation reveals the cause of the
commingled raw milk bacterial count violation is a result of a problem that can
be controlled by the processor; and (3) The processor license
or registration may be reinstated by the director when the cause of the
violation has been corrected.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-25 | Quality, composition and wholesomeness.
Effective:
February 21, 2016
(A) All necessary precautions shall be
taken to prevent contamination or adulteration of the milk or products during
manufacturing. All substances and ingredients used in the processing or
manufacturing of any dairy product shall be subject to inspection and shall be
wholesome and free from impurities. All finished products shall comply with the
requirements of the Federal Food, Drug, and Cosmetic Act (2004) as to
composition and wholesomeness. (B) Chlorinating facilities shall be
provided for butter wash water if needed and all other necessary precautions
shall be taken to prevent contamination of products. (C) The director may sample product as
often as necessary to ensure microbiological control. All samples shall be
collected and held in substantial compliance with the standard methods as
defined in rule 901:11-2-01 of the Administrative Code. (D) All necessary precautions shall be
taken throughout the entire manufacturing operation to prevent the adulteration
of one product with another. The commingling of one type of liquid or dry
product with another shall be considered as an adulteration of that product.
This does not prohibit the normal standardization of similar products in
accordance with good manufacturing practices or the production of specific
products for special uses, provided applicable labeling requirements are
met. (E) All products sampled and tested by
the director shall meet the specifications for that product as specified in the
code of federal regulations. The director may remove or embargo product offered
for sale that has been determined to be a public health risk. Product
determined to be improperly labeled shall not be offered for sale until the
product has been properly labeled as specified in rule 901:11-2-42 of the
Administrative Code. (F) All finished products sampled and
tested by the director shall not exceed total coliform, Escherichia coli and
Escherichia coli O157:H7 standards established by the department. (1) The director shall
order a stop sale on a product lot when the lot sample exceeds five hundred
p/mL total coliform and one hundred p/mL Escherichia coli. The lot shall remain
on hold until the department has completed an official laboratory analysis of a
second sample from the same lot. (2) When a second sample
from the same lot exceeds five hundred p/mL total coliform, one hundred p/mL
Escherichia coli and the presence of Escherichia coli O157:H7 is detected, the
lot shall be destroyed.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-26 | Pasteurization, sterilization and cooking.
(A) When pasteurization is intended or
required, or when a product is designated "pasteurized" every
particle of the product shall be subjected to temperatures and holding periods
that will assure proper pasteurization of the product. When product is desired
to be heat-treated, the product shall be heated to temperatures greater than
one hundred twenty-five degrees Fahrenheit but less than one hundred sixty-one
degrees Fahrenheit, provided, cream may be heated further to less than one
hundred sixty-six degrees Fahrenheit in a continuous heating process and
immediately cooled to forty-five degrees Fahrenheit or less when necessary for
enzyme deactivation for a functional reason. (B) Pasteurization shall comply with the
applicable specifications of item 16p of the PMO. The recording and indicating
thermometers of heat-treating devices shall be checked by the director as often
as required. Nothing in this rule shall be construed as barring any other
pasteurization process that has been recognized by the food and drug
administration to be equally effective and which is approved by the
director. (C) The phenol value of test samples of a
pasteurized finished product shall be no greater than the maximum specified for
that product as determined and specified by the phosphatase test method
prescribed in the official methods. (D) All milk, buttermilk, and whey used
in the manufacture of dry dairy products shall be pasteurized at the plant
where dried. Milk or skim milk to be used in the manufacturing of nonfat dry
milk shall be pasteurized prior to condensing. Condensed skim manufactured from
pasteurized skim milk may be transported to a drying plant, provided, the
condensed skim milk is effectively repasteurized at the drying plant, prior to
drying, at not less than one hundred seventy-five degrees Fahrenheit for at
least twenty-five seconds. (E) All buttermilk or cream from which
the buttermilk is derived shall be pasteurized prior to
condensing. (F) All cheese whey or milk from which
the cheese whey is derived shall be pasteurized prior to
condensing. (G) The milk or cream shall be
pasteurized at the plant where the milk or cream is processed into
butter. (H) The pasteurization of cream for
plastic or frozen cream shall be pasteurized at the plant where the milk or
cream is processed. The temperature for the vat pasteurization method shall be
not less than one hundred seventy degrees Fahrenheit for at least thirty
minutes. Pasteurization by the high-temperature, short-time (HTST) method shall
be at a temperature of not less than one hundred ninety degrees Fahrenheit for
at least fifteen seconds or by any other temperature and holding time which
will assure adequate pasteurization and comparable keeping quality
characteristics. (I) After the HTST unit has been tested
according to appendix I of the PMO. The public health controls shall be sealed
at the correct setting by the director to assure pasteurization. The HTST
pasteurizer shall be tested initially upon installation, at least each six
months, and whenever any alteration or replacement is made which affects the
proper operation of the pasteurizer. When direct steam pasteurizers are used,
the steam, prior to entering the product, shall be conducted through a steam
strainer and steam purifier equipped with a steam trap and only steam meeting
the requirements for culinary steam shall be used. (J) Sterilization or the complete
destruction of all living organisms is performed in one of the following
methods: (1) The complete
in-container method, by heating the container and contents to a range of two
hundred twelve degrees Fahrenheit to two hundred eighty degrees Fahrenheit for
a time sufficient to destroy all living organisms; (2) By a continuous flow
high-heat, short-time (HHST) method at two hundred eighty degrees Fahrenheit or
above for a time sufficient to destroy all living organisms, then packaged
aseptically; or (3) The product is
initially sterilized according to continuous flow HHST method as stated in
paragraph (B) of this rule, then packaged and given further heat treatment to
complete the sterilization process. (K) Cooking. (1) Each batch of cheese
within the cooker, including the optional ingredients, shall be thoroughly
commingled and the contents shall be cooked at a temperature of not less than
one hundred fifty-eight degrees Fahrenheit and held at that temperature for at
least thirty seconds. (2) Cheese particles or
ingredients shall not be added after the cooker batch of cheese has reached the
final heating temperature. After holding for the required period of time, the
hot cheese shall be emptied from the cooker as quickly as
possible. (3) Cookers shall be of
the steam jacketed or direct steam type. Cookers shall be constructed of
stainless steel or other equally corrosion-resistant material. All product
contact surfaces shall be readily accessible for cleaning. (4) Each cooker shall be
equipped with an indicating thermometer, a temperature recording device, and be
tested initially upon installation, at least each six months, and whenever any
alteration or replacement is made which affects the proper operation of the
cooker. (5) Steam check valves on
direct steam type cookers shall be mounted flush with the cooker wall, be
constructed of stainless steel and designed to prevent the backup of product
into the steam line, or the steam line shall be constructed of stainless steel
pipes and fittings which can be readily cleaned. If direct steam is applied to
the product, only culinary steam shall be used.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-27 | Cleaning and sanitizing treatment.
Effective:
February 21, 2016
(A) Equipment and utensils: (1) Equipment, sanitary
piping and utensils used in receiving, storing, and processing of the milk and
manufacturing and handling of the product shall be maintained in a sanitary
condition. Sanitary seal assemblies shall be removable on all agitators, pumps
and vats, and shall be inspected at regular intervals and shall be kept clean.
Unless other provisions are recommended in the following supplemental sections,
all equipment not designed for CIP cleaning shall be disassembled after each
day's use for thorough cleaning. Dairy cleaners, detergents, wetting
agents, sanitizing agents or other similar materials, which will not
contaminate or adversely affect the products shall be used. Steel wool or metal
sponges shall not be used in the cleaning of any dairy equipment or utensils.
All product contact surfaces shall be subjected to an effective sanitizing
treatment immediately prior to use, except where dry cleaning is permitted.
Utensils and portable equipment used in processing and manufacturing operations
shall be stored above the floor in clean, dry locations and in a self-draining
position on racks constructed of impervious, corrosion-resistant
material. (2) CIP cleaning,
including spray ball systems, shall be used only on equipment and pipeline
systems which have been designed and engineered for that purpose. When such
cleaning is used, careful attention shall be given to the proper procedures to
assure satisfactory cleaning. All CIP installations and cleaning procedures
shall be in accordance with 3-A suggested methods for the installation and
cleaning of clean-in-place sanitary milk pipelines for milk and dairy products.
The established cleaning procedure shall be posted or made available to
employees and followed. Following the circulation of the cleaning solution, the
equipment and lines shall be thoroughly rinsed with lukewarm water and
inspected for effectiveness of cleaning. All caps, plugs, special fittings,
valve seats, cross ends, pumps, plates, and tee ends shall be opened or removed
and brushed clean. Product contact surfaces shall be sanitized immediately
prior to beginning the flow of product. (B) A covered or enclosed wash dock and
cleaning and sanitizing facilities shall be available at all plants that
receive or ship milk in bulk milk transport tanks. Bulk milk transport tanks,
sanitary piping, fittings, and pumps shall be cleaned and sanitized at least
once each day after use. If they are not to be used immediately after emptying,
then they shall be washed promptly after use and sanitized immediately before
use. Each bulk milk transport tank shall be identified by a tag attached to the
outlet valve after cleaning and sanitizing. The tag shall bear the plant name
and specific location where cleaned, date and time of cleaning and sanitizing,
the name of the person who cleaned the tank and the name of the person who
sanitized the tank. The tag shall remain in place until removed at the location
where the bulk milk tank transport truck is next received and kept on file for
fifteen days. Tagging is not required in situations where the bulk milk
transport tank truck is received at only one milk plant where responsibility
for cleaning and sanitizing can be definitely established without
tagging. (C) All product contact surfaces of all
multi-use containers, utensils, and equipment used in the transportation,
processing, handling and storage shall be cleaned and sanitized after each
production run. Storage tanks shall be emptied at least once every ninety-six
hours after filling. (D) Dryers, conveyor, sifters, and
storage bins shall be cleaned as often as necessary to maintain such equipment
in a clean and sanitary condition. The cleaning procedure, whether wet or dry,
and the frequency of cleaning shall be based upon observation of actual
operating results and conditions.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-28 | Packaging and general information.
Effective:
February 21, 2016
(A) The size, style, and type of
packaging containers used for dairy products shall be commercially acceptable
and acceptable to the director. The packaging containers and materials shall
satisfactorily cover and protect the quality of the contents under normal
conditions of handling during storage and shipment. The weight and shape within
each size or style shall be as uniform as is possible. (B) Packaging materials for dairy
products shall provide sufficiently low permeability to air and vapor to
prevent the formation of mold growth and surface oxidation. Packaging materials
shall be practically free of bacterial contamination. In addition, the outer
package wrapper should be resistant to punctures, tearing, cracking, or
breaking under normal conditions of handling, shipping, and storage. When
special-type packaging is used the instructions of the manufacturer shall be
followed closely as to application and methods of closure. (C) Caps or covers which extend over the
lip of the container shall be used on all cups or tubs containing two pounds or
less to protect the product from contamination during subsequent
handling. (D) Liners and wrappers. Supplies of
parchment liners, wrappers, and other packaging material shall be protected
against dust, mold, and other possible contamination. (1) Prior to use,
parchment liners for bulk butter packages shall be completely immersed in a
boiling salt solution in a suitable container constructed of stainless steel or
other equally noncorrosive material. The liners shall be maintained in the
solution for not less than thirty minutes. The solution should consist of at
least fifteen pounds of salt for every eighty-five pounds of water and shall be
strengthened or changed as frequently as necessary to keep the solution at full
strength and in good condition. (2) Other liners, such as
polyethylene plastic, shall be treated or handled in a manner to prevent
contamination of the liner prior to filling. (E) Packaging, cutting, and repackaging
of all dairy products shall be conducted under rigid sanitary conditions. The
atmosphere of the packaging rooms shall have an atmosphere relatively free from
mold (not exceeding ten mold colonies per cubic foot of air) and be practically
free from bacterial contamination. Methods for determining the level of
contamination shall be as prescribed by the latest edition of standard
methods. (F) An area shall be provided for filling
bulk bins, drums, bags, or other bulk containers and shall be constructed in
accordance with rules 901:11-2-20 and 901:11-2-22 of the Administrative Code.
The number of control panels and switch boxes in this area shall be kept to a
minimum. Control panels shall be mounted a sufficient distance from the walls
to facilitate cleaning or shall be mounted in the wall and provided with
tight-fitting removable doors to facilitate cleaning. An adequate dust
collection system shall be provided at the point of packaging to minimize the
accumulation of product dust within the packaging area and, where needed, a
dust collector shall be provided and properly maintained to keep roofs and
outside areas free of dry product. Only packaging materials that are used
within one day may be kept in the packaging area. These materials shall be kept
off the floor. Unnecessary fixtures, equipment, or inaccessible areas which may
collect dust and harbor insects, shall not be allowed in the packaging
area. (G) An area shall be provided for the
transfer of bulk dry dairy products from bags or drums to the hoppers and
conveyors which are connected to the fillers. This area shall meet the same
requirements for construction and facilities as the bulk packaging operation.
Areas and facilities provided for the transfer of dry dairy products from
portable bulk bins will be acceptable if gasketed surfaces or direct
connections are used that significantly eliminate the escape of product into
the area. (H) Packages or containers used for the
packaging of nonfat dry milk or other dry milk products shall be any clean,
sound, commercially accepted container or packaging material that is acceptable
to the director. Those packages or containers that satisfactorily protect the
contents through shipment, without significant impairment of quality with
respect to flavor, wholesomeness, or moisture content under the normal
conditions of handling shall be used. In no instance will containers which have
previously been used for nonfood items or food which would be deleterious to
the dairy product be allowed to be used for the bulk handling of dairy
products. (I) Containers to be filled shall be
protected at all times from possible contamination. Containers, which are to be
lined, shall not be prepared more than one hour in advance of filling. Every
precaution shall be taken during the filling operation to minimize product dust
and spillage. When necessary, a mechanical shaker shall be provided. The
tapping of containers shall be prohibited. The containers shall be closed
immediately after filling and the exteriors shall be vacuumed or brushed when
necessary to render them practically free of product particles before transfer
from the filling room to the palleting or dry storage areas. (J) The entire repackaging operation
shall be conducted in a sanitary manner with all precautions taken to prevent
contamination and to minimize dust. All exterior surfaces of individual
containers shall be practically free of product before over wrapping or packing
in shipping containers. The floor shall be kept free of dust accumulation,
waste, cartons, liners, or other refuse. Conveyors, packaging, and carton
making equipment shall be vacuumed frequently during the operating day to
prevent the accumulation of dust. No bottles or glass materials of any kind
shall be permitted in the repackaging or hopper room. The inlet openings of all
hoppers and bins shall be of minimum size, screened and placed considerably
above the floor level. The room and all packaging equipment shall be cleaned as
often as necessary to maintain a sanitary operation. Close attention shall be
given to specific points of equipment where residues of the dry product may
accumulate. A thorough cleanup including windows, doors, walls, light fixtures,
and ledges, shall be performed as frequently as necessary to maintain a high
level of cleanliness and sanitation. All waste dry dairy products including the
remaining product at the fillers shall be properly identified and disposed of
as animal feed. (K) All supplies shall be placed on
dunnage or pallets and arranged in an orderly manner for accessibility and
cleaning of the room. Supplies shall be kept enclosed in their original
packaging material until used. After removal of supplies from the original
containers, the supplies shall be kept in enclosed metal cabinets, bins, or on
shelving and if not enclosed shall be protected from powder and dust or other
contamination. The room shall be vacuumed as often as necessary and shall be
kept clean and orderly. (L) Churn areas, in addition to proper
construction and sanitation, shall be equipped so that the air is kept free
from objectionable odors and vapors and extreme temperatures by means of
adequate ventilation and exhaust systems or air conditioning and heating
facilities. (M) Areas used for packaging print or
bulk butter and related products shall, in addition to proper construction and
sanitation, have an atmosphere relatively free from mold (not exceeding ten
mold colonies per cubic foot of air), dust, or other airborne
contamination. (N) When filling bulk butter containers,
the lined butter containers shall be protected from possible contamination
prior to filling. (O) If cheese is to be paraffined, a
drying room of adequate size shall be provided to accommodate the maximum
production of cheese during the flush period. Adequate shelving and air
circulation shall be provided for proper drying. Suitable temperature and
humidity control facilities shall be provided. (P) For rind cheese, a separate room or
compartment shall be provided for paraffining and boxing the cheese. The room
or compartment shall be of adequate size and the temperature shall be
maintained near the temperature of the drying room to avoid sweating of the
cheese prior to paraffining. (Q) For rindless blocks, a suitable space
shall be provided for proper wrapping and boxing of the cheese. The area shall
be free from dust, condensation, have an atmosphere relatively free from mold
(not exceeding ten mold colonies per cubic foot of air) or other conditions
which may contaminate the surface of the cheese or contribute to an
unsatisfactory packaging of the cheese. (R) Coolers or curing rooms where cheese
is held for curing or storage shall be clean and maintained at the proper
uniform temperature and humidity to adequately protect the cheese. Proper
circulation of air shall be maintained at all times. The rooms shall be free
from rodents, insects, and pests. The shelves shall be kept clean and
dry. (S) When small packages of cheese are cut
and wrapped, an area shall be provided for the cleaning, preparation, cutting
and wrapping operation. (T) Packaging rindless cheese or cutting
and repackaging all styles of bulk cheese shall be conducted under rigid
sanitary conditions. The atmosphere of the packaging rooms and the equipment
and packaging material shall have an atmosphere relatively free from mold (not
exceeding ten mold colonies per cubic foot of air) and be practically free from
bacterial contamination.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-29 | Storage of finished products.
Effective:
February 21, 2016
(A) All fluid processed product for bulk
shipment shall be stored and maintained at a temperature of fifty degrees
Fahrenheit. This does not preclude holding milk or whey at higher temperatures
for a period of time, where applicable to particular manufacturing or
processing practices. (B) Storage rooms for the dry storage of
product shall be adequate in size, clean, orderly, free from rodents, insects,
have an atmosphere relatively free from mold (not exceeding ten mold colonies
per cubic foot of air) and maintained in good repair. Storage rooms shall be
provided with natural or artificial light, well distributed with at least five
foot-candles of light and have sufficient air space and air circulation to
prevent condensation and excessive odors. The ceilings, walls, beams, and
floors shall be free from structural defects and inaccessible areas which may
harbor insects. The dry storage of product shall be stored an adequate distance
from the wall in aisles, rows, or sections and lots, in such a manner as to be
orderly and easily accessible for inspection. Care shall be taken in the
storage of any non-dairy products in the same room, in order to prevent
contamination or damage to the dairy product from mold, odors, vermin or
insects. Control of humidity and temperature shall be maintained at all times,
consistent with good manufacturing practices, to prevent conditions detrimental
to the product and container. (C) Refrigerated storage of finished
product shall be placed on shelves, dunnage, or pallets and properly
identified. All products shall be kept under refrigeration at temperatures of
forty degrees Fahrenheit or lower after packaging and until ready for
distribution or shipment except products that are cured. After curing, the
products shall be kept refrigerated as stated above. The product shall not be
exposed to any substance from which it might absorb any odors or be
contaminated by drippage or condensation. (D) Plastic cream or frozen cream
intended for storage shall be placed in quick freezer rooms immediately after
packaging, for rapid and complete freezing within twenty-four hours. The
packages shall be stacked or spaced in such a manner that air can freely
circulate between and around the packages. The rooms shall be maintained at
minus ten degrees Fahrenheit or lower and shall be equipped with high-velocity
air circulation for rapid freezing. After the products have been completely
frozen, they may be transferred to a freezer storage room for further
storage. (E) The freezer storage room shall be
maintained at a temperature of zero degree Fahrenheit or lower. Adequate air
circulation is desirable. (F) Surge tanks or balance tanks if used
between the evaporators and the dryer shall be used to hold only the minimum
amount of condensed product necessary for a uniform flow to the dryers. Such
tanks holding product at temperatures below one hundred fifty degrees
Fahrenheit shall be completely emptied and washed after each four hours of
operation or less. Alternate tanks shall be provided to permit continuous
operation during washing of tanks.
Last updated February 6, 2024 at 9:59 AM
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Rule 901:11-2-30 | Drying.
Effective:
February 21, 2016
Each dryer should be operated at not more than the
manufacturer's rated capacity for the highest quality dry product and
consistent with the most efficient operation. This does not preclude the
remodeling or redesigning of dryers after installation or after properly
engineering. The dry products shall be removed from the drying chamber
continuously during the drying process.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-31 | Cooling dry products.
Effective:
February 21, 2016
Prior to packaging and immediately following
removal from the drying chamber, the dry product shall be cooled to a
temperature not to exceed one hundred twenty degrees Fahrenheit.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-32 | Requirements for instant nonfat dry milk.
Effective:
February 21, 2016
(A) All instant nonfat dry milk offered
for sale shall be sampled and tested by the director at least once each month
for the purpose of assuring that the product meets the requirements of
paragraph (B) of rule 901:11-2-32 of the Administrative Code. In addition the
dry milk plant shall have each sublot of approximately four-thousand pounds
tested and analyzed prior to being packaged or offered for sale. Product not
meeting the requirements of paragraph (B) of rule 901:11-2-32 of the
Administrative Code shall not be offered as extra grade. (B) Requirements for extra grade instant
nonfat dry milk: (1) The flavor and odor
shall be sweet, pleasing, and desirable but may possess the following flavors
to a slight degree: chalky, cooked, feed, and flat; (2) The physical
appearance shall possess a uniform white to light cream natural color; shall be
reasonably free-flowing, and shall be free from lumps except those that readily
break up with very slight pressure; (3) The standard plate
count shall not exceed thirty thousand per gram; (4) The coliform count
shall not exceed ten per gram; (5) The milkfat shall not
exceed 1.25 per cent; (6) The moisture shall
not exceed 4.5 per cent; (7) Scorched particles
shall not exceed fifteen mg.; (8) The solubility index
shall not exceed one mL.; (9) The titratable
acidity shall not exceed 0.15 per cent; (10) The dispersibility
shall not be less than eighty-five per cent by the modified Moats-Dabbah
method; and (11) The direct
microscopic clump count shall not exceed seventy-five million per
gram.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-33 | Coolers and freezers.
Effective:
February 21, 2016
The coolers and freezers shall be equipped to
maintain proper temperature and humidity conditions, which are consistent with
good manufacturing practices for the applicable product, in order to protect
the quality and condition of the products during storage or during tempering
prior to further processing. Coolers and freezers shall be kept clean, orderly,
free from insects, rodents, and have an atmosphere relatively free from mold,
(not exceeding ten mold colonies per cubic foot of air) and shall be maintained
in good repair. They shall be adequately lighted and proper circulation of air
shall be maintained at all times. The floors, walls, and ceilings shall be of
construction that permits thorough cleaning.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-34 | Starter room.
Effective:
February 21, 2016
Starter rooms or areas shall be properly equipped
and maintained for the propagation and handling of starter cultures. All
necessary precautions shall be taken to prevent contamination of the starter
cultures, room, equipment, and air within the starter room.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-35 | Make room.
Effective:
February 21, 2016
The room in which the cheese is manufactured shall
be of adequate size and be provided with adequate ventilation. The vats shall
be adequately spaced to permit movement around the vats and presses for proper
cleaning and satisfactory working conditions.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-36 | General construction, repair, and installation.
Effective:
February 21, 2016
All equipment and utensils necessary for the
manufacture of cheese and related products shall meet the same general
requirements as outlined in rule 901:11-2-22 of the Administrative Code. In
addition, for certain other equipment the following requirements shall be
met: (A) Bulk starter vats shall be
constructed of stainless steel or equally corrosion-resistant metal and shall
be in good repair, equipped with tight-fitting lids, and have adequate
temperature controls such as valves, indicating and/or recording thermometers.
New vats shall be constructed in accordance with the applicable 3-A sanitary
standards. (B) Cheese vats: (1) The vats used for
making cheese shall be of metal construction with adequate jacket capacity for
uniform heating. The inner liner shall be constructed of at least sixteen gage
stainless steel or other equally corrosion-resistant metal, including copper,
properly pitched from side to center and from rear to front for adequate
drainage. The liner shall be smooth and free from excessive dents or creases.
The liner shall extend over the edge of the outer jacket. The outer jacket,
when metal, shall be constructed of stainless steel or other metal which can be
kept clean and sanitary. The junction of the liner and outer jackets shall be
constructed to prevent milk or cheese from entering the inner
jacket. (2) The vat shall be
equipped with a suitable sanitary outlet valve. Effective valves shall be
provided and properly maintained to control the application of heat to the
vat. (C) Mechanical agitators shall be of
sanitary construction. The carriage and track shall be constructed to prevent
the dropping of dirt or grease into the vat. Metal blades, forks, or stirrers
shall be constructed of stainless steel and of material approved in the 3-A
sanitary standards for plastic and rubber or rubberlike materials and shall be
free from rough or sharp edges which might scratch the equipment or create
metal particles or shavings. (D) Curd mill, knives, hand rakes,
shovels, paddles, strainers, and miscellaneous equipment shall be constructed
of stainless steel or of material approved in the 3-A sanitary standards for
plastic and rubberlike material. The product contact surfaces of the curd mill
shall be stainless steel. All equipment shall be constructed in a manner that
they can be kept clean. The wires in the curd knives shall be stainless steel,
kept tight and replaced when necessary. (E) Hoops, forms, and followers shall be
constructed of stainless steel or heavy tinned steel or of material approved in
the 3-A sanitary standards for plastic and rubberlike material. If tinned, they
shall be kept tinned and free from corrossion. All hoops, forms, and followers
shall be kept in good repair. Drums or other special forms used to press and
store cheese shall be clean and sanitary. (F) The cheese press shall be constructed
of stainless steel, approved materials as listed in 3-A sanitary standards, or
of other materials acceptable to the director. All welded joints and all
surfaces, seams, and openings shall be readily cleanable. Press cloths shall be
maintained in good repair and in a sanitary condition. Single-service press
cloths shall be used only once. (G) The rindless cheese press used to
heat seal the wrapper applied to rindless cheese shall have square interior
corners, reasonably smooth interior surfaces and controls that provide uniform
pressure and heat equally to all surfaces. (H) The metal paraffin tanks shall be
adequate in size, be equipped with wood to support the cheese, have heat
controls, and an indicating thermometer. The cheese wax shall be kept
clean.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-37 | Whey disposal.
Effective:
February 21, 2016
(A) Adequate sanitary facilities shall be
provided for the disposal of whey. Necessary precautions shall be taken to
minimize flies, insects, and development of objectionable odors. (B) Whey or whey products intended for
human consumption shall at all times be handled in a sanitary manner in
accordance with the procedures listed in Chapter 901:11-2 of the Administrative
Code as specified for handling milk and dairy products.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-38 | Operations and operating procedures.
Effective:
February 21, 2016
(A) The natural cheese shall be cleaned
free of all nonedible portions including paraffin, bandages, rind surface mold,
unclean areas, or any other part which is unwholesome or
unappetizing. (B) Forming containers either lined or
unlined shall be assembled and stored in a sanitary manner to prevent
contamination. The handling of containers shall be done with extreme care and
in a sanitary manner. Preforming and assembling of pouch liners and containers
shall be kept to a minimum. The supply shall be rotated to limit exposure to
possible contamination prior to filling. (C) Container filling. (1) Hot fluid cheese from
the cookers may be held in hot wells or hoppers to assure a constant and even
supply of processed cheese to the filler or slice former. (2) Filler valves shall
effectively measure the desired amount of product into the pouch or container
in a sanitary manner and shall cut off sharply without drip or drag of cheese
across the opening. (3) An effective system
shall be used to maintain accurate and precise weight control. (4) Damaged or
unsatisfactory packages shall be removed from production. Cheese may be
salvaged into sanitary containers and added back to cookers. (5) The filling of small
containers with product shall be done in a sanitary manner. The containers
shall not contaminate or detract from the quality of the product in any
way. (6) After filling, the
container shall be hermetically sealed. Bulk containers for unsterilized
product shall be suitable and adequate to protect the product in storage or
transit. (7) The bulk container
(including bulk tankers) shall be cleaned and sanitized before filling, and
filled and closed in a sanitary manner. (D) When filling aseptic product, the
previously sterilized product shall be filled under conditions which prevent
contamination of the product by living organisms or spores. Prior to being
filled, the containers shall be sterilized and maintained in a sterile
condition. The containers shall be sealed in a manner that prevents
contamination of the product.
Last updated February 6, 2024 at 10:00 AM
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Rule 901:11-2-39 | Plant records.
Effective:
February 21, 2016
Adequate plant records shall be maintained of all
required tests on all raw milk receipts. Such records shall be available for
examination at all reasonable times by the director. The following records
shall be maintained for examination at the plant or receiving station where
performed: (A) Rejections of raw milk identifying
the source and reason for rejection shall be retained for two
months; (B) Pasteurization recorder charts shall
be retained for six months; (C) CIP recorder charts shall be retained
for six months; (D) Production records showing date,
quantity, and type of product produced shall be retained for twelve months;
and (E) Milk receipt log or record showing
weigher, sampler identity, route identity, patron number, name of producer,
milk temperature on receipt and milk weight shall be retained for two
months.
Last updated February 6, 2024 at 10:01 AM
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Rule 901:11-2-40 | Insect and rodent control program.
Effective:
February 21, 2016
In addition to any commercial pest control service,
a designated employee shall be made responsible for the performance of a
regularly scheduled insect and rodent control program. Poisonous substances,
insecticides, and rodenticides shall be properly labeled and handled, stored,
and used in such a manner that will not create a health hazard.
Last updated February 6, 2024 at 10:01 AM
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Rule 901:11-2-41 | Clothing and shoe covers.
Effective:
February 21, 2016
Clean clothing and shoe covers shall be provided
exclusively for the purpose of cleaning the interior of the drier when it is
necessary to enter the drier to perform the cleaning operation.
Last updated February 6, 2024 at 10:01 AM
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Rule 901:11-2-42 | Labeling.
Effective:
February 21, 2016
(A) All retail packaged product shall be
legibly labeled in accordance with the applicable requirements of the Federal
Food Drug and Cosmetic Act (2004), the Nutrition Labeling and Education Act
(1990), regulations developed there under, and with: (1) The name of the
product; (2) The net
weight; (3) The name and address
of the packer, manufacturer, or distributor; and, (4) Any other
identification that may be required by the director. (B) All commercial bulk packages
containing dairy products manufactured under the provisions of rules
901:11-2-01 to 901:11-2-44 of the Administrative Code shall be adequately and
legibly labeled with: (1) The name of the
product; (2) The net
weight; (3) The production code
or date of manufacture, vat or lot number; (4) The federal
information processing standards number or the name and address of the
manufacturer; and (5) Any other
identification that may be required by the director. (C) Packages of plastic or frozen cream
shall be labeled in accordance with paragraph (B) of this rule and shall be
marked with the per cent of milkfat.
Last updated February 6, 2024 at 10:01 AM
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Rule 901:11-2-43 | Personnel cleanliness.
Effective:
February 21, 2016
All 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
use of tobacco in any form shall be prohibited in each room and compartment
where any milk, dairy product, or supplies are prepared, stored, or otherwise
handled. Clean white or light-colored washable outer garments and caps (paper
caps or hair nets are acceptable) shall be worn by all persons in receiving,
testing, processing, manufacturing, packaging rooms, or by persons handling
dairy products.
Last updated February 6, 2024 at 10:01 AM
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Rule 901:11-2-44 | Personnel health.
Effective:
February 21, 2016
No person afflicted with a communicable disease
shall be permitted in any room or compartment where milk and dairy products are
prepared, manufactured, or otherwise handled. No person who has a discharging
or infected wound, sore or lesion on hands, arms, or other exposed portion of
the body shall work in any dairy processing rooms or in any capacity resulting
in contact with milk or dairy products. Milk processors who have received
reports, under this rule, from employees who have handled milk, dairy products
or associated product contact surfaces shall immediately report these
conditions to the director. The director may require any or all of the
measurers listed in section thirteen and section fourteen of the PMO.
Last updated February 6, 2024 at 10:01 AM
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