GRADE “A” PASTEURIZED MILK ORDINANCE (GRADE “A” PMO)--2017 REVISION

Question 1

What does the Grade “A” PMO 2017 edition contains?

Answer 1

This edition of the Ordinance contains sanitary standards for Grade “A” raw milk for
pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after
packaging and Grade “A” milk and/or milk products

Question 2

Two other regulations related to PMO

Answer 2

Title 21, Code of Federal Regulations (CFR) and/or the Federal Food, Drug, and Cosmetic Act (FFD&CA) as
amended

Question 3

Definition of ABNORMALITIES OF MILK:

Answer 3

The following types of lacteal secretions are not suitable
for sale for Grade “A” purposes.
A-1. Abnormal Milk: Milk that is visibly changed in color, odor and/or texture.
A-2. Undesirable Milk: Milk that, prior to the milking of the animal, is expected to be
unsuitable for sale, such as milk containing colostrum.
A-3. Contaminated Milk: Milk that is unsaleable or unfit for human consumption following
treatment of the animal with veterinary products, i.e. antibiotics, which have withhold
requirements, or treatment with medicines or insecticides not approved for use on dairy
animals by FDA or the Environmental Protection Agency (EPA).

Question 4

Definition of

Answer 4

ASEPTIC PROCESSING AND PACKAGING: The term “Aseptic Processing and
Packaging”, when used to describe a milk and/or milk product, means that the milk and/or milk
product has been subjected to sufficient heat processing and packaged in a hermetically sealed
container, to conform to the applicable requirements of 21 CFR Parts 108, 113 and 117 and to
maintain the commercial sterility of the milk and/or milk product under normal non-refrigerated
conditions.

Question 5

Definition of

Answer 5

ASEPTIC PROCESSING AND PACKAGING SYSTEM (APPS): For the purposes of
this Ordinance, the Aseptic Processing and Packaging System (APPS) in a milk plant is
comprised of the processes and equipment used to process and package aseptic Grade “A” lowacid milk and/or milk products. The Aseptic Processing and Packaging System (APPS) shall be
regulated in accordance with the applicable requirements of 21 CFR Parts 108, 113 and 117.
The Aseptic Processing and Packaging System (APPS) shall begin at the constant level tank and
end at the discharge of the packaging machine, provided that the Process Authority may provide
written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the product

Question 6

Definition of

Answer 6

E. BULK MILK HAULER/SAMPER: A person responsible for the collection of official
“Universal” samples for regulatory purposes as outlined in Section 6.; and/or Appendix N. of this
Ordinance, including those that are related to reinstatement/clearing samples at dairy farms, if
acceptable to the Regulatory Agency, and may transport raw milk from a dairy farm and/or raw
milk products to or from a milk plant, receiving station or transfer station and has in their
possession a permit from any Regulatory Agency to sample such raw milk and/or raw milk
products. This person is evaluated at least once every twenty-four (24) month period, which
includes the remaining days of the month in which the evaluation is due, by a Sampling
Surveillance Officer (SSO) or a properly delegated Sampling Surveillance Regulatory Agency
Official (dSSO).

Question 7

Definition of

Answer 7

G. BUTTERMILK: Buttermilk is a fluid product resulting from the manufacture of butter from
milk or cream. It contains not less than 8¼ percent of milk solids not fat.
G-1. Grade “A” Dry Buttermilk: Grade “A” dry buttermilk means dry buttermilk, which
complies with the applicable provisions of this Ordinance.
G-2. Grade “A” Dry Buttermilk Products: Grade “A” dry buttermilk products means dry
buttermilk products, which complies with the applicable provisions of this Ordinance.
G-3. Concentrated (Condensed) Buttermilk: Concentrated (condensed) buttermilk is the
product resulting from the removal of a considerable portion of water from buttermilk.
G-4. Grade “A” Concentrated (Condensed) and Dry Buttermilk and Buttermilk
Products: Grade “A” concentrated (condensed) and dry buttermilk and buttermilk products
means concentrated (condensed) or dry buttermilk and buttermilk products, which comply
with the applicable provisions of this Ordinance. The words “concentrated (condensed) and
dry milk products” shall be interpreted to include concentrated (condensed) and dry
buttermilk and buttermilk products.

Question 8

Definition of

Answer 8

L. CONCENTRATED (CONDENSED) MILK: Concentrated (condensed) milk is a fluid
product, unsterilized and unsweetened, resulting from the removal of a considerable portion of
the water from the milk, which when combined with potable water in accordance with
instructions printed on the container label, results in a product conforming with the milkfat and
milk solids not fat levels of milk as defined in this Section.

Question 9

Definition of

Answer 9

L-1. Concentrated (Condensed) Milk Products: Concentrated (condensed) milk products
shall be taken to mean and to include homogenized concentrated (condensed) milk,
concentrated (condensed) skim milk, concentrated (condensed) reduced fat or lowfat milk,
and similar concentrated (condensed) products made from concentrated (condensed) milk or
concentrated (condensed) skim milk, which when combined with potable water in
accordance with instructions printed on the container label, conform with the definitions of
the corresponding milk products in this Section

Question 10

Definition of

Answer 10

L-2. Grade “A” Concentrated (Condensed) Skim Milk: Grade “A” concentrated
(condensed) skim milk means concentrated (condensed) skim milk, which complies with the
applicable provisions of this Ordinance

Question 11

Definition of

Answer 11

M. COOLING POND: A cooling pond is a man-made structure designed for the specific
purpose of cooling cows.

Question 12

Definition of

Answer 12

N. DAIRY FARM: A dairy farm is any place or premises where one (1) or more lactating
animals (cows, goats, sheep, water buffalo, camels or other hooved mammal) are kept for
milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or
offered for sale to a milk plant, receiving station or transfer station. (Refer to the NOTE on page
32.)

Question 13

Definition of

Answer 13

O. DAIRY PLANT SAMPLER: A person responsible for the collection of official samples for
regulatory purposes outlined in Section 6. of this Ordinance. This person is an employee of the
Regulatory Agency and is evaluated at least once every twenty-four (24) month period, which
includes the remaining days of the month in which the evaluation is due, by a Sampling
Surveillance Officer (SSO) or a properly delegated Sampling Surveillance Regulatory Agency
Official (dSSO). Dairy plant samplers that are also Sampling Surveillance Officers (SSOs) or
properly delegated Sampling Surveillance Regulatory Agency Officials (dSSOs) are not required
to be evaluated for sampling collection procedures at least once every twenty-four (24) month
period

Question 14

Definition of

Answer 14

P. EGGNOG OR BOILED CUSTARD: Eggnog or boiled custard is the product defined in 21
CFR 131.170.

Question 15

Definition of

Answer 15

Q. FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic
reaction or response in some individuals. Foods that are considered allergens are defined in the
Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 (Public Law 108-282)
and Section 201(qq) of the Federal Food, Drug and Cosmetic Act (FFD&CA). Information
about Food Allergens may also be found at:
http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.

Question 16

Definition of

Answer 16

S. GOAT MILK: Goat milk is the normal lacteal secretion, practically free of colostrum,
obtained by the complete milking of one (1) or more healthy goats. Goat milk sold in retail
packages shall contain not less than 2½ percent milk fat and not less than 7½ percent milk solids
not fat. Goat milk shall be produced according to the sanitary standards of this Ordinance.

Question 17

Definition of

Answer 17

T-8. CRITICAL LISTING ELEMENT (CLE): An item on FORM FDA 2359M-MILK
PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT
identified with a double star (**). The marking of a CLE by a Milk Sanitation Rating Officer
(SRO) or FDA auditor, indicates a condition that constitutes a major dysfunction likely to
result in a potential compromise to milk and/or milk product safety, or that violates NCIMS
requirements regarding drug residue testing and/or trace back or raw milk sources, whereby a
listing may be denied or withdrawn.

Question 18

Definition of

Answer 18

U. HOOVED MAMMALS’ MILK: Hooved mammals’ milk is the normal lacteal secretion,
practically free of colostrum, obtained by the complete milking of one (1) or more healthy
hooved mammals. Hooved mammals for the purpose of this Ordinance, include but are not
limited to, the members of the Order Cetartiodactyla, such as: Family Bovidae (cattle, water
buffalo, sheep, goats, yaks, etc.), Family Camelidae (llamas, alpacas, camels, etc.), Family
Cervidae (deer, reindeer, moose, etc.), and Family Equidae (horses, donkeys, etc.). This product
shall be produced according to the sanitary standards of this Ordinance. (Refer to the NOTE on
page 32.)

Question 19

Definition of

Answer 19

AA. LOW-ACID ASEPTIC AND RETORT MILK AND/OR MILK PRODUCTS: Milk
and/or milk products having a water activity (aw) greater than 0.85 and a finished equilibrium pH
greater than 4.6 and are regulated under the applicable requirements of 21 CFR Parts 108, 113 and 117. Aseptically processed and packaged low-acid milk and/or milk products and retort
processed after packaging low-acid milk and/or milk products are stored under normal nonrefrigerated conditions. Excluded from this definition are low-acid milk and/or milk products
that are labeled for storage under refrigerated conditions

Question 20

Definition of GG. MILK PRODUCTS: Grade “A” Milk and Milk Products include:

Answer 20

1. All milk and milk products with a standard of identity provided for in 21 CFR Part 131,
   excluding 21 CFR 131.120 Sweetened Condensed Milk.
2. Cottage cheese (21 CFR 133.128) and dry curd cottage cheese (21 CFR 131.129)2
   .
3. Whey and whey products as defined in 21 CFR 184.1979, 184.1979a, 184.1979b, 184.1979c,
   and Section 1., Whey Products of this Ordinance.
4. Modified versions of these foods listed above in Items 1 and 2, pursuant to 21 CFR 130.10-
   requirements for foods named by use of a nutrient content claim and a standardized term.
5. Milk and milk products as defined in Items 1, 2, 3 and 4 above, packaged in combination
   with food(s) not included in this definition that are appropriately labeled with a statement of
   identity to describe the food(s) in final packaged form, e.g., “cottage cheese with pineapple” and
   “fat free milk with plant sterols”.
6. Products not included in Items 1-5 are Grade “A” milk products which have a minimum of
   2.0% milk protein (Total Kjeldahl Nitrogen (TKN) X 6.38) and a minimum of sixty five percent
   (65%) by weight milk, milk product or a combination of milk products.

Question 21

When can non-grade “A” dairy ingredients by utilized in (grade A) milk products

Answer 21

Safe and suitable (as defined in 21 CFR 130.3(d)) non-grade “A” dairy ingredients, can be
utilized in the products defined in Items 1-6 when added to a level needed for a functional or
technical effect, and limited by Good Manufacturing Practices (GMPs) and are either:
a. Prior sanctioned or otherwise approved by FDA, or
b. GRAS (generally recognized as safe), or
c. An approved food additive listed in the CFR

Question 22

Steps to use non-grade “A” dairy ingredients to achieve a functional or technical effect in the finished milk or milk product(s).

Answer 22

Non-grade “A” dairy ingredients may be used after the Regulatory Agency, in
consultation with FDA, has reviewed and accepted information supporting that the use is to
achieve a functional or technical effect in the finished milk or milk product(s). Supporting
information shall be submitted by the milk plant and/or the ingredient manufacturer for review
and approval by the Regulatory Agency and FDA prior to manufacturing and selling the finished
milk or milk product(s). Once the Regulatory Agency, in consultation with FDA, has accepted
the use of a non-grade “A” ingredient to achieve a functional or technical effect in the finished
milk or milk product(s), any formulation or processing changes related to the non-grade “A”
dairy ingredient shall be immediately communicated to the Regulatory Agency, and may result
in the resubmission of supporting data, if it is determined by the Regulatory Agency, in
consultation with FDA, that the change could potentially affect the functional or technical effect
of the finished milk or milk product(s).
The supporting information shall include but is not limited to:
a. A statement of the proposed usage of a non-grade “A” dairy ingredient, including the
expected functional and/or technical effect(s) in the finished milk or milk product(s) and
justification of why this cannot be performed by a currently available Grade “A” dairy
ingredient;
b. Non-grade “A” dairy ingredient description, composition and required usage level;
c. Finished milk or milk product(s) description including the current, if applicable, and
proposed formula(s) including the current, if applicable, and proposed labeling information
(e.g. statement of identity, ingredient declaration) and:
d. Applicable and recognized analytical measurements and/or organoleptic observations and
evaluations that objectively demonstrate that the non-grade “A” dairy ingredient provides a
specific functional and/or technical effect(s) that could not be achieved when using a
currently available Grade “A” dairy ingredient(s) when used at similar concentrations and
with similar proximates, i.e. protein, fat, ash, lactose, moisture, etc

Question 23

Definition of

Answer 23

OO. PASTEURIZATION: The terms “pasteurization”, “pasteurized” and similar terms shall
mean the process of heating every particle of milk or milk product, in properly designed and
operated equipment, to one (1) of the temperatures given in the following chart and held
continuously at or above that temperature for at least the corresponding specified time: [[PAGE 33]]
*If the fat content of the milk product is ten percent (10%) or greater, or a total solids of 18% or
greater, or if it contains added sweeteners, the specified temperature shall be increased by 3ºC
(5ºF)

Question 24

Definition of PASTEURIZATION of eggnog

Answer 24

[[PAGE 33]]

Question 25

Definition of

Answer 25

SS. RATING AGENCY: A Rating Agency shall mean a State Agency, which certifies
interstate milk shippers (BTUs, receiving stations, transfer stations, and milk plants) as having
attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS
List. The ratings are based on compliance with the requirements of the Grade “A” PMO and
were conducted in accordance with the procedures set forth in the Methods of Making Sanitation
Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and
Closures for Milk and/or Milk Products Manufacturers (MMSR). Ratings are conducted by FDA
certified Milk Sanitation Rating Officers (SROs). They also certify single-service containers and
closures for milk and/or milk products manufacturers for inclusion on the IMS List. The
certifications are based on compliance with the requirements of the Grade “A” PMO and were
conducted in accordance with the procedures set forth in the Methods of Making Sanitation
Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and
Closures for Milk and/or Milk Products Manufacturers (MMSR). The definition of a Rating
Agency also includes a Third Party Certifier (TPC) that conducts ratings and certifications of
Milk Companies (MCs) located outside the geographic boundaries of NCIMS Member States
that desire to produce and process Grade “A” milk and/or milk products for importation into the
United States.

Question 26

Definition of

Answer 26

UU. RECONSTITUTED OR RECOMBINED MILK AND/OR MILK PRODUCTS:
Reconstituted or recombined milk and/or milk products shall mean milk or milk products defined
in this Section which result from reconstituting or recombining of milk constituents with potable
water when appropriate

Question 27

Definition of

Answer 27

VV. REGULATORY AGENCY: The Regulatory Agency shall mean the … of the …1 or their
authorized representative. The term, “Regulatory Agency”, whenever it appears in the Ordinance
shall mean the appropriate agency, including a Third Party Certifier (TPC) authorized under the
NCIMS voluntary International Certification Program (ICP), having jurisdiction and control over
the matters embraced within this Ordinance

Question 28

Definition of

Answer 28

CCC. TIME/TEMPERATURE CONTROL FOR SAFETY OF MILK AND/OR MILK
PRODUCTS: Milk and/or milk products that require time/temperature control for safety (TCS)
to limit pathogenic microorganism growth or toxin formation includes:
1. Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or
2. Except as specified in 3 below of this definition, a milk or milk product that because of the
interaction of it’s aw and pH values is designated as Product Assessment (PA) as required in
either Table A or B as follows: either Table A or B as follows: [[PAGE 36]]]]]

Question 29

Definition of

Answer 29

EEE. ULTRA-PASTEURIZATION (UP): The term “Ultra-Pasteurization”, when used to
describe a milk and/or milk product, means that such milk and/or milk product shall have been
thermally processed at or above 138°C (280°F) for at least two (2) seconds, either before or after
packaging, so as to produce a milk and/or milk product, which has an extended shelf-life under
refrigerated conditions. (Refer to 21 CFR 131.3.)

Question 30

Regulations defining the Labeling of bottles, containers and packages containing milk or milk products

Answer 30

FFD&CA,
the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed there
under, the CFR, and in addition, shall comply with applicable requirements of this Section (PMO)